Male external catheter device having a body portion and a bag portion, and related systems and methods of use of the catheter device

Abstract

An example fluid collection assembly includes a fluid impermeable barrier, at least one porous material disposed in a chamber of the fluid impermeable barrier, a body, and one or more straps. The fluid impermeable barrier has a proximal end region and a distal end region, and defines at least the chamber, a first opening sized to receive at least a portion of a penis therethrough, and a fluid outlet disposed at least proximate to the distal end region. The body includes a first region secured to the proximal end region of the fluid impermeable barrier and a second region opposite to and spaced from the first region. The first region defines a second opening aligned with the first opening of the fluid impermeable barrier and sized to receive at least a portion of the penis therethrough. The one or more straps are secured to the second region of the body.

Description

MALE EXTERNAL CATHETER DEVICE HAVING A BODY PORTION AND A BAG PORTION, AND RELATED SYSTEMS AND METHODS OF USEOF THE CATHETER DEVICEBACKGROUND

[0001] A person or animal may have limited or impaired mobility so typical urination processes are challenging or impossible. For example, a person may experience or have a disability that impairs mobility. A person may have restricted travel conditions such as those experienced by pilots, drivers, and workers in hazardous areas. Additionally, sometimes bodily fluids collection is needed for monitoring purposes or clinical testing.

[0002] Urinary catheters, such as a Foley catheter, can address some of these circumstances, such as incontinence. Unfortunately, urinary catheters can be uncomfortable, painful, and can lead to complications, such as infections. Additionally, bed pans, which are receptacles used for the toileting of bedridden individuals are sometimes used. However, bedpans can be prone to discomfort, spills, and other hygiene issues.SUMMARY

[0003] Embodiments disclosed herein are related to fluid collection assemblies, and related systems and methods of use. In an embodiment, a fluid collection assembly includes a fluid impermeable barrier, at least one porous material, a body, and one or more straps. The fluid impermeable barrier has a proximal end region and a distal end region. The fluid impermeable barrier defines at least a chamber, a first opening sized to receive at least a portion of a penis therethrough, and a fluid outlet disposed at least proximate to the distal end region. The at least one porous material is disposed in the chamber. The body includes a first region secured to the proximal end region of the fluid impermeable barrier and a second region opposite to and spaced from the first region. The first region defines a second opening aligned with the first opening of the fluid impermeable barrier and sized to receive at least a portion of the penis therethrough. The one or more straps are secured to the second region of the body.

[0004] In an embodiment, a fluid collection system includes any fluid collection assembly described herein, a fluid storage container, and a vacuum source. The chamber of the fluid collection assembly, the fluid storage container, and the vacuum source are in fluid communication with each other so that, when one or more bodily fluids are present in the chamber, a suction provided from the vacuum source to the chamber of the fluidcollection assembly removes the one or more bodily fluids from the chamber and deposits the bodily fluids in the fluid storage container.

[0005] In an embodiment, a method to collect bodily fluids from a patient is disclosed. The method includes securing a fluid collection assembly at least proximate to a penis of user with one or more straps secured to an upper region of a body of the fluid collection assembly. The method also includes positioning a first opening defined by a fluid impermeable barrier of the fluid collection assembly and second opening defined by a lower region of the body of the fluid collection assembly to receive a penis of the patient through the first opening and into a chamber defined by the fluid impermeable barrier. The fluid impermeable barrier defines at least the chamber, the first opening, and a fluid outlet. The fluid impermeable barrier includes a distal end region including the fluid outlet and a proximal end region secured to a lower region of the body spaced from the upper region of the body. The method also includes discharging bodily fluids onto at least one porous material in the chamber. The method also includes receiving the bodily fluids into at least one porous material of the fluid collection assembly that is disposed in the chamber. The method also includes removing the bodily fluids from the chamber via the fluid outlet.

[0006] Features from any of the disclosed embodiments may be used in combination with one another, without limitation. In addition, other features and advantages of the present disclosure will become apparent to those of ordinary skill in the art through consideration of the following detailed description and the accompanying drawings.BRIEF DESCRIPTION OF THE DRAWINGS

[0007] The drawings illustrate several embodiments of the present disclosure, wherein identical reference numerals refer to identical or similar elements or features in different views or embodiments shown in the drawings.

[0008] FIG. 1A is an isometric side view of a fluid collection assembly, according to an embodiment.

[0009] FIG. IB is a partial cross-sectional view of the fluid collection assembly of FIG. 1A.

[0010] FIG. 2A is a top view of a fluid collection assembly, according to an embodiment.

[0011] FIG. 2B is a cross-sectional view of the fluid collection assembly of FIG. 1A taken along line 2B-2B of FIG. 1A.

[0012] FIG. 3 is a block diagram of a fluid collection system for fluid collection, according to an embodiment.

[0013] FIG. 4 is a flowchart of a method of collecting fluid, according to an embodiment.DETAILED DESCRIPTION

[0014] Embodiments disclosed herein are related to fluid collection assemblies including a fluid impermeable barrier, at least one porous material disposed in a chamber of the fluid impermeable barrier, a body, and one or more straps, and related systems and methods of use of the fluid collection assemblies. In many embodiments, the fluid impermeable barrier has a proximal end region and a distal end region, and defines at least the chamber, a first opening sized to receive at least a portion of a penis therethrough, and a fluid outlet disposed at least proximate to the distal end region. In many embodiments, the body is at least semi-rigid and includes a first region secured to the proximal end region of the fluid impermeable barrier and a second region opposite to and spaced from the first region. The one or more straps are secured to the second region of the body.

[0015] In at least one, some, or all embodiments, the fluid collection assembly is configured such that the straps push the first region of the body and / or a foam cushioning secured thereto against the patient. The body and / or the foam cushion pushed against patient results in the technical effect of forming a seal against the skin of the patient. The body may include a semi-rigid material such as rubber to retain shape and be comfortable for the patient.

[0016] In at least one, some, or all embodiments, the fluid impermeable barrier of the fluid collection assembly may include a material that is bag-like e.g., soft polyethylene bag material) that results in the technical effect of urine flowing to the fluid outlet of the fluid impermeable barrier. For example, the material of the fluid impermeable barrier in combination with the semi-rigid body results in the technical effect of allowing the fluid impermeable barrier to swing or move freely within or relative to the semi-rigid body. In at least one, some, or all embodiments, the material of the fluid impermeable barrier in combination with the semi-rigid housing results in the technical effect of allowing the fluid impermeable barrier to be easily adjusted as the patient moves from one side to the other to ensure urine drains down to the fluid outlet of the fluid impermeable barrier.

[0017] FIG. 1A is an isometric side view of a fluid collection assembly 100 and FIG. IB is a partial cross-sectional view of the fluid collection assembly 100 of FIG. 1A,according to an embodiment. The fluid collection assembly 100 (e.g. , male external catheter assembly) may include a fluid impermeable barrier 102, at least one porous material 122 disposed in a chamber 112 defined by the fluid impermeable barrier 102, a body 101 that is at least semi-rigid and secured to a proximal end region 160 of the fluid impermeable barrier 102; and one or more straps 111 secured the body 101 and spaced from the proximal end region 160 of the fluid impermeable barrier 102.

[0018] The fluid impermeable barrier 102 includes the proximal end region 160 and a distal end region 162 opposite to the proximal end region 160, according to an embodiment. The fluid impermeable barrier 102 also may define at least the chamber 112, a first opening 114 sized to receive at least a portion of a penis therethrough, and a fluid outlet 118 disposed at least proximate to the distal end region 162. In some embodiments, the fluid impermeable barrier 102 may be generally tubular and / or cylindrical shaped to form an elongated sheath having the first opening 114 at the proximal end region 160 and the fluid outlet 118 at the distal end region 162. The inner surface of the fluid impermeable barrier 102 may at least partially define the chamber 112 within the sheath formed by the fluid impermeable barrier 102. The fluid impermeable barrier 102 temporarily stores the bodily fluids in the chamber 1 12.

[0019] The fluid impermeable barrier 102 may be formed of any suitable fluid impermeable material(s), such as a fluid impermeable polymer (e.g., silicone, polypropylene, polyethylene, polyethylene terephthalate, polyurethane, polyethylene, polyvinyl chloride, a polycarbonate, etc.), a metal film, natural rubber, another suitable material, or combinations thereof. As such, the fluid impermeable barrier 102 substantially prevents the bodily fluids from passing through the fluid impermeable barrier 102. In an example, the fluid impermeable barrier 102 may be air permeable and fluid impermeable thus preventing leaks while allowing air flow through the chamber 112 when a vacuum force is applied thereto (?.<?., the chamber 112 remains at about atmospheric pressure thereby preventing the vacuum force from causing a hickie or kinking a conduit in fluid communication with the fluid outlet 118). In such an example, the fluid impermeable barrier 102 may be formed of a hydrophobic material that defines a plurality of pores. At least one or more portions of at least an outer surface of the fluid impermeable barrier 102 may be formed from a soft and / or smooth material, thereby reducing chaffing.

[0020] In an embodiment, the fluid impermeable barrier 102 is formed from polyurethane, such as formed only from polyurethane. It has been found in clinical trialsthat forming the fluid impermeable barrier 102 from polyurethane improves the functionality of the fluid collection assembly 100. For example, the fluid impermeable barrier 102 may exhibit a flexibility when formed from polyurethane that is greater than when the fluid impermeable barrier 102 'is formed from another material. The increased flexibility of the fluid impermeable barrier 102 formed from the polyurethane makes it easier to attach the fluid collection assembly 100 to the individual and maintain the fluid collection assembly 100 attached to the individual. The increased flexibility of the fluid impermeable barrier 102 formed from the polyurethane also help allow the fluid collection assembly 100 to conform to the individual and / or fit underneath the clothing of the individual thereby increasing patient comfort. The polyurethane may also remain flexible when welded or otherwise have seals formed therein. It has also been found that individuals using the fluid collection assembly 100 describe the fluid impermeable barrier 102 formed from polyurethane as being more smooth than when the fluid impermeable barrier 102 is formed from other materials. The smoother feel of the fluid impermeable barrier 102 formed from polyurethane makes wearing the fluid collection assembly 100 more comfortable. It has also been found that forming the fluid impermeable barrier 102 from the polyurethane allows the fluid impermeable barrier 102 to be bent (e.g. , crumpled, wrinkled, etc.) more quietly than if the fluid impermeable barrier 102 was formed from another material. The improved quietness of the fluid impermeable barrier 102 allows the fluid collection assembly 100 to be used more discreetly. For example, movement of an individual using the fluid collection assembly 100 is likely to cause the fluid impermeable barrier 102 to bend. Forming the fluid impermeable barrier 102 from polyurethane allows the individual to move more substantially without the fluid impermeable barrier 102 generating noise. Finally, it has been found that the fluid impermeable barrier 102 that includes polyurethane is able to be welded to a variety of materials thereby facilitating attachment of the foam cushion 103 and or the body 101.

[0021] In an embodiment, at least some e.g., all) of the fluid impermeable barrier 102 is formed from an at least partially transparent fluid impermeable material, such as polyethylene, polypropylene, polyurethane, polycarbonate, or polyvinyl chloride. Forming the fluid impermeable barrier 102 from an at least partially transparent fluid impermeable material allows a person (e.g., medical practitioner) to examiner the penis. For example, the chamber 112 may include a penis receiving area that is configured to receive the penis of the individual when the penis extends into the chamber 112. The penis receiving area may be defined at least partially by a portion of the porous material122 and at least a portion of the at least partially transparent material of the fluid impermeable barrier 102. In other words, the porous material 122 is positioned in the chamber 112 such that the porous material 122 is not positioned between the penis and at least a portion of the transparent portion of fluid impermeable barrier 102 when the penis is inserted into the chamber 112 through the first opening 114. The porous material 122 is generally not transparent and, thus, the portion of the at least partially transparent material of the fluid impermeable barrier 102 that defines the penis receiving area forms a window which allows the person to view into the penis receiving area and examine the penis.

