Patent Description:
Urinary catheters, such as a Foley catheter, can be used to 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 patients are sometimes used. However, bedpans can be prone to discomfort, spills, and other hygiene issues.

<CIT> discloses a pad to absorb urine. Within the pad are open-ended tubes with a multiplicity of holes in their cylindrical wall, to drain urine towards an outlet conduit connected to a vacuum pump.

<CIT> discloses an absorptive pad in which is a tube with a closed end, a multiplicity of through holes in its cylindrical wall. The tube is connected to a vacuum pump to aspirate urine out of the pad, through the holes and into a urine collection vessel.

The invention is defined in the independent claim below. The dependent claims are directed to optional features and preferred embodiments. The pre-characterizing part of claim <NUM> is based on the disclosure of Applicant's <CIT>. In an embodiment, a fluid collection assembly is disclosed. The fluid collection assembly includes a fluid impermeable barrier defining, at least one opening, a chamber in fluid communication with the at least one opening, and at least one fluid outlet. The fluid collection assembly also includes at least one porous material disposed in the chamber. Further, the fluid collection assembly includes at least one conduit attached to the at least one fluid outlet. The fluid collection assembly additionally includes one or more leak prevention features configured to at least inhibit bodily fluids leaking from the chamber.

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.

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

The drawings illustrate several embodiments of the present invention, wherein identical reference numerals refer to identical or similar elements or features in different views or embodiments shown in the drawings.

The following disclosure is of bodily fluids collection assemblies that include one or more leak prevention features along with systems including and methods of using such bodily fluids collection assemblies. An example fluid collection assembly includes a fluid impermeable barrier defining at least one opening, a chamber in fluid communication with the at least one opening, and at least one fluid outlet. The fluid collection assembly also includes at least one porous material (e.g., at least one wicking material) disposed in the chamber. The fluid collection assembly also includes at least one conduit attached to the fluid outlet. During operation, the fluid collection assembly may receive bodily fluids (e.g., urine) from an individual (e.g., human) through the opening and into the chamber. The porous material may receive at least some of the bodily fluids that enter the chamber. A suction applied from the conduit to the chamber may direct the bodily fluids in chamber towards the conduit. The conduit may then remove the bodily fluids from the chamber.

The fluid collection assembly includes one or more leak prevention features. The leak prevention features decrease the likelihood that the fluid collection assembly leaks compared to a substantially similar fluid collection assembly that does not include the leak prevention features. For example, the bodily fluids may leak from the fluid collection assembly when the bodily fluids flow out of the chamber through the opening or the bodily fluids fail to enter the chamber. The leaked bodily fluids may cause the individual embarrassment and an create unsanitary environment. The bodily fluids may leak from the fluid collection assembly for a variety of reasons, examples of which include movement of the individual, oversaturation of the porous material, and/or the opening of the fluid collection assembly becoming spaced from the individual. The leak prevention features of the fluid collection assembly are configured to minimize or prevent at least some of the reasons that cause the fluid collection assembly to leak.

<FIG> is a top plan view of a fluid collection assembly <NUM> that includes one or more leak prevention features, according to an embodiment. <FIG> is a cross-sectional view of the fluid collection assembly <NUM> taken along line 1B-1B shown in <FIG>, according to an embodiment. The fluid collection assembly <NUM> includes a fluid impermeable barrier <NUM>. The fluid impermeable barrier <NUM> defines at least one opening <NUM> configured to receive bodily fluids from an individual. The fluid impermeable barrier <NUM> also defines a chamber <NUM> that is in fluid communication with the opening <NUM> and at least one fluid outlet <NUM>. The fluid collection assembly <NUM> also include at least one porous material <NUM> disposed in the chamber <NUM> and at least one conduit <NUM> attached to the fluid outlet <NUM>. The fluid collection assembly <NUM> also include one or more leak prevention features.

In an embodiment, the leak prevention features of the fluid collection assembly <NUM> includes forming the fluid collection assembly <NUM> to exhibit a generally non-cylindrical shape. For example, some conventional fluid collection assemblies exhibit a generally cylindrical shape (e.g., bent generally cylindrical shape). Generally, the conventional fluid collection assemblies exhibiting the generally cylindrical shape rely on the thighs of the individual contacting the sides of the conventional fluid collection assembly to maintain the conventional fluid collection assembly against the vulva. However, the thighs of thinner individuals may be unable to contact the sides of the conventional fluid collection assembly and/or separating the legs of the individual (e.g., for comfort or movement) may cause the thighs to cease contacting the sides of the conventional fluid collection assembly. When the thighs of the individual do not contact the sides of the conventional fluid collection assembly, at least a portion of the conventional fluid collection assembly may move away from the individual thereby creating a passageway through which bodily fluids may flow without entering the chamber of the conventional fluid collection assembly. As such, in the illustrated embodiment, the fluid collection assembly <NUM> exhibits a generally disk-like shape. The generally disk-like shape of the fluid collection assembly <NUM> has the technical effect of allowing the fluid collection assembly <NUM> to contact the thighs of the individual even when the individual is thin or is separating the thighs thereof.

The generally disk-like shape of the fluid collection assembly <NUM> allows the fluid collection assembly <NUM> to be relatively flat. In particular, the generally disk-like shape of the fluid collection assembly <NUM> allows the opening <NUM> and the portion of the porous material <NUM> adjacent to the opening <NUM> to be generally flat. The generally flat shape of the fluid collection assembly <NUM> allows the fluid collection assembly <NUM> to exhibit a relatively small thickness relative to conventional fluid collection assemblies. The thickness of the fluid collection assembly <NUM> is measured from an outer surface <NUM> of a portion of the fluid impermeable barrier <NUM> defining the opening <NUM> to an opposing portion of the outer surface <NUM> of the fluid impermeable barrier <NUM> in a direction that is perpendicular to a width W and length L of the opening <NUM>. For example, the fluid collection assembly <NUM> may exhibit a thickness that is about <NUM> or less, about <NUM> or less, about <NUM> or less, or in ranges of about <NUM> to about <NUM> or about <NUM> to about <NUM>. Such thickness may make using the fluid collection assembly <NUM> more comfortable than conventional fluid collection assemblies which, for example, may exhibit a thickness greater than about <NUM>. It is noted that, in some embodiments, the fluid collection assembly <NUM> may exhibit a thickness that is greater than about <NUM>, such as at least about <NUM> or at least about <NUM>. The relatively flat shape of the fluid collection assembly <NUM> may also have the technical effect of allowing the fluid collection assembly <NUM> to collect bodily fluids from orifices other than a urethral opening, such as from a wound or sacral drainage. It is noted that other non-cylindrically shaped fluid collection assemblies disclosed herein other than the generally disk-like shaped fluid collection assembly <NUM> (e.g., the fluid collection assembly <NUM> of <FIG>) may also exhibit the relatively flat shape and the relatively small thickness.

The generally disk-like shape of the fluid collection assembly <NUM> allows the opening <NUM> to exhibit a larger width W than conventional fluid collection assemblies. For example, conventional fluid collection assemblies may exhibiting an opening exhibiting a length (e.g., maximum dimension of the opening) that is significantly greater than a width (e.g., a dimension of the opening that is measured perpendicular to the length) of the opening, such as the length of the opening being more than <NUM> times greater than the width. However, the generally disk-like shape of the fluid collection assembly <NUM> allows the opening <NUM> to exhibit a width W that is <NUM>% (i.e., half of) to <NUM>% (i.e., equal to) the length L. For example, the width W may be about <NUM>% to about <NUM>%, about <NUM>% to about <NUM>%, about <NUM>% to about <NUM>%, or about <NUM>% to about <NUM>% of the length L. The increased width W of the opening <NUM> relative to the length L may allow the fluid collection assembly <NUM> to receive more bodily fluid (i.e., prevent leaks) that flow in a directly that is generally parallel (e.g., ±<NUM>°) to the width W compared to convention fluid collection assemblies while receiving the same or substantially the same amount of bodily fluids that flow in a direction that is generally parallel to the length L. The increased width W of the opening <NUM> relative to the length L may also allow the fluid collection assembly <NUM> to accommodate larger displacements (e.g., caused by the individual moving) in a direction that is generally parallel to the width W without leaking than conventional fluid collection assemblies while being able to accommodate the same or substantially same displacements in a direction that is generally parallel to the length L. In other words, the larger width W of the opening <NUM> relative to the length L of the opening <NUM> is another leak prevention feature of the fluid collection assembly <NUM>.

In an embodiment, the generally flat shape of the fluid collection assembly <NUM> and/or the relatively large width W of the opening <NUM> relative to the length L of the opening <NUM> allows the fluid collection assembly <NUM> to be secured to the individual by merely resting the fluid collection assembly <NUM> on the individual (e.g., resting the fluid collection assembly <NUM> adjacent to the urethral opening). In an embodiment, the generally flat shape of the fluid collection assembly <NUM> and/or the relatively large width W of the opening <NUM> relative to the length L of the opening <NUM> allows the fluid collection assembly <NUM> to be secured to the individual using an adhesive, straps, or underwear (e.g., the underwear includes a pocket that receives the fluid collection assembly <NUM> and/or the underwear is configured to press the fluid collection assembly <NUM> against the urethral opening).

As will be discussed in more detail below, the fluid collection assembly <NUM> may exhibit a shape that is not a generally disk-like shape. For example, the fluid collection assembly <NUM> may exhibit a generally semi-cylindrical shape (<FIG>), a generally flat elongated shape, a generally cylindrical shape (<FIG>), or any other suitable shape.

Referring to <FIG>, in an embodiment, the one or more leak prevention features includes occupying substantially all of the chamber <NUM> with the porous material <NUM>. For example, some fluid collection assemblies (e.g., the fluid collection assemblies <NUM>, <NUM>, <NUM>, and <NUM> of <FIG>, <FIG>, <FIG>) include substantially unoccupied fluid reservoir in which bodily fluids may pool before the bodily fluids are removed from the chamber. During normal operation, gravity, the suction force, and fluid dynamics (capillary action and wicking) pulls the bodily fluids from the opening towards these fluid reservoirs. However, movement of the individual using these fluid collection assemblies may cause the bodily fluids pooled in the fluid reservoirs to shift (e.g., splash) into the porous materials in sufficient quantities that gravity, the suction force, and fluid dynamics cannot prevent at least some of the bodily fluids from exiting the chamber through the opening. However, referring back to the fluid collection assembly <NUM>, substantially occupying all of the chamber <NUM> with the porous material <NUM> prevents the bodily fluids from pooling in a single location. Instead, the bodily fluids are distributed through the chamber <NUM>. As such, no single location in the chamber <NUM> may include a sufficient quantity of bodily fluids that, when the individual using the fluid collection assembly <NUM> moves, gravity, the suction force, and fluid dynamics does not pull the bodily fluids towards at least one inlet <NUM> of the conduit <NUM>. In other words, substantially occupying the chamber <NUM> with the porous material <NUM> may decrease the likelihood that the fluid collection assembly <NUM> leaks fluids when the individual moves. Further, substantially occupying the chamber <NUM> allows the conduit <NUM> to remove the bodily fluids regardless of the quantity of bodily fluids that are present in the chamber <NUM>, unlike the fluid reservoirs that must receive a certain quantity of bodily fluids before the conduit <NUM> may remove the bodily fluids. As such, the fluid reservoirs may cause a delay between receiving the bodily fluids and removing the bodily fluids which may increase the likelihood of leaks while substantially occupying all of the chamber <NUM> with the porous material <NUM> prevents such leaks.

