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 region and a distal region, and defines at least a chamber, a first opening sized to receive at least a portion of a penis therethrough, and a fluid outlet disposed proximate the distal region. The body includes a first region secured to the proximal region of the fluid impermeable barrier and a second region opposite and spaced apart 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 a penis therethrough. The one or more straps are secured to the second region of the body.

Description

Background Technology

[0001] Humans or animals may have limited or impaired mobility, making the normal urination process challenging or impossible. For example, a person may experience or have a disability that impairs mobility. A person may have limited mobility conditions, such as those experienced by pilots, drivers, and workers in hazardous areas. In addition, bodily fluids may sometimes be required for monitoring purposes or clinical testing.

[0002] Urinary catheters, such as Foley catheters, can address some of these conditions, including incontinence. Unfortunately, catheters can be uncomfortable, painful, and can lead to complications such as infections. Additionally, bedpans are sometimes used; bedpans are containers for bedridden individuals to use the toilet. However, bedpans are prone to causing discomfort, spills, and other hygiene problems. Summary of the Invention

[0003] The embodiments disclosed herein relate to fluid collection assemblies, related systems, and methods of use. In an embodiment, the 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 region and a distal region. The fluid-impermeable barrier defines at least a chamber, a first opening sized to receive at least a portion of the penis therethrough, and a fluid outlet disposed at least adjacent to the distal region. At least one porous material is disposed within the chamber. The body includes a first region fixed to the proximal region of the fluid-impermeable barrier and a second region opposite and spaced apart from the first region. The first region defines a second opening aligned with the first opening of the fluid-impermeable barrier, and the second opening is sized to receive at least a portion of the penis therethrough. One or more straps are fixed to the second region of the body.

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

[0005] In one embodiment, a method for collecting bodily fluids from a patient is disclosed. The method includes securing the fluid collection assembly, at least adjacent to the user's penis, using one or more straps fixed to an upper region of the 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 a second opening defined by a lower region of the body of the fluid collection assembly to receive the patient's penis 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 region and a proximal region, the distal region including the fluid outlet, and the proximal region being fixed to a lower region of the body spaced from the upper region of the body. The method further includes discharging the bodily fluid onto at least one porous material within the chamber. The method also includes receiving the bodily fluid into at least one porous material disposed within the chamber of the fluid collection assembly. The method further includes removing the bodily fluid from the chamber via the fluid outlet.

[0006] Features from any of the disclosed embodiments can be combined with each other without limitation. Furthermore, other features and advantages of this disclosure will become apparent to those skilled in the art upon consideration of the following detailed description and accompanying drawings. Attached Figure Description

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

[0008] Figure 1A This is an isometric side view of the fluid collection assembly according to an embodiment.

[0009] Figure 1B yes Figure 1A A partial cross-sectional view of the fluid collection component.

[0010] Figure 2A This is a top view of the fluid collection assembly according to an embodiment.

[0011] Figure 2B It is along Figure 1A The line 2B-2B cut Figure 1A A cross-sectional view of the fluid collection component.

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

[0013] Figure 4 This is a flowchart of a method for collecting fluid according to an embodiment. Detailed Implementation

[0014] The embodiments disclosed herein relate to a fluid collection assembly and related systems, and methods of using the fluid collection assembly. The fluid collection assembly includes a fluid-impermeable barrier, at least one porous material disposed within a chamber of the fluid-impermeable barrier, a body, and one or more straps. In many embodiments, the fluid-impermeable barrier has a proximal region and a distal region, and at least defines a chamber, a first opening sized to receive at least a portion of the penis therethrough, and a fluid outlet disposed at least adjacent to the distal region. In many embodiments, the body is at least semi-rigid and includes a first region fixed to the proximal region of the fluid-impermeable barrier and a second region opposite and spaced apart from the first region. One or more straps are fixed to the second region of the body.

[0015] In at least one, some, or all of the embodiments, the fluid collection assembly is configured such that a strap pushes a first region of the body and / or a foam pad attached thereto toward the patient. The body and / or foam pad being pushed toward the patient results in a technical effect of forming a seal against the patient's skin. The body may include a semi-rigid material (such as rubber) to maintain its shape and be comfortable for the patient.

[0016] In at least one, some, or all of the embodiments, the fluid-impermeable barrier of the fluid collection assembly may comprise a bag-like material (e.g., a soft polyethylene bag material), which results in the technical effect of urine flowing to the fluid outlet of the fluid-impermeable barrier. For example, the combination of the material of the fluid-impermeable barrier with a 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 of the embodiments, the combination of the material of the fluid-impermeable barrier with a semi-rigid shell 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 that urine flows downward to the fluid outlet of the fluid-impermeable barrier.

[0017] Figure 1A This is an isometric side view of the fluid collection assembly 100 according to an embodiment. Figure 1B yes Figure 1A A partial cross-sectional view of the fluid collection assembly 100. The fluid collection assembly 100 (e.g., a 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 fixed to a proximal region 160 of the fluid-impermeable barrier 102, and one or more straps 111 fixed to the body 101 and spaced apart from the proximal region 160 of the fluid-impermeable barrier 102.

[0018] According to an embodiment, the fluid-impermeable barrier 102 includes a proximal region 160 and a distal region 162 opposite to the proximal region 160. The fluid-impermeable barrier 102 may also define at least a chamber 112, a first opening 114 sized to receive at least a portion of the penis therethrough, and a fluid outlet 118 disposed at least adjacent to the distal region 162. In some embodiments, the fluid-impermeable barrier 102 may be generally tubular and / or cylindrical in shape to form an elongated sheath having the first opening 114 at the proximal region 160 and the fluid outlet 118 at the distal 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 bodily fluids in the chamber 112.

[0019] The fluid-impermeable barrier 102 can be formed of any suitable fluid-impermeable material, such as fluid-impermeable polymers (e.g., silicone, polypropylene, polyethylene, polyethylene terephthalate, polyurethane, polyethylene, polyvinyl chloride, polycarbonate, etc.), metal membranes, natural rubber, another suitable material, or combinations thereof. Therefore, the fluid-impermeable barrier 102 substantially prevents bodily fluids from passing through it. In an example, the fluid-impermeable barrier 102 can be air-permeable and fluid-impermeable, thus preventing leakage when a vacuum force is applied to it while allowing air to flow through the chamber 112 (i.e., the chamber 112 is maintained at atmospheric pressure, thereby preventing the vacuum force from causing wrinkling or kinking of the conduit in fluid communication with the fluid outlet 118). In such an example, the fluid-impermeable barrier 102 can be formed of a hydrophobic material defining a plurality of pores. At least one or more portions of at least the outer surface of the fluid-impermeable barrier 102 can be formed of a soft and / or smooth material, thereby reducing friction.

[0020] In this embodiment, the fluid-impermeable barrier 102 is formed of polyurethane, such as polyurethane alone. Clinical trials have found that forming the fluid-impermeable barrier 102 with polyurethane improves the functionality of the fluid collection assembly 100. For example, when formed of polyurethane, the fluid-impermeable barrier 102 can exhibit greater flexibility than when formed of another material. The increased flexibility of the fluid-impermeable barrier 102 formed of polyurethane makes it easier to attach and maintain the fluid collection assembly 100 to and from the individual. The increased flexibility of the fluid-impermeable barrier 102 formed of polyurethane also helps allow the fluid collection assembly 100 to conform to the individual and / or fit under the individual's clothing, thereby increasing patient comfort. Polyurethane can also remain flexible when welded or otherwise formed into a seal. It has also been found that individuals using the fluid collection assembly 100 describe the fluid-impermeable barrier 102 formed of polyurethane as smoother than when formed of other materials. The smoother feel of the fluid-impermeable barrier 102 formed of polyurethane makes wearing the fluid collection assembly 100 more comfortable. It has also been found that the fluid-impermeable barrier 102 formed of polyurethane allows for quieter bending (e.g., wrinkling, puckering, etc.) compared to a fluid-impermeable barrier 102 formed of another material. This improved quietness of the fluid-impermeable barrier 102 allows for more discreet use of the fluid collection assembly 100. For example, movement of an individual using the fluid collection assembly 100 may cause the fluid-impermeable barrier 102 to bend. The polyurethane-formed fluid-impermeable barrier 102 allows for greater movement of the individual without generating noise. Finally, it has been found that the polyurethane-incorporated fluid-impermeable barrier 102 can be welded to a variety of materials, facilitating the attachment of the foam liner 103 and / or the body 101.

[0021] In an embodiment, at least some (e.g., all) of the fluid-impermeable barrier 102 is formed of a fluid-impermeable material that is at least partially transparent, such as polyethylene, polypropylene, polyurethane, polycarbonate, or polyvinyl chloride. Forming the fluid-impermeable barrier 102 with a fluid-impermeable material that is at least partially transparent allows a person (e.g., a medical practitioner) to examine the penis. For example, the chamber 112 may include a penis receiving area configured to receive an individual's penis when it is extended into the chamber 112. The penis receiving area may be at least partially defined by a portion of a porous material 122 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 when the penis is inserted into the chamber 112 through the first opening 114, the porous material 122 is not positioned between the penis and at least a portion of the transparent portion of the fluid-impermeable barrier 102. The porous material 122 is generally opaque, so at least a portion of the transparent material of the fluid-impermeable barrier 102 defining the penile receiving area forms a window that allows a person to observe the penile receiving area and examine the penis.

