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

Abstract

Urinary catheters can be uncomfortable and painful and may lead to complications such as infections. Insertion toilets are likely to cause discomfort, leakage, and other hygiene problems. 【Solution means】An exemplary fluid collection assembly 100 includes a fluid-impermeable barrier 102. The fluid-impermeable barrier 102 at least defines a cavity 104, at least one opening 106, and a fluid discharge port 108. The fluid collection assembly 100 also includes at least one porous material 110 disposed within the cavity 104. The porous material 110 includes at least one of a polyurethane foam or a polyethylene foam. In one embodiment, the porous material 110 includes an outer layer 112 disposed on the surface of an inner layer 114, the outer layer 112 includes a polyurethane foam, and the inner layer 114 includes a polyethylene foam.

Description

Technical Field

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

Background Art

[0002] Humans or animals may have difficulty or be unable to perform the normal urination process due to limitations or impairments in their mobility. For example, humans may experience or have impairments that impair their mobility. Humans may be in situations where movement is restricted, such as those experienced by pilots, drivers, and workers in hazardous areas. In addition, collection of body fluids may be required for monitoring purposes or for clinical examinations.

Summary of the Invention

Problems to be Solved by the Invention

[0003] Urinary catheters such as Foley catheters can address some of these situations, such as incontinence. However, unfortunately, urinary catheters can be uncomfortable and painful and may lead to complications such as infections. In addition, an indwelling toilet, which is a container used for the excrement of bedridden individuals, may be used. However, indwelling toilets are prone to causing discomfort, leakage, and other hygiene problems.

Means for Solving the Problems

[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 the fluid collection assembly, and methods of using and forming the 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 discharge port. 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 cavity, at least one opening, and a fluid-impermeable barrier that at least defines a fluid discharge port. The fluid collection assembly also includes at least one porous material disposed in the cavity. The at least one porous material includes a 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 cavity, at least one opening, and a fluid-impermeable barrier that at least defines a fluid discharge port. 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 storage container and a vacuum source. The cavity of the fluid collection assembly, the fluid storage container, and the vacuum source are in fluid communication with each other such that a suction force supplied from the vacuum source to the cavity removes one or more body fluids from the cavity and stores the one or more body fluids in the fluid storage container.

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

Brief Description of the Drawings

[0008] The drawings illustrate several embodiments of the present disclosure, and in the drawings, the same reference numerals refer to the same or similar elements or features from various perspectives shown in the drawings or in various embodiments. [Figure 1A] It is a perspective view of a fluid collection assembly according to one embodiment. [Figure 1B] It is a schematic cross-sectional view of the fluid collection assembly along plane 1B-1B shown in FIG. 1A. [Figure 1C]This is a schematic cross-sectional view of the fluid collection assembly along the plane 1C-1C shown in Figure 1A. [Figure 2A] This is a schematic cross-sectional view of a fluid collection assembly according to one embodiment. [Figure 2B] This is a schematic cross-sectional view of the fluid collection assembly along the plane 2B-2B shown in Figure 2A. [Figure 3] This is a cross-sectional view of a male fluid collection assembly according to one embodiment. [Figure 4A] This is a perspective view of a fluid collection assembly according to one embodiment. [Figure 4B] This is a schematic cross-sectional view of the fluid collection assembly along plane 4B-4B. [Figure 5] This is a block diagram of a fluid collection system for fluid collection according to one embodiment. [Modes for carrying out the invention]

[0009] The embodiments relate to a fluid collection assembly comprising at least one of polyurethane foam and polyethylene foam, a fluid collection system comprising the fluid collection assembly, and methods for using and forming the fluid collection assembly. An exemplary fluid collection assembly comprises a fluid-impermeable barrier defining at least a cavity, at least one opening, and a fluid outlet. The fluid collection assembly also comprises at least one porous material disposed in the cavity. The porous material comprises at least one of polyurethane foam or polyethylene foam. In one embodiment, the porous material comprises an outer layer disposed on the surface of an inner layer, the outer layer comprising polyurethane foam and the inner layer comprising polyethylene foam.

[0010] In use, the fluid collection assembly can be placed in contact with 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 excrete one or more body fluids such as urine, blood, or sweat. The body fluid can flow through the opening and into the porous material. The body fluid can be removed from the cavity via a fluid outlet. In one embodiment, a suction force can be applied to the cavity from a vacuum source, thereby removing the body fluid from the cavity.

[0011] Conventional fluid collection assemblies comprise a porous material other than polyurethane foam and / or polyethylene foam. Such porous materials of such conventional fluid collection assemblies can include a porous thin film, a gauze disposed on a fibrous core of polyethylene terephthalate or spun nylon, or a cover sheet disposed on a cross-lapped non-woven filter material. However, the porous materials used in such conventional fluid collection assemblies can first be difficult to receive body fluids, whereby leakage can occur in such conventional fluid collection assemblies when an individual using such a conventional fluid collection assembly excretes a large amount of body fluid (e.g., urinates) in a short period of time. Further, the porous materials of such conventional fluid collection assemblies are impossible to dry quickly, whereby the skin condition deteriorates if such conventional fluid collection assemblies are not replaced relatively frequently (e.g., if not replaced after being used for nearly at least 12 hours, nearly 18 hours, or nearly 24 hours). Other conventional fluid collection assemblies do not comprise a porous material in an attempt to solve these problems associated with conventional fluid collection assemblies comprising a porous material. However, such conventional fluid collection assemblies that do not comprise a porous material can be difficult to receive body fluids and prevent the body fluid from staying in contact with the individual, and in any case, the skin condition can deteriorate.

[0012] The fluid collection assemblies disclosed herein represent an improvement over conventional fluid collection assemblies as described above, at least because the fluid collection assemblies comprise a porous material comprising at least one of polyurethane foam or polyethylene foam. In one embodiment, the polyurethane foam can rapidly receive bodily fluids from an individual, even if the individual expels a large amount of bodily fluids in a short period of time. The polyurethane foam can also be comfortable to the touch, even when in contact with sensitive skin surrounding the individual's urethral opening (e.g., the vaginal area). In one embodiment, the polyethylene foam facilitates the movement of bodily fluids through the cavities of the fluid collection assembly to the outlet (e.g., a fluid outlet or the inlet of a conduit positioned through the fluid outlet), which may allow the porous material to remain dry. When the porous material comprises both polyurethane foam and polyethylene foam, the porous material can rapidly receive bodily fluids, rapidly move them through the cavities, and be comfortable. Furthermore, bodily fluids received in the polyurethane foam can easily flow from the polyurethane foam into the polyethylene foam, and the polyethylene foam draws in bodily fluids that would otherwise remain in the polyurethane foam. Due to the properties of the porous materials disclosed herein, a fluid collection assembly comprising at least one of the polyurethane foam or polyethylene foam can be used for extended periods without causing deterioration of skin condition. For example, a fluid collection assembly comprising at least one of the 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 schematic cross-sectional views of the fluid collection assembly 100 along planes 1B-1B and 1C-1C, respectively, shown in FIG. 1A. This fluid collection assembly is an example of a fluid collection assembly configured to receive body fluid from a female urethral orifice. The fluid collection assembly 100 includes 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 includes at least one porous material 110 disposed within the cavity 104. In one embodiment, as shown, the porous material 110 includes an outer layer 112 extending across the opening 106 and an inner layer 114 that supports the outer layer 112 (i.e., the outer layer 112 is disposed on the surface of the inner layer 114). The outer layer 112 may include a polyurethane foam, and the inner layer 114 may include a polyethylene foam. However, as will be discussed in detail below, one of the outer layer 112 or the inner layer 114 may include a material other than a polyurethane foam or a polyethylene foam, respectively.