In an embodiment, the one or more leak prevention features includes at least one additional porous material <NUM> at least partially occupying an interior of the conduit <NUM>. As used herein, the additional porous material <NUM> may be integrally formed with at least a portion of the porous material <NUM> that is disposed in the chamber <NUM> (e.g., the additional porous material <NUM> and at least a portion of the porous material <NUM> exhibit single piece construction) or the additional porous material <NUM> may be distinct from the porous material <NUM>. When the conduit <NUM> is not at least partially occupied with the additional porous material <NUM>, the conduit <NUM> may require a suction force to remove bodily fluids from the chamber <NUM>. In some embodiments, the suction force applied to the conduit <NUM> is not continuous since the constant air flow may dry the skin and/or the suction force may cause hickeys. As such, the suction force may not be applied to the conduit <NUM> when discharge of the bodily fluids (e.g., urination) is not expected. However, unexpected bodily fluid discharge may saturate the porous material <NUM> and cause the fluid collection assembly <NUM> to leak when a suction force is not applied to the conduit <NUM> without the additional porous material <NUM>. However, when the conduit <NUM> is at least partially occupied by the additional porous material <NUM>, the additional porous material <NUM> may pull the bodily fluids into the conduit <NUM> via capillary action, absorption, and/or wicking even when a suction force is not applied to the conduit <NUM>. Even though the additional porous material <NUM> may be unable to pull the fluid completely through the conduit <NUM> or may pull the bodily fluids through the conduit <NUM> more slowly than the suction force, the additional porous material <NUM> may increase the quantity of bodily fluids that the fluid collection assembly <NUM> may receive before the porous material <NUM> saturates and the fluid collection assembly <NUM> leaks.

The additional porous material <NUM> extends inwardly from the inlet <NUM> of the conduit <NUM>. The additional porous material <NUM> is positioned in the conduit <NUM> to contact the porous material <NUM> or such that any gap between the porous material <NUM> and the additional porous material <NUM> is sufficiently small that only a small quantity of bodily fluids is necessary to bridge the gap. In an embodiment, the additional porous material <NUM> may extend through an entirety of the conduit <NUM> which allows the additional porous material <NUM> to pull the bodily fluids a far distance into the conduit <NUM>, such as through an entirety of the conduit <NUM>. In an embodiment, the additional porous material <NUM> only extends inwardly from the inlet <NUM> for a distance that is less than a length of the conduit <NUM>. Only extending the additional porous material <NUM> through a portion of the conduit <NUM> may improve fluid flow in the conduit <NUM>. For example, the additional porous material <NUM> may slightly obstruct fluid flow in the portions of the conduit <NUM>.

In an embodiment, the one or more leak prevention features includes a plurality of fluid outlets <NUM> and at least one conduit <NUM> extending from each of the fluid outlets <NUM>. For example, the conduit <NUM> preferentially removes bodily fluids that are closer to the inlet <NUM>. The plurality of fluid outlets <NUM> and the conduit <NUM> attached to each of the fluid outlets <NUM> allows a larger volume of the bodily fluids that are present in the chamber <NUM> to be preferentially removed from the chamber <NUM>. In other words, the plurality of fluid outlets <NUM> and the conduit <NUM> decrease the amount of bodily fluids that remain in the chamber <NUM> thereby decreasing the likelihood that the fluid collection assembly <NUM> leaks. Further, the plurality of conduits <NUM> better distribute any pressure that is applied from the fluid collection assembly <NUM> to the individual thereby decreasing the likelihood that the fluid collection assembly <NUM> causes pressure ulcers. The conduits <NUM> may also be flat tubes which may make the conduits <NUM> more comfortable against the skin.

As previously discussed, the fluid impermeable barrier <NUM> at least partially defines an opening <NUM> and a chamber <NUM> (e.g., interior region). For example, at least one inner surface <NUM> of the fluid impermeable barrier <NUM> at least partially defines the chamber <NUM> within the fluid collection assembly <NUM>. The fluid impermeable barrier <NUM> temporarily stores the bodily fluids in the chamber <NUM>. The fluid impermeable barrier <NUM> may be formed of any suitable fluid impermeable material(s), such as a fluid impermeable polymer (e.g., silicone, polypropylene, polyethylene, polyethylene terephthalate, a polycarbonate, etc.), a metal film, natural rubber, another suitable material, or combinations thereof. As such, the fluid impermeable barrier <NUM> substantially prevents the bodily fluids from passing through the fluid impermeable barrier <NUM>. In an example, the fluid impermeable barrier <NUM> may be air permeable and fluid impermeable. In such an example, the fluid impermeable barrier <NUM> 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 <NUM> of the fluid impermeable barrier <NUM> may be formed from a soft and/or smooth material, thereby reducing chaffing. During use, the outer surface <NUM> of the fluid impermeable barrier <NUM> may contact the wearer. The fluid impermeable barrier <NUM> may be sized and shaped to fit in the gluteal cleft between the legs of a female user.

The opening <NUM> provides an ingress route for bodily fluids to enter the chamber <NUM>. The opening <NUM> may be defined by the fluid impermeable barrier <NUM> such as by an inner edge of the fluid impermeable barrier <NUM>. For example, the opening <NUM> is formed in and extends through the fluid impermeable barrier <NUM>, from the outer surface <NUM> to the inner surface <NUM>, thereby enabling the bodily fluids to enter the chamber <NUM> from outside of the fluid collection assembly <NUM>. In an embodiment, the opening <NUM> may be an elongated hole (the length L is more than <NUM>% greater than the width W, as shown in <FIG>) in the fluid impermeable barrier <NUM>. For example, the opening <NUM> may be defined as a cut-out in the fluid impermeable barrier <NUM>. The opening <NUM> may be located and shaped to be positioned adjacent to a female urethral opening.

The fluid collection assembly <NUM> may be positioned proximate to the female urethral opening and urine may enter the chamber <NUM> of the fluid collection assembly <NUM> via the opening <NUM>. The fluid collection assembly <NUM> is configured to receive the bodily fluids into the chamber <NUM> via the opening <NUM>. When in use, the opening <NUM> may extend from a first location above the urethral opening (e.g., at or near the top of the urethral opening or the pubic hair) to a second location below the urethral opening (e.g., at or near the anus or the vaginal opening).

In some examples, as previously discussed, the fluid impermeable barrier <NUM> may define an fluid outlet <NUM> sized to receive the conduit <NUM>. The at least one conduit <NUM> may be disposed in the chamber <NUM> or otherwise in fluid communication with the chamber <NUM> via the fluid outlet <NUM>. The fluid outlet <NUM> may be sized and shaped to form an at least substantially fluid tight seal against the conduit <NUM> or the at least one tube thereby substantially preventing the bodily fluids from escaping the chamber <NUM>.

The fluid impermeable barrier <NUM> may include markings thereon, such as one or more markings to aid a user in aligning the fluid collection assembly <NUM> on the wearer. For example, a line on the fluid impermeable barrier <NUM> (e.g., opposite the opening <NUM>) may allow a healthcare professional to align the opening <NUM> over the urethral opening of the individual wearing the fluid collection assembly <NUM>. In examples, the markings may include one or more of alignment guide or an orientation indicator, such as a stripe or hashes. Such markings may be positioned to align the fluid collection assembly <NUM> to one or more anatomical features such as a pubic bone, etc..

As previously discussed, the fluid collection assembly <NUM> includes porous material <NUM> disposed in the chamber <NUM>. The porous material <NUM> may cover at least a portion (e.g., all) of the opening <NUM>. The porous material <NUM> is exposed to the environment outside of the chamber <NUM> through the opening <NUM>. The permeable properties referred to herein may be wicking, capillary action, absorption, diffusion, or other similar properties or processes, and are referred to herein as "permeable" and/or "porous. " The porous material <NUM> may also wick the bodily fluids generally towards an interior of the chamber <NUM>, as discussed in more detail below. The porous material <NUM> may include one or more of a fluid permeable membrane <NUM> or a fluid permeable support <NUM>.

In an embodiment, at least a portion of the porous material <NUM> may be a wicking material configured to wick any of the bodily fluids away from the opening <NUM>, thereby preventing bodily fluids from escaping the chamber <NUM>. The wicking material may not include absorption of the bodily fluids into the wicking material. Put another way, substantially no absorption of the bodily fluids into the wicking material may take place after the wicking material is exposed to the bodily fluids. While no absorption is desired, the term "substantially no absorption" may allow for nominal amounts of absorption of the bodily fluids into the wicking material (e.g., absorbency), such as less than about <NUM> wt% of the dry weight of the wicking material, less than <NUM> wt%, less than <NUM> wt%, less than about <NUM> wt%, less than about <NUM> wt%, less than about <NUM> wt%, less than about <NUM> wt%, less than about <NUM> wt%, or less than about <NUM> wt% of the dry weight of the wicking material. In an embodiment, at least a portion of the porous material <NUM> may include an absorbent or adsorbent material.

The fluid collection assembly <NUM> may include the fluid permeable membrane <NUM> disposed in the chamber <NUM>. The fluid permeable membrane <NUM> may cover at least a portion (e.g., all) of the opening <NUM>. The fluid permeable membrane <NUM> may be composed to pull/push the bodily fluids away from the opening <NUM>, thereby preventing the bodily fluids from escaping the chamber <NUM>.

The fluid permeable membrane <NUM> may include any material that may be permeable to the bodily fluids. For example, the fluid permeable membrane <NUM> may include fabric, such as a gauze (e.g., a silk, linen, or cotton gauze), another soft fabric, or another smooth fabric. Forming the fluid permeable membrane <NUM> from gauze, soft fabric, and/or smooth fabric may reduce chaffing caused by the fluid collection assembly <NUM>.

The fluid collection assembly <NUM> may include the fluid permeable support <NUM> disposed in the chamber <NUM>. The fluid permeable support <NUM> is configured to support the fluid permeable membrane <NUM> since the fluid permeable membrane <NUM> may be formed from a relatively foldable, flimsy, or otherwise easily deformable material. For example, the fluid permeable support <NUM> may be positioned such that the fluid permeable membrane <NUM> is disposed between the fluid permeable support <NUM> and the fluid impermeable barrier <NUM>. As such, the fluid permeable support <NUM> may support and maintain the position of the fluid permeable membrane <NUM>. The fluid permeable support <NUM> may include any material that may be permeable to 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 <NUM> when used as the fluid permeable support <NUM>. The fluid permeable support <NUM> may be formed from any fluid permeable material that is less deformable than the fluid permeable membrane <NUM>. For example, the fluid permeable support <NUM> may include a porous polymer (e.g., nylon, polyester, polyurethane, polyethylene, polypropylene, etc.) structure (e.g., spun fibers, such as spun nylong fibers) or an open cell foam. In some examples, the fluid permeable support <NUM> 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 the bodily fluids into the material, such as a water repellent coating. In some examples, the fluid permeable support <NUM> may be formed from fabric, felt, gauze, or combinations thereof. In some examples, the fluid permeable membrane <NUM> may be optional. For example, the porous material <NUM> may include only the fluid permeable support <NUM>. In some examples, the fluid permeable support <NUM> may be optionally omitted from the fluid collection assembly <NUM>. For example, the porous material <NUM> may only include the fluid permeable membrane <NUM>.

In an embodiment, the fluid permeable membrane <NUM> and the fluid permeable support <NUM> are wicking materials. In such an embodiment, the fluid permeable support <NUM> may have a greater ability to wick the bodily fluids than the fluid permeable membrane <NUM>, such as to move the bodily fluids inwardly from the outer surface <NUM> of the fluid collection assembly <NUM>. In some examples, the wicking ability of the fluid permeable support <NUM> and the fluid permeable membrane <NUM> may be substantially the same.

