Fluid collection device, system, and method of use including an opening with increased width

Abstract

Examples of fluid-impermeable barriers for fluid collection devices and methods of forming fluid-impermeable barriers for fluid collection devices. The fluid-impermeable barrier at least partially defines a chamber, a hole configured to receive a conduit therethrough, and an opening. A fluid-permeable body is at least partially positioned within the chamber to extend through at least a portion of the opening and is configured to wick fluid away from the opening. The fluid-permeable body includes a slot extending longitudinally through the fluid-permeable body and configured to at least partially receive the conduit therein.

Description

[0001] Cross - reference to related applications

[0002] This application claims the benefit of priority to U.S. Provisional Patent Application No. 62 / 871,830, filed on Jul. 9, 2019, the disclosure of which is hereby incorporated in its entirety by reference herein. Background of the Invention

[0003] An individual may have limited or impaired mobility, making the normal process of urination challenging or impossible. For example, an individual may have had surgery that impairs mobility or have a disability that impairs mobility. In another example, an individual may have restricted travel conditions, such as those experienced by pilots, drivers, and workers in hazardous areas. Additionally, for monitoring purposes or clinical testing, it may be necessary to collect fluid from an individual.

[0004] Bedpans and catheters (such as Foley catheters) can be used to address some of these situations. However, bedpans and catheters have several problems associated with them. For example, bedpans may be prone to discomfort, pressure sores, spills, and other hygiene issues. Catheters can be uncomfortable, painful, and may lead to urinary tract infections.

[0005] Accordingly, users and manufacturers of fluid collection devices are constantly seeking new and improved devices, systems, and methods for collecting urine. Summary of the Invention

[0006] The embodiments disclosed herein are fluid collection devices and methods of assembling fluid collection devices. In one embodiment, a fluid collection device includes a fluid - impermeable barrier and a fluid - permeable body. The fluid - impermeable barrier at least partially defines a chamber, a hole configured to receive a catheter therethrough, and an opening. The fluid - permeable body is at least partially positioned within the chamber to extend through at least a portion of the opening and is configured to wick fluid away from the opening. The fluid - permeable body includes a slot that extends longitudinally through the fluid - permeable body and is configured to at least partially receive the catheter therein.

[0007] In one embodiment, a fluid collection device includes a fluid - impermeable barrier and a fluid - permeable body. The fluid - impermeable barrier has a first lateral edge, a second lateral edge, and a protrusion. The first lateral edge defines a hole configured to receive a catheter therethrough. The second lateral edge is distal to the first lateral edge. The protrusion extends from the second lateral edge. The fluid - impermeable barrier also defines a chamber and an opening. The fluid - permeable body is at least partially positioned within the chamber to extend through at least a portion of the opening and at least partially define a reservoir with the fluid - impermeable barrier. The reservoir is positioned within the protrusion of the fluid - impermeable barrier. The fluid - permeable body is configured to wick fluid away from the opening to the reservoir.

[0008] In one embodiment, the fluid collection device includes a fluid-impermeable barrier and a fluid-permeable body. The fluid-impermeable barrier has a first lateral edge and a second lateral edge. The first lateral edge defines an aperture configured to receive a conduit therethrough, and the second lateral edge is located distal to the first lateral edge. The fluid-impermeable barrier also defines a chamber and an opening. The opening includes a longitudinal length of at least about 4 cm and a lateral width that is substantially equal to or greater than the longitudinal length. The fluid-permeable body is at least partially positioned within the chamber such that a generally planar portion of the fluid-permeable body extends through at least a portion of the opening. The fluid-permeable body is also at least partially positioned within the chamber to at least partially define a reservoir with the fluid-impermeable barrier, the reservoir being located within a protrusion of the fluid-impermeable barrier. The fluid-permeable body is configured to wick fluid away from the opening to the reservoir.

[0009] Features from any of the disclosed embodiments may be used in combination with each other without limitation. Additionally, other features and advantages of the present disclosure will become apparent to those of ordinary skill in the art by considering the following detailed description and the accompanying drawings. BRIEF DESCRIPTION OF THE DRAWINGS

[0010] The drawings illustrate several embodiments of the present disclosure, wherein like reference numerals refer to the same or similar elements or features in different views or embodiments as shown in the drawings.

[0011] Figure 1 is a front plan view of a fluid collection device according to a first embodiment.

[0012] Figure 2A is a sectional view of the fluid collection device taken along line Figure 1 2-2.

[0013] Figure 2B is a sectional view of the fluid collection device taken along line Figure 1 2-2, with the conduit 108 removed.

[0014] Figure 3 is a sectional view of the fluid collection device taken along line Figure 1 3-3.

[0015] Figure 4 is a sectional view of the fluid-impermeable barrier of the fluid collection device taken along line Figure 1 3-3, with the fluid-permeable body and the conduit removed.

[0016] Figure 5 is a flow chart of a method of assembling a fluid collection device according to an embodiment.

[0017] Figure 6Flowchart of a method for collecting fluid according to one embodiment.

[0018] Figure 7 Block diagram of a system for fluid collection according to one embodiment. Detailed Description

[0019] The embodiments disclosed herein are fluid collection devices and methods of forming fluid collection devices. Proper positioning of a fluid collection device on a user is an important factor for the fluid collection device to collect liquid from the user. However, certain physical attributes of the user often make it difficult to maintain proper positioning of the fluid collection device. For example, in a thin female, a cylindrical fluid collection device may be difficult to keep positioned between the legs of the female and against the female's urethra because the user does not have the muscle required to hold the fluid collection device in place. In another example, a male may have an embedded penis covered by excess skin in the pubic area or scrotum, making it difficult to place the fluid collection device directly against the male's urethra. Embodiments of the fluid collection devices disclosed herein include fluid collection devices that are generally flat and wider than common fluid collection devices. The generally flat, wider fluid collection device allows for easier positioning and fixation of the fluid collection device on a thinner patient. For example, in some embodiments, the generally flat, wider fluid collection device uses the medial thigh or the seam between the thigh and the pelvis to position the fluid collection device more firmly against the urethra of a female user. In another example of a male with an embedded penis, the generally flat, wider fluid collection device can be placed on the skin above the male's embedded penis. The wider fluid collection device covers a greater surface area on the male to allow the fluid collection device to collect more urine discharged from the skin folds leading to the embedded penis. The wider fluid collection device can also be used to cover a wound and collect fluid discharged from the wound.

[0020] In one embodiment, the fluid collection device includes a fluid-impermeable barrier and a fluid-permeable body. The fluid-impermeable barrier at least partially defines: a chamber; a hole configured to receive a catheter therethrough; and an opening. The fluid-permeable body is at least partially positioned within the chamber to extend through at least a portion of the opening and is configured to wick fluid away from the opening. The fluid-permeable body includes a slot that extends longitudinally through the fluid-permeable body and is configured to at least partially receive a catheter therein.

[0021] In one embodiment, the fluid collection device includes a fluid-impermeable barrier and a fluid-permeable body. The fluid-impermeable barrier has a first lateral edge that defines an aperture configured to receive a conduit therethrough, a second lateral edge that is distal to the first lateral edge, and a protrusion that extends from the second lateral edge. The fluid-impermeable barrier also defines a chamber and an opening. The fluid-permeable body is at least partially positioned within the chamber to extend through at least a portion of the opening and, together with the fluid-impermeable barrier, at least partially define a reservoir that is positioned within the protrusion of the fluid-impermeable barrier. The fluid-permeable body is configured to wick fluid away from the opening to the reservoir.

[0022] The fluid collection device disclosed herein is configured to collect fluid from an individual. The fluid collected by the fluid collection device may include urine. The fluid collected by the fluid collection device may also include at least one of vaginal secretions, penile secretions, reproductive fluid, blood, sweat, or other body fluids.

[0023] The fluid collection device described herein may be used in a fluid collection system. The fluid collection system may include a fluid collection device, a fluid storage container, and a portable vacuum source. The fluid (e.g., urine or other body fluid) collected in the fluid collection device may be removed from the fluid collection device through a conduit that extends into the interior region of the fluid collection device. For example, a first open end of the conduit may extend into the fluid collection device, to the reservoir therein. A second open end of the conduit may extend into the fluid collection device or the portable vacuum source. In response to a suction (e.g., vacuum) force applied at the second end of the conduit, the suction force may be introduced into the interior region of the fluid collection device through the first open end of the conduit. The suction force may be applied directly or indirectly by the portable vacuum source to the second open end of the conduit.

[0024] In some embodiments, the portable vacuum source may be disposed within or on the fluid collection device. In such embodiments, the conduit may extend from the fluid collection device and be attached to the portable vacuum source at a first point therein. An additional conduit may be attached to the portable vacuum source at a second point thereon and may extend out of the fluid collection device and may be attached to the fluid storage container. Thus, a vacuum (e.g., suction) may be introduced through the fluid collection device via the fluid storage container. The portable vacuum source may be used to expel fluid, such as urine, from the fluid collection device.

