Fluid collection assembly including a first porous material exhibiting at least one of fluid permeability or compressibility different from that of a second porous material

Abstract

The illustrated fluid collection assembly 100 includes a fluid impermeable layer 102 that at least defines at least one opening 108, a chamber, and a fluid outlet 112. The fluid collection assembly 100 also includes a porous medium 114 disposed within the chamber and extending across the opening 108. The porous medium 114 includes a first porous material 116 and a second porous material 118. The first porous material 116 exhibits a first fluid permeability and a first compressibility. The second porous material 118 exhibits a second fluid permeability and a second compressibility. In one embodiment, the first fluid permeability of the first porous material 116 is greater than the second fluid permeability of the second porous material 118. In one embodiment, the first compressibility of the first porous material is less than the first compressibility of the second porous material 118.

Description

[Technical Field]

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS This application claims priority to U.S. Provisional Patent Application No. 63 / 241,564, filed September 8, 2021, the disclosure of which is incorporated herein by reference in its entirety. [Background technology]

[0002] A person or animal may have mobility limitations or impairments such that the general process of urination is difficult or impossible. For example, a person may suffer from or have a disability that impairs mobility. A person may have a condition that limits mobility, such as those experienced by pilots, drivers, and workers in hazardous locations. Additionally, bodily fluid collection may sometimes be necessary for monitoring or clinical testing.

[0003] Urinary catheters, such as Foley catheters, can address some conditions, such as incontinence. Unfortunately, urinary catheters can be uncomfortable and painful and can lead to complications, such as infection. Additionally, commodes, which are containers used for excretion in bedridden individuals, may be used. However, commodes are prone to discomfort, spillage, and other hygiene issues. [Prior art documents] [Patent documents]

[0004] [Patent Document 1] International Publication No. 2021 / 016026 [Patent Document 2] International Publication No. 2020 / 256865 [Patent Document 3] U.S. Patent Application Publication No. 2021 / 228795 Summary of the Invention [Means for solving the problem]

[0005] Embodiments are directed to a fluid collection assembly including a first porous material exhibiting at least one of a fluid permeability or a compressibility different from that of a second porous material, a fluid collection system including the fluid collection assembly, and a method of using the fluid collection assembly. In one embodiment, a fluid collection assembly is disclosed. The fluid collection assembly includes a fluid-impermeable layer including a proximal end region and a distal end region. The fluid-impermeable layer defines at least one opening, a chamber, and a fluid outlet. The fluid collection assembly also includes a porous medium disposed within the chamber. The porous medium includes a proximal section extending from at or near the proximal end region of the fluid-impermeable layer, a distal section extending from at or near the distal end region of the fluid-impermeable layer, a first porous material exhibiting a first fluid permeability and a first compressibility, and a second porous material exhibiting a second fluid permeability and a second compressibility. The first fluid permeability is greater than the second fluid permeability and / or the first compressibility is less than the second compressibility. The first and second porous materials are disposed in the porous medium such that the proximal section exhibits a fluid permeability greater than the fluid permeability of the distal section and / or the proximal section exhibits a compressibility less than the compressibility of the distal section.

[0006] In one embodiment, a fluid collection system is disclosed. The fluid collection system includes a fluid collection assembly. The fluid collection assembly includes a fluid-impermeable layer having a proximal end region and a distal end region. The fluid-impermeable layer at least defines at least one opening, a chamber, and a fluid outlet. The fluid collection assembly also includes a porous medium disposed within the chamber. The porous medium includes a proximal section extending from at or near the proximal end region of the fluid-impermeable layer, a distal section extending from at or near the distal end region of the fluid-impermeable layer, a first porous material exhibiting a first fluid permeability and a first compressibility, and a second porous material exhibiting a second fluid permeability and a second compressibility. The first fluid permeability is greater than the second fluid permeability and / or the first compressibility is less than the second compressibility. The first and second porous materials are disposed in the porous medium such that the proximal section exhibits a fluid permeability greater than the fluid permeability of the distal section and / or a compressibility less than the compressibility of the distal section. The fluid collection system also includes a fluid reservoir and a vacuum source. The chamber of the fluid collection assembly, the fluid reservoir, and the vacuum source are in fluid communication with each other when one or more bodily fluids are present in the chamber, and a vacuum applied from the vacuum source to the chamber of the fluid collection assembly removes the one or more bodily fluids from the chamber and accumulates the bodily fluids in the fluid reservoir.

[0007] The features of any of the embodiments of the present disclosure can be used in combination with each other without restriction. Furthermore, other features and advantages of the present disclosure will become apparent to those skilled in the art upon review of the following detailed description and accompanying drawings.

[0008] The drawings illustrate several embodiments of the present disclosure, with the same reference numbers referring to the same or similar elements or features in different views or embodiments shown in the drawings. [Brief explanation of the drawings]

[0009] [Figure 1A] FIG. 1 is a top view of a fluid collection assembly according to one embodiment. [Figure 1B]FIG. 1B is a cross-sectional schematic diagram illustrating a fluid collection assembly taken along plane 1B-1B, according to one embodiment. [Figure 2] 1B is a cross-sectional schematic diagram illustrating a fluid collection assembly showing the same top view as the fluid collection assembly shown in FIG. 1A, according to a different embodiment. [Figure 3] 1B is a cross-sectional schematic diagram illustrating a fluid collection assembly showing the same top view as the fluid collection assembly shown in FIG. 1A, according to a different embodiment. [Figure 4A] FIG. 1 is a top view of a fluid collection assembly according to one embodiment. [Figure 4B] FIG. 4B is a cross-sectional schematic view showing the fluid collection assembly taken along plane 4B-4B. [Figure 4C] 1 is a cross-sectional schematic diagram illustrating a fluid collection assembly according to one embodiment. [Figure 5] 1 is a cross-sectional schematic diagram illustrating a fluid collection assembly according to one embodiment. [Figure 6A] FIG. 1 is a top view of a fluid collection assembly according to one embodiment. [Figure 6B] 1 is a cross-sectional schematic diagram illustrating a fluid collection assembly according to one embodiment. [Figure 7] 1 is a cross-sectional schematic diagram illustrating a fluid collection assembly according to one embodiment. [Figure 8A] FIG. 1 is a top view illustrating a fluid collection assembly including a porous medium having a third porous material in addition to a first porous material and a second porous material, according to one embodiment. [Figure 8B] FIG. 8B is a cross-sectional schematic view showing the fluid collection assembly taken along plane 8B-8B. [Figure 9] FIG. 1 is a cross-sectional schematic diagram illustrating a fluid collection assembly including a porous medium having a third porous material in addition to a first porous material and a second porous material, according to one embodiment. [Figure 10] FIG. 1 is a block diagram illustrating a fluid collection system for fluid collection, according to one embodiment. DETAILED DESCRIPTION OF THE INVENTION

[0010] Embodiments are directed to a fluid collection assembly including a first porous material that exhibits at least one of a fluid permeability or compressibility different from that of a second porous material, a fluid collection system including the fluid collection assembly, and a method of using the fluid collection assembly. An exemplary fluid collection assembly includes a fluid-impermeable layer (e.g., a fluid-impermeable barrier) that at least defines at least one opening, a chamber, and a fluid outlet. The fluid collection assembly also includes a porous medium disposed within the chamber and extending across the opening. The porous medium includes a first porous material and a second porous material. The first porous material exhibits a first fluid permeability and a first compressibility. The second porous material exhibits a second fluid permeability and a second compressibility. In one embodiment, the first fluid permeability of the first porous material is greater than the second fluid permeability of the second porous material, thereby enabling the porous medium to at least one of more quickly accept one or more bodily fluids (e.g., urine) or provide more targeted vacuum (e.g., suction). In one embodiment, the first compressibility of the first porous material is less than the second compressibility of the second porous material, which can make the fluid collection assembly more comfortable to use (e.g., prevent rubbing or other contact that may be considered uncomfortable) while allowing unobstructed fluid flow.

[0011] During use, the fluid collection assembly disclosed herein is positioned adjacent to the individual's vaginal region. For example, the fluid collection assembly disclosed herein can be positioned so that a portion of the porous medium extending across the opening is adjacent to or in contact with the individual's urethral opening. After positioning the fluid collection assembly, the individual can excrete one or more bodily fluids (e.g., urine, blood, sweat, etc.). The bodily fluids can be received within the porous medium and within the chamber. The bodily fluids then flow through the porous medium to a conduit in fluid communication with the chamber. The bodily fluids can then be removed from the chamber via the conduit, thereby maintaining the individual dry. In some embodiments, a vacuum can be applied to the chamber via the conduit. The vacuum can direct the bodily fluids through the porous medium and facilitate drawing them into the conduit.

[0012] As previously mentioned, the porous medium is positioned adjacent to the individual's vaginal region, and therefore, due to the sensitivity of the individual's vaginal region, it is desirable to form the porous medium from a comfortable porous material. Generally, a comfortable porous material is smooth to prevent chafing and compressible, allowing the porous medium to conform to the shape of the vaginal region and apply pressure more uniformly. The porous medium is also configured to receive one or more bodily fluids discharged from the individual. When an individual urinates, a relatively large amount of bodily fluid may be discharged from the individual in a short period of time, and the dispersion of the bodily fluid may be concentrated in a narrow portion of the porous medium. Therefore, it is desirable to form the porous medium from a material that exhibits relatively high fluid permeability, allowing the bodily fluid to be rapidly received within the porous medium so as to prevent leakage.

