External menstrual container and fluid collection system including external menstrual container
By designing an external menstrual container and fluid collection assembly, the problems of menstrual fluid collection inconvenience and discomfort caused by catheters in the prior art are solved, and efficient and sanitary menstrual fluid collection and urine treatment are achieved.
Patent Information
- Application Number
- CN202280101893.1
- Authority / Receiving Office
- CN · China
- Patent Type
- Applications(China)
- Current Assignee / Owner
- Filing Date
- 2022-09-21
- Publication Date
- 2025-07-04
AI Technical Summary
Existing catheters and potty can cause discomfort, pain during use, and are prone to spillage and hygiene problems, making it difficult to effectively collect menstrual fluid, especially in individuals with reduced mobility.
An external menstrual container is designed, including a fluid anti-seepage layer, abutting the vaginal area on the top side to accommodate the menstrual fluid, and a bottom side to attach or abut the fluid collection assembly, combining the fluid collection assembly to facilitate the collection of menstrual fluid and the separation of urine.
Effectively accommodate menstrual fluid, prevent it from entering porous materials, reduce leakage, improve the efficiency of fluid collection components, reduce discomfort on individuals, and provide a more hygienic and convenient collection method.
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Figure CN120265234A_ABST
Abstract
Description
Background Art
[0001] The mobility of a person or an animal may be limited or impaired, so the normal urination process is difficult or hard to complete. For example, an individual may suffer from or have a disability that impairs mobility. An individual may be in a restricted mobility condition, such as the conditions experienced by pilots, drivers, and workers in hazardous areas. In addition, sometimes for monitoring purposes or clinical tests, it is necessary to collect body fluids.
[0002] Catheters such as Foley catheters can address some of these situations, such as incontinence. Unfortunately, catheters can be uncomfortable, painful, and may cause complications, such as infections. In addition, sometimes bedpans are used, which are containers for bedridden people to use the toilet. However, bedpans may be prone to discomfort, spills, and other hygiene problems. Summary of the Invention
[0003] In an embodiment, an external menstrual container is disclosed. The external menstrual container includes at least one fluid-impermeable layer defining a container chamber. The at least one fluid-impermeable layer includes a top side configured to abut an individual's vaginal region. The top 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 further includes a bottom side opposite the top side, and the bottom side is at least one of: configured to be attached to a fluid collection assembly; or concave and configured to abut the fluid collection assembly.
[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 barrier defining at least a chamber, an opening, and a fluid outlet. The fluid collection assembly further includes at least one porous material disposed in the chamber and extending through the opening. The fluid collection system further includes an external menstrual container. The external menstrual container includes at least one fluid-impermeable layer defining a container chamber. The at least one fluid-impermeable layer includes a top side configured to abut an individual's vaginal region. The top 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 further includes a bottom side opposite the top side. The bottom side is configured to be at least one of: attached to the fluid collection assembly; attached to the fluid collection assembly; or abut the fluid collection assembly.
[0005] The features from any disclosed embodiment can be used in combination with each other without limitation. In addition, by considering the following detailed description and the drawings, other features and advantages of the present disclosure will become apparent to those of ordinary skill in the art. Brief Description of the Drawings
[0006] The accompanying drawings illustrate several embodiments of the present disclosure, wherein like reference numerals represent the same or similar elements or features in different views or embodiments shown in the drawings.
[0007] Figure 1A is an isometric view of a menstrual container according to an embodiment.
[0008] Figure 1B is a cross-sectional view of a menstrual container taken along plane 1B-1B according to an embodiment.
[0009] Figure 2 is a schematic cross-sectional view of a menstrual container according to an embodiment, the menstrual container including at least one porous material disposed in a container chamber therein.
[0010] Figure 3 is an isometric view of a menstrual container according to an embodiment, the menstrual container including one or more wings configured to directly attach the menstrual container to an individual.
[0011] Figure 4 is an isometric view of a menstrual container according to an embodiment, the menstrual container including one or more wings configured to directly attach the menstrual container to a fluid collection assembly.
[0012] Figure 5A is a side view of a fluid collection assembly according to an embodiment.
[0013] Figure 5B is along Figure 5A a schematic cross-sectional view of a fluid collection assembly taken along plane 5B-5B shown.
[0014] Figure 5C is a schematic cross-sectional view of a fluid collection system according to an embodiment, the fluid collection system including a fluid collection assembly to which a menstrual container is attached.
[0015] Figure 6 is a schematic cross-sectional view of a fluid collection system according to an embodiment, the fluid collection system including a fluid collection assembly and a menstrual container.
[0016] Figure 7 is a schematic cross-sectional view of a fluid collection system disposed on a female individual according to an embodiment.
[0017] Figure 8 is a block diagram of a fluid collection system for fluid collection according to an embodiment. Detailed Description
[0018] The embodiments relate to an external menstrual container, a fluid collection system including the external menstrual container, and a method of using the external menstrual container. Exemplary external menstrual containers (e.g., bags, cups, etc.) include at least one fluid-impermeable layer that defines a container chamber configured to receive one or more menstrual fluids (e.g., blood, vaginal fluids, mucosal tissue, cervical mucus, etc.). The fluid-impermeable layer of the external menstrual container includes a top side configured to abut an individual's vaginal region and a bottom side opposite the top side. The top side of the fluid-impermeable layer may be configured to allow menstrual fluid to flow from the individual's vaginal region into the container chamber. The bottom side is configured to attach to and / or abut a fluid collection assembly.
[0019] A fluid collection assembly configured to be used with the external menstrual container may include a fluid-impermeable barrier that defines a chamber, an opening, and a fluid outlet. The fluid collection assembly may further include at least one porous material disposed within the chamber. The fluid collection assembly may further include at least one conduit that is in fluid communication with the chamber via the fluid outlet. The conduit may be attached directly or indirectly to a fluid storage container and a vacuum source.
[0020] The external menstrual container may be attached to or abut the fluid collection assembly to form a fluid collection system. During use, the fluid collection system is positioned on the individual such that the mouth of the external menstrual container is near the individual's vaginal orifice and a portion of the opening of the fluid collection assembly is near the individual's urethral orifice. This positioning of the fluid collection system 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 body fluids (e.g., urine) discharged from the urethral orifice to be received by the porous material. Body fluids received by the porous material may be removed from the chamber of the fluid collection assembly using the conduit and placed in a fluid storage container. For example, a vacuum source may apply suction to the chamber to facilitate removal of body fluids from the chamber.
[0021] External menstrual containers allow for more effective use of fluid collection components during an individual's menstrual period. For example, setting up only the fluid collection component without an external menstrual container can result in a porous material accommodating menstrual fluid discharged from the vaginal orifice. However, the menstrual fluid accommodated in the porous material may block the pores of the porous material, which in turn inhibits the flow of body fluids through the porous material. For example, the blood in the menstrual fluid may coagulate, permanently clogging the pores of the porous material. Menstrual fluid also exhibits a greater viscosity relative to body fluids, resulting in the menstrual fluid remaining in the porous material for a longer time, both of which inhibit the flow of body fluids through the porous material. The inhibition of body fluid flow through the porous material by menstrual fluid may cause the fluid collection component to leak or be unable to accommodate body fluids discharged from the urethral orifice and may reduce the usage time of the fluid collection component. However, the external menstrual container disclosed herein captures menstrual fluid while preventing or at least inhibiting the entry of menstrual fluid into the porous material. In this way, the external menstrual container allows the fluid collection component to be used for menstruating individuals without affecting the efficiency of the fluid collection component.
