Patent ID: 12251333

DETAILED DESCRIPTION

Embodiments disclosed herein are directed to fluid collection assemblies that include at least one inflation device, methods for using the same, and systems including the same. An example fluid collection assembly includes a fluid impermeable barrier defining at least one opening, a chamber, and at least one fluid outlet. The fluid collection assembly also includes at least one porous material disposed in the chamber. As previously discussed, the fluid collection assembly further includes at least one inflation device. The inflation device includes bladder having one or more walls defining an interior region. The inflation device also includes at least one valve configured to selectively permit fluid flow into and out of the interior region to switch the bladder between a first state (e.g., a deflated and/or initial state) and a second state (e.g., an at least partially inflated state). The inflation device may at least one of controllably change the length of the fluid collection assembly to accommodate different sized vulvas or controllably change the width (e.g., maximum width) of at least a portion of the fluid collection assembly to more comfortably fit the fluid collection assembly within the labia folds of an individual using the fluid collection assembly.

The fluid collection assembly is configured to be positioned about, around, or at least partially within the vulva (e.g., labia majora, labia minora, clitoris, urethral opening, vaginal opening, etc.) of an individual. For example, the fluid collection assembly may be at least partially positioned within or between the labia folds. The fluid collection assembly may also be positioned adjacent to the mons pubis, the perineum, buttocks, and the inner thighs of the individual.

The inflation devices of the fluid collection assemblies disclosed herein allows the fluid collection assemblies to change a size thereof. The ability of the fluid collection assemblies to change a size thereof allows such fluid collection assemblies to be used with a variety of individuals exhibiting different sized anatomy. In particular, the fluid collection assemblies including the at least one inflation device may be used with individuals exhibiting different lengths of vulvas and/or different sizes of labia folds. As used herein, the sizes of the labia folds may refer to the length of one or all of the labia folds, the width of one or all of the labia folds, the thickness of one or all of the labia folds, or, more preferably, the space between two or more of the labia folds in which the fluid collection assembly may be disposed.

Some conventional fluid collection assemblies are unable to change a size thereof which restricts the ability of such conventional fluid collection assemblies to be used effectively with individuals exhibiting different sized anatomies. For example, such conventional fluid collection assemblies may only be used with individuals exhibiting certain sized anatomy. Using such conventional fluid collection assemblies with anatomy that is bigger or smaller than the conventional fluid collection assembly is configured to be used with may result in gaps between the conventional fluid collection assemblies and the vulva. The gaps may allow bodily fluids to leak from the conventional fluid collection assemblies and allow air to enter the chamber of such conventional fluid collection assemblies thereby decreasing the ability of a vacuum pressure to remove bodily fluids from the chamber. Further, such conventional fluid collection assemblies may be uncomfortable to use.

As previously discussed, the inflation devices of the fluid collection assemblies disclosed herein allow the fluid collection assemblies to change a size thereof such that the fluid collection assemblies may be used with different sized anatomy. In an example, the inflation device of the fluid collection assembly may be configured to change a length of the fluid collection assembly. In such an example, the inflation device may be inflated (e.g., at least one inflation fluid may be provided to the inflation device) or deflated (e.g., the inflation fluid may be removed from the inflation device) when the length of the vulva of an individual is greater or less than, respectively, than the length of vulva that the fluid collection assembly is configured to be used with. The ability of the inflation device to increase or decrease the overall length of the fluid collection assembly depending on the length of the vulva of the individual prevents the formation of gaps between the fluid collection assembly and the vulva through which bodily fluids and air may flow. The ability of the inflation device to increase or decrease the overall length of the fluid collection assembly depending on the length of the vulva of the individual may also make the fluid collection assembly more comfortable to use. In an example, the inflation device of the fluid collection assembly may be configured to change a maximum width of the fluid collection assembly. In such an example, the inflation device may be inflated or deflated when the size of the labia folds in which the fluid collection assembly is positioned is greater than or less than the size the labia folds in which the fluid collection assembly is configured to be used with. As such, changing the maximum width of the fluid collection assembly may decrease gaps between the fluid collection assembly and the labia folds and may allow the fluid collection assembly to be positioned closer to the urethral opening of the individual. Further, changing the maximum width of the fluid collection assembly depending on the size of the labia folds allows the fluid collection assembly to be at least partially positioned between the labia folds while maximizing comfort.

It is noted that some conventional fluid collection assemblies may include inflation devices that are configured to be increase the overall width of such conventional fluid collection assemblies such that the conventional fluid collection assemblies contact the thighs of the individual. However, unlike the fluid collection assemblies disclosed herein, such inflation device are not configured to predominately contact and be positioned between the labia folds of the individual since the increase in the width of the fluid collection assemblies required to contact the thighs would make it impossible or uncomfortable to position such a fluid collection assembly between the labia folds.

FIG.1Ais an isometric view of a fluid collection assembly100configured to be used to collect bodily fluids from a female urethral opening, according to an embodiment.FIGS.1B and1Care schematic cross-sectional views of the fluid collection assembly100taken along plane1B-1B when a bladder114of the fluid collection assembly100is in a first state and in a second state, respectively. The fluid collection assembly100includes a fluid impermeable barrier102includes a proximal region end103and a distal end region105opposite the proximal end region103. The fluid impermeable barrier defines at least one opening104, a chamber106, and at least one fluid outlet108. The fluid outlet108may be located at the proximal region end103. The fluid collection assembly100also includes at least one porous material110disposed chamber106. The fluid collection assembly100further includes at least one inflation device112configured to change a length of the fluid collection assembly100. The length of the fluid collection assembly100is measured parallel to a longitudinal axis111of the fluid collection assembly100.

