Fluid collection systems including at least one securement elements and related methods

Abstract

An example fluid collection system includes a fluid collection assembly and at least one securement element. The fluid collection assembly includes a fluid impermeable barrier defining at least a chamber, at least one opening that provides ingress to the chamber, and a fluid outlet. The fluid collection assembly also includes at least one porous material disposed in the chamber. The securement element is configured to position the fluid collection assembly at least proximate to a female urethral opening. The securement element includes a base having at least one surface that is configured to abut at least a portion of the fluid impermeable barrier thereby securing the fluid collection assembly proximate to the female urethral opening.

Description

FLUID COLLECTION SYSTEMS INCLUDING AT LEAST ONE SECUREMENT ELEMENTS AND RELATED METHODSCROSS-REFERENCE TO RELATED APPLICATION(S)

[0001] This application claims priority to U.S. Provisional Application No. 63 / 720,004 filed on November 13, 2024, the disclosure of which is incorporated herein, in its entirety, by this reference.BACKGROUND

[0002] A person or animal may have limited or impaired mobility so typical urination processes are challenging or impossible. For example, a person may experience or have a disability that impairs mobility. A person may have restricted travel conditions such as those experienced by pilots, drivers, and workers in hazardous areas. Additionally, sometimes bodily fluids collection is needed for monitoring purposes or clinical testing.

[0003] Urinary catheters, such as a Foley catheter, can address some of these circumstances, such as incontinence. Unfortunately, urinary catheters can be uncomfortable, painful, and can lead to complications, such as infections. Additionally, bed pans, which are receptacles used for the toileting of bedridden individuals are sometimes used. However, bedpans can be prone to discomfort, spills, and other hygiene issues.SUMMARY

[0004] Embodiments are directed to fluid collection systems including at least one securement elements and related methods. In an embodiment, a fluid collection system is disclosed. The fluid collection system includes a fluid collection assembly. The fluid collection assembly includes a fluid impermeable barrier at least defining a chamber, at least one opening, and a fluid outlet. The fluid collection assembly also includes at least one porous material disposed in the chamber. The fluid collection system further includes a securement element configured to position the fluid collection assembly at least proximate to a female urethral opening. The securement element includes a base having at least one surface configured to abut at least a portion of the fluid impermeable barrier. The securement element includes at least one of: the base at least partially defining at least one gap extending therethrough; or the base configured to be bent to contact inner thighs of a patient, the base- Page 1 - Docket No. 38471.0176P1including at least one of a resilient material configured to bend when stressed and apply a biasing force to inner thighs or includes one or more folds formed therein.

[0005] In an embodiment, a securement element is disclosed. The securement element includes a base having at least one surface configured to abut at least a portion of the fluid impermeable barrier. The securement element includes at least one of: the base at least partially defining at least one gap extending therethrough or the base configured to be bent to contact inner thighs of a patient, the base including at least one of a resilient material configured to bend when stressed and apply a biasing force to inner thighs or includes one or more folds formed therein. The securement element is configured to position the fluid collection assembly at least proximate to a female urethral opening, the securement element.

[0006] In an embodiment, a method of using a fluid collection system is disclosed. The method includes positioning a fluid collection assembly to abut a securement element. The fluid collection system includes a fluid collection assembly. The fluid collection assembly includes a fluid impermeable barrier at least defining a chamber, at least one opening, and a fluid outlet. The fluid collection assembly also includes at least one porous material disposed in the chamber. The fluid collection system further includes a securement element configured to position the fluid collection assembly at least proximate to a female urethral opening. The securement element includes a base having at least one surface configured to abut at least a portion of the fluid impermeable barrier. The securement element includes at least one of: the base at least partially defining at least one gap extending therethrough; or the base configured to be bent to contact inner thighs of a patient, the base including at least one of a resilient material configured to bend when stressed and apply a biasing force to inner thighs or includes one or more folds formed therein. The method also includes positioning the fluid collection assembly proximate to a urethral opening of a patient and attaching the securement element to the patient.

[0007] Features from any of the disclosed embodiments may be used in combination with one another, without limitation. In addition, other features and advantages of the present disclosure will become apparent to those of ordinary skill in the art through consideration of the following detailed description and the accompanying drawings.BRIEF DESCRIPTION OF THE DRAWINGS

[0008] The drawings illustrate several embodiments of the present disclosure, wherein- Page 2 - Docket No. 38471.0176P1identical reference numerals refer to identical or similar elements or features in different views or embodiments shown in the drawings.

[0009] FIG. 1A is an isometric view of a fluid collection assembly that may be used in any of the fluid collection systems and related methods disclosed herein, according to an embodiment.

[0010] FIGS. IB and 1C are cross-sectional views of the fluid collection assembly taken along planes 1B-1B and 1C-1C, as shown in FIG. 1A.

[0011] FIG. 2 is a block diagram of a fluid collection system for fluid collection, according to an embodiment.

[0012] FIG. 3 is an isometric view of at least a portion of a fluid collection system, according to an embodiment.

[0013] FIG. 4 is an isometric view of a fluid collection system, according to an embodiment.

[0014] FIG. 5 is an isometric view of a fluid collection system, according to an embodiment.

[0015] FIG. 6 is an isometric view of a fluid collection system that does not include straps, according to an embodiment.

[0016] FIG. 7A is an isometric view of a fluid collection system, according to an embodiment.

[0017] FIG. 7B is a top view of the fluid collection system on a patient, according to an embodiment.

[0018] FIG. 8 is an isometric view of a fluid collection system on a patient, according to an embodiment.

[0019] FIG. 9A is an isometric view of a fluid collection system, according to an embodiment.

[0020] FIG. 9B is an isometric view of the fluid collection assembly on a patient.

[0021] FIGS. 9C and 9D are top views of the fluid collection system on the patient with the thighs of the patient closed and open, respectively.DETAILED DESCRIPTION

[0022] Embodiments are directed to fluid collection systems including at least one securement elements and related methods. An example fluid collection system includes a- Page 3 - Docket No. 38471.0176P1fluid collection assembly and at least one securement element. The fluid collection assembly includes a fluid impermeable barrier defining at least a chamber, at least one opening that provides ingress to the chamber, and a fluid outlet. The fluid collection assembly also includes at least one porous material disposed in the chamber. The securement element is configured to position the fluid collection assembly at least proximate to a female urethral opening. The securement element includes a base having at least one surface that is configured to abut at least a portion of the fluid impermeable barrier, thereby securing the fluid collection assembly proximate to the female urethral opening.

[0023] During use, the fluid collection assembly may be positioned on a patient such that the opening of the fluid impermeable barrier is positioned to receive urine and other bodily fluids discharged from the urethral opening. For example, the fluid collection assembly may be positioned proximate to the urethral opening. The securement element may be attached to or otherwise contact the fluid collection assembly before or after positioning the fluid collection assembly on the patient. The securement element is positioned to abut or otherwise be attached to the patient. After the fluid collection assembly and the securement element are positioned, the patient may discharge bodily fluids. The bodily fluids may flow through the opening and be received by the porous material. The bodily fluids may flow towards the fluid outlet or an inlet of a conduit positioned through the fluid outlet. In an example, a suction may be provided to the chamber of the fluid collection assembly via the conduit. The suction may cause the bodily fluids to preferentially flow towards the fluid outlet or the inlet of the conduit and remove the bodily fluids from the chamber.

[0024] An issue associated with conventional fluid collection assemblies can be maintaining the correct position of the fluid collection assemblies relative to the female urethral opening. For example, movement of the fluid collection assemblies after positioning the fluid collection assemblies may cause bodily fluids to leak from the fluid collection assemblies or cause the bodily fluids to not be received into the fluid collection assemblies.

[0025] Conventional fluid collection assemblies use a variety of techniques to maintain the position of the conventional fluid collection assemblies. In an example, some conventional fluid collection assemblies rely on direct contact between the conventional fluid collection assemblies and the thighs of the patient to maintain the position of the fluid collection assemblies. Such conventional fluid collection assemblies may have difficulty- Page 4 - Docket No. 38471.0176P1being used with patients with small thighs because the gaps between such patients’ thighs may prevent such contact. Such conventional fluid collection assembly may also be difficult to use with patients with memory issues and children since they may forget to maintain their legs together. In an example, some conventional fluid collection assemblies may rely on adhesives at or near the proximal end regions thereof (i.e., the regions positioned closest to the navel, during use). However, such conventional fluid collection assemblies may be difficult and painful to detach if the patient has pubic or stomach hair. Further, the distal end regions of such conventional fluid collection assemblies are free to move and such movement may cause bodily fluids to leak or fail to be received into the conventional fluid collection assemblies.