[0025] Figure 1is a front plan view of a fluid collection device 100 according to one embodiment. The fluid collection device 100 is an example of a fluid collection device 100 that is configured to receive fluid from a female or male. The fluid collection device 100 includes a fluid-impermeable barrier 102 that has a transverse width BD1 that is substantially equal to or greater than a longitudinal length BD2. Although the terms "longitudinal length" and "transverse width" are used to describe the dimensions of the fluid-impermeable barrier 102 and the opening 106 in the fluid-impermeable barrier, in some embodiments, the transverse width may be equal to or greater than the longitudinal length. Because the transverse width is substantially equal to or greater than the longitudinal length, the fluid-impermeable barrier 102 can include a variety of overall geometric front profiles, such as generally rectangular, generally rhomboidal, generally circular, generally oval, etc. For example, Figure 1 the fluid-impermeable barrier 102 shown in includes a generally rectangular front profile that has a first transverse side 140a, a second transverse side 140b located at the distal end of the first transverse side 140a, and two longitudinal sides 130 that each extend between the first transverse side 140a and the second transverse side 140b. The first transverse side 140a and the second transverse side 140b may each have a transverse width BD1, and the two longitudinal sides 130 may each have a longitudinal length BD2.

[0026] In many embodiments, the lateral width BD1 of the fluid permeable barrier 102 is greater than the longitudinal length BD2 of the fluid impermeable barrier 102. For example, the lateral width BD1 can be at least about 1.25 times the longitudinal length BD2, at least about 1.5 times the longitudinal length BD2, at least about 1.75 times the longitudinal length BD2, at least about 2 times the longitudinal length BD2, at least about 2.25 times the longitudinal length BD2, at least about 2.5 times the longitudinal length BD2, at least about 2.75 times the longitudinal length BD2, at least about 3 times the longitudinal length BD2, from about 1.25 to about 3.25 times the longitudinal length BD2, from about 1.25 to about 2.25 times the longitudinal length BD2, from about 2.25 to about 3.25 times the longitudinal length BD2, from about 1.25 to about 1.75 times the longitudinal length BD2, from about 1.75 to about 2.25 times the longitudinal length BD2, from about 2.25 to about 2.75 times the longitudinal length BD2, or from about 2.75 to about 3.25 times the longitudinal length BD2. The lateral width BD1 can vary according to different embodiments. For example, the lateral width BD1 can be from about 1.5 inches (about 3.8 cm) to about 5 inches (about 12.7 cm), from about 1.5 inches to about 4 inches (about 10.2 cm), from about 1.5 inches to about 3 inches (about 7.6 cm), from about 1.5 inches to about 2.5 inches (about 6.4 cm), from about 2 inches (about 5.1 cm) to about 3 inches, from about 2.5 inches to about 3.5 inches (about 8.9 cm), from about 3 inches to about 4 inches, from about 3.5 inches to about 4.5 inches (about 11.4 cm), from about 4 inches to about 5 inches, from about 1.5 inches to about 2 inches, from about 2 inches to about 2.5 inches, from about 2.5 inches to about 3 inches, from about 3 inches to about 3.5 inches, from about 3.5 inches to about 4 inches, from about 4 inches to about 4.5 inches, about 4.5 inches, about 5 inches, at least about 1.5 inches, at least about 2 inches, at least about 2.5 inches, at least about 3 inches, at least about 3.5 inches, at least about 4 inches, at least about 4.5 inches, at least about 5 inches, about 1.5 inches, about 2 inches, about 2.5 inches, about 3 inches, about 3.5 inches, about 4 inches, about 4.5 inches, about 5 inches, less than about 1.5 inches, less than about 2 inches, less than about 2.5 inches, less than about 3 inches, less than about 3.5 inches, less than about 4 inches, less than about 4.5 inches, or less than about 5 inches.

[0027] Regardless of whether the fluid impermeable barrier 102 includes a generally rectangular, generally diamond-shaped, generally circular, or generally oval front profile, the fluid impermeable barrier 102 can be generally flat or planar (as Figures 2A to 4As shown in []. That is, the fluid-impermeable barrier 102 may include a generally flat back surface and define an opening 106 on a front surface having a generally planar profile. The depth of the fluid-impermeable barrier 102 may vary according to different embodiments. For example, the fluid-impermeable barrier 102 may include a depth BD3 of about 0.25 inches (about 6.4 cm) to about 0.5 inches (about 1.3 cm), 0.5 inches to about 0.75 inches (about 1.9 cm), 0.75 inches to about 1 inch, 0.25 inches to about 0.33 inches (about 0.84 cm), about 0.33 inches to about 0.5 inches, about 0.5 inches to about 0.66 inches (about 1.68 cm), about 0.66 inches to about 0.75 inches, at least about 0.25 inches, at least about 0.33 inches, at least about 0.5 inches, at least about 0.66 inches, at least about 0.75 inches, about 0.25 inches, about 0.33 inches, about 0.5 inches, about 0.66 inches, about 0.75 inches, less than about 0.25 inches, less than about 0.33 inches, less than about 0.5 inches, less than about 0.66 inches, or less than about 0.75 inches, as shown in Figures 2A to 2B As shown in []. The depth BD3 is less than both the lateral width BD1 and the longitudinal length BD2. For example, the longitudinal length BD2 may be at least 1.25 times the depth BD3, at least 1.5 times the depth BD3, at least 1.75 times the depth BD3, at least 2 times the depth BD3, at least 2.5 times the depth BD3, or at least 3 times the depth BD3.

[0028] The fluid-impermeable barrier 102 may further include one or more protrusions extending from one side of the fluid-impermeable barrier 102. For example, Figure 1The fluid-impermeable barrier 102 shown in [reference] includes a protrusion 127 extending longitudinally from a transverse edge 140b. The protrusion 127 may extend from the transverse edge 140b by at least about 0.25 inches, at least about 0.5 inches, at least about 0.75 inches, at least about 1 inch, at least about 1.25 inches (about 3.2 cm), at least about 1.5 inches, at least about 1.75 inches (about 4.4 cm), at least about 2 inches, from about 0.25 inches to about 2 inches, from about 0.25 inches to about 1 inch, from about 1 inch to about 2 inches, from about 0.25 inches to about 0.75 inches, from about 0.5 inches to about 1 inch, from about 0.75 inches to about 1.25 inches, from about 1 inch to about 1.5 inches, from about 1.25 inches to about 1.75 inches, or from about 1.5 inches to about 2 inches. The protrusion 127 may include a maximum transverse width of at least about 0.5 inches, at least about 0.75 inches, at least about 1 inch, at least about 1.25 inches, from about 0.25 inches to about 2 inches, from about 0.25 inches to about 1.25 inches, from about 0.25 inches to about 0.5 inches, from about 0.5 inches to about 0.75 inches, from about 0.75 inches to about 1 inch, or from about 1 inch to about 1.25 inches, from about 1.25 inches to about 1.75 inches, or from about 1.5 inches to about 2 inches. The protrusion 127 may include any combination of the extension dimensions and transverse widths provided above.

[0029] The protrusion 127 may be a spherical, hemispherical, or cylindrical protrusion extending from the transverse edge 140b. The protrusion 127 may also include two portions of the transverse edge 140b that are inclined toward the apex of the protrusion 127. The protrusion 127 at least partially defines a reservoir 122 within the chamber 104 (as Figure 3 shown in [reference]), which will be described in more detail below. The protrusion 127 may be positioned on an axis 107 that is substantially centered on the transverse width OD1 of the opening 106 or the transverse width BD1 of the fluid-impermeable barrier 102. The fluid-impermeable barrier 102 may also include an additional protrusion 125 that is positioned opposite the protrusion 127, such as extending longitudinally from the transverse edge 140a. In some embodiments, the protrusion 125 defines a hole 124 ( Figure 4 shown in [reference]) that is sized to receive a catheter 108 (e.g., at least one tube). The hole 124 may be positioned on an axis 107 that is substantially centered on the transverse width OD1 of the opening 106 or the transverse width BD1 of the fluid-impermeable barrier 102. In other embodiments, the fluid-impermeable barrier 102 may define the hole 124 at different portions of the fluid-impermeable barrier 102. The hole 124 may be configured to form at least a substantially fluid-tight seal against the catheter 108 or at least one tube, thereby substantially preventing fluid from escaping from the chamber 104.

[0030] The fluid-impermeable barrier 102 also at least partially defines a chamber 104 (e.g., an interior region, as shown in Figure 4 ), and includes an inner boundary or edge 129 that defines an opening 106. The opening 106 includes a longitudinal length OD2 and a transverse width OD1 that is substantially equal to or greater than the longitudinal length OD2. Where the transverse width OD1 is substantially equal to or greater than the longitudinal length OD2, the opening 106 can include a variety of overall geometric front profiles, such as generally rectangular, generally rhombic, generally circular, generally oval, etc. For example, Figure 1 the opening 106 shown in includes a generally rectangular opening 106 having a transverse width OD1 and a longitudinal length OD2.

