Fluid collection assembly comprising at least one of polyurethane foam or polyethylene foam

Abstract

An example fluid collection assembly includes a fluid impermeable barrier. The fluid impermeable barrier defines at least a chamber, at least one opening, and a fluid outlet. The fluid collection assembly also includes at least one porous material disposed in the chamber. The porous material includes at least one of polyurethane foam or polyethylene foam. In one example, a porous material includes an outer layer disposed on an inner layer, where the outer layer includes polyurethane foam and the inner layer includes polyethylene foam.

Description

Background Art

[0001] A person or animal may have limited or impaired mobility, making the typical urination process challenging or impossible. For example, a person may experience or have a disability that affects mobility. A person may have a limited travel condition, such as those experienced by pilots, drivers, and personnel in hazardous areas. In addition, sometimes it is necessary to collect body fluids for monitoring purposes or clinical testing.

[0002] Catheters, such as Foley catheters, can address some of these conditions, such as urinary incontinence. Unfortunately, catheters can be uncomfortable, painful, and can lead to complications, such as infection. Also, sometimes a bedpan is used, which is a container used by bedridden people to relieve themselves. However, bedpans can be prone to discomfort, spillage, and other hygiene issues. Summary of the invention

[0003] Embodiments relate to a fluid collection assembly comprising at least one of a polyurethane foam or a polyethylene foam, a fluid collection system comprising the assembly, and methods of using and forming the assembly. In one embodiment, a fluid collection assembly is disclosed. The fluid collection assembly comprises a fluid-impermeable barrier defining at least a chamber, at least one opening, and a fluid outlet. The fluid collection assembly also comprises at least one porous material disposed in the chamber. The at least one porous material comprises polyurethane foam.

[0004] In one embodiment, a fluid collection assembly is disclosed. The fluid collection assembly includes a fluid-impermeable barrier that defines at least 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. The at least one porous material includes polyethylene foam.

[0005] 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 chamber, at least one opening, and a fluid outlet. The fluid collection assembly also includes at least one porous material disposed in the chamber. The at least one porous material includes at least one of polyurethane foam or polyethylene foam. The fluid collection system also includes a fluid storage container and a vacuum source. The chamber, fluid storage container, and vacuum source of the fluid collection assembly are in fluid communication with each other so that suction provided to the chamber from the vacuum source removes one or more body fluids from the chamber and stores the one or more body fluids in the fluid storage container.

[0006] Features from any disclosed embodiment 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 by considering the following detailed description and accompanying drawings. BRIEF DESCRIPTION OF THE DRAWINGS

[0007] The drawings illustrate several embodiments of the present disclosure, wherein like reference numerals represent the same or similar elements or features in the different views or embodiments shown in the drawings.

[0008] Figure 1A is an isometric view of a fluid collection assembly according to one embodiment.

[0009] Figure 1B and Figure 1C Along Figure 1A Schematic diagram of cross-sections of the fluid collection assembly taken along planes 1B-1B and 1C-1C are shown.

[0010] Figure 2A is a schematic cross-sectional view of a fluid collection assembly according to one embodiment.

[0011] Figure 2B For along Figure 2A A schematic cross-sectional view of the fluid collection assembly taken along plane 2B-2B is shown.

[0012] Figure 3 is a cross-sectional view of a male fluid collection component according to one embodiment.

[0013] Figure 4A is an isometric view of a fluid collection assembly according to one embodiment.

[0014] Figure 4B Schematic diagram of a cross-section of the fluid collection assembly taken along plane 4B-4B.

[0015] Figure 5 is a block diagram of a fluid collection system for fluid collection according to one embodiment. DETAILED DESCRIPTION

[0016] Embodiments relate to a fluid collection assembly comprising at least one of polyurethane foam or polyethylene foam, a fluid collection system comprising the assembly, and methods of using and forming the assembly. An exemplary fluid collection assembly comprises 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. The porous material comprises at least one of polyurethane foam or polyethylene foam. In one example, the porous material comprises an outer layer disposed on an inner layer, wherein the outer layer comprises polyurethane foam and the inner layer comprises polyethylene foam.

[0017] During use, the fluid collection assembly can be placed on the individual so that the opening is placed near the female urethral opening or accommodates the male urethral opening (i.e., penis). The individual can discharge one or more body fluids, such as urine, blood, or sweat. The body fluid can flow through the opening and enter the porous material. The body fluid can be removed from the chamber through the fluid outlet. In one embodiment, suction can be applied to the chamber from a vacuum source to remove the body fluid from the chamber.

[0018] Some traditional fluid collection components include porous materials other than polyurethane foam and / or polyethylene foam. The porous material of this traditional fluid collection component may include a porous film, a gauze arranged on a polyethylene terephthalate or spun nylon fiber core, or a cover sheet arranged on a cross-overlapping nonwoven filter material. However, it has been found that the porous material used in this traditional fluid collection component may be difficult to receive body fluids at first, when the individual using this traditional fluid collection component discharges a large amount of body fluids (such as urination) in a short time, this may cause this traditional fluid collection component to leak. In addition, the porous material of this traditional fluid collection component cannot dry quickly, unless this traditional fluid collection component is replaced relatively frequently (for example, replaced after using at least up to 12 hours, up to 18 hours or up to 24 hours), otherwise it will cause skin destruction. Other traditional fluid collection components do not include porous materials in an attempt to solve these problems associated with traditional fluid collection components including porous materials. However, this traditional fluid collection component that does not include porous materials may be difficult to receive body fluids and prevent body fluids from accumulating on individuals, both of which may cause skin destruction.

[0019] The fluid collection assembly disclosed herein is an improvement over these conventional fluid collection assemblies, at least because the fluid collection assembly includes a porous material containing at least one of polyurethane foam or polyethylene foam. In one example, the polyurethane foam is able to quickly receive body fluids from an individual, even if the individual discharges a large amount of body fluids in a short period of time. The polyurethane foam also feels comfortable against the sensitive skin around the individual's urethral opening (e.g., vaginal area). In one example, the polyethylene foam can promote the movement of body fluids through the chamber of the fluid collection assembly and toward an outlet (e.g., a fluid outlet or an inlet of a conduit disposed by the fluid outlet), which allows the porous material to remain dry. When the porous material includes both polyurethane foam and polyethylene foam, the porous material can quickly receive body fluids, can quickly move body fluids through the chamber, and can be comfortable. In addition, it has been surprisingly found that body fluids received in the polyurethane foam can easily flow from the polyurethane foam to the polyethylene foam, and the polyethylene foam absorbs body fluids from the polyurethane foam, otherwise the body fluids will remain in the polyurethane foam. Due to the characteristics of the porous material disclosed herein, a fluid collection assembly including at least one of polyurethane foam or polyethylene foam can be used for a long time without causing skin damage. For example, the fluid collection components disclosed herein comprising at least one of polyurethane foam or polyethylene foam 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 from about 24 hours to about 36 hours, about 30 hours to about 42 hours, or about 36 hours to about 48 hours.

[0020] Figure 1A is an isometric view of a fluid collection assembly 100 according to one embodiment. Figure 1B and 1C For respectively along Figure 1A Schematic diagram of a cross-sectional view of a fluid collection assembly 100 taken along planes 1B-1B and 1C-1C as shown. The fluid collection assembly is an example of a fluid collection assembly configured to receive body fluids from a female urethral opening. The fluid collection assembly 100 includes a fluid-impermeable barrier 102. The fluid-impermeable barrier 102 defines at least a chamber 104, at least one opening 106, and a fluid outlet 108. The fluid collection assembly 100 also includes at least one porous material 110 disposed in the chamber 104. In one embodiment, as shown, the porous material 110 includes an outer layer 112 extending through the opening 106 and an inner layer 114 supporting the outer layer 112 (i.e., the outer layer 112 is disposed on the inner layer 114). The outer layer 112 may include polyurethane foam and the inner layer 114 may include polyethylene foam, but, as will be discussed in more detail below, one of the outer layer 112 or the inner layer 114 may include a material other than polyurethane foam or polyethylene foam, respectively.

