Fluid collection assembly including a fluid-impermeable barrier defining at least one of a flat reservoir or at least one aperture - Patents.com

Abstract

The exemplary fluid collection assembly 100 comprises a fluid-impermeable barrier 102 and at least one porous material 112 disposed within the fluid-impermeable barrier 102. The fluid-impermeable barrier 102 comprises a proximal end region 124 and a distal end region 126 opposite the proximal end region 124. The fluid-impermeable barrier 102 defines a cavity 104, an opening 106, and a fluid outlet 108. The fluid-impermeable barrier 102 also defines at least one of a flattened reservoir 136 or at least one aperture 110 at or near the distal end region 126. The at least one aperture 110 formed in the fluid impermeable barrier 102 may form at least one of: at least one first coupling portion configured to be attached to at least one second coupling portion attached to the porous material 112; at least one vent hole at or near the proximal end region 124; or at least one notch formed in at least one side flange.

Description

[Background technology]

[0001] A human or animal may have limited or impaired mobility, making the normal process of urination difficult or impossible. For example, a human may experience or have a disability that impairs mobility. A human may have limited mobility conditions, such as those experienced by pilots, drivers, and workers in hazardous areas. In addition, it may be necessary to collect bodily fluids for monitoring purposes or clinical testing.

[0002] Urinary catheters, such as Foley catheters, can address some of these conditions, such as incontinence. Unfortunately, urinary catheters can be uncomfortable or painful and can lead to complications, such as infection. In addition, bedpans, which are containers used for waste by bedridden patients, may be used. However, bedpans can be prone to discomfort, leakage, and other hygiene issues. [Prior art documents] [Patent documents]

[0003] [Patent Document 1] International Publication No. 2021 / 216419 [Patent Document 2] US Patent Application Publication No. 2022 / 071811 Summary of the Invention [Means for solving the problem]

[0004] Embodiments herein are directed to a fluid collection assembly having a fluid-impermeable barrier defining at least one of a flat reservoir or at least one aperture, a fluid collection system including the same, and methods of using and forming the same. In one embodiment, a fluid collection assembly is disclosed. The fluid collection assembly includes a fluid-impermeable barrier having a proximal end region and a distal end region opposite the proximal end region. The fluid-impermeable barrier also defines at least a cavity, at least one opening, and a fluid outlet at or near the distal end region. The fluid-impermeable barrier defines at least one flat reservoir or at least one aperture at the distal end region. The fluid collection assembly also includes at least one porous material disposed in the cavity. Where the fluid-impermeable barrier includes at least one aperture, the at least one aperture forms at least one of: at least one first coupling portion configured to be attached to at least one second coupling portion attached to the at least one porous material; at least one vent port at or near the proximal end region; or at least one notch formed in at least one lateral flange extending laterally outward from each portion of the fluid-impermeable barrier that defines the cavity.

[0005] In one embodiment, a fluid collection system is disclosed. The fluid collection system includes a fluid collection assembly. The fluid collection assembly includes a fluid impermeable barrier having a proximal end region and a distal end region opposite the proximal end region. The fluid impermeable barrier also defines at least a cavity, at least one opening, and a fluid outlet at or near the distal end region. The fluid impermeable barrier defines at least one flat reservoir or at least one aperture at the distal end region. The fluid collection assembly also includes at least one porous material disposed in the cavity. When the fluid impermeable barrier comprises at least one aperture, the at least one aperture comprises at least one of at least one first coupling configured to be attached to at least one second coupling attached to the at least one porous material, at least one vent at or near the proximal end region, or at least one notch formed in at least one lateral flange extending laterally outward from each portion of the fluid impermeable barrier that defines the cavity. The fluid collection system also comprises a fluid reservoir and a vacuum source. The cavity of the fluid collection assembly, the fluid reservoir, and the vacuum source are in fluid communication with one another such that, if one or more bodily fluids are present in the cavity, suction provided from the vacuum source to the cavity of the fluid collection assembly removes the one or more bodily fluids from the cavity and collects the bodily fluids in the fluid reservoir.

[0006] 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 skilled in the art upon consideration of the following detailed description and accompanying drawings.

[0007] The drawings illustrate several embodiments of the present disclosure, with the same reference numbers referring to the same or similar elements or features in the various views or embodiments shown in the drawings. [Brief description of the drawings]

[0008] [Figure 1A]FIG. 2 is a side view of a fluid collection assembly, according to one embodiment. [Figure 1B] FIG. 1B is a cross-sectional schematic diagram of a fluid collection assembly along plane 1B-1B, according to one embodiment. [Diagram 2] 1 is a cross-sectional schematic diagram of a fluid collection assembly according to one embodiment. [Figure 3A] 1A-1C are cross-sectional schematic diagrams illustrating a method of securing a porous material to a second bond, according to one embodiment. [Figure 3B] 1A-1C are cross-sectional schematic diagrams illustrating a method of securing a porous material to a second bond, according to one embodiment. [Figure 4A] 1A-1C are cross-sectional schematic diagrams illustrating a method of attaching a porous material to a second coupling portion according to one embodiment. [Figure 4B] 1A-1C are cross-sectional schematic diagrams illustrating a method of attaching a porous material to a second coupling portion according to one embodiment. [Diagram 5] 1 is a cross-sectional schematic diagram of a porous material having a second coupling portion attached thereto, according to one embodiment. [Figure 6] 1 is a cross-sectional schematic diagram of a porous material having a second coupling portion attached thereto, according to one embodiment. [Figure 7] FIG. 13 is a cross-sectional schematic diagram of a second coupling portion according to one embodiment. [Figure 8A] FIG. 13 is a top view of a second joint including a fastener and a spine separately according to one embodiment. [Figure 8B] FIG. 8B is a cross-sectional schematic diagram of the fully assembled second joint, the cross-section being along the plane 8B-8B of the spine shown in FIG. 8A. [Figure 8C] 11A-11D are cross-sectional schematic diagrams of different methods of attaching a spine to a porous material according to different embodiments. [Figure 8D] 11A-11D are cross-sectional schematic diagrams of different methods of attaching a spine to a porous material according to different embodiments. [Figure 9] 1 is a cross-sectional schematic diagram of a second coupling defining one or more passageways extending therethrough, according to one embodiment. FIG. [Figure 10A] FIG. 13 is a side view of a second coupling portion, which is a clip, according to one embodiment. [Figure 10B] 1 is a cross-sectional schematic view of a fluid collection assembly including a clip, according to one embodiment. [Figure 11] 1 is a cross-sectional view of a fluid collection assembly comprising a fluid-impermeable barrier defining an exhaust port (ie, an aperture) at or near a proximal end region thereof, according to one embodiment. [Figure 12] FIG. 1 illustrates an isometric view of a fluid collection assembly comprising a fluid impermeable barrier having an aperture formed in at least one side flange, according to one embodiment. [Figure 13] FIG. 2 is a front view of a fluid collection assembly, according to one embodiment. [Figure 14] 1 is a cross-sectional view of a fluid collection assembly according to one embodiment. [Figure 15] FIG. 1 is a block diagram of a fluid collection system for fluid collection, according to one embodiment. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0009] Embodiments herein are directed to a fluid collection assembly having a fluid-impermeable barrier defining at least one of a flat reservoir or at least one aperture, a fluid collection system including the same, and methods of using and forming the same. An exemplary fluid collection assembly includes a fluid-impermeable barrier and at least one porous material disposed within the fluid-impermeable barrier. The fluid-impermeable barrier includes a proximal end region (i.e., the region that may be closest to the patient's navel during use) and a distal end region opposite the proximal end region. The fluid-impermeable barrier defines a cavity, at least one opening that allows bodily fluid discharged by the patient to flow into the cavity, and a fluid outlet at or near the distal end region of the fluid-impermeable barrier. The fluid-impermeable barrier also defines at least one of a flat reservoir or at least one aperture at or near the distal end region. The at least one aperture formed in the fluid-impermeable barrier may form at least one of at least one first coupling portion configured to be attached to at least one second coupling portion attached to the porous material, at least one vent extending through the fluid-impermeable barrier at or near its proximal end region, or at least one notch formed in at least one lateral flange extending laterally outward from each portion of the fluid-impermeable barrier that defines the cavity.

[0010] In use, the liquid collection assembly can be positioned relative to a patient such that the porous material is disposed adjacent to the urethral opening of the patient (e.g., the individual using the fluid collection assembly). The patient can discharge one or more bodily fluids (e.g., urine, blood, sweat, etc.). The discharged bodily fluids can be received within the porous material. The bodily fluids can flow through the porous material to an inlet of a conduit positioned to pass through a fluid outlet defined by a fluid impermeable barrier. The bodily fluids can then flow through the conduit and be removed from the fluid collection assembly. In one embodiment, a vacuum can be applied from the conduit to the porous material. The vacuum facilitates the flow of the bodily fluid through the porous material to the inlet of the conduit. The vacuum can also facilitate the flow of the bodily fluid through the conduit. The vacuum can be applied from a vacuum source in fluid communication with the conduit.

[0011] As discussed in detail below, the fluid collection assemblies disclosed herein may exhibit one or more improvements over conventional fluid collection assemblies. For example, the fluid impermeable barrier of conventional fluid collection assemblies may be flimsy, making it difficult to secure the porous material therein without the use of adhesives. However, adhesives may block or otherwise occlude at least some of the pores in the porous material, thereby preventing bodily fluids from flowing therethrough. The fluid collection assemblies disclosed herein may have at least one first coupling portion and at least one second coupling portion that, when attached to one another, allow the porous material to be secured to the fluid impermeable barrier without the use of adhesives. For example, conventional fluid collection assemblies often have vents formed therein at or near their distal end regions to facilitate air flow into the cavity. However, the location of the vents in such conventional fluid collection assemblies increases the likelihood that bodily fluids will leak from the conventional fluid collection assemblies, as bodily fluids tend to flow toward and accumulate near the fluid outlet. The fluid collection assemblies disclosed herein may include at least one vent formed in or near the distal end region of the fluid impermeable barrier, which has been found to minimize the likelihood of bodily fluids leaking from the cavity while still facilitating airflow through the cavity. For example, it has been found that older patients have difficulty holding (e.g., dropping) and handling (e.g., bending) conventional fluid collection assemblies that include side flanges. The fluid collection assemblies disclosed herein, when including at least one side flange, may have at least one notch formed in the side flange, which aids in the patient's holding the fluid collection assembly (e.g., reducing the likelihood that the patient will drop the fluid collection assembly) and in the patient's handling of the fluid collection assembly. For example, conventional fluid collection assemblies may include a positioning component configured to be positioned adjacent to the patient's vaginal opening to facilitate proper positioning of the conventional fluid collection assembly. However, it has been found that such a positioning component may be inadvertently inserted into the vaginal opening, which may cause discomfort to the patient.The fluid collection assemblies disclosed herein may include a flat reservoir in place of the positioning components of conventional fluid collection assemblies, which has been found to facilitate positioning of the fluid collection assembly and reduce the likelihood of the flat reservoir being inserted into the vaginal opening.

