A fluid collection assembly and system

Abstract

An example fluid collection assembly includes a fluid-impermeable layer defining at least one opening, a chamber, and a fluid outlet. The fluid collection assembly also includes a porous medium disposed in the chamber and extending through 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 embodiments, the first fluid permeability of the first porous material is greater than the second fluid permeability of the second porous material. In embodiments, the first compressibility of the first porous material is less than the second compressibility of the second porous material.

Description

[0001] Cross-references to related applications

[0002] This application claims priority to U.S. Provisional Patent Application No. 63 / 241,564, filed on September 8, 2021, the disclosure of which is incorporated herein by reference in its entirety. Background Technology

[0003] Humans or animals may have limited or impaired mobility, making the normal urination process challenging or impossible. For example, a person may experience or suffer from a disability that impairs mobility. A person may have limited travel conditions, such as those experienced by pilots, drivers, and workers in hazardous areas. In addition, bodily fluid collection is sometimes required for monitoring purposes or clinical testing.

[0004] Urinary catheters (such as Foley catheters) can address some of these situations, such as incontinence. Unfortunately, catheters can be uncomfortable, painful, and can lead to complications such as infections. Additionally, bedpans are sometimes used as a container for bedridden individuals to use the toilet. However, bedpans can be prone to discomfort, spills, and other hygiene problems. Summary of the Invention

[0005] Various embodiments relate to fluid collection assemblies, including fluid collection assemblies made of a first porous material and methods of using the fluid collection assembly, wherein the first porous material exhibits at least one of fluid permeability or compressibility different from that of a second porous material. In one embodiment, a fluid collection assembly is disclosed. The fluid collection assembly includes a fluid-impermeable layer comprising a proximal region and a distal 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 region, a distal region, a first porous material, and a second porous material, wherein the proximal region extends from or near the proximal region of the fluid-impermeable layer, and the distal region extends from or near the distal region of the fluid-impermeable layer to the proximal region; the first porous material exhibits a first fluid permeability and a first compressibility, and the second porous material exhibits a second fluid permeability and a second compressibility. At least one of the following is satisfied: the first fluid permeability is greater than the second fluid permeability or the first compressibility is less than the second compressibility. The first porous material and the second porous material are disposed in a porous medium such that at least one of the following is satisfied: the fluid permeability of the proximal region is greater than that of the distal region, or the compressibility of the proximal region is less than that of the distal region.

[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 comprising a proximal region and a distal 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 region, a distal region, a first porous material, and a second porous material. The proximal region extends from or near the proximal region of the fluid-impermeable layer, and the distal region extends from or near the distal region of the fluid-impermeable layer to the proximal region. The first porous material exhibits a first fluid permeability and a first compressibility, and the second porous material exhibits a second fluid permeability and a second compressibility. At least one of the following is satisfied: the first fluid permeability is greater than the second fluid permeability, or the first compressibility is less than the second compressibility. The first and second porous materials are disposed in a porous medium such that at least one of the following is satisfied: the fluid permeability of the proximal region is greater than the fluid permeability of the distal region, or the compressibility of the proximal region is less than the compressibility of the distal region. The fluid collection system also includes a fluid storage container and a vacuum source. The chamber of the fluid collection assembly, the fluid storage container, and the vacuum source are in fluid communication with each other. When one or more bodily fluids are present in the chamber, a vacuum supplied from the vacuum source to the chamber of the fluid collection assembly removes the one or more bodily fluids from the chamber and deposits them in the fluid storage container.

[0007] Features from any of the disclosed embodiments can be used in combination with each other without limitation. Furthermore, other features and advantages of this disclosure will become apparent to those skilled in the art upon consideration of the following detailed description and accompanying drawings. Attached Figure Description

[0008] The accompanying drawings illustrate several embodiments of this disclosure, wherein the same reference numerals denote the same or similar elements or features in different views or embodiments shown in the drawings.

[0009] Figure 1A This is a top plan view of the fluid collection assembly according to an embodiment.

[0010] Figure 1B This is a schematic cross-sectional view of the fluid collection assembly taken along plane 1B-1B according to an embodiment.

[0011] Figure 2 and Figure 3 These are schematic cross-sectional views of fluid collection assemblies according to different embodiments, demonstrating their relationship with... Figure 1A The same top plan view is shown for the fluid collection assembly.

[0012] Figure 4A This is a top plan view of the fluid collection assembly according to an embodiment.

[0013] Figure 4B This is a schematic diagram of a cross-section of the fluid collection assembly taken along plane 4B-4B.

[0014] Figure 4C This is a cross-sectional schematic diagram of a fluid collection assembly according to an embodiment.

[0015] Figure 5 This is a cross-sectional schematic diagram of a fluid collection assembly according to an embodiment.

[0016] Figure 6A This is a top plan view of the fluid collection assembly according to an embodiment.

[0017] Figure 6B This is a cross-sectional schematic diagram of a fluid collection assembly according to an embodiment.

[0018] Figure 7 This is a cross-sectional schematic diagram of a fluid collection assembly according to an embodiment.

[0019] Figure 8A This is a top plan view of a fluid collection assembly according to an embodiment, the fluid collection assembly including a porous medium having a third porous material in addition to a first porous material and a second porous material.

[0020] Figure 8B This is a schematic diagram of a cross-section of the fluid collection assembly taken along plane 8B-8B.

[0021] Figure 9 This is a cross-sectional schematic diagram of a fluid collection assembly according to an embodiment, the fluid collection assembly including a porous medium having a third porous material in addition to a first porous material and a second porous material.

[0022] Figure 10 This is a block diagram of a fluid collection system for fluid collection according to an embodiment. Detailed Implementation

[0023] Various embodiments relate to fluid collection assemblies, including fluid collection assemblies made of a first porous material and methods of using the fluid collection assembly, the first porous material exhibiting at least one of fluid permeability or compressibility different from that of a second porous material. An exemplary fluid collection assembly includes a fluid-impermeable layer (e.g., a fluid-impermeable barrier) that defines at least one opening, a chamber, and a fluid outlet. The fluid collection assembly also includes a porous medium disposed in the chamber and extending through 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 embodiments, the first fluid permeability of the first porous material is greater than the second fluid permeability of the second porous material, which may allow the porous medium to receive one or more bodily fluids (e.g., urine) more quickly or provide a more directional vacuum (e.g., aspiration). 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., preventing chafing or other contact that may be considered uncomfortable) while allowing unobstructed fluid flow.

[0024] During use, the fluid collection assembly disclosed herein is positioned adjacent to the vaginal region of an individual. For example, the fluid collection assembly disclosed herein may be positioned such that a portion of the porous medium extending across the opening is adjacent to or abuts against the individual's urethral opening. After positioning the fluid collection assembly, the individual may expel one or more bodily fluids (e.g., urine, blood, sweat, etc.). The bodily fluids may be received into the porous medium and 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 through the conduit, thereby keeping the individual dry. In some embodiments, a vacuum may be provided to the chamber via the conduit. This vacuum may help draw the bodily fluids through the porous medium, toward the conduit, and into the conduit.

[0025] As previously discussed, the porous media is positioned adjacent to the vaginal region of the individual, and therefore, it is desirable to form the porous media from a comfortable porous material, as the vaginal region is sensitive. Typically, a comfortable porous material is smooth to prevent chafing and is also compressible to allow the porous media to adapt to the vaginal region and apply pressure more evenly. Furthermore, the porous media is configured to receive one or more bodily fluids expelled from the individual. When an individual urinates, a relatively large volume of bodily fluid can be expelled from the individual in a short time, and the jet of fluid can be concentrated in a small portion of the porous media. Therefore, it is desirable to form the porous media from a material exhibiting a relatively high fluid permeability to allow bodily fluids to be rapidly received into the porous media and to prevent leakage.

[0026] Generally, smooth materials exhibit relatively low fluid permeability because increased fluid permeability increases the surface roughness of porous materials. For example, soft materials tend to have small pores, which limits the amount of bodily fluid that a soft material can receive at any given time. Moreover, compressible materials are typically compressible, which can block or otherwise close the pathways defined by the compressible material, thus inhibiting fluid flow through them. Materials exhibiting relatively high fluid permeability tend to define large pores, which increase the surface roughness of the material and make it incompressible to prevent the collapse of the pathways thus defined.