[0022] A first opening 114, defined by a fluid-impermeable barrier 102, provides an entry path for fluid into chamber 112 when the penis is concealed, and / or allows the penis to enter chamber 112 (e.g., penile receiving area 131) when the penis is not concealed. The first opening 114 may be defined by the fluid-impermeable barrier 102. For example, the opening 114 is formed in the fluid-impermeable barrier 102 and extends through the fluid-impermeable barrier 102 at a proximal region 160, thereby allowing bodily fluids to enter chamber 112 from the outside of the fluid collection assembly 100.

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

[0024] The distal 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 within the chamber 112 or otherwise in fluid communication with the chamber 112 via the fluid outlet 118. The fluid outlet 118 may be sized and shaped to form a seal with the conduit that is at least substantially impermeable to fluid, thereby substantially preventing leakage of bodily fluids from the chamber 112. The conduit may be attached to the fluid outlet 118 using adhesives, welding, interference fits, or friction fits, or otherwise bonded to the fluid outlet 118. Attaching the conduit to the fluid outlet 118 prevents leakage and prevents accidental detachment of the conduit 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-impermeable barrier 102 may include a port 130 directly attached to the fluid-impermeable barrier 102 and configured to be attached to the conduit.

[0025] Port 130 includes a first portion 144 and a second portion 146. The first portion 144 is configured to attach to a fluid-impermeable barrier 102 and optionally, at least partially, is disposed within chamber 112. The second portion 146 is configured to attach to a conduit. The first portion 144 defines an inlet 148, and the second portion 146 defines an outlet 150 of port 130, which is located downstream of inlet 148. Port 130 also defines a passage extending from inlet 148 to outlet 150. It should be noted that inlet 148 refers to the inlet of the passage, and not necessarily the inlet of port 130. In the example, when port 130 does not include a sump, inlet 148 can be the inlet of both port 130 and the passage. In the example, as shown, when port 130 includes a sump, inlet 148 may not be the inlet of port 130 because the sump forms the inlet of port 130.

[0026] The first portion 144 of port 130 can be attached to the fluid-impermeable barrier 102 using any suitable technique. In embodiments, the first portion 144 is attached to the fluid-impermeable barrier 102 using at least one of adhesive, pulse heating, direct heating, ultrasonic welding, radio frequency welding, any other attachment technique disclosed herein, or any other suitable attachment technique.

[0027] At least the second portion 146 exhibits a stiffness greater than that of the fluid-impermeable barrier 102. The second portion 146 can exhibit greater stiffness than the fluid-impermeable barrier 102 because it exhibits a thickness greater than the thickness of the fluid-impermeable barrier 102 and / or at least a portion of the second portion 146 is formed of a material exhibiting a Young's modulus (i.e., elastic modulus) greater than that of the material forming at least a portion of the fluid-impermeable barrier 102. This increased stiffness of the second portion 146 relative to the fluid-impermeable barrier 102 allows the second portion 146 to be attached to the conduit using techniques that might be difficult or impossible when the conduit is directly attached to the fluid-impermeable barrier 102. In an example, the conduit can be attached to the second portion 146 using an interference fit, which might be difficult or impossible when the conduit is directly attached to the fluid-impermeable barrier 102. In such an example, the surface of the second portion 146 configured to abut the conduit is tapered. The tapered surface of the second portion 146 facilitates easier insertion of the second portion 146 into the conduit when it forms a male connector, and facilitates easier reception of the conduit into the second portion 146 when it forms a female connector. The tapered surface of the second portion 146 also allows control over the strength of the interference fit between the second portion 146 and the conduit by controlling the degree to which the second portion 146 is inserted into the conduit or the degree to which the conduit is inserted into the second portion 146. In an example not shown, the surface of the second portion 146 is configured to thread onto the conduit, which may be difficult or impossible when the conduit is directly attached to the fluid impermeable barrier 102. In such an example, the second portion 146 may include one or more helically extending ridges extending from the surface of the second portion 146 that contacts the conduit or is closest to the conduit. It should be noted that the surface including the thread and / or the thread may be tapered. In an example not shown, the surface of the second portion 146 that contacts the conduit or is closest to the conduit may include circumferentially extending ridges. It should be noted that the surface including the ridge and / or the ridge may be tapered.

[0028] In this embodiment, at least the second portion 146 exhibits greater rigidity than the conduit. The second portion 146 can exhibit greater rigidity than the conduit because it exhibits a thickness greater than the conduit's thickness and / or at least a portion of the second portion 146 is formed of a material exhibiting a Young's modulus greater than that of the material forming at least a portion of the conduit. This increased rigidity of the second portion 146 prevents channel collapse in the port 130. For example, it has been found that, in certain situations, directly attaching a conduit to the fluid-impermeable barrier 102 may cause at least partial collapse of the portion of the conduit 142 attached to the fluid-impermeable barrier 102 when a strong vacuum is applied to the chamber 112. However, the increased rigidity of the port 130 prevents such collapse.

[0029] In this embodiment, the first portion 144 exhibits greater rigidity than the fluid-impermeable barrier 102 and / or the conduit. For example, the first portion 144 may exhibit rigidity comparable to that of the second portion 146. The increased rigidity of the first portion 144 prevents collapse of the inlet 148, any portion of the passage in the port 130 defined therein, and the collection tank. The increased rigidity of the first portion 144 also makes it easier to attach the port 130 to the first portion 144, as pressure can be applied to the first portion 144 during attachment without substantially deforming it.

[0030] The first portion 144 may exhibit a different shape than the second portion 146. For example, the first portion 144 may exhibit a first elongated shape that extends in a direction generally perpendicular to the longitudinal axis 140, and the second portion 146 may exhibit a second elongated shape (e.g., a 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 portion 144 can strengthen the attachment between the first portion 144 and the fluid-impermeable barrier 102 by increasing the surface area of ​​the first portion 144 attached to the fluid-impermeable barrier 102. The first elongated shape of the first portion 144 also prevents or at least inhibits torsion of the sheath 102. Examples of the first elongated shape include a generally rectangular cross-sectional shape, a generally elliptical cross-sectional shape, and a generally rhomboid cross-sectional shape. In a particular example, the first elongated shape is a generally rhomboid cross-sectional shape because the relatively sharp corners of the generally rhomboid cross-sectional shape, which are furthest from the second portion 146, facilitate attachment of the fluid-impermeable barrier 102 to the first portion 144 without creating a gap between the first portion 144, the first panel 108, and the second panel 110, compared to more rounded corners. In a particular example, the first elongated shape includes rounded corners because rounded corners are less likely to cause uncomfortable pressure on the individual than sharp corners. The second elongated shape of the second portion 146, extending parallel to the longitudinal axis 140, facilitates attachment to the conduit 142. In some embodiments, the port 130 may include at least one tab extending from the first portion 144 into the chamber 112 to prevent the fluid-impermeable barrier from clogging the inlet 148.

[0031] Fluid outlet 118 and port 130 may be located at or near the distal region 162 of the fluid-impermeable barrier 102, which is intended to be the gravitational low point of chamber 112 when worn by a user. Positioning the fluid outlet 118 and port 130 at or near the distal region 162 of the fluid-impermeable barrier 102 allows the catheter to receive more bodily fluid than if the fluid outlet 118 and port 130 were located elsewhere, and reduces the likelihood of accumulation (e.g., fluid accumulation can lead to microbial growth and foul odor). However, bodily fluids may exhibit a preference for flowing in the direction of gravity. Therefore, when worn by a user, the fluid outlet 118 and port 130 may be located in a position within the fluid collection assembly 100 intended to be the gravitational low point of the fluid collection assembly 100.

[0032] As previously described, the sheath 102 includes at least one porous material 122 disposed within the chamber 112. In some embodiments, the porous material 122 may guide bodily fluids to one or more selected areas of the chamber 112, such as away from the penis and toward the fluid outlet 118. Thus, the porous material 122 may facilitate the removal of bodily fluids from the chamber 112. The porous material 122 may also buffer urine flow from the penis. The porous material 122 may be shaped as a continuous cylinder and / or a plurality of discs of porous material 122 that together form a cylinder positioned within the chamber 112 of the fluid-impermeable barrier 102. Thus, at least one porous material 122 disposed within the chamber 112 may include one or more discs of at least one porous material 122 disposed within the chamber 112 or one or more cylinders of at least one porous material 122, such that at least one porous material 122 maintains at least a portion of the chamber 112 and at least a portion of the fluid-impermeable barrier 102 in a generally cylindrical or tubular shape.

[0033] In many embodiments, the porous material 122 comprises a porous spun nylon fiber structure. In some embodiments, the porous material 122 comprises a fluid-permeable wicking membrane comprising gauze that at least partially surrounds the spun nylon fiber structure. For example, the porous material 122 may comprise gauze or other wicking fabric positioned to contact a user's penis within chamber 112. In some embodiments, the gauze or other wicking fabric is wrapped around the body of the spun nylon fiber material.

[0034] In an embodiment, the porous material 122 may include a wicking material configured to draw any bodily fluids away from the opening 114, thereby preventing the fluids from escaping from the chamber 112. This "wicking" may not include the absorption of fluid into the wicking material. In other words, substantially no fluid is absorbed into the material after a period of time following exposure to and removal from the fluid. While absorption is not desired, the term "substantially no absorption" may allow a nominal amount of fluid to be absorbed into the wicking material (e.g., absorbability), such as less than about 30 wt%, 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 fluid generally toward the interior of the chamber 112, as discussed in more detail below. In an embodiment, the porous material 122 is configured to adsorb or absorb bodily fluids. Similar to wicking materials, this adsorbent or absorbent material can remove bodily fluids from the opening 114, thereby preventing bodily fluids from overflowing from the chamber 112.