[0013] Generally, smooth materials exhibit relatively low fluid permeability because increasing fluid permeability can increase the surface roughness of porous materials. For example, soft materials tend to have fine pores, which limit the amount of bodily fluid that can be accommodated in the soft material at any one time. Also, compressible materials generally tend to compress easily, which can obstruct or otherwise close passages defined by the compressible material, potentially impeding fluid flow through the passages. Materials that exhibit relatively high fluid permeability tend to define large pores that increase the surface roughness of the material, preventing them from compressing and collapsing passages defined by the material.

[0014] Conventional fluid collection assemblies address these issues by forming a porous medium that includes an outer layer and an inner layer. To make conventional fluid collection assemblies more comfortable to use, the outer layer is formed from a material that is relatively compressible and / or smooth compared to the inner layer. To improve fluid flow through conventional fluid collection assemblies, the inner layer is formed from a material that exhibits relatively high fluid permeability compared to the outer layer. The thicknesses of the inner and outer layers remain relatively constant along the entire length of the porous medium of conventional fluid collection assemblies. During use, at least initially, the amount of discharged bodily fluid is concentrated in a relatively small portion of the outer layer. However, because the outer layer was selected based on the compressibility and / or smoothness of the material rather than its fluid permeability, the outer layer may not exhibit sufficient fluid permeability to accommodate the bodily fluid discharged by an individual. Therefore, particularly during large urine volumes, the outer layer of conventional fluid collection assemblies may not be able to accommodate all of the discharged bodily fluid, thereby causing leakage of the bodily fluid. Furthermore, in such conventional fluid collection assemblies, a vacuum tends to be introduced into a portion of the porous material that is distant from the individual's urethral opening. The uniform thickness of the outer and inner pore layers of the porous media in conventional fluid collection assemblies means that the airflow generated by the vacuum is not directed toward the portion of the porous media adjacent the urethral opening (i.e., the portion of the porous media that most needs the vacuum). Conversely, the vacuum may dissipate (e.g., leak from the porous media) before reaching the portion of the porous media adjacent the urethral opening. Also, the thickness of the outer layer may be very thin, thereby reducing the benefits provided by the compressibility of the outer layer.

[0015] The fluid collection assemblies disclosed herein use different fluid permeabilities and / or compressibility of the first and second porous materials to solve at least some of these problems of conventional fluid collection assemblies. For example, the different fluid permeabilities and / or compressibility of the first and second porous materials can be configured to increase the rate at which bodily fluids are accepted into the porous materials, direct a vacuum to selected portions of the porous materials, or prevent collapse of passages through which bodily fluids can flow, while making the fluid collection assembly as comfortable as possible. In one embodiment, the different permeabilities and / or compressibility of the first and second porous materials can be configured to form different compartments within the porous medium, with the different compartments exhibiting different fluid permeabilities and / or compressibility. The different compartments can be used to improve fluid flow through the porous medium and / or to make the porous medium more comfortable. In one example, the porous material can include a proximal compartment and a distal compartment. The proximal compartment can include a portion of the porous material that is likely to contact or otherwise be positioned near the urethral opening during use, while the distal compartment is less likely to contact the urethral opening. Thus, the proximal compartment can exhibit greater fluid permeability than the distal compartment and / or less compressibility than the distal compartment, thereby improving fluid flow through the porous medium at or near the urethral opening (e.g., where fluid flow through the porous medium is most critical) and making the porous material more comfortable for portions of the vaginal region remote from the urethral opening. The first and second porous materials can be disposed within the porous medium such that the porous medium comprises a proximal compartment and a distal compartment.

[0016] It should be noted that in some embodiments, fluid permeability may refer to the permeability of a vacuum through a porous medium in addition to the permeability of bodily fluids through the porous medium. It should also be noted that a material that exhibits relatively high fluid permeability does not necessarily exhibit relatively low compressibility. For example, some materials that exhibit high fluid permeability may exhibit relatively high compressibility, and some materials that exhibit low fluid permeability may exhibit relatively low compressibility.

[0017] FIG. 1A is a top view of a fluid collection assembly 100 according to one embodiment. FIG. 1B is a cross-sectional schematic view of the fluid collection assembly 100 taken along plane 1B-1B according to one embodiment. The fluid collection assembly includes a fluid-impermeable layer 102 including a proximal end region 104 and a distal end region 106. The fluid-impermeable layer 102 at least defines at least one opening 108, a chamber 110, and a fluid outlet 112. The fluid collection assembly 100 also includes a porous medium 114 disposed within the chamber 110. The porous medium 114 includes a first porous material 116 and a second porous material 118. The first porous material 116 exhibits a first fluid permeability and a first compressibility, and the second porous material 118 exhibits a second fluid permeability and a second compressibility. The first fluid permeability is greater than the second permeability and / or the first compressibility is less than the second compressibility.

[0018] The different fluid permeabilities and / or compressibility of the first and second porous materials 116, 118 cause the porous medium 114 to include a proximal section 120 and a distal section 122. The proximal section 120 may include a portion of the porous medium 114 configured to contact or otherwise be positioned adjacent to the urethral opening, while the distal section 122 may include a portion of the porous medium 114 that is less likely to contact or otherwise be positioned adjacent to the urethral opening. In other words, the proximal section 120 is more likely to receive a large amount of bodily fluid from the urethral opening than the distal section 122. Thus, the ability of the proximal section 120 to receive and allow bodily fluid to flow rapidly therethrough may be more important than quickly receiving bodily fluid into the distal section 122. On the other hand, the distal section 122 may be configured to be more comfortable for the vaginal area because quickly receiving bodily fluid therein is not a priority. Thus, the first and second porous materials 116, 118 can be arranged in the porous medium 114 such that the proximal section 120 exhibits at least one of greater fluid permeability or less compressibility than the distal section 122.

[0019] Generally, the proximal section 120 is relatively closer to the proximal end region 104 of the fluid impermeable layer 102 than the distal section 122. Thus, the proximal section 120 can extend a distance from at or near the proximal end region 104 of the fluid impermeable layer 102. Generally, the distal section 122 is relatively closer to the distal end region 106 of the fluid impermeable layer 102 than the proximal section 120. Thus, the distal section 122 can extend a distance from at or near the distal end region 106 of the fluid impermeable layer 102 (e.g., from at or near the reservoir 124). In one embodiment, the distal section 122 extends from at or near the distal end region 106 to the proximal section 120. In one embodiment, the proximal and distal section 120, 122 can refer to the distal or proximal halves of the porous medium 114.

[0020] The first porous material 116 extends from a portion of the outer surface 128 of the porous medium 114. For example, the first porous material 116 can extend from at least a portion of the outer surface 128 of the proximal section 120. Thus, the first porous material 116 is positioned directly against, adjacent to, or otherwise in close proximity to the individual's urethral opening, thereby allowing the porous medium 114 to quickly accept larger amounts of bodily fluid than if the first porous material 116 did not extend from the outer surface 128.

[0021] In one embodiment, as shown, the first porous material 116 extends from the outer surface 128 through the porous medium 114. If the porous medium 114 defines holes configured to receive the conduits 132 (as shown), the first porous material 116 can extend from the outer surface 128 to the inner surface 130 of the porous medium 114 that defines the holes. Extending the first porous material 116 through the porous medium 114 can facilitate the formation of the porous medium 114. In one embodiment, the porous medium 114 can be formed by providing a second porous material 118, such as by providing a generally hollow cylindrical second porous material 118. A cutout can be formed in the second porous material 118 and removed from the second porous material 118. The cutout can extend completely through the second porous material 118, thereby allowing it to be easily removed from the second porous material 118 by punching or otherwise. The first porous material 116 can exhibit a size and shape corresponding to the size and shape of the cutout. Thus, the first porous material 116 can be positioned within the cutout to form the porous medium 114. When the porous medium 114 is formed using such a method, the first porous material 116 can include one or more first sides 134, and the second porous material 118 can include one or more second sides 136. The second sides 136 can completely surround the first sides 134.

[0022] In one embodiment, as described above, the first porous material 116 can exhibit a first fluid permeability, and the second porous material 118 can exhibit a second fluid permeability that is less than the first fluid permeability. The first fluid permeability can be greater than the second fluid permeability because the first porous material 116 exhibits at least one of a different pores per inch ("PPI"), density, or hydrophilicity than the second porous material 118. The greater fluid permeability of the first porous material 116 compared to the second porous material 118 can allow the first porous material 116 to accept bodily fluids more quickly than the second porous material 118. The greater fluid permeability of the first porous material 116 compared to the second porous material 118 can also allow a vacuum (e.g., vacuum-induced airflow) to preferentially pass through the first porous material 116 over the second porous material 118. On the other hand, the fluid permeability of the second porous material 118 does not take priority over comfort, so the second porous material 118 may be smoother, more compressible, or otherwise more comfortable against the individual's vaginal area than the first porous material 116. Referring to the illustrated embodiment, as previously described, the first porous material 116 is configured to be positioned adjacent to or otherwise closer to the individual's urethral opening. Thus, the first porous material 116 is the first to receive bodily fluids discharged from the urethral opening. The relatively high fluid permeability of the first porous material 116 allows bodily fluids to be quickly received within the porous medium 114, thereby preventing leakage of the bodily fluids. Additionally, the relatively high fluid permeability of the first porous material 116 allows the vacuum to be preferentially delivered to the first porous material 116 relative to the portion of the second porous material 118 surrounding the first porous material 116, particularly at least a portion of the portion of the second porous material 118 between the first porous material 116 and the proximal end region 104. By preferentially delivering the vacuum to the first porous material 116, the rate at which bodily fluids are received within, flow through, and from the first porous material 116 to the second porous material 118 is increased. However, the first porous material 116 may present a rougher or otherwise less comfortable surface to an individual's vaginal area than the second porous material 118.The presence of the second porous material limits the portion of the vaginal area exposed to the less comfortable first porous material 116, thereby making the fluid collection assembly 100 more comfortable to use.

