Patent Publication Number: US-2022211537-A1

Title: Male external catheter with attachment interface configured to bias against penis

Description:
CROSS-REFERENCE TO RELATED APPLICATIONS 
     This application claims priority to U.S. Provisional Application No. 63/133,892 filed on Jan. 5, 2021, the disclosure of which is incorporated herein, in its entirety, by this reference. 
    
    
     BACKGROUND 
     In various circumstances, a person or animal 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. 
     Urinary catheters, such as a Foley catheter, can be used to address some of these circumstances, such as incontinence. Unfortunately, however, 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. Males who can suffer 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. 
     SUMMARY 
     Embodiments for attachment interfaces and methodologies disclosed herein improve upon conventional devices and methods for attaching urine collection devices to a subject&#39;s penis. The devices disclosed herein enable improved attachment to the penis while still allowing for easy removal without injury or irritation to the subject. In an embodiment, a male urine collection device for collection of urine discharged from a subject is disclosed. The male urine collection device includes a receptacle defining an internal volume, the receptacle configured to receive a penis and to collect urine, and a plurality of flaps movable to access the internal volume of the receptacle. The plurality of flaps are configured to bias against the penis when the penis is at least partially received by the receptacle. 
     In an embodiment, a male urine collection device for collection of urine discharged from a penis is disclosed. The male urine collection device includes a receptacle defining an internal volume, the receptacle configured to collect urine, and a clamshell having two halves movable with respect to each other via a hinge, the clamshell configured to close around the penis to secure the receptacle about the penis when the penis is at least partially received by the receptacle. The clamshell is removably secured to the penis via friction. 
     Features from any of the disclosed embodiments may be used in combination with one another, without limitation. In addition, other features and advantages of the present disclosure will become apparent to those of ordinary skill in the art through consideration of the following detailed description and the accompanying drawings. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
       The drawings illustrate several embodiments of the present disclosure, wherein identical reference numerals refer to identical or similar elements or features in different views or embodiments shown in the drawings. 
         FIGS. 1A and 1B  are top and bottom isometric views, respectively, of a male urine collection device, according to an embodiment. 
         FIG. 2A  is an isometric view of a male urine collection device, according to an embodiment. 
         FIG. 2B  is a cross-sectional side view of the male urine collection device of  FIG. 2A . 
         FIG. 3A  is a top view of a urine collection device, according to an embodiment. 
         FIG. 3B  is a cross-sectional side view of the urine collection device of  FIG. 3A . 
         FIG. 4A  is an isometric view of a urine collection device, according to an embodiment. 
         FIG. 4B  is a top view of an attachment interface, according to an embodiment. 
         FIG. 5  is a top view of an attachment interface, according to an embodiment. 
         FIG. 6  is a top view of an attachment interface, according to an embodiment. 
         FIG. 7  is an isometric view of a bandage, according to an embodiment. 
         FIG. 8  is an isometric view of the bandage of  FIG. 5  coupled to a urine collection device, according to an embodiment. 
         FIG. 9  is a top view of an attachment interface, according to an embodiment. 
         FIG. 10  is a bottom isometric view of a urine collection device, according to an embodiment. 
         FIG. 11  is a bottom isometric view of a urine collection device having both the attachment interfaces of  FIGS. 4B and 7 , according to an embodiment. 
         FIG. 12A  is a side view of a securement feature, according to an embodiment. 
         FIG. 12B  is a side view of a securement feature, according to an embodiment. 
         FIG. 12C  is an isometric view of the securement feature of  FIG. 11B  in an engaged state, according to an embodiment. 
         FIG. 13  is a bottom isometric view of a urine collection device having the attachment interfaces of  FIGS. 4B and 7  and the securement feature of  FIG. 11B , according to an embodiment. 
         FIG. 14  is a schematic illustration of a urine collection device disposed on the body of a user, according to an embodiment. 
     
    
    
     DETAILED DESCRIPTION 
     Embodiments for attachment interfaces and methodologies disclosed herein improve upon conventional devices and methods for attaching urine collection devices, such as male external catheters, to a subject&#39;s penis. The devices disclosed herein enable improved attachment to the penis while still allowing for easy removal without injury or irritation to the subject. A urine collection device is disclosed that is suitable for collecting and transporting urine away from the body of a person or other animal, particularly a male. The disclosed urine collection device includes a urine collecting assembly that can include an attachment interface for improved functionality and securement to the penis. 
     In some embodiments, the attachment interface includes a plurality of flaps that can surround the penis to removably secure to the penis. In some embodiments, the attachment interface can include a clamshell device configured to lightly clamp onto the penis. The urine collection device can further include a fluid receptacle configured to collect urine from a subject. The attachment interfaces described herein can at least partially define the receptacle. For example, the attachment interface can define one or more walls of the receptacle. The receptacle also includes a fluid outlet in fluid communication with an outlet tube that may be, for example, in fluid communication with a vacuum pump. The urine collection device can be configured to receive a user&#39;s penis such that the urethral opening of the penis is disposed within the receptacle (e.g., disposed within the interior region of the receptacle) and the shaft of the penis is in sealing relationship with a peripheral edge of an opening defined by the attachment interface such that the urine collection device is configured to receive urine discharged from the urethral opening into the receptacle, and to have the received urine withdrawn from the receptacle via the outlet. 
