Male fluid collection assemblies and methods of manufacturing

Abstract

An example fluid collection assembly includes a sheath and a base. The sheath includes a fluid impermeable barrier including a proximal region and a distal region extending from the proximal region, the proximal region defining an opening and the distal region defining a fluid outlet. The fluid impermeable barrier at least defines an outlet. The fluid impermeable barrier includes a first panel and a second panel sealed to the first panel along a perimeter of the first and second panels. A portion of the perimeter includes a seal configured to releaseably seal the perimeter of the first and second panels. The sheath also includes at least one porous material disposed in the chamber. The base is configured to be secured to the proximal region of the sheath. The base is configured to be attached to skin surrounding a penis the base defining an aperture that corresponds to the opening of the sheath.

Description

MALE FLUID COLLECTION ASSEMBLIES AND METHODS OF MANUFACTURINGBACKGROUND

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

[0002] Urinary catheters, such as a Foley catheter, can be used to address some of these circumstances, such as incontinence. Unfortunately, urinary catheters can be uncomfortable, painful, and can lead to complications, such as infections. Additionally, bed pans, which are receptacles used for the toileting of bedridden patients, such as those in a health care facility, are sometimes used. Bed pans, however, can be prone to discomfort, spills, and other hygiene issues.

[0003] Males who suffer the most severe consequences of urinary incontinence, such as discomfort, rashes, and sores are typically elderly and often bedbound. They also require continuous assistance to maintain hygiene. Characteristics often found in these patients: they typically lay on their back, the size of the penis often decreases with age, skin rolls containing fat tissue cause the penis to recede, often pointing upward while in a laying position, patients have difficulty reaching the penis and manipulating devices. A urine capture device should be designed with reference to these characteristics.

[0004] Thus, there is a need for an improved device capable of collecting urine from a male.SUMMARY

[0005] Embodiments disclosed herein are directed to male fluid collection assemblies, systems including the same, and methods of using the same. In an embodiment, a fluid collection assembly is disclosed. The fluid collection assembly includes a sheath. The sheath includes at least one fluid impermeable barrier including a proximal region and a distal region extending from the proximal region, the proximal region defining a first opening and the distal region defining a fluid outlet, the fluid impermeable barrier at least defining a chamber. The fluid impermeable barrier including a first panel and a second panel sealed to the first panel along a perimeter of the first and second panels. A portion ofthe perimeter can include a seal configured to releasably seal the perimeter of the first and second panels. The sheath also includes at least one porous material disposed in the chamber. The fluid collection assembly also includes a base configured to be secured to the proximal region of the sheath, the base configured to be attached to skin surrounding a penis, the base defining an aperture that corresponds to the opening of the sheath.

[0006] In some embodiments, a fluid collection assembly can include a sheath. The sheath can include a fluid impermeable barrier having a proximal region and a distal region extending from the proximal region, the proximal region defining an opening and the distal region defining a fluid outlet, the fluid impermeable barrier at least defining a chamber. In some examples, at least one porous material can be disposed in the chamber, the porous material including a flexible sheet having a proximal edge and a distal edge, the proximal edge secured to the proximal region of the fluid impermeable barrier and the distal edge movable between an extended and a retracted position. The fluid collection assembly also includes an actuator connected to the distal edge of the flexible sheet, the actuator configured to move the porous material between the extended position and the retracted position. The fluid collection assembly also includes a base secured to or configured to be secured to the proximal region of the sheath, the base configured to be attached to skin surrounding a penis, the base defining an aperture that corresponds to the opening of the sheath.

[0007] In some embodiments, a method of using a system to collect bodily fluids from an individual can include attaching a base of a fluid collection device to skin surrounding a penis, the base secured to or configured to be secured to a sheath, the base defining an aperture that corresponds to the opening of the sheath. The sheath can include a fluid impermeable barrier having a proximal region and a distal region extending from the proximal region, the proximal region defining an opening and the distal region defining a fluid outlet, the fluid impermeable barrier at least defining a chamber. At least one porous material can be disposed in the chamber, the porous material including a flexible sheet having a proximal edge and a distal edge, the proximal edge secured to the proximal region of the fluid impermeable barrier and the distal edge movable between an extended and a retracted position. The method can also include receiving fluid discharged from the user in the fluid collection device and receiving fluid discharged from the fluid collection device in a fluid collection container.BRIEF DESCRIPTION OF THE DRAWINGS

[0008] The drawings illustrate several embodiments of the present disclosure, whereinidentical reference numerals refer to identical or similar elements or features in different views or embodiments shown in the drawings.

[0009] FIGS. 1 and 2 are top and bottom isometric views, respectively, of a fluid collection assembly, according to an embodiment.

[0010] FIG. 3A-3C are cross-sectional schematics of the fluid collection assembly, according to an embodiment.

[0011] FIG. 4 is an isometric view of a fluid collection assembly with a seal opened along a perimeter of a first and second panel, according to an embodiment.

[0012] FIGS. 5A and SB are isometric view of a fluid collection assembly with a porous material including a flexible sheet movable between an extended and a retracted position, according to an embodiment.

[0013] FIG. 6 is a block diagram of a system for fluid collection, according to an embodiment.