[0031] In many embodiments, the transverse width OD of the opening 106 l is greater than the longitudinal length OD2 of the opening 106. For example, the transverse width OD lIt can be at least about 1.25 times the longitudinal length OD2, at least about 1.5 times the longitudinal length OD2, at least about 1.75 times the longitudinal length OD2, at least about 2 times the longitudinal length OD2, at least about 2.25 times the longitudinal length OD2, at least about 2.5 times the longitudinal length OD2, at least about 2.75 times the longitudinal length OD2, at least about 3 times the longitudinal length OD2, from about 1.25 to about 3.25 times the longitudinal length OD2, from about 1.25 to about 2.25 times the longitudinal length OD2, from about 2.25 to about 3.25 times the longitudinal length OD2, from about 1.25 to about 1.75 times the longitudinal length OD2, from about 1.75 to about 2.25 times the longitudinal length OD2, from about 2.25 to about 2.75 times the longitudinal length OD2, or from about 2.75 to about 3.25 times the longitudinal length OD2. The transverse width OD1 can vary according to different embodiments. For example, the transverse width OD1 can be from about 1.5 inches to about 5 inches, from about 1.5 inches to about 4 inches, from about 1.5 inches to about 3 inches, from about 1.5 inches to about 2.5 inches, from about 2 inches to about 3 inches, from about 2.5 inches to about 3.5 inches, from about 3 inches to about 4 inches, from about 3.5 inches to about 4.5 inches, from about 4 inches to about 5 inches, from about 1.5 inches to about 2 inches, from about 2 inches to about 2.5 inches, from about 2.5 inches to about 3 inches, from about 3 inches to about 3.5 inches, from about 3.5 inches to about 4 inches, from about 4 inches to about 4.5 inches, about 4.5 inches, about 5 inches, at least about 1.5 inches, at least about 2 inches, at least about 2.5 inches, at least about 3 inches, at least about 3.5 inches, at least about 4 inches, at least about 4.5 inches, at least about 5 inches, about 1.5 inches, about 2 inches, about 2.5 inches, about 3 inches, about 3.5 inches, about 4 inches, about 4.5 inches, about 5 inches, less than about 1.5 inches, less than about 2 inches, less than about 2.5 inches, less than about 3 inches, less than about 3.5 inches, less than about 4 inches, less than about 4.5 inches, or less than about 5 inches.

[0032] The fluid-impermeable barrier 102 can form a lip surrounding at least a portion of the opening 106. The lip surrounding at least a portion of the opening can be approximately half the difference between BD1 and OD1 or BD2 and OD2. BD1 can be at least approximately 0.125 inches (about 0.32 cm), at least approximately 0.25 inches, at least approximately 0.5 inches, at least approximately 0.75 inches, at least approximately 1 inch, at least approximately 1.25 inches, at least approximately 1.5 inches, at least approximately 1.75 inches, at least approximately 2 inches, from about 0.125 inches to about 2 inches, from about 0.125 inches to about 0.25 inches, from about 0.25 inches to about 0.5 inches, from about 0.5 inches to about 0.75 inches, from about 0.75 inches to about 1 inch, from about 1 inch to about 1.25 inches, from about 1.25 inches to about 1.5 inches, from about 1.5 inches to about 1.75 inches, from about 1.75 inches to about 2 inches, about 0.125 inches, about 0.5 inches, about 0.75 inches, about 1 inch, about 1.25 inches, about 1.5 inches, about 1.75 inches, or about 2 inches larger than OD1. BD2 can be at least approximately 0.125 inches (about 0.32 cm), at least approximately 0.25 inches, at least approximately 0.5 inches, at least approximately 0.75 inches, at least approximately 1 inch, at least approximately 1.25 inches, at least approximately 1.5 inches, at least approximately 1.75 inches, at least approximately 2 inches, from about 0.125 inches to about 2 inches, from about 0.125 inches to about 0.25 inches, from about 0.25 inches to about 0.5 inches, from about 0.5 inches to about 0.75 inches, from about 0.75 inches to about 1 inch, from about 1 inch to about 1.25 inches, from about 1.25 inches to about 1.5 inches, from about 1.5 inches to about 1.75 inches, from about 1.75 inches to about 2 inches, about 0.125 inches, about 0.5 inches, about 0.75 inches, about 1 inch, about 1.25 inches, about 1.5 inches, about 1.75 inches, or about 2 inches larger than OD2.

[0033] An opening 106 is formed in and extends through the fluid-impermeable barrier 102 such that fluid can enter the chamber 104 from outside the fluid collection device 100. The opening 106 can be configured to be positioned adjacent to the female urethra, adjacent to the skin above the female urethra, or adjacent to the skin above the penis of a male with an embedded penis. A fluid collection device having at least one of the following allows for easier positioning and securing of the fluid collection device 100 on a thinner patient: the lateral width BD1 of the fluid-impermeable barrier 102 is greater than that of a common fluid collection device or the lateral width OD1 of the opening 106 is greater than that of a common fluid collection device. As described above, the generally flat and wider fluid collection device 100 can use the inner thigh or the seam between the thigh and the pelvis to position the fluid collection device 100 more securely against the female user's urethra. In some embodiments, the back surface of the fluid-impermeable barrier 102 can include a crease or seam that enables the fluid-impermeable barrier to more easily achieve a double-fold configuration to more securely position the fluid collection device 100 between the legs and against the female user's urethra. The crease or seam can be positioned on the back surface of the fluid-impermeable barrier and is substantially aligned with the axis 107. In another example of a male with an embedded penis, the generally flat and wider fluid collection device 102 can be placed on the skin above the male's embedded penis. The wider fluid collection device 100 covers a larger surface area on the male to allow the fluid collection device to collect more urine discharged from the skin folds leading to the embedded penis. The wider fluid collection device 100 can also be used to cover a wound and collect fluid discharged from the wound.

[0034] Since the fluid collection device 100 is positioned adjacent to the female urethra, adjacent to the skin above the female urethra, or adjacent to the skin above the penis of a male with an embedded penis, urine can enter the interior region or chamber 104 of the fluid collection device 100 through the opening 106. Accordingly, the fluid collection device 100 is configured to receive fluid into the chamber 104 through the opening 106. In an embodiment, the fluid-impermeable barrier 102 can be configured to be attached to an individual, such as adhesively attached to an individual (e.g., using a hydrogel adhesive). For example, an adhesive can be used to secure at least a portion of the lip surrounding the opening to the individual. According to an embodiment, a suitable adhesive is a hydrogel layer, such as those disclosed in U.S. Patent Application Publication No. 2017 / 0189225, the disclosure of which is incorporated herein by reference in its entirety.

[0035] The fluid-impermeable barrier 102 can also temporarily store fluid in the chamber 104. For example, the fluid-impermeable barrier 102 can be formed of any suitable fluid-impermeable material, such as a fluid-impermeable polymer (e.g., silicone, polypropylene, polyethylene, polyethylene terephthalate, polycarbonate, etc.), a polyurethane film, a thermoplastic elastomer (TPE), rubber, thermoplastic polyurethane, oil, another suitable material, or a combination thereof. Thus, the fluid-impermeable barrier 102 substantially prevents fluid from leaving the portion of the chamber 104 spaced apart from the opening 106. The fluid-impermeable barrier is flexible, allowing the fluid collection device 100 to be bent or flexed when positioned against the wearer's body. Example fluid-impermeable barriers can include, but are not limited to, fluid-impermeable barriers including at least one of Versaflex CL 2000X TPE, Dynaflex G6713 TPE, or Silpuran 6000 / 05A / B silicone. In an embodiment, the fluid-impermeable barrier 102 can be air-permeable and fluid-impermeable. In such an embodiment, the fluid-impermeable barrier 102 can be formed of a hydrophobic material defining a plurality of pores. The fluid-impermeable barrier 102 can include markings, such as one or more markings to assist the user in aligning the device 100 on the wearer. For example, a line (e.g., opposite the opening 106) on the fluid-impermeable coating 102 can allow a healthcare professional to align the opening 106 over the wearer's urethra or penis. For example, the markings can include one or more of alignment guides or direction indicators, such as stripes or hashes. Such markings can be positioned to align the device 100 with one or more anatomical features, such as the pubis.