[0021] The fluid-impermeable barrier 102 at least partially defines a chamber 104 (e.g., an interior area) and an opening 106. The fluid-impermeable barrier 102 temporarily stores body fluids in the chamber 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 metal film, natural rubber, other suitable materials, any other fluid-impermeable material disclosed herein, or a combination thereof. Therefore, the fluid-impermeable barrier 102 substantially prevents body fluids from passing through the fluid-impermeable barrier 102. In one example, the fluid-impermeable barrier 102 can be gas-permeable and fluid-impermeable. In these examples, the fluid-impermeable barrier 102 can be formed of a hydrophobic material defining a plurality of pores. At least one or more portions of at least the outer surface of the fluid-impermeable barrier 102 can be formed of a soft and / or smooth material to reduce abrasions.

[0022] The opening 106 provides an entry path for bodily fluid to enter the chamber 104. The opening 106 can be defined by the fluid-impermeable barrier 102, such as by an inner edge of the fluid-impermeable barrier 102. For example, the opening 106 is formed in the fluid-impermeable barrier 102 and extends through the barrier, thereby allowing bodily fluid to enter the chamber 104 from the exterior of the fluid collection assembly 100.

[0023] In some examples, the fluid-impermeable barrier 102 can define a fluid outlet 108 sized to accommodate a conduit 116. At least one conduit 116 can be disposed in the chamber 104 through the fluid outlet 108. The size and shape of the fluid outlet 108 can form an at least substantially fluid-tight seal against the conduit 116 or at least one tube, thereby substantially preventing bodily fluids from escaping from the chamber 104.

[0024] As previously described, the fluid collection assembly 100 includes a porous material 110 disposed in the chamber 104. The porous material 110 may cover at least a portion (e.g., all) of the opening 106. The porous material 110 may include an outer layer 112 and an inner layer 114. The porous material 110 is exposed to the environment outside the chamber 104 through the opening 106.

[0025] As previously mentioned, outer layer 112 may include polyurethane foam. In one embodiment, polyurethane foam may be hydrophilic. The hydrophilicity of polyurethane foam may allow polyurethane foam to quickly absorb body fluid therein, thereby preventing or at least inhibiting the leakage of body fluid caused by a large amount of body fluid discharged in a short period of time. When the contact angle of polyurethane foam with water (the main component of body fluid) is about 0 ° to about 10 °, about 5 ° to about 15 °, about 10 ° to about 20 °, about 15 ° to about 25 °, about 20 ° to about 30 °, about 25 ° to about 35 °, about 30 ° to about 40 °, about 35 ° to about 45 °, about 40 ° to about 50 °, about 45 ° to about 55 °, about 50 ° to about 60 °, about 55 ° to about 65 °, about 60 ° to about 70 °, about 65 ° to about 75 °, about 70 ° to about 80 °, about 75 ° to about 85 ° or about 80 ° to 90 °, polyurethane foam may be hydrophilic. Generally, increasing the hydrophilicity of the polyurethane foam (i.e., reducing the contact angle between the polyurethane foam and water) increases the amount of body fluid that the polyurethane foam can receive in a certain period of time. However, increasing the hydrophilicity of the polyurethane foam may increase the amount of body fluid that is retained in the polyurethane foam after the polyurethane foam receives the body fluid. Therefore, the hydrophilicity of the polyurethane foam can be selected based on the balance between the need to quickly receive body fluids and keeping the porous material 110 dry. For example, a fluid collection assembly 100 configured for use by an individual with a large bladder for a short period of time may include a polyurethane foam that is more hydrophilic than a fluid collection assembly 100 configured for use by an individual with a medium to small sized bladder for a long period of time.

[0026] In one embodiment, the hydrophilicity of the polyurethane foam may be an inherent property of the polyurethane foam. In one embodiment, the hydrophilicity of the polyurethane foam may be changed by at least one of impurities (e.g., fibers) or functional groups added to the polyurethane foam, or by treating the polyurethane foam, or by coating the polyurethane foam with a material that exhibits a hydrophilicity different from that of the polyurethane foam.

[0027] The polyurethane foam defines one or more pores. These pores form channels through the polyurethane foam through which one or more body fluids can flow. In one example, the porosity of the polyurethane foam is about 4 pores / cm 2 To about 6 pores / cm 2 , 5 pores / cm 2 To about 7 pores / cm 2 , 6 pores / cm 2 About 8 pores / cm 2 , 7 pores / cm 2 To about 9 pores / cm 2 , 8 pores / cm 2 About 10 pores / cm 2 , 9 pores / cm2 To about 11 pores / cm 2 , 10 pores / cm 2 About 12 pores / cm 2 , 11 pores / cm 2 To about 13 pores / cm 2 , 12 pores / cm 2 To about 14 pores / cm 2 , 13 pores / cm 2 To about 15 pores / cm 2 , 14 pores / cm 2 To about 16 pores / cm 2 or 15 pores / cm 2 To about 17 pores / cm 2 The porosity of the polyurethane foam may be selected based on the maximum amount of body fluid expected to flow through the polyurethane foam in a certain period of time, the density of the polyurethane foam, and the surface roughness of the polyurethane foam which affects the comfort of the polyurethane foam against the vaginal area.

[0028] The porosity of the polyurethane foam also depends on the average transverse dimension of the pores taken in a direction perpendicular to the longitudinal axis 118 of the fluid collection component 100. The average transverse dimension of the pores can 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 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. Generally, increasing the average transverse size of the pores can reduce the porosity, reduce the density of the polyurethane foam, and increase the amount of body fluid that the polyurethane foam can receive in a certain period of time. However, increasing the average transverse size of the pores may increase the surface roughness of the polyurethane foam, which makes the polyurethane foam more comfortable against the vaginal area. Therefore, the average transverse size of the pores of the polyurethane foam can be selected based on balancing these factors. For example, a fluid collection assembly (such as a gauze layer on a polyurethane foam) configured for use by individuals with large bladders Figure 2A and 2B ) can include polyurethane foam having pores with an average lateral dimension that is larger than that configured for use by individuals with medium or small bladders and / or configured so that the polyurethane foam directly contacts the vaginal area.

[0029] The average density of polyurethane foam is about 70 kg / m 3 About 90kg / m 3 , about 80kg / m 3 About 100kg / m 3 , about 90kg / m 3 About 110kg / m 3 , about 100kg / m 3 About 120kg / m 3 , about 110kg / m 3 About 130kg / m 3 , about 120kg / m 3 About 140kg / m 3 or about 130kg / m 3 About 150kg / m 3 Generally, reducing the density of the polyurethane foam can at least one of increase the porosity of the polyurethane foam, increase the average lateral size of the pores, increase the amount of body fluid that the polyurethane foam can receive in a certain period of time, increase the surface roughness of the polyurethane foam, and reduce the strength and toughness of the polyurethane foam. Therefore, as previously described, the density of the polyurethane foam can be selected based on balancing these factors.