[0023] In one embodiment, the first porous material 116 can exhibit a first compressibility, and the second porous material 118 can exhibit a second compressibility greater than the first compressibility. The first compressibility can be less than the second compressibility because the first porous material 116 exhibits at least one of a PPI, average fiber diameter, Young's modulus (e.g., elastic modulus), yield strength or ultimate tensile strength, fiber entanglement, or density that is different from that of the second porous material 118. The lower compressibility of the first porous material 116 compared to the second porous material 118 can better inhibit collapse of passageways within the first porous material 116 than the second porous material 118. Restraining collapse of passageways in the first porous material 116 can enable better fluid flow. On the other hand, the higher compressibility of the second porous material 118 compared to the first porous material 116 allows the second porous material 118 to better conform to the shape of the vaginal area and better distribute pressure applied to the vaginal area, both of which improve comfort. Referring to the illustrated embodiment, as previously described, the first porous material 116 is configured to be positioned adjacent to or otherwise closer to the individual's urethral opening. Thus, the first porous material 116 is the first to receive bodily fluids expelled from the urethral opening. Preventing collapse of the passageway within the first porous material 116 allows bodily fluids to be quickly received within the porous medium 114, preferentially delivering vacuum to the first porous material 116. However, the first porous material 116 may have difficulty conforming to the shape of the vaginal area and / or distributing pressure evenly across the vaginal area. The presence of the second porous material 118 limits the portion of the vaginal area exposed to the less comfortable first porous material 116, thereby making the fluid collection assembly 100 more comfortable to use.

[0024] In one embodiment, the first porous material 116 can exhibit a PPI greater than that exhibited by the second porous material 118. In general, increasing the PPI of a material can increase the number of pores within the material, thereby increasing the rate at which bodily fluids and vacuum can flow therethrough. Thus, the first porous material 116 may exhibit a PPI greater than the second porous material. Increasing the PPI can also increase the compressibility of the material by decreasing the solids content of the material, potentially increasing surface roughness. The first and second porous materials 116, 118 can be independently selected to exhibit a PPI of about 10 PPI or more, about 15 PPI or more, about 20 PPI or more, about 25 PPI or more, about 30 PPI or more, about 35 PPI or more, about 40 PPI or more, about 50 PPI or more, about 60 PPI or more, about 75 PPI or more, about 100 PPI or more, or in the ranges of about 10 PPI to about 20 PPI, about 15 PPI to about 25 PPI, about 20 PPI to about 30 PPI, about 25 PPI to about 35 PPI, about 30 PPI to about 40 PPI, about 35 PPI to about 50 PPI, about 40 PPI to about 60 PPI, about 50 PPI to about 75 PPI, or about 60 PPI to about 100 PPI. The PPI of the first and second porous materials 116, 118 may be selected based on their desired fluid permeability and / or compressibility.

[0025] In one embodiment, the first porous material 116 can exhibit a density that is lower than the density exhibited by the second porous material 118. Generally, decreasing the density of a material can increase the porosity of the material, thereby increasing the rate at which bodily fluids and vacuum can pass through the material. Decreasing the density of a material can also increase the compressibility of the material by decreasing the solids content of the material, which can increase the surface roughness of the material. The first and second porous materials 116, 118 can have a density of about 0.8 grams per cubic centimeter ("g / cc") or less, about 0.7 g / cc or less, about 0.65 g / cc or less, about 0.6 g / cc or less, about 0.55 g / cc or less, about 0.5 g / cc or less, about 0.45 g / cc or less, about 0.4 g / cc or less, about 0.35 g / cc or less, about 0.3 g / cc or less, about 0.25 g / cc or less, about 0.2 g / cc or less, about 0.15 g / cc or less, or the like. Density of about 0.1 g / cc or less, about 0.075 g / cc or less, about 0.05 g / cc or less, about 0.04 g / cc or less, about 0.03 g / cc or less, about 0.02 g / cc or less, about 0.015 g / cc or less, about 0.01 g / cc or less, about 0.0075 g / cc or less, or about 0.0075 g / cc to about 0.015 g / cc, about 0.01 g / cc to about 0.02 g / cc, about 0.015 g / cc to about 0.03 g / cc c, about 0.02g / cc to about 0.04g / cc, about 0.03g / cc to about 0.05g / cc, about 0.04g / cc to about 0.075g / cc, about 0.05g / cc to about 0.1g / cc, about 0.75g / cc to about 0.15g / cc, about 0.1g / cc to about 0.2g / cc, about 0.15g / cc to about 0.25g / cc, about 0.2g / cc to about 0.3g / cc, about 0.25g / cc to about 0.35g / cc , about 0.3 g / cc to about 0.4 g / cc, about 0.35 g / cc to about 0.45 g / cc, about 0.4 g / cc to about 0.5 g / cc, about 0.45 g / cc to about 0.55 g / cc, about 0.5 g / cc to about 0.6 g / cc, about 0.55 g / cc to about 0.65 g / cc, about 0.6 g / cc to about 0.7 g / cc, or about 0.65 g / cc to about 0.8 g / cc.The densities of the first and second porous materials 116, 118 may be from about 0.1% to about 99%, e.g., from about 0.1% to about 0.5%, from about 0.25% to about 0.75%, from about 0.5% to about 1%, from about 0.75% to about 1.5%, from about 1% to about 2%, from about 1.5% to about 2.5%, from about 2% to about 3% of their theoretical maximum density (i.e., the density of the first and second porous materials if the materials had no pores). , about 2.5% to about 3.5%, about 3% to about 4%, about 3.5% to about 5%, about 4% to about 6%, about 5% to about 7.5%, about 7% to about 10%, about 9% to about 12%, about 10% to about 15%, about 12.5% ​​to about 20%, about 15% to about 25%, about 20% to about 40%, about 30% to about 50%, about 40% to about 65%, or about 60% to about 99%. The density of the first and second porous materials 116, 118 can be selected based on their desired fluid permeability and / or compressibility. The density of the first and second porous materials 116, 118 can also be selected based on their desired PPI.

[0026] In one embodiment, the first porous material 116 may exhibit a greater percent porosity than the percent porosity exhibited by the second porous material 118. The greater percent porosity of the first porous material 116 may indicate that the first porous material 116 exhibits larger and / or more numerous pores that can accept bodily fluids more quickly than the second porous material 118. The percent porosity of the first and second porous materials 116, 118 can be independently selected to be from about 1% to about 20%, from about 10% to about 30%, from about 20% to about 40%, from about 30% to about 50%, from about 40% to about 55%, from about 50% to about 60%, from about 55% to about 65%, from about 60% to about 70%, from about 65% to about 75%, from about 70% to about 80%, from about 75% to about 82.5%, from about 80% to about 85%, from about 82.5% to about 87.5%, from about 85% to about 90%, from about 87.5% to about 92.5%, from about 90% to about 95%, from about 92.5% to about 97.5%, or from about 95% to about 99%. The percent porosity of the first and second porous materials 116, 118 can be selected based on their desired fluid permeability, surface roughness, and compressibility. The percent porosity of the first and second porous materials 116, 118 can depend in part on the density of the first and second porous materials 116, 118.

[0027] In one embodiment, the first porous material 116 can exhibit a hydrophilicity that is greater than that exhibited by the second porous material 118. In other words, the first porous material 116 can exhibit a contact angle with water that is less than the contact angle formed between the second porous material 118 and water (a major component of bodily fluids). In general, increasing hydrophilicity increases the material's ability to draw bodily fluids into the material. However, increasing the hydrophilicity of a material also increases the difficulty of removing bodily fluids from the material. The first and second porous materials 116, 118 may be angled at angles ranging from about 0° to about 10°, from about 5° to about 15°, from about 10° to about 20°, from about 15° to about 25°, from about 20° to about 30°, from about 25° to about 35°, from about 30° to about 40°, from about 35° to about 45°, from about 40° to about 50°, from about 45° to about 55°, from about 50° to about 60°, from about 55° to about 65°, from about 60° to about 70°, from about 65° to about 75°, from about 70° to about 80°, from about 75° to about 85°, from about 80° to about 90°, from about 85° to about 95°, from about 90° to about 100°, from about 100° to about 120°, from about 120° to about 130°, from about 130° to about 140°, from about 140° to about 150°, from about 150° to about 160°, from about 160° to about 170°, from about 170° to about 180°, from about 180° to about 190°, from about 190° to about 210°, from about 210° to about 220°, from about 220° to about 230°, from about 230° to about 240°, from about 240° to about 250°, from about 250° to about 300°, from about 250° to about 350°, from about 300° to about 400°, from about The hydrophilicity (i.e., contact angle with water) of the first and second porous materials 116, 118 can be independently selected based on the materials forming the first and second porous materials 116, 118. In one example, the first porous material 116 can be formed from a material that exhibits less hydrophilicity (i.e., a higher contact angle with water) than the material forming the second porous material 118. In one example, the first porous material 116 can be at least partially coated with a material that increases its hydrophilicity (e.g., decreases its contact angle with water), and / or the second porous material 118 can be at least partially coated with a material that decreases its hydrophilicity.