[0014] The fluid-impermeable barrier 102 at least defines the cavity 104 (e.g., an internal region) and the opening 106. The fluid-impermeable barrier 102 temporarily stores body fluid 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 metal thin 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 body fluid from permeating through the fluid-impermeable barrier 102. In one example, the fluid-impermeable barrier 102 can be air-permeable and fluid-impermeable. In such an example, the fluid-impermeable barrier 102 can be formed of a hydrophobic material that defines a plurality of small holes. At least one or more portions of at least one outer surface of the fluid-impermeable barrier 102 can be formed of a flexible and / or smooth material, thereby reducing the occurrence of injuries.

[0015] The opening 106 provides an entry route for bodily fluids into the cavity 104. The opening 106 can be defined by the fluid-impermeable barrier 102, such as the inner edge of the fluid-impermeable barrier 102. For example, the opening 106 may be formed within and extending 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 embodiments, the fluid-impermeable barrier 102 can define a fluid outlet 108 sized to receive a conduit 116. At least one conduit 116 can be positioned within the cavity 104 through the fluid outlet 108. The fluid outlet 108 can be sized and shaped to form at least a substantially fluid-sealed state with respect to the conduit 116 or at least one tube, thereby substantially preventing bodily fluids from leaking out of the cavity 104.

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

[0018] As described above, the outer layer 112 may include a polyurethane foam. In one embodiment, the polyurethane foam may be hydrophilic. The hydrophilicity of the polyurethane foam allows it to rapidly draw bodily fluids into itself, thereby preventing or at least inhibiting the leakage of bodily fluids that would otherwise occur due to the rapid discharge of large amounts of bodily fluids in a short period of time. Polyurethane foam can be hydrophilic if it exhibits contact angles of approximately 0° to 10°, 5 to 15°, 10° to 20°, 15° to 25°, 20° to 30°, 25° to 35°, 30° to 40°, 35° to 45°, 40° to 50°, 45° to 55°, 50° to 60°, 55° to 65°, 60° to 70°, 65° to 75°, 70° to 80°, 75° to 85°, or 80° to 90° with respect to water (the main component of body fluids). Generally, as the hydrophilicity of a polyurethane foam increases (i.e., as the contact angle between the polyurethane foam and water decreases), the amount of body fluid that the polyurethane foam can absorb in a given time increases. However, increasing the hydrophilicity of the polyurethane foam can increase the amount of bodily fluid retained within the polyurethane foam after it has received it. Therefore, the hydrophilicity of the polyurethane foam can be selected based on adequately meeting the need for rapid bodily fluid reception while also maintaining the dryness of the porous material 110. For example, a fluid collection assembly 100 configured for short-term use in individuals with large bladders may contain a polyurethane foam that exhibits stronger hydrophilicity than the polyurethane foam in a fluid collection assembly 100 configured for long-term use in individuals with average to small-sized bladders.

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

[0020] The polyurethane foam defines one or more small pores. The small pores form passages through the polyurethane foam through which one or more body fluids can flow. In one embodiment, the polyurethane foam has about 4 small pores / cm 2 ~ about 6 small pores / cm 2 , 5 small pores / cm 2 ~ about 7 small pores / cm 2 , 6 small pores / cm 2 ~ about 8 small pores / cm 2 , 7 small pores / cm 2 ~ about 9 small pores / cm 2 , 8 small pores / cm 2 ~ about 10 small pores / cm 2 , 9 small pores / cm 2 ~ about 11 small pores / cm 2 , 10 small pores / cm 2 ~ about 12 small pores / cm 2 , 11 small pores / cm 2 ~ about 13 small pores / cm 2 , 12 small pores / cm 2 ~ about 14 small pores / cm 2 , 13 small pores / cm 2 ~ about 15 small pores / cm 2 , 14 small pores / cm 2 ~ about 16 small pores / cm 2 , or 15 small pores / cm 2 ~ about 17 small pores / cm 2 and exhibits a porosity of. The porosity of the polyurethane foam can be selected based on the desired maximum amount of body fluid flowing through the polyurethane foam over a certain period of time, the density of the polyurethane foam, and the roughness of the surface of the polyurethane foam that affects the degree of comfort when the polyurethane foam contacts the vaginal area.

[0021] The porosity of the polyurethane foam also depends on the average lateral dimension of the pores along the direction perpendicular to the longitudinal axis 118 of the fluid collection assembly 100. The average lateral dimension of the small holes can be selected to be approximately 100 μm to 300 μm, 200 μm to 400 μm, 300 μm to 500 μm, 400 μm to 600 μm, 500 μm to 700 μm, 600 μm to 800 μm, 700 μm to 900 μm, 800 μm to 1 mm, 900 μm to 1.2 mm, 1 mm to 1.5 mm, 1.25 mm to 1.75 mm, 1.5 mm to 2 mm, 1.75 mm to 2.5 mm, 2 mm to 3 mm, 2.5 mm to 3.5 mm, 3 mm to 4 mm, 3.5 mm to 4.5 mm, or 4 mm to 5 mm. Generally, increasing the average lateral dimension of the pores can decrease porosity, reduce the density of the polyurethane foam, and potentially increase the amount of bodily fluid that can be received into the polyurethane foam in a given time. However, increasing the average lateral dimension of the pores can also increase the surface roughness of the polyurethane foam, which may make it more comfortable when in contact with the vaginal region. Therefore, the average lateral dimension of the pores of the polyurethane foam can be selected based on balancing these factors. For example, a fluid collection assembly configured for use with individuals with large bladders, or one with a gauze layer covering the polyurethane foam (as shown in Figure 2A or 2B), may contain a polyurethane foam with a larger average lateral dimension of pores than the polyurethane foam in a fluid collection assembly configured for use with individuals with average or small bladders and / or configured to be in direct contact with the vaginal region.