[0030] The polyurethane foam can be configured to flow at about 10 milliliters per second ("mL / s") or greater, about 12.5 mL / s or greater, about 15 mL / s or greater, about 17.5 mL / s or greater, about 20 mL / s or greater, about 22.25 mL / s, about 25 mL / s or greater, about 27.5 mL / s or greater, about 30 mL / s or greater, about 35 mL / s or greater, about 40 mL / s or greater, or at about 10 mL / s to about The polyurethane foam may be provided with a polyurethane foam having a body fluid therein at a rate of about 15 mL / s, about 12.5 mL / s to about 17.5 mL / s, about 15 mL / s to about 20 mL / s, about 17.5 mL / s to about 22.5 mL / s, about 20 mL / s to about 25 mL / s, about 22.5 mL / s to about 27.5 mL / s, about 25 mL / s to about 30 mL / s, about 27.5 mL / s to about 35 mL / s, or about 30 mL / s to about 40 mL / s. As previously described, the rate at which the polyurethane foam receives body fluids depends at least in part on the porosity, average lateral size of the pores, density, and hydrophilicity of the polyurethane foam.

[0031] As previously mentioned, the polyurethane foam may be formed of a hydrophilic material, which may allow the polyurethane foam to retain body fluids therein. In order to reduce the amount of body fluids retained by the polyurethane foam, the outer layer 112 may be configured to be relatively thin. For example, the outer layer 112 can be configured to have a thickness measured perpendicular to the longitudinal axis 118 (e.g., radially measured) of 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 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 total volume of the polyurethane foam, thereby reducing the volume of body fluids that can be retained in the polyurethane foam. The reduction in the volume of body fluids retained in the polyurethane foam allows air to flow through chamber 104 to quickly evaporate the body fluids retained in the polyurethane foam, thereby keeping porous material 110 dry. In addition, reducing the thickness of outer layer 112 can allow inner layer 114 (e.g., polyethylene foam) to wick more body fluids from the polyurethane foam.

[0032] In one example, the polyurethane foam of the outer layer 112 can be formed by extrusion, such as co-extruded with the inner layer 114. In one example, the polyurethane foam can be formed into a sheet (e.g., using molding, casting, extrusion, or casting techniques) and then disposed on the inner layer 114. In one example, the polyurethane foam can be molded or cast on (e.g., around) the previously formed inner layer 114.

[0033] In some embodiments, the outer layer 112 may include at least one additional material in addition to or instead of the polyurethane foam. In one example, the additional material of the outer layer 112 may include a fabric, such as gauze (e.g., silk, linen, or cotton gauze), a woven material, a nonwoven material, other soft fabrics, other smooth fabrics, polyethylene foam, or other suitable porous materials. The additional material of the outer layer 112 formed of gauze, soft fabric, and / or smooth fabric can reduce abrasions caused by the fluid collection assembly 100. In one example, the hydrophobicity, porosity, average lateral size of the pores, density, or rate at which the additional material of the outer layer 112 receives body fluids may be the same or different from the hydrophobicity, porosity, average lateral size of the pores, density, or rate at which the additional material receives body fluids (e.g., mL / s) described above with respect to the polyurethane foam.

[0034] As previously described, the porous material 110 can include an inner layer 114 disposed in the chamber 104. The inner layer 114 is configured to support the outer layer 112 because the outer layer 112 can be formed of a relatively foldable, thin, or easily deformable material. For example, the inner layer 114 can be positioned so that the outer layer 112 is disposed between the inner layer 114 and the fluid-impermeable barrier 102. Thus, the inner layer 114 can support and maintain the position of the outer layer 112.

[0035] As previously described, the inner layer 114 can include polyethylene foam. In one embodiment, the polyethylene foam can be hydrophobic. The hydrophobicity of the polyethylene foam can allow the polyethylene foam to quickly push body fluids or allow body fluids to be drawn through it toward the outlet of the fluid collection assembly 100 (e.g., toward the fluid outlet 108 or the inlet of the conduit 116 disposed in the chamber 104). Pushing or drawing body fluids toward the outlet of the fluid collection assembly 100 can cause the porous material 110 to dry or substantially dry shortly after receiving the body fluids. The polyethylene foam may be hydrophobic when the contact angle of the polyethylene foam with water (the major component of body fluids) is from about 90° to about 100°, from about 95° to about 105°, from about 100° to about 110°, from about 105° to about 115°, from about 110° to about 120°, from about 115° to about 125°, from about 120° to about 130°, from about 125° to about 135°, from about 130° to about 140°, from about 135° to about 145°, from about 140° to about 150°, from about 145° to about 155°, from about 150° to about 160°, from about 155° to about 165°, from about 160° to about 170°, from about 165° to about 175°, or from 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 move body fluids toward an outlet more quickly. However, increasing the hydrophobicity of the polyethylene foam may reduce the amount of bodily fluid that the polyethylene foam can receive in a given period of time. However, it has been unexpectedly discovered that the use of polyurethane foam allows a greater amount of bodily fluid to enter the polyethylene foam compared to porous material 110 comprising other materials. Therefore, the hydrophobicity of the polyethylene foam can be selected based on a balance between the need to quickly move bodily fluid to the outlet of the fluid collection assembly 100 while also allowing the polyethylene foam to receive bodily fluid from the outer layer 114. For example, a fluid collection assembly 100 that is configured for use by an individual with a large bladder for a short period of time may include a polyethylene foam that is less hydrophobic than a fluid collection assembly 100 that is configured for use by an individual with a medium to small sized bladder for an extended period of time.

[0036] In one embodiment, the hydrophobicity of the polyethylene foam (i.e., the contact angle between the polyethylene foam and water) can be an inherent property of the polyethylene foam. In one embodiment, the hydrophobicity of the polyethylene foam can be changed by at least one of impurities (e.g., fibers) or functional groups added to the polyethylene foam, or can be changed by treating the polyethylene foam, or by coating the polyethylene foam with a material having a hydrophobicity different from that of the polyethylene foam.

[0037] The polyethylene foam defines one or more pores. The pores form channels through the polyethylene foam through which one or more body fluids can flow. In one example, the porosity of the polyethylene foam is 8 pores / cm 2 About 10 pores / cm 2 , 9 pores / cm 2 To about 11 pores / cm 2 , 10 pores / cm 2 About 12 pores / cm 2 , 11 pores / cm 2 To about 13 pores / cm 2 , 12 pores / cm 2 About 14 pores / cm 2 , 13 pores / cm 2 To about 15 pores / cm 2 , 14 pores / cm 2 To about 16 pores / cm 2 , 15 pores / cm 2 To about 17 pores / cm 2 , about 16 pores / cm 2 About 18 pores / cm 2 , 19 pores / cm 2 About 21 pores / cm 2 , about 20 pores / cm 2 To about 22 pores / cm 2 , 21 pores / cm 2 To about 23 pores / cm 2 , 22 pores / cm 2 About 24 pores / cm 2 , 23 pores / cm 2 About 25 pores / cm 2 , about 24 pores / cm 2 To about 26 pores / cm 2 , 25 pores / cm 2 To about 27 pores / cm 2 , 26 pores / cm 2 To about 28 pores / cm2 , 27 pores / cm 2 To about 29 pores / cm 2 or about 28 pores / cm 2 About 30 pores / cm 2 The porosity of the polyethylene foam can be selected based on the expected amount of body fluid that the polyethylene foam can receive and flow through the polyethylene foam in a certain period of time, the average transverse dimension of the pores, and the density of the polyethylene foam.

