Fluid collection assembly comprising hydrophilic fluid permeable outer layer

Abstract

An example fluid collection assembly includes a fluid impermeable layer. The fluid impermeable layer defines at least a chamber, at least one opening allowing bodily fluid to enter the chamber, and a fluid outlet allowing bodily fluid to exit from the chamber. The fluid collection assembly also includes a porous material at least partially disposed in the chamber. The porous material includes a hydrophilic fluid permeable outer layer and a fluid permeable inner layer. The fluid permeable inner layer includes at least one of a foam or a non-woven fabric material.

Description

Background Art

[0001] A person or an animal may have restricted or inconvenient movement, so the normal urination process may be challenging or impossible. For example, a person may suffer from or have a disability with inconvenient movement. A person may have restricted mobility, such as experienced by pilots, drivers, and workers in hazardous areas. In addition, it is sometimes necessary to collect body fluids for monitoring or clinical testing.

[0002] Catheters such as Foley catheters can address some of these situations, such as urinary incontinence. Unfortunately, catheters may cause discomfort, pain, and may lead to complications such as infections. In addition, bedpans are sometimes used, which are containers for bedridden people to use the toilet. However, bedpans are prone to causing discomfort, leakage, and other hygiene problems. Summary of the Invention

[0003] Embodiments are directed to a fluid collection assembly, a fluid collection system including the assembly, and methods of manufacturing and using the same. Example fluid collection assemblies include a fluid-impermeable layer (e.g., a fluid-impermeable barrier). In an embodiment, a fluid collection assembly is disclosed. The fluid collection assembly includes a fluid-impermeable layer that at least defines a chamber, at least one opening, and a fluid outlet. The fluid collection assembly further includes a porous material disposed at least partially within the chamber. The porous material includes a hydrophilic fluid-permeable outer layer and a fluid-permeable inner layer, which includes at least one non-woven material or foam.

[0004] In an embodiment, a fluid collection system is disclosed. The fluid collection system includes a fluid collection assembly. The fluid collection assembly includes a fluid-impermeable layer that at least defines a chamber, at least one opening, and a fluid outlet. The fluid collection assembly further includes a porous material disposed at least partially within the chamber. The porous material includes a hydrophilic fluid-permeable outer layer and a fluid-permeable inner layer that includes at least one of a non-woven material or foam. The fluid collection system further includes a fluid storage container and a vacuum source. The chamber of the fluid collection assembly, the fluid storage container, and the vacuum source are in fluid communication with each other, and when one or more body fluids are present in the chamber, the suction provided by the vacuum source to the chamber of the fluid collection assembly removes the one or more body fluids from the chamber and deposits the body fluids in the fluid storage container.

[0005] In an embodiment, a method of collecting body fluid is disclosed. The method includes positioning at least one opening of a fluid collection assembly near the urethral orifice of a female. The fluid collection assembly includes a fluid-impermeable layer that defines at least a chamber, at least one opening, and a fluid outlet. The fluid collection assembly further includes a porous material disposed at least partially within the chamber. The porous material includes a hydrophilic fluid-permeable outer layer and a fluid-permeable inner layer that includes at least one of a foam or a non-woven fabric material. The method further includes receiving body fluid from the urethral orifice of the female into the chamber.

[0006] In an embodiment, a method of forming a fluid collection assembly is disclosed. The method includes providing a porous material. The porous material includes a hydrophilic fluid-permeable outer layer and a fluid-permeable inner layer. The method further includes disposing the porous material through at least one opening and into a chamber. The fluid-permeable inner layer includes at least one of a non-woven fabric material or a foam. The at least one opening and the chamber are defined by a fluid-impermeable layer. The fluid-impermeable layer further defines a fluid inlet.

[0007] The features of any disclosed embodiment can be used in combination with each other without limitation. Additionally, other features and advantages of the present disclosure will become apparent to those of ordinary skill in the art by considering the following detailed description and the drawings. BRIEF DESCRIPTION OF THE DRAWINGS

[0008] The drawings illustrate various embodiments of the present disclosure, where like reference numerals represent the same or similar elements or features shown in different views or embodiments of the drawings.

[0009] Figure 1A is an isometric view of a fluid collection assembly according to an embodiment.

[0010] Figure 1B and Figure 1C are cross-sectional schematic views of the fluid collection assembly according to an embodiment taken along planes 1B-1B and 1C-1C, respectively.

[0011] Figure 2 is a schematic view of a method of forming a porous material according to an embodiment.

[0012] Figure 3A is an isometric view of a fluid collection assembly according to an embodiment.

[0013] Figure 3B and 3C are cross-sectional schematic views of the fluid collection assembly according to an embodiment taken along planes 3B-3B and 3C-3C, respectively.

[0014] Figure 4 is a block diagram of a fluid collection system for fluid collection according to an embodiment. DETAILED DESCRIPTION

[0015] Embodiments are directed to a fluid collection assembly, a fluid collection system including the fluid collection assembly, and methods of making and using the same. Example fluid collection assemblies include a fluid-impermeable layer (e.g., a fluid-impermeable barrier). The fluid-impermeable layer at least defines a chamber, at least one opening that permits a body fluid (e.g., urine, blood, sweat, etc.) to enter the chamber, and a fluid outlet that permits the body fluid to exit the chamber. The fluid collection assembly further includes a porous material disposed at least partially within the chamber. The porous material includes a hydrophilic fluid-permeable outer layer ("outer layer") and a fluid-permeable inner layer ("inner layer"). The fluid-permeable inner layer includes a foam or non-woven fabric material.

[0016] In use, the liquid collection assembly can be positioned such that the opening and the portion of the porous material extending therethrough are located near the female urethral orifice. After positioning the liquid collection assembly, an individual can excrete a body fluid from the urethral orifice. The excreted body fluid can flow through the opening and into the chamber. For example, the body fluid can be received by the outer layer and flow into the inner layer. The body fluid can then be discharged from the chamber via the fluid outlet, e.g., using a catheter passing through the fluid outlet. In a specific example, suction can be provided to the chamber via a vacuum source (e.g., via a catheter) in fluid communication with the chamber. The suction can cause the body fluid in the porous material to generally flow towards the fluid outlet and / or the inlet of the catheter passing through the fluid outlet. The suction then discharges the body fluid reaching the fluid outlet and / or the inlet of the catheter. The body fluid discharged from the chamber can be stored in a fluid storage container in fluid communication with both the chamber and the vacuum source.

[0017] The porous materials of some conventional fluid collection assemblies include gauze, cross-lapped porous non-woven fabric materials, or other porous materials that are positioned to initially receive the body fluids of a human body using these conventional fluid collection assemblies. These porous materials are configured to be hydrophobic. However, it has been found that many gauzes, cross-lapped non-woven fabric materials, and other porous materials that are positioned to initially receive the body fluids of a human body may not effectively capture the body fluids excreted by the human body, which increases the likelihood of leakage of conventional body fluid collection assemblies. Further, it has been found that many gauzes and other porous materials remain wet after the human body excretes body fluids, which renders conventional body fluid collection assemblies unable to be used for an extended period of time (e.g., more than 12 hours) without causing skin damage to the human body.

[0018] The porous material of the body fluid collection assembly disclosed herein (i.e., the porous material including an outer layer and an inner layer) solves at least some of the problems associated with the porous materials of conventional body fluid collection assemblies. For example, the outer layer is configured to effectively receive body fluid, thereby preventing or at least inhibiting body fluid leakage. The outer layer can also be configured to dry relatively quickly after receiving body fluid, which enables the fluid collection assembly disclosed herein to be used for a long period of time (e.g., over a period of about 24 hours, such as about 24 hours to about 36 hours, about 30 hours to about 42 hours, or about 36 hours to about 48 hours). The outer layer can effectively receive body fluid or remain dry, for example, due to at least one or more of the hydrophilicity of the outer layer or the thickness of the outer layer. The inner layer is capable of quickly or effectively receiving body fluid from the outer layer. The foam or non-woven fabric inner layer also facilitates the flow of the received body fluid to the fluid outlet and / or the inlet of the catheter.

