Patent ID: 12239567

DETAILED DESCRIPTION

A system is disclosed that is suitable for collecting and transporting urine away from the body of a person or animal. The disclosed system includes an assembly that may include a fluid impermeable casing having a fluid reservoir at a first end, a fluid outlet at a second end, and a longitudinally extending fluid impermeable layer coupled to the fluid reservoir and the fluid outlet and defining a longitudinally elongated opening between the fluid reservoir and the fluid outlet. The assembly can further include a fluid permeable support disposed within the casing with a portion extending across the elongated opening, and a fluid permeable membrane disposed on the support and covering at least the portion of the support that extends across the elongated opening, so that the membrane is supported on the support and disposed across the elongated opening. The assembly can further include a tube having a first end disposed in the reservoir and extending behind at least the portion of the support and the portion of the membrane disposed across the elongated opening and extending through the fluid outlet to a second, fluid discharge end. The assembly can be configured to be disposed with the opening adjacent to a urethral opening of a user, to receive urine discharged from the urethral opening through the opening of the fluid impermeable layer, the membrane, the support, and into the reservoir, and to have the received urine withdrawn from the reservoir via the tube and out of the fluid discharge end of the tube.

In some embodiments, a method includes disposing in operative relationship with the urethral opening of a female user, a urine collecting apparatus. The urine collecting apparatus can include a fluid impermeable casing having a fluid reservoir at a first end, a fluid outlet at a second end, and a longitudinally extending fluid impermeable layer coupled to the fluid reservoir and the fluid outlet and defining a longitudinally elongated opening between the fluid reservoir and the fluid outlet. The urine collecting apparatus can also include a fluid permeable support disposed within the casing with a portion extending across the elongated opening, a fluid permeable membrane disposed on the support and covering at least the portion of the support that extends across the elongated opening, so that the membrane is supported on the support and disposed across the elongated opening, and a tube having a first end disposed in the reservoir and extending behind at least the portion of the support and the portion of the membrane disposed across the elongated opening and extending through the fluid outlet to a second, fluid discharge end. The operative relationship can include the opening being adjacent to the urethral opening. The method can further include allowing urine discharged from the urethral opening to be received through the opening of the fluid impermeable layer, the membrane, the support, and into the reservoir; and allowing the received urine to be withdrawn from the reservoir via the tube and out of the fluid discharge end of the tube.

In some embodiments, an apparatus includes a fluid permeable support disposed between a fluid permeable membrane and a fluid reservoir, and a fluid outlet. The apparatus can be configured to be disposed with a portion of the fluid permeable membrane adjacent to a urethral opening of a user, to receive urine discharged from the urethral opening through the fluid permeable membrane, the fluid permeable support, and into the reservoir, and to have the received urine withdrawn from the reservoir via the outlet.

As used in this specification, the singular forms “a,” “an” and “the” include plural referents unless the context clearly dictates otherwise. Thus, for example, the term “a member” is intended to mean a single member or a combination of members, “a material” is intended to mean one or more materials, or a combination thereof.

The embodiments described herein can be formed or constructed of one or more biocompatible materials. Examples of suitable biocompatible materials include metals, ceramics, or polymers. Examples of suitable metals include pharmaceutical grade stainless steel, gold, titanium, nickel, iron, platinum, tin, chromium, copper, and/or alloys thereof. Examples of polymers include nylons, polyesters, polycarbonates, polyacrylates, polymers of ethylene-vinyl acetates and other acyl substituted cellulose acetates, non-degradable polyurethanes, polystyrenes, polyvinyl chloride, polyvinyl fluoride, poly(vinyl imidazole), chlorosulphonate polyolefins, polyethylene oxide, polyethylene terephthalate (PET), polytetrafluoroethylene (PTFE), and/or blends and copolymers thereof.

FIG.1is a schematic block diagram of a system100. The system100includes an assembly102. The assembly102includes a reservoir110, a permeable support140, and a permeable membrane130. The assembly102also includes an outlet120in fluidic communication with the reservoir110. The assembly102can be arranged such that a fluid can flow through the permeable membrane130, through the permeable support140, into the reservoir110, and out of the outlet120. In some implementations, the assembly102can also include an impermeable layer150for directing fluid toward the reservoir110and reducing and/or preventing fluid from exiting the assembly102except via the outlet120. In some implementations, the system100can include a discharge line122. The discharge line122can be fluidically coupled to an external receptacle160. The external receptacle160can be in fluidic communication with a vacuum source170via a vacuum line124. The discharge line122and the vacuum line124can both include flexible tubing, such as, for example, flexible plastic tubing.