As previously discussed, the fluid permeable membrane <NUM> and the fluid permeable support <NUM> may at least substantially completely fill the portions of the chamber <NUM> that are not occupied by the conduit <NUM>. In an example, not shown, the fluid permeable membrane <NUM> and the fluid permeable support <NUM> may not substantially completely fill the portions of the chamber <NUM> that are not occupied by the conduit <NUM>. In such an example, the fluid collection assembly <NUM> includes a fluid reservoir (e.g., fluid reservoir <NUM> illustrated in <FIG>) disposed in the chamber <NUM>.

The fluid reservoir is a substantially unoccupied portion of the chamber <NUM>. The fluid reservoir may be defined between the fluid impermeable barrier <NUM> and one or both of the fluid permeable membrane <NUM> and fluid permeable support <NUM>. The bodily fluids that are in the chamber <NUM> may flow through the fluid permeable membrane <NUM> and/or fluid permeable support <NUM> to the fluid reservoir. The fluid reservoir may retain of the bodily fluids therein. The bodily fluids that are in the chamber <NUM> may flow through the fluid permeable membrane <NUM> and/or fluid permeable support <NUM> and, optionally, to the fluid reservoir. The fluid impermeable barrier <NUM> may retain the bodily fluids in the fluid reservoir. The fluid reservoir may be located in a portion of the chamber <NUM> that is designed to be located in a gravimetrically low point of the fluid collection assembly when the device is worn. In some examples (not shown), the fluid collection assembly <NUM> may include multiple fluid reservoirs, such as fluid reservoirs that are located adjacent to each of the fluid outlets <NUM>.

In an embodiment, not shown, the conduit <NUM> may be at least partially disposed in the chamber <NUM>. The conduit <NUM> may be used to remove fluid form the chamber <NUM>. The conduit <NUM> (e.g., a tube) includes the inlet <NUM> and an outlet (not shown) positioned downstream from the inlet <NUM>. The outlet may be operably coupled to a suction source, such as a vacuum pump for withdrawing the bodily fluids form the chamber through the conduit <NUM>. The conduit <NUM> fluidly couples the chamber <NUM> with the fluid storage container (not shown) or the vacuum source (not shown).

The conduit <NUM> may include a flexible material such as plastic tubing (e.g., medical tubing). Such plastic tubing may include a thermoplastic elastomer, polyvinyl chloride, ethylene vinyl acetate, polytetrafluoroethylene, etc., tubing. In some examples, the conduit <NUM> may include silicon or latex. In some examples, the conduit <NUM> may include one or more portions that are resilient, such as to by having one or more of a diameter or wall thickness that allows the conduit to be flexible. In an embodiment, the conduit <NUM> may include a plurality of conduits <NUM> extending from each of the fluid outlet <NUM>. In such an embodiment, each of the conduits <NUM> may be connected to a common conduit <NUM> that is connected to the vacuum source or each of the conduits <NUM> may be connected to the same vacuum source or different vacuum sources.

In an example, the conduit <NUM> is configured to be at least insertable into the chamber <NUM>. In such an example, the conduit <NUM> may include one or more markers (not shown) on an exterior thereof that are located to facilitate insertion of the conduit <NUM> into the chamber <NUM>. For example, the conduit <NUM> may include one or more markings thereon that are configured to prevent over or under insertion of the conduit <NUM>, such as when the conduit <NUM> defines an inlet <NUM> that is configured to be disposed in or adjacent to the reservoir. In another example, the conduit <NUM> may include one or more markings thereon that are configured to facilitate correct rotation of the conduit <NUM> relative to the chamber <NUM>. The one or more markings may include a line, a dot, a sticker, or any other suitable marking.

As described in more detail below, the conduit <NUM> is configured to be coupled to, and at least partially extend between, one or more of the fluid storage container (Fluid storage container <NUM> of <FIG>) and the vacuum source (vacuum source <NUM> of <FIG>). In an example, the conduit <NUM> is configured to be directly connected to the vacuum source (not shown). In such an example, the conduit <NUM> may extend from the fluid impermeable barrier <NUM> by at least <NUM> (one foot), at least <NUM> (two feet), at least <NUM> (three feet), or at least <NUM> (six feet). In another example, the conduit <NUM> is configured to be indirectly connected to at least one of the fluid storage container (not shown) and the vacuum source (not shown). In some examples, the conduit <NUM> is secured to a wearer's skin with a catheter securement device, such as a STATLOCK® catheter securement device available from C. , including but not limited to those disclosed in <CIT>; <CIT>; and <CIT>.

The inlet <NUM> and the outlet of the conduit <NUM> are configured to fluidly couple (e.g., directly or indirectly) the vacuum source (not shown) to the chamber <NUM> (e.g., the reservoir). As the vacuum source (<FIG>) applies a vacuum/suction in the conduit <NUM>, the bodily fluids in the chamber <NUM> may be drawn into the inlet <NUM> and out of the fluid collection assembly <NUM> via the conduit <NUM>. In some examples, the conduit <NUM> may be frosted or opaque (e.g., black) to obscure visibility of the bodily fluids therein.

<FIG> is a top plan view of a fluid collection assembly <NUM>, according to an embodiment. Except as otherwise disclosed herein, the fluid collection assembly <NUM> is the same or substantially similar to any of the fluid collection assemblies disclosed herein. For example, the fluid collection assembly <NUM> includes a fluid impermeable barrier <NUM> defining an opening <NUM>, a chamber <NUM>, and at least one fluid outlet <NUM>. The fluid collection assembly <NUM> also includes at least one porous material <NUM> disposed in the chamber <NUM> and a conduit <NUM> attached to the fluid outlet <NUM>.

The fluid collection assembly <NUM> exhibits a generally elongated shape. The elongated shape of the fluid collection assembly <NUM> may allow the fluid collection assembly <NUM> to exhibit a size and shape that fits in the gluteal cleft between the legs of an individual, especially a non-thin individual. The elongated shape of the fluid collection assembly <NUM> allows the opening <NUM> to exhibit an elongated shape wherein a length L of the opening <NUM> is greater (e.g., at least about <NUM> times greater, at least about <NUM> times greater, or at least <NUM> times greater) than the width W of the opening <NUM>. The opening <NUM> 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 <NUM> (e.g., longitudinally extending opening). The opening <NUM> in the fluid impermeable barrier <NUM> may exhibit a length that is measured along the longitudinal axis of the fluid collection assembly <NUM> that may be at least about <NUM>% of the length of the fluid collection assembly <NUM>, such as about <NUM>% to about <NUM>%, about <NUM>% to about <NUM>%, about <NUM>% to about <NUM>%, about <NUM>% to about <NUM>%, or about <NUM>% to about <NUM>% of the length of the fluid collection assembly <NUM>.

The leak prevention feature of the fluid impermeable barrier <NUM> may include the cross-sectional shape of the fluid impermeable barrier <NUM>. <FIG> is a cross-sectional view of the fluid impermeable barrier <NUM> taken along ling 2B-2B, according to an embodiment. As shown in <FIG>, the fluid impermeable barrier <NUM> may exhibit a concavely curved cross-sectional shape, such as a generally semi-circular (e.g., generally half circular) cross-sectional shape or other generally elliptical cross-sectional shape. In an embodiment, the concavely curved cross-sectional shape of the fluid impermeable barrier <NUM> inhibits leaks because the curved outermost surface <NUM> of the porous material <NUM> (e.g., the surface of the porous material <NUM> extending across the opening <NUM>) is able to press against the labia folds of the vulva and may even cause the outermost surface <NUM> to extend between labia folds. Pressing the outermost surface <NUM> against the labia folds may cause the fluid collection assembly <NUM> to receive bodily fluids that would otherwise flow between the labia folds.

In an embodiment, the concavely curved cross-sectional shape of the fluid impermeable barrier <NUM> allows the conduit <NUM> to be positioned adjacent to a back surface <NUM> of the fluid impermeable barrier <NUM>. Since the conduit <NUM> is positioned adjacent to the back surface <NUM>, any air flow caused by a suction force applied to the conduit <NUM> is concentrated between the inlet of the conduit <NUM> and the opening <NUM>. This concentration of the air flow may increase the amount of bodily fluids that are sucked into the conduit <NUM> and are removed from the chamber <NUM>. Meanwhile, a substantially similar fluid collection assembly that includes a conduit spaced from the back surface may cause some of the air to flow between the conduit and the back surface of the fluid impermeable barrier thereby decreasing the amount of air flow between the opening and the conduit and the amount of bodily fluids received by the conduit.

The porous material <NUM> of the fluid impermeable barrier <NUM> includes a fluid permeable membrane <NUM> and a fluid permeable support <NUM>. In an embodiment, the porous material <NUM> may include at least one absorbent layer <NUM> positioned between the fluid permeable membrane <NUM> and the fluid impermeable support <NUM>. The absorbent layer <NUM> may be a leak prevention feature of the fluid impermeable barrier <NUM>. For example, the fluid permeable membrane <NUM> may be a wicking material. Disposing the absorbent layer <NUM> downstream from the fluid permeable membrane <NUM> may help pull bodily fluids through the fluid permeable membrane <NUM>. As such the absorbent layer <NUM> may increase the flow rate of bodily fluids through the fluid permeable membrane <NUM> and through the chamber <NUM> as a whole thereby decreasing leaking caused by oversaturation of the porous material <NUM>. The absorbent layer <NUM> may include any suitable absorbent material, such as, super absorbent polymers, absorbent materials used in diapers, absorbent materials used in astronaut underwear, sponge-like material, one or more hydrophilic materials, etc..

It is noted that the fluid collection assembly <NUM> may exhibit shapes other than the concavely curved cross-sectional shape illustrated in <FIG>. In an example, the fluid collection assembly <NUM> may exhibit an elongated shape exhibiting a generally rectangular cross-sectional shape (e.g., a generally square cross-sectional shape or a generally rectangular cross-sectional shape with one or more curved surfaces) that exhibits some of the benefits of the fluid collection assembly <NUM> illustrated in <FIG>. In an example, the fluid collection assembly <NUM> may exhibit a generally cylindrical shape.

<FIG> are isometric and cross-sectional views of a fluid collection assembly <NUM>, according to an embodiment. Except as otherwise disclosed herein, the fluid collection assembly <NUM> may be the same or substantially to any of the fluid collection assemblies disclosed herein. For example, the fluid collection assembly <NUM> may include a fluid impermeable barrier <NUM> defining an opening <NUM>, a chamber <NUM>, and a fluid outlet <NUM>. The fluid impermeable barrier <NUM> also includes at least one porous material <NUM> disposed in the chamber <NUM> and at least one conduit <NUM> secured to the fluid outlet <NUM>.

The fluid collection assembly <NUM> exhibits a generally cylindrical shape. The elongated shape of the fluid collection assembly <NUM> may allow the fluid collection assembly <NUM> to exhibit a size and shape that fits in the gluteal cleft between the legs of an individual, especially a non-thin individual. The elongated shape of the fluid collection assembly <NUM> allows the opening <NUM> to exhibit an elongated shape wherein a length of the opening <NUM> is significantly greater than the width of the opening <NUM>. The opening <NUM> 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 <NUM> (e.g., longitudinally extending opening). Further, the curved outermost surface of the fluid collection assembly <NUM>, and more particularly the curved outermost surface <NUM> of the porous material <NUM>, will press against the labia folders.