[0019] Figure 1A is an isometric view of a fluid collection assembly 100 according to an embodiment. Figure 1B and Figure 1C are schematic cross-sectional views of a fluid collection assembly 100 according to an embodiment taken along planes 1B-1B and 1C-1C, respectively. The fluid collection assembly 100 is an example of a female fluid collection assembly for receiving and collecting female body fluids. The fluid collection assembly 100 includes a fluid-impermeable layer 102. The fluid-impermeable layer 102 defines at least a chamber 104, at least one opening 106, and a fluid outlet 108. The fluid collection assembly 100 further includes a porous material 110 located within the chamber 104. The porous material 100 includes an outer layer 112 (e.g., a fluid-permeable membrane) and an inner layer 114 (e.g., a fluid-permeable support). The fluid collection assembly 100 may further include at least one catheter 116, which is partially located within the fluid outlet 108, and the fluid outlet 108 is configured to discharge one or more body fluids from the chamber 104. The catheter 116 may not extend through the porous material 110.

[0020] The fluid-impermeable layer 102 may include a proximal region 118 and a distal region 120 opposite the proximal region 118. Generally, during use, the distal region 120 is closer to the patient's gluteal cleft than the proximal region 118. The fluid-impermeable layer 102 may be made of silicone, neoprene, thermoplastic elastomer, or other fluid-impermeable materials.

[0021] The opening 106 may be an elongated hole in the fluid-impermeable layer 102. For example, the opening 106 may be defined as a cut in the fluid-impermeable layer 102. The position and shape of the opening 106 may be located near the female urethral orifice. The opening 106 may have an elongated shape because when a female's legs are closed, the space between the legs is relatively small, thus allowing body fluid to flow only along a path corresponding to the elongated shape of the opening 106 (e.g., an opening 106 extending longitudinally).

[0022] The fluid collection assembly 100 can be placed in a position near the female urethral orifice, and body fluids can enter the chamber 104 of the fluid collection assembly 100 via the opening 106. The fluid collection assembly 100 is configured to introduce body fluids into the chamber 104 via the opening 106. In use, the opening 106 can be in an elongated shape that extends from a first position below the urethral orifice (e.g., at or near the anus or vaginal orifice) to a second position above the urethral orifice (e.g., at or near the vaginal orifice or the top of the pubic hair).

[0023] In an embodiment, the fluid-impermeable layer 102 includes one or more flanges 126. The flanges 126 can provide more positions on the underwear or other clothing that can contact and press against the fluid collection assembly 100, which can facilitate fixing the fluid collection assembly 100 to the vaginal area of the patient and can improve the comfort of the patient. In an embodiment, the flange 126 can include at least one of an upper flange that forms at least a part of the proximal region 118 or a lower flange that is opposite to the upper flange that forms at least a part of the distal region 120.

[0024] The flange 126 of the body can extend from the rest of the fluid-impermeable layer 102 by a distance of about 1 mm or more, about 1 mm or more, about 3 mm or more, about 4 mm or more, about 5 mm or more, about 6 mm or more, about 7.5 mm or more, about 1 cm or more, about 1.25 cm or more, about 1.5 cm or more, about 1 cm or more, about 1.5 cm or more, about 3 cm or more, about 4 cm or more, about 5 cm or more, or within a range of about 1 mm to about 3 mm, about 1 mm to about 4 mm, about 3 mm to about 5 mm, about 4 mm to about 6 mm, about 5 mm to about 7.5 mm, about 6 mm to about 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 cm, about 1.5 cm to about 1.5 cm, about 1 cm to about 3 cm, about 1.5 cm to about 4 cm, or about 3 cm to about 5 cm. The extension distance of the flange 126 from the rest of the fluid-impermeable layer 102 can be selected based on the expected size of the individual's vaginal area (e.g., the larger the vaginal area, the larger the flange 126) or based on the expected rotational force applied to the fluid collection assembly 100 during use. In some examples, at least some of the flanges 126 can extend farther from the rest of the fluid-impermeable layer 102 than other flanges 126. For example, the bottom flange can extend farther from the rest of the fluid-impermeable layer 102 than the upper flange, because some people may find a longer bottom flange more comfortable.

[0025] In an embodiment, one or more flanges 126 may present a concave curve relative to the front side of the housing. The concave curve of the flange 126 may extend from the proximal region 118 to the distal region 120. Since the vaginal region is curved, the concave curve of the flange 126 may enable the flange 126 to better conform to the shape of the vaginal region. Making the flange 126 conform to the shape of the vaginal region may make the fluid collection assembly 100 more comfortable by more evenly distributing the pressure across the vaginal region, especially when the flange 126 contacts the labia majora. In an embodiment, the flange 126 may be planar. In such an embodiment, the flange 126 may be flexible, allowing the flange to bend.

[0026] In an embodiment, the fluid-impermeable layer 102 may include a collection trough 130 at or near the distal region 120. The collection trough 130 may or may not extend outwardly from the front side 122 of the housing. During use, the collection trough 130 is configured to be located at, near, or otherwise in fluid communication with the gravity low point of the porous material 110. For example, the collection trough 130 may receive a portion of the porous material 110 therein. The collection trough 130 may receive at least a portion of the body fluid contained by the porous material 110. The collection trough 130 may prevent or at least inhibit leakage of body fluid from the fluid collection assembly 100.

[0027] The collection trough 130 may extend through a portion of the fluid-impermeable layer 102 that forms the flange 126. For example, the collection trough 130 may include a protrusion 132 that extends through a hole defined by a portion of the fluid-impermeable layer 102 that forms the flange 126. The protrusion 132 of the collection trough 130 increases the volume of the collection trough 130, and thus increases the amount of body fluid that can be received within the collection trough 130. When the fluid outlet 108 is located near the rear surface 124 of the fluid-impermeable layer 102, the protrusion 132 of the collection trough 130 also allows the collection trough 130 to define the fluid outlet 108.

[0028] In an embodiment, the fluid-impermeable layer 102 presents a single-piece structure (e.g., integrally formed). In an embodiment, the fluid-impermeable layer 102 includes a plurality of components attached together to form a complete layer. In an example, as shown, the fluid-impermeable layer 102 includes a first component (e.g., a housing) defining a chamber 104, an opening 106, a fluid outlet 108, and a sump 130, and a second component forming a flange 126. In such an embodiment, the first and second components may be attached together, for example, using an adhesive or ultrasonic welding. In an example, the fluid-impermeable layer 102 may include a first component (e.g., a housing) and a second component (e.g., a connector) attached to the first component. The second component may extend through portions of the fluid-impermeable layer 102 that form a flange 126 (e.g., rather than a protrusion 132) and form a fluid outlet 108. Further examples of fluid-impermeable layers formed from multiple components are disclosed in PCT patent applications PCT / US2022 / 032424, filed on June 7, 2022, and PCT / US2022 / 022111, filed on March 28, 2022, the disclosures of which are hereby incorporated by reference in their entireties.

[0029] In an embodiment, the fluid-impermeable layer 102 (e.g., the portion of the fluid-impermeable layer 102 in which the flange 126 is formed) may define a groove or channel configured to receive the conduit 116. The groove may extend from the proximal region 118 or near it to the distal region 120 or near it, thereby allowing the conduit 116 to extend from or near the abdominal region of the individual to the fluid outlet 108. In an embodiment, the groove may be configured such that the fluid-impermeable layer 102 surrounds and / or abuts less than 50% of the circumference 50 of the conduit 116, thereby allowing the conduit 116 to freely enter and exit the groove during use. Allowing the conduit 116 to freely enter and exit the groove may facilitate positioning the liquid collection assembly 100 such that the porous material 110 is close to the vaginal region even if the conduit 116 is bent away from the vaginal region. Moreover, allowing the conduit 116 to freely enter and exit the groove may increase the likelihood that the porous material 110 does not move relative to the vaginal region when the conduit 116 moves, as movement of the porous material 110 may cause leakage. In an embodiment, at least a portion of the groove may be configured such that the fluid-impermeable layer 102 surrounds and / or abuts more than 50% of the circumference of the conduit 116 (e.g., 51% to about 55%, about 53% to about 57%, or about 55% to about 60%). Surrounding more than 50% of the circumference of the conduit 116 may more firmly attach the conduit 116 to the housing and may provide additional structure to the housing by the conduit 116. The proportion of the conduit 116 surrounded and / or abutted by the housing may be selected such that the inherent elasticity of at least one of the housing or the conduit 116 enables the conduit 116 to snap easily into and out of the groove. Thus, the conduit 116 may be removed from the groove to facilitate positioning the porous material 110 near the vaginal region or for positioning when the conduit 116 moves.