The permeable membrane130can be formed of a material that has permeable properties with respect to liquids such as urine. The permeable properties can be wicking, capillary action, diffusion, or other similar properties or processes, and are referred to herein as “permeable” and/or “wicking.” The permeable membrane130can have a high absorptive rate and a high permeation rate such that urine can be rapidly absorbed by the permeable membrane130and/or transported through the permeable membrane130. In some implementations, the permeable membrane130can be a ribbed knit fabric. In some implementations, the permeable membrane130can include and/or have the moisture-wicking characteristic of gauze, felt, terrycloth, thick tissue paper, and/or a paper towel. In some implementations, the permeable membrane130can be soft and/or minimally abrasive such that the permeable membrane130does not irritate the skin of the user. The permeable membrane130can be configured to wick fluid away from the urethral opening and/or the skin of the user such that the dampness of the skin of the user is lessened and infections are prevented. Additionally, the wicking properties of the permeable membrane130can help prevent urine from leaking or flowing beyond the assembly onto, for example, a bed. In some implementations, the permeable membrane130can be formed of fine denier polyester fibers coated with a thermoplastic water-based binder system. The tensile with the Webb direction can be, for example, about 45 lbs/inch2measured using an Instron test method. The weight per permeable membrane can be, for example, about 12 grams measured using the Mettle Gram Scale. The thickness per ten permeable membrane can be, for example, about 2.5″, measured using the Gustin-Bacon/Measure-Matic.

The permeable support140can be positioned relative to the permeable membrane130such that the permeable support140maintains the permeable membrane130in a particular shape and allows for fluid, such as, for example, urine, to flow through the permeable membrane130, through the permeable support140, and into the reservoir110. In some implementations, the permeable support140can be configured to maintain the permeable membrane130against or near a urethral opening of a user. For example, the permeable support140can include a portion having a curved shape in contact with the permeable membrane130such that the permeable membrane130is also curved, thus creating a comfortable and secure interface for engagement with a user's urethral opening and/or the area of the body near the urethral opening. In some implementations, the permeable support140can be made of a rigid plastic. In some implementations, the permeable support140can have any suitable shape and be formed of any suitable material. For example, the permeable support140can be flexible. Additionally, the permeable support140can be formed of aluminum, a composite of plastic and aluminum, some other metal and/or a composite of plastic and another metal. In some implementations, the permeable support140can be formed of a natural material, such as, for example, plant fibers (e.g., Greener Clean manufactured by 3M®). The natural material can include openings that allow fluid to flow through the natural material. In some embodiments, the permeable support140can be cylindrical and can define a lumen. In some embodiments, the permeable support140can be formed of perforated coated paper, such as tubular waxed paper.

The permeable support140can define one or more openings (e.g., an array of openings) to allow for fluid flow from the permeable membrane130to the reservoir110. In some implementations, the permeable support140can be formed as a tube, a cylinder, or a curved cylinder with one or more openings. In some implementations, the permeable support140can include membrane supports (e.g., struts) extending across an opening such that the opening is divided into an array of distinct slot-shaped openings. The membrane supports can be used to support the permeable membrane130. For example, the membrane supports can maintain the shape of the permeable membrane130against or near a user's urethral opening such that urine flowing from the urethral opening contacts and travels through the permeable membrane130. In some implementations, the permeable support140can define several openings having a variety of shapes, such as a plurality of round openings. In some implementations, the permeable support140can be formed as a cylinder of spun plastic (e.g., non-woven permeable nylon and polyester webbing) such that the permeable support140can have many openings. For example, a rectangular portion of spun plastic can be folded or rolled into a cylinder shape for use in the assembly102. In some implementations, the permeable support140can be formed of a porous material. For example, the permeable support140can be a porous glass tubular container defining frits. In other implementations, the permeable support140can define an opening in a sidewall of the permeable support140and the sidewall can be covered by a mesh screen defining many smaller openings.

The reservoir110can be any suitable shape and/or size capable of collecting fluid transported through the permeable support140. In some implementations, the reservoir110can be sized such that the reservoir is capable of collecting and temporarily holding a large or small amount of urine until the urine can be removed from the reservoir via the outlet120. For example, the reservoir110can be sized such that the reservoir110is configured to hold a small amount of urine as may be released due to incontinence. In some implementations, the reservoir110can be sized such that the reservoir110is configured to hold a large amount of urine as may be released during voiding of a full bladder. In some implementations, the reservoir110can be sized such that the reservoir is configured to collect and hold a small or large amount of urine while the urine is simultaneously removed via, for example, gravity and/or a pump, such as the vacuum source170. Said another way, the reservoir110can function as a sump and be sized such that the reservoir110can form a portion of a passageway for urine from the permeable membrane130, through the permeable support140, through the reservoir110, and out of the outlet120. In a condition where the flow rate of urine into the assembly102via the permeable membrane130is greater than the flow rate of urine through the discharge line122, a temporary backup of urine may occur in the reservoir110. Thus, the reservoir110can be sized to contain a volume of fluid that may temporarily accumulate due to the difference in flow rates into and out of the assembly102.