[0014] FIG. 7 is a flow diagram of a method to collect fluid, according to an embodiment.DETAILED DESCRIPTION

[0015] Embodiments disclosed herein are directed to male fluid collection assemblies, systems including the same, methods of manufacturing the same, and methods of using the same. An example fluid collection assembly includes a sheath and a base. The sheath includes a fluid impermeable barrier formed from at least a first panel and a second panel connected together. The fluid impermeable barrier includes a proximal region and a distal region extending from the proximal region. The proximal region defines an opening and the distal region defines a fluid outlet. The first panel and the second panel define a chamber therebetween. The first panel and the second panel are sealed along a perimeter of the first and second panels. A portion of the perimeter includes a grip seal. The sheath also includes at least one porous material disposed in the chamber. The base may be configured to be secured to the proximal region of the sheath. The base defines an aperture that corresponds to the opening of the sheath. The base is configured to be attached to skin surrounding a penis of an individual with the penis extending thought the opening and into the chamber. As such, the chamber of the sheath may be configured to receive bodily fluids (<?.g., urine, semen, sweat, etc.) from penis.An example method of using the fluid collection assembly includes attaching the base to skin surrounding a penis of an individual. The base is positioned on the individual such that the penis extends through the aperture defined by the base. The base can besecured or be configured to be secured to the sheath. In some examples, the sheath may also be permanently attached to the base. For example, the sheath may be permanently attached to the base before, during, or after securing the base to the region about the penis. After the base is secured to the region about the penis and the sheath is attached to the base, the individual may discharge bodily fluids from the penis. In some examples, the fluid collection assembly includes at least one porous material disposed in the chamber. The porous material can include a flexible sheet having a proximal edge and a distal edge, the proximal edge secured to the proximal region of the fluid impermeable barrier and the distal edge movable between an extended and a retracted position. The bodily fluids enter the chamber of the sheath and the method includes receiving fluid discharged from the user in the fluid collection device. Skin checks can be conducted in the individual or user by either separating the base from the sheath or withdrawing an actuator coupled to the distal edge of the porous material. The actuator can include a rod. When the rod is withdrawn, the genitals of the individual show through the fluid impermeable barrier. The rod can then be returned and the porous material restored to the extended position. The porous material may receive at least some of the bodily fluids that enter the chamber and direct the bodily fluids towards the outlet. The method may receiving fluid discharged from the user in the fluid collection device and receiving fluid discharged from the fluid collection device in a fluid collection container, for instance, when a suction force is applied to the outlet via a vacuum source by using a pump to pull a vacuum through a conduit in fluid communication with the fluid outlet of the fluid collection device effective to draw fluid from the fluid collection device and into the fluid collection container.

[0016] FIGS. 1 and 2 are isometric top and bottom views, respectively, of a fluid collection assembly 100, according to an embodiment. The fluid collection assembly 100 includes a sheath 102 and a base 104. The sheath 102 includes a fluid impermeable barrier 106 that is at least partially formed from a first panel 108 attached to a second panel 110. The fluid impermeable barrier 106 also defines a chamber 112 between the first panel 108 and the second panel, an opening 114 at a proximal end region 116 of the sheath 102, and an outlet 118 at a distal end region 120 of the sheath 102. In other words, the fluid impermeable barrier 106 includes a proximal region 116 and a distal region 120 extending from the proximal region 116, the proximal region 116 defining the opening 114 and the distal region 120 defining the fluid outlet 118. The sheath 102 also includes at least one porous material 122 disposed in the chamber 112. The base 104 includes an aperture 124. The base 104 is configured to be attached and / or secured to the proximal end region 116 ofthe sheath 102 such that the aperture 124 of the base 104 is aligned with the opening 114 of the sheath 102. In some examples, the sheath 102 can be detached from the base 104 without damaging at least one of the sheath 102 or the base 104, so that skin checks can be performed. The sheath can include a port attached to the fluid outlet 118, the port including a first part defining an inlet and a second part defining an outlet, the second part configured to be attached to a conduit 146, as described in greater detail below.

[0017] FIG. 2 shows that the second panel 110 defines the entirety of the opening 114. For example, the opening 114 is a cutout defined by the second panel 110 that is spaced from the perimeter of the second panel 110. In such an example, the second panel 110 may exhibit a shape that substantially corresponds to the shape of the first panel 108 which may facilitate attaching the first panel 108 to the second panel 110 along the outer edges thereof. It also allows the first panel 108 and the second panel 110 to lie substantially flat when the penis is not in the chamber 112 which may make wearing the fluid collection assembly 100 more discrete and inhibit pooling of bodily fluids against the individual.

[0018] Referring to FIGS. 3A-3C, the inner surfaces 126 of the fluid impermeable barrier 106 (e.g., inner surfaces of the first and second panels 108, 110) at least partially defines the chamber 112 within the fluid collection assembly 100. The fluid impermeable barrier 106 temporarily stores the bodily fluids in the chamber 112. The fluid impermeable barrier 106 may be formed of any suitable fluid impermeable material(s), such as a fluid impermeable polymer (e.g., silicone, polypropylene, polyethylene, polyethylene terephthalate, a polycarbonate, etc.), another suitable material, or combinations thereof. As such, the fluid impermeable barrier 106 substantially prevents the bodily fluids from passing through the fluid impermeable barrier 106. In an example, the fluid impermeable barrier 106 may be air permeable and fluid impermeable thus preventing leaks while allowing air flow through the chamber 112 when a suction force is applied thereto (i.e. , the chamber 112 remains at about atmospheric pressure thereby preventing the suction force from causing suction damage to the skin or kinking the conduit). In such an example, the fluid impermeable barrier 106 may be formed of a hydrophobic material that defines a plurality of pores. Alternatively or additionally, the fluid impermeable barrier 106 may include at least one perforation (e.g., vacuum relief hole) that allows the chamber 112 to remain substantially at atmospheric pressure. At least one or more portions of at least an outer surface 130 of the fluid impermeable barrier 106 may be formed from a soft and / or smooth material, thereby reducing chaffing.