[0036] The fluid collection device 100 includes a fluid-permeable body 120 or layer disposed in the chamber 104. The fluid-permeable body 120 can cover or extend through at least a portion (e.g., all) of the opening 106. For example, the fluid-permeable body 120 includes a top or first surface 111 (as Figure 2A and Figure 2B shown) extending through at least a portion of the opening 106 and a bottom or second surface 109 opposite the first surface (as Figure 2A and Figure 2BAs shown in []. At least most (e.g., all) of the second surface 109 can be joined to the inner surface 103 of the fluid-impermeable barrier 102. In one embodiment, the fluid-permeable body 120 and at least a portion of the conduit 108 can at least substantially completely fill the chamber 104. In another example, the fluid-permeable body 120 and at least a portion of the conduit may not substantially completely fill the chamber 104. In such an example, the fluid collection device 100 includes a reservoir 122 disposed in the chamber 104, which will be described in more detail below. The fluid in the chamber 104 can flow through the fluid-permeable body 120 to the reservoir 122. In these and other embodiments, the fluid-permeable body 120, at least a portion of the conduit 108, and the reservoir 122 can at least substantially completely fill the chamber 104. In some embodiments, the fluid-permeable body 120 extends at least partially into the protrusion 127 of the fluid-impermeable barrier 102. The fluid-permeable body 120 may also not be present in the protrusion 127 of the fluid-impermeable barrier 102.

[0037] The fluid-permeable body 120 can be configured to wick any fluid away from the opening 106, thereby preventing fluid from escaping the chamber 104. The fluid-permeable body 120 can also wick fluid generally toward the interior of the chamber 104, as discussed in more detail below. A portion of the fluid-permeable body 120 can define a portion of the outer surface of the fluid collection device 100. Specifically, the portion of the fluid-permeable body 120 that defines a portion of the outer surface of the fluid collection device 100 can be the portion of the fluid-permeable body 120 that is exposed by the opening 106 defined by the fluid-impermeable barrier 102 that contacts the user. In addition, the portion of the fluid-permeable device that defines a portion of the outer surface of the fluid collection device 100 may not be covered by gauze or other wicking material at the opening.

[0038] The fluid-permeable body 120 can include any material that can wick fluid. The permeable properties mentioned herein can be wicking, capillary action, diffusion, or other similar properties or processes, and are referred to herein as "permeable" and / or "wicking". Such "wicking" may not include absorption into a wicking material. The fluid-permeable body 120 can include a unidirectional fluid-moving fabric. Thus, the fluid-permeable body 120 can remove fluid from the area around the female urethra, keeping the urethra dry. The fluid-permeable body 120 can enable fluid to generally flow toward the reservoir 122 in the void space formed within the chamber 104 ( Figure 3as shown in). For example, the fluid-permeable body 120 may comprise a porous or fibrous material such as a hydrophilic polyolefin. In some embodiments, the fluid-permeable body 120 consists of or consists essentially of a porous or fibrous material such as a hydrophilic polyolefin. Examples of polyolefins that can be used for the fluid-permeable body 120 include, but are not limited to, polyethylene, polypropylene, polyisobutylene, ethylene-propylene rubber, ethylene-propylene-diene monomer, or combinations thereof. The porous or fibrous material can be extruded into a generally flat or planar shape to fit within the chamber 104 of the fluid-impermeable barrier 102. The shape of the fluid-permeable body 120 can be generally complementary to the shape of the fluid-impermeable barrier 102. For example, the fluid-permeable body 120 can at least include a generally flat or planar portion that extends through at least a portion of the opening 106. The fluid-permeable body 120 can additionally or alternatively include a generally flat or planar portion that engages the back surface of the fluid-impermeable barrier 102 that is opposite the opening 106. The fluid-permeable body 120 can include different densities or sizes. Additionally, the fluid-permeable body 120 can be manufactured according to various manufacturing methods such as molding, extrusion, or sintering.

[0039] In some embodiments, the fluid-permeable body 120 comprises a single porous body. That is, during use, the fluid-permeable body 120 extends from the conduit 108 to engage the fluid-impermeable barrier 102 and the opening 106. The single fluid-permeable body 120 is advantageous for common systems that typically require an air-laid nonwoven pad covered by a ribbed fabric compression bandage because the single fluid-permeable body 120 reduces the number of components in the fluid collection device 100, reduces the assembly time of the fluid collection device 100, requires shelf-life data for only a single component, and provides a latex-free single component. In some embodiments, at least a portion of the single porous material of the fluid-permeable body 120 extends continuously between the opening 106 and the reservoir 122 to wick any fluid directly from the opening 106 to the reservoir 122. Additionally, since the fluid-impermeable barrier 102 is flexible and the fluid-permeable body 120 is configured to wick fluid from the body rather than absorb fluid from the body and hold the fluid against the body, in some embodiments, the fluid collection device 100 does not have a seal or buffer ring located on the inner edge 129 that defines the opening 106. In these and other embodiments, the fluid-permeable body 120 includes an outer surface and a single layer or single type of material located between the opening 106 and the conduit 108 positioned within the fluid-permeable body 120.

[0040] In other embodiments, the fluid-permeable body 120 may include two or more layers of fluid-permeable material and there may be no more than two layers of material between the opening 106 and the conduit 108 positioned within the fluid-permeable body 120. For example, the fluid collection device 100 may include a fluid-permeable membrane that covers or wraps at least a portion of the fluid-permeable body, and both the fluid-permeable membrane and the fluid-permeable body are disposed within the chamber 104. The fluid-permeable membrane may cover or extend across at least a portion (e.g., all) of the opening 106. The fluid-permeable membrane may be configured to wick any fluid away from the opening 106, thereby preventing fluid from escaping the chamber 104. The permeable characteristics referred to herein may be wicking, capillary action, diffusion, or other similar characteristics or processes and are referred to herein as "permeable" and / or "wicking". In some embodiments, at least one of the fluid-permeable membrane or the fluid-permeable support includes nylon configured to wick fluid away from the opening 106. The materials of the fluid-permeable membrane and the fluid-permeable support may also include natural fibers. In such an example, the material may have a coating configured to prevent or limit fluid absorption into the material, such as a waterproof coating. Such "wicking" may not include absorption into the wicking material. In other words, after the material is exposed to fluid and removed from the fluid for a period of time, substantially no fluid is absorbed into the material, or after the material is exposed to fluid and removed from the fluid for a period of time, substantially all or most of the fluid is not present in the wicking material and / or the fluid-permeable body 120. Although absorption is not desired, the term "substantially non-absorbent" may allow a nominal amount of fluid to be absorbed into the wicking material (e.g., absorption rate), such as less than about 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.

[0041] The fluid-permeable membrane may also wick fluid generally toward the interior of chamber 104, as discussed in more detail below. The fluid-permeable membrane may include any material that can wick fluid. For example, the fluid-permeable membrane may include a fabric such as gauze (e.g., silk, linen, polymer-based materials such as polyester, or cotton gauze), nylon, another soft fabric (e.g., a plain knit fabric, etc.), or another smooth fabric (e.g., rayon, satin, etc.). Forming the fluid-permeable membrane from gauze, soft fabric, and / or smooth fabric may reduce abrasion caused by fluid collection device 100. Other embodiments of the fluid-permeable membrane, fluid-permeable support, chamber, and their shapes and configurations are disclosed in U.S. Patent Application No. 15 / 612,325, filed June 2, 2017, U.S. Patent Application No. 15 / 260,103, filed September 8, 2016, U.S. Patent Application No. 15 / 611,587, filed June 1, 2017, and PCT Patent Application No. PCT / US19 / 29608, filed April 29, 2019, the disclosures of each of which are hereby incorporated by reference in their entirety. In many embodiments, the fluid-permeable body 120 includes: a fluid-permeable support including a porous nylon structure (e.g., spun nylon fibers); and a fluid-permeable membrane including a gauze surrounding or overlying the porous nylon structure.

[0042] Figure 2A is a cross-sectional view of fluid collection device 100 taken along Figure 1 line 2-2 of Figure 2B is a cross-sectional view of fluid collection device 100 taken along Figure 1 line 2-2 of, where conduit 108 has been removed. The fluid-permeable body 120 also includes a slot sized to at least partially receive conduit 108 therein. The slot extends longitudinally along the fluid-permeable body 120 and may extend from the second surface 109 to a suitable depth within the fluid-permeable body 120. The slot enables conduit 108 to be positioned within the fluid-permeable body 120 by pushing conduit 108 through the longitudinal length of the fluid-permeable body 120.