[0012] FIG. 1A is a side view of a fluid collection assembly 100, according to one embodiment. FIG. 1B is a cross-sectional schematic view of the fluid collection assembly 100 along plane 1B-1B, according to one 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 comprises a fluid-impermeable barrier 102 that at least defines a cavity 104, at least one opening 106, and a fluid outlet 108. The fluid-impermeable barrier 102 also comprises at least one first coupling portion. In one example, as shown, the first coupling portion is an aperture 110 extending through the fluid-impermeable barrier 102. The fluid collection assembly 100 also comprises at least one porous material 112 located within the cavity 104. The fluid collection assembly 100 also comprises at least one second coupling portion attached to the porous material 112 and configured to interact with the first coupling portion. In one embodiment, as shown, the second coupling comprises a fastener 114 located partially through the aperture 110. The fluid collection assembly 100 may also include at least one conduit 116 located partially within the fluid outlet 108 that is configured to remove one or more bodily fluids from the cavity 104. The conduit 116 does not have to extend through the porous material 112.

[0013] The fluid-impermeable barrier 102 at least partially defines a cavity 104 (e.g., an interior region) and an opening 106. For example, an inner surface 117 of the fluid-impermeable barrier 102 at least partially defines the cavity 104 within the fluid collection assembly 100. The fluid-impermeable barrier 102 temporarily stores bodily fluids within the cavity 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 polymer, 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 substantially prevents bodily fluids from passing through the fluid-impermeable barrier 102. In one embodiment, the fluid-impermeable barrier 102 can be air-permeable and fluid-impermeable. In such embodiments, the fluid impermeable barrier 102 may be formed from a hydrophobic material defining a plurality of pores. At least one or more portions of at least the outer surface 118 of the fluid impermeable barrier 102 may be formed from a flexible and / or smooth material, thereby reducing debris generation.

[0014] The opening 106 provides an entry path for bodily fluids to enter the cavity 104. The opening 106 may 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 may be formed in the fluid-impermeable barrier 102 and extend through the fluid-impermeable barrier 102 from the outer surface 118 to the inner surface 117, thereby allowing bodily fluids to enter the cavity 104 from outside the fluid collection assembly 100.

[0015] The opening 106 may be an elongated hole in the fluid impermeable barrier 102. For example, the opening 106 may be defined as a cutout in the fluid impermeable barrier 102. The opening 106 may be located and shaped to be located adjacent to a female's urethral opening. The opening 106 may have an elongated shape because the space between a woman's legs is relatively small when the woman's legs are closed, such that bodily fluids may only flow along a path that corresponds to the elongated shape of the opening 106 (e.g., a longitudinally extending opening).

[0016] The fluid collection assembly 100 can be positioned proximate to a female's urethral opening and bodily fluids can enter a cavity 104 of the fluid collection assembly 100 via an opening 106. The fluid collection assembly 100 is configured to receive bodily fluids into the cavity 104 via the opening 106. In use, the opening 106 can have an elongated shape that extends from a first location below the urethral opening (e.g., at or near the anus or vaginal opening) to a second location above the urethral opening (e.g., at or near the top of the vaginal opening or pubic hair).

[0017] In some examples, the fluid impermeable barrier 102 may define a fluid outlet 108 dimensioned to receive a conduit 116. At least one conduit 116 may be disposed within the cavity 104 via the fluid outlet 108. The fluid outlet 108 may be sized and shaped to form an at least substantially fluid-tight seal with the conduit 116 or at least one tube, thereby substantially preventing bodily fluids from escaping the cavity 104.

[0018] In one embodiment, the fluid impermeable barrier 102 may comprise a shell 120 and a connecting piece 122 secured to the shell 120. The shell 120 of the fluid collection assembly 100 comprises a proximal end region 124, a distal end region 126 opposite the proximal end region 124, a front side 128, and a back side 130 opposite the front side 128. Typically, during use, the distal end region 126 is closer to the patient's intergluteal cleft than the proximal end region 124 and the front side 128, which generally face the patient's vaginal region. The shell 120 may be formed from silicone, neoprene, a thermoplastic elastomer, or other fluid permeable material.

[0019] In one embodiment, the shell 120 includes one or more flanges. The flanges may provide additional points for undergarments or other garments to contact and press against the fluid collection assembly 100, thereby facilitating securing the fluid collection assembly 100 to the patient's vaginal area and improving patient comfort. In one embodiment, the flanges may include at least one of an upper flange 132 forming the proximal end region 124 and a lower flange 134 opposite the upper flange 132 forming the distal end region 126. The flanges may also include at least one lateral flange (shown in FIGS. 12 and 13) extending laterally outward from each portion of the fluid impermeable barrier 102 that defines the cavity 104.

[0020] The flange of the body may extend from the remainder of the shell 120 a distance in the range 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 from about 1 mm to about 3 mm, from about 1 mm to about 4 mm, from about 3 mm to about 5 mm, from about 4 mm to about 6 mm, from about 5 mm to about 7.5 mm, from about 6 mm to about 1 cm, from about 7.5 mm to about 1.25 cm, from about 1 cm to about 1.5 cm, from about 1.25 cm to about 1 cm, from about 1.5 cm to about 1.5 cm, from about 1 cm to about 3 cm, from about 1.5 cm to about 4 cm, or from about 3 cm to about 5 cm. The distance that the flanges extend from the remainder of the shell 120 can be selected based on the expected size of the patient's vaginal area (e.g., larger flanges for larger vaginal areas) or the expected rotational forces that will be exerted on the fluid collection assembly 100 during use. In some embodiments, at least some of the flanges may extend further from the remainder of the shell 120 than other flanges. For example, as shown, the lower flange 134 may extend further from the remainder of the fluid impermeable barrier 102 than the upper flange 132, as some patients may find a longer lower flange 134 to be more comfortable.

[0021] In one embodiment, one or more flanges may present a concave curved surface relative to the front side 128 of the shell 120. The concave curved surface of the flanges may extend from the proximal end region 124 to the distal end region 126. Because the vaginal region is curved, the concave curved surface of the flanges may allow the flanges to better conform to the shape of the vaginal region. With the flanges conforming to the shape of the vaginal region, the fluid collection assembly 100 may be more comfortable by distributing pressure more evenly across the vaginal region, especially when the flanges contact the labia majora.

[0022] In one embodiment, the shell 120 may include a reservoir 136 at or near the distal end region 126. The reservoir 136 may extend outwardly from the front side 128 of the shell 120 and / or the porous material 112 to facilitate positioning of the fluid collection assembly 100. For example, the reservoir 136 may extend outwardly such that the reservoir 136 mates with (e.g., abuts or is partially inserted into) the patient's vaginal opening. This alignment of the reservoir 136 with the vaginal opening facilitates proper positioning of the fluid collection assembly 100 relative to the patient. It is noted that the reservoir 136 may have a curved (e.g., not flat) shape.

[0023] The reservoir 136 may extend outwardly from the front side 128 of the shell 120 and / or the porous material 112 a distance d. The distance d may be between about 1 mm and about 3 mm, between about 2 mm and about 4 mm, between about 3 mm and about 5 mm, between about 4 mm and about 6 mm, between about 5 mm and about 7 mm, between about 6 mm and about 8 mm, between about 7 mm and about 9 mm, between about 8 mm and about 10 mm, between about 9 mm and about 11 mm, between about 10 mm and about 12 mm, between about 11 mm and about 13 mm, between about 12 mm and about 14 mm, or between about 13 mm and about 15 mm. The distance d may be selected based on a number of factors. For example, as the distance d increases, the likelihood that the reservoir 136 will be aligned with the vaginal opening increases, but so does the likelihood that the reservoir 136 will be partially inserted into the vaginal opening or otherwise cause discomfort when wearing the fluid collection assembly 100.

[0024] In use, the reservoir 136 is configured to define portions of the cavity 104 at or near a gravitational low point of the porous material 112 or otherwise in fluid communication therewith. For example, the portions of the cavity 104 defined by the reservoir 136 can receive a portion of the porous material 112 therein. The portions of the cavity 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 bodily fluid from leaking out of the fluid collection assembly 100. The reservoir 136 can include at least a portion of the connection piece 122 at least partially disposed therein.

[0025] In one embodiment, the shell 120 may define a recess configured to receive the conduit 116. The recess may extend from at or near the proximal end region 124 to at or near the distal end region 126, thereby allowing the conduit 116 to extend from at or near the abdominal region of the patient to the coupling piece 122. In one embodiment, the recess may be configured such that the shell 120 surrounds and / or abuts less than 50% of the circumference of the conduit 116, thereby allowing the conduit 116 to move freely in and out of the recess during use. Allowing the conduit 116 to move freely in and out of the recess may facilitate positioning the fluid collection assembly 100 with the porous material 112 adjacent the vaginal region, even if the conduit 116 bends away from the vaginal region. Additionally, since movement of the porous material 112 can result in leakage, allowing the conduit 116 to move freely in and out of the recess can increase the likelihood that the porous material 112 will not move relative to the vaginal area as the conduit 116 moves. In one embodiment, at least a portion of the recess can be configured such that the shell 120 surrounds and / or abuts more than 50% (e.g., 51% to about 55%, about 53% to about 57%, or about 55% to about 60%) of the circumference of the conduit 116. Surrounding more than 50% of the circumference of the conduit 116 can more securely attach the conduit 116 to the shell 120 and can allow the conduit 116 to provide additional structure to the shell 120. The percentage of the conduit 116 that is surrounded and / or abuts the shell 120 can be selected such that the natural resiliency of the shell 120 and the conduit 116 allows the conduit 116 to easily snap into and out of the recess. Thus, the conduit 116 may be removed from the recess to facilitate positioning the porous material 112 adjacent the vaginal area or when the conduit 116 is moved.