[0028] In one embodiment, the first porous material can exhibit an average fiber diameter that is greater than the average fiber diameter exhibited by the second porous material. In general, increasing the average fiber diameter increases the force the material can withstand without significantly flexing, thereby decreasing the compressibility of the material. The first and second porous materials 116, 118 can have a fiber diameter of about 0.1 μm to about 0.2 μm, about 0.15 μm to about 0.25 μm, about 0.2 μm to about 0.3 μm, about 0.25 μm to about 0.35 μm, about 0.3 μm to about 0.4 μm, about 0.35 μm to about 0.5 μm, about 0.4 μm to about 0.6 μm, about 0.5 μm to about 0.7 μm, or about 0.6 μm to about 0. 8 μm, about 0.7 μm to about 0.9 μm, about 0.8 μm to about 1 μm, about 0.9 μm to about 1.25 μm, about 1 μm to about 1.5 μm, about 1.25 μm to about 2 μm, about 1.5 μm to about 2.5 μm, about 2 μm to about 3 μm, about 2.5 μm to about 4 μm, about 3 μm to about 5 μm, about 4 μm to about 6 μm, about 5 μm to about 7 μm, about 6 μm to about 8 μm, About 7 μm to about 9 μm, about 8 μm to about 10 μm, about 9 μm to about 12.5 μm, about 10 μm to about 15 μm, about 12.5 μm to about 20 μm, about 15 μm to about 25 μm, about 20 μm to about 30 μm, about 25 μm to about 40 μm, about 30 μm to about 50 μm, about 40 μm to about 60 μm, about 50 μm to about 70 μm, about 60 μm to about 80 μm, about 7 The first and second porous materials 116, 118 may be independently selected to exhibit an average fiber diameter of 0 μm to about 90 μm, about 80 μm to about 100 μm, about 90 μm to about 125 μm, about 100 μm to about 150 μm, about 125 μm to about 200 μm, about 150 μm to about 250 μm, about 200 μm to about 300 μm, about 250 μm to about 400 μm, or about 300 μm to about 500 μm. The average fiber diameter may be selected based on the desired compressibility of the first and second porous materials 116, 118, as increasing the average fiber diameter decreases the compressibility of the material, and vice versa. Note that the average fiber diameter may affect the PPI and / or density of the first and second porous materials 116, 118. For example, increasing the average fiber diameter may decrease the PPI and / or density. Thus, the average fiber diameter may be selected based on the desired PPI and / or density.

[0029] In one embodiment, the first porous material may exhibit at least one of a Young's modulus greater than that exhibited by the second porous material, a yield strength greater than that exhibited by the second porous material 118, or a maximum tensile strength greater than that exhibited by the second porous material. Generally, increasing the Young's modulus, yield strength, or maximum tensile strength of a material reduces the compressibility of the material. Young's modulus, yield strength, and maximum tensile strength are material properties, and therefore, the Young's modulus, yield strength, and maximum tensile strength of the first and second porous materials 116, 118 depend on the materials forming the first and second porous materials 116, 118. In one embodiment, the first and second porous materials 116, 118 have a pressure of about 0.2 gigapascals ("GPa") or greater, about 0.3 GPa or greater, about 0.5 GPa or greater, about 0.75 GPa or greater, about 1 GPa or greater, about 1.5 GPa or greater, about 2 GPa or greater, about 3 GPa or greater, about 4 GPa or greater, about 5 GPa or greater, about 6 GPa or greater, about 7 GPa or greater, about 8 GPa or greater, about 9 GPa or greater Above, about 10 GPa or more, about 11 GPa or more, about 12.5 GPa or more, about 15 GPa or more, about 20 GPa or more, about 25 GPa or more, about 30 GPa or more, about 40 GPa or more, about 50 GPa or more, about 75 GPa or more, 100 GPa or more, or about 0.2 GPa to about 0.5 GPa, about 0.3 GPa to about 0.75 GPa, about 0.5 GPa to about 1 GPa, about 0. They can be independently selected to exhibit a Young's modulus ranging from 75 GPa to about 1.5 GPa, from about 1 GPa to about 2 GPa, from about 1.5 GPa to about 3 GPa, from about 2 GPa to about 4 GPa, from about 3 GPa to about 5 GPa, from about 4 GPa to about 6 GPa, from about 5 GPa to about 7 GPa, from about 6 GPa to about 8 GPa, from about 7 GPa to about 9 GPa, from about 8 GPa to about 10 GPa, from about 9 GPa to about 11 GPa, from about 10 GPa to about 12.5 GPa, from about 11 GPa to about 15 GPa, from about 12.5 GPa to about 20 GPa, from about 15 GPa to about 25 GPa, from about 20 GPa to about 30 GPa, from about 25 GPa to about 40 GPa, from about 30 GPa to about 50 GPa, from about 35 GPa to about 75 GPa, or from about 50 GPa to about 100 GPa.In one embodiment, the first and second porous materials 116, 118 have a pressure of about 3 megapascals ("MPa") or greater, about 5 MPa or greater, about 7.5 MPa or greater, about 10 MPa or greater, about 15 MPa or greater, about 20 MPa or greater, about 30 MPa or greater, about 40 MPa or greater, about 50 MPa or greater, about 60 MPa or greater, about 70 MPa or greater, about 80 MPa or greater, about 100 MPa or greater, about 125 MPa or greater, about 150 MPa or greater, about 200 MPa or greater, about 250 MPa or greater, about 300 MPa or greater, about 400 MPa or greater, about 500 MPa or greater, about 600 MPa or greater, about 700 MPa or greater, about 800 MPa or greater, about 1 GPa or greater, or about 3 MPa to about 7.5 MPa, about 5 MPa to about 10 MPa, about 7.5 MPa to about 15 MPa, about 10 MPa The compositions can be independently selected to exhibit a yield strength or ultimate tensile strength ranging from about 1 GPa to about 20 MPa, from about 15 MPa to about 30 MPa, from about 20 MPa to about 40 MPa, from about 30 MPa to about 50 MPa, from about 40 MPa to about 60 MPa, from about 50 MPa to about 70 MPa, from about 60 MPa to about 80 MPa, from about 70 MPa to about 100 MPa, from about 80 MPa to about 125 MPa, from about 100 MPa to about 150 MPa, from about 100 MPa to about 200 MPa, from about 150 MPa to about 300 MPa, from about 200 MPa to about 400 MPa, from about 300 MPa to about 500 MPa, from about 400 MPa to about 600 MPa, from about 500 MPa to about 700 MPa, from about 600 MPa to about 800 MPa, or from about 700 MPa to about 1 GPa.

[0030] In one embodiment, the first porous material 116 can exhibit greater fiber entanglement than that exhibited by the second porous material 118. In general, increasing the fiber entanglement of a material decreases the compressibility of the fibers. Fiber entanglement can depend, for example, on the average fiber length, the weave pattern used to form the material, and the nonwoven technology used to form the material. Thus, the first porous material 116 can at least one of exhibit a longer average fiber length than the second porous material 118, exhibit a different weave pattern than the second porous material 118, or be formed using a different nonwoven technology than the second porous material 118.

[0031] In one embodiment, the first and second porous materials 116, 118 may be formed from the same isotropic material. Isotropic materials may exhibit different compressibility and / or fluid permeability in different orientations. Thus, the isotropic material of the first porous material 116 may exhibit a different orientation than the isotropic material of the second porous material 118.

[0032] The porous medium 114 is disposed within the chamber 110. The porous medium 114 can cover at least a portion (e.g., all) of the opening 108. The porous medium 114 is exposed to the environment outside the chamber 110 through the opening 108. In one embodiment, the porous medium 114 can be configured to wick any bodily fluid through the opening 108, thereby preventing the bodily fluid from escaping the chamber 110. As used herein, permeability may be wicking, capillary action, diffusion, or other similar property or process, and is referred to herein as "permeability" and / or "wicking." Such "wicking" and / or "permeability" may not include absorption of bodily fluid into at least a portion of the porous medium 114. In other words, there may be substantially no absorption or dissolution of bodily fluid into the material after the material is exposed to and briefly removed from the bodily fluid. While no absorption or dissolution is desirable, the term "substantially no absorption" can allow for a small amount of absorption and / or dissolution (e.g., absorbency) of bodily fluid into the porous medium 114, such as less than about 30% by weight of the dry weight of the porous medium 114, less than about 20% by weight, less than about 10% by weight, less than about 7% by weight, less than about 5% by weight, less than about 3% by weight, less than about 2% by weight, less than about 1% by weight, or less than about 0.5% by weight of the dry weight of the porous medium 114. The porous medium 114 can also wick bodily fluid generally toward the interior of the chamber 110, as described in more detail below. In one embodiment, the porous medium 114 can include at least one absorbent or absorbing material.

[0033] The porous medium 114 can be formed from any suitable porous material. Examples of materials from which the porous medium 114 (e.g., the first and second porous materials 116, 118) can be formed include gauze (e.g., silk, linen, or cotton gauze), felt, cotton, wool, silk, other fabrics, porous polymer (e.g., nylon, polyester, polyurethane, polyethylene, polypropylene, etc.) structures, open-cell foams, spun polymers (e.g., spun nylon fibers), paper, nonwoven materials, woven fabrics, or combinations thereof.

