Miniature Fluid Collection System

Abstract

An example fluid collection system includes a fluid collection assembly including a fluid impermeable barrier defining at least a chamber, at least one opening, and a fluid outlet. The fluid collection assembly further includes at least one porous material disposed within the chamber. The fluid collection system also includes a fluid reservoir and a vacuum source, both of which are in fluid communication with the chamber of the fluid collection assembly.

Description

[Background technology]

[0001] A person or animal may have limited or impaired mobility, making the normal process of urination difficult or impossible. For example, a person may experience or have a disability that impairs mobility. A person may have restricted movement conditions, such as those experienced by pilots, drivers, and workers in hazardous areas. Additionally, collection of bodily fluids may be necessary for monitoring purposes or clinical trials.

[0002] Urinary catheters, such as Foley catheters, may address some of these conditions, such as incontinence. Unfortunately, urinary catheters can be uncomfortable, painful, and can lead to complications, such as infection. In addition, bedpans may provide a toilet receptacle for bedridden individuals. However, bedpans may be prone to discomfort, overflow, and other hygiene issues. [Prior art documents] [Patent documents]

[0003] [Patent Document 1] U.S. Pat. No. 10,973,678 [Patent Document 2] U.S. Pat. No. 10,390,989 [Patent Document 3] U.S. Pat. No. 10,226,376 [Patent Document 4] U.S. Pat. No. 10,952,889 [Patent Document 5] International Publication No. 2022 / 006256 [Patent Document 6] U.S. Patent Application Serial No. 16 / 433,773 [Patent Document 7] U.S. Provisional Patent Application No. 63 / 134,754 [Patent Document 8] International Publication No. 2021 / 016026 [Patent Document 9] International Publication No. 2021 / 207621 [Patent Document 10] U.S. Patent Application Serial No. 17 / 597,673 [Patent Document 11] U.S. Provisional Patent Application No. 63 / 208,262 Summary of the Invention [Means for solving the problem]

[0004] Embodiments relate to fluid collection systems and methods of using the fluid collection systems. In one embodiment, a fluid collection system is disclosed. The fluid collection system includes a fluid collection assembly. The fluid collection assembly includes a fluid impermeable barrier defining at least a chamber, at least one opening, and a fluid outlet. The fluid collection assembly further includes at least one porous material disposed within the chamber. The fluid collection system also includes a fluid reservoir and a vacuum source. The fluid collection assembly, the fluid reservoir, and the vacuum source are in fluid communication with each other such that at least a portion of one or more bodily fluids are received in the chamber and removed from the chamber using suction provided by the vacuum source and deposited in the fluid reservoir. The fluid impermeable barrier is in direct contact with at least one of the fluid reservoir or the vacuum source, or the fluid collection system further includes at least one conduit having a length of about 50 cm or less connected to the fluid outlet of the fluid collection assembly and one of the fluid reservoir or the vacuum source.

[0005] In one embodiment, a method of using a fluid collection system is disclosed. The method includes positioning at least one opening of the fluid collection assembly adjacent to a urethral opening of the individual or such that the individual's penis passes through the at least one opening. The fluid collection assembly includes a fluid impermeable barrier defining at least a chamber, at least one opening, and a fluid outlet. The fluid collection assembly further includes at least one porous material disposed within the chamber. The method also includes receiving at least one bodily fluid from the individual into the chamber and into the at least one porous material, applying suction to the chamber via a vacuum source to remove at least a portion of the bodily fluid within the chamber, and collecting the bodily fluid in a fluid reservoir. The fluid impermeable barrier is in direct contact with at least one of the fluid reservoir or the vacuum source, or the fluid collection system further includes at least one conduit having a length of about 50 cm or less connected to the fluid outlet of the fluid collection assembly and one of the fluid reservoir or the vacuum source.

[0006] Features from any of the disclosed embodiments may be used in combination with each other without limitation.Furthermore, other features and advantages of the present disclosure will become apparent to those skilled in the art upon consideration of the following detailed description and accompanying drawings.

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

[0008] [Figure 1A] 1 illustrates an isometric view of a fluid collection system, according to one embodiment. [Figure 1B] FIG. 1B is a schematic cross-sectional view of the fluid collection system along plane 1B-1B. [Diagram 2] 1 is a schematic diagram of a fluid collection system, according to one embodiment. [Diagram 3] 1 is a schematic diagram of a fluid collection system, according to one embodiment. [Figure 4A]FIG. 1 illustrates an isometric view of a fluid collection assembly, according to one embodiment. [Figure 4B] FIG. 4B is a cross-sectional schematic diagram of a fluid collection assembly along plane 4B-4B, according to one embodiment. [Diagram 5] FIG. 1 is a cross-sectional view of a male fluid collection assembly according to one embodiment. [Figure 6] 1 is a cross-sectional view of a fluid collection assembly according to one embodiment. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0009] Embodiments relate to fluid collection systems and methods of using fluid collection systems. An example fluid collection system includes a fluid collection assembly. The fluid collection assembly includes a fluid impermeable barrier that defines at least a chamber, at least one opening, and a fluid outlet. The fluid collection assembly further includes at least one porous material disposed within the chamber. The fluid collection system also includes a fluid reservoir and a vacuum source, both of which are in fluid communication with the chamber of the fluid collection assembly.

[0010] In use, the opening of the fluid collection assembly is positioned adjacent to a urethral opening (e.g., a female urethral opening or a urethral opening of a buried penis) or the penis is placed through the opening. After positioning the fluid collection assembly, an individual using the fluid collection assembly may drain urine or other bodily fluids (e.g., blood, sweat, etc.) into the chamber of the fluid collection assembly. The bodily fluid drained into the chamber may be received by the porous material. The bodily fluid may be removed from the chamber via the fluid outlet. Removal of bodily fluids from the chamber may be facilitated by a vacuum source, which is in fluid communication with the chamber via the fluid outlet. For example, the vacuum source may apply suction to the chamber, drawing the bodily fluids toward the fluid outlet. A fluid reservoir may also be in fluid communication with the chamber and the vacuum source, and bodily fluids removed from the chamber may be deposited and stored in the fluid reservoir.

[0011] The fluid collection systems disclosed herein exhibit miniaturization and / or are portable. The miniaturization and / or portability of the fluid collection systems disclosed herein are an improvement over conventional fluid collection systems. For example, the miniaturization and / or portability of the fluid collection systems disclosed herein allows the fluid collection systems disclosed herein to be used in embodiments where conventional fluid collection systems cannot be readily used and / or where conventional fluid collection systems cannot be used individually.

[0012] An example of an embodiment in which the compactness and / or portability of the fluid collection system disclosed herein is an improvement over conventional fluid collection systems includes using the fluid collection system disclosed herein with an individual who is wheelchair bound. There are several options available for individuals who are wheelchair bound to drain bodily fluids. In one example, the individual may use a restroom that has a wheelchair accessible stall. However, the use of a wheelchair accessible stall is limited by the availability of such stalls and requires the individual to transfer from the wheelchair to the toilet bowl and back to the wheelchair, which may be difficult for some individuals (e.g., infirm individuals or elderly individuals). An alternative to using a wheelchair accessible stall in a restroom includes using an internal catheter (e.g., a Foley catheter) configured to drain into a toilet bowl or drainage bag. However, such internal catheters require specialized training and a clean environment (which may not be available in public restrooms) to control urinary tract infections. Furthermore, internal catheters that drain into a drainage bag essentially include a drainage bag and a relatively long conduit that runs from the individual's urethral opening to the drainage bag, both of which are easily visible, making the internal catheter less discreet and potentially embarrassing to the individual. Alternatives to internal catheters include using an external catheter to receive bodily fluids drained from the individual. However, such external catheters are often used with a wall-mounted vacuum source or a vacuum source that must be plugged in, both of which limit the areas in which the external catheter can be used. Portable vacuum sources may be used with external catheters. However, like internal catheters, portable vacuum sources are configured to drain bodily fluids into a drainage bag, which requires a relatively long conduit that runs from the urethral opening to the drainage bag, making the external catheter less discreet. Furthermore, the relatively long conduit and drainage bag may also make such fluid collection systems difficult to use intermittently without leaking bodily fluids, such that such fluid collection systems are left in place for extended periods of time (e.g., left in place during multiple urinations).

[0013] The compactness and / or portability of the fluid collection systems disclosed herein solves at least some of these problems. For example, the fluid collection systems can be used even when wheelchair accessible private rooms are not available, and have a lower risk of urinary tract infections compared to internal catheters. The compactness and / or portability of the fluid collection systems disclosed herein also allows the fluid collection systems disclosed herein to be used without a visible drainage bag, and may be used without a conduit or with a relatively short conduit (e.g., a conduit exhibiting a length of less than 80 cm, or more preferably less than 50 cm). The compactness and / or portability of the fluid collection systems disclosed herein also allows for intermittent use of such fluid collection systems, e.g., only when an individual is actively draining bodily fluids and stored when the individual is in a public place.

[0014] It should be noted that the fluid collection systems disclosed herein may be used in other embodiments besides for wheelchair bound individuals, for example, the fluid collection systems disclosed herein may be used for individuals who are bedridden, in hospital beds, or who do not want to get out of bed to urinate at night.

[0015] FIG 1A is an isometric view of a fluid collection system 100, according to one embodiment. FIG 1B is a schematic cross-sectional view of the fluid collection system 100 along plane 1A-1A. The fluid collection system 100 includes a fluid collection assembly 102, a fluid reservoir 104, and a vacuum source 106. The fluid collection system 100 is configured such that the fluid collection assembly 102 is in direct contact with (e.g., attached to) the fluid reservoir 104 and the fluid reservoir 104 is in direct contact with (e.g., attached to) the vacuum source 106. With the fluid collection assembly 102 in direct contact with the fluid reservoir 104 and the fluid reservoir in direct contact with the vacuum source 106, the fluid collection system 100 exhibits a small, compact size, facilitating individual manipulation of the fluid collection system 100, as described in more detail below.

[0016] The fluid collection assembly 102 is an example of a female fluid collection assembly for receiving and collecting bodily fluids from a female. The fluid collection assembly 102 includes a fluid impermeable barrier 108 that defines a chamber 110, at least one opening 112, and a fluid outlet 114. The fluid collection assembly 102 also includes at least one porous material 124 disposed within the chamber 110. The fluid collection assembly 102 may further include a conduit 116 disposed through the fluid outlet 114, the conduit 116 being in fluid communication with the chamber 110.