[0038] The porosity of the polyethylene foam also depends on the average transverse dimension of the pores taken in a direction perpendicular to the longitudinal axis 118 of the fluid collection component 100. The average transverse dimension of the pores can 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. Generally, increasing the average transverse dimension of the cells can reduce the porosity, reduce the density of the polyethylene foam, and increase the amount of body fluid that the polyethylene foam can receive and flow through the polyethylene foam in a certain period of time. However, increasing the average transverse dimension of the cells may weaken the polyethylene foam and allow body fluid to accumulate therein. Therefore, the average transverse dimension of the cells of the polyethylene foam can be selected based on balancing these factors.

[0039] The average density of polyethylene foam is about 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 About 110kg / m 3 , about 100kg / m 3 About 120kg / m 3 , about 110kg / m 3 About 130kg / m 3 , about 120kg / m 3 About 140kg / m 3 or about 130kg / m 3 About 150kg / m 3In general, reducing the density of the polyethylene foam can at least one of increase the porosity of the polyethylene foam, increase the average lateral size of the pores, increase the amount of body fluid that the polyethylene foam can receive and flow through the polyethylene foam in a certain period of time, and reduce the strength and toughness of the polyethylene foam. Therefore, as described above, the density of the polyethylene foam can be selected based on balancing these factors.

[0040] The polyethylene foam of the inner layer 114 can be formed using any suitable technique. In one example, the polyethylene foam can be formed into a cylindrical or substantially cylindrical shape (e.g., a substantially hollow cylindrical shape) by a casting or molding technique. In one example, the polyethylene foam can be extruded, such as co-extruded with the outer layer 112. In one example, the polyethylene foam can be formed into a sheet (e.g., by casting, molding, extrusion, or casting) and then rolled into a cylindrical or substantially cylindrical shape.

[0041] In one embodiment, the outer layer 112 comprises polyurethane foam and the inner layer 114 comprises polyethylene foam. It has been found that selecting a porous material 110 comprising both polyurethane foam and polyethylene foam can allow the porous material 110 to receive body fluids more quickly, move body fluids toward the outlet of the fluid collection assembly 100 more quickly, and better keep the porous material 110 dry, compared to a porous material 110 comprising only one of the polyurethane foam and the polyethylene foam. For example, it has been found that body fluids received into the polyurethane foam can quickly flow from the polyurethane foam to the polyethylene foam. In addition, the polyethylene foam can move at least some body fluids from the polyurethane foam that would otherwise remain in the polyurethane foam.

[0042] In one embodiment, when the porous material 110 includes polyurethane foam and polyethylene foam, the porosity and density of the polyurethane foam can be less than and greater than the porosity and density of the polyethylene foam, respectively. It is believed that in these embodiments, body fluids can flow more efficiently from the polyurethane foam to the polyethylene foam.

[0043] In some embodiments, the inner layer 114 may include at least one additional material in addition to or in place of the polyurethane foam. In one example, the additional material of the inner layer 114 may 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 fiber), any other porous material disclosed herein, or any other suitable porous material. In one example, the hydrophobicity, porosity, average lateral size of the pores, density, or rate at which the additional material of the inner layer 114 receives body fluids is the same or different from the hydrophobicity, porosity, average lateral size of the pores, density, or rate at which the additional material receives body fluids described above with respect to the polyethylene foam.

[0044] In one embodiment, at least one of the outer layer 112 or the inner layer 114 may be omitted from the porous material 110 .

[0045] The porous material 110 may at least substantially completely fill the portion of the chamber 104 not occupied by the conduit 116. In some examples, the porous material 110 may not substantially completely fill the portion of the chamber 104 not occupied by the conduit 116. In these examples, the fluid collection assembly 100 includes a reservoir 120 disposed in the chamber 104.

[0046] The reservoir 120 is a substantially unoccupied portion of the chamber 104. The reservoir 120 can be defined between one or both of the outer layer 112 or the inner layer 114 and the fluid-impermeable barrier 102. Bodily fluid in the chamber 104 can flow through the porous material 110 to the reservoir 120. The reservoir 120 can retain the bodily fluid therein.

[0047] Bodily fluids in the chamber 104 can flow through the porous material 110 to the reservoir 120. The fluid-impermeable barrier 102 can retain the bodily fluids in the reservoir 120. Although shown in the distal region 122, the reservoir 120 can be located in any portion of the chamber 104, such as the proximal region 124. The reservoir 120 can be located in a portion of the chamber 104 that is designed to be at a gravitational low point of the fluid collection assembly when the fluid collection assembly is worn.

[0048] In some examples (not shown), the fluid collection assembly 100 can include multiple reservoirs, such as a first reservoir located in a portion of the chamber 104 closest to the entrance of the conduit 116 (e.g., the distal region 122), and a second reservoir located in a portion at or near the proximal region 124 of the chamber 104. In another example, the inner layer 114 is separated from at least a portion of the conduit 116, and the reservoir 120 can be the space between the inner layer 114 and the conduit 116.

[0049] The conduit 116 can be at least partially disposed in the chamber 104. The conduit 116 can be used to remove body fluids from the chamber 104. The conduit 116 includes at least one wall defining an inlet, an outlet (not shown) downstream of the inlet, and a passageway. The outlet of the conduit 116 can be operably connected to a vacuum source, such as a vacuum pump, for extracting fluid from the chamber 104 through the conduit 116. For example, the conduit 116 can extend from the proximal region 124 into the fluid-impermeable barrier 102, and can extend to the distal region 122 to a point close to the reservoir 120 therein, so that the inlet is in fluid communication with the reservoir 120. The conduit 116 fluidly connects the chamber 104 to a fluid storage container (not shown) or a vacuum source (not shown).

[0050] The conduit 116 can extend through the bore in the porous material 110. In one embodiment, the conduit 116 extends from the fluid outlet 108, through the bore, to a location proximate to the reservoir 120. In these embodiments, the inlet may not extend into the reservoir 120, but rather, the inlet may be disposed in the porous material 110 or at an end thereof. For example, the end of the conduit 116 may be coextensive with or recessed into the porous material 110. In one embodiment, the conduit 116 is at least partially disposed in the reservoir 120, and the inlet may extend into or be located in the reservoir 120. Bodily fluid collected in the fluid collection assembly 100 may be removed from the chamber 104 via the conduit 116.

[0051] Positioning the inlet of conduit 116 at or near a location that is expected to be a gravitational low point in chamber 104 when worn by an individual enables conduit 116 to receive more bodily fluid than if the inlet were located elsewhere and reduces the possibility of accumulation (e.g., accumulation of bodily fluid may result in microbial growth and malodor). For example, bodily fluid in porous material 110 may flow in any direction due to capillary forces. However, bodily fluid may exhibit a preference for flowing in the direction of gravity, particularly when at least a portion of porous material 110 is saturated with bodily fluid. Thus, one or more of the inlet or reservoir 120 of conduit 116 may be located in fluid collection assembly 100 that is expected to be a gravitational low point in fluid collection assembly 100 when worn by an individual, such as distal region 122.

[0052] The conduit 116 is configured to place a vacuum source (not shown) in fluid communication with the chamber 104 (e.g., the reservoir 120). When the vacuum source applies vacuum / suction in the conduit 116, bodily fluid in the chamber 104 (e.g., at the distal region 122 (e.g., in the reservoir 120)) can be drawn into the inlet of the conduit 116 and discharged from the fluid collection assembly 100 through the conduit 116. In some examples, the conduit 116 can be frosted or opaque (e.g., black) to obscure the visibility of the bodily fluid therein.