[0035] The porous material 122 can be formed from any suitable porous material. For example, the porous material 122 can be formed from nylon (e.g., spun nylon fibers), polyester, polyurethane, polyethylene, polypropylene, other porous polymers, hydrophobic foam, open-cell foam, wool, silk, linen, cotton (e.g., cotton gauze), felt, other fabrics, coated porous materials (e.g., waterproof coated porous materials), 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 layer of the porous material 122 may be a woven material. The porous material 122 may also include a plurality of fibers forming a layer between the first and second layers of the porous material 122. Each of the first layer, the second layer, and the plurality of fibers defines a plurality of pores, thereby allowing fluid transport and air circulation through the porous material 122. The pores defined by the plurality of fibers may be larger and / or more, thereby reducing the likelihood of dried fluid clogging the porous material 122. The presence of the plurality of fibers also makes the porous material 122 feel soft against the penis and provides a cushioning effect. The plurality of fibers also prevent the porous material from collapsing due to vacuum forces.

[0037] The first layer, second layer, and multiple fibers of the porous material 122 can be formed of any suitable material, such as hydrophobic materials, hydrophilic materials, polyester, cotton, or any other porous material disclosed herein. In an embodiment, one or more of the first layer, second layer, or multiple fibers of the porous material 122 are formed of a hydrophobic material that inhibits the storage of bodily fluids therein, which facilitates the removal of bodily fluids from the chamber 112. In an embodiment, one or more of the first layer, second layer, or multiple fibers of the porous material 122 are formed of a hydrophilic material that allows the porous material 122 to temporarily store bodily fluids therein, thereby limiting the amount of bodily fluids accumulating around the individual's skin. In an embodiment, two or more of the first layer, second layer, or multiple fibers of the porous material 122 are formed of different materials. In such an embodiment, the first layer may define a penile receiving area or otherwise be closer to the penile receiving area than the second layer. The first layer may be formed of a hydrophobic material, while the multiple fibers may be formed of a hydrophilic material. This configuration can result in bodily fluids being drawn across the first layer and temporarily stored in the multiple fibers. However, the first layer can remain essentially dry due to its hydrophobicity, which makes the porous material 122 feel dry to the penis. In an embodiment, at least one of the first or second layers is formed of a fabric (e.g., fabric gauze), and the plurality of fibers are formed of nylon fibers (e.g., spun nylon fibers).

[0038] In embodiments, the porous material 122 may be formed of two layers. For example, the porous material 122 may be formed of a fluid-permeable membrane and a fluid-permeable support. The fluid-permeable support may define a penile receiving area or otherwise be closer to the penile receiving area than the fluid-permeable support itself. The fluid-permeable membrane may be configured and / or constructed to wick or otherwise draw bodily fluids away from the penile receiving area, thereby minimizing the amount of bodily fluid present in the penile receiving area or otherwise in contact with the individual's skin. It should also be noted that the fluid-permeable membrane may also be configured to adsorb or absorb bodily fluids to minimize the amount of bodily fluid present in the penile receiving area or otherwise in contact with the individual's skin. The fluid-permeable membrane may be formed of any porous material disclosed herein. For example, the fluid-permeable membrane may be formed of fabrics, such as gauze (e.g., silk, linen, or cotton gauze), another soft fabric, another smooth fabric, woven or non-woven materials (e.g., spun nylon fibers), or any other suitable porous material. A fluid-permeable membrane formed from gauze, soft fabric, and / or smooth fabric (or any other porous material 122 disclosed herein that is in contact with the penis) can reduce chafing caused by the fluid collection assembly 100.

[0039] In some embodiments, a fluid-permeable support is configured to support a fluid-permeable membrane, since the fluid-permeable membrane can be formed of a relatively foldable, fragile, or otherwise deformable material. For example, the fluid-permeable support can be positioned such that the fluid-permeable membrane is disposed between the fluid-permeable support and the fluid-impermeable barrier 102. Thus, the fluid-permeable support can support and maintain the position of the fluid-permeable membrane. The fluid-permeable support can include any fluid-permeable membrane material disclosed herein. For example, when used as a fluid-permeable support, the fluid-permeable membrane material can be used in a more dense or rigid form than in a fluid-permeable membrane. The fluid-permeable support can be formed of any fluid-permeable material that is less deformable than a fluid-permeable membrane. For example, the fluid-permeable support can 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 can be formed of natural materials such as cotton, wool, silk, or combinations thereof. In such examples, the material can have a coating to prevent or limit fluid absorption into the material, such as a waterproof coating. In some examples, fluid-permeable supports may be formed of fabric, felt, gauze, or a combination thereof.

[0040] In embodiments, the porous material 122 may comprise a single layer (e.g., a first layer, a second layer, a layer formed of multiple fibers, a fluid-permeable membrane, a fluid-permeable support, or other porous layer). In embodiments, the porous material 122 may be formed of four or more layers.

[0041] In some embodiments, porous material 122 may be disposed within chamber 112 such that porous material 122 maintains at least some of the fluid impermeable barrier 102 and chamber 112 in a generally cylindrical and / or tubular shape. Thus, porous material 122 may be configured to space opposing regions of the fluid impermeable barrier 102 apart within chamber 112. In these and other embodiments, porous material 122 may comprise one or more sheets of porous material 122 including spacer fabrics that impart three-dimensional properties (e.g., cylindrical) to the chamber 112 to space two opposing regions of the fluid impermeable barrier 102. In some embodiments, porous material 122 comprises a first layer and a second layer, with an intermediate layer disposed therebetween (as described above).

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

[0043] The porous material 122 may exhibit a shape that generally corresponds to the fluid-impermeable barrier 102, such that the porous material 122 partially or substantially completely occupies all or a portion of the chamber 112. For example, as shown, the porous material 122 may individually or collectively exhibit a generally cylindrical shape. In some embodiments, the porous material 122 exhibits a cylindrical shape with 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 may also include a body 101 (e.g., a housing) that is at least semi-rigid. The body 101 includes rigidity that allows it to maintain its shape during use, even under pressure from the strap 111. The body 101 may comprise a material that is at least partially transparent. In some embodiments, the body 101 may be formed of any suitable fluid-impermeable and at least semi-rigid material, such as fluid-impermeable polymers (e.g., silicone, polypropylene, polyethylene, polyethylene terephthalate, polycarbonate, etc.), polyurethane membranes, thermoplastic elastomers (TPEs), rubber, thermoplastic polyurethane, another suitable material, or a combination thereof. The body 101 may also be at least somewhat flexible in combination with the aforementioned rigidity, allowing it to bend, curve, or flex for use and / or removal of the fluid collection device 100. Exemplary fluid-impermeable barriers may include, but are not limited to, at least one of Versaflex CL 2000X TPE, Dynaflex G6713 TPE, Silpuran 6000 / 05 A / B silicone resin, or Santoprene TPE. In embodiments, the body 101 may be air-permeable. In such embodiments, the body 101 may be formed of a hydrophobic material defining a plurality of pores. In embodiments, at least one or more portions of the outer surface of the body 101 may be formed of a soft and / or smooth material to reduce abrasion.

[0045] The body 101 may include a first region 101a (e.g., a lower or bottom region) fixed to a proximal region 160 of a fluid-impermeable barrier 102 and a second region 101c (e.g., a top or upper region) generally opposite and spaced apart 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 a portion of a penis passing through it. More specifically, the first region 101a of the body 101 may include an edge 101e defining the second opening 124 and extending from the first region 101a toward the second region 101c. For example, the edge 101e may extend inward from the first region 101a to an inner region 113 of the body 101, which is at least partially (e.g., completely) defined by the body 101. Since the second opening 124 may be defined by the edge 101e, the edge 101e is sized to receive at least a portion of a penis passing through it. The proximal region 160 of the fluid-impermeable barrier 102 may be secured around the edge 101e 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 that secures the proximal region 160 of the fluid-impermeable barrier 102 to the edge 101e of the body 101. In some embodiments, the O-ring 109 tightly surrounds the proximal region 160 of the fluid-impermeable barrier 102 and the edge 101e of the first region 101a of the body 101. In some embodiments, the proximal region 160 is secured to the edge 101e using one or more of heat-sealing or adhesives. Securing the proximal region 160 to the first region 101a of the body 101 allows the penis to pass through the second opening 124, the first opening 114, and into the chamber 112 of the fluid-impermeable barrier 102. The fluid-impermeable barrier 102 and the body 101 are secured, wherein the first opening 114 of the fluid-impermeable barrier 102 is aligned with the second opening 124 in the first region 101a of the body 101, and fluid communication between the second opening 124 and the chamber 112 through the first opening 114 is also provided, thereby allowing the fluid collection assembly 110 to be placed on the implanted penis and still allowing fluid to be drawn into the chamber 112.

[0046] In some embodiments, the body 101 further includes one or more sidewalls 101b, 101d extending between the first region 101a and the second region 101c. The one or more sidewalls 101b, 101d may be disposed at least adjacent to the proximal region 160 of the fluid-impermeable barrier 102. In some embodiments, the distal sidewall 101d 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. In other words, the fluid-impermeable barrier 102 may extend from the edge 101e in the body 101, through the additional opening 105, and further distally to the distal region 162 of the fluid-impermeable barrier 102. In some embodiments, the first region 101a extends distally beyond the distal wall 101d of the body 101, such that the first region 101a at least partially defines an additional opening 105 having a fluid-impermeable barrier 102 extending therethrough.