[0027] Conventional fluid collection assemblies address these issues by forming a porous medium comprising an outer and inner layer. To make the conventional fluid collection assembly more comfortable to use, the outer layer is formed of a relatively compressible and / or smooth material compared to the inner layer. To improve fluid flow through the conventional fluid collection assembly, the inner layer is formed of a material with a 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 the conventional fluid collection assembly. During use, at least initially, the volume of expelled bodily fluid is concentrated in a relatively small portion of the outer layer. However, because the outer layer is selected based on the compressibility and / or smoothness of the material rather than its fluid permeability, it may not exhibit a fluid permeability sufficient to receive the expelled bodily fluid. Thus, especially during heavy urination, the outer layer of the conventional fluid collection assembly may not be able to receive all the expelled bodily fluid, leading to leakage. Furthermore, in such conventional fluid collection assemblies, a vacuum tends to be introduced at the location of the porous medium spaced apart from the individual's urethral opening. The uniform thickness of the outer and inner layers of the porous media in a conventional fluid collection assembly means that airflow induced by a vacuum will not be directed to the portion of the porous media adjacent to the urethral orifice (i.e., the portion of the porous media most in need of vacuum). Instead, the vacuum will dissipate before reaching the portion of the porous media adjacent to the urethral orifice (e.g., leaking from the porous media). Furthermore, the outer layer thickness may be minimal, which reduces any benefits arising from the compressibility of the outer layer.

[0028] The fluid collection assembly disclosed herein addresses at least some of these problems of conventional fluid collection assemblies by employing different fluid permeabilities and / or compressibility of a first porous material and a second porous material. For example, the different fluid permeabilities and / or compressibility of the first and second porous materials are configured to increase the rate at which bodily fluids are received into the porous material, to direct a vacuum to selected portions of the porous material, or to prevent collapse of pathways through which bodily fluids can flow, while simultaneously making the fluid collection assembly as comfortable as possible. In embodiments, the different fluid permeabilities and / or compressibility of the first and second porous materials can be configured to form different regions in the porous medium, wherein the different regions exhibit different fluid permeabilities and / or compressibility. These different regions can be used to improve fluid flow through the porous medium and / or to make the porous medium more comfortable. In an example, the porous material may include a proximal region and a distal region. The proximal region may include multiple portions of the porous material that may come into contact with or be otherwise positioned near the urethral orifice during use, while the distal region does not come into contact with the urethral orifice. In this way, the fluid permeability of the proximal region can be greater than that of the distal region and / or the compressibility of the proximal region can be less than that of the distal region. This can improve fluid flow through the porous medium at or near the urethral orifice (e.g., where fluid flow through the porous medium is most important), and allow the porous material to more comfortably abut against a portion of the vaginal region separated from the urethral orifice. A first porous material and a second porous material can be disposed within the porous medium such that the porous medium comprises a proximal region and a distal region.

[0029] It should be noted that in some embodiments, fluid permeability can 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 materials exhibiting relatively high fluid permeability do not necessarily exhibit relatively low compressibility. For example, some materials exhibiting high fluid permeability may exhibit relatively high compressibility, while some materials exhibiting low fluid permeability may exhibit relatively low compressibility.

[0030] Figure 1A This is a top plan view of the fluid collection assembly 100 according to an embodiment. Figure 1BThis is a cross-sectional schematic diagram of a fluid collection assembly 100 taken along plane 1B-1B according to an embodiment. The fluid collection assembly includes a fluid-impermeable layer 102, which includes a proximal region 104 and a distal region 106. The fluid-impermeable layer 102 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 in 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. At least one of the following is satisfied: the first fluid permeability is greater than the second fluid permeability or the first compressibility is less than the second compressibility.

[0031] The different fluid permeability and / or compressibility of the first porous material 116 and the second porous material 118 cause the porous medium 114 to include a proximal region 120 and a distal region 122. The proximal region 120 may include multiple portions of the porous medium 114 configured to contact or otherwise be located adjacent to the urethral orifice, while the distal region 122 may include multiple portions of the porous medium 114 that are less likely to contact or otherwise be located adjacent to the urethral orifice. In other words, the proximal region 120 is more likely to receive a large amount of bodily fluid from the urethral orifice than the distal region 122. Thus, the ability of the proximal region 120 to receive bodily fluid and allow it to flow rapidly through it is more important than the ability to rapidly receive bodily fluid into the distal region 122. Simultaneously, the distal region 122 may be configured to be more comfortable relative to the vaginal region, where rapid fluid reception is not prioritized. Therefore, the first and second porous materials 116, 118 can be disposed in the porous medium 114 such that the proximal region 120 exhibits at least one of the following: a fluid permeability greater than that of the distal region 122 or a compressibility less than that of the distal region 122.

[0032] Generally, the proximal region 120 is relatively closer to the proximal region 104 of the fluid-impermeable layer 102 than the distal region 122. Thus, the proximal region 120 can extend a certain distance from or near the proximal region 104 of the fluid-impermeable layer 102. Generally, the distal region 122 is relatively closer to the distal region 106 of the fluid-impermeable layer 102 than the proximal region 120. Thus, the distal region 122 can extend a certain distance from or near the distal region 106 of the fluid-impermeable layer 102 (e.g., from or near the reservoir 124). In an embodiment, the distal region 122 extends from or near the distal region 106 to the proximal region 120. In an embodiment, the proximal region 120 and the distal region 122 may refer to the distal and proximal halves of the porous medium 114.

[0033] A 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 may extend from at least a portion of the outer surface 128 of the proximal region 120. In this way, the first porous material 116 can be directly adjacent to, positioned near, or otherwise positioned near the urethral opening of an individual, which allows the porous medium 114 to rapidly receive a larger volume of bodily fluid than would be without the first porous material 116 extending from the outer surface 128.

[0034] In an embodiment, as shown, a first porous material 116 extends from an outer surface 128 and through a porous medium 114. The first porous material 116 may extend from the outer surface 128 to the inner surface 130 of the porous medium 114 defining the orifice configured to receive a conduit 132 (as shown). Allowing the first porous material 116 to extend through the porous medium 114 facilitates the formation of the porous medium 114. In an embodiment, the porous medium 114 may be formed by providing a second porous material 118, such as a generally hollow cylindrical second porous material 118. A cut may be formed in and removed from the second porous material 118. The cut may extend completely through the second porous material 118, allowing for easy punching or otherwise cutting of the cut from the second porous material 118. The first porous material 116 may exhibit dimensions and shapes corresponding to the size and shape of the cut. Therefore, a first porous material 116 can be positioned in the cut to form a porous medium 114. When forming the porous medium 114 using this method, the first porous material 116 may include one or more first side surfaces 134, while the second porous material 118 may include one or more second side surfaces 136. The second side surfaces 136 may completely surround the first side surfaces 134.

[0035] In embodiments, as previously discussed, a first porous material 116 may exhibit a first fluid permeability, and a second porous material 118 may exhibit a second fluid permeability less than the first fluid permeability. The first fluid permeability may be greater than the second fluid permeability because the first porous material 116 exhibits at least one of different porosity per inch (“PPI”), density, or hydrophilicity compared to the second porous material 118. The greater fluid permeability of the first porous material 116 compared to the second porous material can allow the first porous material 116 to receive bodily fluids more quickly than the second porous material 118. Furthermore, the greater fluid permeability of the first porous material 116 compared to the second porous material 118 can allow a vacuum (e.g., an airflow due to a vacuum) to preferentially move within the first porous material 116 compared to the second porous material 118. Simultaneously, the second porous material 118 can abut against the individual's vaginal region more smoothly, more compressibly, or otherwise more comfortably than the first porous material 116, because the fluid permeability of the second porous material 118 is not prioritized over comfort. Referring to the illustrated embodiment, as previously discussed, the first porous material 116 is configured to be positioned adjacent to or otherwise close to the individual's urethral orifice. Thus, the first porous material 116 initially receives bodily fluids discharged from the urethral orifice. The relatively high fluid permeability of the first porous material 116 allows bodily fluids to be rapidly received into the porous medium 114, thereby preventing bodily fluid leakage. Furthermore, the relatively high fluid permeability of the first porous material 116 allows for preferential delivery of vacuum to the first porous material 116, rather than at least some portions of the second porous material 118 surrounding the first porous material 116, particularly to the portions of the second material 118 between the first porous material 116 and the proximal region 104. Preferably, vacuum delivery to the first porous material 116 increases the rate at which bodily fluids are received into, flow through, and from the first porous material 116 to the second porous material 118. However, the first porous material 116 may have a rougher surface than the second porous material 118 or otherwise be less comfortable for the individual's vaginal area. The presence of the second porous material limits the exposure of the vaginal area to the less comfortable portion of the first porous material 116, thereby making the use of the fluid collection assembly 100 more comfortable.

