Fluid collection assembly including fluid impermeable barrier defining at least one of flat sump or at least one orifice

Abstract

An example fluid collection assembly includes a fluid impermeable barrier and at least one porous material disposed in the fluid impermeable barrier. The fluid impermeable barrier includes a proximal region and a distal region opposite the proximal region. The fluid impermeable barrier defines a chamber, an opening, and a fluid outlet. The fluid impermeable barrier also defines at least one of a flat sump or at least one orifice at or near the distal region. At least one aperture formed in the fluid impermeable barrier may form at least one of at least one first coupler, at least one vent at or near the proximal end region, or at least one recess formed in the at least one lateral flange, the first coupler is configured to be attached to at least one second coupler attached to the porous material.

Description

Background Art

[0001] A person or animal may have limited or impaired mobility, so that the typical urination process is challenging or impossible. For example, a person may experience or have a disability that impairs mobility. A person may have a restricted mobility condition, such as that experienced by pilots, drivers, and workers in hazardous areas. In addition, sometimes body fluid collection is required for monitoring purposes or clinical testing.

[0002] A urinary catheter (such as a Foley catheter) can address some of these conditions, such as incontinence. Unfortunately, a urinary catheter can be uncomfortable, painful, and can lead to complications, such as infection. Additionally, a bedpan, which is a container for bedridden patients to use the toilet, is sometimes used. However, bedpans can be prone to discomfort, overflow, and other hygiene issues. Summary of the invention

[0003] Embodiments relate to a fluid collection assembly having a fluid-impermeable barrier, a fluid collection system including the fluid collection assembly, and a method of using and forming the fluid collection assembly, wherein the fluid-impermeable barrier defines at least one of a flat sump or at least one orifice. In an embodiment, a fluid collection assembly is disclosed. The fluid collection assembly includes a fluid-impermeable barrier having a proximal region and a distal region opposite the proximal region. The fluid-impermeable barrier also defines at least a chamber, at least one opening, and a fluid outlet at or near the distal region. The fluid-impermeable barrier defines at least one flat sump or at least one orifice at its distal region. The fluid collection assembly also includes at least one porous material disposed in the chamber. When the fluid-impermeable barrier includes at least one orifice, the at least one orifice forms at least one of the following: at least one first coupler configured to be attached to at least one second coupler, the at least one second coupler being attached to at least one porous material; at least one vent at or near the proximal region; or at least one notch formed in at least one lateral flange, the at least one lateral flange extending laterally outward from a portion of the fluid-impermeable barrier defining the chamber.

[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 having a proximal region and a distal region opposite the proximal region. The fluid impermeable barrier also defines at least a chamber, at least one opening, and a fluid outlet at or near the distal region. The fluid impermeable barrier defines at least one flat sump or at least one orifice at its distal region. The fluid collection assembly also includes at least one porous material disposed in the chamber. When the fluid impermeable barrier includes at least one orifice, the at least one orifice includes at least one of the following: at least one first connector, the first connector is configured to be attached to at least one second connector, and at least one second connector is attached to at least one porous material; at least one vent at or near the proximal region; or at least one notch formed in at least one lateral flange, at least one lateral flange extending laterally outward from a portion of the fluid impermeable barrier defining the chamber. The fluid collection system also includes a fluid storage container and a vacuum source. The chamber of the fluid collection component, the fluid storage container and the vacuum source are in fluid communication with each other, and when one or more body fluids are present in the chamber, the suction provided from the vacuum source to the chamber of the fluid collection component removes the one or more body fluids from the chamber and stores the body fluids in the fluid storage container.

[0005] Features from any of the disclosed embodiments may be used in combination with each other without limitation. In addition, other features and advantages of the present disclosure will become apparent to those of ordinary skill in the art by considering the following detailed description and accompanying drawings. BRIEF DESCRIPTION OF THE DRAWINGS

[0006] The drawings illustrate several embodiments of the present disclosure, wherein like reference numerals refer to the same or similar elements or features in different views or embodiments shown in the drawings.

[0007] Figure 1A is a side view of a fluid collection assembly according to an embodiment.

[0008] Figure 1B is a schematic cross-sectional view of a fluid collection assembly according to an embodiment, taken along plane 1B-1B.

[0009] Figure 2 is a schematic cross-sectional view of a fluid collection assembly according to an embodiment.

[0010] Figure 3A and Figure 3B is a cross-sectional schematic diagram illustrating a method of fixing a porous material to a second coupler according to an embodiment.

[0011] Figure 4A and Figure 4Bis a cross-sectional schematic diagram illustrating a method of attaching a porous material to a second coupler according to an embodiment.

[0012] Figure 5 is a schematic cross-sectional view of a porous material with a second coupler attached according to an embodiment.

[0013] Figure 6 is a schematic cross-sectional view of a porous material with a second coupler attached according to an embodiment.

[0014] Figure 7 is a cross-sectional schematic diagram of a second coupling according to an embodiment.

[0015] Fig. 8A is a top plan view of a second coupler including separate fasteners and ridges according to an embodiment.

[0016] Figure 8B is a schematic cross-sectional view of a fully assembled second coupling, wherein the cross section is taken along Fig. 8A The ridge shown in FIG. 8 is taken at plane 8B-8B.

[0017] Figure 8C and Fig.8D are cross-sectional schematic diagrams of different methods of attaching ridges to porous materials according to different embodiments.

[0018] Fig. 9 is a cross-sectional schematic diagram of a second coupling defining one or more passages extending therethrough according to an embodiment.

[0019] Fig. 10A is a side view of a second coupler as a clip according to an embodiment.

[0020] Fig. 10B is a cross-sectional schematic diagram of a fluid collection assembly including a clamp according to an embodiment.

[0021] Fig.11 is a cross-sectional view of a fluid collection assembly including a fluid-impermeable barrier defining a vent (ie, orifice) at or near a proximal region thereof, according to an embodiment.

[0022] Fig.12 is an isometric view of a fluid collection assembly including a fluid impermeable barrier having an aperture formed in at least one lateral flange according to an embodiment.

[0023] Fig.13 is a front elevation view of a fluid collection assembly according to an embodiment.

[0024] Fig.14 is a cross-sectional view of a fluid collection assembly according to an embodiment.

[0025] Fig.15 is a block diagram of a fluid collection system for fluid collection according to an embodiment. DETAILED DESCRIPTION

[0026] Embodiments relate to a fluid collection assembly including a fluid-impermeable barrier defining at least one of a flat reservoir or at least one orifice, a fluid collection system including the fluid collection assembly, and methods of using and forming the fluid collection assembly. An example fluid collection assembly includes a fluid-impermeable barrier and at least one porous material disposed in the fluid-impermeable barrier. The fluid-impermeable barrier includes a proximal region (i.e., a region that is closest to the patient's navel during use) and a distal region opposite the proximal region. The fluid-impermeable barrier defines a chamber, at least one opening that allows body fluids discharged from the patient to flow into the chamber, and a fluid outlet at or near the distal region of the fluid-impermeable barrier. The fluid-impermeable barrier also defines at least one of a flat reservoir or at least one orifice at or near the distal region. At least one orifice formed in the fluid-impermeable barrier can form at least one of: at least one first connector configured to attach to at least one second connector attached to the porous material; at least one vent extending through the fluid-impermeable barrier at or near a proximal region thereof; or at least one notch formed in at least one lateral flange extending laterally outward from a portion of the fluid-impermeable barrier defining a chamber.

[0027] During use, the fluid collection assembly can be positioned on a patient (e.g., an individual using the fluid collection assembly) so that the porous material is positioned adjacent to the patient's urethral opening. The patient can discharge one or more body fluids (e.g., urine, sweat, blood, etc.). The discharged body fluid can be received in the porous material. The body fluid can flow through the porous material to the inlet of the catheter, which is positioned by a fluid outlet defined by a fluid-impermeable barrier. The body fluid can then flow through the catheter to be removed from the fluid collection assembly. In an embodiment, a vacuum can be provided from the catheter to the porous material. The vacuum can promote the flow of body fluids through the porous material to the inlet of the catheter. The vacuum can also promote the flow of body fluids through the catheter. The vacuum can be provided from a vacuum source that is fluidly connected to the catheter.

[0028] As will be discussed in more detail below, the fluid collection assembly disclosed herein can present one or more improvements over conventional fluid collection assemblies. In an example, the fluid impermeable barrier of a conventional fluid collection assembly can be fragile, which makes it difficult to fix a porous material therein unless an adhesive is used. However, the adhesive can block or otherwise obstruct at least some of the holes in the porous material, thereby inhibiting the flow of body fluids through it. The fluid collection assembly disclosed herein can be at least one first coupler and at least one second coupler, and when attached together, at least one first coupler and at least one second coupler allow the porous material to be fixed to the fluid impermeable barrier without using an adhesive. In an example, a conventional fluid collection assembly typically has a vent formed therein at or near its distal region to facilitate air flow in the chamber. However, such a position of the vent in such a conventional fluid collection assembly increases the possibility of body fluids leaking from a conventional fluid collection assembly because the body fluids flow toward the fluid outlet and tend to gather near the fluid outlet. The fluid collection assembly disclosed herein may include at least one vent formed in or near the proximal region of the fluid-impermeable barrier, which has been found to still facilitate air flow through the chamber while minimizing the possibility of body fluid leakage from the chamber. In an example, it has been found that elderly patients have difficulty holding (e.g., dropping) and manipulating (e.g., bending) conventional fluid collection assemblies including lateral flanges. The fluid collection assembly disclosed herein may include at least one notch formed in the lateral flange when including at least one lateral flange, which helps the patient hold the fluid collection assembly (e.g., reduces the possibility of the patient dropping the fluid collection assembly) and helps the patient manipulate the fluid collection assembly. In an example, a conventional fluid collection assembly may include a positioning feature configured to be positioned adjacent to the vaginal opening of the patient to facilitate the correct positioning of the conventional fluid collection assembly. However, it has been found that such a positioning feature may inadvertently penetrate into the vaginal opening, which may cause discomfort to the patient. The fluid collection assembly disclosed herein may include a flat sump instead of the positioning feature of a conventional fluid collection assembly. It has been found that a flat reservoir facilitates positioning of the fluid collection assembly while reducing the likelihood of the flat reservoir penetrating into the vaginal opening.