[0053] The fluid collection assemblies disclosed herein may include one or more additional layers in place of or in addition to at least one of the outer layer or the inner layer. Figure 2A is a schematic cross-sectional view of a fluid collection assembly 200 according to one embodiment. Figure 2B For along Figure 2ASchematic diagram of a cross-section of a fluid collection assembly 200 taken along plane 2B-2B as shown. Unless otherwise disclosed herein, the fluid collection assembly 200 is the same 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 defines at least a chamber 204 and at least one opening 206. The fluid collection assembly 200 may also include at least one porous material 210 disposed in the chamber 204. The porous material 210 may include an outer layer 212 and an inner layer 214.

[0054] The porous material 210 may include one or more additional layers 226 in place of or in addition to the outer layer 212 or the inner layer 214. In one embodiment, as shown, the additional layer 226 may be disposed on the outer layer 212 and extend across the opening 206. In these embodiments, the additional layer may include gauze or other material that may fit comfortably against the vaginal area of ​​the individual or be more aesthetically pleasing than the outer layer 212. Note 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) to minimize any effect of the additional layer 226 on the porous material 210 receiving the body fluids discharged by the individual. In one embodiment, the additional layer 226 is located between the outer layer 212 and the inner layer 214. In one embodiment, the additional layer 226 may be located between the inner layer 214 and the conduit 216.

[0055] 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 at least one of on 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.

[0056] Figures 1A to 2B The fluid collection assembly shown is an example of a female fluid collection assembly that is configured to collect bodily fluids from females (e.g., urine from a female urethra). However, the fluid collection assemblies, systems, and methods disclosed herein may include male fluid collection assemblies of shapes, sizes, and other configurations for collecting bodily fluids from males (e.g., urine from a male urethra). Figure 3 is a cross-sectional view of a male fluid collection assembly 300 according to one embodiment.

[0057] refer to Figure 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 connected to the skin around the male urethral opening (e.g., the penis) and the male urethral opening is placed therethrough. For example, the base 330 can define an orifice 334. The base 330 is sized and shaped so that it is located around the male urethral opening (e.g., around and / or on the penis), and the orifice 334 can be configured to allow the male urethral opening to be placed therethrough. The base 330 is sized, shaped, made of a material, or otherwise configured to be connected (e.g., bonded (e.g., with a hydrogel adhesive)) to the skin around the male urethral opening (e.g., around the penis). In one example, the base 330 can take on the general shape or contour of the skin surface to which the base 330 is selected to be connected. The base 330 can be flexible so that the base 330 conforms to any shape of the skin surface. The base 330 also defines a hollow area configured to accommodate (e.g., seal) the sheath 332. The base 330 is located at the proximal region 324 (relative to the wearer) of the fluid collection assembly 300.

[0058] The sheath 332 includes (e.g., can be formed from) a fluid-impermeable barrier 302 that is sized and shaped to fit within 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. In one or more aspects, the fluid-impermeable barrier 302 can be similar or identical to the fluid-impermeable barriers disclosed herein. For example, the fluid-impermeable barrier 302 can be made of any material disclosed herein for a fluid-impermeable barrier. The fluid-impermeable barrier 302 at least partially defines a chamber 304. For example, an inner surface 338 of the fluid-impermeable barrier 302 at least partially defines an edge of the chamber 304. The chamber 304 can at least temporarily retain body fluids therein. As shown, the fluid collection assembly 300 can include a porous material 310 therein. In one or more aspects, the porous material 310 can be similar or identical to any porous material disclosed herein. For example, the porous material 310 may include one or more of an inner layer 312, an outer layer 314, or one or more additional layers. The inner layer 312 may include polyurethane and / or the outer layer 314 may include polyethylene. The fluid-impermeable barrier 302 may also define an opening 306 extending through the fluid-impermeable barrier 302, the opening 306 being configured to allow a male urethral opening to be placed therethrough.

[0059] The sheath 332 also includes at least a portion of the conduit 316 therein, such as at least partially disposed in the chamber 304. For example, the conduit 316 can extend from the sheath 332 at the distal region 322 to a proximal region 324 at least proximal to the opening 306. The proximal region 324 can be disposed near or on the skin around the male urethral opening (e.g., on the penis or on the pubic region around it). Thus, when the individual is lying on his back, body fluids (e.g., urine) can collect near the opening 306 against the subject's skin. The body fluids can be removed from the chamber 304 through the conduit 316.

[0060] In some examples, the material of construction and / or thickness of fluid-impermeable barrier 302 can allow sheath 332 to collapse when placed under a vacuum to remove air around the penis in fluid collection assembly 300 during use. In these examples, conduit 316 can extend only to or into distal region 322 in chamber 304 (e.g., without passing through to reach an area adjacent opening 306). In these examples, urine can be collected and removed from fluid collection assembly 300.

[0061] In one example, due to the different sizes and hardness of male penises, a portion of the chamber 304 can be substantially empty. However, in some examples, the outermost area of ​​the chamber 304 (e.g., the periphery of the inner area of ​​the sheath 332) can include a porous material 310. For example, the porous material 310 can be bonded to the inner surface 338 of the fluid-impermeable barrier 302. The porous material 310 can be placed (e.g., at the distal end of the chamber 304) to slow down the flow of urine from the male urethral opening, thereby limiting splashing and / or directing bodily fluids to a selected area of ​​the chamber 304. Since the chamber 304 is substantially empty (e.g., substantially all of the chamber 304 forms a reservoir), bodily fluids are likely to accumulate at the gravitational low point of the chamber 304. The gravitational low point of the chamber 304 can be located at the intersection of the individual's skin and the fluid collection assembly 300, at a corner formed in the sheath 332, or other suitable locations depending on the orientation of the wearer.

[0062] As previously described, the porous material 310 may include one or more of an outer layer 312 or an 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 chamber 304. The outer layer 312 may be located between the fluid-impermeable barrier 302 and the penis inserted into the chamber 304, such as between the inner layer 314 and the penis of the wearer, as shown. The inner layer 314 may be located between the outer layer 312 and the fluid-impermeable barrier 302. The inner surface 338, optionally including the end of the chamber 304 substantially opposite the opening 306, may be covered with one or both of the outer layer 312 or the outer layer 314. The outer layer 312 or the inner layer 314 may be fixed (e.g., bonded) to the fluid-impermeable barrier 302. The outer layer 312 and the inner layer 314 may be fixed to each other. In some examples, the porous material 310 includes only the outer layer 312 or the inner layer 314.

[0063] The fluid collection assembly 300 includes a protective cap 340 located at the distal region 322. The protective cap 340 defines an internal passage through which bodily fluid can be removed from the fluid collection assembly 300. The internal passage is in fluid communication with the chamber 304. The protective cap 340 can be disposed on at least a portion of the distal region 322 of one or more of the fluid-impermeable barrier 302 or the porous material 310. The protective cap 340 can be made of a polymer, rubber, or any other fluid-impermeable material. The protective cap 340 can be connected to one or more of the fluid-impermeable barrier 302, the porous material 310, or the conduit 316. The protective cap 340 can cover at least a portion of the distal region 322 of the fluid collection assembly 300. The protective cap 340 can define a fluid outlet 308 that is sized and configured to accommodate the conduit 316 and to provide a fluid seal thereto. The conduit 316 may extend a distance within or through the protective cap 340, such as to the porous material 310, through the porous material 310, or to a point set-off from the porous material 310. In the latter example, the interior passageway of the protective cap 340 may define a reservoir 320 therein.