The inflation device112includes a bladder114. The bladder114includes one or more walls116defining an interior region118. The inflation device112also includes at least one valve120in fluid communication with the interior region118. The valve120is configured to selectively permit flow of at least one inflation fluid into and/or out the interior region118. For example, the valve120may allow the inflation fluid to enter the interior region118when it is desirable to at least one of increase the length of the bladder114which, in turn, increases the length of the fluid collection assembly100. The valve120may also enable removing the inflation fluid from the interior region118when it is desirable to decrease the length (e.g., return to the initial length) of the of the fluid collection assembly100.

Disposing or removing the inflation fluid into and from the interior region118changes the state of the bladder114. The bladder114may exhibit at least a first state and a second state. The amount (volume or weight) of inflation fluid present in the interior region118is greater when the bladder114is in the second state than when the bladder114is in the first state. In an example, as shown inFIG.1B, the bladder114is in the first state when the bladder114is in a deflated state (e.g., there are no or substantially no fluids in the interior region118). However, it is noted that the bladder114may be in the first state when some inflation fluid is present in the interior region118. It is noted that the bladder114is illustrated inFIG.1Bas being slightly inflated to facilitate labeling of the interior region118. The first state of the bladder114also generally corresponds to an initial state of the bladder114(i.e., generally, the bladder114is not provided with the inflation fluid) though, in some examples, the first state of the bladder114may not correspond to the initial state of the bladder114(e.g., the bladder114is provided with fluids). In an example, as shown inFIG.1C, the bladder114is in the second state when the bladder114is in an at least partially inflated state. The bladder114is generally not in the initial state when the bladder114is in the second state though, in some examples, the initial state and the second state of the bladder114are the same (e.g., the bladder114is provided with fluids).

The bladder114may exhibit one or more additional states (e.g., third state, fourth state, and so forth) besides the first and second states discussed above. In an embodiment, the one or more additional states may include less of the inflation fluid in the interior region118(e.g., is more deflated) than the first state (e.g., the first state is a partially inflated state). In such an embodiment, the one or more additional states may include a deflated or partially deflated state and may be formed by removing the inflation fluid from the interior region118when the bladder114is in the first or second state. In an embodiment, the one or more additional states may include more of the inflation fluid in the interior region118(e.g., is more inflated) than the first state (e.g., the first state is a deflated or partially inflated state) and include less of the inflation fluid in the interior region118than the second state. In such an embodiment, the one or more additional states include a partially inflated state and may be formed by adding the inflation fluid to or removing the inflation fluid from the interior region118when the bladder114is in the first state or second state, respectively. In an embodiment, the one or more additional states may include more of the inflation fluid in the interior region118than the second state (e.g., the second state is a partially inflated state). In such an embodiment, the one or more additional states may be an at least partially inflated state and may be formed by adding the inflation fluid to the interior region118when the bladder114is in the first state or second state. It is noted that, in some embodiments, the bladder114may only include the first and second states.

As shown inFIGS.1B and1C, switching the bladder114from the first state to the second state (or any of the other states thereof) changes the shape of the bladder114and/or increases a distance that a portion of the bladder114extends from the fluid impermeable barrier102thereby changing the length of the fluid collection assembly100. For example, referring toFIG.1B, the fluid collection assembly100may exhibit a shape that generally conforms to the shape of the portion of the fluid impermeable barrier102to which the bladder114is attached when the bladder114is in the first state. The fluid collection assembly100may exhibit a first length L1when the bladder114is in the first state. Switching the bladder114to the second state changes the shape of the fluid collection assembly100, as shown inFIG.1C, to a shape that does not conform to the shape of the fluid impermeable barrier102to which the bladder114is attached. Further, switching the bladder114from the first state to the second state increases the distance that a portion of the bladder114extends from the fluid impermeable barrier102thereby increasing the length of the fluid collection assembly100. For instance, switching the bladder114from the first state to the second state increases the length of the fluid collection assembly100to the second length L2which is greater than the first length L1. The increased length of the fluid collection assembly100may allow the fluid collection assembly100to be used with longer vulvas without forming gaps between the fluid collection assembly100and the vulva through which bodily fluids and air may flow. It is noted that the inflation fluid may be removed from the interior region118using the valve120, for example, when too much of the inflation fluid is added to the interior region118which may at least one of increase the risk that the bladder114ruptures, make the fluid collection assembly100more uncomfortable, or increase the likelihood that the fluid collection assembly100leaks bodily fluids since the fluid collection assembly100exhibits a length that is too great for the vulva.

The walls116are formed from a material is substantially impermeable to the inflation fluid (e.g., substantially impermeable to a gas and/or a liquid) which allows the bladder114to retain the inflation fluid without embarrassing leaks. The walls116may also be formed from a flexible material. The flexible material of the walls116allows the bladder114and, by extension, the fluid collection assembly100to at least one of increase in size or change a shape thereof. For example, the flexible material of the walls116allow the interior region118to increase a volume thereof when the interior region118receives an inflation fluid and decrease a volume thereof when the inflation fluid is removed from the interior region118. Examples of materials that may form the walls116of the bladder114include silicone, rubber, latex, polychloroprene, nylon fabric, polypropylene, polyvinyl chloride, nitrile rubber, other suitable polymers, a metal foil, a composite, or combinations thereof. In an embodiment, the walls116are configured to stretch (e.g., elastically or plastically stretch) so the walls116remain taut when the bladder114is at least partially inflated. In an embodiment, the wall116forms a plurality of wrinkles when the bladder114is at least partially deflated and adding inflation fluid into the interior region118decreases the wrinkles, similar to an accordion.

The bladder114of the inflation device112and, in particular, the walls116of the bladder114may exhibit any suitable shape. In an embodiment, as previously discussed, the bladder114may exhibit a shape that generally corresponds to the shape of the region of the fluid impermeable barrier102that the bladder114is adjacent to when the bladder114is in the deflated state. In such an embodiment, the bladder114may exhibit a shape that is different than the region of the fluid impermeable barrier102that the bladder114is adjacent to when the bladder114is in at least partially inflated state. In an embodiment, the fluid collection assembly100may include a bladder114adjacent to the proximal region end103of the fluid impermeable barrier102. In such an embodiment, the bladder114may exhibit a generally annular shape, a generally C-shape, or another suitable shape (e.g., a shape defining a hole) which allows the bladder114to not obstruct the fluid outlet108.