[0026] The fluid collection systems disclosed herein are an improvement over such conventional fluid collection assemblies. For example, the fluid collection systems disclosed herein include at least one securement element that is distinct from the fluid collection assemblies. The securement element is configured to secure the fluid collection assemblies to the individual instead of or in addition to using contact between the fluid collection assemblies and the thighs of the patient or using the adhesive at or near the proximal end region of the fluid collection assemblies. As such, the fluid collection systems disclosed herein, due to the securement elements, are better able to maintain the position of the fluid collection assemblies, minimize movement of the fluid collection assemblies, and prevent or inhibit leaks compared to fluid collection assemblies that are not used with the securement elements.

[0027] The fluid collection systems and related methods disclosed herein may be used with any suitable fluid collection assembly. FIG. 1A is an isometric view of an example fluid collection assembly 100 that may be used in any of the fluid collection systems and related methods disclosed herein, according to an embodiment. FIGS. IB and 1C are cross-sectional views of the fluid collection assembly 100 taken along planes 1B-1B and 1C-1C, as shown in FIG. 1A. Although the fluid collection systems and related methods disclosed herein are primarily discussed with regards to the fluid collection assembly 100, it is noted that the fluid collection assembly 100 is merely one example of a fluid collection assembly that may be used with any of the fluid collection systems and related methods disclosed herein. For example, the fluid collection systems and related methods disclosed herein may be used with- Page 5 - Docket No. 38471.0176P1any conventional fluid collection assembly, such as cylindrical or non-cylindrical conventional fluid collection assemblies. That said, it is noted that the securement elements disclosed herein may be most effective when used with cylindrical fluid collection assemblies and, more particularly, with the fluid collection assembly 100.

[0028] The fluid collection assembly 100 is an example of a female fluid collection assembly for receiving and collecting bodily fluids from a female. The fluid collection assembly 100 includes a fluid impermeable barrier 102 defining at least an opening 104, a chamber 106, and a fluid outlet 108. The fluid collection assembly 100 also includes at least one porous material 110 disposed in a chamber 106. The fluid collection assembly 100 may further include a conduit 112 disposed through the fluid outlet 108 such that an inlet 114 of the conduit 112 is disposed in the chamber 106.

[0029] The fluid impermeable barrier 102 at least partially defines a chamber 106 (e.g, interior region) and an opening 104. For example, the inner surface(s) 116 of the fluid impermeable barrier 102 at least partially defines the chamber 106 within the fluid collection assembly 100. The fluid impermeable barrier 102 temporarily stores the bodily fluids in the chamber 106. The fluid impermeable barrier 102 may be formed of any suitable fluid impermeable material (s), such as a fluid impermeable polymer (e.g., silicone, polypropylene, polyethylene, polyethylene terephthalate, neoprene, a polycarbonate, etc.), a metal film, natural rubber, another suitable material, any other fluid impermeable material disclosed herein, or combinations thereof. As such, the fluid impermeable barrier 102 substantially prevents the bodily fluids from passing through the fluid impermeable barrier 102. In an example, the fluid impermeable barrier 102 may be air permeable and fluid impermeable. In such an example, the fluid impermeable barrier 102 may be formed of a hydrophobic material that defines a plurality of pores. At least one or more portions of at least an outer surface 118 of the fluid impermeable barrier 102 may be formed from a soft and / or smooth material, thereby reducing chafing.

[0030] In some examples, the fluid impermeable barrier 102 may be tubular (ignoring the opening 104), such as substantially cylindrical (as shown), oblong, prismatic, or flattened tubes. During use, the outer surface 118 of the fluid impermeable barrier 102 may contact the individual. The fluid impermeable barrier 102 may be sized and shaped to fit between the labia and / or the gluteal cleft between the legs of a female user.- Page 6 - Docket No. 38471.0176P1

[0031] The opening 104 provides an ingress route for bodily fluids to enter the chamber 106. The opening 104 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 104 is formed in and extends through the fluid impermeable barrier 102, from the outer surface 118 to the inner surface 116, thereby enabling bodily fluids to enter the chamber 106 from outside of the fluid collection assembly 100.

[0032] The opening 104 may be an elongated hole in the fluid impermeable barrier 102. For example, the opening 104 may be defined as a cut-out in the fluid impermeable barrier 102. The opening 104 may be located and shaped to be positioned adjacent to a female urethral opening. The opening 104 may have an elongated shape because the space between the legs of a female is relatively small when the legs of the female are closed, thereby only permitting the flow of the bodily fluids along a path that corresponds to the elongated shape of the opening 104 (e.g., longitudinally extending opening 104).

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

[0034] In some examples, the fluid impermeable barrier 102 may define a fluid outlet 108 sized to receive the conduit 112. The at least one conduit 112 may be disposed in the chamber 106 via the fluid outlet 108. The fluid outlet 108 may be sized and shaped to form an at least substantially fluid tight seal against the conduit 112 or the at least one tube thereby substantially preventing the bodily fluids from escaping the chamber 106.

[0035] In an embodiment, the porous material 110 may be configured to wick any bodily fluids away from the opening 104, thereby preventing the bodily fluids from escaping the chamber 106. The permeable properties referred to herein may be wicking, capillary action, diffusion, or other similar properties or processes, and are referred to herein as “permeable” and / or “wicking.” Such “wicking” and / or “permeable” properties may not include absorption of the bodily fluids into at least a portion of the porous material 110, such as not include- Page 7 - Docket No. 38471.0176P1adsorption of the bodily fluids into the fluid permeable body 120. Put another way, substantially no absorption or solubility of the bodily fluids into the material may take place after the material is exposed to the bodily fluids and removed from the bodily fluids for a time. While no absorption or solubility is desired, the term “substantially no absorption” may allow for nominal amounts of absorption and / or solubility of the bodily fluids into the porous material 110 (e.g., absorbency), such as less than about 30 wt% of the dry weight of the porous material 110, less than about 20 wt%, less than about 10 wt%, less than about 7 wt%, less than about 5 wt%, less than about 3 wt%, less than about 2 wt%, less than about 1 wt%, or less than about 0.5 wt% of the dry weight of the porous material 110. The porous material 110 may also wick the bodily fluids generally towards an interior of the chamber 106, as discussed in more detail below. In an embodiment, the porous material 110 may include at least one absorbent or adsorbent material.

[0036] In some examples, the fluid permeable membrane 122 may be optional. For example, the porous material 110 may include only the fluid permeable body 120. In some examples, the fluid permeable body 120 may be optionally omitted from the fluid collection assembly 100. For example, the porous material 110 may only include the fluid permeable membrane 122.

[0037] In an embodiment, at least a portion of the porous material 110 (e.g., one or more of the fluid permeable membrane 122 or, more preferably, the fluid permeable body 120) may be hydrophobic. The porous material 110 may be hydrophobic when the porous material 110 exhibits a contact angle with water (a major constituent of bodily fluids) that is greater than about 90°, such as in ranges of about 90° to about 120°, about 105° to about 135°, about 120° to about 150°, about 135° to about 175°, or about 150° to about 180°. The hydrophobicity of the porous material 110 may limit absorption, adsorption, and solubility of the bodily fluids in the porous material 110 thereby decreasing the amount of bodily fluids held in the porous material 110. In an embodiment, at least a portion of the porous material 110 is hydrophobic or hydrophilic. In an embodiment, the fluid permeable body 120 is more hydrophobic (e.g., exhibits a larger contact angle with water) than the fluid permeable membrane 122. The lower hydrophobicity of the fluid permeable membrane 122 may help the porous material 110 receive the bodily fluids from the urethral opening while the- Page 8 - Docket No. 38471.0176P1hydrophobicity of the fluid permeable body 120 limits the bodily fluids that are retained in the porous material 110.

[0038] In an embodiment, the porous material 110 may include the fluid permeable membrane 122 disposed in the chamber 106. The fluid permeable membrane 122 may cover at least a portion (e.g., all) of the opening 104. The fluid permeable membrane 122 may be composed to wick the bodily fluids away from the opening 104, thereby preventing the bodily fluids from escaping the chamber 106.