     Examples of male urine collection devices that are configured to collected bodily fluids from a male urethral opening and methods of using such fluid collection assemblies are disclosed in International Application No. PCT/US2020/42262 filed on Jul. 14, 2020, U.S. Patent Publication No. 2019/0282391 filed on Jun. 6, 2019, U.S. Pat. No. 10,376,406 patented on Aug. 13, 2019, and U.S. Provisional Patent Application No. 63/067,542 filed on Aug. 19, 2020, the disclosure of each of which is incorporated herein, in its entirety, by this reference. Other embodiments of fluid impermeable barriers, fluid permeable membranes, fluid permeable supports, chambers, and their shapes and configurations are disclosed in U.S. patent application Ser. No. 15/612,325 filed on Jun. 2, 2017; U.S. patent application Ser. No. 15/260,103 filed on Sep. 8, 2016; and U.S. Pat. No. 10,225,376 filed on Jun. 1, 2017, the disclosure of each of which is incorporated herein, in its entirety, by this reference. 
       FIGS. 1A and 1B  are isometric top and bottom views, respectively, of a urine collection device  100 , according to an embodiment. The urine collection device  100  includes a sheath  102  and a base  104 . The sheath  102  includes a fluid impermeable barrier  109  that is at least partially formed from a first panel  108  attached to a second panel  110 . In an embodiment, as illustrated, the first panel  108  and the second panel  110  are distinct sheets. The fluid impermeable barrier  109  also defines a chamber  112  between the first panel  108  and the second panel  110 , 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 . The sheath  102  also includes at least one porous material disposed in the chamber  112 . The base  104  includes an aperture  124 . The base  104  is permanently attached to the proximal end region  116  of the sheath  102  such that the aperture  124  is aligned with the opening  114 . Permanently attached means that the sheath  102  cannot be detached from the base  104  without damaging at least one of the sheath  102  or the base  104 , using a blade to separate the sheath  102  from the base  104 , and/or using chemicals to dissolve the adhesive that attaches the sheath  102  from the base  104 . 
     The inner surfaces  126  of the fluid impermeable barrier  109  (e.g., inner surfaces of the first and second panels  108 ,  110 ) at least partially defines the chamber  112  within the urine collection device  100 . The fluid impermeable barrier  109  temporarily stores the bodily fluids in the chamber  112 . The fluid impermeable barrier  109  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.), a metal film, natural rubber, another suitable material, or combinations thereof. As such, the fluid impermeable barrier  109  substantially prevents the bodily fluids from passing through the fluid impermeable barrier  109 . In an example, the fluid impermeable barrier  109  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 a bruise or kinking the conduit  136 ). In such an example, the fluid impermeable barrier  109  may be formed of a hydrophobic material that defines a plurality of pores. Alternatively or additionally, the fluid impermeable barrier  109  may include at least one perforation  128  (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  109  may be formed from a soft and/or smooth material, thereby reducing chaffing. 
     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, polycarbonate, or polyvinyl chloride. 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. 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. However, configuring the sheath to be detachable from the base may allow leaks between the sheath and the base. As previously discussed, the sheath  102  is 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 ). Selecting at least one of the first panel  108  or the second panel  110  to be formed from an at least partially transparent impermeable material allows the penis to be examined without detaching the entire urine collection device  100  from the region about the penis. For example, the chamber  112  may include a penis receiving area  132  that is configured to receive the penis of the individual when the penis extends into the chamber  112 . 
     The porous material in the chamber  112  may include permeable material designed to wick or pass fluid therethrough. Suitable permeable or porous materials can include spun nylon fibers. The permeable properties referred to herein may 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 of fluid into the wicking material. Put another way, substantially no absorption of fluid into the material may take place after the material is exposed to the fluid and removed from the fluid for a time. While no absorption is desired, the term “substantially no absorption” may allow for nominal amounts of absorption of fluid into the wicking material (e.g., absorbency), such as less than about 30 wt % of the dry weight of the wicking material, less than about 20 wt %, less than about 10 wt %, less than about 7 wt %, less than about 5 wt %, less than about 2 wt %, or less than about 0.5 wt % of the dry weight of the wicking material. Wicking material can include natural fibers. In such examples, the material may have a coating to prevent or limit absorption of fluid into the material, such as a water repellent coating. In an embodiment, the porous material includes a body of spun nylon fibers with an outer permeable membrane made of fabric such as gauze. 
     The penis receiving area  132  may be defined by at least the porous material 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 is positioned in the chamber  112  such that the porous material is not positioned between the penis and at least a portion of the transparent portion of the first panel  108  and/or second panel  110  when the penis is inserted into the chamber  112  through the opening  114 . The porous material 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 penis receiving area  132  forms a window which allows the person to view into the penis receiving area  132  and examine the penis. 
     In an embodiment, the second panel  110  is at least partially formed from the at least partially transparent material and forms the window that allows the person to view into the penis receiving area  132 . Further, the porous material is positioned between the penis receiving area  132  and at least a portion of the first panel  108 . Such an embodiment may help maintain the dignity of the individual using the urine collection device  100 . For example, during use, the second panel  110  is generally adjacent to the individual, such as adjacent to the thighs and/or perineum. 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 is not transparent and/or the first panel  108  is formed from a non-transparent material. Thus, in such an embodiment, the first panel  108  and/or the porous material prevent person(s) from viewing the penis unless such examination is necessary, thereby preserving the dignity of the individual using the urine collection device  100 . In an embodiment, the first panel  108  is formed from the at least partially transparent material and forms the window that allows the person to view into the penis receiving area  132 . Further, the porous material is positioned between the penis receiving area  132  and at least a portion of the second panel  110 . In such an embodiment, the person does not need to perform the additional act of lifting the sheath  102  to view into the penis receiving area  132  but may not maintain the dignity of the individual using the urine collection device  100  since passersby may also view into the penis receiving area  132 . 
     As previously discussed, at least a portion of the first panel  108  and at least a portion of 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. As will be discussed in more detail below, forming the fluid impermeable barrier  109  from the first panel  108  and the second panel  110  may improve the rate of manufacturing the urine collection device  100 , especially when the first panel  108  and the second panel  110  are attached together using a non-sewing technique. In an embodiment, the first panel  108  and the second panel  110  can be a single unitary piece, such as a tube. 