[0036] In an embodiment, the first porous material 116 may exhibit a first compressibility, and the second porous material 118 may exhibit a second compressibility greater than the first fluid permeability. The first compressibility may be less than the second compressibility because the first porous material 116 exhibits at least one of the following different values ​​than the second porous material 118: PPI, average fiber diameter, Young's modulus (i.e., elastic modulus), yield or ultimate tensile strength, fiber entanglement, or density. The lower compressibility of the first porous material 116 compared to the second porous material 118 may better suppress the collapse of channels in the first porous material 116. Suppressing the collapse of channels in the first porous material 116 allows for better fluid flow. Simultaneously, 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 region and better distribute any pressure applied to the vaginal region, both of which improve comfort. Referring to the illustrated embodiment, as previously discussed, the first porous material 116 is configured to be positioned adjacent to or otherwise close to the individual's urethral orifice. Therefore, the first porous material 116 initially receives bodily fluids draining from the urethral orifice. To prevent the passageway in the first porous material 116 from collapsing, allowing bodily fluids to be rapidly received into the porous medium 114, and preferably with vacuum delivery to the first porous material 116. However, the first porous material 116 may be difficult to adapt to the shape of the vaginal region and / or may be difficult to distribute pressure evenly to the vaginal region. The presence of the second porous material 118 limits the vaginal region exposed to the less comfortable portion of the first porous material 116, thereby making the use of the fluid collection assembly 100 more comfortable.

[0037] In an embodiment, the first porous material 116 may exhibit a higher PPI than the second porous material 118. Generally, increasing the PPI of a material increases the number of pores in the material, which can increase the rate at which bodily fluids and vacuum can flow through it. Therefore, the first porous material 116 may exhibit a higher PPI than the second porous material. Furthermore, increasing the PPI can increase the compressibility of the material by reducing its solids content and increasing its surface roughness. The first and second porous materials 116, 118 can be independently selected to present a PPI of about 10 PPI or greater, about 15 PPI or greater, about 20 PPI or greater, about 25 PPI or greater, about 30 PPI or greater, about 35 PPI or greater, about 40 PPI or greater, about 50 PPI or greater, about 60 PPI or greater, about 75 PPI or greater, about 100 PPI or greater, or within the range 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 can be selected based on the desired fluid permeability and / or compressibility.

[0038] In embodiments, the density of the first porous material 116 may be less than the density of the second porous material 118. Generally, reducing the density of a material can increase its porosity, which can increase the rate through which bodily fluids and vacuum can flow. Furthermore, reducing the density of a material can increase its compressibility by reducing its solids content and increasing its surface roughness. The first and second porous materials 116, 118 may be independently selected to exhibit densities of about 0.8 g / cm³ (“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. 0.2g / cc or less, about 0.15g / cc or less, about 0.1g / cc or less, about 0.075g / cc or less, about 0.05g / cc or less, about 0.04g / cc or less, about 0.03g / cc or less, about 0.02g / cc or less, about 0.015g / cc or less, about 0.01g / cc or less, about 0.0075g / cc or less, or about 0.0075g / cc to about 0.015g / cc, about 0.01g / cc to about 0 0.02g / cc, about 0.015g / mm to about 0.03g / cc, 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. The range is approximately 0.25 g / cc to approximately 0.35 g / cc, approximately 0.3 g / cc to approximately 0.4 g / cc, approximately 0.35 g / cc to approximately 0.45 g / cc, approximately 0.4 g / cc to approximately 0.5 g / cc, approximately 0.45 g / cc to approximately 0.55 g / cc, approximately 0.5 g / cc to approximately 0.6 g / cc, approximately 0.55 g / cc to approximately 0.65 g / cc, approximately 0.6 g / cc to approximately 0.7 g / cc, or approximately 0.65 g / cc to approximately 0.8 g / cc.The densities of the first and second porous materials 116, 118 can be selected to be from about 0.1% to about 99% of their theoretical maximum density (i.e., the densities of the first and second porous materials 116, 118 if the material is non-porous), such as about 0.1% to about 0.5%, about 0.25% to about 0.75%, about 0.5% to about 1%, about 0.75% to about 1.5%, about 1% to about 2%, and about 1.5% to about 2%. 5%, about 2% to about 3%, 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 densities of the first and second porous materials 116, 118 may be selected based on their desired fluid permeability and / or compressibility. The densities of the first and second porous materials 116, 118 may also be selected based on their desired PPI.

[0039] In an embodiment, the first porous material 116 may exhibit a greater percentage of porosity than the second porous material 118. This greater percentage of porosity in the first porous material 116 may result in the first porous material 116 exhibiting a larger and / or greater number of pores than the second porous material 118, which can rapidly receive bodily fluids. The porosity percentages of the first and second porous materials 116, 118 can be independently selected as about 1% to about 20%, about 10% to about 30%, about 20% to about 40%, about 30% to about 50%, about 40% to about 55%, about 50% to about 60%, about 55% to about 65%, about 60% to about 70%, about 65% to about 75%, about 70% to about 80%, about 75% to about 82.5%, about 80% to about 85%, about 82.5% to about 87.5%, about 85% to about 90%, about 87.5% to about 92.5%, about 90% to about 95%, about 92.5% to about 97.5%, or about 95% to about 99%. The porosity percentages of the first and second porous materials 116, 118 can be selected based on their desired fluid permeability, surface roughness, and compressibility. The porosity percentage of the first and second porous materials 116 and 118 may depend in part on the density of the first and second porous materials 116 and 118.

[0040] In this embodiment, the first porous material 116 may exhibit greater hydrophilicity than the second porous material 118. In other words, the contact angle between the first porous material 116 and water (a major component of bodily fluids) may be smaller than the contact angle between the second porous material 118 and water. Generally, increasing hydrophilicity enhances a material's ability to absorb bodily fluids. However, increasing the hydrophilicity of a material also increases the difficulty of removing bodily fluids from it. The first and second porous materials 116 and 118 can be independently selected to present contact angles of about 0° to about 10°, about 5° to about 15°, about 10° to about 20°, about 15° to about 25°, about 20° to about 30°, about 25° to about 35°, about 30° to about 40°, about 35° to about 45°, about 40° to about 50°, about 45° to about 55°, about 50° to about 60°, about 55° to about 65°, about 60° to about 70°, about 65° to about 75°, about 70° to about 80°, about 75° to about 85°, and about 80° to about Contact angles of 90°, about 85° to about 95°, about 90° to about 100°, about 95° to about 105°, about 100° to about 120°, about 115° to about 125°, about 120° to about 130°, about 125° to about 135°, about 130° to about 140°, about 135° to about 145°, about 140° to about 50°, about 145° to about 155°, about 150° to about 160°, about 155° to about 165°, about 160° to about 170°, about 165° to about 175°, or about 170° to about 180°. The hydrophilicity (i.e., contact angle with water) of the first and second porous materials 116, 118 can be selected based on the materials forming the first and second porous materials 116, 118. In the example, the first porous material 116 may be formed of a material that exhibits hydrophilicity less than (i.e., a contact angle with water greater than) that forms the second porous material 118. In the example, the first porous material 116 may be at least partially coated with a material that increases its hydrophilicity (e.g., reduces the contact angle with water) and / or the second porous material 118 may be at least partially coated with a material that reduces its hydrophilicity.