Referring to <FIG>, the fluid collection assembly <NUM> includes a first end <NUM> and a second end <NUM> spaced from the first end <NUM>. The first end <NUM> may define a substantially unoccupied fluid reservoir <NUM>. The second end <NUM> may define the fluid outlet <NUM>. The conduit <NUM> may include an outlet portion <NUM> disposed in the fluid outlet <NUM>. For example, the outlet portion <NUM> may secure the conduit <NUM> to the fluid outlet <NUM> via press fitting, an adhesive, ultrasonic welding, or any other suitable attachment technique. The conduit <NUM> may extend longitudinally from the fluid outlet <NUM>, behind at least partially of the porous material <NUM> (e.g., through a central region of the porous material <NUM>), to the fluid reservoir <NUM>. For example, the conduit <NUM> may include an open terminal end <NUM> that is positioned adjacent to or within the fluid reservoir <NUM>. The open terminal end <NUM> is configured to remove bodily fluids that are present in the fluid reservoir <NUM>, for example, when a suction force is applied to the conduit <NUM>.

The open terminal end <NUM> of the conduit <NUM> may substantially only remove bodily fluids when the bodily fluids are present in the fluid reservoir <NUM> in sufficient quantity that the bodily fluids contact the open terminal end <NUM>. As such, solely relying on the open terminal end <NUM> to remove bodily fluids may delay removal of the bodily fluids from the chamber <NUM> since the bodily fluids must first flow into the fluid reservoir <NUM> in sufficient quantity to be removed and at least some of the bodily fluids may not be removed from the chamber <NUM> when the quantity of bodily fluids in the fluid reservoir <NUM> are insufficient to contact the open terminal end <NUM>, both of which may increase the likelihood that the fluid collection assembly <NUM> leaks. As such, the one or more leak prevention features of the fluid collection assembly <NUM> may include at least one conduit inlet <NUM> formed in the conduit <NUM> (e.g., the conduit <NUM> includes a plurality of inlets, namely the open terminal end <NUM> and the at least one conduit inlet <NUM>). The conduit inlet <NUM> includes an inlet formed in the conduit <NUM> between the outlet portion <NUM> and the open terminal end <NUM> that is in fluid communication with an interior <NUM> (e.g., passageway) of the conduit <NUM>. As used herein, the conduit inlet <NUM> refer to inlets formed in the conduit <NUM> that are distinct from the open terminal end <NUM>. The conduit inlet <NUM> allows the conduit <NUM> to remove bodily fluids from the chamber <NUM> that are spaced from the fluid reservoir <NUM> in addition to the bodily fluids that are present in the fluid reservoir <NUM>. In an embodiment, not shown, the open terminal end <NUM> of the conduit <NUM> may be omitted and the conduit <NUM> may only include one or more conduit inlets <NUM>.

In an embodiment, the conduit inlet <NUM> may include a one-way valve (not shown). The one-way valve may be configured to allow the bodily fluids to flow from an exterior (e.g., the chamber <NUM>) of the conduit <NUM> into an interior <NUM> of the conduit <NUM> and restrict the flow of the bodily fluids from the interior <NUM> to the exterior of the conduit <NUM>. The one-way valve may prevent bodily fluids that are received upstream from one of the conduit inlet <NUM> from exiting the conduit <NUM>. Allowing the bodily fluids to exit the conduit <NUM> at a location downstream from where the bodily fluids were received may increase the likelihood that the fluid collection assembly <NUM> leaks. The one-way valve may include any suitable one-way valve. In an example, the one-way valve is a flap formed in the interior <NUM> of the conduit <NUM>. The flap may be configured to open when the flow of the bodily fluids is from the exterior to the interior <NUM> of the conduit <NUM> and close when the flow of the bodily fluids is from the interior <NUM> to the exterior of the conduit <NUM>. In an example, the one-way valve includes a ball valve that substantially only permits the bodily fluids to flow from the exterior to the interior <NUM> of the conduit <NUM>.

The conduit inlets <NUM> may also allow the fluid collection assembly <NUM> to be used when the individual using the fluid collection assembly <NUM> is in different positions. For example, when the individual is lying down, the fluid reservoir <NUM> is the gravimetrically lowest point of the chamber <NUM>. As such, gravity pulls the bodily fluids towards the fluid reservoir <NUM> in addition to the permeability of the porous material <NUM> and the suction force. However, switching the position of the individual from the lying position to another position (e.g., sitting or standing position) may change the gravimetrically low point of the chamber <NUM>. <FIG> is an isometric view of the conduit <NUM> illustrating how the at least one conduit inlet <NUM> may facilitate removing bodily fluids from the chamber <NUM> when the individual using the fluid collection assembly <NUM> is in a position other than lying down, according to an embodiment. For example, the conduit <NUM> may include one or more of the open terminal end <NUM> that is configured to receive bodily fluids when the individual is lying down, at least one first conduit inlet <NUM> that is configured to receive bodily fluids when the individual is sitting down, at least one second conduit inlet <NUM> that is configured to receive bodily fluids when the individual is standing up, and at least one third conduit inlet <NUM> that is configured to receive bodily fluids when the individual is leaning forward. In such an example, the conduit <NUM> may exhibit a length measured from the open terminal end <NUM> to the outlet portion <NUM> (cross-hatched for illustrative purposes). The first conduit inlet <NUM> may be spaced from the open terminal end <NUM> by about <NUM>% to about <NUM>% (e.g., about <NUM>% to about <NUM>%, about <NUM>% to about <NUM>%, about <NUM>% to about <NUM>%, or about <NUM>%) of the length of the conduit <NUM> which may position the first conduit inlet <NUM> at or near the gravimetrically lowest point of the chamber <NUM> when the individual is sitting. The second conduit inlet <NUM> may be spaced from the open terminal end <NUM> by about <NUM>% to about <NUM>% (e.g., about <NUM>% to about <NUM>%, about <NUM>% to about <NUM>%, about <NUM>% to about <NUM>%, or about <NUM>%) of the length of the conduit <NUM> which may position the second conduit inlet <NUM> at or near the gravimetrically lowest point of the chamber <NUM> when the individual is standing. The third conduit inlet <NUM> may be spaced from the open terminal end <NUM> by about <NUM>% to about <NUM>% (e.g., about <NUM>% to about <NUM>%, about <NUM>% to about <NUM>%, about <NUM>% to about <NUM>%) of the length of the conduit <NUM> which may position the third conduit inlet <NUM> at or near the gravimetrically lowest point of the chamber <NUM> when the individual is leaning forward. It is noted that the distance of the first, second, and third conduit inlets <NUM>, <NUM>, <NUM> may vary depending on the size and placement of the fluid collection assembly <NUM> but the values provided above are accurate for most embodiments where the fluid collection assembly <NUM> exhibits an elongated shape.

In an embodiment, the conduit <NUM> may include valve (not shown) that closes at least one of the inlets of the conduit <NUM> (e.g., the open terminal end <NUM> or one of the conduit inlets <NUM>) when the inlet is not at or near the gravimetrically low point of the chamber <NUM>. The valve may close the inlet when the inlet is not at or near the gravimetrically low point of the chamber <NUM> since the inlet is more likely to pull air into the conduit <NUM> when the inlet is not at or near the gravimetrically low point of the chamber <NUM> and decreases the overall efficiency of the conduit <NUM>. In an example, the valve may include a ball valve that is configured to close an inlet of the conduit <NUM> when the inlet is not at or near the gravimetrically low point of the chamber <NUM> and open the inlet of the conduit <NUM> when the inlet is at or near the gravimetrically low point of the chamber <NUM>. For instance, a ball of the ball valve may press against the inlet of the conduit <NUM> when the inlet is not at or near the gravimetrically low point of the chamber <NUM> and the ball of move into a recess thereby opening the inlet when the inlet is at or near the gravimetrically low point of the chamber <NUM>.

<FIG> is an isometric view of a conduit 312a that may be used in any of the fluid collection assemblies disclosed herein, according to an embodiment. Except as otherwise disclosed herein, the conduit 312a may be the same or substantially similar to any of the conduits disclosed herein. For example, the conduit 312a includes an open terminal end 340a and at least one conduit inlet 342a. Generally, the open terminal end 340a removes more bodily fluids from a chamber (e.g., chamber <NUM> of <FIG>) than the conduit inlets 342a and the conduit inlets 342a closer to the open terminal end 340a remove more bodily fluids from the chamber than other conduit inlets 342a. Further, the inlets of the conduit 312a (e.g., the open terminal end 340a and the conduit inlets 342a) will remove air from the chamber preferentially over bodily fluids. In other words, if any of the inlets of the conduit 312a are exposed to air instead of bodily fluids, the conduit 312a will remove significantly less bodily fluids than if each of the inlets were exposed to the bodily fluids. As such, the inlets of the conduit 312a may be configured to exhibit different sizes (e.g., diameter) depending on the likelihood that the inlets will remove bodily fluids or air at any given time. For example, the open terminal end 340a may exhibit the largest opening (e.g., largest diameter) of the conduit 312a since the open terminal end 340a is most likely to remove the most bodily at any given time. The conduit inlets 342a may also exhibit different sizes, wherein the size (e.g., diameter) of the conduit inlets 342a progressively get smaller with increased distance from the open terminal end 340a since the conduit inlets 342a are less likely to remove bodily fluids with increased distance from the open terminal end 340a. The various sizes of the openings of the conduit 312a are leak prevention features since they decrease the amount of air pulled into the conduit 312a thereby increasing the amount of bodily fluids that are pulled into the conduit 312a and decreasing the likelihood of leaks.

The conduit inlets illustrated in <FIG> and <FIG> exhibit a generally circular shape. However, the conduit inlets may exhibit any suitable shape. For example, <FIG> is an isometric view of a conduit 312b that may be used in any of the fluid collection assemblies disclosed herein, according to an embodiment. Except as otherwise disclosed herein, the conduit 312b may be the same or substantially similar to any of the conduits disclosed herein. For example, the conduit 312b may include an open terminal end 340b and at least one conduit inlet 342b. The conduit inlet 342b, in the illustrated embodiment, exhibits a slot-like shape instead of the generally circular shapes illustrated in <FIG> and <FIG>. The slot-like shape of the conduit inlet 342b may increase the volume of bodily fluids that are preferentially pulled into the conduit inlet 342b. The slot-like shape of the conduit inlet 342b may also increase the flexibility of the conduit 312b thereby allowing the fluid collection assembly that includes the conduit 312b to more easily conform to the shape the individual. In other words, the slot-like shape of the conduit inlets 342b are leak prevention features since it may improve the amount of bodily fluids that are pulled into the conduit 312b and may allow the fluid collection assembly to better conform to the shape of the individual, both of which may decrease the likelihood that the fluid collection assembly leaks.

<FIG> is an isometric view of a plurality of conduits that may be used in any of the fluid collection assemblies disclosed herein (e.g., the fluid collection assembly may include the plurality of conduits instead of a single conduits), according to an embodiment. The plurality of conduits are illustrated and discussed as having a first conduit 312c, a second conduit 312d, and a third conduit 312e. However, this is for illustrative purposes only and it is understood that the plurality of conduits may include two conduits or four or more conduits and that the same principles disclosed herein are applicable regardless of the number of conduits. Except as otherwise disclosed herein, each of the first, second, and third conduits 312c, 312d, 312e may be the same or substantially similar to any of the conduits disclosed herein. For example, each of the first, second, and third conduits 312c, 312d, 312e may include a first, second, and third outlet portion 338c, 338d, 338e (cross-hatched for illustrative purposes) and a first, second, and third open terminal end 340c, 340d, 340e, respectively. At least one of the first, second, or third conduits 312c, 312d, 312e may also include at least one conduit inlet (not shown).