[0043] The slot may be configured as an L-shaped (not shown) or a T-shaped slot having: a first portion 204 that is generally planar and substantially parallel to the first surface 111 and the second surface 109 of the fluid-permeable body 120; and a second portion 206 that is substantially perpendicular or otherwise angled relative to the first surface 111 and the second surface 109 of the fluid-permeable body 120. The second portion 206 of the slot may extend from the second surface 109 to the first portion 204 of the slot. The second portion 206 of the slot enables access to the first portion 204 of the slot through which the conduit 108 may be inserted. The first portion 204 of the slot may be positioned at about half or less than half of the distance from the second surface 109 to the first surface 111 of the fluid-permeable body 120. The first portion 204 and the second portion 206 of the slot may include incisions or divisions in the fluid-permeable body 120 to allow the conduit 108 to move through the slot of the fluid-permeable body 120 and position the conduit 108 within the slot of the fluid-permeable body 120. At least one of the first portion 204 or the second portion 206 of the slot may be configured to allow adjacent portions of the fluid-permeable body 120 separated by the first portion 204 or the second portion 206 to engage with each other at the respective first portion 204 or second portion 206. In some embodiments, at least one of the first portion 204 or the second portion 206 of the slot may be configured to provide a gap or space between portions of the fluid-permeable body 120 separated by the first portion 204 or the second portion 206 of the slot. In some embodiments, the slot may be configured as an I-shaped slot (not shown) that is substantially perpendicular or otherwise angled relative to the first surface 111 and the second surface 109 of the fluid-permeable body 120. The slot may extend from the second surface 109 to a certain depth within the fluid-permeable body. For example, the slot may extend into the fluid-permeable body 120 no more than half of it.

[0044] In some embodiments, the slot includes a hole or passage sized to be complementary to the conduit 108. In embodiments having a hole or passage sized to be complementary to the conduit 108, the slot may include a second portion 206 of the hole or passage leading from the second surface 109 of the fluid-permeable body 120. Alternatively, the hole or passage may extend longitudinally through the fluid-permeable body 120 without a slot leading from the second surface 109 to the hole or passage.

[0045] The fluid-permeable body 120 may also include one or more covers 202 that at least partially cover the slot or cover at least a portion of the slot. For example, as Figure 2B, the T-slot forms two covers 202 covering a first portion 204 of the slot. The two covers 202 can engage with each other at a second portion 206 of the slot, thereby substantially enclosing the conduit 108 within the fluid-permeable body 120. For example, the conduit 108 can be inserted into the slot by moving the conduit 108 through the second portion 206 of the slot between the two covers 202 until the conduit 108 reaches the first portion 204 of the slot.

[0046] Figure 3 is along Figure 1 3-3 of FIG. 1 . The fluid collection device 100 also includes a conduit 108 at least partially disposed in the chamber 104. The conduit 108 (e.g., a tube) includes: an inlet 110, which is located at a protrusion 127 of the fluid-impermeable barrier 102; and an outlet 112, which is located downstream of the inlet 110 and at a protrusion 125 of the fluid-impermeable barrier 102. The conduit 108 provides fluid communication between the interior area of ​​the chamber 104 and a fluid storage container (not shown) or a portable vacuum source (not shown). For example, the conduit 108 can directly or indirectly connect the interior area of ​​the chamber 104 and / or the reservoir 122 to the fluid storage container or the portable vacuum source. With the conduit 108 positioned within the fluid-permeable body 120, when the fluid collection device 100 is secured to a user using any of a plurality of securing devices, the fluid received in the chamber 104 can be removed through the conduit 108.

[0047] In the illustrated embodiment, the conduit 108 is at least partially disposed in the chamber 104 and engages at least a portion of the slot of the fluid-permeable body 120. For example, the conduit 108 may extend from the protrusion 125 (e.g., near the outlet 112) into the fluid-impermeable barrier 102, and may extend through the slot in the fluid-permeable body 120 to the protrusion 127 (e.g., opposite the protrusion 125) to a point near the reservoir 122, so that the inlet 110 is in fluid communication with the reservoir 122. For example, in the illustrated embodiment, the inlet 110 is positioned in the reservoir 122. However, in other embodiments, the inlet 110 may be flush with or positioned behind the end of the fluid-permeable body 120 that partially defines the reservoir 122. Fluid collected in the fluid collection device 100 may be removed from the interior area of ​​the chamber 104 via the conduit 108. The conduit 108 may include a flexible material, such as plastic tubing (e.g., medical tubing). Such plastic tubing may include tubing made of thermoplastic elastomers, polyvinyl chloride, ethylene vinyl acetate, polytetrafluoroethylene, etc. In some embodiments, the catheter 108 may include silicone or latex.

[0048] The fluid-impermeable barrier 102 can store fluid in the reservoir 122. The reservoir 122 is the unoccupied portion of the chamber 104 and has no other materials. In some embodiments, the reservoir 122 is at least partially defined by the fluid-permeable body 120 and the fluid-impermeable barrier 102. The reservoir 122 can be disposed in any part of the interior region of the chamber 104. For example, the fluid reservoir 122 can be at least partially or completely located in the protrusion 127 of the chamber 104. In the illustrated embodiment, the reservoir 122 is defined by at least a portion of the end 123 of the fluid-permeable body 120 and the protrusion 127 of the fluid-impermeable barrier 102. In one embodiment, the reservoir 122 can be located at the portion of the chamber 104 closest to the inlet 110 (e.g., the second end region). However, the reservoir 122 can be located at different positions in the chamber 104. In some embodiments, the conduit 108 can extend through the fluid-impermeable barrier 102 to the reservoir 122 without extending through the fluid-permeable body 120. Thus, in these and other embodiments, the fluid-permeable body 120 can be free of holes (e.g., the holes can be absent in the fluid-permeable body 120). In another embodiment, the fluid collection device 100 can include multiple reservoirs, such as a first reservoir located at the chamber portion of the chamber 104 closest to the inlet 110 (e.g., the second end region) and a second reservoir located at the chamber portion of the chamber 104 closest to the outlet 112 (e.g., the first end region). In another example, the fluid-permeable body 120 is separated from at least a portion of the conduit 108, and the reservoir 122 can be the space between the fluid-permeable body 120 and the conduit 108.

[0049] Other embodiments of the reservoir, the fluid-impermeable barrier, the fluid-permeable membrane, the fluid-permeable body, the chamber, and their materials and configurations are disclosed in U.S. Patent Application No. 15 / 612,325, filed on June 2, 2017, U.S. Patent Application No. 15 / 260,103, filed on September 8, 2016, and U.S. Patent Application No. 15 / 611,587, filed on June 1, 2017. The disclosures of each of the patent applications are hereby incorporated by reference in their entirety.

[0050] The fluid-impermeable barrier 102 and the fluid-permeable body 120 can be configured such that the conduit 108 is at least partially disposed within the chamber 104. For example, the fluid-permeable body 120 can be configured to form a space, such as a slot, for receiving the conduit 108. In another example, the fluid-impermeable barrier 102 can define an aperture 124 sized and designed to receive the conduit 108 (e.g., at least one tube). The at least one conduit 108 can be disposed within the chamber 104 through the aperture 124. The aperture 124 can be configured to form a fluid-tight seal with the conduit 108 or at least one tube, thereby substantially preventing fluid from escaping the chamber 104.

[0051] In some embodiments, the conduit 108 can extend through the fluid-permeable body 120 and at least partially into the reservoir 122 and / or the protrusion 127. In some embodiments, the conduit 108 can extend through the fluid-permeable body 120 and terminate at or before the body 123 of the fluid-permeable body 120 such that the conduit 108 does not extend into the reservoir 122 (or the reservoir 122 is not present within the conduit 108). For example, an end of the conduit 108, such as the inlet 110, can be generally flush or coplanar with the end 123 of the fluid-permeable body 120. In other embodiments, the end of the conduit 108 can be recessed from the end 123 of the fluid-permeable body 120. The end of the conduit 108 can also be selectively moved between partially extending into the reservoir 122 and being recessed from the end 123 of the fluid-permeable body 120.

[0052] When secured to the fluid collection device 100, the conduit 108 is configured to provide fluid communication with one or more of a fluid storage container (not shown) and a portable vacuum source (not shown) and at least partially extend between one or more of the fluid storage container (not shown) and the portable vacuum source (not shown). For example, the conduit 108 can be configured to be fluidly coupled to one or more of a fluid storage container and a portable vacuum source and at least partially extend between one or more of the fluid storage container and the portable vacuum source. In one embodiment, the conduit 108 is configured to be directly connected to a portable vacuum source (not shown). In such an example, the conduit 108 can extend from the fluid-impermeable barrier 102 for at least one foot, at least two feet, at least three feet, or at least six feet. In another example, the conduit 108 is configured to be indirectly connected to at least one of a fluid storage container (not shown) or a portable vacuum source (not shown). In some examples, the conduit can be frosted or opaque (e.g., black) to obscure the visibility of the fluid therein. In some embodiments, the conduit is secured to the skin of the wearer with a conduit securing device, such as those available from C.R.Bard, Inc. A catheter fixation device, including but not limited to those disclosed in U.S. Pat. Nos. 6,117,163, 6,123,398, and 8,211,063, the disclosures of which are hereby incorporated by reference in their entirety.

