External menstrual container and fluid collection system having same

Abstract

In one example external menstrual container (e.g., bag, cup, etc.), at least one fluid-impermeable layer (102) defines a container chamber (104) configured to receive one or more types of menstrual fluid (e.g., blood, vaginal fluid, mucosal tissue, cervical mucus, etc.). The fluid-impermeable layer of the external menstrual container has an upper portion (106) configured to be placed against an individual's vaginal region and a lower portion (108) opposite the upper portion. The upper portion of the fluid-impermeable layer can be configured to allow menstrual fluid to flow from the individual's vaginal region into the container chamber. The lower portion is configured to be attached to and / or placed against a fluid collection assembly.

Description

[Technical Field]

[0001] The present invention relates to an external menstrual container and a fluid collection system having the same. [Background technology]

[0002] People and animals may have limited or impaired mobility, making the normal process of urination difficult or impossible. For example, a person may suffer or be burdened with an injury that impairs mobility. A person may have a mobility-limiting condition, such as that experienced by pilots, drivers, and workers in hazardous areas. Additionally, bodily fluid collection may sometimes be necessary for monitoring purposes or for clinical trials.

[0003] Urinary catheters, such as Foley catheters, can address some of these conditions, such as incontinence. Unfortunately, urinary catheters can be uncomfortable and painful, and can lead to complications, such as infection. In addition, potty chairs, containers used by bedridden people as toilets, are sometimes used. However, potty chairs are prone to discomfort, leakage, and other hygiene issues. [Prior art documents] [Patent documents]

[0004] [Patent Document 1] International Publication No. 2021 / 211599 [Patent Document 2] International Publication No. 2021 / 211801 [Patent Document 3] European Patent Application Publication No. 0241064 [Patent Document 4] U.S. Patent No. 10,806,623 [Patent Document 5] International Publication No. 2021 / 211568 [Patent Document 6] US Patent Application Publication No. 2019 / 314189 [Patent Document 7] International Publication No. 2021 / 211799 [Patent Document 8] International Publication No. 2022 / 086898 [Patent Document 9] US Patent Application Publication No. 2022 / 117775 Summary of the Invention [Means for solving the problem]

[0005] In one embodiment, an external menstrual container is disclosed. The external menstrual container has at least one fluid-impermeable layer defining a container chamber. The at least one fluid-impermeable layer has an upper side configured to be contacted against an individual's vaginal region. The upper side defines a bag opening configured to allow menstrual fluid to flow from the vaginal region into the container chamber. The at least one fluid-impermeable layer also has a lower side opposite the upper side, the lower side being at least one of: configured to be attached to a fluid collection assembly; and the lower side being concave and configured to be contacted against the fluid collection assembly.

[0006] In one embodiment, a fluid collection system is disclosed. The fluid collection system includes a fluid collection assembly. The fluid collection assembly includes a fluid-impermeable barrier that defines at least a chamber, an opening, and a fluid outlet. The fluid collection assembly also includes at least one porous material disposed within the chamber and extending across the opening. The fluid collection system also includes an external menstrual container. The external menstrual container includes at least one fluid-impermeable layer that defines a container chamber. The at least one fluid-impermeable layer has an upper portion configured to be placed against an individual's vaginal region. The upper portion defines a bag opening configured to allow menstrual fluid to flow from the vaginal region into the container chamber. The at least one fluid-impermeable layer also includes a lower portion opposite the upper portion. The lower portion is at least one of: configured to be attached to the fluid collection assembly; attached to the fluid collection assembly; and abutting the fluid collection assembly.

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

[0008] The drawings depict several embodiments of the present disclosure, with the same reference numerals indicating the same or similar elements or features in the various views or embodiments shown. [Brief explanation of the drawings]

[0009] [Figure 1A] FIG. 1 is an isometric view of a menstrual container according to one embodiment. [Figure 1B] 1B is a cross-sectional view of a menstrual container according to one embodiment, taken along plane 1B-1B. [Figure 2] 1 is a schematic cross-sectional view of a menstrual container having at least one porous material disposed within the container chamber, according to one embodiment. [Figure 3] FIG. 1 is an isometric view of a menstrual container having one or more wings configured to allow the menstrual container to be attached directly to an individual, according to one embodiment. [Figure 4] FIG. 1 is an isometric view of a menstrual container having one or more wings configured to allow the menstrual container to be directly attached to a fluid collection assembly, according to one embodiment. [Figure 5A] FIG. 1 is a side view of a fluid collection assembly according to one embodiment. [Figure 5B] 5B is a schematic cross-sectional view of the fluid collection assembly taken along plane 5B-5B shown in FIG. 5A. [Figure 5C] 1 is a schematic cross-sectional view of a fluid collection system having a fluid collection assembly and a menstrual container attached thereto, according to one embodiment. [Figure 6] 1 is a schematic cross-sectional view of a fluid collection system having a fluid collection assembly and a menstrual container, according to one embodiment. [Figure 7] FIG. 1 is a schematic cross-sectional view of a fluid collection system in place on a female individual, according to one embodiment. [Figure 8] 1 is a block diagram of a fluid collection system for fluid collection according to one embodiment. DETAILED DESCRIPTION OF THE INVENTION

[0010] Embodiments are directed to external menstrual containers, fluid collection systems including same, and methods of use. In one example external menstrual container (e.g., a bag, cup, etc.), at least one fluid-impermeable layer defines a container chamber configured to receive one or more types of menstrual fluid (e.g., blood, vaginal fluid, mucosal tissue, cervical mucus, etc.). The fluid-impermeable layer of the external menstrual container has an upper portion configured to be placed against an individual's vaginal region and a lower portion opposite the upper portion. The upper portion of the fluid-impermeable layer can be configured to allow menstrual fluid to flow from the individual's vaginal region into the container chamber. The lower portion is configured to be attached to and / or placed against a fluid collection assembly.

[0011] The fluid collection assembly can be configured for use with the external menstrual container and can include a fluid-impermeable barrier defining a chamber, an opening, and a fluid outlet. The fluid collection assembly can also include at least one porous material disposed within the chamber. The fluid collection assembly can further include at least one conduit in fluid communication with the chamber through the fluid outlet. The conduit can be attached directly or indirectly to a fluid reservoir and a vacuum source.

[0012] The external menstrual container can be attached to or abutted against a fluid collection assembly to form a fluid collection system. During use, the fluid collection system is placed on an individual, with the bag opening of the external menstrual container positioned near the individual's vaginal opening and a portion of the opening of the fluid collection assembly positioned near the individual's urethral opening. Positioning the fluid collection system in this manner allows menstrual fluid discharged by the individual to be received by the external menstrual container rather than by the porous material of the fluid collection assembly, and allows bodily fluid (e.g., urine) discharged by the urethral opening to be received by the porous material. Bodily fluid received by the porous material can be removed from the chamber of the fluid collection assembly using a conduit and disposed of in a fluid reservoir. For example, suction can be applied to the chamber by a vacuum source to facilitate removal of bodily fluid from the chamber.

[0013] The presence of an external menstrual container allows for more efficient use of the fluid collection assembly when an individual is menstruating. For example, when the fluid collection assembly is deployed without an external menstrual container, the porous material receives menstrual fluid discharged by the vaginal opening. However, menstrual fluid received within the porous material can block the pores of the porous material, thereby impeding the flow of bodily fluid through the porous material. For example, blood in the menstrual fluid can clog the pores, permanently blocking the pores. The high viscosity of menstrual fluid compared to bodily fluids can also cause menstrual fluid to remain in the porous material for extended periods; both of these factors impede the flow of bodily fluid through the porous material. The obstruction of the flow of bodily fluid through the porous material by menstrual fluid can result in a failure to receive bodily fluid discharged from the urethral opening, e.g., leakage, in the fluid collection assembly, and can reduce the amount of time the fluid collection assembly can be used. In contrast, the external menstrual container disclosed herein captures menstrual fluid while preventing or at least impeding the menstrual fluid from entering the porous material, thereby allowing a menstruating individual to use the fluid collection assembly without compromising its efficiency.