[0022] The first opening 114 defined by the fluid impermeable barrier 102 provides an ingress route for fluids to enter the chamber 112 when the penis is a buried penis and / or allows the penis to enter the chamber 112 (<?.g., the penis receiving area 131) when the penis is not buried. The first opening 114 may be defined by the fluid impermeable barrier 102. For example, the opening 114 formed in and extends through the fluid impermeable barrier 102 at the proximal end region 160 of the fluid impermeable barrier 102, thereby enabling bodily fluids to enter the chamber 112 from outside of the fluid collection assembly 100.

[0023] As previously discussed, the fluid impermeable barrier 102 includes a proximal end region 160 and a distal end region 162 including the fluid outlet 118 (e.g., to the port 130). The proximal end region 160 may define the first opening 114 and the distal end region 162 may define the fluid outlet 118. Both the proximal end region 160 and the distal end region 162 may at least partially define the chamber 112.

[0024] The distal end region 162 of the fluid impermeable barrier 102 defines a fluid outlet 118. In an embodiment, not shown, the fluid outlet 118 is configured to be directly attached to a conduit. In such an embodiment, the conduit may be at least partially disposed in the chamber 112 or otherwise in fluid communication with the chamber 112 through the fluid outlet 118. The fluid outlet 118 may be sized and shaped to form an at least substantially fluid tight seal against the conduit, thereby substantially preventing the bodily fluids from escaping the chamber 112. The conduit may be attached to the fluid outlet 118 using an adhesive, a weld, an interference or friction fit, or otherwise bonding the fluid outlet 118 to the fluid outlet 118. Attaching the conduit to the fluid outlet 118 may prevent leaks and may prevent the conduit from inadvertently becoming detached from the fluid outlet 118. In an embodiment, as shown, the fluid outlet 118 is configured to be indirectly attached to the conduit. In such an embodiment, the fluid impermeablebarrier 102 may include a port 130 that is directly attached to the fluid impermeable barrier 102 and configured to be attached to the conduit.

[0025] The port 130 includes a first part 144 and a second part 146. The first part 144 is configured to be attached to the fluid impermeable barrier 102 and, optionally, to be at least partially disposed in the chamber 112. The second part 146 is configured to attach to the conduit. The first part 144 defines an inlet 148 and the second part 146 defines an outlet 150 of the port 130 that is downstream from the inlet 148. The port 130 also defines a channel extending from the inlet 148 to the outlet 150. It is noted that the inlet 148 refers to the inlet of the channel and not necessarily the inlet of the port 130. In an example, the inlet 148 may be the inlet of both the port 130 and the channel when the port 130 does not include a sink. In an example, as illustrated, the inlet 148 may not be the inlet of the port 130 when the port 130 includes sink since the sink forms the inlet of the port 130.

[0026] The first part 144 of the port 130 may be attached to the fluid impermeable barrier 102 using any suitable technique. In an embodiment, the first part 144 is attached to the fluid impermeable barrier 102 using at least one of an adhesive, impulse heating, direct heating, US welding, RF welding, any other attachment technique disclosed herein, or another other suitable attachment technique.

[0027] At least the second part 146 exhibits a rigidity that is greater than the fluid impermeable barrier 102. The second part 146 may exhibit a rigidity that is greater than the fluid impermeable barrier 102 because at least one of second part 146 exhibits a thickness that is greater than the fluid impermeable barrier 102 or at least a portion of the second part 146 is formed from a material exhibiting a Young’s modulus (i.e., modulus of elasticity) that is greater than a Young’s modulus of a material forming at least a portion of the fluid impermeable barrier 102. The increased rigidity of the second part 146 relative to the fluid impermeable barrier 102 allows the second part 146 to be attached to the conduit using techniques that may be difficult or impossible to do when the conduit is directly attached to the fluid impermeable barrier 102. In an example, the conduit may be attached to the second part 146 using an interference fit which may be difficult or impossible to do when the conduit is directly attached to the fluid impermeable barrier 102. In such an example, a surface of the second part 146 that is configured to abut the conduit is tapered. The tapered surface of the second part 146 may make inserting the second part 146 into the conduit easier when the second part 146 forms a male connector and may make receiving the conduit into the second part 146 easier when the second part146 forms a female connector. The tapered surface of the second part 146 also allows the strength of the interference fit between the second part 146 and the conduit to be controlled by controlling how much the second part 146 is inserted into the conduit or how much the conduit is inserted into the second part 146. In an example, not shown, a surface of the second part 146 is configured to be threadedly attached to the conduit which may be difficult or impossible to do when the conduit is directly attached to the fluid impermeable barrier 102. In such an example, the second part 146 may include one or more helically extending ridges extending from a surface of the second part 146 that contacts or is closest to the conduit. It is noted that the surface of the second part 146 that includes the threads and / or the threads may be tapered. In an example, not shown, a surface of the second part 146 that contacts or is closest to the conduit may include circumferentially extending ridges. It is noted that the surface of the second part 146 that includes the ridges and / or the ridges may be tapered.

[0028] In an embodiment, at least the second part 146 exhibits a rigidity that is greater than the conduit. The second part 146 may exhibit a rigidity that is greater than the conduit because at least one of the second part 146 exhibits a thickness that is greater than the conduit or at least a portion of the second part 146 is formed from a material exhibiting a Young’s modulus that is greater than a Young’s modulus of a material forming at least a portion of the conduit. The increased rigidity of the second part 146 prevents collapse of the channel in the port 130. For example, it has been found that, in certain circumstances, directly attaching the conduit to the fluid impermeable barrier 102 may cause the portions of the conduit 142 attached to the fluid impermeable barrier 102 to at least partially collapse when a strong vacuum is applied to the chamber 112. However, the increased rigidity of the port 130 prevents such collapse.

[0029] In an embodiment, the first part 144 exhibits a rigidity that is greater than the fluid impermeable barrier 102 and / or the conduit. For example, the first part 144 may exhibit a rigidity that is comparable to the second part 146. The increased rigidity of the first part 144 prevents collapse of the inlet 148, any portions of the channel in the port 130 defined thereby, and the sink. The increased rigidity of the first part 144 may also make attaching the port 130 to the first part 144 easier since pressure may be applied to the first part 144 during the attachment process substantially without deforming the first part 144.

[0030] The first part 144 may exhibit a shape that is different than the second part 146. For example, the first part 144 may exhibit a first elongated shape that extend in adirection that is generally perpendicular to the longitudinal axis 140 and the second part 146 may exhibit a second elongated shape (e.g., generally cylindrical shape) that extends generally parallel to the longitudinal axis of the generally tubular fluid impermeable barrier 102. The first elongated shape of the first part 144 may strengthen the attachment between the first part 144 and the fluid impermeable barrier 102 by increasing the surface area of the first part 144 that is attached to the fluid impermeable barrier 102. The first elongated shape of the first part 144 also prevents or at least inhibits twisting of the sheath 102. Examples of the first elongated shape include a generally rectangular cross-sectional shape, a generally oval cross-sectional shape, a generally elliptical cross-sectional shape, or a generally diamond cross-sectional shape. In a particular example, the first elongated shape is a generally diamond cross-sectional shape since the relatively sharp comers of the generally diamond cross-sectional shape that are furthest spaced from the second part 146 facilitate attaching the fluid impermeable barrier 102 to the first part 144 without forming a gap between the first part 144, the first panel 108, and the second panel 110 compared to a more rounded corner. In a particular example, the first elongated shape included rounded corners since the rounded comers are less likely to uncomfortably press into the individual than sharp comers. The second elongated shape of the second part 146 that extends parallel to the longitudinal axis 140 may facilitate attachment to the conduit 142. In some embodiments, the port 130 may include at least one tab extending from the first part 144 into the chamber 112 to prevent the fluid impermeable barrier from clogging the inlet 148.

[0031] The fluid outlet 118 and the port 130 may be located at or near the distal end region 162 of the fluid impermeable barrier 102 which is expected to be the gravimetrically low point of the chamber 112 when worn by a user. Locating the fluid outlet 118 and the port 130 at or near the distal end region 162 of the fluid impermeable barrier 102 enables the conduit to receive more of the bodily fluids than if the fluid outlet 118 and the port 130 was located elsewhere and reduce the likelihood of pooling e.g., pooling of the bodily fluids may cause microbe growth and foul odors). However, the bodily fluids may exhibit a preference to flow in the direction of gravity. Accordingly, the fluid outlet 118 and the port 130 may be located in the fluid collection assembly 100 in a position expected to be the gravimetrically low point in the fluid collection assembly 100 when worn by a user.

[0032] As previously discussed, the sheath 102 includes at least one porous material 122 disposed in the chamber 112. In some embodiments, the porous material 122 maydirect the bodily fluids to one or more selected regions of the chamber 112, such as away from the penis and towards the fluid outlet 118. As such, the porous material 122 may facilitate the removal of the bodily fluids from the chamber 112. The porous material 122 may also blunt a stream of urine from the penis. The porous material 122 be shaped as a continuous cylinder and / or a plurality of discs of the porous material 122 that together form a cylinder positioned within the chamber 112 of the fluid impermeable barrier 102. Accordingly, the at least one porous material 122 disposed in the chamber 112 may include one or more discs of the at least one porous material 122 or one or more cylinders of the at least one porous material 122 disposed in the chamber 112 such that the at least one porous material 122 retains at least a portion of the chamber 112 and at least a portion of the fluid impermeable barrier 102 in a shape that is substantially cylindrical or tubular.

[0033] In many embodiments, the porous material 122 includes a porous spun nylon fiber structure. In some embodiments, the porous material 122 includes a fluid permeable wicking membrane including gauze at least partially enclosing the spun nylon fiber structure. For example, the porous material 122 may include a gauze or other wicking fabric positioned to contact the penis of the user in the chamber 112. In some embodiments, the gauze or other wicking fabric is wrapped around a body of spun nylon fibers material.

[0034] In an embodiment, the porous material 122 may include a wicking material configured to wick any bodily fluids away from the opening 114 thereby preventing the bodily fluids from escaping the chamber 112. Such “wicking” may not include absorption of fluid into the wicking material. Put another way, substantially no absorption of fluid into the material may take place after the material is exposed to the fluid and removed from the fluid for a time. While no absorption is desired, the term “substantially no absorption” may allow for nominal amounts of absorption of fluid into the wicking material (e.g., absorbency), such as less than about 30 wt% of the dry weight of the wicking material, less than 20 wt%, less than 15 wt%, less than 10 wt%, less than about 7 wt%, less than about 5 wt%, less than about 3 wt%, less than about 2 wt%, less than about 1 wt%, or less than about 0.5 wt% of the dry weight of the wicking material. The wicking material may also wick the fluid generally towards an interior of the chamber 112, as discussed in more detail below. In an embodiment, the porous material 122 is configured to adsorb or absorb the bodily fluids. Similar, to the wicking material, such adsorbing or absorbing material may move bodily fluids away from the opening 114 thereby preventing the bodily fluids from escaping the chamber 112.

[0035] The porous material 122 may be formed from any suitable porous material. For example, the porous material 122 may be formed from nylon (e.g. , spun nylon fibers), polyester, polyurethane, polyethylene, polypropylene, other porous polymers, hydrophobic foam, an open cell foam, wool, silk, linen, cotton (e.g., cotton gauze), felt, other fabrics, a coated porous material (e.g., a water repellent coated porous material), any other suitable porous materials, or combinations thereof.