[0030] As previously described, the fluid collection assembly 100 includes a porous material 110 disposed within the chamber 104. At least a portion of the porous material 110 can be configured to wick away any body fluid from the opening 106 by capillary action, thereby preventing the body fluid from escaping the chamber 104. The porous material 110 can also wick the body fluid generally into the interior of the chamber 104. The permeability referred to herein can be capillary action, capillarity, diffusion, or other similar properties or processes, referred to herein as "permeability" and / or "wicking". Such "wicking" and / or "permeability" may not include the absorption of the body fluid by at least a portion of the porous material 110. In other words, after the material is exposed to and removed from the body fluid for a period of time, the material may be substantially non-absorbent or insoluble in the body fluid. Although non-absorption or insolubility is not desired, the term "substantially non-absorbent" can allow for nominal absorption and / or dissolution (e.g., absorption rate) of the body fluid in the porous material 110, such as less than about 30 wt%, 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 less than about 0.5 wt% of the dry weight of the porous material 110. In an embodiment, the porous material 110 can include at least one absorbent or adsorbent material.

[0031] As previously described, the porous material 110 includes an outer layer 112 and an inner layer 114. In an embodiment, the porous material 110 consists only of the outer layer 112 and the inner layer 114. In an embodiment, the porous material 110 includes one or more additional layers, such as an outermost layer disposed on the outer layer 112. The outermost layer can include, for example, gauze, cotton, or other materials that are more comfortable than the outer layer 112.

[0032] The outer layer 112 can extend through at least a portion (e.g., all) of the opening 106. The outer layer 112 is configured to quickly receive the body fluid discharged from the urethral orifice. In other words, the outer layer 112 is configured to enable the body fluid to quickly pass through the opening 106 and enter the chamber 104 (e.g., away from the opening 106), thereby preventing or at least inhibiting the leakage of the body fluid from the porous material 110.

[0033] The outer layer 112 can be made of a hydrophilic material. Forming the outer layer 112 with a hydrophilic material is at least contrary to some conventional liquid collection components. For example, continuous contact of a porous material containing body fluid with an individual's vaginal area (e.g., urethral orifice, labial folds, etc.) may cause at least one of skin degradation (e.g., rash) or general discomfort. It is well known that hydrophilic porous materials retain more body fluid in them compared to hydrophobic porous materials. In other words, it has been conventionally believed that hydrophilic porous materials are more likely to keep the vaginal area in continuous contact with body fluid compared to hydrophobic porous materials. Therefore, the porous material of conventional liquid collection components generally only includes hydrophobic materials to prevent or at least minimize the body fluid stored therein from potentially contacting the vaginal area. Contrary to general knowledge and these conventional liquid collection components, it has surprisingly been found that even if the outer layer 112 is made of a hydrophilic material, due to the reasons described herein, the outer layer 112 disclosed herein does not retain body fluid in it. Instead, it has unexpectedly been found that the outer layer 112 is more likely to remain dry compared to the hydrophobic porous materials of at least some conventional liquid collection components.

[0034] As previously discussed, the outer layer 112 is formed of a hydrophilic material. The hydrophilic material of the outer layer 112 can include a porous material having a contact angle with water (the main component of body fluid) less than 90°, such as in the range of about 1° 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 about 89°. Generally, increasing the hydrophilicity of the outer layer 112 (e.g., reducing the contact angle between the outer layer 112 and water) improves the ability of the outer layer 112 to quickly or effectively receive body fluid. In other words, increasing the hydrophilicity of the outer layer 112 enables the outer layer 112 to receive a large amount of body fluid discharged in a short period of time. Moreover, increasing the hydrophilicity of the outer layer 112 generally prevents or at least inhibits the leakage of body fluid from the porous material 110. However, increasing the hydrophobicity of the outer layer 112 at least limits the materials for forming the outer layer 112, which may increase the cost of forming the outer layer 112 or hinder the outer layer 112 from being formed of a comfortable (e.g., soft and smooth) material. Therefore, the selection of the material constituting the outer layer 112 can be made based on balancing these factors.

[0035] In an embodiment, the outer layer 112 can include at least one of bamboo, cellulose, or other natural materials. Bamboo and cellulose are inexpensive and readily available materials that are hydrophobic and feel comfortable when applied to the vaginal area. The outer layer 112 including bamboo can also include bamboo kun (a chemical substance naturally present in bamboo), which has antibacterial properties and can keep the outer layer 112 in contact with the vaginal area for a longer time without causing urinary tract infections.

[0036] In an embodiment, the outer layer 112 can be formed of a synthetic material, such as at least one of polypropylene, polyethylene, or other suitable synthetic materials. Polypropylene and polyethylene are inexpensive and readily available materials that are generally comfortable when pressed against the vaginal area. However, both polypropylene and polyethylene are naturally hydrophobic materials (e.g., having a contact angle with water greater than 90°). Thus, the outer layer 112 can include at least one of treated polypropylene or treated polyethylene. In an embodiment, treated polypropylene or treated polyethylene refers to polypropylene or polyethylene that has been immersed in a solution that renders the polypropylene or polyethylene hydrophilic. In an embodiment, treated polypropylene or treated polyethylene refers to polypropylene or polyethylene that is at least partially coated with a hydrophilic material.

[0037] In an embodiment, the outer layer 112 can be formed of a non-woven material. In an example, the non-woven material of the outer layer 112 can include at least one carded web, and due to its anisotropic structure, the strength and flow characteristics of the outer layer 112 can be selected based on its fiber orientation. In an example, the outer layer 112 can include at least one needled web because the needled web has good flow characteristics, especially in its thickness direction. In an example, the outer layer 112 can include at least one air-laid web because air-laid webs generally have high porosity and / or high bulkiness. In an example, the non-woven material of the outer layer 112 can include at least one spunbond web because spunbond webs generally have high porosity, high bulkiness, and / or relatively good water absorbency. In an example, the non-woven material of the outer layer 112 can include at least one hydroentangled web because hydroentangled webs contact the patient's skin more comfortably than at least some other non-woven materials. In an example, the non-woven material of the outer layer 112 can include at least one vertically lapped non-woven, at least one horizontally lapped non-woven, or at least one cross-lapped non-woven because these non-woven materials can generally cause capillary action of body fluids in both horizontal and vertical directions. In an example, the non-woven material of the outer layer 112 can include any other suitable non-woven material or a combination of the above non-woven materials. In an embodiment, the outer layer 112 includes a woven material to replace or supplement the non-woven material. Compared with non-woven materials, forming the outer layer 112 with a woven material can improve the durability of the porous material 110. However, forming the outer layer 112 with a woven material may reduce the compressibility of the porous material 110, thereby reducing the comfort of the porous material 110 and / or making it more difficult for the porous material 110 to conform to the vaginal area.

[0038] The density of the outer layer 112 can be selected to be about 50 kg / m 3 to about 100 kg / m 3 、about 75 kg / m 3 to about 125 kg / m 3 、about 100 kg / m 3 to about 150 kg / m 3, about 125 kg / m 3 to about 175 kg / m 3 , about 150 kg / m 3 to about 200 kg / m 3 , about 175 kg / m 3 to about 225 kg / m 3 , about 200 kg / m 3 to about 250 kg / m 3 , about 225 kg / m 3 to about 275 kg / m 3 , about 250 kg / m 3 to about 300 kg / m 3 , about 275 kg / m 3 to about 325 kg / m 3 , about 300 kg / m 3 to about 350 kg / m 3 , about 325 kg / m 3 to about 375 kg / m 3 , about 350 kg / m 3 to about 400 kg / m 3 , about 375 kg / m 3 to about 425 kg / m 3 , about 400 kg / m 3 to about 450 kg / m 3 , about 425 kg / m 3 to about 475 kg / m 3 , about 450 kg / m 3 to about 500 kg / m 3 , about 475 kg / m 3 to about 525 kg / m 3 , about 500 kg / m 3 to about 550 kg / m 3 , about 525 kg / m 3 to about 575 kg / m 3 or about 550 kg / m 3 to about 600 kg / m 3 .