[0039] In an embodiment, the fluid permeable membrane 122 may include any material that may wick the bodily fluids. For example, the fluid permeable membrane 122 may include fabric, such as a gauze (e.g., a silk, linen, or cotton gauze), another soft fabric, another smooth fabric, a nonwoven material, or any of the other porous materials disclosed herein. Forming the fluid permeable membrane 122 from gauze, soft fabric, and / or smooth fabric may reduce chafing caused by the fluid collection assembly 100. In an example, the fluid permeable membrane 122 may include a horizontal lapped nonwoven material, a cross lapped nonwoven material, a porous polymer (e.g., nylon, polyester, polyurethane, polyethylene, polypropylene, etc.) structure or an open cell foam (e.g., spun nylon fiber), or any other suitable porous material. The fluid permeable membrane 122 may be formed from natural fibers which may be more sustainable and biodegradable than the synthetic fibers. Examples of natural fibers includes cellulose, cotton, bamboo, wool, or the like. In some examples, the fibers of the fluid permeable membrane 122 (e.g., gauze) may include a blend of natural fibers and synthetic fibers. For example, the fluid permeable membrane 122 may include bamboo fibers and polypropylene fibers. The fluid permeable membrane 122 may include a single layer (as shown) or two or more layers.

[0040] The fluid collection assembly 100 may include the fluid permeable body 120 disposed in the chamber 106. The fluid permeable body 120 is configured to support the fluid permeable membrane 122 since the fluid permeable membrane 122 may be formed from a relatively foldable, flimsy, or otherwise easily deformable material. For example, the fluid permeable body 120 may be positioned such that the fluid permeable membrane 122 is disposed between the fluid permeable body 120 and the fluid impermeable barrier 102. As such, the fluid permeable body 120 may support and maintain the position of the fluid permeable membrane 122. The fluid permeable body 120 may include any material that may- Page 9 - Docket No. 38471.0176P1wick, absorb, adsorb, or otherwise allow fluid transport of the bodily fluids, such as any of the fluid permeable membrane materials disclosed herein above. For example, the fluid permeable membrane material(s) may be utilized in a more dense or rigid form than in the fluid permeable membrane 122 when used as the fluid permeable body 120. The fluid permeable body 120 may be formed from any fluid permeable material that is less deformable than the fluid permeable membrane 122. For example, the fluid permeable body 120 may include a porous polymer (e.g., nylon, polyester, polyurethane, polyethylene, polypropylene, etc.) structure or an open cell foam, such as spun nylon fiber. In some examples, the fluid permeable body 120 may include a nonwoven material. In some examples, the fluid permeable body 120 may be formed from a natural material, such as cotton, wool, silk, or combinations thereof. In such examples, the material may have a coating to prevent or limit absorption of fluid into the material, such as a water repellent coating. In some examples, the fluid permeable body 120 may be formed from fabric, felt, gauze, or combinations thereof. In some examples, the fluid permeable body 120 may include a synthetic material, such as synthetic fibers or foam may include a polyester (e.g., polyethylene terephthalate), polyethylene, polypropylene, polyurethane (e.g., viscoelastic polyurethane), latex, silicone, nylon, nitrile, or the like. The fluid permeable body 120 may include a single layer (as shown) or two or more layers.

[0041] In some embodiments, a surfactant may be disposed on at least a portion of the porous material 110, such as on the fluid permeable membrane 122. The surfactant may include, for example, polyethylene glycol fatty acid ester (“PEGFA”). The surfactant may be disposed on the porous body using any suitable technique. In an embodiment, the surfactant may be disposed on the porous body using a spray coating technique, a kiss roll coating technique, a dip coating technique, or any other suitable technique.

[0042] In a particular embodiment, the porous material 110 may include a fluid permeable membrane 122 including two layers and a single fluid permeable body 120. The two layers of the fluid permeable membrane 122 may include an outer layer and an intermediate layer positioned between the outer layer and the fluid permeable body 120. In a particular example, the outer layer includes polypropylene or polyethylene with at least one surfactant (e.g., PEGFA), the intermediate layer includes bamboo, and the fluid permeable body 120 includes polyurethane, polyether, nylon, polyethylene terephthalate, or- Page 10 - Docket No. 38471.0176P1hydrophobic polypropylene. In a particular example, the outer layer includes polypropylene or polyethylene with at least one surfactant (e.g., PEGFA), the intermediate layer includes bamboo, and the fluid permeable body includes a nonwoven (e. , vertical lapped nonwoven material) polyethylene terephthalate. It is currently believed that these particular porous materials may exhibit a relatively good synergistic relationship compared to other porous materials.

[0043] The porous material 110 may at least substantially completely fill the portions of the chamber 106 that are not occupied by the conduit 112. In some examples, the porous material 110 may not substantially completely fill the portions of the chamber 106 that are not occupied by the conduit 112. In such an example, the fluid collection assembly 100 includes the reservoir 124 disposed in the chamber 106.

[0044] The reservoir 124 is a substantially unoccupied portion of the chamber 106. The reservoir 124 may be defined between the fluid impermeable barrier 102 and one or both of the fluid permeable membrane 122 and fluid permeable body 120. The bodily fluids that are in the chamber 106 may flow through the fluid permeable membrane 122 and / or fluid permeable body 120 to the reservoir 124. The reservoir 124 may retain of the bodily fluids therein.

[0045] The bodily fluids that are in the chamber 106 may flow through the fluid permeable membrane 122 and / or fluid permeable body 120 to the reservoir 124. The fluid impermeable barrier 102 may retain the bodily fluids in the reservoir 124. While depicted in the distal end region 128, the reservoir 124 may be located in any portion of the chamber 106 such as the proximal end region 126. The reservoir 124 may be located in a portion of the chamber 106 that is designed to be located in a gravimetrically low point of the fluid collection assembly when the fluid collection assembly is worn.

[0046] In some examples (not shown), the fluid collection assembly 100 may include multiple reservoirs, such as a first reservoir that is located at the portion of the chamber 106 closest to the inlet of the conduit 112 (e.g., distal end region 128) and a second reservoir that is located at the portion of the of the chamber 106 that is at or near proximal end region 126). In another example, the fluid permeable body 120 is spaced from at least a portion of the conduit 112, and the reservoir 124 may be the space between the fluid permeable body 120 and the conduit 112.- Page 11 - DocketNo. 38471.0176P1

[0047] The conduit 112 may be at least partially disposed in the chamber 106. The conduit 112 may be used to remove the bodily fluids from the chamber 106. The conduit 112 includes at least one wall defining an inlet 114, an outlet (not shown) downstream from the inlet 114, and a passageway 130. The outlet of the conduit 112 may be operably coupled to a vacuum source, such as a vacuum pump for withdrawing fluid from the chamber 106 through the conduit 112. For example, the conduit 112 may extend into the fluid impermeable barrier 102 from the proximal end region 126 and may extend to the distal end region 128 to a point proximate to the reservoir 124 therein such that the inlet 114 is in fluid communication with the reservoir 124. The conduit 112 fluidly couples the chamber 106 with the fluid storage container (not shown) or the vacuum source (not shown).

[0048] The conduit 112 may extend through a bore in the porous material 110. In an embodiment, the conduit 112 extends from the fluid outlet 108, through the bore, to a location that is proximate to the reservoir 124. In such an embodiment, the inlet 114 may not extend into the reservoir 124 and, instead, the inlet 114 may be disposed within the porous material 110 or at a terminal end thereof. For example, an end of the conduit 112 may be coextensive with or recessed within the fluid permeable membrane 122 and / or fluid permeable body 120. In an embodiment, the conduit 112 is at least partially disposed in the reservoir 124 and the inlet 114 may be extended into or be positioned in the reservoir 124. The bodily fluids collected in the fluid collection assembly 100 may be removed from the chamber 106 via the conduit 112.

[0049] Locating the inlet 114 at or near a location expected to be the gravimetrically low point of the chamber 106 when worn by an individual enables the conduit 112 to receive more of the bodily fluids than if inlet 114 was located elsewhere and reduce the likelihood of pooling (e.g., pooling of the bodily fluids may cause microbe growth and foul odors). For instance, the bodily fluids in the fluid permeable membrane 122 and the fluid permeable body 120 may flow in any direction due to capillary forces. However, the bodily fluids may exhibit a preference to flow in the direction of gravity, especially when at least a portion of the fluid permeable membrane 122 and / or the fluid permeable body 120 is saturated with the bodily fluids. Accordingly, one or more of the inlet 114 or the reservoir 124 may be located in the fluid collection assembly 100 in a position expected to be the gravimetrically low point- Page 12 - Docket No. 38471.0176P1in the fluid collection assembly 100 when worn by an individual, such as the distal end region 128.