[0036] In some embodiments, the porous material 122 includes a first layer and a second layer. The first and second layers of the porous material 122 may be a woven material. The porous material 122 also may a plurality of fibers forming a layer between the first layer and the second layer of the porous material 122. Each of the first layer, the second layer, and the plurality of fibers define a plurality of pores, thereby allowing transport of the bodily fluids and air circulation through the porous material 122. The pores defined by the plurality of fibers may be at least one of larger or more numerous, thereby decreasing the likelihood that dried bodily fluids clog the porous material 122. The presence of the plurality of fibers also cause the porous material 122 feel soft against the penis and provides a cushioning effect to the penis. The plurality of fibers may also prevent the vacuum force from collapsing the porous material.

[0037] The first layer, the second layer, and the plurality of fibers of the porous material 122 may be formed from any suitable material, such as a hydrophobic material, a hydrophilic material, polyester, cotton, or any other porous material disclosed herein. In an embodiment, one or more of the first layer, the second layer, or the plurality of fibers of the porous material 122 are formed from a hydrophobic material that inhibits the porous material 122 from storing the bodily fluids therein which may facilitate removal of the bodily fluids from the chamber 112. In an embodiment, one or more of the first layer, and second layer, or the plurality of fibers of the porous material 122 are formed from a hydrophilic material which allows the porous material 122 to temporarily store the bodily fluids therein thereby limiting the quantity of bodily fluids that pool around the skin of the individual. In an embodiment, two or more of the first layer, the second layer, or the plurality of fibers of the porous material 122 are formed from different materials. In such an embodiment, the first layer may define the penis receiving area or is otherwise closer to the penis receiving area than the second layer. The first layer may be formed from a hydrophobic material while the plurality of fibers are formed from a hydrophilic material. Such a configuration may cause the bodily fluids to be pulled through the first layer and temporarily stored in the plurality of fibers. However, the first layer may remainsubstantially dry due to the hydrophobicity thereof which allows the porous material 122 to feel dry to the penis. In an embodiment, at least one of the first layer or the second layer is formed from a fabric (e.g., fabric gauze) and the plurality of fibers is formed from nylon fibers (e.g., spun nylon fibers).

[0038] In an embodiment, the porous material 122 may be formed from two layers. For example, the porous material 122 may be formed from a fluid permeable membrane and a fluid permeable support. The fluid permeable support may define or otherwise be closer to the penis receiving area than the fluid permeable support. The fluid permeable membrane may be composed and / or structured to wick or otherwise draw bodily fluids away from the penis receiving area, thereby minimizing the quantity of bodily fluids that are present in the penis receiving area or otherwise present against the skin of the individual. It is also noted that the fluid permeable membrane may also be configured to adsorb or absorb the bodily fluids to minimize the quantity of bodily fluids that are present in the penis receiving area or otherwise present against the skin of the individual. The fluid permeable membrane may be formed from any of the porous materials disclosed herein. For example, the fluid permeable membrane may be formed from fabric, such as a gauze e.g. , silk, linen, or cotton gauze), another soft fabric, another smooth fabric, a woven or non wo ven material (e.g., spun nylon fiber), or any other suitable porous material. Forming the fluid permeable membrane from gauze, soft fabric, and / or smooth fabric (or any of the other porous materials 122 disclosed herein that may contact the penis) may reduce chaffing caused by the fluid collection assembly 100.

[0039] In some embodiments, the fluid permeable support is configured to support the fluid permeable membrane since the fluid permeable membrane may be formed from a relatively foldable, flimsy, or otherwise easily deformable material. For example, the fluid permeable support may be positioned such that the fluid permeable membrane is disposed between the fluid permeable support and the fluid impermeable barrier 102. As such, the fluid permeable support may support and maintain the position of the fluid permeable membrane. The fluid permeable support may include any of the fluid permeable membrane materials disclosed herein above. For example, the fluid permeable membrane material(s) may be utilized in a more dense or rigid form than in the fluid permeable membrane when used as the fluid permeable support. The fluid permeable support may be formed from any fluid permeable material that is less deformable than the fluid permeable membrane. For example, the fluid permeable support may include a porous polymer (e.g., nylon, polyester, polyurethane, polyethylene, polypropylene, etc.)structure or an open cell foam. In some examples, the fluid permeable support may be formed from a natural material, such as cotton, wool, silk, or combinations thereof. In such examples, the material may have a coating to prevent or limit absorption of fluid into the material, such as a water repellent coating. In some examples, the fluid permeable support may be formed from fabric, felt, gauze, or combinations thereof.

[0040] In an embodiment, the porous material 122 may include a single layer (e.g., one of the first layer, the second layer, the layer formed from the plurality of fibers, the fluid permeable membrane, the fluid permeable support, or another porous layer). In an embodiment, the porous material 122 may be formed from four or more layers.

[0041] In some embodiment porous material 122 may be disposed in the chamber 112 such that the porous material 122 retains at least some of the fluid impermeable barrier 102 and the chamber 112 in a substantially cylindrical and / or tubular shape. Accordingly, the porous material 122 may be configured to space opposing regions of the fluid impermeable barrier 102 from one another in the chamber 112. In these and other embodiments, the porous material 122 may include one or more sheets of porous material 122 including a spacer fabric that imparts a three-dimensional property (e.g., cylindrical) to the chamber 1 12 to space apart two opposing regions of the fluid impermeable barrier 102. In some embodiments, the porous material 122 includes a first layer and a second layer, with an intermediary disposed therebetween (as described above).

[0042] Examples of other materials that may form the porous material 122 are disclosed in U.S. Provisional Patent Application No. 63 / 134,754 filed on January 7, 2021; U.S. Provisional Patent Application No. 63 / 241,575 filed on September 8, 2021; and U.S. Provisional Patent Application No. 63 / 247,491 filed on September 23, 2021; the disclosures of each of which are incorporated herein, in its entirety, by this reference.

[0043] The porous material 122 may exhibit a shape that generally corresponds to the shape of the fluid impermeable barrier 102 such that the porous material 122 partially or substantially completely occupies all of a portion or segment of the chamber 112. For example, as illustrated, the porous material 122 may exhibit a generally cylindrical shape either individually or collectively. In some embodiments, the porous material 122 exhibits a cylindrical shape having an axial length of at least about 2 cm, at least about 4 cm, at least about 6 cm, at least about 8 cm, at least about 10 cm, about 2 cm to about 10 cm, about 2 cm to about 6 cm, about 6 cm to about 10 cm, about 2 cm to about 4 cm, about 3 cm to about 5 cm, about 4 cm to about 6 cm, about 5 cm to about 7 cm, about 6 cm to about 8 cm, about 7 cm to about 9 cm, or about 8 cm to about 10 cm.

[0044] The fluid collection assembly 100 also may include the body 101 (e.g. , housing) that is at least semi-rigid. The body 101 includes a rigidity that allows the body 101 to maintain its shape during use, even under pressure from the straps 111. The body 101 may include an at least partially transparent material. In some embodiments, body 101 may be formed of any suitable fluid impermeable and at least semi-rigid materials, such as a fluid impermeable polymer (e.g., silicone, polypropylene, polyethylene, polyethylene terephthalate, a polycarbonate, etc.), polyurethane films, thermoplastic elastomer (TPE), rubber, thermoplastic polyurethane, another suitable material, or combinations thereof. The body 101 may also be at least somewhat flexible in combination with the rigidity described above, thereby enabling the body 101 to bend, curve, or flex, use, and / or removal of the fluid collection device 100. Example fluid impermeable barriers may include, but are not limited to, a fluid impermeable barrier including at least one of Versaflex CL 2000X TPE, Dynaflex G6713 TPE, Silpuran 6000 / 05 A / B silicone, or Santoprene TPE. In an embodiment, the body 101 may be air permeable. In such an embodiment, body 101 may be formed of a hydrophobic material that defines a plurality of pores. In an embodiment, one or more portions of at least the outer surface of body 101 may be formed from a soft and / or smooth material, thereby reducing chaffing.

[0045] The body 101 may include a first region 101a (e.g., lower or bottom region) secured to the proximal end region 160 of the fluid impermeable barrier 102 and a second region 101c (e.g. , top or upper region) generally opposite to and spaced from the first region 101a. In some embodiments, the first region 101a of the body 101 defines a second opening 124 sized to receive at least the portion of the penis therethrough. More specifically, the first region 101a of the body 101 may include a rim lOle defining the second opening 124 and extending from the first region 101a towards the second region 101c. For example, the rim lOle may extend inward from the first region 101a into an interior region 113 of the body 101 defined at least partially (e.g., entirely) by the body 10 le. As the second opening 124 may be defined by the rim 10 le, the rim lOle is sized to receive at least a portion of the penis therethrough. The proximal end region 160 of the fluid impermeable barrier 102 may be secured around the rim 10 le to align the first opening 114 of the fluid impermeable barrier 102 with the second opening 124 of the body 101. For example, the fluid collection assembly 100 may include an o-ring 109 securing the proximal end region 160 of the fluid impermeable barrier 102 to the rim lOle of the body 101. In some embodiments, the o-ring 109 tightly surrounds theproximal end region 160 of the fluid impermeable barrier 102 and the rim 10 le of the first region 101a of the body 101. In some embodiments, the proximal end region 160 is secured to the rim 10 le with one or more of a heat seal or an adhesive. Securement of the proximal end region 160 to the first region 101a of the body 101 allows a penis to be inserted through the second opening 124, the first opening 114, and into the chamber 112 of the fluid impermeable barrier 102. Securement of the fluid impermeable barrier 102 and the body 101 with first opening 114 of the fluid impermeable barrier 102 aligned with the second opening 124 in the first region 101a of the body 101 also provides fluid communication between the second opening 124 and the chamber 112 through the first opening 114, thereby allowing the fluid collection assembly 110 to be placed over a buried penis and still have fluid drawn into the chamber 112.

[0046] In some embodiments, the body 101 also includes one or more sidewalls 101b, lOld extending between the first region 101a and the second region 101c. The one or more sidewalls 101b, lOld may be disposed at least proximate to the proximal end region 160 of the fluid impermeable barrier 102. In some embodiments, the distal sidewall lOld of the body 101 defines an additional opening 105 between the first region 101a and the second region 101c of the body 101 . In these embodiments, the fluid impermeable barrier 102 may extend from the second opening 124 in the first region 101a and through the additional opening 105. Said another way, the fluid impermeable barrier 102 may extend from the rim lOle in the body 101, through the additional opening 105, and further distally to the distal end region 162 of the fluid impermeable barrier 102. In some embodiments, the first region 101a extends distally beyond the distal sidewall lOld of the body 101 such that the first region 101a at least partially defines the additional opening 105 having the fluid impermeable barrier 102 extending therethrough.

[0047] In some embodiments, the second region 101c of the body 101 defines one or more apertures 129 through which the one or more straps 111 may be secured to the body 101 spaced from the first region 101a and the foam cushion 103. The second region 101c also may define a hole 107 in the second region 101c that allows a user or caregiver to view inside the body 101 to confirm proper placement and functioning of the fluid collection assembly 100. In some embodiments, the hole 107 may include a transparent window.

[0048] The fluid collection assembly 100 also may include a foam cushion 103 secured to the first region 101a of the body 101 and positioned to contact skin of a user around the penis of the user. In some embodiments, the foam cushion 103 includes a fluidimpermeable foam material. For example, the foam cushion 103 may include an integral skin foam and / or a closed cell foam. In some embodiments, the foam cushion 103 may include a skinned ethylene propylene diene monomer (EPDM), neoprene, PVC, skinned open cell foam, and / or unskinned closed cell foam. The integral skin foam may include a multilayer polyurethane foam.