The valve120may include any suitable valve configured to allow for the controllable addition and remove of the inflation fluid from the interior region118. In an embodiment, the valve120is a luer valve and includes a male-tapper fitting or a female-taper fitting. In an embodiment, the valve120includes a fluid impermeable membrane with a slit or opening formed. The slit or opening of the fluid impermeable membrane remains substantially closed when no external load is applied thereto but opens when an external load is applied thereto (e.g., an external load caused by pressing a syringe against the fluid impermeable membrane). In an embodiment, the valve120may include a mechanical valve, such as a ball valve, a butterfly valve, or any other suitable mechanical valve. The mechanical valve may be manually operated or controlled using a computer. In an embodiment, the valve120may include a check valve to limit leaks from the bladder114and to make the fluid collection assembly100easier to use. In such an embodiment, the valve120may only add or remove (but not both) inflation fluid from the interior region118and, as such, the fluid collection assembly100is configured for single use.

In an embodiment, the valve120extends from or near the proximal region end103, the distal end region105, or a back side122of the fluid impermeable barrier102. The back side122of the fluid impermeable barrier102is the side of the fluid impermeable barrier102that is generally opposite the opening104. The valve120at or near the proximal region end103, the distal end region105, or a back side122may allow a user of the fluid collection assembly100(e.g., medical practitioner, nurse, or the individual using the fluid collection assembly100) to access the valve120when the fluid collection assembly100is adjacent to the vulva since, generally, the inner thighs of the individual may contact or obstruct the surfaces of the fluid impermeable barrier102except the proximal region end103, the distal end region105, or a back side122. Further, the valve120at or near the proximal region end103, the distal end region105, or a back side122prevents the valve120from pressing against the inner thighs during use which may cause discomfort.

In an embodiment, the fluid collection assembly100may only include a single inflation device112(e.g., a single bladder114and/or a single valve120). For example, the fluid collection assembly100may only include the inflation device112at the proximal region end103or distal end region105. In an embodiment, the fluid collection assembly100may include a plurality of inflation device112(e.g., a plurality of bladders114) and/or a plurality of valves120. For example, as illustrated, the fluid collection assembly100may include two inflation devices112. One of the inflation device112may be attached to or otherwise proximate to the proximal region end103of the fluid impermeable barrier102and the other inflation device112may be attached to or otherwise proximate to the distal end region105of the fluid impermeable barrier102. The two inflation devices112attached to the proximal and distal end regions103,105allow the length of the fluid collection assembly100to increase from either or both of the proximal or distal end regions103,105thereof. Increasing the length of the fluid collection assembly100from one or both of the proximal or distal end regions103,105allows better control over the position of the fluid collection assembly100such that the opening104is adjacent to the urethral opening of the individual and allows for the fluid collection assembly to better fit the vulva. Each inflation device112(e.g. each bladder114) may include one or more valves120to allow for independent inflation of the bladders114which allows for better control of the shape and size of the fluid collection assembly100. However, the fluid collection assembly100may only include a single valve120for two or more bladders114when the two or more bladders114are fluidly coupled together using one or more tubes extending therebetween. In some examples, a single bladder114may include a plurality of valves120, for instance, to increase the likelihood that one valve120is easily accessible.

The inflation device112may include additional components other than the components discussed above. For example, the inflation device112may include less flexible material (e.g., rigid material or material that is less flexible than the walls116) that are used to control the shape of the bladder114when the bladder114is inflated (e.g., switched from the first state to the second state). The less flexible material may form parts of the walls116, wrap around the walls116, or extend in the interior region118between opposing portions of the walls116which limits expansion of the walls116at and near the less flexible material.

The at least one inflation fluid added or removed from the interior region118may include any suitable fluid, such as any suitable liquid or any suitable gas. In an embodiment, the inflation fluid is formed from at least one generally regarded as safe (“GRAS”) material. Forming the inflation fluid from a GRAS material may decrease health risks caused by inadvertently exposing the individual to the inflation fluid. Examples of GRAS materials that may form the inflation fluid includes water, saline solution, alcohol solution, atmospheric air, nitrogen, or combinations thereof.

As previously discussed, the fluid collection assembly100includes a fluid impermeable barrier102. In an embodiment, as shown, the fluid impermeable barrier102forms at least a portion of the inflation device112since the fluid impermeable barrier102defines a portion of the interior region118. In such an embodiment, the walls116of the bladder114are attached to the fluid impermeable barrier102in a substantially fluid tight manner to prevent the inflation fluid leaking from the interior region118. In an embodiment, the bladder114is distinct from the fluid impermeable barrier102(e.g., the fluid impermeable barrier102does not partially define the interior region118). In such an embodiment, the wall116of the bladder114may be attached to the fluid impermeable barrier102. In an embodiment, the bladder114is spaced from the fluid impermeable barrier102, such as when the bladder114is disposed within the chamber106. Examples of other locations of the bladder114relative to the fluid impermeable barrier102are disclosed in U.S. Provisional Patent Application No. 63/030,685 filed on May 27, 2020, the disclosure of which is incorporated herein, in its entirety, by this reference.

The fluid impermeable barrier102may be formed of any suitable fluid imporous 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. The fluid impermeable barrier102substantially prevents the bodily fluids from passing through the fluid impermeable barrier102. In an example, the fluid impermeable barrier102may be air permeable and fluid impermeable. In such an example, the fluid impermeable barrier102may be formed of a hydrophobic material that defines a plurality of pores. At least a surface of the fluid impermeable barrier102that may contact the individual may be formed from a soft and/or smooth material (e.g., silicone), thereby reducing chaffing. In an embodiment, the fluid impermeable barrier102may be formed from a flexible material, such as silicone, which allows the fluid impermeable barrier102to be bent into a shape that conforms the anatomy of the individual. Further, as shown inFIGS.1B and1C, forming the fluid impermeable barrier102from a flexible material allows the fluid impermeable barrier102to accommodate the shape and/or size changes by switching the fluid collection assembly100and the bladder114between states.