[0017] The fluid-impermeable barrier 108 at least partially defines a chamber 110 (e.g., an interior region) and an opening 112. For example, the inner surface(s) 118 of the fluid-impermeable barrier 108 at least partially defines the chamber 110 in the fluid collection assembly 102. The fluid-impermeable barrier 108 temporarily stores bodily fluids in the chamber 110. The fluid-impermeable barrier 108 may be formed of any suitable fluid-impermeable material(s), such as a fluid-impermeable polymer (e.g., silicone, polypropylene, polyethylene, polyethylene terephthalate, neoprene, polycarbonate, etc.), a metal film, natural rubber, another suitable material, other fluid-impermeable materials disclosed herein, or a combination thereof. Thus, the fluid-impermeable barrier 108 substantially prevents bodily fluids from passing through the fluid-impermeable barrier 108. In one example, the fluid-impermeable barrier 108 may be air-permeable and fluid-impermeable. In such an example, the fluid-impermeable barrier 108 may be formed of a hydrophobic material that defines a plurality of pores. At least one or more portions of at least the outer surface 120 of the fluid-impermeable barrier 108 may be formed of a soft and / or lubricious material, thereby reducing chafing.

[0018] At least a portion of the exterior surface 120 of the fluid impermeable barrier 108 may directly contact the fluid reservoir 104. For example, the exterior surface 120 may include a rear surface 122 opposite the opening 112. At least a portion of the rear surface 122 may directly contact the fluid reservoir 104, thereby preventing, or at least inhibiting, the fluid reservoir 104 and vacuum source 106 from blocking the opening 112 or preventing the opening 112 from being positioned adjacent the urethral opening.

[0019] The opening 112 provides an ingress path for bodily fluid to enter the chamber 110. The opening 112 may be defined by the fluid-impermeable barrier 108, for example, by an inner edge of the fluid-impermeable barrier 108. For example, the opening 112 is formed in the fluid-impermeable barrier 108 and extends through the fluid-impermeable barrier 108 from the outer surface 120 to the inner surface 118, thereby allowing bodily fluid to enter the chamber 110 from outside the fluid collection assembly 102.

[0020] In some examples, the fluid impermeable barrier 108 may define a fluid outlet 114 sized to receive a conduit 116. At least one conduit 116 may be disposed within the chamber 110 via the fluid outlet 114. The fluid outlet 114 may be sized and shaped to form at least a substantially fluid-tight seal with the conduit 116 or at least one conduit, thereby substantially preventing bodily fluids from escaping the chamber 110.

[0021] In one embodiment, the porous material 124 may be configured to wick bodily fluids up through the openings 112, thereby preventing the bodily fluids from leaking out of the chamber 110. The permeability property referred to herein may be wicking, capillary action, diffusion, or another similar property or process, and is referred to herein as "permeability" and / or "wicking". Such "wicking" and / or "permeability" properties may not include absorption of bodily fluids into at least a portion of the porous material 124, e.g., not including adsorption of bodily fluids into the fluid-permeable support 126. In other words, absorption or dissolution of bodily fluids into the material may not occur substantially until some time after the material has been exposed to and removed from the bodily fluid. While no absorption or solubility is desired, the term "substantially non-absorbent" may allow for a nominal amount of absorption and / or solubility (e.g., absorbency) of bodily fluids into the porous material 124, such as less than about 30% by weight, less than about 20% by weight, less than about 10% by weight, less than about 7% by weight, less than about 5% by weight, less than about 3% by weight, less than about 2% by weight, less than about 1% by weight, or less than about 0.5% by weight of the dry weight of the porous material 124. The porous material 124 may also wick bodily fluids generally toward the interior of the chamber 110, as described in more detail below. In one embodiment, the porous material 124 may include at least one absorbent or adsorbent material.

[0022] In one embodiment, the porous material 124 may include a fluid-permeable membrane 128 disposed within the chamber 110. The fluid-permeable membrane 128 may cover at least a portion (e.g., all) of the opening 112. The fluid-permeable membrane 128 may be configured to wick bodily fluids away from the opening 112, thereby preventing the bodily fluids from leaking out of the chamber 110.

[0023] In one embodiment, the fluid-permeable membrane 128 may include any material capable of wicking up bodily fluids. For example, the fluid-permeable membrane 128 may include a fabric, such as gauze (such as silk, linen, or cotton gauze), another soft fabric, another smooth fabric, a nonwoven material, or any of the other porous materials disclosed herein. Forming the fluid-permeable membrane 128 from gauze, a soft fabric, and / or a smooth fabric may reduce chafing caused by the fluid collection assembly 102.

[0024] The fluid collection assembly 102 may include a fluid-permeable support 126 disposed within the chamber 110. The fluid-permeable support 126 is configured to support the fluid-permeable membrane 128, such that the fluid-permeable membrane 128 may be formed from a relatively foldable, thin, or easily deformable material. For example, the fluid-permeable support 126 may be positioned such that the fluid-permeable membrane 128 is disposed between the fluid-permeable support 126 and the fluid-impermeable barrier 108. Thus, the fluid-permeable support 126 may support and maintain the position of the fluid-permeable membrane 128. The fluid-permeable support 126 may include any material that wicks up, absorbs, adsorbs, or otherwise enables fluid transport of 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 denser or more rigid form than the fluid-permeable membrane 128 when used as the fluid-permeable support 126. The fluid-permeable support 126 may be formed from any fluid-permeable material that is less susceptible to deformation than the fluid-permeable membrane 128. For example, the fluid-permeable support 126 may include a porous polymer (e.g., nylon, polyester, polyurethane, polyethylene, polypropylene, etc.) structure or an open-cell foam, such as spun nylon fibers. In some examples, the fluid-permeable support 126 may include a nonwoven material. In some examples, the fluid-permeable support 126 may be formed from natural materials, such as cotton, wool, silk, or combinations thereof. In such examples, the material may have a coating to prevent or limit absorption of fluid into the material, such as a water-repellent coating. In some examples, the fluid-permeable support 126 may be formed from a woven fabric, felt, gauze, or combinations thereof.

[0025] In some examples, the fluid-permeable membrane 128 may be optional. For example, the porous material 124 may include only the fluid-permeable support 126. In some examples, the fluid-permeable support 126 may be omitted from the fluid collection assembly 102 as desired. For example, the porous material 124 may include only the fluid-permeable membrane 128.

[0026] In one embodiment, at least a portion of the porous material 124 (e.g., one or more of the fluid-permeable membranes 128 or, more preferably, the fluid-permeable support 126) can be hydrophobic. The porous material 124 can be hydrophobic if the porous material 124 exhibits a contact angle with water (the main component of bodily fluids) greater than about 90°, e.g., in the range of about 90° to about 120°, about 105° to about 135°, about 120° to about 150°, about 135° to about 175°, or about 150° to about 180°. The hydrophobicity of the porous material 124 can limit the absorption, adsorption, and solubility of bodily fluids in the porous material 124, thereby reducing the amount of bodily fluid retained by the porous material 124. In one embodiment, at least a portion of the porous material 124 is hydrophobic or hydrophilic. In one embodiment, the fluid-permeable support 126 is more hydrophobic (e.g., has a higher contact angle with water) than the fluid-permeable membrane 128. The lower hydrophobicity of the fluid-permeable membrane 128 helps the porous material 124 receive bodily fluids from the urethral opening, while the hydrophobicity of the fluid-permeable support 126 limits the bodily fluids that are retained in the porous material 124.

[0027] The porous material 124 may at least substantially completely fill the portion of the chamber 110 not occupied by the conduit 116. In some examples, the porous material 124 may not substantially completely fill the portion of the chamber 110 not occupied by the conduit 116. In such examples, the fluid collection assembly 102 includes a reservoir 130 disposed within the chamber 110.

[0028] The reservoir 130 is a substantially unoccupied portion of the chamber 110. The reservoir 130 may be defined between the fluid-impermeable barrier 108 and one or both of the fluid-permeable membrane 128 and the fluid-permeable support 126. Bodily fluid within the chamber 110 may flow through the fluid-permeable membrane 128 and / or the fluid-permeable support 126 to the reservoir 130. The reservoir 130 may hold bodily fluid therein.

[0029] Bodily fluid within the chamber 110 may flow through the fluid permeable membrane 128 and / or the fluid permeable support 126 to the reservoir 130. The fluid impermeable barrier 108 may retain bodily fluid within the reservoir 130. Although shown in the distal end region 132, the reservoir 130 may be located in any portion of the chamber 110, such as the proximal end region 134. The reservoir 130 may be located in a portion of the chamber 110 designed to be located at a gravimetrically low point of the fluid collection assembly 102 when the fluid collection assembly is attached.

[0030] In some examples (not shown), the fluid collection assembly 102 may include multiple reservoirs, such as a first reservoir disposed in a portion of the chamber 110 closest to the inlet 136 of the conduit 116 (e.g., distal end region 132) and a second reservoir disposed at or near the proximal end region 134 of the chamber 110. In another example, the fluid-permeable support 126 is spaced from at least a portion of the conduit 116, and the reservoir 130 may be the space between the fluid-permeable support 126 and the conduit 116.

[0031] The conduit 116 may be at least partially disposed within or in fluid communication with the chamber 110. The conduit 116 may be used to remove bodily fluids from the chamber 110. The conduit 116 includes an inlet 136. The inlet 136 of the conduit 116 may be disposed adjacent to, within, or after the reservoir 130.

[0032] As shown, in one embodiment, the fluid outlet 114 is formed in or near the distal end region 132. In such an embodiment, the inlet 136 of the conduit 116 may be located in or near the fluid outlet 114 such that the inlet 136 is located adjacent to or within the reservoir 130. In an embodiment not shown, the conduit 116 may extend through holes in the porous material 124 when the fluid outlet 114 is formed in or near the proximal end region 134.

[0033] The conduit 116 extends from the fluid collection assembly 102 to the fluid reservoir 104, with the fluid reservoir 104 in fluid communication with the fluid collection assembly 102. However, it is noted that in some embodiments, the conduit 116 is omitted from the fluid collection system 100, as the fluid collection assembly 102 directly interfaces with the fluid reservoir 104. In such embodiments, the fluid outlet 114 of the fluid collection assembly 102 is attached directly to the fluid inlet 136 of the fluid reservoir 104. To facilitate directly attaching the fluid outlet 114 to the fluid inlet 136, the fluid outlet 114 and the fluid inlet 136 may be formed from materials capable of forming an interference fit with one another (e.g., non-brittle materials) or may be attached together using an adhesive, welding (e.g., ultrasonic welding, radio frequency welding, etc.), another attachment technique, or a combination thereof.

[0034] The fluid reservoir 104 includes one or more fluid impermeable walls 138. The fluid impermeable walls 138 of the fluid reservoir 104 at least partially define an enclosure 140 (e.g., an interior region), a fluid inlet 136, and an outlet 142. The fluid reservoir 104 stores one or more bodily fluids removed from the chamber 110 of the fluid collection assembly 102 in the enclosure 140. In one embodiment, the enclosure 140 is substantially empty, maximizing the volume of bodily fluid that may be stored in the enclosure 140. In one embodiment, the enclosure 140 may include at least one porous material therein to inhibit migration of bodily fluids within the enclosure 140 and, if the porous material is hydrophilic, to inhibit the bodily fluids from exiting the enclosure 140.

