Liquid collection assembly comprising a porous material having a first porous layer, a second porous layer, and a support layer
The liquid collection assembly with a hydrophilic-hydrophobic porous structure efficiently collects and dries bodily fluids, addressing leakage and extended use issues in conventional systems.
Patent Information
- Application Number
- JP2024518575
- Authority / Receiving Office
- JP · JP
- Patent Type
- Patents
- Current Assignee / Owner
- Priority Date
- 2021-09-23
- Filing Date
- 2022-09-20
- Publication Date
- 2025-11-10
- Estimated Expiration
- 2042-09-20
AI Technical Summary
Existing urinary catheters and bedpans are uncomfortable, painful, and can lead to complications such as infection, while conventional fluid collection assemblies suffer from leakage and inability to be used for extended periods due to insufficient absorption and retention of bodily fluids.
A liquid collection assembly comprising a porous material with a first hydrophilic porous layer, a second hydrophobic porous layer, and a support layer, configured to efficiently accept and quickly dry bodily fluids, reducing leakage and enabling extended use.
The assembly effectively collects and dries bodily fluids, preventing leakage and skin damage, allowing for use up to 48 hours without discomfort or complications.
Smart Images

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Abstract
Description
[Technical Field]
[0001] CROSS-REFERENCE TO RELATED APPLICATIONS This application claims priority to U.S. Provisional Patent Application No. 63 / 247,491, filed September 23, 2021, the disclosure of which is incorporated herein by reference in its entirety. [Background technology]
[0002] A person or animal may have limited or impaired mobility, making normal urination difficult or impossible. For example, a person may experience or have a disability that impairs mobility. A person may have restricted mobility conditions, such as those experienced by pilots, drivers, and workers in hazardous areas. Additionally, collection of bodily fluids may be required for clinical trial purposes or health checkups. [Prior art documents] [Patent documents]
[0003] [Patent Document 1] U.S. Patent Application Publication No. 2020 / 306075 Summary of the Invention [Problem to be solved by the invention]
[0004] Urinary catheters, such as Foley catheters, can alleviate some of these conditions, such as incontinence. However, urinary catheters can be uncomfortable, painful, and can lead to complications, such as infection. Additionally, bedpans, which are containers used by bedridden individuals to urinate, may be used. However, bedpans are often inconvenient and can lead to spillage and other hygiene issues. [Means for solving the problem]
[0005]
[0003] Embodiments relate to a liquid collection assembly comprising a porous material having a first porous layer, a second porous layer, and a support layer extending between the first and second porous layers. Embodiments also relate to liquid collection systems including the liquid collection assembly and methods of forming and using the liquid collection assembly. In embodiments, a liquid collection assembly is disclosed. The liquid collection assembly comprises at least a chamber, at least one opening, and a liquid-impermeable layer defining the chamber. The liquid collection assembly further comprises a porous material disposed within the chamber. The porous material has a first porous layer, a second porous layer, and a support layer disposed and extending between the first and second porous layers.
[0006] In an embodiment, a liquid collection system is disclosed. The liquid collection system includes a liquid collection assembly. The liquid collection assembly includes at least a chamber, at least one opening, and a liquid-impermeable layer defining the chamber. The liquid collection assembly further includes a porous material disposed within the chamber. The porous material has a first porous layer, a second porous layer, and a support layer disposed and extending between the first and second porous layers. The liquid collection system further includes a reservoir and a vacuum source. The chamber of the liquid collection assembly, the reservoir, and the vacuum source are in fluid communication with each other. Thus, when one or more bodily fluids are present in the chamber, suction provided by the vacuum source to the chamber of the liquid collection assembly removes the one or more bodily fluids from the chamber and collects the bodily fluids in the reservoir.
[0007] Features from any of the disclosed embodiments may be used in combination with each other without limitation. Furthermore, other features and advantages of the present disclosure will become apparent to those skilled in the art upon careful consideration of the following detailed description and accompanying drawings.
[0008] The drawings illustrate several embodiments of the present disclosure, with the same reference numerals indicating the same or similar elements of the disclosure in different drawings or embodiments illustrated in the drawings. [Brief explanation of the drawings]
[0009] [Figure 1] 1 is a schematic cross-sectional view of an embodiment of a porous material that may be used in any of the liquid collection assemblies disclosed herein. [Figure 2] 1 is a schematic cross-sectional view of an embodiment of a porous material that may be used in any of the liquid collection assemblies disclosed herein. [Figure 3A] 1 is an isometric view of a liquid collection assembly having a porous material according to an embodiment. [Figure 3B] 3B is a schematic cross-sectional view of the liquid collection assembly taken along the plane 3B-3B shown in FIG. 3A. [Figure 3C] 3C is a schematic cross-sectional view of the liquid collection assembly taken along plane 3C-3C shown in FIG. 3A. [Figure 4] 1 is a schematic cross-sectional view of a liquid collection assembly according to an embodiment. [Figure 5A] 1 is a cross-sectional view of a liquid collection assembly having a formable conduit according to an embodiment. [Figure 5B] 5B is a cross-sectional view of a liquid collection assembly according to an embodiment taken along plane 5B-5B. [Figure 6] 1 is a cross-sectional view of a liquid collection assembly according to an embodiment. [Figure 7] 1 is a cross-sectional view of a liquid collection assembly according to an embodiment. [Figure 8] 1 is a block diagram of a liquid collection system for a liquid collection assembly according to an embodiment. DETAILED DESCRIPTION OF THE INVENTION
[0010]
[0003] Embodiments relate to a liquid collection assembly comprising a porous material having a first porous layer, a second porous layer, and a support layer extending between the first and second porous layers. The embodiments further relate to liquid collection systems including the liquid collection assembly and methods of forming and using the liquid collection assembly. An exemplary liquid collection assembly comprises a liquid-impermeable layer (e.g., a liquid-impermeable barrier) defining at least a chamber, at least one opening, and a liquid outlet. The liquid collection assembly further comprises a porous material disposed within the chamber. The porous material has a first porous layer (e.g., a liquid-permeable membrane), a second porous layer, and a support layer. The first porous layer can be disposed within the chamber to receive bodily fluid before the second porous layer. The support layer can be disposed to be disposed and extend between the first and second porous layers.
[0011] In use, the liquid collection assembly can be positioned on an individual so that the porous material is adjacent to or contains the urethral opening (e.g., female genitalia) of the individual. The individual can excrete one or more bodily fluids (e.g., urine, sweat, blood, etc.). The excreted bodily fluids can be received within the porous material. The bodily fluids can flow through the porous material to an entrance of a conduit disposed through a liquid outlet defined by the liquid-impermeable layer. The bodily fluids can then be removed from the liquid collection assembly by flowing through the conduit. In embodiments, a vacuum can be applied from the conduit to the porous material. The vacuum can facilitate the flow of the bodily fluid through the porous material to the entrance of the conduit. The vacuum can also facilitate the flow of the bodily fluid through the conduit. The vacuum can be provided from a vacuum source in fluid communication with the conduit.
[0012] The porous material in some conventional fluid collection assemblies includes gauze, cross-wrapped porous nonwoven materials, or other porous materials positioned to initially receive bodily fluids from an individual using the conventional fluid collection assembly. The porous material is hydrophobic or otherwise configured to wick the bodily fluids into the conventional fluid collection assembly. However, it has been found that many gauze, cross-wrapped nonwoven materials, or other porous materials positioned to initially receive bodily fluids from an individual can be insufficient to capture the bodily fluids discharged from the individual. This increases the likelihood of leakage of the bodily fluids from the liquid collection assembly. Furthermore, it has been found that many gauze and other porous materials remain wet after an individual discharges the bodily fluids. This prevents conventional fluid collection assemblies from being used for extended periods (e.g., more than 12 hours) without damaging the individual's skin.
[0013] The porous material of the liquid collection assembly disclosed herein (i.e., the porous material including the first porous layer, the second porous layer, and the support layer therebetween) overcomes at least some of these problems associated with the porous material of conventional liquid collection assemblies. For example, the first porous layer is configured to efficiently accept bodily fluids, thereby preventing or at least reducing leakage of the bodily fluids. The first porous layer can also be configured to dry relatively quickly after accepting bodily fluids. This allows the liquid collection assemblies disclosed herein to be usable for extended periods of time (e.g., for periods greater than about 24 hours, such as from about 24 hours to about 36 hours, from about 30 hours to about 42 hours, or from about 36 hours to about 48 hours). As described in more detail below, the first porous layer can remain dry and efficiently accept bodily fluids due to, for example, at least one of the hydrophilicity of the first porous layer, the average macropore size of the first porous layer, the thickness of the first porous layer, and the properties of the other layers of the porous material. The second porous layer facilitates the flow of bodily fluid out of the porous material toward the inlet of the conduit. This flow may remove the bodily fluid from the liquid collection assembly. As described in more detail below, the second porous layer facilitates this flow due to, for example, at least one of the hydrophobicity of the second porous layer, the average macropore size of the second porous layer, and other material properties of the porous material. The support layer maintains the distance between the first and second porous layers and provides an effective path for bodily fluid to flow therethrough. In particular, the support layer provides an effective path for bodily fluid to flow toward the inlet of the conduit. For example, the support layer may provide an effective path due to at least one of its relatively high porosity, the fibers forming the support layer, the orientation of the fibers, or properties of other layers of the porous material.
[0014] 1 is a schematic cross-sectional view of an embodiment of a porous material 100 that may be used in any of the liquid collection assemblies disclosed herein. The porous material 100 includes a first porous layer 102, a second porous layer 104 on a second side of the porous material 100, and a support layer 106 extending between the first and second porous layers 102, 104. Generally, the porous material 100 is positioned to receive bodily fluids discharged from an individual's urethral opening before the second porous layer 104 and the support layer 106. Thus, in use, the first porous layer 102 may be positioned closer to the opening or otherwise closer to the urethral opening than the corresponding (adjacent) portions of the second porous layer 104 and the support layer 106.
[0015] As discussed above, the first porous layer 102 is configured to receive bodily fluids discharged from an individual's urethral opening before the second porous layer 104 and the support layer 106. Thus, the first porous layer 102 is configured to efficiently receive bodily fluids to prevent, or at least inhibit, leakage of the bodily fluids through the porous material 100. As used herein, efficiently receiving bodily fluids refers to the ability of the first porous layer 102 to receive and channel large volumes of bodily fluids therethrough in a short period of time. For example, the first porous layer 102 may have a flow rate of about 10 ml / s or more, about 20 ml / s or more, about 30 ml / s or more, about 40 ml / s or more, about 50 ml / s or more, or about 6 ml / s to about 10 ml / s, about 8 ml / s to about 12 ml / s, about 10 ml / s to about 15 ml / s, about 12.5 ml / s to about 17.5 ml / s, about 15 ml / s to about 20 ml / s, about 17.5 ml / s to about 22.5 ml / s, about 20 ml / s A bodily fluid is said to be capable of efficiently receiving bodily fluid if it can receive and / or flow through its interior at a rate of about 6 ml / s or more, such as in the range of about 1 / s to about 25 ml / s, about 22.5 ml / s to about 27.5 ml / s, about 25 ml / s to about 30 ml / s, about 27.5 ml / s to about 35 ml / s, about 30 ml / s to about 40 ml / s, about 35 ml / s to about 45 ml / s, or about 40 ml / s to about 50 ml / s.
[0016] Additionally, due to the proximity of the first porous layer 102 to the individual's urethral opening, the first porous layer 102 is configured to dry relatively quickly after receiving bodily fluid, thereby preventing or at least reducing skin damage during extended use of a liquid collection assembly including the porous material 100. As used herein, the term "relatively quickly drying" refers to bodily fluid forming less than about 10 wt % (e.g., less than about 7.5 wt %, less than about 5 wt %, less than about 2.5 wt %, or less than about 1 wt %) of the first porous layer 102 in less than about 1 hour (e.g., less than about 45 minutes, less than about 30 minutes, less than about 15 minutes, less than about 10 minutes, less than about 5 minutes, or less than about 1 minute) after the first porous layer 102 receives the bodily fluid.