In some examples, the fluid impermeable barrier102may be tubular (ignoring the opening), such as substantially cylindrical (as shown), oblong, prismatic, or flattened tubes when the bladder114is in the first state and/or the second state. During use, the outer surface124of the fluid impermeable barrier102may contact the individual. The fluid impermeable barrier102may be sized and shaped to fit in the gluteal cleft between the legs of a female user when the bladder114are in at least the second state.

The opening104provides an ingress route for fluids to enter the chamber106. The opening104may be defined by the fluid impermeable barrier102such as by an inner edge of the fluid impermeable barrier102. For example, the opening104is formed in and extends through the fluid impermeable barrier102, from the outer surface124to the inner surface126, thereby enabling fluid(s) to enter the chamber106from outside of the fluid collection assembly100. The opening104may be an elongated hole in the fluid impermeable barrier102. For example, the opening104may be defined as a cut-out in the fluid impermeable barrier102. The opening104may be located and shaped to be positioned adjacent to a female urethra.

The fluid collection assembly100may be positioned proximate to the female urethral opening and urine may enter the chamber of the fluid collection assembly100via the opening104. The fluid collection assembly100is configured to receive the bodily fluids into the chamber106via the opening104. When in use, the opening104may have an elongated shape that extends from a first location below the urethral opening (e.g., at or near the anus or the vaginal opening) to a second location above the urethral opening (e.g., at or near the top of the vaginal opening or the pubic hair).

The opening104may 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 fluid(s) along a path that corresponds to the elongated shape of the opening104(e.g., longitudinally extending opening). The opening104in the fluid impermeable barrier102may exhibit a length measured along the longitudinal axis111of the fluid collection assembly100that may be at least about 10% of the length of the fluid collection assembly100, such as about 25% to about 50%, about 40% to about 60%, about 50% to about 75%, about 65% to about 85%, or about 75% to about 95% of the length of the fluid collection assembly100.

The opening104in the fluid impermeable barrier102may exhibit a width measured transverse to the longitudinal axis111of the fluid collection assembly100that may be, when the fluid collection assembly100and the bladder114are in the first state, at least about 10% of the circumference of the fluid collection assembly100, such as about 25% to about 50%, about 40% to about 60%, about 50% to about 75%, about 65% to about 85%, or about 75% to about 100% of the circumference of the fluid collection assembly100. The opening104may exhibit a width that is greater than 50% of the circumference of the fluid collection assembly100since the vacuum (e.g., suction) through the conduit128pulls the fluid through the porous material110and into the conduit128. As shown inFIGS.1B and1C, switching the bladder114from the first state to the second state increases the width of the opening104. The increased width of the opening104may allow the opening104to receive more bodily fluids than if the opening104did not exhibit the increased width.

In some examples, the opening104may be vertically oriented (e.g., having a major axis parallel to the longitudinal axis111of the fluid collection assembly100). In some examples (not shown), the opening104may be horizontally oriented (e.g., having a major axis perpendicular to the longitudinal axis111of the fluid collection assembly100). In an example, the fluid impermeable barrier102may be configured to be attached to the individual, such as adhesively attached (e.g., with a hydrogel adhesive) to the individual. According to an example, a suitable adhesive is a hydrogel layer.

As previously discussed, the fluid impermeable barrier102may define fluid outlet108configured to remove bodily fluids from the chamber106. The fluid outlet108is distinct from the opening104and the valve120. In some examples, the fluid outlet108is sized to receive the conduit128. The conduit128may be disposed in the chamber106via the fluid outlet108. The fluid outlet108may be sized and shaped to form an at least substantially fluid tight seal against the conduit128or the at least one tube substantially preventing the bodily fluids from escaping the chamber106.

The fluid impermeable barrier102may include markings thereon, such as one or more markings to aid a user in aligning the fluid collection assembly100on the individual. For example, a line on the fluid impermeable barrier102(e.g., opposite the opening104) may allow a healthcare professional to align the opening104over the urethral opening of the individual. 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 assembly100to one or more anatomical features such as a pubic bone, etc.

As previously discussed, the fluid collection assembly100includes porous material110disposed in the chamber106. The porous material110may cover at least a portion (e.g., all) of the opening104. The porous material110is exposed to the environment outside of the chamber106through the opening104. 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 material110may also wick the bodily fluids generally towards an interior of the chamber106, as discussed in more detail below. The porous material110may include one or more of a fluid permeable membrane130or a fluid permeable support132.

In an embodiment, at least a portion of the porous material110may be a wicking material configured to wick and/or allow flow of the bodily fluids away from the opening104, thereby preventing bodily fluids from escaping the chamber106. 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 about 10 wt % of the dry weight of the wicking material, about 7 wt %, about 5 wt %, about 3 wt %, about 2 wt %, about 1 wt %, or about 0.5 wt % of the dry weight of the wicking material.

The fluid collection assembly100may include the fluid permeable membrane130disposed in the chamber106. The fluid permeable membrane130may cover at least a portion (e.g., all) of the opening104. The fluid permeable membrane130may be composed to pull/push the bodily fluids away from the opening104, thereby promoting fluid flow into the chamber106, prevent fluid remaining on the vulva of the individual, and preventing the bodily fluids from escaping the chamber106.

The fluid permeable membrane130may include any material that may be permeable to the bodily fluids. For example, the fluid permeable membrane130may 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 membrane130from gauze, soft fabric, and/or smooth fabric may reduce chaffing caused by the fluid collection assembly100and makes wearing the fluid collection assembly more comfortable. In an embodiment, the fluid permeable membrane130is formed from a flexible material, such as gauze, since the shape and/or size of the fluid permeable membrane130may change when the fluid collection assembly100and the bladder114switch between states, as shown inFIGS.1B and1C. In an embodiment, the fluid permeable membrane130may define a plurality of perforations or may be continuous (e.g., does not define perforations). In an embodiment, the fluid permeable membrane130defines at least one hole that is configured to allow the valve120to extend through the fluid permeable membrane130.