[0053] The inlet 110 and the outlet 112 are configured to provide fluid communication (e.g., directly or indirectly) between a portable vacuum source (not shown) and the chamber 104 (e.g., the reservoir 122). For example, the inlet 110 and the outlet 112 of the catheter 108 can be configured to fluidly couple the portable vacuum source directly or indirectly to the reservoir 122. In one embodiment, the inlet 110 and / or the outlet 112 can form a male connector. In another example, the inlet 110 and / or the outlet 112 can form a female connector. In one embodiment, the inlet 110 and / or the outlet 112 can include ribs configured to facilitate a secure connection. In one embodiment, the inlet 110 and / or the outlet 112 can form a tapered shape. In one embodiment, the inlet 110 and / or the outlet 112 can include a rigid or flexible material.

[0054] Positioning the inlet 110 at or near the gravity low point of the chamber 104 enables the catheter to receive more fluid than would be the case if the inlet 110 were located elsewhere and reduces the likelihood of pooling (e.g., pooling of fluid can lead to microbial growth and foul odors). For example, the fluid in the fluid-permeable body 120 can flow in any direction due to capillary forces. However, the fluid may exhibit a preference for flowing in the direction of gravity, especially when at least a portion of the fluid-permeable body 120 is saturated with fluid.

[0055] When a portable vacuum source applies a vacuum / suction in the catheter 108, the fluid in the chamber 104 (such as in the reservoir 122 located at the first end region 125, the second end region 127, or other intermediate positions within the chamber 104) can be drawn into the inlet 110 through the catheter 108 and withdrawn from the fluid collection device 100.

[0056] In one embodiment, the conduit 108 is configured to be insertable at least into the chamber 104. In such an embodiment, the exterior of the conduit 108 may include one or more markers configured to facilitate insertion of the conduit 108 into the chamber 104. For example, the conduit 108 may include one or more markers configured to prevent over-insertion or under-insertion of the conduit 108, such as when the conduit 108 defines an inlet 110 configured to be disposed in or adjacent to the reservoir 122. In another embodiment, the conduit 108 may include one or more markers configured to facilitate proper rotation of the conduit 108 relative to the chamber 104. In one embodiment, the one or more markers may include lines, dots, stickers, or any other suitable markers. In an example, the conduit 108 may extend from a first end region (e.g., near the outlet 112) into the fluid-impermeable barrier 102 and may extend to a second end region (e.g., opposite the first end region) to a point near the reservoir 122 such that the inlet 110 is in fluid communication with the reservoir 122. In some embodiments (not shown), the conduit 108 may enter the second end region and the inlet 110 may be disposed in the second end region (e.g., in the reservoir 122). Fluid collected in the fluid collection device 100 may be removed through the conduit 108 from the interior region of the chamber 104. The conduit 108 may include a flexible material, such as the plastic tubing (e.g., medical tubing) disclosed herein. In some examples, the conduit 108 may include one or more resilient portions, such as by having one or more of a diameter or wall thickness that allows the conduit to be flexible.

[0057] In one embodiment, one or more components of the fluid collection device 100 may include an antimicrobial material, such as an antibacterial material with which the fluid collection device may come into contact with the wearer or the wearer's body fluids. The antimicrobial material may include an antimicrobial coating, such as a nitrofurazone or silver coating. The antimicrobial material may inhibit microbial growth, such as microbial growth resulting from pooling or stagnation of fluid. In one embodiment, one or more components of the fluid collection device 100 (e.g., the impermeable barrier 102, the conduit 108, etc.) may include an odor-blocking or absorbing material, such as a material containing cyclodextrin or a TPE polymer.

[0058] In any of the embodiments disclosed herein, the conduit 108 may include or be operatively coupled to: a flow meter (not shown) to measure the flow rate of the fluid therein; one or more securing devices (e.g., a StatLock securing device, not shown) or fittings to secure the conduit 108 to one or more components of the systems or devices disclosed herein (e.g., a portable vacuum source or a fluid storage container); or one or more valves to control the flow of fluid in the systems and devices herein.

[0059] In one embodiment, at least a portion of the conduit 108 of the fluid collection device or system herein may be formed of at least partially opaque material that may obscure the fluid present therein. For example, a first portion of the conduit 108 disclosed herein may be formed of opaque or translucent material, while a second portion may be formed of transparent or translucent material. In some embodiments, the first portion may include transparent or translucent material. Different from opaque or nearly opaque materials, translucent materials allow users of the devices and systems herein to visually identify the fluid or identify problems that impede the flow of fluid within the conduit 108.

[0060] In any example of the systems or devices disclosed herein, the system of the fluid collection device may include a moisture sensor (not shown) disposed inside the chamber of the fluid collection device. In such an example, the moisture sensor may be operably coupled to a controller or directly coupled to a portable vacuum source, and may provide an electrical signal indicative of the detection or non-detection of moisture in one or more portions of the chamber. The moisture sensor may provide an indication of the presence of moisture, and in response thereto, the controller or the portable vacuum device may directly initiate suction to the chamber to remove fluid from the chamber. Suitable moisture sensors may include capacitive sensors, volumetric sensors, potentiometric sensors, resistive sensors, frequency domain reflectometer sensors, time domain reflectometer sensors, or any other suitable moisture sensors. In practice, the moisture sensor may detect moisture in the chamber and may provide a signal to the controller or the portable vacuum source to activate the portable suction device.

[0061] Figure 4 is a cross-sectional view of the fluid-impermeable barrier 102 of the fluid collection device 100 taken along line 3-3, where the fluid-permeable body 120 and the conduit 108 are removed. Figure 1 Figure 4 Shows a chamber 104 at least partially defined by the inner surface 103 of the fluid-impermeable barrier 102 and a hole 124 defined by a protrusion 125. In some embodiments, the fluid-impermeable barrier 102 does not include a protrusion 127, or the protrusion 127 is absent, and the hole 124 may be defined by a first lateral side 140a or another portion of the fluid-impermeable barrier 102.

[0062] Figure 5 ​FIG. 500 is a flow chart of a method 500 for assembling a fluid collection device and / or fluid collection system disclosed herein according to one embodiment. Method 500 may include an action 505 that recites providing a fluid-impermeable barrier. The fluid-impermeable barrier may include any of the fluid-impermeable barriers described herein, such as fluid-impermeable barrier 102. The fluid-impermeable barrier at least partially defines a chamber and an opening extending through the chamber. The opening is configured to be positioned adjacent to the female urethra, adjacent to the skin above the female urethra, adjacent to the skin above the penis of a male having an embedded penis, or above a wound.

[0063] The method may include an action 510 that recites inserting a fluid-permeable body into the chamber of the fluid-impermeable barrier. The fluid-permeable body may include any of the fluid-permeable bodies described herein, such as fluid-permeable body 120. When the fluid-permeable body is inserted into the chamber of the fluid-impermeable barrier, the fluid-permeable body engages at least a portion of the fluid-impermeable barrier and covers at least a portion of the opening. The fluid-permeable body is configured to wick any fluid away from the opening. In some embodiments, action 510 may include inserting or positioning the fluid-permeable body in the chamber of the fluid-impermeable barrier such that a reservoir is defined within the chamber by a protrusion of the fluid-permeable body located distal to the aperture. In some embodiments, action 510 may include inserting or positioning the fluid-permeable body and a catheter in fluid communication with the following reservoir into the chamber defined by the fluid-impermeable barrier: the reservoir is located in a protrusion of the fluid-impermeable barrier and is at least partially defined by a protrusion of the fluid-impermeable barrier located distal to the aperture. In some embodiments, action 510 may include inserting or positioning the fluid-permeable body in the chamber of the fluid-impermeable barrier such that the fluid-permeable body, the catheter, and the reservoir substantially fill the entire chamber.

[0064] The method may include an action 515 that recites inserting an inlet of a catheter into the fluid-permeable body. The catheter may be inserted into the fluid-permeable body through an aperture defined by the fluid-impermeable barrier at a protrusion of the fluid-impermeable barrier.

[0065] The method may include act 520, which recites inserting at least a portion of a catheter, such as an inlet of the catheter, at least partially into a slot that longitudinally extends through a fluid-permeable body. The slot at least partially extends through the fluid-permeable body and is defined by the fluid-permeable body. The catheter engages at least a portion of the fluid-permeable body. In some embodiments, inserting the catheter into the slot of the fluid-permeable body includes inserting the catheter into a T-shaped slot that longitudinally extends through the fluid-permeable body such that one or more lids of the fluid-permeable body at least partially cover the slot and wrap the catheter within the fluid-permeable body. The fluid-permeable body may be squeezed to open the T-shaped slot between two lids of the fluid-permeable body to allow insertion of the catheter.

[0066] Acts 505, 510, 515, and 520 of method 500 are for illustrative purposes. For example, acts 505, 510, 515, and 520 of method 500 may be performed in a different order, divided into multiple acts, modified, supplemented, or combined. For example, in some embodiments, act 510 is before acts 515 and 520, while in other embodiments, acts 515 and 520 are before act 510. In one embodiment, one or more of acts 505, 510, 515, and 520 of method 500 may be omitted from method 500. Any one of acts 505, 510, 515, and 520 may include using any fluid collection device or system disclosed herein.