     The opening  114  defined by the fluid impermeable barrier  109  provides an ingress route for fluids to enter the chamber  112  when the penis is a buried penis and allow the penis to enter the chamber  112  (e.g., the penis receiving area  132 ) when the penis is not buried. The opening  114  may be defined by the fluid impermeable barrier  109  (e.g., an inner edge of the fluid impermeable barrier  109 ). For example, the opening  114  is formed in and extends through the fluid impermeable barrier  109 , from the outer surface  130  to the inner surface  126 , thereby enabling bodily fluids to enter the chamber  112  from outside of the urine collection device  100 . 
     In an embodiment, the urine collection device  100  includes one or more attachment interfaces  106 ,  107  disposed in or about the opening  114 . The attachment interfaces  106 ,  107  can be the same or similar to any of the attachment interfaces disclosed herein, for example, the attachment interface  106  can be substantially similar to the attachment interface  306  and the attachment interface  107  (also referred to as a clamshell), can be substantially similar to the attachment interface  407  as described below. As discussed below, the attachment interfaces  106 ,  107  can be used to provide improve attachment of the urine collection device  100  to the penis of the subject. It will be appreciated that the attachment interfaces  106 ,  107  can be used with a wide variety of urine collection devices and the embodiment shown in  FIG. 1B  is non-limiting. Further examples of attachment interfaces being implemented on urine collection devices are provided below with reference to  FIGS. 2A and 2B . 
       FIG. 2A  is an isometric view of a urine collection device  202 , according to an embodiment. The urine collection device  202  can be similar to any of the urine collection devices disclosed herein. For example, the urine collection device  202  can include a body  240  having an open proximal end  242  and an at least partially closed distal end  244 , a reservoir  210  at least partially defined by the body  240 , attachment interfaces  206 ,  207 , and tubing  226  fluidly coupled to the reservoir  210 . 
     The body  240  of the urine collection device  202  can include a ring  262  at or near the open proximal end  242  of the body  240 , a sheath  264  extend from or near the open proximal end  242  to or near the at least partially closed distal end  244  of the body  240 , and a sump  266  at the at least partially closed distal end  244  of the body  240 . In an embodiment, the ring  262 , the sheath  264 , and the sump  266  are all distinct components from each other. In an embodiment, at least two of the ring  262 , the sheath  264 , or the sump  266  are integrally formed together (e.g., are formed from a single piece). The sheath  264  is configured to prevent a fluid (e.g., urine) escaping from the reservoir  210  and to move the fluid towards the sump  266  and the tubing  226 . The sheath  264  can include a plurality of layers that facilitate the operation of the sheath  264 . 
     The urine collection device  202  can include attachment interfaces  206 ,  207  located at or near the open proximal end  242  of the body  240 . The attachment interfaces  206 ,  207  can be similar to the attachment interfaces discussed herein, for example, the attachment interface  206  can be substantially similar to the attachment interface  306  and the attachment interface  207  (also referred to as a clamshell), can be substantially similar to the attachment interface  407  as described below. A subject&#39;s penis may enter the body  240  of the urine collection device  202  by passing the attachment interfaces  206 ,  207 . The urine collection device  202  may then be securely affixed to the subject&#39;s penis via the flaps of the attachment interface  206  and clamshell  207  as discussed herein. Further details of attachment interfaces being incorporated onto urine collection devices are discussed below. Specifically, the remaining figures disclose structural and functional details of the attachment interfaces and highlight the applicability of the attachment interfaces to generic urine collection devices. 
       FIG. 2B  is a cross-sectional side view of a urine collection device  202 , according to an embodiment. For example, with reference to  FIG. 2B  the sheath  264  can include a fluid impermeable layer  268 , a fluid permeable layer (e.g., a one-way fluid movement fabric, gauze, or cloth), and a fluid permeable support  272  positioned between the fluid permeable layer and the fluid impermeable layer  268 . The fluid permeable support  272  may include a porous layer (e.g., a spun polymer layer. The fluid impermeable layer  268  can form an external surface of the body  240  and prevent the fluid from leaking through the sheath  264 . The fluid permeable layer  274  can form an internal surface of the body  240 . The fluid permeable layer  274  can be configured to move the fluid from the reservoir  210  to the fluid permeable support  272  and may substantially prevent the fluid that is in the fluid permeable support  272  from flowing back into the reservoir  210 . As such, the fluid permeable layer  274  can remove fluid from around a penis thereby leaving the penis dry. The fluid permeable support  272  can form an inner layer between the fluid permeable layer  274  and the fluid impermeable layer  268 . The fluid permeable support  272  can enable the fluid to flow generally towards the tubing  226 . 
     It is noted that one or more layers of the sheath  264  can be omitted. For example, the fluid permeable layer  274  can be omitted such that the fluid permeable support  272  forms the internal surface of the body  240 . In such an example, the sheath  264  can rely on the wicking ability of the fluid permeable support  272  and a suction force applied to the urine collection device  202  to remove the fluid from the penis. In another example, the sheath  264  only include the fluid impermeable layer  268 . In such an example, the sheath  264  can rely on the suction force applied to the urine collection device  202  to remove the fluid from the penis. In another example, the sheath  264  only includes the fluid impermeable layer  268  and the fluid permeable layer  274 . In such an example, the sheath  264  can form a channel (not shown) between the fluid impermeable layer  268  and the fluid permeable layer  274  and the channel is fluidly coupled to the tubing  226 . 
     The fluid permeable layer  274  and/or the fluid permeable support  272  may include permeable material designed to wick or pass fluid therethrough. The permeable properties referred to herein may 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 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. Wicking material can include natural fibers. In such examples, the material may have a coating to prevent or limit absorption of fluid into the material, such as a water repellent coating. 