The fluid collection assembly100may include the fluid permeable support132disposed in the chamber106. The fluid permeable support132is configured to support the fluid permeable membrane130and maintain the shape of the chamber106since the fluid impermeable barrier102and the fluid permeable membrane130may be formed from a relatively foldable, flimsy, or otherwise easily deformable material. For example, the fluid permeable support132may be positioned so the fluid permeable membrane130is disposed between the fluid permeable support132and the fluid impermeable barrier102. The fluid permeable support132may support and maintain the position of the fluid permeable membrane130and the shape of the chamber106. The fluid permeable support132may include any material that may be permeable to the bodily fluids, such as any of the fluid permeable membrane130materials disclosed above. For example, the fluid permeable membrane130material(s) may be utilized in a more dense or rigid form than in the fluid permeable membrane130when used as the fluid permeable support132. The fluid permeable support132may be formed from any fluid porous material that is less deformable than the fluid permeable membrane130. For example, the fluid permeable support132may include a porous polymer (e.g., nylon, polyester, polyurethane, polyethylene, polypropylene, etc.) structure (e.g., spun fibers such as spun nylon fibers) or a foam (e.g., an open cell foam). In some examples, the fluid permeable support132may 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 support132may be formed from fabric, felt, gauze, or combinations thereof.

In some examples, the fluid permeable membrane130may be optional. For example, the porous material110may include only the fluid permeable support132. In such examples, the bladder114may be positioned within the fluid permeable support132since, for instance, at least some materials of the support132disclosed herein are flexible enough to accommodate the shape and/or size changes discussed herein. In some examples, the fluid permeable support132may be optionally omitted from the fluid collection assembly100and the porous material110may only include the fluid permeable membrane130. In such examples, the bladder114may be positioned within the fluid permeable membrane130.

In an embodiment, the fluid permeable membrane130and/or the fluid permeable support132are wicking materials. In such an embodiment, the fluid permeable support132may have a greater ability to wick the bodily fluids than the fluid permeable membrane130, such as to move the bodily fluids inwardly from the116of the fluid collection assembly100. In some examples, the wicking ability of the fluid permeable support132and the fluid permeable membrane130may be substantially the same. In an embodiment, the fluid permeable membrane130and/or the fluid permeable support132are non-wicking materials (e.g., absorbent materials).

In an embodiment, not shown, the fluid permeable membrane130and the fluid permeable support132may at least substantially completely fill the portions of the chamber106not occupied by the inflation device112and the conduit128. In an embodiment, as shown inFIGS.1B and1C, the fluid permeable membrane130and the fluid permeable support132may not substantially completely fill the portions of the chamber106not occupied by the inflation device112or the conduit128. In such an embodiment, the fluid collection assembly100includes the fluid reservoir134disposed in the chamber106.

The fluid reservoir134is a substantially unoccupied portion of the chamber106. The fluid reservoir134may be defined between the fluid impermeable barrier102and at least one of the inflation device112, the fluid permeable membrane130, or the fluid permeable support132. The bodily fluids in the chamber106may flow through the fluid permeable membrane130and/or fluid permeable support132to the fluid reservoir134. The fluid reservoir134may retain of the bodily fluids. The bodily fluids in the chamber106may flow through the fluid permeable membrane130and/or fluid permeable support132and, optionally, to the fluid reservoir134. The fluid impermeable barrier102may retain the bodily fluids in the fluid reservoir134. The fluid reservoir134may be in a portion of the chamber106designed to be in a gravimetrically low point of the fluid collection assembly100when the fluid collection assembly100is worn.

The inflation devices and, in particular, the bladders disclosed herein may be located adjacent to regions of the fluid collection assemblies other than or in addition to the proximal end region and the distal end region of the fluid impermeable barrier. For example,FIG.2Ais an isometric view of a fluid collection assembly200that includes at least one inflation device212adjacent to at least one lateral side236of the fluid impermeable barrier202, according to an embodiment.FIGS.2B and2Care cross-sectional schematics of the fluid collection assembly200taken along plane2B-2B when the bladder214of the inflation device212is in the first and second states, respectively. The inflation device212adjacent to the lateral side236of the fluid impermeable barrier202allows a width of the fluid collection assembly200to be selectively and controllably changed. The width of the fluid collection assembly200is measured perpendicular to a longitudinal axis211of the fluid collection assembly200. Except as otherwise disclosed herein, the fluid collection assembly200is the same or substantially similar to any of the fluid collection assemblies disclosed herein. For example, the fluid collection assembly200may include a fluid impermeable barrier202defining at least one opening204, a chamber206, and a fluid outlet208. As previously discussed, the fluid collection assembly200also includes at least one inflation device212. The inflation device212includes a bladder214having one or more walls216defining an interior region218and at least one valve220.

The fluid collection assembly200is configured to be at least partially positioned between the labia folds of an individual. Positioning the fluid collection assembly200at least partially between the labia folds may decrease the number and/or size of gaps formed between the fluid collection assembly200and the vulva thereby minimizing leakage of the bodily fluids and the suction pressure between the fluid collection assembly200and the vulva. Also, positioning the fluid collection assembly200at least a portion between the labia folds may decrease the distance between the urethral opening of the individual and the fluid collection assembly200which increases the quantity of bodily fluids that are discharged from the urethral opening that are received by the fluid collection assembly200(e.g., received through the opening204and into the porous material210). As previously discussed, the size of the labia folds may vary from individual to individual. Fluid collection assemblies exhibiting a maximum width that is too large for the particular size of the labia folds may make positioning such a fluid collection assembly between the labia folds difficult, uncomfortable, and may limit the ability to position such a wide fluid collection assembly proximate to the urethral opening of the individual. Fluid collection assembly exhibiting a maximum width that is too small for the particular size of the labia folds may form gaps between the narrow fluid collection assembly and the labia folds through which the bodily fluids and the suction pressure may leak.