[0049] As previously discussed, the foam cushion 103 may be configured to be positioned on the skin that surrounds the penis (e.g. , mons pubis, thighs, testicles, and / or perineum) and have the penis disposed therethrough. For example, the foam cushion 103 may define an opening aligned with the first opening 114 and the second opening 124 and configured to have the penis positioned therethrough. The foam cushion 103 may be flexible, thereby allowing the foam cushion 103 to conform to any shape of the skin surface. The foam cushion 103 may include a foam ring or other shape secured to the first region 101a of the body 101. In some embodiments, the foam cushion 103 may include a shape generally complementary to the shape of the first region 101a. Accordingly, the foam cushion 103 includes a cushioning opening aligned with and sized complementary or sized larger than the second opening 124 in the first region 101a.

[0050] The foam cushion 103 may be configured to be attached (e.g., permanently attached) to the first region 101a of the body 101. The foam cushion 103 may be attached to the first region 101a of the body 101 using any suitable technique. For example, the foam cushion 103 may be attached to the first region 101a of the body 101 using an adhesive, sewing, heat sealing, impulse heating, RF welding, or US welding.

[0051] The fluid collection assembly 101 also may include on or more straps 111 secured to the second region 101c of the body 101 such that the portion of the straps 111 secured to the body 101 are spaced from the first region 101a and the foam cushion 103 contacting the user or patient. More particularly, the one or more straps 111 may be secured to the second region 101c of the body 101 through one or more apertures 129 in the second region 101c. The one or more straps 111 may be adjustable and are configured to wrap around one or more (e.g. , all) of the waist, buttocks, and / or thighs (through the crotch) of the user or patient. During use, the one or more straps 111 hold the body 101 against the user such that the first opening 114 and the second opening 124 allow the penis to extend at least partially therethrough or are positioned over a buried penis. In at least one, some, or all embodiments, the one or more straps holding the body 101 against the user results in the technical effect of the foam cushion 103 forming a seal against the skin of the user around the first opening 114 and the second opening 124. Also duringuse, in at least one, some or all embodiments, the material of the fluid impermeable barrier 102 results in the technical effect of ensuring urine can flow down to the fluid outlet 118 and also allowing the fluid impermeable barrier 102 to swing or move freely within the additional opening 105 of the body 101, thereby allowing the fluid impermeable barrier to be easily adjusted as the patient moves from one side to the other to ensure urine drains down to the fluid outlet 118.

[0052] As previously discussed, the fluid collection assembly 100 may include a conduit in fluid communication with the chamber 112 through the fluid outlet 118. The conduit may be secured or securable to the port 130. The conduit may include a flexible material such as plastic tubing (e.g., medical tubing). Such plastic tubing may include a thermoplastic elastomer, polyvinyl chloride, ethylene vinyl acetate, polytetrafluoroethylene, etc., tubing. In some examples, the conduit may include silicon or latex. In some examples, the conduit may include one or more portions that are resilient, such as to by having one or more of a diameter or wall thickness that allows the conduit to be flexible.

[0053] As described in more detail below, the conduit is configured to be coupled to, and at least partially extend between, one or more of the fluid storage container (not shown) and the vacuum source (not shown). In an example, the conduit is configured to be directly connected to the vacuum source (not shown). In such an example, the conduit may extend from the fluid impermeable barrier 202 by at least one foot, at least two feet, at least three feet, or at least six feet. In another example, the conduit is configured to be indirectly connected to at least one of the fluid storage container (not shown) and the vacuum source (not shown). In some examples, the conduit is secured to a wearer’s skin with a catheter securement device, such as a STATLOCK® catheter securement device available from C. R. Bard, Inc., including but not limited to those disclosed in U.S. Patent Nos. 6,117,163; 6,123,398; and 8,211,063, the disclosures of which are all incorporated herein by reference in their entirety.

[0054] The inlet and an outlet of the conduit are configured to fluidly couple (e.g., directly or indirectly) the vacuum source (not shown) to the chamber 112. As the vacuum source applies a vacuum / vacuum in the conduit, the bodily fluids in the chamber 112 may be drawn into the inlet 148 and out of the fluid collection assembly 100 via the conduit. In some examples, the conduit may be frosted or opaque (e.g., black) to obscure visibility of the bodily fluids therein. In some examples, the vacuum source may be remotely located from the fluid collection device. In such examples, the conduit may be fluidlyconnected to the fluid storage container, which may be disposed between the vacuum source and the fluid collection assembly 100.

[0055] During operation, a male using the fluid collection assembly 100 may discharge bodily fluids (e. ., urine) into the chamber 112. The bodily fluids may pool or otherwise be collected in the chamber 112 (e.g., received into the porous material 122). At least some of the bodily fluids may be pulled through the interior of the conduit via the inlet. The bodily fluids may be drawn out of the fluid collection assembly 100 via the vacuum / vacuum provided by the vacuum source.

[0056] FIG. 2A is a top view of a fluid collection assembly 200 and FIG. 2B is a cross-sectional view of the fluid collection assembly 200 taken along line 2B-2B of FIG. 1A, according to an embodiment. The fluid collection assembly 200 (e.g., male external catheter assembly) may include a fluid impermeable barrier 202, at least one porous material 222 disposed in a chamber 212 defined by the fluid impermeable barrier 202, a body 201 that is at least semi-rigid and secured to a proximal end region 260 of the fluid impermeable barrier 202; and one or more straps 211 secured the body 201 and spaced from the proximal end region 260 of the fluid impermeable barrier 202.

[0057] The fluid impermeable barrier 202 may be formed as sheath 206. In an embodiment, the fluid impermeable barrier 202 that is at least partially formed from a first panel 208 attached to a second panel 210. In an embodiment, as illustrated, the first panel 208 and the second panel 210 are distinct sheets. The fluid impermeable barrier 202 also may define a chamber 212 between the first panel 208 and the second panel 210, the opening 214 at the proximal end region 260, and a fluid outlet 218 at the distal end region 262. The fluid collection assembly 200 also may include a foam cushion defining a cushion opening. The foam cushion 203 may be attached to the proximal end region 260 of the fluid impermeable barrier 202 such that the cushion opening is aligned with the first opening 214 and the second opening 224 of the fluid impermeable barrier 202. The inner surfaces 226 of the fluid impermeable barrier 202 e.g., inner surfaces of the first and second panels 208, 210) may at least partially define the chamber 212 within the sheath 206. The fluid impermeable barrier 202 temporarily stores the bodily fluids in the chamber 212.

[0058] The fluid impermeable barrier 202 may be formed of any suitable fluid impermeable material(s), such as a fluid impermeable polymer (e.g., silicone, polypropylene, polyethylene, polyethylene terephthalate, polyurethane, polyethylene, polyvinyl chloride, a polycarbonate, etc.), a metal film, natural rubber, another suitablematerial, or combinations thereof. As such, the fluid impermeable barrier 202 substantially prevents the bodily fluids from passing through the fluid impermeable barrier 202. In an example, the fluid impermeable barrier 202 may be air permeable and fluid impermeable thus preventing leaks while allowing air flow through the chamber 212 when a vacuum force is applied thereto (i.e., the chamber 212 remains at about atmospheric pressure thereby preventing the vacuum force from causing a hickie or kinking a conduit in fluid communication with the fluid outlet 218). In such an example, the fluid impermeable barrier 202 may be formed of a hydrophobic material that defines a plurality of pores. At least one or more portions of at least an outer surface 227 of the fluid impermeable barrier 202 may be formed from a soft and / or smooth material, thereby reducing chaffing. In many embodiments, the fluid impermeable barrier 202 may include any of the materials described above in relation to the fluid impermeable barrier 102.

[0059] In an embodiment, at least one of the first panel 208 or the second panel 210 is formed from an at least partially transparent fluid impermeable material, such as polyethylene, polypropylene, polyurethane, polycarbonate, or polyvinyl chloride. Forming at least one of the first panel 208 or the second panel 210 from an at least partially transparent fluid impermeable material allows a person (e.g., medical practitioner) to examiner the penis. In some embodiments, both the first panel 208 and the second panel 210 are formed from at least partially transparent fluid impermeable material. Selecting at least one of the first panel 208 or the second panel 210 to be formed from an at least partially transparent impermeable material allows the penis to be examined without detaching the entire fluid collection assembly 200 from the region about the penis. For example, the chamber 212 may include a penis receiving area 231 that is configured to receive the penis of the individual when the penis extends into the chamber 212. The penis receiving area 231 may be defined at least partially by at least a portion of the porous material 222 and at least a portion of the at least partially transparent material of the first panel 208 and / or the second panel 210. In other words, the porous material 222 may be positioned in the chamber 212 such that the porous material is not positioned between the penis and at least a portion of the transparent portion of the first panel 208 and / or second panel 210 when the penis is inserted into the chamber 212 through the first opening 214. The porous material 222 is generally not transparent and, thus, the portion of the at least partially transparent material of the first panel 208 and / or the second panel 210 that defines the penis receiving area 231 forms awindow which allows the person to view into the penis receiving area 231 and examine the penis.

[0060] In an embodiment, the second panel 210 is at least partially formed from the at least partially transparent material and forms the window that allows the person to view into the penis receiving area 231. Further, the porous material 222 may be positioned between the penis receiving area 231 and at least a portion of the first panel 208. Such an embodiment may help maintain the dignity of the individual using the fluid collection assembly 200. For example, during use, the second panel 210 is generally adjacent to the individual, such as adjacent to the thighs and / or perineum. Thus, the second panel 210 is generally obscured during use and a person cannot view the penis without first lifting the sheath 206 away from the individual. Meanwhile, the first panel 208 may face away from the individual and be more easily viewable than the second panel 210. However, a person (e.g., a passerby, a visitor, etc.) cannot view the penis through the first panel 208 because the porous material 222 is not transparent and / or the first panel 208 is formed from a nontransparent material. Thus, in such an embodiment, the first panel 208 and / or the porous material 222 prevent person(s) from viewing the penis unless such examination is necessary, thereby preserving the dignity of the individual using the fluid collection assembly 200. In an embodiment, the first panel 208 is formed from the at least partially transparent material and forms the window that allows the person to view into the penis receiving area 231. Further, the porous material 222 is positioned between the penis receiving area 231 and at least a portion of the second panel 210. In such an embodiment, the person does not need to perform the additional act of lifting the sheath 206 to view into the penis receiving area 231 but may not maintain the dignity of the individual using the fluid collection assembly 200 since passersby may also view into the penis receiving area 231.

[0061] As previously discussed, at least a portion of the first panel 208 and at least a portion of the second panel 210 may be attached together. In an embodiment, as shown, the first and second panels 208, 210 are attached together along at least a portion of the outer edges thereof (e.g. , the top and lateral edges 236, 238). In such an embodiment, the first and second panels 208, 210 are attached using any suitable technique, such as with an adhesive, sewing, heat sealing, impulse heating, direct heating, radio frequency (“RF”) welding, ultrasonic (“US”) welding, or any other technique. In a particular embodiment, the first and second panels 208, 210 are attached together using impulse heating since impulse heating is quick and is effective at attaching polyurethane panels together.Forming the fluid impermeable barrier 202 from the first panel 208 and the second panel 210 may improve the rate of manufacturing the fluid collection assembly 200, especially when the first panel 208 and the second panel 210 are attached together using a nonsewing technique.

[0062] In an embodiment, the sheath 206 includes one or more vents 234 attached to the fluid impermeable barrier 202 that extend across one or more orifices in the fluid impermeable barrier 202. Though not shown, the vents 234 also may be included on the fluid impermeable barrier 102 of the fluid collection assembly 100.

[0063] The vents 234 are configured to allow air to flow therethrough while preventing water (a major constituent of bodily fluids) from flowing therethrough. The vents 234 facilitate air flow through the chamber 212. For example, as previously discussed, a vacuum may be provided to the chamber 212 from a vacuum source. The vacuum may pull air through the vents 234, thereby allowing air flow from the vents 234 to the fluid outlet 218. The air flow from the vents 234 helps move bodily fluids towards the fluid outlet 218. The vents 234 also prevent the vacuum applied to the chamber 212 from bursting small superficial blood vessels (e.g., cause a hickie) in or otherwise damage the penis or the area about the penis. The vents 234 may include a porous hydrophobic material. The pores defined by the porous hydrophobic material may be interconnected thereby allowing air to flow through the vents 234. The hydrophobic properties of the porous hydrophobic material may prevent water from flowing through the vents 234. Generally, the size of the pores is dependent on the hydrophobicity of the porous hydrophobic material and vice versa. For example, increasing the hydrophobicity of the porous hydrophobic material allows the size of the pores to be increased.