[0019] In an embodiment, at least one of the first panel 108 or the second panel 110 is formed from an at least partially transparent fluid impermeable material, such as polyethylene, polypropylene, or polycarbonate. In some examples, the fluid impermeable barrier 106 may be formed from any suitable non-permeable material. For example, the fluid impermeable barrier 106 may be formed from polyurethane, polyethylene, polypropylene, other polymers, any other suitable impermeable materials, or combinations thereof. Forming at least one of the first panel 108 or the second panel 110 from an at least partially transparent fluid impermeable material allows a person (e.g. , medical practitioner) to examiner the penis and / or perform skin checks. In some embodiments, both the first panel 108 and the second panel 110 are formed from at least partially transparent fluid impermeable material. For example, some conventional fluid collection assemblies that include a sheath and a base may allow the sheath to be reversibly detached from the base after the base is secured to the region about the penis. Detaching the sheath from the base allows the person to examine the penis. In some examples, the sheath 102 can be permanently attached to the base 104 which substantially prevents leaks between the sheath 102 and the base 104 when the base 104 is appropriately attached to the sheath 102 (e.g., no wrinkles were allowed to form between the sheath 102 and base 104). However, to enable the skin checks, in some examples, the base 104 can be detached from the sheath 102.

[0020] FIG. 3B illustrates the base 104 disconnected from the sheath 102. In some examples, the base can be releasably attached to the proximal region 116 of the sheath 102. For example, the base 104 and the sheath 102 interface can include an interference fit. In other words, as a pressed fit or friction fit. The interference fit can be defined herein as a form of fastening between two tight-fitting and / or mating parts that produces a joint which is held together by friction after the parts are pushed together. In some examples, the sheath 102 and the base 104 can be twisted in a first direction (e.g., clockwise) to lock the components together, and twisted in a second direction (e.g., counter clockwise) to unlock the components for the skin checks or to replace the sheath 102 or the base 104 due to soiling or degradation. Referring back to FIG. 2, in some examples, the base 104 and the sheath 102 can include a fastener 128 configured to attach the base 104 and the sheath 102 and also align the aperture 124 with the opening 114.

[0021] The porous material 122 can be positioned to help maintain the dignity of the individual using the fluid collection assembly 100. For example, during use, the second panel 110 is generally adjacent to the individual, such as adjacent to the thighs and / orperineum. Thus, the second panel 110 is generally obscured during use and a person cannot view the penis without first lifting the sheath 102 away from the individual. Meanwhile, the first panel 108 may face away from the individual and be more easily viewable than the second panel 110. However, a person (e.g. , a passerby, a visitor, etc.) cannot view the penis through the first panel 108 because the porous material 122 is not transparent. Thus, in such an embodiment, the porous material 122 prevents person(s) from viewing the penis unless such examination is necessary, thereby preserving the dignity of the individual using the fluid collection assembly 100. The porous material 122 is positioned between the penis and at least a portion of the first panel 108. In such an embodiment, the caretaker needs to move the porous material 122 to view into the chamber 112.

[0022] In an embodiment, the porous material 122 is a wicking material configured to wick any bodily fluids away from the opening 114 thereby preventing the bodily fluids from escaping the chamber 112. Such “wicking” may not include absorption of fluid into the wicking material. Put another way, substantially no absorption of fluid into the material may take place after the material is exposed to the fluid and removed from the fluid for a time. While no absorption is desired, the term “substantially no absorption” may allow for nominal amounts of absorption of fluid into the wicking material (e.g., absorbency), such as less than about 10 wt% of the dry weight of the wicking material, less than about 7 wt%, less than about 5 wt%, less than about 3 wt%, less than about 2 wt%, less than about 1 wt%, or less than about 0.5 wt% of the dry weight of the wicking material. The wicking material may also wick the fluid generally towards an interior of the chamber 112, as discussed in more detail below. In an embodiment, the porous material 122 is configured to adsorb or absorb the bodily fluids. Similar, to the wicking material, such adsorbing or absorbing material may move bodily fluids away from the opening 114 thereby preventing the bodily fluids from escaping the chamber 112.

[0023] The porous material 122 may be formed from any suitable porous material. For example, the porous material 122 may be formed from nylon (e.g., spun nylon fibers), polyester, polyurethane, polyethylene, polypropylene, other porous polymers, hydrophobic foam, an open cell foam, wool, silk, linen, cotton (e.g., cotton gauze), felt, other fabrics, a coated porous material (e.g., a water repellent coated porous material), any other suitable porous materials, or combinations thereof. For example, the porous material 122 can include a spun nylon inner layer combined with a fabric gauze exterior layer that contacts the skin of the subject.

[0024] In an embodiment, the porous material 122 may be a sheet. Forming the porous material 122 as a sheet may facilitate the manufacturing of the fluid collection assembly 100. For example, forming the porous material 122 as a sheet allows the first panel 108, the second panel 110, and the porous material 122 to each be sheets. During the manufacturing of the fluid collection assembly 100, the first panel 108, the second panel 110, and the porous material 122 may be stacked and then attached to each other in the same manufacturing step. For instance, the porous material 122 may exhibit a shape that is the same size or, more preferably, slightly smaller than the size of the first panel 108 and the second panel 110. As such, attaching the first panel 108 and the second panel 110 together along the outer edges 134 thereof may also attach the porous material 122 to the first panel 108 and the second panel 110.

[0025] FIG. 4 is an isometric view of fluid collection assembly 100 with a seal 132 opened along a perimeter of a first panel 108 and second panel 110, according to an embodiment. As described above, the chamber 112 may include the at least one porous material 122 disposed between the first panel 108 and the second panel 110. The at least one porous material 122 can be generally not transparent and, thus, needs to be moved in order to conduct skin checks on the patient. As previously discussed, the first panel 108 and the second panel 110 are attached together. In an embodiment, as shown, the first and second panels 108, 110 are attached together along at least a portion of the outer edges 134 thereof. In such an embodiment, the first and second panels 108, 110 are attached using any suitable technique, such as with an adhesive, sewing, heat sealing, radio frequency (“RF”) welding, ultrasonic (“US”) welding, or any other technique.