[0022] Figure 1A is an isometric view of a menstrual container 100 according to an embodiment. Figure 1B is a cross-sectional view of the menstrual container 100 taken along plane 1B-1B according to an embodiment. The menstrual container 100 includes one or more fluid-impermeable layers 102 that define a container chamber 104. The fluid-impermeable layer 102 also includes a top side 106 and a bottom side 108, the top side 106 being configured to abut the vaginal region of an individual and the bottom side 108 being opposite the top side 106. The top side 106 defines a bag opening 110 that allows menstrual fluid to flow into the container chamber 104. The bottom side 108 is configured to abut a fluid collection component (such as Figures 5A to 6 shown).
[0023] The fluid impermeable layer 102 at least partially defines a container chamber 104 and a 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 stores the menstrual fluid contained in the menstrual container 100 within the container chamber 104. The container chamber 104 may present 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 a number of factors. In an example, the volume of the container chamber 104 can be selected based on the period of time an individual anticipates using the menstrual container 100, as the volume of the container chamber 104 may need to increase as the anticipated period of time increases. In an example, the volume of the container chamber 104 can be selected based on the anticipated volume of menstrual fluid discharged. For example, when the anticipated volume of menstrual fluid discharged is high (e.g., during the first and second days of menstruation), the volume of the container chamber 104 can be increased, and when the anticipated volume of menstrual fluid discharged is expected to be low (e.g., during menstrual spotting or near the end of menstruation), the volume of the container chamber 104 can be decreased. In an 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 can cause the portion of the fluid collection assembly adjacent to the menstrual container 100 to move away from the vaginal area. Moving the fluid collection assembly away from the vaginal area may increase the likelihood of the fluid collection assembly leaking body fluids.
[0024] The fluid impermeable layer 102 can be formed from any suitable fluid impermeable material, e.g., a fluid impermeable polymer (e.g., silicone, polypropylene, polyethylene, polyethylene terephthalate, neoprene, polycarbonate, etc.), a metal film, natural rubber, another suitable material, any other fluid impermeable material disclosed herein, or a combination thereof. As such, the fluid impermeable layer 102 substantially prevents body 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 can be formed from a soft and / or smooth material to reduce abrasion.
[0025] In an embodiment, at least a portion of the fluid impermeable layer 102 is transparent. In such an embodiment, the transparent portion of the fluid impermeable layer 102 allows an individual using the menstrual container 100 or another individual (e.g., a practicing physician) to easily observe the container chamber 104. For example, the transparent portion of the fluid impermeable layer 102 allows these individuals to quickly determine the amount of menstrual fluid in the container chamber 104, e.g., quickly determine when the menstrual container 100 needs to be emptied or disposed of before menstrual fluid leaks from the menstrual container 100.
[0026] In an embodiment, the fluid impermeable layer 102 includes a ring 116 that forms at least a portion of the top side 106. The ring 116 exhibits greater rigidity than the remainder of the fluid impermeable layer 102. The ring 116 may exhibit rigidity because at least one of the rings 116 exhibits a greater thickness or Young's modulus (i.e., modulus of elasticity) 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 the bag opening 110 from collapsing when the ring 116 is positioned between the labial folds of an individual. The ring 116 also allows the top side 106 of the fluid impermeable layer 102 to be molded or shaped to present a shape corresponding to a portion of the vaginal region (e.g., corresponding to the portion of the vaginal region that defines the vaginal opening). In a particular embodiment, the ring 116 may be formed of silicone.
[0027] In an embodiment, the top side 106 (e.g., the ring 116) of the fluid impermeable layer 102 may define a generally circular bag opening 110. In an embodiment, the top side 106 may present an elongated (e.g., generally oval) bag opening 110. The elongated opening 110 allows the bag opening 110 to extend along a greater length of the vaginal region while also fitting between the thighs of an individual.
[0028] The menstrual container 100 may be configured as an external menstrual container 100 that does not insert into the vaginal opening of an individual. Configuring the menstrual container 100 as an external menstrual container reduces the likelihood of the menstrual container 100 causing an infection in the vaginal region and may allow the menstrual container 100 to be sterilized in a less cumbersome manner (e.g., the menstrual container 100 does not need to be formed of materials that must withstand a cumbersome sterilization process). Instead, the menstrual container 100 may be configured to be positioned such that at least one of the bag openings 110 is adjacent to the vaginal opening, at least a portion of the menstrual container 100 (e.g., at least the ring 116) is located between the labial folds, or the bag opening 110 is adjacent to the labial folds. This position of the menstrual container 100 allows the menstrual container 100 to contain at least some menstrual fluid while minimizing the likelihood of menstrual fluid leaking or not being contained within the container chamber 104.
[0029] In an embodiment, when the menstrual container 100 is an external menstrual container, the menstrual container 100 can include a forward adhesion structure 118 disposed on at least a portion of the top side 106 of the fluid impermeable layer 102 or at least a portion of the fluid impermeable layer 102 adjacent to the top side 106 (e.g., the outer side of the ring 116). The forward adhesion structure 118 can 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 inhibits movement of the menstrual container 100 relative to the vaginal orifice, because movement of the menstrual container 100 relative to the vaginal orifice may allow menstrual fluid to flow around the menstrual container 100 rather than through the bag opening 110 into the container chamber 104. Attaching the fluid impermeable layer 102 to the vaginal area also forms a seal that prevents or at least inhibits menstrual fluid from flowing out of the container chamber 104. The forward adhesion structure 118 includes an adhesive 120. The adhesive 120 can include any chemical or physical component capable of attaching to the vaginal area. For example, the adhesive 120 can include a pressure-sensitive adhesive, a water-activated adhesive, a heat-sensitive adhesive, a nanobelt (also known as a gecko tape), another van der Waals attachment, or any other suitable adhesive. In an example, the forward adhesion structure 118 further includes a release liner 122 that protects the adhesive 120 and prevents the adhesive 120 from adhering to structures other than the individual's vaginal area. In an example, the forward adhesion structure 118 can include a substrate (e.g., a polymer film, not shown) to which the adhesive 120 is attached. The substrate can be attached to the fluid impermeable layer 102.
[0030] The adhesion structure 118 may cause irritation to the vaginal area and / or may be painful for some patients to separate the menstrual container 100 from the vaginal area. Thus, in an embodiment, the menstrual container 100 does not include the forward adhesion structure 118. In such an embodiment, the menstrual container 100 can remain against or adjacent to the vaginal orifice because, for example, at least one menstrual container 100 is located between the labial folds and the labial folds hold the position of the menstrual container 100, or the fluid collection assembly to which the menstrual container 100 abuts holds the position of the menstrual container 100.
[0031] The bottom side 108 of the menstrual container 100 is configured to abut a fluid collection assembly. In an embodiment, the bottom side 108 can present a shape that generally corresponds to the shape of the portion of the fluid collection assembly to which the bottom side 108 abuts. For example, as Figures 5A to 6 shown, the bottom side 108 is configured to abut a convexly curved portion of the fluid collection assembly. Thus, the bottom side 108 can present a concave curve that generally corresponds to the convexly curved portion of the fluid collection assembly. In an embodiment, the bottom side 108 can be relatively flat.
[0032] In an embodiment, the menstrual container 100 may include a rearward adhesion structure 124 disposed on at least a portion of the bottom side 108 of the fluid-impermeable layer 102. The rearward adhesion structure 124 may be configured to attach the fluid-impermeable layer 102 to the fluid collection assembly. Attaching the fluid-impermeable layer 102 to the fluid collection assembly prevents the menstrual container 100 from moving relative to the fluid collection assembly and allows the fluid collection assembly to hold the position of the menstrual container 100.