[0029] Figure 1A is a side view of a fluid collection assembly 100 according to an embodiment. Figure 1B1B-1B is a schematic cross-sectional view of a fluid collection assembly 100 taken along plane 1B-1B according to an embodiment. The fluid collection assembly 100 is an example of a female fluid collection assembly for receiving and collecting bodily fluids from a female. The fluid collection assembly 100 includes a fluid-impermeable barrier 102, which defines at least a chamber 104, at least one opening 106, and a fluid outlet 108. The fluid-impermeable barrier 102 also includes at least one first connector. In the example, as shown, the first connector is an orifice 110 extending through the fluid-impermeable barrier 102. The fluid collection assembly 100 also includes at least one porous material 112 positioned within the chamber 104. The fluid collection assembly 100 also includes at least one second connector, which is configured to be attached to the porous material 112 and interact with the first connector. In the example, as shown, the second connector includes a fastener 114 positioned partially through the orifice 110. The fluid collection assembly 100 may also include at least one conduit 116 positioned partially within the fluid outlet 108, the at least one conduit 116 configured to remove one or more bodily fluids from the chamber 104. The conduit 116 may not extend through the porous material 112.

[0030] The fluid-impermeable barrier 102 at least partially defines a chamber 104 (e.g., an interior area) and an opening 106. For example, an inner surface 117 of the fluid-impermeable barrier 102 at least partially defines the chamber 104 within the fluid collection assembly 100. The fluid-impermeable barrier 102 temporarily stores body fluids in the chamber 104. The fluid-impermeable barrier 102 can be formed of any suitable fluid-impermeable material, such as a fluid-impermeable polymer (e.g., silicone, polypropylene, polyethylene, polyethylene terephthalate, neoprene, polycarbonate, thermoplastic polymers, 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 102 generally prevents body fluids from passing through the fluid-impermeable barrier 102. In an example, the fluid-impermeable barrier 102 can be air permeable and fluid-impermeable. In such an example, the fluid-impermeable barrier 102 can be formed of a hydrophobic material defining a plurality of pores. At least one or more portions of at least one exterior surface 118 of the fluid-impermeable barrier 102 may be formed of a soft and / or slippery material, thereby reducing abrasions.

[0031] The opening 106 provides an entry path for bodily fluid to enter the chamber 104. The opening 106 can be defined by the fluid-impermeable barrier 102, such as by an inner edge of the fluid-impermeable barrier 102. For example, the opening 106 is formed in the fluid-impermeable barrier 102 and extends through the fluid-impermeable barrier 102 from the outer surface 118 to the inner surface 117, thereby enabling bodily fluid to enter the chamber 104 from the exterior of the fluid collection assembly 100.

[0032] The opening 106 can be an elongated hole in the fluid-impermeable barrier 102. For example, the opening 106 can be defined as a cutout in the fluid-impermeable barrier 102. The opening 106 can be positioned and shaped to be positioned adjacent to the female urethral opening. The opening 106 can have an elongated shape because the space between the female's legs is relatively small when the female's legs are closed, thereby allowing body fluids to flow only along a path corresponding to the elongated shape of the opening 106 (e.g., a longitudinally extending opening).

[0033] The fluid collection assembly 100 can be positioned near the female urethral opening, and bodily fluid can enter the chamber 104 of the fluid collection assembly 100 via the opening 106. The fluid collection assembly 100 is configured to receive bodily fluid into the chamber 104 via the opening 106. When in use, the opening 106 can have an elongated shape extending from a first position below the urethral opening (e.g., at or near the anus or vaginal opening) to a second position above the urethral opening (e.g., at or near the vaginal opening or the top of the pubic hair).

[0034] In some examples, the fluid impermeable barrier 102 can define a fluid outlet 108 that is sized to receive a conduit 116. At least one conduit 116 can be disposed in the chamber 104 via the fluid outlet 108. The fluid outlet 108 can be sized and shaped to form an at least substantially fluid-tight seal against the conduit 116 or at least one tube, thereby substantially preventing bodily fluids from escaping from the chamber 104.

[0035] In an embodiment, the fluid impermeable barrier 102 may include a housing 120 and a connector 122 secured to the housing 120. The housing 120 of the fluid collection assembly 100 includes a proximal region 124, a distal region 126 opposite the proximal region 124, a front side 128, and a rear side 130 opposite the front side 128. Typically, during use, the distal region 126 is closer to the patient's gluteal cleft than the proximal region 124, and the front side 128 generally faces the patient's vaginal region. The housing 120 may be formed of silicone, neoprene, thermoplastic elastomer, or other fluid impermeable materials.

[0036] In an embodiment, the housing 120 includes one or more flanges. The flanges can provide more locations for underwear or other clothing to contact and press against the fluid collection assembly 100, which can help secure the fluid collection assembly 100 to the patient's vaginal area and can improve patient comfort. In an embodiment, the flanges can include at least one of an upper flange 132 forming the proximal region 124 and a bottom flange 134 opposite the upper flange 132 forming the distal region 126. The flanges can also include at least one lateral flange (at Fig.12 and Fig.13 ), the lateral flange extends laterally outward from the portion of the fluid-impermeable barrier 102 that defines the chamber 104.

[0037] The flange of the body can extend from the rest of the shell 120 a distance of about 1 mm or more, about 1 mm or more, about 3 mm or more, about 4 mm or more, about 5 mm or more, about 6 mm or more, about 7.5 mm or more, about 1 cm or more, about 1.25 cm or more, about 1.5 cm or more, about 1 cm or more, about 1.5 cm or more, about 3 cm or more, about 4 cm or more, about 5 cm or more, or 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 flange extends from the rest of the housing 120 can be selected based on the expected size of the patient's vaginal area (e.g., a larger flange for a larger vaginal area) or the expected rotational forces applied to the fluid collection assembly 100 during use. In some examples, at least some of the flanges can extend further from the rest of the housing 120 than other flanges. For example, as shown, the bottom flange 134 can extend farther from the rest of the fluid-impermeable barrier 102 than the upper flange 132 because some patients can find a longer bottom flange 134 more comfortable.

[0038] In an embodiment, one or more flanges may present a concave curve relative to the front side 128 of the housing 120. The concave curve of the flange may extend from the proximal region 124 to the distal region 126. The concave curve of the flange may allow the flange to better conform to the shape of the vaginal area because the vaginal area is curved. Conforming the flange to the shape of the vaginal area may make the fluid collection assembly 100 more comfortable by distributing pressure more evenly on the vaginal area, especially when the flange contacts the labia majora.

[0039] In an embodiment, the housing 120 can include a reservoir 136 at or near the distal region 126. The reservoir 136 can extend outward from the front side 128 of the housing 120 and / or the porous material 112, which can facilitate positioning of the fluid collection assembly 100. For example, extending the reservoir 136 outward can allow the reservoir 136 to engage (e.g., abut or partially penetrate) the patient's vaginal opening. Such engagement between the reservoir 136 and the vaginal opening can allow the fluid collection assembly 100 to be properly positioned on the patient. It should be noted that the reservoir 136 can have a curved (e.g., uneven) shape.

[0040] The reservoir 136 can extend outwardly from the front side 138 of the housing 120 and / or the porous material 112 by a distance d. The distance d can be about 1 mm to about 3 mm, about 2 mm to about 4 mm, about 3 mm to about 5 mm, about 4 mm to about 6 mm, about 5 mm to about 7 mm, about 6 mm to about 8 mm, about 7 mm to about 9 mm, about 8 mm to about 10 mm, about 9 mm to about 11 mm, about 10 mm to about 12 mm, about 11 mm to about 13 mm, about 12 mm to about 14 mm, or about 13 mm to about 15 mm. The distance d can be selected based on a number of factors. For example, increasing the distance d increases the likelihood that the reservoir 136 will engage the vaginal opening, but also increases the likelihood that the reservoir 136 will partially penetrate the vaginal opening or otherwise make the fluid collection assembly 100 uncomfortable to wear.

[0041] During use, the reservoir 136 is configured to define a portion of the chamber 104 that is at, near, or otherwise in fluid communication with a low point in weight of the porous material 112. For example, the portion of the chamber 104 defined by the reservoir 136 can receive a portion of the porous material 112 therein. The portion of the chamber 104 defined by the reservoir 136 can receive at least some of the bodily fluid received by the porous material 112. The reservoir 136 can prevent or at least inhibit leakage of the bodily fluid from the fluid collection assembly 100. The reservoir 136 can include at least a portion of the connector 122 at least partially disposed therein.

[0042] In an embodiment, the housing 120 may define a recess configured to receive the catheter 116. The recess may extend from or near the proximal region 124 to or near the distal region 126, thereby allowing the catheter 116 to extend from or near the abdominal region of the patient to the connector 122. In an embodiment, the recess may be configured such that the housing 120 encloses and / or abuts less than 50% of the circumference of the catheter 116, thereby allowing the catheter 116 to freely enter and exit the recess during use. Allowing the catheter 116 to freely enter and exit the recess may facilitate positioning of the fluid collection assembly 100 so that the porous material 112 is adjacent to the vaginal region, even when the catheter 116 is bent away from the vaginal region. Moreover, allowing the catheter 116 to freely enter and exit the recess may increase the likelihood that movement of the catheter 116 does not cause the porous material 112 to move relative to the vaginal region, as movement of the porous material 112 may cause leakage. In embodiments, at least a portion of the recess can be configured such that the housing 120 encloses and / or abuts greater 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 116. Enclosing greater than 50% of the circumference of the conduit 116 can more securely attach the conduit 116 to the housing 120 and can allow the conduit 116 to provide additional structure to the housing 120. The percentage of the conduit 116 enclosed and / or abutted by the housing 120 can be selected such that the inherent elasticity of the housing 120 and the conduit 116 allows the conduit 116 to easily snap into and out of the recess. Thus, the conduit 116 can be removed from the recess to facilitate positioning the porous material 112 adjacent to the vaginal area or when the conduit 116 is moved.

[0043] As previously discussed, the fluid-impermeable barrier 102 includes a connector 122 that is attached (e.g., by adhesive, welding, interference fit, etc.) to or integrally formed with the housing 120. The connector 122 is positioned at or near the distal region 126 of the housing 120, which allows the connector 122 to receive body fluids that flow to the low point of the porous material 112. In an embodiment, a portion of the connector 122 may be positioned in a reservoir 136 of the housing 120. In an embodiment not shown, the connector 122 may form the reservoir 136 instead of the housing 120.

[0044] The connector 122 is configured to be connected (e.g., fluidly connected) to the conduit 116. As such, the connector 122 can define a fluid outlet 108 that is configured to be attached to or otherwise be in fluid communication with the conduit 116. The fluid outlet 108 can be located adjacent to the back side 130 of the fluid-impermeable barrier 102. The connector 122 can also define a channel 138 (e.g., a tube) that is configured to allow the porous material 112 and the reservoir 136 to be in fluid communication with the conduit 116.

[0045] In an embodiment, at least a portion of the connector 122 may exhibit a greater stiffness than the housing 120. The increased stiffness of the connector 122 relative to the housing 120 may facilitate attaching the conduit 116 to the connector 122. In an example, when the connector 122 is formed of a material that exhibits at least one of a Young's modulus (i.e., elastic modulus), a yield strength, or an ultimate tensile strength greater than the material forming the housing 120, the connector 122 may exhibit greater rigidity than the housing 120. In an example, when the connector 122 exhibits a thickness greater than the housing 120, the connector 122 may exhibit a greater stiffness than the housing 120.