[0026] In some examples, the opening 114 is a first opening and the seal 132 includes a two-part strip defining a second opening 133 that seals in an interference fit when the first panel 108 and second panel 110 are pressed together and opens when the first panel 108 and second panel 110 are pulled apart. In other words, a portion of the outer edges 134 of the first panel 108 and the second panel 110 are also attached by the seal 132. The seal 132 includes a sealing strip at outer perimeter of the first panel 108 and the second panel 110. When opening, the user and / or caretaker can use two hands to pinch both the first panel 108 and the second panel 110 and pull outward to open the sealing strip of the seal 132. In other words, the seal is configured to operate the same or similar as a ZIPLOCK® seal. This opening method is relatively simple and convenient. In some examples, the seal 132 can include a two-part strip defining an opening that seals in an interference fit when the first panel 108 and the second panel 110 are pressed together and opens when the first panel108 and second panel 110 are pulled apart. In other words, the first panel 108 includes a strip and the second panel 110 includes a strip that can be sealed to teach other in an interference fit. The two strips are attached or molded into the inner surface 126 of the first panel 108 and the second panel 110, respectively. Concave strips and convex ribs that seal with each other are provided on the opposite sides of the first panel 108 and the second panel 11 Op, and the concave strips and the convex ribs are arranged in pairs to provide a fluid impermeable seal 132. In other words, the seal can include grooves and ribs that interjoin when pressed together. As such, any fluid would have to pass through a mechanical interlock to have any leakage. The seal has a tight tolerance, and as such, no leakage through the seal is expected at ambient pressure when the grooves and ribs are pressed together.

[0027] Forming the fluid impermeable barrier 106 from the first panel 108 and the second panel 110 may improve the rate of manufacturing the fluid collection assembly 100, especially when the first panel 108 and the second panel 110 are attached together using the seal 132. In some examples, the perimeter of the first panel 108 and the second panel 110 can include a rectangular shape. The portion of the perimeter including the seal 132 can include at least two sides of the rectangular shape.

[0028] In some examples, the seal 132 can include an adhesive. The first panel 108 and the second panel 110 can include a resealable adhesive. The resealable adhesive may be more strongly attached to the second panel 110 than the first panel 108 such that the resealable adhesive is carried by the second panel 110 when the second panel 110 is separated from the first panel 108. A resealable adhesive includes an adhesive which allows two surfaces to adhere to one another and which also allows the surfaces to be separated non-destructively from one another and to re-adhere to one another. An example of a resealable adhesive is a Pressure Sensitive Adhesive (PSA), such as a peelable PSA, where an adhesive bond is achieved by applying pressure to the adhesive. The term “resealed” means that two surfaces can be refastened to one another. A degree of sealing may be achieved between the two surfaces when they are refastened to one another. In other words, at ambient pressures, the two surfaces can be held together by the adhesive and prevent or substantially eliminate the leakage of fluids.

[0029] FIG. 5A and SB are isometric view of the fluid collection assembly 100 with the porous material 122 including a flexible sheet movable between an extended and a retracted position, according to an embodiment. Selecting at least one of the first panel 108 or the second panel 110 to be formed from an at least partially transparent impermeablematerial allows the penis to be examined without detaching the entire fluid collection assembly 100 from the region about the penis or opening a portion of the fluid impermeable barrier 106. For example, the chamber 112 may include the at least one porous material 122 and at least a portion of the at least partially transparent material of the first panel 108 and / or the second panel 110. In other words, the porous material 122 is positioned in the chamber 112 and is generally not transparent and, thus, the portion of the at least partially transparent material of the first panel 108 and / or the second panel 110 that defines the chamber 112 forms a window which allows the person to view into the chamber 112 and examine the penis, when the porous material 122 is moved. The at least one porous material 122 exhibits a shape that generally corresponds to a shape of the first panel 108 and the second panel 110. As shown, the first panel 108 and the second panel 110 are rectangular and the porous material 122 is also rectangular.

[0030] In some examples, the porous material 122 can include a flexible sheet having a proximal edge 136 and a distal edge 138. The proximal edge 136 can be secured to the proximal region 116 of the fluid impermeable barrier and the distal edge 138 can be movable between an extended (as shown in FIG. 5A) and a retracted (as shown in FIG. 5B) position. Also, attaching the porous material 122 to the proximal region 1 16 may prevent the porous material 122 from significantly moving in the chamber 112, such as preventing the porous material 122 from bunching together near the outlet 118. In an example, the porous material 122 may be attached to the first panel 108 or the second panel 110 (e.g., via an adhesive), at the proximal region 116 before or after attaching the first panel 108 to the second panel 110.

[0031] In some examples, the fluid collection assembly 100 can further include an actuator 140 attached to the distal edge 138 or at least a distal region of the porous material 122. The actuator 140 can include a material having a stiffness that is sufficient to withdraw and restore the porous material 122 to the extended positon. The actuator 140 can be configured to move the porous material 122 between the extended position and the retracted position. In some examples, the actuator can include a rod. The actuator 140 can extend through a hole 142 in the fluid impermeable barrier 106. In some examples, the hole 142 can be disposed at least proximate to the proximal region 116 of the sheath 102. When the actuator 140 as a rod is withdrawn, the distal edge 138 of the porous material 122 is drawn toward the proximal edge 136. Generally the hole 142 can be located least proximate to the proximal region 116 of the sheath 102 to minimize any fluid exiting through the hole 142.By design of the fluid collection assembly 100, the fluid is configured to move toward the distal end of the assembly.