[0033] The rearward adhesion structure 124 includes an adhesive 126. The adhesive 126 may include any chemical or physical component that can attach to the fluid collection assembly. In an embodiment, the adhesive 126 may be configured to attach to a porous material (e.g., Figure 5A and Figure 5B porous material 560) of the fluid collection assembly. In such an embodiment, the adhesive 126 may include a plurality of hook-like structures (e.g., hook-like structures similar to Velcro attachments) capable of gripping the fibers of the porous material, a pressure-sensitive adhesive configured to attach to the surface of the porous material and substantially not flow into the porous material, a nano-tape, another van der Waals attachment, or any other suitable adhesive. In an embodiment, the adhesive 126 is configured to allow the menstrual container 100 to be separated from the porous material with substantially no damage to the adhesive 126 and the porous material. In such an embodiment, the menstrual container 100 may be separated from the porous material for inspection, emptying the menstrual container 100, or for other purposes, and then the menstrual container 100 may be reattached to the porous material for further use. In an example, the adhesive 126 does not include a glue or other adhesive that may enter and clog the pores of the porous material because, as previously described, clogging the pores of the porous material inhibits the flow of body fluids through the porous material. In an embodiment, the rearward adhesion structure 124 is configured to attach to a fluid-impermeable barrier (e.g., Figure 5A and Figure 5B fluid-impermeable barrier 552) of the fluid collection assembly. In such an embodiment, the adhesive 126 may include a pressure-sensitive adhesive, a nano-tape, another van der Waals attachment, a glue, or any other suitable adhesive.
[0034] In addition to the adhesive 126, the rearward adhesion structure 124 may include one or more structures. In an example, the rearward adhesion structure 124 includes a release liner 128 that protects the adhesive 126 and prevents the adhesive 126 from adhering to structures other than the individual vaginal area. In an example, the rearward adhesion structure 124 may include a substrate (e.g., a polymer film, not shown) to which the adhesive 126 is attached. The substrate may be attached to the fluid-impermeable layer 102.
[0035] In an embodiment, the menstrual container 100 may include one or more markings 130. The markings 130 may include any structure visually distinguishable on or in the fluid-impermeable layer 102 that is formed on the fluid-impermeable layer 102. For example, the markings 130 may be printed on the fluid-impermeable layer 102, formed by one or more grooves formed in the fluid-impermeable layer 102, or formed by one or more protrusions extending from the fluid-impermeable layer 102.
[0036] The markings 130 may be configured to facilitate positioning the menstrual container 100 on the fluid collection assembly. For example, Figures 5A to 6 The illustrated fluid collection assembly includes an elongated opening. In the case where the menstrual container 100 is not adjacent to the fluid collection assembly, the top of the elongated opening is positioned adjacent to the urethral orifice, and the bottom of the elongated opening (e.g., the portion closer to the distal region than the top) is positioned adjacent to the urethral orifice. When attaching the menstrual container 100 to such a fluid collection assembly, it is important to accurately position the menstrual container 100 on the fluid collection assembly. For example, positioning the menstrual container 100 close to the top of the elongated opening may cause the menstrual container 100 to block or otherwise interfere with the fluid collection assembly that receives body fluid from the urethral orifice. Similarly, positioning the menstrual container 100 away from the top of the elongated opening may make it difficult to correctly position the fluid collection assembly on the individual while keeping the bag opening 110 close to the vaginal orifice. Incorrect positioning of the fluid collection assembly may result in leakage and / or movement of the fluid collection system. Additionally, when the bag opening 110 has an elongated shape, the markings 130 may facilitate aligning the menstrual container 100 with the vaginal region.
[0037] In an embodiment, the markings 130 on the menstrual container 100 are configured to align with one or more features on the fluid collection assembly. For example, the markings 130 may be a line configured to align with the boundary of the opening of the fluid collection assembly, an arrow aligned with the terminus of the opening (as shown), or one or more markings formed on the fluid collection assembly, etc.
[0038] In an embodiment, the menstrual container 100 may be reusable. The menstrual container 100 is reusable when it can be used two or more times without damage and is sterilized between each use. In an embodiment, the menstrual container 100 may be configured to be disposable. For example, when at least a portion of the fluid-impermeable layer 102 is formed of a film (e.g., having a minimum thickness of less than 0.5 mm), the menstrual container 100 may be configured to be disposable.
[0039] In an embodiment, as shown, the menstrual container 100 has a maximum width at or near the bag opening 110, and the width of the menstrual container 100 remains relatively constant from the top side 106 to the bottom side 108 or from near the top side 106 to the bottom side 108. In an embodiment, the menstrual container 100 has a maximum width at a position spaced apart from the bag opening 110, such as at the bottom side 108 or at a position between the front side 106 and the bottom side 108. In such an embodiment, the container chamber 104 of the menstrual container 100 can present a volume that is equal to or greater than the volume of the container chamber 104 of the menstrual container 100 when it presents the maximum width at or near the top side 106, while preventing or minimizing the distance by which the menstrual container 100 displaces the fluid collection assembly from the vaginal region.
[0040] The container chamber 104 of the menstrual container 100 is substantially unoccupied, which maximizes the amount of menstrual fluid retained in the container chamber 104, making it easier to empty the container chamber 104 and minimizing the distance by which the menstrual container can displace the fluid collection assembly from the vaginal region compared to a situation where the container chamber 104 is at least partially occupied by a porous material. However, the substantially unoccupied container chamber 104 allows the menstrual fluid contained therein to flow therein, which may result in leakage of the menstrual fluid from the container chamber 104. Thus, in some embodiments, the menstrual containers disclosed herein can include at least one porous material disposed in the container chamber 104. For example, Figure 2 is a cross-sectional schematic view of a menstrual container 200 according to an embodiment, the menstrual container 200 including at least one porous material 232 disposed in a container chamber 204 therein. Unless otherwise disclosed herein, the menstrual container 200 can be the same as or substantially similar to any of the menstrual containers disclosed herein.
[0041] The porous material 232 can include any material that can hold menstrual fluid. For example, the porous material 232 can include fabrics, gauzes (such as silk, linen, or cotton gauzes), another soft fabric, another smooth fabric, non-woven materials, woven materials (such as spun nylon fibers), porous polymer (such as nylon, polyester, polyurethane, polyethylene, polypropylene, etc.) structures, open-cell foams, or more than two different porous materials (such as a top layer and a bottom layer).
[0042] As previously mentioned, the menstrual containers disclosed herein can include a structure for directly attaching the menstrual container to an individual. For example, as regarding Figure 1A and Figure 1BDiscussed in more detail, the menstrual containers disclosed herein can include a forward adhesion structure 118 configured to attach the menstrual container 100 to the vaginal region. However, it should be noted that the menstrual containers disclosed herein can include structures different from the forward adhesion structure 118, or can include other structures in addition to the forward adhesion structure 118, which are configured to attach the menstrual container 100 directly to an individual. Figure 3 Figure 3 is an isometric view of a menstrual container 300 according to an embodiment, the menstrual container 300 including one or more wings 334 configured to attach the menstrual container 300 directly to an individual. Unless 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 that includes a top side 306 and a bottom side 308, the top side 306 defining a bag opening 310. The fluid-impermeable layer 302 can also include a ring 316.