[0041] In embodiments, the average fiber diameter of the first porous material may be greater than that of the second porous material. Generally, increasing the average fiber diameter increases the force the material can withstand without significant bending, which in turn reduces the material's compressibility. The first and second porous materials 116, 118 can be independently selected to exhibit average fiber diameters 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, and about 0.5 μm. Approximately 0.7 μm, approximately 0.6 μm to approximately 0.8 μm, approximately 0.7 μm to approximately 0.9 μm, approximately 0.8 μm to approximately 1 μm, approximately 0.9 μm to approximately 1.25 μm, approximately 1 μm to approximately 1.5 μm, approximately 1.25 μm to approximately 2 μm, approximately 1.5 μm to approximately 2.5 μm, approximately 2 μm to approximately 3 μm, approximately 2.5 μm to approximately 4 μm, approximately 3 μm to approximately 5 μm, approximately 4 μm to approximately 6 μm Approximately 5μm to approximately 7μm, approximately 6μm to approximately 8μm, approximately 7μm to approximately 9μm, approximately 8μm to approximately 10μm, approximately 9μm to approximately 12.5μm, approximately 10μm to approximately 15μm, approximately 12.5μm to approximately 20μm, approximately 15μm to approximately 25μm, approximately 20μm to approximately 30μm, approximately 25μm to approximately 40μm, approximately 30μm to approximately 50μm, approximately 40μm to approximately 60μm, approximately 5 The average fiber diameter can 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. It should be noted that the average fiber diameter can affect the PPI and / or density of the first and second porous materials 116, 118. For example, increasing the average fiber diameter can decrease the PPI and / or density. Therefore, the average fiber density can be selected based on the desired PPI and / or density.

[0042] In embodiments, at least one of the first porous materials may exhibit a Young's modulus greater than that of the first porous material, a yield strength greater than that of the second porous material, or an ultimate tensile strength greater than that of the first porous material. Generally, increasing the Young's modulus, yield strength, or ultimate tensile strength of a material reduces its compressibility. Young's modulus, yield strength, and ultimate tensile strength are material properties, and therefore, the Young's modulus, yield strength, and ultimate 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 the embodiments, the first and second porous materials 116 and 118 may be independently selected to exhibit an ultimate tensile strength 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, about 10 GPa or greater, about 11 GPa or greater, about 12.5 GPa or greater, about 15 GPa or greater, about 20 GPa or greater, about 25 GPa or greater, about 30 GPa or greater, about 40 GPa or greater, about 50 GPa or greater, about 75 GPa or greater, about 100 GPa or greater, or from about 0.2 GPa to about 0. The range is approximately 5 GPa, approximately 0.3 GPa to approximately 0.75 GPa, approximately 0.5 GPa to approximately 1 GPa, approximately 0.75 GPa to approximately 1.5 GPa, approximately 1 GPa to approximately 2 GPa, approximately 1.5 GPa to approximately 3 GPa, approximately 2 GPa to approximately 4 GPa, approximately 3 GPa to approximately 5 GPa, approximately 4 GPa to approximately 6 GPa, approximately 5 GPa to approximately 7 GPa, approximately 6 GPa to approximately 8 GPa, approximately 7 GPa to approximately 9 GPa, approximately 8 GPa to approximately 10 GPa, approximately 9 GPa to approximately 11 GPa, approximately 10 GPa to approximately 12.5 GPa, approximately 11 GPa to approximately 15 GPa, approximately 12.5 GPa to approximately 20 GPa, approximately 15 GPa to approximately 25 GPa, approximately 20 GPa to approximately 30 GPa, approximately 25 GPa to approximately 40 GPa, approximately 30 GPa to approximately 50 GPa, approximately 35 GPa to approximately 75 GPa, or approximately 50 GPa to approximately 100 GPa.In the embodiments, the first and second porous materials 118, 118 can be independently selected to exhibit a yield strength or ultimate tensile strength of about 3 MPa (“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 Approximately 7.5 MPa, approximately 5 MPa to approximately 10 MPa, approximately 7.5 MPa to approximately 15 MPa, approximately 10 MPa to approximately 20 MPa, approximately 15 MPa to approximately 30 MPa, approximately 20 MPa to approximately 40 MPa, approximately 30 MPa to approximately 50 MPa, approximately 40 MPa to approximately 60 MPa, approximately 50 MPa to approximately 70 MPa, approximately 60 MPa to approximately 80 MPa, approximately 70 MPa to approximately 100 MPa, approximately 80 MPa The range is approximately 125 MPa, approximately 100 MPa to approximately 150 MPa, approximately 100 MPa to approximately 200 MPa, approximately 150 MPa to approximately 300 MPa, approximately 200 MPa to approximately 400 MPa, approximately 300 MPa to approximately 500 MPa, approximately 400 MPa to approximately 600 MPa, approximately 500 MPa to approximately 700 MPa, approximately 600 MPa to approximately 800 MPa, and approximately 700 MPa to approximately 1 GPa.

[0043] In an embodiment, the first porous material 116 may exhibit greater fiber entanglement than the second porous material 118. Generally, increasing fiber entanglement in a material reduces its compressibility. Fiber entanglement can depend on, for example, the average fiber length, the weave pattern used to form the material, and the nonwoven technique used to form the material. Therefore, the first porous material 116 may satisfy at least one of the following: exhibiting an average fiber length greater than the second porous material 118, exhibiting a different weave pattern than the second porous material 118, or being formed using a nonwoven technique different from that used for the second porous material 118.

[0044] In an embodiment, the first and second porous materials 116, 118 may be formed of the same isotropic material. This isotropic material may exhibit different compressibility and / or fluid permeability in different orientations. Therefore, the isotropic material of the first porous material 116 may exhibit an orientation different from that of the isotropic material of the second porous material 118.

[0045] A porous medium 114 is disposed within a chamber 110. The porous medium 114 may cover at least a portion (e.g., all) of an opening 108. The porous medium 114 is exposed to the environment outside the chamber 110 through the opening 108. In embodiments, the porous medium 114 may be configured to wick any bodily fluid from the opening 108, thereby preventing leakage of bodily fluid from the chamber 110. The permeability characteristic mentioned herein may be wicking, capillary action, diffusion, or other similar characteristics or processes, and is referred to herein as “permeable” and / or “wicking.” This “wicking” and / or “permeable” characteristic may not include the absorption of bodily fluid into at least a portion of the porous medium 114. In other words, substantially no absorption or dissolution of bodily fluid into the material occurs after the material has been exposed to and removed from the bodily fluid for a period of time. While absorption or dissolution is not desired, the term "substantially non-absorbent" may allow for nominal amounts of body fluid to be absorbed and / or dissolved (e.g., absorbability) in the porous medium 114, such as less than about 30 wt%, about 20 wt%, about 10 wt%, about 7 wt%, about 5 wt%, about 3 wt%, about 2 wt%, about 1 wt%, or about 0.5 wt% of the dry weight of the porous medium 114. The porous medium 114 may also entrain body fluid substantially toward the interior of the chamber 110, as discussed in more detail below. In embodiments, the porous medium 114 may comprise at least one absorbent or absorbent material.

[0046] The porous medium 114 can be formed from any suitable porous material. Examples of materials that can form the porous medium 114 (e.g., the first porous material 116 and the second porous material 118) 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 materials, or combinations thereof.

[0047] As previously discussed, the fluid collection assembly 100 may include a fluid-impermeable layer 102. The fluid-impermeable layer 102 at least partially defines a chamber 110 (e.g., an internal region) and an opening 108. For example, one or more inner surfaces 138 of the fluid-impermeable layer 102 at least partially define the chamber 110 within the fluid collection assembly 100. The fluid-impermeable layer 102 temporarily stores bodily fluids within the chamber 110. The fluid-impermeable layer 102 may be formed of any suitable one or more fluid-impermeable materials, such as fluid-impermeable polymers (e.g., silicone, polypropylene, polyethylene, polyethylene terephthalate, neoprene rubber, polycarbonate, etc.), metal membranes, natural rubber, other suitable materials, any other fluid-impermeable materials disclosed herein, or combinations thereof. Thus, the fluid-impermeable layer 102 substantially prevents bodily fluids from passing through it. In an example, the fluid-impermeable layer 102 may be air-permeable and fluid-impermeable. In this example, the fluid-impermeable layer 102 may be formed of a hydrophobic material that defines a plurality of pores. At least one or more portions of at least one outer surface 140 of the fluid-impermeable layer 102 may be formed of a soft and / or smooth material, thereby reducing abrasion.

[0048] Opening 108 provides an entry path for bodily fluids into chamber 110. Opening 108 may be defined by a fluid-impermeable layer 102, such as by the inner edge of the fluid-impermeable layer 102. For example, opening 108 is formed in the fluid-impermeable layer 102 and extends through the fluid-impermeable layer from the outer surface 140 to the inner surface 138, thereby allowing bodily fluids to enter chamber 110 from the outside of the fluid collection assembly 100.