[0064] In an embodiment, the vents 234 may include a porous polytetrafluoroethylene (“PTFE”) layer. It is currently believed that the porous PTFE layer is exceptionally effectively at allowing air to flow therethrough while preventing water from flow therethrough even when the porous PTFE layer is exposed to acidic bodily fluids. However, porous PTFE is difficult to weld to other materials, such as polyurethane. As such, the porous PTFE layer may be attached to a substrate. The substrate may include a porous material or define one or more passageways therethrough. The substrate may be selected to be easily attached to the porous PTFE layer and the fluid impermeable barrier 202. For example, the substrate may be selected to be formed from polyvinyl chloride since polyvinyl chloride may be easily attached to the porous PTFE layer and attached to the fluid impermeable barrier 202.

[0065] In an embodiment, the orifices are formed in and the vents 234 are attached to the first panel 208 of the fluid impermeable barrier 202. In such an embodiment, the orifices 232 and the vents 234 are unlikely to be covered by and contact the skin of the individual. Covering the orifices and the vents 234 with the skin may prevent or at least inhibit air flow through the portions of the orifices and the vents 234 at are covered by the skin. Further, an individual may find the vents 234 contacting the skin to be uncomfortable and, thus, disposing the vents 234 on the first panel 208 may make the fluid collection assembly 200 more comfortable to wear. In an embodiment, the vents 234 are attached to an interior of the first panel 208 to prevent the edges of the vents 234 from rubbing or otherwise irritating the skin of the individual.

[0066] In an embodiment, as illustrated, at least one of the orifices is formed in and at least one of the vents 234 is attached to a portion of the fluid impermeable barrier 202 that is at or near to top edge 236 of the fluid impermeable barrier 202. The top edge 236 of the fluid impermeable barrier 202 may include an edge of the fluid impermeable barrier 206 that is above the opening 214 when the individual is standing and the fluid collection assembly 200 is allowed to freely hang from the pubic region of the individual. Forming the orifices and attaching the vents 234 at or near the top edge 236 causes air flowing through the vents 234 to pass over the penis (thereby keeping the penis dry) and inhibits pooling of the bodily fluids near the top edge 236. In an embodiment, as illustrated, at least one of the orifices is formed in and at least one of the vents 234 is attached to a portion of the fluid impermeable barrier 202 that is at or near to a lateral edge 238 of the fluid impermeable barrier 206. The lateral edge 238 of the fluid impermeable barrier 206 may include an edge of the fluid impermeable barrier 206 that extends from or near the top edge 236. Generally, air preferentially flows in a path extending from the vents 234 towards the fluid outlet 218. When the vents 234 are spaced from the lateral edges 238 and / or at or near the top edge 236, the preferential air flow from these vents 234 may cause at least some of the portions of the chamber 212 adjacent to the lateral edges 238 to have minimal air flow therethrough. Positioning the orifices and the vents 234 at or near the lateral edges 238 may increase the air flow through the portions of the chamber 212 adjacent to the lateral edges 238 thereby preventing or at least inhibiting pooling of bodily fluids in such portions of the chamber 212.

[0067] The first opening 214 defined by the fluid impermeable barrier 202 provides an ingress route for fluids to enter the chamber 212 when the penis is a buried penisand / or allows the penis to enter the chamber 212 (e.g., the penis receiving area 231) when the penis is not buried. The first opening 214 may be defined by the fluid impermeable barrier 202 (e.g., an inner edge of the fluid impermeable barrier 202). For example, the opening 214 is formed in and extends through the fluid impermeable barrier 202, from the outer surface 227 to the inner surface 226, thereby enabling bodily fluids to enter the chamber 212 from outside of the fluid collection assembly 200.

[0068] In an embodiment, the second panel 210 defines the entirety of the first opening 214. For example, the opening 214 is a cutout defined by the second panel 210 that is spaced from the outer periphery (e.g., edges) of the second panel 210. In such an example, the second panel 210 may exhibit a shape that substantially corresponds to the shape of the first panel 208 which may facilitate attaching the first panel 208 to the second panel 210 along the outer periphery thereof. It also allows the first panel 208 and the second panel 210 to lie substantially flat when the penis is not in the chamber 212 and the sheath 206 is lying on a flat surface. The ability of the first and second panels 208, 210 to lie substantially flat may make wearing the fluid collection assembly 200 more discrete and inhibit pooling of bodily fluids against the individual. However, in some embodiments, the opening 214 is not spaced from the outer periphery of the second panel 210. In such embodiments, the first opening 214 may be a cutout extending inwardly from at least one outer periphery of the second panel 210. Other examples of forming the opening 214 in the second panel 210 are disclosed in International Patent Application No. PCT / US2021 / 039866 filed on June 30, 2021, the disclosure of which is incorporated herein, in its entirety, by this reference.

[0069] As previously discussed, the fluid impermeable barrier 202 includes a proximal end region 160 and a distal end region 162 including the fluid outlet 218 (e.g., to the port 230). The proximal end region 260 may define the first opening 214 and the distal end region 262 may define the fluid outlet 218. Both the proximal end region 260 and the distal end region 262 may at least partially define the chamber 112.

[0070] In an embodiment, the fluid impermeable barrier 202 exhibits a generally bullet shape. As used, herein, the fluid impermeable barrier 202 exhibits the generally bullet shape when the portion of the proximal end region 260 extending from the body 201 towards the distal end region 262 exhibits a substantially constant first width and the distal end region 262 of the fluid impermeable barrier 206 exhibits a second width that is less than the first width. The first and second widths may be measured perpendicularly to the longitudinal axis 240 and may be greater than a thickness of the sheath 206 when thesheath 206 lies on a flat surface. It is noted that the fluid impermeable barrier 102 may exhibit a shape other than the generally bullet shape. In an example, the fluid impermeable barrier 202 may exhibit a generally rectangular shape, as discussed in more detail in International Patent Application No. PCT / US2021 / 039866 filed on lune 30, 2021, the disclosure of which was previously incorporated herein. In an example, the fluid impermeable barrier 202 may exhibit a generally triangular shape, a semi-oval shape, or any other suitable shape.

[0071] The fluid impermeable barrier 202 defines a fluid outlet 218. The fluid outlet 218 may be formed from a portion of the first panel 208 and the second panel 210 that are not attached together. In an embodiment, not shown, the fluid outlet 218 is configured to be directly attached to a conduit (not shown). In such an embodiment, the conduit may be at least partially disposed in the chamber 212 or otherwise in fluid communication with the chamber 212 through the fluid outlet 218. The fluid outlet 218 may be sized and shaped to form an at least substantially fluid tight seal against the conduit, thereby substantially preventing the bodily fluids from escaping the chamber 212. The conduit may be attached to the fluid outlet 218 (e.g., to the first and second panels 208, 210) using an adhesive, a weld, an interference or friction fit, or otherwise bonding the fluid outlet 218 to the fluid outlet 218. Attaching the conduit to the fluid outlet 218 may prevent leaks and may prevent the conduit from inadvertently becoming detached from the fluid outlet 218. In an example, the conduit may be attached to the fluid outlet 218 in the same manufacturing step that attaches the first and second panels 208, 210 together. In an embodiment, as shown, the fluid outlet 218 is configured to be indirectly attached to the conduit. In such an embodiment, the sheath 206 may include a port 230 that is directly attached to the fluid impermeable barrier 202 and configured to be attached to the conduit. The port 130 may include any aspect of the port 130 described above in relation to the fluid collection assembly 100.

[0072] The fluid outlet 218 and the port 130 may be located at or near the distal end region 262 of the sheath 206 which is expected to be the gravimetrically low point of the chamber 212 when worn by a user. Locating the fluid outlet 218 and the port 130 at or near the distal end region 262 of the sheath 202 enables the conduit to receive more of the bodily fluids than if the fluid outlet 218 and the port 130 was located elsewhere and reduce the likelihood of pooling (e.g. , pooling of the bodily fluids may cause microbe growth and foul odors). However, the bodily fluids may exhibit a preference to flow in the direction of gravity. Accordingly, the fluid outlet 218 and the port 130 may be locatedin the fluid collection assembly 200 in a position expected to be the gravimetrically low point in the fluid collection assembly 200 when worn by a user.

[0073] As previously discussed, the sheath 106 includes at least one porous material 222 disposed in the chamber 212. The porous material 222 may direct the bodily fluids to one or more selected regions of the chamber 212, such as away from the penis and towards the fluid outlet 218. As such, the porous material 222 may facilitate the removal of the bodily fluids from the chamber 212 and form a padding layer that prevents the penis from resting against a damp material which may cause degradation of the skin of the penis and / or make the fluid collection assembly 100 more uncomfortable to wear. The porous material 222 may also blunt a stream of urine from the penis.

[0074] In an embodiment, the porous material 222 includes a wicking material configured to wick any bodily fluids away from the first opening 214 thereby preventing the bodily fluids from escaping the chamber 212. Such “wicking” may not include absorption of fluid into the wicking material. Put another way, substantially no absorption of fluid into the material may take place after the material is exposed to the fluid and removed from the fluid for a time. While no absorption is desired, the term “substantially no absorption” may allow for nominal amounts of absorption of fluid into the wicking material (e.g., absorbency), such as less than about 30 wt% of the dry weight of the wicking material, less than 20 wt%, less than 15 wt%, less than 10 wt%, less than about 7 wt%, less than about 5 wt%, less than about 3 wt%, less than about 2 wt%, less than about 1 wt%, or less than about 0.5 wt% of the dry weight of the wicking material. The wicking material may also wick the fluid generally towards an interior of the chamber 212, as discussed in more detail below. In an embodiment, the porous material 222 is configured to adsorb or absorb the bodily fluids. Similar, to the wicking material, such adsorbing or absorbing material may move bodily fluids away from the opening 214 thereby preventing the bodily fluids from escaping the chamber 212.

[0075] The porous material 222 may be formed from any suitable porous material. For example, the porous material 222 may be formed from nylon (e.g., spun nylon fibers), polyester, polyurethane, polyethylene, polypropylene, other porous polymers, hydrophobic foam, an open cell foam, wool, silk, linen, cotton (e.g., cotton gauze), felt, other fabrics, a coated porous material (e.g., a water repellent coated porous material), any other suitable porous materials, or combinations thereof.

[0076] In some embodiments (not shown), the porous material 222 includes a first layer and a second layer. The first and second layers of the porous material 222 may be awoven material. The porous material 222 also may include a plurality of fibers forming a layer between the first layer and the second layer of the porous material 222. Each of the first layer, the second layer, and the plurality of fibers of the porous material 222 may define a plurality of pores, thereby allowing transport of the bodily fluids and air circulation through the porous material 222. The pores defined by the plurality of fibers may be at least one of larger or more numerous, thereby decreasing the likelihood that dried bodily fluids clog the porous material 222. The presence of the plurality of fibers also cause the porous material 222 feel soft against the penis and provides a cushioning effect to the penis. The plurality of fibers may also prevent the vacuum force from collapsing the porous material. In an embodiment, the plurality of fibers may cause the first layer to be spaced from the second layer.