[0050] The inlet 114 and the outlet of the conduit 112 are configured to fluidly couple (e.g., directly or indirectly) the vacuum source (not shown) to the chamber 106 (e.g., the reservoir 124). As the vacuum source (236 of FIG. 2) applies a vacuum / suction in the conduit 112, the bodily fluids in the chamber 106 (e.g., at the distal end region 128 such as in the reservoir 124) may be drawn into the inlet 114 and out of the fluid collection assembly 100 via the conduit 112. In some examples, the conduit 112 may be frosted or opaque (e.g., black) to obscure visibility of the bodily fluids therein.

[0051] As previously discussed, the conduit 112 may be configured to be at least insertable into the chamber 106. In an example, the conduit 112 may be positioned in the chamber 106 such that a terminal end of the conduit 112 is spaced from the fluid impermeable barrier 102 or other components of the fluid collection assembly 100 that may at least partially obstruct or block the inlet 114. Further, the inlet 114 of the conduit 112 may be offset relative to a terminal end of the porous material 110 such that the inlet 114 is closer to the proximal end region 126 of the fluid collection assembly 100 than the terminal end of the porous material 110. Offsetting the inlet 114 in such a manner relative to the terminal end of the porous material 110 allows the inlet 114 to receive bodily fluids directly from the porous material 110 and, due to hydrogen bonding, pulls more bodily fluids from the porous material 110 into the conduit 112.

[0052] Other embodiments of reservoirs, fluid impermeable barriers, fluid permeable membranes, fluid permeable bodies, chambers, and their shapes and configurations are disclosed in U.S. Patent No. 10,973,678 filed on June 2, 2017; U.S. Patent No. 10,390,989 filed on September 8, 2016; U.S. Patent No. 10,226,376 filed on June 3, 2017; U.S. Patent Application No. 15 / 612,325 filed on June 2, 2017; U.S. Patent Application No. 15 / 260,103 filed on September 8, 2016; PCT International Application No. PCT / US2022 / 011281 filed on January 5, 2022; PCT International Application No. PCT / US2022 / 042719 filed on September 7, 2022; PCT International Application No. PCT / US2022 / 042725 filed on September 7, 2022; PCT International Application No. PCT / US2022 / 015418 filed on February 7, 2022; PCT International Application No. PCT / US2022 / 015420 filed on February 7, 2022; PCT Patent Application No. PCT / US2020 / 042262 filed on July 16, 2020; PCT- Page 13 - Docket No. 38471.0176P1Patent Application No. PCT / US2024 / 053681 filed on October 30, 2024; U.S. Patent Application No. 63 / 568,615 filed on March 22, 2024; and U.S. Patent Application No. 15 / 611,587 filed on June 1, 2017, the disclosure of each of which is incorporated herein, in its entirety, by this reference.

[0053] FIG. 2 is a block diagram of a fluid collection system 232 for fluid collection, according to an embodiment. The fluid collection system 232 includes a fluid collection assembly 200, a fluid storage container 234, and a vacuum source 236. The fluid collection assembly 200 may be the same or substantially similar to any of the fluid collection assemblies disclosed herein or any conventional fluid collection assembly. The fluid collection assembly 200, the fluid storage container 234, and the vacuum source 236 may be fluidly coupled to each other via one or more conduits 212. For example, fluid collection assembly 200 may be operably coupled to one or more of the fluid storage container 234 or the vacuum source 236 via the conduit 212. The bodily fluids collected in the fluid collection assembly 200 may be removed from the fluid collection assembly 200 via the conduit 212 which protrudes into the fluid collection assembly 200. For example, an inlet of the conduit 212 may extend into the fluid collection assembly 200, such as to a reservoir therein. The outlet of the conduit 212 may extend into the fluid collection assembly 200 or the vacuum source 236. Suction force may be introduced into the chamber of the fluid collection assembly 200 via the inlet of the conduit 212 responsive to suction (e.g., vacuum) force applied at the outlet of the conduit 212.The suction force may be applied to the outlet of the conduit 212 by the vacuum source 236 either directly or indirectly. The suction force may be applied indirectly via the fluid storage container 234. For example, the outlet of the conduit 212 may be disposed within the fluid storage container 234 and an additional conduit 212 may extend from the fluid storage container 234 to the vacuum source 236. Accordingly, the vacuum source 236 may apply suction to the fluid collection assembly 200 via the fluid storage container 234. The suction force may be applied directly via the vacuum source 236. For example, the outlet of the conduit 212 may be disposed within the vacuum source 236. An additional conduit 212 may extend from the vacuum source 236 to a point outside of the fluid collection assembly 200, such as to the fluid storage container 234. In such examples, the vacuum source 236- Page 14 - Docket No. 38471.0176P1may be disposed between the fluid collection assembly 200 and the fluid storage container 234.The fluid storage container 234 is sized and shaped to retain bodily fluids therein. The fluid storage container 234 may include a bag (e.g., drainage bag), a bottle or cup (e.g., collection jar), or any other enclosed container for storing bodily fluids such as urine. In some examples, the conduit 212 may extend from the fluid collection assembly 200 and attach to the fluid storage container 234 at a first point therein. An additional conduit 212 may attach to the fluid storage container 234 at a second point thereon and may extend and attach to the vacuum source 236. Accordingly, a vacuum (e.g., suction) may be drawn through fluid collection assembly 200 via the fluid storage container 234. Bodily fluids, such as urine, may be drained from the fluid collection assembly 200 using the vacuum source 236.

[0054] The vacuum source 236 may include one or more of a manual vacuum pump, and electric vacuum pump, a diaphragm pump, a centrifugal pump, a displacement pump, a magnetically driven pump, a peristaltic pump, or any pump configured to produce a vacuum. The vacuum source 236 may provide a vacuum or suction to remove bodily fluids from the fluid collection assembly 200. In some examples, the vacuum source 236 may be powered by one or more of a power cord (e.g., connected to a power socket), one or more batteries, or even manual power (e.g., a hand operated vacuum pump). In some examples, the vacuum source 236 may be sized and shaped to fit outside of, on, or within the fluid collection assembly 200. For example, the vacuum source 236 may include one or more miniaturized pumps or one or more micro pumps. The vacuum sources 236 disclosed herein may include one or more of a switch, a button, a plug, a remote, or any other device suitable to activate the vacuum source 236.

[0055] The fluid collection system 232 also includes at least one securement element 240 configured to position the fluid collection assembly 200 against a female urethral opening and maintain the fluid collection assembly 200 against the urethral opening. FIGS. 3-9D illustrate different securement elements that may be included in the fluid collection system 232. It is noted that the fluid collection system 232 may include any of the securement elements disclosed herein, including combinations of any of the securement elements disclosed herein.- Page 15 - Docket No. 38471.0176P1

[0056] FTG. 3 is an isometric view of at least a portion of a fluid collection system 332, according to an embodiment. The fluid collection system 332 includes a fluid collection assembly 300 and a securement element 340. Except as otherwise disclosed herein, the fluid collection assembly 300 and the securement element 340 may be the same as or substantially similar to any of the fluid collection assemblies and securement elements disclosed herein.

[0057] The securement element 340 includes a base 342. In the illustrated embodiment, the base 342 includes a plurality of straps (e.g., wearable mesh material) that are integrally formed together (z.c., exhibit single piece construction) or are configured to be attached together. For example, the base 342 includes two waist straps 344 and a genitalia-facing strap 346. The two waist straps 344 and the genitalia-facing strap 346 may include a mesh material, other types of fabric, or any other suitable material. The two waist straps 344 and the genitalia-facing strap 346 may extend from each other. The two waist straps 344 are configured to extend around a waist of a patient and the genitalia-facing strap 346 is configured to be positioned over the genitalia of the patient and, optionally extend between the legs and over the buttock of the patient. For instance, the genitalia-facing strap 346 may be configured to extend from an intersection with the two waist straps 344, between the inner thighs of the patient, over the genitalia of the patient, and to a portion of the waist straps 344 at, below, or otherwise near the navel of the patient. It is noted that the base 342 may include more straps than the waist straps 344 and the genitalia-facing strap 346 and / or may omit at least one of the waist straps 344 or the genitalia-facing strap 346.