[0049] In some examples, a fluid-impermeable layer 102 may define a fluid outlet 112, the size of which is determined to receive a conduit 132. At least one conduit 132 may be disposed in the chamber 110 via the fluid outlet 112. The size and shape of the fluid outlet 112 may be determined to form a seal against the conduit 132 or at least one tube that is at least substantially impermeable to fluid, thereby substantially preventing leakage of bodily fluids from the chamber 110.

[0050] The porous medium 114 may at least substantially completely fill the portion of the chamber 110 not occupied by the conduit 132. In some examples, the porous medium 114 may not substantially completely fill the portion of the chamber 110 not occupied by the conduit 132. In such an example, the fluid collection assembly 100 includes a reservoir 124 disposed in the chamber 110.

[0051] Reservoir 124 is a substantially unoccupied portion of chamber 110. Reservoir 124 may be defined between a fluid-impermeable layer 102 and a porous medium 114 (e.g., one or more of a first or second porous material 116, 118). Body fluids in chamber 110 may flow to reservoir 124 through porous medium 114 (e.g., one or more of a first or second porous material 116, 118). Reservoir 124 may retain body fluids therein.

[0052] Bodily fluids in chamber 110 can flow to reservoir 124 through porous medium 114. A fluid-impermeable layer 102 can retain the bodily fluids in reservoir 124. Although depicted in distal region 106, reservoir 124 can be located in any part of chamber 110, such as proximal region 104. Reservoir 124 can be located in a portion of chamber 110 designed to be at the lowest point of gravity of fluid collection assembly 100 when it is worn.

[0053] In some examples (not shown), the fluid collection assembly 100 may include multiple reservoirs, such as a first reservoir located at the portion of chamber 110 closest to the inlet of catheter 132 (e.g., distal region 106) and a second reservoir located at or near the portion of chamber 110 at proximal region 104. In another example, porous media 114 is spaced apart from at least a portion of catheter 132, and reservoir 124 may be the space between porous media 114 and catheter 132.

[0054] A conduit 132 may be at least partially disposed within chamber 110. Conduit 132 may be used to remove bodily fluids from chamber 110. Conduit 132 includes at least one wall defining an inlet, an outlet (not shown) downstream of the inlet, and a passageway. The outlet of conduit 132 may be operatively coupled to a vacuum source, such as a vacuum pump for extracting fluid from chamber 110 through conduit 132. For example, conduit 132 may extend from proximal region 104 into fluid-impermeable layer 102 and may extend from distal region 106 to a point near reservoir 124 therein, such that the inlet is in fluid communication with reservoir 124. Conduit 132 fluidly connects chamber 110 to a fluid storage container (not shown) or a vacuum source (not shown).

[0055] The conduit 132 may extend through a hole in the porous medium 114. In one embodiment, the conduit 132 extends from the fluid outlet 112 through the hole to a location adjacent to the reservoir 124. In this embodiment, the inlet may not extend into the reservoir 124, and alternatively, the inlet may be located within or at the end of the porous medium 114. For example, the end of the conduit 132 may extend along with or be recessed within the porous medium 114. In one embodiment, the conduit 132 is at least partially located in the reservoir 124, and the inlet may extend into or be located within the reservoir 124. Bodily fluids collected in the fluid collection assembly 100 may be removed from the chamber 110 via the conduit 132.

[0056] When worn by an individual, the inlet is positioned at or near the intended low point of gravimetric analysis in chamber 110, allowing catheter 132 to receive more bodily fluid than if the inlet were located elsewhere, and reducing the likelihood of pooling (e.g., pooling of bodily fluid can lead to microbial growth and foul odor). For example, bodily fluid in porous media 114 can flow in any direction due to capillary action. However, bodily fluid may tend to flow more in the direction of gravity, especially when at least a portion of porous media 114 is saturated with bodily fluid. Therefore, one or more of the inlets or reservoirs 124 may be located at an intended location in the fluid collection assembly 100, such as the distal region 106, when worn by an individual.

[0057] The inlet and outlet of conduit 132 are configured to fluidly connect (e.g., directly or indirectly) a vacuum source (not shown) to chamber 110 (e.g., reservoir 124). When the vacuum source ( Figure 10 When a vacuum / vacuum state is applied in the conduit 132, bodily fluids in the chamber 110 (e.g., at the distal region DER, such as in the reservoir 124) can be drawn into the inlet of the fluid collection assembly 100 and extracted from the fluid collection assembly 100 via the conduit 132. In some examples, the conduit 132 may be frosted or opaque (e.g., black) to obscure the visibility of the bodily fluids therein.

[0058] As previously discussed, catheter 132 can be configured to be inserted into at least chamber 110. In this example, catheter 132 can be positioned within chamber 110 such that its distal end is spaced apart from the fluid-impermeable layer 102 or other components of the fluid collection assembly 100, which may at least partially block or obstruct the inlet. Furthermore, the inlet of catheter 132 can be offset relative to the distal end of porous media 114, such that the inlet is closer to the proximal region 104 of the fluid collection assembly 100 than the distal end of porous media 114. This offsetting of the inlet relative to the distal end of porous media 114 allows the inlet to receive bodily fluid directly from porous media 114 and, due to hydrogen bonding, draws more bodily fluid from porous media 114 into catheter 132.

[0059] Figure 2 and Figure 3 This is a schematic cross-sectional view of a fluid collection assembly according to different embodiments, showing a fluid collection assembly with... Figure 1A The fluid collection assembly 100 shown is the same top plan view. Unless otherwise disclosed herein, Figure 2 and Figure 3 The fluid collection assembly shown is the same as or substantially similar to any fluid collection assembly disclosed herein. For example, Figure 2 and Figure 3 The fluid collection assembly shown may include a fluid-impermeable layer defining a chamber and a porous medium disposed within the chamber. The porous medium may include a first porous material and a second porous material. The first porous material may exhibit at least one different fluid permeability or compressibility than the second porous material. The first and second porous materials may be arranged such that the porous medium includes a proximal region and a distal region.

[0060] refer to Figure 2The first porous material 216 includes an outer portion 242 and an inner portion 244. The outer portion 242 extends inwardly from a portion of the outer surface 228 of the porous medium 214, which is configured to contact, be located adjacent to, or otherwise be located close to the urethral orifice of an individual. The inner portion 244 may 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 outwardly from the inner portion 244. During use, the outer portion 242 can receive a relatively large amount of bodily fluid from the urethral orifice. Regardless of whether the first porous material 216 exhibits a greater fluid permeability than the second porous material 218 or less compressibility than the second porous material 216, bodily fluid can be rapidly received into the outer portion 242 of the first porous material 216 due to the greater fluid permeability or unfolded passage defined therein. Then, the bodily fluid received by the external 242 can flow into the interior of the first porous material 216. Again, regardless of whether the first porous material 216 exhibits a higher fluid permeability than the second porous material 218 or lower compressibility, the bodily fluid can rapidly flow through the internal portion 244 to the inlet of the reservoir 224 and / or conduit 232 due to the greater fluid permeability or uncollapsed pathways confined therein. In fact, the bodily fluid can be more... Figure 1B The porous medium 114 shown flows through the porous medium 214 more quickly because at least some bodily fluid can flow through the porous medium 214 (i.e., preferentially flowing through the internal portion 244 of the first porous material 216), while avoiding the second porous material 218. Moreover, compared to... Figure 1B In the portion of the first porous material 116 shown, vacuum may more preferably be provided to the outer portion 242 of the first porous material 216, since vacuum will preferably travel through the inner portion 244 of the first porous material 216, and the second porous material 218 will form a barrier to prevent vacuum from leaking from the chamber 210 defined by the fluid impermeable layer 202.

[0061] The second porous material 218 still improves the comfort of the fluid collection assembly 200 because it limits contact between the individual's vaginal area and a portion of the less comfortable first porous material 216. It should be noted that, compared to... Figure 1B Compared to the second porous material 118 shown, the second porous material 218 can exhibit a reduced thickness measured perpendicular to the longitudinal axis of the fluid collection assembly 200 because the internal portion 244 of the first porous material 216 extends behind the second porous material 218. Since the second porous material 218 exhibits greater compressibility than the first porous material 216, the reduced thickness of the second porous material 218 can slightly reduce the impact of the increased compressibility of the second porous material 218 on improving the comfort of the fluid collection assembly 200.