[0067] Figure 6is a flowchart of a method 600 for collecting fluid. In a specific example, method 600 includes a method for collecting fluid from a user with an embedded penis. Method 600 includes an action 605 of positioning a fluid collection device on the user's body. Action 605 may include positioning the opening of the fluid collection device above the user's embedded penis, where the opening is defined by a fluid-impermeable barrier and includes a longitudinal length of at least about 4 cm and a transverse width that is substantially equal to or greater than the longitudinal length. In some embodiments, action 605 may include positioning the opening of the fluid collection device above or adjacent to the user's female urethra, positioning the opening of the fluid collection device above the skin above the female urethra or adjacent to the skin above the female urethra, or positioning the opening of the fluid collection device above a wound. The fluid-impermeable barrier may include any of the fluid-impermeable barriers described herein, such as fluid-impermeable barrier 102. In some embodiments, positioning the opening of the fluid collection device above the user's embedded penis includes positioning the fluid-permeable body of the fluid collection device adjacent to the skin above the embedded penis. The fluid-permeable body is disposed within the chamber of the fluid-impermeable barrier of the fluid collection device and is exposed to the user's body through the opening defined by the fluid-impermeable barrier in the fluid collection device.

[0068] Method 600 further includes an action 610 of securing the fluid collection device to the user. Method 600 further includes an action 615 of receiving fluid from the user into the chamber of the fluid collection device. Action 615 may include receiving the fluid into a reservoir that is positioned within and at least partially defined by a distal protrusion of the fluid-impermeable barrier. In some embodiments, method 600 includes an action of applying suction to effectively draw fluid from the chamber through a conduit disposed within the chamber.

[0069] Actions 605, 610, and 615 of method 600 are for illustrative purposes. For example, actions 605, 610, and 615 of method 600 may be performed in a different order, divided into multiple actions, modified, supplemented, or combined. In one embodiment, one or more of actions 605, 610, and 615 of method 600 may be omitted from method 600. Any of actions 605, 610, and 615 may include using any of the fluid collection devices or systems disclosed herein.

[0070] Figure 7FIG. 0 is a block diagram of a system 10 for fluid collection according to one embodiment. The system 10 includes a fluid collection device 12, a fluid storage container 14, and a portable vacuum source 16. The fluid collection device 12 may include any fluid collection device described herein, such as the fluid collection device 100. The fluid collection device 12, the fluid storage container 14, and the portable vacuum source 16 may be fluidly coupled to each other through one or more conduits 17. The conduit 17 may include any conduit described herein, such as the conduit 108. The fluid collection device 12 may be operably coupled to one or more of the fluid storage container 14 or the portable vacuum source through the conduit 17. The fluid (e.g., urine or other body fluid) collected in the fluid collection device 12 may be removed from the fluid collection device 12 through a conduit 17 that extends into the interior region of the fluid collection device 12. For example, a first open end of the conduit 17 may extend into the fluid collection device 12 to a reservoir therein. A second open end of the conduit 17 may extend into the fluid collection device 12 or the portable vacuum source 16. In response to a suction (e.g., vacuum) force applied to the second end of the conduit 17, the suction force may be introduced into the interior region of the fluid collection device 12 through the first open end of the conduit 17. The suction force may be directly or indirectly applied by the portable vacuum source 16 to the second open end of the conduit 17.

[0071] The suction force may be indirectly applied through the fluid storage container 14. For example, the second open end of the conduit 17 may be disposed within the fluid storage container 14, and an additional conduit 17 may extend from the fluid storage container 14 to the portable vacuum source 16. Thus, the portable vacuum source 16 may apply suction to the fluid collection device 12 through the fluid storage container 14. The suction force may be directly applied through the fluid storage container 14. For example, the second open end of the conduit 17 may be disposed within the portable vacuum source 16. An additional conduit 17 may extend from the portable vacuum source 16 to a point external to the fluid collection device 12, such as to the fluid storage container 14. In such an example, the portable vacuum source 16 may be disposed between the fluid collection device 12 and the fluid storage container 14.

[0072] The shape and size of the fluid collection device 12 can be designed to be positioned adjacent to the female urethra or on the skin above the buried penis of a male. The fluid collection member of the fluid collection device 12 can include a fluid-impermeable barrier that at least partially defines a chamber (e.g., the interior region of the fluid collection device member) of the fluid collection device 12. As described in more detail above, the fluid collection device 12 can include an opening that is wider than common fluid collection devices. The fluid-impermeable barrier also defines an opening that extends therethrough from the external environment. The opening can be positioned on the fluid collection member to be aligned adjacent to the female urethra or aligned above the buried penis of a male. The fluid collection member of the fluid collection device 12 can include a fluid-permeable body disposed within the fluid-impermeable barrier. The fluid-permeable body can include a fluid-permeable membrane and a fluid-permeable support disposed within the fluid-permeable membrane. The conduit 17 can extend into the fluid collection device 12 at a first end region, through one or more of the fluid-impermeable barrier, the fluid-permeable membrane, or the fluid-permeable support, to a second end region of the fluid collection member of the fluid collection device 12. Example fluid collection devices for use with the systems and methods herein are described in more detail below.

[0073] In some embodiments, the fluid storage container 14 can include a bag (e.g., a drainage bag), a bottle, or a cup (e.g., a collection jar), or any other enclosed container for storing body fluids such as urine. In an example, the conduit 17 can 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 can be attached to the fluid storage container 14 at a second point thereon, and can extend and be attached to the portable vacuum source 16. For example, the fluid storage container 14 can include a container fluidly coupled to a first conduit portion that is also fluidly coupled to the fluid collection member of the fluid collection device 12. The container can be fluidly coupled to a second portion of the conduit 17 that is also fluidly connected to the portable vacuum source. In such an example, the portable vacuum source 16 can provide a vacuum / suction through the container to the fluid collection member to provide suction in the chamber of the fluid collection member. Thus, a vacuum (e.g., suction) can be introduced through the fluid collection device 12 via the fluid storage container 14. When the fluid is discharged from the chamber, the fluid can travel through the first portion of the conduit to the fluid storage container where the fluid can be retained. The portable vacuum source 16 can be used to discharge fluid such as urine from the fluid collection device 12.

[0074] In some embodiments, the portable vacuum source 16 may be disposed in or on the fluid collection device 12. In such an example, the 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) may be introduced through the fluid collection device 12 via the fluid storage container 14.

[0075] The 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 positive displacement pump, a magnetic drive pump, a peristaltic pump, or any pump configured to generate a vacuum. The portable vacuum source 16 may provide a vacuum or suction to remove fluid from the fluid collection member of the fluid collection device 12. In some embodiments, the portable vacuum source 16 may be powered by one or more of a power cord (e.g., connected to a power outlet), one or more batteries, or even manual power (e.g., a manual vacuum pump). In an example, the size and shape of the portable vacuum source 16 may be designed to fit outside, on, or within the fluid collection device 12. For example, the portable vacuum source 16 may include one or more small pumps or one or more micropumps. The portable vacuum source 16 disclosed herein may include one or more of a switch, a button, a plug, a remote control, or any other device suitable for activating the portable vacuum source 16. It should be understood that the portable vacuum source 16 disclosed herein may provide a portable device for providing suction or a vacuum to allow the use of the devices and systems herein in environments where vacuum line access to a patient's room or a larger (e.g., larger or heavier than easily portable by a patient) vacuum source is located outside of a care facility or hospital. For example, the portable vacuum source may be small and light enough to be carried by a user (e.g., a patient) or an assisting person (e.g., a nurse) during transport of the user.

[0076] As used herein, the terms "about" or "substantially" refer to a ±10% or ±5% allowable deviation of the term modified by "about" or "substantially". Additionally, the terms "less than", "or less", "greater than", "more than", or "or more" include the value modified by the terms "less than", "or less", "greater than", "more than", or "or more" as an endpoint.

[0077] Although 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.

Claims

1. A fluid collection device, comprising: A fluid-impermeable barrier that at least partially defines a chamber, a hole, and an opening, the hole being configured to receive a catheter therethrough; and A fluid-permeable body having a first surface and a second surface opposite the first surface, the fluid-permeable body being at least partially positioned within the chamber such that the first surface extends through at least a portion of the opening and is configured to wick fluid away from the opening, and the second surface being positioned generally opposite the opening, the fluid-permeable body including a slot that extends longitudinally through the fluid-permeable body and is configured to at least partially receive the catheter therein, the slot extending inwardly from at least a portion of the second surface of the fluid-permeable body into the fluid-permeable body to a predetermined depth within the fluid-permeable body, wherein the opening includes a longitudinal length of at least about 4 cm and a transverse width that is substantially equal to or greater than the longitudinal length, and the hole is positioned on an axis that is generally centered on the transverse width of the opening.