[0022] Polyurethane foam has a weight of approximately 70 kg / m³. 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~about 130 kg / m 3 、about 120 kg / m 3 ~about 140 kg / m 3 、or about 130 kg / m 3 ~about 150 kg / m 3 It may exhibit an average density that is. Generally, when the density of the polyurethane foam decreases, at least one of the following may occur: the porosity of the polyurethane foam increases, the average lateral dimension of the small holes increases, the amount of body fluid that can be received into the polyurethane foam within a certain time increases, the surface roughness of the polyurethane foam increases, and the strength and toughness of the polyurethane foam decrease. Therefore, the density of the polyurethane foam can be selected based on taking the balance of these factors as described above.

[0023] The polyurethane foam can be configured to receive body fluid 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 in the range of about 10 mL / s to about 15 mL / s, about 12.5 mL / s to about 17.5 mL / s, about 15 mL / s to about 20 mL / s, about 17.5 mL / s to about 22.5 mL / s, about 20 mL / s to about 25 mL / s, about 22.5 mL / s to about 27.5 mL / s, about 25 mL / s to about 30 mL / s, about 27.5 mL / s to about 35 mL / s, or about 30 mL / s to about 40 mL / s within itself. As described above, the rate at which the polyurethane foam receives body fluid depends at least in part on the porosity of the polyurethane foam, the average lateral dimension of the small holes, the density, and the hydrophilicity.

[0024] As described above, the polyurethane foam can be formed from a hydrophilic material, whereby the polyurethane foam can hold body fluid within itself. To reduce the amount of body fluid held by the polyurethane foam, the outer layer 112 can be configured to be relatively thin. For example, the outer layer 112 can be configured to have a thickness 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 in the range of 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, measured perpendicular to the longitudinal axis 118 (e.g., measured radially). By the relatively small thickness of the outer layer 112, the total volume of the polyurethane foam is reduced, whereby the volume of body fluid that can be held within the polyurethane foam is reduced. By reducing the volume of body fluid held within the polyurethane foam, the airflow through the cavity 104 can rapidly evaporate the body fluid held within the polyurethane foam, thereby keeping the porous material 110 in a dry state. Further, by reducing the thickness of the outer layer 112, the inner layer 114 (e.g., polyethylene foam) may be able to draw more body fluid from the polyurethane foam.

[0025] In one embodiment, the polyurethane foam of the outer layer 112 can be formed by extrusion, such as co-extruded with the inner layer ۱۱۴. In one embodiment, the polyurethane foam can be formed as a sheet (e.g., using techniques of molding, casting, extrusion, or tape casting) and then disposed to cover the inner layer 114. In one embodiment, the polyurethane foam can be molded or cast (e.g., around it) to cover the 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, the polyurethane foam. In one embodiment, the additional material of the outer layer 112 may include gauze (e.g., silk, linen, or cotton gauze), woven material, nonwoven material, textiles such as another flexible fabric, another smooth fabric, polyethylene foam, or another suitable porous material. By forming the additional material of the outer layer 112 from gauze, flexible fabric, and / or smooth fabric, the occurrence of scratches caused by the fluid collection assembly 100 can be reduced. In one embodiment, the additional material of the outer layer 112 may exhibit the same or different hydrophobicity, porosity, average lateral dimension of pores, density, or rate at which the additional material can receive body fluids (e.g., mL / s) as described above with respect to the polyurethane foam.

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

[0028] As described above, the inner layer 114 may contain polyethylene foam. In one embodiment, the polyethylene foam may be hydrophobic. The hydrophobicity of the polyethylene foam allows the polyethylene foam to rapidly push out the bodily fluid, or the bodily fluid to be drawn through the polyethylene foam to the outlet of the fluid collection assembly 100 (for example, to the fluid outlet 108, or to the inlet of the conduit 116 located in the cavity 104). By pushing or drawing out the bodily fluid to the outlet of the fluid collection assembly 100, the porous material 110 can be dried or substantially dried immediately after receiving the bodily fluid. Polyethylene foam can be hydrophobic if it exhibits contact angles of approximately 90° to 100°, 95° to 105°, 100° to 110°, 105° to 115°, 110° to 120°, 115° to 125°, 120° to 130°, 125° to 135°, 130° to 140°, 135° to 145°, 140° to 150°, 145° to 155°, 150° to 160°, 155° to 165°, 160° to 170°, 165° to 175°, or 170° to 180° with respect to water (a major component of body fluids). Generally, increasing the hydrophobicity of polyethylene foam (i.e., increasing the contact angle between the polyethylene foam and water) allows the polyethylene foam to move bodily fluids to the outlet more quickly. However, increased hydrophobicity of polyethylene foam can reduce the amount of bodily fluid that can be received into the polyethylene foam in a given time. Surprisingly, however, it has been found that using polyurethane foam allows a larger amount of bodily fluid to enter the polyethylene foam than when the porous material 110 is made of other materials. Therefore, the hydrophobicity of the polyethylene foam can be selected based on adequately meeting the need to quickly move bodily fluids to the 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 in an individual with a large bladder may contain polyethylene foam that exhibits weaker hydrophobicity than the polyethylene foam of a fluid collection assembly 100 configured for long-term use in an individual with an average to small bladder size.

[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. In one embodiment, the hydrophobicity of the polyethylene foam can be altered by adding at least one of impurities (e.g., fibers) or functional groups to the polyethylene foam, otherwise by treating the polyethylene foam, or by coating the polyethylene foam with a material that exhibits different hydrophobicity than the polyethylene foam.