[0077] The first layer, the second layer, and the plurality of fibers of the porous material 222 may be formed from any suitable material, such as a hydrophobic material, a hydrophilic material, polyester, cotton, or any other porous material disclosed herein. In an embodiment, one or more of the first layer, the second layer, or the plurality of fibers of the porous material 222 are formed from a hydrophobic material that inhibits the porous material 222 from storing the bodily fluids therein which may facilitate removal of the bodily fluids from the chamber 212. In an embodiment, one or more of the first layer, and second layer, or the plurality of fibers of the porous material 222 are formed from a hydrophilic material which allows the porous material 222 to temporarily store the bodily fluids therein thereby limiting the quantity of bodily fluids that pool around the skin of the individual. In an embodiment, two or more of the first layer, the second layer, or the plurality of fibers of the porous material 222 are formed from different materials. In such an embodiment, the first layer may define the penis receiving area 231 or is otherwise closer to the penis receiving area 231 than the second layer. The first layer may be formed from a hydrophobic material while the plurality of fibers are formed from a hydrophilic material. Such a configuration may cause the bodily fluids to be pulled through the first layer and temporarily stored in the plurality of fibers. However, the first layer may remain substantially dry due to the hydrophobicity thereof which allows the porous material 222 to feel dry to the penis. In an embodiment, at least one of the first layer or the second layer is formed from a fabric (e.g., fabric gauze) and the plurality of fibers is formed from nylon fibers (e.g., spun nylon fibers).

[0078] In an embodiment, not shown, the porous material 222 may be formed from two layers instead of the three layers. For example, the porous material 222 may beformed from a fluid permeable membrane and a fluid permeable support. The fluid permeable support may define or otherwise be closer to the penis receiving area 231 than the fluid permeable support. The fluid permeable membrane may be composed and / or structured to wick bodily fluids away from the penis receiving area 231, thereby minimizing the quantity of bodily fluids that are present in the penis receiving area 231 or otherwise present against the skin of the individual. It is also noted that the fluid permeable membrane may also be configured to adsorb or absorb the bodily fluids to minimize the quantity of bodily fluids that are present in the penis receiving area 231 or otherwise present against the skin of the individual. The fluid permeable membrane may be formed from any of the porous materials disclosed herein. For example, the fluid permeable membrane may be formed from fabric, such as a gauze (e.g., silk, linen, or cotton gauze), another soft fabric, another smooth fabric, a woven or nonwoven material (e.g., spun nylon fiber), or any other suitable porous material. Forming the fluid permeable membrane from gauze, soft fabric, and / or smooth fabric (or any of the other porous materials 222 disclosed herein that may contact the penis) may reduce chaffing caused by the fluid collection assembly 200.

[0079] The fluid permeable support is configured to support the fluid permeable membrane since the fluid permeable membrane may be formed from a relatively foldable, flimsy, or otherwise easily deformable material. For example, the fluid permeable support may be positioned such that the fluid permeable membrane is disposed between the fluid permeable support and the fluid impermeable barrier 202. As such, the fluid permeable support may support and maintain the position of the fluid permeable membrane. The fluid permeable support may include any of the fluid permeable membrane materials disclosed herein above. For example, the fluid permeable membrane material(s) may be utilized in a more dense or rigid form than in the fluid permeable membrane when used as the fluid permeable support. The fluid permeable support may be formed from any fluid permeable material that is less deformable than the fluid permeable membrane. For example, the fluid permeable support may include a porous polymer (e.g., nylon, polyester, polyurethane, polyethylene, polypropylene, etc.) structure or an open cell foam. In some examples, the fluid permeable support may be formed from a natural material, such as cotton, wool, silk, or combinations thereof. In such examples, the material may have a coating to prevent or limit absorption of fluid into the material, such as a water repellent coating. In some examples, the fluid permeable support may be formed from fabric, felt, gauze, or combinations thereof.

[0080] In an embodiment, the porous material 222 may include a single layer (e.g., one of the first layer, the second layer, the layer formed from the plurality of fibers, the fluid permeable membrane, the fluid permeable support, or another porous layer). In an embodiment, the porous material 222 may be formed from four or more layers. Examples of other materials that may form the porous material 122 are disclosed in U.S. Provisional Patent Application No. 63 / 134,754 filed on January 7, 2021; U.S. Provisional Patent Application No. 63 / 241,575 filed on September 8, 2021; and U.S. Provisional Patent Application No. 63 / 247,491 filed on September 23, 2021; the disclosures of each of which are incorporated herein, in its entirety, by this reference.

[0081] In an embodiment, the porous material 222 may be a sheet (e.g., a multi-layer sheet). The porous material 222 is a sheet when the porous material 222 at least one of is generally planar when lying on a flat surface, does not define a cavity (e.g., is not tubular), or exhibits a length and width that is greater than a thickness thereof. Forming the porous material 222 as a sheet may facilitate the manufacturing of the fluid collection assembly 200. For example, forming the porous material 222 as a sheet allows the first panel 208, the second panel 210, and the porous material 222 to each be sheets. During the manufacturing of the fluid collection assembly 200, the first panel 208, the second panel 210, and the porous material 222 may be stacked and then attached to each other in the same manufacturing step. For instance, the porous material 222 may exhibit a shape that is the same size or, more preferably, slightly smaller than the size of the first panel 208 and the second panel 210. As such, attaching the first panel 208 and the second panel 210 together along the outer edges (e.g. , top edges 236 and lateral edges 238) thereof may also attach the porous material 222 to the first panel 208 and the second panel 210. The porous material 222 may be slightly smaller than the first panel 208 and the second panel 210 such that the first panel 208 and / or the second panel 210 extend around the porous material 222 such that the porous material 222 does not form a passageway through the fluid impermeable barrier 202 through which the bodily fluids may leak. Also, attaching the porous material 222 to the first panel 108 and / or the second panel 210 may prevent the porous material 222 from significantly moving in the chamber 212, such as preventing the porous material 222 from bunching together near the fluid outlet 218. In an example, the porous material 222 may be attached to the first panel 208 or the second panel 210 (e.g., via an adhesive) before or after attaching the first panel 208 to the second panel 210. In an example, the porous material 222 may merely be disposed in the chamber 212 without attaching the porous material 222 to at least one of the first panel 208 or thesecond panel 210. In an embodiment, as will be discussed in more detail below, the porous material 222 may exhibit shapes other than a sheet, such as a hollow generally cylindrical shape.

[0082] The porous material 222 may exhibit a shape that generally corresponds to the shape of the fluid impermeable barrier 202 such that the porous material 222 partially or substantially completely occupies all of the chamber 212. For example, as illustrated, the porous material 222 may exhibit a generally bullet shape. The porous material 222 may exhibit a generally bullet shape when the porous material 222 includes a proximal portion corresponding to the proximal end region 260 and a distal portion extending from the proximal portion that corresponds to the distal end region 262. The proximal portion may exhibit a substantially constant first width and the distal portion may exhibit a second width that is less than the first width. The second width may be constant or vary (e.g., vary at a constant or variable rate). The porous material 222 may exhibit a shape other than the generally bullet shape, such as a generally rectangular shape, generally semi-oval shape, or any other suitable shape.

[0083] Generally, the sheath 206 is substantially flat when the penis is not in the penis receiving area 231 and the sheath 206 is resting on a flat surface. The sheath 206 is substantially flat because the fluid impermeable barrier 202 is formed from the first panel 208 and the second panel 210 instead of a generally tubular fluid impermeable barrier. Further, as previously discussed, the porous material 222 may be a sheet, which also causes the sheath 206 to be substantially flat. It is noted that the sheath 206 is described as being substantially flat because at least one of the porous material 222 may cause a slight bulge to form in the sheath 206 depending on the thickness of the porous material 222, the port 130 may cause a bulge thereabout. It is also noted that the sheath 206 may also be compliant and, as such, the sheath 206 may not be substantially flat during use since, during use, the sheath 206 may rest on a non- flat surface e.g., may rest on the testicles, the perineum, and / or between the thighs) and the sheath 206 may conform to the surface of these shapes.

[0084] The ability of the sheath 206 to be substantially flat when the penis is not in the penis receiving area 131 and the sheath 206 is resting on a flat surface allows the fluid collection assembly 200 to be used with a buried and a non-buried penis. For example, when the fluid collection assembly 200 is being used with a buried penis, the penis does not extend into the penis receiving area 231 which causes the sheath 206 to lie relatively flat across the second opening 224. When the sheath 206 lies relatively flat across thesecond opening 224, the porous material 222 may extend across the second opening 224 and is in close proximity to the buried penis. As such, the porous material 222 prevents or inhibits pooling of bodily fluids discharged from the buried penis against the skin of the individual since the porous material 222 will receive and remove at least a significant portion of the bodily fluids that would otherwise pool against the skin of the individual. Thus, the skin of the individual remains dry thereby improving comfort of using the fluid collection assembly 200 and preventing skin degradation. However, unlike other conventional fluid collection assemblies that are configured to be used with buried penises, the fluid collection assembly 200 may still be used with a non-buried penis since the non-buried penis can still be received into the penis receiving area 231, even when the penis is fully erect. Additionally, the ability of the sheath 206 to be substantially flat allows the fluid collection assembly 200 to be used more discretely than if the sheath 206 was not substantially flat thereby avoiding possibly embarrassing scenarios.

[0085] When the sheath 206 is substantially flat, the porous material 222 may occupy substantially all of the chamber 212 and the penis receiving area 231 is collapsed (shown as being non-collapsed in FIG. 2B for illustrative purposes). In other words, the sheath 206 may not define a region that is constantly unoccupied by the porous material 222. When the porous material 222 occupies substantially all of the chamber 212, the bodily fluids discharged into the chamber 212 are unlikely to pool for significant periods of time since pooling of the bodily fluids may cause sanitation issues, cause an odor, and / or may cause the skin of the individual to remain in contact with the bodily fluids which may cause discomfort and skin degradation.

[0086] As previously discussed, the first panel 208, the second panel 210, and the porous material 222 may be selected to be relatively flexible. The first panel 208, the second panel 210, and the porous material 222 are relatively flexible when the first panel 208, the second panel 210, and the porous material 222, respectively, are unable to maintain their shape when unsupported. The flexibility of the first panel 208, the second panel 210, and the porous material 222 may allow the sheath 206 to be substantially flat, as discussed above. The flexibility of the first panel 208, the second panel 210, and the porous material 222 may also allow the sheath 206 to conform to the shape of the penis even when the size and shape of the penis changes (e.g., becomes erect) and to minimize any unoccupied spaces in the chamber 112 in which bodily fluids may pool.

[0087] The fluid collection assembly 200 also include the body 201. Unless otherwise noted, the body 201 may include any aspect of the body 101, such as the materials of thebody 101 described above. In many embodiments, the body 201 is at least semi-rigid and includes a first region 201a (e.g. bottom or lower region) secured to the proximal end region 260 of the fluid impermeable barrier 202 and a second region 201c (e.g., top or upper region) opposite to and spaced from the first region 201a. In some embodiments, the first region 201a may extend distally from the sidewall 201b past the first opening 214. For example, the first region 201a may include a terminating end that is positioned between the first opening 214 and the distal end region 262 of the fluid impermeable barrier 202. In these and other embodiments, the first region 201a may define a second opening 224 aligned with and shaped generally complementary to the first opening 214 in the fluid impermeable barrier 202. Accordingly, the second opening 224 may be sized to allow at least a portion of the penis to extend therethrough into the first opening 214 and into the chamber 212. In some embodiments, the first region 201a may be substantially ring shaped. Though not shown in FIG. 2B, the first region 201a of the body 201 may optionally include a rim similar to or the same as the rim lOle that defines the second opening 224.

[0088] In some embodiments, the body 201 includes one or more sidewalls 201b extending between the first region 201a and the second region 201 c of the body 201 to at least partially define a concave region 213 in the body 201. The concave region 213 may include at least a portion of the proximal end region 260 of the fluid impermeable barrier 202 positioned therein. In many embodiments, the second region 201c of the body 201 defines one or more apertures 229 through which the one or more straps 211 may be secured to the body 201 spaced from the first region 201a and the foam cushion 203. The concave region 213 of the body 201 allows a user or caregiver to view inside the body201 to confirm proper placement and functioning of the fluid collection assembly 200.