[0043] As previously described, the menstrual container 300 includes one or more wings 334. The wings 334 are structures attached to the fluid-impermeable layer 302 and extending laterally away from the fluid-impermeable layer 302 (e.g., radially with respect to the bag opening 310). The wings 334 are configured to attach the menstrual container 300 to an individual. The wings 334 can extend from the top side 306 or near the top side 306 of the fluid-impermeable layer 302. For example, when the fluid-impermeable layer 302 includes a ring 316 (as shown), the wings 334 can extend from the portion of the ring 316 that defines the top side 306, the side surface of the ring 316, or from the bottom edge of the ring 316 (e.g., the edge of the ring 316 opposite the top side 306).
[0044] The wing 334 includes a front wing side 336 and a rear wing side 338, and the rear wing side 338 is opposite to the front wing side 338. The front wing side 336 is the side of the wing 334 that faces an individual (e.g., the vaginal area and / or thigh of the individual) during use. For example, the front wing side 336 may face substantially the same direction as the top side 306 of the fluid impermeable layer 302. The wing 334 includes a wing adhesion structure 340 (schematically shown in cross-section on the wing 334) disposed on at least a portion of the front wing side 336. The wing adhesion structure 340 is configured to attach the wing 334 to an individual, such as to the vaginal area and / or thigh of the individual. The wing adhesion structure 340 may be substantially similar to any adhesion structure disclosed herein. For example, the wing adhesion structure 340 includes an adhesive (e.g., any adhesive disclosed herein) and may optionally include other structures, such as a release liner or a substrate. In an example, the wing adhesion structure 340 includes an adhesive that is weaker than the adhesive that attaches the menstrual container 300 to the fluid collection assembly. The weaker adhesion of the wing adhesion structure 340 reduces the likelihood of causing harm or unnecessary pain to the individual when separating the menstrual container 300 from the individual, and reduces the likelihood that significant movement of the fluid collection assembly (e.g., removing the fluid collection assembly from the individual) will separate the menstrual container 300 from the fluid collection assembly.
[0045] In an embodiment, the wing adhesion structure 340 covers all or substantially all of the front wing side 336. In such an embodiment, the wing adhesion structure 340 attaches to the vaginal area and, if the wing 334 is long enough, to the thigh of the individual. In an embodiment, the wing adhesion structure 340 covers only a portion of the front wing side 336. For example, the wing adhesion structure 340 may cover only the portion of the front wing side 336 that is spaced apart from the fluid impermeable layer 302. In such an example, spacing the wing adhesion structure 340 from the fluid impermeable layer 302 can reduce the percentage of the sensitive vaginal area to which the wing 334 is attached, thereby reducing the pain caused by separating the wing 334 from the vaginal area. In an embodiment, the wing adhesion structure 340 is formed of two or more different adhesives having different adhesion strengths. For example, the portion of the wing adhesion structure 340 that is configured to attach to the vaginal area may exhibit a weaker adhesion strength than the portion of the wing adhesion structure 340 that is configured to attach to the thigh of the individual. In such an example, the adhesion structure 340 allows the wing 334 to firmly attach to the individual while minimizing any discomfort or pain caused by separating the menstrual container 300 from the individual.
[0046] In an embodiment, as shown, the wing 334 does not surround the fluid impermeable layer 302 (e.g., does not surround the ring 316). In an embodiment, the wing 334 may completely surround the fluid impermeable layer 302 (e.g., completely surround the ring 316), which can facilitate forming a seal around the vaginal opening.
[0047] As previously described, the menstrual containers disclosed herein can include structures that directly attach the menstrual container to a fluid collection assembly. For example, as discussed in more detail with respect to Figure 1A and Figure 1B the menstrual containers disclosed herein can include a rearward adhesion structure 124 that is configured to attach the menstrual container 100 to a fluid collection assembly. However, it should be noted that the menstrual containers disclosed herein can include structures different from the rearward adhesion structure 124, or can include other structures in addition to the rearward adhesion structure 124 that are configured to directly attach the menstrual container 100 to a fluid collection assembly. Figure 4 FIG. Figure 4 is an isometric view of a menstrual container 400 according to an embodiment that includes one or more wings 434 that are configured to directly attach the menstrual container to a fluid collection assembly. Unless 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 that includes a top side 406 and a rear side (covered by the wing 434), and the top side 406 defines a pouch opening 410. The fluid impermeable layer 402 can also include a ring 416.
[0048] As previously described, the menstrual container 400 includes one or more wings 434. The wings 434 are structures that are attached to the fluid impermeable layer 402 and extend laterally away from the fluid impermeable layer 402 (e.g., radially with respect to the pouch opening 410). The wings 434 are configured to attach the menstrual container 400 to a fluid collection assembly. The wings 434 extend from the bottom side 408 or near the bottom side 408 of the fluid impermeable layer 402.
[0049] The wings 434 include a front wing side 436 and a rear wing side 438 that is opposite the front wing side 436. The rear wing side 438 is the side of the wing 434 that faces the fluid collection assembly during use. For example, the rear wing side 438 can face in generally the same direction as the bottom side 408 of the fluid impermeable layer 402. The wings 434 include a wing adhesion structure 440 (schematically shown in cross-hatch on the wing 434) disposed on at least a portion of the rear wing side 438. The wing adhesion structure 440 is configured to attach the wing 436 to a fluid collection assembly. The wing adhesion structure 440 can be substantially similar to any of the adhesion structures disclosed herein. For example, the wing adhesion structure 440 includes an adhesive (e.g., any of the adhesives disclosed herein) and can optionally include other structures such as a release liner or substrate.
[0050] In an embodiment, the wing adhesive structure 440 covers all or substantially all of the posterior wing side 438. In such an embodiment, the wing adhesive structure 440 may be attached to a porous material, which, as previously described, may limit the type of adhesive for attaching the wing adhesive structure 440 to the fluid collection assembly to prevent or limit adhesive blockage of the pores. In an embodiment, the wing adhesive structure 440 covers only a portion of the posterior wing side 438. For example, the wing adhesive structure 440 may cover a lateral portion (e.g., a non-central portion) of the posterior wing side 438. In such an example, the wing adhesive structure 440 may not be attached to the porous material of the fluid collection assembly, thereby allowing a wider variety of adhesives to be selected for the wing adhesive structure 440. In an embodiment, the wing adhesive structure 440 is formed of two or more different adhesives. For example, the portion of the wing adhesive structure 440 configured to be attached to the porous material may be selected from an adhesive that does not block or substantially does not block the pores of the porous material, while the adhesive of the wing adhesive structure 440 not configured to be attached to the porous material may be formed of an adhesive that may at least partially block the pores of the porous material when attached to the porous material.
[0051] As previously described, the menstrual containers disclosed herein may be used with a fluid collection assembly. Figure 5A is a side view of a fluid collection assembly 550 according to an embodiment. Figure 5B is along Figure 5A A cross-sectional schematic view of the fluid collection assembly 550 taken along the plane 5B-5B shown. The fluid collection assembly 550 includes a fluid impermeable barrier 552. The fluid impermeable barrier 552 defines a chamber 554, an opening 556, and a fluid outlet 558. The fluid collection assembly 550 further includes at least one porous material 560 disposed in the chamber 554 and at least partially occupying the chamber 554.