The first conduit 312c exhibits a first length measured from the first outlet portion 338c to the first open terminal end 340c. The second conduit 312d exhibits a second length measured from the second outlet portion 338d to the second open terminal end 340d. The third conduit 312e exhibits a third length measured from the third outlet portion 338e to the third open terminal end 340e. In an embodiment, as illustrated, the first distance is greater than the second distance and the second distance is greater than the third distance. The different distances of the first, second, and third conduits 312c, 312d, 312e causes the first, second, and third open terminal ends 340c, 340d, 340e to be positioned in different locations of a chamber. Similar to the different locations of the inlets of the conduits discussed in <FIG>, the different locations of the first, second, and third opening terminal ends 340c, 340d, 340e are leak prevention features since it allows bodily fluids to be removed from a variety of different locations in the chamber. In an embodiment, at least one of the first, second, or third distances are the same which allows the a greater volume of bodily fluids to be removed from a single location of the chamber (e.g., a fluid reservoir). In an embodiment, the first open terminal end 340c is larger than the second open terminal end 340d and the second open terminal end 340d is larger than the third open terminal end 340e. In such an embodiment, the first, second, and third conduits 312c, 312d, 312e may operate similar to the conduit 312b illustrated in <FIG>.

In an embodiment, the first, second, and third conduits 312c, 312d, 312e may intersect and form a common conduit or intersect at the fluid storage container. In such an embodiment, a suction force applied to one of the first, second, and third conduits 312c, 312d, 312e is also applied to the other ones of the first, second, and third conduits 312c, 312d, 312e. As such, each of the first, second, and third conduits 312c, 312d, 312e may include any of the valves discussed so that the first, second, and third conduits 312c, 312d, 312e to pull the bodily fluids therein and minimize the amount of air pulled therein. In an embodiment, the first, second, and third conduits 312c, 312d, 312e may each be connected to separate vacuum sources thereby eliminating the need for valves. However, many locations (e.g., hospitals) may not include multiple vacuum sources and/or the multiple vacuum sources may increase the cost of using a fluid collection assembly that includes the first, second, and third conduits 312c, 312d, 312e.

In an embodiment, the first, second, and third conduits 312c, 312d, 312e may be connected to a suction control apparatus that controls the amount of suction that is applied to each of the first, second, and third conduits 312c, 312d, 312e. <FIG> is an isometric view of a system <NUM> that includes the first, second, and third conduits 312c, 312d, 312e and a suction control apparatus <NUM>, according to an embodiment. The first, second, and third conduits 312c, 312d, 312e are connected to the suction control apparatus <NUM> and the suction control apparatus <NUM> is configured to control how much suction is applied to each of the first, second, and third conduits 312c, 312d, 312e. For example, the suction control apparatus <NUM> may include one or more sensors that detect whether the first, second, and/or third conduits 312c, 312d, 312e are removing bodily fluids or air. The sensors may include one or more moisture sensors configured to detect the presence of the bodily fluids in the conduit <NUM>, one or more optical sensors configured to detect the presence of the bodily fluids in an at least partially transparent conduit <NUM>, one or more acoustic sensors configured to detect the sound of bodily fluids through the conduit <NUM>, one or more oxygen sensors configured to detect the presence of oxygen (e.g., air) in the conduit <NUM>, or any other suitable sensor. The suction control apparatus <NUM> may include control circuitry that, responsive to what is sensed by the sensors, may decrease the suction force applied to which ever ones of the first, second, and/or third conduits 312c, 312d, 312e are removing air while maintaining and/or increasing the suction force applied to whichever ones of the first, second, and/or third conduits 312c, 312d, 312e are pulling bodily fluids. The suction control apparatus <NUM> may be a leak prevention features since the suction control apparatus <NUM> may cause more bodily fluids to be removed from the chamber than if the system <NUM> did not include the suction control apparatus <NUM>.

As previously discussed, the conduits discussed with regards to <FIG> are configured to collect bodily fluids from a variety of locations in the chamber. However, the ability of the conduits to remove the bodily fluids are partially obstructed and slowed by the porous material. For example, as previously discussed, the porous material may obstruct flow of the bodily fluids more than unoccupied space. As such, a leak prevention feature that may be used in any of the fluid collection assemblies disclosed herein includes a substantially unoccupied fluid reservoir extending along the conduit to improve fluid flow to the different locations along the conduit. For example, <FIG> is a cross-sectional view of a fluid collection assembly <NUM> that includes a fluid reservoir <NUM> extending along the conduit <NUM>, according to an embodiment. Except as otherwise disclosed herein, the fluid collection assembly <NUM> is the same or substantially similar to any of the fluid collection assemblies disclosed herein. For example, the fluid collection assembly <NUM> is illustrated as being substantially similar to the fluid collection assembly <NUM> and, as such, includes a fluid impermeable barrier <NUM> defining a chamber <NUM>, at least partially porous material <NUM> disclosed in the chamber <NUM>, and at least one conduit <NUM>. However, it is noted that the principles discussed herein are also applicable to the other fluid collection assemblies disclosed herein.

The fluid collection assembly <NUM> includes at least one fluid reservoir <NUM> that is substantially unoccupied. As previously discussed, the fluid reservoir <NUM> extends at least partially along the length of the conduit <NUM>. The fluid reservoir <NUM> may be a leak prevention feature since the fluid reservoir <NUM> may facilitate quick removal of any bodily fluids that are present in the chamber <NUM>. For example, the conduit <NUM> may define a plurality of inlets <NUM> longitudinally spaced from each other, which allows the conduit <NUM> to remove bodily fluids from a plurality of different locations in the chamber <NUM>. At least one of the plurality of inlets <NUM> of the conduit <NUM> may be adjacent to the fluid reservoir <NUM>. The fluid reservoir <NUM> may allow the bodily fluids to quickly and easily flow to the plurality of inlets <NUM>. For instance, the fluid reservoir <NUM> may allow the bodily fluids to accumulate adjacent to at least one of the inlets <NUM> when the individual is in a sitting position. The fluid reservoir <NUM> may then allow the bodily fluids to quickly and easily flow to another one(s) of the inlets <NUM> when the individual moves, such as moves from the sitting position to a standing position. Thus, the fluid reservoir <NUM> allows for the quick removal of bodily fluids from the chamber <NUM>, even when the individual moves.

In the illustrated embodiment, the fluid reservoir <NUM> is defined by and positioned between the fluid impermeable barrier <NUM> and the conduit <NUM>. For example, the fluid impermeable barrier <NUM> may include a bulge <NUM> extending outwardly from the rest of the fluid impermeable barrier <NUM>. The bulge <NUM> may partially define the fluid reservoir <NUM>. In an embodiment, the fluid reservoir <NUM> is defined between at least the porous material <NUM> and the conduit <NUM>, between at least the fluid impermeable barrier <NUM> and the porous material <NUM>, or within the porous material <NUM>.

In an embodiment, the one or more leak prevention features of any of the fluid collection assemblies disclosed herein may include a leak prevention layer that forms a portion of the porous material. The leak prevention layer is configured to encourage flow of the bodily fluids therein in a first direction and discourage flow of the bodily fluids therein in a second direction that is opposite the first direction thereby inhibiting the bodily fluids from leaking from the chamber. <FIG> is a schematic cross-sectional view of a leak prevention layer <NUM>, which is an embodiment of the leak prevention feature which characterizes the present invention. The leak prevention layer <NUM> includes a plurality of sheets <NUM>. The leak prevention layer <NUM> includes at least one first sheet 554a and at least one second sheet 554b positioned downstream from the first sheet 554a. As used with regards to <FIG>, downstream is the direction that the leak prevention layer <NUM> encourages the bodily fluids to flow. The downstream direction extends from the first sheet 554a towards the second sheet 554b and, during operation, generally extends from the urethral opening of the individual towards the chamber. The leak prevention layer <NUM> may also include one or more additional sheets positioned downstream from the second sheet 554b, such as the at least one third sheet 554c illustrated in <FIG>.

Each of the sheets <NUM> define a plurality of void spaces <NUM> extending therethrough. The void spaces <NUM> may include apertures (as shown), a plurality of interconnected pores, etc. The plurality of void spaces <NUM> are configured to control the flow rate of the bodily fluids flowing therethrough. Generally, the void spaces <NUM> are configured such that the flow rate of the bodily fluids increases the further downstream the bodily fluids flow (e.g., with further distance from the first sheet 554a and/or the urethral opening) which encourages the bodily fluids to flow in the downstream direction. The void spaces <NUM> also discourage the bodily fluids flowing in an upstream direction (e.g., a direction opposite the downstream direction) since the flow rate of the bodily fluids flowing in an upstream direction generally decreases. For example, referring to <FIG>, the leak prevention layer <NUM> inhibits leaks because any bodily fluids that are present in the second sheet 554b are more likely to flow to and through the third sheet 554c than the first sheet 554a (ignoring suction forces, wicking and capillary actions, and gravity). In such an example, any bodily fluids that are present in the second sheet 554b are more likely to flow to and through the third sheet 554c than the first sheet 554a since more of the bodily fluids may flow through the third sheet 554c during a given time period than the first sheet 554a.

In an embodiment, the rate at which the bodily fluids flow through each of the sheets <NUM> may depend on the collective cross-sectional area of the void spaces <NUM> (e.g., the sum of the cross-sectional area of each of the void spaces <NUM> along a selected plane). Generally, increasing the collective cross-sectional area of the void spaces <NUM> increases the flow rate of the bodily fluids and decreasing the collective cross-sectional area of the void spaces <NUM> decreases the flow rate of the bodily fluids. As such, the collective cross-sectional area of the void spaces <NUM> generally increases in the downstream direction.

In an embodiment, the collective cross-sectional area of the void spaces <NUM> depends on the number density of void spaces <NUM> that are formed in each of the sheets <NUM> in a selected area. In such an embodiment, the number density of void spaces <NUM> formed in each sheet <NUM> generally increases in the downstream direction. For example, as illustrated, the first sheet 554a may exhibit a first number density of the void spaces <NUM>, the second sheet 554b may exhibit a second number density of void spaces <NUM> that is greater than the first number density, and the third sheet 554c may exhibit a third number density of void spaces <NUM> that is greater than the second number density.

In an embodiment, the collective cross-sectional area of the void spaces <NUM> depends on the average cross-sectional area of each of the void spaces <NUM> that are formed in each of the sheets <NUM> in a selected area. In such an embodiment, the average cross-sectional area of each of the void spaces <NUM> formed in each sheet <NUM> generally increases in the downstream direction. For example, as illustrated, each of the void spaces <NUM> of the first sheet 554a may exhibit a first average cross-sectional area, each of the void spaces <NUM> of the second sheet 554b may exhibit a second average cross-sectional area that is greater than the first average cross-sectional area, and each of the void spaces <NUM> of the third sheet 554c may exhibit a third average cross-sectional area that is greater than the second average cross-sectional area.

In an embodiment, each of the sheets <NUM> are not attached to each other or only selected portions of the sheets <NUM> are attached to each other. In such an embodiment, passageways <NUM> are allowed to form between adjacent sheets <NUM>. For example, as illustrated, the void spaces <NUM> of adjacent sheets <NUM> may not align with each other. Without the passageways <NUM>, the bodily fluid may be unable to flow through void spaces <NUM> that are not aligned with each other, especially if the sheets <NUM> are formed from a fluid impermeable material or a material exhibiting limited fluid permeability. Thus, without the passageways <NUM>, the leak prevention layer <NUM> may be unable to encourage the bodily fluids to flow in the downstream direction.