[0026] As discussed above, the fluid impermeable barrier 102 includes a connection piece 122 that is attached to or integrally formed with the shell 120 (e.g., by adhesive, welding, an interference fit, etc.). The connection piece 122 is located at or near a distal end region 126 of the shell 120, which allows the connection piece 122 to receive bodily fluids that flow to a gravitationally lower portion of the porous material 112. In one embodiment, a portion of the connection piece 122 can be positioned within a reservoir 136 of the shell 120. In an embodiment not shown, the connection piece 122 can form the reservoir 136 in place of the shell 120.

[0027] The connection piece 122 is configured to be connected (e.g., fluidly coupled) to the conduit 116. As such, the connection piece 122 may define a fluid outlet 108 configured to be attached to or otherwise in fluid communication with the conduit 116. The fluid outlet 108 may be positioned adjacent to the rear side 130 of the fluid impermeable barrier 102. The connection piece 122 may also define a conduit 138 (e.g., a tube) configured to allow the porous material 112 and the reservoir 136 to be in fluid communication with the conduit 116.

[0028] In one embodiment, at least a portion of the connecting piece 122 may exhibit a greater stiffness than the shell 120. The greater stiffness of the connecting piece 122 relative to the shell 120 may facilitate attachment of the conduit 116 to the connecting piece 122. In one example, the connecting piece 122 may exhibit a greater stiffness than the shell 120 if it is formed from a material that exhibits at least one of a greater Young's modulus (i.e., modulus of elasticity), yield strength, or ultimate tensile strength than the material forming the shell 120. In one example, the connecting piece 122 may exhibit a greater stiffness than the shell 120 if it exhibits a greater thickness than the shell 120.

[0029] As described above, the fluid impermeable barrier 102 includes a first joint and a second joint. The first joint and the second joint may enable the fluid collection assembly 100 to exhibit one or more improvements over conventional fluid collection assemblies. For example, the porous material 112 may be relatively weak (e.g., flexible or stretchy), which may make it difficult to secure the porous material 112 to the fluid impermeable barrier 102. For example, simply placing the porous material 112 within the cavity 104 defined by the fluid impermeable barrier 102 may not prevent the porous material 112 from falling out of the cavity 104 due to its weakness. Conventional fluid collection assemblies often secure their porous material to their fluid impermeable barrier by extending a conduit into the cavity and positioning the conduit within the porous material (e.g., the porous material defines a lumen configured to receive the conduit). Positioning the conduit within the porous material helps to maintain the porous material within the cavity, as the conduit provides structure to the porous material. However, placing the conduit within the cavity creates several problems. For example, it may generally be desirable for the porous material 112 to assume a shape that corresponds to the shape of the area around the urethral opening of the patient to prevent bodily fluids from leaking out. In particular, since the shape of the area around the urethral opening may vary from patient to patient, placing the conduit within the cavity will result in the porous material in which the conduit is located assuming a shape that corresponds to the shape of the conduit, which may differ from the shape of the area around the urethral opening. Furthermore, over-inserting the conduit within the cavity may inhibit bodily fluids from flowing into the conduit, for example, if the inlet is pressed against the fluid-impermeable barrier due to over-insertion of the conduit. Conventional fluid collection assemblies also often secure the porous material to the fluid-impermeable barrier by adhesively attaching the porous material to the fluid-impermeable barrier, instead of or in addition to using a conduit to secure the porous material to the fluid-impermeable barrier.However, using an adhesive to secure the porous material to the fluid impermeable barrier complicates manufacturing by requiring an additional manufacturing step of applying the adhesive to at least one of the porous material or the fluid impermeable barrier, and can make it more difficult to automate the manufacture of the fluid collection assembly. Additionally, the porous material tends to absorb or otherwise accept the adhesive, thereby blocking passages in the porous material through which bodily fluids can flow.

[0030] The fluid collection assembly 100 uses a first bond and a second bond to ameliorate the above problems of using conduits and / or adhesives to secure the porous material to the fluid impermeable barrier. In particular, the first bond and the second bond interact with each other to secure the porous material 112 to the fluid impermeable barrier 102. In one embodiment, the first bond of the fluid impermeable barrier includes at least one aperture 110 formed therein (i.e., an aperture formed in the fluid impermeable barrier 102). The fluid impermeable barrier may already have an aperture 110 formed therein because the fluid impermeable barrier often defines perforations therein as vacuum relief openings, and therefore, selecting the first bond to be the aperture 110 causes little or no deformation to the fluid impermeable barrier. In one embodiment, as shown, the second bond may include at least one fastener 114 located partially through the aperture 110 and secured to the porous material. It is noted herein that the first bond and the second bond may not include an adhesive or a conduit for removing bodily fluids from the cavity.

[0031] The first joint may include an aperture 110 extending through the fluid impermeable barrier 102. In one embodiment, the aperture 110 may be formed in the shell 120 as shown. For example, the aperture 110 may be formed in the shell 120 at or near the proximal end region 124. Attaching the porous material 112 at or near the proximal end region 124 may allow the porous material 112 to suspend from the first joint during use, which may reduce the likelihood that a portion of the porous material 112 will fall out of the cavity 104 than if the aperture 110 were formed at or near the distal end region of the shell 120. In one embodiment, the aperture 110 may be formed at or near the distal end region 126 of the shell 120, in a central portion of the shell 120, or in the connecting piece 122. It is noted that the first joint may include structure other than or in addition to the aperture 110. For example, the first connection may include a loop / hook type hook and loop fastener extending from the fluid-impermeable barrier 102, a hoop+loop type hook and loop fastener structure (e.g., Velcro®), perforations extending only partially through the fluid-impermeable barrier 102, or any other suitable structure.

[0032] As discussed above, the fluid collection assembly 100 includes a second coupling. In one embodiment, as shown, the second coupling 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 bonding), threaded attachment (e.g., the rod 142 includes threads that engage with the fibers of the porous material 112), or any other attachment technique.

[0033] The head 140 and rod 142 exhibit lateral dimensions configured to substantially 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 exhibit a lateral dimension (e.g., a maximum lateral dimension) that is greater than a corresponding lateral dimension of the rod 142. The lateral dimension of the head 140 may be greater than a corresponding lateral dimension of a portion of the aperture 110. The lateral dimension of the head 140 being greater than the corresponding lateral dimension of the aperture 110 may inhibit the head 140 from passing completely through the aperture 110. In other words, the lateral dimension of the head 140 being greater than the corresponding lateral dimension of the aperture 110 may form an obstacle to the head 140 passing through the aperture 110. However, it is noted that the fluid impermeable barrier 102, and in particular the shell 120, can be formed from a stretchable material that allows the head 140 to be forced through the 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 large enough that it is unlikely that the head 140 will pass through the fluid impermeable barrier 102 during use. The lateral dimensions of the rod 142 are smaller than or substantially equal to the corresponding lateral dimensions of the aperture 110, thereby allowing the rod 142 to pass through the aperture 110. Thus, the rod 142 can pass from one side of the fluid impermeable barrier 102 to the other. The attachment of the rod 142 together with the head 140 to the porous material 112 substantially prevents the fastener 114 from passing through the aperture 110.

[0034] In one embodiment, the aperture 110 is configured such that the head 140 is not located within it. In such an embodiment, the head 140 may protrude from the fluid impermeable barrier 102, which may make the fluid collection assembly 100 more uncomfortable to use and may push the conduit 116 through the fluid impermeable barrier 102. In one embodiment, the aperture 110 is configured such that the head 140 is located within a portion of it. In such an embodiment, the aperture 110 may include a first portion and a second portion. The first portion may be configured such that at least a portion of the head 140 is located within it. For example, the first portion may exhibit a lateral dimension that is equal to or slightly larger than a corresponding lateral dimension of the head 140. Positioning the head 140 within the first portion may result in the head 140 not extending from the fluid-impermeable barrier 102, or at least reducing the distance the head 140 extends from the fluid-impermeable barrier 102, which may in any case be more comfortable to use the fluid collection assembly 100 and may allow the conduit 116 to be positioned adjacent the fluid-impermeable barrier 102. The second portion of the aperture 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 exhibit a smaller lateral dimension than the head 140.

[0035] As mentioned above, the aperture 110 may form a vacuum relief opening when the catch 114 is not positioned therethrough. The vacuum relief opening allows air to enter the cavity 104, thereby improving fluid flow through the porous material 112 and avoiding suction that may be created by the fluid collection assembly 100 for the patient, which may result in general discomfort. The catch 114 may be positioned through the aperture 110 to block the vacuum relief opening such that air cannot enter the cavity 104 through the aperture 110. Thus, in some embodiments, the catch 114 may define a passage 144 extending therethrough. For example, the passage 144 may extend from the head 140 to a portion of the rod 142 (e.g., may extend centrally from the head 140 to the rod 142) without being blocked by the fluid impermeable barrier 102. The passageway 144 allows air to flow through the fastener 114 and into the cavity 104. It is noted that the fluid impermeable barrier 102 may define a vacuum relief opening that is spaced from the fastener 114 and is not at least partially occupied by the fastener 114.

[0036] As described above, the porous material 112 is disposed within the cavity 104. The porous material 112 may cover at least a portion (e.g., all) of the opening 106. The porous material 112 may comprise a fluid-permeable membrane 146 and a fluid-permeable support 148. The porous material 112 is exposed to the environment outside the cavity 104 through the opening 106. In one embodiment, the porous material 112 may be configured to wick away any bodily fluid from the opening 106, thereby preventing the bodily fluid from escaping the cavity 104. The permeability characteristics referred to herein may be wicking, capillary action, diffusion, or other similar characteristics or processes, and are referred to herein as "permeable" and / or "wicking." Such "wicking" or "permeable" characteristics may not include absorbing bodily fluid into at least a portion of the porous material 112, such as not including adsorption of bodily fluid into the fluid-permeable support 148. In other words, substantially no absorption or incorporation of bodily fluids into the material may occur for a period of time after the material is exposed to and removed from the bodily fluid. The term "substantially no absorption" may contemplate a nominal amount of absorption and / or incorporation (e.g., absorbency) of bodily 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 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 may also wick bodily fluids generally toward the interior of the cavity 104, as discussed in more detail below. In one embodiment, the porous material 112 may include at least one absorbent or adsorbent material.

[0037] In one embodiment, the porous material 112 may include a fluid-permeable membrane 146 disposed within the cavity 104. The fluid-permeable membrane 146 may cover at least a portion (e.g., all) of the opening 106. The fluid-permeable membrane 146 may be configured to wick bodily fluids away from the opening 106, thereby preventing the bodily fluids from escaping the cavity 104.