Although the outlet120is shown as extending from the side of the reservoir110, in some implementations, the outlet120can extend from the bottom of the reservoir110. Positioning the outlet120lower in the reservoir110such that less or no urine can pool at the bottom of the reservoir110can allow for urine to be removed from the reservoir110more quickly and/or completely. In other implementations, the outlet120can be positioned within the reservoir such that at least a portion of tubing associated with the outlet120extends from the top of the reservoir110. For example, a portion of tubing associated with the outlet120can extend from the top of the reservoir110through at least a portion of the permeable support140(e.g., a central channel) and, optionally, through at least a portion of the permeable membrane130. In such an implementation, the outlet120can be positioned a distance from the reservoir110such that fluid can flow from the reservoir, through the tubing associated with the outlet120, and from the outlet120. In such implementations, positioning the reservoir end of the tubing associated with the outlet120towards the bottom of the reservoir110such that less or no urine can pool at the bottom of the reservoir110can allow for urine to be removed from the reservoir110more quickly and/or completely. In some implementations, the tubing associated with the outlet120can be precurved at least in the portion extending through the permeable support140.

In some implementations, the reservoir110and the permeable support140can be formed as separate components and coupled together during assembly. In some implementations, the permeable support140and the reservoir110can be formed as a cylindrical integral, unitary structure that is sealed at one end by a closed end of the reservoir110and at the other end by a closed end of the permeable support140.

The external receptacle160, via the discharge line122, can collect fluid exiting the reservoir110through the outlet120. The external receptacle160can be a sealed container. In some implementations, the external receptacle160can be disposable. In some implementations, the external receptacle160can be configured to be sterilized and reused.

In some implementations, gravity can cause fluid within the reservoir110to follow a flow path (i.e., the fluid flow path including the outlet120and the discharge line122) from the reservoir110to the external receptacle160. In some implementations, the vacuum source170can assist and/or provide the pressure differential needed to draw fluid voided from the urethral opening of a user into the permeable support140, into the reservoir110, and from the reservoir110into the external receptacle160. The vacuum source170can be fluidically coupled to the external receptacle160via a vacuum line124such that gaseous fluid is drawn from the external receptacle160via the vacuum line124. As a result of the decrease in pressure within the external receptacle160caused by the drawing of gaseous fluid out of the external receptacle160, liquid and/or gaseous fluid can be drawn from the reservoir110, through the outlet120, through the discharge line122, and into the external receptacle160. In some implementations, the vacuum source170can 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 female user is lying on her side).

The vacuum source170can have a sufficiently high vacuum strength and air volume transport rate such that rapid air and liquid aspiration is maintained over a portion of or the entire permeable membrane130. In some implementations, the one or more openings of the permeable support140are distributed over an area that is slightly larger than the area of the permeable membrane130that is configured to be wetted by urine flow in operation. Thus, the partial vacuum created by the vacuum source170in combination with the one or more openings of the permeable support140and the permeable membrane130can draw the urine contacting the permeable membrane130into the assembly102. In some implementations, however, the one or more openings of the permeable support140should not be distributed over too large of an area of the permeable support140because the partial vacuum strength may be reduced, thereby reducing the urine collection rate and the efficiency of the system100.

In some implementations, the vacuum source170can be a pump that is readily available, inexpensive, relatively quiet, and/or configured to run continuously. For example, the vacuum source170can be an aquarium aerator pump. The vacuum line124can be attached to the intake port of the aquarium aerator pump (rather than the exhaust port of the aerator) such that gaseous fluid is drawn into the aquarium aerator pump from the external receptacle160via the vacuum line124. In some implementations, the necessary static vacuum of the system100is about 3-10 feet of water (10%-30% of one atmosphere; 80-250 mm Hg) with a free-flow rate of about 10-100 cubic centimeters per second. In some implementations, the necessary static vacuum of the system100is higher or lower depending on the size of the user and the expected rate of urine flow from the user and/or through the system100. In some implementations, the discharge line122can be about 0.25″ in diameter and the vacuum source170can be configured to cause about 500 cubic centimeters of urine to flow through the discharge line122to the external receptacle160over the duration of a typical urination event for a user, which may typically range from 10 to 20 seconds but may be shorter or longer, e.g., 5 to 90 seconds. In some implementations, the vacuum source170can include a wall-mounted vacuum system, such as is found in hospitals. In some implementations, a wall-mounted vacuum system can be configured to apply a vacuum of, for example, about 20 mm Hg to about 40 mm Hg. In some implementations, the vacuum source170can 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 system100during transportation via a wheel chair or motor vehicle, the vacuum source170can be powered by DC power.