[0017] In one example, the first porous layer 102 is hydrophilic and therefore can efficiently accept bodily fluids. If the first porous layer 102 is hydrophilic, the first porous layer 102 draws bodily fluids into the first porous layer 102. Therefore, the first porous layer 102 can efficiently accept bodily fluids. Additionally, the hydrophilic first porous layer 102 distributes the bodily fluids throughout the first porous layer 102. This allows the first porous layer 102 to accept a relatively large amount of bodily fluid and promotes the transport of the bodily fluids from the first porous layer 102 to the support layer 106. The first porous layer 102 may be hydrophilic if the contact angle with water of the first porous layer 102 is about 80° or less, about 70° or less, about 60° or less, about 50° or less, about 40° or less, about 30° or less, about 20° or less, about 10° or less, or 90° or less, such as within the ranges of about 0° to about 20°, about 10° to about 30°, about 20° to about 40°, about 30° to about 50°, about 40° to about 60°, about 50° to about 70°, about 60° to about 80°, or about 70° to 90°. Generally, increasing the hydrophilicity of the first porous layer 102 (i.e., decreasing the contact angle with water) increases the efficiency with which the first porous layer 102 can absorb bodily fluids. However, increasing the hydrophilicity of the first porous layer 102 may make it more difficult for the first porous layer 102 to dry quickly. Therefore, the hydrophilicity of the first porous layer 102 can be selected based on which requirement (efficiently accepting bodily fluids or quickly drying the first porous layer 102) is more important in a particular application, and by balancing these two factors. In an embodiment, the first porous layer 102 is formed from a hydrophilic material. In an embodiment, the first porous layer 102 is formed from a material that has been treated to improve its hydrophilicity (e.g., a hydrophobic material), or a base layer coated with a hydrophilic material.
[0018] The first porous layer 102 may have a thickness t1 that is significantly smaller than the thickness of a top layer conventionally used in porous materials in conventional liquid collection assemblies (e.g., the thickness of a top layer in a conventional liquid collection assembly may be greater than 1 mm). For example, the thickness t1 of the first porous layer 102 may be about 500 μm or less, such as about 400 μm or less, about 300 μm or less, about 250 μm or less, about 200 μm or less, about 150 μm or less, about 100 μm or less, or within a range of about 50 μm to about 150 μm, about 100 μm to about 200 μm, about 150 μm to about 250 μm, about 200 μm to about 300 μm, about 250 μm to about 400 μm, or about 300 μm to about 500 μm. The thickness t1 of the first porous layer 102 may allow bodily fluid to be efficiently accommodated within the first porous layer 102 by reducing the distance the bodily fluid must flow through the first porous layer 102. The thickness t1 of the first porous layer 102 may also allow the first porous layer 102 to dry quickly because the thickness t1 of the first porous layer 102 allows the first porous layer 102 to retain only a relatively small amount of bodily fluid at any given time. The relatively small amount of bodily fluid present within the first porous layer 102 may be easily removed (e.g., evaporated) into the atmosphere or by airflow caused by a vacuum applied to the chamber of the liquid collection assembly. The limited amount of bodily fluid retained within the first porous layer 102 may allow the first porous layer 102 to be formed of a hydrophilic material. For example, conventional material selection for liquid collection assemblies precludes the use of hydrophilic materials, particularly in the vicinity of the urethral opening. This is because hydrophilic materials tend to retain bodily fluids and remain wet. Therefore, conventional material selection for liquid collection assemblies tends to use hydrophobic materials (i.e., materials with a contact angle with water greater than 90°) because hydrophobic materials do not retain large amounts of liquid. However, hydrophobic materials may not effectively accept bodily fluids.
[0019] Generally, decreasing the thickness t1 increases the efficiency with which the first porous layer 102 receives bodily fluids, allowing the first porous layer 102 to dry more quickly. On the other hand, decreasing the thickness t1 decreases the durability of the first porous layer 102. Reducing the thickness t1 can further restrict the diffusion of bodily fluids into the first porous layer 102 in a direction substantially parallel to the longitudinal axis 108. This can promote the flow of bodily fluids from the first porous layer 102 into the support layer 106.
[0020] The first porous layer 102 can define a plurality of first macropores 110 extending at least partially therethrough. The first macropores 110 include pores having a largest dimension, measured perpendicular to the longitudinal axis 108, that is about 1 mm or greater. The first macropores 110 can have a first average macropore diameter D1, measured perpendicular to the longitudinal axis 108, that is about 1 mm or greater, about 2 mm or greater, about 3 mm or greater, about 4 mm or greater, about 5 mm or greater, about 6 mm or greater, about 7 mm or greater, about 8 mm or greater, about 9 mm or greater, about 10 mm or greater, or in a range from about 1 mm to about 3 mm, about 2 mm to about 4 mm, about 3 mm to about 5 mm, about 4 mm to about 6 mm, about 5 mm to about 7 mm, about 6 mm to about 8 mm, about 7 mm to about 9 mm, or about 8 mm to about 10 mm. The first average macropore diameter D1 can be determined using the maximum dimension of the first macropores 110 or the average dimension of the first macropores 110. In general, increasing the first average macropore diameter D1 increases the bodily fluid acceptance efficiency of the first porous layer 102. However, increasing the first average macropore diameter D1 can increase the surface roughness of the first porous layer 102, which can reduce the user's comfort when using the liquid collection assembly. Additionally, the first porous layer 102 can further define a plurality of micropores (not shown). The micropores include pores having a maximum dimension, measured perpendicular to the longitudinal axis 108, that is about 1 mm or less.
[0021] The first macropores 110 can have any suitable cross-sectional shape along a plane parallel to the longitudinal axis 108 and the outer surface 111 of the first porous layer 102. For example, the first macropores 110 can have a generally circular cross-sectional shape, a generally rectangular (e.g., square) cross-sectional shape, a generally pentagonal cross-sectional shape, a generally hexagonal cross-sectional shape, a generally octagonal cross-sectional shape, a generally elliptical or ellipsoidal cross-sectional shape, a generally elongated cross-sectional shape, or any other suitable shape. The cross-sectional shape of the first macropores 110 can affect how efficiently the first porous layer accepts bodily fluids and how quickly the first porous layer 102 dries. For example, a cross-sectional shape that provides a large surface area for the first macropores 110 compared to other cross-sectional shapes can facilitate the drawing of bodily fluids into the first porous layer 102 if the first porous layer 102 is relatively hydrophilic. On the other hand, a cross-sectional shape in which the first macropores 110 have a small surface area compared to other cross-sectional shapes may promote the flow of body fluids within the first porous layer 102 when the first porous layer 102 is less hydrophilic.
[0022] As described above, the porous material 100 includes the second porous layer 104. In one example, the second porous layer 104 is hydrophobic. The hydrophobicity of the second porous layer 104 prevents, or at least inhibits, bodily fluids present in the support layer 106 from flowing into the second porous layer 104. Thus, the hydrophobicity of the second porous layer 104 generally retains bodily fluids within the support layer 106 (i.e., the layer through which bodily fluids flow). Furthermore, the hydrophobicity of the second porous layer 104 generally repels bodily fluids, thereby promoting the flow of bodily fluids through the support layer 106 and out of the porous material 100. By promoting the flow of bodily fluids through the support layer 106, the porous material 100 dries faster, and the moisture gradient draws more bodily fluids from the first porous layer 102 into the support layer 106. The second porous layer 104 can be hydrophobic when the contact angle of the second porous layer 104 with water is about 90° or greater, such as about 100° or greater, about 110° or greater, about 120° or greater, about 130° or greater, about 140° or greater, about 150° or less, about 160° or greater, about 170° or greater, or within the ranges of about 90° to about 110°, about 100° to about 120°, about 110° to about 130°, about 120° to about 140°, about 130° to about 150°, about 140° to about 160°, about 150° to about 170°, or about 160° to about 180°. Generally, increasing the hydrophobicity of the second porous layer 104 (i.e., increasing the contact angle with water) improves liquid flow through the porous material 100. In embodiments, the first porous layer 102 is formed from a material that has been processed to increase its hydrophobicity (eg, a hydrophilic material) or is coated with a hydrophobic material.
[0023] The second porous layer 104 may have a thickness t2 of about 500 μm or less, such as about 400 μm or less, about 300 μm or less, about 250 μm or less, about 200 μm or less, about 150 μm or less, about 100 μm or less, or within a range of about 50 μm to about 150 μm, about 100 μm to about 200 μm, about 150 μm to about 250 μm, about 200 μm to about 300 μm, about 250 μm to about 400 μm, or about 300 μm to about 500 μm. As described above, the second porous layer 104 may be hydrophobic and at least inhibit the flow of bodily fluids therethrough. This reduces the volume of bodily fluid that can be temporarily stored within the porous material 100. Reducing the volume of bodily fluid that can be temporarily stored within the porous material 100 may increase the likelihood of bodily fluids leaking therethrough. Therefore, having the second porous layer 104 have any of the above-described relatively small thicknesses t2 may minimize the effect of the second porous layer 104 on the volume of bodily fluid that can be temporarily stored within the porous material 100. The relatively small thickness t2 may also increase the overall thickness of the support layer 106 and the volume of bodily fluid that can flow therethrough in any given period of time.
[0024] The second porous layer 104 can define a plurality of second macropores 112 extending at least partially therethrough. The second macropores 112 include pores having a largest dimension, measured perpendicular to the longitudinal axis 108, that is about 1 mm or greater. The second macropores 112 can have a second average macropore diameter D2, measured perpendicular to the longitudinal axis 108, that is about 1 mm or greater, about 2 mm or greater, about 3 mm or greater, about 4 mm or greater, about 5 mm or greater, about 6 mm or greater, about 7 mm or greater, about 8 mm or greater, about 9 mm or greater, about 10 mm or greater, or in a range from about 1 mm to about 3 mm, about 2 mm to about 4 mm, about 3 mm to about 5 mm, about 4 mm to about 6 mm, about 5 mm to about 7 mm, about 6 mm to about 8 mm, about 7 mm to about 9 mm, or about 8 mm to about 10 mm. The second average macropore diameter D2 can be determined using the maximum dimension of the second macropores 112 or the average dimension of the second macropores 112. It has been determined that the presence of the second macropores 112 can improve bodily fluid flow through the support layer 106. However, generally, increasing the second average macropore diameter D2 allows more bodily fluid to enter the second porous layer 104. This is because some of the bodily fluid within the second macropores 112 may not come into contact with the hydrophobic layer of the second porous layer. The bodily fluid that does not come into contact with the second porous layer 104 may be relatively dry in the porous material 100, which may not promote flow through the support layer 106. This may inhibit drying of the porous material 100. Therefore, increasing the second average macropore diameter D2 may cause the porous material 100 to become slightly more wettable.
[0025] The second macropores 112 can have any suitable cross-sectional shape along a plane parallel to the longitudinal axis 108 and the outer surface 111 of the second porous layer 104. For example, the second macropores 112 can have a generally circular cross-sectional shape, a generally rectangular (e.g., square) cross-sectional shape, a generally pentagonal cross-sectional shape, a generally hexagonal cross-sectional shape, a generally octagonal cross-sectional shape, a generally elliptical or ellipsoidal cross-sectional shape, a generally elongated cross-sectional shape, or any other shape. The cross-sectional shape of the second macropores 112 can affect how effectively the second porous layer 104 repels bodily fluids when the second porous layer 104 is hydrophobic.