[0039] As previously mentioned, the outer layer 112 can be formed of a hydrophilic material, which can cause the outer porous material to retain body fluids. To reduce the amount of body fluid retained by the outer layer 112, the outer layer 112 can be configured to be relatively thin. For example, the outer layer 112 can be configured to exhibit a thickness measured perpendicular to the longitudinal axis (e.g., a radial measurement), i.e., about 250 μm or less, about 200 μm or less, about 150 μm or less, about 130 μm or less, about 100 μm or less, about 75 μm or less, about 60 μm or less, about 50 μm or less, about 40 μm or less, about 30 μm or less, about 25 μm or less, about 20 μm or less, about 15 μm or less, about 10 μm or less, or in the range of about 10 μm to about 20 μm, about 15 μm to about 25 μm, about 20 μm to about 30 μm, about 25 μm to about 40 μm, about 30 μm to about 50 μm, about 40 μm to about 60 μm, about 50 μm to about 75 μm, about 60 μm to about 100 μm, about 75 μm to about 130 μm, about 100 μm to about 150 μm, about 130 μm to about 200 μm, or about 150 μm to about 250 μm. The relatively small thickness of the outer layer 112 reduces the overall volume of the outer layer 112, thereby reducing the amount of body fluid that can be retained in the outer layer 112. The reduction in the amount of body fluid retained in the outer layer 112 enables the airflow through the chamber 104 to rapidly evaporate the body fluid retained in the outer layer 112, thereby keeping the outer layer 112 dry. Further, reducing the thickness of the outer layer 112 can enable the inner layer 114 to absorb more body fluid from the outer layer 112. It should be noted that it has been found that increasing the thickness to more than about 250 μm may also have an adverse effect on the flow of body fluid.

[0040] The outer porous material of the porous material 110 can be selected to exhibit the following basis weights: about 10 g / m 2 to about 20 g / m 2 、about 15 g / m 2 to about 25 g / m 2 、about 20 g / m 2 to about 30 g / m 2 、about 25 g / m 2 to about 35 g / m 2 、about 30 g / m 2 to about 40 g / m 2 、about 35 g / m 2 to about 45 g / m 2 、about 40 g / m 2 to about 50 g / m 2 、about 45 g / m 2 to about 55 g / m 2 、about 50 g / m 2 to about 60 g / m 2 、about 55 g / m2 to about 70 g / m 2 、about 60 g / m 2 to about 80 g / m 2 、about 70 g / m 2 to about 90 g / m 2 、about 80 g / m 2 to about 100 g / m 2 、about 90 g / m 2 to about 110 g / m 2 or about 100 g / m 2 to about 120 g / m 2 。The basis weight of the outer layer 112 is related to its density and thickness. Thus, the basis weight of the outer layer 112 can be selected for any reason that is the same as the reason for selecting the density and thickness of the outer layer 112.

[0041] The outer layer 112 is formed by a plurality of fibers. These fibers may have an average length and an average lateral dimension (e.g., diameter). In an example, the average diameter of the plurality of fibers can be selected to be about 500 μm to about 2 mm, 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, about 8 mm to about 1 cm, about 9 mm to about 1.2 cm, about 1 cm to about 1.4 cm, about 1.2 cm to about 1.6 cm, about 1.4 cm to about 1.8 cm, about 1.6 cm to about 2 cm, about 1.8 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 3.25 cm, about 3 cm to about 3.5 cm, about 3.25 cm to about 3.75 cm, about 3.5 cm to about 4 cm, about 3.75 cm to about 4.25 cm, about 4 cm to about 4.5 cm, about 4.25 cm to about 4.75 cm, about 4.5 cm to about 5 cm, about 4.75 cm to about 5.5 cm, about 5 cm to about 6 cm, about 5.5 cm to about 6.5 cm, about 6 cm to about 7 cm, about 6.5 cm to about 7.5 cm, about 7 cm to about 8 cm, about 7.5 cm to about 8.5 cm, about 8 cm to about 9 cm, about 8.5 cm to about 9.5 cm, or about 9 cm to about 10 cm. In an example, the average lateral dimension of the fibers can be selected to be about 1 μm to about 2 μm, about 1.5 μm to about 3 μm, about 2 μm to about 4 μm, about 3 μm to about 5 μm, about 4 μm to about 7 μm, about 6 μm to about 10 μm, about 8 μm to about 12.5 μm, about 10 μm to about 15 μm, about 12.5 μm to about 17.5 μm, about 15 μm to about 20 μm, about 17.5 μm to about 25 μm, about 20 μm to about 30 μm, about 25 μm to about 35 μm, about 30 μm to about 40 μm, about 35 μm to about 45 μm, about 40 μm to about 50 μm, about 45 μm to about 55 μm, about 50 μm to about 60 μm, about 55 μm to about 65 μm, about 60 μm to about 70 μm, about 65 μm to about 75 μm, about 70 μm to about 80 μm, about 75 μm to about 85 μm, about 80 μm to about 90 μm, about 85 μm to about 95 μm, or about 90 μm to about 100 μm. The average length and the average lateral dimension of the fibers can be selected such that the fibers exhibit an average aspect ratio.For example, the average length and average transverse dimension of the fibers can be selected such that the average aspect ratio (average length: average transverse dimension) of the fibers is from about 100:1 to about 200:1, about 150:1 to about 250:1, about 200:1 to about 300:1, about 250:1 to about 350:1, about 300:1 to about 400:1, about 350:1 to about 450:1, about 400:1 to about 500:1, about 450:1 to about 550:1, about 500:1 to about 600:1, about 550:1 to about 650:1, about 600:1 to about 700:1, about 650:1 to about 750:1, about 700:1 to about 800:1, about 750:1 to about 850:1, about 800:1 to about 900:1, about 850:1 to about 950:1, or about 900:1 to about 1000:1.

[0042] The average length, average transverse dimension, and average aspect ratio of the fibers can be selected based on a variety of factors. In an example, increasing the aspect ratio (e.g., decreasing the average length and / or increasing the average transverse dimension) can improve the durability of the outer layer 112, but may reduce the strength of the outer layer 112. In an example, increasing the aspect ratio of the fibers (e.g., increasing the average length) can enhance the mechanical bonding of the fibers. For example, increasing the aspect ratio of the fibers is beneficial for fiber entanglement, which improves the strength and / or durability of the external porous material. Fiber entanglement can also eliminate or minimize other bonding techniques applied to the outer layer 112, such as thermal bonding, chemical bonding, or other mechanical bonding (e.g., further entanglement caused by needling or high-pressure water jets). However, increasing the aspect ratio of the fibers may make the dispersion of the fibers more difficult (e.g., it is difficult to maintain the uniformity of the external porous material). Further, increasing the aspect ratio may limit the types of nonwoven webs that can form the outer layer 112. Therefore, the average length, average transverse dimension, and average aspect ratio of the fibers can be selected based on the required strength, mechanical bonding between the fibers, the amount of processing of the external porous material (e.g., whether further processing is required to increase bonding via heat or the like), the type of nonwoven web including the fibers, the uniformity of the fibers, etc.

[0043] Typically, the urination speed of an ordinary person is about 6 ml / s to about 50 ml / s, for example, about 10 ml / s to about 25 ml / s. The urination speed of a person may vary, for example, based on at least one factor such as the body size or age of the person. The outer layer 112 can be selected to receive body fluid and allow the body fluid to flow through a part of it at a rate comparable to the rate at which the individual excretes the body fluid to prevent leakage. For example, the outer layer 112 can be selected to receive body fluid or allow the body fluid to flow through a part of it at at least one of the following rates: greater than about 6 ml / s, greater than about 10 ml / s, greater than about 20 ml / s, greater than about 30 ml / s, greater than about 40 ml / s, greater than about 50 ml / s, or within the range of 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 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.

[0044] The rate at which the outer layer 112 receives body fluid or allows the body fluid to flow through a part of it may depend on many factors. In an example, the rate at which the outer layer 112 receives body fluid or allows the body fluid to flow through a part of it may be inversely proportional to the density and basis weight of the outer layer 112, where increasing the density and / or basis weight of the outer layer 112 may reduce the rate at which the outer layer 112 receives body fluid or allows the body fluid to flow through a part of it, and vice versa. In an example, the rate at which the outer layer 112 receives body fluid or allows the body fluid to flow through a part of it may depend on the hydrophilicity of the outer layer 112. In an example, the rate at which the outer layer 112 receives body fluid or allows the body fluid to flow through a part of it may depend on the type of non-woven fabric (e.g., carded web, needle-punched web, etc.), as the rate at which the external porous material of each type of non-woven fabric captures and / or transports body fluid may be different.

[0045] As previously discussed, the porous material 110 includes an inner layer 114. Since the outer layer 112 may be thin (e.g., due to its relatively small thickness), the inner layer 114 is configured to support the outer layer 112. For example, the inner layer 114 can be positioned such that the outer layer 112 is disposed between at least a part of the inner layer 114 and the fluid-impermeable layer 102. Thus, the inner layer 114 can support and maintain the position of the outer layer 112.