[0034] As described above, the fluid collection assembly 100 can include a fluid-impermeable layer 102. The fluid-impermeable layer 102 at least partially defines a chamber 110 (e.g., an interior region) and an opening 108. For example, the inner surface 138 of the fluid-impermeable layer 102 at least partially defines the chamber 110 within the fluid collection assembly 100. The fluid-impermeable layer 102 temporarily stores bodily fluid within the chamber 110. The fluid-impermeable layer 102 can be formed of 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. Thus, the fluid-impermeable layer 102 substantially prevents bodily fluid from passing through the fluid-impermeable layer 102. In one embodiment, the fluid-impermeable layer 102 can be breathable and fluid-impermeable. In such an embodiment, the fluid impermeable layer 102 can be formed of a hydrophobic material that defines a plurality of pores. At least one or more portions of at least the outer surface 140 of the fluid impermeable layer 102 can be formed of a soft and / or smooth material, which can reduce chafing.

[0035] The opening 108 provides an access path for bodily fluid to enter the chamber 110. The opening 108 may be defined by the fluid-impermeable layer 102, such as by an inner edge of the fluid-impermeable layer 102. For example, the opening 108 may be formed in the fluid-impermeable layer 102 and extend through the fluid-impermeable layer 102 from the outer surface 140 to the inner surface 138, thereby allowing bodily fluid to enter the chamber 110 from outside the fluid collection assembly 100.

[0036] In some examples, the fluid impermeable layer 102 can define a fluid outlet 112 sized to receive a conduit 132. At least one conduit 132 can be disposed within the chamber 110 through the fluid outlet 112. The fluid outlet 112 can be sized and shaped to form an at least substantially fluid-tight seal with the conduit 132 or at least one tube, thereby substantially preventing bodily fluids from escaping the chamber 110.

[0037] The porous medium 114 may at least substantially completely fill the portion of the chamber 110 not occupied by the conduit 132. In some embodiments, the porous medium 114 may not substantially completely fill the portion of the chamber 110 not occupied by the conduit 132. In such embodiments, the fluid collection assembly 100 includes a reservoir 124 disposed within the chamber 110.

[0038] The reservoir 124 is a substantially open portion of the chamber 110. The reservoir 124 can be defined between the fluid-impermeable layer 102 and the porous medium 114 (e.g., one or more of the first or second porous materials 116, 118). Bodily fluid within the chamber 110 can flow through the porous medium 114 (e.g., one or more of the first or second porous materials 116, 118) to the reservoir 124. The reservoir 124 can hold bodily fluid therein.

[0039] Bodily fluid within the chamber 110 can flow through the porous medium 114 to the reservoir 124. The fluid-impermeable layer 102 can retain the bodily fluid within the reservoir 124. Although illustrated in the distal end region 106, the reservoir 124 can be located in any portion of the chamber 110, such as the proximal end region 104. The reservoir 124 may be located in a portion of the chamber 110 designed to be located at a gravimetric low point on the fluid collection assembly 100 when the fluid collection assembly 100 is worn.

[0040] In some embodiments (not shown), the fluid collection assembly 100 may include multiple reservoirs, such as a first reservoir located in a portion of the chamber 110 closest to the inlet of the conduit 132 (e.g., the distal end region 106) and a second reservoir located in a portion of the chamber 110 at or near the proximal end region 104. In another embodiment, the porous medium 114 may be spaced apart from at least a portion of the conduit 132, and the reservoir 124 may be the space between the porous medium 114 and the conduit 132.

[0041] The conduit 132 may be at least partially within the chamber 110. The conduit 132 may be used to remove bodily fluids from the chamber 110. The conduit 132 includes at least one wall defining an inlet, an outlet (not shown) downstream of the inlet, and a passageway. The outlet of the conduit 132 may be operably coupled to a vacuum source, such as a vacuum pump, for drawing fluid from the chamber 110 through the conduit 132. For example, the conduit 132 may extend from the proximal end region 104 into the fluid-impermeable layer 102, extend to the distal end region 106, and extend to a point near the reservoir 124 such that the inlet is in fluid communication with the reservoir 124. The conduit 132 fluidly couples the chamber 110 to a fluid reservoir (not shown) or a vacuum source (not shown).

[0042] The conduit 132 can extend through a hole in the porous medium 114. In one embodiment, the conduit 132 can extend from the fluid outlet 112 through a hole to a location near the reservoir 124. In such an embodiment, the inlet may not extend into the reservoir 124; instead, the inlet may be located within or at the end of the porous medium 114. For example, one end of the conduit 132 may be coextensive with or recessed within the porous medium 114. In one embodiment, the conduit 132 is at least partially located within the reservoir 124, with the inlet extending into or positioned within the reservoir 124. Bodily fluid collected in the fluid collection assembly 100 can be removed from the chamber 110 via the conduit 132.

[0043] Locating the inlet at or near a location that is predicted to be a gravimetric low point of the chamber 110 when worn by an individual may allow the conduit 132 to receive more bodily fluid than if the inlet were located elsewhere, reducing the likelihood of stagnation (e.g., stagnant bodily fluids, which can lead to bacterial growth and foul odors). For example, bodily fluids within the porous medium 114 may flow in any direction due to capillary forces. However, bodily fluids may have a greater tendency to flow in the direction of gravity, particularly when at least a portion of the porous medium 114 becomes saturated with bodily fluid. Thus, one or more of the inlets or reservoirs 124 may be located within the fluid collection assembly 100 at a location that is predicted to be a gravimetric low point of the fluid collection assembly 100 when worn by an individual, such as the distal end region 106.

[0044] The inlet and outlet of the conduit 132 are configured to fluidly couple (e.g., directly or indirectly) a vacuum source (not shown) to the chamber 110 (e.g., the reservoir 124). When the vacuum source (FIG. 10) applies a vacuum / negative pressure within the conduit 132, bodily fluid within the chamber 110 (e.g., at a distal end region DER, such as the reservoir 124) can be drawn through the conduit 132 into the inlet and out of the fluid collection assembly 100. In some embodiments, the conduit 132 can be frosted or opaque to reduce the visibility of bodily fluid therein.

[0045] As previously mentioned, the conduit 132 can be configured to be insertable into at least the chamber 110. In one embodiment, the conduit 132 can be positioned in the chamber 110 such that the distal end of the conduit is separated from the fluid-impermeable layer 102 or other components of the fluid collection assembly 100 that may at least partially obstruct or block the inlet. Additionally, the inlet of the conduit 132 can be offset relative to the distal end of the porous medium 114 such that the inlet is closer to the proximal end region 104 of the fluid collection assembly 100 than the distal end of the porous medium 114. By offsetting the inlet relative to the distal end of the porous medium 114 in this manner, the inlet can receive bodily fluid directly from the porous medium 114, allowing for hydrogen bonding to draw more bodily fluid from the porous medium 114 into the conduit 132.

[0046] 2 and 3 are cross-sectional schematic diagrams illustrating fluid collection assemblies showing the same top view as fluid collection assembly 100 shown in FIG. 1A according to different embodiments. Except as otherwise disclosed herein, the fluid collection assemblies shown in FIGS. 2 and 3 are the same as or substantially similar to any of the fluid collection assemblies disclosed herein. For example, the fluid collection assemblies shown in FIGS. 2 and 3 can include a fluid-impermeable layer defining a chamber and a porous medium disposed within the chamber. The porous medium can include a first porous material and a second porous material. The first porous material can exhibit at least one of a fluid permeability or compressibility that is different from that of the second porous material. The first and second porous materials can be configured such that the porous medium includes a proximal section and a distal section.

[0047] Referring to FIG. 2 , the first porous material 216 includes an outer portion 242 and an inner portion 244. The outer portion 242 extends inward from a portion of the outer surface 228 of the porous medium 214 that is configured to contact, be positioned adjacent to, or otherwise be positioned near an individual's urethral opening. The inner portion 224 can extend behind and support the second porous material 218 (e.g., a fluid-permeable membrane) and the outer portion 242. Thus, the outer portion 242 can extend outward from the inner portion 244. During use, the outer portion 242 can accept a relatively large amount of bodily fluid from the urethral opening. Whether the first porous material 216 exhibits greater fluid permeability or less compressibility than the second porous material 218, bodily fluid can be quickly accepted into the outer portion 242 of the first porous material 216 due to the greater fluid permeability or the non-collapseable passages defined therein. The bodily fluid received by the outer portion 242 can then flow into the inner portion of the first porous material 216. Again, regardless of whether the first porous material 216 exhibits greater fluid permeability or less compressibility than the second porous material 218, the bodily fluid can flow more rapidly through the inner portion 244 to the inlet of the reservoir 224 and / or conduit 232 due to the greater fluid permeability or non-collapsible passages defined therein. Indeed, because at least a portion of the bodily fluid can flow through the porous medium 214 (i.e., preferentially through the inner portion 244 of the first porous material 216) and avoid the second porous material 218, the bodily fluid can flow more rapidly through the porous medium 214 than through the porous medium 114 shown in FIG. 1B. Additionally, the vacuum may be applied preferentially to the outer portion 242 of the first porous material 216 compared to the portion of the first porous material 116 shown in FIG. 1B because the vacuum will preferentially pass through the inner portion 244 of the first porous material 216 and the second porous material 218 will form a barrier that prevents the vacuum from escaping from the chamber 210 defined by the fluid-impermeable layer 202.