[0038] The fluid collection assembly 100 may include a fluid-permeable support 148 disposed within the cavity 104. The fluid-permeable membrane 146 may be formed from a relatively foldable, flimsy, or otherwise easily deformable material such that the fluid-permeable support 148 is configured to support the fluid-permeable membrane 146. For example, the fluid-permeable support 148 may be positioned such that the fluid-permeable membrane 146 is disposed between the fluid-permeable support 148 and the fluid-impermeable barrier 102. In that manner, the fluid-permeable support 148 may support and maintain the position of the fluid-permeable membrane 146. The fluid-permeable support 148 may include any material capable of wicking, absorbing, adsorbing, or otherwise enabling fluid transport of bodily fluids, such as any of the fluid-permeable membrane materials disclosed hereinabove. For example, the fluid-permeable membrane material may be used in a denser or stiffer form when used as the fluid-permeable support 148 than in the fluid-permeable membrane 146. The fluid-permeable support 148 may be formed from any fluid-permeable material that is less susceptible to deformation than the fluid-permeable membrane 146. For example, the fluid-permeable support 148 may include a porous polymer (e.g., nylon, polyester, polyurethane, polyethylene, polypropylene, etc.) structure or an open cell foam, such as nylon spun fibers. In some embodiments, the fluid-permeable support 148 may include a nonwoven material. In some embodiments, the fluid-permeable support 148 may be formed from a natural material, such as cotton, wool, silk, or a combination thereof. In such embodiments, the material may have a coating to prevent or limit fluid absorption into the material, such as a water repellent coating. In some embodiments, the fluid-permeable support 148 may be formed from a fabric, felt, gauze, or a combination thereof.

[0039] In one embodiment, the fluid-permeable membrane 146 may include any material capable of wicking bodily fluids. For example, the fluid-permeable membrane 146 may 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 a gauze, soft fabric, and / or a smooth fabric may reduce debris generation caused by the fluid collection assembly 100. In some examples, the fluid-permeable membrane 146 may be optional. For example, the porous material 112 may include only the fluid-permeable support 148. In some examples, the fluid-permeable support 148 may be optionally omitted from the fluid collection assembly 100. For example, the porous material 112 may include only the fluid-permeable membrane 146.

[0040] In one embodiment, at least a portion of the porous material 112 (e.g., one or more of the fluid-permeable membrane 146 or, more preferably, the fluid-permeable support 148) may be hydrophobic. The porous material 112 may be hydrophobic if it exhibits a contact angle with water (a major component of bodily 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 135°, about 135° to about 175°, or about 180°. The hydrophobicity of the porous material 112 may limit the absorption, adsorption, and incorporation of bodily fluids into the porous material 112, thereby reducing the amount of bodily fluid retained within the porous material 112. In one embodiment, at least a portion of the porous material 112 is hydrophobic or hydrophilic. In one embodiment, the fluid-permeable support 148 is more hydrophobic (e.g., exhibits a greater contact angle with water) than the fluid-permeable membrane 146. The less hydrophobic nature of the fluid-permeable membrane 146 may aid the porous material 112 in receiving bodily fluids from the urethral opening, while the hydrophobic nature of the fluid-permeable support 148 limits the bodily fluids that are retained within the porous material 112.

[0041] The porous material 112 may at least substantially completely fill the portions of the cavity 104 that are not occupied by the conduit 116 or the connecting piece 122. In some embodiments, the porous material 112 may not substantially completely fill the portions of the cavity 104 that are not occupied by the conduit 116 and the connecting piece 122. In such embodiments, the fluid collection assembly 100 includes a reservoir disposed within the cavity 104. Bodily fluid present within the cavity 104 may flow through the fluid-permeable membrane 146 and / or the fluid-permeable support 148 to the reservoir. The reservoir may hold bodily fluid within itself. The reservoir may be located within a portion of the cavity 104 that is designed to be located at a low point relative to the gravity of the fluid collection assembly 100 when the fluid collection assembly 100 is worn.

[0042] The conduit 116 can be disposed at least partially within the cavity 104. The conduit 116 can be used to remove bodily fluids from the cavity 104. The conduit 116 includes at least one wall defining an inlet 152 and an outlet (not shown) located downstream of the inlet 152. The outlet of the conduit 116 can be operatively coupled to a vacuum source, such as a vacuum pump, to draw fluid from the cavity 104 through the conduit 116. For example, the conduit 116 can extend from the proximal end region 124 into the fluid-impermeable barrier 102 and can extend to the distal end region 126 to a location proximate a reservoir in the fluid-impermeable barrier 102 such that the inlet 152 is in fluid communication with the reservoir. The conduit 116 fluidly couples the cavity 104 to a fluid reservoir (not shown) or a vacuum source (not shown).

[0043] In one embodiment, the conduit 116 extends from the fluid outlet 108 to a point proximate to the reservoir. In one embodiment, the conduit 116 is at least partially disposed within the reservoir, and the inlet 152 may extend or be located within the reservoir. Bodily fluid collected within the fluid collection assembly 100 may be removed from the cavity 104 via the conduit 116.

[0044] By locating the inlet 152 at or near a location that is expected to be a gravitational low point in the cavity 104 when worn by a patient, the conduit 116 may receive more bodily fluid than if the inlet 152 were located elsewhere, reducing the chance of stagnation (e.g., stagnation of bodily fluids, which may result in microbial growth and foul odors). For example, bodily fluids within the fluid-permeable membrane 146 and the fluid-permeable support 148 may flow in any direction due to capillary forces. However, bodily fluids may exhibit a preference to flow in the direction of gravity, particularly if at least a portion of the fluid-permeable membrane 146 and / or the fluid-permeable support 148 is saturated with bodily fluid. Thus, one or more of the inlet 152 or reservoirs may be located within the fluid collection assembly 100 at a location that is expected to be a gravitational low point in the fluid collection assembly 100 when worn by a patient, such as the distal end region 126.

[0045] The inlet 152 and outlet of the conduit 116 are configured to fluidly couple (e.g., directly or indirectly) a vacuum source (not shown) to the cavity 104 (e.g., the reservoir). When a vacuum source ( FIG. 15 ) applies a vacuum / suction into the conduit 116, bodily fluids in the cavity 104 (e.g., at the distal end region 126, such as in the reservoir) can be pulled into the inlet 152 and out of the fluid collection assembly 100 via the conduit 116. In some embodiments, the conduit 116 can be frosted or opaque (e.g., black) to prevent the bodily fluids therein from being seen.

[0046] As discussed above, the conduit 116 can be configured to be at least insertable into the cavity 104. In one embodiment, the conduit 116 can be positioned within the cavity 104 such that a terminal end of the conduit 116 is spaced from the fluid impermeable barrier 102 or other components of the fluid collection assembly 100 that may at least partially occlude or block the inlet 152. Additionally, the inlet 152 of the conduit 116 can be offset relative to a terminal end of the porous material 112 such that the inlet 152 is closer to the proximal end region 124 of the fluid collection assembly 100 than the terminal end of the porous material 112. By offsetting the inlet 152 relative to a terminal end of the porous material 112 in this manner, the inlet 152 can receive bodily fluid directly from the porous material 112, drawing more bodily fluid from the porous material 112 into the conduit 116 through hydrogen bonding.

[0047] The fluid collection assembly 100 includes only a single first coupling and a single second coupling. However, the fluid collection assemblies disclosed herein may include multiple first couplings and multiple second couplings. For example, FIG. 2 is a cross-sectional schematic diagram of a fluid collection assembly 200, according to one embodiment. Except as otherwise disclosed herein, the fluid collection assembly 200 is the same as or substantially similar to any of the fluid collection assemblies disclosed herein. For example, the fluid collection assembly 200 may include a fluid impermeable barrier 202 and at least one porous material 212.

[0048] The fluid impermeable barrier 202 includes a plurality of first bonds and the porous material 212 includes a plurality of second bonds. 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 located through the apertures 210. In one 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 can be located at or near the proximal end region 224 and the other perforation can be located near the end of the porous material 212 opposite the proximal end region 224. Thus, the aperture 210 and the fastener 214 secure opposing ends of the porous material 212 to the fluid-impermeable barrier 202, thereby allowing the porous material 212 to be more stably secured to the fluid-impermeable barrier 202 than if the aperture 210 were otherwise positioned.

[0049] The fasteners shown in Figures 1A-2 are illustrated as being attached directly to the porous material. However, a patient using the fluid collection assembly shown in Figures 1A-2 may feel the fasteners through the porous material, especially when sitting. Because pressure generated by the fasteners is not distributed over a large surface area, feeling the fasteners through the porous material may cause discomfort to the patient. Thus, in some embodiments, the fasteners may be indirectly attached to the porous material via the spine.

[0050] 3A and 3B are cross-sectional schematic diagrams illustrating a method of securing a porous material 312 to a second coupling 352, according to one embodiment. Except as otherwise disclosed herein, the porous material 312 and the second coupling 352 may be the same as or substantially similar to any of the porous material and second couplings disclosed herein, respectively, and may be used in any of the fluid collection assemblies disclosed herein. For example, the porous material 312 may comprise a fluid-permeable membrane 346 and a fluid-permeable support 348, and the second coupling 352 may comprise a fastener 314 comprising a head 340 and a rod 342. It is noted that the porous material 312 is illustrated with the fluid-permeable membrane 346 disposed on only one side of the fluid-permeable support 348. However, it is noted that the fluid-permeable membrane 346 may surround the periphery of the fluid-permeable support 348, at least as shown in FIGS. 1B, 2, 8C, and 8D.

[0051] The porous material 312 defines a number of passages 354 extending therethrough. For example, the passages 354 may extend through the fluid-permeable membrane 346 and the fluid-permeable support 348. The passages 354 are configured to accommodate the rods 342 of the fasteners 314 disposed therein. Thus, the porous material 312 may define as many passages 354 as the second coupling 352 comprises fasteners 314. The passages 354 may have a size and shape that generally corresponds to the size and shape of the rods 342. However, the passages 354 may have a size and / or shape that inhibits movement of the head 340 therethrough. However, the porous material 312 may be sufficiently elastic that when a sufficiently large force is applied to the fasteners 314, the head 340 may be forced through the corresponding passages 354 without substantially damaging the porous material 312, thereby allowing the rods 342 to be positioned within the passages 354. It is noted that the force required to urge head 340 through passageway 354 is greater than the force expected to be exerted on fastener 314 during use.