[0014] FIG. 1A is an isometric view of one embodiment of a menstrual container 100. FIG. 1B is a cross-sectional view of one embodiment of the menstrual container 100 taken along plane 1B-1B. The menstrual container 100 includes one or more fluid-impermeable layers 102 that define a container chamber 104. The fluid-impermeable layers 102 have an upper portion 106 configured to abut against an individual's vaginal area, and a lower portion 108 opposite the upper portion 106. A bag opening 110 defined by the upper portion 106 allows menstrual fluid to enter the container chamber 104. The lower portion 108 is configured to abut against a fluid collection assembly (depicted in FIGS. 5A-6).

[0015] The fluid impermeable layer 102 at least partially defines the container chamber 104 and the bag opening 110. For example, the inner surface 112 of the fluid impermeable layer 102 at least partially defines the chamber 104 within the menstrual container 100. The fluid impermeable layer 102 at least temporarily retains menstrual fluid received by the menstrual container 100 within the container chamber 104. The container chamber 104 can have a volume of about 5 milliliters ("ml") or greater, such as about 5 ml to about 15 ml, about 10 ml to about 20 ml, about 15 ml to about 25 ml, about 20 ml to about 30 ml, about 25 ml to about 35 ml, about 30 ml to about 40 ml, about 35 ml to about 45 ml, about 40 ml to about 50 ml, about 45 ml to about 55 ml, about 50 ml to about 60 ml, about 55 ml to about 65 ml, about 60 ml to about 70 ml, about 65 ml to about 75 ml, about 70 ml to about 80 ml, about 75 ml to about 85 ml, about 80 ml to about 90 ml, about 85 ml to about 95 ml, or about 90 ml to about 100 ml. The volume of the container chamber 104 can be selected based on several factors. For example, the volume of the container chamber 104 may be selected based on the expected duration of use of the menstrual container 100 by the individual; this may require a larger volume for the container chamber 104 as the expected duration increases. For example, the volume of the container chamber 104 may be selected based on the expected volume of menstrual fluid discharge. For example, the volume of the container chamber 104 may be larger when the expected volume of menstrual fluid discharge is large (e.g., on the first and second days of menstruation) and smaller when the expected volume of menstrual fluid discharge is expected to be smaller (e.g., during light bleeding or near the end of a period). For example, the volume of the container chamber 104 is selected to be as small as possible because increasing the volume of the container chamber 104 would move the portion of the fluid collection assembly adjacent to the menstrual container 100 away from the vaginal area. Moving the fluid collection assembly away from the vaginal area may increase the likelihood of bodily fluid leakage from the fluid collection assembly.

[0016] The fluid impermeable layer 102 may be formed from any suitable fluid impermeable material(s), including a fluid impermeable polymer (e.g., silicone, polypropylene, polyethylene, polyethylene terephthalate, neoprene, polycarbonate, etc.), a metal film, natural rubber, other suitable materials, any other fluid impermeable material disclosed herein, or a combination thereof, such that the fluid impermeable layer 102 substantially prevents bodily fluids from passing through the fluid impermeable layer 102. At least one or more portions of at least the outer surface 114 of the fluid impermeable layer 102 may be formed from a soft and / or smooth material to reduce chafing.

[0017] In some embodiments, at least a portion of the fluid-impermeable layer 102 is transparent. In such embodiments, the transparent portion of the fluid-impermeable layer 102 allows the individual using the menstrual container 100 or another person (e.g., a physician) to easily observe the container chamber 104. For example, the transparent portion of the fluid-impermeable layer 102 allows such an individual to quickly determine the amount of menstrual fluid in the container chamber 104, such as when the menstrual container 100 needs to be emptied or discarded before menstrual fluid leaks from the menstrual container 100.

[0018] In one embodiment, the fluid-impermeable layer 102 includes a ring 116 that forms at least a portion of the upper portion 106. The ring 116 exhibits greater stiffness than the remainder of the fluid-impermeable layer 102. The ring 116 can be made stiffer by at least one of having a greater thickness and a greater Young's modulus (i.e., elastic modulus) than the remainder of the fluid-impermeable layer 102. The ring 116 provides additional structure to the portion of the fluid-impermeable layer 102 that defines the bag opening 110, thereby preventing collapse of the bag opening 110 when the ring 116 is positioned between the individual's vaginal folds. The ring 116 can also shape the upper portion 106 of the fluid-impermeable layer 102, i.e., to conform to a portion of the vaginal region (e.g., the portion of the vaginal region that borders the vaginal opening). According to one specific embodiment, the ring 116 may be formed from silicone.

[0019] In some embodiments, the upper portion 106 (e.g., ring 116) of the fluid impermeable layer 102 can define a generally circular bag opening 110. In some embodiments, the upper portion 106 can present an elongated (e.g., generally oval) shape to the bag opening 110. The elongated shape of the opening 110 allows the bag opening 110 to expand along the length of the vaginal area as well as fit between an individual's thighs.

[0020] The menstrual container 100 can be configured to be an external menstrual container 100 that is not inserted into an individual's vaginal opening. Configuring the menstrual container 100 to be an external menstrual container reduces the likelihood of the menstrual container 100 causing infection in the vaginal area and allows the menstrual container 100 to be sterilized using less aggressive means (e.g., eliminating the need to construct the menstrual container 100 from materials that necessarily withstand aggressive sterilization processes). Alternatively, the menstrual container 100 can be configured to be positionable with the bag opening 110 proximate the vaginal opening, with at least a portion of the menstrual container 100 (e.g., at least the ring 116) positioned between the vaginal folds, and / or with the bag opening 110 proximate the vaginal folds. Positioning the menstrual container 100 in this manner allows the menstrual container 100 to receive at least some menstrual fluid while reducing the likelihood of menstrual fluid leaking or not being received into the container chamber 104.

[0021] In embodiments where the menstrual container 100 is an external menstrual container, the menstrual container 100 may be provided with a forward-facing adhesive structure 118 disposed on at least a portion of the upper side 106 of the fluid impermeable layer 102 and / or at least a portion of the fluid impermeable layer 102 adjacent the upper side 106 (e.g., a lateral side of the ring 116). The forward-facing adhesive structure 118 may be configured to attach the fluid impermeable layer 102 to the vaginal area. Attaching the fluid impermeable layer 102 to the vaginal area prevents or at least impedes movement of the menstrual container 100 relative to the vaginal opening, which could allow menstrual fluid to flow around the menstrual container 100 instead of through the bag opening 110 and into the container chamber 104. The fluid-impermeable layer 102 adheres to the vaginal area, forming a seal that prevents or at least impedes menstrual fluid from leaking out of the reservoir chamber 104. The forward-facing adhesive structure 118 includes an adhesive portion 120. The adhesive portion 120 can include any chemical or physical component that can adhere to the vaginal area. For example, the adhesive portion 120 can include a pressure-sensitive adhesive, a water-activated adhesive, a temperature-sensitive adhesive, Nanotape® (also known as Gecko Tape), other van der Waals attachments, or any other suitable adhesive. For example, the forward-facing adhesive structure 118 can also include a release liner 122 that protects the adhesive portion 120 and prevents it from adhering to structures other than the individual's vaginal area. For example, the forward-facing adhesive structure 118 can include a substrate (e.g., a polymer film, not shown) to which the adhesive portion 120 is attached. The substrate can be attached to the fluid-impermeable layer 102.

[0022] The adhesive structure 118 may cause irritation in the vaginal area and / or may make removal of the menstrual container 100 from the vaginal area painful for some patients. Therefore, in some embodiments, the menstrual container 100 does not have a forward-facing adhesive structure 118. In such embodiments, the menstrual container 100 may be maintained against or adjacent to the vaginal opening, for example, by being positioned between the vaginal folds and maintained in position by the vaginal folds, and / or by a fluid collection assembly against which the menstrual container 100 abuts.