[0048] The second porous material 218 also increases the comfort of the fluid collection assembly 200 by limiting the portion of the individual's vaginal region that comes into contact with the less comfortable first porous material 216. Note that because the inner portion 244 of the first porous material 216 extends behind the second porous material 218, the second porous material 218 may exhibit a reduced thickness measured perpendicular to the longitudinal axis of the fluid collection assembly 200 compared to the second porous material 118 shown in FIG. 1B. If the second porous material 218 exhibits greater compressibility than the first porous material 216, the reduced thickness of the second porous material 218 may slightly reduce the effect that the increased compressibility of the second porous material 218 has on increasing the comfort of the fluid collection assembly 200.

[0049] The porous media 214 can be formed by forming a cutout in the second porous material 218 and forming a protrusion (i.e., outer portion 242) in the first porous material 216 that corresponds to the cutout formed in the second porous material 218. The first porous material 216 can then be placed within the second porous material 218 with the outer portion 242 positioned through the cutout. Thus, the second porous material 218 can completely surround the outer portion 242.

[0050] Referring to FIG. 3 , the second porous material 318 includes an outer portion 342 and an inner portion 344. The outer portion 342 extends inward from a portion of the outer surface 328 of the porous medium 314 that is not configured to contact, be positioned adjacent to, or otherwise be positioned near an individual's urethral opening. The inner portion 344 can extend behind and support the first porous material 316 (e.g., a fluid-permeable membrane). Thus, the outer portion 342 can extend outward from the inner portion 344. The second porous material 318 increases the comfort of the fluid collection assembly 300 by limiting the portion of the individual's vaginal region that comes into contact with the less comfortable first porous material 316. The second porous material 318 can define a recess adjacent the inner portion 344. The first porous material 316 can be positioned in this recess. During use, the first porous material 316 can receive a relatively large amount of bodily fluid from the urethral opening. Whether the first porous material 316 exhibits greater fluid permeability or less compressibility than the second porous material 318, the greater fluid permeability or non-collapseable passageways defined therein allows bodily fluid to be rapidly admitted into the first porous material 316. The bodily fluid admitted by the first porous material 316 can then flow into the second porous material 318.

[0051] The porous medium 314 may be formed by forming a recess in the second porous material 318 and forming (e.g., molding) the first porous material 316 to fit within the recess. The first porous material 316 may then be placed within the recess defined by the second porous material 318. Thus, the second porous material 318 may completely surround the outer portion 342.

[0052] Figure 4A is a top view of a fluid collection assembly 400 according to one embodiment. Figure 4B is a cross-sectional schematic view of the fluid collection assembly 400 taken along plane 4B-4B. Except as otherwise disclosed herein, the fluid collection assembly 400 is the same as or substantially similar to any of the fluid collection assemblies disclosed herein. For example, the fluid collection assembly 400 includes a fluid-impermeable layer 402 including a proximal end region 404 and a distal end region 406. The fluid collection assembly 400 also includes a porous medium 414 disposed in the fluid-impermeable layer 402. The porous medium 414 includes a first porous material 416 and a second porous material 418.

[0053] The second porous material 418 forms the entire outer surface 428 of the porous medium 414, thereby making the entire outer surface 428 in contact with the individual's vaginal region more comfortable. However, the thickness of the second porous material 418 is tapered along at least a portion (e.g., the entire) of the length of the porous medium 414 measured parallel to the longitudinal axis of the fluid collection assembly 400. For example, the thickness of the second porous material 418 decreases as the proximal end region 404 is approached. Because the urethral opening is generally located near the proximal end region 404, the reduced thickness of the second porous material 418 can prevent, or at least reduce, the second porous material 418 from being a significant obstacle to bodily fluids entering the porous medium 414. The thickness of the second porous material 418 can increase as the distal end region 406 is approached. Thus, if the second porous material 418 exhibits greater compressibility than the first porous material 416, the effect of the increased compressibility of the second porous material 418 on the comfort of the fluid collection assembly 400 may be greater as one approaches the distal end region 406.

[0054] The first porous material 416 is spaced from the outer surface 428 of the porous medium 414, which, as described above, can make the fluid collection assembly 400 more comfortable to use. However, the thickness of the first porous material 416 is tapered along at least a portion (e.g., all) of the length of the porous medium 414 in an opposite manner to that of the second porous material 418. For example, the thickness of the first porous material 416 may increase approaching the proximal end region 404 and decrease approaching the distal end region 406. Thus, the thickness of the first porous material 416 may be significantly greater than the thickness of the second porous material 418 at a location adjacent an individual's urethral opening during use. The increased thickness of the first porous material 416 can facilitate the drawing of bodily fluids through the second porous material 418 adjacent the urethral opening, as the first porous material 416 can exhibit greater fluid permeability and / or a more unobstructed passageway compared to the second porous material 418. The variation in thickness of the first porous material 416 also facilitates delivery of vacuum to the portion of the porous medium 414 proximate the urethral opening. For example, as described above, vacuum preferentially flows through the first porous material 416. The increased thickness of the second porous material 418 near the distal end region 406 inhibits vacuum from escaping from the porous medium 414 at locations proximate the distal end region 406 (i.e., away from the urethral opening). The decreased thickness of the second porous material 418 near the proximal end region 404 allows more of the vacuum to escape from the porous medium 414 at locations proximate the proximal end region 404, thereby facilitating the drawing of bodily fluids into the porous medium 414 (e.g., drawing bodily fluids through the second porous material 418 and into the first porous material 416).

[0055] 4C is a cross-sectional schematic diagram of a fluid collection assembly 400′ according to one embodiment. Except for the differences disclosed herein, fluid collection assembly 400′ is the same as or substantially similar to any of the fluid collection assemblies disclosed herein. For example, fluid collection assembly 400′ includes a fluid-impermeable layer 402′ including a proximal end region 404′ and a distal end region 406′. Fluid collection assembly 400′ also includes a porous medium 414′ disposed in fluid-impermeable layer 402′. Porous medium 414′ includes a first porous material 416′ and a second porous material 418′.

[0056] The fluid collection assembly 400' is substantially similar to the fluid collection assembly 400 of Figures 4A and 4B, except that the first porous material 416' forms the entire outer surface 428' of the porous medium 414' instead of the second porous material 418'. Forming the entire outer surface 428' from the first porous material 416' may make the fluid collection assembly 400' more uncomfortable than the fluid collection assembly 400. However, forming the entire outer surface 428' from the first porous material 416' prevents the second porous material 418' from acting as a barrier to the inflow of bodily fluids into the first porous material 416'. For example, bodily fluids discharged from the urethral opening may come into direct contact with the first porous material 416'. Thus, bodily fluids can flow more quickly through the first porous material 416' and into the porous medium 414' due to the increased fluid permeability of the first porous material 416' than if the second porous material 418' formed at least a portion of the porous medium 414'. Thus, the fluid collection assembly 400' can be more effective at accepting bodily fluids than the fluid collection assembly 400 of Figures 4A and 4B, especially when an individual excretes bodily fluids at a relatively high rate.

[0057] Additionally, forming the entire outer surface 428' from the first porous material 416' can facilitate use of the fluid collection assembly 400' in situations where the fluid collection assembly 400' may move during use. For example, the fluid collection assembly 400' may use contact between the individual's thigh and the fluid-impermeable layer 402' to maintain the correct position of the fluid collection assembly 400' relative to the urethral opening. However, individuals with thin thighs, who are forgetful (e.g., individuals with dementia, young children, etc.), or who move frequently may have difficulty maintaining sufficient contact between their thighs and the fluid-impermeable layer 402' to maintain the position of the fluid collection assembly 400'. Therefore, when used with such individuals, the fluid collection assembly 400' is likely to move. Typically, allowing any fluid collection assembly to move relative to the individual increases the likelihood of the fluid collection assembly leaking bodily fluids, either because bodily fluids come into contact with unexpected portions of the porous medium or because gaps form between the fluid collection assembly and the individual. However, forming the entire exterior surface 428' from the first porous material 416' reduces the amount of bodily fluid that may leak when the fluid collection assembly 400' is used with such an individual. For example, the high fluid permeability of the first porous material 416' quickly draws bodily fluid into the porous material 414', regardless of which portion of the porous material 414' initially receives the bodily fluid. Also, forming the entire exterior surface 428' from the first porous material 416' ensures that a greater percentage of bodily fluid that comes into contact with the porous material 414' is received by the porous material 414' than if the second porous material 418' formed any portion of the exterior surface 428'.

[0058] The thickness of the first porous material 416' is tapered along at least a portion (e.g., all) of the length of the porous medium 414' measured parallel to the longitudinal axis of the fluid collection assembly 400'. For example, the thickness of the first porous material 416' increases approaching the proximal end region 404'. As discussed above, the increased thickness of the first porous material 416' can facilitate receiving bodily fluids deeper within the porous medium 414'. The thickness of the second porous material 418' is tapered along at least a portion (e.g., all) of the length of the porous medium 414' in an opposite manner to the first porous material 416'. In one embodiment, the second porous material 418' is more compressible than the first porous material 416'. In such an embodiment, the decreasing and increasing thicknesses of the first and second porous materials 416' and 418', respectively, approaching the distal end region 406' cause the overall compressibility of the porous medium 414' to increase as it approaches the distal end region 406'. In other words, even though the second porous material 418' does not form part of the outer surface 428', the second porous material 418' can still improve the comfort of the fluid collection assembly 400'.