     The sheath  264  is configured to have a penis disposed therein. To facilitate fluid collection and improve comfort, the sheath  264  can be flexible thereby allowing the sheath  264  to correspond to the shape of a penis. For example, the flexible sheath  264  can at least partially collapse when the penis is not erect and at least partially expand and bend to the shape of the penis as the penis becomes erect. Forming the layers of the sheath  264  from at least one of thin layers (e.g., less than 500 μm thick, and more particularly less than 250 μm thick, less than 100 μm thick, or less than 50 μm thick), flexible layers, or fabric can allow the sheath  264  to be sufficiently flexible. 
     The ring  262  can be more rigid than the sheath  264 . For example, the ring  262  can be formed from a flexible polymer that is at least one of thicker than the entire sheath  264  or exhibits a Young&#39;s modulus that is greater than sheath  264 . As such, the ring  262  can provide some structure at or near the open proximal end  242 . The increased rigidity of the ring  262  can cause the open proximal end  242  to remain open thereby facilitating insertion of a penis into the attachment interface  206  and/or clamshell  207 . Further, in an embodiment, the increased rigidity of the ring  262  can enable the ring  262  to act as an attachment mechanism. For example, as illustrated, the ring  262  can be adjacent to or enable placement of the attachment interface  206  and/or the clamshell  207 . 
     The sump  266  is configured to attach the rest of the urine collection device  202  to the tube  226 . For example, the sump  266  can define an outlet  220  extending through at least the fluid impermeable layer  268  thereby coupling the tubing  226  to the fluid permeable support  272  and/or the reservoir  210 . Further, the sump  266  can close the at least partially closed distal end  244 . For example, the sump  266  can bunch up the sheath  264  and close any gaps that may form. 
     The ring  262 , the sheath  264 , the sump  266 , and attachment interface  206 ,  200  can be attached together using any suitable method. For example, at least two of the ring  262 , the sheath  264 , the sump  266 , or attachment interfaces  206 ,  207  can be attached together using at least one of an interference fit, an adhesive, stitching, welding (e.g., ultrasonic welding), tape, any other suitable method, or combinations thereof. 
     The reservoir  210  may include one or more sections. For example, the reservoir  210  may include a first section  210   a  that is defined by the sheath  264 . However, as illustrated, the reservoir  210  may include one or more additional sections that are defined by one or more additional components of the urine collection device  202 . For example, sump  266  may exhibit a bulbous portion  267  extending from an outlet  220  of the sump  266  towards an open proximal end  242  of the sheath  264 . The bulbous portion  267  may define a second section  210   b  of the reservoir  210 . The second section  210   b  may provide a location to store the fluid that is spaced from a penis of a user that is partially disposed in the urine collection device  202 . As such, the second section  210   b  may decrease the amount of fluids that contact the penis. 
     The sheath  264  extends from or near an open proximal end  242  of the urine collection device  202  to or near an at least partially closed distal end  244  of the urine collection device  202 . However, in an embodiment, the portion of the sheath  264  at or near the at least partially closed distal end  244  defines a hole (e.g., opening). In such an embodiment, the urine collection device  202  may include a porous top layer  276  that at least partially covers the hole. The porous top layer  276  may separate the first section  210   a  of the reservoir  210  from the second section  210   b  of the reservoir  210 . 
     The porous top layer  276  may be the same as or substantially similar to any of the fluid impermeable supports or fluid permeable layers disclosed herein. For example, the porous top layer  276  may include a one-way fluid movement fabric, thereby allowing fluid to flow from the first section  210   a  of the reservoir  210  to the second section  210   b  of the reservoir  210  while preventing the fluid from flowing from the second section  210   b  back to the first section  210   a . As such, the porous top layer  276  may decrease the amount of fluid that contacts the penis when the porous top layer  276  includes the one-way fluid movement fabric. However, it is noted that the porous top layer  276  may include gauze, other types of fabric, or any other suitable porous material instead of or in addition to the one-way fluid movement fabric. 
     The sump  266  includes a bulbous portion  267 . The sump  266  may also include one or more ridges  269  extending from or near the outlet  220  towards the open proximal end  242 . In an embodiment, the ridges  269  may direct any fluids that are in the second section  210   b  of the reservoir  210  towards the outlet  220 . In an embodiment, the ridges  269  may provide at least some structural support to the bulbous portion  267  such that ridges  269  resist the deformation and/or collapse of the bulbous portion  267 . It is noted that the bulbous portion  267  may include one or more structural elements instead of or in addition to the ridges  269 . For example, the bulbous portion  267  may define one or more recesses that resist bending stresses. 
     The sump  266  may be exposed to the atmosphere, which allows the sump  266  to be visible, and may be exposed to an interior of the urine collection device  202 . As such, the sump  266  may provide fluid communication between the atmosphere and the interior of the urine collection device  202  and/or provide information. For example, the sump  266  may be formed from a porous material that is configured to assist in suction balance. In an embodiment, the sump  266  may be formed from a material that is configured to change color or state when exposed to bacteria to indicate that an individual using the urine collection device  202  has an infection. 
     The urine collection device  202  may include an upper ring  278 . The upper ring  278  may be configured to be positioned adjacent to the portion of the sump  266  that is connected to the sheath  264 . In an embodiment, the upper ring  278  provides additional strength and/or rigidity to the portion of the sump  266  that is connected to the sheath  264 . For example, the sheath  264  may be flexible, thereby allowing the sheath  264  to conform to the environment as well as gravity to create a shape that conforms to the anatomy of the individual wearing the urine collection device  202  thus giving the urine collection device  202  an adjustable length. Meanwhile, the upper ring  278  provides some rigidity to the urine collection device  202 , thereby inhibiting leakage and patient injuries that the sheath  264 , by itself, cannot prevent. In an embodiment, the upper ring  278  may be connected to the sheath  264 . In such an embodiment, the upper ring  278  may be connected to the sheath  264  along with the sump  266  thereby increasing the attachment strength between the sheath  264  and the sump  266  or the upper ring  278  may indirectly connect the sump  266  to the sheath  264  (e.g., only the upper ring  278  is directly connected to the sheath  264 ). 