[0023] The lower portion 108 of the menstrual container 100 is configured to abut against a fluid collection assembly. In some embodiments, the lower portion 108 may have a shape that generally corresponds to the shape of the portion of the fluid collection assembly against which the lower portion 108 abuts. For example, as shown in FIGS. 5A-6, the lower portion 108 may be configured to abut against a convexly curved portion of the fluid collection assembly. In this way, the lower portion 108 may have a concave curve that generally corresponds to the convexly curved portion of the fluid collection assembly. In some embodiments, the lower portion 108 may be relatively flat.

[0024] According to one embodiment, the menstrual container 100 may be provided with a rearward adhesive structure 124, which is disposed on at least one of at least a portion of the lower side 108 of the fluid impermeable layer 102. The rearward adhesive structure 124 may be configured to attach the fluid impermeable layer 102 to a fluid collection assembly. Attaching the fluid impermeable layer 102 to the fluid collection assembly prevents movement of the menstrual container 100 relative to the fluid collection assembly, allowing the fluid collection assembly to maintain the position of the menstrual container 100.

[0025] The rearward-facing adhesive structure 124 includes an adhesive portion 126. The adhesive portion 126 can include any chemical or physical entity capable of adhering to the fluid collection assembly. In some embodiments, the adhesive portion 126 is configured to be attached to the porous material of the fluid collection assembly (e.g., porous material 560 in FIGS. 5A and 5B). In such embodiments, the adhesive portion 126 may include a plurality of hooks capable of grasping fibers of the porous material (e.g., similar to the hooks of a Velcro® attachment), a pressure-sensitive adhesive configured to adhere to the surface of the porous material without substantially flowing into the porous material, Nanotape®, other van der Waals attachment, or any other suitable adhesive. In one example, the adhesive portion 126 is configured to allow the menstrual container 100 to be removed from the porous material without substantially damaging the adhesive portion 126 or the porous material. In such instances, the menstrual container 100 can be removed from the porous material for inspection, emptying, or other purposes, and then reattached to the porous material for reuse. By way of example, the adhesive 126 is free of glues or other adhesives that can penetrate and clog the pores of the porous material, which, as discussed above, can prevent the flow of bodily fluids through the porous material. In some embodiments, the rearward-facing adhesive structure 124 is configured to be attached to a fluid-impermeable barrier of a fluid collection assembly (e.g., the fluid-impermeable barrier 552 in FIGS. 5A and 5B ). In such embodiments, the adhesive 126 can comprise a pressure-sensitive adhesive, Nanotape®, other van der Waals attachment, glue, or any other suitable adhesive.

[0026] The rearward-facing adhesive structure 124 may include one or more structures in addition to the adhesive portion 126. For example, the rearward-facing adhesive structure 124 may include a release liner 128 to protect the adhesive portion 126 and prevent adhesion of the adhesive portion 126 to structures other than the individual's vaginal area. For example, the rearward-facing adhesive structure 124 may include a substrate (e.g., a polymer film, not shown) to which the adhesive portion 126 is attached. The substrate may be attached to the fluid-impermeable layer 102.

[0027] According to certain embodiments, the menstrual container 100 may be provided with one or more markings 130. The markings 130 may be any structure formed on or within the fluid impermeable layer 102 that is visually distinguishable on the fluid impermeable layer 102. For example, the markings 130 may be printed on the fluid impermeable layer 102, may be formed as one or more depressions formed in the fluid impermeable layer 102, or may be formed as one or more protrusions extending from the fluid impermeable layer 102.

[0028] Appropriate configuration of the markings 130 can facilitate positioning of the menstrual container 100 on the fluid collection assembly. For example, the fluid collection assembly depicted in FIGS. 5A-6 has an elongated opening. When the menstrual container 100 is not abutted against the fluid collection assembly, the top of the elongated opening is positioned near the urethral opening, and the base of the elongated opening (e.g., a portion closer to the distal end region than the top) is positioned near the urethral opening. When the menstrual container 100 is attached to the fluid collection assembly, it is important to properly position the menstrual container 100 on the fluid collection assembly. For example, positioning the menstrual container 100 near the top of the elongated opening may cause the menstrual container 100 to obstruct or otherwise interfere with the fluid collection assembly's receipt of bodily fluid from the urethral opening. Similarly, when the menstrual container 100 is positioned far from the top of the elongated opening, it may be difficult to accurately position the fluid collection assembly on an individual while maintaining the bag opening 110 near the vaginal opening. Failure to correctly position the fluid collection assembly can result in leakage and / or movement in the fluid collection system. The markings 130 can also facilitate alignment of the menstrual container 100 with respect to the vaginal area when the bag opening 110 is in an extended configuration.

[0029] In some embodiments, the marking 130 on the menstrual container 100 is configured to align with one or more features on the fluid collection assembly. For example, the marking 130 can be a line configured to align with a boundary of the opening of the fluid collection assembly, an arrow (as shown) that can align with an edge of the opening or with one or more markings formed on the fluid collection assembly, etc.

[0030] In some embodiments, the menstrual container 100 is reusable. A menstrual container 100 is reusable if it can be used more than once and sterilized between uses without damage. In some embodiments, the menstrual container 100 is configured for single use. For example, the menstrual container 100 can be configured for single use by having at least a portion of the fluid impermeable layer 102 formed from a film (e.g., having a minimum thickness of less than 0.5 mm).

[0031] In the illustrated embodiment, the menstrual container 100 has its widest width at or near the bag opening 110, and the width of the menstrual container 100 remains relatively constant from or near the top portion 106 to the bottom portion 108. In some embodiments, the menstrual container 100 has its widest width at a location spatially distant from the bag opening 110, such as at the bottom portion 108 or between the front portion 106 and the bottom portion 108. In such embodiments, the volume of the container chamber 104 of the menstrual container 100 can be equal to or greater than the volume of the container chamber 104 of a menstrual container 100 that has its widest width at or near the top portion 106, while still preventing or minimizing the distance that the menstrual container 100 moves the fluid collection assembly away from the vaginal area.

[0032] By making the reservoir chamber 104 of the menstrual container 100 substantially unoccupied and maximizing the amount of menstrual fluid retained therein, the reservoir chamber 104 can be more easily emptied and the distance the menstrual container requires the fluid collection assembly to move away from the vaginal area can be reduced compared to when the reservoir chamber 104 is at least partially occupied by a porous material. However, a substantially empty reservoir chamber 104 allows menstrual fluid received therein to move within, potentially resulting in leakage of the menstrual fluid. Therefore, in some embodiments, the menstrual containers disclosed herein may have at least one porous material disposed within the reservoir chamber 104. For example, FIG. 2 is a schematic cross-sectional view of a menstrual container 200 having at least one porous material 232 disposed within the reservoir chamber 204 according to one embodiment. Except as otherwise disclosed herein, the menstrual container 200 may be the same as or substantially similar to any of the menstrual containers disclosed herein.

[0033] The porous material 232 can include any material capable of receiving menstrual fluid. For example, the porous material 232 can be a fabric, a gauze (e.g., silk, linen, or cotton gauze), other soft fabrics, other smooth fabrics, a nonwoven material, a woven material (e.g., spun nylon fibers), a porous polymer (e.g., nylon, polyester, polyurethane, polyethylene, polypropylene, etc.) structure, an open cell foam, or two or more separate porous materials (e.g., an upper and lower layer).