[0046] The outer layer 112 can be disposed on the outer surface of the inner layer 114. In an embodiment, the outer layer 112 is located on the inner layer 114 to prevent or at least minimize the formation of an air gap between the outer layer 112 and the inner layer 114. As used herein, an "air gap" refers to an unoccupied gap between the outer layer 112 and the inner layer 114 that is significantly larger (e.g., at least 5 times larger or at least 10 times larger) than the average pore size of the outer layer 112 and the inner layer 114. In an example, the outer layer 112 is disposed on the inner layer 114 such that at most 10% (e.g., at most 7.5%, at most 5%, at most 3%, at most 2%, or at most 1%) of the surface area of the inner layer 114 adjacent to the outer layer 112 has an air gap adjacent thereto. It has been unexpectedly found that body fluid received by the outer layer 112 can flow relatively freely from the outer layer 112 into the inner layer 114. Due to hydrogen bonding (e.g., body fluid flowing through the inner layer 114 will pull the body fluid out of the outer layer 112) or a difference in moisture content between the outer layer 112 and the inner layer 114, the body fluid can flow relatively freely from the outer layer 112 into the inner layer 114. However, the formation of an air gap between the outer layer 112 and the inner layer 114 forms a barrier that prevents the body fluid from flowing out of the outer layer 112 and the inner layer 114. Therefore, preventing or at least minimizing the formation of an air gap between the outer layer 112 and the inner layer 114 improves the flow of body fluid between the outer layer 112 and the inner layer 114.

[0047] The inner layer 114 can include any material capable of wicking, absorbing, adsorbing, or otherwise allowing the fluid transport of body fluid, such as any of the fluid external porous materials discussed above. For example, when used as the inner layer 114, the external porous material can be used in a denser or harder form than the outer layer 112. The inner layer 114 can be made of any fluid-permeable material that deforms less than the outer layer 112. For example, the inner layer 114 can include a porous polymer (e.g., nylon, polyester, polyurethane, polyethylene, polypropylene, polyvinyl chloride, etc.) structure or an open-cell foam. In an example, the inner layer 114 can include spun nylon fibers, polyurethane foam, polyethylene foam, or polyvinyl chloride foam. In some examples, the inner layer 114 can include a non-woven fabric (e.g., a vertical non-woven fabric web or any other non-woven fabric web disclosed herein) or a spun fabric material. In some examples, the inner layer 114 can be formed of natural materials, such as cotton, wool, silk, bamboo, or a combination thereof. In these examples, the material can have a coating to prevent or limit the absorption of liquid into the material, such as a waterproof coating. In some examples, the inner layer 114 can be formed of a fabric, felt, gauze, or a combination thereof.

[0048] In an embodiment, at least a portion of the inner layer 114 can be hydrophobic. When the contact angle of the inner layer 114 with water (a major component of body fluid) is greater than about 90°, for example, within the range of about 90° to about 120°, about 105° to about 135°, about 120° to about 150°, about 135° to about 175°, or about 150° to about 180°, the inner layer 114 can be hydrophobic. The hydrophobicity of the inner layer 114 can limit the absorption, adsorption, and dissolution of body fluid in the inner layer 114, thereby reducing the amount of body fluid retained in the inner layer 114. The lower hydrophilicity of the outer layer 112 can assist the porous material 110 in receiving body fluid from the urethral orifice, while the hydrophobicity of the inner layer 114 limits the amount of body fluid retained in the porous material 110.

[0049] The inner layer 114 can exhibit the following thicknesses (e.g., radius and / or diameter): about 1 mm or greater, about 2 mm or greater, about 4 mm or greater, about 6 mm or greater, about 8 mm or greater, about 10 mm or greater, about 12 mm or greater, about 14 mm or greater, about 16 mm or greater, about 18 mm or greater, about 20 mm or greater, about 22 mm or greater, about 25 mm or greater, or within the range of about 1 mm to about 4 mm, about 2 mm to about 6 mm, about 4 mm to about 8 mm, about 6 mm to about 10 mm, about 8 mm to about 12 mm, about 10 mm to about 14 mm, about 12 mm to about 16 mm, about 14 mm to about 18 mm, about 16 mm to about 20 mm, about 18 mm to about 22 mm, or about 20 mm to about 25 mm. Generally speaking, increasing the thickness of the inner layer 114 can increase the quantity of at least one type of body fluid that can be temporarily stored in or flow through the inner layer 114, thereby reducing the likelihood of leakage of the fluid collection assembly 100. However, increasing the thickness of the inner layer 114 will at least weaken the suction force applied to the chamber 104 or make it difficult to position the liquid collection assembly 100 close to the urethral orifice.

[0050] In an embodiment, the inner layer 114 includes at least one internal porous material. As used herein, internal porous materials include at least one of vertically lapped non-woven materials, polyurethane foams, polyvinyl chloride foams, or polyethylene foams. Even if an individual excretes a large amount of body fluid in a short period of time, the internal porous material can quickly receive the individual's body fluid. In an example, the internal porous material can facilitate the passage of body fluid through the chamber 104 of the fluid collection assembly 100 and towards the outlet (e.g., the liquid outlet 108 or the inlet of the conduit 116 disposed through the liquid outlet 108), thereby keeping the porous material 110 dry. Further, surprisingly, the body fluid received in the external porous material can easily flow from the external porous material into the internal porous material, and the internal porous material will suck out the body fluid from the external porous material, which would otherwise remain in the outer layer 112.

[0051] In an embodiment, the inner layer 114 may comprise a vertically oriented nonwoven material. It has been found that forming the inner layer 114 with a vertically oriented nonwoven material enables the inner layer 114 to rapidly draw body fluid out of the outer layer 112 and convey the body fluid to the fluid outlet 108 and / or the inlet of the conduit 116. Thus, compared to conventional fluid collection assemblies, forming the inner layer 114 with a vertically oriented nonwoven material enables the porous material 110 to remain drier. The vertically oriented nonwoven material of the inner layer 114 is formed from a folded nonwoven web (e.g., any of the nonwoven webs disclosed herein). The vertically oriented nonwoven material of the inner layer 114 may include a plurality of folds and a plurality of intermediate portions extending between the folds. The vertically oriented nonwoven material of the inner layer 114 may include an outer surface (e.g., the surface adjacent to the outer layer 112) and an opposite inner surface. The folds of the vertically oriented nonwoven material of the inner layer 114 may extend generally parallel to its outer and inner surfaces. The intermediate portions may extend between the inner and outer surfaces. In an embodiment, when at least one region of the inner layer 114 is cylindrical, the folds of the cylindrical region of the inner layer generally extend parallel to the longitudinal (e.g., central) axis of the porous material 110 and / or circumferentially. In an embodiment, when at least one region of the inner layer 114 is cylindrical, the intermediate portions may generally extend parallel to the longitudinal axis of the porous material 110 and / or radially with respect to the longitudinal axis.

[0052] Due to the properties of the vertically oriented nonwoven material, when the inner layer comprises a vertically oriented nonwoven material, the thickness of the inner layer 114 may be narrower than that disclosed above. For example, the thickness of the inner layer 114 may be from about 8 mm to about 20 mm, such as in the range of about 8 mm to about 10 mm, about 9 mm to about 11 mm, about 10 mm to about 12 mm, about 11 mm to about 13 mm, about 12 mm to about 14 mm, about 13 mm to about 15 mm, about 14 mm to about 16 mm, about 15 mm to about 17 mm, about 16 mm to about 18 mm, about 17 mm to about 19 mm, or about 18 mm to about 20 mm.

[0053] The inner layer 114 comprises a vertically oriented nonwoven material, and the density of the inner layer 114 may be about 100 kg / m 2 ·cm or greater, about 125 kg / m 2 ·cm or greater, about 150 kg / m 2 ·cm or greater, about 175 kg / m 2 ·cm or greater, about 200 kg / m 2 ·cm or greater, or in the range of about 100 kg / m 2 ·cm to about 150 kg / m 2 ·cm, about 125 kg / m 2 ·cm to about 175 kg / m 2 ·cm or about 150 kg / m2 · cm to about 200 kg / m 2 · cm. Generally, increasing the density of the vertical nonwoven material increases the strength of the inner layer 114. However, increasing the density of the vertical nonwoven material may reduce the porosity of the inner layer 114, thereby reducing the amount of body fluid that can be temporarily stored in the inner layer 114 or reducing the flow rate of body fluid through the inner layer 114. Therefore, the density of the vertical nonwoven material can be selected based on balancing the required strength, porosity, and / or the flow rate of body fluid through the inner layer 114.