[0026] As described above, the support layer 106 is disposed between the first and second porous layers 102, 104 and configured to form a pathway for bodily fluid flow. In an embodiment, the support layer 106 is formed from a plurality of fibers, such as a plurality of microfilaments. In one example, the plurality of fibers may be aligned along a first direction extending generally from the first porous layer 102 to the second porous layer 104 (e.g., aligned generally perpendicular to the longitudinal axis 108). By aligning the fibers along the first direction, the support layer 106 may more securely attach the first and second porous layers 102, 104. Furthermore, bodily fluid may flow slightly more easily in a direction parallel to the fibers. Thus, by aligning the fibers in a second direction, bodily fluid may be drawn through the support layer 106 more quickly than if the fibers were oriented in a different direction. This may allow bodily fluid to flow through a greater percentage of the support layer 106 than if the bodily fluid were aligned in another direction. By allowing bodily fluid to flow through a greater percentage of the support layer 106, a greater volume of bodily fluid may flow through the porous material 100 at any given time, reducing the likelihood of bodily fluid leaking out of the porous material 100.
[0027] In embodiments, the support layer 106 may have a higher porosity than the first and second porous layers 102, 104. Porosity is the volume of a layer not occupied by solid material divided by the total volume of the layer. The support layer 106 may have a porosity that is greater than the porosity of the first and second porous layers 102, 104 by about 10% or more, about 20% or more, about 30% or more, about 40% or more, about 50% or more, about 75% or more, about 100% or more, about 150% or more, about 200% or more, about 250% or more, about 300% or more, about 400% or more, about 500% or more, or by a range of about 10% to about 30%, about 20% to about 40%, about 30% to about 50%, about 40% to about 75%, about 50% to about 150%, about 100% to about 200%, about 150% to about 250%, about 200% to about 300%, about 250% to about 400%, or about 300% to about 500%. Increasing the porosity of the support layer 106 relative to the first and second porous layers 102, 104 promotes bodily fluid flow therethrough. Promotion of bodily fluid flow through the support layer 106 may cause the support layer 106 to draw bodily fluid from the first porous layer 102 due to moisture gradients and / or hydrogen bonding between water molecules, both of which may allow the first porous layer 102 to efficiently accept bodily fluids and dry relatively quickly.
[0028] Surprisingly, it has been found that the support layer 106 can be formed of either hydrophilic and / or hydrophobic materials. In one example, the support layer 106 can be formed of a hydrophilic material having any of the hydrophilic properties disclosed herein. As described above, the porous materials of conventional liquid collection assemblies are not formed of hydrophilic materials because such materials typically retain bodily fluids. On the other hand, the hydrophobicity of the second porous layer 104 limits the bodily fluid that can be retained in the support layer 106. Furthermore, increasing the porosity limits the bodily fluid that can be retained within the support layer 106, dispersing the bodily fluid over a larger surface area and promoting evaporation of the bodily fluid. When the support layer 106 is hydrophilic, the support layer 106 generally has a lower hydrophilicity (e.g., a larger contact angle with water) than the first porous layer 102. In one example, the support layer 106 can be made of a hydrophobic material having any of the hydrophobic properties disclosed herein. In such an example, the support layer 106 may have a lower hydrophobicity (e.g., a lower contact angle with water) than the second porous layer 104. This may facilitate the flow of bodily fluids from the first porous layer 102 to the support layer 106, while allowing the second porous layer 104 to repel bodily fluids.
[0029] The first porous layer 102, the second porous layer 104, and the support layer 106 may be formed of any suitable material. In one example, at least one of the first porous layer 102, the second porous layer 104, or the support layer 106 may be formed from one or more of polyester, polypropylene, nylon, cellulose, cotton, bamboo, or a combination thereof. In one example, at least one of the first porous layer 102, the second porous layer 104, or the support layer 106 may include a base material coated with a material. In such an example, the coating material may have a different hydrophilicity or hydrophobicity than the base material. In one example, at least one of the first porous layer 102, the second porous layer 104, or the support layer 106 may be formed from at least one material that has been treated to change its hydrophilicity or hydrophobicity.
[0030] The porous material 100 may have a thickness T measured from the first porous layer 102 to the second porous layer 104 . The thickness T can be about 5 mm or greater, such as about 7.5 mm or greater, about 1 cm or greater, about 1.25 cm or greater, about 1.5 cm or greater, about 1.75 cm or greater, about 2 cm or greater, about 2.25 cm or greater, about 2.5 cm or greater, about 2.75 cm or greater, about 3 cm or greater, about 3.5 cm or greater, about 4 cm or greater, or within the range of about 5 mm to 1 cm, about 7.5 mm to about 1.25 cm, about 1 cm to about 1.5 cm, about 1.25 cm to about 1.75 cm, about 1.5 cm to about 2 cm, about 1.75 cm to about 2.25 cm, about 2 cm to about 2.5 cm, about 2.25 cm to about 2.75 cm, about 2.5 cm to about 3 cm, about 2.75 cm to about 3.5 cm, or about 3 cm to about 4 cm. The thickness T of the porous material 100 may depend on the size of the chamber in which the porous material 100 is placed, whether the porous material 100 is placed in a generally planar configuration or rolled into a generally cylindrical configuration within the chamber, and the thicknesses of the first porous layer 102, the second porous layer 104, and the support layer 106.
[0031] The porous material 100 has a resistance of about 5 kg / m 3 to about 10 kg / m 3 , about 7.5kg / m 3 to approximately 12.5 kg / m 3 , about 10kg / m 3 to about 15 kg / m 3 , about 12.5kg / m 3 to approximately 17.5 kg / m 3 , about 15kg / m 3 to about 20 kg / m 3 , about 17.5kg / m 3 to approximately 22.5 kg / m 3 , about 20kg / m 3 to about 25 kg / m 3 , about 22.5kg / m 3 to approximately 27.5 kg / m 3 , about 25kg / m 3 to about 30 kg / m 3 , about 27.5kg / m 3 to approximately 32.5 kg / m 3 , about 30kg / m 3 to about 35 kg / m 3 , about 32.5kg / m3 to approximately 37.5 kg / m 3 , about 35kg / m 3 to approximately 37.5 kg / m 3 , about 35kg / m 3 to about 40 kg / m 3 , about 37.5kg / m 3 to approximately 42.5 kg / m 3 , about 40kg / m 3 to about 45 kg / m 3 , about 42.5kg / m 3 to approximately 47.5 kg / m 3 , or approximately 45 kg / m 3 to about 50 kg / m 3 The density of the porous material 100 may be selected to have a density of 0.05 to 0.05 mm. Generally, increasing the density of the porous material 100 increases the strength of the porous material 100. On the other hand, increasing the density of the porous material 100 may decrease the porosity of the porous material 100. This may reduce the volume of bodily fluid that can be temporarily stored in the porous material 100 and may reduce the flow rate of the bodily fluid through the porous material 100. Therefore, the density of the porous material 100 may be selected based on a balance of the desired strength, porosity, and flow rate of the bodily fluid through the porous material 100.
[0032] The porous material 100 has a density of about 50 g / m 2 to about 100g / m 2 , about 75g / m 2 to approximately 125 g / m 2 , about 100g / m 2 to approximately 150 g / m 2 , about 125g / m 2 to approximately 175 g / m 2 , about 150g / m 2 to approximately 200 g / m 2 , about 175g / m 2 to approximately 225 g / m 2 , about 200g / m 2 to approximately 250 g / m 2 , about 225g / m 2 from approximately 275 g / m 2 , about 250g / m 2 to approximately 300 g / m 2 , about 275g / m 2 to approximately 325 g / m 2 , about 300g / m2 to approximately 375 g / m 2 , about 350g / m 2 to approximately 450 g / m 2 , about 400g / m 2 to approximately 500 g / m 2 , about 450g / m 2 to approximately 550 g / m 2 , about 500g / m 2 to approximately 600 g / m 2 , about 550g / m 2 to approximately 650 g / m 2 , about 600g / m 2 to approximately 700 g / m 2 , about 650g / m 2 to approximately 750 g / m 2 , about 600g / m 2 to approximately 700 g / m 2 , about 650g / m 2 to approximately 750 g / m 2 , about 700g / m 2 to approximately 800 g / m 2 , about 750g / m 2 to approximately 850 g / m 2 , about 800g / m 2 to approximately 900 g / m 2 , about 850g / m 2 to approximately 950 g / m 2 , or approximately 900 g / m 2 to approximately 1000 g / m 2 The basis weight of the porous material 100 is based on the density and thickness of the porous material 100. Thus, the basis weight of the porous material 100 may be selected for any of the same reasons as the density and thickness of the porous material 100.
[0033] 1, the first and second macropores 110, 112 in the first and second porous layers 102, 104, respectively, can be substantially identical. For example, the first and second average macropore diameters can be substantially similar, and the cross-sectional shapes of the first and second macropores 110, 112 can be substantially identical. The first and second macropores 110, 112 can be substantially identical for various reasons. In one example, the first and second macropores 110, 112 can be substantially identical if the first and second porous layers 102, 104 are made of the same material, except that, for example, at least one of the first and second porous layers 102, 104 may be coated or treated to have a different contact angle with water. In one example, by selecting the first and second macropores 110, 112 to be substantially the same, the first and second porous layers 102, 104 can be formed in the same process, except that, for example, different materials may be used in the process.
[0034] On the other hand, the first and second macropores of the porous materials disclosed herein may be different. For example, Figure 2 is a schematic cross-sectional view of a porous material 200 according to an embodiment that may be used in any of the liquid collection assemblies disclosed herein. Unless otherwise disclosed herein, the porous material 200 may be the same as or substantially similar to any of the porous materials disclosed herein. For example, the porous material 200 may have a first porous layer 202, a second porous layer 204, and a support layer 206 between the first and second porous layers 202, 204.
[0035] The first porous layer 202 has a plurality of first macropores 210, and the second porous layer 204 has a plurality of second macropores 212. The first and second macropores 210, 212 are different from each other. In embodiments, the first average macropore diameter D1 of the first macropores 210 can be different from the second average macropore diameter D2 of the second macropores 212. The first and second average macropore diameters D1, D2 can be selected to be different based on the desired properties for the reasons discussed above. For example, as shown, the first average macropore diameter D1 can be selected to be larger than the second average macropore diameter D2. A larger first average macropore diameter D1 can allow for more efficient acceptance of body fluids than when the first average macropore diameter D1 is the same as the second average macropore diameter D2. A smaller second average macropore diameter D2 may allow the porous material 200 to be more dryable than if the second average macropore diameter D2 is the same as the first average macropore diameter D1. In embodiments, the first macropores 210 may have a different cross-sectional shape than the second macropores 212. The first and second macropores 210, 212 may be selected to have different cross-sectional shapes for the reasons discussed above.
[0036] Forming the first and second porous layers 202 and 204 to have different average macropore sizes and / or different cross-sectional shapes can facilitate the formation of the liquid collection assembly, as described below. For example, in some instances, the first and second porous layers of the porous material disclosed herein can be visually similar (e.g., similar color, similar texture, etc.). If such visually similar first and second porous layers had the same average macropore size and pore cross-sectional shape, it could be difficult to properly position the porous material within the liquid collection assembly so that the first porous layer receives bodily fluid before the second porous layer. Improper placement of the porous material within the liquid collection assembly could result in excessive leakage of bodily fluid. On the other hand, different average macropore sizes and / or cross-sectional shapes of the first and second porous layers 202, 204 can facilitate visual differentiation between the porous layers, thereby facilitating the formation of the liquid collection assembly, as described below.
[0037] FIG. 3A is an isometric view of a liquid collection assembly 320 including a porous material 300 according to an embodiment. FIGS. 3B and 3C are schematic cross-sectional views of the liquid collection assembly 320 taken along planes 3B-3B and 3C-3C, respectively, shown in FIG. 3A. The liquid collection assembly 320 is an example of a feminine liquid collection assembly for receiving and collecting bodily fluids from a woman. The liquid collection assembly 320 includes a liquid-impermeable layer 322 (e.g., a liquid-impermeable barrier) that defines at least an opening 324, a chamber 326, and a liquid outlet 328. The liquid collection assembly 320 further includes a porous material 300 disposed within the chamber 326. The porous material 300 can be the same as or substantially similar to any of the porous materials disclosed herein. The liquid collection assembly 320 can further include a conduit 330. The conduit 330 is disposed through the liquid outlet 328 such that an inlet 332 of the conduit 330 is disposed within the chamber 326.