[0058] In an embodiment, each of the waist straps 344 and the genitalia-facing strap 346 are configured to be attached together. For example, at least one of the waist straps 344 and the genitalia-facing strap 346 may include a pad 352 at or near a terminal end thereof. The pad 352 is configured to be attached to a portion of the base 342. For example, the pad 352 may include a hook-and-loop type attachment, an adhesive, or any other device that may be attached to a portion of the base 342. Referring to the illustrated embodiment, at least one of the waist straps 344 and the genitalia-facing strap 346 each include a pad 352. During use, the waist straps 344 may be wrapped around the waist of the patient. After such wrapping, the pad 352 of one of the waist straps 344 may be attached to the other waist strap 344 thus securing the waist straps 344 together. The genitalia-facing strap 346 may be positioned between the thighs and contact the waist straps 344. The pad 352 of the genitalia-facing strap- Page 16 - Docket No. 38471.0176P1346 may be attached to at least one of the waist straps 344 thereby attaching the genitalia-facing strap 346 to the waist straps 344.

[0059] The waist straps 344 and the genitalia-facing strap 346 may at least partially define at least one gap 350 therebetween. The gap 350 between the waist straps 344 and the genitalia-facing strap 346 may allow the legs of the patient to pass through the base 342 when the base 342 is attached to the patient. The gap 350 also allows a medical practitioner (e.g., nurse, doctor, etc.) to be able to access the fluid collection assembly 300 through the base 342. For example, the gap 350 allows the medical practitioner to hold the fluid collection assembly 300 and position the fluid collection assembly 300 proximate to the urethral opening while attaching the securement element 340 to the patient. The gap 350 also allows the medical practitioner to adjust the fluid collection assembly 300 after positioning the fluid collection assembly 300. The gap 350 also allows the medical practitioner to access the labia or other anatomical features of the patient near the urethral opening which may be necessary to position the fluid collection assembly 300 as near to the urethral opening as possible and to improve patient comfort.

[0060] In an embodiment, the securement element 340 is configured to be attached to the fluid collection assembly 300. In the illustrated embodiment, the base 342 defines a slit 354. The slit 354 may be formed in the portion of the base 342 that is configured to abut the fluid collection assembly 300 during use. For example, the slit 354 may be formed in the portion of the genitalia-facing strap 346 that is positioned over the genitalia of the patient during use. The fluid collection assembly 300 includes a tab 356. The tab 356 may extends from (e.g., is attached to or integrally formed with) a portion of the fluid collection assembly 300 that contacts the base 342 during use. For example, the tab 356 may extend from a back side of the fluid impermeable barrier 302 that is generally opposite the opening 304. The tab 356 is configured to extend through the slit 354, thereby securing the fluid collection assembly 300 to the base 342.

[0061] In a particular example, the tab 356 include a widened portion and a narrowed portion between the widened portion and the fluid impermeable barrier 302. The widened portion of the tab 356 is sized and shaped to fit through the slit 354. With the widened portion positioned through the slit 354, the base 342 may lie between the widened portion and the fluid impermeable barrier 302 (e.g, adjacent to the narrowed portion). The widened- Page 17 - Docket No. 38471.0176P1portion of the tab 356 may provide resistance to the tab 356 passing back through the slit 354.

[0062] In an embodiment, the tab 356 may exhibit a length that is less than a length of the slit 354, wherein the lengths of the tab 356 and the slit 354 are measured parallel to a longitudinal axis of the slit 354 when the tab 356 extends through the slit 354. The smaller length of the tab 356 allows the tab 356 to slide in the slit 354 which allows the fluid collection assembly 300 to be positioned proximate to the urethral opening of the patient regardless if the urethral opening is positioned proximate to (relative to orientation of the base 342 shown in FIG. 3) an upper portion of the slit 354, a lower portion of the slit 354, or any other portion therebetween. In other words, the smaller length of the tab 356 may allow the fluid collection assembly 300 to be positioned proximate to the urethral opening regardless of the position of the base 342 on the patient.

[0063] It is noted that the fluid collection assembly 300 may be attached to the base 342 using techniques other than or in addition to the slit 354 and the tab 356 shown in FIG. 3. In an example, the base 342 may include a tab and the fluid collection assembly 300 may define a slit. In an example, the fluid collection assembly 300 may be attached to the base 342 using a hook-and-loop type fastener, snaps, an adhesive, or any other suitable technique. In an example, the base 342 is not attached to the fluid collection assembly 300. In such an example, the base 342 uses friction to maintain the position of the fluid collection assembly 300.

[0064] It is noted that the securement elements disclosed herein may include other structures than the structure illustrated in FIG. 3, even when the securement element includes one or more straps. For example, FIG. 4 is an isometric view of a fluid collection system 432, according to an embodiment. The fluid collection system 432 includes a fluid collection assembly 400 and a securement element 440. Except as otherwise disclosed herein, the fluid collection assembly 400 and the securement element 440 may be the same as or substantially similar to any of the fluid collection assemblies or securement elements disclosed herein.

[0065] The securement element 440 includes a base 442. The base 442 includes two straps 444 and a genitalia-facing strap 446. The genitalia-facing strap 446 includes a back surface 447 that faces away from the patient during use and is not configured to contact the- Page 18 - Docket No. 38471.0176P1fluid collection assembly 400 during use. It is noted that FIG. 4 is oriented to show the back surface 447.

[0066] Unlike the securement element 340 of FIG. 3, the two straps 444 are not configured to extend around the waist of the patient. Instead, the straps 444 may be configured to extend from one side of the genitalia-facing strap 446, around a buttock of the patient and to an opposing side of the genitalia-facing strap 446. The opposing side of the genitalia-facing strap 446 may include one or more wings 458 extending therefrom that are configured to be attached to the straps 444. The straps 444 and the genitalia-facing strap 446 define at least one gap 450 therebetween. At least one of the straps 444 or the genitalia-facing straps 446 may include a pad 452, thereby allowing the straps 444 and the genitalia-facing straps 446 to be attached together. It is noted that the two straps 444 and the genitalia-facing strap 446 may be directly attached to the patient if the two straps 444 and the genitalia-facing strap 446 are too small to extend around the patient.

[0067] The fluid collection assembly 400 may be configured to be attached to the base 442 using any suitable technique. In an example, as shown, the genitalia-facing strap 446 defines a slit 454 and the fluid collection assembly 400 includes a tube 456 that is configured to be positioned through the slit 454.

[0068] FIG. 5 is an isometric view of a fluid collection system 532, according to an embodiment. The fluid collection system 532 includes a fluid collection assembly 500 and a securement element 540. Except as otherwise disclosed herein, the fluid collection assembly 500 and the securement element 540 may be the same as or substantially similar to any of the fluid collection assemblies or securement elements disclosed herein.

[0069] The securement element 540 includes a base 542. The base 542 includes two straps 544 that are positioned to form an X-like configuration. Such straps 544 are configured to extend around an upper portion of the thighs of the individual, such as over the genitalia, between the thigh, around the buttocks, and back towards the genitalia. The ends of the straps 544 may be configured to be attached together or to the patient (if the straps 544 are too short). The straps 544 define at least one gap 550 therebetween through which the legs of the patient may be positioned through and through which the fluid collection assembly 500 may be accessed by a medical practitioner. It is noted that the base 542 may exhibit the X-like- Page 19 - Docket No. 38471.0176P1configuration if the base 542 included three or more straps, such as four straps attached to each other at a common intersection.

[0070] The portion of the straps 544 that extend over the genitalia of the patientthe intersection of the two straps 544) may be configured to abut the fluid collection assembly 500 thereby helping maintain the position of the fluid collection assembly 500 proximate to the urethral opening of the patient. In an embodiment, at least one of the fluid collection assembly 500 or the straps 544 includes a device that attaches the fluid collection assembly 500 to the straps 544. In an example, as illustrated, the fluid collection assembly 500 includes a band 560. The band 560 may define a passageway that the straps 544 may be received into. For instance, the straps 544 may be threaded under the band 560 and through the passageway thereby securing the fluid collection assembly 500 to the straps 544.

[0071] In an example, the band 560 is attached to or integrally formed with the fluid impermeable barrier 502 and extends over a portion of the fluid impermeable barrier 502. In such an example, the passageway is defined between the band 560 and the portion of the fluid impermeable barrier 502 that the band 560 extends over. In an example, the band 560 is formed by two slots cut into the fluid impermeable barrier 502. In such an example, the passageway may be formed between the band 560 and the porous material (not shown) disposed in the chamber defined by the fluid impermeable barrier 502.

[0072] It is noted that the fluid collection assembly 500 may be attached to the straps 544 using any other suitable technique, such as using a hook-and-loop type fastener, snaps, an adhesive, a slit formed in the straps 544 and a tab extending from the fluid collection assembly 500, any other technique disclosed herein, or any other suitable technique.