[0034] As previously discussed, the menstrual containers of the present disclosure can be provided with structure that allows the menstrual container to be attached directly to an individual. For example, as discussed in detail in connection with FIGS. 1A and 1B, the menstrual containers of the present disclosure can be provided with a forward-facing adhesive structure 118 configured to allow the menstrual container 100 to be attached to the vaginal area. However, it is noted that the menstrual containers of the present disclosure can include structure that allows the menstrual container 100 to be attached directly to an individual, in addition to or in addition to the forward-facing adhesive structure 118. FIG. 3 is an isometric view of a menstrual container 300 having one or more wings 334 configured to allow the menstrual container 300 to be attached directly to an individual, according to one embodiment. Except as otherwise disclosed herein, the menstrual container 300 can be the same as or substantially similar to any of the menstrual containers disclosed herein. For example, the menstrual container 300 can include a fluid impermeable layer 302 having an upper portion 306 and a lower portion 308 that define a bag opening 310. The fluid impermeable layer 302 can also include a ring 316.

[0035] As discussed above, the menstrual container 300 includes one or more wings 334. The wings 334 are structurally attached to the fluid impermeable layer 302 and extend laterally (e.g., radially relative to the bag opening 310) away from the fluid impermeable layer 302. The wings 334 are configured to allow the menstrual container 300 to be attached to an individual. The wings 334 may extend from or near the upper portion 306 of the fluid impermeable layer 302. For example, if the fluid impermeable layer 302 includes a ring 316 (as shown), the wings 334 may extend from a portion of the ring 316 defining the upper portion 306, a side surface of the ring 316, or a lower edge of the ring 316 (e.g., an edge of the ring 316 opposite the upper portion 306).

[0036] Wing 334 has a front wing side 336 and a rear wing side 338 opposite the front wing side 338. The front wing side 336 is the side of wing 334 that faces an individual during use (e.g., faces the individual's vaginal area and / or thighs). For example, front wing side 336 may be oriented generally in the same direction as upper portion 306 of fluid-impermeable layer 302. Wing 334 has a wing adhesive structure 340 (schematically depicted on wing 334 using cross-hatching) disposed on at least a portion of front wing side 336. Wing adhesive structure 340 is configured to attach wing 334 to an individual, for example, the individual's vaginal area and / or thighs. Wing adhesive structure 340 may be substantially similar to any of the adhesive structures disclosed herein. For example, the wing attachment structure 340 can include an adhesive (e.g., any of the adhesives disclosed herein) and optionally include other structures such as a release liner, a substrate, etc. In one example, the wing attachment structure 340 includes an adhesive that is weaker than the adhesive that attaches the menstrual container 300 to the fluid collection assembly. A weaker adhesive in the wing attachment structure 340 reduces the likelihood of injury or unnecessary discomfort to an individual when the menstrual container 300 is removed from the individual, and reduces the likelihood of the menstrual container 300 becoming detached from the fluid collection assembly due to large movements of the fluid collection assembly (e.g., when removing the fluid collection assembly from the individual).

[0037] In some embodiments, the wing adhesive structure 340 covers all or substantially all of the front wing side 336. In such embodiments, the wing adhesive structure 340 adheres to the vaginal area and, if the wings 334 are long enough, may also adhere to the individual's thighs. In some embodiments, the wing adhesive structure 340 covers only a portion of the front wing side 336. For example, the wing adhesive structure 340 may cover only portions of the front wing side 336 that are spatially separated from the fluid-impermeable layer 302. In such an example, the spatial separation of the wing adhesive structure 340 from the fluid-impermeable layer 302 may reduce adhesion of the wings 334 to the sensitive vaginal area, thereby reducing discomfort caused by peeling the wings 334 from the vaginal area. In some embodiments, the wing adhesive structure 340 is formed of two or more adhesives having different adhesive strengths. For example, portions of the wing adhesive structure 340 configured to adhere to the vaginal area may exhibit a weaker adhesive strength than portions of the wing adhesive structure 340 configured to adhere to the individual's thighs. In such an example, the adhesive structure 340 may provide a strong attachment of the wings 334 to the individual while minimizing any discomfort or distress caused by removing the menstrual container 300 from the individual.

[0038] In the illustrated embodiment, the wings 334 do not surround the fluid impermeable layer 302 (e.g., do not surround the ring 316). According to some embodiments, the wings 334 can completely surround the fluid impermeable layer 302 (e.g., completely surround the ring 316) to form a seal around the vaginal opening.

[0039] As previously discussed, the menstrual containers disclosed herein can be provided with structure for directly attaching the menstrual container to a fluid collection assembly. For example, as discussed in detail in connection with FIGS. 1A and 1B, the menstrual containers disclosed herein can have a rearward-facing adhesive structure 124 configured to attach the menstrual container 100 to a fluid collection assembly. However, it is noted that the menstrual containers disclosed herein can have structure configured to directly attach the menstrual container 100 to a fluid collection assembly, in addition to or in addition to the rearward-facing adhesive structure 124. FIG. 4 is an isometric view of a menstrual container 400 having one or more wings 434 configured to directly attach the menstrual container 400 to a fluid collection assembly, according to one embodiment. Except as otherwise disclosed herein, the menstrual container 400 can be the same as or substantially similar to any of the menstrual containers disclosed herein. For example, the menstrual container 400 can include a fluid impermeable layer 402 having a top portion 406 that defines a bag opening 410 and a bottom portion (which is concealed by wings 434). The fluid impermeable layer 402 can also include a ring 416.

[0040] As discussed above, the menstrual container 400 includes one or more wings 434. The wings 434 are structured to be attached to the fluid impermeable layer 402 and extend laterally (e.g., radially relative to the bag opening 410) away from the fluid impermeable layer 402. The wings 434 are configured to allow the menstrual container 400 to be attached to a fluid collection assembly. The wings 434 extend from or near the underside 408 of the fluid impermeable layer 402.

[0041] The vane 434 has a leading vane side 436 and a trailing vane side 438 opposite the leading vane side 436. The trailing vane side 438 is the side of the vane 434 that faces the fluid collection assembly during use. For example, the trailing vane side 438 may face generally in the same direction as the lower portion 408 of the fluid impermeable layer 402. The vane 434 has a vane bonding structure 440 (schematically depicted on the vane 434 using cross-hatching) disposed on at least a portion of the trailing vane side 438. The vane bonding structure 440 is configured to attach the vane 436 to the fluid collection assembly. The vane bonding structure 440 may be substantially similar to any of the bonding structures disclosed herein. For example, the vane adhesive structure 440 can include an adhesive (e.g., any of the adhesives disclosed herein) and optionally include other structures such as a release liner, a substrate, etc.

[0042] In some embodiments, the vane bonding structure 440 covers the entire or substantially the entire trailing vane side 438. In such embodiments, the vane bonding structure 440 can be attached to a porous material, and as discussed above, the type of adhesive used to attach the vane bonding structure 440 to the fluid collection assembly can be limited based on the porous material to prevent or limit clogging of the pores with the adhesive. In some embodiments, the vane bonding structure 440 covers only a portion of the trailing vane side 438. For example, the vane bonding structure 440 can cover a lateral portion (e.g., a portion other than the center) of the trailing vane side 438. In such an example, the vane bonding structure 440 cannot adhere to the porous material of the fluid collection assembly, allowing the adhesive for the vane bonding structure 440 to be selected from a wider range of adhesives. In some embodiments, the vane bonding structure 440 is formed of two or more types of adhesive. For example, for portions of the blade bonding structure 440 that are configured to adhere to a porous material, an adhesive may be selected that does not clog or substantially clog the pores of the porous material, and adhesive portions of the blade bonding structure 440 that are not configured to adhere to a porous material may be formed with an adhesive that, when applied to the porous material, is likely to at least partially clog the pores of the porous material.

[0043] As previously discussed, the menstrual containers disclosed herein can be used in conjunction with a fluid collection assembly. Figure 5A is a side view of a fluid collection assembly 550 according to one embodiment. Figure 5B is a schematic cross-sectional view of the fluid collection assembly 550, taken along plane 5B-5B shown in Figure 5A. The fluid collection assembly 550 includes a fluid-impermeable barrier 552 that defines a chamber 554, an opening 556, and a fluid outlet 558. The fluid collection assembly 550 includes at least one porous material 560 disposed within the chamber 554, at least partially occupying it.