[0030] The polyethylene foam defines one or more pores. The pores form passages that penetrate the polyethylene foam, through which one or more bodily fluids can flow. In one embodiment, the polyethylene foam has 8 pores / cm². 2 ~Approximately 10 small holes / cm 2 9 small holes / cm 2 ~Approximately 11 small holes / cm 2 10 small holes / cm 2 ~Approximately 12 small holes / cm 2 , 11 small holes / cm 2 ~Approximately 13 small holes / cm 2 12 small holes / cm 2 ~Approximately 14 small holes / cm 2 13 small holes / cm 2 ~Approximately 15 small holes / cm 2 14 small holes / cm 2 ~Approximately 16 small holes / cm 2 15 small holes / cm 2 ~Approximately 17 small holes / cm 2 Approximately 16 small holes / cm 2 ~Approximately 18 small holes / cm 2 17 small holes / cm 2 ~Approximately 19 small holes / cm 2 18 small holes / cm 2~Approximately 20 small holes / cm 2 19 small holes / cm 2 ~Approximately 21 small holes / cm 2 Approximately 20 small holes / cm 2 ~Approximately 22 small holes / cm 2 21 small holes / cm 2 ~Approximately 23 small holes / cm 2 , 22 small holes / cm 2 ~Approximately 24 small holes / cm 2 23 small holes / cm 2 ~Approximately 25 small holes / cm 2 Approximately 24 small holes / cm 2 ~Approximately 26 small holes / cm 2 25 small holes / cm 2 ~Approximately 27 small holes / cm 2 26 small holes / cm 2 ~Approximately 28 small holes / cm 2 27 small holes / cm 2 ~Approximately 29 small holes / cm 2 , or approximately 28 small holes / cm 2 ~Approximately 30 small holes / cm 2 It exhibits a porosity. The porosity of polyethylene foam can be selected based on the desired amount of bodily fluid that can be received by the polyethylene foam and flow through it in a given 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 small holes along a direction perpendicular to the longitudinal axis 118 of the fluid collection assembly 100. The average lateral dimension of the small holes 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. Generally, as the average lateral dimension of the small holes increases, the porosity decreases, the density of the polyethylene foam decreases, and the amount of body fluid that can be received into and flow through the polyethylene foam over a certain period of time may increase. However, as the average lateral dimension of the small holes increases, the polyethylene foam may become fragile and body fluid may be able to remain therein. Therefore, the average lateral dimension of the small holes of the polyethylene foam can be selected based on balancing these factors.

[0032] The polyethylene foam has a density of about 60 kg / m 3 ~ about 80 kg / m 3 、 a density of about 70 kg / m 3 ~ about 90 kg / m 3 、 a density of about 80 kg / m 3 ~ about 100 kg / m 3 、 a density of about 90 kg / m 3 ~ about 110 kg / m 3 、 a density of about 100 kg / m 3 ~ about 120 kg / m 3 、 a density of about 110 kg / m 3 ~ about 130 kg / m 3 、 a density of about 120 kg / m 3 ~ about 140 kg / m 3 、 or a density of about 130 kg / m 3 ~ about 150 kg / m 3It may exhibit an average density of . Generally, when the density of polyethylene foam decreases, at least one of the following may occur: the porosity of the polyethylene foam increases, the average lateral dimension of the small pores increases, the amount of fluid that can be received into and flow through the polyethylene foam in a given time increases, and the strength and toughness of the polyethylene foam decreases. Therefore, the density of polyethylene foam can be selected based on balancing these factors, as described above.

[0033] The polyethylene foam of the inner layer 114 can be formed using any suitable technique. In one embodiment, the polyethylene foam can be formed into a cylindrical or generally cylindrical shape (for example, a generally hollow cylindrical shape) by casting or molding techniques. In one embodiment, the polyethylene foam can be extruded, such as by co-extrusion molding together with the outer layer 112. In one embodiment, the polyethylene foam can be formed as a sheet (for example by molding, casting, extrusion molding, 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. By selecting the porous material 110 to include both polyurethane foam and polyethylene foam, it has been found that the porous material 110 can receive bodily fluids more quickly, move the bodily fluids more quickly to the outlet of the fluid collection assembly 100, and keep the porous material 110 drier than if the porous material 110 contained only one of the polyurethane foam or polyethylene foam. For example, it has been found that bodily fluids received in the polyurethane foam can flow rapidly from the polyurethane foam to the polyethylene foam. Furthermore, the polyethylene foam can remove at least some of the bodily fluids that would otherwise have remained in the polyurethane foam.

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

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

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

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

[0039] The storage section 120 is a substantially unoccupied portion of the cavity 104. The storage section 120 can be defined between the fluid-impermeable barrier 102 and one or both of the outer layer 112 or the inner layer 114. Body fluid present in the cavity 104 can flow through the porous material 110 to the storage section 120. The storage section 120 can hold body fluid inside.

[0040] The bodily fluids within the cavity 104 can flow through the porous material 110 to the reservoir 120. The fluid-impermeable barrier 102 can retain the bodily fluids within the reservoir 120. The reservoir 120 is illustrated in the distal end region 122, but can be installed in any part of the cavity 104, such as the proximal end region 124. The reservoir 120 can be installed in a part of the cavity 104 that is designed to be located lower relative to the gravity of the fluid collection assembly when the fluid collection assembly is installed.

[0041] In some embodiments (not shown), the fluid collection assembly 100 may comprise multiple reservoirs, such as a first reservoir located in the portion of the cavity 104 closest to the inlet of the conduit 116 (e.g., the distal end region 122) and a second reservoir located in the portion of the cavity 104 located in or close to the proximal end region 124. In another embodiment, the inner layer 114 is separated 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 positioned at least partially within the cavity 104. The conduit 116 can be used to remove bodily fluids from the cavity 104. The conduit 116 comprises at least one wall defining an inlet, an outlet (not shown) downstream from the inlet, and a passage. The outlet of the conduit 116 can be operably coupled to a vacuum source, such as a vacuum pump, for removing fluid from the cavity 104 through the conduit 116. For example, the conduit 116 can extend from a proximal end region 124 into the fluid-impermeable barrier 102, and can extend to a distal end region 122, close to the reservoir 120, so that the inlet is in fluid communication with the reservoir 120. The conduit 116 fluidly connects the cavity 104 to a fluid storage container (not shown) or a vacuum source (not shown).

[0043] The conduit 116 may 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 position close to the reservoir 120. In such an embodiment, the inlet does not extend into the reservoir 120, but instead may be located within the porous material 110 or at its end. For example, the end of the conduit 116 may be coplanar with the porous material 110 or embedded within the porous material 110. In one embodiment, the conduit 116 may be located at least partially within the reservoir 120, and the inlet may extend into the reservoir 120 or be located within the reservoir 120. The bodily fluid collected in the fluid collection assembly 100 can be removed from the cavity 104 via the conduit 116.

[0044] By positioning the inlet of the conduit 116 at or near a location that is expected to be lower relative to gravity in the cavity 104 when worn by an individual, the conduit 116 can receive more bodily fluids than if the inlet were located elsewhere, and mitigating situations similar to stagnation (for example, stagnation of bodily fluids can lead to the growth of microorganisms and the generation of unsanitary odors). For example, bodily fluids in the porous material 110 can flow in any direction due to capillary forces. However, bodily fluids may exhibit a preference for flowing in the direction of gravity, especially if at least a portion of the porous material 110 is filled with bodily fluids. Therefore, one or more inlets or reservoirs 120 of the conduit 116 can be positioned in the fluid collection assembly 100 at locations that are expected to be lower relative to gravity in the fluid collection assembly 100 when worn by an individual, such as the 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., the reservoir 120). When a vacuum / suction force is applied in the conduit 116 by the vacuum source, the fluid in the cavity 104 (e.g., in the distal end region 122, such as inside the reservoir 120) can be drawn into the inlet of the conduit 116 and through the conduit 116 to the outside of the fluid collection assembly 100. In some embodiments, the conduit 116 can be frosted or opaque to obscure the fluid inside it.