[0038] The liquid-impermeable layer 322 at least partially defines a chamber 326 (e.g., an interior region) and an opening 324. For example, the inner surface(s) 334 of the liquid-impermeable layer 322 at least partially define the chamber 326 within the liquid collection assembly 320. The liquid-impermeable layer 322 temporarily stores bodily fluids within the chamber 326. The liquid-impermeable layer 322 can be formed from any suitable liquid-impermeable material(s), such as a liquid-impermeable polymer (e.g., silicone, polypropylene, polyethylene, polyethylene terephthalate, neoprene, polycarbonate, etc.), a metal film, natural rubber, other suitable materials, any other liquid-impermeable material disclosed herein, or a combination thereof. Thus, the liquid-impermeable layer 322 substantially prevents bodily fluids from passing through the liquid-impermeable layer 322. In one example, the liquid-impermeable layer 322 can be breathable and liquid-impermeable. In such an example, the liquid-impermeable layer 322 may be made of a hydrophobic material that defines a plurality of pores. At least one or more portions of at least the outer surface 336 of the liquid-impermeable layer 322 may be made of a soft and / or smooth material, which reduces chafing.
[0039] In some examples, the liquid-impermeable layer 322 can be tubular (disregarding the opening 324), such as a generally cylindrical (as shown), elongated, prismatic, or flattened tube. In use, the outer surface 336 of the liquid-impermeable layer 322 can contact the individual. The liquid-impermeable layer 322 can be sized and shaped to fit between the legs of a female user, between the labia and / or intergluteal cleft.
[0040] The opening 324 provides a path for bodily fluid to enter the chamber 326. The opening 324 may be defined by the liquid-impermeable layer 322, such as by the inner edge of the liquid-impermeable layer 322. For example, the opening 324 may be formed in the liquid-impermeable layer 322 and extend therethrough from the outer surface 336 to the inner surface 334. This allows bodily fluid to enter the chamber 326 from outside the liquid collection assembly 320.
[0041] The opening 324 may be a slot in the liquid-impermeable layer 322. For example, the opening 324 may be defined as a cut in the liquid-impermeable layer 322. The opening 324 may be positioned and shaped to be located adjacent to the female urethral opening. The opening 324 may have an elongated shape such that when a woman's legs are closed, the space between her legs is relatively narrow and bodily fluids can only flow along a path that corresponds to the elongated shape of the opening 324 (e.g., a longitudinally extending opening 324).
[0042] The liquid collection assembly 320 may be positioned proximate the female urethral opening, and bodily fluids may enter the chamber 326 of the liquid collection assembly 320 through the opening 324. The liquid collection assembly 320 is configured to receive bodily fluids into the chamber 326 through the opening 324. In use, the opening 324 may have an elongated shape that extends from a first location below the urethral opening (e.g., at or near the anus or vaginal opening) to a second location above the urethral opening (e.g., at or near the vaginal opening or pubic hair).
[0043] In some examples, the liquid-impermeable layer 322 can define a liquid outlet 328 sized to accommodate the conduit 330. At least one conduit 330 can be disposed within the chamber 326 through the liquid outlet 328. The size and shape of the liquid outlet 328 can be such that it forms an at least substantially liquid-tight seal with the conduit 330, or at least one tube, thereby substantially preventing bodily fluids from escaping the chamber 326.
[0044] As described above, the porous material 300 is disposed within the chamber 326. The porous material 300 may be the same as or substantially similar to any of the porous materials disclosed herein. For example, the porous material 300 may have a first porous layer 302, a second porous layer 304, and a support layer 306. The porous material 300 may be disposed within the chamber 326 such that the first porous layer 302 is closer to the individual's urethral opening than the second porous layer 304. For example, the first porous layer 302 may extend across the opening 324 and be exposed outside the liquid collection assembly 320. Thus, the first porous layer 302 may contact the individual's vaginal region when the liquid collection assembly 320 is disposed adjacent to the vaginal region. The porous material 300 may further be disposed such that the second porous layer 304 defines a hole that accommodates the conduit 330.
[0045] The porous material 300 may have a generally cylindrical shape. In embodiments, the porous material 300 may be provided having a generally cylindrical shape. In embodiments, the porous material 300 may be provided in a sheet form. In such embodiments, the porous material 300 may be rolled into a generally cylindrical shape with its opposite edges touching.
[0046] The porous material 300 may substantially completely fill the portion of the chamber 326 that is not filled with the conduit 330. In some examples, the porous material 300 may not substantially completely fill the portion of the chamber 326 that is not filled with the conduit 330. In such examples, the liquid collection assembly 320 includes a reservoir 338 disposed within the chamber 326.
[0047] Reservoir 338 is a substantially empty portion of chamber 326. Reservoir 338 may be defined between liquid-impermeable layer 322 and porous material 300. Bodily fluid within chamber 326 may flow from first porous layer 302 to support layer 306, and from support layer 306 through liquid in reservoir 338. Reservoir 338 may store bodily fluid therein.
[0048] Bodily fluid within the chamber 326 can flow through the support layer 306 to the reservoir 338. The liquid-impermeable layer 322 can retain the bodily fluid within the reservoir 338. Although the reservoir 338 is illustrated in the distal region 340, it can be located anywhere within the chamber 326, such as in the proximal region 342. The reservoir 338 can be located in a portion of the chamber 326 designed to be located at the lowest point of the liquid collection assembly in the direction of gravity when the liquid collection assembly is being worn.
[0049] In some examples (not shown), the liquid collection assembly 320 can have multiple reservoirs, such as a first reservoir located at a portion of the chamber 326 closest to the entrance of the conduit 330 (e.g., distal region 340) and a second reservoir located at or near the proximal region 342 of the chamber 326. In another example, the porous material 300 can be spaced from at least a portion of the conduit 330, and the reservoir 338 can be the space between the porous material 300 and the conduit 330.
[0050] Conduit 330 may be at least partially disposed within chamber 326. Conduit 330 may be used to remove bodily fluids from chamber 326. Conduit 330 has at least one wall defining an inlet 332, an outlet (not shown) downstream from inlet 332, and a passageway. The outlet of conduit 330 may be operatively coupled to a vacuum source, such as a vacuum pump, that draws fluid from chamber 326 through conduit 330. For example, conduit 330 may extend from proximal region 342 into liquid-impermeable layer 322 and further to a point proximal to reservoir 338 in distal region 340, thereby fluidly connecting inlet 332 to reservoir 338. Conduit 330 fluidly couples chamber 326 to a fluid reservoir (not shown) or a vacuum source (not shown).
[0051] The conduit 330 may extend through holes in the porous material 300 (e.g., holes defined by the second porous layer 304). In embodiments, the conduit 330 extends from the liquid outlet 328 through a hole to a location proximate to the reservoir 338. In such embodiments, the inlet 332 may not extend into the reservoir 338; instead, the inlet 332 may be located within the porous material 300 or at a terminal end thereof. In embodiments, the conduit 330 is at least partially located within the reservoir 338, and the inlet 332 may extend into or be located within the reservoir 338. Bodily fluid collected in the liquid collection assembly 320 may be removed from the chamber 326 through the conduit 330.
[0052] Locating the inlet 332 at or near the location where the chamber 326 is expected to be at its lowest point in the direction of gravity when worn by an individual allows the conduit 330 to receive more bodily fluid than if the inlet 332 were located elsewhere, reducing the likelihood of stagnation (e.g., stagnation of bodily fluids, which can result in microbial growth and foul odors). For example, bodily fluid within the support layer 306 can flow in any direction due to capillary forces. However, bodily fluids may be more likely to flow in the direction of gravity. This is particularly true when at least a portion of the support layer 306 is saturated with bodily fluid. Therefore, one or both of the inlet 332 and the reservoir 338 may be located in the liquid collection assembly 320, such as in the tip region 340, at a location where the liquid collection assembly 320 is expected to be at its lowest point in the direction of gravity when worn by an individual.
[0053] The inlet 332 and outlet of the conduit 330 are configured to fluidly couple (e.g., directly or indirectly) a vacuum source (not shown) to the chamber 326 (e.g., reservoir 338). When the vacuum source ( FIG. 7 ) applies vacuum / suction to the conduit 330, bodily fluid within the chamber 326 (e.g., in the tip region 340, such as in reservoir 338) may be drawn into the inlet 332 and flow out of the liquid collection assembly 320 through the conduit 330. In some examples, the conduit 330 may be frosted or opaque (e.g., black), which reduces the visibility of bodily fluid therein.
[0054] As described above, the conduit 330 may be configured to be insertable into at least the chamber 326. In one example, the conduit 330 may be positioned within the chamber 326 such that the terminal end of the conduit 330 is spaced from the liquid-impermeable layer 322 or other components of the liquid collection assembly 320 that may at least partially obstruct or occlude the inlet 332. Additionally, the inlet 332 of the conduit 330 may be offset relative to the terminal end of the porous material 300 such that the inlet 332 is closer to the proximal region 342 of the liquid collection assembly 320 than the terminal end of the porous material 300. By offsetting the inlet 332 relative to the terminal end of the porous material 300 in this manner, the inlet 332 can receive bodily fluid directly from the porous material 300, drawing more bodily fluid from the porous material 300 into the conduit 330 through hydrogen bonding.
[0055] The porous materials disclosed herein may have one or more additional layers. For example, FIG. 4 is a schematic cross-sectional view of a liquid collection assembly 420 according to an embodiment. Unless otherwise disclosed herein, the liquid collection assembly 420 is the same as or substantially similar to any liquid collection assembly disclosed herein. For example, the liquid collection assembly 420 has a liquid-impermeable layer 422 that defines at least an opening 424 and a chamber 426. The liquid collection assembly 420 further has a porous material 400 disposed within the chamber 426.
[0056] The porous material 400 includes a first porous layer 402, a second porous layer 404, and a support layer 406 disposed between the first and second porous layers 402, 404. The porous material 400 further includes a liquid-permeable membrane 444. The liquid-permeable membrane 444 is disposed on the first porous layer 402 and extends across the opening 424. The liquid-permeable membrane 444 may improve the comfort of the liquid collection assembly 420. For example, the first porous layer 402 may include a plurality of macropores (not shown). As discussed above, the macropores of the first porous layer 402 may be uncomfortable against an individual's vaginal area, especially if the macropores are large. The liquid-permeable membrane 444 may be more comfortable against an individual's vaginal area than the first porous layer 402. Therefore, including the liquid-permeable membrane 444 in the porous material 400 may improve the comfort of the liquid collection assembly 420.
[0057] The liquid-permeable membrane 444 may be configured to wick bodily fluid through the opening 424, thereby preventing the bodily fluid from escaping the chamber 426. In embodiments, the liquid-permeable membrane 444 may be configured to wick any bodily fluid through the opening 424, thereby preventing the bodily fluid from escaping the chamber 426. The liquid-permeable properties described herein may refer to wicking, capillary action, diffusion, or similar properties or processes, and are referred to herein as "liquid-permeable" and / or "wicking." The "wicking" and / or "liquid-permeable" properties may not include absorption of bodily fluid into at least a portion of the liquid-permeable membrane 444. In other words, after the material is exposed to and temporarily removed from the bodily fluid, there may be substantially no absorption or dissolution of bodily fluid into the material. While absorption or dissolution is not desired, the phrase "substantially no absorption" may mean that absorption and / or dissolution of a small amount of bodily fluid into the liquid-permeable membrane 444 (e.g., absorbent) may be acceptable. This amount can be less than about 30 wt% of the weight of the dry liquid-permeable membrane 444, less than about 20 wt%, less than about 10 wt%, less than about 7 wt%, less than about 5 wt%, less than about 3 wt%, less than about 2 wt%, less than about 1 wt%, or about 0.5 wt% or less of the weight of the dry liquid-permeable membrane 444. The liquid-permeable membrane 444 can also wick bodily fluids generally into the chamber 426. In embodiments, the liquid-permeable membrane 444 can include at least one absorbent or adsorbent material. Note that including the liquid-permeable membrane 444 within the porous material 400 can reduce the efficiency with which the porous material 400 accepts bodily fluids and extend the time the porous material 400 remains wet.