[0073] The securement elements illustrated in FIGS. 3-5 include one or more straps. However, the securement elements disclosed herein may not include one or more straps. For example, FIG. 6 is an isometric view of a fluid collection system 632 that does not include straps, according to an embodiment. The fluid collection system 632 includes a fluid collection assembly 600 and a securement element 640. Except as otherwise disclosed herein, the fluid collection assembly 600 and the securement element 640 may be the same as or substantially similar to any of the fluid collection assemblies or securement elements disclosed herein.- Page 20 - Docket No. 38471.0176P1

[0074] The securement element 640 includes a base 642. The base 642 exhibits a generally triangular shape. For example, the base 642 includes three apexes 662 and a plurality of struts 664 extending between the apexes 662. The base 642 may include two struts 664 (e.g., the base 642 exhibits a generally an open, triangular V-like shape) or three struts 664 (e.g., the base 642 exhibits a closed triangular shape). The generally triangular shape of the base 642 allows the base 642 to fit within the generally triangular shape of the genital region of the patient extending between the waistline and the upper-most part of the thighs. The generally triangular shape of the base 642 may allow at least a portion of the base 642 to fit within the genital region and, optionally, within the skin folds at or near the waistline and the upper-most part of the thighs thereby securing the base 642 to the patient. Due to the curved nature of the genital region of the patient, the struts 664 of the base 642 may be curved to match the curves of the genital region.

[0075] In an embodiment, the base 642 may be formed from a flexible material, such as a flexible polymeric material. The genital region of the patient may vary from patient to patient, such as in size, shape, curvature thereof. Forming the base 642 from a flexible material allows the base 642 to be deformed to generally correspond to the shape of the genital region. Further, the shape of the genital region may change overtime, such as when the patient switches between a stand, sitting, or lying state. The flexible material of the base 642 may allow the base 642 to deform to accommodate such changes in the shape of the genital region. Examples of flexible material include a polymer (e.g., resilient polymer), cardboard, a metal, a composite, or any other suitable material.

[0076] The base 642 defines at least one gap 650. For example, the gap 650 may be between the struts 664 of the base 642. Similar to the other gaps disclosed herein, the gap 650 may allow a medical practitioner to access the fluid collection assembly 600 which, in turn, at least facilitates positioning the fluid collection assembly 600 and adjusting the position of the fluid collection assembly 600.

[0077] In an embodiment, the securement element 640 includes one or more adhesive pads 652 that are configured to secure the base 642 to the patient. For example, the adhesive pads 652 may be attached to the strut 664 that is configured to be positioned on the waistline or in otherwise positioned closest to the waistline. As such, the adhesive pads 652 are- Page 21 - Docket No. 38471.0176P1attached to the mons pubis, waist, or stomach of the patient which are less sensitive body parts than the rest of the genital region of the patient.

[0078] The apexes 662 of the base 642 may include a distal apex 662a. The distal apex 662a is the apex 662 that is configured to be position proximate to at least one of a lower portion of the vagina (relative to gravity when the patient is standing), the perineum, buttocks of the patient, or otherwise spaced from the waistline. During use, the distal apex 662a may abut or otherwise be positioned near the distal end region (not labeled, covered by distal apex 662a) of the fluid collection assembly 600. The distal apex 662a and / or the portions of the base 642 thereabout may define a recess or pocket that is configured to receive the distal end region of the fluid collection assembly 600. Positioning the distal end region of the fluid collection assembly 600 in the recess or pocket may prevent or at least inhibit movement of the distal end region of the fluid collection assembly 600 and may be used to attach the fluid collection assembly 600 to the base 642.

[0079] In an embodiment, the base 642 may include an extension 666 extending from the distal apex 662a. The extension 666 may be configured to extend between the buttock of the patient. Positioning the extension 666 between the button of the patient may help secure the base 642 to the patient (e. , even when the base 642 is not positioned within the skin folds of the patient) and may minimize movement of the base 642 and, by extension, the fluid collection assembly 600.

[0080] In an embodiment, the securement element 640 includes a conduit fastener 668. The conduit fastener 668 is configured to be attached to the conduit 612 extending from the fluid collection assembly 600. The conduit fastener 668 may include a clasp (as shown), a hook, an adhesive, one or more tabs, or any other device that may be attached to the conduit 612. The conduit fastener 668 may be attached to or integrally formed with the base 642. As such, the conduit fastener 668 may attach the conduit 612 to the base 642. Attaching the conduit 612 to the base 642 also causes the fluid collection assembly 600 to be indirectly attached to the base 642 and limits movement of the fluid collection assembly 600 relative to the base 642. It is noted that the fluid collection assembly 600 may be attached to the base 642 using other techniques other than or in addition to the pocket, recess, or conduit fastener 668, such as using an adhesive, hook-and-loop fastener, or any other technique disclosed herein.- Page 22 - Docket No. 38471.0176P1

[0081] FTG. 7A is an isometric view of a fluid collection system 732, according to an embodiment. FIG. 7B is a top view of the fluid collection system 732 on a patient 777, according to an embodiment. The fluid collection system 732 includes a fluid collection assembly 700 and a securement element 740. Except as otherwise disclosed herein, the fluid collection assembly 700 and the securement element 740 may be the same as or substantially similar to any of the fluid collection assemblies or securement elements disclosed herein.

[0082] The securement element 740 includes a base 742 having a central region 770 and two thigh regions 772 extending from the central region 770. The central region 770 and the two thigh regions 772 may be integrally formed together or at least one of the thigh regions 772 may be attached to the central region 770. The central region 770 is configured to receive or otherwise abut the fluid collection assembly 700. The securement element 740 is configured to bend at or near the intersection between the central region 770 and the two thigh regions 772, as will be discussed in more detail with regards to FIG. 7B. For example, the base 742 may include one or more bends, folds (e.g., creases), or other feature that causes the base 742 to preferentially bend at or near the intersection between the central region 770 and the two thigh regions 772. The base 742 may include any of the materials disclosed herein, such as a resilient material.

[0083] The two thigh regions 772 include a user-facing surface 774. The securement element 740 includes two thigh pads 776 and each of the thigh pads 776 are attached to or otherwise disposed on the user-facing surface 774 of one of the two thigh regions 772. That is, each of the two thigh regions 772 includes a thigh pad 776 attached or otherwise disposed thereon. The thigh pads 776 are configured to contact the thighs of the patient 777 during use. The thigh pads 776 may be more compressible than the thigh regions 772 which may make using the securement element 740 more comfortable to use. For example, the bending the base 742 may cause thigh regions 772 to spring back to their original shape or another shape. The rigidness of the thigh regions 772 may cause the thigh regions 772 to press into the patient 777 which may cause discomfort. The thigh pads 776, meanwhile, are less likely to uncomfortably press into the patient 777 thereby increasing patient comfort.

[0084] In an embodiment, an exterior surface 778 of the thigh pads 776 opposite the user-facing surface 774 is not parallel to the user-facing surface 774. For example, the exterior surface 778 of the thigh pads 776 may be tapered such that a thickness of the thigh- Page 23 - Docket No. 38471.0176P1pads 776 increases with increasing distance from the central region 770. The non-parallel exterior surface 778 may further increase patient comfort.

[0085] In an embodiment, the base 742 may define at least one gap 750. Similar to the other gaps disclosed herein, the gap 750 may allow a medical practitioner to hold the fluid collection assembly 700 against the base 742 during positioning of the fluid collection assembly 700 and the securement element 740, allow for adjustments of the fluid collection assembly 700 after placement, access to the anatomy of the patient 777 around the fluid collection assembly 700, etc. It is noted that, generally, the thigh pads 776 do not cover the gaps 750 or, at most, cover a negligible portion of the gap 750. For example, as shown, the thigh pads 776 may define cutouts that correspond to the gaps 750.

[0086] In an embodiment, the central region 770 of the base 742 defines a recess that is configured to receive the fluid collection assembly 700. The recess may be in the form of a curved user-facing surface. At least a portion of the recess may exhibit a shape that generally corresponds to the shape of at least a portion of the fluid impermeable barrier 702 of fluid collection assembly 700 though, it is noted, that the recess may exhibit a shape that does not correspond to the shape of the fluid impermeable barrier 702. The recess may limit movement of the fluid collection assembly 700 relative to the base 742 during use. It is noted that the movement of the fluid collection assembly 700 may be most limited when the recess exhibits a shape that generally corresponds to the shape of the fluid impermeable barrier 702. The recess of the fluid impermeable barrier 702 may include an adhesive or other attachment device that is configured to attach the fluid collection assembly 700 to the base 742.