In an embodiment, the leak prevention layer <NUM> may be formed from wicking materials (e.g., at least one hydrophobic material). In an embodiment, the leak prevent layer <NUM> may be formed from any of the same materials as the fluid permeable membranes or the fluid permeable supports disclosed herein. In an embodiment, the leak prevention layer <NUM> may be formed from non-wicking material, such as at least one non-polyester polymer, at least one hydrophilic material, or any other absorbent or adsorbent material.

<FIG> is a schematic partial cross-sectional view of a portion of a fluid collection assembly 500a that includes at least one leak prevention layer 552a. Except as otherwise disclosed herein, the fluid collection assembly 500a is the same or substantially similar to any of the fluid collection assemblies disclosed herein. For example, the fluid collection assembly 500a may include a fluid impermeable barrier 502a defining an opening 504a and a chamber 506a. The fluid collection assembly 500a may also include at least one porous material 510a.

The porous material 510a includes the leak prevention layer 552a and at least one additional layer 560a. The additional layer 560a may include, for example, a fluid permeable membrane, a fluid permeable support, or an absorption layer. The leak prevention layer 552a extends at least partially across the opening 504a. As such, the leak prevention layer 552a may contact or otherwise be positioned proximate to the a urethral opening of the individual during operation. The additional layer 560a may be positioned downstream from the leak prevention layer 552a and support the leak prevention layer 552a.

<FIG> is a schematic partial cross-sectional view of a portion of a fluid collection assembly 500b that includes at least one leak prevention layer 552b. Except as otherwise disclosed herein, the fluid collection assembly 500b is the same or substantially similar to any of the fluid collection assemblies disclosed herein. For example, the fluid collection assembly 500b may include a fluid impermeable barrier 502b defining an opening 504b and a chamber 506b. The fluid collection assembly 500b may also include at least one porous material 510b.

The porous material 510b includes the leak prevention layer 552b, a fluid permeable membrane <NUM>, and at least one additional layer 560b. The additional layer 560b may include, for example, a fluid permeable support, or an absorption layer. The fluid permeable membrane <NUM> may be selected to be softer or otherwise more comfortable when contacting the vulva of an individual than the leak prevention layer 552b. As such, the fluid permeable membrane <NUM> extends at least partially across the opening 504b thereby preventing the leak prevention layer 552b from contacting the vulva. Instead, the fluid permeable membrane <NUM> may contact or otherwise be positioned proximate to the a urethral opening of the individual during operation. The leak prevention layer <NUM> may be positioned between the fluid permeable membrane <NUM> and the additional layer 560b thereby allowing the additional layer 560b to be positioned downstream from and support the leak prevention layer 552b.

<FIG> is a schematic partial cross-sectional view of a portion of the fluid collection assembly <NUM>. Except as otherwise disclosed herein, the fluid collection assembly <NUM> is the same or substantially similar to any of the fluid collection assemblies disclosed herein. For example, the fluid collection assembly <NUM> may include a fluid impermeable barrier <NUM> defining an opening <NUM> and a chamber <NUM>. The fluid collection assembly <NUM> further includes a porous material <NUM> and a conduit <NUM> disposed in the chamber <NUM>.

The fluid collection assembly <NUM> also includes a fluid reservoir <NUM> that is substantially unoccupied. The conduit <NUM> includes at least one inlet <NUM> (e.g., open terminal end or conduit inlet) that is adjacent to or positioned in the fluid reservoir <NUM>. The conduit <NUM> may not extend all the way into the fluid reservoir <NUM> to prevent the fluid impermeable barrier <NUM> from being suctioned to and completely obstructing the inlet <NUM>. Generally, the conduit <NUM> is only able to remove bodily fluids that accumulate in the fluid reservoir <NUM> once the bodily fluids contact or are adjacent to the inlet <NUM>, otherwise the inlet <NUM> merely pull air into the conduit <NUM>. In other words, the conduit <NUM> may only remove bodily fluids from the fluid reservoir <NUM> when a certain quantity of bodily fluids are present in the fluid reservoir <NUM>. As such, there may be a delay from when the bodily fluids enter the fluid reservoir <NUM> and when the conduit <NUM> begins to remove the bodily fluids from the fluid reservoir <NUM>. Further, bodily fluids may remain in the fluid reservoir <NUM> long after the individual discharges the bodily fluids. The delay in removing the bodily fluids and leaving some bodily fluids in the fluid reservoir <NUM> may increase the likelihood that the fluid collection assembly <NUM> leaks.

The fluid collection assembly <NUM> includes a leak prevention feature that is configured to minimize any delay in removing the bodily fluids and minimize the amount of bodily fluids that remain the fluid reservoir <NUM>. The leak prevention feature includes an additional porous material <NUM> that is partially disposed in at least a portion of an interior <NUM> of conduit <NUM>. The additional porous material <NUM> also extends from the inlet <NUM> into the fluid reservoir <NUM>, such as from the inlet <NUM> to the fluid impermeable barrier <NUM>. During operation, the bodily fluids that enter the fluid reservoir <NUM> contact the addition porous material <NUM> before the bodily fluids contact or are adjacent to the inlet <NUM> of the conduit <NUM>. The additional porous material <NUM> pulls the bodily fluids into the interior <NUM> of the conduit <NUM> via wicking, capillary action, or absorption. The conduit <NUM> may remove the bodily fluids that are pulled into the interior <NUM> of the conduit <NUM>. Thus, the additional porous material <NUM> may decrease the delay between the bodily fluids entering the fluid reservoir and removing the bodily fluids from the fluid reservoir <NUM>. Further, the additional porous material <NUM> may continue to pull the bodily fluids from the fluid reservoir <NUM> even when the individual ceases to discharge bodily fluids into the chamber <NUM>. For example, the additional porous material <NUM> may remove the bodily fluids from the fluid reservoir <NUM> until all or substantially all of the bodily fluids are removed from the fluid reservoir <NUM>. Thus, the additional porous material <NUM> decreases the likelihood that the fluid collection assembly <NUM> leaks the bodily fluids.

In an embodiment, the one or more leak prevention features of any of the fluid collection assemblies disclosed herein include one or more features that are configured to allow the fluid collection assemblies to conform to a shape of a vulva and a region about the vulva. For example, the shape, size, and topography of the vulva and the region about the vulva may vary. These variations may cause gaps to form between the fluid collection assembly and the vulva and the region about the vulva and bodily fluids may leak through these gaps. As such, the leak prevention features may be configured to cause the fluid collection assembly to better conform to the shape, size, and topography of the vulva and the region about the vulva to eliminate or at least minimize any gaps between the fluid collection assembly and the vulva and the region about the vulva. For example, <FIG> is a schematic cross-sectional view of a fluid collection assembly <NUM> that is configured to conform to the vulva and the region about the vulva, according to an embodiment. Except as otherwise disclosed herein, the fluid collection assembly <NUM> may be the same or substantially similar to any of the fluid collection assemblies disclosed herein. For example, the fluid collection assembly <NUM> may include a fluid impermeable barrier <NUM> defining an opening <NUM> and a chamber <NUM>. The fluid collection assembly <NUM> may also include at least one porous material <NUM> and at least one conduit <NUM> disposed in the chamber <NUM>.

The conduit <NUM> exhibits a "crinkle" structure. For example, the conduit <NUM> may include one or more peaks <NUM> (e.g., a plurality of circumferentially extending peaks <NUM> or single helically extending peak <NUM>). The conduit <NUM> may also include one or more valleys <NUM> (e.g., a plurality of circumferentially extending valleys <NUM> or a single helically extending valley <NUM>) disposed between portions of the peaks <NUM> spaced apart along a longitudinal direction of the conduit <NUM>. The conduit <NUM> may be configured to be bent. The peaks <NUM> and valleys <NUM> may allow the conduit <NUM> to more freely bend when an external force is applied thereto and to maintain the bent shape after the external force is removed. The bent shape of the conduit <NUM> also causes the rest of the fluid collection assembly <NUM> to bend. Thus, the conduit <NUM> may allow the fluid collection assembly <NUM> to be conformed to a shape that generally corresponds to the shape of the vulva and the region about the vulva and to maintain said shape thereby inhibiting or preventing leaks.

In an embodiment, the valleys <NUM> remain substantially unoccupied. For example, the porous material <NUM> may not extend into the valleys <NUM> which may prevent the porous material <NUM> from inhibiting the conduit <NUM> from bending or prevent the conduit <NUM> from maintaining the shape thereof after the external force is removed. Also, configuring the porous material <NUM> to not extend into the valleys <NUM> may allow the porous material <NUM> to be formed using an extruding process instead of other more complicated processes. In an embodiment, the valleys <NUM> are occupied by the porous material <NUM>.

<FIG> is a bottom plan view of a fluid collection assembly <NUM> that is configured to conform to the vulva and the region about the vulva. Except as otherwise disclosed herein, the fluid collection assembly <NUM> may be the same or substantially similar to any of the fluid collection assemblies disclosed herein. For example, the fluid collection assembly <NUM> may include a fluid impermeable barrier <NUM> defining a bottom surface <NUM> (e.g., the surface of the fluid impermeable barrier <NUM> opposite the opening defined by the fluid impermeable barrier <NUM>).

The fluid collection assembly <NUM> includes a shape memory material <NUM>. The shape memory material <NUM> may include a shape memory polymer or a metal (e.g., shape memory metal). Suitable shape memory materials are composed to adopt an intermediate or permanent shape in response to a stimuli. The stimuli may include an external physical force (e.g., bending force), heat, electrical bias, or a magnetic field. While the term "shape memory" is used to describe some of the "shape memory materials" herein, it should be understood that, in some examples, the material modified by the term "shape memory" may not necessarily need to return to a preselected shape upon application of a stimuli, as understood as the classical definition of the "shape memory material. " Rather, at least some of the shape memory materials herein may simply hold a selected shape when bent, set, or cured into a specific shape and/or when cooled in a specific shape, regardless of the stimuli applied thereto after. The shape memory materials may be returned to the original shape or changed to a new shape by application of stimuli. For example, a metal wire bent to a first shape may be utilized as the shape memory material, whereinafter the metal wire may be modified to a second shape via physical force applied thereto or via heating. For example, the shape memory material <NUM> may include a shape memory alloy (e.g., nitinol), a shape memory polymer, copper, aluminum, steel, iron, or any other suitable material that is bendable and maintains its shape after being bent. In the illustrated embodiment, the shape memory material <NUM> is a wire exhibiting a general zig-zag shape. The generally zig-zag shape of the shape memory material <NUM> allows the shape memory material <NUM> to change the shape of a greater portion of fluid collection assembly <NUM> than if the shape memory material <NUM> was a generally straight or curved wire while exhibiting a lesser weight than if the shape memory material <NUM> was a plate.

As illustrated, the shape memory material <NUM> may be attached to the bottom surface <NUM> of the fluid impermeable barrier <NUM>. The shape memory material <NUM> may be attached to the bottom surface <NUM> via an adhesive or any other suitable attachment technique. When the shape memory material <NUM> is attached to the bottom surface <NUM>, a coating may be applied to the shape memory material <NUM> to prevent the shape memory material <NUM> from chaffing the individual. In an embodiment, the shape memory material <NUM> may be disposed in the fluid impermeable barrier <NUM> or attached to an inner surface of the fluid impermeable barrier <NUM>. In an embodiment, the shape memory material <NUM> is disposed in or attached to the at least one porous material or the conduit of the fluid collection assembly.