[0052] 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 stores body fluid in the chamber 554. The fluid impermeable barrier 552 can be formed of any suitable fluid impermeable material, such as a fluid impermeable polymer (e.g., silicone, polypropylene, polyethylene, polyethylene terephthalate, neoprene, polycarbonate, etc.), a metal film, natural rubber, another suitable material, any other fluid impermeable material disclosed herein, or a combination thereof. Thus, the fluid impermeable barrier 552 substantially prevents body fluid from passing through the fluid impermeable barrier 552. In an example, the fluid impermeable barrier 552 can be air permeable and fluid impermeable. In such an example, the fluid impermeable barrier 552 can be formed of a hydrophobic material that defines a plurality of pores. At least one or more portions of at least the outer surface of the fluid impermeable barrier 552 can be formed of a soft and / or smooth material to reduce abrasion.
[0053] In some examples, the fluid impermeable barrier 552 can be tubular (ignoring the opening 556), e.g., substantially cylindrical (as shown), oval, prismatic, or a flat tube. During use, the outer surface of the fluid impermeable barrier 552 can contact an individual. The size and shape of the fluid impermeable barrier 552 can be designed to fit between the labia and / or the gluteal cleft of a female user's legs.
[0054] The opening 556 provides an entry path for body fluid to enter the chamber 554. The opening 556 can be defined by the fluid impermeable barrier 552, e.g., by the inner edge of the fluid impermeable barrier 552. For example, the opening 556 is formed in the fluid impermeable barrier 552 and extends through the fluid impermeable barrier 552 from the outer surface to the inner surface such that body fluid can enter the chamber 554 from the exterior of the fluid collection assembly 550.
[0055] The opening 556 can be an elongated aperture in the fluid impermeable barrier 552. For example, the opening 556 can be defined as a cutout in the fluid impermeable barrier 552. The position and shape of the opening 556 can be designed to be positioned adjacent to the female urethral orifice. The opening 556 can have an elongated shape because the space between a female's legs is relatively small when the female's legs are closed, thereby allowing body fluid to flow only along a path corresponding to the elongated shape of the opening 556 (e.g., an opening 556 that extends longitudinally).
[0056] The fluid collection assembly 550 can be positioned near the female urethral orifice, and body fluid can enter the chamber 554 of the fluid collection assembly 550 via the opening 556. The fluid collection assembly 550 is configured to receive body fluid into the chamber 554 via the opening 556. In use, the opening 556 can have an elongated shape extending from a first position below the urethral orifice (e.g., located at or near the anus or vaginal orifice) to a second position above the urethral orifice (e.g., located at or near the top of the vaginal orifice or pubic hair).
[0057] In some examples, the fluid impermeable barrier 552 can define a fluid outlet 558 sized to accommodate a catheter 562. At least one catheter 562 can be disposed in the chamber 554 via the fluid outlet 558. The size and shape of the fluid outlet 558 can be designed to form at least a substantially liquid-tight seal with the catheter 562 or at least one tube, thereby substantially preventing body fluid from escaping the chamber 554.
[0058] In an embodiment, the fluid impermeable barrier 552 can include one or more markings 530. The markings 530 can include any structure visually distinguishable on or in the fluid impermeable barrier 552 formed on the fluid impermeable barrier 552. For example, the markings 530 can be printed on the fluid impermeable barrier 552, formed by one or more grooves formed in the fluid impermeable barrier 552, or formed by one or more protrusions extending from the fluid impermeable barrier 552.
[0059] The markings 530 can be configured to facilitate positioning of the menstrual container on the fluid collection assembly. For example, as previously described, failure to correctly position the menstrual container on the fluid collection assembly 550 can result in leakage and / or movement of the fluid collection assembly 550. In an embodiment, 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 can be an arrow configured to align with a marking on the menstrual container (e.g., Figure 1A the marking 130).
[0060] In an embodiment, the porous material 560 can be configured to wick any body fluid from the opening 556, thereby preventing the body fluid from escaping the chamber 554. The permeable characteristics referred to herein can be wicking, capillary action, diffusion, or other similar characteristics or processes, and are referred to herein as "permeable" and / or "wicking". Such "wicking" and / or "permeable" performance may not include absorbing the body fluid into at least a portion of the porous material 560, for example, not including absorbing the body fluid into the fluid permeable support 568. In other words, after the material is exposed to and removed from the body fluid for a period of time, the body fluid may be substantially unabsorbed or undissolved in the material. Although no absorption or dissolution is desired, the term "substantially unabsorbed" may allow a nominal amount of body fluid to be absorbed and / or dissolved in the porous material 560 (e.g., absorbent), for example, 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 560. The porous material 560 can also wick the body fluid generally into the interior of the chamber 554, as discussed in more detail below. In an embodiment, the porous material 560 can include at least one absorbent or adsorbent material.
[0061] In an embodiment, the porous material 560 can include a fluid permeable membrane 564 disposed in the chamber 554. The fluid permeable membrane 564 can cover at least a portion (e.g., all) of the opening 556. The fluid permeable membrane 564 can be configured to wick the body fluid from the opening 556, thereby preventing the body fluid from spilling out of the chamber 554.
[0062] In an embodiment, the fluid permeable membrane 564 can include any material that can wick the body fluid. For example, the fluid permeable membrane 564 can include a fabric, such as a gauze (e.g., silk, linen, or cotton gauze), another soft fabric, another smooth fabric, a nonwoven material, or any other porous material disclosed herein. Forming the fluid permeable membrane 564 from gauze, soft fabric, and / or smooth fabric can reduce abrasion caused by the fluid collection assembly 550.
[0063] The fluid collection assembly 550 may include a fluid permeable support 568 disposed within the chamber 554. Since the fluid permeable membrane 564 may be formed of a relatively foldable, thin, or otherwise deformable material, the fluid permeable support 568 is configured to support the fluid permeable membrane 564. For example, the fluid permeable support 568 may be positioned such that the fluid permeable membrane 564 is disposed between the fluid permeable support 568 and the fluid impermeable barrier 552. In this way, the fluid permeable support 568 can support and hold the position of the fluid permeable membrane 564. The fluid permeable support 568 may include any material that can wick, absorb, adsorb, or otherwise allow for the transport of body fluid, such as any of the fluid permeable membrane materials disclosed above herein. For example, when used as the fluid permeable support 568, the fluid permeable membrane material may be used in a denser or more rigid form than 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 include a porous polymer (e.g., nylon, polyester, polyurethane, polyethylene, polypropylene, etc.) structure or an open cell foam, such as spun nylon fibers. In some examples, the fluid permeable support 568 may include a nonwoven material. In some examples, the fluid permeable support 568 may be formed of natural materials, such as cotton, wool, silk, or combinations thereof. In these examples, the material may have a coating, such as a waterproof coating, to prevent or limit the absorption of fluid into the material. In some examples, the fluid permeable support 568 may be formed of a fabric, felt, gauze, or combinations thereof.
[0064] In some examples, the fluid permeable membrane 564 may be optional. For example, the porous material 560 may include only the fluid permeable support 568. In some examples, the fluid permeable support 568 may optionally be omitted from the fluid collection assembly 550. For example, the porous material 560 may include only the fluid permeable membrane 564.
[0065] In an embodiment, at least a portion of the porous material 560 (e.g., one or more fluid-permeable membranes 564, or more preferably, the fluid-permeable support 568) can be hydrophobic. The porous material 560 can be hydrophobic when it exhibits a contact angle with water (a major component of body fluid) greater than about 90°, such as in the range of about 90° to about 120°, in the range of about 105° to about 135°, in the range of about 120° to about 150°, in the range of about 135° to about 175°, or in the range of about 150° to about 180°. The hydrophobicity of the porous material 560 can limit the absorption, adsorption, and solubility of body fluid in the porous material 560, thereby reducing the amount of body fluid retained in the porous material 560. In an embodiment, at least a portion of the porous material 560 is hydrophobic or hydrophilic. In an embodiment, the fluid-permeable support 568 is more hydrophobic than the fluid-permeable membrane 564 (e.g., exhibits a greater contact angle with water). The lower hydrophobicity of the fluid-permeable membrane 564 can help the porous material 560 accommodate body fluid from the urethral orifice, while the hydrophobicity of the fluid-permeable support 568 limits the body fluid retained in the porous material 560.