[0052] The second coupling portion 352 includes an elongated spine 356. The fasteners 314 of the second coupling portion 352 may be attached to the spine 356, and the spine 356 may extend longitudinally between the fasteners 314. The spine 356 may provide structure to the second coupling portion 352. For example, the spine 356 may maintain a selected distance between the fasteners 314. The distance that the spine 356 maintains the fasteners 314 apart from each other may help maintain a curve formed in the porous material 312 (as discussed in connection with FIG. 3B) and may facilitate attachment of the second coupling portion 352 to a shell (not shown). The spine 356 may also make the fluid collection assembly more comfortable to use. For example, as described above, a patient using the fluid collection assembly 100, 200 shown in FIGS. 1A-2 may be able to feel the fasteners (more specifically, rods) through the porous material, such as when sitting down. Pressure caused by the fasteners, felt through the porous material, can make the fluid collection assembly uncomfortable, but by including the spine 356 in the second coupling portion 352, the pressure caused by the fasteners is distributed over a larger area, making the fluid collection assembly more comfortable to use.

[0053] The spine 356 may also provide structure to the porous material 312 and at least a portion of the fluid impermeable barrier to which the second coupling portion 352 is attached. For example, the spine 356 may cause the porous material 312 and at least a portion of the fluid impermeable barrier to which the second coupling portion 352 is attached to assume a shape that generally corresponds to the shape of the spine 356. In one embodiment, the spine 356 may be formed from a shape memory material. As used herein, a shape memory material includes any material that can be molded and retain a shape in response to a force (e.g., chemical force, physical force, heat, etc.). Examples of shape memory materials include Nitinol, copper, steel, or aluminum. When the spine 356 is formed from a shape memory material, the spine 356 may assume a first shape. The porous material 312 and at least a portion of the fluid impermeable barrier may assume a shape that corresponds to the first shape of the spine 356. The spine 356 can be bent from a first shape to a second shape different from the first shape. The spine 356 can maintain the second shape because it is formed from a shape memory material. Bending the spine 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 spine 356. The spine 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 with whom the fluid collection assembly is to be used. Bending the spine 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 a patient with whom the fluid collection assembly is to be used. At least a portion of the porous material 312 and fluid impermeable barrier may be shaped to generally correspond to the shape of the vaginal area to inhibit bodily fluids from leaking out of the fluid collection assembly and / or to allow the porous material 112 to receive a greater portion of bodily fluids discharged from the patient. In one embodiment, the spine 356 is formed from a stretchy material (i.e., a material that is not very brittle) so that it may be shaped or bent as needed without breaking or otherwise failing.

[0054] In one embodiment, as shown, the fastener 314 can be integrally formed with the spine 356. For example, the second coupling portion 352 can be formed using injection molding techniques, 3D printing, or another suitable technique. By integrally forming the fastener 314 and the spine 356, the number of manufacturing steps required to form the second coupling portion 352 can be minimized since the fastener 314 and the spine 356 do not need to be attached to one another.

[0055] It is noted that unlike the fastener 114 shown in FIG. 1B, the head 340 is illustrated as being curved. Having a curved head 340 may make it easier to push the head 340 through the porous material 312 and through the shell. However, unlike the generally flat head shown in FIG. 1B, the curved head 340 may not be flush with the shell. It is noted that the head 340 may be tapered, elongated, conical, or hemispherical in shape, as these shapes (and other similar shapes) may make it easier to push the head 340 through the porous material 312 and through the shell.

[0056] Prior to attaching the porous material 312 to the second coupling portion 352, the porous material 312 may have a length greater than the length of the second coupling portion 352. Referring to FIG. 3B, the greater length of the porous material 312 allows the porous material 312 to bend around the second coupling portion 352. The fastener 314 may be positioned through a passage 354 defined by the porous material 312. For example, the head 340 of the fastener 314 may be pushed through the passage 354 such that the rod 342 is positioned within the passage 354. With the fastener 314 positioned through the passage 354, the second coupling portion 352 is attached to the porous material 312.

[0057] In one embodiment, a void 358 can be formed between the terminal edges 360 (e.g., the top and bottom edges) of the porous material 312 after the porous material 312 is attached to the second coupling portion 352. The void 358 can increase the volume of bodily fluid that can be temporarily stored within the cavity defined by the fluid impermeable barrier. However, the void 358 can allow bodily fluid to remain trapped within the cavity, which can cause leakage of the bodily fluid and / or promote biological growth within the cavity. Thus, in such an embodiment, the void 358 can be eliminated or at least reduced in size. In one example, the porous material 312 can be long enough that the terminal edges 360 abut each other after the porous material 312 is attached to the bend fastener 314 (e.g., the porous material 312 is ...) after the porous material 312 is attached to the bend fastener 314 (e.g., the porous material 312 is long enough that the terminal edges 360 abut each other after the porous material 312 is attached to the bend fastener 314). In one embodiment, the porous material 312 may include an additional porous material configured to fit within or at least partially fill the void 358 .

[0058] In one embodiment, the spine 356 is not directly attached to the porous material 312. In such an embodiment, the spine 356 is indirectly attached to the porous material 312 via fasteners 314 positioned through passages 354. In one embodiment, the spine 356 is directly attached to the porous material 312, which may allow the porous material 312 to assume a shape that more closely matches the shape of the spine 356. In one example, the spine 356 is attached to the porous material 312 with an adhesive. However, attaching the spine 356 to the porous material 312 with an adhesive may result in the adhesive being absorbed into the porous material 312 before it hardens, thereby at least partially blocking at least some of the passages through the porous material 312. In one example, the spine 356 is welded (e.g., ultrasonically bonded) to the porous material 312, thereby solving at least some of the problems that arise from attaching the spine 356 to the porous material 312 with an adhesive. If the spine 356 is welded to the porous material 312, the spine 356 may be at least partially formed from a weldable material, such as acrylonitrile butadiene styrene ("ABS"), ABS-polycarbonate blends or copolymers, polyethylene, polypropylene, polycarbonate, or another suitable material. In other words, the spine 356 is not formed from a non-weldable material, such as silicone, multi-temperature elastomer, or thermoplastic. If the spine 356 includes a shape memory material that is non-weldable to the porous material 312, the spine 356 may include a coating of a weldable material on at least a portion of the surface of the shape memory material. In one embodiment, the spine 356 may be sewn or otherwise attached to the porous material 312, although it is noted that sewing or otherwise attaching the spine 356 to the porous material 312 during an automated manufacturing process may be more difficult than welding the spine 356 to the porous material 312.

[0059] It is noted that in addition to positioning the fasteners 314 through the porous material 312, the fasteners 314 can also be attached to the porous material 312 using attachment techniques. For example, the fasteners 314 can be adhesively attached, welded (as the fasteners 314 can be formed, at least in part, from the same weldable material as the spine 356), sewn, or otherwise attached to the porous material 312.

[0060] In one embodiment, the rod 342 may exhibit a length that is greater than a thickness of the porous material 312, allowing a portion of the rod 342 to extend outwardly from the porous material 312 without compressing the porous material 312. The portion of the rod 342 that extends outwardly from the porous material 312 may be located within the first joint (e.g., through a perforation).

[0061] The porous material 312 and second coupling portion 352 may be attached to the shell 220 shown in FIG. 2, since the shell 220 may be attached using multiple fasteners. However, the porous material and second coupling portion comprising a spine may be configured to be attached to the shell 120 shown in FIG. 1B. For example, FIGS. 4A and 4B are cross-sectional schematic diagrams illustrating a method of attaching the porous material 412 to the second coupling portion 452, according to one embodiment. Referring to FIG. 4A, the porous material 412 and second coupling portion 452 are provided. The porous material 412 and second coupling portion 452 may be identical to the porous material 312 and second coupling portion 352 shown in FIGS. 3A and 3B, except that the porous material 412 defines only a single passageway 454 and / or the second coupling portion 452 comprises a single fastener 414. 4B, the porous material 412 can be bent around a portion of the second connector 452 such that the fastener 414 is located within the passageway 454. Although only one fastener 414 is located through the porous material 412, the second connector 452 (e.g., the spine 456 of the second connector 452) provides structure to the porous material 412, allowing the porous material 412 to assume a particular shape and making a fluid collection assembly including the porous material 412 more comfortable to use.

[0062] 5 is a cross-sectional schematic diagram of a porous material 512 with a second coupling portion 552 attached thereto, according to one embodiment. Except as otherwise disclosed, the porous material 512 and the second coupling portion 552 are the same as or substantially similar to any of the porous materials and second coupling portions disclosed herein, respectively, and may be used in any of the fluid collection assemblies disclosed herein. However, unlike other porous materials and second coupling portions disclosed herein, the porous material 512 does not define at least one aperture, and / or the fastener 514 of the second coupling portion 552 does not pass through an aperture. Instead, the spine 556 is attached directly to the porous material 512 (e.g., attached to a surface of the porous material 512 opposite the opening), for example, by adhesive, welding, sewing, or another suitable technique.

[0063] 6 is a cross-sectional schematic diagram of a porous material 612 having a second coupling portion 652 attached thereto, according to one embodiment. Except as otherwise disclosed herein, the porous material 612 and the second coupling portion 652 are identical to any of the porous material and second coupling portions, respectively, disclosed herein and may be used in any of the fluid collection assemblies disclosed herein. For example, the porous material 612 may comprise a fluid-permeable membrane 646 and a fluid-permeable support 648, and the second coupling portion 652 may comprise one or more fasteners 614 and a spine 656.

[0064] The spine 656 exhibits a "crinkle" or sawtooth structure. The crinkle structure of the spine 656 includes one or more circumferential or spirally extending ridges 662 and defines one or more circumferential or spirally extending valleys 664 between the ridges 662. The ridges 662 exhibit a lateral dimension (e.g., diameter) that is greater than the portions of the spine 656 that define the valleys 664. The crinkle structure of the spine 656 may facilitate shaping of the spine 656 and, if the spine 656 is formed from a shape memory material, may facilitate maintaining the shape of the spine 656. For example, the crinkle structure of the spine 656 may allow the spine 656 to bend by reducing the distance between adjacent ridges 662. The valleys 664 provide a place for the ridges 662 to move into as the distance between them decreases.