[0044] The fluid-impermeable barrier 552 at least partially defines a chamber 554 (e.g., an interior region) and an opening 556. For example, the inner surface of the fluid-impermeable barrier 552 at least partially defines the chamber 554 within the fluid collection assembly 550. The fluid-impermeable barrier 552 temporarily retains bodily fluid within the chamber 554. The fluid-impermeable barrier 552 may be formed of any suitable fluid-impermeable material, including, for example, a fluid-impermeable polymer (e.g., silicone, polypropylene, polyethylene, polyethylene terephthalate, neoprene, polycarbonate, etc.), a metal film, natural rubber, other suitable materials, any other fluid-impermeable material disclosed herein, or a combination thereof. In this manner, the fluid-impermeable barrier 552 substantially prevents bodily fluid from passing through the impermeable barrier 552. For example, the fluid-impermeable barrier 552 may be air-permeable and fluid-impermeable. In such an example, the fluid-impermeable barrier 552 may be formed from a hydrophobic material having a plurality of pores defined therein. At least one or more portions of at least the outer surface of the fluid-impermeable barrier 552 may be formed from a soft and / or smooth material to reduce chafing.

[0045] In certain examples, the fluid-impermeable barrier 552 (excluding the opening 556) can be tubular, such as a substantially cylindrical (as shown), ellipsoidal, prismatic, or oblate tube. The outer surface of the fluid-impermeable barrier 552 can be in contact with an individual during use. The fluid-impermeable barrier 552 can be sized and shaped to fit between the legs of a female user, in the intergluteal cleft and / or between the labia.

[0046] The opening 556 provides an ingress route for bodily fluid to enter the chamber 554. The opening 556 may be defined by the fluid-impermeable barrier 552, such as by an inner edge of the fluid-impermeable barrier 552. For example, the opening 556 may be formed in the fluid-impermeable barrier 552 and extend from its outer surface to its inner surface, allowing bodily fluid to enter the chamber 554 from outside the fluid collection assembly 550.

[0047] Opening 556 may be an elongated hole in fluid-impermeable barrier 552. For example, opening 556 may be defined as a cutout in fluid-impermeable barrier 552. Opening 556 may be located and shaped to be positioned near a woman's urethral opening. Because the space between a woman's legs is relatively small when they are closed, opening 556 may be elongated to only allow bodily fluid flow along a path consistent with the elongated opening 556 (e.g., a flared opening 556).

[0048] Fluid collection assembly 550 can be positioned near a woman's urethral opening, allowing bodily fluids to enter chamber 554 of fluid collection assembly 550 via opening 556. Fluid collection assembly 550 is configured to receive bodily fluids into chamber 554 via opening 556. In use, opening 556 can have an elongated shape that extends from a first location posterior to the urethral opening (e.g., at or near the anus or vaginal opening) to a second location anterior to the urethral opening (e.g., at or near the top of the vaginal opening or pubic hair).

[0049] In certain examples, the fluid-impermeable barrier 552 can define a fluid outlet 558 sized to receive a conduit 562. The at least one conduit 562 can be disposed within the chamber 554 via the fluid outlet 558. By appropriately sizing and shaping the fluid outlet 558, it can form at least a substantially fluid-tight seal with the conduit 562 or at least one tube, thereby substantially preventing bodily fluids from escaping the chamber 554.

[0050] According to some embodiments, the fluid-impermeable barrier 552 may include one or more markings 530. The markings 530 may comprise any structure formed in or on the fluid-impermeable barrier 552 that is visually distinguishable on the fluid-impermeable barrier 552. For example, the markings 530 may be printed on the fluid-impermeable barrier 552, may be formed by one or more depressions formed in the fluid-impermeable barrier 552, or may be formed by one or more protrusions extending from the fluid-impermeable barrier 552.

[0051] The markings 530 may be configured to facilitate positioning of the menstrual container on the fluid collection assembly. For example, as discussed above, improper positioning of the menstrual container on the fluid collection assembly 550 may result in leakage and / or movement of the fluid collection assembly 550. In some embodiments, the markings 530 on the fluid-impermeable barrier 552 are configured to align with one or more features on the menstrual container. For example, the markings 530 may be arrows configured to align with markings on the menstrual container (e.g., markings 130 in FIG. 1A ).

[0052] According to certain embodiments, porous material 560 can be configured to wick any bodily fluid away from opening 556, thereby preventing the bodily fluid from escaping chamber 554. As used herein, permeability characteristics, such as wicking, capillary action, diffusion, or similar properties or processes, are referred to herein as "permeable" and / or "wicking." These "wicking" and / or "permeable" characteristics do not involve absorption of bodily fluid into at least a portion of porous material 560, such as adsorption of bodily fluid into fluid-permeable support material 568. In other words, the material is substantially incapable of absorbing or dissolving bodily fluid after being exposed to and removed from bodily fluid for a period of time. While non-absorbent or non-dissolving is desirable, the term "substantially non-absorbent" allows for a small amount of absorption and / or dissolution (e.g., absorbency) of bodily fluids into the porous material 560, such as less than about 30%, less than about 20%, less than about 10%, less than about 7%, less than about 5%, less than about 3%, less than about 2%, less than about 1%, or less than about 0.5% by weight of the dry weight of the porous material 560. Additionally, the porous material 560 can generally wick bodily fluids toward the interior of the chamber 554, as discussed in more detail below. According to certain embodiments, the porous material 560 can include at least one absorbent or adsorbent material.

[0053] According to one embodiment, porous material 560 can include a fluid-permeable membrane 564 disposed within chamber 554. Fluid-permeable membrane 564 can cover at least a portion (e.g., all) of opening 556. Fluid-permeable membrane 564 can be configured to wick bodily fluids away from opening 556, thereby preventing the bodily fluids from escaping chamber 554.

[0054] According to some embodiments, the fluid-permeable membrane 564 can be made of any material capable of wicking bodily fluids. For example, the fluid-permeable membrane 564 can be made of a fabric such as gauze (e.g., silk, linen, or cotton gauze), other soft fabrics, other smooth fabrics, nonwoven materials, or any of the other porous materials disclosed herein. Forming the fluid-permeable membrane 564 from gauze, soft fabrics, and / or smooth fabrics can reduce chafing caused by the fluid collection assembly 550.

[0055] The fluid collection assembly 550 can include a fluid-permeable support 568 disposed within the chamber 554. The fluid-permeable support 568 is configured to support the fluid-permeable membrane 564, taking into account that the fluid-permeable membrane 564 can be formed from a relatively flexible, thin, or other easily deformable material. For example, the fluid-permeable support 568 can be positioned between the fluid-permeable support 568 and the fluid-impermeable barrier 552. In this manner, the fluid-permeable support 568 can support and maintain the position of the fluid-permeable membrane 564. The fluid-permeable support 568 can include any material that wicks, absorbs, adsorbs, or otherwise facilitates fluid transport of bodily fluids, such as any of the fluid-permeable membrane materials previously disclosed herein. For example, when used as the fluid-permeable support 568, the fluid-permeable membrane material(s) can be used in a denser or more rigid form than that within the fluid-permeable membrane 564. The fluid-permeable support 568 may be formed of any fluid-permeable material that is less deformable than the fluid-permeable membrane 564. For example, the fluid-permeable support 568 may have a porous polymer (e.g., nylon, polyester, polyurethane, polyethylene, polypropylene, etc.) structure or an open-cell foam, such as spun nylon fibers. In certain examples, the fluid-permeable support 568 may contain a nonwoven material. In certain examples, the fluid-permeable support 568 may be formed of a natural material, such as cotton, wool, silk, or a combination thereof. In such examples, the material may have a coating that prevents or limits fluid absorption into the material, such as a water-repellent coating. In certain examples, the fluid-permeable support 568 may be formed of fabric, felt, gauze, or a combination thereof.