[0054] In an embodiment, the inner layer 114 may include a foam. Examples of the foam may be a polyurethane foam, a polyvinyl chloride foam, or a polyethylene foam. It has been unexpectedly found that forming the inner layer 114 with a polyurethane foam, a polyvinyl chloride foam, or a polyethylene foam can make the inner layer 114 hydrophilic or hydrophobic. For example, polyurethane foam and polyvinyl chloride foam are naturally hydrophilic, while polyethylene foam is naturally hydrophobic. It should be noted that these foams can be treated to make them exhibit non-natural hydrophilicity or hydrophobicity. It is currently believed that the structure of these foams enables the inner layer 114 to be both hydrophilic and hydrophobic while remaining dry. Constructing the inner layer 114 to be hydrophilic can promote the inflow of body fluid into the inner layer 114, and unexpectedly, it does not cause the inner layer 114 to retain body fluid. Constructing the inner layer 114 to be hydrophilic is contrary to at least some traditional fluid collection components. For example, at least some traditional fluid collection components including an inner layer are selected to design the inner layer to be hydrophobic to prevent the inner layer from retaining body fluid. However, the hydrophobicity of the inner layer of traditional fluid collection components may inhibit the entry of body fluid into the inner layer.

[0055] Due to the characteristics of polyurethane foam, polyvinyl chloride foam, and polyethylene foam, the average porosity of the inner layer 114 exhibits from about 7.5 pores / cm² to about 12.5 pores / cm², such as in the range of about 7.5 pores / cm² to about 8.5 pores / cm², about 8 pores / cm² to about 9 pores / cm², about 8.5 pores / cm² to about 9.5 pores / cm², about 9 pores / cm² to about 10 pores / cm², about 9.5 pores / cm² to about 10.5 pores / cm², about 10 pores / cm² to about 11 pores / cm², about 10.5 pores / cm² to about 11.5 pores / cm², about 11 pores / cm² to about 12 pores / cm², or about 11.5 pores / cm² to about 12.5 pores / cm². Generally, increasing the number of pores per square centimeter of the foam can increase the number of interconnected pores formed in the porous material, increase the amount of body fluid that can be stored in the foam, and / or increase the number and rate of body fluid flowing through the foam. However, increasing the number of pores per square centimeter will reduce the strength of the foam. Therefore, the number of pores per square centimeter of the foam can be selected based on balancing these factors.

[0056] Moreover, when the inner layer 114 includes at least one of polyurethane foam, polyvinyl chloride foam, or polyethylene foam, the density of the inner layer can be about 15 kg / m 2 ·cm to about 125 kg / m 2 ·cm, for example, in the range of about 15 kg / m 2 ·cm to about 30 kg / m 2 ·cm, about 20 kg / m 2 ·cm to about 40 kg / m 2 ·cm, about 30 kg / m 2 ·cm to about 50 kg / m 2 ·cm, about 40 kg / m 2 ·cm to about 75 kg / m 2 ·cm, about 50 kg / m 2 ·cm to about 100 kg / m 2 ·cm, or about 75 kg / m 2 ·cm to about 125 kg / m 2 ·cm. Generally, increasing the density of the foam will increase the strength of the inner layer 114. However, increasing the density of the foam may reduce the porosity of the internal porous material, thereby reducing the amount of body fluid that can be temporarily stored in the porous material 110, or reducing the flow rate of body fluid through the internal porous material 114. Therefore, the density of the foam can be selected based on a balance of the required strength, porosity, and / or the flow rate of body fluid through the internal porous material 114.

[0057] Figure 2 is a schematic diagram of a method for forming the porous material 110 according to an embodiment. Figure 2 The method shown uses a conveyor belt 234 to move the components of the porous material from one location to another. However, it should be noted that the method for forming the porous material can use devices or structures other than the conveyor belt 234. For example, the method can be performed by one or more people (e.g., a single person) at one or more workstations (e.g., a single workstation).

[0058] A first sheet 236 may be disposed on the conveyor belt 234. The first sheet 236 is configured to form one of the outer layer 112 or the inner layer 114. In an example, the first sheet 236 may be a sheet including at least one of bamboo fiber, cellulose fiber, treated polypropylene fiber, or polyethylene fiber, which forms a spunbond material when the first sheet 236 forms the outer layer 112, or more preferably, forms a non-woven material. In an example, when the first sheet 236 forms the inner layer 114, the first sheet 236 may be a sheet including at least one of vertical non-woven material, polyurethane foam, polyethylene foam, or polyethylene foam. As will be discussed in more detail below, a second sheet 242 may be disposed on the first sheet 236, where the second sheet 242 includes the other layer that does not form the first sheet 236 in the outer layer 112 or the inner layer 114.

[0059] In an embodiment, the method of forming the porous material 110 includes disposing an adhesive 238 on the surface 240 of the first sheet 236. The adhesive 238 may include any adhesive 238 that can attach the first sheet 236 to the second sheet 242 to maintain the structure of the porous material 110. For example, the adhesive 238 may include hot melt adhesive. The adhesive 238 may be sprayed on the surface 240 or otherwise disposed on the surface 240. In an embodiment, the adhesive 238 is disposed only on a portion of the surface 240, which can prevent the adhesive 238 from hindering the flow of body fluid from the second sheet 242 to the first sheet 236. In an embodiment, the method of forming the porous material 110 includes attaching the first sheet 236 and the second sheet 242 together without using the adhesive 238. In such an embodiment, the first sheet 236 and the second sheet 242 may be attached together by entanglement between their fibers (e.g., entanglement generated by jetting air or water flow through the sheets). In an embodiment, the method of forming the porous material 110 does not include attaching the first sheet 236 and the second sheet 242 together. In such an embodiment, when the porous material 110 is disposed in the cavity 104, the contact between the porous material 110 and the fluid-impermeable layer 102 can maintain the structure of the porous material 110.

[0060] The method of forming the porous material 110 includes disposing the second sheet 242 near the surface 240 of the first sheet 236. In an embodiment, after disposing the adhesive 238 on at least a portion of the surface 240, the second sheet 242 may be disposed near the surface 240. In an embodiment, such as when the adhesive 238 is not disposed on the surface 240, the second sheet 242 may be directly disposed on the surface 240.

[0061] In an embodiment, after the second sheet 242 is disposed near the first sheet 236, the method of forming the porous material 110 includes disposing the first sheet 236 and the second sheet 242 between adjacent rollers 244. Placing the first sheet 236 and the second sheet 242 between the rollers 244 may cause fiber entanglement between the first sheet 236 and the second sheet 242, which may facilitate attaching the first sheet 236 and the second sheet 242 together. In an embodiment, at least one roller 244 may be heated. Placing the first sheet 236 and the second sheet 242 between the heated rollers 244 may melt the adhesive 238 to attach the first sheet 236 and the second sheet 242 together.

[0062] Note that the porous materials disclosed herein can be formed using other methods than Figure 2 the methods shown. For example, the outer layer 112 and the inner layer 114 can be coextruded.

[0063] Referring back to Figures 1A to 1C , the formed porous material 110 can be disposed in the chamber 104. In an embodiment, as Figure 1C shown, the porous material 110 disposed in the chamber 104 can be generally U-shaped. For example, when the porous material 110 is initially disposed in a sheet configuration (similar to the porous material 110 formed by the method shown in accordance with Figure 2 ), the porous material 110 can be generally U-shaped. The generally U-shaped porous material 110 can be placed in the chamber 104 such that the outer layer 112 extends through the opening 106, and the surfaces of the inner layer 114 opposite the outer layer 112 can be placed adjacent to each other. Compared with porous materials of other shapes, the U-shaped porous material 110 can exhibit various advantages. In an example, when the porous material 110 is U-shaped, the outer layer 112 may not be positioned adjacent to the rear inner surface 146 of the fluid-impermeable layer 102 (i.e., the surface of the fluid-impermeable layer 102 opposite the opening 106). The outer layer 112 near the rear inner surface 146 may retain body fluid therein due to its hydrophilicity and / or lack of internal air flow, which may hinder the flow of body fluid through the chamber 104. Not placing the outer layer 112 adjacent to the rear inner surface 146 can prevent the outer layer 112 from obstructing the flow of body fluid near the rear inner surface 146. In other words, not placing the outer layer 112 adjacent to the rear inner surface 146 can improve the flow of body fluid through the porous material 110.