[0032] In some examples, the actuator 140 can include a grip 144 that can be held by the user and / or a caretaker to move the actuator 140. The grip 144 can also prevent the actuator 140 from passing completely through the hole 142. The hole 142 can also include a diameter only slightly larger than the diameter of the actuator 140 to minimize the likelihood of leakage. As the actuator 140 is withdrawn, the porous material 122 can bend and / or crease to expose the genitals to conduct the skin checks. The porous material 122 can include a flexible material that is resilient to damage from the creasing.

[0033] In some examples, the fluid collection assembly 100 with the porous material 122 including a flexible sheet movable between an extended and a retracted position also includes the seal 132 that can be opened along a perimeter of a first panel 108 and second panel 110. The first panel 108 includes a strip and the second panel 110 includes a strip that can be sealed to teach other in an interference fit. As such, the genitals of the user can be accessed in more than one manner. For example, the flexible sheet porous material 122 can be movable between an extended position and a retracted position with the actuator 140, the fluid impermeable barrier 106 can be opened through the seal to access the area, and / or the sheath 102 can be separated from the base 104 to access the area.

[0034] As discussed above, the fluid impermeable barrier 106 defines an outlet 118 sized to receive a conduit 146. Referring back to FIGS. 3A-3C, the conduit 146 may be at least partially disposed in the chamber 112 or otherwise in fluid communication with the chamber 112 through the outlet 118. The outlet 118 may be sized and shaped to form an at least substantially fluid tight seal against the conduit 146 thereby substantially preventing the bodily fluids from escaping the chamber 112, except through the conduit 146. In an embodiment, the outlet 118 may be formed from a portion of the first panel 108 and the second panel 110 that are not attached together. In such an embodiment, the fluid impermeable barrier 106 may not include a cap exhibiting a rigidity that is greater than the portions of the fluid impermeable barrier 106 thereabout which may facilitate manufacturing of the fluid collection assembly 100 may decreasing the number of parts that are used to form the fluid collection assembly 100 and may decrease the time required to manufacture the fluid collection assembly 100. The lack of the cap may make securing the conduit 146 to the outlet 118 using interference fit to be difficult though, it is noted, attaching the conduit 146 to the outlet 118 may still be possible. As such, the conduit 146 may be attached to the outlet 118 (e.g. , to the first and second panels 108, 110) using anadhesive, a weld, or otherwise bonding the outlet 118 to the outlet 118. Attaching the conduit 146 to the outlet 118 may prevent leaks and may prevent the conduit 146 from inadvertently becoming detached from the outlet 118. In an example, the conduit 146 may be attached to the outlet 118 in the same manufacturing step that attaches the first and second panels 108, 110 together.

[0035] The conduit 146 may include a flexible material such as plastic tubing (e.g., medical tubing). Such plastic tubing may include a thermoplastic elastomer, polyvinyl chloride, ethylene vinyl acetate, polytetrafluoroethylene, etc., tubing. In some examples, the conduit 146 may include silicon or latex. In some examples, the conduit 146 may include one or more portions that are resilient, such as to by having one or more of a diameter or wall thickness that allows the conduit to be flexible.

[0036] An inlet 148 of the conduit 146 may be located at or near the distal end region 120 of the sheath 102 which is expected to be the gravimetrically low point of the chamber 112 when worn by a user. Locating the inlet 148 at or near the distal end region 120 of the sheath 102 enables the conduit 146 to receive more of the bodily fluids than if the inlet 148 was located elsewhere and reduce the likelihood of pooling (e.g., pooling of the bodily fluids may cause microbe growth and foul odors). For instance, the bodily fluids in porous material 122 due to capillary forces. However, the bodily fluids may exhibit a preference to flow in the direction of gravity, especially when at least a portion of the porous material 122 is saturated with the bodily fluids. Accordingly, the inlet 148 may be located in the fluid collection assembly 100 in a position expected to be the gravimetrically low point in the fluid collection assembly 100 when worn by a user.

[0037] As previously discussed, the first panel 108, the second panel 110, and the porous material 122 may be selected to be relatively flexible. The first panel 108, the second panel 110, and the porous material 122 are relatively flexible when the first panel 108, the second panel 110, and the porous material 122, respectively, are unable to maintain their shape when unsupported. The flexibility of the first panel 108, the second panel 110, and the porous material 122 may allow the sheath 102 to be substantially flat. The flexibility of the first panel 108, the second panel 110, and the porous material 122 may also allow the sheath 102 to conform to the shape of the penis even when the size and shape of the penis changes e.g., becomes erect) and to minimize any unoccupied spaces in the chamber 112 in which bodily fluids may pool.

[0038] As previously discussed, the fluid collection assembly 100 includes a base 104 that is configured to be attached to the sheath 102. The base is configured to be attachedto the sheath 102 when, for example, when the fluid collection assembly 100 is provided with the base 104 permanently attached to the sheath 102 or the base 104 is provided without being permanently attached to the sheath 102 but removeably attached to be able to conduct skin checks and / or replace the sheath 102.

[0039] As previously discussed, the base 104 is sized, shaped, and made of a material to be coupled to the skin that surrounds the penis (e.g., mons pubis, thighs, testicles, and / or perineum) and have the penis disposed therethrough. For example, the base 104 may define an aperture 124 configured to have the penis positioned therethrough. In an example, the base 104 may exhibit the general shape or contours of the skin surface that the base 104 is configured to be coupled with. The base 104 may be flexible, thereby allowing the base 104 to conform to any shape of the skin surface and mitigate the base 104 pulling the on skin surface. The base 104 may extend laterally past the sheath 102 thereby increasing the surface area of the skin of the individual to which the fluid collection assembly 100 may be attached compared to a substantially similar fluid collection assembly 100 that did not include a base.

[0040] In an embodiment, the base 104 is at least partially transparent. In such an embodiment, a person (e.g., medical practitioner) may be able to examiner the skin surrounding the penis, such as to determine the health of the skin in the area surrounding the penis. Further, the person may be able to detect any gaps between the base 104 and the skin of the individual through which bodily fluids may leak. A person may be able to eliminate the gaps or replace the fluid collection assembly 100 after detecting the gaps to prevent leaks and prevent degradation of the skin caused by the skin being in contact with the bodily fluids.