[0058] In embodiments, the fluid-permeable membrane 444 may include any material capable of wicking bodily fluids. For example, the fluid-permeable membrane 444 may include a fabric such as gauze (e.g., silk, linen, or cotton gauze), another soft fabric, another smooth fabric, a nonwoven material, a fabric such as bamboo fiber, polypropylene fiber, cellulose fiber, any other porous material disclosed herein, or any combination of the foregoing. Forming the fluid-permeable membrane 444 from gauze, a soft fabric, and / or a smooth fabric may reduce abrasion by the liquid collection assembly 420.
[0059] The porous material 400 may include additional layers instead of or in addition to the liquid-permeable membrane 444. In embodiments, the porous material 400 may have a liquid-permeable support configured to support the liquid-permeable membrane 444, which may be made of a relatively pliable, brittle, or otherwise easily deformable material. Thus, the liquid-permeable support may contact and extend inwardly from the liquid-permeable membrane 444 (e.g., between the liquid-permeable membrane 444 and the first porous layer 402 or the conduit 430). The liquid-permeable support may be stronger than the liquid-permeable membrane 444 and may, for example, have a porous polymer (e.g., nylon, polyester, polyurethane, polyethylene, polypropylene, etc.) structure or an open-cell foam such as spun nylon fibers. In embodiments, the porous material 400 may include a foam such as polyurethane foam, polypropylene foam, or polyethylene foam. In embodiments, at least one of the first porous layer 402, the second porous layer 404, or the support layer 406 may be omitted such that the porous material 400 includes one or more additional layers. The additional layers may be formed from any of the porous materials disclosed herein or any other suitable porous material. Further examples of porous materials that may form one or more additional layers are disclosed in PCT International Application No. PCT / US2022 / 011281, filed January 5, 2022, PCT International Application No. PCT / US2022 / 042719, filed September 7, 2022, PCT International Application No. PCT / US2022 / 042725, filed September 7, 2022, U.S. Provisional Patent Application No. 63 / 241,564, filed September 8, 2021, PCT International Application No. PCT / US2022 / 015418, filed February 7, 2022, and PCT International Application No. PCT / US2022 / 015420, filed February 7, 2022, the disclosures of each of which are incorporated herein by reference in their entireties.
[0060] The liquid collection assemblies disclosed herein may have features (e.g., shape memory materials) different from or in addition to the porous materials comprising the first porous layer, second porous layer, and support layer. Figure 5A is a cross-sectional view of a liquid collection assembly 520 having a moldable conduit 530, according to an embodiment. Figure 5B is a cross-sectional view of the liquid collection assembly 520 along plane 5B-5B, according to an embodiment. Unless otherwise disclosed herein, the liquid collection assembly 520 is the same as or substantially similar to any liquid collection assembly disclosed herein. For example, the liquid collection assembly 520 has a liquid-impermeable layer 522 that defines at least one opening 524, a chamber 526, and a liquid outlet 528. The liquid collection assembly 520 further includes at least one porous material 500 and a conduit 530.
[0061] Conduit 530 defines at least a first passageway 531 and a second passageway 533. First passageway 531 is configured to remove bodily fluid from chamber 526. For example, first passageway 531 may be in fluid communication with a reservoir and a vacuum source (e.g., reservoir 872 and vacuum source 874 in FIG. 8 ). This allows suction from the vacuum source to remove bodily fluid from chamber 526 and collect in the reservoir through first conduit 730. Second passageway 533 is configured to contain shape memory material 535 and is not configured to receive bodily fluid from chamber 526. Thus, second passageway 533 may not be in fluid communication with the reservoir or vacuum source. Because second passageway 533 is not configured to receive bodily fluid from chamber 526, second passageway 533 may have a cross-sectional area smaller (e.g., at least one-fifth or at most one-tenth) than the cross-sectional area of first passageway 531.
[0062] The first and second passages 531, 533 are provided separately from one another. For example, the conduit 530 has an inner wall 537 separating the first and second passages 531, 533 from one another. The inner wall 537 may be a liquid-impermeable material and may be integrally formed with the remainder of the conduit 530 (e.g., a single-piece construction). In embodiments, the conduit 530 has a generally cylindrical outer wall 539, which allows the conduit 530 to be used in a liquid collection assembly configured to use cylindrical conduits. In such embodiments, the inner wall 537 may extend inward from the outer wall 539, which allows the first passage 531 to have a generally crescent shape.
[0063] As described above, the conduit 530 includes a shape memory material 535. The shape memory material 535 can be sized, shaped, and positioned within the conduit 530 to maintain at least a portion of the conduit 530 in a selected shape (e.g., a configuration). The selected shape can also cause the remainder of the liquid collection assembly 520 to assume a similar shape because the conduit 530 is at least partially disposed within the chamber 526. In embodiments, the shape memory material 535 is configured to bend, mold, or otherwise deform (hereinafter collectively referred to as "shaped," "shaped," or "molding"). In one example, the shape memory material 535 is configured to be molded along its entire length. Having the shape memory material 535 moldable along its entire length can enable the liquid collection assembly 520 to assume a shape that generally corresponds to the anatomical features of the wearer. In one example, the shape memory material 535 is configured to be molded at one or more selected locations thereof. In such an example, selected portions of the shape memory material 535 may be preferentially molded relative to the remainder of the shape memory material 535. Configuring the shape memory material 535 to be moldable at selected locations may inhibit the liquid collection assembly 520 from assuming a shape that generally corresponds to the wearer's anatomical features, but may also facilitate moldability of the liquid collection assembly 520, particularly for inexperienced wearers. In embodiments, the shape memory material 535 may not be configured to be moldable. Instead, the shape memory material 535 may have a selected shape that corresponds to or generally corresponds to the wearer's anatomical features. In such an embodiment, the shape memory material 535 may be stiffer and / or more elastic than other portions of the liquid collection assembly 520, thereby allowing at least a portion of the liquid collection assembly 520 to conform to the selected shape of the shape memory material 535.
[0064] The shape memory material 535 may include a shape memory polymer and / or a metal (e.g., a shape memory metal). Generally, the shape memory material 535 is configured to assume a temporary or permanent shape in response to a stimulus. The stimulus may include an external physical force (bending force), heat, an electrical bias, or a magnetic field. While the term "shape memory" is used to describe some "shape memory materials" herein, materials modified as "shape memory" do not necessarily need to return to their original selected shape in response to a stimulus, as understood from the general definition of "shape memory material." Rather, at least some of the shape memory materials 535 disclosed herein, once bent, set, or solidified into a particular shape and / or cooled to a particular shape, may simply maintain the selected shape regardless of a subsequent stimulus. The shape memory material 535 may return to its original shape or change to a new shape when stimulated. For example, a metal wire bent into a first shape can be utilized as the shape memory material 535, after which the metal wire can be transformed into a second shape by the application of a physical force or heat. Alternatively, in some embodiments, the shape memory material 535 can have a selected shape as described above, and upon application of a particular stimulus, the shape memory material 535 can transform (e.g., elastically deform or bend) into an intermediate shape. In such embodiments, the shape memory material 535 can return to its initial shape when the stimulus is removed, such that it does not maintain the intermediate shape.
[0065] In embodiments, the shape memory material 535 may include a shape memory metal, such as a metal, an alloy, or a shape memory alloy. Suitable shape memory metals may include plain steel, stainless steel, carbon alloy steel, headed steel, aluminum, silver, copper, iron, nickel, zinc, tin, beryllium, etc. Suitable shape memory alloys may include stainless steel, galvanized steel, aluminum alloys, Nitinol, nickel-titanium alloys such as Ni-Ti-Cu, Ni-Ti, Co, copper-based alloys such as Cu-Zn-Al, Cu-Al-Ni, Cu-Al-Sn, Co-Cr-Ni-Mo alloys (e.g., Elgiloy®), etc., or any other alloy with shape memory properties. As mentioned above, a shape memory metal or alloy may simply be a metal or alloy that can be formed into a selected configuration. In some examples, a shape memory metal or alloy may return to its initial shape upon receiving an external stimulus. In some examples, the outer surface of the shape memory metal may be at least partially coated with a polymer (e.g., polyvinyl chloride), anodized, passivated, or otherwise treated to prevent corrosion. At least partially coating the shape memory metal with a polymer further prevents metal ions from the shape memory material 535 from entering the chamber 526 and contacting the vaginal area, which could cause discomfort.
[0066] Shape memory polymers ("SMPs") may include polyurethane-based SMPs such as copolymers (e.g., copolyesters, polyurethanes, polyetheresters, etc.) containing one or more blocks of poly(s-caprolactone), polyethylene terephthalate (PET), polyethylene oxide (PEO), polyethylene glycol (PEG), polystyrene, polymethyl methacrylate (PMMA), polybutyl methacrylate (PBMA), poly(N,N-butadiene), poly(N-methyl-N-oxazoline), polytetrahydrofuran, or poly(butylene terephthalate), thermoplastic polymers such as polyetheretherketone (PEEK), nylon, acetal, polytetrafluoroethylene (PTFE), polypropylene, polyethylene, acrylonitrile butadiene styrene (ABS), polysulfone, polynorbornene, other deformable polymers, or any other shape memory polymer.
[0067] The liquid collection assembly 520 can be shaped to conform to the anatomy of the wearer using the liquid collection assembly 520. This improves comfort and keeps the assembly in place during use compared to conventional devices. The liquid collection assembly 520 can be manipulated to conform to the anatomy of the wearer's groin area. For example, the conduit 530 can be shaped upward so that the liquid collection assembly 520 maintains a generally arcuate shape. In such an example, the distal region 540 can be positioned within the wearer's intergluteal cleft. The proximal region 542 can be positioned opposite the wearer's upper vaginal or pubic hair region. The portion between these regions can be shaped to conform to the wearer's anatomy. Depending on the size and shape of the wearer, the interior of the liquid collection assembly 520 can have a more or less arcuate shape. Thus, the liquid collection assembly 520 can be used by wearers of various different sizes.
[0068] The shape memory material 535 comprises at least one wire (e.g., at least one rod). The wire has a length measured along the longitudinal axis of the wire, a width measured perpendicular to the length, and a thickness measured perpendicular to the length and width. The length of the wire is significantly greater than its width and thickness. In embodiments, the wire is sized and configured such that its length is generally aligned with the longitudinal axis of the liquid-impermeable layer 522. In such embodiments, the wire may change the shape of the liquid collection assembly 520 and / or the overall shape of the liquid-impermeable layer 522 along its longitudinal axis. In embodiments, the wire is sized and configured such that its length is not aligned with the longitudinal axis of the liquid-impermeable layer 522.
[0069] The length of the wire may be at least 10%, such as 10% to 100%, 30% to 100%, 10% to 40%, 30% to 60%, 60% to 90%, 40% to 80%, 50% to 100%, less than 100%, less than 70%, of the longitudinal length of the conduit 530 disposed within the chamber 526, or may be greater than 100% of the length of the conduit 530 disposed within the chamber 526. Note that selecting a length of the wire that is equal to or greater than a substantial length of the conduit 530 disposed within the chamber 526 allows for an overall change in the shape of the liquid collection assembly 520. In one example, the wire may have a generally circular cross-sectional shape.
[0070] In an embodiment, the conduit 530 has a plug 551 disposed within the second passageway 533. The plug 551 may prevent over-insertion of the shape memory material 535 into the second passageway 533, which may prevent shaping of one or more desired regions of the liquid collection assembly 520. In one example, the plug 551 may be disposed at or near the liquid outlet 528, allowing the shape memory material 535 to be disposed along substantially the entire length of the conduit 530. Thus, the shape memory material 535 may affect the overall shape of the liquid collection assembly 520. The plug 551 may also form a substantially fluid-tight seal within the second passageway 533, preventing the flow of bodily fluids through the second passageway 533.