[0062] The porous medium 214 can be formed by forming a cut in the second porous material 218 and forming a protrusion (i.e., an outer portion 242) in the first porous material 216 corresponding to the cut in the second porous material 218. The first porous material 216 can then be disposed within the second porous material 218, with the outer portion 242 disposed through the cut. Therefore, the second porous material 218 can completely surround the outer portion 242.

[0063] refer to Figure 3 The second porous material 318 includes an outer portion 342 and an inner portion 344. The outer portion 342 extends inwardly from a portion of the outer surface 328 of the porous medium 314, and this portion is not configured to contact, be located adjacent to, or otherwise be located close to the urethral opening of an individual. The inner portion 344 may extend behind and support the first porous material 316 (e.g., a fluid-permeable membrane). Thus, the outer portion 342 may extend outwardly from the inner portion 344. The second porous material 318 improves the comfort of the fluid collection assembly 300 because it limits contact between the less comfortable portion of the first porous material 316 and the vaginal area of ​​the individual. The second porous material 318 may define a recess adjacent to the inner portion 344. The first porous material 316 may be positioned within the recess. During use, the first porous material 316 may receive a relatively large amount of bodily fluid from the urethral opening. Regardless of whether the first porous material 316 exhibits a higher fluid permeability than the second porous material 318 or lower compressibility than the second porous material 318, body fluid can be rapidly received into the first porous material 316 due to its greater fluid permeability or the non-collapsed pathways defined therein. The body fluid received by the first porous material 316 can then flow into the second porous material 318.

[0064] The porous medium 314 can be formed by creating a recess in the second porous material 318 and forming (e.g., molding) a first porous material 316 to fit within the recess. The first porous material 316 can then be disposed within the recess defined by the second porous material 318. Thus, the second porous material 318 can completely surround the outer portion 342.

[0065] Figure 4A This is a top plan view of the fluid collection assembly 400 according to an embodiment. Figure 4BThis is a schematic cross-sectional view of the fluid collection assembly 400 taken along plane 4B-4B. Unless otherwise disclosed herein, the fluid collection assembly 400 is identical or substantially similar to any fluid collection assembly disclosed herein. For example, the fluid collection assembly 400 includes a fluid-impermeable layer 402 comprising a proximal region 404 and a distal region 406. The fluid collection assembly 400 also includes a porous medium 414 disposed within the fluid-impermeable layer 402. The porous medium 414 comprises a first porous material 416 and a second porous material 418.

[0066] The second porous material 418 forms all the outer surfaces 428 of the porous medium 414, which makes all the outer surfaces 428 in contact with the vaginal region of the individual more comfortable to use. However, the thickness of the second porous material 418 gradually decreases 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 second porous material 418 decreases as it approaches the proximal region 404. Since the urethral orifice is typically located near the proximal region 404, the reduced thickness of the second porous material 418 can prevent or at least inhibit the second porous material 418 from becoming a significant barrier to the entry of bodily fluids into the porous medium 414. The thickness of the second porous material 418 can increase as it approaches the distal region 406. Therefore, when the second porous material 418 exhibits greater compressibility than the first porous material 416, the increased compressibility of the second porous material 418 can have a greater impact on the comfort of the fluid collection assembly 400 as it approaches the distal region 406.

[0067] The first porous material 416 is spaced apart from the outer surface 428 of the porous medium 414, as previously discussed, which can make the fluid collection assembly 400 more comfortable to use. However, the thickness of the first porous material 416 gradually decreases along at least a portion (e.g., all) of the length of the porous medium 414 in a manner opposite to that of the second porous material 418. For example, the thickness of the first porous material 416 may increase with increasing proximity to the proximal region 404 and may decrease with increasing proximity to the distal region 406. Thus, during use, at a location adjacent to the individual's urethral orifice, the thickness of the first porous material 416 can be significantly greater than the thickness of the second porous material 418. The increased thickness of the first porous material 416 can facilitate the aspiration of bodily fluids through the second porous material 418 near the urethral orifice, because the first porous material 416 can exhibit higher fluid permeability and / or a more unobstructed pathway compared to the second porous material 418. Variations in the thickness of the first porous material 416 can also facilitate vacuum delivery to a portion of the porous medium 414 near the urethral orifice. For example, as previously described, vacuum preferentially flows through the first porous material 416. The increased thickness of the second porous material 418 near the distal region 406 suppresses vacuum leakage from the porous medium 414 at locations near the distal region 406 (i.e., spaced apart from the urethral orifice). The decreased thickness of the second porous material 418 near the proximal region 404 results in more vacuum leakage from the porous medium 414 at locations near the proximal region 404, which facilitates the aspiration of bodily fluids into the porous medium 414 (e.g., aspiration of bodily fluids through the second porous material 418 and into the first porous material 416).

[0068] Figure 4C This is a schematic cross-sectional view of a fluid collection assembly 400' according to an embodiment. Unless otherwise disclosed herein, the fluid collection assembly 400' is identical or substantially similar to any fluid collection assembly disclosed herein. For example, the fluid collection assembly 400' includes a fluid-impermeable layer 402' comprising a proximal region 404' and a distal region 406'. The fluid collection assembly 400' also includes a porous medium 414' disposed within the fluid-impermeable layer 402'. The porous medium 414' comprises a first porous material 416' and a second porous material 418'.

[0069] Except that the first porous material 416' replaces the second porous material 418' to form the entire outer surface 428' of the porous medium 414', the fluid collection assembly 400' is essentially similar to Figure 4A and 4BThe fluid collection assembly 400. Forming the entire outer surface 428' with a first porous material 416' would make the fluid collection assembly 400' less comfortable than the fluid collection component 400'. However, forming the entire outer surface 428' with the first porous material 416' prevents the second porous material 418' from becoming a barrier to the inflow of bodily fluids into the first porous material 416'. For example, bodily fluids discharged from the urethra can immediately contact the first porous material 416'. Therefore, compared to the case where the second porous material 418' forms at least a portion of the porous medium 414', bodily fluids can flow into the first porous material 416' more quickly due to the high fluid permeability of the first porous material 416', and subsequently into the interior of the porous medium 414'. Therefore, the fluid collection assembly 400' can receive bodily fluids more efficiently than the second porous material 418'. Figure 4A and 4B The first collection component 400 is more efficient, especially when the individual excretes bodily fluids at a relatively high rate.

[0070] Furthermore, the formation of the entire outer surface 428' of the first porous material 416' can facilitate the use of the fluid collection assembly 400' when it may move during use. For example, the fluid collection assembly 400' can be maintained in the correct position at the urethral opening using the contact between an individual's thigh and the fluid-impermeable layer 402'. However, individuals with thin thighs, forgetfulness (e.g., individuals with dementia, young children, etc.), or those who move frequently may have difficulty maintaining sufficient contact between their thigh and the fluid-impermeable layer 402' to maintain the position of the fluid collection assembly 400'. Therefore, the fluid collection assembly 400' may move when used with such individuals. Generally, allowing any movement of the fluid collection assembly relative to the individual increases the likelihood of leakage of bodily fluids from the fluid collection assembly, as bodily fluids come into contact with unexpected portions of the porous medium or create gaps between the fluid collection assembly and the individual. However, the formation of the entire outer surface 428' of the first porous material 416' reduces the amount of bodily fluid that may leak when the fluid collection assembly 400' is used with such individuals. For example, the high fluid permeability of the first porous material 416' rapidly draws bodily fluids into the porous medium 414', regardless of which portions of the porous medium 414' initially receive the fluids. Furthermore, having the entire outer surface 428' formed by the first porous material 416' ensures a greater percentage of any bodily fluids in contact with the porous medium 414' are received into the porous medium 414' compared to if the second porous material 418' forms any portion of the outer surface 428'.

[0071] The thickness of the first porous material 416' gradually decreases 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 with increasing proximity to the proximal region 404'. As previously discussed, the increased thickness of the first porous material 416' can facilitate deeper reception of bodily fluids into the porous medium 414'. The thickness of the second porous material 418' gradually decreases along at least a portion (e.g., all) of the length of the porous medium 414' in a manner opposite to that of the first porous material 416'. In this example, the second porous material 418' is more compressible than the first porous material 416'. In this example, the decreasing thickness of the first porous material 416' and the increasing thickness of the second porous material 418', respectively, increase with increasing proximity to the distal region 406', thereby increasing the overall compressibility of the porous medium 414' with increasing proximity to the distal region 406'. In other words, even if 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'.