[0047] In some embodiments, a second region 101c of the body 101 defines one or more holes 129 through which one or more straps 111 can be secured to the body 101, spaced apart from the first region 101a and the foam padding 103. The second region 101c may also define an opening 107 within the second region 101c, which allows a user or caregiver to view the interior of the body 101 to confirm the correct placement and function of the fluid collection assembly 100. In some embodiments, the opening 107 may include a transparent window.

[0048] The fluid collection assembly 100 may further include a foam pad 103 that is attached to a first region 101a of the body 101 and positioned to contact the user's skin around the penis. In some embodiments, the foam pad 103 comprises a fluid-impermeable foam material. For example, the foam pad 103 may comprise a monolayer foam and / or a closed-cell foam. In some embodiments, the foam pad 103 may comprise ethylene propylene diene monomer (EPDM) with a skin, neoprene rubber, PVC, an open-cell foam with a skin, and / or a closed-cell foam without a skin. A monolayer foam may comprise a multilayer polyurethane foam.

[0049] As previously described, the foam pad 103 can be configured to be positioned on the skin surrounding the penis (e.g., mons pubis, thigh, scrotum, and / or perineum) and allow the penis to pass through the foam pad. For example, the foam pad 103 can define openings aligned with the first opening 114 and the second opening 124 and is configured to allow the penis to pass through and be positioned therethrough. The foam pad 103 can be flexible, allowing it to conform to any shape of the skin surface. The foam pad 103 may include a foam ring or other shape attached to a first region 101a of the body 101. In some embodiments, the foam pad 103 may include a shape substantially complementary to the shape of the first region 101a. Thus, the foam pad 103 includes a cushioned opening aligned with and complementary to or larger than the second opening 124 in the first region 101a.

[0050] The foam pad 103 can be configured to be attached (e.g., permanently attached) to a first region 101a of the body 101. The foam pad 103 can be attached to the first region 101a of the body 101 using any suitable technique. For example, the foam pad 103 can be attached to the first region 101a of the body 101 using adhesives, stitching, heat sealing, pulse heating, radio frequency welding, or ultrasonic welding.

[0051] The fluid collection assembly 101 may also include one or more straps 111 secured to a second region 101c of the body 101, such that portions of the straps 111 secured to the body 101 are spaced apart from the first region 101a and the foam pad 103 in contact with the user or patient. More specifically, the one or more straps 111 may be secured to the second region 101c of the body 101 through one or more holes 129 in the second region 101c. The one or more straps 111 may be adjustable and configured to wrap around one or more (e.g., all) of the user's or patient's waist, hips, and / or thighs (through the groin). 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 through them or be positioned over a concealed penis. In at least one, some, or all of the embodiments, the one or more straps holding the body 101 against the user results in a technical effect whereby the foam pad 103 forms a seal against the user's skin around the first opening 114 and the second opening 124. Also during use, in at least one, some, or all of the embodiments, the material of the fluid-impermeable barrier 102 results in the technical effect of ensuring that urine can flow downward to the fluid outlet 118 and 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 that urine is discharged downward to the fluid outlet 118.

[0052] As previously described, the fluid collection assembly 100 may include a conduit in fluid communication with the chamber 112 via a fluid outlet 118. The conduit may be fixed or can be fixed to port 130. The conduit may include a flexible material, such as a plastic tube (e.g., a medical tube). Such a plastic tube may include thermoplastic elastomers, polyvinyl chloride, ethylene-vinyl acetate, polytetrafluoroethylene, etc. In some examples, the conduit may include silicone or latex. In some examples, the conduit may include one or more elastic portions, for example, through one or more of a diameter or wall thickness that allows for conduit flexibility.

[0053] As described in more detail below, the catheter is configured to be coupled to one or more of a fluid storage container (not shown) and a vacuum source (not shown), and extends at least partially therebetween. In one example, the catheter is configured to be directly connected to a vacuum source (not shown). In such an example, the catheter may extend from a 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 catheter is configured to be indirectly connected to at least one of a fluid storage container (not shown) and a vacuum source (not shown). In some examples, the catheter is secured to the wearer's skin using a catheter fixation device, such as the STATLOCK® catheter fixation device available from CR 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 incorporated herein by reference in their entirety.

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

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

[0056] Figure 2A This is a top view of the fluid collection assembly 200 according to an embodiment. Figure 2B It is along Figure 1A The fluid collection assembly 200 is a cross-sectional view taken along line 2B-2B. The fluid collection assembly 200 (e.g., a 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 fixed to a proximal region 260 of the fluid-impermeable barrier 202, and one or more straps 211 fixed to the body 201 and spaced apart from the proximal region 260 of the fluid-impermeable barrier 202.

[0057] The fluid-impermeable barrier 202 may be formed as a sheath 206. In an embodiment, the fluid-impermeable barrier 202 is at least partially formed by a first panel 208 attached to the second panel 210. In an embodiment, as shown, the first panel 208 and the second panel 210 are different sheets. The fluid-impermeable barrier 202 may also define a chamber 212 between the first panel 208 and the second panel 210, an opening 214 at a proximal region 260, and a fluid outlet 218 at a distal region 262. The fluid collection assembly 200 may also include a foam liner defining a liner opening. The foam liner 203 may be attached to the proximal region 260 of the fluid-impermeable barrier 202 such that the liner opening is aligned with the first opening 214 and the second opening 224 of the fluid-impermeable barrier 202. The inner surface 226 of the fluid-impermeable barrier 202 (e.g., the 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 bodily fluids in chamber 212.

[0058] The fluid-impermeable barrier 202 can be formed of any suitable fluid-impermeable material, such as fluid-impermeable polymers (e.g., silicone, polypropylene, polyethylene, polyethylene terephthalate, polyurethane, polyethylene, polyvinyl chloride, polycarbonate, etc.), metal membranes, natural rubber, another suitable material, or combinations thereof. Therefore, the fluid-impermeable barrier 202 substantially prevents bodily fluids from passing through it. In an example, the fluid-impermeable barrier 202 can be air-permeable and fluid-impermeable, thus preventing leakage when a vacuum force is applied to it while allowing air to flow through chamber 212 (i.e., chamber 212 is maintained at approximately atmospheric pressure, thereby preventing the vacuum force from causing wrinkling or kinking of the conduit in fluid communication with fluid outlet 218). In such an example, the fluid-impermeable barrier 202 can be formed of a hydrophobic material defining a plurality of pores. At least one or more portions of the outer surface 227 of the fluid-impermeable barrier 202 can be formed of a soft and / or smooth material, thereby reducing abrasion. In many embodiments, the fluid-impermeable barrier 202 can comprise any of the materials described above with respect to the fluid-impermeable barrier 102.

[0059] In embodiments, at least one of the first panel 208 or the second panel 210 is formed of a fluid-impermeable material that is at least partially transparent, such as polyethylene, polypropylene, polyurethane, polycarbonate, or polyvinyl chloride. Forming at least one of the first panel 208 or the second panel 210 with a fluid-impermeable material that is at least partially transparent allows a person (e.g., a medical practitioner) to examine the penis. In some embodiments, both the first panel 208 and the second panel 210 are formed of a fluid-impermeable material that is at least partially transparent. Selecting at least one of the first panel 208 or the second panel 210 to be formed of a fluid-impermeable material that is at least partially transparent allows for examination of the penis without separating the entire fluid collection assembly 200 from the area surrounding the penis. For example, the chamber 212 may include a penis receiving area 231 configured to receive an individual's penis when it extends into the chamber 212. The penis receiving area 231 may be at least partially defined by a portion of a 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 can be positioned within the chamber 212 such that when the penis is inserted into the chamber 212 through the first opening 214, 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 the second panel 210. The porous material 222 is not normally transparent; therefore, a portion of the transparent material defining at least a portion of the penis receiving area 231 of the first panel 208 and / or the second panel 210 forms a window that allows a person to observe the penis receiving area 231 and examine the penis.

[0060] In one embodiment, the second panel 210 is at least partially formed of a partially transparent material and forms a window allowing a person to observe the penis receiving area 231. Furthermore, a 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 helps maintain the dignity of the individual using the fluid collection assembly 200. For example, during use, the second panel 210 is typically adjacent to the individual, such as near the thigh and / or perineum. Therefore, the second panel 210 is typically obscured during use, and the person cannot observe the penis without first lifting the sheath 206 from the individual. Meanwhile, the first panel 208 can be positioned away from the individual and is more easily seen than the second panel 210. However, a person (e.g., a passerby, visitor, etc.) cannot see the penis through the first panel 208 because the porous material 222 is not transparent and / or the first panel 208 is formed of a non-transparent material. Therefore, in such an embodiment, the first panel 208 and / or the porous material 222 prevent a person from seeing the penis unless such an examination is necessary, thereby maintaining the dignity of the individual using the fluid collection assembly 200. In one embodiment, the first panel 208 is formed of at least partially transparent material and forms a window allowing a person to observe the penis receiving area 231. Furthermore, a 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, a person does not need to perform the additional action of lifting the sheath 206 to observe the penis receiving area 231, but this may compromise the dignity of the individual using the fluid collection assembly 200, as passersby may also see the penis receiving area 231.

[0061] As previously described, at least a portion of the first panel 208 and at least a portion of the second panel 210 can be attached together. In an embodiment, as shown, the first and second panels 208, 210 are attached together along at least a portion of their outer edges (e.g., top edge 236 and side edge 238). In such an embodiment, the first and second panels 208, 210 are attached using any suitable technique, such as with adhesives, stitching, heat sealing, pulse 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 pulse heating because pulse heating quickly and efficiently attaches the polyurethane panels together. Forming a fluid-impermeable barrier 202 from the first panel 208 and the second panel 210 can increase 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 non-stitching technique.