2. The fluid collection device according to claim 1, wherein, The transverse width is greater than the longitudinal length.

3. The fluid collection device according to claim 1, wherein, The transverse width is at least 1.5 times the longitudinal length.

4. The fluid collection device according to claim 1, wherein, The transverse width is from about 5 cm to about 7.5 cm.

5. The fluid collection device according to any one of claims 1 to 4, further comprising a reservoir, the reservoir being at least partially defined by the fluid-permeable body and the fluid-impermeable barrier, the reservoir being positioned at a distal end of the hole.

6. The fluid collection device according to claim 5, wherein, The reservoir is aligned on the axis that is generally centered on the transverse width of the opening.

7. The fluid collection device according to claim 5, wherein, The fluid-impermeable barrier includes: A first transverse side that defines the hole; A second transverse side that is distal to the first transverse side; and A protrusion that extends from the second transverse side, the reservoir being positioned within the protrusion.

8. The fluid collection device according to claim 7, wherein, The fluid-impermeable barrier includes two longitudinal sides that extend between the first transverse side and the second transverse side, and wherein the opening is generally rectangular.

9. The fluid collection device according to claim 5, further comprising a conduit, the conduit including an inlet and an outlet, wherein, At least a portion of the catheter extends through the hole and is positioned within the slot of the fluid-permeable body to locate the inlet in fluid communication with the reservoir.

10. The fluid collection device according to any one of claims 1 to 4, wherein, The slot is generally T-shaped or L-shaped, and the fluid-permeable body includes one or more covers that cover at least a portion of the slot.

11. A fluid collection device, comprising: A fluid-impermeable barrier having a first transverse side, a second transverse side, and a protrusion, the first transverse side defining a hole configured to receive a catheter therethrough, the second transverse side being distal to the first transverse side and having a generally planar profile, the protrusion extending from the generally planar profile of the second transverse side, the fluid-impermeable barrier further defining a chamber and an opening; and A fluid-permeable body that is at least partially positioned within the chamber to extend through at least a portion of the opening and at least partially define a reservoir with the fluid-impermeable barrier, the reservoir being positioned within the protrusion of the fluid-impermeable barrier, the fluid-permeable body being configured to wick fluid away from the opening to the reservoir, wherein the opening includes a transverse width and a longitudinal length, and the hole and the protrusion are positioned on an axis that is generally centered on the transverse width of the opening, and Wherein, the longitudinal length is at least about 4 cm, and the transverse width is substantially equal to or greater than the longitudinal length.

12. The fluid collection device according to claim 11, wherein, The transverse width is from about 5 cm to about 7.5 cm.

13. The fluid collection device according to claim 11, wherein, The transverse width is at least 1.5 times the longitudinal length.

14. The fluid collection device according to claim 11, wherein, The fluid-impermeable barrier includes two longitudinal sides extending between the first transverse side and the second transverse side; and The opening is generally rectangular.

15. The fluid collection device according to any one of claims 11 to 14 further comprises a conduit, the conduit comprising an inlet and an outlet, wherein, At least a portion of the catheter extends through the hole and the fluid-permeable body to position the inlet in fluid communication with the reservoir.

16. The fluid collection device according to claim 15, wherein, The fluid-permeable body includes two or fewer material layers positioned between the catheter and the opening.

17. The fluid collection device according to claim 15, wherein, The fluid-permeable body includes a slot, and at least a portion of the catheter is positioned within the slot.

18. The fluid collection device according to claim 17, wherein, The fluid-permeable body includes one or more covers that cover at least a portion of the slot when at least a portion of the catheter is positioned within the slot.

19. The fluid collection device according to any one of claims 11 to 14, wherein, The fluid-permeable body includes a slot sized to at least partially receive the catheter therein.

20. The fluid collection device according to claim 19, wherein, The fluid-permeable body includes one or more covers that at least partially cover the slot.

21. A fluid collection device comprising: A fluid-impermeable barrier having a first transverse side and a second transverse side, the first transverse side defining a hole configured to receive a catheter therethrough, the second transverse side being distal to the first transverse side, the fluid-impermeable barrier further defining a chamber and an opening, the opening including a longitudinal length of at least about 4 cm and a transverse width substantially equal to or greater than the longitudinal length; and A fluid-permeable body at least partially positioned within the chamber such that a generally planar portion of the fluid-permeable body extends through at least a portion of the opening and at least partially defines a reservoir with the fluid-impermeable barrier, the reservoir being positioned within a protrusion of the fluid-impermeable barrier, the fluid-permeable body being configured to wick fluid away from the opening to the reservoir.

22. The fluid collection device according to claim 21, wherein, The opening defined by the fluid-impermeable barrier includes a generally flat profile, and the fluid-impermeable barrier includes a protrusion extending from the second transverse side, the hole and the protrusion being positioned on an axis substantially centered on the transverse width of the opening.

23. The fluid collection device according to claim 21, wherein, The transverse width is from about 5 cm to about 7.5 cm.

24. The fluid collection device according to claim 21, wherein, The transverse width is at least 1.5 times the transverse width.

25. The fluid collection device according to claim 21, wherein, The fluid-impermeable barrier includes two longitudinal sides extending between the first transverse side and the second transverse side; and The opening is generally rectangular.

26. The fluid collection device according to any one of claims 21 to 25 further comprises a conduit, the conduit comprising an inlet and an outlet, wherein, At least a portion of the catheter extends through the hole and the fluid-permeable body to position the inlet in fluid communication with the reservoir.

27. The fluid collection device according to claim 26, wherein, The fluid-permeable body includes two or fewer material layers positioned between the catheter and the opening.

28. The fluid collection device according to claim 26, wherein, The fluid-permeable body includes a first surface extending through the opening, a second surface opposite the first surface and the opening, and a slot that extends longitudinally through the fluid-permeable body and extends inward from at least a portion of the second surface of the fluid-permeable body into the fluid-permeable body to a predetermined depth within the fluid-permeable body, wherein the conduit is at least partially positioned within the slot.

29. The fluid collection device according to claim 28, wherein, The fluid-permeable body includes one or more covers that cover at least a portion of the slot when the conduit is at least partially positioned within the slot.

30. A method of collecting fluid from a user having an embedded penis, the method comprising: Position the opening of the fluid collection device above the user's buried penis, the opening being defined by a fluid-impermeable barrier and including a longitudinal length of at least about 4 cm and a transverse width that is substantially equal to or greater than the longitudinal length; and Receive the fluid discharged from the user's buried penis into the chamber of the fluid collection device defined by the fluid-impermeable barrier.

31. The method according to claim 30, wherein, Positioning the opening of the fluid collection device above the user's buried penis includes positioning the fluid-permeable body of the fluid collection device adjacent to the skin above the buried penis, the fluid-permeable body being disposed within the chamber and exposed to the user's skin through the opening of the fluid collection device.

32. The method according to claim 30, wherein, Receiving the fluid discharged from the user's buried penis into the chamber of the fluid collection device defined by the fluid-impermeable barrier includes receiving the fluid into a reservoir that is positioned within a protrusion of the fluid-impermeable barrier and is at least partially defined by the protrusion of the fluid-impermeable barrier.

33. The method according to any one of claims 30 to 32, further comprising applying suction to effectively aspirate the fluid from the chamber through a catheter disposed in the chamber.

34. A method of assembling a fluid collection system, the method comprising: Insert a conduit through a hole in the fluid-impermeable barrier of the fluid collection device; Insert the conduit into a slot that extends longitudinally through the fluid-permeable body, the slot extending inward from at least a portion of the second surface into the fluid-permeable body to a predetermined depth within the fluid-permeable body and being configured to at least partially receive the conduit therein; and Position the fluid-permeable body within the chamber defined by the fluid-impermeable barrier such that a first surface of the fluid-permeable body opposite the second surface of the fluid-permeable body extends through at least a portion of the opening in the fluid-impermeable barrier, wherein the opening includes a longitudinal length of at least about 4 cm and a transverse width that is substantially equal to or greater than the longitudinal length, and the hole is positioned on an axis that is substantially centered on the transverse width of the opening.

35. The method according to claim 34, wherein, Inserting the conduit into the slot that extends longitudinally through the fluid-permeable body includes inserting the conduit into a T-shaped slot that extends longitudinally through the fluid-permeable body such that one or more covers of the fluid-permeable body at least partially cover the slot and wrap the conduit within the fluid-permeable body.

36. The method according to claim 34 or 35, wherein, Positioning the fluid-permeable body in a chamber defined by the fluid-impermeable barrier includes positioning the fluid-permeable body together with the conduit in fluid communication with the reservoir in the chamber defined by the fluid-impermeable barrier, the reservoir being positioned in a protrusion of the fluid-impermeable barrier distal to the aperture and at least partially defined by the protrusion of the fluid-impermeable barrier distal to the aperture.

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