[0041] As described in more detail below, the conduit 146 is configured to be coupled to, and at least partially extend between, one or more of the fluid storage container (not shown) and the vacuum source (not shown). In an example, the conduit 146 is configured to be directly connected to the vacuum source (not shown). The inlet 148 and an outlet of the conduit 146 are configured to fluidly couple e.g., directly or indirectly) the vacuum source (not shown) to the chamber 112. As the vacuum source (FIG. 6) applies a vacuum / suction in the conduit 146, the bodily fluids in the chamber 112 may be drawn into the inlet 148 and out of the fluid collection assembly 100 via the conduit 146. In some examples, the vacuum source may be remotely located from the fluid collection assembly 100. In such examples, the conduit 146 may be fluidly connected to a fluid storagecontainer, which may be disposed between the vacuum source and the fluid collection assembly 100.

[0042] During operation, a male using the fluid collection assembly 100 may discharge bodily fluids (e.g., urine) into the chamber 112. The bodily fluids may pool or otherwise be collected in the chamber 112 (e.g. , received into the porous material 122). At least some of the bodily fluids may be pulled through the interior of the conduit 146 via the inlet 148. The bodily fluids may be drawn out of the fluid collection assembly 100 via the vacuum / suction provided by the vacuum source.

[0043] FIG. 6 is a block diagram of a system 600 for fluid collection, according to an embodiment. The system 600 includes a fluid collection assembly 602, a fluid storage container 604, and a vacuum source 606. The fluid collection assembly 602, the fluid storage container 604, and the vacuum source 606 may be fluidly coupled to each other via one or more conduits 608. For example, fluid collection assembly 602 may be operably coupled to one or more of the fluid storage container 604 or the vacuum source 606 via the conduit 608. Bodily fluids (e.g., urine or other bodily fluids) collected in the fluid collection assembly 602 may be removed from the fluid collection assembly 602 via the conduit 608 which protrudes into the fluid collection assembly 602. Suction force may be introduced into the chamber of the fluid collection assembly 602 via the inlet of the conduit 608 responsive to suction (e.g., vacuum) force applied at the outlet of the conduit 608.

[0044] The suction force may be applied to the outlet of the conduit 608 by the vacuum source 606 either directly or indirectly. The suction force may be applied indirectly via the fluid storage container 604. For example, the outlet of the conduit 608 may be disposed within the fluid storage container 604 and an additional conduit 608 may extend from the fluid storage container 604 to the vacuum source 606. Accordingly, the vacuum source 606 may apply suction to the fluid collection assembly 602 via the fluid storage container 604. The suction force may be applied directly via the vacuum source 606. For example, the outlet of the conduit 608 may be disposed within the vacuum source 606. An additional conduit 608 may extend from the vacuum source 606 to a point outside of the fluid collection assembly 602, such as to the fluid storage container 604. In such examples, the vacuum source 606 may be disposed between the fluid collection assembly 602 and the fluid storage container 604.

[0045] The fluid collection assembly 602 may be similar or identical to any of the fluid collection assemblies disclosed herein in one or more aspects. For example, the fluid collection assembly 602 may include a fluid impermeable barrier at least partially defininga chamber of the fluid collection assembly 602. The fluid impermeable barrier also defines an opening extending therethrough. The opening may be positioned adjacent to or have a penis positioned therethrough. The fluid collection assembly 602 may include at least one porous material disposed within the fluid impermeable barrier. The conduit 608 includes an inlet and an outlet, the outlet being fluidly coupled to the fluid storage container and the inlet being positioned at or near a portion of the chamber selected to be at a gravimetrically low point of the fluid collection assembly 602 when worn.

[0046] The fluid storage container 604 is sized and shaped to retain a fluid therein. The fluid storage container 604 may include a bag (e.g., drainage bag), a bottle or cup (e.g., collection jar), or any other enclosed container for storing the bodily fluids. In some examples, the conduit 608 may extend from the fluid collection assembly 602 and attach to the fluid storage container 604 at a first point therein. An additional conduit 608 may attach to the fluid storage container 604 at a second point thereon and may extend and attach to the vacuum source 606. Accordingly, a vacuum e.g., suction) may be drawn through fluid collection assembly 602 via the fluid storage container 604. Fluid, such as urine, may be drained from the fluid collection assembly 602 using the vacuum source 606.

[0047] The vacuum source 606 may include one or more of a manual vacuum pump, and electric vacuum pump, a diaphragm pump, a centrifugal pump, a displacement pump, a magnetically driven pump, a peristaltic pump, or any pump configured to produce a vacuum. The vacuum source 606 may provide a vacuum or suction to remove fluid from the fluid collection assembly 602. In some examples, the vacuum source 606 may be powered by one or more of a power cord (e.g., connected to a power socket), one or more batteries, or even manual power (e.g., a hand operated vacuum pump). In some examples, the vacuum source 606 may be sized and shaped to fit outside of, on, or within the fluid collection assembly 602. For example, the vacuum source 606 may include one or more miniaturized pumps or one or more micro pumps. The vacuum sources 606 disclosed herein may include one or more of a switch, a button, a plug, a remote, or any other device suitable to activate the vacuum source 606.

[0048] FIG. 7 is a flow diagram of a method 700 of using a system to collect bodily fluids from an individual, according to an embodiment. The method 700 of collecting fluid may utilize use any of the fluid collection assemblies and / or fluid collection systems disclosed herein. The method 700 may include act 702, which recites “attaching a base of a fluid collection device to skin surrounding a penis, the base secured to or configured to be secured to a sheath, the base defining an aperture that corresponds to the opening of thesheath.” Act 702 may be followed by act 704, which recites “receiving fluid discharged from the user in the fluid collection device.”