[0062] In one embodiment, the sheath 206 includes one or more vents 234 attached to the fluid impermeable barrier 202, the vents extending through one or more openings in the fluid impermeable barrier 202. Although not shown, the vents 234 may also be included on the fluid impermeable barrier 102 of the fluid collection assembly 100.

[0063] Vent 234 is configured to allow air to flow through it while preventing water (a major component of bodily fluids) from flowing through it. Vent 234 facilitates airflow through chamber 212. For example, as previously described, a vacuum can be provided to chamber 212 from a vacuum source. The vacuum can draw air in through vent 234, thereby allowing air to flow from vent 234 to fluid outlet 218. The air flowing out of vent 234 helps to move bodily fluids to fluid outlet 218. Vent 234 also prevents the vacuum applied to chamber 212 from rupturing small superficial blood vessels in or around the penis (e.g., causing bruising) or otherwise damaging the penis or surrounding area. Vent 234 may comprise a porous hydrophobic material. The pores defined by the porous hydrophobic material can interconnect, thereby allowing airflow through vent 234. The hydrophobic properties of the porous hydrophobic material prevent water from flowing through vent 234. Typically, the size of the pores depends on the degree of hydrophobicity of the porous hydrophobic material, and vice versa. For example, increasing the hydrophobicity of porous hydrophobic materials allows for an increase in pore size.

[0064] In an embodiment, the vent 234 may include a porous polytetrafluoroethylene (“PTFE”) layer. Porous PTFE layers are currently considered highly effective in allowing airflow while preventing water flow, even when exposed to acidic body fluids. However, porous PTFE is difficult to weld to other materials, such as polyurethane. Therefore, the porous PTFE layer may be attached to a substrate. The substrate may include a porous material or define one or more channels through the substrate. The substrate may be selected to readily attach to the porous PTFE layer and the fluid-impermeable barrier 202. For example, the substrate may be selected to be formed of polyvinyl chloride (PVC) because PVC can readily attach to both the porous PTFE layer and the fluid-impermeable barrier 202.

[0065] In one embodiment, the orifice is formed in the first panel 208 of the fluid-impermeable barrier 202, and the vent 234 is attached to the first panel 208. In such an embodiment, the orifice 232 and the vent 234 are unlikely to be covered by and in contact with an individual's skin. Covering the orifice and vent 234 with skin may prevent or at least inhibit airflow through the portion of the orifice and vent 234 covered by skin. Furthermore, an individual may find the vent 234 uncomfortable in contact with their skin; therefore, placing the vent 234 on the first panel 208 can make the fluid collection assembly 200 more comfortable to wear. In another embodiment, the vent 234 is attached to the interior of the first panel 208 to prevent the edges of the vent 234 from rubbing against or otherwise irritating the individual's skin.

[0066] In one embodiment, as shown, at least one orifice is formed in a portion of the fluid-impermeable barrier 202 located at or near the top edge 236 of the fluid-impermeable barrier 202, and at least one vent 234 is attached to this portion. The top edge 236 of the fluid-impermeable barrier 202 may include the edge of the fluid-impermeable barrier 206 located above the opening 214 when the individual is standing and the fluid collection assembly 200 allows free hanging from the individual's genitals. Forming the orifice at or near the top edge 236 and attaching the vent 234 causes air to flow through the vent 234 across the penis (thus keeping the penis dry) and inhibits the accumulation of bodily fluids near the top edge 236. In another embodiment, as shown, at least one orifice is formed in a portion of the fluid-impermeable barrier 202 located at or near the side edge 238 of the fluid-impermeable barrier 206, and at least one vent 234 is attached to this portion. The side edge 238 of the fluid-impermeable barrier 206 may include the edge of the fluid-impermeable barrier 206 extending from or near the top edge 236. Typically, air preferentially flows along the path from vent 234 toward fluid outlet 218. When vent 234 is spaced apart from side edge 238 and / or at or near top edge 236, the preferential airflow from these vents 234 may result in minimal airflow through at least some portions of the adjacent side edge 238 of chamber 212. Positioning the orifice and vent 234 at or near side edge 238 can increase airflow through portions of the adjacent side edge 238 of chamber 212, thereby preventing or at least inhibiting the accumulation of bodily fluids in these portions of chamber 212.

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

[0068] In one embodiment, the second panel 210 defines the entirety of the first opening 214. For example, the opening 214 is a cut defined by the second panel 210, spaced apart from the outer periphery (e.g., edge) of the second panel 210. In such an example, the second panel 210 may exhibit a shape substantially corresponding to the shape of the first panel 208, which facilitates attachment of the first panel 208 to the second panel 210 along its outer periphery. 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 lies flat on a flat surface. The substantially flat lying position of the first and second panels 208, 210 can make wearing the fluid collection assembly 200 more discreet and inhibit the accumulation of bodily fluids on the individual. However, in some embodiments, the opening 214 is not spaced apart from the outer periphery of the second panel 210. In such an embodiment, the first opening 214 may be a cut extending inward from at least one outer periphery of the second panel 210. Other examples of forming an opening 214 in the second panel 210 are disclosed in International Patent Application No. PCT / US2021 / 039866, filed June 30, 2021, the disclosure of which is incorporated herein by reference in its entirety.

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

[0070] In an embodiment, the fluid-impermeable barrier 202 exhibits a generally bullet-shaped form. As used herein, the fluid-impermeable barrier 202 exhibits a generally bullet-shaped form when a portion of the proximal region 260 extending from the body 201 toward the distal region 262 exhibits a substantially constant first width, and the distal region 262 of the fluid-impermeable barrier 206 exhibits a second width less than the first width. The first and second widths may be measured perpendicular to the longitudinal axis 240 and may be greater than the thickness of the sheath 206 when it is laid flat on a flat surface. Note that the fluid-impermeable barrier 102 may exhibit shapes other than a generally bullet-shaped form. 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 June 30, 2021, the disclosure of which is previously incorporated herein by reference. In an example, the fluid-impermeable barrier 202 may exhibit a generally triangular shape, a semi-elliptical shape, or any other suitable shape.

[0071] A fluid-impermeable barrier 202 defines a fluid outlet 218. The fluid outlet 218 may be formed from unattached portions of the first panel 208 and the second panel 210. 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 within the chamber 212 or otherwise in fluid communication with the chamber 212 via the fluid outlet 218. The fluid outlet 218 may be sized and shaped to form a seal with the conduit that provides at least a substantially fluid seal, thereby substantially preventing leakage of bodily fluids from the chamber 212. The conduit may be attached to the fluid outlet 218 using adhesives, welding, interference fits, or friction fits (e.g., to the first panel 208 and the second panel 210), or otherwise incorporated into the fluid outlet 218. Attaching the conduit to the fluid outlet 218 prevents leakage and also prevents accidental detachment of the conduit from the fluid outlet 218. In the example, the conduit can be attached to the fluid outlet 218 in the same manufacturing step that attaches the first panel 208 and the second panel 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 with respect to the fluid collection assembly 100.

[0072] Fluid outlet 218 and port 130 may be located at or near the distal region 262 of sheath 206, which is intended to be the lowest point of gravity in chamber 212 when worn by a user. Positioning fluid outlet 218 and port 130 at or near the distal region 262 of sheath 202 allows the catheter to receive more bodily fluid than if fluid outlet 218 and port 130 were located elsewhere, and reduces the likelihood of buildup (e.g., fluid buildup can lead to microbial growth and foul odor). However, bodily fluids may exhibit a preference for flowing in the direction of gravity. Therefore, fluid outlet 218 and port 130 may be located within the fluid collection assembly 200 at a location intended to be the lowest point of gravity in the fluid collection assembly 200 when worn by a user.

[0073] As previously described, the sheath 106 includes at least one porous material 222 disposed within the chamber 212. The porous material 222 can guide bodily fluids to one or more selected areas of the chamber 212, such as away from the penis and towards the fluid outlet 218. Therefore, the porous material 222 facilitates the removal of bodily fluids from the chamber 212 and forms a padding layer to prevent the penis from coming into contact with a moist material that could cause penile skin atrophy and / or make the fluid collection assembly 100 more uncomfortable to wear. The porous material 222 can also cushion the flow 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 bodily fluids from overflowing from the chamber 212. This "wicking" may not include the absorption of fluid into the wicking material. In other words, substantially no fluid is absorbed into the material after a period of time following exposure to and removal from the fluid. While absorption is not desired, the term "substantially no absorption" may allow a nominal amount of fluid to be absorbed into the wicking material (e.g., absorbability), such as less than about 30 wt% of the dry weight of the wicking material, less than 20 wt% of the dry weight of the wicking material, 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%. The wicking material may also wick fluid generally toward the interior of the chamber 212, as discussed in more detail below. In an embodiment, the porous material 222 is configured to adsorb or absorb bodily fluids. Similar to wicking materials, this adsorbent or absorbent material can remove bodily fluids from the opening 214, thereby preventing bodily fluids from overflowing from the chamber 212.

[0075] The porous material 222 can be formed from any suitable porous material. For example, the porous material 222 can be formed from nylon (e.g., spun nylon fibers), polyester, polyurethane, polyethylene, polypropylene, other porous polymers, hydrophobic foam, open-cell foam, wool, silk, linen, cotton (e.g., cotton gauze), felt, other fabrics, coated porous materials (e.g., waterproof coated porous materials), 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 woven materials. The porous material 222 may also include a plurality of fibers forming a layer between the first and second layers 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 fluid transport and air circulation through the porous material 222. The pores defined by the plurality of fibers may be larger and / or more, thereby reducing the likelihood of dried fluid clogging the porous material 222. The presence of the plurality of fibers also makes the porous material 222 feel soft to the penis and provides a cushioning effect. The plurality of fibers also prevent the porous material from collapsing due to vacuum forces. In embodiments, the plurality of fibers may space the first layer between the second layer.