[0056] In certain examples, the fluid-permeable membrane 564 may be optional. For example, the porous material 560 may include only the fluid-permeable support material 568. In certain examples, the fluid-permeable support material 568 may be optionally omitted from the fluid collection assembly 550. For example, the porous material 560 may include only the fluid-permeable membrane 564.

[0057] According to some embodiments, at least a portion of the porous material 560 (e.g., one or more of the fluid-permeable membrane 564 and the fluid-permeable support material 568, preferably the latter) can be hydrophobic. The porous material 560 is hydrophobic when the contact angle it exhibits with water (a major component of bodily fluids) is greater than about 90°, e.g., in 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°. A hydrophobic porous material 560 can limit the absorption, adsorption, and dissolution of bodily fluids in the porous material 560, thereby reducing the amount of bodily fluid retained within the porous material 560. In some embodiments, at least a portion of the porous material 560 is hydrophobic or hydrophilic. In one embodiment, the fluid-permeable support material 568 is more hydrophobic (e.g., exhibits a larger contact angle with water) than the fluid-permeable membrane 564. The less hydrophobic fluid-permeable membrane 564 helps the porous material 560 accept bodily fluids from the urethral meatus, while the hydrophobic fluid-permeable support material 568 limits bodily fluid retention in the porous material 560.

[0058] A conduit 562 may be disposed at least partially within chamber 554. The conduit 562 may be used to remove bodily fluids from chamber 554. The conduit 562 may be operably coupled to a vacuum source, such as a vacuum pump, to draw fluid from chamber 554 through the conduit 562. For example, the conduit 562 may extend from proximal end region 572, into the fluid-impermeable barrier 552, and toward distal end region 570 to a point near reservoir 574, thereby placing the inlet in fluid communication with reservoir 574. The conduit 562 fluidly couples chamber 554 to a fluid storage container (not shown) or a vacuum source (not shown).

[0059] Conduit 562 is configured to allow a vacuum source (not shown) to be fluidly coupled (e.g., directly or indirectly) to chamber 554 (e.g., reservoir 574). By applying a vacuum / suction force within conduit 562 via a vacuum source (e.g., vacuum source 894 in FIG. 8 ), bodily fluid within chamber 554 (e.g., within distal end region 570, e.g., reservoir 574) can be drawn into conduit 562 and through conduit 562 out of fluid collection assembly 550. In certain examples, conduit 562 can be matte or opaque (e.g., black) to obscure the view of bodily fluid therein.

[0060] The porous material 560 may at least substantially completely fill the portion of the chamber 554 not occupied by the conduit 562. In certain instances, the porous material 560 may less completely fill the portion of the chamber 554 not occupied by the conduit 562. In such instances, the fluid collection assembly 550 may include a reservoir 574 disposed within the chamber 554.

[0061] Reservoir 574 is a substantially empty portion of chamber 554. Reservoir 574 may be defined between fluid-impermeable barrier 552 and one or both of fluid-permeable membrane 564 and fluid-permeable support material 568. Bodily fluid within chamber 554 may flow through fluid-permeable membrane 564 and / or fluid-permeable support material 568 into reservoir 574. The bodily fluid may be retained within reservoir 574.

[0062] Bodily fluid within the chamber 554 can flow through the fluid-permeable membrane 564 and / or the fluid-permeable support material 568 into the reservoir 574. The fluid-impermeable barrier 552 allows the bodily fluid to remain within the reservoir 574. Although depicted within the distal end region 570, the reservoir 574 can be located anywhere within the chamber 554, such as the proximal end region 572. The reservoir 574 can be located in a portion of the chamber 554 designed to be at a gravimetric low point of the fluid collection assembly when the assembly is worn. The conduit 562 can extend into the fluid reservoir 574 and / or its inlet can be located adjacent to or near the fluid reservoir 574.

[0063] In some examples (not shown), the fluid collection assembly 550 can include multiple reservoirs, such as a first reservoir located in the portion of the chamber 554 closest to the entrance of the conduit 562 (e.g., distal end region 570) and a second reservoir located at or near the proximal end region 572 of the chamber 554. In other examples, the fluid-permeable support 568 can be spatially separated from at least a portion of the conduit 562, with the space between the fluid-permeable support 568 and the conduit 562 being the reservoir 574.

[0064] 5C is a schematic cross-sectional view of a fluid collection system 590 including a fluid collection assembly 550 and a menstrual container 500 attached thereto, according to one embodiment. The menstrual container 500 can be the same as or substantially similar to any of the menstrual containers disclosed herein. In the illustrated embodiment, the menstrual container 500 is attached to a portion of the porous material 560 closer to the distal end region 570 of the fluid collection assembly 550 than to the proximal end region 572 of the fluid collection assembly 550. In such an example, the menstrual container 500 can be positioned near the individual's vaginal opening, portions of the porous material 560 closer to the proximal end region 572 can be positioned near the urethral opening, and the conduit 562 can extend from the fluid collection assembly 550 toward the individual's abdomen, which may prove more comfortable and less likely to leak. In some embodiments, not shown, the menstrual container 500 may be attached to a portion of the fluid-impermeable barrier 552 that is between the opening 556 and the distal-most portion of the fluid-impermeable barrier 552.

[0065] 5D illustrates a cross-sectional view of a fluid collection system 590 in use according to one embodiment. As shown, the fluid collection system 590 can be positioned near the vaginal region of an individual 571 such that the menstrual container 506 is positioned near or at least partially within the vaginal opening 573. For example, as shown, the menstrual container 506 is positioned over the vaginal opening 573. However, it should be noted that the menstrual container 506 may also be positioned at least partially within the vaginal opening 573, such as between the vaginal folds, or at least partially within the vaginal canal 575. Such a positioning of the menstrual container 506 allows the menstrual container 506 to receive at least some (e.g., substantially all) of the menstrual fluid expelled from the vaginal opening 573. The fluid collection system 590 is also positioned such that the opening 556 and porous material 560 of the fluid collection assembly 550 are positioned near the urethral opening 577. In this way, urine and other bodily fluids expelled from the urethral meatus 577 flow through the openings 556 and are received within the porous material 560 .

[0066] 6 is a schematic cross-sectional view of a fluid collection system 690 including a fluid collection assembly 650 and a menstrual container 600, according to one embodiment. The fluid collection assembly 650 is an example of a female fluid collection assembly for receiving and collecting bodily fluids from a female. Except as otherwise disclosed herein, the menstrual container 600 and the fluid collection assembly can be the same as or substantially similar to any of the menstrual containers and fluid collection assemblies disclosed herein.

[0067] The fluid collection assembly 650 includes a fluid-impermeable barrier 652, which may be identical or similar to any of the fluid-impermeable barriers disclosed herein on one or more sides. The fluid-impermeable barrier 652 defines at least a chamber 654, at least one opening 656, and a fluid outlet 658. The fluid collection assembly 650 also includes at least one porous material 660 disposed within the chamber 654. The porous material 660 may be identical or similar to any of the porous materials disclosed herein on one or more sides. The fluid collection assembly 650 also includes at least one conduit 662 configured to remove one or more bodily fluids from the chamber 654 and located partially within the fluid outlet 658. The conduit 662 does not have to pass through the porous material 660.

[0068] According to one embodiment, the fluid-impermeable barrier 652 can include a shell 676 and a connector piece 678 secured to the shell 676. The shell 676 of the fluid collection assembly 650 has a proximal end region 672, a distal end region 670 opposite the proximal end region 672, a front side 684, and a rear side 686 opposite the front side 684. Typically, during use, the distal end region 670 is closer to the individual's intergluteal cleft than the proximal end region 672, and the front side 684 generally faces the individual's vaginal region. The shell 676 can be formed from a fluid-impermeable material such as silicone, neoprene, a thermoplastic elastomer, or other suitable material.