[0049] Acts 702 and 704 of the method 700 are for illustrative purposes. For example, the acts 702 and 704 of the method 700 may be performed in different orders, split into multiple acts, modified, supplemented, or combined. In an example, one or more of the acts 702 or 704 of the method 700 may be omitted from the method 700. Any of the acts 702 or 704 may include using any of the fluid collection assemblies or systems disclosed herein.

[0050] Act 702 recites “attaching a base of a fluid collection device to skin surrounding a penis, the base secured to or configured to be secured to a sheath.” The act 702 of attaching a base of a fluid collection device to skin surrounding a penis may include utilizing any of the fluid collection assemblies or systems disclosed herein. In some examples, act 702 may include positioning the opening of the fluid collection assembly such that it aligns with an aperture of the base such that the penis can extend into the chamber of the fluid collection assembly. In some examples, act 702 may include positioning a sheath of the male fluid collection assembly and attaching to the base, such that at least a portion of the penis is positioned through an opening of the sheath and in the chamber of the fluid collection assembly.

[0051] The sheath can include a fluid impermeable barrier including a proximal region and a distal region extending from the proximal region, the proximal region defining an opening and the distal region defining a fluid outlet, the fluid impermeable barrier at least defining a chamber. The sheath can also include at least one porous material disposed in the chamber, the porous material including a flexible sheet having a proximal edge and a distal edge, the proximal edge secured to the proximal region of the fluid impermeable barrier and the distal edge movable between an extended and a retracted position.

[0052] Act 704 recites, “receiving fluid discharged from the user in the fluid collection device.” In some examples, receiving fluid discharged from the user includes receiving the bodily fluids through the opening of the fluid collection assembly. Receiving fluid from the penis into a chamber of the fluid collection assembly may include wicking, absorbing, or adsorbing the bodily fluids away from the opening using the porous material. In some examples, receiving receiving fluid discharged from the user may include receiving the bodily fluids into the chamber of the sheath of the fluid collection assembly. Receiving fluid discharged from the user may include flowing the bodily fluids towards a portion of the chamber that is fluidly coupled to an inlet of a conduit in fluid communication a vacuumsource. For instance, receiving fluid discharged from the user may include flowing the bodily fluids to a gravimetric ally low point of the chamber, etc., such as via gravity, wicking, or suction force.

[0053] The method 700 may include act 706, which recites “conducting skin checks on the individual by separating the base from the sheath.” Act 706 can include temporarily separating the base from the sheath of the fluid collection assembly to examine the skin of the user and then restoring the sheath to the base. In some examples, the sheath and the base are connected with an adhesive. In some examples, the adhesive is a resealable adhesive. In other examples, the base and the sheath are connected in an interference fit. The interference fit can include a “twist to lock” connection.

[0054] In some examples, the method 700 may include act 708, which recites “conducting skin checks on the individual by withdrawing an actuator coupled to the distal edge of the porous material.” The porous material can include a proximal edge coupled to a proximal region of the fluid collection assembly and a distal edge. The porous material can include a flexible sheet where the distal edge is movable between an extended and a retracted position. The actuator can include a rod. The actuator can include a material having a stiffness that is sufficient to withdraw and restore the porous material to an extended positon. In some examples, the actuator can extend through a hole in the fluid impermeable barrier. In some examples, the hole can be disposed at least proximate to the proximal region of the sheath. When the actuator is withdrawn, the distal edge of the porous material is drawn toward the proximal edge to conduct skin checks on the patient.

[0055] The method 700 may include an Act 710 which recites “receiving fluid discharged from the fluid collection device in a fluid collection container.” The fluid can be configured to drain through a conduit connected to the fluid collection assembly into the fluid collection container. In some examples, the fluid is withdrawn by applying suction with a vacuum source effective to suction the bodily fluids from the chamber via a conduit disposed therein and fluidly coupled to the vacuum source may include using any of the vacuum sources disclosed herein. Applying suction with a vacuum source may include activating the vacuum source (e.g., suction device) in fluid communication with the inlet of the conduit in the fluid collection assembly.

[0056] The method 700 can further include an Act 712, which recites “using a pump to pull a vacuum through a conduit in fluid communication with the fluid outlet of the fluid collection device effective to draw fluid from the fluid collection device and into the fluid collection container.” In other words, in some examples, applying suction with a pumpeffective to suction the bodily fluids from the chamber via a conduit disposed therein and fluidly coupled to the vacuum source may be effective to remove at least some bodily fluids from the chamber of the fluid collection assembly. In some examples, applying suction with a pump effective to draw the bodily fluids from the fluid collection device and transfer at least some of the bodily fluids from the device to a fluid storage container (e.g., a bottle or bag).

[0057] In some examples, the pump (e.g., suction device) may be disposed on or within the fluid collection assembly and applying suction with the vacuum source may include activating the vacuum source. In some examples, the pump and / or vacuum source may be spaced from the fluid collection assembly and applying suction with the vacuum source may include activating the vacuum source.

[0058] In an example, the method 700 may include collecting the bodily fluids that are removed from the fluid collection assembly, such as into a fluid storage container that is spaced from the fluid collection assembly and fluidly coupled to the conduit. The fluid storage container may include any of the fluid storage containers disclosed herein.

[0059] It is noted that the embodiments disclosed above relate to fluid collection assemblies configured to collection bodily fluids from a male. However, it is noted that such fluid collection assemblies may also be used to collection bodily fluids from a female since the urethral opening of the female is, functionally, similar to a buried penis.

[0060] While various aspects and embodiments have been disclosed herein, other aspects and embodiments are contemplated. The various aspects and embodiments disclosed herein are for purposes of illustration and are not intended to be limiting.