[0077] The first layer, second layer, and multiple fibers of porous material 222 can be formed of any suitable material, such as hydrophobic materials, hydrophilic materials, polyester, cotton, or any other porous material disclosed herein. In an embodiment, one or more of the first layer, second layer, or multiple fibers of porous material 222 are formed of a hydrophobic material that inhibits the storage of bodily fluids therein, which facilitates the removal of bodily fluids from chamber 212. In an embodiment, one or more of the first layer, second layer, or multiple fibers of porous material 222 are formed of a hydrophilic material that allows the porous material 222 to temporarily store bodily fluids therein, thereby limiting the amount of bodily fluids that accumulate around the individual's skin. In an embodiment, two or more of the first layer, second layer, or multiple fibers of porous material 222 are formed of different materials. In such an embodiment, the first layer may define a penile receiving area 231 or otherwise be closer to the penile receiving area 231 than the second layer. The first layer may be formed of a hydrophobic material, while the multiple fibers may be formed of a hydrophilic material. This configuration allows bodily fluids to be drawn through the first layer and temporarily stored in the multiple fibers. However, the first layer can remain substantially dry due to its hydrophobicity, making the porous material 222 feel dry to the penis. In an embodiment, at least one of the first or second layers is formed of a fabric (e.g., woven gauze), and the multiple fibers are formed of nylon fibers (e.g., spun nylon fibers).

[0078] In an embodiment not shown, the porous material 222 may be formed of two layers instead of three layers. For example, the porous material 222 may be formed of a fluid-permeable membrane and a fluid-permeable support. The fluid-permeable support may define the penile receiving area 231 or otherwise be located closer to the penile receiving area 231 than the fluid-permeable support. The fluid-permeable membrane may be configured and / or constructed to draw bodily fluids away from the core of the penile receiving area 231, thereby minimizing the amount of bodily fluids present in the penile receiving area 231 or otherwise in contact with the individual's skin. It should also be noted that the fluid-permeable membrane may also be configured to adsorb or absorb bodily fluids to minimize the amount of bodily fluids present in the penile receiving area 231 or otherwise in contact with the individual's skin. The fluid-permeable membrane may be formed of any porous material disclosed herein. For example, the fluid-permeable membrane may be formed of gauze (e.g., silk, linen, or cotton gauze), another soft fabric, another smooth fabric, woven or non-woven materials (e.g., spun nylon fibers), or any other suitable porous material. A fluid-permeable membrane formed from gauze, soft fabric, and / or smooth fabric (or any other porous material 222 disclosed herein that is in contact with the penis) can reduce chafing caused by the fluid collection assembly 200.

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

[0080] In embodiments, the porous material 222 may comprise a single layer (e.g., a first layer, a second layer, a layer formed of multiple fibers, a fluid-permeable membrane, a fluid-permeable support, or other porous layer). In embodiments, the porous material 222 may be formed of 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 January 7, 2021; U.S. Provisional Patent Application No. 63 / 241,575, filed September 8, 2021; and U.S. Provisional Patent Application No. 63 / 247,491, filed September 23, 2021; the disclosures of each application are incorporated herein by reference in their entirety.

[0081] In embodiments, the porous material 222 may be a sheet (e.g., a multilayer sheet). The porous material 222 is a sheet when it is at least generally planar when laid flat on a flat surface, does not define a cavity (e.g., is not tubular), or exhibits a length and width greater than its thickness. Forming the porous material as a sheet facilitates the manufacture 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 a sheet. During the manufacture 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 example, the porous material 222 may exhibit a shape that is the same as or more preferably slightly smaller than the dimensions of the first panel 208 and the second panel 210. Therefore, attaching the first panel 208 and the second panel 210 together along their outer edges (e.g., top edge 236 and side edge 238) also allows the porous material 222 to be attached 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, preventing the porous material 222 from forming a channel through which bodily fluids could leak from the fluid-impermeable barrier 202. Furthermore, attaching the porous material 222 to the first panel 208 and / or the second panel 210 prevents significant movement of the porous material 222 within the chamber 212, such as preventing the porous material 222 from agglomerating near the fluid outlet 218. In this example, the porous material 222 may be attached to the first panel 208 or the second panel 210 before or after attaching the first panel 208 to the second panel 210 (e.g., by adhesive). In the example, the porous material 222 may be disposed solely within the chamber 212 without attaching the porous material 222 to at least one of the first panel 208 or the second panel 210. In embodiments, as will be discussed in more detail below, the porous material 222 may exhibit shapes other than sheet materials, such as a hollow, generally cylindrical shape.

[0082] The porous material 222 can exhibit a shape that generally corresponds to the fluid-impermeable barrier 202, such that the porous material 222 partially or substantially completely occupies the entire chamber 212. For example, as shown, the porous material 222 can exhibit a generally bullet-shaped form. The porous material 222 can exhibit a generally bullet-shaped form when it includes a proximal portion corresponding to the proximal region 260 and a distal portion extending from the proximal portion corresponding to the distal region 262. The proximal portion can exhibit a substantially constant first width, and the distal portion can exhibit a second width smaller than the first width. The second width can be constant or variable (e.g., changing at a constant or variable rate). The porous material 222 can exhibit shapes other than a generally bullet-shaped form, such as a generally rectangular shape, a generally semi-elliptical shape, or any other suitable shape.

[0083] Typically, when the penis is not in the penile receiving area 231 and the sheath 206 lies flat on a flat surface, the sheath 206 is substantially flat. The sheath 206 is substantially flat because the fluid-impermeable barrier 202 is formed by the first panel 208 and the second panel 210, rather than being a generally tubular fluid-impermeable barrier. Furthermore, as previously mentioned, the porous material 222 can be a sheet, which also results in the sheath 206 being substantially flat. It should be noted that the sheath 206 is described as substantially flat because at least one of the following: depending on the thickness of the porous material 222, the porous material may cause slight bulges to form in the sheath 206, and the port 130 may cause bulges around it. It should also be noted that the sheath 206 can also be flexible, and therefore, the sheath 206 may not be substantially flat during use, as during use the sheath 206 may rest on non-flat surfaces (e.g., between the testicles, perineum, and / or thighs), and the sheath 206 may conform to the shape of these surfaces.

[0084] When the penis is not in the penis receiving area 131 and the sheath 206 lies flat on a flat surface, the sheath 206 is able to lie substantially flat, which allows the fluid collection assembly 200 to be used with both concealed and unconcealed penises. For example, when the fluid collection assembly 200 is used with a concealed penis, the penis does not extend into the penis receiving area 231, causing the sheath 206 to lie relatively flat across the second opening 224. When the sheath 206 lies relatively flat across the second opening 224, the porous material 222 can extend across the second opening 224 and be very close to the concealed penis. Therefore, the porous material 222 prevents or inhibits the accumulation of bodily fluids discharged from the concealed penis on the individual's skin, because the porous material 222 will receive and remove at least most of the bodily fluids that would otherwise accumulate on the individual's skin. As a result, the individual's skin remains dry, thereby improving the comfort of using the fluid collection assembly 200 and preventing skin atrophy. However, unlike other conventional fluid collection components configured for use with concealed penises, the fluid collection component 200 can still be used with non-concealed penises because the non-concealed penis can still be received in the penis receiving area 231, even when the penis is fully erect. Furthermore, the ability of the sheath 206 to be substantially flat allows the fluid collection component 200 to be used more discreetly than when the sheath 206 is not substantially flat, thus avoiding potentially embarrassing situations.

[0085] When the sheath 206 is substantially flat, the porous material 222 can occupy almost the entire cavity 212, and the penile receiving area 231 is collapsed (in Figure 2B (Shown as not collapsed for illustrative purposes). In other words, the sheath 206 may not define an area that is never occupied by the porous material 222. When the porous material 222 occupies substantially the entirety of the chamber 212, bodily fluids drained into the chamber 212 are unlikely to accumulate for extended periods, as accumulation could lead to hygiene problems, odor, and / or cause the individual's skin to remain in contact with the fluids, potentially resulting in discomfort and skin degeneration.

[0086] As previously described, the first panel 208, the second panel 210, and the porous material 222 can be selected to be relatively flexible. The first panel 208, the second panel 210, and the porous material 222 are relatively flexible when they are unsupported and unable to maintain their shape. The flexibility of the first panel 208, the second panel 210, and the porous material 222 allows the sheath 206 to be substantially flat, as described above. The flexibility of the first panel 208, the second panel 210, and the porous material 222 also allows the sheath 206 to conform to the shape of the penis, even when the size and shape of the penis change (e.g., during erection), and minimizes any unoccupied space where bodily fluids may accumulate in the chamber 112.

[0087] The fluid collection assembly 200 also includes a body 201. Unless otherwise stated, the body 201 may include any aspect of the body 101, such as the material of the body 101 described above. In many embodiments, the body 201 is at least semi-rigid and includes a first region 201a (e.g., a bottom or lower region) fixed to a proximal region 260 of the fluid-impermeable barrier 202 and a second region 201c (e.g., a top or upper region) opposite and spaced apart from the first region 201a. In some embodiments, the first region 201a may extend distally from the sidewall 201b beyond the first opening 214. For example, the first region 201a may include a terminating end located between the first opening 214 and the distal 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 substantially complementary in shape to the first opening 214 in the fluid-impermeable barrier 202. Therefore, the second opening 224 can be sized to allow at least a portion of the penis to pass through it into the first opening 214 and into chamber 212. In some embodiments, the first region 201a can be generally annular. Although Figure 2B Not shown, but the first region 201a of the body 201 may optionally include a side similar to or the same as the side 101e that defines the second opening 224.