[0065] The second coupling shown in FIGS. 3A-6 shows a fastener and spine that are integrally formed together. However, it is noted that the second coupling disclosed herein can be formed from two or more separate components that are attached to one another. Forming the second coupling from two or more separate components may allow the second coupling to be manufactured using more manufacturing techniques than if it were formed from a single piece. For example, FIG. 7 is a cross-sectional schematic diagram of a second coupling 652 according to one embodiment. Except as otherwise disclosed herein, the second coupling 652 may be the same as or substantially similar to any of the second couplings disclosed herein and may be used in any of the fluid collection assemblies disclosed herein. The second coupling 652 is formed from two or more separate components that are attached to one another. In one embodiment, as shown, the second coupling 652 comprises one or more fasteners 614 and a spine 656 that are separate and attached to one another. In such embodiments, the fasteners 614 and spine 656 may be attached to one another using adhesives, welding (e.g., ultrasonic bonding), threaded attachment, or any other suitable technique. If the fasteners 614 and spine 656 are attached to one another using ultrasonic bonding, the fasteners 614 and spine 656 may be formed from a weldable material, as described above. In one embodiment, one or more of the fasteners 614 are formed from separate components (e.g., the head 640 and rod 642 are separate) that are attached to one another. In one embodiment, the spine 656 may be formed from two or more separate components.

[0066] Another example of a second coupling part formed from two or more separate components is shown in Figures 8A and 8B. Figure 8A is a top view of a second coupling part 852 including a fastener 814 and a spine 856 separately, according to one embodiment. Figure 8B is a cross-sectional schematic diagram of a fully assembled second coupling part 852, the cross-section being along a plane 8B-8B of the spine 856 shown in Figure 8A. Referring to Figure 8A, the fastener 814 includes two heads 840 and a rod 842 extending between the two heads 840. The spine 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 one embodiment, as shown, the slit 866 is completely surrounded by the spine 856. In such an embodiment, the first portion 868 has a lateral dimension large enough to receive the head 840 of the fastener 814, and the second portion 870 has a lateral dimension large enough to receive the rod 842 and small enough not to receive the head 840 at all. In other words, the lateral dimension of the slit 866 varies. The lateral dimension of the slit 866 varies to allow one of the heads 840 to be inserted through the first portion 868 such that the heads 840 are located on different sides of the spine 856. The fastener 814 can then slide along the length of the slit 866 such that the rod 842 moves from the first portion 868 to the second portion 870. FIG. 8B illustrates the arrangement of the second coupling portion 852 when the rod 842 is located within the second portion 870. As shown in FIG. 8B, head 840 cannot pass through slit 866 when rod 842 is located within second portion 870 , thereby securing fastener 814 to spine 856 .

[0067] The fastener 814 can be detached from the spine 856 by sliding the fastener 814 along the slit 866 such 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 passes through the slit 866, thereby detaching the fastener 814 from the spine 856. The ability to detach the fastener 814 from the spine 856 can allow replacement of damaged parts, or allow a porous material (not shown) to be attached to the spine 856 such that it can be detached from the shell (e.g., replaced after use) without the fastener 814 detaching from the shell. In one not shown embodiment, the slit 866 is not completely surrounded by the spine 856. In such an embodiment, the slit 866 can extend from an edge of the spine 856.

[0068] The spine 856 allows the second coupling 852 shown in Figures 8A and 8B to be attached to the porous material in a variety of ways. For example, Figures 8C and 8D are cross-sectional schematics of different ways of attaching the spine 856 to the porous material according to different embodiments. It is noted that the cross-sectional schematics of Figures 8C and 8D are taken along a plane transverse to the longitudinal axis of the porous material. Except as otherwise disclosed herein, the porous material shown in Figures 8C and 8D is the same as or substantially similar to any of the porous materials disclosed herein. The porous material and second coupling 852 shown in Figures 8C and 8D can be used in any of the fluid collection assemblies disclosed herein.

[0069] 8C, the spine 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. Disposing the spine 856 within the porous material 812c can allow the spine 856 to be secured to the porous material 812c without adhesives, welding, sewing joints, or the like. Not securing the spine 856 to the porous material 812c with adhesives, welding, sewing joints, or the like can also allow the spine 856 to slide within the porous material 812c. Sliding the spine 856 within the porous material 812c can allow the rod 842 to move from the first portion 868 to the second portion 870 (first portion 868 and second portion 870 are shown in FIG. 8A), or vice versa. Positioning the spine 856 within the porous material 812c may require forming a recess in the porous material 812c for the fastener 814 to seat through. With reference to FIG. 8D, the spine 856 can be attached to an exterior surface of the porous material 812d. For example, as shown, the spine 856 can be attached to an exterior surface of the fluid permeable membrane 846. The spine 856 can be attached to the exterior surface of the porous material 812d using adhesives, welding, sewing, or any other suitable technique.

[0070] Similar to the fastener 814 shown in FIG. 1B, the fasteners of the second couplings shown in FIGS. 3-8D may block perforations formed in the shell that are configured to allow air to flow into the cavity. Thus, the second couplings shown in FIGS. 3-8 may define one or more perforations to allow air to flow through the shell. For example, FIG. 9 is a cross-sectional schematic diagram of a second coupling 952 that defines one or more passages 944 extending through an interior thereof, according to one embodiment. Except as otherwise disclosed herein, the second coupling 952 may be the same as or substantially similar to any of the second couplings disclosed herein and may be used in any of the fluid collection assemblies disclosed herein. The second coupling 952 comprises one or more fasteners 914 and a spine 956. At least one of the fasteners 914 defines a passage 944 extending at least partially therethrough, as described herein above. For example, the passageway 944 may extend from the head 940 of the fastener 914, since the head 940 may be exposed to the atmosphere outside the cavity defined by the shell. The passageway 944 may extend from the head 940 and through at least a portion of the rod 942 to a portion of the second coupling portion 952 that is in fluid communication with the cavity. In one embodiment, as shown, the passageway 944 may extend over a portion of the spine 956. The passageway 944 extending through the spine 956 may allow the passageway 944 to follow a generally straight path, which may facilitate forming the passageway 944 through the fastener 914. For example, the straight path of the passageway 944 may allow the passageway 944 to be formed by boring or may allow the passageway 944 to be formed using injection molding.

[0071] The second coupling portion disclosed herein may include elements other than or in addition to a fastener. For example, FIG. 10A is a side view of a second coupling portion that is a clip 1072, according to one embodiment. The clip 1072 may include a first arm 1074, a second arm 1076, and a curved portion 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.

[0072] 10B is a cross-sectional schematic diagram of a fluid collection assembly 1000 including a clip 1072, according to one embodiment. Except as otherwise disclosed herein, the fluid collection assembly 1000 is the same as or substantially similar to any of the fluid collection assemblies disclosed herein. For example, the fluid collection assembly may include a fluid impermeable barrier 1002 that defines a cavity 1004, an opening 1006, and a fluid outlet 1008. The fluid impermeable barrier 1002 also includes a shell 1020 and a first coupling portion. In the illustrated embodiment, the first coupling portion includes an aperture 1010 formed in the shell 1020. The fluid collection assembly 1000 also includes at least one porous material 1012.

[0073] As described above, the clip 1072 is configured to secure the porous material 1012 to the fluid impermeable barrier 1002. The first arm 1074 is configured to attach to the porous material 1012. For example, the first arm 1074 can be at least partially disposed within the porous material 1012 (e.g., between the fluid permeable membrane 1046 and the fluid permeable support 1048) or attached to an exterior surface of the porous material 1012 (e.g., with an adhesive, welding, stitching, etc.). The second arm 1076 is configured to attach 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 shell 1020. Thus, the clip 1072 secures the porous material 1012 to the fluid impermeable barrier 1002.

[0074] Referring again to FIG. 10A, in one embodiment, the clip 1072 may assume a first shape when no external force is applied to the clip 1072. When the clip 1072 assumes the first shape, the first arm 1074 and the second arm 1076 may be spaced apart from one another by a first distance. The clip 1072 may be configured to assume a second shape. The second shape may be formed by a force that pulls the first arm 1074 and the second arm 1076 apart. When the clip 1072 assumes the second shape, the first arm 1074 and the second arm 1076 may be spaced apart from one another by a second distance that is greater than the first distance. The clip 1072 may be formed from a material that is sufficiently elastic to only elastically deform when switching from the first shape to the second shape. Thus, the clip 1072 may attempt to return to the first shape. It is noted that the clip 1072 may include one or more additional shapes, such as a third shape where the distance between the first arm 1074 and the second arm 1076 is greater than the first distance and greater or less than the second distance.

[0075] As shown in FIG. 10A, the clip 1072 may assume a first shape when it is not securing the porous material 1012 to the fluid impermeable barrier 1002. In one embodiment, as shown in FIG. 10B, the clip 1072 may assume a second shape when it is securing the porous material 1012 to the fluid impermeable barrier 1002. In other words, the components of the fluid collection assembly 1000 between the first arm 1074 and the second arm 1076 are greater than the first distance. Thus, the first arm 1074 and the second arm 1076 may apply a compressive force to the porous material 1012 and / or the fluid impermeable barrier 1002. The compressive force may minimize movement between the porous material 1012 and the fluid impermeable barrier 1002 during use. In one embodiment, the clip 1072 may assume a second shape while performing the attachment of the porous material 1012 to the fluid impermeable barrier 1002. In such embodiments, the clip 1072 may need to deform while 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 may revert 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.

[0076] As mentioned above, 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 joint. For example, FIG. 11 is a cross-sectional view of a fluid collection assembly 1100 including a fluid-impermeable barrier 1102 defining an exhaust port 1110 (i.e., an aperture) at or near its proximal end region, according to one embodiment. Except as otherwise disclosed herein, the fluid collection assembly 1100 is the same as or substantially similar to any of the fluid collection assemblies disclosed herein. For example, the fluid-impermeable barrier 1102 may define a cavity 1104, at least one opening 1106, and a fluid exhaust port 1108, and the fluid collection assembly 1100 may include at least one porous material 1112 disposed within the cavity 1104.