[0046] As previously discussed, the fluid impermeable barrier 102 includes a first coupler and a second coupler. The first coupler and the second coupler can allow the fluid collection assembly 100 to present one or more improvements over conventional fluid collection assemblies. For example, the porous material 112 can be relatively fragile (e.g., flexible or elastic), which makes it difficult to secure the porous material 112 to the fluid impermeable barrier 102. For example, simply arranging the porous material 112 in a chamber 104 defined by the fluid impermeable barrier 102 cannot prevent the porous material 112 from falling from the chamber 104 due to its fragility. Conventional fluid collection assemblies often secure their porous materials to their fluid impermeable barriers by extending a conduit into the chamber and positioning the conduit within the porous material (e.g., the porous material defines a hole configured to receive the conduit). Positioning the conduit within the porous material helps to keep the porous material in the chamber because the conduit provides structure to the porous material. However, there are several problems with arranging the conduit in the chamber. For example, it is generally preferred that the porous material 112 presents a shape corresponding to the shape of the area around the urethral opening of the patient to prevent leakage of body fluids. The catheter arranged in the chamber presents a shape corresponding to the shape of the catheter with the porous material having the catheter therein, which may be different from the shape of the area around the urethral opening, particularly because the shape of the area around the urethral opening may vary from patient to patient. In addition, excessive insertion of the catheter into the chamber may inhibit the flow of body fluids into the catheter, for example when excessive insertion of the catheter causes the entrance to be pressed against the fluid-impermeable barrier. Instead of or in addition to using a catheter to fix the porous material to the fluid-impermeable barrier, conventional fluid collection assemblies often fix the porous material to the fluid-impermeable barrier by adhesively attaching the porous material to the fluid-impermeable barrier. However, the use of an adhesive to fix the porous material to the fluid-impermeable barrier complicates manufacturing because an additional manufacturing step is required to apply the adhesive to at least one of the porous material or the fluid-impermeable barrier, and may make automation of the manufacture of the fluid collection assembly more difficult. In addition, the porous material tends to absorb or otherwise receive an adhesive that blocks the passage of the porous material through which body fluids can flow.

[0047] The fluid collection assembly 100 uses a first coupler and a second coupler to remedy these problems of using a conduit and / or adhesive to secure a porous material to a fluid impermeable barrier. Specifically, the first coupler and the second coupler interact with each other to secure a porous material 112 to a fluid impermeable barrier 102. In an example, the first coupler of the fluid impermeable barrier includes at least one orifice 110 formed therein (i.e., an orifice formed in the fluid impermeable barrier 102). The fluid impermeable barrier may already have an orifice 110 formed therein, because fluid impermeable barriers typically define perforations therein as vacuum relief openings, and as such, selecting the first coupler as the orifice 110 allows little or no modification of the fluid impermeable barrier. In an example, as shown, the second coupler may include at least one fastener 114 that is partially positioned to pass through the orifice 110 and is secured to the porous material. It should be noted that, as used herein, the first coupler and the second coupler may not include an adhesive or conduit to remove body fluids from the chamber.

[0048] The first coupler may include an aperture 110 extending through the fluid impermeable barrier 102. In embodiments, as illustrated, the aperture 110 may be formed in the housing 120. For example, the aperture 110 may be formed in the housing 120 at or near the proximal region 124. Attaching the porous material 112 at or near the proximal region 124 may allow the porous material 112 to hang from the first coupler during use, which may reduce the likelihood that a portion of the porous material 112 will fall out of the chamber 104 compared to if the aperture 110 is formed at or near the distal region of the housing 120. In embodiments, the aperture 110 may be formed at or near the distal region 126 of the housing, in the middle of the housing 120, or at at least one location in the connector 122. It should be noted that the first coupler may include a structure other than or in addition to the aperture 110. For example, the first coupler may include a loop or hook extending from the fluid impermeable barrier 102, a hook and loop structure (eg, Velcro), a perforation extending only partially through the fluid impermeable barrier 102, or any other suitable structure.

[0049] As previously discussed, the fluid collection assembly 100 includes a second coupler. In an embodiment, as shown, the second coupler is a fastener 114 (e.g., a bolt). The fastener 114 includes a head 140 and a rod or shaft 142 extending from the head 140. At least a portion of the rod 142 is configured to be attached to the porous material 112. For example, at least a portion of the rod 142 opposite the head 140 is attached to the porous material 112 using an adhesive, welding (e.g., ultrasonic welding), threaded attachment (e.g., the rod 142 includes threads that engage fibers of the porous material 112), or any other attachment technique.

[0050] The head 140 and the rod 142 present lateral dimensions configured to generally prevent the head 140 from moving through the aperture 110 and to allow the rod 142 to pass through the aperture 110. For example, the head 140 may present a lateral dimension (e.g., a maximum lateral dimension) that is greater than the corresponding lateral dimension of the rod 142. The lateral dimension of the head 140 may be greater than the corresponding lateral dimension of a portion of the aperture 110. The larger lateral dimension of the head 140 compared to the corresponding lateral dimension of the aperture 110 may inhibit the head 140 from completely passing through the aperture 110. In other words, the larger lateral dimension of the head 140 compared to the corresponding lateral dimension of the aperture 110 may form an obstacle to the head 140 passing through the aperture 110. However, it should be noted that the fluid-impermeable barrier 102, and in particular the housing 120, may be formed of an elastic material that allows the head 140 to be forced through the open aperture 110 when a force large enough to deform the fluid-impermeable barrier 102 is applied. However, the force required to force the head 140 through the fluid impermeable barrier 102 is sufficiently great that the head 140 is unlikely to pass through the fluid impermeable barrier 102 during use. The lateral dimension of the stem 142 is less than or substantially equal to the corresponding lateral dimension of the aperture 110, thereby allowing the stem 142 to pass through the aperture 110. In this way, the stem 142 can pass from one side of the fluid impermeable barrier 102 to the other side. Attaching the stem 142 to the porous material 112 in conjunction with the head 140 substantially prevents the fastener 114 from passing through the aperture 110.

[0051] In an embodiment, the orifice 110 is configured such that the head 140 is not positioned therein. In such an embodiment, the head 140 may protrude from the fluid-impermeable barrier 102, which may make the fluid collection assembly 100 less comfortable to use and may push the catheter 116 away from the fluid-impermeable barrier 102. In an embodiment, the orifice 110 is configured such that the head 140 is positioned in a portion thereof. In an embodiment, the orifice 110 may include a first portion and a second portion. The first portion may be configured to position at least a portion of the head 140 therein. For example, the first portion may present a lateral dimension that is equal to or slightly greater than a corresponding lateral dimension of the head 140. Positioning the head 140 in the first portion may prevent the head 140 from extending from the fluid-impermeable barrier 102, or at least reduce the distance that the head 140 extends from the fluid-impermeable barrier 102, either of which may make the use of the fluid collection assembly 100 more comfortable and may allow the catheter 116 to be positioned adjacent to the fluid-impermeable barrier 102. The second portion of the orifice 110 may be configured to prevent or at least inhibit the head 140 from passing therethrough. For example, the second portion of the aperture 110 may present a smaller lateral dimension than the head 140 .

[0052] As previously described, when the fastener 114 is not positioned to pass through the orifice 110, the orifice 110 can form a vacuum relief opening. The vacuum relief opening allows air to enter the chamber 104, which improves fluid flow through the porous material 112 and prevents the fluid collection assembly 100 from being sucked into the patient, which may cause general discomfort. Positioning the fastener 114 through the orifice 110 can block the vacuum relief opening so that air cannot pass through the orifice 110 into the chamber 104. Therefore, in some embodiments, the fastener 114 can define a channel 144 extending therethrough. For example, the channel 144 can extend from the head 140 to a portion of the rod 142 that is not blocked by the fluid-impermeable barrier 102 (e.g., from the head 140 centrally to the rod 142). The channel 144 allows air to flow through the fastener 114 and into the chamber 104. It should be noted that the fluid impermeable barrier 102 may define a vacuum relief opening that is spaced apart from the fastener 114 and is not at least partially occupied by the fastener 114 .

[0053] As previously described, the porous material 112 is disposed in the chamber 104. The porous material 112 may cover at least a portion (e.g., all) of the opening 106. The porous material 112 may include a fluid permeable membrane 146 and a fluid permeable support 148. The porous material 112 is exposed to the environment outside the chamber 104 through the opening 106. In an embodiment, the porous material 112 may be configured to wick any body fluid away from the opening 106, thereby preventing the body fluid from escaping the chamber 104. The permeable properties mentioned herein may be wicking, capillary action, diffusion, or other similar properties or processes, and are referred to herein as "permeable" and / or "wicking". Such "wicking" and / or "permeable" properties may not include absorbing body fluid into at least a portion of the porous material 112, such as not including absorbing body fluid into the fluid permeable support 148. In other words, after the material is exposed to body fluid and removed from the body fluid for a period of time, there is generally no absorption or dissolution of body fluid into the material. Although absorption or solubility is not required, the term "substantially nonabsorbent" can allow for a nominal amount of absorption and / or solubility (e.g., absorbency) of body fluids into the porous material 112, such as less than about 30 wt% of the dry weight of the porous material 112, less than about 10 wt%, less than about 10 wt%, less than about 7 wt%, less than about 5 wt%, less than about 3 wt%, less than about 1 wt%, less than about 1 wt%, or less than about 0.5 wt% of the dry weight of the porous material 112. The porous material 112 can also generally wick body fluids toward the interior of the chamber 104, as discussed in more detail below. In embodiments, the porous material 112 can include at least one absorbent or adsorbent material.

[0054] In an embodiment, the porous material 112 can include a fluid permeable membrane 146 disposed in the chamber 104. The fluid permeable membrane 146 can cover at least a portion (e.g., all) of the opening 106. The fluid permeable membrane 146 can be configured to wick bodily fluid away from the opening 106, thereby preventing the bodily fluid from escaping the chamber 104.