     In an embodiment, the upper ring  278  may include a writeable area that is configured to receiving one or more markings thereon, for example, from a pencil or marker. The writeable area of the upper ring  278  may allow medical practitioners to indicate when the urine collection device  202  was disposed on the individual or to indicate other useful information. In an embodiment, the upper ring  278  may include a material that exhibits a color change at or around a certain time after being exposed to air which allows the upper ring  278  to indicate how long the urine collection device  202  has been in use. 
     Referring to  FIGS. 34 and 3B , an embodiment of a urine collection device  280  includes a chamber assembly  312 . The chamber assembly  312  includes a thin layer of wicking material  313  and a porous material  316 . The porous material  316  is configured to form a continuous ring-like chamber  317  in which urine can be collected for transport. The wicking material  313  can be disposed about the porous material  316 . The chamber  317  has a port for receiving a tube  318  so that urine collected within the chamber  317  can be transported from the chamber  317  by being drawn from the chamber  317  when a partial vacuum is applied within the chamber  317  via the received tube  318 . The received tube  318  can extend within the chamber  317 . The chamber assembly  312  is dimensioned and configured to define a perimeter  328 . The perimeter  328  can define an opening. An attachment interface  306  comprising a plurality of flaps  310  can extend from the perimeter  328  of the chamber assembly  312  through which the head of a penis can be inserted. The attachment interface  306  can be substantially similar to the attachment interfaces  106  and  206  discussed above. 
     In another embodiment (not shown), the porous material is configured to form a discontinuous C-shaped chamber in which urine can be collected for transport, with opposing portions of the chamber assembly being sufficiently adjacent as to define an opening through which the head of a penis can be inserted. 
     As illustrated in  FIG. 3B , a flexible sheet of impermeable material  330  is so attached to the chamber assembly  312  to cover one side of the opening formed by the perimeter  328  and thereby provide a receptacle  320  for receiving the head of an inserted penis. Urine flowing into the receptacle  320  from the penis can be drawn through the wicking material  313  and the porous material  316  into the chamber  317  when a partial vacuum is applied within the chamber  317  via the tube  318 . 
     In an embodiment, the sheet of impermeable material  330  is so dimensioned in relation to the breadth of the perimeter  328  as to extend sufficiently away from the chamber assembly  312  to provide adequate space in the receptacle to receive the head of the penis. The attachment interface  306  and the impermeable material  330  can form a volume to house the penis. The layer of impermeable material  330  further covers at least the exterior sides of the chamber assembly  312 , The layer of impermeable material  330  can cover a portion of the interior sides of the chamber assembly  312 . 
     The layer of impermeable material  330  can be attached to the chamber assembly  312  by an adhesive material. In another embodiment (not shown), retainer clips or other fasteners attach the impermeable material  330  to the chamber assembly  312 . The impermeable material  330  can be integrally formed with the chamber assembly  312 . Likewise, the attachment interface  306  can be attached to the chamber assembly  312  by an adhesive or other fastener. The attachment interface  306  can be integrally formed from the chamber assembly  312 . 
     In an embodiment, the urine collection device  280  includes a cushion  334  which is disposed adjacent the impermeable material  330  for receiving the head of an inserted penis. The cushion  334  is so disposed over the layer of impermeable material  330  as to contact the wicking material  313  of the chamber assembly  312 . The cushion  334  includes a layer of wicking material  336 , such as medical gauze, disposed over a bed of porous material  338 . 
     In an embodiment, the porous material  316  is provided as a web of a, spun plastic material, such as nylon or polyester. In an embodiment, the chamber  317  is formed by folding together opposite sides of a web of spun plastic material, whereby the chamber  317  does not necessarily have a closed cross-section as shown in  FIG. 2 . In  FIGS. 3A and 3B , the relative dimensions of the various components are not necessarily shown to scale. 
     In operation, when a man&#39;s penis is inserted through the flaps  310  of the attachment interface  306 , expelled urine can flow between the layer of porous material  338  and the sheet of impermeable material  330  and into the chamber  317  and thence to the outlet tube  318 . The urine collection device  280  can thus advantageously capture urine as it flows against gravity without having to attach a catheter to the penis. The attachment interface  306  can further prevent urine from escaping the urine collection device  280  and can direct urine toward the chamber  317 . 
       FIG. 4A  is an isometric view of a urine collection device  300  (such as a male external catheter), according to an embodiment. The urine collection device  300  can include a receptacle  304  configured to collect urine from a subject. The receptacle  304  can be formed from silicone or other polymer materials. The urine collection device  300  can further include an attachment interface  306  configured to releasably couple to the subject. The attachment interface  306  can be integrally formed with the receptacle  304  or can be a separately formed unit that is coupled to the receptacle  304 . For example, the attachment interface  306  can be configured to releasably attach to a penis. The attachment interface  306  can include a plurality of flaps  310  that are formed by one or more slits on the attachment interface  306 . The plurality of flaps  310  can form an opening  308  that reveals the interior volume of the receptacle  304 . The flaps  310  can be made from a flexible, resilient, and/or elastic material that is configured to retain its shape, such as a polymer material. For example, the flaps can be made from plastics such as polyethylene or polypropylene or from elastomers such as rubber. The flaps  310  can be configured to retain their position after being deformed. In this manner, the flaps  310  can generate an elastic tension against the subject&#39;s penis. Thus, a subject&#39;s penis can be brought in fluid communication with the interior volume of the receptacle  304  via opening  308 . In some embodiments, the urine collection device  300  can include a wicking material  314  positioned proximate the attachment interface  306  within the interior volume of the receptacle  304 . The wicking material  314  can be configured to draw fluid away from the opening  308  and the subject&#39;s body. For example, the wicking material  314  can be positioned in the V-shaped gaps between the flaps  310  and the subject&#39;s penis. 