[0071] As described above, the liquid collection assembly 520 includes a porous material 500 disposed within the chamber 526. In an embodiment (not shown), the porous material 500 includes the porous material shown in FIGS. 1 to 4 , i.e., a first porous layer, a second porous layer, and a support layer disposed therebetween. In an embodiment, the porous material 500 includes a liquid-permeable outer layer 502 and a liquid-permeable inner layer 504. In one example, the outer layer 502 can be thinner than the inner layer 504. For example, the outer layer 502 can have a thickness of about 0.1 mm to about 0.5 mm, and the inner layer 504 can have a thickness of about 5 mm to about 10 mm.
[0072] The outer layer 502 and the inner layer 504 can have any porous material disclosed herein. In one example, the outer layer 502 and / or the inner layer 504 can have the porous material shown in FIGS. 1 to 4, i.e., a first porous layer, a second porous layer, and a support layer therebetween. In one example, the outer layer 502 and / or the inner layer 504 have one or two of a first porous layer, a second porous layer, and a support layer. In one example, the outer layer 502 is a liquid-permeable membrane. In such an example, the outer layer 502 can include gauze, bamboo fiber, polypropylene fiber, cellulose fiber, any other liquid-permeable membrane disclosed herein, or any combination thereof. When the outer layer 502 is a liquid-permeable membrane, the outer layer 502 has a weight of about 25 g / m 2 to about 100g / m 2 The outer layer 502 may have a density of 25 g / m² because it has been confirmed that the outer layer 502 having this density efficiently absorbs bodily fluids from the wearer. However, the liquid-permeable membrane of the outer layer 502 may have a density of 25 g / m². 2 or below 100g / m 2 It is noted that the inner layer 504 may have a density greater than about 100 g / m. In one example, the inner layer 504 may be a liquid-permeable support. In such an example, the inner layer 504 may include foam, any other liquid-permeable support disclosed herein, or any combination thereof. When the inner layer 504 is a liquid-permeable support, the inner layer 504 may have a density greater than about 100 g / m. 2 to approximately 350 g / m 2The inner layer 504 may have a density of 100 g / m or less because it has been confirmed that the inner layer 504 having such a density allows body fluids to flow efficiently through the inner layer 504. However, the liquid-permeable support of the inner layer 504 may have a density of 100 g / m or less. 2 or below 350 g / m 2 It is noted that the porous material 500 may have a density greater than 1000 . In embodiments, the porous material 500 may comprise a single material.
[0073] The liquid collection assemblies shown in Figures 3A through 4 are examples of female liquid collection assemblies configured to collect bodily fluids from women (e.g., to collect urine from the female urethra). However, the liquid collection assemblies, systems, and methods disclosed herein may include male liquid collection assemblies shaped, sized, and otherwise configured to collect bodily fluids from men (e.g., to collect urine from the male urethra). 6 1 is a male liquid collection assembly according to an embodiment of the present invention. 6 20 is a cross-sectional view.
[0074] Liquid Collection Assembly 6 20 is the base 6 46 (e.g., a toric base) and a sheath 6 48 and has a base 6 46 is of a size, shape, and material that will fit the skin around the male urethral opening (e.g., male genitalia), and the male urethral opening is placed through its interior. 6 46 is the opening 6 50. Base 6 46 is sized and shaped to be placed around the male urethral opening (e.g., placed around and / or over the male genitalia) and to close the opening. 6 The base 50 may be configured to have the male urethral meatus positioned therethrough. 6 46 may further be sized, shaped, made of a material, or otherwise configured to be bonded (e.g., adhesively attached, such as using a hydrogel adhesive) to the skin around the male urethral opening (e.g., around the penis). 6 46 is the base 646 may have the general shape and contour of the skin surface to which it is selected to be bonded. 6 46 can be flexible. This allows the base 6 46 can be adapted to any shape of skin surface. 6 46 is a flange extending laterally (e.g., radially) 6 52. Base 6 46 furthermore, sheath 6 48. For example, the base 6 46 is the base 6 a longitudinally extending flange extending upwardly from 46 6 54. A longitudinally extending flange 6 54 is sheath 6 48 is incorrectly based 6 46 can be sufficiently tall to prevent removal from the base (e.g., at least 0.25 cm, 1 cm, at least 3 cm, or at least 5 cm in height). 6 46 is a liquid collection assembly 6 20 proximal region (relative to the wearer) 6 42.
[0075] sheath 6 48 is the base 6 A liquid-impermeable layer sized and shaped to fit within the hollow area of 46. 6 22 (e.g., may be formed by) a sheath 6 The liquid-impermeable layer 48 may be generally cylindrical or cup-shaped as shown. 6 22 is sheath 6 48 exteriors 6 36. 6 In one or more embodiments, 22 can be similar to or identical to the liquid-impermeable layer disclosed herein. For example, the liquid-impermeable layer 6 22 may be made of any of the materials disclosed herein for the liquid-impermeable layer. 6 22 is the chamber 6 26. For example, the liquid-impermeable layer6 The inside of 22 6 34 is the chamber 6 26 at least partially defines the outer periphery of the chamber. 6 26 can at least temporarily retain bodily fluids therein. 6 20 has a porous material inside 6 00. Porous material 6 00 may, in one or more embodiments, be similar to or identical to the porous materials disclosed herein. For example, porous materials 6 00 is the first porous layer 6 02 and the second porous layer 6 04 and the first and second porous layers 6 02 Support layer placed between 6 06. Optionally, a porous material 6 00 is the first porous layer 6 02. The liquid-permeable membrane (not shown) may be disposed on the chamber 02. 6 It comes into contact with the male genitalia placed inside 26, increasing comfort. 6 22 also includes a liquid-impermeable layer configured to allow the male urethral opening to be placed therethrough. 6 An opening extending through 22 6 24 can be defined.
[0076] sheath 6 48 further includes a chamber therein. 6 26. A conduit at least partially disposed within 6 30, etc., conduit 6 30. For example, although not shown, the conduit 6 30 is the tip region 6 40 sheaths 6 48 to at least opening 6 Proximal region adjacent to 24 6 42. Proximal Region 6 42 may be placed on or near the skin surrounding the male urethra (e.g., the penis or surrounding pubic area). Thus, when the individual is lying on their back, the opening 6 Body fluids (e.g., urine) may accumulate near 24 against the subject's skin.6 Chambers through 30 6 26 can be removed.
[0077] In some instances, the liquid-impermeable layer 6 22 is sheath 6 48 may be made of a material and / or have a thickness that allows it to collapse when placed under a vacuum, thereby reducing the size of the liquid collection assembly in use. 6 The air around the male genitalia in 20 is removed, etc. In such an example, 6 30 is the chamber 6 26 within the cutting edge region 6 40 or may extend only into the opening 6 24 adjacent areas). In such instances, urine is collected by the fluid collection assembly. 6 20 can be collected and removed.
[0078] In one example, due to the different sizes and hardness of men's penises, 6 26 may be partially substantially empty. However, in some instances, the chamber 6 The outermost region of 26 (e.g., sheath 6 48) is made of porous material 6 00. For example, porous materials 6 00 is a liquid-impermeable layer 6 The inside of 22 6 34. Porous material 6 00 may be positioned to slow the flow of urine from the male urethral opening (e.g., a chamber 6 26 tip). This limits splashing and / or keeps fluids in the chamber. 6 26 selected areas. 6 26 is substantially empty (e.g., chamber 6 26 forms the reservoir), and the body fluid is 6 It tends to accumulate at the lowest point in the direction of gravity. 6 The lowest point of gravity in the direction of 26 is the individual's skin and sheath. 6Liquid collection assembly formed within 48 6 20 corner, or other suitable location depending on the orientation of the wearer.
[0079] porous material 6 00 is a liquid-impermeable layer 6 22 and the chamber 6 The first porous layer can be placed between the male organ inserted in the first porous layer. 6 02 is the second porous layer 6 Between 04 and the male genitalia, and the support base 6 06 and the male genitalia, etc., an impermeable layer 6 22 and the chamber 6 26. Optionally, the opening 6 Chamber approximately opposite to 24 6 Inner surface including 26 edges 6 34 is the second porous layer 6 04. The second porous layer 6 04 is a liquid-impermeable layer 6 22.
[0080] Liquid Collection Assembly 6 20 is the cutting edge area 6 Capped at 40 6 56. Cap 6 56 may define an internal passageway through which bodily fluid may pass to the fluid collection assembly. 6 20. The internal passage can be removed from the chamber. 6 26. Cap 6 56 is a liquid-impermeable layer 6 22 or porous material 6 One or both apical regions of 00 6 40 may be disposed at least partially on the cap. 6 Cap 56 may be made of polymer, rubber, or any other liquid-impermeable material. 6 56 is a liquid-impermeable layer 6 22, porous material 6 00, or conduit 6 30. Cap 656 is a liquid collection assembly 6 20 cutting-edge fields 6 40. 6 56 is a conduit 6 a liquid outlet sized and configured to receive and liquid seal the liquid supply port 30; 6 28. The conduit 6 30 is a cap 6 56. 6 Up to 00, porous materials 6 00 through or porous material 6 00 to a point that is offset from the cap. 6 The internal passage of 56 has a reservoir inside. 6 38 can be defined.
[0081] Storage section 6 38 is a cap 6 56 is a void space in the device that is free of other materials. 6 38 is a porous material 6 00 and cap 6 56. In use, the chamber 6 The body fluid in 26 is 6 Storage section through 00 6 Up to 38 can flow. 6 38 may contain at least a portion of the bodily fluid therein and / or may be configured to conduct the bodily fluid. 6 30. In some instances, the porous material 6 At least a portion of the internal passage and chamber 6 26. The openings 26 may extend continuously between at least a portion of the openings 26. This allows any bodily fluid to pass from the openings to the reservoir. 6 It is sucked up directly into 38.
[0082] In some instances (not shown), a liquid-impermeable layer 6 22 is a cap 6 Chamber 56 6 26. Seal the cap 656 or above.
[0083] proximal region 6 42 may be placed on or near the skin around the male urethral meatus (e.g., around the penis) and may be used to 6 The entrance of 30 is the base region 6 42. 6 The outlet of 30 may be directly or indirectly coupled to a vacuum source. 6 Chambers through 30 6 26 proximal regions 6 42.
[0084] base 6 46. Sheath 6 48. Cap 6 56, and conduit 6 30 may be attached to each other in any suitable manner. For example, 6 46. Sheath 6 48. Cap 6 56, or conduit 6 At least two of the 30 may be attached to one another by at least one of an interference fit, adhesive, stitching, welding (eg, ultrasonic welding), tape, any other suitable method, or a combination thereof.
[0085] In some instances (not shown), a liquid collection assembly 6 20 may have a unitary design, in which case the sheath 6 48, bass 6 46, and Cap 6 One or more of the 56 will be a single integral body.
[0086] Also, as shown in the figure, the conduit 6 30 may be disposed at least partially with the chamber of the liquid collection assembly. 6 30 is the tip region 6 40 to the base region 6 42. For example, the conduit 6 30 is the base 6 Cap to the point adjacent to 466 56. 6 30 is sized and configured to be coupled to a reservoir or vacuum source (FIG. 8 ). conduit 6 The outlet of 30 may be operatively coupled, directly or indirectly, to a vacuum source. 6 30 Entrances 6 32 is a liquid collection assembly when in use 6 20, the lowest point of gravity is expected to be in the chamber. 6 26. 6 32 is placed at a position that is expected to be the lowest point of the liquid collection assembly in the direction of gravity when worn by a user, 6 The fluid introduced into 26 is 6 30. This allows the body fluid to be removed from the chamber. 6 Retention and accumulation within 26 is prevented.