[0087] In an embodiment, the base 742 includes a proximal extension 768 extending proximally from or congruent with the central region 770. The proximal extension 768 may be configured to be attached to the conduit 712 extending from the fluid collection assembly 700. As such, the proximal extension 768 causes the fluid collection assembly 700 to be indirectly attached to the base 742 and limits movement of the fluid collection assembly 700 relative to the base 742. The proximal extension 768 may be configured to be attached to the conduit 712 using any suitable technique, such as any of the techniques disclosed herein with regard to the conduit fastener 668. In an example, as shown, the proximal extension 768 includes one or more tabs 780 that are configured to loop around the conduit 712. The tabs 780 may be configured to be attached together or to another portion of the securement- Page 24 - Docket No. 38471.0176P1element 740, for instance, using a hook-and-loop fastener or an adhesive. It is noted that the proximal extension 768 (e.g., the tabs 780) may also extend around the proximal end region 726 of the fluid collection assembly 700.

[0088] It is noted that the securement element 740 may include one or more features other than or in addition to the recess of the central region 770 or the proximal extension 768 that attaches or otherwise limits movement of the fluid collection assembly 700 to the base 742. For example, the securement element 740 (e.g., the central region 770) may define a pocket that receives the distal end region 728 of the fluid collection assembly 700 (similar to the fluid collection system 632 of FIG. 6), an adhesive, a slit and tab (similar to the fluid collection system 332 of FIG. 3), a band (similar to the fluid collection assembly 500 of FIG. 5), etc.

[0089] Referring to FIG. 7B, the base 742 may be bent. For example, a portion of the base 742 at or near the intersection of the central region 770 and the thigh regions 772 may be bent. The base 742, when bent, may exhibit a generally U-like cross-sectional shape. The base 742 may be formed from a resilient material such that the base 742, when bent, is biased to return to the original shape thereof. With the base 742 bent, the central region 770 may be able to generally face the urethral opening and the portions of the patient 777 near the urethral opening (e.g., the vagina, the labia folds, etc.) and the thigh regions 772 (e.g., the exterior surface 778 of the thigh pads 776) may generally face the inner thighs of the patient 777. The fluid collection assembly 700 and the securement element 740 may be positioned such that the fluid collection assembly 700 is proximate to the urethral opening. The thigh regions 772 (e.g., the thigh pads 776) may then cause the securement element 740 to press against the thighs of the patient 777 thereby maintaining the position of the securement element 740 and the fluid collection assembly 700. It is noted that the structure of the base 742 may allow the thigh regions 772 to maintain contact even when the patient 777 opens their legs, such as be the case when the fluid collection system 732 is used with a juvenile patient or a patient with memory issues. It is also noted that the structure of the base 742 may allow the patient 777 to move their thighs when the patient 777 desires, for instance, to improve patient 777 comfort. It is further noted that closing the thighs may cause the securement element 740 to press the fluid collection assembly 700 more strongly into the- Page 25 - Docket No. 38471.0176P1vaginal region of the patient 777 and opening the thighs decreases the pressure applied from the fluid collection assembly 700 to the vaginal region.

[0090] FIG. 8 is an isometric view of a fluid collection system 832 on a patient 877, according to an embodiment. The fluid collection system 832 includes a fluid collection assembly 800 and a securement element 840. Except as otherwise disclosed herein, the fluid collection assembly 800 and the securement element 840 may be the same as or substantially similar to any of the fluid collection assemblies or securement elements disclosed herein.

[0091] The securement element 840 includes a base 842. The base 842 includes a central region 870 and two thigh regions 872. The central region 870 is configured to contact the fluid collection assembly 800 during use. As such, the central region 870 may generally face at least the vaginal region of the patient 877. It is noted that the fluid collection assembly 800 may merely abut the central region 870 or may be attached to the central region 870 using any of the techniques disclosed herein. The thigh regions 872 are configured to abut the inner thighs of the patient 877, during use. The thigh regions 872 may be attached to (as shown) or integrally formed with the central region 870. In an embodiment, as shown, the thigh regions 872 are adhesively attached to the inner thighs of the patient 877. Adhesively attaching the thigh regions 872 to the patient 877 may prevent movement of the securement element 840, during use. That said, the thigh regions 872 may merely abut the thighs of the patient 877.

[0092] In an embodiment, as shown, the central region 870 and the thigh regions 872 are distinct and separate from each other. In such an embodiment, the central region 870 may be configured to be attached to the thigh regions 872. In an example, each of the thigh regions 872 may include an attachment body 882. Each attachment body 882 may define one or more holes (not labeled, occupied), such as two holes. The central region 870 may include one or more protrusions (not shown, disposed in holes) extending from each side of the central region 870, such as two protrusions from each side. Each of the protrusions are configured to be disposed within the holes. The holes and protrusions allow the central region 870 be reversibly attached to the thigh regions 872. For example, closing the thighs may cause the protrusions to be pressed more strongly into the holes (and cause the fluid collection assembly 800 to press more strongly into the vaginal region) and opening the thighs may cause the protrusions to press less strongly into the holes which may make detaching the central region 870 from the thigh regions 872 easier. It is noted that allowing the central- Page 26 - Docket No. 38471.0176P1region 870 to be easily detached from the thigh regions 872 allows the central region 870 to be replaced, such as when the central region 870 is damaged, contaminated with bodily fluids or fecal matter, or incorrectly sized (e.g, too big or too small).

[0093] It is noted that the central region 870 may be attached to the thigh regions 872 using techniques other than or in addition to the attachment body 882, the holes, and the protrusions discussed above. In an example, the attachment body 882 may include the protrusions and the central region 870 may define the holes configured to receive the protrusions. In an example, the central region 870 may be attached to the thigh regions 872 using a hook-and-loop fastener, an adhesive, or any other suitable technique.

[0094] In an embodiment, the central region 870 exhibits a length that is significantly less than a length of the fluid collection assembly 800, wherein both lengths are measured parallel to a longitudinal axis of the fluid collection assembly 800. For example, the central region 870 may exhibit a length that is about 20% to about 80% smaller than the fluid collection assembly 800, such as in ranges of about 20% to about 40%, about 30% to about 50%, about 40% to about 60%, about 50% to about 70%, or about 60% to about 80%. The smaller length of the central region 870 allows the fluid collection assembly 800 and the anatomy of the patient 877 to be accessed even when the central region 870 does not define at least one gap (as shown). That said, in an embodiment, the central region 870 may at least one of define at least one gap or exhibit a length that is comparable to the length of the fluid collection assembly 800.

[0095] FIG. 9A is an isometric view of a fluid collection system 932, according to an embodiment. FIG. 9B is an isometric view of the fluid collection assembly 900 on a patient 977. FIGS. 9C and 9D are top views of the fluid collection system 932 on the patient 977 with the thighs of the patient 977 closed and open, respectively. The fluid collection system 932 includes a fluid collection assembly 900 and a securement element 940. Except as otherwise disclosed herein, the fluid collection assembly 900 and the securement element 940 may be the same as or substantially similar to any of the fluid collection assemblies or securement elements disclosed herein.

[0096] The securement element 940 includes a base 942. The base 942 includes a central region 970 and two thigh regions 972. The central region 970 is configured to contact the fluid collection assembly 900 during use. As such, the central region 970 may generally face- Page 27 - Docket No. 38471.0176P1at least the vaginal region of the patient 977. It is noted that the fluid collection assembly 900 may merely abut the central region 970 or may be attached to the central region 970 using any of the techniques disclosed herein. The thigh regions 972 are configured to abut the inner thighs of the patient 977, during use. The thigh regions 972 may be integrally formed with (as shown) or attached to the central region 970. In an embodiment, as shown, the thigh regions 972 are adhesively attached to the inner thighs of the patient 977 with adhesive pads 952. Adhesively attaching the thigh regions 972 to the patient 977 may prevent movement of the securement element 940, during use. That said, the thigh regions 972 may merely abut the thighs of the patient 977.

[0097] In an embodiment, the base 942 may define at least one gap 950, such as a plurality of gaps 950. Similar to the other gaps disclosed herein, the gap 950 may allow a medical practitioner to hold the fluid collection assembly 900 against the base 942 during positioning of the fluid collection assembly 900 and the securement element 940, allow for adjustments of the fluid collection assembly 900 after placement, access to the anatomy of the patient 977 around the fluid collection assembly 900, etc.