     In some embodiments, the internal volume of the receptacle  304  defines an outlet that is in fluid communication with a conduit or tube  318 . The tube  318  can be in fluid communication with a vacuum pump configured to draw a vacuum in the receptacle to suck any collected fluid out of the receptacle  304 . Further details of the attachment interface  306  are provided below with reference to  FIGS. 4 and 5 . 
       FIG. 4B  is a top view of an example attachment interface  306 , according to an embodiment. The attachment interface  306  can include multiple flaps  310  that are formed by slits in the attachment interface  306 . The slits allow the flaps to deform, bend, or fold to reveal the opening  308  into the receptacle  304 . As shown in  FIG. 4B , the slits can be arranged in a star-like pattern. In some embodiments, the flaps  310  are biased toward a neutral or flat position that is in-plane with the attachment interface  306 , such that the opening  308  is covered when the flaps  310  are in their natural or unbiased position. 
     In some embodiments, the attachment interface  306  can include spun plastic. The attachment interface  306  can include multiple layers. In some embodiments, the attachment interface  306  includes an inner layer exposed to the internal volume of the receptacle  304 . The inner layer can include a wicking material. The attachment interface  306  can include an outer layer exposed to the outside environment. The outer layer can include a fluid impermeable layer. A middle layer can be disposed between the inner layer and the outer layer. The inner layer can include spun plastic. The flaps  310  can be made from a flexible material that is configured to retain its shape. The flaps  310  can be configured to retain their position after being deformed. In this manner, the flaps  310  can generate an elastic tension against the subject&#39;s penis. In some embodiments, the flaps  310  can form a partial or complete seal against the subject&#39;s penis. For example, when the subject&#39;s penis is inserted through the opening  308 . The flaps  310  bias against or press against the shaft of the penis to improve coupling between the receptacle  304  and the penis and to also generate a partial seal between the receptacle and the penis. In some embodiments, the flaps  310  entirely converge such that the opening  308  is entirely covered when the flaps are un-deformed. When the penis is positioned in the opening  308  and the flaps  310  are bent around the shaft of the penis, the shape of the flaps  310  naturally resist the penis exiting the attachment interface  306 . In this way, the flaps  310  act as a type of one-way trap, allowing the penis to easily enter the opening  308 , while resisting removal of the penis from the opening. However, removal of the penis from the attachment interface  306  can be easily performed and will not result is discomfort or injury to the subject. 
       FIG. 5  is a top view of an example attachment interface  306 , according to an embodiment. The attachment interface  306  illustrated in  FIG. 5  can be substantially similar to the attachment interface  306  disclosed with reference to  FIG. 4B . The attachment interface  306  can include multiple flaps  310  that are formed by slits or cut-outs in the attachment interface  306 . As shown in  FIG. 5 , a star-like cut-out can define an opening  320  into the receptacle  304 . In some embodiments, the flaps  310  are biased toward a neutral or flat position. When the flaps  310  are in the neutral or unbiased state the opening  320  can be at a minimum diameter, which is expanded when the flaps  310  are deformed. In the embodiment shown in  FIG. 5 , the opening  320  remains at least partially exposed even when the flaps are in their unbiased position. 
       FIG. 6  illustrates an embodiment of an attachment interface  306  in which two ends of the attachment interface  306  are separated to form a gap  324 , according to an embodiment. The gap  324  can be configured to allow a penis to enter the opening  320  through the gap  324 . In other words, instead of having the penis enter the opening  320  by inserting the penis passed the flaps  310 , the attachment interface  306  can wrap around the penis by permitting passage of the penis into the attachment interface  306 . In an open state (i.e., with the gap  324  expanded) the attachment interface  306  can easily be wrapped around the penis, and in a closed state (i.e., with the gap closed or contracted) the penis can be secured within the attachment interface  306 . Although the flaps shown herein are generally triangular in shape, it will be understood the other shapes are also possible, for example, the flaps can be semi-circular or rectangular. 
       FIG. 7  illustrates a bandage  350 . The bandage  350  can be an attachment interface and can be substantially similar to the attachment interfaces discussed herein, such as the attachment interfaces  306  of  FIGS. 3-6 , according to an embodiment. The bandage  350  can be configured to operationally couple with a urine collection device, such as with the receptacle  304  of urine collection device  300  discussed above. The bandage  350  can be formed of a silicone contact layer  354  and can include a wicking material  358 . In some embodiments, the bandage  350  can comprise a foam dressing. The bandage  350  can include several slits or cut-outs that form a plurality of flaps  310 . For example, the bandage  350  can include flaps  310  similar to the flaps discussed above with reference to the attachment interfaces  306  of  FIGS. 3-6 . In some embodiments, the bandage  350  includes an inner layer configured to directly contact the receptacle  304 . The inner layer can include a wicking material and/or a tacky material, such as a silicone contact layer. The bandage  350  can include an outer layer exposed to the outside environment and configured to come into contact with the subject&#39;s body. The outer layer can include a fluid impermeable layer. A middle layer can be disposed between the inner layer and the outer layer. The inner layer can include spun plastic. 