[0046] 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 or inner layers. Figure 2A is a schematic cross-sectional view of a fluid collection assembly 200 according to one embodiment. Figure 2B is a schematic cross-sectional view of a fluid collection assembly along the line 2B-2B shown in Figure 2A. Unless otherwise disclosed herein, the fluid collection assembly 200 is identical or substantially similar to any fluid collection assembly disclosed herein. For example, the fluid collection assembly 200 may include a fluid-impermeable barrier 202 defining at least 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 have one or more additional layers 226 instead of or in addition to the outer layer 212 or inner layer 214. In one embodiment, as shown, the additional layer 226 may be located on the surface of the outer layer 212 and extend across the opening 206. In such an embodiment, the additional layer may include gauze or other material that is comfortable in contact with the individual's vaginal area or is visually more pleasing than the outer layer 212. It is known that the thickness of the additional layer 226 can be minimized (e.g., about 1 mm or less or about 0.5 mm or less) so that any influence the additional layer 226 has on the porous material 210 that receives bodily fluids discharged by the individual is minimized. 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.

[0048] In some embodiments, the porous material 210 may comprise one or more additional layers. For example, the porous material 210 may comprise one or more additional layers located on the surface 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 comprise 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 women (e.g., urine from a woman's urethra). However, the fluid collection assemblies, fluid collection systems, and fluid collection methods disclosed herein may include male fluid collection assemblies shaped, dimensioned, and otherwise configured to collect bodily fluids from men (e.g., urine from a man's urethra). Figure 3 is a cross-sectional view of a male fluid collection assembly 300 according to one embodiment.

[0050] Referring to Figure 3, the fluid collection assembly 300 comprises a base 330 (e.g., an annular base) and a sheath 332. The base 330 is bonded to the skin surrounding the male urethral opening (e.g., the penis) and is made of a material and shape such that the male urethral opening is positioned through it. For example, the base 330 may define a hole 334. The base 330 may be dimensioned and shaped to be positioned around the male urethral opening (e.g., around or on the penis), and the hole 334 may be configured such that the male urethral opening passes through it. The base 330 may also be dimensioned, shaped, made of such a material, or otherwise configured to bond to the skin around the male urethral opening (e.g., around the penis) (e.g., adhesively attached, such as by using a hydrogel adhesive). In one embodiment, the base 330 may exhibit the general shape or contour of the skin surface to which the base 330 is bonded. The base 330 is flexible, which allows it to conform to any shape of the skin surface. The base 330 also defines a hollow region configured to receive (for example, seal to) the sheath 332. The base 330 is located in the proximal end region 324 (relative to the wearer) of the fluid collection assembly 300.

[0051] The sheath 332 comprises a fluid-impermeable barrier 302 that is dimensioned and shaped to fit into a hollow region of the base 330 (for example, it can be formed from a fluid-impermeable barrier 302). For example, the sheath 332 may be substantially tubular or cup-shaped as shown. The fluid-impermeable barrier 302, being substantially tubular or cup-shaped, can at least partially define the outer surface 336 of the sheath 332. In one or more embodiments, the fluid-impermeable barrier 302 may be similar to or identical to any fluid-impermeable barrier disclosed herein. For example, the fluid-impermeable barrier 302 may be made of any material disclosed herein for a fluid-impermeable barrier. The fluid-impermeable barrier 302 at least partially defines the cavity 304. For example, the inner surface 338 of the fluid-impermeable barrier 302 at least partially defines the periphery of the cavity 304. The cavity 304 holds bodily fluids within itself at least temporarily. As shown in the figure, the fluid collection assembly 300 may comprise a porous material 310 within itself. In one or more embodiments, the porous material 310 may be similar to or identical to any porous material disclosed herein. For example, the porous material 310 may comprise one or more of an inner layer 312, an outer layer 314, or one or more additional layers. The inner layer 312 may contain polyurethane and / or the outer layer 314 may contain polyethylene. The fluid-impermeable barrier 302 may also define an opening 306 extending through the fluid-impermeable barrier 302, which is configured to be positioned so as to allow a male urethral orifice to pass through it.

[0052] The sheath 332 also comprises, for example, at least a portion of the conduit 316 positioned internally, at least partially within the cavity 304. For example, the conduit 316 may extend from the distal end region 322 of the sheath 332 to at least the proximal end region 324 adjacent to the opening 306. The proximal end region 324 may be positioned on or near the surface of the skin around the male urethral opening (e.g., on the penis or the surrounding genital area). Thus, when the individual lies on their back, bodily fluids (e.g., urine) may collect near the opening 306 in contact with the subject's skin. The bodily fluids can be removed from the cavity 304 via the conduit 316.

[0053] In some embodiments, the fluid-impermeable barrier 302 may be made of a material that can collapse when the sheath 332 is placed under vacuum, and / or may have such a thickness, in order to remove air around the penis within the fluid collection assembly 300 in use. In such embodiments, the conduit 316 may extend only to the distal end region 322 of the cavity 304, or into its interior, (for example, without penetrating to the region adjacent to the opening 306). In such embodiments, it is possible to collect and remove urine from the fluid collection assembly 300.

[0054] In one embodiment, some portions of the cavity 304 may be substantially empty due to the variability of the size and rigidity of the male penis. However, in some embodiments, the outermost region of the cavity 304 (e.g., the periphery of the internal region of the sheath 332) may comprise 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 may be positioned (e.g., at the distal end of the cavity 304) to reduce the flow of urine from the male urethral opening and thereby prevent splashing, and / or to guide bodily fluids into a selected region 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 accumulate in the lower, gravity-relative areas of the cavity 304. The lowest points in the cavity 304 relative to gravity may, depending on the wearer's body position, be areas where the individual's skin comes into contact with the corners formed in the fluid collection assembly 300, sheath 332, or other preferred locations.

[0055] As described above, the porous material 310 may comprise 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 can be positioned between the fluid-impermeable barrier 302 and the penis inserted into the cavity 304. The outer layer 312 can be positioned 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 in the figure. The inner layer 314 can be positioned between the outer layer 312 and the fluid-impermeable barrier 302. The inner surface 338 can optionally include the end of the cavity 304 substantially opposite the opening 306 and be covered by one or both of the outer layer 312 and the inner layer 314. The outer layer 312 or the inner layer 314 can be attached to (e.g., bonded to) the fluid-impermeable barrier 302. The outer layer 312 and the inner layer 314 can be attached to each other. In some embodiments, the porous material 310 comprises only an outer layer 312 or an inner layer 314.