[0064] The reservoir 320 is a portion of the device that is not occupied (e.g., in the protective cover 340) and is free of other materials. In some examples, the reservoir 320 is at least partially defined by the porous material 310 and the protective cover 340. During use, body fluid in the chamber 304 can flow through the porous material 310 to the reservoir 320. The reservoir 320 can store at least some body fluid therein and / or place the body fluid to be removed by the conduit 316. In some examples, at least a portion of the porous material 310 can extend continuously between at least a portion of the opening of the internal passage and the chamber 304 to wick any body fluid directly from the opening to the reservoir 320.

[0065] In some examples (not shown), the fluid-impermeable barrier 302 can be disposed on or above the protective cover 340 , such as to enclose the protective cover 340 within the chamber 304 .

[0066] In some examples, the sheath 332 can include at least a portion of the conduit 316 therein, e.g., at least partially disposed in the chamber 304. For example, the conduit 316 can extend from the sheath 332 to a region at least proximate the opening 306. An inlet of the conduit 316 can be positioned proximate the annular base 342. The inlet of the conduit 316 can be positioned proximate or near a gravitational low point of the chamber 304, e.g., proximate the annular base 342. For example, the inlet can be coextensive with the opening 306 or offset from the opening 306. In an example, the inlet can be positioned proximate the distal region 322 of the sheath 332 (e.g., substantially opposite the opening 306).

[0067] The proximal region 324 can be disposed near or on the skin around the male urethral opening (e.g., around the penis), and the inlet of the conduit 316 can be located in the proximal region 324. The outlet of the conduit 316 can be directly or indirectly connected to a vacuum source. Thus, body fluids can be removed from the proximal region 324 of the chamber 304 through the conduit 316.

[0068] The base 330, the sheath 332, the protective cover 340, and the conduit 316 may be connected together using any suitable method. For example, at least two of the base 330, the sheath 332, the protective cover 340, or the conduit 316 may be connected together using at least one of an interference fit, an adhesive, sewing, welding (e.g., ultrasonic welding), tape, any other suitable method, or a combination thereof.

[0069] In some examples (not shown), the fluid collection assembly 300 can have a one-piece design, wherein one or more of the sheath 332, base 330, and protective cover 340 are a single, integrally formed component.

[0070] Also as shown, conduit 316 can be at least partially disposed in the chamber of the fluid collection assembly. Conduit 316 can extend from distal region 322 to proximal region 324. For example, conduit 316 can extend through protective cover 340 to a point adjacent to base 330. Conduit 316 is sized and positioned to be connected to a fluid reservoir or a vacuum source. The outlet of conduit 316 can be directly or indirectly operably connected to a vacuum source. The inlet of conduit 316 can be located in chamber 304, such as at a position expected to be a low point of gravity of the fluid collection assembly during use. By positioning the inlet of conduit 316 at a position expected to be a low point of gravity of the fluid collection assembly when worn by the user, the body fluid introduced into chamber 304 can be removed by conduit 316 to prevent body fluid from accumulating or stagnating in chamber 304.

[0071] In some examples, the vacuum source can be remote from the fluid collection assembly 300. In these examples, the conduit 316 can be fluidly connected to a fluid storage container, which can be disposed between the vacuum source and the fluid collection assembly 300.

[0072] During operation, a male using fluid collection assembly 300 may discharge bodily fluids (e.g., urine) into chamber 304. Bodily fluids may accumulate or otherwise collect in chamber 304. At least some of the bodily fluids may be drawn through the interior of conduit 316 via the inlet. Bodily fluids may be drawn out of fluid collection assembly 300 via vacuum / suction provided by a vacuum source.

[0073] The porous materials disclosed herein can be used in addition to Figures 1A to 3 For use with fluid collection assemblies other than those shown. Figure 4A is an isometric view of a fluid collection assembly 400 according to one embodiment. Figure 4B 4B-4B is a schematic cross-sectional view of a fluid collection assembly 400 taken along plane 4B-4B. Fluid collection assembly 400 is an example of a male fluid collection assembly, but in some embodiments, fluid collection assembly 400 can be used to receive body fluids from a female urethral opening. Fluid collection assembly 400 includes a sheath 432 and a base 430. Base 430 is configured to be connected (e.g., permanently connected or configured to be permanently connected) to sheath 432. Base 430 is also configured to be connected to an area around the urethral opening of an individual (e.g., a penis).

[0074] The sheath 432 includes a fluid impermeable barrier 402 formed at least in part by a first panel 444 and a second panel 446. The first panel 444 and the second panel 446 are connected or integrally formed together (e.g., presenting a single piece structure). In one embodiment, as shown in the figure, the first panel 444 and the second panel 446 are different sheets. The fluid impermeable barrier 402 also defines a chamber 404 between the first panel 444 and the second panel 446, an opening 406 at the proximal region PER of the sheath 432, and a fluid outlet 408 at the distal region DER of the sheath 432. The sheath 432 also includes at least one porous material 410 disposed in the chamber 404.

[0075] The inner surface of the fluid-impermeable barrier 402 (e.g., the inner surface of the first panel 444 and the second panel 446) at least partially defines a chamber 404 within the fluid collection assembly 400. The fluid-impermeable barrier 402 temporarily stores bodily fluids in the chamber 404. The fluid-impermeable barrier 402 can be formed of any fluid-impermeable material disclosed herein. Thus, the fluid-impermeable barrier 402 substantially prevents bodily fluids from passing through the fluid-impermeable barrier 402.

[0076] In one embodiment, at least one of the first panel 444 or the second panel 446 is formed by at least partially transparent fluid-impermeable material, such as polyethylene, polypropylene, polycarbonate or polyvinyl chloride. At least one of the first panel 444 or the second panel 446 formed by at least partially transparent fluid-impermeable material allows people (such as medical practitioners) to check the penis. For example, the chamber 404 may include a penis-accommodating area 448, which is configured to accommodate individual penis when the penis extends into the chamber 404. The penis-accommodating area 448 may be limited by at least a portion of at least a porous material 410 and 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 located in the chamber 404 so that when the penis is inserted into the chamber 404 through the opening 406, the porous material 410 is not located between at least a portion of the transparent portion of the penis and the first panel 444 and / or the second panel 446. The porous material 410 is generally opaque, and thus, portions of the at least partially transparent material of the first panel 444 and / or the second panel 446 defining the penis receiving area 448 form windows that allow a person to view the penis receiving area 448 and inspect a penis.

[0077] The opening 406 defined by the fluid-impermeable barrier 402 provides an entry path for bodily fluids to enter the chamber 404 when the penis is buried, and allows the penis to enter the chamber 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., the inner edge of the fluid-impermeable barrier 402). For example, the opening 406 is formed in the fluid-impermeable barrier 402 and extends through the barrier, thereby allowing bodily fluids to enter the chamber 404 from the outside of the fluid collection assembly 400.

[0078] The fluid-impermeable barrier 402 defines the size of the fluid outlet 408 to accommodate the conduit 416. The conduit 416 can be at least partially disposed in the chamber 404, or in fluid communication with the chamber 404 through the fluid outlet 408. The size and shape of the fluid outlet 408 is to form at least a substantially fluid seal against the conduit 416, thereby substantially preventing body fluids from escaping the chamber 404. In one embodiment, the fluid outlet 408 can be formed by a portion of the first panel 444 and the second panel 446 that are not connected together or integrally formed together. In these embodiments, the fluid-impermeable barrier 402 can not include a protective cover that is more rigid than the portion of the fluid-impermeable barrier 402 surrounding it, which facilitates the manufacture of the fluid collection assembly 400, can reduce the number of parts used to form the fluid collection assembly 400, and can reduce the time required to manufacture the fluid collection assembly 400. The lack of a protective cover may make it difficult to secure the conduit 416 to the fluid outlet 408 using an interference fit, but it is worth noting that it is still possible to connect the conduit 416 to the fluid outlet 408. Thus, the conduit 416 can be connected to the fluid outlet 408 (e.g., to the first panel 444 and the second panel 446) using adhesive, welding, or otherwise. Connecting the conduit 416 to the fluid outlet 408 can prevent leakage and can prevent the conduit 416 from being inadvertently separated from the fluid outlet 408. In one example, the conduit 416 can be connected to the fluid outlet 408 in the same manufacturing step that the first panel 444 and the second panel 446 are connected together.