[0077] The vent 1110 is located at or near the proximal end region 1124 of the fluid impermeable barrier 1102. Such location of the vent 1110 prevents or at least inhibits bodily fluids from leaking out of the cavity 1104. For example, as described above, bodily fluids enter the cavity 1104 through the opening 106 and flow through the porous material 1112 toward the fluid outlet 1108 and the conduit 1116 due to the vacuum source provided by the conduit 1116 and due to gravity. Thus, bodily fluids are significantly more likely to reside and / or accumulate in portions of the cavity 1104 proximate the distal end region 1126 than the proximal end region 1124. Conventional fluid collection assemblies may include vents at or near their distal end regions, and bodily fluids may leak through such vents due to the bodily fluids being present and accumulating at or near the distal end region of the conventional fluid collection assembly. However, the smaller amount of bodily fluid adjacent to the exhaust port 1110 compared to the exhaust port of a conventional fluid collection assembly makes bodily fluid significantly less likely to leak through the exhaust port 1110 than the exhaust port of a conventional fluid collection assembly.

[0078] Because bodily fluids are less likely to leak through the vent 1110, the vent 1110 may exhibit a minimum cross-sectional area that may be larger than the vents of at least some conventional fluid collection assemblies. For example, the vent 1110 may be approximately 7.5 mm 2 ~Approx. 15cm 2 , about 10mm 2 ~about 20cm 2 , about 15mm 2 ~about 25cm 2 , about 20mm 2 ~about 30cm 2 , about 25mm 2 ~Approx. 35cm 2 , about 30mm 2 ~about 40cm 2 , about 35mm 2 ~ approx. 45cm 2 , approx. 40mm 2 ~about 50cm 2 , about 45mm 2 ~55cm 2 , about 50 mm 2 ~about 60cm 2 , about 55mm 2 ~65cm 2 , about 60mm 2 ~about 70cm 2 , about 65mm 2 ~Approx. 75cm 2 , about 70mm 2 ~about 80cm 2 , or about 75 mm 2 ~ approx. 85cm 2 The vent 1110 may have a minimum cross-sectional area of ​​0.1 mm to 0.5 mm. In general, a larger minimum cross-sectional area of ​​the vent 1110 increases the amount of air that may flow through the vent 1110 and through the cavity 1104 while increasing the amount of bodily fluids that may flow toward the fluid outlet 1108. Additionally, a larger minimum cross-sectional area of ​​the vent 1110 may soften the proximal end region 1124 of the fluid impermeable barrier 1102, thereby allowing the fluid impermeable barrier 1102 to better conform to the shape of the patient's vaginal area, which in turn may make the fluid collection assembly 1100 more comfortable to use. However, a larger minimum cross-sectional area of ​​the vent 1110 increases the likelihood that bodily fluids will leak through the vent 1110.

[0079] In one embodiment, the vent 1110 comprises a water-impermeable, air-permeable membrane configured to prevent or at least inhibit bodily fluids from flowing therethrough. In one embodiment, the vent 1110 does not comprise a water-impermeable, air-permeable membrane because bodily fluids are less likely to leak through the vent 1110 due to the positioning of the vent 1110. It is noted that not having a water-impermeable, air-permeable membrane in the vent 1110 may reduce the number of parts that make up the fluid collection assembly 1100 and may simplify manufacturing of the fluid collection assembly 1100 by eliminating the need to attach a membrane to the fluid collection assembly 1100.

[0080] The location of the exhaust port 1110 at or near the proximal end region 1124 also facilitates air flow through the cavity 1104. For example, air drawn into the cavity 1104 through the exhaust port 1110 will flow from the exhaust port 1110 to the fluid outlet 1108. Thus, air from the exhaust port 1110 may flow through substantially the entire cavity 1104. The flow of air through substantially the entire cavity 1104 may encourage bodily fluids to flow toward the fluid outlet 1108 and inhibit bodily fluids from pooling within portions of the cavity 1104 at or near the proximal end region 1124. In contrast, conventional fluid collection assemblies that include an exhaust port at or near their proximal end region allow air to flow substantially only to small portions of the cavity between the exhaust port and the fluid outlet. Thus, the exhaust ports of such conventional fluid collection assemblies allow air to flow through the cavity 1104 but do not encourage fluid to flow through the cavity 1104 and the exhaust port 1110.

[0081] In one embodiment, not shown, the vent 1110 is at the proximal end region 1124 of the fluid impermeable barrier 1102. In such an embodiment, the vent 1110 may extend from the cavity 1104 to the proximal end region 1124. In one embodiment, as shown, the vent 1110 is near the proximal end region 1124. In such embodiments, the vent 1110 can be spaced (measured parallel to the longitudinal axis of the cavity 1104) from the proximal end region 1124 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 from the proximal end region 1124, the vent 1110 can extend from the cavity 1104 to the rear surface 1130 of the fluid impermeable barrier 1102.

[0082] As discussed above, the fluid collection assembly may include a fluid-impermeable barrier defining at least one aperture instead of or in addition to the apertures forming the first coupling and / or the exhaust port. For example, FIG. 12 is an isometric view of a fluid collection assembly 1200 including a fluid-impermeable barrier 1202 defining an aperture (i.e., a notch 1210) formed in at least one side flange 1280, according to one embodiment. Except as otherwise disclosed herein, the fluid collection assembly 1200 is the same as or substantially similar to any of the fluid collection assemblies disclosed herein. For example, the fluid-impermeable barrier 1202 may define at least one opening 1206, and the fluid collection assembly 1200 may include at least one porous material 1212 disposed within the fluid-impermeable barrier 1202.

[0083] As discussed above, the fluid impermeable barrier 1202 may comprise one or more flanges. For example, the fluid impermeable barrier 1202 may comprise an upper flange 1232 forming at least a portion of the proximal end region 1224 of the fluid impermeable barrier 1202, a lower flange 1234 forming at least a portion of the distal end region 1226 of the fluid impermeable barrier 1202, and at least one lateral flange 1280 extending between the upper flange 1232 and the lower flange 1234. In other words, the lateral flange 1280 may extend laterally from a portion of the fluid impermeable barrier 1202 that defines a cavity (not shown).

[0084] It has been found that during use of a conventional fluid collection assembly having a side flange, a patient may grab the side flange of the conventional fluid collection assembly 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, particularly an elderly patient, is more likely to drop the conventional fluid collection assembly when grasping the side flange of the fluid collection assembly than when grasping other parts of the conventional fluid collection assembly. Dropping the conventional fluid collection assembly may cause contamination of the conventional fluid collection assembly. Additionally, dropping the conventional fluid collection assembly after using the conventional fluid collection assembly may cause bodily fluids present in the cavity to leak from the cavity.

[0085] The fluid collection assembly 1200 includes at least one notch 1210 (i.e., aperture) formed in a portion of the lateral flange 1280. The notch 1210 may extend partially through the lateral flange 1280 or completely through the lateral flange 1280. The notch 1210 forms a point where the patient may grasp while using the fluid collection assembly 1200. The notch 1210 increases the surface area of ​​the lateral flange 1280 that contacts the patient's fingers, moving the patient's fingers closer to the portions of the fluid impermeable barrier 1202 that define the cavity, thereby assisting the patient in grasping the fluid collection assembly 1200 without dropping it. It is noted that the notch 1210 may make it easier for individuals other than the patient (e.g., medical practitioners) to grasp the fluid collection assembly 1200 without dropping it.

[0086] The notch 1210 may facilitate easier handling of the fluid collection assembly 1200. For example, as described above, the fluid collection assembly 1200 may bend to conform to the shape of the patient's vaginal area. It has been found that the notch 1210 softens a portion of the flange, making the fluid collection assembly 1200 easier to bend. In other words, the notch 1210 forms a portion of the fluid collection assembly 1200 that will preferentially bend. Thus, the notch 1210 may be formed in a portion of the fluid impermeable barrier 1202 that may bend when the fluid collection assembly 1200 is adapted to conform to the vaginal area. For example, the notch 1210 may be located closer to the proximal end region 1224 than to the distal end region 1226 of the fluid impermeable barrier 1202. In such an embodiment, the notch 1210 may be located in a portion of the fluid impermeable barrier 1202 where there is more opportunity for bending when the fluid collection assembly 1200 is adapted to conform to the vaginal area.

[0087] In one embodiment, the fluid impermeable barrier 1202 defines only a single notch 1210. In one embodiment, the fluid impermeable barrier 1202 defines two notches 1210 on opposing sides of the fluid collection assembly 1200. In such an embodiment, the two notches 1210 facilitate grasping the fluid collection assembly 1200 between two fingers (e.g., between a thumb and index finger). In one embodiment, the fluid impermeable barrier 1202 defines a single notch 1210 on one side and multiple notches 1210 on the opposite side. In such an embodiment, the single notch 1210 can be captured by the thumb and the multiple notches 1210 can be captured by one or more other fingers. In one embodiment, the fluid impermeable barrier 1202 defines a number of notches 1210 on either side of the fluid collection assembly 1200, allowing the fluid collection assembly 1200 to be grasped by either dominant hand.

[0088] The notch 1210 may include one or more features that make the fluid collection assembly 1200 easier to grip. For example, FIG. 13 is a front view of a fluid collection assembly 1300, according to one embodiment. Except as otherwise disclosed herein, the fluid collection assembly 1300 is the same as the fluid collection assembly 1200 of FIG. 12. The fluid impermeable barrier 1302 includes one or more protrusions 1382 extending from portions of the fluid impermeable barrier 1302 that define the notch 1310. The protrusions 1382 make the fluid collection assembly 1300 even easier to grip. It is noted that even if the side flange 1380 does not define the notch 1310, other portions of the side flange 1380 may include the protrusions 1382.

[0089] As mentioned above, the fluid collection assemblies disclosed herein may include a flat reservoir instead of or in addition to any of the apertures disclosed herein. Figure 14 is a cross-sectional view of a fluid collection assembly 1400, according to one embodiment. Except as otherwise disclosed herein, the fluid collection assembly 1400 is the same as or substantially similar to any of the fluid collection assemblies disclosed herein. For example, the fluid collection assembly 1400 includes a fluid-impermeable barrier 1402 that defines at least a cavity 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 within the cavity 1404.

[0090] The fluid impermeable barrier 1402 includes a reservoir 1436 at a distal end region 1426 of the fluid impermeable barrier 1402. The reservoir 1436 may extend outwardly from a front side 1428 of the fluid impermeable barrier 1402. The reservoir 1436 extends outwardly so that the reservoir 1436 can mate with the vaginal area of ​​the patient to facilitate proper positioning of the fluid collection assembly 1400 against the patient.