[0055] The fluid collection assembly 100 may include a fluid permeable support 148 disposed in the chamber 104. The fluid permeable support 148 is configured to support the fluid permeable membrane 146 because the fluid permeable membrane 146 can be formed by a relatively foldable, fragile, or otherwise easily deformable material. For example, the fluid permeable support 148 can be positioned so that the fluid permeable membrane 146 is disposed between the fluid permeable support 148 and the fluid impermeable barrier 102. In this way, the fluid permeable support 148 can support and maintain the position of the fluid permeable membrane 146. The fluid permeable support 148 may include any material that can wick, absorb, adsorb or otherwise allow fluid transport of body fluids, such as any of the fluid permeable membrane materials disclosed above. For example, when used as a fluid permeable support 148, the fluid permeable membrane material can be used in a more dense or rigid form than in the fluid permeable membrane 146. Fluid permeable support 148 can be formed by any fluid permeable material less deformed than fluid permeable membrane 146. For example, fluid permeable support 148 can include porous polymer (e.g., nylon, polyester, polyurethane, polyethylene, polypropylene, etc.) structure or open-cell foam, such as spun nylon fiber. In some examples, fluid permeable support 148 can include nonwoven material. In some examples, fluid permeable support 148 can be formed by natural materials, such as cotton, wool, silk or their combination. In such examples, material can have a coating that prevents or limits fluid absorption into the material, such as a waterproof coating. In some examples, fluid permeable support 148 can be formed by fabric, felt, gauze or their combination.

[0056] In an embodiment, the fluid permeable membrane 146 can include any material that can wick body fluids. For example, the fluid permeable membrane 146 can include a fabric, such as 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 146 from gauze, soft fabric, and / or smooth fabric can reduce abrasions caused by the fluid collection assembly 100. In some examples, the fluid permeable membrane 146 can be optional. For example, the porous material 112 can include only a fluid permeable support 148. In some examples, the fluid permeable support 148 can be optionally omitted from the fluid collection assembly 100. For example, the porous material 112 can include only a fluid permeable membrane 146.

[0057] In an embodiment, at least a portion of the porous material 112 (e.g., one or more of the fluid permeable membranes 146 or, more preferably, the fluid permeable support 148) may be hydrophobic. The porous material 112 may be hydrophobic when the porous material 112 presents a contact angle with water (a major component of body fluids) greater than about 90°, such as in the range of about 90° to about 120°, about 105° to about 135°, about 120° to about °, about 135° to about 175°, or about ° to about 180°. The hydrophobicity of the porous material 112 may limit the absorption, adsorption, and solubility of body fluids in the porous material 112, thereby reducing the amount of body fluids retained in the porous material 112. In an embodiment, at least a portion of the porous material 112 is hydrophobic or hydrophilic. In an embodiment, the fluid permeable support 148 is more hydrophobic (e.g., presents a larger contact angle with water) than the fluid permeable membrane 146. The lower hydrophobicity of the fluid-permeable membrane 146 may help the porous material 112 receive body fluids from the urethral opening, while the hydrophobicity of the fluid-permeable support 148 restricts body fluids from being retained in the porous material 112 .

[0058] The porous material 112 can at least substantially completely fill the portion of the chamber 104 not occupied by the conduit 116 or the connector 122. In some examples, the porous material 112 can substantially incompletely fill the portion of the chamber 104 not occupied by the conduit 116 and the connector 122. In such examples, the fluid collection assembly 100 includes a reservoir disposed in the chamber 104. Bodily fluid in the chamber 104 can flow through the fluid permeable membrane 146 and / or the fluid permeable support 148 to the reservoir. The reservoir can retain the bodily fluid therein. The reservoir can be located in a portion of the chamber 104 that is designed to be located at a gravimetric low point of the fluid collection assembly when the fluid collection assembly is worn.

[0059] The conduit 116 can be at least partially disposed in the chamber 104. The conduit 116 can be used to remove body fluids from the chamber 104. The conduit 116 includes at least one wall that defines an inlet 152 and an outlet (not shown) downstream of the inlet 152. The outlet of the conduit 116 can be operatively coupled to a vacuum source, such as a vacuum pump for withdrawing fluid from the chamber 104 through the conduit 116. For example, the conduit 116 can extend from the proximal region 124 into the fluid impermeable barrier 102 and can extend to the distal region 126 to a point proximate to a reservoir therein, such that the inlet 152 is in fluid communication with the reservoir. The conduit 116 fluidly couples the chamber 104 to a fluid storage container (not shown) or a vacuum source (not shown).

[0060] In an embodiment, conduit 116 extends from fluid outlet 108 to a location proximate to the reservoir. In an embodiment, conduit 116 is at least partially disposed in the reservoir, and inlet 152 can extend into or be positioned in the reservoir. Bodily fluid collected in fluid collection assembly 100 can be removed from chamber 104 via conduit 116.

[0061] Positioning the inlet 152 at or near a location that is expected to be a gravimetric low point in the chamber 104 when worn by a patient enables the conduit 116 to receive more body fluids than if the inlet 152 were positioned elsewhere, and reduces the likelihood of pooling (e.g., pooling of body fluids can cause microbial growth and malodor). For example, due to capillary forces, body fluids in the fluid permeable membrane 146 and the fluid permeable support 148 can flow in any direction. However, body fluids may appear to flow preferentially in the direction of gravity, particularly when at least a portion of the fluid permeable membrane 146 and / or the fluid permeable support 148 are saturated with body fluids. Thus, one or more of the inlet 152 or the reservoir can be positioned in the fluid collection assembly 100 at a location that is expected to be a gravimetric low point in the fluid collection assembly 100 when worn by a patient, such as the distal region 126.

[0062] The inlet 152 and outlet of the conduit 116 are configured to fluidly couple (eg, directly or indirectly) a vacuum source (not shown) to the chamber 104 (eg, a reservoir). Fig.15 ) When vacuum / suction is applied in conduit 116, bodily fluid in chamber 104 (e.g., at distal region 126, such as in a reservoir) can be drawn into inlet 152 and out of fluid collection assembly 100 via conduit 116. In some examples, conduit 116 can be frosted or opaque (e.g., black) to mask visibility of bodily fluid therein.

[0063] As previously discussed, the conduit 116 can be configured to be at least insertable into the chamber 104. In examples, the conduit 116 can be positioned in the chamber 104 such that the end of the conduit 116 is spaced apart from the fluid-impermeable barrier 102 or other components of the fluid collection assembly 100 that can at least partially block or obstruct the inlet 152. Additionally, the inlet 152 of the conduit 116 can be offset relative to the end of the porous material 112 such that the inlet 152 is closer to the proximal region 124 of the fluid collection assembly 100 than the end of the porous material 112. Offsetting the inlet 152 relative to the end of the porous material 112 in this manner allows the inlet 152 to receive bodily fluid directly from the porous material 112 and, due to hydrogen bonding, pull more bodily fluid from the porous material 112 into the conduit 116.

[0064] The fluid collection assembly 100 includes only a single first connector and a single second connector. However, the fluid collection assembly disclosed herein may include multiple first connectors and multiple second connectors. For example, Figure 2 2 is a cross-sectional schematic diagram of a fluid collection assembly 200 according to an embodiment. Unless otherwise disclosed herein, the fluid collection assembly 200 is the same or substantially similar to any fluid collection assembly disclosed herein. For example, the fluid collection assembly 200 can include a fluid impermeable barrier 202 and at least one porous material 212.

[0065] The fluid impermeable barrier 202 includes a plurality of first couplers and the porous material 212 includes a plurality of second couplers. In the illustrated embodiment, the fluid impermeable barrier 202 includes a plurality of apertures 210, and the porous material 212 includes a plurality of fasteners 214 positioned through the apertures 210. In an example, the fluid impermeable barrier 202 includes two apertures 210 and the porous material 212 includes two fasteners 214. In such an example, one of the apertures 210 may be located at or near the proximal region 224, and the other aperture may be located near the end of the porous material 212 opposite the proximal region 224. Thus, the apertures 210 and the fasteners 214 anchor the opposite ends of the porous material 212 to the fluid impermeable barrier 202, which may more stably secure the porous material 212 to the fluid impermeable barrier 202 than if the apertures 210 were otherwise positioned.

[0066] Figure 1A-Figure 2 The fasteners shown in are shown attached directly to the porous material. Figure 1A-Figure 2 The patient of the fluid collection assembly shown in FIG. 3 can feel the fasteners passing through the porous material, especially when the patient is sitting. Feeling the fasteners passing through the porous material can cause discomfort to the patient because the pressure caused by the fasteners is not distributed across a large surface area. Therefore, in some embodiments, the fasteners can be indirectly attached to the porous material via ridges.

[0067] Figure 3A and Figure 3Bis a cross-sectional schematic diagram illustrating a method of securing a porous material 312 to a second connector 352 according to an embodiment. Unless otherwise disclosed herein, the porous material 312 and the second connector 352 may be the same or substantially similar to any porous material and second connector disclosed herein, respectively, and may be used in any fluid collection assembly disclosed herein. For example, the porous material 312 may include a fluid permeable membrane 346 and a fluid permeable support 348, and the second connector 352 may include a fastener 314, the fastener 314 including a head 340 and a rod 342. It should be noted that the porous material 312 is illustrated as having a fluid permeable membrane 346 disposed on only one side of the fluid permeable support 348. However, it should be noted that the fluid permeable membrane 346 may surround the circumference of the fluid permeable support 348, such as at least Figure 1B , Figure 2 , Figure 8C and Fig.8D As shown in .

[0068] The porous material 312 defines a plurality of channels 354 extending therethrough. For example, the channels 354 may extend through the fluid permeable membrane 346 and the fluid permeable support 348. The channels 354 are configured to have a rod 342 of a fastener 314 disposed therein. Thus, the porous material 312 may define as many channels 354 as the fasteners 314 included by the second coupler 352. The channels 354 may present a size and shape that generally corresponds to the size and shape of the rod 342. However, the channels 354 may present a size and / or shape that inhibits the head 340 from moving through it. However, it should be noted that the porous material 312 may present sufficient elasticity so that when a sufficiently large force is applied to the fastener 314, the head 340 may be forced to pass through the corresponding channel 354 without substantially damaging the porous material 312, thereby allowing the rod 342 to be positioned in the channel 354. It should be noted that the force required to force the head 340 to pass through the channel 354 is greater than the expected force applied to the fastener 314 during use.

[0069] The second coupler 352 includes an elongated ridge 356. The fasteners 314 of the second coupler 352 are attached to the ridge 356 and the ridge 356 can extend longitudinally between the fasteners 314. The ridge 356 can provide structure to the second coupler 352. For example, the ridge 356 can maintain a selected distance between the fasteners 314. The distance that the ridge 356 maintains the fasteners 314 can help maintain the bends formed in the porous material 312 (such as the bonding Figure 3B 356) and can facilitate attachment of the second coupler 352 to the housing (not shown). The ridge 356 can also make use of the fluid collection assembly more comfortable. For example, as previously discussed, using Figure 1A-Figure 2A patient of the fluid collection assembly 100, 200 shown in FIG. 1 may be able to feel the fasteners (more specifically the bars) passing through its porous material, such as when the patient is sitting down. Pressure caused by the fasteners passing through the porous material, as felt, may make the fluid collection assembly uncomfortable. However, including ridges 356 to second connector 352 distributes the pressure caused by the fasteners over a larger area, thereby making the fluid collection assembly more comfortable to use.