The fluid collection assembly200is configured to change a width of at least a portion thereof thereby allowing the fluid collection assembly200to be used effectively with individuals with differently sized labia folds. In particular, the inflation device212allows the width of the fluid collection assembly200to be selectively and controllably changed thereby allowing the width of at least a portion of the fluid collection assembly200to be controllably and selectively changed. As previously discussed, the inflation device212may be disposed adjacent to the at least one lateral side236of the fluid impermeable barrier202which allows the inflation device212to control the width of at least a portion of the fluid collection assembly200. The lateral side236of the fluid impermeable barrier202may include a side of the fluid impermeable barrier202that is between the opening204and the back side222of the fluid impermeable barrier202and between the proximal and distal end regions203,205of the fluid impermeable barrier202. As shown inFIG.2B, a portion of the fluid collection assembly200may exhibit a first width W1when the bladder214is in the first (e.g., deflated) state. The fluid collection assembly200may be used with relatively small sized labia folds when the fluid collection assembly200exhibits the first width W1(e.g., when the bladder214is in the first state). However, the fluid collection assembly200may also be used with relatively large sized labia folds (e.g., labia folds that are larger than the relatively small sized labia folds). When used with the relatively large sized labia folds, the at least one inflation fluid may be disposed in the interior region218of the bladder214via the valve220to switch the bladder214to the second state thereof. As shown inFIG.2C, switching the bladder214from the first state to the second state increases the width of the portion of the fluid collection assembly200from the first width W1to a second width W2that is greater than the first width W1. As such, the fluid collection assembly200may be used more effectively with the relatively large sized labia folds when the fluid collection assembly200exhibits the second width W2than when the fluid collection assembly200exhibits the first width W1.

At least some convention fluid collection assemblies exhibit a maximum width that is greater than 3 cm. Such widths of the conventional fluid collection assemblies allows the conventional fluid collection assemblies to be used with a significant number (but not all) individuals. In an embodiment, the fluid collection assembly200may exhibit a maximum width that is about 3 cm or greater when the bladder214exhibits the deflated state. In an embodiment, the fluid collection assembly200may exhibit a maximum width when the bladder214exhibits the deflated state that is about 3 cm or less, such as about 2.75 cm or less, about 2.5 cm or less, about 2.25 cm or less, about 2 cm or less, about 1.75 cm or less, about 1.5 cm or less, or in ranges of about 1.5 cm to about 2 cm, about 1.75 cm to about 2.25 cm, about 2 cm to about 2.5 cm, about 2.25 cm to about 2.75 cm, or about 2.5 cm to about 3 cm. Selecting the maximum width of the fluid collection assembly200to be about 3 cm or less may decrease the volume of the chamber206which limits the quantity of bodily fluids that may be stored in the chamber206but also allows the fluid collection assembly200to be used with individuals having relatively small sized labia folds. Further, the inflation device212allows the fluid collection assembly200to be used with individuals having relatively large sized labia folds by switching the bladder214from the first state to the second state even when the fluid collection assembly200exhibits a maximum width that is less than 3 cm.

In an embodiment, the at least one inflation device212may be configured such that the maximum difference between the second width W2is greater than the first width W1by about 2 cm or less, about 1.75 cm or less, about 1.5 cm or less, about 1.25 cm or less, about 1 cm or less, about 7.5 mm or less, about 6 mm or less, about 5 mm or less, about 4 mm or less, about 3 mm or less, about 2 mm or less, about 1 mm or less, or in ranges of about 1 mm to about 3 mm, about 2 mm to about 4 mm, about 3 mm to about 5 mm, about 4 mm to about 6 mm, about 5 mm to about 7.5 mm, about 6 mm to about 1 cm, about 7.5 mm to about 1.25 cm, about 1 cm to about 1.5 cm, about 1.25 cm to about 1.75 cm, or about 1.5 cm to about 2 cm. For example, the difference in sizes of the labia folds from a relatively small sized labia folds to a relatively large sized labia folds may only vary by at most 2 cm and, more commonly, less than 1.5 cm and less than 1 cm. Restricting the maximum change in the width that the portion of the fluid collection assembly200may exhibit may prevent overinflation of the bladder214when the fluid collection assembly200is positioned between the labia folds since overinflation may injure the labia folds. In an embodiment, the fluid collection assembly200may include a rigid band extending around at least a portion of or integrally formed with the inflation device212that prevents overinflation of the bladder214.

In an embodiment, the inflation device212(e.g., the bladder214) is positioned adjacent to a portion of the lateral side236of the fluid impermeable barrier202that is closer to the opening204than the back side222of the fluid impermeable barrier202. The inflation device212may exhibit such a location since the portion of the lateral sides236that is closer to the opening204than the back side222is more likely to be positioned between the labia folds of the individual than a portion of the lateral side236that is closer to the back side222than the opening204. As such, positioning the inflation device212to be closer to the opening204than the back side222better ensures that the inflation device212(e.g., the bladder214) is positioned between the labia folds and that the bladder214is more likely to contact the labia folds than the thighs of the individual. In an embodiment, the inflation device212may be positioned adjacent to a portion of the lateral side236that is equally spaced from the opening204and the back side222or closer to the back side222than the opening204.

In an embodiment, positioning the inflation device212to be closer to the opening204than the back side222allows the fluid collection assembly200to include one or more additional inflation devices (not shown) that are distinct and separate from the inflation devices212. The additional inflation devices may be positioned adjacent to a portion of the lateral sides236that is closer to the back side222than the opening204. The additional inflation devices may be configured to contact the thighs of the patient instead of the labia folds of the individual since the additional inflation devices are positioned closer to the back side222which decreases the likelihood that the addition inflation devices contact the labia folds. The additional inflation devices may be configured to increase the width of the fluid collection assembly200more than the inflation devices212.