[0091] The reservoir 1436 includes a flat surface 1484. The flat surface 1484 may be generally parallel (±30°) to the longitudinal axis 1486 of the cavity 1404 and is generally flat. The flat surface 1484 is generally flat if it exhibits at least one of an average radius of curvature that is significantly smaller than the periphery of the fluid impermeable barrier 1402 or an average 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 be inserted into the vaginal opening compared to other positioning features. Thus, the flat surface 1484 may make the fluid collection assembly 1400 more comfortable to use, as some patients may be uncomfortable with the reservoir or other positioning features being inserted into the vaginal opening.

[0092] The reservoir 1436 may extend a distance d outward from the front side 1428 and / or the porous material 1412. The distance d may be between about 1 mm and about 3 mm, between about 2 mm and about 4 mm, between about 3 mm and about 5 mm, between about 4 mm and about 6 mm, between about 5 mm and about 7 mm, between about 6 mm and about 8 mm, between about 7 mm and about 9 mm, between about 8 mm and about 10 mm, between about 9 mm and about 11 mm, between about 10 mm and about 12 mm, between about 11 mm and about 13 mm, between about 12 mm and about 14 mm, or between about 13 mm and about 15 mm.

[0093] It is noted that the apertures and flat reservoirs can be used with fluid collection assemblies other than those shown in Figures 1A-2, 8C, 8D, and 10B-14. Examples of fluid collection assemblies that may include any of the apertures and / or reservoirs disclosed herein are disclosed in U.S. Patent Application No. 16 / 433,773, filed June 6, 2019, U.S. Patent No. 10,226,376, filed June 1, 2017, and International Application No. PCT / US21 / 39866, filed June 30, 2021, the disclosures of each of which are incorporated herein by reference in their entirety.

[0094] 15 is a block diagram of a fluid collection system 1590 for fluid collection, according to one embodiment. The fluid collection system 1590 comprises a fluid collection assembly 1500, a fluid reservoir 1592, and a vacuum source 1594. The fluid collection assembly 1500 may be the same as or substantially similar to any of the fluid collection assemblies disclosed herein. The fluid collection assembly 1500, the fluid reservoir 1592, and the vacuum source 1594 may be fluidly coupled to one another via one or more conduits 1516. For example, the fluid collection assembly 1500 may be operably coupled to one or more of the fluid reservoir 1592 or the vacuum source 1594 via the conduit 1516. Bodily fluid collected within the fluid collection assembly 1500 may be removed from the fluid collection assembly 1500 via the conduit 1516 that protrudes into the fluid collection assembly 1500. For example, the inlet of the conduit 1516 may extend into the fluid collection assembly 1500, such as into a reservoir within the fluid collection assembly 1500. The outlet of the conduit 1516 may extend into the fluid collection assembly 1500 or into the vacuum source 1594. In response to a suction (e.g., vacuum) force applied to the outlet of the conduit 1516, a suction force can be introduced into the cavity of the fluid collection assembly 1500 via the inlet of the conduit 1516.

[0095] The suction force can be applied directly or indirectly to the outlet of the conduit 1516 by the vacuum source 1594. The suction force can be applied indirectly via the fluid reservoir 1592. For example, the outlet of the conduit 1516 can be disposed within the fluid reservoir 1592, and the additional conduit 1516 can extend from the fluid reservoir 1592 to the vacuum source 1594. Thus, the vacuum source 1594 can apply suction to the fluid collection assembly 1500 via the fluid reservoir 1592. The suction force can be applied directly via the vacuum source 1594. For example, the outlet of the conduit 1516 can be disposed within the vacuum source 1594. The additional conduit 1516 can extend from the vacuum source 1594 to a location outside the fluid collection assembly 1500, such as the fluid reservoir 1592. In such an example, the vacuum source 1594 can be disposed between the fluid collection assembly 1500 and the fluid reservoir 1592.

[0096] The fluid reservoir 1592 is sized and shaped to hold bodily fluid therein. The fluid reservoir 1592 may include a bag (e.g., a drainage bag), a bottle or cup (e.g., a collection jar), or any other enclosure for storing bodily fluids, such as urine. In some embodiments, a conduit 1516 may extend from the fluid collection assembly 1500 and be attached to the fluid reservoir 1592 at a first location therein. An additional conduit 1516 may be attached to the fluid reservoir 1592 at a second location on its surface and may extend and be attached to a vacuum source 1594. Thus, a vacuum (e.g., suction) may be drawn through the fluid collection assembly 1500 via the fluid reservoir 1592. Fluids, such as urine, may be evacuated from the fluid collection assembly 1500 using the vacuum source 1594.

[0097] The vacuum source 1594 may include one or more of a manual vacuum pump, an electric vacuum pump, a diaphragm pump, a centrifugal pump, a positive displacement pump, a magnetic drive pump, a peristaltic pump, or any pump configured to generate a vacuum. The vacuum source 1594 may provide a vacuum or suction to remove bodily fluids from the fluid collection assembly 1500. In some examples, the vacuum source 1594 may be powered by one or more power cords (e.g., connected to a power socket), one or more batteries, or even by manual force (e.g., a manual vacuum pump). In some examples, the vacuum source 1594 may be sized and shaped to fit on the exterior, surface, or interior of the fluid collection assembly 1500. For example, the vacuum source 1594 may include one or more miniature pumps or one or more micro pumps. The vacuum sources 1594 disclosed herein may comprise one or more of a switch, a button, a plug, a remote controller, or any other device suitable for activating the vacuum source 1594.

[0098] While various aspects and embodiments are disclosed herein, other aspects and embodiments are contemplated. The various aspects and embodiments disclosed herein are for purposes of illustration and are not intended to be limiting.

[0099] A degree term (e.g., "about," "substantially," "approximately," etc.) indicates a variation that is not significant structurally or functionally. For example, when a degree term is described with a quantity term, the degree term is interpreted to mean ±20%, ±5%, or ±2% of the quantity term. For example, when a degree term is used to modify a shape, the degree term indicates that the shape modified by the degree term has the appearance of the disclosed shape. For example, the degree term can 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 from it, is elongated, is the same as the disclosed shape, etc.

Claims

1. a fluid impermeable barrier having a proximal end region and a distal end region opposite said proximal end region, the fluid impermeable barrier defining at least a cavity, at least one opening, and a fluid outlet at or near said distal end region, and defining at least one flat reservoir or at least one aperture in said distal end region; at least one porous material disposed in the cavity; 1. A fluid collection assembly comprising: When the fluid impermeable barrier defines the at least one aperture, the at least one aperture comprises: at least one first coupling portion configured to be attached to at least one second coupling portion attached to the at least one porous material; at least one exhaust port at or near the proximal end region; or at least one notch formed in at least one lateral flange extending laterally outwardly from each portion of said fluid impermeable barrier defining said cavity; 11. A fluid collection assembly comprising:

2. 2. The fluid collection assembly of claim 1, wherein the fluid impermeable barrier defines the at least one aperture forming the at least one first coupling portion, the fluid collection assembly further comprising the at least one second coupling portion attached to the porous material.

3. 3. The fluid collection assembly of claim 2, wherein the at least one first joint is defined by the fluid-impermeable barrier and is at least one perforation extending through the fluid-impermeable barrier.

4. 4. The fluid collection assembly of claim 3, wherein the at least one second coupling comprises at least one fastener extending through the at least one perforation.

5. 5. The fluid collection assembly of claim 4, wherein the at least one fastener defines at least one passageway extending therethrough.

6. 6. The fluid collection assembly of claim 4, wherein the at least one fastener comprises at least one head and a rod extending from the at least one head.

7. 7. A fluid collection assembly according to claim 4, wherein the at least one fastener comprises a first fastener located at or near a proximal end region of the at least one porous material and a second fastener located at or near a distal end region of the at least one porous material, the proximal end region being opposite the distal end region.

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

9. 9. The fluid collection assembly of claim 8, wherein the elongated spine exhibits a corrugated structure comprising one or more ridges and defining one or more valleys.

10. 10. A fluid collection assembly as claimed in claim 8 or 9, wherein the at least one porous material defines one or more perforations extending therethrough, the at least one porous material is bent, and the at least one fastener is positioned through the one or more perforations.

11. 11. A fluid collection assembly according to any one of claims 8 to 10, wherein the elongated spine is attached directly to the at least one porous material.

12. 12. The fluid collection assembly of any one of claims 8 to 11, wherein the elongated spine is ultrasonically bonded to the at least one porous material.

13. 13. The fluid collection assembly of claim 8, wherein the elongated spine comprises at least one of acrylonitrile butadiene styrene, polycarbonate-acrylonitrile butadiene styrene blends or copolymers, polyethylene, polypropylene, or polycarbonate.

14. 8. A fluid collection assembly as described in any one of claims 4 to 7, further comprising a spine defining at least one slit therein, the at least one slit comprising a first portion and a second portion extending from the first portion, the first portion exhibiting a greater lateral dimension than the second portion.

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

16. 16. A fluid collection assembly according to any one of claims 3 to 15, wherein the second coupling portion comprises a clip, the clip comprising a first arm, a second arm, and a curved portion extending between the first arm and the second arm.

17. 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. 18. A fluid collection assembly as described in any one of claims 1 to 17, wherein the fluid-impermeable barrier defines the at least one aperture, the at least one aperture comprising the at least one exhaust port at or near the proximal end region.

19. 20. The fluid collection assembly of claim 18, wherein the at least one vent is about 7.5 mm ２ ~about 85mm ２ 13. A fluid collection assembly comprising: a fluid collection assembly having a cross-sectional area of:

20. 20. A fluid collection assembly as described in 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. 21. The fluid collection assembly of claim 20, wherein the fluid impermeable barrier comprises one or more projections extending laterally outward from each of the portions of the fluid impermeable barrier that define the at least one aperture.

22. 22. The fluid collection assembly of claim 1, wherein the fluid impermeable barrier defines the flat reservoir.

23. 23. The fluid collection assembly of claim 1, wherein the at least one porous material defines a lumen configured to receive a conduit.

24. 24. The fluid collection assembly of claim 1, wherein the at least one porous material is adhesive-free within and on the surface thereof.

25. The fluid collection assembly according to any one of claims 1 to 24; A fluid storage container; Vacuum source and 1. A fluid collection system comprising: A fluid collection system, characterized in that the cavity of the fluid collection assembly, the fluid storage container, and the vacuum source are fluidly connected to one another such that, when one or more bodily fluids are present in the cavity, suction action provided from the vacuum source to the cavity of the fluid collection assembly removes the one or more bodily fluids from the cavity and stores the bodily fluids in the fluid storage container.

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