       FIG. 8  illustrates the bandage  350  coupled to a receptacle  304  of a urine collection device, according to an embodiment. In some embodiments, the bandage  350  can include a sticky or tacky material, such as a silicone contact layer  354 . For example, a major surface of the bandage  350  can include a tacky material that is capable of adhering to the receptacle  304 . A second major surface of the bandage, opposite, the sticky side of the bandage  350  can include a soft material, such as polyurethane foam, intended to be comfortable against the subject&#39;s skin. In some embodiments, the bandage  350  does not use an adhesive to attach to the receptacle  304 . In some embodiments, an adhesive is used to couple the bandage  350  to the receptacle  304 . The hole  320  in the bandage  350  can be positioned adjacent a hole (not shown in  FIG. 8 ) in the receptacle  304 , such that the opening  320  is aligned with and in fluid communication with the interior of the receptacle  304  and further in fluid communication with the vacuum tube  318 . 
     In some embodiments, the bandage  350  is coupled to a urine collection device, such as the urine collection devices of  FIGS. 1-3 . In this manner, a urine collection device could include multiple layers of flaps. For example, a first layer of flaps could be present on a wall of the receptacle  304  and a second layer of flaps could be present on the bandage  350 . The layers of flaps can be oriented relative to each other such that the flaps  310  are in line with one another, or the layers can be off-set such that the flaps  310  of the bandage  350  are rotationally off-set from the flaps of the receptacle. In some embodiments, the flaps of each layer are different in shape and/or size. In some embodiments, the bandage  350  include multiple layers of flaps  310 . 
       FIG. 9  illustrates an attachment mechanism or attachment interface  407  for attaching a urine collection device to a subject&#39;s penis, according to an embodiment. The attachment interface  407  is referred to herein as a clamshell, however, it will be understood that this term does not necessarily assign any properties, characteristics, or limitations onto the attachment mechanism  407 . The clamshell  407  can include a first half  403   a  and a second half  403   b . The first half  403   a  can be substantially similar or identical to the second half  403   b , such that the clamshell  407  is symmetrical about an axis. The first half  403   a  can be connected to the second half  403   b  via a pivot point  409  at a distal end  413  of the clamshell  407 . The pivot point  409  can include a hinge, joint, axle, pin, spring or any other mechanism capable of allowing relative motion between the first half  403   a  and the second half  403   b . In some embodiments, the clamshell  407  is flexible such that the first half  403   a  and the second half  403   b  can be bent toward or away from one another. The clamshell  407  can be biased toward a closed position (i.e., where the first half  403   a  and second half  403   b  are closest at a proximal end of the clamshell  407 ). 
     In some embodiments, the clamshell  407  can include a vacuum tube and wicking layers such as those discussed above with reference to the urine collection device  280  of  FIGS. 3A and 3B . For example, the clamshell  407  can include a layer, of wicking material, such as a matrix of spun plastic that at least partially surrounding a vacuum tube to collect and transport urine. The clamshell  407  can further be in fluid communication with an outlet tube attached to a sump of the clamshell  407 . In some embodiments, the clamshell  407  can include a securing feature (not shown in  FIG. 9 ) configured to secure the proximal end of the first half  403   a  to the proximal end of the second half  403   b . In other words, the securing feature can be configured to secure the clamshell in the closed position. The securing feature can include Velcro, an adhesive, or a strip, such as the strip  500  discussed below with reference to  FIGS. 12A-13 . 
     In operation, the clamshell  407  can be position around a penis, with the penis positioned between the first half  403   a  and the second half  403   b  in the opening  420 . When in the closed position, the clamshell  407  can be frictionally secured to the penis. In some embodiments, the clamshell  407  can be configured to secure a base of the urine collection device to the base of the penis. The clamshell  407  can be configured to clamp, constrict, or squeeze the penis sufficient to secure the clamshell  407  to the penis, while still allowing urine flow. In some examples, the clamshell  407  can include different levels of constriction or clamping. For example, the degree of clamping or the pressure applied onto the penis can be increased to improve the fit or attachment onto the penis. The clamshell  407  can include an inner layer  417  that is tacky or sticky to enhance the friction securement between the clamshell  407  and the penis. In some embodiments, the inner layer  417  includes a rugged surface with enhanced friction. For example, the inner layer  417  can include spun plastic. In an embodiment, the inner layer  417  includes flaps similar to the flaps  310 . 
       FIG. 10  illustrates a clamshell  407  functionally coupled with the receptacle  304  of a urine collection device  450 , according to an embodiment. The urine collection device  450  can be substantially similar to the urine collection device  300  discussed above with reference to  FIG. 4A . For example, the urine collection device  450  can include a receptacle  304  in fluid communication with a vacuum tube  318 . The clamshell  407  can be integrally formed with the receptacle  304  or can be a separate and distinct piece configured to attach and form a seal with the receptacle  304 . The urine collection device  450  can include a sump  439  configured to collect urine to be suctioned from the receptacle  304 . In some embodiments, the sump  439  is coupled to the clamshell  407 . 
       FIG. 11  illustrates a urine collection device  470  including an attachment interface  306  and a clamshell  407  operationally coupled to the receptacle  304 , according to an embodiment. The attachment interface  306  and clamshell  407  can be substantially similar to the attachment interfaces and clamshells discussed herein. In some embodiments, the flaps  310  of the attachment interface  306  can extend from a perimeter of the clamshell  407 . The flaps  310  can be integrally formed from the inner sidewall of the clamshell  407 . A gap  324  in the attachment interface  306  can coincide with the gap  424  in the clamshell  407 . In this manner, the features and improvements of the attachment interfaces can be combined with the features and improvements of the clamshell  407  to produce enhanced attachment methodologies of the urine collection device. The gaps  324  and  424  in the urine collection device  470  could be closed and secured using any securement method, such as Velcro, adhesive, knots, or the strips disclosed herein. 