[0064] In an embodiment, when the porous material 110 presents a U-shape, the porous material 110 may define a gap 148. The gap 148 may be defined by the fluid-impermeable layer 102 and the inner layer 114. The gap 148 may be a substantially unoccupied space in the chamber 104. The gap 148 may allow the chamber 104 to receive a greater amount of bodily fluid than if the chamber 104 did not include the gap 148. For example, any bodily fluid that enters the gap 148 may flow to the fluid outlet 108 and / or the inlet of the conduit 116 more quickly than the bodily fluid in the porous material 110. Since the gap 148 is spaced apart from the opening 106, the fact that the gap 148 is unoccupied does not increase the likelihood of bodily fluid leaking from the chamber 104.

[0065] It should be noted that the porous material 110 may take on a shape other than a U. For example, the porous material 110 may take on a generally cylindrical shape, with the inner layer 114 being concentrically located within the outer layer 112 .

[0066] The fluid-impermeable layer 102 may have difficulty retaining the porous material 110 in the chamber 104, especially when the porous material 110 is in a U-shape. Therefore, in an embodiment, the fluid-impermeable layer 102 may include one or more barbs 150 extending into the chamber 104. The barbs 150 are configured to grab and retain the porous material 110, thereby preventing the porous material 110 from leaving the chamber 104. For example, the barbs 150 may include plastic hooks similar to hook and loop fasteners (e.g., Velcro™), because such hooks can grab and retain the porous material 110. In an embodiment, the barbs 150 may be located on at least a portion of the rear inner surface 146 of the fluid-impermeable layer 102. When the porous material 110 is in a U-shape, the barbs 150 on the rear inner surface 146 can grab the edges of the porous material 110.

[0067] The porous material 110 can at least substantially completely fill the portion of the chamber 104 not occupied by the conduit 116. In some examples, the porous material 110 may not substantially completely fill the portion of the chamber 104 not occupied by the conduit 116. In these examples, the fluid collection assembly 100 includes a reservoir 152 disposed within the chamber 104.

[0068] The reservoir 152 is a substantially unoccupied portion of the chamber 104. The reservoir 152 may be defined between the fluid-impermeable layer 102 and one or both of the outer layer 112 and the inner layer 114. Bodily fluid in the chamber 104 may flow through the porous material 110 to the reservoir 152. The reservoir 152 may retain the bodily fluid therein.

[0069] The body fluid in chamber 104 can flow to reservoir 152 through outer layer 112 and / or inner layer 114. Fluid-impermeable layer 102 can retain the body fluid in reservoir 152. Although reservoir 152 is shown in the distal region 120 (e.g., within sump 130) in the illustration, it can be located in any part of chamber 104, such as proximal region 118. Reservoir 152 can be located in a part of chamber 104 that is designed to be at the gravity low point of fluid collection assembly 100 when fluid collection assembly 100 wears out.

[0070] In some examples (not shown), fluid collection assembly 100 can include multiple reservoirs, such as a first reservoir located in the part of chamber 104 closest to the inlet of conduit 116 (e.g., distal region 120) and a second reservoir located in the part of chamber 104 in or near proximal region 118. In another example, inner layer 114 is spaced apart from at least a portion of conduit 116, and reservoir 152 can be the space between inner layer 114 and conduit 116.

[0071] Conduit 116 can be at least partially disposed in chamber 104. Conduit 116 can be used to remove body fluid from chamber 104. Conduit 116 includes at least one wall that defines an inlet, an outlet (not shown) downstream of the inlet, and a channel. The outlet of conduit 116 can be operably coupled to a vacuum source, such as a vacuum pump that draws fluid from chamber 104 through conduit 116.

[0072] Compared with the inlet of conduit 116 being located at other positions, setting the inlet of conduit 116 at or near the gravity low point of chamber 104 when worn by an individual enables conduit 116 to receive more body fluid and reduces the likelihood of deposition (e.g., body fluid deposition may cause microbial growth and foul odor). For example, due to capillary force, the body fluid in porous material 110 can flow in any direction. However, the body fluid may tend to flow in the direction of gravity, especially when at least a portion of porous material 110 is saturated with body fluid. Therefore, one or more inlets of conduit 116 or reservoir 152 can be located in fluid collection assembly 100 at a position expected to be the gravity low point in fluid collection assembly 100 when worn by an individual, such as distal region 120.

[0073] The inlet and outlet of conduit 116 are configured to fluidly couple (e.g., directly or indirectly) a vacuum source (not shown) to chamber 104 (e.g., reservoir 152). When the vacuum source ( Figure 4When a vacuum / suction is applied in the conduit 116, body fluid in the chamber 104 (e.g., in the distal region 120 in the reservoir 152) can be drawn into the inlet of the conduit 116 and the fluid collection assembly 100 can discharge the fluid via the conduit 116. In some examples, the conduit 116 can be frosted or opaque (e.g., black) to obscure the visibility of the body fluid therein.

[0074] The porous material 110 disclosed herein is particularly effective when used with the fluid collection assembly 100. However, it should be noted that the porous material 110 (or a substantially similar porous material having a similar structure and / or material) can be used with other fluid collection assemblies. For example, Figure 3A is an isometric view of a fluid collection assembly 300 according to an embodiment. Figure 3B and 3C are cross-sectional schematic views of the fluid collection assembly 300 according to an embodiment taken along planes 3B-3B and 3C-3C, respectively. Unless otherwise specified herein, the fluid collection assembly 300 is the same as or substantially similar to any fluid collection assembly disclosed herein. For example, the fluid collection assembly 300 can include a fluid-impermeable layer 302 that at least defines a chamber 304, at least one opening 306, and a fluid outlet 308. The fluid collection assembly 300 also includes a porous material 310 disposed in the chamber 304. The porous material 310 includes an outer layer 312 and an inner layer 314.

[0075] In some examples, the fluid-impermeable layer 302 can be tubular (ignoring the opening 306), such as generally cylindrical (as shown), rectangular, prismatic, or a flat tube. During use, the outer surface of the fluid-impermeable layer 302 can contact an individual. The size and shape of the fluid-impermeable layer 302 can be adapted to fit between the labia of a female user and / or the cleft of the buttocks between the legs.

[0076] In some examples, the fluid-impermeable layer 302 can define the fluid outlet 308. The fluid outlet 308 can be located on the proximal region 318 of the fluid-impermeable layer 302. The size of the fluid outlet 308 can be designed to accommodate the conduit 316. At least one conduit 316 can be disposed in the chamber 304 via the fluid outlet 308. For example, the conduit 316 can extend from the proximal region 318 into the fluid-impermeable layer 302 and can extend to the distal region 320 up to a point near the reservoir 352 therein such that the inlet of the conduit 316 is in fluid communication with the reservoir 352. The conduit 316 fluidly couples the chamber 304 to a fluid storage container (not shown) or a vacuum source (not shown).

[0077] The conduit 316 can extend through the pores in the porous material 310. In an embodiment, the conduit 316 extends from the fluid outlet 308 through the pores to a position near the reservoir 352. In such an embodiment, the inlet of the conduit 316 may not extend into the reservoir 352. Instead, the inlet of the conduit 316 may be disposed within or at the end of the porous material 310. For example, the end of the conduit 316 may be connected to or recessed into the outer layer 312 and / or the inner layer 314. In an embodiment, the conduit 316 is at least partially disposed within the reservoir 352, and the inlet of the conduit 316 may extend into or be positioned within the reservoir 352. The body fluid collected in the fluid collection assembly 300 may be discharged from the chamber 304 via the conduit 316.

[0078] Other examples of fluid collection assemblies that may include the porous materials disclosed herein are disclosed in U.S. Patent No. 10,973,678, filed on June 2, 2017, U.S. Patent No. 10,390,989, filed on September 8, 2016, U.S. Patent No. 10,226,376, filed on June 3, 2017, PCT Patent Application No. PCT / US2021 / 039866, filed on June 30, 2021, and U.S. Patent Application No. 16 / 433,773, filed on June 6, 2019. The disclosure of each of these patent applications is hereby incorporated by reference in its entirety.