[0035] The enclosure 140 of the fluid storage container 104 may exhibit a volume of about 100 milliliters ("mL") to about 200 mL, about 150 mL to about 250 mL, about 200 mL to about 300 mL, about 250 mL to about 350 mL, about 300 mL to about 400 mL, about 350 mL to about 450 mL, about 400 mL to about 500 mL, about 450 mL to about 600 mL, about 500 mL to about 700 mL, about 600 mL to about 800 mL, about 700 mL to about 900 mL, about 800 mL to about 1 liter, about 900 mL to about 1.25 liters, or more than 1 liter. The volume of the enclosure 140 depends on a variety of factors. In general, it is desirable to minimize the volume of the enclosure 140 to minimize the size of the fluid collection system 100, which facilitates placement of at least a portion of the fluid collection system 100 under an individual's clothing and / or between the individual's legs. However, the volume of the enclosure 140 should be sized to enable the enclosure 140 to receive substantially all of the bodily fluid discharged from the individual. Thus, the volume of the enclosure 140 may be selected based on a balance of these two factors.

[0036] In one embodiment, the volume of the enclosure 140 may be selected based on the age and size of the individual. For example, the volume of the enclosure 140 may be relatively small for a child (e.g., less than 200 ml) and relatively large for a larger adult (e.g., about 500 ml or more). In one embodiment, the volume of the enclosure 140 may be less than 500 ml if the fluid reservoir 104 is disposable (discussed in more detail below) or configured to be emptied after each discharge of bodily fluids, while the volume of the enclosure 140 may be 500 ml or more if the fluid reservoir 104 is not disposable or configured to receive multiple urinations, which may reduce waste and reduce the need to clean the fluid collection system 100. In one embodiment, the volume of the enclosure 140 may depend on whether the enclosure 140 is substantially empty or occupied by a porous material, as the porous material may reduce the volume of bodily fluid that can be stored within the enclosure 140 for a given volume of the enclosure 140.

[0037] The fluid impermeable wall 138 may be formed from any of the fluid impermeable materials disclosed herein, or any other suitable fluid impermeable material. In one embodiment, the fluid impermeable wall 138 is formed from a hard material that exhibits sufficient rigidity that the fluid impermeable wall 138 is unlikely to collapse (e.g., maintain its shape) when suction is applied from the vacuum source 106 to the enclosure 140. The rigidity of the fluid impermeable wall 138 may ensure that there is air within the enclosure 140 if the enclosure 140 is not completely filled with bodily fluid. The air within the enclosure 140 provides something for the vacuum source 106 to draw other than bodily fluid from the enclosure 140, because drawing bodily fluid from the enclosure 140 into the vacuum source 106 may contaminate the vacuum source 106 (which may be difficult to clean) and may damage the vacuum source 106 (such as causing the vacuum source 106 to short out). In one embodiment, the fluid impermeable wall 138 is formed from a thin material (i.e., a material that may collapse when suction from the vacuum source 106 is applied to the enclosure 140). Forming the fluid impermeable wall 138 from a thin material may allow the fluid collection system 100 to have the smallest possible volume, which may facilitate placement of the fluid collection assembly 102.

[0038] The fluid impermeable wall 138 may include a front surface 145 and a rear surface 147 opposite the front surface 145. At least a portion of the front surface 145 may be in direct contact with the fluid collection assembly 102, and the rear surface 147 may be in direct contact with the vacuum source 106. Having the rear surface 147 in direct contact with the vacuum source 106 prevents, or at least inhibits, the vacuum source from blocking the opening 112 of the fluid collection assembly 102 or from interfering with placement of the opening 112 against the individual's urethral opening. However, it should be noted that the vacuum source 106 may be in direct contact with a side of the fluid impermeable wall 138 (e.g., a surface of the fluid impermeable wall 138 that is not opposite the front surface 145).

[0039] In one embodiment, the fluid impermeable wall 138 is permanently or temporarily attached directly to the fluid collection assembly 102 and / or the vacuum source 106. For example, the fluid impermeable wall 138 may be glued, snapped (e.g., using spring snaps), strapped, or otherwise attached to the fluid collection assembly 102 and / or the vacuum source 106.

[0040] The fluid inlet 136 provides an entry path for bodily fluids to enter the enclosure 140. The fluid inlet 136 extends through a fluid impermeable wall 138, thereby allowing bodily fluids to enter the enclosure 140. In one embodiment, the fluid inlet 136 is formed in a portion of the fluid impermeable wall 138 adjacent to the fluid outlet 114 of the fluid collection assembly 102, which allows the fluid inlet 136 to be directly attached to the fluid outlet 114 or allows the conduit 116 extending from the fluid outlet 114 to the fluid inlet 136 to be as short as possible. For example, the fluid inlet 136 may be formed at or near the distal region 144 of the fluid reservoir 104 if the fluid outlet 114 is formed at or near the distal end region 132 of the fluid collection assembly 102, or the fluid inlet 136 may be formed at or near the proximal region 146 of the fluid reservoir 104 if the fluid outlet 114 is formed at or near the proximal end region 134 of the fluid collection assembly 102. In one embodiment, the fluid inlet 136 is formed in a portion of the fluid impermeable wall 138 that is not adjacent to the fluid outlet 114 of the fluid collection assembly 102. In such an embodiment, the conduit 116 may extend from the fluid outlet 114 to the fluid inlet 136, for example, between the fluid collection assembly 102 and the fluid reservoir 104 or adjacent to a portion where the fluid collection assembly 102 and the fluid reservoir 104 directly contact each other. By forming the fluid inlet 136 in a portion of the fluid storage container 104 away from the fluid outlet 114, backflow of bodily fluids from the enclosure 140 into the chamber 110 can be prevented, for example, when the fluid outlet 114 is formed in or near the distal end region 132.

[0041] In one embodiment, the fluid collection system 100 includes a first sealing element 148 (schematically illustrated using a box in FIG. 1B). The first sealing element 148 is configured to prevent backflow of bodily fluid from the enclosure 140 to the chamber 110. In one embodiment, the first sealing element 148 includes a check valve configured to allow bodily fluid to flow from the chamber 110 to the enclosure 140 while substantially preventing backflow of bodily fluid from the enclosure 140 to the chamber 110. In one such embodiment, suction provided by the vacuum source 106 may open the check valve, but backflow of bodily fluid (e.g., caused by turning off the vacuum source 106) closes the check valve. In one embodiment, the first sealing element 148 includes a clamp. The clamp may be removed before the fluid collection assembly 102 receives bodily fluid, and the clamp may be reattached to the conduit 116 at least one of after the fluid collection assembly 102 stops receiving bodily fluid, after substantially all of the bodily fluid has been removed from the fluid collection assembly 102, or before the vacuum source 106 is turned off.

[0042] The outlet 142 provides an ingress path for introducing suction provided by the vacuum source 106 into the enclosure 140 so that suction may be provided to the chamber 110. The outlet 142 extends through the fluid impermeable wall 138, allowing bodily fluids to enter the enclosure 140. In one embodiment, the outlet 142 is formed in a portion of the fluid impermeable wall 138 adjacent to the port 152 of the vacuum source, such that the outlet 142 may be directly attached to the port 152 or the conduit 116 extending from the outlet 142 to the port 152 may be as short as possible. In one embodiment, the outlet 142 is formed in a portion of the fluid impermeable wall 138 away from the port 152. In such an embodiment, the conduit 116 may extend from the outlet 142 to the port 152, for example, between the fluid reservoir 104 and the vacuum source 106 or adjacent to a portion where the fluid reservoir 104 and the vacuum source 106 directly contact each other.

[0043] In one embodiment, the outlet 142 of the fluid reservoir 104 may be located at the proximal end 146 of the fluid reservoir 104. Bodily fluids within the enclosure 140 tend to collect at or near the distal region 144 of the fluid reservoir 104. Locating the outlet 142 at the proximal end 146 of the fluid reservoir 104 reduces the likelihood of bodily fluids within the enclosure 140 reaching the outlet 142. In general, it is not advisable to allow bodily fluids to reach the outlet 142, as bodily fluids that reach the outlet 142 may flow into the vacuum source 106 and contaminate and / or damage the vacuum source 106. In one embodiment, the outlet 142 may be spaced apart from the proximal end 146 of the fluid reservoir 104, for example, if the outlet 142 or the vacuum source 106 includes a liquid-impermeable (e.g., water-impermeable) and gas-permeable filter to prevent or at least inhibit bodily fluids from flowing into the vacuum source 106.

[0044] In one embodiment, the fluid collection system 100 includes a second sealing element 150 (schematically illustrated using a box in FIG. 1B). The second sealing element 150 is configured to prevent the flow of bodily fluids from the enclosure 140 to the vacuum source 106. In one embodiment, the second sealing element 150 includes a liquid-impermeable (e.g., water-impermeable) and gas-permeable filter, such as a porous polytetrafluoroethylene filter. In one such embodiment, the liquid-impermeable and gas-permeable filter may allow the vacuum source 106 to provide suction to the enclosure 140 while simultaneously preventing the flow of bodily fluids from the enclosure to the vacuum source 106. In one embodiment, the second sealing element 150 includes a clamp. The clamp may be removed before the fluid collection assembly 102 receives bodily fluid, and the clamp may be reattached to the conduit 116 after the fluid collection assembly 102 stops receiving bodily fluid, after substantially all bodily fluid has been removed from the fluid collection assembly 102, or before the vacuum source 106 is turned off. In one embodiment, the second sealing element 150 may include another type of seal (e.g., a check valve) configured to open when suction is applied and close when suction is removed (e.g., turned off). In one such embodiment, the seal substantially prevents bodily fluid from reaching the vacuum source 106 when the vacuum source 106 is not providing suction (e.g., when the fluid collection system 100 is being carried instead of being used).

[0045] The vacuum source 106 may include one or more of a manual vacuum pump, an electric vacuum pump, a diaphragm pump, a centrifugal pump, a positive displacement pump, a magnetic drive pump, a peristaltic pump, or any pump configured to generate a vacuum. The vacuum source 106 may provide a vacuum or suction to remove bodily fluids from the fluid collection assembly 102. In some examples, the vacuum source 106 may be powered by one or more of a power cord (e.g., connected to a power socket), one or more batteries, or even a manual power source (e.g., a manual vacuum pump). In some examples, the vacuum source 106 may be sized and shaped to fit outside, on, or inside the fluid collection assembly 102. For example, the vacuum source 106 may include one or more miniature pumps or one or more micro pumps. The vacuum sources disclosed herein may include one or more of a switch, a button, a plug, a remote control, or any other device suitable for activating the vacuum source 106.

[0046] The vacuum source 106 may include one or more supports 154 that are configured to perform at least one of the following functions: supporting the fluid reservoir 104, aiding in positioning the fluid reservoir 104 when the fluid reservoir 104 is attached to the vacuum source 106, or maintaining the shape of the fluid reservoir 104. In one illustrated embodiment, the supports 154 may include an upper panel and / or a lower panel that extends from the remainder of the vacuum source 106. The upper panel and / or the lower panel may be formed from a material that is more rigid than the fluid reservoir 104, thereby allowing the supports 154 to aid in maintaining the shape of the fluid reservoir 104.