[0098] The securement element 940 may be configured to have the thigh regions 972 adhesively secured to the patient 977. For example, the securement element 940 may include one or more adhesive pads 952 attached to the thigh regions 972. In an embodiment, the thigh regions 972 of the base 942 includes one or more tabs 984 extending from the rest of the thigh regions 972. The tabs 984 may be configured to have the adhesive pads 952 attached thereto.

[0099] Referring to FIGS. 9B-9D, the base 942 may be bent. For example, a portion of the base 942 at or near the intersection of the central region 970 and the thigh regions 972 may be bent. With the base 942 bent, the central region 970 may be able to generally face the urethral opening and the portions of the patient 977 near the urethral opening and the thigh regions 972 may generally face and be attached to the inner thighs of the patient 977. The fluid collection assembly 900 and the securement element 940 may be positioned such that the fluid collection assembly 900 is proximate to the urethral opening. The thigh regions 972 may then cause the securement element 940 to press against the inner thighs of the patient 977 and the adhesive pads 952 may maintain the position of the securement element 940 and- Page 28 - Docket No. 38471.0176P1the fluid collection assembly 900. It is noted that the structure of the base 942 may allow the thigh regions 972 to maintain contact even when the patient 977 opens their legs.

[0100] In an embodiment, the base 942 may include one or more folds 986 (e.g., creases) formed therein. At least some of the folds 986 may be at or near an intersection of the central region 970 and the thigh regions 972 thereby allowing the central region 970 to generally face the vaginal region of the patient 977 and the thigh regions 972 to generally face the inner thighs of the patient 977. The base 942 may also include one or more folds 986 formed in the central region 970. As best shown in FIGS. 9C and 9D, the folds 986 in the central region 970 may include a convex fold 982a that is configured to bend towards the vaginal region when bent. The convex fold 982a in the central region 970 may be convex relative to the vaginal region when folded. The convex fold 982a may press the fluid collection assembly 900 into the vaginal region when the thighs are closed (as shown in FIG. 9C) and may cause the fluid collection assembly 900 to press less hard into the vaginal region when the thighs are opened (as shown in FIG. 9D). As such, the convex fold 982a of the central region 970 may allow the patient 977 to control how hard the fluid collection assembly 900 presses into the vaginal region. For instance, the patient 977 may close their legs when urinating to minimize leaks and may open their legs when not urinating to improve comfort.

[0101] While various aspects and embodiments have been 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.

[0102] Terms of degree (e.g., “about,” “substantially,” “generally,” etc.) indicate structurally or functionally insignificant variations. In an example, when the term of degree is included with a term indicating quantity, the term of degree is interpreted to mean ± 10%, ±5%, or +2% of the term indicating quantity. In an example, when the term of degree is used to modify a shape, the term of degree indicates that the shape being modified by the term of degree has the appearance of the disclosed shape. For instance, the term of degree may be used to indicate that the shape may have rounded corners instead of sharp comers, curved edges instead of straight edges, one or more protrusions extending therefrom, is oblong, is the same as the disclosed shape, etc.- Page 29 - Docket No. 38471.0176P1

Claims

CLAIMSWhat is claimed is:

1. A fluid collection system, comprising:a fluid collection assembly including:a fluid impermeable barrier at least defining a chamber, at least one opening, and a fluid outlet;at least one porous material disposed in the chamber; anda securement element configured to position the fluid collection assembly at least proximate to a female urethral opening, the securement element including a base having at least one surface configured to abut at least a portion of the fluid impermeable barrier, the securement element including at least one of:the base at least partially defining at least one gap extending therethrough; or the base configured to be bent to contact inner thighs of a patient, the base including at least one of a resilient material configured to bend when stressed and apply a biasing force to inner thighs or includes one or more folds formed therein.

2. The fluid collection system of claim 1, wherein the securement element includes the base at least partially defining the at least one gap extending therethrough.

3. The fluid collection system of claim 2, wherein the base includes at least one waist strap and a genitalia-facing strap, the at least one waist strap and the genitalia-facing strap at least partially defining the at least one gap therebetween.

4. The fluid collection system of any one of claims 2 or 3, wherein the base includes a first strap and a second strap, the first strap and the second strap at least partially defining the at least one gap therebetween.

5. The fluid collection system of any one of claim 2-4, wherein the base exhibits a generally triangular shape including three apexes and curved struts extending between adjacent ones of the apexes, the three apexes and the curved struts at least partially defining the at least one gap.

6. The fluid collection system of claim 5, wherein the three apexes include a distal apex, the distal apex including a distal extension configured to be positioned between buttocks of a user.- Page 30 - Docket No. 38471.0176P17. The fluid collection system of any one of claims 5 or 6, wherein the three apexes include a distal apex, the distal apex at least partially defining a pocket configured to receive a portion of the fluid collection assembly.

8. The fluid collection system of any one of claims 1-7, wherein the base configured to be bent to contact inner thighs of a patient, the base including at least one of a resilient material configured to bend when stressed and apply a biasing force to inner thighs or includes one or more folds formed therein.

9. The fluid collection system of any claim 8, wherein the base includes a central region and two thigh regions extending from the central region, the base including the one or more folds formed therein.

10. The fluid collection system of any one of claims 8 or 9, wherein the one or more folds are at or near an intersection of the central region and the two thigh regions.

11. The fluid collection system of any one of claims 8-10, wherein the one or more folds includes at least one convex fold formed in the central region, the at least one convex fold configured to be convexly folded relative to a vaginal region.

12. The fluid collection system of any one of claims 8-11, wherein the base includes a central region and two thigh regions extending from the central region, the central region including the resilient material, each of the two thigh regions includes an attachment body that is configured to be attached to the central region.

13. The fluid collection system of any one of claims 1-12, wherein the base includes a central region and two thigh regions extending from the central region; andthe securement element further includes at least one adhesive pad configured to be secured to the inner thigh.

14. The fluid collection system of claim 13, wherein the at least one adhesive pad includes a plurality of adhesive pads configured to be secured to the inner thigh, each of the two thigh regions includes at least one of the plurality of adhesive pads.

15. The fluid collection system of any one of claims 1-14, wherein:the fluid collection assembly includes at least one tab extending from a back side of the fluid impermeable barrier, the back side opposite the at least one opening; andthe securement element includes a base defining at least one slot configured to receive the at least one tab.- Page 31 - DocketNo. 38471.0176P116. The fluid collection system of any one of claims 1-15, wherein the base includes a wearable mesh material.

17. The fluid collection system of any one of claims 1-16, wherein the base defines a recess or pocket configured to receive a distal end region of the fluid collection assembly.

18. The fluid collection system of any one of claims 1-17, wherein the securement element further includes a conduit fastener configured to be secured to a conduit extending from the fluid outlet of the fluid impermeable barrier.

19. The fluid collection system of any one of claims 1-18, further comprising:a fluid storage container; anda vacuum source;wherein the chamber of the fluid collection assembly, the fluid storage container, and the vacuum source are in fluid communication with each other that, when one or more bodily fluids are present in the chamber, a suction provided from the vacuum source to the chamber of the fluid collection assembly removes the one or more bodily fluids from the chamber and deposits the bodily fluids in the fluid storage container20. A securement element, comprising:a base having at least one surface configured to abut at least a portion of the fluid impermeable barrier, the securement element including at least one of:the base at least partially defining at least one gap extending therethrough; or the base configured to be bent to contact inner thighs of a patient, the base including at least one of a resilient material configured to bend when stressed and apply a biasing force to inner thighs or includes one or more folds formed therein; wherein the securement element is configured to position the fluid collection assembly at least proximate to a female urethral opening, the securement element.

21. A method of using a fluid collection system, the method comprising: positioning a fluid collection assembly to abut a securement element;wherein the fluid collection assembly includes:a fluid impermeable barrier at least defining a chamber, at least one opening, and a fluid outlet;at least one porous material disposed in the chamber; and- Page 32 - Docket No. 38471.0176P1wherein the securement element is configured to position the fluid collection assembly at least proximate to a female urethral opening, the securement element including a base having at least one surface configured to abut at least a portion of the fluid impermeable barrier, the securement element including at least one of:the base at least partially defining at least one gap extending therethrough; or the base configured to be bent to contact inner thighs of a patient, the base including at least one of a resilient material configured to bend when stressed and apply a biasing force to inner thighs or includes one or more folds formed therein.- Page 33 - Docket No. 38471.0176P1

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