[0070] The ridge 356 can also provide structure to at least a portion of the fluid-impermeable barrier to which the porous material 312 and the second coupler 352 are attached. For example, the ridge 356 can cause at least a portion of the fluid-impermeable barrier to which the porous material 312 and the second coupler 352 are attached to present a shape that generally corresponds to the shape of the ridge 356. In an embodiment, the ridge 356 can be formed of a shape memory material. As used herein, a shape memory material includes any material that can be shaped and maintain the shape in response to a force (e.g., a chemical force, a physical force, heat, etc.). Examples of shape memory materials include nitinol, copper, steel, or aluminum. When the ridge 356 is formed of a shape memory material, the ridge 356 can present a first shape. The porous material 312 and at least a portion of the fluid-impermeable barrier can present a shape corresponding to the first shape of the ridge 356. The ridge 356 can be bent from the first shape to a second shape different from the first shape. The ridge 356 can maintain the second shape because the ridge 356 is formed of a shape memory material. Bending the ridge 356 to the second shape can cause the porous material 312 and at least a portion of the fluid-impermeable barrier to assume a shape that generally corresponds to the second shape of the ridge 356. The ridge 356 can be bent from the first shape to the second shape when the porous material 312 and at least a portion of the fluid-impermeable barrier do not assume a shape that generally corresponds to the shape of the vaginal region of a patient using the fluid collection assembly. Bending the ridge 356 to the second shape can cause the porous material 312 and at least a portion of the fluid-impermeable barrier to assume a shape that better corresponds to the shape of the vaginal region of the patient. Causing the porous material 312 and at least a portion of the fluid-impermeable barrier to assume a shape that generally corresponds to the shape of the vaginal region can inhibit leakage of bodily fluids from the fluid collection assembly and / or cause the porous material 312 to receive a greater percentage of bodily fluids discharged by the patient. In an embodiment, the ridge 356 is formed of an elastic material (i.e., a non-brittle material) so that the ridge 356 can be shaped or bent as desired without breaking or otherwise failing.

[0071] In an embodiment, as shown, the fastener 314 can be integrally formed with the ridge 356. For example, the second coupler 352 can be formed using injection molding techniques, 3D printing, or other suitable techniques. Integrally forming the fastener 314 and the ridge 356 can minimize the number of manufacturing steps required to form the second coupler 352 because the fastener 314 and the ridge 356 do not need to be attached together.

[0072] It should be noted that Figure 3B Unlike the fastener 114 shown in FIG. 1 , the head 340 is shown as being curved. Curving the head 340 may help push the head 340 through the porous material 312 and through the housing. Figure 1B Unlike the generally flat head shown in FIG, the curved head 340 may not be flush with the housing. It should be noted that the head 340 may have a conical, elliptical, conical, or hemispherical shape, as these shapes (and other similar shapes) may facilitate pushing the head 340 through the porous material 312 and through the housing.

[0073] Before the porous material 312 is attached to the second coupler 352, the porous material 312 may have a length greater than the length of the second coupler 352. Figure 3B , the longer length of the porous material 312 allows the porous material 312 to bend around the second coupler. The fastener 314 can be positioned through the channel 354 defined by the porous material 312. For example, the head 340 of the fastener 314 can be forced through the channel 354 so that the rod 340 is positioned within the channel 354. Positioning the fastener 314 through the channel 354 attaches the second coupler 352 to the porous material 312.

[0074] In an embodiment, after the porous material 312 is attached to the second coupler 352, a gap 358 can be formed between the end edges 360 (e.g., the top edge and the bottom edge) of the porous material 312. The gap 358 can increase the volume of bodily fluid that can be temporarily stored in the chamber defined by the fluid-impermeable barrier. However, the gap 358 can allow bodily fluid to pool in the chamber, which can lead to leakage of the bodily fluid and / or promote the growth of organisms in the chamber. Thus, in some embodiments, the gap 358 can be eliminated or at least reduced in size. In an example, the porous material 312 can present a length sufficient to cause the end edges 360 to abut each other after the porous material 312 is bent and attached to the fastener 314 (e.g., the porous material 312 presents a gap of less than 30 mm). Figure 3A and Figure 3B In an example, porous material 312 can include additional porous material that is configured to fit within gap 358 and at least partially fill gap 358.

[0075] In an embodiment, the ridges 356 are not directly attached to the porous material 312. In such an embodiment, the ridges 356 are indirectly attached to the porous material 312 by fasteners 314 positioned through the channels 354. In an embodiment, the ridges 356 are directly attached to the porous material 312, which can cause the porous material 312 to assume a shape that more closely conforms to the shape of the ridges 356. In an example, the ridges 356 are adhesively attached to the porous material 312. However, adhesively attaching the ridges 356 to the porous material 312 can cause the adhesive to be absorbed into the porous material 312 before the adhesive cures, which causes the adhesive to at least partially block at least some of the channels through the porous material 312. In an example, the ridges 356 are welded (e.g., ultrasonically welded) to the porous material 312, which solves at least some of the problems caused by adhesively attaching the ridges 356 to the porous material 312. When the ridges 356 are welded to the porous material 312, the ridges 356 may be at least partially formed of a weldable material, such as acrylonitrile butadiene styrene (“ABS”), an ABS-polycarbonate blend or copolymer, polyethylene, polypropylene, polycarbonate, or another suitable material. In other words, the ridges 356 are not formed of a non-weldable material, such as silicone, a polythermal elastomer, or a thermoplastic. When the ridges 356 include a shape memory material that is not weldable to the porous material 312, the ridges 356 may include a coating of a weldable material on at least a portion of the shape memory material. In an example, the ridges 356 may be sewn or otherwise attached to the porous material 312, but it should be noted that sewing or otherwise attaching the ridges 356 to the porous material 312 in an automated manufacturing process may be more difficult than welding the ridges 356 to the porous material 312.

[0076] It should be noted that the fastener 314 may be attached to the porous material 312 using attachment techniques other than positioning the fastener 314 through the porous material 312. For example, the fastener 314 may be adhesively attached, welded (as the fastener 314 may be at least partially formed of the same weldable material as the ridges 356), sewn, or otherwise attached to the porous material 312.

[0077] In an example, the rod 340 may present a length greater than the thickness of the porous material 312, which allows a portion of the rod 340 to extend outward from the porous material 312 without compressing the porous material 312. The portion of the rod 340 extending outward from the porous material 312 may be positioned within the first coupler (e.g., by a perforation).

[0078] The porous material 312 and the second coupler 352 may be attached to Figure 2The housing 220 shown in FIG. 1 is shown in FIG. 2 because the housing 220 can be attached using multiple fasteners. However, the porous material and the second coupler including the ridges can be configured to be attached to Figure 1B For example, Figure 4A and Figure 4B 4 is a cross-sectional schematic diagram showing a method of attaching the porous material 412 to the second coupler 452 according to an embodiment. Figure 4A , providing a porous material 412 and a second coupling 452. In addition to the porous material 412 defining only a single channel 454 and / or the second coupling 452 including a single fastener 414, the porous material 412 and the second coupling 452 can be connected with Figure 3A and Figure 3B The porous material 312 and the second coupling 352 shown in FIG. Figure 4B , the porous material 412 can be bent around a portion of the second coupler 452 so that the fastener 414 is positioned within the channel 454. Even if only one fastener 414 is positioned through the porous material 412, the second coupler 452 (e.g., the ridges 456 of the second coupler 452) provides structure to the porous material 412, can enable the porous material 412 to assume a particular shape, and can make the use of a fluid collection assembly including the porous material 412 more comfortable to use.

[0079] Figure 5 is a cross-sectional schematic diagram of a porous material 512 with a second coupler 552 attached according to an embodiment. Unless otherwise disclosed, the porous material 512 and the second coupler 552 are the same or substantially similar to any porous material and second coupler disclosed herein, respectively, and can be used in any fluid collection assembly disclosed herein. However, unlike other porous materials and second couplers disclosed herein, the porous material 512 does not define at least one orifice and / or the fastener 514 of the second accessory is not positioned through the orifice. Instead, the ridge 556 is directly attached to the porous material 512 (e.g., attached to the surface of the porous material 512 opposite the opening), for example, using an adhesive, welding, sewing, or other suitable technique.

[0080] Figure 6 6 is a cross-sectional schematic diagram of a porous material 612 with a second coupler 652 attached according to an embodiment. Unless otherwise disclosed herein, the porous material 612 and the second coupler 652 are the same as any porous material and second coupler disclosed herein, respectively, and can be used in any fluid collection assembly disclosed herein. For example, the porous material 612 can include a fluid permeable membrane 646 and a fluid permeable support 648, and the second coupler 652 can include one or more fasteners 614 and ridges 656.

[0081] The ridges 656 exhibit a "corrugated" or sawtooth-like structure. The corrugated structure of the ridges 656 includes one or more circumferentially or spirally extending ridges 662 and defines one or more circumferentially or spirally extending valleys 664 positioned between the ridges 662. The ridges 662 exhibit a lateral dimension (e.g., diameter) that is wider than the portion of the ridges 656 that defines the valleys 664. The corrugated structure of the ridges 656 can facilitate shaping of the ridges 656 and, when the ridges 656 are formed of a shape memory material, can facilitate maintaining the shape of the ridges 656. For example, the corrugated structure of the ridges 656 allows the ridges 656 to bend by reducing the distance between adjacent ridges 662. The valleys 664 provide locations to which the ridges 662 move when the distance between adjacent ridges 662 is reduced.

[0082] Figure 3A-Figure 6 The second coupler shown in shows the fastener and the ridge being integrally formed together. However, it should be noted that the second coupler disclosed herein may be formed from two or more different parts attached together. Forming the second coupler from two or more different parts may allow the second coupler to be formed using more manufacturing techniques than forming the second coupler from a single piece. For example, Figure 7 652 is a cross-sectional schematic diagram of a second coupler 652 according to an embodiment. In addition to the disclosure herein, the second coupler 652 may be the same or substantially similar to any second coupler disclosed herein, and may be used in any fluid collection assembly disclosed herein. The second coupler 652 is formed by two or more different parts attached together. In an embodiment, as shown, the second coupler 652 includes one or more fasteners 614 and ridges 656 that are different from each other and attached. In such an embodiment, the fastener 614 and the ridge 656 may be attached together using adhesives, welding (e.g., ultrasonic welding), threaded attachment, or any other suitable technology. When the fastener 614 and the ridge 656 are attached together using ultrasonic welding, the fastener 614 and the ridge 656 may be formed by weldable materials, as described above. In an embodiment, one or more of the fasteners 614 are formed by different parts attached together (e.g., the head 640 and the rod 642 are different). In an embodiment, the ridge 656 may be formed by two or more different parts.