[0047] As described in more detail below, the fluid collection system 100 may be configured to fit at least partially between the urethral opening and the garment and / or between the thighs of an individual. The space between the urethral opening and the garment and between the thighs of an individual may be generally triangular, with the urethral opening of the individual being the apex of the generally triangular cross-sectional shape. Thus, the fluid reservoir 104 and the vacuum source 106 may exhibit a generally triangular cross-sectional shape at one or more locations thereof, which may facilitate positioning the fluid reservoir 104 and the vacuum source between the urethral opening and the garment and / or between the thighs of an individual. The fluid collection assembly 102 may be attached to or extend from the apex of the generally triangular cross-sectional shape formed by the fluid reservoir 104 and the vacuum source 106, to position the opening 112 of the fluid collection assembly 102 adjacent the urethral opening of an individual. Examples of shapes that exhibit a generally triangular cross-sectional shape include a generally triangular prism, a triangular pyramid, a square pyramid, or similar shapes with convex and / or rounded edges. It should be noted that the fluid reservoir 104 and the vacuum source 106 may exhibit a cross-sectional shape that is not generally triangular, such as a generally circular cross-sectional shape, a generally semicircular cross-sectional shape, or a generally dome-shaped cross-sectional shape, as these shapes may at least partially fit within the space between an individual's urethral opening and clothing, and between the thighs.

[0048] As previously mentioned, the fluid collection assembly 102 is in direct contact with the fluid reservoir 104, which is in direct contact with the vacuum source 106. This configuration allows the fluid collection system 100 to exhibit a substantial compactness. The substantial compactness of the fluid collection system 100 allows the fluid collection system 100 to be positioned at least partially between the individual's urethral opening and the individual's clothing and / or between the individual's legs. The compactness also allows the fluid collection system 100 to be used intermittently only when the individual is discharging bodily fluids. For example, the compactness allows the fluid collection system 100 to be positioned adjacent the individual's urethral opening during use and away from the urethral opening when the individual is not discharging bodily fluids. The compactness of the fluid collection system 100 also allows the fluid collection system 100 to be stored separately in a bag or other container when not in use. Additionally, the compactness of the fluid collection system 100 also allows the fluid collection system 100 to be operated and handled with one hand while the other hand can be used, for example, to pull elastic pants away from the waist and open a zipper so that the fluid collection system 100 can be positioned with the opening 112 adjacent to an individual's urethral opening.

[0049] During use, the individual may move to a private location, such as a bathroom stall (not necessarily a wheelchair accessible stall), a bedroom closet, or other private location. It is noted that the individual does not necessarily have to move to a private location, but that in a private location, the fluid collection system 100 may be used more discreetly. The individual may then manipulate the garment to allow the fluid collection system 100 access to the individual's urethral opening. For example, if the individual is wearing stretchy pants and / or underwear ("stretchy garment"), the individual may pull the stretchy garment away from the urethral opening with one hand and then move the fluid collection system 100 toward the urethral opening with the other hand, so that the opening 112 is adjacent the urethral opening. It is noted that in such an example, releasing the stretchy garment presses against the fluid collection system 100, which in turn presses against the opening 112 of the fluid collection assembly 102 adjacent the urethral opening. Pressing the opening 112 against the urethral opening reduces the likelihood that bodily fluids discharged from the urethral opening will leak onto the individual's clothing or onto the individual's hands. Additionally, using a stretchable garment to press the opening 112 against the urethral opening allows the individual to discharge bodily fluids without having to place the individual's hands near the urethral opening, minimizing the likelihood of the individual's hands becoming soiled with bodily fluids and may make the use of the fluid collection system 100 more comfortable (i.e., the individual may be less reluctant to use the fluid collection system 100). In one example, if the individual is wearing pants with a zipper, the individual may unzip the zipper, open the zipper as needed with one hand, and position the fluid collection system 100 with the other hand so that the opening 112 is adjacent the urethral opening. In such an example, the individual may need to pull the stretchable garment away from the urethral opening. In one example, if the individual is wearing a relatively tight garment, the individual may need to pull the garment down to the legs. It should be noted that positioning the fluid collection system 100 adjacent the urethral opening may be performed by one individual without special training.Positioning the fluid collection system 100 adjacent to the urethral opening can also be performed with little movement of the lower body (especially if the individual is using stretch or zippered garments), which can be beneficial for individuals who are wheelchair bound or bedridden.

[0050] The vacuum source 106 may be initially provided in an off state, in which case no suction is applied. The vacuum source 106 may be switched to an on state before, during, or after placement of the fluid collection system 100. In one embodiment, the vacuum source 106 may include a button, switch, or other actuator to allow the vacuum source 106 to be switched between an off state and an on state. In one embodiment, the vacuum source 106 may include one or more sensors (e.g., optical sensors, accelerometers, proximity sensors, etc.) to detect when the fluid collection system 100 is placed at or adjacent to the urethral opening. The vacuum source 106 may switch from an off state to an on state when the sensor detects that the fluid collection system 100 is placed at or adjacent to the urethral opening, and may switch from an on state to an off state when the sensor detects that the fluid collection system 100 is away from the urethral opening. In one embodiment, the vacuum source 106 may include one or more sensors to detect bodily fluids (e.g., moisture) in the chamber 110. In one such embodiment, the vacuum source 106 may switch from an off state to an on state when the sensor detects bodily fluid in the chamber 110, and may switch from an on state to an off state when the sensor detects that there is substantially no moisture in the chamber 110.

[0051] After positioning the fluid collection system 100 and switching the vacuum source 106 on, if desired, the individual may expel bodily fluids through the opening 112 into the chamber 110 and into the porous material 124. Suction provided from the vacuum source 106 to the enclosure 140 and chamber 110 may move the bodily fluids towards the fluid outlet 114, removing the bodily fluids from the chamber 110 and into the enclosure 140.

[0052] In one embodiment, at least one of the fluid collection assembly 102 or the fluid reservoir 104 is disposable (e.g., configured for one-time use). Disposing of the fluid collection assembly 102 and / or the fluid reservoir 104 reduces the amount of cleaning of the fluid collection system 100 required after draining the fluid collection system 100. The fluid collection assembly 102 and / or the fluid reservoir 104 is disposable if the fluid collection assembly 102 and / or the fluid reservoir 104 can be removed from the vacuum source 106 without damaging the fluid collection assembly 102, the fluid reservoir 104, and the vacuum source 106 and without causing substantial leakage of bodily fluids from the fluid reservoir 104. The fluid collection assembly 102 and / or the fluid reservoir 104 is disposable if, for example, the fluid collection assembly 102 is attached to the fluid reservoir 104 and / or the fluid reservoir 104 is attached to the vacuum source 106 using a weak adhesive, snaps, straps, or an interference fit, respectively. If at least one of the fluid collection assembly 102 or the fluid reservoir 104 is disposable, a method of using the fluid collection system 100 may include removing the fluid collection assembly 102 from the fluid reservoir 104 and / or the fluid reservoir 104 from the vacuum source 106 after the individual has drained the bodily fluid into the chamber 110, and discarding the fluid collection assembly 102 and / or the fluid reservoir 104. In some examples, the method may also include removing the fluid collection assembly 102 from the fluid reservoir 104 or the fluid reservoir 104 from the vacuum source 106 to prevent the bodily fluid from leaking from the fluid reservoir 104 after using a sealing element (e.g., a clamp, etc.) to prevent the bodily fluid from leaking from the enclosure 140. After discarding the fluid collection assembly 102 and / or the fluid reservoir 104, a replacement fluid collection assembly and / or a replacement fluid reservoir may be added to the fluid collection system 100, allowing the fluid collection system 100 to be reused. The replacement fluid collection assembly and / or the replacement fluid reservoir may be the same as or different from the original fluid collection assembly 102 and / or the original fluid reservoir 104 .

[0053] Regardless of whether the fluid collection assembly 102 and / or fluid reservoir 104 are disposable, the vacuum source 106 and the components that remain attached to the vacuum source 106 may require cleaning after an individual has expelled bodily fluids. Cleaning the remaining components of the fluid collection system 100 may include wiping such components with a wipe (such as a disinfectant wipe), flowing a sterile fluid over any portions of the remaining components through which bodily fluids may have flowed, or otherwise cleaning such components.

[0054] The fluid collection system 100 includes a fluid collection assembly 102 located upstream of a fluid reservoir 104, and a fluid reservoir 104 located upstream of a vacuum source 106. However, it should be noted that the fluid collection systems disclosed herein may have different configurations. For example, FIG. 2 is a schematic diagram of a fluid collection system 200 according to one embodiment. Except as otherwise disclosed herein, the fluid collection system 200 may be the same as or substantially similar to any of the fluid collection systems disclosed herein. For example, the fluid collection system 200 includes a fluid collection assembly 202, a fluid reservoir 204, and a vacuum source 206.

[0055] The components of the fluid collection system 200 are positioned such that the fluid collection assembly 202 is located upstream of the vacuum source 206, and the vacuum source 206 is located upstream of the fluid reservoir 204 (e.g., the fluid reservoir 204 is downstream of the vacuum source 206). This allows the fluid collection assembly 202 and the fluid reservoir 204 to be in direct contact with (e.g., directly attached to) the vacuum source 206. In one example, the vacuum source 206 may be more rigid than the fluid collection assembly 202 and the fluid reservoir 204. In this manner, by having the fluid collection assembly 202 and the fluid reservoir 204 in direct contact with the vacuum source 206, the vacuum source 206 can provide structure and support to the fluid collection assembly 202 and the fluid reservoir 204. In one example, when the fluid collection system 200 is at least partially disposed between the individual's thighs, by locating the fluid reservoir 204 downstream of the vacuum source 206, the fluid reservoir 204 is located farther from the individual's urethral opening than if the fluid reservoir 204 were located upstream of the vacuum source 206. The space between the thighs increases with increasing distance from the urethral opening. Thus, locating the fluid reservoir 204 downstream of the vacuum source 206 (e.g., farther from the urethral opening) provides more space for locating the fluid reservoir 204, thereby allowing the enclosure of the fluid reservoir 204 to exhibit a larger volume. In one example, when the fluid reservoir 204 is located downstream of the vacuum source 206, the fluid reservoir 204 can be formed of a thinner material than when the fluid reservoir 204 is located upstream of the vacuum source 206, because the fluid reservoir 204 does not support the fluid collection assembly 202.

[0056] In the illustrated embodiment, the vacuum source 206 includes a first port in fluid communication with a fluid outlet of the fluid collection assembly 202 , and the vacuum source 206 includes a second port in fluid communication with an inlet of the fluid reservoir 204 .