[0072] Figure 5 This is a cross-sectional schematic diagram of the fluid collection assembly 500 according to an embodiment. Except for the first porous material 516 and the second porous material 518, which gradually thin only along a portion of the length of the porous medium 514, the fluid collection assembly 500 and... Figures 4A to 4B The fluid collection assembly 400 shown is identical. Gradually thinning the first porous material 516 and the second porous material 518 only along a portion of the length of the porous medium 514 allows 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, which is configured to be positioned adjacent to the urethral orifice. Therefore, with... Figure 4B Compared to the porous medium 414 shown, the portion of the outer surface 528 formed by the fluid-rich porous material 516 allows improved fluid entry into the porous medium 514 because the second porous material 518 may not form a barrier for bodily fluids to enter the first porous material 516. It should be noted that the first porous material 516 and the second porous material 518 can interact with... Figure 4C The same direction shown (not in) Figure 5 It gradually thins in the direction shown.

[0073] Figure 6A This is a top plan view of the fluid collection assembly 600 according to an embodiment. Figure 6BThis is a schematic cross-sectional view of a fluid collection assembly 600 according to an embodiment. Unless otherwise disclosed herein, the fluid collection assembly 600 is identical or substantially similar to any fluid collection assembly disclosed herein. For example, the fluid collection assembly 600 includes a fluid-impermeable layer 602 comprising a proximal region 604 and a distal region 606. The fluid collection assembly 600 also includes a porous medium 614 disposed within the fluid-impermeable layer 602. The porous medium 614 comprises a first porous material 616 and a second porous material 618.

[0074] The first and second porous materials 616 and 618 form partitioned portions of the porous medium 614, such that the first porous material 616 forms the proximal region of the porous medium 614, and the second porous material 618 forms the distal region of the porous medium 614. For example, each of the first and second porous materials 616 and 618 may form a portion of the outer surface 628 of the porous medium 614. Each of the first porous material 616 and the second porous material 618 may respectively include one or more first side surfaces 634 and one or more second side surfaces 636 extending from the outer surface 628 through the porous medium 614 (e.g., from the outer surface 628 defining the pores to the inner surface 630). In embodiments, the first and second porous materials 616 and 618 may exhibit shapes corresponding to the overall shape of the porous medium 614, except that the lengths of the first and second porous materials 616 and 618 are shorter. For example, when the porous medium 614 has a generally cylindrical shape, the first and second porous materials 616 and 618 may also have a generally cylindrical shape.

[0075] The porous medium 614 can be manufactured more easily than other porous media disclosed herein. For example, the porous medium 614 can be formed without forming cuts, recesses, protrusions, or positioning one porous material on or within another porous material. Instead, the 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 each other to form the porous medium 614.

[0076] Figure 7 This is a schematic cross-sectional view of the fluid collection assembly 700 according to an embodiment. It should be noted that the fluid collection assembly 700 may present a shape similar to... Figure 6AThe fluid collection assembly 600 shown is the same top plan view. Unless otherwise disclosed herein, the fluid collection assembly 700 is identical or substantially similar to any fluid collection assembly disclosed herein. For example, the fluid collection assembly 700 includes a fluid-impermeable layer 702 comprising a proximal region 704 and a distal region 706. The fluid collection assembly 700 also includes a porous medium 714 disposed within the fluid-impermeable layer 702. The porous medium 714 comprises a first porous material 716 and a second porous material 718.

[0077] Similar to Figure 2 The porous medium 214, 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, which is configured to contact, be located adjacent to, or otherwise be located close to the urethral opening of an individual. The inner portion 744 may 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. The second porous material 718 still improves the comfort of the fluid collection assembly 700 because it limits the contact portion of the individual's vaginal area with the less comfortable first porous material 716.

[0078] In addition to the first and second porous materials discussed above, the porous media disclosed herein may also include at least one intermediate porous material (e.g., a third porous material, a fourth porous material, etc.). The intermediate porous material may exhibit intermediate fluid permeability and intermediate compressibility. In embodiments, the intermediate fluid permeability of the intermediate porous material may be less than and greater than the first fluid permeability of the first porous material and the second fluid permeability of the second porous material, respectively. In embodiments, the intermediate compressibility of the intermediate porous material may be greater than and less than the first compressibility of the first porous material and the second compressibility of the second porous material, respectively. The intermediate porous material may be positioned between or otherwise contacted with one or more of the first or second porous materials. Compared to the case where the porous medium only includes the first and second porous materials, the intermediate porous material allows for greater control over the fluid permeability and compressibility of the porous medium. The intermediate porous material may form part of the proximal region of the porous medium, the distal region of the porous medium, or an intermediate region of the porous medium between the proximal and distal regions.

[0079] Figure 8A This is a top plan view of a fluid collection assembly 800 including a porous medium 814 according to an embodiment, the porous medium 814 having a third porous material 846 in addition to a first porous material 816 and a second porous material 818. Figure 8BThis is a schematic cross-sectional view of the fluid collection assembly 800 taken along plane 8B-8B. Unless otherwise disclosed herein, the fluid collection assembly 800 is identical or substantially similar to any fluid collection assembly disclosed herein. For example, the fluid collection assembly 800 includes a fluid-impermeable layer 802 and a porous medium 814 disposed within the fluid-impermeable layer 802. The porous medium 814 includes a first porous material 816 and a second porous material 818.

[0080] Similar to Figure 1B The fluid collection assembly 100 shown has a first porous material 816 and a second porous material 818 extending from the outer surface 828 of a porous medium 814 and through the porous medium 814 (e.g., to the inner surface 830). A third porous material 846 is positioned between the first and second porous materials 816 and extends from the outer surface 828 of the porous medium 814 and through the porous medium 814. In embodiments, the third porous material 846 can facilitate the operation of the fluid collection assembly 800 when it is misplaced or improperly positioned. For example, the fluid collection assembly 800 is configured such that the urethral opening of an individual is positioned near the urethral opening. However, the fluid collection assembly 800 may be misplaced on the individual such that the urethral opening is not positioned adjacent to it. When the fluid collection assembly 800 is misplaced, the urethral orifice can be positioned adjacent to the third porous material 846, and therefore, bodily fluids can be better received into the porous medium 814 compared to if the urethral orifice were positioned adjacent to the second porous material 818 (which might happen if the porous medium 814 does not include the third porous material 846). Furthermore, the third porous material 846 can 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 of the first porous material 816.

[0081] Figure 9 This is a schematic cross-sectional view of a fluid collection assembly 900 according to an embodiment, which includes a porous medium 914 having a third porous material 946 in addition to a first porous material 916 and a second porous material 918. Unless otherwise disclosed herein, the fluid collection assembly 900 may be identical or substantially similar to any fluid collection assembly disclosed herein. For example, the fluid collection assembly 900 may be comparable to... Figure 2The fluid collection assembly 200 shown is identical or substantially similar, except that the outer portion 242 and the inner portion 244 are formed of different porous materials. In an embodiment, as shown, the fluid collection assembly 900 includes a fluid-impermeable layer 902 and a porous medium 914 disposed within the fluid-impermeable layer. The porous medium 914 includes a first porous material 916 and a second porous material 918 forming 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 extending behind at least a portion of the first porous material 916 and the second porous material 918 (i.e., the third porous material 946 forms the inner portion). The first porous material 916 may facilitate the entry of bodily fluids into the porous medium 914, and the second porous material 918 may make the fluid collection assembly 900 more comfortable. Compared to the fluid collection assembly 200, the third porous material 946 improves the compressibility of the porous medium 914 while minimizing any reduction in the total fluid permeability of the porous medium 914. In an embodiment not shown, the third porous material 946 forms the outer portion, and the first porous material 916 forms the inner portion. In this embodiment, compared to... Figure 9 Compared to the illustrated embodiment, the third porous material 946 can make the outer surface 928 smoother or otherwise more comfortable, and the first porous material 916 can improve fluid flow through the porous medium 914.

[0082] It should be noted that any other embodiments disclosed herein may include an intermediate porous material.