[0059] FIG. 5 is a cross-sectional schematic diagram of a fluid collection assembly 500 according to one embodiment. The fluid collection assembly 500 is the same as the fluid collection assembly 400 shown in FIGS. 4A and 4B , except that the first and second porous materials 516, 518 are tapered along only a portion of the length of the porous medium 514. Tapering the first and second porous materials 516, 518 along only a portion of the length of the porous medium 514 can allow a portion of the first porous material 516 to form a portion of the outer surface 528 of the porous medium 514. For example, the first porous material 516 can form a portion of the outer surface 528 configured to be positioned adjacent the urethral opening. Thus, the portion of the outer surface 528 formed by the fluid porous material 516 can allow improved fluid flow into the porous medium 514 compared to the porous medium 414 shown in FIG. 4B because the second porous material 518 cannot form a barrier to bodily fluids entering the first porous material 516. It should be noted that the first and second porous materials 516, 518 may be tapered in the same direction as shown in FIG. 4C instead of the direction shown in FIG.

[0060] Figure 6A is a top view of a fluid collection assembly 600 according to one embodiment. Figure 6B is a cross-sectional schematic view of a fluid collection assembly 600 according to one embodiment. Except as otherwise disclosed herein, the fluid collection assembly 600 is the same as or substantially similar to any of the fluid collection assemblies disclosed herein. For example, the fluid collection assembly 600 includes a fluid-impermeable layer 602 including a proximal end region 604 and a distal end region 606. The fluid collection assembly 600 also includes a porous medium 614 disposed within the fluid-impermeable layer 602. The porous medium 614 includes a first porous material 616 and a second porous material 618.

[0061] The first and second porous materials 616, 618 form distinct portions of the porous medium, such that the first porous material 616 forms a proximal section of the porous medium 614 and the second porous material 618 forms a distal section of the porous medium 614. For example, the first and second porous materials 616, 618 can each form a portion of an outer surface 628 of the porous medium 614. The first and second porous materials 616, 618 can each include one or more first sides 634 and one or more second sides 636, respectively, that extend from the outer surface 628 through the porous medium 614 (e.g., extending from the outer surface 628 to an inner surface 630 that defines a hole). In one embodiment, the first and second porous materials 616, 618 can exhibit a shape that corresponds to the overall shape of the porous medium 614, except that the first and second porous materials 616, 618 exhibit a shorter length. For example, if the porous medium 614 exhibits a generally cylindrical shape, the first and second porous materials 616, 618 may exhibit a generally cylindrical shape.

[0062] Porous medium 614 may be easier to manufacture than other porous media disclosed herein. For example, porous medium 614 can be formed without forming cutouts, recesses, protrusions, or positioning one porous material on or within another. Instead, porous medium 614 can be formed by providing first and second porous materials 616, 618 and optionally adjusting the lengths of the first and second porous materials. The first and second porous materials 616, 618 can then be positioned adjacent to one another to form porous medium 614.

[0063] FIG. 7 is a cross-sectional schematic diagram of a fluid collection assembly 700 according to one embodiment. Note that fluid collection assembly 700 may exhibit the same top view as fluid collection assembly 600 shown in FIG. 6A. Except as otherwise disclosed herein, fluid collection assembly 700 is the same as or substantially similar to any of the fluid collection assemblies disclosed herein. For example, fluid collection assembly 700 includes a fluid-impermeable layer 702 including a proximal end region 704 and a distal end region 706. Fluid collection assembly 700 also includes a porous medium 714 disposed in fluid-impermeable layer 702. Porous medium 714 includes a first porous material 716 and a second porous material 718.

[0064] Similar to the porous medium 214 of FIG. 2 , the first porous material 716 includes an outer portion 742 and an inner portion 744. The outer portion 742 extends inwardly from a portion of the outer surface 728 of the porous medium 714 that is configured to contact, be positioned adjacent to, or otherwise be positioned near an individual's urethral opening. The inner portion 744 can extend behind the second porous material 718 and the outer portion 742. Thus, the outer portion 742 can extend outwardly from the inner portion 744. Again, the second porous material 718 improves the comfort of the fluid collection assembly 700 because it limits the portion of the individual's vaginal region that comes into contact with the less comfortable first porous material 716.

[0065] The porous media disclosed herein may include at least one intermediate porous material (e.g., a third porous material, a fourth porous material, etc.) in addition to the first and second porous materials described above. The intermediate porous material may exhibit intermediate fluid permeability and intermediate compressibility. In one embodiment, the intermediate fluid permeability of the intermediate porous material may be less than the first fluid permeability of the first porous material and greater than the second fluid permeability of the second porous material. In one embodiment, the intermediate compressibility of the intermediate porous material may be greater than the first compressibility of the first porous material and less than the second compressibility of the second porous material. The intermediate porous material may be positioned between or otherwise in contact with one or more of the first or second porous materials. The intermediate porous material may allow for more control over the fluid permeability and compressibility of the porous medium than if the porous medium included only the first and second porous materials. The intermediate porous material may form part of a proximal section of the porous medium, a distal section of the porous medium, or an intermediate section of the porous medium between the proximal and distal sections.

[0066] FIG. 8A is a top view of a fluid collection assembly 800 including a porous medium 814 having a third porous material 846 in addition to a first porous material 816 and a second porous material 818, according to one embodiment. FIG. 8B is a cross-sectional schematic view of the fluid collection assembly 800 taken along plane 8B-8B. Except as otherwise disclosed herein, the fluid collection assembly 800 is the same as or substantially similar to any of the fluid collection assemblies disclosed herein. For example, the fluid collection assembly 800 includes a fluid-impermeable layer 802 and a porous medium 814 disposed on the fluid-impermeable layer 802. The porous medium 814 includes a first porous material 816 and a second porous material 818.

[0067] 1B , the first porous material 816 and the second porous material 818 extend from the outer surface 828 of the porous medium 814 and through the porous medium 814 (e.g., to the inner surface 830). The third porous material 846 is positioned between the first porous material 816 and the second porous material 818 and extends from the outer surface 828 of the porous medium 814 and through the porous medium 814. In one embodiment, the third porous material 846 can facilitate operation of the fluid collection assembly 800 if the fluid collection assembly 800 is misplaced or mispositioned. For example, the fluid collection assembly 800 is configured such that the individual's urethral opening is positioned adjacent the urethral opening. However, the fluid collection assembly 800 may be misplaced on an individual such that the urethral opening is not positioned adjacent the urethral opening. If the fluid collection assembly 800 is misplaced, the urethral opening can be positioned adjacent to the third porous material 846, and thus bodily fluids can be better received within the porous medium 814 than if the urethral opening were positioned adjacent to the second porous material 818 (which would occur if the porous medium 814 did not include the third porous material 846). The third porous material 846 can also be more comfortable than the first porous material 816, and therefore the third porous material 846 can make the fluid collection assembly 800 more comfortable than if the third porous material 846 were instead formed from the first porous material 816.

[0068] FIG. 9 is a cross-sectional schematic diagram of a fluid collection assembly 900 including a porous medium 914 having a third porous material 946 in addition to a first porous material 916 and a second porous material 918, according to one embodiment. Except as disclosed herein, the fluid collection assembly 900 may be the same as or substantially similar to any of the fluid collection assemblies disclosed herein. For example, the fluid collection assembly 900 may be the same as or substantially similar to the fluid collection assembly 200 shown in FIG. 2, except that the outer portion 242 and the inner portion 244 are formed from different porous materials. In one embodiment, as shown, the fluid collection assembly 900 includes a fluid-impermeable layer 902 and a porous medium 914 disposed therein. The porous medium 914 includes a first porous material 916 and a second porous material 918 that form a portion of the outer surface 928 of the porous medium 914 (i.e., the first porous material 916 forms the outer portion). The porous medium 914 also includes a third porous material 946 that extends behind at least a portion of the first and second porous materials 916, 918 (i.e., the third porous material 946 forms the interior portion). The first porous material 916 can facilitate the entry of bodily fluids into the porous medium 914, and the second porous medium 918 can make the fluid collection assembly 900 more comfortable. Compared to the fluid collection assembly 200, the third porous material 946 can improve the compressibility of the porous medium 914 while minimizing a decrease in the overall fluid permeability of the porous medium 914. In one embodiment not shown, the third porous material 946 forms the exterior portion and the first porous material 916 forms the interior portion. In such an embodiment, the third porous material 946 can make the exterior surface 928 smoother or otherwise more comfortable, and the first porous material 916 can improve fluid flow through the porous medium 914, compared to the embodiment shown in FIG. 9 .

[0069] It should be noted that any of the other embodiments disclosed herein may include an intermediate porous material.

[0070] FIG. 10 is a block diagram of a fluid collection system 1050 for fluid collection, according to one embodiment. The fluid collection system 1050 includes a fluid collection assembly 1000, a fluid reservoir 1052, and a vacuum source 1054. The fluid collection assembly 1000 may be the same as or substantially similar to any of the fluid collection assemblies disclosed herein. The fluid collection assembly 1000, the fluid reservoir 1052, and the vacuum source 1054 may be fluidly coupled to one another via one or more conduits 1032. For example, the fluid collection assembly 1000 may be operably coupled to one or more of the fluid reservoir 1052 or the vacuum source 1054 via the conduit 1032. Bodily fluid collected within the fluid collection assembly 1000 can be removed from the fluid collection assembly 1000 via the conduit 1032 that protrudes into the fluid collection assembly 1000. For example, the inlet of the conduit 1032 may extend to a reservoir or the like within the fluid collection assembly 1000. The outlet of the conduit 1032 may extend into the fluid collection assembly 1000 or into the vacuum source 1054. In response to a vacuum (e.g., negative pressure) force applied to the outlet of the conduit 1032, a vacuum force may be introduced into the chamber of the fluid collection assembly 1000 via the inlet of the conduit 1032.