[0083] exist Fig. 8A and Figure 8B Another example of a second coupling formed from two or more different components is shown in FIG. Fig. 8A is a top plan view of a second coupler 852 including separate fasteners 814 and ridges 856 according to an embodiment. Figure 8B is a schematic cross-sectional view of the fully assembled second coupling 852, wherein the cross section is taken along Fig. 8AThe ridge 856 shown in FIG. is taken along plane 8B-8B. Fig. 8A , the fastener 814 includes two heads 840 and a rod 842 extending between the two heads 840. The ridge 856 defines a slit 866 formed therein. The slit 866 includes a first portion 868 and a second portion 870. The first portion 868 is configured to allow the head 840 to pass therethrough. The second portion 870 is configured to receive the rod 842 and prevent the head 840 from passing therethrough. In an embodiment, as shown, the slit 866 is completely surrounded by the ridge 866. In this embodiment, the first portion 868 presents a lateral dimension that is large enough to receive the head 840 of the fastener 814, and the second portion 870 presents a lateral dimension that is large enough to receive the rod 842 and small enough not to receive the head 840. That is, the lateral dimension of the slit 866 varies. The varying lateral dimension of the slit 866 allows one of the heads 840 to be inserted through the first portion 868, such that the head 840 is positioned on a different side of the ridge 856. The fastener 814 may then be slid along the length of the slot 866 such that the rod 842 moves from the first portion 868 to the second portion 870 . Figure 8B The configuration of the second coupler 852 is shown when the rod 842 is positioned in the second portion 870. Figure 8B As shown, when the rod 842 is positioned in the second portion 870 , the head 840 may not pass through the slot 866 , thereby securing the fastener 814 to the ridge 856 .

[0084] It should be noted that the fastener 814 can be removed from the ridge 856 by sliding the fastener 814 along the slit 866 so that the rod 842 moves from the second portion 870 to the first portion 868. When the rod 842 is in the first portion 868, the head 840 can pass through the slit 866, thereby allowing the fastener 814 to be removed from the ridge 856. Being able to remove the fastener 814 from the ridge 856 can allow for replacement of damaged parts and allow the porous material (not shown) attached to the ridge 856 to be removed from the housing (e.g., replaced after use) without also removing the fastener 814 from the housing. In embodiments not shown, the slit 866 is not completely surrounded by the ridge 856. In such embodiments, the slit 866 can extend from the edge of the ridge 856.

[0085] Ridge 856 allows Fig. 8A and Figure 8B The second coupler 852 is shown attached to the porous material in various ways. For example, Figure 8C and Fig.8D is a cross-sectional schematic diagram of different methods of attaching ridges 856 to porous materials according to different embodiments. It should be noted that Figure 8C and Fig.8DThe cross-sectional schematic diagram of is taken along a plane transverse to the longitudinal axis of the porous material. Unless otherwise disclosed herein, Figure 8C and Fig.8D The porous material shown in is the same or substantially similar to any porous material disclosed herein. Figure 8C and Fig.8D The porous material and second connector 852 shown may be used in any fluid collection assembly disclosed herein.

[0086] refer to Figure 8C , the ridge 856 can be disposed within the porous material 812c, such as between the fluid permeable membrane 846c and the fluid permeable support 848c of the porous material 812c. Placing the ridge 856 within the porous material 812c can allow the ridge 856 to be secured to the porous material 812c without the use of adhesives, welds, sewn joints, etc. Securing the ridge 856 to the porous material 812c without adhesives, welds, sewn joints, etc. also allows the ridge 856 to slide within the porous material 812c. Sliding the ridge 856 within the porous material 812c can move the rod 842 from the first portion 868 to the second portion 870 (the first portion 868 and the second portion 880 are in a Fig. 8A ), or vice versa. Placing ridge 856 within porous material 812c may require forming a recess in porous material 812c for fastener 814 to be positioned therethrough. Fig.8D , ridges 856 can be attached to the outer surface of the porous material 812d. For example, as shown, ridges 856 can be attached to the outer surface of the fluid permeable membrane 846. Ridges 856 can be attached to the outer surface of the porous material 812d using adhesives, welding, sewing, or any other suitable technique.

[0087] Similar to Figure 1B The fastener 114 shown in FIG. 3- Fig.8D The fastener of the illustrated second coupler may block a perforation formed in the housing, the perforation being configured to allow air to flow into the chamber. Thus, the second coupler illustrated in FIGS. 3-8 may also define one or more perforations so that air may flow through the housing. For example, Fig. 9944 is a cross-sectional schematic diagram of a second coupler 952 according to an embodiment, the second coupler defining one or more channels 944 extending therethrough. Except as otherwise disclosed herein, the second coupler 952 may be the same or substantially similar to any second coupler disclosed herein and may be used in any fluid collection assembly disclosed herein. The second coupler 952 includes one or more fasteners 914 and a ridge 956. At least one of the fasteners 914 defines a channel 944 that extends at least partially through the fastener, as discussed previously herein. For example, the channel 944 may extend from the head 940 of the fastener 914 because the head 940 may be exposed to the atmosphere outside the chamber defined by the housing. The channel 944 may extend from the head 940 and through at least a portion of the rod 942 to a portion of the second coupler 952 that is in fluid communication with the chamber. In an embodiment, as shown, the channel 944 may extend through a portion of the ridge 956. Extending the channel 944 through the ridge 956 may allow the channel 944 to follow a generally linear path, which may facilitate forming the channel 944 through the fastener 914. For example, the linear path of the channel 944 may allow the channel 944 to be formed by drilling or may allow the channel 944 to be formed using injection molding.

[0088] The second coupling disclosed herein may include elements other than or in addition to the fastener. For example, Fig. 10A 1072. The second coupler is a clip 1072 according to an embodiment. The clip 1072 may include a first arm 1074, a second arm 1076, and a bend 1078 extending between the first arm 1074 and the second arm 1076. The clip 1072 is configured to secure the porous material 1012 to the fluid impermeable barrier 1002.

[0089] Fig. 10B 1072 is a cross-sectional schematic diagram of a fluid collection assembly 1000 including a clip 1072 according to an embodiment. Unless otherwise disclosed herein, the fluid collection assembly 1000 is the same or substantially similar to any fluid collection assembly disclosed herein. For example, the fluid collection assembly can include a fluid impermeable barrier 1002 defining a chamber 1004, an opening 1006, and a fluid outlet 1008. The fluid impermeable barrier 1002 also includes a housing 1020 and a first coupler. In the illustrated embodiment, the first coupler includes an orifice 1010 formed in the housing 1020. The fluid collection assembly 1000 also includes at least one porous material 1012.

[0090] As previously discussed, the clip 1072 is configured to secure the porous material 1012 to the fluid impermeable barrier 1002. The first arm 1074 is configured to be attached to the porous material 1012. For example, the first arm 1074 can be at least partially disposed in the porous material 1012 (e.g., between the fluid permeable membrane 1046 and the fluid permeable support 1048) or attached to an outer surface of the porous material 1012 (e.g., using an adhesive, welding, sewing, etc.). The second arm 1076 is configured to be attached to the fluid impermeable barrier 1002. For example, the second arm 1076 can be at least partially disposed through the aperture 1010 formed in the housing 1020. Thus, the clip 1072 secures the porous material 1012 to the fluid impermeable barrier 1002.

[0091] Return to reference Fig. 10A In an embodiment, when no external force is applied to the clip 1072, the clip 1072 may present a first shape. When the clip 1072 presents the first shape, the first arm 1074 and the second arm 1076 may be spaced apart from each other by a first distance. The clip 1072 may be configured to present a second shape. The second shape may be formed by a force pulling the first arm 1074 and the second arm 1076 apart. When the clip 1072 presents the second shape, the first arm 1074 and the second arm 1076 may be spaced apart from each other by a second distance greater than the first distance. The clip 1072 may be formed of a sufficiently elastic material so that the clip 1072 is elastically deformed only when the clip 1072 switches from the first shape to the second shape. In this way, the clip 1072 may wish to return to the first shape. It should be noted that when the distance between the first arm 1074 and the second arm 1076 is greater than the first distance and greater than or less than the second distance, the clip 1072 may include one or more additional shapes, such as a third shape.

[0092] like Fig. 10A As shown, when the clip 1072 is not securing the porous material 1012 to the fluid impermeable barrier 1002, the clip 1072 can assume a first shape. Fig. 10BAs shown, the clip 1072 can assume the second shape when the clip 1072 secures the porous material 1012 to the fluid impermeable barrier 1002. In other words, the portion of the fluid collection assembly 1000 between the first arm 1074 and the second arm 1076 is greater than the first distance. As such, the first arm 1074 and the second arm 1076 can apply a compressive force to the porous material 1012 and / or the fluid impermeable barrier 1002. During use, the compressive force can minimize movement between the porous material 1012 and the fluid impermeable barrier 1002. In an embodiment, the clip 1072 can assume the second shape during the act of attaching the porous material 1012 to the fluid impermeable barrier 1002. In such an embodiment, the clip 1072 may need to be deformed when attaching the porous material 1012 to the fluid impermeable barrier 1002. After attaching the porous material 1012 to the fluid impermeable barrier 1002, the clip 1072 can return to the first shape or form a third shape in which the distance between the first arm 1074 and the second arm 1076 is greater than the first distance and less than the second distance.

[0093] As previously discussed, the fluid collection assemblies disclosed herein may include a fluid-impermeable barrier defining at least one aperture, instead of or in addition to the aperture forming the first coupler. For example, Fig.11 1 is a cross-sectional view of a fluid collection assembly 1100 according to an embodiment, the fluid collection assembly including a fluid impermeable barrier 1102 defining a vent 1110 (i.e., an orifice) at or near a proximal region 1124 thereof. Unless otherwise disclosed herein, the fluid collection assembly 1100 is the same or substantially similar to any fluid collection assembly disclosed herein. For example, the fluid impermeable barrier 1102 can define a chamber 1104, at least one opening 1106, and a fluid outlet 1108, and the fluid collection assembly 1100 can include at least one porous material 1112 disposed in the chamber 1104.

[0094] The vent 1110 is positioned at or near the proximal region 1124 of the fluid-impermeable barrier 1102. Such positioning of the vent 1110 prevents or at least inhibits leakage of bodily fluid from the chamber 1104. For example, as previously discussed, bodily fluid enters the chamber 1104 through the opening 1106 and flows through the porous material 1112 toward the fluid outlet 1108 and the conduit 1116 due to the vacuum source provided to the chamber 1104 from the conduit 1116 and due to gravity. Therefore, bodily fluid is significantly more likely to be present at and / or collect in portions of the chamber 1104 that are closer to the distal region 1126 than the proximal region 1124. Conventional fluid collection assemblies may include vents at or near the distal region thereof, and bodily fluid may leak through such vents due to the presence and collection of bodily fluid at or near the distal region of conventional fluid collection assemblies. However, the reduced amount of bodily fluid adjacent to vent 1110 as compared to vents of conventional fluid collection assemblies results in bodily fluid being significantly less likely to leak through vent 1110 than vents of conventional fluid collection assemblies.