[0066] The catheter 562 can be at least partially disposed within the chamber 554. The catheter 562 can be used to remove body fluid from the chamber 554. The catheter 562 can be operably coupled to a vacuum source, such as a vacuum pump, to draw fluid from the chamber 554 through the catheter 562. For example, the catheter 562 can extend from the proximal region 572 into the fluid-impervious barrier 552 and can extend to the distal region 570 to a point near the reservoir 574 therein such that the inlet is in fluid communication with the reservoir 574. The catheter 562 fluidly couples the chamber 554 to a fluid storage container (not shown) or a vacuum source (not shown).
[0067] The catheter 562 is configured to fluidly couple (e.g., directly or indirectly) a vacuum source (not shown) to the chamber 554 (e.g., the reservoir 574). When a vacuum source (e.g., Figure 8 the vacuum source 894) applies a vacuum / suction force in the catheter 562, the body fluid in the chamber 554 (e.g., at the distal region 570, such as the body fluid in the reservoir 574) can be drawn into the catheter 562 and the fluid is discharged from the fluid collection assembly 550 via the catheter 562. In some examples, the catheter 562 can be frosted or opaque (e.g., black) to obscure the visibility of the body fluid therein.
[0068] The porous material 560 can at least substantially completely fill the portion of the chamber 554 not occupied by the conduit 562. In some examples, the porous material 560 may not substantially completely fill the portion of the chamber 554 not occupied by the conduit 562. In such an example, the fluid collection assembly 550 includes a reservoir 574 disposed in the chamber 554.
[0069] The reservoir 574 is a substantially unoccupied portion of the chamber 554. The reservoir 574 can be defined between the fluid impermeable barrier 552 and one or both of the fluid permeable membrane 564 and the fluid permeable support 568. Body fluid in the chamber 554 can flow through the fluid permeable membrane 564 and / or the fluid permeable support 568 into the reservoir 574. The reservoir 574 can retain the body fluid therein.
[0070] Body fluid in the chamber 554 can flow through the fluid permeable membrane 564 and / or the fluid permeable support 568 into the reservoir 574. The fluid impermeable barrier 552 can retain the body fluid in the reservoir 574. Although described as being in the distal region 570, the reservoir 574 can be located in any portion of the chamber 554, such as in the proximal region 572. The reservoir 574 can be located in a portion of the chamber 554 designed to be the gravitational low point of the fluid collection assembly when the fluid collection assembly wears. The conduit 562 can extend into the fluid reservoir 574, and / or the inlet of the conduit 562 can be positioned adjacent to or proximate to the fluid reservoir 574.
[0071] In some examples (not shown), the fluid collection assembly 550 can include multiple reservoirs, such as a first reservoir and a second reservoir, the first reservoir being located in the portion of the chamber 554 closest to the inlet of the conduit 562 (e.g., the distal region 570), and the second reservoir being located in the portion of the chamber 554 located at or near the proximal region 572. In another example, the fluid permeable support 568 is spaced apart from at least a portion of the conduit 562, and the reservoir 574 can be the space between the fluid permeable support 568 and the conduit 562.
[0072] Figure 5CFIG. 0 is a cross-sectional schematic view of a fluid collection system 590 according to an embodiment, the fluid collection system 590 including a fluid collection assembly 550 to which a menstrual container 500 is attached. The menstrual container 500 may be the same as or substantially similar to any menstrual container disclosed herein. In an embodiment, as shown, the menstrual container 500 is attached to a portion of a porous material 560 that is closer to the distal region 570 of the fluid collection assembly 550 than to the proximal region 572. In such an embodiment, the menstrual container 500 may be positioned near the vaginal opening of an individual, a portion of the porous material 560 that is closer to the proximal region 572 may be positioned near the urethral opening, and a conduit 562 may extend from the fluid collection assembly 550 toward the stomach of the individual, which has been shown to be more comfortable and better prevent leakage. In an embodiment not shown, the menstrual container 500 may be attached to a portion of a fluid impermeable barrier 552 that is between an opening 556 and the farthest portion of the fluid impermeable barrier 552.
[0073] FIG. 5D is a cross-sectional view of a fluid collection system 590 during use according to an embodiment. As shown, the fluid collection system 590 may 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 above the vaginal opening 573. However, it is noted that the menstrual container 506 may be at least partially positioned within the vaginal opening 573, such as between the labial folds, or at least partially within the vaginal canal 575. This positioning of the menstrual container 506 allows the menstrual container 506 to receive at least some (e.g., substantially all) of the menstrual fluid dispensed from the vaginal opening 573. The fluid collection system 590 is also positioned such that the opening 556 of the fluid collection assembly 550 and the porous material 560 are positioned near the urethral opening 577. In this way, urine or other body fluids dispensed from the urethral opening 577 flow through the opening 556 and are received into the porous material 560.
[0074] Figure 6 FIG. 7 is a cross-sectional schematic view of a fluid collection system 690 according to an embodiment, the fluid collection system 690 including a fluid collection assembly 650 and a menstrual container 600. The fluid collection assembly 650 is an example of a female fluid collection assembly for receiving and collecting body fluids from a female. Unless otherwise disclosed herein, the menstrual container 600 and the fluid collection assembly are the same as or substantially similar to any menstrual container and fluid collection assembly disclosed herein.
[0075] The fluid collection assembly 650 includes a fluid impermeable barrier 652 that is the same as or similar to any fluid impermeable barrier disclosed herein in one or more aspects. The fluid impermeable barrier 652 at least defines 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 located within the chamber 654. The porous material 660 can be the same as or similar to any porous material disclosed herein in one or more aspects. The fluid collection assembly 650 can also include at least one conduit 662 that is partially located within the fluid outlet 658, and the at least one conduit 662 is configured to remove one or more body fluids from the chamber 654. The conduit 662 may not extend through the porous material 660.
[0076] In an embodiment, the fluid impermeable barrier 652 can include a housing 676 and a connector 678 secured to the housing 676. The housing 676 of the fluid collection assembly 650 includes a proximal region 672, a distal region 670 opposite the proximal region 672, a front side 684, and a rear side 686 opposite the front side 684. Generally, during use, the distal region 670 is closer to the individual's gluteal cleft than the proximal region 672, and the front side 684 generally faces the individual's vaginal region. The housing 676 can be formed of silicone, neoprene, thermoplastic elastomer, or other fluid impermeable materials.
[0077] In an embodiment, the housing 676 includes one or more flanges. The flanges can provide more locations for undergarments or other clothing to contact and press against the fluid collection assembly 650, which can facilitate securing the fluid collection assembly 650 to the individual's vaginal region and can improve patient comfort. In an embodiment, the flanges can include at least an upper flange 680 and a lower flange, the upper flange 680 forms the proximal region 672, and the lower flange is opposite the upper flange 680 and forms the distal region 670.