[0079] Figure 4 is a block diagram of a fluid collection system 460 for fluid collection according to an embodiment. The fluid collection system 460 includes a fluid collection assembly 400, a fluid storage container 462, and a vacuum source 464. The fluid collection assembly 400 may be the same as or substantially similar to any of the fluid collection assemblies disclosed herein. The fluid collection assembly 400, the fluid storage container 462, and the vacuum source 464 may be fluidly coupled to each other via one or more conduits 416. For example, the fluid collection assembly 400 may be operably coupled to one or more of the fluid storage container 462 or the vacuum source 464 via the conduit 416. The body fluid collected in the fluid collection assembly 400 may be discharged from the fluid collection assembly 400 via the conduit 416 that protrudes into the fluid collection assembly 400. For example, the inlet of the conduit 416 may extend into the fluid collection assembly 400, such as into a reservoir therein. The outlet of the conduit 416 may extend into the fluid collection assembly 400 or the vacuum source 464. In response to a suction (e.g., vacuum) force applied at the outlet of the conduit 416, the suction force may be introduced into the chamber of the fluid collection assembly 400 via the inlet of the conduit 416.

[0080] Suction can be applied directly or indirectly by a vacuum source 464 to the outlet of the conduit 416. The suction can be applied indirectly via the fluid storage container 462. For example, the outlet of the conduit 416 can be disposed within the fluid storage container 462, and an additional conduit 416 can extend from the fluid storage container 462 to the vacuum source 464. Thus, the vacuum source 464 can apply suction to the fluid collection assembly 400 via the fluid storage container 462. The suction can be applied directly via the vacuum source 464. For example, the outlet of the conduit 416 can be disposed within the vacuum source 464. An additional conduit 416 can extend from the vacuum source 464 to a point external to the fluid collection assembly 400, such as the fluid storage container 462. In these examples, the vacuum source 464 can be disposed between the fluid collection assembly 400 and the fluid storage container 462.

[0081] The fluid storage container 462 is sized and shaped to hold body fluid therein. The fluid storage container 462 can include a bag (e.g., a drainage bag), a bottle, or a cup (e.g., a collection jar) or any other enclosed container for storing body fluid such as urine. In some examples, the conduit 416 can extend from the fluid collection assembly 400 and be attached to the fluid storage container 462 at a first point therein. An additional conduit 416 can be attached to the fluid storage container 462 at a second point thereof and can extend and be attached to the vacuum source 464. Thus, a vacuum (e.g., suction) can be drawn through the fluid collection assembly 400 via the fluid storage container 462. A body fluid such as urine can be drained from the fluid collection assembly 400 using the vacuum source 464.

[0082] The vacuum source 464 can 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. The vacuum source 464 can provide a vacuum or suction to remove body fluid from the fluid collection assembly 400. In some examples, the vacuum source 464 can be powered by one or more of a power cord (e.g., connected to an electrical outlet), one or more batteries, or even manual power (e.g., a manual vacuum pump). In some examples, the vacuum source 464 can be sized and shaped to fit externally, above, or within the fluid collection assembly 400. For example, the vacuum source 464 can include one or more small pumps or one or more micropumps. The vacuum source 464 disclosed herein can include one or more of a switch, a button, a plug, a remote control, or any other device suitable for activating the vacuum source 464.

[0083] Although various aspects and embodiments have been disclosed herein, other aspects and embodiments are contemplated. The various aspects and embodiments disclosed herein are for illustrative purposes and are not intended to be limiting.

[0084] Degree terms (e.g., "about", "substantially", "generally", etc.) indicate changes that are not significant in structure or function. In an example, when a degree term is used with a term representing a quantity, the degree term shall be interpreted as representing ±10%, ±5%, or +2% of the quantity term. For example, when a degree term is used to modify a shape, the degree term indicates that the shape modified by the degree has the appearance of the disclosed shape. For example, the degree term can be used to indicate that the shape can have rounded corners instead of sharp corners, curved edges instead of straight edges, one or more protrusions extending therefrom, an oval shape, the same as the disclosed shape, etc.

Claims

1. A fluid collection assembly, comprising: A fluid-impermeable layer defining at least a chamber, at least one opening, and a fluid outlet ； A porous material disposed at least partially within the chamber, the porous material comprising: A hydrophilic fluid-permeable outer layer; And A fluid-permeable inner layer comprising at least one of a non-woven material or a foam.

2. The fluid collection assembly according to claim 1, wherein, The porous material comprises only a single hydrophilic fluid-permeable outer layer and a single fluid-permeable inner layer.

3. The fluid collection assembly according to any one of claims 1 or 2, wherein, The porous material is generally U-shaped.

4. The fluid collection assembly according to any one of claims 1 to 3, wherein, The hydrophilic fluid-permeable outer layer comprises at least one of bamboo or cellulose.

5. The fluid collection assembly according to any one of claims 1 to 4, wherein, The hydrophilic fluid-permeable outer layer comprises at least one of a treated polypropylene non-woven material or a treated polyethylene.

6. The fluid collection assembly according to any one of claims 1 to 5, wherein, The surface density of the hydrophilic fluid-permeable outer layer is about 25 g / m 2 to about 55 g / m 2 .

7. The fluid collection assembly according to any one of claims 1 to 6, wherein, The thickness of the hydrophilic fluid-permeable outer layer is from about 25 μm to about 125 μm.

8. The fluid collection assembly according to any one of claims 1 to 7, wherein The fluid-permeable inner layer comprises a non-woven material.

9. The fluid collection assembly according to claim 8, wherein, The fluid-permeable inner layer comprises a vertical non-woven material.

10. The fluid collection assembly according to claim 9, wherein, The density of the vertical non-woven material ranges from about 100 kg / m²cm to about 200 kg / m²cm.

11. The fluid collection assembly according to any one of claims 9 or 10, wherein, The thickness of the vertical non-woven material is from about 8 mm to about 20 mm.

12. The fluid collection assembly according to any one of claims 1 to 11, wherein, The fluid-permeable inner layer comprises at least one foam.

13. The fluid collection assembly according to claim 12, wherein, The at least one foam comprises at least one of a polyurethane foam, a polyvinyl chloride foam, or a polyethylene foam.

14. The fluid collection assembly according to any one of claims 12 or 13, wherein, The average pore diameter of the at least one foam is about 7.75 pores / cm 2 to about 12.5 cm 2 .

15. The fluid collection assembly according to any one of claims 12 to 14, wherein, The density of the at least one foam is from about 15 kg / m 3 to about 125 kg / m 3 .

16. The fluid collection assembly according to any one of claims 1 to 15, wherein, The porous material further comprises an adhesive disposed between the hydrophilic fluid-permeable outer layer and the fluid-permeable inner layer.

17. The fluid collection assembly according to any one of claims 1 to 16, further comprising one or more barbs extending from at least one inner back surface of the fluid impermeable layer, wherein, The at least one inner back surface defines a portion of the chamber.

18. A fluid collection system, comprising: The fluid collection assembly according to any one of claims 1 to 17; A fluid storage container; And A vacuum source; Wherein the chamber of the fluid collection assembly, the fluid storage container, and the vacuum source are in fluid communication with each other, and when one or more body fluids are present in the chamber, the suction force provided by the vacuum source to the chamber of the fluid collection assembly discharges the one or more body fluids from the chamber and deposits the body fluids in the fluid storage container.

19. A method of collecting body fluids, the method comprising: Placing at least one opening of a fluid collection assembly near the female urethral orifice, the fluid collection assembly comprising: A fluid-impermeable layer defining at least a chamber, the at least one opening, and a fluid outlet; A porous material disposed at least partially within the chamber, the porous material comprising: A hydrophilic fluid-permeable outer layer; and A fluid-permeable inner layer comprising at least one of a foam or a non-woven material; and Introducing the body fluid from the female urethral orifice into the chamber.

20. A method of forming a fluid collection assembly, the method comprising: Providing a porous material comprising a hydrophilic fluid-permeable outer layer and a fluid-permeable inner layer, the fluid-permeable inner layer comprising at least one of a non-woven material or a foam; And Passing the porous material through at least one opening and placing it into a chamber, the at least one opening and the chamber being defined by a fluid-impermeable layer, the fluid-impermeable layer defining a fluid inlet.

21. The method according to claim 20, wherein Providing the porous material comprises: Providing a first sheet comprising one of the hydrophilic fluid-permeable outer layer or the fluid-permeable inner layer; After providing the first sheet, an adhesive is provided on at least a portion of the top surface of the first sheet; and After providing the adhesive on at least a portion of the top surface of the first sheet, a second sheet is provided on at least the adhesive, the second sheet including the other of the hydrophilic fluid permeable outer layer or the fluid impermeable inner layer.

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