[0079] As previously described, the sheath 432 includes at least one porous material 410 disclosed in the chamber 404. The porous material 410 can direct bodily fluid to one or more selected areas of the chamber 404, such as away from the penis and toward the fluid outlet 408. The porous material 410 can be formed of any porous material disclosed herein. In one example, the porous material 410 can be formed of 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).

[0080] In one embodiment, the porous material 410 can be a sheet. Forming the porous material 410 as a sheet can facilitate the manufacture of the fluid collection assembly 400. For example, forming the porous material 410 as a sheet allows the first panel 444, the second panel 446, and the porous material 410 to each be a sheet. During the manufacture of the fluid collection assembly 400, the first panel 444, the second panel 446, and the porous material 410 can be stacked and then connected to each other in the same manufacturing step. For example, the porous material 410 can be in a shape that is the same size as the first panel 444 and the second panel 446, or more preferably, slightly smaller than the size of the first panel 444 and the second panel 446. Therefore, connecting the first panel 444 and the second panel 446 together along their outer edges can also connect the porous material 410 to the first panel 444 and the second panel 446. The porous material 410 can 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 extend around the porous material 410, so that the porous material 410 does not form a channel through the fluid-impermeable barrier 402 through which body fluids may leak. In addition, connecting the porous material 410 to the first panel 444 and / or the second panel 446 can prevent the porous material 410 from moving significantly in the chamber 404, such as preventing the porous material 410 from gathering near the fluid outlet 408. In one example, the porous material 410 can be connected (e.g., by an adhesive) to the first panel 444 or the second panel 446 before or after the first panel 444 is connected to the second panel 446. In one example, the porous material 410 can be disposed only in the chamber 404 without connecting the porous material 410 to at least one of the first panel 444 or the second panel 446. In one embodiment, the porous material 410 may take on a shape other than a sheet, such as a hollow, generally cylindrical shape.

[0081] Typically, when the penis is not in the penis receiving area 448 and the sheath 432 rests on a flat surface, the sheath 432 is substantially flat. The sheath 432 is substantially flat because the fluid impermeable barrier 402 is formed by the first panel 444 and the second panel 446, rather than by a generally tubular fluid impermeable barrier. In addition, as previously described, the porous material 410 can be a sheet, which also allows the sheath 432 to be substantially flat. The sheath 432 can also be substantially flat because the fluid collection assembly 400 can include relatively rigid rings or protective covers that are more rigid than the portion of the fluid impermeable barrier 402 surrounding it, because these rings and protective covers may prevent the sheath 432 from being substantially flat. It should be noted that the sheath 432 is described as being substantially flat because, depending on the thickness of the porous material 410, at least one of the porous materials 410 may cause a slight bulge to form in the sheath 432, the fluid outlet 408 and / or the conduit 416 may cause a bulge around it, or the base 430 may pull portions of the sheath 432 around it. It should also be noted that the sheath 432 may also be compliant, and thus, the sheath 432 may not be substantially flat during use because, during use, the sheath 432 may rest on uneven surfaces (e.g., may rest between the testicles, perineum, and / or thighs), and the sheath 432 may conform to these shaped surfaces.

[0082] The ability of the sheath 432 to be substantially flat allows the fluid collection assembly 400 to be used for both buried and non-buried penises when the penis is not in the penis receiving area 448 and the sheath 432 rests on a flat surface. For example, when the fluid collection assembly 400 is used for a buried penis, the penis does not extend into the penis receiving area 448, which allows the sheath 432 to pass relatively flat through the orifice 434 of the base 430. When the sheath 432 passes relatively flat through the orifice 434, the porous material 410 extends through the opening 406 and the orifice 434 and is very close to the buried penis. Therefore, the porous material 410 prevents or inhibits the body fluids discharged from the buried penis from accumulating on the skin of the individual because the porous material 410 will receive and remove at least most of the body fluids that would otherwise accumulate on the skin of the individual. Therefore, the skin of the individual remains dry, thereby improving the comfort of using the fluid collection assembly 400 and preventing skin damage. However, unlike other conventional fluid collection assemblies that are configured for use with a buried penis, fluid collection assembly 400 can still be used with a non-buried penis because a non-buried penis can still be accommodated in penis receiving area 448 even when the penis is fully erect. Furthermore, the ability of sheath 432 to be substantially flat allows fluid collection assembly 400 to be used more discretely than if sheath 432 were not substantially flat, thereby avoiding potentially embarrassing situations.

[0083] When the sheath 432 is substantially flat, the porous material 410 occupies substantially the entire chamber 404 and the penis receiving area 448 is collapsed (at Figure 4B 448 for illustrative purposes to illustrate the penis receiving area 448). In other words, the sheath 432 may not define an area that is not always occupied by the porous material 410. When the porous material 410 substantially occupies the entire chamber 404, bodily fluids discharged into the chamber 404 may not accumulate for an extended period of time, as the accumulation of bodily fluids may cause hygiene issues, produce odors, and / or may cause the individual's skin to remain in contact with the bodily fluids, thereby causing discomfort and skin damage.

[0084] As previously described, 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 relatively flexible when the first panel 444, the second panel 446, and the porous material 410, respectively, cannot maintain their shapes when unsupported. As described above, the flexibility of the first panel 444, the second panel 446, and the porous material 410 can allow the sheath 432 to be substantially flat. The flexibility of the first panel 444, the second panel 446, and the porous material 410 can also allow the sheath 432 to conform to the shape of the penis even when the size and shape of the penis changes (e.g., becomes erect), and minimize any unoccupied space in the chamber 404 that may accumulate body fluids.

[0085] As previously described, the fluid collection assembly 400 includes a base 430 configured to be connected to the sheath 432. For example, the base 430 is configured to be permanently connected to the sheath 432. The base 430 is configured to be permanently connected to the sheath 432, for example, when the fluid collection assembly 400 is provided with the base 430 permanently connected to the sheath 432, or when the base 430 is not provided to be permanently connected to the sheath 432, but is configured to be permanently connected to the sheath 432 at some time in the future. Permanently connected means that the sheath 432 cannot be separated from the base 430 without damaging at least one of the sheath 432 or the base 430, without using a blade to separate the sheath 432 from the base 430, and / or without using a chemical to dissolve the adhesive bonding the sheath 432 and the base 430. The base 430 can be permanently connected to the sheath 432 using an adhesive, suturing, heat sealing, radio frequency welding, or ultrasonic welding. In one embodiment, the base 430 is configured to be reversibly connected to the sheath 432. In one embodiment, the base 430 is integrally formed with the sheath 432.

[0086] Base 430 includes an orifice 434. Base 430 is permanently connected to sheath 432 so that orifice 434 is aligned with opening 406. The size, shape and material of base 430 are connected to the skin around the penis (e.g., pubic bone, thigh, testicles and / or perineum) and allow the penis to be placed therethrough. For example, base 430 can define an orifice 434 that is configured to allow the penis to be placed therethrough. In one example, base 430 can present a general shape or contour of the skin surface to which base 430 is configured to be connected. Base 430 can be flexible, thereby allowing base 430 to conform to any shape of the skin surface and reducing the pulling of base 430 on the skin surface. Base 430 can extend laterally beyond sheath 432, thereby increasing the surface area of ​​the individual skin to which fluid collection assembly 400 is connected compared to a substantially similar fluid collection assembly 400 that does not include a base.