[0057] In one embodiment, the vacuum source 206 is a peristaltic pump because such a pump may limit contamination of the vacuum source 206 by bodily fluids. A peristaltic pump includes compressible tubing, and bodily fluids flowing through the vacuum source 206 are restricted to the compressible tubing as the bodily fluids flow from a first port to a second port of the vacuum source 206. Restricting contamination of the vacuum source 206 by bodily fluids to the compressible tubing may facilitate cleaning of the vacuum source 206 (e.g., the vacuum source 206 may be cleaned by simply flowing a fluid, such as a sterile fluid, through the compressible tubing) and prevent damage to the remainder of the vacuum source 206. In one embodiment, the vacuum source 206 may include other suitable vacuum sources, such as any of the vacuum sources disclosed herein.

[0058] The fluid collection systems shown in FIGS. 1A-2 show that the fluid collection assembly, the fluid reservoir, and the vacuum source are in direct contact, improving the compactness of the fluid collection system. However, in some embodiments, one or more of the fluid collection assembly, the fluid reservoir, and the vacuum source of any of the fluid collection systems disclosed herein may be separated from each other by at least one conduit. For example, FIG. 3 is a schematic diagram of a fluid collection system 300, according to one embodiment. Except as otherwise disclosed herein, the fluid collection system 300 may be the same as or substantially similar to any of the fluid collection systems disclosed herein. For example, the fluid collection system 300 includes a fluid collection assembly 302, a fluid reservoir 304, and a vacuum source 306.

[0059] In the illustrated embodiment, the fluid collection assembly 302 is separated from the fluid reservoir 304 and the vacuum source 306 by at least one conduit 316. The conduit 316 provides additional flexibility in positioning the fluid collection assembly 302 adjacent to the individual's urethral opening. The conduit 316 also allows for the fluid collection assembly 302 to be positioned adjacent to the urethral opening where the fluid reservoir 304 and vacuum source 306 are not positioned between the individual's urethral opening and clothing or between the individual's thighs.

[0060] Separating the fluid reservoir 304 and vacuum source 306 from a location that is not between the individual's urethral opening and the individual's clothing or between the individual's thighs allows the fluid reservoir 304 and vacuum source 306 to exhibit a shape and / or size that may be difficult to position between the individual's urethral opening and the individual's clothing or between the individual's thighs. However, the fluid reservoir 304 and vacuum source 306 may exhibit any of the sizes described above, as the sizes described above may facilitate handling and separate storage of the fluid reservoir 304 and vacuum source 306. The fluid reservoir 304 and vacuum source 306 may also exhibit any of the sizes and shapes described above, which allows an individual to position the fluid reservoir 304 and vacuum source 306 between the individual's urethral opening and clothing and / or between the individual's thighs, as desired.

[0061] The conduit 316 allows the fluid collection assembly 302 to be spaced a maximum distance d from the fluid reservoir 304 and the vacuum source 306 . The maximum distance d is approximately 1cm to approximately 5cm, approximately 2.5cm to approximately 7.5cm, approximately 5cm to approximately 10cm, approximately 7.5cm to approximately 12.5cm, approximately 10cm to approximately 15cm, approximately 12.5cm to approximately 17.5cm, approximately 15cm to approximately 20cm, approximately 17.5cm to approximately 22.5cm, approximately 20cm to approximately 25cm, approximately 22.5cm to approximately 30cm. cm, about 25 cm to about 35 cm, about 30 cm to about 40 cm, about 35 cm to about 45 cm, about 40 cm to about 50 cm, about 45 cm to about 55 cm, about 50 cm to about 60 cm, about 55 cm to about 65 cm, about 60 cm to about 70 cm, about 65 cm to about 75 cm, or about 70 cm to about 80 cm. In general, it is desirable to minimize the maximum distance d to facilitate individual handling of the fluid collection system 300, ease of cleaning the fluid collection system 300, and ease of storing the fluid collection system 300. However, it should be noted that the maximum distance d is selected to be large enough so that the fluid reservoir 304 and vacuum source 306 are not positioned between the individual's urethral opening and clothing and / or between the individual's thighs, if such a location of the fluid reservoir 304 and vacuum source 306 is desired. The maximum distance d disclosed herein may be too small for conventional fluid collection assemblies because the maximum distance d disclosed herein is too small to extend from a urine receiving device (e.g., a Foley catheter) to a conventionally used drainage bag (e.g., a drainage bag hanging from a bend, the back of a wheelchair, or under the seat of a wheelchair) or a conventionally used vacuum source (e.g., a vacuum source on a nightstand or a vacuum source mounted on a wall), especially if it is less than 50 cm.

[0062] The fluid collection assembly 102 shown in Figures 1A and 1B is just one example of a fluid collection assembly that may be used in the fluid collection systems disclosed herein. Further examples of fluid collection assemblies that may be used in the disclosed fluid collection systems are shown and described in connection with Figures 4A-6. Except as otherwise disclosed herein, the fluid collection assemblies of Figures 4A-6 are the same as or substantially similar to any of the fluid collection assemblies disclosed herein and may be used in any of the fluid collection systems disclosed herein.

[0063] FIG. 4A is an isometric view of a fluid collection assembly 402 according to one embodiment. FIG. 4B is a cross-sectional schematic view of the fluid collection assembly 402 along plane 4B-4B according to one embodiment. The fluid collection assembly 402 is an example of a female fluid collection assembly for receiving and collecting bodily fluids from a female. The fluid collection assembly 402 includes a fluid impermeable barrier 408, which may be the same as or similar to any of the fluid impermeable barriers disclosed in one or more aspects herein. The fluid impermeable barrier 408 defines at least a chamber 410, at least one opening 412, and a fluid outlet 414. The fluid collection assembly 402 also includes at least one porous material 424 disposed within the chamber 410. The porous material 424 may be the same as or similar to any of the porous materials disclosed in one or more aspects herein. In one embodiment, as shown, the fluid collection assembly 402 may also include at least one conduit 416 that is partially disposed within a fluid outlet 414 configured to remove one or more bodily fluids from the chamber 410. The conduit 416 may not extend entirely through the porous material 424. In one embodiment, the conduit 416 may be omitted if the fluid outlet 414 is attached directly to a fluid inlet of a fluid reservoir (not shown) or a port of a vacuum source (not shown).

[0064] In one embodiment, the fluid impermeable barrier 408 may include a shell 456 and a connector piece 458 secured to the shell 456. The shell 456 of the fluid collection assembly 402 includes a proximal end region 434, a distal end region 432 opposite the proximal end region 434, a front surface 445, and a rear surface 447 opposite the front surface 445. Typically, during use, the distal end region 432 is closer to the individual's intergluteal cleft than the proximal end region 434, and the front surface 445 generally faces the individual's vaginal area. The shell 456 may be formed from silicone, neoprene, a thermoplastic elastomer, or other fluid impermeable material.

[0065] In one embodiment, the shell 456 includes one or more flanges. The flanges may provide more areas for undergarments or other garments to press against the fluid collection assembly 402, which may facilitate securing the fluid collection assembly 402 to an individual's vaginal area and improve patient comfort. In one embodiment, the flanges may include at least one of an upper flange 460 forming the proximal end region 434 and a lower flange 462 opposite the upper flange 460 forming the distal end region 432.

[0066] The flange of the body may extend from the remainder of the shell 456 by about 1 mm or more, about 1 mm or more, about 3 mm or more, about 4 mm or more, about 5 mm or more, about 6 mm or more, about 7.5 mm or more, about 1 cm or more, about 1.25 cm or more, about 1.5 cm or more, about 1 cm or more, about 1.5 cm or more, about 3 cm or more, about 4 cm or more, about 5 cm or more, or from about 1 mm to about 3 mm, from about 1 mm to about 4 mm, from about 3 mm to about 5 mm, from about 4 mm to about 6 mm, from about 5 mm to about 7.5 mm, from about 6 mm to about 1 cm, from about 7.5 mm to about 1.25 cm, from about 1 cm to about 1.5 cm, from about 1.25 cm to about 1 cm, from about 1.5 cm to about 1.5 cm, from about 1 cm to about 3 cm, from about 1.5 cm to about 4 cm, or from about 3 cm to about 5 cm. The distance that the flanges extend from the remainder of the shell 456 may be selected based on the expected size of the individual's vaginal area (e.g., larger flanges for larger vaginal areas) or the expected rotational forces that will be applied to the fluid collection assembly 402 during use. In some examples, at least some of the flanges may extend further from the remainder of the shell 456 than other flanges. For example, as shown, the lower flange 462 may extend further from the remainder of the fluid impermeable barrier 408 than the upper flange 460 because some individuals may be more comfortable with a longer lower flange 462.

[0067] In one embodiment, one or more flanges may exhibit a concave curvature relative to the front surface 445 of the shell 456. The concave curvature of the flanges may extend from the proximal end region 434 to the distal end region 432. The concave curvature of the flanges may allow the flanges to better conform to the shape of the vaginal region as the vaginal region curves. Having the flanges conform to the shape of the vaginal region may make the fluid collection assembly 402 more comfortable by distributing pressure more evenly across the vaginal region, especially when the flanges contact the labia majora.

[0068] In one embodiment, the shell 456 may include a reservoir 464 at or near the distal end region 432. The reservoir 464 may extend outwardly from the front surface 445 of the shell 456. In use, the reservoir 464 is configured to be at, near, or otherwise in fluid communication with a gravimetrically low point of the porous material 424. For example, the reservoir 464 may contain a portion of the porous material 424 therein. The reservoir 464 may receive at least a portion of the bodily fluid received by the porous material 424. The reservoir 464 may prevent, or at least inhibit, bodily fluid from leaking out of the fluid collection assembly 402. The reservoir 464 may at least partially contain at least a portion of the connector piece 458 therein.

[0069] In one embodiment, the shell 456 may define a recess configured to accommodate the conduit 416. The recess may extend from or near the proximal end region 434 to or near the distal end region 432, thereby allowing the conduit 416 to extend from or near the abdominal region of the individual to the connector piece 458. In one embodiment, the recess may be configured such that the shell 456 surrounds and / or abuts less than 50% of the circumference of the conduit 416, thereby allowing the conduit 416 to move freely in and out of the recess during use. Allowing the conduit 416 to move freely in and out of the recess may facilitate positioning the fluid collection assembly 402 such that the porous material 424 is adjacent to the vaginal region even when the conduit 416 is bent away from the vaginal region. Also, by allowing the conduit 416 to move freely in and out of the recess, movement of the conduit 416 is less likely to displace the porous material 424 relative to the vaginal area, which may cause leakage. In one embodiment, at least a portion of the recess may be configured such that the shell 456 surrounds and / or abuts 50% or more (e.g., 51% to about 55%, about 53% to about 57%, or about 55% to about 60%) of the circumference of the conduit 416. Surrounding 50% or more of the circumference of the conduit 416 may provide a more secure attachment of the conduit 416 to the shell 456 and may allow the conduit 416 to provide additional structure to the shell 456. The percentage of the conduit 416 that is surrounded and / or abutted by the shell 456 may be selected such that the inherent elasticity of the shell 456 and the conduit 416 allows the conduit 416 to easily snap in and out of the recess. Thus, the conduit 416 may be removed from the recess to facilitate positioning the porous material 424 adjacent the vaginal area or when the conduit 416 is moved.