[0069] In some embodiments, the shell 676 may include one or more flanges that may provide additional contact points for undergarments or other clothing to press against the fluid collection assembly 650, thereby facilitating securement of the fluid collection assembly 650 to an individual's vaginal area and improving patient comfort. According to some embodiments, the flanges may include at least one of an upper flange 680 that defines the proximal end region 672 and a lower flange opposite the upper flange 680 that defines the distal end region 670.

[0070] The distance that the body flange extends from the remainder of the shell 676 can be 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 in the 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. The distance that the flanges extend from the remainder of the shell 676 can be selected based on the expected size of an individual's vaginal area (e.g., larger flanges for larger vaginal areas) and the expected rotational forces that will be applied to the fluid collection assembly 650 during use. In certain examples, at least some of the flanges can extend farther from the remainder of the shell 676 than other flanges.

[0071] According to one embodiment, the shell 676 can have a sump 682 at or near the distal end region 670. The sump 682 can extend outward from a front side 684 of the shell 676. The sump 682 is configured to be located at, near, or otherwise in fluid communication with a gravimetric low point of the porous material 660 during use. For example, the sump 682 can contain a portion of the porous material 660. The sump 682 can receive at least some of the bodily fluid received by the porous material 660. The sump 682 can prevent or at least inhibit leakage of bodily fluid from the fluid collection assembly 650. At least a portion of the connector piece 678 can be at least partially disposed within the sump 682.

[0072] According to certain embodiments, the shell 676 can define a recess configured to receive the conduit 662. The recess can extend from at or near the proximal end region 672 to at or near the distal end region 670, allowing the conduit 662 to extend from at or near the individual's abdomen to the connector piece 678. According to certain embodiments, the recess can be configured such that the shell 676 surrounds and / or abuts less than 60% of the circumference of the conduit 662, thereby allowing the conduit 662 to freely move in and out of the recess during use. The ability of the conduit 662 to freely move in and out of the recess can facilitate positioning of the fluid collection assembly 650 and position the porous material 660 adjacent to the vaginal area even when the conduit 662 is bent away from the vaginal area. Additionally, allowing the conduit 662 to move freely in and out of the recess increases the likelihood that movement of the conduit 662 will not cause the porous material 660 to move relative to the vaginal area, which could result in leakage. In some embodiments, at least a portion of the recess may be configured such that the shell 676 surrounds and / or abuts more than 50% of the circumference of the conduit 662 (e.g., between 51% and about 55%, between about 53% and about 57%, or between about 55% and about 60%). Surrounding more than 60% of the circumference of the conduit 662 may more securely attach the conduit 662 to the shell 676 and may provide additional structure to the shell 676. The proportion of the conduit 662 that is surrounded and / or abutted by the shell 676 may be selected so that the inherent elasticity of the shell 676 and the conduit 662 allows the conduit 662 to be easily fitted into and removed from the recess, allowing the conduit 662 to be removed from the recess and to effect positioning of the porous material 660 adjacent the vaginal area or to move the conduit 662.

[0073] As discussed above, the fluid-impermeable barrier 652 includes a connector piece 678 attached to or integrally formed with the shell 676 (e.g., by adhesive, welding, an interference fit, etc.). The connector piece 678 is located at or near the distal end region 670 of the shell 676 so that the connector piece 678 can capture bodily fluids that flow to a gravimetric low point in the porous material 660. In some embodiments, a portion of the connector piece 678 may be located within a sump 682 of the shell 676. In some embodiments, not shown, the connector piece 678 may define the sump 682 instead of the shell 676.

[0074] The connector piece 678 is configured to be coupled to the conduit 662. The connector piece 678 may then define a fluid outlet 658 configured to be attached to or otherwise in communication with the conduit 662. The fluid outlet 658 may be located near a rear side 686 of the fluid-impermeable barrier 652. The connector piece 678 may also define a channel 688 (e.g., a tube) configured to allow the porous material 660 and the sump 682 to communicate with the conduit 662.

[0075] According to certain embodiments, at least a portion of connector piece 678 can exhibit a greater stiffness than shell 676. Increasing the stiffness of connector piece 678 relative to shell 676 can facilitate attachment of conduit 662 to connector piece 678. As one example, connector piece 678 can be formed from a material that has a greater Young's modulus (i.e., modulus of elasticity), yield strength, or ultimate tensile strength than the material forming shell 676, thereby increasing the stiffness of connector piece 678 relative to shell 676. As one example, connector piece 678 can be formed from a thickness that is greater than that of shell 676, thereby increasing the stiffness of connector piece 678 relative to shell 676.

[0076] In the illustrated embodiment, the menstrual container 600 is attached to a portion of the porous material 660 that is closer to the distal end region 670 of the fluid collection assembly 650 than to the proximal end region 672. In such an example, the menstrual container 600 may be positioned near the individual's vaginal opening, portions of the porous material 660 near the proximal end region 672 may be positioned near the urethral opening, and the conduit 662 may extend from the fluid collection assembly 650 toward the individual's abdomen, which may be found to be more comfortable and less likely to cause leakage. In some embodiments, not shown, the menstrual container 600 may be attached to a portion of the fluid-impermeable barrier 652 that is between the opening 656 and the distal-most portion of the fluid-impermeable barrier 652.

[0077] Further examples of fluid collection assemblies configured to receive bodily fluids from a female urethral meatus are disclosed in U.S. Patent No. 10,226,376, filed June 1, 2017, U.S. Patent No. 10,390,989, filed September 8, 2016, U.S. Patent No. 10,952,889, filed June 2, 2016, International Patent Application No. PCT / US2021 / 026607, filed April 10, 2020, U.S. Patent Application No. 17 / 597,673, filed June 16, 2020, and U.S. Provisional Patent Application No. 63 / 208,262, filed June 8, 2021, the disclosures of each of which are incorporated herein by reference in their entirety.

[0078] 7 is a schematic cross-sectional view of a fluid collection system 790 deployed on a female individual 796 according to one embodiment. Except as otherwise disclosed herein, the fluid collection system 790 can be the same as or substantially similar to any of the fluid collection systems disclosed herein. For example, the fluid collection system 790 can include a fluid collection assembly 750 and a menstrual container 700 that are the same as or substantially similar to any of the fluid collection assemblies and menstrual containers disclosed herein. For illustrative purposes, the fluid collection system 790 is depicted as being substantially identical to the fluid collection system 590 depicted in FIG. 5C.

[0079] The fluid collection system 790 can be positioned on the individual 796 such that the menstrual container 700 is positioned near a vaginal opening 797. Positioning the menstrual container 700 in this manner allows the menstrual container 700 to receive at least some blood and other menstrual fluids discharged from the vaginal opening 797. In other words, the menstrual container 700 prevents blood and other menstrual fluids from entering the porous material 760. The fluid collection assembly 750 is positioned on the individual 796 such that its opening is positioned near the individual's urethral opening 798, allowing at least some of the bodily fluids discharged from the urethral opening 798 to be received by the fluid collection assembly 750.

[0080] FIG. 8 is a block diagram of a fluid collection system 890 for fluid collection, according to one embodiment. The fluid collection system 890 includes a menstrual container 800, a fluid collection assembly 850, a fluid reservoir 892, and a vacuum source 894. The menstrual container 800 and the fluid collection assembly 850 can be the same as or substantially similar to any of the menstrual containers and fluid collection assemblies disclosed herein. The fluid collection assembly 850, the fluid reservoir 892, and the vacuum source 894 can be fluidly coupled to one or more of the fluid reservoir 892 and the vacuum source 894 via one or more conduits 862. For example, the fluid collection assembly 850 can be operably connected to one or more of the fluid reservoir 892 and the vacuum source 894 via the conduit 862. Bodily fluid collected in the fluid collection assembly 850 can be removed from the fluid collection assembly 850 via the conduit 862 extending into the fluid collection assembly 850. For example, the inlet of conduit 862 can extend into fluid collection assembly 850, e.g., to a reservoir therein. The outlet of conduit 862 can extend into fluid collection assembly 850 or into vacuum source 894. In response to application of a suction (e.g., vacuum) force to the outlet of conduit 862, a suction force can be introduced into a chamber of fluid collection assembly 850 via the inlet of conduit 862.