[0095] Because bodily fluids are less likely to leak through vent 1110, vent 1110 can present a minimum cross-sectional area that can be larger than the vents of at least some conventional fluid collection assemblies. For example, vent 1110 can present a minimum cross-sectional area of ​​approximately 7.5 mm. 2 To about 15cm 2 , about 10mm 2 To about 20cm 2 , about 15mm 2 To about 25cm 2 , about 20mm 2 About 30cm 2 , about 25mm 2 To about 35cm 2 、About 30mm 2 To about 40cm 2 、Approx. 35mm 2 To about 45cm 2 、Approx. 40mm 2 To about 50cm 2 , about 45mm 2 To about 55cm 2 , about 50mm 2 About 60cm 2 、Approx. 55mm 2 To about 65cm 2 、Approx. 60mm 2 About 70cm 2 、Approx. 65mm 2 To about 75cm 2 、Approx. 70mm 2 To about 80cm 2 , or about 75mm2 To about 85cm 2 In general, increasing the minimum cross-sectional area of ​​vent 1110 increases the amount of air that can flow through vent 1110 and through chamber 1104, which in turn increases the amount of bodily fluid that flows toward fluid outlet 1118. Additionally, increasing the minimum cross-sectional area of ​​vent 1110 weakens proximal region 1124 of fluid-impermeable barrier 1102, which allows fluid-impermeable barrier 1102 to better conform to the shape of the patient's vaginal region, which can make fluid collection assembly 1100 more comfortable to use. However, increasing the minimum cross-sectional area of ​​vent 1110 increases the likelihood of bodily fluid leaking through vent 1110.

[0096] In an embodiment, vent 1110 includes an impermeable and breathable membrane configured to prevent, or at least inhibit, the flow of bodily fluids therethrough. In an embodiment, vent 1110 does not include an impermeable and breathable membrane because bodily fluids are less likely to leak through vent 1110 due to the positioning of the vent. It should be noted that not including an impermeable and breathable membrane in vent 1110 can simplify the manufacture of fluid collection assembly 1100 by reducing the number of parts that form fluid collection assembly 1100 and preempting the need to attach a membrane to fluid collection assembly 1100.

[0097] The positioning of the vent 1110 at or near the proximal region 1124 also promotes air flow through the chamber 1104. For example, air drawn into the chamber 1104 through the vent 1110 will flow from the vent 1110 to the fluid outlet 1108. Therefore, air from the vent 1110 can flow through substantially all of the chamber 1104. The flow of air through substantially all of the chamber 1104 can promote the flow of body fluids toward the fluid outlet 1108 and inhibit the body fluids from collecting in the portion of the chamber 1104 at or near the proximal region 1126. At the same time, conventional fluid collection assemblies that include a vent at or near their proximal region generally cause air flow only in a small portion of the chamber between the vent and the fluid outlet. Therefore, the air flowing through the chamber 1104 caused by the vent of such a conventional fluid collection assembly does not promote fluid flow through the chamber 1104 and the vent 1110.

[0098] In an embodiment not shown, the vent 1110 is at the proximal region 1124 of the fluid impermeable barrier 1102. In such an embodiment, the vent 1110 can extend from the chamber 1104 to the proximal region 1124. In an embodiment, as illustrated, the vent 1110 is proximal to the proximal region 1124. In such an embodiment, the vent 1110 can be spaced apart from the proximal region 1124 (measured parallel to the longitudinal axis of the chamber 1104) by about 1 mm to about 3 mm, about 2 mm to about 4 mm, about 3 mm to about 5 mm, about 4 mm to about 6 mm, about 5 mm to about 7 mm, about 6 mm to about 8 mm, about 7 mm to about 9 mm, about 8 mm to about 10 mm, about 9 mm to about 11 mm, about 10 mm to about 12 mm, about 11 mm to about 13 mm, about 12 mm to about 14 mm, or about 13 mm to about 15 mm. When the vent 1110 is spaced apart from the proximal region 1124 , the vent 1110 may extend from the chamber 1104 to the back side 1130 of the fluid impermeable barrier 1102 .

[0099] As previously discussed, the fluid collection assembly may include a fluid impermeable barrier that defines at least one aperture instead of or in addition to the aperture forming the first coupler and / or the aperture forming the vent. Fig.12 1 is an isometric view of a fluid collection assembly 1200 according to an embodiment, the fluid collection assembly including a fluid impermeable barrier 1202 defining an aperture (i.e., a notch 1210) formed in at least one lateral flange 1280. Unless otherwise disclosed herein, the fluid collection assembly 1200 is the same or substantially similar to any fluid collection assembly disclosed herein. For example, the fluid impermeable barrier 1202 can define at least one opening 1206, and the fluid collection assembly 1200 can include at least one porous material 1212 disposed in the fluid impermeable barrier 1202.

[0100] As previously discussed, the fluid impermeable barrier 1202 can include one or more flanges. For example, the fluid impermeable barrier 1202 can include an upper flange 1232 that forms at least a portion of the proximal region 1224 of the fluid impermeable barrier 1202, a bottom flange 1234 that forms at least a portion of the distal region 1226 of the fluid impermeable barrier 1202, and at least one lateral flange 1280 extending between the upper flange 1232 and the bottom flange 1234. In other words, the lateral flange 1280 can extend laterally from the portion of the fluid impermeable barrier 1202 that defines a chamber (not shown).

[0101] It has been found that during use of a conventional fluid collection assembly that includes side flanges, a patient may grasp the conventional fluid collection assembly by the side flanges while moving the conventional fluid collection assembly (e.g., moving the conventional fluid collection assembly toward or away from the vaginal area). It has also been found that a patient is more likely to drop the conventional fluid collection assembly when the patient grasps the fluid collection assembly by the side flanges, particularly when the patient is older, than when the patient grasps other portions of the conventional fluid collection assembly. Dropping the conventional fluid collection assembly may result in contamination of the conventional fluid collection assembly. Moreover, dropping the conventional fluid collection assembly after use may cause bodily fluid present in the chamber to leak from the chamber.

[0102] Fluid collection assembly 1200 includes at least one notch 1210 (i.e., an orifice) formed in a portion of lateral flange 1280. Notch 1210 may extend partially through lateral flange 1280 or completely through lateral flange 1280. Notch 1210 forms a location that a patient may grip when using fluid collection assembly 1200. Notch 1210 helps the patient grip fluid collection assembly 1210 without dropping fluid collection assembly 1200 by increasing the surface area of ​​lateral flange 1280 that contacts the patient's fingers and by moving the patient's fingers closer to the portion of fluid impermeable barrier 1200 that defines the chamber. It should be noted that notch 1210 may facilitate individuals other than the patient (e.g., a medical practitioner) to grip fluid collection assembly 1200 without dropping fluid collection assembly 1200.

[0103] The notch 1210 can facilitate manipulation of the fluid collection assembly 1200. For example, as previously discussed, the fluid collection assembly 1200 can be bent into a shape that allows the fluid collection assembly 1200 to conform to the vaginal region of the patient. It has been found that the notch 1210 facilitates bending of the fluid collection assembly 1200 by weakening a portion of the flange. In other words, the notch 1210 forms a portion of the fluid collection assembly 1200 that is preferably bent. Thus, the notch 1210 can be formed on a portion of the fluid impermeable barrier 1202 that is likely to bend when the fluid collection assembly 1200 is conformed to the vaginal region. For example, the notch 1210 can be positioned closer to the proximal region 1224 of the fluid impermeable barrier 1202 than the distal region 1226. In such an example, the notch 1210 can be located at a location of the fluid impermeable barrier 1202 that is more likely to bend when the fluid collection assembly 1200 is conformed to the vaginal region.

[0104] In an embodiment, the fluid impermeable barrier 1200 defines only a single notch 1210. In an embodiment, the fluid impermeable barrier 1200 defines two notches 1210 on opposite sides of the fluid collection assembly 1200. In such an embodiment, the two notches 1210 facilitate grasping the fluid collection assembly 1200 by sandwiching the fluid collection assembly 1200 between two fingers (e.g., between a thumb and an index finger). In an embodiment, the fluid impermeable barrier 1202 defines a single notch 1210 on one side and multiple notches on the opposite side. In such an embodiment, the single notch 1210 can be grasped with a thumb, and the multiple notches 1210 can be grasped by one or more other fingers. In an embodiment, the fluid impermeable barrier 1202 defines multiple notches 1210 on both sides of the fluid collection assembly 1200, which allows the fluid collection assembly 1200 to be grasped by both hands.

[0105] The recess 1210 may include one or more features that facilitate gripping of the fluid collection assembly 1200. For example, Fig.13 1 is a front view of a fluid collection assembly 1300 according to an embodiment. Except as disclosed herein, fluid collection assembly 1300 and Fig.12 The fluid collection assembly 1200 of the embodiment of the present invention is the same as the fluid collection assembly 1200 of the embodiment of the present invention. The fluid impermeable barrier 1302 includes one or more protrusions 1382 extending from the portion of the fluid impermeable barrier 1302 that defines the recess 1310. The protrusions 1382 further facilitate gripping of the fluid collection assembly 1300. Note that other portions of the lateral flange 1380 can include the protrusions 1382 even when the lateral flange 1380 does not define the recess 1310.

[0106] As previously discussed, the fluid collection assemblies disclosed herein may include a flat sump in lieu of, or in addition to, any of the orifices disclosed herein. Fig.14 14 is a cross-sectional view of a fluid collection assembly 1400 according to an embodiment. Unless otherwise disclosed herein, the fluid collection assembly 1400 is the same or substantially similar to any fluid collection assembly disclosed herein. For example, the fluid collection assembly 1400 includes a fluid impermeable barrier 1402 defining at least one chamber 1404, at least one opening 1406, and a fluid outlet 1408. The fluid collection assembly 1400 also includes at least one porous material 1412 disposed in the chamber 1404.

[0107] The fluid impermeable barrier 1402 includes a reservoir 1436 at a distal region 1426 of the fluid impermeable barrier 1402. The reservoir 1436 can extend outwardly from the front side 1428 of the fluid impermeable barrier 1402. Extending the reservoir 1436 outwardly allows the reservoir 1436 to engage the patient's vaginal opening to facilitate proper positioning of the fluid collection assembly 1400 on the patient.