In an embodiment, the fluid collection assembly200includes a plurality of inflation devices212(e.g., plurality of bladders214). In such an embodiment, at least one of the inflation devices212may be positioned on one side of the opening204and at least one other inflation device212may be positioned on the other side of the opening204. Positioning the inflation devices212on both sides of the opening204allows for better control of the position of the opening204relatively to the urethral opening. For example, positioning the inflation devices212on both sides of the opening204may allow the central portion of the opening204to be positioned adjacent to the urethral opening of the individual by controllably inflating and/or deflating the bladders214on one or both sides of the opening204. Positioning the central portion of the opening204adjacent to the urethral opening may maximize the quantity of bodily fluids that are received into the fluid collection assembly200.

The fluid collection assemblies illustrated inFIGS.1A to2Care only configured to controllably and selectively change a length or a width thereof. However, any of the fluid collection assemblies disclosed herein may be configured to change both the length and the width thereof. For example,FIG.3is a cross-sectional schematic of a fluid collection assembly300that is configured to change a length and a width thereof, according to an embodiment. Except as otherwise disclosed herein, the fluid collection assembly300is the same or substantially similar to any of the fluid collection assemblies disclosed herein.

The fluid collection assembly300includes a fluid impermeable barrier302that includes a proximal end region303, a distal end region305opposite the proximal end region303, and at least one lateral side336. The fluid collection assembly300includes at least one first inflation device312a(e.g., at least one first inflation device312aadjacent to the proximal end region303and at least one other inflation device312aadjacent to the distal end region305) that is configured to controllably change the length of the fluid collection assembly300. For example, the first inflation device312amay be the same or substantially similar to the inflation device(s)112illustrated inFIGS.1A-1C. The fluid collection assembly300also includes at least one second inflation device312b(e.g., at least one second inflation device312bon one side of the opening (not shown) and at least one other second inflation device312bon the other side of the opening) on the at least one lateral side336of the fluid impermeable barrier302. The second inflation device312bis configured to controllably change the width of at least a portion of the fluid collection assembly300and, as such, the second inflation device312bmay be the same or substantially similar to the inflation device(s)212illustrated inFIGS.2A-2C. Thus, the first and second inflation devices312a,312ballow the fluid collection assembly300to controllably change the length and the width thereof thereby allowing the fluid collection assembly300to be configured to be used with a wider variety of individuals regardless of the length of the vulva and the size of the labia folds of the individual.

The at least one first inflation device312aand the at least one second inflation device312bare distinct and separate from each other. Further, the first inflation device312aand the second inflation devices312bare not in fluid communication with each other. This allows the first and second inflation devices312a,312bto be independently switched from the first state to second state and vice versa (e.g., independently inflated and deflated). Independently switching the first and second inflation devices312a,312ballows for better control of the size of the fluid collection assembly300. For example, the first inflation device312amay be inflated when the vulva of the individual is relatively long but the second inflation device312bmay remain deflated when the labia folds of the individual are relatively small.

The first and second inflation devices312a,312bmay be in fluid communication with each other. For example,FIG.4is a cross-sectional schematic of a fluid collection assembly400that includes two or more inflation devices in fluid communication with each other, according to an embodiment. Except as otherwise disclosed herein, the fluid collection assembly400is the same or substantially similar to any of the fluid collection assemblies disclosed herein.

The fluid collection assembly400includes a fluid impermeable barrier402that includes a proximal end region403, a distal end region405opposite the proximal end region403, and at least one lateral side436. The fluid collection assembly400includes at least one first inflation device412athat is configured to controllably change the length of the fluid collection assembly400. The first inflation device412amay include, for example, at least one first inflation device412aadjacent to the proximal end region403and/or at least one other first inflation device412aadjacent to the distal end region405. The fluid collection assembly also includes at least one second inflation device412bconfigured to control the width of at least a portion of the fluid collection assembly400. The second inflation device412bmay include at least one second inflation device412bon one side of the opening (not shown) and/or at least one other second inflation device412bon the other side of the opening.

At least two of the inflation devices of the fluid collection assembly400may be in fluid communication with each other. The inflation devices of the fluid collection assembly400may be in fluid communication with each other when the inflation fluid in one inflation device may flow to another inflation device through at least one tube438. The tube438may include any structure that defines a passageway that allows the inflation fluid to flow therein and substantially prevents the inflation fluid from leaving the passageway. The tube438allows inflating one inflation device to also inflate at least one other inflation device and deflating one inflation to also deflate at least one other inflation device. Configuring at least two of the inflation devices to be in fluid communication with each other may help improve the comfort of using the fluid collection assembly400and prevent rupturing the bladders thereof when the individual using the fluid collection assembly400moves. For example, when the individual using the fluid collection assembly400moves, the individual may compress a portion of the bladder of one of the plurality of inflation devices. When the inflation device is not in fluid communication with another inflation device, the inflation fluid present in the bladder may cause another portion of the bladder to bulge with may cause discomfort or rupture the bladder. However, when the inflation devices are in fluid communication with each other, the inflation fluid displaced by the compression may be distributed over a larger area thereby preventing or at least minimizing the formation of bulges.

In an embodiment, as illustrated, the tube438may extending within the chamber406. However, extending the tube438within the chamber406may decrease the quantity of bodily fluids that may be stored in the chamber406and may make disposing the porous material410in the chamber406more difficult. In an embodiment, the tube438may extend within the fluid impermeable barrier402(e.g., the fluid impermeable barrier402forms the tube438) or extends outside of the chamber406and the fluid impermeable barrier402. In an embodiment, the at least one tube438includes a plurality of tubes438. In such an embodiment, at least one (e.g., all) of the plurality of tubes438may be disposed in the chamber406, within the fluid impermeable barrier402, outside of the chamber406and the fluid impermeable barrier402, or combinations thereof.