[0089] In some embodiments, the first opening 214 in the fluid impermeable barrier202 is spaced distally from the first region 201a of the body 201 e.g., the first opening 214 in the fluid impermeable barrier 202 is disposed between the first region 201a of the body 201 and the distal end region 262. As noted above, the at least one porous material 222 may be generally planar. In some embodiments, the at least one porous material 222 extends in the chamber 212 to be at least partially within the concave region 213 of the body 201. Accordingly, the at least one porous material 222 may extend generally planar between the fluid outlet 218 and the first region 201a and / or the side wall 201b of the body 201.

[0090] The fluid collection assembly 200 also may include a foam cushion 203 secured to the first region 201a of the body 201 and positioned to contact skin of a user around the penis of the user. The foam cushion 203 may include any aspect of the foam cushion 103 described above, including the material of the foam cushion 103.

[0091] The foam cushion 203 may be configured to be positioned on the skin that surrounds the penis (e.g., mons pubis, thighs, testicles, and / or perineum) and have the penis disposed therethrough. For example, the foam cushion 203 may define a cushion opening aligned with the first opening 214 and the second opening 224 and configured to have at least a portion of the penis positioned therethrough. In some embodiments, the foam cushion 203 includes a shape or profile that is complementary (e.g., the same as) the shape or profile of the first region 201. For example, both the first region 201a and the foam cushion 203 may be substantially ring or O-shaped.

[0092] The foam cushion 203 may be flexible, thereby allowing the foam cushion 203 to conform to any shape of the skin surface. The foam cushion 203 may include a foam ring or other shape secured to the first region 201a of the body 201 and / or the second panel 210 of the fluid impermeable barrier 202. In some embodiments, the first region201 a of the body is secured to the foam cushion 203 between the foam cushion 203 and a portion of the fluid impermeable barrier 202 (e.g. , a portion of the second panel 210 of the fluid impermeable barrier 202). In embodiments having the first region 201a extending distally beyond the first opening 214, the foam cushion 203 may be shaped to cover all of the first region 201a (e.g., the foam cushion 203 may be shaped complementary to the shape of the first region 201a). In these and other embodiments, the opening 224 of the foam cushion 203 may be aligned and generally complementary with the opening of the first region 201a and the first opening 214 of the fluid impermeable barrier 202. The foam cushion 203 may be configured to be attached (e.g., permanently attached) to the first region 201a of the body 201 and / or the second panel 210 of the fluid impermeable barrier 202. The foam cushion 203 may be attached to the first region 201a of the body 201 and / or the second panel 210 of the fluid impermeable barrier 202 using any suitable technique. For example, the foam cushion 203 may be attached to the first region 201a of the body 201 / or the second panel 210 of the fluid impermeable barrier202 using an adhesive, sewing, heat sealing, impulse heating, RF welding, or US welding.

[0093] The fluid collection assembly 201 also may include on or more straps 211 secured to the second region 201c of the body 201 such that the portion of the straps 211 secured to the body 201 are spaced from the first region 201a and the foam cushion2contacting the user or patient. More particularly, the one or more straps 211 may be secured to the second region 201c of the body 201 through one or more apertures 229 in the second region 201c. The one or more straps 211 may be adjustable and are configured to wrap around one or more (e.g. , all) of the waist, buttocks, and / or thighs (through the crotch) of the user or patient. During use, the one or more straps 211 hold the body 201 against the user such that the first opening 214 and the opening 224 allow the penis to extend at least partially therethrough or are positioned over a buried penis. In at least one, some, or all embodiments, the one or more straps holding the body 201 against the user results in the technical effect of the foam cushion 203 forming a seal against the skin of the user around the first opening 214 and the opening 224. Also during use, in at least one, some or all embodiments, the material of the fluid impermeable barrier 202 results in the technical effect of ensuring urine can flow down to the fluid outlet 218 and also allowing the fluid impermeable barrier 202 to swing or move freely within the concave region 213 of the body 201, thereby allowing the fluid impermeable barrier 202 to be easily adjusted as the patient moves from one side to the other to ensure urine drains down to the fluid outlet 218.

[0094] As previously discussed, the fluid collection assembly 200 is formed from the first panel 208 and the second panel 210 that are distinct sheets which may allow the first panel to be at least partially opaque while the second panel is at least partially transparent. However, forming the first and second panels 208, 210 from distinct sheets may form edges that may cause patient discomfort and requires a significant amount of manufacturing e.g., welding or other attachment technique) to attach the first panel 208 to the second panel 210. As such, in some embodiments, the fluid collection assemblies disclosed herein may be formed from first and second panels that are integrally formed together (e.g., exhibit single piece construction) which may eliminate at least some of the edges and simplify manufacturing of such fluid collection assemblies. In an embodiment, the first and second panels 208, 210 are formed from a single sheet that is folded. Forming the first and second panels 208, 210 from the single folded sheet precludes the need to attach one of the longitudinal edges of the first and second panels 208, 210 together. However, the portions of the first and second panels 208, 210 that form the proximal end region, the distal end region, and the portion opposite the fold may need to be attached together using any of the attachment techniques disclosed herein. Thus, forming the first and second panels 208, 210 from a single folded sheet makes manufacturing of the fluid collection assembly 200 more efficient and decreases thenumber of edges that are formed compared to forming the first and second panels 208, 210 from two distinct sheets. It is noted that, in either embodiment, the first panel 208 and the second panel 210 may still lie substantially flat when the penis is not in the chamber 212.

[0095] FIG. 3 is a block diagram of a system 10 for fluid collection, according to an embodiment. The system 10 includes a fluid collection device 12, a fluid storage container 14, and a vacuum source 16 (<?.g., portable vacuum source). The fluid collection device 12 may include any of the fluid collection devices described herein, such as the fluid collection device 100, 200, 300, 400. The fluid collection device 12, the fluid storage container 14, and the portable vacuum source 16 may be fluidly coupled to each other via one or more conduits 17. The conduit 17 may include any of the conduits described herein, such as the conduit 108. The fluid collection device 12 may be operably coupled to one or more of the fluid storage container 14 or the portable vacuum source via the conduit 17. Fluid (e.g., urine or other bodily fluids) collected in the fluid collection device 12 may be removed from the fluid collection device 12 via the conduit 17. The second open end of the conduit 17 may extend into the fluid storage container 14 or the portable vacuum source 16. The suction force may be introduced into the interior region of the fluid collection device 12 via the first open end of the conduit 17 responsive to a suction e.g., vacuum) force applied at the second end of the conduit 17. The suction force may be applied to the second open end of the conduit 17 by the portable vacuum source 16 either directly or indirectly.

[0096] The suction force may be applied indirectly via the fluid storage container 14. For example, the second open end of the conduit 17 may be disposed within the fluid storage container 14 and an additional conduit 17 may extend from the fluid storage container 14 to the portable vacuum source 16. Accordingly, the portable vacuum source 16 may apply suction to the fluid collection device 12 via the fluid storage container 14. The suction force may be applied directly via the fluid storage container 14. For example, the second open end of the conduit 17 may be disposed within the portable vacuum source 16. An additional conduit 17 may extend from the portable vacuum source 16 to a point outside of the fluid collection device 12, such as to the fluid storage container 14. In such examples, the portable vacuum source 16 may be disposed between the fluid collection device 12 and the fluid storage container 14.

[0097] The fluid collection device 12 may be shaped and sized to receive at least a portion of the penis of a user. The fluid collection member of the fluid collection device12 may include a fluid impermeable barrier at least partially defining a chamber (e.g., interior region of the fluid collection device member) of the fluid collection device 12. Example fluid collection devices for use with the systems and methods herein are described in more detail below.

[0098] In some embodiments, the fluid storage container 14 may include a bag e.g., drainage bag), a bottle or cup (e.g., collection jar), or any other enclosed container for storing bodily fluids such as urine. In examples, the conduit 17 may extend from the fluid collection device 12 and attach to the fluid storage container 14 at a first point therein. An additional conduit 17 may attach to the fluid storage container 14 at a second point thereon and may extend and attach to the portable vacuum source 16. For example, the fluid storage container 14 may include a container fluidly coupled to a first conduit section that is also fluidly coupled to the fluid collection member of the fluid collection device 12. The container may be fluidly coupled to a second section of the conduit 17 that is also fluidly coupled to a portable vacuum source. In such examples, the portable vacuum source 16 may provide a vacuum / suction through the container to the fluid collection member to provide suction in the chamber of the fluid collection member. Accordingly, a vacuum (e.g., suction) may be drawn through fluid collection device 12 via the fluid storage container 14. As the fluid is drained from the chamber, the fluid may travel through the first section of conduit to the fluid storage container where it may be retained. Fluid, such as urine, may be drained from the fluid collection device 12 using the portable vacuum source 16.

[0099] In some embodiments, the portable vacuum source 16 may be disposed in or on the fluid collection device 12. In such examples, the conduit 17 may extend from the fluid collection device and attach to the portable vacuum source 16 at a first point therein. An additional conduit 17 may attach to the portable vacuum source 16 at a second point thereon and may extend out of the fluid collection device 12, and may attach to the fluid storage container 14. Accordingly, a vacuum (e.g., suction) may be drawn through fluid collection device 12 via the fluid storage container 14.

[0100] The portable vacuum source 16 may include one or more of a manual vacuum pump, and electric vacuum pump, a diaphragm pump, a centrifugal pump, a displacement pump, a magnetically driven pump, a peristaltic pump, or any pump configured to produce a vacuum. The portable vacuum source 16 may provide a vacuum or suction to remove fluid from the fluid collection member of the fluid collection device 12. In some embodiments, the portable vacuum source 16 may be powered by one or more of a powercord (e.g., connected to a power socket), one or more batteries, or even manual power (e.g., a hand operated vacuum pump). In examples, the portable vacuum source 16 may be sized and shaped to fit outside of, on, or within the fluid collection device 12. For example, the portable vacuum source 16 may include one or more miniaturized pumps or one or more micro pumps. The portable vacuum sources 16 disclosed herein may include one or more of a switch, a button, a plug, a remote, or any other device suitable to activate the portable vacuum source 16. It should be understood that the portable vacuum sources 16 disclosed herein may provide a portable means of providing a suction or vacuum that allows use of the devices and systems herein outside of hospital or care facility environments where vacuum lines are plumbed into patient rooms or large (e.g., larger or heavier than a patient can readily carry) vacuum sources are located. For example, a portable vacuum source may be small and light enough to be carried by a user (e.g., patient) or aid (e.g., nurse) during transportation of the user.

[0101] FIG. 4 is a flow diagram of a method 400 for collecting fluids, according to an embodiment. The method 400 may utilize any fluid collection assembly described herein, such as the fluid collection assembly 100, 200. The method 400 includes an act 402 of securing a fluid collection assembly at least proximate to a penis of user with one or more straps secured to an upper region of a body of the fluid collection assembly that is at least semi-rigid. The method 400 also includes an act 404 of positioning a first opening defined by a fluid impermeable barrier of the fluid collection assembly to receive a penis of the patient through the first opening and into a chamber defined by the fluid impermeable barrier. The fluid impermeable barrier may define at least the chamber, the first opening, and a fluid outlet. The fluid impermeable barrier may include a distal end region including the fluid outlet and a proximal end region secured to a lower region of the body spaced from the upper region of the body. The method 400 also includes an act 406 of discharging bodily fluids onto at least one porous material in the chamber. The method 400 also includes an act 408 of receiving the bodily fluids into at least one porous material of the fluid collection assembly that is disposed in the chamber and an act 410 of removing the bodily fluids from the chamber via the fluid outlet.