[0056] The fluid collection assembly 300 includes a cap 340 at its distal end region 322. The cap 340 defines an internal conduit from which bodily fluids can be removed from the fluid collection assembly 300. The internal conduit is in fluid communication with a cavity 304. The cap 340 can be positioned to cover at least a portion of the distal end region 322, one or more of the fluid-impermeable barrier 302 or the porous material 310. The cap 340 can be made of 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 receives the conduit 316 and is sized and configured to fluid-seal to the conduit 316. The conduit 316 can extend a certain distance, such as inside or through the cap 340 to the porous material 310, through the porous material 310, or to a point separated from the porous material 310. In the latter example, the internal conduit of the cap 340 can define a reservoir 320 inside.

[0057] The reservoir 320 is an unoccupied portion of the device, such as the cap 340, and is free from the presence 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 fluids in the cavity 304 can flow through the porous material 310 into the reservoir 320. The reservoir 320 can accommodate bodily fluids so that at least some of them are stored inside and / or removed 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 fluids to be drawn directly into the reservoir 320 from the opening.

[0058] In some embodiments (not shown), the fluid-impermeable barrier 302 can be positioned on the surface of the cap 340 or covering the cap 340 so as to surround the cap 340 within the cavity 304.

[0059] In some embodiments, the sheath 332 may be equipped with a conduit 316, such that at least a portion of the conduit 316 is located inside the cavity 304. For example, the conduit 316 may extend from the sheath 332 to at least a region adjacent to the opening 306. The inlet of the conduit 316 may be located adjacent to the annular base 342. The inlet of the conduit 316 may be located adjacent to or near a low point in the cavity 304 relative to gravity, such as adjacent to the annular base 342. For example, the inlet may extend to the same position as the opening 306, or it may be offset from the opening 306. In some embodiments, the inlet may be located adjacent to the distal end region 322 of the sheath 332 (substantially opposite the opening 306).

[0060] The proximal end region 324 can be located 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 within the proximal end region 324. The outlet of the conduit 316 can be connected directly or indirectly 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, sheath 332, cap 340, and conduit 316 can be attached together using any preferred method. For example, at least two of the base 330, sheath 332, cap 340, and conduit 316 can be attached together using at least one of the following: interference fit, adhesive, stitching, welding (e.g., ultrasonic bonding), tape, any other preferred method, or a combination thereof.

[0062] In some embodiments (not shown), the fluid collection assembly 300 may 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 component.

[0063] As shown in the figure, the conduit 316 can be positioned at least partially 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 to adjacent to the base 330. The conduit 316 is sized and positioned to be coupled to a fluid storage container or vacuum source. The outlet of the conduit 316 can be coupled to the vacuum source directly or indirectly in an operable manner. The inlet of the conduit 316 can be positioned in the cavity 304 at a location expected to be low relative to gravity of the fluid collection assembly in use. By positioning the inlet of the conduit 316 at a location expected to be low relative to gravity of the fluid collection assembly when worn by the user, bodily fluids introduced into the cavity 304 can be removed through the conduit 316 to prevent the bodily fluids from accumulating or stagnating in 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 can be fluidly connected to a fluid storage container that can be located between the vacuum source and the fluid collection assembly 300.

[0065] During operation, a man using the fluid collection assembly 300 can discharge bodily fluids (e.g., urine) into the cavity 304. The bodily fluids may remain in the cavity 304 or be collected. At least some of the bodily fluids can be drawn in through the inlet to the inlet of the conduit 316. The bodily fluids can be discharged from the fluid collection assembly 300 by the vacuum / suction force provided by the vacuum source.

[0066] The porous materials disclosed herein can be used for 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 schematic cross-sectional view of the fluid collection assembly along plan 4B-4B. The fluid collection assembly 400 is an example of a male fluid collection assembly, but in some embodiments, the fluid collection assembly 400 can be used to collect bodily fluids from the female urethral opening. The fluid collection assembly 400 comprises a sheath 432 and a base 430. The base 430 is configured to attach to the sheath 432 (e.g., permanently attached or configured to be permanently attached). The base 430 is also configured to attach to the area around the individual's urethral opening (e.g., the penis).

[0067] The sheath 432 comprises a fluid-impermeable barrier 402 formed at least partially 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 formed integrally together (for example, in the form of a single part). 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 in the proximal end region PER of the sheath 432, and a fluid outlet 408 in the 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 surfaces of the fluid-impermeable barrier 402 (for example, the inner surfaces of the first panel 444 and the second panel 446) at least partially define the 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. Thus, 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 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 at least partially transparent fluid-impermeable material allows a person (e.g., a general practitioner) to examine the penis. For example, the cavity 404 may include a penile receiving area 448 configured to receive the penis when the individual's penis extends into the cavity 404. The penile receiving area 448 can be defined by at least a 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 the 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 portion of the first panel 444 and / or the second panel 446. The porous material 410 is not generally transparent, and therefore, at least a portion of the partially transparent material of the first panel 444 and / or the second panel 446, which defines the penile receiving area 448, forms a window that allows a person to look into the penile receiving area 448 and examine the penis.

[0070] The opening 406, defined by the fluid-impermeable barrier 402, provides an entry route for bodily fluids into the cavity 404 when the penis is buried, and allows the penis to enter the cavity 404 (e.g., the penile receiving region 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 may be formed within the fluid-impermeable barrier 402 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 located within the cavity 404, otherwise it is in fluid communication with the cavity 404 through the fluid outlet 408. The fluid outlet 408 is sized and shaped to form at least substantially a fluid-sealed seal with respect to the conduit 416, thereby substantially preventing body fluid from leaking out of the cavity 404. In one embodiment, the fluid outlet 408 can be formed from portions of a first panel 444 and a second panel 446 that are not adhering to each other or integrally formed together. In such an embodiment, the fluid-impermeable barrier 402 does not need to have a cap that is more rigid than the surrounding portion of the fluid-impermeable barrier 402, thereby facilitating the manufacture of the fluid collection assembly 400, reducing the number of parts used to form the fluid collection assembly 400, and reducing the time required to manufacture the fluid collection assembly 400. The absence of a cap may make it difficult to secure the conduit 416 to the fluid outlet 408 using a pressure fit, but it is known that it may still be possible to attach the conduit 416 to the fluid outlet 408. Therefore, the conduit 416 can be attached to the fluid outlet 408 by bonding the conduit 416 to the fluid outlet 408 with adhesive, welding, or by other means. Attaching the conduit 416 to the fluid outlet 408 prevents leakage and prevents the conduit 416 from being accidentally detached from the fluid outlet 408. In one embodiment, the conduit 416 can be attached to the fluid outlet 408 in the same manufacturing step as bonding the first panel 444 and the second panel 446 together.