[0087] As previously described, fluid collection assembly 400 includes conduit 416. The inlet of conduit 416 can be located near the distal region DER of sheath 432, which is expected to be the gravitational low point of chamber 404 when worn by an individual.

[0088] Figure 5 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 storage container 552, and a vacuum source 554. The fluid collection assembly 500 can be the same or substantially similar to any fluid collection assembly disclosed herein. The fluid collection assembly 500, the fluid storage container 552, and the vacuum source 554 can be fluidically connected to each other through one or more conduits 516. For example, the fluid collection assembly 500 can be operably connected to one or more of the fluid storage container 552 or the vacuum source 554 through the conduit 516. The body fluid collected in the fluid collection assembly 500 can be removed from the fluid collection assembly 500 through the conduit 516 extending into the fluid collection assembly 500. For example, the inlet of the conduit 516 can extend into the fluid collection assembly 500, such as into a reservoir therein. The outlet of the conduit 516 can extend into the fluid collection assembly 500 or the vacuum source 554. Suction force can be introduced into the chamber of fluid collection assembly 500 through the inlet of conduit 516 in response to a suction (eg, vacuum) force applied at the outlet of conduit 516 .

[0089] Suction may be applied to the outlet of conduit 516 directly or indirectly via vacuum source 554. Suction may be applied indirectly via fluid storage container 552. For example, the outlet of conduit 516 may be disposed within fluid storage container 552, and other conduits 516 may extend from fluid storage container 552 to vacuum source 554. Thus, vacuum source 554 may apply suction to fluid collection assembly 500 via fluid storage container 552. Suction may be applied directly via vacuum source 554. For example, the outlet of conduit 516 may be disposed within vacuum source 554. Other conduits 516 may extend from vacuum source 554 to a point outside of fluid collection assembly 500, such as to fluid storage container 552. In these examples, vacuum source 554 may be disposed between fluid collection assembly 500 and fluid storage container 552.

[0090] Fluid storage container 552 is sized and shaped to retain body fluids therein. Fluid storage container 552 may include a bag (e.g., a drainage bag), a bottle or cup (e.g., a collection can), or any other closed container for storing body fluids (e.g., urine). In some examples, conduit 516 may extend from fluid collection assembly 500 and connect to a first point in fluid storage container 552. Additional conduits 516 may be connected to a second point on fluid storage container 552 and may extend and connect to vacuum source 554. Thus, a vacuum (e.g., suction) may be drawn through fluid collection assembly 500 through fluid storage container 552. Bodily fluids, such as urine, may be drained from fluid collection assembly 500 using vacuum source 554.

[0091] 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 piston pump, a magnetically driven pump, a peristaltic pump, or any pump configured to generate a vacuum. The vacuum source 554 may provide a vacuum or suction to remove body fluids from the fluid collection assembly 500. In some instances, the vacuum source 554 may be powered by one or more power cords (e.g., connected to an electrical outlet), one or more batteries, or even a manual power source (e.g., a manual vacuum pump). In some instances, the size and shape of the vacuum source 554 is suitable for the exterior, surface, or interior of the fluid collection assembly 500. For example, the vacuum source 554 may include one or more small pumps or one or more micro pumps. The vacuum source 554 disclosed herein may include one or more of a switch, a button, a plug, a remote control, or any other device suitable for activating the vacuum source 554.

[0092] While various aspects and embodiments have been disclosed herein, other aspects and embodiments are also contemplated. The various aspects and embodiments disclosed herein are for illustration purposes only and are not intended to be limiting.

[0093] Terms of degree (e.g., "about," "substantially," "generally," and the like) indicate insignificant variations in structure or function. In one example, when a term of degree includes a term indicating a quantity, the term of degree is interpreted to mean ±10%, ±5%, or ±2% of the term indicating the quantity. In one example, when a term of degree is used to modify a shape, the term of degree means that the shape modified by the term of degree has the appearance of the disclosed shape. For example, a term of degree can be used to indicate that a shape has rounded corners instead of sharp corners, curved edges instead of straight edges, one or more protrusions extending therefrom, is rectangular, is the same as a disclosed shape, and the like.

Claims

1. A fluid collection assembly comprising: A fluid-impermeable barrier defining at least the following structures: chamber; at least one opening; as well as fluid outlet; At least one porous material is disposed in the chamber, the at least one porous material comprising polyurethane foam.

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

3. The fluid collection assembly of any one of claims 1 or 2, wherein the polyurethane foam has an average of 6 pores / cm 2 Up to 14 pores / cm 2 .

4. The fluid collection assembly according to any one of claims 1 to 3, wherein the average density of the polyurethane foam is about 100 kg / m 3 About 170kg / m 3 .

5. The fluid collection assembly of any one of claims 1 to 4, wherein the at least one porous material comprises an inner layer and an outer layer disposed on the inner layer, the outer layer comprising the polyurethane foam.

6. The fluid collection assembly of claim 5, wherein the inner layer comprises polyethylene foam.

7. The fluid collection assembly of claim 6, wherein the polyethylene foam is hydrophobic.

8. The fluid collection assembly of any one of claims 6 or 7, wherein the polyethylene foam has an average of about 12 pores / cm 2 Up to 28 pores / cm 2 .

9. The fluid collection assembly of any one of claims 6 to 8, wherein the polyethylene foam has a pore / cm2 greater than that of the polyurethane foam. 2 .

10. The fluid collection assembly according to any one of claims 6 to 9, wherein the density of the polyethylene foam is 70 kg / m 3 About 150kg / m 3 .

11. The fluid collection assembly according to any one of claims 6 to 10, wherein the pores / cm of the polyethylene foam are 2 The number is greater than the pores / cm of the polyurethane foam 2 The number of 12. The fluid collection assembly of any one of claims 1 to 11, wherein the at least one porous material comprises one or more additional layers disposed on the polyurethane foam.

13. The fluid collection assembly of any one of claims 1 to 12, wherein the polyurethane foam extends through the at least one opening.

14. The fluid collection assembly of any one of claims 1 to 13, wherein the fluid collection assembly is configured to receive bodily fluid from a female urethra.

15. The fluid collection assembly of any one of claims 1 to 13, wherein the fluid collection assembly is configured to receive one or more bodily fluids from a male urethra.

16. The fluid collection set of claims 1 to 15, wherein the fluid collection set can be used for a period of more than 24 hours.

17. A fluid collection assembly comprising: A fluid-impermeable barrier defining at least the following structures: chamber; at least one opening; as well as fluid outlet; At least one porous material is disposed in the chamber, the at least one porous material comprising polyethylene foam.

18. The fluid collection assembly of claim 17, wherein the polyethylene foam is hydrophobic.

19. The fluid collection assembly of claim 18, wherein the at least one porous material comprises an inner layer and an outer layer disposed on the inner layer, wherein the inner layer comprises the polyethylene foam and the outer layer comprises a polyurethane foam.

20. A fluid collection system comprising: The fluid collection assembly according to any one of claims 1 to 19; fluid storage containers; and Vacuum source; The chamber of the fluid collection assembly, the fluid storage container and the vacuum source are fluidically connected to each other, so that suction provided to the chamber from the vacuum source removes one or more body fluids from the chamber and stores the one or more body fluids in the fluid storage container.

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