       FIG. 12A  illustrates a strip  500 , according to an embodiment. The strip  500  can be considered an attachment interface and can be used as a closing, tightening, or constricting device. For example, the strip  500  can be used in conjunction with the attachment interfaces discussed herein to further aid is securing the urine collection device to the penis. In some embodiments, the strip  500  can be used to wrap directly around the penis and can, in some cases, be used to constrict the penis to restrict urine flow. The strip  500  can be formed from a piece of coarse spun plastic. The strip  500  can include a tip  538  formed on a first end of the strip  500  and a slot  534  formed on a second end of the strip  500 , opposite the first end. The tip  538  can include one or more catches or jagged section  542  configured to pass through the slot  534  in one direction and catch or snag on the slot  534  in a second direction. In this manner, the strip  500  can be a pull-through strap configured to secure to itself via friction. 
       FIG. 12B  illustrates the strip  500  including a shelf or stop  550  configured to prevent the tip  538  from entering any further into the slot  534 .  FIG. 12C  illustrates the strip  500  with the tip  538  engaged in the slot  534 . As illustrated, when the tip  538  is fed through the slot  534 , the strip  500  forms a loop or noose  546 . In some embodiments, the loop formed by the strip  500  can act as an attachment or securement mechanism. The catches  542  can help prevent the tip  538  from backing out of the slot  534 , and the shelf  550  can prevent the strip  500  from being pulled too tight. In some embodiments, the strip  500  is formed of a coarse material. The course nature of the strip  500  can aid the tip  538  from slipping out of the slot  534 . The coarseness of the strip  500  can also help keep the strip  500  in place against the user&#39;s skin and thereby reducing abrasive forces against the user&#39;s skin. The strip  500  can be used in conjunction with any of the attachment interfaces or clamshell devices disclosed herein. For example, the strip  500  can be used to close or tighten the gap  324  of the attachment interface  306  and the gap  424  of the clamshell  407 . 
       FIG. 13  is a bottom isometric view of a urine collection device  550  having multiple attachment features as described herein, according to an embodiment. The urine collection device  550  of  FIG. 13  can include an attachment interface  306  and clamshell  407  for removably securing the urine collection device to the penis. Further, a strip  500 , similar to the strips disclosed herein, can be positioned on either ends of the attachment interface  306  and/or the clamshell  407  such that the clamshell  407  and the attachment interface  306  can be closed around the penis when the strip  500  is pulled through itself, thereby closing the gap  424 . The strip  500  can be integrally formed with either of the clamshell  407  or attachment interface  306 , such that cinching the strip  500  also causes the clamshell  407  or attachment interface  306  to tighten around the penis. In an embodiment, the strip  500  is positioned along an inner circumference of the receptacle  304 . In an embodiment, the strip  500  wraps around the circumference of the receptacle  304 . Thus, it will be understood that each of the attachment interfaces described herein (e.g., attachment interface  306 , clamshell  407 , and strip  500 ) can be used individually or in combination to improve attachment of the urine collection device to the penis. 
       FIG. 14  is a schematic illustration of a urine collecting system  600  disposed on the body of a subject  691 , according to an embodiment. The urine collecting system  600  can utilize any of the urine collection devices and attachment interfaces disclosed herein. The urine collecting system  600  can include a receptacle  304  to collect urine and an attachment interface  606 . The attachment interface  606  can be the same or similar in structure and/or function to any of the attachment interfaces described herein, such as attachment interfaces  106 ,  306 ,  350 ,  407 ,  500 , and any combination thereof. The urine collecting system  600  can include an external receptacle  660  and a vacuum source  670 . The external receptacle  660  can be a temporary storage location for urine drawn from the receptacle  304 . In an embodiment, the vacuum source  670  can assist and/or provide the pressure differential needed to draw fluid voided from the urethral opening of a user into the receptacle  104 , and from the receptacle  304  into the external receptacle  660 . The vacuum source  670  can be fluidly coupled to the external receptacle  660  via a vacuum line  624  such that urine is drawn from the external receptacle  660  via the vacuum line  624 . As a result of the decrease in pressure within the external receptacle  660  caused by the drawing of fluid out of the external receptacle  660 , liquid and/or gaseous fluid can be drawn from the receptacle  304 , through the tube  318 , and into the external receptacle  660 . In an embodiment, the vacuum source  670  can apply sufficient suction to capture all or substantially all of the urine voided by a user in a variety of positions (e.g., when a user is lying on his side). 
     In an embodiment, the vacuum source  670  can be a pump that is readily available, inexpensive, relatively quiet, and/or configured to run continuously. For example, the vacuum source  670  can be a pump. In an embodiment, the vacuum source  670  can be powered by electrical AC or DC power. For example, in mobile applications when the user is away from an AC power source, such as when the user is using the urine collecting system  600  during transportation via a wheel chair or motor vehicle, the vacuum source  670  can be powered by DC power. One suitable non-limiting example of a pump that can be used is the DryDoc Vacuum Station, available from PureWick, Inc. 
     In use, as shown in  FIG. 14 , the urine collecting system  600  can be positioned such that the attachment interface  606  encloses a portion of the penis of the subject  491 . For example, the attachment interface  606  can be positioned such that the urethral opening of the user  691  is within an internal volume of the receptacle  304 . 
     While various embodiments of the urine collecting system, methods and devices have been described above, it should be understood that they have been presented by way of example only, and not limitation. Where methods and steps described above indicate certain events occurring in certain order, those of ordinary skill in the art having the benefit of this disclosure would recognize that the ordering of certain steps may be modified and such modifications are in accordance with the variations of the invention. Additionally, certain of the steps may be performed concurrently in a parallel process when possible, as well as performed sequentially as described above. The embodiments have been particularly shown and described, but it will be understood that various changes in form and details may be made. 
     For example, although various embodiments have been described as having particular features and/or combinations of components, other embodiments are possible having any combination or sub-combination of any features and/or components from any of the embodiments described herein. In addition, the specific configurations of the various components can also be varied. For example, the size and specific shape of the various components can be different than the embodiments shown, while still providing the functions as described herein.