[0070] As previously mentioned, the fluid impermeable barrier 408 includes a connector piece 458 that is attached (e.g., adhesively, welded, interference fit, etc.) to or formed integrally with the shell 456. The connector piece 458 is disposed at or near the distal end region 432 of the shell 456, allowing the connector piece 458 to receive bodily fluids that flow to a gravimetrically low point in the porous material 424. In one embodiment, a portion of the connector piece 458 may be disposed in a reservoir 464 of the shell 456. In an embodiment not shown, the connector piece 458 may form the reservoir 464 in place of the shell 456.

[0071] The connector piece 458 is configured to be connected to the conduit 416. As such, the connector piece 458 may define a fluid outlet 414 configured to be attached to or in fluid communication with the conduit 416. The fluid outlet 414 may be disposed adjacent the rear surface 447 of the fluid impermeable barrier 408. The connector piece 458 may also define a channel 466 (e.g., a conduit) configured to allow the porous material 424 and the reservoir 464 to be in fluid communication with the conduit 416.

[0072] In one embodiment, at least a portion of connector piece 458 may exhibit a greater stiffness than shell 456. The increased stiffness of connector piece 458 relative to shell 456 may facilitate attachment of conduit 416 to connector piece 458. In one example, connector piece 458 may exhibit a greater stiffness than shell 456 when connector piece 458 is formed from a material that exhibits at least one of a greater Young's modulus (i.e., modulus of elasticity), yield strength, or tensile strength than the material forming shell 456. In one example, connector piece 458 may exhibit a greater stiffness than shell 456 when connector piece 458 is thicker than shell 456.

[0073] The fluid collection assemblies shown in Figures 1A, 1B, 4A, and 4B are examples of female fluid collection assemblies configured to collect bodily fluids from a female (e.g., collect urine from a female urethra). However, the fluid collection assemblies, systems, and methods disclosed herein may include male fluid collection assemblies that are shaped, sized, and otherwise configured to collect bodily fluids from a male (e.g., collect urine from a male urethra). Figure 5 is a cross-sectional view of a male fluid collection assembly 502 according to one embodiment.

[0074] The fluid collection assembly 502 includes a base 568 (e.g., an annular base) and a sheath 570. The base 568 is sized, shaped, and made of a material to be coupled to the skin surrounding the male urethral opening (e.g., the penis) and disposed therethrough. For example, the base 568 may define an opening 572. The base 568 may be sized and shaped to be disposed around the male urethral opening (e.g., around and / or on the penis), and the opening 572 may be configured to be disposed therethrough. The base 568 may also be sized, shaped, and made of a material or otherwise configured to be coupled to the skin surrounding the male urethral opening (e.g., around the penis) (e.g., adhered with a hydrogel adhesive, etc.). In one example, the base 568 may follow the general shape or contour of the skin surface selected to be coupled to the base 568. The base 568 may be flexible such that the base 568 can conform to any shape of the skin surface. The base 568 may include a laterally (e.g., radially) extending flange 574. The base 568 also defines a hollow region configured to receive (e.g., fit) the sheath 570. For example, the base 568 may include a longitudinally extending flange 576 that extends upwardly from the base 568. The longitudinally extending flange 576 may be of sufficient height (e.g., at least 0.25 cm high, at least 1 cm high, at least 3 cm high, or at least 5 cm high) to prevent the sheath 570 from being inadvertently dislodged from the base 568. The base 568 is disposed at a proximal end region 534 (relative to the wearer) of the fluid collection assembly 502.

[0075] The sheath 570 includes (e.g., may be formed from) a fluid-impermeable barrier 508, which is sized and shaped to fit within a hollow region of the base 568. For example, the sheath 570 may be generally tubular or cup-shaped, as shown. The generally tubular or cup-shaped fluid-impermeable barrier 508 may at least partially define an outer surface 520 of the sheath 570. The fluid-impermeable barrier 508 may, in one or more embodiments, be similar or identical to any of the fluid-impermeable barriers disclosed herein. For example, the fluid-impermeable barrier 508 may be constructed from any of the materials disclosed herein as fluid-impermeable barriers. The fluid-impermeable barrier 508 at least partially defines a chamber 510. For example, the inner surface 518 of the fluid-impermeable barrier 508 at least partially defines a perimeter of the chamber 510. The chamber 510 may at least temporarily retain bodily fluid therein. As shown, the fluid collection assembly 502 can include a porous material 524 therein. The porous material 524 can, in one or more embodiments, be similar or identical to any of the porous materials disclosed herein. For example, the porous material 524 can include one or more of a fluid-permeable membrane 528 or a fluid-permeable support 526. The fluid-impermeable barrier 508 also defines an opening 512 extending therethrough, the opening 512 being configured for a male urethral opening to be positioned therethrough.

[0076] The sheath 570 includes at least a portion of the conduit 516 therein, and may be at least partially disposed within the chamber 510, for example. For example, the conduit 516 may extend from a distal end region 532 of the sheath 570 to a proximal end region 534 at least proximal to the opening 512. The proximal end region 534 may be disposed near or on the skin surrounding the male urethral opening (e.g., on the penis or on the surrounding pubic area). Thus, when an individual lies on their back, bodily fluids (e.g., urine) may collect on the subject's skin near the opening 512. The bodily fluids may be removed from the chamber 510 via the conduit 516. In one embodiment, the conduit 516 may be omitted, for example, if the fluid outlet 514 is directly connected to a fluid inlet of a fluid reservoir (not shown) or a port of a vacuum source (not shown).

[0077] In some examples, the fluid impermeable barrier 508 may be constructed of a material and / or have a thickness that allows the sheath 570 to collapse when placed under a vacuum, e.g., to remove air around the penis within the fluid collection assembly 502 during use. In such examples, the conduit 516 may extend only to or within the distal end region 532 within the chamber 510 (e.g., not passing to the region adjacent the opening 512). In such examples, urine may be collected and removed from the fluid collection assembly 502.

[0078] In one example, a portion of the chamber 510 may be substantially empty due to differences in the size and hardness of male penises. However, in some examples, the outermost region of the chamber 510 (e.g., around the interior region of the sheath 570) may include a porous material 524 (e.g., one or more of a fluid-permeable membrane 528 and a fluid-permeable support 526). For example, the porous material 524 may be bonded to the inner surface 518 of the fluid-impermeable barrier 508. The porous material 524 may be positioned (e.g., at the distal end of the chamber 510) to slow the flow of urine from the male urethral opening, thereby limiting splashing, and / or direct bodily fluids to selected regions of the chamber 510. Because the chamber 510 is substantially empty (e.g., substantially all of the chamber 510 forms a reservoir), bodily fluids tend to collect at gravimetrically low points in the chamber 510. The gravimetric low point of the chamber 510 may be the intersection of the individual's skin and the fluid collection assembly 502, a corner formed in the sheath 570, or another suitable location depending on the orientation of the wearer.

[0079] The porous material 524 may include one or more of a fluid-permeable membrane 528 or a fluid-permeable support 526. The fluid-permeable membrane 528 and the fluid-permeable support 526 may, in one or more embodiments, be similar or identical to any of the fluid-permeable membranes and fluid-permeable supports, respectively, disclosed herein. One or more of the fluid-permeable membrane 528 or the fluid-permeable support 526 may be disposed between the fluid-impermeable barrier 508 and the penis inserted into the chamber 510. The fluid-permeable membrane 528 may be disposed between the fluid-impermeable barrier 508 and the penis inserted into the chamber 510, for example, between the fluid-permeable support 526 and the penis of the wearer as shown. The fluid-permeable support 526 may be disposed between the fluid-permeable membrane 528 and the fluid-impermeable barrier 508. Optionally, the inner surface 518, including the end of the chamber 510 substantially opposite the opening 512, may be covered with one or both of a fluid-permeable membrane 528 or a fluid-permeable support 526. The fluid-permeable support 526 or the fluid-permeable membrane 528 may be secured (e.g., glued) to the fluid-impermeable barrier 508. The fluid-permeable support 526 or the fluid-permeable membrane 528 may be secured to one another. In some examples, the porous material 524 includes only the fluid-permeable membrane 528 or the fluid-permeable support 526.

[0080] The fluid collection assembly 502 includes a cap 578 at the distal end region 532. The cap 578 defines an internal channel through which bodily fluids may be removed from the fluid collection assembly 502. The internal channel is in fluid communication with the chamber 510. The cap 578 may be disposed over at least a portion of the distal end region 532 of one or more of the fluid impermeable barrier 508 or the porous material 524. The cap 578 may be made of a polymer, rubber, or other fluid impermeable material. The cap 578 may be attached to one or more of the fluid impermeable barrier 508, the porous material 524, or the conduit 516. The cap 578 may cover at least a portion of the distal end region 532 of the fluid collection assembly 502. The cap 578 may define a fluid outlet 514 that is sized and configured to receive and fluidly seal the conduit 516. The conduit 516 can extend a distance, such as into or through the cap 578 to the porous material 524, through the porous material 524, or to a point away from the porous material 524. In the latter example, as shown in FIG. 5B, an interior channel of the cap 578 can define a reservoir 530 therein.

[0081] The reservoir 530 is an unoccupied portion of the device, such as the cap 578, and is free of other materials. In some examples, the reservoir 530 is at least partially defined by the porous material 524 and the cap 578. During use, bodily fluid within the chamber 510 can flow through the porous material 524 to the reservoir 530. The reservoir 530 can be positioned to store at least a portion of the bodily fluid therein and / or to remove the bodily fluid via the conduit 516. In some examples, at least a portion of the porous material 524 extends continuously between at least a portion of the opening of the interior channel and the chamber 510 and can wick bodily fluid directly from the opening to the reservoir 530.

[0082] In some examples (not shown), the fluid impermeable barrier 508 may be disposed on or over the cap 578 , for example, disposed to surround the cap 578 within the chamber 510 .

[0083] In some examples, the sheath 570 can include at least a portion of the conduit 516 therein, e.g., at least partially disposed within the chamber 510. For example, the conduit 516 can extend from the sheath 570 to a region at least proximate the opening 512. An inlet of the conduit 516 can be disposed adjacent the annular base 580. An inlet of the conduit 516 can be disposed adjacent the annular base 580, e.g., adjacent or proximate to a gravimetrically low point of the chamber 510. For example, the inlet can be coextensive with the opening 512 or offset from the opening 512. In an example, the inlet can be disposed adjacent the distal end region 532 of the sheath 570 (e.g., substantially opposite the opening 512).