[0072] As described above, the sheath 432 comprises at least one porous material 410 exposed to the cavity 404. The porous material 410 can guide bodily fluids to one or more selected areas of the cavity 404, such as away from the penis toward the fluid outlet 408. The porous material 410 can be formed from any porous material 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 may be a sheet. Forming the porous material 410 as a sheet allows for easy manufacturing 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 sheets. 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 each other in the same manufacturing step. For example, the porous material 410 may have the same dimensions as the first panel 444 and the second panel 446, or more preferably, a slightly smaller shape. Therefore, by attaching the first panel 444 and the second panel 446 integrally along their respective outer edges, the porous material 410 can also be attached to the first panel 444 and the second panel 446. By making the porous material 410 slightly smaller than the first panel 444 and the second panel 446, the first panel 444 and / or the second panel 446 can extend around the porous material 410, preventing the porous material 410 from forming a passage through the fluid-impermeable barrier 402 from which bodily fluids could leak. Furthermore, by adhering the porous material 410 to the first panel 444 and / or the second panel 446, it is possible to prevent the porous material 410 from moving significantly within the cavity 404, such as preventing the porous material 410 from accumulating near the fluid outlet 408. In one embodiment, the porous material 410 can be adhering to the first panel 444 or the second panel 446 (for example, by adhesive) before or after adhering the first panel 444 to the second panel 446. In one embodiment, the porous material 410 can be simply placed in 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 may have a shape other than a sheet, such as a hollow, generally cylindrical shape.

[0074] Generally, the sheath 432 is substantially flattened when the penis is not in the penile receiving area 448 and the sheath 432 is placed on a flat surface. The sheath 432 is substantially flattened because the fluid-impermeable barrier 402 is not a generally tubular fluid-impermeable barrier, but is formed from a first panel 444 and a second panel 446. Furthermore, as described above, the porous material 410 may be a sheet, which also results in the sheath 432 being substantially flattened. The sheath 432 may also be substantially flattened if the fluid collection assembly 400 does not have a relatively rigid ring or cap that exhibits greater rigidity than the surrounding fluid-impermeable barrier 402 portion. This is because such rings and caps may prevent the sheath 432 from being substantially flattened. The sheath 432 is described as having a substantially flat shape because at least one porous material 410 may form some bulges within the sheath 432 depending on the thickness of the porous material 410, the fluid outlets 408 and / or conduits 416 may create bulges around them, or the base 430 may pull on parts of the sheath 432 around itself. Furthermore, it is known that the sheath 432 may be placed on non-flat surfaces during use (for example, between the testicles, perineum, and / or thighs), and the sheath 432 may conform to the shape of those surfaces, so the sheath 432 is also shape-adaptive, and therefore may not have a substantially flat shape during use.

[0075] When the penis is not present in the penile receiving area 448 and the sheath 432 is placed on a flat surface, the sheath 432 can be substantially flat, which makes it possible to use the fluid collection assembly 400 for both buried and unburied penises. For example, when the fluid collection assembly 400 is used for a buried penis, the penis does not extend within the penile receiving area 448, and the sheath 432 lies in a relatively flat shape so as to block the aperture 434 of the base 430. When the sheath 432 lies in a relatively flat shape so as to block the aperture 434, the porous material 410 extends to block the opening 406 and the aperture 434, and comes into very close proximity to the buried penis. Therefore, the porous material 410 receives and removes at least a substantial portion of the bodily fluids that would otherwise remain in contact with the individual's skin, thus preventing or inhibiting the accumulation of bodily fluids discharged from a buried penis in contact with the individual's skin. Consequently, the individual's skin remains dry, thereby improving the comfort of using the fluid collection assembly 400 and preventing deterioration of skin condition. However, unlike other conventional fluid collection assemblies configured for use with buried penises, the fluid collection assembly 400 can still receive an unburied penis within the penile receiving area 448 even when the penis is fully erect, and can therefore also be used with an unburied penis. In addition, the fact that the sheath 432 can be substantially flattened allows the fluid collection assembly 400 to be used more gently than if the sheath 432 were not substantially flattened, thereby avoiding the development of potentially embarrassing events.

[0076] If the sheath 432 is roughly flat, the porous material 410 occupies almost the entire cavity 404, and the penile receiving area 448 is crushed (in Figure 4B, it is shown in an uncrushed form for illustrative purposes to show the penile 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 almost the entire cavity 404, bodily fluids discharged into the cavity 404 tend not to remain for a considerable time, because if bodily fluids remain, sanitary problems may arise, odors may be generated, and / or the individual's skin may remain in contact with the bodily fluids, potentially causing discomfort and deterioration of the skin condition.

[0077] As described 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 enough 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 substantially flat shape, as described 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 even when the size and shape of the penis changes (for example, when erect), and minimizes any unoccupied space within the cavity 404 where bodily fluids may accumulate.

[0078] As described above, the fluid collection assembly 400 includes a base 430 configured to be attached to the sheath 432. For example, the base 430 is configured to be permanently attached to the sheath 432. The base 430 is provided with, for example, a base 430 permanently attached to the sheath 432 in the fluid collection assembly 400, or 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 by using a cutting tool to separate the sheath 432 from the base 430 and / or by using a chemical that breaks down the adhesive that is adhering the sheath 432 to the base 430 without damaging at least one of the sheath 432 or the base 430. The base 430 can be permanently attached to the sheath 432 by adhesive, stitching, heat welding, high-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 dimensioned, shaped, and made of such material to bond to the skin surrounding the penis (e.g., the pubic mound, thigh, testicles, and / or perineum) and the penis is positioned to pass through it. For example, the base 430 can define an aperture 434 configured to bond to the penis. In one embodiment, the base 430 may take on the general shape or contour of the skin surface to which the base 430 is configured to bond. The base 430 may be flexible so that it can conform to any shape of the skin surface and reduce the pulling of the base 430 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, compared to a substantially similar fluid collection assembly 400 without a base.