[0108] The reservoir 1436 includes a flat surface 1484. The flat surface 1484 can be substantially parallel (±30°) to the longitudinal axis 1486 of the chamber 1404 and substantially flat. The flat surface 1484 is generally flat when the flat surface 1484 presents at least one of a mean radius of curvature that is significantly less than the surrounding portion of the fluid-impermeable barrier 1402 or presents a mean radius of curvature that is greater than about 7.5 cm (e.g., greater than about 10 cm, greater than about 15 cm, or greater than about 20 cm). The flat surface 1484 of the reservoir 1436 reduces the likelihood that the reservoir 1436 will penetrate the vaginal introitus compared to other positioning features. As such, the flat surface 1484 can make the use of the fluid collection assembly 1400 more comfortable, as some patients find it uncomfortable to have the reservoir or other positioning features penetrate the vaginal introitus.

[0109] The reservoir 136 can extend a distance d outward from the front side 1428 and / or the porous material 112. The distance d can be about 1 mm to about 3 mm, about 2 mm to about 4 mm, about 3 mm to about 5 mm, about 4 mm to about 6 mm, about 5 mm to about 7 mm, about 6 mm to about 8 mm, about 7 mm to about 9 mm, about 8 mm to about 10 mm, about 9 mm to about 11 mm, about 10 mm to about 12 mm, about 11 mm to about 13 mm, about 12 mm to about 14 mm, or about 13 mm to about 15 mm.

[0110] It should be noted that the orifice and flat tank can be used with Figure 1A-Figure 2 , Figure 8C , Fig.8D as well as Figure 10B to Figure 14 Examples of fluid collection assemblies that may include any orifice and / or flat sump disclosed herein are disclosed in U.S. Patent Application No. 16 / 433,773, filed on June 6, 2019, U.S. Patent No. 10,226,376, filed on June 1, 2017, and International Application No. PCT / US21 / 39866, filed on June 30, 2021, the disclosures of each of which are incorporated herein by reference in their entirety.

[0111] Fig.151 is a block diagram of a fluid collection system 1590 for fluid collection according to an embodiment. The fluid collection system 1590 includes a fluid collection assembly 1500, a fluid storage container 1592, and a vacuum source 1594. The fluid collection assembly 1500 may be the same or substantially similar to any fluid collection assembly disclosed herein. The fluid collection assembly 1500, the fluid storage container 1592, and the vacuum source 1594 may be fluidically coupled to each other via one or more conduits 1516. For example, the fluid collection assembly 1500 may be operated to couple to one or more of the fluid storage container 1592 or the vacuum source 1594 via the conduit 1516. Bodily fluid collected in the fluid collection assembly 1500 may be removed from the fluid collection assembly 1500 via the conduit 1516 protruding into the fluid collection assembly 1500. For example, the inlet of the conduit 1516 may extend into the fluid collection assembly 1500, such as to a reservoir therein. The outlet of the conduit 1516 may extend into the fluid collection assembly 1500 or the vacuum source 1594. Suction force can be introduced into the chamber of fluid collection assembly 1500 via the inlet of conduit 1516 in response to a suction (e.g., vacuum) force applied at the outlet of conduit 1516.

[0112] Suction force may be applied directly or indirectly to the outlet of conduit 1516 via vacuum source 1594. Suction force may be applied indirectly via fluid storage container 1592. For example, the outlet of conduit 1516 may be disposed within fluid storage container 1592, and an additional conduit 1516 may extend from fluid storage container 1592 to vacuum source 1594. Thus, vacuum source 1594 may apply suction to fluid collection assembly 1500 via fluid storage container 1592. Suction force may be applied directly via vacuum source 1594. For example, the outlet of conduit 1516 may be disposed within vacuum source 1594. An additional conduit 1516 may extend from vacuum source 1594 to a point outside of fluid collection assembly 1500, such as to fluid storage container 1592. In such examples, vacuum source 1594 may be disposed between fluid collection assembly 1500 and fluid storage container 1592.

[0113] Fluid storage container 1592 is sized and shaped to retain bodily fluids therein. Fluid storage container 1592 may include a bag (e.g., a drainage bag), a bottle or cup (e.g., a collection can), or any other closed container for storing bodily fluids (such as urine). In some examples, conduit 1516 may extend from fluid collection assembly 1500 and be attached to fluid storage container 1592 at a first point therein. Additional conduit 1516 may be attached to fluid storage container 1592 at a second point on the fluid storage container and may extend and be attached to vacuum source 1594. Thus, a vacuum (e.g., suction) may be drawn through fluid collection assembly 1500 via fluid storage container 1592. Bodily fluids (such as urine) may be discharged from fluid collection assembly 1500 using vacuum source 1594.

[0114] The vacuum source 1594 may include one or more of a manual vacuum pump and an electric vacuum pump, a diaphragm pump, a centrifugal pump, a displacement pump, a magnetically driven pump, a peristaltic pump, or any pump configured to generate a vacuum. The vacuum source 1594 can provide a vacuum or suction to remove body fluids from the fluid collection assembly 1500. In some examples, the vacuum source 1594 can be powered by one or more of a power cord (e.g., connected to an electrical outlet), one or more batteries, or even a manual power source (e.g., a manually operated vacuum pump). In some examples, the vacuum source 1594 can be sized and shaped to fit outside, on, or within the fluid collection assembly 1500. For example, the vacuum source 1594 may include one or more micropumps or one or more micropumps. The vacuum source 1594 disclosed herein may include one or more of a switch, a button, a plug, a remote control, or any other device suitable for activating the vacuum source 1594.

[0115] While various aspects and embodiments have been disclosed herein, other aspects and embodiments may be contemplated. The various aspects and embodiments disclosed herein are for purposes of illustration and are not intended to be limiting.

[0116] Terms of degree (e.g., "about," "substantially," "generally," etc.) indicate insignificant changes in structure or function. In the examples, when a term of degree is included with a term indicating an amount, the term of degree is interpreted as ±20%, ±5%, or ±2% of the term indicating the amount. In the examples, when a term of degree is used to modify a shape, the term of degree indicates that the shape modified by the term of degree has the appearance of the disclosed shape. For example, a term of degree may be used to indicate that the shape may have rounded corners instead of sharp corners, curved edges instead of straight edges, one or more protrusions extending therefrom, be oval, be the same as a disclosed shape, etc.

Claims

1. A fluid collection assembly, comprising: a fluid-impermeable barrier, the fluid-impermeable barrier comprising a proximal region and a distal region opposite the proximal region, the fluid-impermeable barrier defining at least a chamber, at least one opening, and a fluid outlet at or near the distal region, the fluid-impermeable barrier defining at least one flat sump or at least one orifice at the distal region thereof; as well as at least one porous material disposed in the chamber; and wherein, when the fluid impermeable barrier defines the at least one orifice, the at least one orifice forms at least one of: at least one first coupler configured to be attached to at least one second coupler attached to the at least one porous material; at least one vent at or near the proximal region; or At least one notch is formed in at least one lateral flange extending laterally outward from a portion of the fluid impermeable barrier defining the chamber.

2. The fluid collection assembly according to claim 1, wherein: The fluid impermeable barrier defines the at least one aperture, the at least one aperture forming the at least one first coupler, and wherein the fluid collection assembly further comprises the at least one second coupler attached to the porous material.

3. The fluid collection assembly according to claim 2, wherein: The at least one first coupler is at least one aperture defined by and extending through the fluid impermeable barrier.

4. The fluid collection assembly according to claim 3, wherein: The at least one second coupler includes at least one fastener extending through the at least one aperture.

5. The fluid collection assembly according to claim 4, wherein: The at least one fastener defines at least one passage extending therethrough.

6. The fluid collection assembly according to any one of claims 4 or 5, wherein: The at least one fastener includes at least one head and a stem extending from the at least one head.

7. The fluid collection assembly according to any one of claims 4 to 6, wherein: The at least one fastener includes a first fastener positioned at or near a proximal region of the at least one porous material and a second fastener positioned at or near a distal region of the at least one porous material, the proximal region being opposite the distal region.

8. The fluid collection assembly of any one of claims 4 to 7, further comprising an elongated ridge attached to or formed integrally with the at least one fastener.

9. The fluid collection assembly according to claim 8, wherein: The elongated ridges exhibit a corrugated structure including one or more ridges and defining one or more valleys.

10. The fluid collection assembly according to any one of claims 8 or 9, wherein: The at least one porous material defines one or more perforations extending therethrough, and wherein the at least one porous material is curved and the at least one fastener is positioned through the one or more perforations.

11. The fluid collection assembly according to any one of claims 8 to 10, wherein: The elongated ridges are directly attached to the at least one porous material.

12. The fluid collection assembly according to any one of claims 8 to 11, wherein: The elongated ridges are ultrasonically welded to the at least one porous material.

13. The fluid collection assembly according to any one of claims 8 to 12, wherein: The elongated ridges include at least one of acrylonitrile butadiene styrene, a polycarbonate acrylonitrile butadiene styrene blend or copolymer, polyethylene, polypropylene, or polycarbonate.

14. The fluid collection assembly of any one of claims 4 to 7, further comprising a ridge defining at least one slit therein, the at least one slit comprising a first portion and a second portion extending from the first portion, wherein: The first portion presents a lateral dimension that is greater than the second portion.

15. The fluid collection assembly of claim 14, wherein: The at least one slit is completely surrounded by the ridge.

16. The fluid collection assembly according to any one of claims 3 to 15, wherein: The second coupler includes a clip including a first arm, a second arm, and a bend extending between the first arm and the second arm.

17. The fluid collection assembly of claim 16, wherein: The first arm is configured to be at least partially disposed within the at least one porous material, and the second arm is configured to be positioned through the at least one perforation.

18. The fluid collection assembly according to any one of claims 1 to 17, wherein: The fluid impermeable barrier defines the at least one orifice including the at least one vent at or near the proximal region.

19. The fluid collection assembly of claim 18, wherein: The at least one vent presents a 7.5 mm 2 To about 85mm 2 cross-sectional area.

20. The fluid collection assembly according to any one of claims 1 to 19, wherein: The fluid impermeable barrier defines the at least one aperture, the at least one aperture comprising at least one notch formed in the at least one lateral flange.

21. The fluid collection assembly of claim 20, wherein: The fluid impermeable barrier includes one or more projections extending laterally outward from a portion of the fluid impermeable barrier defining the at least one aperture.

22. The fluid collection assembly according to any one of claims 1 to 21, wherein: The fluid impermeable barrier defines the planar reservoir.

23. The fluid collection assembly according to any one of claims 1 to 22, wherein: The at least one porous material does not define a hole configured to receive a catheter.

24. The fluid collection assembly according to any one of claims 1 to 23, wherein: The at least one porous material is free of a binder therein and thereon.

25. A fluid collection system comprising: The fluid collection assembly according to any one of claims 1 to 24; Fluid storage containers; as well as Vacuum source; wherein the chamber of the fluid collection component, the fluid storage container and the vacuum source are fluidically connected to each other, so that when one or more body fluids are present in the chamber, the suction provided to the chamber of the fluid collection component from the vacuum source removes the one or more body fluids from the chamber and stores the body fluids in the fluid storage container.

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