[0084] The proximal end region 534 may be located near or on the skin around the male urethral opening (e.g., around the penis) and the inlet of the conduit 516 may be located at the proximal end region 534. The outlet of the conduit 516 may be directly or indirectly coupled to a vacuum source. Thus, bodily fluids may be removed from the proximal end region 534 of the chamber 510 via the conduit 516.

[0085] The base 568, the sheath 570, the cap 578, and the conduit 516 may be attached together using any suitable method. For example, at least two of the base 568, the sheath 570, the cap 578, or the conduit 516 may be attached together using at least one of an interference fit, adhesive, stitching, welding (such as ultrasonic welding), tape, other suitable methods, or a combination thereof.

[0086] In some examples (not shown), the fluid collection assembly 502 may be of a one-piece design, where one or more of the sheath 570, base 568, and cap 578 are a single, integrally formed part.

[0087] 6 is a cross-sectional view of a fluid collection assembly 602, according to one embodiment. Although the fluid collection assembly 602 is an example of a male fluid collection assembly, in some embodiments, the fluid collection assembly 602 may be used to receive bodily fluids from a female urethral opening. The fluid collection assembly 602 includes a sheath 670 and a base 668. The base 668 is configured to be attached (e.g., permanently attached or configured to be permanently attached) to the sheath 670. The base 668 is also configured to be attached to the area surrounding the individual's urethral opening (e.g., the penis).

[0088] The sheath 670 includes a fluid impermeable barrier 608 formed at least in part from a first panel 682 and a second panel 684. The first panel 682 and the second panel 684 may be attached together or integrally formed (e.g., shown as a single piece construction). As shown, in one embodiment, the first panel 682 and the second panel 684 are separate sheets. The fluid impermeable barrier 608 also defines a chamber 610 between the first panel 682 and the second panel 684, an opening 612 at the proximal end region 634 of the sheath 670, and a fluid outlet 614 at the distal end region 632 of the sheath 670. The sheath 670 further includes at least one porous material 624 disposed within the chamber 610.

[0089] The inner surface(s) of the fluid impermeable barrier 608 (e.g., the inner surfaces of the first panel 682 and the second panel 684) at least partially define a chamber 610 within the fluid collection assembly 602. The fluid impermeable barrier 608 temporarily stores bodily fluids within the chamber 610. The fluid impermeable barrier 608 may be formed from any of the fluid impermeable materials disclosed herein. Thus, the fluid impermeable barrier 608 substantially prevents bodily fluids from passing through the fluid impermeable barrier 608.

[0090] In one embodiment, at least one of the first panel 682 or the second panel 684 is formed from an at least partially transparent, fluid impermeable material, such as polyethylene, polypropylene, polycarbonate, or polyvinyl chloride. Forming at least one of the first panel 682 or the second panel 684 from an at least partially transparent, fluid impermeable material allows a person (e.g., a physician) to examine the penis. In some embodiments, both the first panel 682 and the second panel 684 are formed from an at least partially transparent, fluid impermeable material. By selecting at least one of the first panel 682 or the second panel 684 to be formed from an at least partially transparent, impermeable material, the penis can be examined without removing the entire fluid collection assembly 602 from the area surrounding the penis. For example, the chamber 610 includes a penis receiving area 686 that is configured to receive an individual's penis when the penis extends into the chamber 610. Penis receiving area 686 may be defined by at least porous material 624 and at least a portion of the at least partially transparent material of first panel 682 and / or second panel 684. In other words, porous material 624 is disposed in chamber 610 such that porous material 624 is not located between the penis and at least a portion of the transparent portion of first panel 682 and / or second panel 684 when the penis is inserted into chamber 610 through opening 612. Porous material 624 is generally not transparent, and thus the portion of the at least partially transparent material of first panel 682 and / or second panel 684 that defines penis receiving area 686 forms a window that allows a person to look into penis receiving area 686 and inspect the penis.

[0091] The opening 612 defined by the fluid impermeable barrier 608 provides an access path for bodily fluids to enter the chamber 610 when the penis is buried and allows the penis to enter the chamber 610 (e.g., the penis receiving area 686) when the penis is not buried. The opening 612 may be defined by the fluid impermeable barrier 608 (e.g., an inner edge of the fluid impermeable barrier 608). For example, the opening 612 is formed in and extends through the fluid impermeable barrier 608 such that bodily fluids can enter the chamber 610 from outside the fluid collection assembly 602.

[0092] The fluid impermeable barrier 608 defines a fluid outlet 614 sized to receive a conduit 616. The conduit 616 may be at least partially disposed within the chamber 610 or in fluid communication with the chamber 610 via the fluid outlet 614. The fluid outlet 614 may be sized and shaped to form at least a substantially fluid-tight seal with the conduit 616, thereby substantially preventing bodily fluids from escaping the chamber 610. In one embodiment, the fluid outlet 614 may be formed from portions of the first panel 682 and the second panel 684 that are not attached or integrally formed together. In one such embodiment, the fluid impermeable barrier 608 may not include a cap that is more rigid than the surrounding portions of the fluid impermeable barrier 608, which may facilitate the manufacture of the fluid collection assembly 602 by reducing the number of parts used to form the fluid collection assembly 602 and may reduce the time required to manufacture the fluid collection assembly 602. It should be noted that while the lack of a cap may make it difficult to secure the conduit 616 to the fluid outlet 614 using an interference fit, it is still possible to attach the conduit 616 to the fluid outlet 614. Thus, the conduit 616 may be attached to the fluid outlet 614 (e.g., the first and second panels 682, 684) using adhesives, welding, or other methods of joining the conduit 616 to the fluid outlet 614. Attaching the conduit 616 to the fluid outlet 614 may prevent leakage and may prevent the conduit 616 from accidentally being removed from the fluid outlet 614. In one example, the conduit 616 may be attached to the fluid outlet 614 in the same manufacturing step as attaching the first and second panels 682, 684 together.

[0093] As previously described, the sheath 670 includes at least one porous material 624 disclosed in the chamber 610. The porous material 624 may direct bodily fluids to one or more selected regions of the chamber 610, such as away from the penis, toward the fluid outlet 614. The porous material 624 may be formed from any of the porous materials disclosed herein. In one example, the porous material 624 may be formed from a single layer, two layers (e.g., a fluid-permeable membrane and a fluid-permeable support extending across the opening 612, as the fluid-permeable membrane may be formed from a relatively foldable, thin, or easily deformable material), or three or more layers. In one example, the porous material 624 may be formed from a nonwoven or woven material (e.g., spun nylon fibers). In one example, the porous material 624 may include at least one material that is substantially non-absorbent, or at least one absorbent or adsorbent material.

[0094] In one embodiment, the porous material 624 can be a sheet. Forming the porous material 624 as a sheet can facilitate manufacturing of the fluid collection assembly 602. For example, forming the porous material 624 as a sheet can provide the first panel 682, the second panel 684, and the porous material 624 as sheets. During manufacturing of the fluid collection assembly 602, the first panel 682, the second panel 684, and the porous material 624 can be stacked in the same manufacturing step and then attached to one another. For example, the porous material 624 can exhibit a shape that is the same size as the first panel 682 and the second panel 684, or more desirably, slightly smaller than the size of the first panel 682 and the second panel 684. Thus, the porous material 624 can also be attached to the first panel 682 and the second panel 684 when the first panel 682 and the second panel 684 are attached together along their outer edges. The porous material 624 may be slightly smaller than the first panel 682 and the second panel 684 such that the first panel 682 and / or the second panel 684 extend around the porous material 624 so that the porous material 624 does not form a passageway through the fluid impermeable barrier 608 through which bodily fluids may leak. Attaching the porous material 624 to the first panel 682 and / or the second panel 684 may also prevent the porous material 624 from moving significantly within the chamber 610, such as preventing the porous material 624 from bunching up near the fluid outlet 614. In one example, the porous material 624 may be attached (e.g., via an adhesive) to the first panel 682 or the second panel 684 before or after attaching the first panel 682 to the second panel 684. In one example, the porous material 624 may simply be disposed within the chamber 610 without attaching the porous material 624 to at least one of the first panel 682 or the second panel 684. In one embodiment, the porous material 624 may exhibit a shape other than a sheet, such as a hollow generally cylindrical shape.

[0095] Generally, the sheath 670 is substantially flat when the penis is not in the penis receiving area 686 and the sheath 670 is resting on a flat surface. The sheath 670 is substantially flat because the fluid impermeable barrier 608 is formed from the first panel 682 and the second panel 684 instead of a generally tubular fluid impermeable barrier. Additionally, as previously discussed, the porous material 624 may be a sheet, which also renders the sheath 670 substantially flat. The sheath 670 is substantially flat may further be because the fluid collection assembly 602 does not include any relatively rigid rings or caps that are more rigid than the surrounding portions of the fluid impermeable barrier 608, which may prevent the sheath 670 from being substantially flat. It is noted that the sheath 670 is described as being substantially flat because at least one of the porous materials 624 may cause the sheath 670 to bulge slightly depending on the thickness of the porous material 624, the fluid outlet 614 and / or the conduit 616 may cause a bulge around it, or the base 668 may pull a portion of the sheath 670 around it. It is also noted that the sheath 670 may be compliant, such that the sheath 670 may not be substantially flat during use, because during use the sheath 670 may be placed on a non-flat surface (e.g., between the testicles, perineum, and / or thighs) and the sheath 670 may conform to these shaped surfaces.

[0096] The ability of the sheath 670 to lie substantially flat when the penis is not within the penis receiving area 686 and the sheath 670 is resting on a flat surface allows the fluid collection assembly 602 to be used with both buried and non-buried penises. For example, when the fluid collection assembly 602 is used with a buried penis, the penis does not extend into the penis receiving area 686, causing the sheath 670 to lie relatively flat across the opening 672 in the base 668. When the sheath 670 is relatively flat across the opening 672, the porous material 624 extends across the opening 612 and the opening 672 and is adjacent to the buried penis. In this manner, the porous material 624 prevents or inhibits bodily fluids drained from the buried penis from pooling on the individual's skin because the porous material 624 receives and removes at least a substantial portion of the bodily fluids that would otherwise pool on the individual's skin. Thus, the individual's skin remains dry, thereby improving comfort and preventing skin deterioration when using the fluid collection assembly 602. However, unlike other conventional fluid collection assemblies configured for use with a buried penis, the fluid collection assembly 602 can also be used with a non-buried penis, since a non-buried penis can be received within the penis receiving area 686 even when the penis is fully erect. Additionally, the ability of the sheath 670 to be substantially flat allows the fluid collection assembly 602 to be used more discreetly than if the sheath 670 were not substantially flat, avoiding embarrassing situations.

[0097] When the sheath 670 is substantially flat, the porous material 624 occupies substantially all of the chamber 610 and the penis receiving area 686 is folded (shown in FIG. 6 in an unfolded state for illustrative purposes to show the penis receiving area 686). In other words, the sheath 670 may not define an area that is always free of the porous material 624. When the porous material 624 occupies substantially all of the chamber 610, bodily fluids discharged into the chamber 610 are less likely to pool for an extended period of time, as pooling of bodily fluids may create hygiene issues, produce odors, and / or leave the individual's skin in contact with the bodily fluids, causing discomfort and skin deterioration.