The composition of the shape memory material <NUM> and examples of different shape memory materials that may form a leak prevention feature are disclosed in International Application No. <CIT>.

Some conventional fluid collection assemblies include a conduit exhibiting an outer diameter that is greater than about <NUM> that extends through substantially all of the fluid collection assembly. Such conventional fluid collection assemblies may exhibit a fluid reservoir that may hold about <NUM> milliliters ("ml") to about <NUM> of bodily fluids and may hold about <NUM> of bodily fluids in the chamber before leaking. Some individuals may discharge more than <NUM> of bodily fluids in the first second of urination which may cause the fluid collection assembly to leak, especially if there is any delay in removing the bodily fluids from the chamber. However, it is currently believed by the inventors that the diameter of the conduit may be decreased without decreasing the amount of bodily fluids that are removed from the chamber thereby increasing the amount of bodily fluids that may be held in the chamber. In other words, the one or more leak prevention features of any of the fluid collection assemblies disclosed herein may include using a conduit exhibiting a diameter that is about <NUM> to about <NUM>, such as in ranges of about <NUM> to about <NUM>, about <NUM> to about <NUM>, about <NUM> to about <NUM>, about <NUM> to about <NUM>, about <NUM> to about <NUM>, about <NUM> to about <NUM>, or about <NUM> to about <NUM>. In an example, a fluid collection assembly including a conduit exhibiting an outer diameter of about <NUM> may hold about <NUM>% more bodily fluids before leaking than a substantially similar fluid collection assembly including a conduit exhibiting an outer diameter of about <NUM> (this number inherently depends on the length, diameter, and shape of the fluid collection assembly and the porosity of the porous material). The <NUM>% increase in the amount of bodily fluids that are held in the chamber may be sufficient to prevent the fluid collection assembly from leaking. In an example, a fluid collection assembly including a conduit exhibiting an outer diameter of about <NUM> may hold about <NUM>% more bodily fluids before leaking than a substantially similar fluid collection assembly including a conduit exhibiting an outer diameter of about <NUM>. The <NUM>% increase in the amount of bodily fluids that are held in the chamber may be sufficient to prevent the fluid collection assembly from leaking. In an example, a fluid collection assembly including a conduit exhibiting an outer diameter of about <NUM> may hold about <NUM>% more bodily fluids before leaking than a substantially similar fluid collection assembly including a conduit exhibiting an outer diameter of about <NUM>. The <NUM>% increase in the amount of bodily fluids that are held in the chamber may be sufficient to prevent the fluid collection assembly from leaking.

In an embodiment, the one or more leak prevention features used in any of the fluid collection assemblies disclosed herein may include pre-moistening the at least one porous material before the fluid collection assemblies receive bodily fluids. Pre-moistening the porous material may include moistening the porous material with a non-bodily fluid, such as water, saline, or another suitable liquid. Pre-moistening the porous material may improve flow of the bodily fluids through the porous material. For example, the flow of the bodily fluids through a dry porous material may be slower than the flow of the bodily fluids through a moistened porous material (e.g., a pre-moistened porous material or a previously used porous material).

The fluid collection assemblies shown in <FIG> are examples of female fluid collection assemblies that are configured to collect bodily fluids from females. However, the fluid collection assemblies, systems, and method disclosed herein may include male fluid collection assemblies shaped, sized, and otherwise configured to collection bodily fluids from males (e.g., collect urine from a male urethral opening).

<FIG> is an isometric view of a fluid collection assembly <NUM>. <FIG> is a cross-sectional view of the fluid collection assembly <NUM> of <FIG> taken along the plane B-B of <FIG>. Referring to <FIG> and <FIG>, the fluid collection assembly <NUM> includes a receptacle <NUM> and a sheath <NUM>. The receptacle <NUM> is sized, shaped, and made of a material to be coupled to skin that surrounds the male urethra and have the male urethra positioned therethrough. For example, the receptacle <NUM> may include an annular base <NUM> that defines an opening <NUM> in the receptacle <NUM>. The annular base <NUM> is sized and shaped to be positioned around the male urethra (e.g., positioned around and/or over the penis) and the opening <NUM> may be configured to have the male urethra positioned therethrough. The annular base <NUM> may also be sized, shaped, made of a material, or otherwise configured to be coupled (e.g., adhesively attached, such as with a hydrogel adhesive) to the skin around the male urethral opening (e.g., around the penis). In an example, the annular base <NUM> may exhibit the general shape or contours of the skin surface that the annular base <NUM> is selected to be coupled with. The annular base <NUM> may be flexible thereby allowing the annular base <NUM> to conform to any shape of the skin surface. The annular base <NUM> may include a laterally extending flange <NUM>. The receptacle <NUM> also defines a hollowed region that is configured to receive (e.g., seal against) the sheath <NUM>. For example, the receptacle <NUM> may include a longitudinally extending flange <NUM> that extends upwardly from the annular base <NUM>. The longitudinally extending flange <NUM> may be tall enough to prevent the sheath <NUM> from being accidentally removed from the receptacle <NUM> (e.g., at least <NUM> tall, <NUM> tall, at least <NUM> tall, or at least <NUM> tall). The receptacle <NUM> is located at a proximal region <NUM> (with respect to a wearer) of the fluid collection assembly <NUM>.

The sheath <NUM> includes (e.g., may be formed from) a fluid impermeable barrier <NUM> that is sized and shaped to fit into the hollowed region of the receptacle <NUM>. For example, the sheath <NUM> may be generally tubular or cup-shaped, as shown. The generally tubular or cup-shaped fluid impermeable barrier <NUM> may at least partially define the outer surface <NUM> of the sheath <NUM>. The fluid impermeable barrier <NUM> may be similar or identical to any of the fluid impermeable barriers disclosed herein, in one or more aspects. For example, the fluid impermeable barrier <NUM> may be constructed of any of the materials disclosed herein for the fluid impermeable barrier <NUM>. The fluid impermeable barrier <NUM> at least partially defines the chamber <NUM>. For example, the inner surface <NUM> of the fluid impermeable barrier <NUM> at least partially defines the perimeter of the chamber <NUM>. The chamber <NUM> may be similar or identical to any of the chambers disclosed herein in one or more aspects. For example, the chamber <NUM> may at least temporarily retain bodily fluids therein. As shown, the fluid collection assembly <NUM> may include at least one porous material <NUM> therein. The porous material <NUM> may be similar or identical to any of the porous materials disclosed herein in one or more aspects. For example, the porous material <NUM> may include one or more of a fluid permeable membrane <NUM>, a fluid permeable support <NUM>, an absorbent layer (not shown), or a leak prevention layer (not shown). The fluid impermeable barrier <NUM> may also define an opening <NUM> extending through the fluid impermeable barrier <NUM> that is configured to have a male urethral opening (e.g., penis) positioned therethrough.

The sheath <NUM> and fluid impermeable barrier <NUM> may also include at least one vacuum relief hole <NUM> that allows the chamber <NUM> to remain substantially at atmospheric pressure. The vacuum relief hole <NUM> may be located at any point on the sheath <NUM>, such as near or nearer the opening <NUM>. In some examples (not shown), the vacuum relief hole <NUM> may extend through the cap <NUM> or be disposed beneath the cap <NUM>. In some examples, the fluid collection assembly <NUM> may not include the vacuum relief hole <NUM>, such as when a more complete seal as desired for the chamber <NUM>.

The sheath <NUM> also includes at least a portion of the conduit <NUM> therein, such as at least partially disposed in the chamber <NUM> of the conduit <NUM> only disposed in the fluid outlet <NUM>. For example, the conduit <NUM> may extend from the sheath <NUM> at the distal region <NUM> to a proximal region <NUM> at least proximate to the opening <NUM>. The proximal region <NUM> may be disposed near or on the skin around the male urethral opening (e.g., on the penis or pubic area therearound). Accordingly, when a patient lays on their back, bodily fluids (e.g., urine) may aggregate near the opening <NUM> against the skin of the subject. The bodily fluids may be removed from the chamber <NUM> via the conduit <NUM>.

In some examples, the fluid impermeable barrier <NUM> may be constructed of a material and/or have a thickness that allows the sheath <NUM> to collapse when placed under vacuum, such as to remove air around a penis in the fluid collection assembly <NUM> during use. In such examples, the conduit <NUM> may extend only to or into the distal region <NUM> in the chamber <NUM> (e.g., not through to the area adjacent the opening).

In an example, portions of the chamber <NUM> may be substantially empty due to the varying sizes and rigidity of the male penis. However, in some examples, the outermost regions of the chamber <NUM> (e.g., periphery of the interior regions of the sheath <NUM>) may include porous material <NUM> (e.g., one or more of the fluid permeable membrane <NUM> and fluid permeable support <NUM>). For example, the porous material <NUM> may be bonded to the inner surface <NUM> of the fluid impermeable barrier <NUM>. The porous material <NUM> may be positioned (e.g., at the distal end of the chamber <NUM>) to blunt a stream of urine from the male urethral opening thereby limiting splashing and/or to direct the bodily fluids to a selected region of the chamber <NUM>. Since the chamber <NUM> is substantially empty (e.g., substantially all of the chamber <NUM> forms a reservoir), the bodily fluids are likely to pool at a gravimetrically low point of the chamber <NUM>. The gravimetrically low point of the chamber <NUM> may be at an intersection of the skin of an individual and the fluid collection assembly <NUM>, a corner formed in the sheath <NUM>, or another suitable location depending on the orientation of the wearer.

The porous material <NUM> may include one or more of the fluid permeable membrane <NUM> or the fluid permeable support <NUM>. The fluid permeable membrane <NUM> and the fluid permeable support <NUM> may be similar or identical to any of the fluid permeable membranes or fluid permeable supports as respectively disclosed herein, in one or more aspects such as material make-up or wicking ability. One or more of the fluid permeable membrane <NUM> or the fluid permeable support <NUM> may be disposed between the fluid impermeable barrier <NUM> and a penis inserted into the chamber <NUM>. The fluid permeable membrane <NUM> may be positioned between the fluid impermeable barrier <NUM> and a penis inserted into the chamber <NUM>, such as between the fluid permeable support <NUM> and penis of a wearer as shown. The fluid permeable support <NUM> may be positioned between the fluid permeable membrane <NUM> and the fluid impermeable barrier <NUM>. The inner surface <NUM>, optionally including the end of the chamber <NUM> substantially opposite the opening <NUM>, may be covered with one or both the fluid permeable membrane <NUM> or the fluid permeable support <NUM>. The fluid permeable support <NUM> or the fluid permeable membrane <NUM> may be affixed (e.g., adhered) to the fluid impermeable barrier <NUM>. The fluid permeable support <NUM> or the fluid permeable membrane <NUM> may be affixed to each other. In some examples, the porous material <NUM> only includes the fluid permeable membrane <NUM> or the fluid permeable support <NUM>.

In some examples, the fluid collection assembly <NUM> includes a cap <NUM> at a distal region <NUM>. The cap <NUM> defines an interior channel through which the bodily fluids may be removed from the fluid collection assembly <NUM>. The interior channel is in fluid communication with the chamber <NUM>. The cap <NUM> may be disposed over at least a portion of the distal region <NUM> of one or more of the fluid impermeable barrier <NUM> or the porous material <NUM>. The cap <NUM> may be made of a polymer, rubber, or any other fluid impermeable material. The cap <NUM> may be attached to one or more of the fluid impermeable barrier <NUM>, the porous material <NUM>, or the conduit <NUM>. The cap <NUM> may have a laterally extending flange <NUM> and a longitudinally extending flange <NUM>. The laterally extending flange <NUM> may cover at least a portion of the distal region <NUM> of the fluid collection assembly <NUM>. The longitudinally extending flange <NUM> may laterally extend a distance from the sheath <NUM>. The longitudinally extending flange <NUM> is sized and configured to receive and fluidly seal against the conduit <NUM>, such as within the interior channel. The conduit <NUM> may extend a distance within or through the cap <NUM>, such as to the porous material <NUM>, through the porous material <NUM>, or to a point set-off from the porous material <NUM>. In the latter example, as depicted in <FIG>, the interior channel of the cap <NUM> may define a reservoir <NUM> therein.