[0087] In some examples, the vacuum source is 6 20. In such an example, the conduit 6 30 is a vacuum source and liquid collection assembly 6 20. The fluid reservoir may be fluidly connected to a fluid reservoir that may be disposed between the fluid reservoir and the fluid reservoir.
[0088] In operation, the liquid collection assembly 6 20 men using the chamber 6 Body fluids (e.g., urine) can be discharged into the chamber 26. 6 At least a portion of the bodily fluid may pool or otherwise collect within 26. 6 The fluid can be drawn into the fluid collection assembly 30 by vacuum / suction from the vacuum source. 6 In operation, body fluids can be drawn from the chamber 20. 6 26 and subsequently removed therefrom, a vacuum relief valve (not shown) allows the chamber 6 The pressure within 26 may be maintained substantially at atmospheric pressure.
[0089] figure 71 is a liquid collection assembly according to an embodiment. 7 20 is a cross-sectional view of the liquid collection assembly. 7 20 is an example of a male fluid collection assembly, but in some embodiments, the fluid collection assembly 7 20 may be used to receive bodily fluids from the female urethral meatus. Unless otherwise disclosed herein, the fluid collection assembly 7 20 is the same as or substantially similar to any of the liquid collection assemblies disclosed herein. 7 20 is sheath 7 48 and base 7 It has a 46. base 7 46 is sheath 7 48. Configured to be mounted (e.g., permanently mounted or configured to be permanently mounted) to the base 7 46 is also configured to be attached to the area around the individual's urethral opening (eg, male genitalia).
[0090] sheath 7 48 is the first panel 7 58 and 2nd panel 7 60, a liquid-impermeable layer formed at least in part from 7 22. First Panel 7 58 and 2nd panel 7 60 are attached to or integrally formed with one another (e.g., have a unitary construction). In an embodiment, as shown, the first panel 7 58 and 2nd panel 7 60 is an individual sheet. Liquid-impermeable layer 7 22 further states that the first panel 7 58 and 2nd panel 7 60 chambers 7 26, sheath 7 48 proximal regions 7 Opening at 42 7 24, sheath 7 48 cutting-edge areas 7 Liquid outlet at 40 7 Define 28. Sheath 7 48 further includes a chamber 7At least one porous material disposed within 26 7 00.
[0091] liquid impermeable layer 7 22 inner surface(s), e.g., first and second panels 7 58, 7 The inner surface of the liquid collection assembly 7 20 chambers 7 26. Liquid-impermeable layer 7 22 is the chamber 7 The body fluid is temporarily stored in the liquid-impermeable layer 26. 7 22 can be formed from any of the liquid-impermeable materials disclosed herein. 7 22 is a layer impermeable to body fluids 7 22.
[0092] In an embodiment, the first panel 7 58 or 2nd panel 7 At least one of the first panel 60 is formed from an at least partially transparent, liquid-impermeable material such as polyethylene, polypropylene, polycarbonate, or polyvinyl chloride. 7 58 or 2nd panel 7 At least one of the first panel 60 may be formed at least partially from a transparent, liquid-impermeable material to allow an individual (e.g., a physician) to examine the male genitalia. 7 58 and 2nd panel 7 Both the first panel 60 and the second panel 61 are formed at least in part from a transparent, liquid-impermeable material. 7 58 or 2nd panel 7 60 at least partially formed of a transparent, liquid-impermeable material, 7 It is possible to examine the male genitalia without completely removing the chamber 20 from the area around the male genitalia. 7 26 is the chamber 7 a male genitalia receiving area configured to receive the male genitalia of an individual when the male genitalia extends within the area; 762. Male genitalia receiving area 7 62 is at least a porous material 7 00 and the first panel 7 58 and / or 2nd panel 7 60 and at least a portion of the at least partially transparent material. 7 Chambers through 24 7 When inserted into 26, the porous material 7 00 is the male genitalia, the first panel 7 58 and / or 2nd panel 7 60 and at least a portion of the transparent portion of the porous material. 7 00 is chamber 7 26. Porous Material 7 00 is generally opaque and therefore does not cover the penis-containing area. 7 First panel defining 62 7 58 and / or 2nd panel 7 60, a portion of at least partially transparent material is provided to the individual in the penis receiving area. 7 62, creating a window that allows one to look inside and examine the male genitalia.
[0093] liquid impermeable layer 7 The opening defined by 22 7 24. When the male genitalia is buried, bodily fluids enter the chamber. 7 26 for penetration into the chamber and when the penis is not buried 7 26 (e.g., the male genitalia 7 62) to provide an access route that allows entry into the 7 24 is a liquid-impermeable layer 7 22 (e.g., liquid-impermeable layer 7 22) can be defined by the opening. 7 24 is a liquid-impermeable layer 7 22 and extending therethrough, thereby allowing bodily fluid to pass through the fluid collection assembly. 7 20 Chamber from outside 7 It is possible to enter within 26.
[0094] liquid impermeable layer7 22 is a conduit 7 Liquid outlet sized to accommodate 30 7 Define 28. Conduit 7 30 is the chamber 7 26 at least partially disposed within or otherwise connected to a liquid outlet 7 Chambers through 28 7 26. 7 28 at least conduit 7 30. This allows the bodily fluid to pass through the chamber. 7 26 is substantially prevented from leaving the liquid outlet. 7 28 is the first panel 7 58 and 2nd panel 7 60. In such an embodiment, the liquid-impermeable layer 60 may be formed from portions that are not attached to or integrally formed with one another. 7 22 is a liquid-impermeable layer 7 22. This allows the liquid collection assembly to be 7 20, the number of parts used to form the liquid collection assembly is reduced 7 20. Without the cap, the conduit 7 30 liquid outlet 7 28, it may be difficult to fix it by a tight fit. 7 30 is for use with adhesives, welding, or liquid outlets 7 28 Liquid outlet 7 28 by other means connected to the liquid outlet 7 28 (e.g., first and second panels 7 58, 7 60). In one example, the conduit 7 30 is the first and second panels 7 58, 7 60 are attached to each other in the same manufacturing process 7 28. In one example, the liquid-impermeable layer 7 22 has a cap and a conduit 728 may be attached to the cap (eg, by an interference fit).
[0095] As mentioned above, the sheath 7 48 is the chamber 7 At least one porous material disclosed in 26 7 00. Porous material 7 00 is the liquid exit from the male genitals 7 28 towards the chamber 7 26. The porous material may direct bodily fluids to one or more selected areas. 7 00 can be made of any porous material disclosed herein. For example, 7 00 is the first porous layer 7 02 and the second porous layer 7 04 and the first and second porous layers 7 02. 7 04 supporters 7 06. In an embodiment, the first porous layer 7 02 is the area where the male genitalia are housed 7 The second porous layer may be disposed to define at least a portion of the second porous layer. 7 04 is the first panel 7 58.
[0096] In an embodiment, the porous material 7 00 can be a sheet. Porous material 7 00 as a sheet to form a liquid collection assembly 7 20 can be easier to manufacture. 7 00 as a sheet to form the first panel 7 58, 2nd panel 7 60, and porous materials 7 00Each can be a sheet. 7 20 manufacturing, first panel 7 58, 2nd panel 7 60, and porous materials 7 00 can be stacked and attached to each other in the same manufacturing process. For example, porous materials 7 00 is the first panel 7 58 and 2nd panel7 60, or more preferably, slightly smaller in size. 7 58 and 2nd panel 7 60 along their outer edges to form a porous material 7 00 also first panel 7 58 and 2nd panel 7 60. Porous material 7 00 is the first panel 7 58 and 2nd panel 7 This can be slightly smaller than 60. 7 58 and / or 2nd panel 7 60 is porous material 7 00. Therefore, the porous material 7 00 is a liquid-impermeable layer 7 22 does not form a path through which body fluids can leak. 7 00 for the first panel 7 58 and / or 2nd panel 7 By attaching to 60, liquid outlet 7 Porous material near 28 7 00 hardens, etc., porous materials 7 00 is chamber 7 In one example, the porous material 7 00 is the first panel 7 58 to the second panel 7 Before or after attaching to 60, first panel 7 58 or 2nd panel 7 60 (e.g., via adhesive). In one example, the porous material 7 00 is porous material 7 00 for the first panel 7 58 or 2nd panel 7 60. Simply attach the chamber 7 26. In an embodiment, the porous material 7 00 may have a shape other than a sheet, such as a hollow, generally cylindrical shape.
[0097] Generally, the penis is located in the penis-receiving area.7 62, and sheath 7 With 48 placed on a flat surface, the sheath 7 48 is substantially flat. 7 22 is not a substantially cylindrical liquid-impermeable layer, but a first panel 7 58 and 2nd panel 7 60, so the sheath 7 48 is generally flat. Furthermore, as mentioned above, the porous material 7 00 can be a sheet, which also forms a sheath 7 48 becomes approximately flat. 7 48 may also be substantially flat because the liquid collection assembly 7 20 is a liquid-impermeable layer 7 22 has higher rigidity than the surrounding part, and the sheath 7 This is because the sheath 48 does not have a relatively rigid ring or cap that may prevent it from being substantially flat. 7 Although 48 is described as being substantially flat, it is a porous material. 7 Depending on the thickness of the 00, porous material 7 00, sheath 7 48 may have some swelling, 7 28 and / or conduit 7 30 may cause a bulge around the base 7 46 is the surrounding sheath 7 At least one of the sheaths can be pulled up over the portion 48. 7 48 can also be flexible. 7 48 may not be substantially flat when in use. 7 48 may be placed on a non-flat surface (e.g., on the testicles, on the perineum, and / or in the groin), and the sheath 7 48 may follow the plane of these shapes.
[0098] The male genitalia are the area where the male genitalia are housed. 7 62, and sheath 7 When the sheath 48 is placed on a flat surface, 748 can be made substantially flat, allowing the liquid collection assembly 7 20 can be used with buried and non-buried male genitalia. For example, the fluid collection assembly 7 When 20 is used with a buried penis, the penis is placed in the penis receiving area. 7 62. This prevents the sheath from extending into the 7 48 is the base 7 46 openings 7 The entire sheath 50 is laid relatively flat. 7 Based on 48 7 46 openings 7 When placed relatively flat across the entire 50, the porous material 7 00 is the opening 7 24 and opening 7 50 and is close to the buried male genitalia. 7 00 prevents or inhibits the retention of fluids discharged from the buried male genitalia against the individual's skin. 7 00 to receive or remove at least a majority of bodily fluids that may accumulate against the individual's skin, thereby keeping the individual's skin dry and the fluid collection assembly 7 20 improves comfort and prevents skin damage. Meanwhile, unlike other conventional fluid collection assemblies designed for use with buried male genitalia, the fluid collection assembly 7 20 can also be used for the uncovered penis. Even when the uncovered penis is fully erect, the penis receiving area 7 62. Furthermore, the sheath 7 48 can be made almost flat, 7 48 is not flat, the liquid collection assembly 7 20 can be used on a more situation-specific basis, thus preventing potentially embarrassing situations.
[0099] sheath 7 If 48 is substantially flat, it is a porous material. 7 00 is the chamber 7 26, located almost entirely in the area housing the male genitalia 762 is in a collapsed state (Fig. 7 For illustration purposes, the male genitalia area 7 (As can be seen in Figure 62, it is shown uncollapsed.) In other words, the sheath 7 48 is a porous material 7 It is not necessary to define an area where the 00 is always absent. Porous materials are not recommended because retention of bodily fluids can create hygiene problems, produce foul odors, and / or keep an individual's skin in contact with bodily fluids, causing discomfort and skin damage. 7 00 is chamber 7 26 is present throughout the chamber 7 26 makes it difficult for body fluids discharged into the bladder to remain there for a long period of time.