[0083] Figure 10 This is a block diagram of a fluid collection system 1050 for fluid collection according to an embodiment. The fluid collection system 1050 includes a fluid collection assembly 1000, a fluid storage container 1052, and a vacuum source 1054. The fluid collection assembly 1000 may be the same as or substantially similar to any fluid collection assembly disclosed herein. The fluid collection assembly 1000, the fluid storage container 1052, and the vacuum source 1054 may be fluidly connected to each other via one or more conduits 1032. For example, the fluid collection assembly 1000 may be operatively connected to one or more of the fluid storage container 1052 or the vacuum source 1054 via the conduit 1032. Bodily fluids collected in the fluid collection assembly 1000 may be removed from the fluid collection assembly 1000 via the conduit 1032 protruding into the fluid collection assembly 1000. For example, the inlet of the conduit 1032 may extend into the fluid collection assembly 1000, such as into a reservoir within the fluid collection assembly. The outlet of the conduit 1032 may extend into the fluid collection assembly 1000 or the vacuum source 1054. In response to a vacuum force (e.g., a vacuum) applied at the outlet of the conduit 1032, the vacuum force can be introduced into the chamber of the fluid collection assembly 1000 via the inlet of the conduit 1032.

[0084] The vacuum force can be applied directly or indirectly to the outlet of the conduit 1032 via the vacuum source 1054. The vacuum force can also be applied indirectly via the fluid storage container 1052. For example, the outlet of the conduit 1032 can be located within the fluid storage container 1052, and an additional conduit 1032 can extend from the fluid storage container 1052 to the vacuum source 1054. Therefore, the vacuum source 1054 can apply a vacuum to the fluid collection assembly 1000 via the fluid storage container 1052. The vacuum force can also be applied directly via the vacuum source 1054. For example, the outlet of the conduit 1032 can be located within the vacuum source 1054. An additional conduit 1032 can extend from the vacuum source 1054 to a point outside the fluid collection assembly 1000, such as extending to the fluid storage container 1052. In this example, the vacuum source 1054 can be located between the fluid collection assembly 1000 and the fluid storage container 1052.

[0085] The fluid storage container 1052 is sized and shaped to retain bodily fluids therein. The fluid storage container 1052 may include a bag (e.g., a drainage bag), a bottle or cup (e.g., a collection can), or any other closed container for storing bodily fluids such as urine. In some examples, a catheter 1032 may extend from the fluid collection assembly 1000 and be attached to the fluid storage container 1052 at a first point therein. An additional catheter 1032 may be attached to the fluid storage container 1052 at a second point thereon and may extend further to be attached to a vacuum source 1054. Therefore, a vacuum (e.g., a vacuum) can be drawn through the fluid collection assembly 1000 via the fluid storage container 1052. Bodily fluids (such as urine) can be drained from the fluid collection assembly 1000 using the vacuum source 1054.

[0086] Vacuum source 1054 may include one or more of the following: manual vacuum pump and electric vacuum pump, diaphragm pump, centrifugal pump, displacement pump, magnetically driven pump, peristaltic pump, or any pump configured to generate a vacuum. Vacuum source 1054 can provide a vacuum or vacuum state to remove bodily fluids from fluid collection assembly 1000. In some examples, vacuum source 1054 may be powered by one or more of the following: a power cord (e.g., connected to a power outlet), one or more batteries, or even a manual power source (e.g., a manually operated vacuum pump). In some examples, the size and shape of vacuum source 1054 may be determined to fit externally, on top of, or within fluid collection assembly 1000. For example, vacuum source 1054 may include one or more miniature pumps or one or more micropumps. Vacuum source 1054 disclosed herein may include one or more of the following: a switch, button, plug, remote control, or any other device suitable for activating vacuum source 1054.

[0087] While various aspects and embodiments have been disclosed herein, other aspects and embodiments are contemplated. The various aspects and embodiments disclosed herein are for illustrative purposes and are not intended to be limiting.

[0088] Terms indicating degree (e.g., "about," "basically," "generally," etc.) indicate minor structural or functional changes. In the example, when a term indicating degree is included alongside a term indicating quantity, the term indicating degree is interpreted as ±10%, ±5%, or +2% of the term indicating quantity. In the example, when a term indicating degree is used to modify a shape, the term indicating degree indicates that the shape modified by the term has the appearance of the disclosed shape. For example, a term indicating degree might be used to indicate that the shape may have rounded corners instead of sharp corners, curved edges instead of straight edges, one or more protrusions extending from it, be elliptical, be the same as the disclosed shape, etc.

Claims

1. A fluid collection assembly, comprising: A fluid-impermeable layer comprising a proximal region and a distal region, the fluid-impermeable layer defining at least one opening, a chamber, and a fluid outlet; as well as A porous medium, wherein the porous medium is disposed in the chamber, the porous medium comprising: The proximal region extends from or near the proximal region of the fluid-impermeable layer; The distal region extends from or near the distal region of the fluid-impermeable layer to the proximal region; A first porous material, the first porous material exhibiting a first fluid permeability and a first compressibility; and The second porous material exhibits a second fluid permeability and a second compressibility; Wherein, at least one of the following is satisfied: the first fluid permeability is greater than the second fluid permeability or the first compressibility is less than the second compressibility; and Wherein, the first porous material and the second porous material are disposed in the porous medium such that at least one of the following is satisfied: The fluid permeability of the proximal region is greater than that of the distal region; or The proximal region exhibits less compressibility than the distal region.

2. The fluid collection assembly according to claim 1, wherein, The first fluid permeability is greater than the second fluid permeability, and the fluid permeability exhibited in the proximal region is greater than the fluid permeability exhibited in the distal region.

3. The fluid collection assembly according to claim 2, wherein, Meet at least one of the following: The first porous material exhibits a higher porosity per inch than the second porous material; or The porosity percentage of the first porous material is greater than that of the second porous material.

4. The fluid collection assembly according to claim 2, wherein, Meet at least one of the following: The density exhibited by the first porous material is less than the density exhibited by the second porous material; or The first porous material exhibits greater hydrophilicity than the second porous material.

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

6. The fluid collection assembly according to claim 1, wherein, The first compressibility is less than the second compressibility, and the compressibility exhibited by the proximal region is less than the compressibility exhibited by the distal region.

7. The fluid collection assembly according to claim 6, wherein, The average fiber diameter of the first porous material is greater than that of the second porous material.

8. The fluid collection assembly according to claim 6, wherein, Meet at least one of the following: The first porous material exhibits a larger pore size per inch than the second porous material; The Young's modulus exhibited by the first porous material is greater than that exhibited by the second porous material; The yield strength exhibited by the first porous material is greater than that exhibited by the second porous material; or The fiber entanglement exhibited by the first porous material is greater than that exhibited by the second porous material.

9. The fluid collection assembly according to claim 6, wherein, The first porous material and the second porous material are formed of isotropic materials with different orientations.

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

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

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

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

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

16. The fluid collection assembly according to claim 1, wherein, The porous medium exhibits an outer surface exposed through the at least one opening, the outer surface being formed solely of the second porous material.

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

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

19. The fluid collection assembly according to claim 1, wherein, The fluid outlet is located at or near the proximal region, and the distal region of the fluid-impermeable layer defines a substantially unoccupied reservoir.

20. A fluid collection system, comprising: Fluid collection components; The fluid collection assembly includes: A fluid-impermeable layer comprising a proximal region and a distal region, the fluid-impermeable layer defining at least one opening, a chamber, and a fluid outlet; and A porous medium, wherein the porous medium is disposed in the chamber, the porous medium comprising: The proximal region extends from or near the proximal region of the fluid-impermeable layer; The distal region extends from or near the distal region of the fluid-impermeable layer to the proximal region; A first porous material, the first porous material exhibiting a first fluid permeability and a first compressibility; and The second porous material exhibits a second fluid permeability and a second compressibility; Wherein, at least one of the following is satisfied: the first fluid permeability is greater than the second fluid permeability or the first compressibility is less than the second compressibility; and Wherein, the first porous material and the second porous material are disposed in the porous medium such that at least one of the following is satisfied: The fluid permeability of the proximal region is greater than that of the distal region; or The compressibility of the proximal region is less than that of the distal region; Fluid storage containers; and Vacuum source; The chamber of the fluid collection assembly, the fluid storage container, and the vacuum source are in fluid communication with each other, such that when one or more bodily fluids are present in the chamber, the vacuum provided from the vacuum source to the chamber of the fluid collection assembly removes the one or more bodily fluids from the chamber.

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