[0102] In some embodiments, the method 400 includes an act of positioning a second opening defined by the first region of the body to receive the penis of the patient through the second opening and into the first opening and the chamber. In these and other embodiments, the body may include one or more sidewalls extending between the first region and the second region, the one or more sidewalls being disposed at least proximateto the proximal end region of the fluid impermeable barrier. The fluid impermeable barrier may be secured to the first region of the body with the first opening of the fluid impermeable barrier aligned with the second opening of the first region, the fluid impermeable barrier extending away from the one or more sidewalls of the body. In some embodiments, positioning a second opening defined by the first region of the body to receive the penis of the patient may include positioning a rim defining the second opening to receive the penis of the patient. The rim may extend from the first region towards the second region and the proximal end region of the fluid impermeable barrier being secured around the rim to align the first opening of the fluid impermeable barrier with the second opening of the body. In some embodiments, the body may define an additional opening between the first region and the second region of the body, and the fluid impermeable barrier may extend from the second opening in the first region and through the additional opening. The second region of the body may define one or more apertures, and the one or more straps being secured to the second region of the body through the one or more apertures in the second region.

[0103] In some embodiments, the method 400 further comprises positioning a foam cushion secured to the first region of the base to contact skin of the patient around the penis of the patient. In these and other embodiments, the fluid impermeable barrier may include a substantially cylindrical or tubular bag having the first opening at the proximal end region and the fluid outlet at the distal end region. The at least one porous material disposed in the chamber may include one or more discs of the at least one porous material or one or more cylinders of the at least one porous material disposed in the chamber such that the at least one porous material retains at least a portion of the chamber and at least a portion of the fluid impermeable barrier in a shape that is substantially cylindrical or tubular.

[0104] In some embodiments, of the method 400, the body includes one or more sidewalls extending between the first region and the second region to define a concave region in the body having at least a portion of the proximal end region positioned therein, the second region defines one or more apertures, and the one or more straps may be secured to the second region of the body through the one or more apertures in the second region. In these and other embodiments of the method 400, the first opening in the fluid impermeable barrier may be spaced distally from the first region of the body and the at least one porous material may be generally planar. The fluid impermeable barrier may include a first panel region defining the first opening and secured to the first region of thebody, and a second panel region opposite to the first panel region. The at least one porous material may be positioned in the chamber between the first panel region and the second panel region. In some embodiments, the at least one porous material may be at least partially secured to the second panel region and extends in the chamber between the distal end region at least partially into the concave region of the body. The method 400 may further comprise positioning a foam cushion secured to at least one the first region of the base and / or the first panel region of the fluid impermeable barrier on the skin around the penis of the patient with a second opening defined by the foam cushion positioned to receive the penis.

[0105] Acts of the method 400 are for illustrative purposes. For example, the acts of the method 400 may be performed in different orders, split into multiple acts, modified, supplemented, or combined. Any of the acts of the method 400 may include using any of the fluid collection devices or systems disclosed herein.

[0106] While various aspects and embodiments have been disclosed herein, other aspects and embodiments are contemplated. The various aspects and embodiments disclosed herein are for purposes of illustration and are not intended to be limiting.

[0107] Terms of degree (e.g., “about,” “substantially,” “generally,” etc.) indicate structurally or functionally insignificant variations. In an example, when the term of degree is included with a term indicating quantity, the term of degree is interpreted to mean ± 10%, ±5%, or +2% of the term indicating quantity. In an example, when the term of degree is used to modify a shape, the term of degree indicates that the shape being modified by the term of degree has the appearance of the disclosed shape. For instance, the term of degree may be used to indicate that the shape may have rounded corners instead of sharp corners, curved edges instead of straight edges, one or more protrusions extending therefrom, is oblong, is the same as the disclosed shape, etc.

Claims

CLAIMSWhat is claimed is:

1. A fluid collection assembly, comprising: a fluid impermeable barrier having a proximal end region and a distal end region, the fluid impermeable barrier defining at least a chamber, a first opening sized to receive at least a portion of a penis therethrough, and a fluid outlet disposed at least proximate to the distal end region; at least one porous material disposed in the chamber; a body including a first region secured to the proximal end region of the fluid impermeable barrier and a second region opposite to and spaced from the first region, the first region defining a second opening aligned with the first opening of the fluid impermeable barrier and sized to receive at least a portion of the penis therethrough; and one or more straps secured to the second region of the body.

2. The fluid collection assembly of claim 1, wherein: the body includes one or more sidewalls extending between the first region and the second region, the one or more sidewalls being disposed at least proximate to the proximal end region of the fluid impermeable barrier; and the fluid impermeable barrier is secured to the first region of the body with the first opening of the fluid impermeable barrier aligned with the second opening of the first region, the fluid impermeable barrier extending away from the one or more sidewalls of the body.

3. The fluid collection assembly of claim 2, wherein the first region of the body includes a rim defining the second opening and extending from the first region towards the second region, the proximal end region of the fluid impermeable barrier being secured around the rim to align the first opening of the fluid impermeable barrier with the second opening of the body.

4. The fluid collection assembly of claim 3, wherein the proximal end region is secured to the rim with an o-ring surrounding the proximal end region of the fluid impermeable barrier and the rim of the first region of the body.

5. The fluid collection assembly of claim 3, wherein the proximal end region is secured to the rim with one or more of a heat seal or an adhesive.

6. The fluid collection assembly of any of claims 2-5, wherein the body defines an additional opening between the first region and the second region of the body,and the fluid impermeable barrier extends from the second opening in the first region and through the additional opening.

7. The fluid collection assembly of any of claims 2-5, wherein the second region of the body defines one or more apertures, the one or more straps being secured to the second region of the body through the one or more apertures in the second region.

8. The fluid collection assembly of any of claims 1-7, further comprising a foam cushion secured to the first region of the body and positioned to contact skin of a user around the penis of the user.

9. The fluid collection assembly of claim 8, wherein the foam cushion includes a cushion opening aligned with the first opening and the second opening, the cushion opening being sized to receive at least a portion of the penis therethrough.

10. The fluid collection assembly of any of claims 1-9, wherein the fluid impermeable barrier includes a substantially cylindrical or tubular bag having the first opening at the proximal end region and the fluid outlet at the distal end region.

11. The fluid collection assembly of claim 10, wherein the at least one porous material disposed in the chamber includes one or more discs of the at least one porous material or one or more cylinders of the at least one porous material disposed in the chamber such that the at least one porous material retains at least a portion of the chamber and at least a portion of the fluid impermeable barrier in a shape that is substantially cylindrical or tubular.

12. The fluid collection assembly of claim 1, wherein: the body includes one or more sidewalls extending between the first region and the second region to define a concave region in the body having at least a portion of the proximal end region positioned therein; the second region defines one or more apertures; and the one or more straps are secured to the second region of the body through the one or more apertures in the second region.

13. The fluid collection assembly of claim 12, wherein the first opening in the fluid impermeable barrier is spaced distally from the first region of the body and the at least one porous material is generally planar.

14. The fluid collection assembly of claim 13, wherein the fluid impermeable barrier includes a first panel region defining the first opening and secured to the first region of the body, and a second panel region opposite to the first panel region, the at least one porous material being positioned in the chamber between the first panel regionand the second panel region.

15. The fluid collection assembly of claim 14, wherein the at least one porous material is at least partially secured to the second panel region and extends in the chamber between the distal end region at least partially into the concave region of the body.

16. The fluid collection assembly of either claim 14 or 15, further comprising a foam cushion secured to at least one the first region of the body, the foam cushion defining a cushion opening sized to receive at least a portion of the penis at least partially therethrough and aligned with the first opening of the fluid impermeable barrier, wherein the foam cushion is positioned to contact skin of a user around the penis of the user.

17. A fluid collection system, comprising: the fluid collection assembly of any one of claims 1-16; a fluid storage container; and a vacuum source; wherein the chamber of the fluid collection assembly, the fluid storage container, and the vacuum source are in fluid communication with each other so that, when one or more bodily fluids are present in the chamber, a suction provided from the vacuum source to the chamber of the fluid collection assembly removes the one or more bodily fluids from the chamber and deposits the bodily fluids in the fluid storage container.

18. A method to collect bodily fluids from a patient, the method comprising: securing a fluid collection assembly at least proximate to a penis of user with one or more straps secured to an upper region of a body of the fluid collection assembly; positioning a first opening defined by a fluid impermeable barrier of the fluid collection assembly and second opening defined by a lower region of the body of the fluid collection assembly to receive a penis of the patient through the first opening and into a chamber defined by the fluid impermeable barrier, the fluid impermeable barrier defining at least the chamber, the first opening, and a fluid outlet, wherein the fluid impermeable barrier includes a distal end region including the fluid outlet and a proximal end region secured to the lower region of the body spaced from the upper region of the body; discharging bodily fluids onto at least one porous material in the chamber; receiving the bodily fluids into at least one porous material of the fluid collection assembly that is disposed in the chamber; and removing the bodily fluids from the chamber via the fluid outlet.

19. The method of claim 18, wherein:the body includes one or more sidewalls extending between the first region and the second region, the one or more sidewalls being disposed at least proximate to the proximal end region of the fluid impermeable barrier; and the fluid impermeable barrier is secured to the first region of the body with the first opening of the fluid impermeable barrier aligned with the second opening of the first region, the fluid impermeable barrier extending away from the one or more sidewalls of the body.

20. The method of claim 19, wherein positioning a second opening defined by the first region of the body to receive the penis of the patient includes positioning a rim defining the second opening to receive the penis of the patient, the rim extending from the first region towards the second region and the proximal end region of the fluid impermeable barrier being secured around the rim to align the first opening of the fluid impermeable barrier with the second opening of the body.

21. The method of either claim 19 or 20, wherein the body defines an additional opening between the first region and the second region of the body, and the fluid impermeable barrier extends from the second opening in the first region and through the additional opening.

22. The method of any of claims 19-21, wherein the second region of the body defines one or more apertures, the one or more straps being secured to the second region of the body through the one or more apertures in the second region.

23. The method of any of claims 18-22, further comprising positioning a cushion opening defined by a foam cushion secured to the first region of the body to receive at least a portion of the penis therethrough such that the foam cushion contacts skin of the patient around the penis of the patient.

24. The method of any of claims 18-23, wherein the fluid impermeable barrier includes a substantially cylindrical or tubular bag having the first opening at the proximal end region and the fluid outlet at the distal end region.

25. The method of claim 24, wherein the at least one porous material disposed in the chamber includes one or more discs of the at least one porous material or one or more cylinders of the at least one porous material disposed in the chamber such that the at least one porous material retains at least a portion of the chamber and at least a portion of the fluid impermeable barrier in a shape that is substantially cylindrical or tubular.

26. The method of claim 18, wherein: the body includes one or more sidewalls extending between the first region andthe second region to define a concave region in the body having at least a portion of the proximal end region positioned therein; the second region defines one or more apertures; and the one or more straps are secured to the second region of the body through the one or more apertures in the second region.

27. The method of claim 26, wherein the first opening in the fluid impermeable barrier is spaced distally from the first region of the body and the at least one porous material is generally planar.

28. The method of claim 27, wherein the fluid impermeable barrier includes a first panel region defining the first opening and secured to the first region of the body, and a second panel region opposite to the first panel region, the at least one porous material being positioned in the chamber between the first panel region and the second panel region.

29. The method of claim 28, wherein the at least one porous material is at least partially secured to the second panel region and extends in the chamber between the distal end region at least partially into the concave region of the body.

30. The method of either claim 28 or 29, further comprising positioning a foam cushion secured to at least one the first region of the body and / or the first panel region of the fluid impermeable barrier on the skin around the penis of the patient with a second opening defined by the foam cushion positioned to receive the penis.

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