[0098] As previously mentioned, the first panel 682, the second panel 684, and the porous material 624 may be selected to be relatively flexible. The first panel 682, the second panel 684, and the porous material 624 may be relatively flexible, where each of the first panel 682, the second panel 684, and the porous material 624 may not be able to maintain its shape when unsupported. As previously mentioned, the flexibility of the first panel 682, the second panel 684, and the porous material 624 may allow the sheath 670 to be substantially flattened. The flexibility of the first panel 682, the second panel 684, and the porous material 624 may allow the sheath 670 to conform to the shape of the penis even as the penis changes in size and shape (e.g., when erect) and minimize unoccupied space within the chamber 610 where bodily fluids may accumulate.

[0099] As mentioned above, the fluid collection assembly 602 includes a base 668, which is configured to be attached to the sheath 670. For example, the base 668 is configured to be permanently attached to the sheath 670. The base 668 is configured to be permanently attached to the sheath 670, for example, if the fluid collection assembly 602 includes a base 668 that is permanently attached to the sheath 670 or if the base 668 is not permanently attached to the sheath 670, but is configured to be permanently attached to the sheath 670 at some point in the future. Permanently attached means that the sheath 670 cannot be removed from the base 668 without damaging at least one of the sheath 670 or the base 668, using a blade to remove the sheath 670 from the base 668, and / or using a chemical to dissolve the adhesive that attached the sheath 670 to the base 668. The base 668 may be permanently attached to the sheath 670 using adhesives, stitching, heat sealing, RF welding, or US welding. In one embodiment, the base 668 is configured to be reversibly attached to the sheath 670. In one embodiment, the base 668 is integrally formed with the sheath 670.

[0100] The base 668 includes an aperture 672. The base 668 is permanently attached to the distal end region 632 of the sheath 670, with the aperture 672 aligned with the opening 612.

[0101] The base 668 is sized, shaped, and made of a material to be coupled to the skin surrounding the penis (e.g., the mons pubis, thighs, testicles, and / or perineum) and through which the penis is placed. For example, the base 668 may define an opening 672 that is configured for the penis to be placed therethrough. In one example, the base 668 may follow the general shape or contour of a skin surface to which the base 668 is configured to be coupled. The base 668 may be flexible, thereby allowing the base 668 to conform to any shape of the skin surface and reduce pulling on the skin surface by the base 668. The base 668 may extend laterally beyond the sheath 670, thereby increasing the surface area of ​​an individual's skin to which the fluid collection assembly 602 can be attached as compared to a substantially similar fluid collection assembly 602 that does not include a base.

[0102] As previously mentioned, the fluid collection assembly 602 may include a conduit 616. The inlet of the conduit 616 may be located near the distal end region 632 of the sheath 670, which is expected to be a gravimetrically low point of the chamber 610 when worn by an individual. By locating the inlet at or near the distal end region 632 of the sheath 670, the conduit 616 may receive more bodily fluid than if the conduit 616 inlet were located elsewhere, reducing the possibility of pooling (e.g., pooling of bodily fluids may cause microbial growth and foul odors). In one embodiment, the conduit 616 may be omitted, for example, if the fluid outlet 614 is attached directly to a fluid inlet of a fluid reservoir (similar to that shown in FIGS. 1A-2) or a port of a vacuum source (not shown).

[0103] Other examples of fluid collection assemblies that may be used in the fluid collection systems disclosed herein are disclosed in U.S. Patent No. 6,393,636, filed June 2, 2017, U.S. Patent No. 6,393,636, filed September 8, 2016, U.S. Patent No. 6,393,636, filed June 3, 2017, U.S. Patent No. 6,393,636, published January 6, 2022, U.S. Patent No. 6,393,636, filed June 6, 2019, U.S. Patent No. 7,393,636, published January 28, 2021, U.S. Patent No. 9,393,636, published October 14, 2021, U.S. Patent No. 6,393,636, filed June 16, 2020, and U.S. Patent No. 6,393,636, filed June 8, 2021, the disclosures of each of which are incorporated herein by reference in their entirety. In one embodiment, these fluid collection assemblies may be attached directly to the fluid inlet of the fluid reservoir (see FIG. 2) or to the port of the vacuum source. In one embodiment, the fluid collection assemblies may include conduits connecting the fluid collection assemblies to a fluid reservoir, as shown in FIG.

[0104] While various aspects and embodiments are disclosed herein, other aspects and embodiments are contemplated. The various aspects and embodiments disclosed herein are intended to be illustrative and not limiting.

[0105] Terms of degree (e.g., "about," "substantially," "generally," etc.) indicate structurally or functionally insignificant variations. In one example, when a term of degree is included in a term indicating a quantity, the term of degree is interpreted to mean ±10%, ±5%, or +2% of the term indicating a quantity. In one example, when a term of degree is used to modify a shape, the term of degree indicates that the shape modified by the term of degree has the appearance of the disclosed shape. For example, the term of degree can be used to indicate that the shape may have rounded corners instead of sharp corners, curved edges instead of straight edges, one or more protrusions extending therefrom are rectangular, the same as the disclosed shape, etc.

Claims

1. 1. A fluid collection system comprising:

1. A fluid collection assembly comprising: a fluid impermeable barrier defining at least a chamber, at least one opening, and a fluid outlet; at least one porous material disposed within the chamber; A fluid storage container; and a vacuum source; Where: the fluid collection assembly, the fluid reservoir, and the vacuum source being in fluid communication with one another such that at least a portion of one or more bodily fluids are received in the chamber, removed from the chamber using suction provided by the vacuum source, and deposited in the fluid reservoir; at least, the fluid impermeable barrier is in direct contact with at least one of the fluid reservoir or the vacuum source; or the fluid collection system further comprising at least one conduit connected to the fluid outlet of the fluid collection assembly and one of the fluid reservoir or the vacuum source, the at least one conduit having a length of about 50 cm or less; Fluid collection system.

2. The fluid collection system of claim 1 , wherein the fluid impermeable barrier is in direct contact with at least one of the fluid reservoir or the vacuum source.

3. The fluid collection system of claim 2 , wherein the fluid impermeable barrier is in direct contact with the fluid reservoir.

4. The fluid collection system of claim 2 , wherein the fluid impermeable barrier is in direct contact with the vacuum source.

5. 5. The fluid collection system of claim 1, further comprising at least one conduit connected to the fluid outlet of the fluid collection assembly and one of the fluid storage container or the vacuum source, the at least one conduit having a length of about 50 cm or less.

6. 6. The fluid collection system of claim 1, wherein the fluid storage container and the vacuum source are configured to be positioned at least partially between an individual's urethral opening and the individual's clothing or between the individual's thighs, where the opening of the fluid collection assembly is positioned adjacent to the individual's urethral opening or receives the individual's penis.

7. The fluid collection system of claim 1 , wherein at least one of the fluid reservoir or the vacuum source has a shape that exhibits a generally triangular cross-sectional shape.

8. The fluid collection system of claim 1 , wherein the fluid collection assembly and the fluid reservoir are configured for single use.

9. The fluid collection system of claim 1 , wherein the fluid reservoir defines an enclosure exhibiting a volume of about 500 mL or less.

10. The fluid collection system of claim 1 , further comprising at least one sealing element configured to prevent bodily fluids from escaping from the fluid reservoir.

11. The fluid collection system of claim 1 , wherein the fluid reservoir is located upstream of the vacuum source.

12. The fluid collection system of claim 1 , wherein the vacuum source is located upstream of the fluid reservoir.

13. 1. A method of using a fluid collection system, comprising: positioning at least one opening of a fluid collection assembly adjacent to a urethral opening of an individual or such that the individual's penis passes through said at least one opening, said fluid collection assembly including a fluid impermeable barrier defining at least a chamber, said at least one opening, and a fluid outlet, said fluid collection assembly including at least one porous material disposed within said chamber; receiving at least one bodily fluid from the individual into the chamber and within the at least one porous material; applying suction to the chamber via a vacuum source to remove at least a portion of the bodily fluid within the chamber and depositing the bodily fluid in a fluid reservoir; Here, at least, the fluid impermeable barrier is in direct contact with at least one of the fluid reservoir or the vacuum source; or the fluid collection system further comprising at least one conduit connected to the fluid outlet of the fluid collection assembly and one of the fluid reservoir or the vacuum source, the at least one conduit having a length of about 50 cm or less; method.

14. The method of claim 13 , wherein the fluid impermeable barrier is in direct contact with at least one of the fluid reservoir or the vacuum source.

15. 15. The method of claim 13, wherein the fluid collection system further comprises at least one conduit connected to the fluid outlet of the fluid collection assembly and one of the fluid storage container or the vacuum source, and wherein the at least one conduit has a length of about 50 cm or less.

16. 16. The method of any one of claims 13 to 15, wherein positioning the at least one opening of the fluid collection assembly adjacent to the urethral opening of the individual or such that the penis of the individual passes through the at least one opening and receiving one or more bodily fluids from the individual into the chamber and into the at least one porous material is performed while the individual is in a sitting position.

17. 17. The method of any one of claims 13 to 16, wherein positioning the at least one opening of the fluid collection assembly adjacent to the urethral opening of the individual or such that the penis of the individual passes through the at least one opening, receiving one or more bodily fluids from the individual into the chamber and into the at least one porous material, and providing suction to the chamber via a vacuum source are performed substantially without removing clothing from the individual.

18. 18. The method of any one of claims 13 to 17, wherein positioning the at least one opening of the fluid collection assembly adjacent to the urethral opening of the individual or such that the individual's penis passes through the at least one opening comprises positioning at least a portion of the fluid storage container and the vacuum source between the urethral opening of the individual and a garment of the individual.

19. 19. The method of any one of claims 13 to 18, wherein positioning the at least one opening of the fluid collection assembly adjacent to the urethral opening of the individual or such that the individual's penis passes through the at least one opening comprises positioning at least a portion of the fluid storage container and the vacuum source between the individual's thighs.

20. 20. The method of claim 13, further comprising applying suction to the chamber via a vacuum source to remove at least a portion of the bodily fluid within the chamber and depositing the bodily fluid in a fluid storage container, followed by removing the fluid collection assembly from the vacuum source and discarding the fluid collection assembly.

21. 21. The method of any one of claims 13 to 20, further comprising applying suction to the chamber via a vacuum source to remove at least a portion of the bodily fluid within the chamber, depositing the bodily fluid in a fluid reservoir, then removing the fluid reservoir from the vacuum source and discarding the fluid reservoir.

22. applying suction to the chamber via a vacuum source to remove at least a portion of the bodily fluid within the chamber and depositing the bodily fluid in a fluid reservoir; removing the one or more bodily fluids from the fluid collection container; 21. The method of any one of claims 13 to 20, further comprising cleaning the fluid reservoir.

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