[0088] In some embodiments, the body 201 includes one or more sidewalls 201b extending between a first region 201a and a second region 201c of the body 201 to at least partially define a concave region 213 within the body 201. The concave region 213 may include at least a portion of the proximal region 260 of a fluid-impermeable barrier 202. In many embodiments, the second region 201c of the body 201 defines one or more orifices 229 through which one or more straps 211 can be secured to the body 201, spaced apart from the first region 201a and the foam liner 203. The concave region 213 of the body 201 allows a user or caregiver to view the interior of the body 201 to confirm the correct placement and function of the fluid collection assembly 200.

[0089] In some embodiments, the first opening 214 in the fluid-impermeable barrier 202 is distally spaced 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 region 262). As described above, at least one porous material 222 may be generally planar. In some embodiments, at least one porous material 222 extends in the chamber 212 to be at least partially located within the concave region 213 of the body 201. Thus, at least one porous material 222 may extend generally planarly between the fluid outlet 218 and the first region 201a and / or sidewall 201b of the body 201.

[0090] The fluid collection assembly 200 may also include a foam pad 203 that is attached to a first region 201a of the body 201 and positioned to contact the user's skin around the penis. The foam pad 203 may include any aspects described above with respect to the foam pad 103, including the material of the foam pad 103.

[0091] The foam pad 203 can be configured to be positioned on the skin surrounding the penis (e.g., mons pubis, thigh, scrotum, and / or perineum) and to allow the penis to pass through it. For example, the foam pad 203 can define pad openings aligned with the first opening 214 and the second opening 224 and is configured to allow at least a portion of the penis to pass through it. In some embodiments, the foam pad 203 includes a shape or contour complementary to (e.g., identical to) the shape or contour of the first region 201a. For example, both the first region 201a and the foam pad 203 can be generally annular or O-shaped.

[0092] The foam pad 203 can be flexible, allowing it to conform to any shape on the skin surface. The foam pad 203 may include a foam ring or other shape attached to a first region 201a of the body 201 and / or a second panel 210 of the fluid-impermeable barrier 202. In some embodiments, the first region 201a of the body is attached to the foam pad 203, located between the foam pad 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 where the first region 201a extends distally beyond the first opening 214, the foam pad 203 may be shaped to cover the entire first region 201a (e.g., the foam pad 203 may be shaped to complement the shape of the first region 201a). In these and other embodiments, the opening 224 of the foam pad 203 may be aligned with and substantially complementary to the opening of the first region 201a and the first opening 214 of the fluid-impermeable barrier 202. The foam pad 203 can be configured to be attached (e.g., permanently attached) to a first region 201a of the body 201 and / or a second panel 210 of the fluid-impermeable barrier 202. The foam pad 203 can 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 pad 203 can be attached to the first region 201a of the body 201 and / or the second panel 210 of the fluid-impermeable barrier 202 using adhesives, stitching, heat sealing, pulse heating, radio frequency welding, or ultrasonic welding.

[0093] The fluid collection assembly 200 may also include one or more straps 211 secured to a second region 201c of the body 201, such that portions of the straps 211 secured to the body 201 are spaced apart from the first region 201a and the foam pad 203 in contact with the user or patient. More specifically, the one or more straps 211 may be secured to the second region 201c of the body 201 through one or more holes 229 in the second region 201c. The one or more straps 211 may be adjustable and configured to wrap around one or more (e.g., all) of the user's or patient's waist, hips, and / or thighs (via the groin). During use, the one or more straps 211 hold the body 201 against the user, such that the first openings 214 and 224 allow the penis to extend at least partially through them or be positioned over a concealed penis. In at least one, some, or all of the embodiments, the one or more straps holding the body 201 against the user results in a technical effect whereby the foam pad 203 forms a seal against the user's skin around the first openings 214 and 224. Also during use, in at least one, some, or all of the embodiments, the material of the fluid-impermeable barrier 202 results in the technical effect of ensuring that urine can flow downward to the fluid outlet 218 and 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 that urine is discharged downward to the fluid outlet 218.

[0094] As previously described, the fluid collection assembly 200 is formed of a first panel 208 and a second panel 210, which are different sheets. This allows 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 different sheets can create edges that may cause patient discomfort and require extensive manufacturing processes (e.g., welding or other attachment techniques) to attach the first panel 208 to the second panel 210. Therefore, in some embodiments, the fluid collection assembly disclosed herein can be formed from first and second panels integrally formed together (e.g., presenting a monolithic construction), which can eliminate at least some edges and simplify the manufacture of such a fluid collection assembly. In an embodiment, the first and second panels 208, 210 are formed from a folded monolithic sheet. Forming the first and second panels 208, 210 from a folded monolithic sheet eliminates the need to attach one of the longitudinal edges of the first and second panels 208, 210 together. However, portions of the first and second panels 208, 210 forming the proximal region, the distal region, and the folded opposing portions may require attachment together using any of the attachment techniques disclosed herein. Therefore, forming the first and second panels 208, 210 from a folded single sheet makes the manufacture of the fluid collection assembly 200 more efficient and reduces the number of edges formed compared to forming the first and second panels 208, 210 from two different sheets. It should be noted that in either embodiment, the first panel 208 and the second panel 210 remain substantially flat when the penis is not in the chamber 212.

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

[0096] Suction force can be applied indirectly via the fluid storage container 14. For example, the second open end of the conduit 17 can be disposed within the fluid storage container 14, and an additional conduit 17 can extend from the fluid storage container 14 to the portable vacuum source 16. Therefore, the portable vacuum source 16 can apply suction to the fluid collection device 12 via the fluid storage container 14. Suction force can also be applied directly via the fluid storage container 14. For example, the second open end of the conduit 17 can be disposed within the portable vacuum source 16. The additional conduit 17 can extend from the portable vacuum source 16 to a point outside the fluid collection device 12, such as the fluid storage container 14. In such an example, the portable vacuum source 16 can 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 a user's penis. The fluid collection component of the fluid collection device 12 may include a fluid-impermeable barrier that at least partially defines a chamber of the fluid collection device 12 (e.g., an internal region of the fluid collection device component). Exemplary fluid collection devices used in the systems and methods described herein are described in more detail below.

[0098] In some embodiments, the fluid storage container 14 may include a bag (e.g., a drainage bag), a bottle or cup (e.g., a collection can), or any other closed container for storing bodily fluids such as urine. In an example, a conduit 17 may extend from the fluid collection device 12 and be attached to the fluid storage container 14 at a first point therein. An additional conduit 17 may be attached to the fluid storage container 14 at a second point thereon and may extend and be attached to a portable vacuum source 16. For example, the fluid storage container 14 may include a container fluidly connected to a first conduit segment, which is also fluidly connected to a fluid collection member of the fluid collection device 12. The container may be fluidly connected to a second segment of the conduit 17, which is also fluidly connected to the portable vacuum source. In such an example, the portable vacuum source 16 may provide a vacuum / suction to the fluid collection member through the container to provide suction within the chamber of the fluid collection member. Thus, a vacuum (e.g., suction) can be drawn through the fluid collection device 12 via the fluid storage container 14. As fluid exits from the chamber, the fluid may travel through the first segment of the conduit to the fluid storage container, where the fluid can be retained. Fluids, such as urine, can be discharged from the fluid collection device 12 using a portable vacuum source 16.

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

[0100] Portable vacuum source 16 may include one or more of a manual vacuum pump, an electric vacuum pump, a diaphragm pump, a centrifugal pump, a displacement pump, a magnetically driven pump, a peristaltic pump, or any pump configured to generate a vacuum. Portable vacuum source 16 can provide a vacuum or suction to remove fluid from the fluid collection member of fluid collection device 12. In some embodiments, portable vacuum source 16 may be powered by one or more of a power cord (e.g., connected to a power outlet), one or more batteries, or even manual power (e.g., a manual vacuum pump). In examples, portable vacuum source 16 may be sized and shaped to fit externally, on, or internally to fluid collection device 12. For example, portable vacuum source 16 may include one or more micropumps or one or more micro-pumps. The portable vacuum source 16 disclosed herein may include one or more of a switch, button, plug, remote control, or any other device suitable for activating portable vacuum source 16. It should be understood that the portable vacuum source 16 disclosed herein can provide a portable device for providing suction or vacuum, allowing the use of the devices and systems herein outside of hospital or nursing facility environments where vacuum lines are laid to patient rooms or where large (e.g., larger or heavier than a patient could easily carry) vacuum sources are located. For example, the portable vacuum source can be small and light enough to be carried by the user (e.g., patient) or assistant (e.g., nurse) during transport.

[0101] Figure 4This is a flowchart of a method 400 for collecting fluid according to an embodiment. Method 400 can utilize any fluid collection assembly described herein, such as fluid collection assemblies 100, 200. Method 400 includes an action 402 of securing the fluid collection assembly at least adjacent to the user's penis, the securing being achieved by one or more straps secured to an upper region of a body of the fluid collection assembly, which is at least semi-rigid. Method 400 also includes an action 404 of positioning a first opening defined by a fluid-impermeable barrier of the fluid collection assembly to receive the patient's penis through the first opening and into a chamber defined by the fluid-impermeable barrier. The fluid-impermeable barrier may at least define the chamber, the first opening, and a fluid outlet. The fluid-impermeable barrier may include a distal region containing the fluid outlet and a proximal region secured to a lower region of the body, spaced apart from the upper region of the body. Method 400 also includes an action 406 of discharging bodily fluid onto at least one porous material within the chamber. Method 400 also includes an action 408 of receiving bodily fluid into at least one porous material disposed in a chamber of a fluid collection assembly, and an action 410 of removing bodily fluid from the chamber via a fluid outlet.