In an embodiment, as illustrated, each of the first and second inflation devices412a,412bare in fluid communication with each other. In such an embodiment, the fluid collection assembly400may only include a single valve420which is used to inflate and deflate each of the first and second inflation devices412a,412b. It is noted that the fluid collection assembly400may include a plurality of valves420even when each of the first and second inflation devices412a,412bare in fluid communication with each other. In an embodiment, at least some of the plurality of inflation devices are not in fluid communication with each other. For example, when the first and second inflation devices412a,412beach include two or more inflation devices, the first inflation devices412amay be in fluid communication with each other and the second inflation devices412bmay be in fluid communication with each other. As such, the length and width of the fluid collection assembly400may be control independently from each other.

In an embodiment, the fluid collection assemblies disclosed herein may include a single inflation device that is configured to controllably change the length and width of the fluid collection assembly.FIG.5is a cross-sectional schematic of a fluid collection assembly500including a single inflation device512that is configured to controllably change the length and width of the fluid collection assembly500, according to an embodiment. Except as otherwise disclosed herein, the fluid collection assembly500is the same as or substantially similar to any of the fluid collection assemblies disclosed herein.

The inflation device512may include a single bladder514and at least one valve520. The bladder514includes one or more walls516defining a single interior region518and the valve520is in fluid communication with the interior region such that the valve520may add the inflation fluid to or remove inflation fluid from the interior region518. The inflation device512is positioned adjacent to at least one of the proximal end region503or the distal end region505of the fluid impermeable barrier502. The inflation device512is also positioned adjacent to at least a portion of the lateral side536of the fluid impermeable barrier502on either one or both sides of the opening (not shown). As such, the inflation device512is able to control the length and the width of the fluid collection assembly500. Further, the inflation device512may exhibit a relatively large size compared to an inflation device that was only adjacent to one of the proximal end region503, the distal end region505, or a portion of the lateral side536. The greater size of the inflation device512allows the inflation fluid to be distributed therein without or minimizing bulging when movement of the individual using the fluid collection assembly500compresses a portion of the inflation device.

FIG.6is a block diagram of a system601for fluid collection, according to an embodiment. The system601includes a fluid collection assembly600, a fluid storage container607, and a vacuum source609. The fluid collection assembly600, the fluid storage container607, and the vacuum source609may be fluidly coupled to each other via one or more conduits628. For example, fluid collection assembly600may be operably coupled to one or more of the fluid storage container607or the vacuum source609via the conduit628. Fluid (e.g., urine or other bodily fluids) collected in the fluid collection assembly600may be removed from the fluid collection assembly600via the conduit628which protrudes into the fluid collection assembly600. For example, an inlet of the conduit628may extend into the fluid collection assembly600, such as to a reservoir. The outlet of the conduit628may extend into the fluid collection assembly600or the vacuum source609. Suction may be introduced into the chamber of the fluid collection assembly600via the inlet of the conduit628responsive to suction (e.g., vacuum) force applied at the outlet of the conduit628.

The suction force may be applied to the outlet of the conduit628by the vacuum source609either directly or indirectly. The suction force may be applied indirectly via the fluid storage container607. For example, the outlet of the conduit628may be disposed within the fluid storage container607and an additional conduit628may extend from the fluid storage container607to the vacuum source609. The vacuum source609may apply suction to the fluid collection assembly600via the fluid storage container607. The suction force may be applied directly via the vacuum source609. For example, the outlet of the conduit628may be disposed within the vacuum source609. An additional conduit628may extend from the vacuum source609to a point outside of the fluid collection assembly600, such as to the fluid storage container607. In such examples, the vacuum source609may be disposed between the fluid collection assembly600and the fluid storage container607.

The fluid collection assembly600may be similar or identical to any of the fluid collection assemblies disclosed herein in one or more aspects. For example, the fluid collection assembly600may include a fluid impermeable barrier including a proximal end region, a distal end region, and at least one lateral side. The fluid impermeable barrier defines at least one opening, a chamber, and a fluid outlet at the proximal end region. The fluid collection assembly may at least one include at least one porous material and at least one inflation device. The inflation device is configured to controllably change a length and/or width of the fluid collection assembly.

The fluid storage container607is sized and shaped to retain a fluid. The fluid storage container607may include a bag (e.g., drainage bag), a bottle or cup (e.g., collection jar), or any other enclosed container for storing bodily fluid(s) such as urine. In some examples, the conduit628may extend from the fluid collection assembly600and attach to the fluid storage container607at a first point. An additional conduit628may attach to the fluid storage container607at a second point thereon and may extend and attach to the vacuum source609. A vacuum (e.g., suction) may be drawn through fluid collection assembly600via the fluid storage container607. Fluid, such as urine, may be drained from the fluid collection assembly600using the vacuum source609.

The vacuum source609may 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 source609may provide a vacuum or suction to remove fluid from the fluid collection assembly600. In some examples, the vacuum source609may 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 source609may be sized and shaped to fit outside of, on, or within the fluid collection assembly600. For example, the vacuum source609may include one or more miniaturized pumps or one or more micro pumps. The vacuum sources609disclosed herein may include one or more of a switch, a button, a plug, a remote, or any other device suitable to activate the vacuum source609.

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

Terms of degree (e.g., “about,” “substantially,” “generally,” etc.) indicate structurally or functionally insignificant variations. In an example, when the term of degree is included with a term indicating quantity, the term of degree is interpreted to mean±10%, ±5%, or +2% of the term indicating quantity. In an example, when the term of degree is used to modify a shape, the term of degree indicates that the shape being modified by the term of degree has the appearance of the disclosed shape. For instance, the term of degree may be used to indicate that the shape may have rounded corners instead of sharp corners, curved edges instead of straight edges, one or more protrusions extending therefrom, is oblong, is the same as the disclosed shape, etc.