[0078] The flange of the body can extend a certain distance from the remainder of the housing 676, the distance being about 1 mm or greater, about 1 mm or greater, about 3 mm or greater, about 4 mm or greater, about 5 mm or greater, about 6 mm or greater, about 7.5 mm or greater, about 1 cm or greater, about 1.25 cm or greater, about 1.5 cm or greater, about 1 cm or greater, about 1.5 cm or greater, about 3 cm or greater, about 4 cm or greater, about 5 cm or greater, or in the range of about 1 mm to about 3 mm, in the range of about 1 mm to about 4 mm, in the range of about 3 mm to about 5 mm, in the range of about 4 mm to about 6 mm, in the range of about 5 mm to about 7.5 mm, in the range of about 6 mm to about 1 cm, in the range of about 7.5 mm to about 1.25 cm, in the range of about 1 cm to about 1.5 cm, in the range of about 1.25 cm to about 1 cm, in the range of about 1.5 cm to about 1.5 cm, in the range of about 1 cm to about 3 cm, in the range of about 1.5 cm to about 4 cm, or in the range of about 3 cm to about 5 cm. The distance that the flange extends from the remainder of the housing 676 can be selected based on the expected size of the individual's vaginal region (e.g., larger vaginal region, larger flange) or the expected rotational force applied to the fluid collection assembly 650 during use. In some examples, at least some of the flanges can extend further from the remainder of the housing 676 than other flanges.
[0079] In an embodiment, the housing 676 can include a reservoir 682 located at or near the distal region 670. The reservoir 682 can extend outwardly from the front side 684 of the housing 676. During use, the reservoir 682 is configured to be located at, near, or otherwise in fluid communication with the gravity low point of the porous material 660. For example, the reservoir 682 can receive a portion of the porous material 660 therein. The reservoir 682 can receive at least some of the body fluid contained by the porous material 660. The reservoir 682 can prevent or at least inhibit leakage of body fluid from the fluid collection assembly 650. The reservoir 682 can include at least a portion of a connector 678 disposed at least partially therein.
[0080] In an embodiment, the housing 676 can define a recess configured to receive the conduit 662. The recess can extend from or near the proximal region 672 to or near the distal region 670, thereby allowing the conduit 662 to extend from or near the abdominal region of the individual to the connector 678. In an embodiment, the recess can be configured such that the housing 676 surrounds and / or abuts less than 60% of the circumference of the conduit 662, thereby allowing the conduit 662 to freely enter and exit the recess during use. Allowing the conduit 662 to freely enter and exit the recess can facilitate positioning of the fluid collection assembly 650 such that the porous material 660 is adjacent to the vaginal region, even when the conduit 662 is curved away from the vaginal region. Additionally, allowing the conduit 662 to freely enter and exit the recess can increase the likelihood that movement of the conduit 662 will not move the porous material 660 relative to the vaginal region, as movement of the porous material 660 can cause leakage. In an embodiment, at least a portion of the recess can be configured such that the housing 676 surrounds and / or abuts more than 50% (e.g., 51% to about 55%, about 53% to about 57%, or about 55% to about 60%) of the circumference of the conduit 662. Surrounding more than 60% of the circumference of the conduit 662 can more securely attach the conduit 662 to the housing 676 and can allow the conduit 662 to provide additional structure to the housing 676. The percentage of the conduit 662 that is surrounded and / or abutted by the housing 676 can be selected such that the inherent elasticity of the housing 676 and the conduit 662 allows the conduit 662 to easily snap into and out of the recess. Thus, to facilitate positioning the porous material 660 near the vaginal region or when the conduit 662 is moved, the conduit 662 can be removed from the recess.
[0081] As previously described, the fluid impermeable barrier 652 includes a connector 678 that is attached to (e.g., attached to the housing 676 using an adhesive, welding, interference fit, etc.) or integrally formed with the housing 676. The connector 678 is located at or near the distal region 670 of the housing 676, which allows the connector 678 to receive body fluid flowing to the low point of the weight of the porous material 660. In an embodiment, a portion of the connector 678 can be located within the reservoir 682 of the housing 676. In an embodiment not shown, the reservoir 682 can be formed by the connector 678 rather than by the housing 676.
[0082] The connector 678 is configured to connect to the conduit 662. Thus, the connector 678 can define a fluid outlet 658 that is configured to attach to the conduit 662 or otherwise be in fluid communication with the conduit 662. The fluid outlet 658 can be located near the rear side 686 of the fluid impermeable barrier 652. The connector 678 can also define a passage 688 (e.g., a tube) that is configured to allow fluid communication between the porous material 660 and the reservoir 682 and the conduit 662.
[0083] In an embodiment, at least a portion of the connector 678 may exhibit greater rigidity than the housing 676. The increased rigidity of the connector 678 relative to the housing 676 may facilitate attachment of the conduit 662 to the connector 678. In an example, the connector 678 may exhibit greater rigidity than the housing 676 when the connector 678 is formed of a material having at least one of a greater Young's modulus (i.e., modulus of elasticity), yield strength, or ultimate tensile strength than the material forming the housing 676. In an example, the connector 678 may exhibit greater rigidity than the housing 676 when the connector 678 presents a greater thickness than the housing 676.
[0084] In an embodiment, as shown, the menstrual container 600 is attached to a portion of the porous material 660 that is closer to the distal region 670 of the fluid collection assembly 650 than the proximal region 672. In such an embodiment, the menstrual container 600 may be positioned near the vaginal orifice of the individual, the portion of the porous material 660 closer to the proximal region 672 may be positioned near the urethral orifice, and the conduit 662 may extend from the fluid collection assembly 650 toward the stomach of the individual, which has been shown to be more comfortable and better prevent leakage. In an embodiment 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 farthest portion of the fluid impermeable barrier 652.
[0085] Further examples of fluid collection assemblies configured to receive body fluid from a female urethral orifice 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; PCT 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 disclosure of each document is hereby incorporated herein by reference in its entirety.
[0086] Figure 7 is a cross-sectional schematic view of a fluid collection system 790 disposed on a female individual 796 according to an embodiment. Unless otherwise disclosed herein, the fluid collection system 790 may be the same as or substantially similar to any fluid collection system disclosed herein. For example, the fluid collection system 790 may include a fluid collection assembly 750 and a menstrual container 700, which are respectively the same as or substantially similar to any fluid collection assembly and menstrual container disclosed herein. For illustrative purposes, the fluid collection system 790 is shown as being substantially the same as Figure 5C the fluid collection system 590 shown.
[0087] A fluid collection system 790 may be located on an individual 796 such that the menstrual container 700 is positioned near the vaginal orifice 797. This positioning of the menstrual container 700 allows the menstrual container 700 to receive at least some of the blood and other menstrual fluids discharged from the vaginal orifice 797. In other words, the menstrual container 700 may prevent blood and other menstrual fluids from entering the porous material 760. The fluid collection assembly 750 is located on the individual 796 such that the opening of the fluid collection assembly 750 is positioned near the urethral orifice 798 of the individual, thereby allowing the fluid collection assembly 750 to receive at least some of the body fluids discharged from the urethral orifice 798.