[0081] The suction force can be applied directly or indirectly to the outlet of the conduit 862 by the vacuum source 894. The suction force can also be applied indirectly via the fluid reservoir 892. For example, the outlet of the conduit 862 can be disposed within the fluid reservoir 892, and an additional conduit 862 can extend from the fluid reservoir 892 to the vacuum source 894. The vacuum source 894 can then apply suction to the fluid collection assembly 850 via the fluid reservoir 892. The suction force can also be applied directly by the vacuum source 894. For example, the outlet of the conduit 862 can be disposed within the vacuum source 894. The additional conduit 862 can extend from the vacuum source 894 to a point outside the fluid collection assembly 850, such as to the fluid reservoir 892. In this type of example, the vacuum source 894 can be disposed between the fluid collection assembly 850 and the fluid reservoir 892.

[0082] The fluid reservoir 892 is sized and shaped to allow bodily fluid to be retained therein. The fluid reservoir 892 can comprise a bag (e.g., a drainage bag), a bottle, a cup (e.g., a collection jar), or any other closed container capable of storing bodily fluid, such as urine. According to certain examples, a conduit 862 can extend from the fluid collection assembly 850 and attach to the fluid reservoir 892 at a first point therein. An additional conduit 862 can be attached to the fluid reservoir 892 at a second point thereon and extend to and attach to a vacuum source 894. In this manner, a vacuum force (e.g., suction force) can be drawn through the fluid collection assembly 850 via the fluid reservoir 892. Bodily fluid, such as urine, can be expelled from the fluid collection assembly 850 using the vacuum source 894.

[0083] The vacuum source 894 may include one or more of a manual vacuum pump, an electric vacuum pump, a diaphragm pump, a centrifugal pump, a positive displacement pump, a magnetic drive pump, a peristaltic pump, or any pump configured to generate a vacuum. The vacuum source 894 may provide a vacuum or suction force to remove bodily fluids from the fluid collection assembly 850. In certain examples, the vacuum source 894 may be powered by one or more of a power cord (e.g., connected to a power socket), one or more batteries, or even human power (e.g., a hand-operated vacuum pump). In certain examples, the vacuum source 894 may be sized and shaped to fit on, on, or within the fluid collection assembly 850. For example, the vacuum source 894 may include one or more miniature pumps or one or more micropumps. The vacuum source 894 disclosed herein may be accompanied by a switch, button, plug, remote control, or any other suitable device for activating the vacuum source 894.

[0084] While various implementations and embodiments are disclosed herein, other implementations and embodiments are contemplated, and the various implementations and embodiments disclosed herein are for illustrative purposes and are not intended to be limiting.

[0085] Degree indicators (e.g., "about," "substantially," "generally," etc.) indicate insignificant structural or functional variations. For example, when a degree indicator is incorporated with a quantity term, the degree indicator is interpreted to mean ±10%, ±5%, or +2% of the subsequently indicated amount. For example, when a degree indicator is used to modify a shape, the degree indicator indicates that the shape modified by the degree indicator exhibits the appearance of the disclosed shape. For example, the degree indicator can be used to indicate that the shape has rounded corners rather than sharp corners, curved edges rather than straight edges, one or more protrusions extending therefrom, is oval, is the same as the disclosed shape, etc.

Claims

1. 1. An external menstrual container comprising: at least one fluid impermeable layer defining a container chamber, the at least one fluid impermeable layer comprising: an upper portion configured to be placed against the vaginal region of an individual, the upper portion defining a container opening configured to allow menstrual fluid to flow from the vaginal region into the container chamber; and a lower portion opposite the upper portion, the lower portion being at least one of: configured to be attached to a fluid collection assembly; and configured to be abutted against the fluid collection assembly and having a concave shape; External menstrual vessel.

2. 10. The external menstrual container of claim 1, wherein the at least one fluid-impermeable layer has a ring forming the upper side and defining the container opening, the ring exhibiting a stiffness greater than the stiffness of the remainder of the at least one fluid-impermeable barrier.

3. 3. The external menstrual container of claim 1 or 2, wherein at least a portion of said at least one fluid impervious layer is at least partially transparent.

4. 4. The external menstrual container of claim 1, wherein the top portion comprises an adhesive portion configured to chemically or physically attach the top portion to the vaginal area.

5. 5. The external menstrual container of claim 1, further comprising an adhesive portion on the lower side of the at least one fluid impermeable layer, the adhesive portion configured to attach the bag side to the fluid collection assembly.

6. 6. The external menstrual container of claim 5, wherein the adhesive is glue-free.

7. 7. The external menstrual container of claim 5, wherein the adhesive portion comprises a plurality of hooks.

8. 8. The external menstrual container of claim 1, wherein the fluid impermeable layer has one or more markings thereon, the one or more markings configured to facilitate accurate attachment of the external menstrual container to the fluid collection assembly.

9. 9. The external menstrual container of claim 1, further comprising one or more wings extending from or near at least a portion of the upper side of the fluid impermeable layer.

10. 10. The external menstrual container of claim 9, wherein the one or more wings have a front wing side and a rear wing side opposite the front wing side, at least a portion of the front wing side faces the vaginal area when the upper portion of the fluid-impermeable layer is in contact with the vaginal area, and at least a portion of the front wing side has an adhesive portion.

11. 11. The external menstrual container of claim 1, further comprising one or more wings extending from or near at least a portion of the lower portion of the fluid-impermeable layer, the one or more wings having a front wing side and a rear wing side opposite the front wing side, at least a portion of the front wing side facing the vaginal area when the upper portion of the fluid-impermeable layer is in contact with the vaginal area, and at least a portion of the rear wing side having an adhesive portion.

12. 12. The external menstrual container of any one of claims 1 to 11, wherein the container chamber is substantially empty.

13. The external menstrual container of any one of claims 1 to 12, further comprising at least one porous material disposed within the container chamber.

14. 1. A fluid collection system comprising: a fluid collection assembly; a fluid-impermeable barrier defining at least a chamber, an opening, and a fluid outlet; at least one porous material disposed within the chamber and extending across the opening; a fluid collection assembly having an external menstrual receptacle, The container has at least one fluid impermeable layer defining a chamber, the at least one fluid impermeable layer comprising: an upper portion configured to be placed against the vaginal area of ​​an individual, the upper portion defining a bag opening configured to allow menstrual fluid to flow from the vaginal area into the container chamber; and a lower portion opposite the upper portion, the lower portion being at least one of: configured to be attached to the fluid collection assembly; attached to the fluid collection assembly; and abutting the fluid collection assembly; an external menstrual receptacle; A fluid collection system comprising:

15. 15. The fluid collection system of claim 14, wherein the fluid impermeable barrier has one or more markings thereon that facilitate attachment of the external menstrual container to the fluid collection assembly.

16. 16. The fluid collection system of claim 14, wherein the external menstrual container has one or more markings, and the one or more markings on the external menstrual container are configured to be aligned with the one or more markings on the fluid-impermeable barrier when the external menstrual container is attached to the fluid collection assembly.

17. 17. The fluid collection system of any one of claims 14 to 16, wherein the external menstrual container is not attached to the fluid collection assembly.

18. 18. The fluid collection system of any one of claims 14 to 17, wherein the external menstrual container is attached to the at least one porous material.

19. 19. The fluid collection system of any one of claims 14 to 18, wherein the external menstrual container is attached to the fluid impermeable barrier.

20. 20. The fluid collection system of claim 14, wherein the fluid-impermeable barrier has a proximal end region defining the fluid outlet and a distal end region opposite the proximal end region, and the external menstrual container is attached to the fluid collection assembly at a location closer to the distal end region than to the proximal end region.

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