[0071] The vacuum force can be applied to the outlet of the conduit 132 directly or indirectly by the vacuum source 1054. The vacuum force may also be applied indirectly via the fluid reservoir 1052. For example, the outlet of the conduit 1032 may be disposed within the fluid reservoir 1052, and an additional conduit 1032 may extend from the fluid reservoir 1052 to the vacuum source 1054. Thus, the vacuum source 1054 can apply a vacuum to the fluid collection assembly 1000 via the fluid reservoir 1052. The vacuum force may also be applied directly by the vacuum source 1054. For example, the outlet of the conduit 1032 may be disposed within the vacuum source 1054. The additional conduit 1032 may extend from the vacuum source 1054 to a point external to the fluid collection assembly 1000, such as to the fluid reservoir 1052. In such an embodiment, the vacuum source 1054 may be disposed between the fluid collection assembly 1000 and the fluid reservoir 1052.

[0072] The fluid reservoir 1052 is sized and shaped to hold a bodily fluid therein. The fluid reservoir 1052 may include a bag (e.g., a drainage bag), a bottle, or a cup (e.g., a collection jar), or any other sealed container for storing a bodily fluid, such as urine. In some embodiments, the conduit 1032 may extend from the fluid collection assembly 1000 and couple to the fluid reservoir 1052 at a first point within the fluid reservoir 1052. An additional conduit 1032 may couple to the fluid reservoir 1052 at a second point on the fluid reservoir 1052 and may extend to and couple to a vacuum source 1054. Thus, a vacuum (e.g., negative pressure) can be drawn through the fluid collection assembly 1000 via the fluid reservoir 1052. Bodily fluids, such as urine, can be evacuated from the fluid collection assembly 1000 using the vacuum source 1054.

[0073] The vacuum source 1054 may include a manual vacuum pump, an electric vacuum pump, a diaphragm pump, a centrifugal pump, a positive displacement pump, a magnetic drive pump, a peristaltic pump, or any pump configured to generate a vacuum. The vacuum source 1054 can apply a vacuum or negative pressure to remove bodily fluid from the fluid collection assembly 1000. In some embodiments, the vacuum source 1054 can be powered by one or more of a power cord (e.g., connected to a power socket), one or more batteries, or manual power (e.g., a manual vacuum pump). In some embodiments, the vacuum source 1054 can be sized and shaped to fit outside, on, or within the fluid collection assembly 1000. For example, the vacuum source 1054 may include one or more miniature pumps or one or more micropumps. The vacuum sources 1054 disclosed herein may include one or more switches, buttons, plugs, remote controls, or any other devices suitable for activating the vacuum source 1054.

[0074] While various aspects and embodiments have been disclosed herein, other aspects and embodiments are contemplated. The various aspects and embodiments disclosed herein are for purposes of illustration and are not intended to be limiting.

[0075] Terms of degree (e.g., "about," "substantially," "approximately," etc.) indicate structurally or functionally insignificant variations. In one example, when 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 one example, when a term of degree is used to modify a shape, the term of degree indicates that the shape modified by the term of degree has the appearance of a disclosed shape. For example, the term of degree may be used to indicate that a shape may have rounded corners instead of sharp corners, curved edges instead of straight edges, one or more protrusions extending therefrom, be oval, be the same as a disclosed shape, etc.

Claims

1. a fluid impermeable layer including a proximal end region and a distal end region, the fluid impermeable layer defining at least one opening, a chamber, and a fluid outlet; a porous medium disposed within the chamber, The porous medium is a proximal section extending from or near the proximal end region of the fluid impermeable layer; a distal section extending from at or near the distal end region of the fluid impermeable layer to the proximal section; a first porous material exhibiting a first fluid permeability and a first compressibility; a second porous material exhibiting a second fluid permeability and a second compressibility; at least one of the first fluid permeability being greater than the second fluid permeability or the first compressibility being less than the second compressibility; The first porous material and the second porous material are the proximal compartment exhibits a fluid permeability that is greater than the fluid permeability of the distal compartment; or the proximal section exhibits a compressibility that is less than the compressibility of the distal section; a fluid collection assembly disposed in the porous medium such that the fluid collection assembly is one of:

2. 2. The fluid collection assembly of claim 1, wherein the first fluid permeability is greater than the second fluid permeability, and the proximal section exhibits a fluid permeability greater than the fluid permeability exhibited by the distal section.

3. 3. The fluid collection assembly of claim 2, the first porous material exhibits a greater number of pores per inch than the number of pores per inch exhibited by the second porous material; or the first porous material exhibits a percent porosity greater than the percent porosity exhibited by the second porous material; 10. A fluid collection assembly comprising:

4. 3. The fluid collection assembly of claim 2, the first porous material exhibits a density lower than that exhibited by the second porous material, or the first porous material exhibits a hydrophilicity that is higher than the hydrophilicity exhibited by the second porous material; 10. A fluid collection assembly comprising:

5. 3. The fluid collection assembly of claim 2, wherein the porous medium includes at least one intermediate porous material, the at least one intermediate porous material exhibiting a fluid permeability that is less than the first fluid permeability and greater than the second fluid permeability.

6. 2. The fluid collection assembly of claim 1, wherein the first compressibility is less than the second compressibility, and the proximal section exhibits a compressibility less than the compressibility exhibited by the distal section.

7. 7. The fluid collection assembly of claim 6, wherein the first porous material exhibits an average fiber diameter that is greater than an average fiber diameter exhibited by the second porous material.

8. 7. The fluid collection assembly of claim 6, the first porous material exhibits a greater number of pores per inch than the number of pores per inch exhibited by the second porous material; the first porous material exhibits a Young's modulus greater than that exhibited by the second porous material; the first porous material exhibits a yield strength greater than the yield strength exhibited by the second porous material; or the first porous material exhibits an average fiber length greater than the average fiber length exhibited by the second porous material; 10. A fluid collection assembly comprising:

9. 7. The fluid collection assembly of claim 6, wherein the first porous material and the second porous material exhibit at least one of different compressibility or different fluid permeability in different orientations, and the first porous material and the second porous material have different orientations.

10. 7. The fluid collection assembly of claim 6, wherein the porous medium includes at least one intermediate porous material, the at least one intermediate porous material exhibiting a compressibility greater than the first compressibility and less than the second compressibility.

11. 10. The fluid collection assembly of claim 1, wherein the porous medium exhibits an exterior surface exposed through the at least one opening, the exterior surface being formed by the first porous material and the second porous material.

12. 12. The fluid collection assembly of claim 11, wherein a portion of the first porous material extends behind at least a portion of the second porous material.

13. 12. The fluid collection assembly of claim 11, wherein the first porous material includes at least one side extending inward from the outer surface of the porous material, and the second porous material completely surrounds at least one of the sides of the first porous material.

14. 12. The fluid collection assembly of claim 11, wherein the first porous material includes at least one side extending inward from the outer surface of the porous material, and the second porous material is adjacent only a portion of the at least one side.

15. 10. The fluid collection assembly of claim 1, wherein the porous medium exhibits an exterior surface exposed through the at least one opening, the exterior surface being formed solely by the first porous material.

16. 10. The fluid collection assembly of claim 1, wherein the porous medium presents an exterior surface exposed through the at least one opening, the exterior surface being formed solely by the second porous material.

17. 10. The fluid collection assembly of claim 1, wherein the thickness of at least a portion of the first porous material decreases along a direction extending from the proximal end region to the distal end region.

18. 10. The fluid collection assembly of claim 1, wherein the thickness of at least a portion of the second portion increases along a direction extending from the proximal end region to the distal end region.

19. 2. A fluid collection assembly according to claim 1, wherein the fluid outlet is at or near the proximal end region and the distal end region of the fluid impermeable layer defines a substantially empty reservoir.

20. 1. A fluid collection assembly comprising: a fluid impermeable layer including a proximal end region and a distal end region, the fluid impermeable layer defining at least one opening, a chamber, and a fluid outlet; a porous medium disposed within the chamber; The porous medium is a proximal section extending from or near the proximal end region of the fluid impermeable layer; a distal section extending from at or near the distal end region of the fluid impermeable layer to the proximal section; a first porous material exhibiting a first fluid permeability and a first compressibility; a second porous material exhibiting a second fluid permeability and a second compressibility; at least one of the first fluid permeability being greater than the second fluid permeability or the first compressibility being less than the second compressibility; The first porous material and the second porous material are the proximal compartment exhibits a fluid permeability that is greater than the fluid permeability of the distal compartment; or the proximal section exhibits a compressibility that is less than the compressibility of the distal section; a fluid collection assembly disposed in the porous medium such that a fluid reservoir; A vacuum source; 1. A fluid collection system comprising:

1. A fluid collection system, comprising: a chamber of the fluid collection assembly, a fluid reservoir, and a vacuum source in fluid communication with each other, such that when one or more bodily fluids are present in the chamber of the fluid collection assembly, a vacuum is generated in the chamber of the fluid collection assembly from the vacuum source to remove the one or more bodily fluids from the chamber and accumulate the bodily fluids in the fluid reservoir.

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