[0088] Figure 8 is a block diagram of a fluid collection system 890 for fluid collection according to an embodiment. The fluid collection system 890 includes a menstrual container 800, a fluid collection assembly 850, a fluid storage container 892, and a vacuum source 894. The menstrual container 800 and the fluid collection assembly 850 may be the same as or substantially similar to any menstrual container and fluid collection assembly disclosed herein. The fluid collection assembly 850, the fluid storage container 892, and the vacuum source 894 may be fluidly coupled to each other via one or more conduits 862. For example, the fluid collection assembly 850 may be operably coupled to one or more of the fluid storage container 892 or the vacuum source 894 via the conduit 862. Body fluids collected in the fluid collection assembly 850 may be removed from the fluid collection assembly 850 via a conduit 862 extending into the fluid collection assembly 850. For example, the inlet of the conduit 862 may extend into the fluid collection assembly 850, such as into a reservoir therein. The outlet of the conduit 862 may extend into the fluid collection assembly 850 or the vacuum source 894. In response to suction (e.g., vacuum) applied at the outlet of the conduit 862, the suction may be introduced into the chamber of the fluid collection assembly 850 via the inlet of the conduit 862.
[0089] The suction may be applied to the outlet of the conduit 862 directly or indirectly by the vacuum source 894. The suction may be applied indirectly via the fluid storage container 892. For example, the outlet of the conduit 862 may be disposed within the fluid storage container 892, and an additional conduit 862 may extend from the fluid storage container 892 to the vacuum source 894. Thus, the vacuum source 894 may apply suction to the fluid collection assembly 850 via the fluid storage container 892. The suction may be applied directly via the vacuum source 894. For example, the outlet of the conduit 862 may be disposed within the vacuum source 894. An additional conduit 862 may extend from the vacuum source 894 to a point outside the fluid collection assembly 850, such as to the fluid storage container 892. In these examples, the vacuum source 894 may be disposed between the fluid collection assembly 850 and the fluid storage container 892.
[0090] The size and shape of the fluid storage container 892 can be designed to retain body fluids therein. The fluid storage container 892 can include a bag (e.g., a drainage bag), a bottle, or a cup (e.g., a collection jar), or any other closed container for storing body fluids such as urine. In some examples, the catheter 862 can extend from the fluid collection assembly 850 and be attached to the fluid storage container 892 at a first point therein. An additional catheter 862 can be attached to the fluid storage container 892 at a second point thereon and can extend and be attached to a vacuum source 894. Thus, a vacuum (e.g., suction) can be drawn in the fluid collection assembly 850 via the fluid storage container 892. The use of the vacuum source 894 can discharge body fluids, such as urine, from the fluid collection assembly 850.
[0091] The vacuum source 894 can include one or more of a manual vacuum pump and 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 894 can provide a vacuum or suction to remove body fluids from the fluid collection assembly 850. In some examples, the vacuum source 894 can be powered by one or more of a power cord (e.g., a power cord connected to a power outlet), one or more batteries, or even manual power (e.g., a manual vacuum pump). In some examples, the size and shape of the vacuum source 894 can be designed to fit on the exterior, surface, or interior of the fluid collection assembly 850. For example, the vacuum source 894 can include one or more small pumps or one or more micropumps. The vacuum source 894 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 894.
[0092] Although various aspects and embodiments have been disclosed herein, other aspects and embodiments are also contemplated. The various aspects and embodiments disclosed herein are for illustrative purposes and not for limitation.
[0093] Degree terms (e.g., "about", "substantially", "generally", etc.) indicate changes that are structurally or functionally immaterial. In an example, when a degree term is included in a term indicating a quantity, the degree term is interpreted to mean ±10%, ±5%, or +2% of the term indicating the quantity. In an example, when a degree term is used to modify a shape, the degree term indicates that the shape modified by the degree term has the appearance of the disclosed shape. For example, a degree term can be used to indicate that a 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. An external menstrual container, comprising: at least one fluid-impermeable layer defining a container chamber, the at least one fluid-impermeable layer comprising: a top side configured to abut an individual's vaginal region, the top side defining a container opening configured to allow menstrual fluid to flow from the vaginal region into the container chamber; and a bottom side opposite the top side, the bottom side being at least one of: configured to be attached to a fluid collection assembly, or concave and configured to abut the fluid collection assembly.
2. The external menstrual container according to claim 1, wherein, The at least one fluid-impermeable layer includes a ring that forms the top side and defines the container opening, the ring exhibiting a greater stiffness than the remainder of the at least one fluid-impermeable barrier.
3. The external menstrual container according to any one of claims 1 or 2, wherein, At least a portion of the at least one fluid-impermeable layer is at least partially transparent.
4. The external menstrual container according to any one of claims 1 to 3, wherein, The top side includes an adhesive configured to chemically or physically attach the top side to the vaginal region.
5. The external menstrual container according to any one of claims 1 to 4, further comprising an adhesive on the bottom side of the at least one fluid-impermeable layer, the adhesive configured to attach the bag side to the fluid collection assembly.
6. The external menstrual container according to claim 5, wherein, The adhesive is free of glue.
7. The external menstrual container according to any one of claims 5 or 6, wherein, The adhesive includes a plurality of hook-like structures.
8. The external menstrual container according to any one of claims 1 to 7, wherein, The fluid-impermeable layer includes one or more markings thereon configured to facilitate correct attachment of the external menstrual container to the fluid collection assembly.
9. The external menstrual container according to any one of claims 1 to 8, further comprising one or more wings extending from at least a portion or near at least a portion of the top side of the fluid-impermeable layer.
10. The external menstrual container according to claim 9, wherein, The one or more wings include 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 region when the top side of the fluid-impermeable layer abuts the vaginal region, and at least a portion of the front wing side including an adhesive.
11. The external menstrual container according to any one of claims 1 to 10, further comprising one or more wings extending from at least a portion or near at least a portion of the bottom side of the fluid-impermeable layer, the one or more wings including 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 region when the top side of the fluid-impermeable layer abuts the vaginal region, and at least a portion of the rear wing side including an adhesive.
12. The external menstrual container according to any one of claims 1 to 11, wherein, The container chamber is substantially unoccupied.
13. The external menstrual container according to any one of claims 1 to 12, further comprising at least one porous material disposed in the container chamber.
14. A fluid collection system, comprising: a fluid collection assembly, comprising: a fluid-impermeable barrier defining at least a chamber, an opening, and a fluid outlet; and at least one porous material disposed in the chamber and extending through the opening; and an external menstrual container, comprising: At least one fluid-impermeable layer defining a container chamber, the at least one fluid-impermeable layer comprising: A top side configured to abut an individual's vaginal region, the top side defining a bag opening configured to permit menstrual fluid to flow from the vaginal region into the container chamber; and A bottom side opposite the top side, the bottom side configured to be at least one of: attached to the fluid collection assembly, attached to the fluid collection assembly, or abutting the fluid collection assembly.
15. The fluid collection system according to claim 14, wherein, The fluid-impermeable barrier includes one or more markings thereon that facilitate attachment of the external menstrual container to the fluid collection assembly.
16. The fluid collection system according to any one of claims 14 or 15, wherein The external menstrual container includes one or more markings, and wherein the one or more markings of the external menstrual container are configured to align with the one or more markings of the fluid-impermeable barrier when the external menstrual container is attached to the fluid collection assembly.
17. The fluid collection system according to any one of claims 14 to 16, wherein, The external menstrual container is not attached to the fluid collection assembly.
18. The fluid collection system according to any one of claims 14 to 17, wherein, The external menstrual container is attached to the at least one porous material.
19. The fluid collection system according to any one of claims 14 to 18, wherein, The external menstrual container is attached to the fluid-impermeable barrier.
20. The fluid collection system according to any one of claims 14 to 19, wherein, The fluid-impermeable barrier includes a proximal region defining the fluid outlet and a distal region opposite the proximal region, and the external menstrual container is attached to the fluid collection assembly at a location closer to the distal region than to the proximal region.
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