[0102] In some embodiments, method 400 includes the action of positioning a second opening defined by a first region of the body to receive a patient's penis through the second opening and into the first opening and chamber. In these and other embodiments, the body may include one or more sidewalls extending between the first and second regions, the one or more sidewalls being disposed at least adjacent to a proximal region of a fluid-impermeable barrier. The fluid-impermeable barrier may be secured to the first region of the body, wherein a first opening of the fluid-impermeable barrier is aligned with a second opening of the first region, and the fluid-impermeable barrier extends away from one or more sidewalls of the body. In some embodiments, positioning the second opening defined by the first region of the body to receive a patient's penis may include positioning an edge defining the second opening to receive the patient's penis. The edge may extend from the first region toward the second region, and a proximal region of the fluid-impermeable barrier is secured around the edge 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 located between the first and second regions 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 orifices, and one or more straps are secured to the second region of the body through one or more orifices in the second region.

[0103] In some embodiments, method 400 further includes positioning a foam pad, fixed to a first region of the base, in contact with the patient's skin around the patient's penis. In these and other embodiments, the fluid-impermeable barrier may comprise a generally cylindrical or tubular bag having a first opening at a proximal region and a fluid outlet at a distal region. At least one porous material disposed within the chamber may comprise one or more discs or one or more cylinders of at least one porous material disposed within the chamber, such that at least one porous material maintains at least a portion of the chamber and at least a portion of the fluid-impermeable barrier in a generally cylindrical or tubular shape.

[0104] In some embodiments of method 400, the body includes one or more sidewalls extending between a first region and a second region to define a concave region in the body, wherein at least a portion of the proximal region is located, the second region defines one or more holes, and one or more straps are secured to the second region of the body through one or more holes in the second region. In these and other embodiments of method 400, a first opening in the fluid-impermeable barrier may be distally spaced from the first region of the body, and at least one porous material may be substantially planar. The fluid-impermeable barrier may include a first panel region defining the first opening and secured to the first region of the body, and a second panel region opposite the first panel region. At least one porous material may be positioned in a chamber between the first panel region and the second panel region. In some embodiments, at least one porous material may be at least partially secured to the second panel region and in a concave region extending at least partially into the body in the distal region of the chamber. Method 400 may also include positioning a foam pad secured to at least one of the first region and / or the first panel region of the fluid-impermeable barrier to the base on the skin around the patient's penis, wherein a second opening defined by the foam pad is positioned to receive the penis.

[0105] The actions of method 400 are for illustrative purposes. For example, the actions of method 400 may be performed in a different order, broken down into multiple actions, modified, supplemented, or combined. Any action of method 400 may include the use of any fluid collection device or system disclosed herein.

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

[0107] Degree terms (e.g., "about," "basically," "generally," etc.) indicate changes that are not structurally or functionally significant. In the examples, when a degree term is included together with a term indicating quantity, the degree term is interpreted as ±10%, ±5%, or ±2% of the term indicating quantity. In the examples, when a degree term is used to modify a shape, the degree term indicates that the shape modified by the degree term has the appearance of the disclosed shape. For example, a degree term might 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 from it, be elliptical, be the same as the disclosed shape, etc.

Claims

1. A fluid collection assembly, comprising: A fluid-impermeable barrier having a proximal region and a distal region, the fluid-impermeable barrier defining at least a chamber, a first opening, and a fluid outlet, the first opening being sized to receive at least a portion of the penis through the first opening, and the fluid outlet being disposed at least adjacent to the distal region; At least one porous material is disposed in the chamber; The body includes a first region and a second region, the first region being fixed to the proximal region of the fluid-impermeable barrier, the second region being opposite to and spaced apart from the first region, the first region defining a second opening, the second opening being aligned with the first opening of the fluid-impermeable barrier and sized to receive at least a portion of the penis through the second opening; as well as One or more straps are attached to the second region of the body.

2. The fluid collection assembly according to 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 adjacent to the proximal region of the fluid-impermeable barrier; and The fluid-impermeable barrier is fixed to the first region of the body, wherein the first opening of the fluid-impermeable barrier is aligned with the second opening of the first region, and the fluid-impermeable barrier extends away from the one or more sidewalls of the body.

3. The fluid collection assembly according to claim 2, wherein, The first region of the body includes an edge defining the second opening and extending from the first region toward the second region, and the proximal region of the fluid-impermeable barrier is fixed around the edge so that the first opening of the fluid-impermeable barrier is aligned with the second opening of the body.

4. The fluid collection assembly according to claim 3, wherein, The proximal region is secured to the edge using an O-ring surrounding the proximal region of the fluid-impermeable barrier and the edge of the first region of the body.

5. The fluid collection assembly according to claim 3, wherein, The proximal region is fixed to the edge using one or more of heat sealing or adhesives.

6. The fluid collection assembly according to any one of claims 2-5, wherein, The body defines an additional opening located 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 according to any one of claims 2-5, wherein, The second region of the body defines one or more holes, through which one or more straps are secured to the second region of the body.

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

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

10. The fluid collection assembly according to any one of claims 1-9, wherein, The fluid-impermeable barrier comprises a generally cylindrical or tubular bag having the first opening in the proximal region and the fluid outlet in the distal 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 disposed in the chamber or one or more cylinders of the at least one porous material, such that the at least one porous material maintains at least a portion of the chamber and at least a portion of the fluid impermeable barrier in a generally cylindrical or tubular shape.

12. The fluid collection assembly according to 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, at least a portion of the proximal region being located in the concave region; The second region defines one or more holes; and The one or more straps are secured to the second region of the body through the one or more holes 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 and a second panel region, the first panel region defining the first opening and fixed to the first region of the body, the second panel region being opposite to the first panel region, and the at least one porous material being positioned in the chamber between the first panel region and the second panel region.

15. The fluid collection assembly of claim 14, wherein, The at least one porous material is at least partially fixed to the second panel region and extends at least partially into the concave region of the body within the cavity between the distal regions.

16. The fluid collection assembly of claim 14 or 15, further comprising a foam pad attached to at least one of the first regions of the body, the foam pad defining a pad opening sized to receive at least a portion of the penis at least partially through the pad opening and aligned with the first opening of the fluid-impermeable barrier, wherein the foam pad is positioned to contact the user's skin around the user's penis.

17. A fluid collection system, comprising: The fluid collection assembly according to any one of claims 1-16; Fluid storage containers; as well as Vacuum source; The chamber, the fluid storage container, and the vacuum source of the fluid collection assembly are in fluid communication with each other, such that when one or more bodily fluids are present in the chamber, 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 for collecting bodily fluids from a patient, the method comprising: The fluid collection assembly is secured at least adjacent to the user's penis using one or more straps fixed to the upper region of the body of the fluid collection assembly; A first opening defined by a fluid-impermeable barrier of the fluid collection assembly and a second opening defined by a lower region of the body of the fluid collection assembly are positioned to receive the patient's penis through the first opening and into a chamber defined by the fluid-impermeable barrier, the fluid-impermeable barrier at least defining the chamber, the first opening, and a fluid outlet, wherein the fluid-impermeable barrier includes a distal region and a proximal region, the distal region including the fluid outlet, and the proximal region being fixed to the lower region of the body spaced apart from the upper region of the body; Bodily fluids are discharged onto at least one porous material in the chamber; The body fluid is received into the fluid collection assembly within the chamber by at least one porous material; and The bodily fluid is removed 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 adjacent to the proximal region of the fluid-impermeable barrier; and The fluid-impermeable barrier is fixed to the first region of the body, wherein the first opening of the fluid-impermeable barrier is aligned with the second opening of the first region, and the fluid-impermeable barrier extends away from the one or more sidewalls of the body.

20. The method according to claim 19, wherein, Positioning a second opening defined by the first region of the body to receive a patient's penis includes positioning an edge defining the second opening to receive the patient's penis, the edge extending from the first region toward the second region, and fixing the proximal region of the fluid-impermeable barrier around the edge to align the first opening of the fluid-impermeable barrier with the second opening of the body.

21. The method according to claim 19 or 20, wherein, The body defines an additional opening located 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 according to any one of claims 19-21, wherein, The second region of the body defines one or more holes, through which one or more straps are secured to the second region of the body.

23. The method of any one of claims 18-22, further comprising positioning a pad opening defined by a foam pad fixed to the first region of the body to receive at least a portion of the penis through the pad opening, such that the foam pad contacts the patient's skin around the penis.

24. The method according to any one of claims 18-23, wherein, The fluid-impermeable barrier comprises a generally cylindrical or tubular bag having the first opening in the proximal region and the fluid outlet in the distal region.

25. The method according to 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 disposed in the chamber or one or more cylinders of the at least one porous material, such that the at least one porous material maintains at least a portion of the chamber and at least a portion of the fluid impermeable barrier in a generally cylindrical or tubular shape.

26. The method of claim 18, 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, at least a portion of the proximal region being located in the concave region; The second region defines one or more holes; and The one or more straps are secured to the second region of the body through the one or more holes in the second region.

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

29. The method according to claim 28, wherein, The at least one porous material is at least partially fixed to the second panel region and extends at least partially into the concave region of the body within the cavity between the distal regions.

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

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