The reservoir <NUM> is an unoccupied portion of device such as in the cap <NUM> and is void of other material. In some examples, the reservoir <NUM> is defined at least partially by the porous material <NUM> and the cap <NUM>. During use, the bodily fluids that are in the chamber <NUM> may flow through the porous material <NUM> to the reservoir <NUM>. The reservoir <NUM> may store at least some of the bodily fluids therein and/or position the bodily fluids for removal by the conduit <NUM>. In some examples, at least a portion of the porous material <NUM> may extend continuously between at least a portion of the opening of the interior channel and chamber <NUM> to move any bodily fluid from the opening directly to the reservoir <NUM>.

In some examples (not shown), the fluid impermeable barrier <NUM> may be disposed on or over the cap <NUM>, such as enclosing the cap <NUM> within the chamber <NUM>.

In some examples, the sheath <NUM> may include at least a portion of the conduit <NUM> therein, such as at least partially disposed in the chamber <NUM>. For example, the conduit <NUM> may extend from the sheath <NUM> to a region at least proximate to the opening <NUM>. The inlet of the conduit <NUM> may be positioned adjacent to the annular base <NUM>. The inlet of the conduit <NUM> may be positioned to be adjacent or proximate to the gravimetrically low point of the chamber <NUM>, such as adjacent to the annular base <NUM>. For example, the inlet may be co-extensive with or offset from the opening <NUM>. In examples, the inlet may be positioned adjacent to the distal region <NUM> of the sheath <NUM>.

The proximal region <NUM> may be disposed near or on the skin around the male urethral opening (e.g., around the penis) and the inlet of the conduit <NUM> may be positioned in the proximal region <NUM>. The outlet of the conduit <NUM> may be directly or indirectly coupled to a vacuum source. Accordingly, the bodily fluids may be removed from the proximal region <NUM> of the chamber <NUM> via the conduit <NUM>.

The receptacle <NUM>, the sheath <NUM>, the cap <NUM>, and the conduit <NUM> may be attached together using any suitable method. For example, at least two of the receptacle <NUM>, the sheath <NUM>, the cap <NUM>, or the conduit <NUM> may be attached together using at least one of an interference fit, an adhesive, stitching, welding (e.g., ultrasonic welding), tape, any other suitable method, or combinations thereof.

In some examples (not shown), the fluid collection assembly <NUM> may have a one piece design, with one or more of the sheath <NUM>, the receptacle <NUM>, and the cap <NUM> being a single, integrally formed piece.

Also as shown, the conduit <NUM> may be at least partially disposed with the chamber <NUM> of a fluid collection assembly <NUM>. The conduit <NUM> may extend from the distal region <NUM> to the proximal region <NUM>. For example, the conduit <NUM> may extend through the cap <NUM> to a point adjacent to the receptacle <NUM>. The conduit <NUM> is sized and positioned to be coupled to a fluid storage container or the vacuum source (<FIG>. An outlet of the conduit <NUM> may be operably coupled to the vacuum source, directly or indirectly. The inlet <NUM> (e.g., open terminal end) of the conduit <NUM> may be positioned within or adjacent to the chamber <NUM> such as at a location expected to be at the gravimetrically low point of the fluid collection assembly <NUM> during use. By positioning the inlet <NUM> in a location expected to be at the gravimetrically low point of the fluid collection assembly <NUM> when worn by the user, the bodily fluids introduced into the chamber <NUM> may be removed via the conduit <NUM> to prevent pooling or stagnation of the fluid within the chamber <NUM>.

The fluid collection assembly <NUM> includes any of the leak prevention features disclosed herein. Specifically, as shown, the one or more leak prevent features of the fluid collection assembly <NUM> may include the porous material <NUM> having least one additional layer <NUM>. The additional layer <NUM> may be an absorbent layer similar to the absorbent layer <NUM> of <FIG> or a leak prevention layer similar to the leak prevention layer <NUM> of <FIG>. In an example, the one or more leak prevent features of the fluid collection assembly <NUM> may include the chamber <NUM> completely filled with porous material <NUM> (except for the portion configured to receive the male penis) such that the chamber <NUM> does not include a fluid reservoir. In an example, the one or more leak prevent features of the fluid collection assembly <NUM> may include the conduit <NUM> at least partially occupied with an additional porous material and, optionally, the additional porous material may extend from the conduit <NUM> into the fluid reservoir <NUM>. In an example, the one or more leak prevent features of the fluid collection assembly <NUM> may include the conduit <NUM> exhibiting a "crinkle" structure or the fluid collection assembly <NUM> including at least one shape memory material.

Further examples of fluid collection assemblies that are configured to collect bodily fluids from males are disclosed in <CIT>.

In some examples, the vacuum source may be remotely located from the fluid collection assembly <NUM>. In such examples, the conduit <NUM> may be fluidly connected to the fluid storage container, which may be disposed between the vacuum source and the fluid collection assembly <NUM>.

During operation, a male using the fluid collection assembly <NUM> may discharge bodily fluids into the chamber <NUM>. The bodily fluids may pool or otherwise be collected in the chamber <NUM>. At least some of the bodily fluids may be pulled through the interior of the conduit <NUM> via the inlet. The bodily fluids may be drawn out of the fluid collection assembly <NUM> via the vacuum/suction provided by the vacuum source. During operation, the aperture <NUM> may substantially maintain the pressure in the chamber <NUM> at atmospheric pressure even though the bodily fluids are introduced into and subsequently removed from the chamber <NUM>.

<FIG> is a block diagram of a system <NUM> for fluid collection. The system <NUM> includes a fluid collection assembly <NUM>, a fluid storage container <NUM>, and a vacuum source <NUM>. The fluid collection assembly <NUM>, the fluid storage container <NUM>, and the vacuum source <NUM> may be fluidly coupled to each other via one or more conduits <NUM>. For example, fluid collection assembly <NUM> may be operably coupled to one or more of the fluid storage container <NUM> or the vacuum source <NUM> via the conduit <NUM>. The bodily fluids collected in the fluid collection assembly <NUM> may be removed from the fluid collection assembly <NUM> via the conduit <NUM> which protrudes into the fluid collection assembly <NUM>. For example, an inlet of the conduit <NUM> may extend into the fluid collection assembly <NUM>, such as to a reservoir therein. The outlet of the conduit <NUM> may extend into the fluid collection assembly <NUM> or the vacuum source <NUM>. Suction force may be introduced into the chamber of the fluid collection assembly <NUM> via the inlet of the conduit <NUM> responsive to suction (e.g., vacuum) force applied at the outlet of the conduit <NUM>.

The suction force may be applied to the outlet of the conduit <NUM> by the vacuum source <NUM> either directly or indirectly. The suction force may be applied indirectly via the fluid storage container <NUM>. For example, the outlet of the conduit <NUM> may be disposed within the fluid storage container <NUM> and an additional conduit <NUM> may extend from the fluid storage container <NUM> to the vacuum source <NUM>. Accordingly, the vacuum source <NUM> may apply suction to the fluid collection assembly <NUM> via the fluid storage container <NUM>. The suction force may be applied directly via the vacuum source <NUM>. For example, the outlet of the conduit <NUM> may be disposed within the vacuum source <NUM>. An additional conduit <NUM> may extend from the vacuum source <NUM> to a point outside of the fluid collection assembly <NUM>, such as to the fluid storage container <NUM>. In such examples, the vacuum source <NUM> may be disposed between the fluid collection assembly <NUM> and the fluid storage container <NUM>.

The fluid collection assemblies <NUM> may be similar or identical to any of the fluid collection assemblies disclosed herein. The fluid collection assembly <NUM> may be shaped and sized to be positioned adjacent to a female urethral opening or have a male urethral opneing positioned therethrough (e.g., receive a penis therein). For example, the fluid collection assembly <NUM> may include a fluid impermeable barrier at least partially defining a chamber (e.g., interior region) of the fluid collection assembly <NUM>. The fluid impermeable barrier also defines an opening extending therethrough from the external environment. The opening may be positioned adjacent to a female urethral opening or have a male urethral opening positioned therethrough. The fluid collection assembly <NUM> may include a fluid permeable membrane disposed within the fluid impermeable barrier. The fluid collection assembly <NUM> may include at least one porous material disposed in the chamber such as one or more of a fluid permeable support and a fluid permeable membrane. The fluid collection assembly <NUM> includes the shape memory material on or incorporated in one or more components thereof. The shape memory material is sized, shaped, and positioned to retain a selected geometric configuration as disclosed herein. The conduit <NUM> may extend into the fluid collection assembly <NUM> at a first end (e.g., proximal) region, through one or more of the fluid impermeable barrier, fluid permeable membrane, or the fluid permeable support to a second end (e.g., distal) region of the fluid collection assembly <NUM>. The conduit <NUM> includes an inlet and an outlet, the outlet being fluidly coupled to the fluid storage container and the inlet being positioned in a portion of the chamber selected to be at a gravimetrically low point of the fluid collection assembly <NUM> when worn.

The fluid storage container <NUM> is sized and shaped to retain the bodily fluids therein. The fluid storage container <NUM> 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 <NUM> may extend from the fluid collection assembly <NUM> and attach to the fluid storage container <NUM> at a first point therein. An additional conduit <NUM> may attach to the fluid storage container <NUM> at a second point thereon and may extend and attach to the vacuum source <NUM>. Accordingly, a vacuum (e.g., suction) may be drawn through fluid collection assembly <NUM> via the fluid storage container <NUM>. The bodily fluids, such as urine, may be drained from the fluid collection assembly <NUM> using the vacuum source <NUM>.

The vacuum source <NUM> 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 <NUM> may provide a vacuum or suction to remove the bodily fluids from the fluid collection assembly <NUM>. In some examples, the vacuum source <NUM> 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 <NUM> may be sized and shaped to fit outside of, on, or within the fluid collection assembly <NUM>. For example, the vacuum source <NUM> may include one or more miniaturized pumps or one or more micro pumps. The vacuum sources <NUM> 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 <NUM>.

Claim 1:
A fluid collection assembly (<NUM>) for capturing one or more bodily fluids from an individual, comprising:
a fluid impermeable barrier (<NUM>) defining:
at least one opening (<NUM>);
a chamber (<NUM>) in fluid communication with the at least one opening; and
at least one fluid outlet (<NUM>);
at least one porous material (<NUM>) disposed in the chamber;
at least one conduit (<NUM>) attached to the at least one fluid outlet; and
at least one leak prevention feature configured to at least inhibit bodily fluids leaking from the chamber; and wherein:
the leak prevention feature includes a leak prevention layer (<NUM>) that forms a portion of the porous material, the leak prevention layer including a plurality of sheets (<NUM>) including at least one first sheet (554a) and at least one second sheet (554b) positioned downstream from the first sheet, each of the said sheets defining a plurality of void spaces (<NUM>) extending therethrough, characterised by
the collective cross-sectional area of the void spaces increasing in the downstream direction.