[0100] As mentioned above, the first panel 7 58, 2nd panel 7 60, and porous materials 7 00 can be chosen to be relatively flexible. First Panel 7 58, 2nd panel 7 60, and porous materials 7 If each of the 00 panels cannot maintain its shape without support, the first panel 7 58, 2nd panel 7 60, and porous materials 7 00 is relatively flexible. First panel 7 58, 2nd panel 7 60, and porous materials 7 The flexibility of the 00 allows for the sheath to be 7 The first panel 48 may be substantially flat. 7 58, 2nd panel 7 60, and porous materials 7 The flexibility of the 00 also allows the sheath to conform to the shape of the male genitalia as the size and shape of the male genitalia changes (e.g., erection). 7 The shape of 48 may be able to conform to the shape of the chamber, which may allow bodily fluids to accumulate. 7 Any gaps in 26 can be minimized.
[0101] As mentioned above, the liquid collection assembly 7 20 is sheath 7A base configured to be attached to 48 7 46. For example, the base 7 46 is sheath 7 48. For example, the liquid collection assembly 7 20, sheath 7 Permanently attached base to 48 7 46 is provided, or the base 7 46 is sheath 7 It is not permanently attached to the 48, but it may be sheathed at some point in the future. 7 48, provided that the base is configured to be permanently attached to the 7 46 is sheath 7 48. Permanently attached means that the sheath 7 Based on 48 7 Use the blade to separate from the 46 and / or sheath 7 Based on 48 7 By using chemicals to dissolve the adhesive that attaches the sheath to the 46, 7 48 or base 7 46 without damaging at least one of the sheaths. 7 Based on 48 7 This means that it cannot be removed from the 46. 7 46 can be sheathed by adhesive, stitching, heat sealing, RF welding, or US welding. 7 48. In an embodiment, the base 7 46 is sheath 7 48. In an embodiment, the base 7 46 is sheath 7 It is formed integrally with 48.
[0102] base 7 46 is the opening 7 It has a 50. base 7 46 is the opening 7 50 opening 7 Sheath to align to 24 7 48 cutting-edge areas 7Permanently attached to 40.
[0103] base 7 46 is sized, shaped, and made of a material that allows it to be attached to the skin around the male genitalia (e.g., mons pubis, thighs, testicles, and / or perineum) and within which the male genitalia is placed. 7 46 is an opening configured to allow a male genitalia to be placed therein 7 50. In one example, the base 7 46 is the base 7 46 may have the general shape or contour of a skin surface to which it is configured to bond. 7 46 can be flexible. This allows the base 7 46 can conform to any shape of the skin surface, 7 This minimizes the pulling of the 46 on the skin surface. 7 46 is sheathed horizontally 7 48. This allows for a substantially similar liquid collection assembly without the base. 7 20 compared to the liquid collection assembly 7 20 can be attached to increase the surface area of an individual's skin.
[0104] Further examples of liquid collection assemblies that may include the porous materials disclosed herein are disclosed in U.S. patent application Ser. No. 15 / 612,325, filed June 2, 2017, U.S. patent application Ser. No. 15 / 260,103, filed September 8, 2016, U.S. Patent No. 10,390,989, filed September 8, 2016, U.S. Provisional Patent Application Ser. No. 63 / 067,542, filed August 19, 2020, and U.S. patent application Ser. No. 16 / 433,773, filed June 6, 2019, the disclosures of each of which are incorporated herein by reference in their entireties.
[0105] figure 8 1 is a liquid collection assembly according to an embodiment. 8 Liquid collection system for 20 8 70 is a block diagram of a liquid collection system. 8 70 is a liquid collection assembly 820 and a liquid storage container 8 72 and the vacuum source 8 74. The liquid collection assembly 8 20 can be the same as or substantially similar to any of the liquid collection assemblies disclosed herein. 8 20 and a liquid storage container 8 72 and the vacuum source 8 74 means one or more conduits 8 30. For example, the liquid collection assembly 8 20 is a conduit 8 30 through the liquid storage container 8 72 or vacuum source 8 74. 8 The collected body fluid in the fluid collection assembly 20 8 20 Inward-protruding conduit 8 30 through the liquid collection assembly 8 20. For example, the conduit 8 30 inlets for the liquid collection assembly 8 20, may extend into a reservoir therein, etc. 8 30 outlets for liquid collection assembly 8 20 or vacuum source 8 74. 8 Depending on the suction (e.g., vacuum) force applied to the outlet of the conduit, 8 Through the 30 inlet, the liquid collection assembly 8 A suction force can be introduced into the chamber of 20 .
[0106] The suction power is generated by a vacuum source. 8 74, directly or indirectly, conduit 8 The suction force can be applied to the outlet of the reservoir. 8 72. For example, the voltage may be applied indirectly via a conduit 8 The outlet of 30 is a storage container 8 72, an additional conduit may be disposed within 8 30 is a liquid storage container 8 72 to vacuum source 8 74. Thus, the vacuum source 8 74 is a liquid storage container8 Liquid collection assembly via 72 8 Suction may be applied to 20. The suction force may be generated by a vacuum source. 8 74. For example, the 8 The outlet of 30 is a vacuum source. 8 74. Additional conduits 8 30 is the vacuum source 8 74 to storage container 8 Up to 72 etc., liquid collection assembly 8 In such an example, the vacuum source 8 74 is a liquid collection assembly 8 20 and a storage container 8 72.
[0107] Liquid storage container 8 72 is sized and shaped to hold bodily fluids therein. 8 72 may include a bag (e.g., a drainage bag), a bottle or cup (e.g., a collection bottle), or other enclosed container for storing bodily fluids such as urine. 8 30 is a liquid collection assembly 8 20, extending from the liquid storage container 8 72. The additional conduit may be attached at a first point inside 72. 8 30 is a liquid storage container 8 72, which may be attached to a second point on the vacuum source 8 74 and can be attached thereto. 8 via 72, liquid collection assembly 8 A vacuum can be extracted (e.g., suction) through 20. Body fluids such as urine can be drawn from the vacuum source. 8 74 using a liquid collection assembly 8 Can be ejected from 20.
[0108] vacuum source 8 74 may include one or more of a manual vacuum pump, an electric vacuum pump, a diaphragm pump, a centrifugal pump, a displacement pump, a magnetic drive pump, a peristaltic pump, or any pump configured to generate a vacuum. 8 74 is a liquid collection assembly 8A vacuum or suction may be provided to remove bodily fluids from 20. In some examples, a vacuum source 8 74 may be powered by a power cord (e.g., plugged into an electrical outlet), one or more batteries, or even a manual power source (e.g., a manual vacuum pump). 8 74 is a liquid collection assembly 8 20. For example, the vacuum source 8 74 may include one or more miniature pumps, or one or more micropumps. 8 74 is a switch, button, plug, remote control, or vacuum source. 8 74 may include any other device suitable for operation.
[0109] While various aspects and embodiments have been disclosed herein, other aspects and embodiments are contemplated, and the various aspects and embodiments disclosed herein are for illustrative purposes only and are not intended to be limiting.
[0110] Terms of degree (e.g., "about," "approximately," "generally," etc.) indicate structurally or functionally insignificant variations. In one example, when a term of degree is included in a term of quantity, the term of degree is interpreted as ±10%, ±5%, or +2% of the term of quantity. In one example, when a term of degree is used to describe a shape modification, the term of degree indicates that the shape modified by the term of degree has the appearance of the disclosed shape. For example, the term of degree can be used to indicate that a shape may have rounded corners instead of sharp corners, may have curved edges instead of straight edges, may have one or more protrusions extending therefrom, may be elliptical, may be identical to a disclosed shape, etc.
Claims
1. a liquid-impermeable layer defining at least a chamber, at least one opening, and a liquid outlet; a porous material disposed within the chamber; a conduit disposed within the chamber, the conduit defining a first passageway and a separate second passageway separated from the first passageway, the conduit comprising: The exterior wall and a conduit having an inner wall extending inwardly from the outer wall, the inner wall configured to separate the first passage from the second passage; a shape memory material disposed within the second passageway, the shape memory material being capable of retaining a selected shape; and at least one plug disposed within the second passageway.
2. The liquid collection assembly of claim 1 , wherein the porous material has a liquid-permeable inner layer and a liquid-permeable outer layer.
3. 2. The liquid collection assembly of claim 1, wherein the porous material comprises a first porous layer, a second porous layer, and a support layer, the support layer extending between the first and second porous layers over at least substantially the entire length of the first porous layer and at least substantially the entire length of the second porous layer.
4. 2. The liquid collection assembly of claim 1, wherein the porous material has a first porous layer, a second porous layer, and a support layer extending between the first porous layer and the second porous layer, and the first porous layer comprises polypropylene.
5. 2. The liquid collection assembly of claim 1, wherein the porous material has a first porous layer, a second porous layer, and a support layer extending between the first porous layer and the second porous layer, the support layer comprising bamboo.
6. 2. The liquid collection assembly of claim 1, wherein the porous material has a first porous layer, a second porous layer, and a support layer extending between the first and second porous layers, the second porous layer comprising polyester.
7. 2. The liquid collection assembly of claim 1, wherein the porous material includes a first porous layer, a second porous layer, and a support layer extending between the first and second porous layers, the second porous layer including a foam.
8. 2. The liquid collection assembly of claim 1, wherein the porous material has a first porous layer, a second porous layer, and a support layer extending between the first porous layer and the second porous layer, the first porous layer comprising polypropylene, the support layer comprising bamboo, and the second porous layer comprising polyester.
9. The liquid collection assembly of claim 1 , wherein the conduit includes the outer wall that is generally cylindrical.
10. The fluid collection assembly of claim 1 , wherein the first passageway is configured to remove bodily fluid from the chamber.
11. The liquid collection assembly of claim 1 , wherein the conduit has the outer wall, and the inner wall is in a single piece with the outer wall.
12. The liquid collection assembly of claim 1 , wherein the conduit has a generally cylindrical outer wall and the first passage has a generally crescent shape.
13. The liquid collection assembly of claim 1 , wherein the second passageway has a cross-sectional area that is smaller than a cross-sectional area of the first passageway.
14. 14. The liquid collection assembly of claim 13, wherein the cross-sectional area of the second passageway is at least one-fifth or less than the cross-sectional area of the first passageway.
15. The liquid collection assembly of claim 1 , wherein the shape-memory material is moldable into a selected shape.
16. The liquid collection assembly of claim 1 , wherein the shape memory material comprises aluminum or an aluminum alloy.
17. The liquid collection assembly of claim 1 , wherein the shape memory material comprises at least one wire.
18. 18. The liquid collection assembly of claim 17, wherein the at least one wire has a length generally aligned with a longitudinal axis of the liquid-impermeable layer.
19. 18. The liquid collection assembly of claim 17, wherein the length of the at least one wire is about 50% to about 100% of the length of the conduit disposed within the chamber.
20. The liquid collection assembly of claim 1 , wherein the plug is located at or near the liquid outlet.
21. The liquid collection assembly of claim 1 , wherein the plug forms a substantially fluid-tight seal within the second passageway.
22. a liquid collection assembly; A liquid storage container; a vacuum source; and a liquid collection system comprising: The liquid collection assembly includes: a liquid-impermeable layer defining at least a chamber, at least one opening, and a liquid outlet; a porous material disposed within the chamber; a conduit disposed within the chamber, the conduit defining a first passageway and a separate second passageway separated from the first passageway, the conduit comprising: The exterior wall and a conduit having an inner wall extending inwardly from the outer wall, the inner wall configured to separate the first passage from the second passage; a shape memory material disposed in the second passage; at least one plug disposed in the second passage; the chamber of the liquid collection assembly, the reservoir, and the vacuum source are in fluid communication with one another, such that, when one or more bodily fluids are present in the chamber, suction provided by the vacuum source to the chamber of the liquid collection assembly removes the one or more bodily fluids from the chamber and stores them in the reservoir; Liquid collection system.
23. 23. The liquid collection system of claim 22, wherein the first passageway is in fluid communication with the reservoir and the vacuum source.
24. 23. The liquid collection system of claim 22, wherein the second passage is not in fluid communication with the reservoir and the vacuum source.
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