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

[0081] Figure 5 is a block diagram of a fluid collection system 550 for fluid collection according to one embodiment. The fluid collection system 550 comprises a fluid collection assembly 500, a fluid storage container 552, and a vacuum source 554. The fluid collection assembly 500 may be identical 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 fluidly connected to each other via 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 via the conduits 516. Bodily fluids collected in the fluid collection assembly 500 can be removed from the fluid collection assembly 500 via the conduits 516 protruding into the fluid collection assembly 500. For example, the inlet of the conduit 516 may extend into the fluid collection assembly 500, for example, into a storage area therein. The outlet of the conduit 516 may extend into the fluid collection assembly 500 or the vacuum source 554. A suction force can be introduced into the cavity of the fluid collection assembly 500 through the inlet of the conduit 516 in response to a suction (e.g., vacuum) force applied to the outlet of the conduit 516.

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

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

[0084] The vacuum source 554 may include one or more of the following: a manual vacuum pump, an electric vacuum pump, a diaphragm pump, a centrifugal pump, a capacitive pump, a magnetically driven pump, a peristaltic pump, or any pump configured to generate a vacuum. The vacuum source 554 can provide a vacuum or suction force to remove bodily fluids from the fluid collection assembly 500. In some embodiments, the vacuum source 554 may be powered by one or more of the following: a power cord (e.g., connected to a power socket), one or more batteries, or even manual force (e.g., a manual vacuum pump). In some embodiments, the vacuum source 554 may be sized and shaped to be mounted externally, on the surface, or internally of the fluid collection assembly 500. For example, the vacuum source 554 may include one or more miniaturized pumps or one or more micropumps. The vacuum source 554 disclosed herein may comprise one or more of the following: a switch, a button, a plug, a remote controller, or any other device suitable for operating the vacuum source 554.

[0085] While various aspects and embodiments have been disclosed herein, other aspects and embodiments are conceivable. The various aspects and embodiments disclosed herein are for illustrative purposes only and are not intended to be limiting.

[0086] Terms of degree (e.g., “approximately,” “roughly,” “substantially,” “generally,” “approximately”) refer to variations that are not structurally or functionally significant. In any embodiment, if a term of degree is included with a term of quantity, the term of degree is interpreted to mean ±10%, ±5%, or +2% of the term of quantity. In any embodiment, if 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 mean that a shape may have rounded corners instead of sharp corners, curved edges instead of straight edges, one or more projections extending from itself, be oblong, or be identical to the disclosed shape.

Claims

1. A fluid collection assembly, cavity, At least one opening, and fluid outlet A fluid-impermeable barrier that at least defines, At least one porous material is disposed in the cavity and comprises an inner layer and an outer layer disposed on the surface of the inner layer, wherein the inner layer comprises polyethylene foam and the outer layer comprises hydrophilic polyurethane foam. A fluid collection assembly characterized by comprising the following features.

2. A fluid collection assembly according to claim 1, wherein the average porosity of the polyurethane foam is 6 pores / cm² ２ ~14 small holes / cm ２ A fluid collection assembly characterized by being within a certain range.

3. A fluid collection assembly according to claim 1, wherein the average density of the polyurethane foam is approximately 100 kg / m³ ３ ~Approx. 150kg / m ３ A fluid collection assembly characterized by being within a certain range.

4. A fluid collection assembly according to claim 1, wherein the polyethylene foam is hydrophobic.

5. A fluid collection assembly according to claim 1, wherein the average porosity of the polyethylene foam is about 12 pores / cm². ２ ~28 pores / cm ２ A fluid collection assembly characterized by being within a certain range.

6. A fluid collection assembly according to claim 1, wherein the polyethylene foam has a larger number of pores / cm than the polyurethane foam. ２ A fluid collection assembly characterized by exhibiting the following features.

7. The fluid collection assembly according to claim 1, wherein the density of the polyethylene foam is 70 kg / m ３ to about 150 kg / m ３ and is within the range of. A fluid collection assembly characterized by this.

8. A fluid collection assembly according to claim 1, wherein the polyethylene foam is the number of pores of the polyurethane foam / cm ２ Larger number of pores / cm ２ A fluid collection assembly characterized by exhibiting the following features.

9. A fluid collection assembly according to claim 1, wherein the at least one porous material comprises one or more additional layers disposed on the surface of the polyurethane foam.

10. A fluid collection assembly according to claim 1, wherein the polyurethane foam extends to cover the at least one opening.

11. A fluid collection assembly according to claim 1, characterized in that the opening is positioned adjacent to the female urethral opening so as to receive bodily fluids from the female urethral opening.

12. A fluid collection assembly according to claim 1, comprising a sheath having a fluid-impermeable barrier, wherein the male urethral opening is positioned to pass through the opening, thereby being configured to receive one or more bodily fluids from the male urethral opening.

13. A fluid collection assembly according to claim 1, characterized in that it can store bodily fluids in the cavity for a period of time longer than 24 hours.

14. A fluid collection assembly according to claim 1, characterized in that the outer layer has a thickness of about 0.4 mm or less.

15. A fluid collection assembly according to claim 1, wherein the polyurethane foam exhibits a higher density than the polyethylene foam.

16. A fluid collection assembly, cavity, At least one opening, and fluid outlet A fluid-impermeable barrier that at least defines, At least one porous material comprising an inner layer and an outer layer disposed on the surface of the inner layer, wherein the inner layer comprises a hydrophobic polyethylene foam and the outer layer comprises a hydrophilic polyurethane foam, A fluid collection assembly characterized by comprising the following features.

17. A fluid collection assembly according to claim 16, The polyethylene foam is the number of pores in the polyurethane foam / cm ２ Larger number of pores / cm ２ It presents, The fluid collection assembly is characterized in that the polyurethane foam exhibits a higher density than the polyethylene foam.

18. A fluid collection assembly according to claim 16, The aforementioned polyurethane foam has an average porosity of approximately 6 pores / cm². ２ ~Approximately 14 small holes / cm ２ It is within the range, and the average density is approximately 100 kg / m³. ３ ~Approx. 150kg / m ３ Within the range, The polyethylene foam has an average porosity of approximately 12 pores / cm². ２ ~Approximately 28 small holes / cm ２ It is within the range, and the density is approximately 70 kg / m³. ３ ~Approx. 150kg / m ３ A fluid collection assembly characterized by being within a certain range.

19. cavity, At least one opening, and fluid outlet A fluid-impermeable barrier that at least defines, At least one porous material is disposed in the cavity and comprises an inner layer and an outer layer disposed on the surface of the inner layer, wherein the inner layer comprises polyethylene foam and the outer layer comprises hydrophilic polyurethane foam. A fluid collection assembly characterized by comprising, Fluid storage container, A vacuum source, A fluid collection system comprising, A fluid collection system characterized in that the cavity of the fluid collection assembly, the fluid storage container, and the vacuum source are in fluid communication with each other such that the suction force provided to the cavity from the vacuum source removes one or more bodily fluids from the cavity and stores the one or more bodily fluids in the fluid storage container.

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