[0061] Terms of degree (e.g., “about,” “substantially,” “generally,” etc.) indicate structurally or functionally insignificant variations. In an example, when the term of degree is included with a term indicating quantity, the term of degree is interpreted to mean ± 10%, ±5%, or +2% of the term indicating quantity. In an example, when the term of degree is used to modify a shape, the term of degree indicates that the shape being modified by the term of degree has the appearance of the disclosed shape. For instance, the term of degree may be used to indicate that the shape may have rounded corners instead of sharp corners, curved edges instead of straight edges, one or more protrusions extending therefrom, is oblong, is the same as the disclosed shape, etc.

Claims

CLAIMSWe claim:

1. A fluid collection assembly, comprising: a sheath including: a fluid impermeable barrier including a proximal region and a distal region extending from the proximal region, the proximal region defining an opening and the distal region defining a fluid outlet, the fluid impermeable barrier at least defining a chamber, the fluid impermeable barrier including a first panel and a second panel sealed to the first panel along a perimeter of the first and second panels, wherein a portion of the perimeter includes a seal configured to releasably seal the perimeter of the first and second panels; and at least one porous material disposed in the chamber; and a base configured to be secured to the proximal region of the sheath, the base configured to be attached to skin surrounding a penis, the base defining an aperture that corresponds to the opening of the sheath.

2. The fluid collection assembly of claim 1, wherein the opening is a first opening and the seal includes a two-part strip defining a second opening that seals in an interference fit when the first panel and the second panel are pressed together and opens when the first panel and second panel are pulled apart.

3. The fluid collection assembly of claim 1, wherein the seal includes an adhesive.

4. The fluid collection assembly of any one of claims 1-3, wherein the fluid impermeable barrier includes polyurethane or polyethylene.

5. The fluid collection assembly of any one of claims 1-4, wherein the at least one porous material exhibits a shape that generally corresponds to a shape of the first portion and the second portion of the fluid impermeable barrier.

6. The fluid collection assembly of any one of claims 1 -5, wherein the sheath further includes a port attached to the fluid outlet, the port including a first part defining an inlet and a second part defining an outlet, the second part configured to be attached to a conduit.

7. The fluid collection assembly of any one of claims 1-6, wherein the base is releaseably attached to the proximal region of the sheath.

8. The fluid collection assembly of claim 7, wherein the base includes aresealable adhesive between the base and the proximal region of the sheath.

9. The fluid collection assembly of any one of claims 1-8, wherein the at least one porous material includes a non-transparent fabric.

10. The fluid collection assembly of any one of claims 1-9, wherein a portion of the perimeter of the first and second panels include a partially rectangular shape and the portion of the perimeter including the seal includes at least two sides of the rectangular shape.

11. A fluid collection assembly, comprising: a sheath including: a fluid impermeable barrier including a proximal region and a distal region extending from the proximal region, the proximal region defining an opening and the distal region defining a fluid outlet, the fluid impermeable barrier at least defining a chamber; and at least one porous material disposed in the chamber, the porous material including a flexible sheet having a proximal edge and a distal edge, the proximal edge secured to the proximal region of the fluid impermeable barrier and the distal edge movable between an extended position and a retracted position; an actuator connected to the distal edge of the flexible sheet, the actuator configured to move the porous material between the extended position and the retracted position; and a base secured to or configured to be secured to the proximal region of the sheath, the base configured to be attached to skin surrounding a penis, the base defining an aperture that corresponds to the opening of the sheath.

12. The fluid collection assembly of claim 11, wherein the actuator includes a rod coupled to the distal edge of the flexible sheet, wherein the rod extends through a hole in the fluid impermeable barrier, wherein when the rod is withdrawn the distal edge of the porous material is drawn toward the proximal edge.

13. The fluid collection assembly of claims 11 or 12, wherein the at least one porous material includes a non-transparent fabric.

14. The fluid collection assembly of any of claims 11 to 13, wherein the at least one porous material exhibits a shape that generally corresponds to a shape of the chamber.

15. The fluid collection assembly of claim 11, wherein the base is releaseably attached to the proximal region of the sheath.

16. The fluid collection assembly of claim 11, wherein the sheath further includes a port attached to the fluid outlet, the port including a first part defining an inlet and a second part defining an outlet, the second part configured to be attached to a conduit.

17. A method of using a system to collect bodily fluids from an individual, the method comprising: attaching a base of a fluid collection device to skin surrounding a penis, the base secured to or configured to be secured to a sheath, the base defining an aperture that corresponds to an opening defined by the sheath, the sheath including: a fluid impermeable barrier including a proximal region and a distal region extending from the proximal region, the proximal region defining the opening and the distal region defining a fluid outlet, the fluid impermeable barrier at least defining a chamber; at least one porous material disposed in the chamber, the porous material including a flexible sheet having a proximal edge and a distal edge, the proximal edge secured to the proximal region of the fluid impermeable barrier and the distal edge movable between an extended and a retracted position; receiving fluid discharged from the individual in the fluid collection device; and receiving fluid discharged from the fluid collection device in a fluid collection container.

18. The method of claim 17, further comprising conducting skin checks on the individual by separating the base from the sheath.

19. The method of claim 17, further comprising conducting skin checks on the individual by withdrawing an actuator coupled to the distal edge of the porous material, the actuator extending through a hole in the fluid impermeable barrier, the hole disposed at least proximate to the proximal region of the sheath, wherein when the actuator is withdrawn the distal edge of the porous material is drawn toward the proximal edge exposing the penis of the individual.

20. The method of claim 17, further comprising using a pump to pull a vacuum through a conduit in fluid communication with the fluid outlet of the fluid collection device effective to draw fluid from the fluid collection device and into the fluid collection container.

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