The impermeable layer150can be impermeable to fluid, such as, for example, urine. In some implementations, the impermeable layer150can have a fluid transportation function and can assist in directing fluid towards the reservoir110and/or through the outlet120of the reservoir110. In some implementations, the impermeable layer150can be formed as an integral, unitary structure. In other implementations, the impermeable layer150can be a multi-piece structure. The impermeable layer150can be a pre-molded (e.g., injection or blow molded) component. Alternatively, the impermeable layer150can be formed of a material, such as elongate strips of an adhesive tape, wrapped around at least a portion of the reservoir, a portion of the permeable support140, and/or a portion of the permeable membrane130. In some implementations, the impermeable layer150can be formed of cardboard, pressed paper, and/or coated paper.

In some implementations, as shown inFIG.1, the assembly102can optionally include a shape-defining or shape-retaining element151. The shape-retaining element151can be attached to the impermeable layer150and can cause at least a portion of the assembly102to assume or maintain a curved shape. In some implementations, the shape-retaining element151can be disposed between the impermeable layer150and the permeable support140and/or the permeable membrane130. In some implementations, the shape-retaining element151can be attached to an outer surface of the impermeable layer150or can be imbedded in the impermeable layer150. In some embodiments the tubing associated with the outlet120can constitute the shape-retaining element151, i.e. the tubing can be relatively rigid and having a curved shape that defines the desired curved shape for at least a portion of the assembly102.

In some implementations, the permeable support140can optionally include a spine148. The spine148can divide an inner volume of the permeable support140into two or more longitudinal chambers and can strengthen the permeable support140such that the permeable support140maintains an intended shape. The two chambers can be aligned with an inlet of the permeable support140(i.e., the one or more openings in the permeable support140) such that fluid can flow through the inlet, through at least one of the two chambers, and into the reservoir110. Although only one spine148is described, in some implementations, the permeable support140can include additional spines such that the permeable support140is divided into additional chambers.

In some implementations, the permeable support140can optionally include a tunnel146. The tunnel146can be coupled to the outlet120of the assembly102in a configuration in which the outlet120is positioned on the top of the assembly102. In some implementations, an external tube can be inserted through the tunnel146into contact with fluid in the reservoir110such that the fluid in the reservoir110can be removed from the assembly102via the external tube (e.g., using a vacuum source such as vacuum source170). In some implementations, a length of tubing, such as the discharge line122, can be fluidically coupled to an end of the tunnel146such that fluid can be drawn up the tunnel146from the reservoir110and out of the assembly102.

In some implementations, the impermeable layer150can include an extension portion156. The extension portion156can extend away from the permeable membrane130and/or the permeable support140such that the extension portion156can be gripped by a user or caregiver without contacting the permeable membrane130. Thus, the extension portion156can be used to remove the permeable membrane130and the impermeable layer150from the permeable support140. In some implementations, the extension portion156can be shaped as an elongated tab that extends along the length of the assembly102on one or more sides of the assembly102. In some implementations, the extension portion156can be configured to prevent urine from traveling beyond the border between the permeable membrane130and the impermeable layer150. For example, the extension portion156can be shaped and disposed relative to the permeable membrane130such that in a condition where the rate of urine flowing from the urethral opening exceeds the rate the permeable membrane130or a portion of the permeable membrane130can wick fluid and/or the rate that fluid can travel through the permeable membrane130and permeable support140, the extension portion156can prevent urine from flowing onto an outer surface of the impermeable layer150beyond the extension portion156and can redirect urine along the permeable membrane130such that the urine is directed through the permeable membrane130.

In some implementations, the impermeable layer150can include a stabilizer154. The stabilizer154can be configured to stabilize the assembly102relative to a user's body. For example, in some situations of use, such as for incontinence, for disability that limits or impairs mobility, for restricted travel conditions (e.g., conditions experienced by pilots, drivers, and/or workers in hazardous areas), for monitoring purposes, or for clinical testing, it may aid the engagement between the permeable membrane130and the user's urethral opening and/or the area surrounding the urethral opening to include the stabilizer154. The stabilizer154can be coupled to or integrally formed with the impermeable layer150. In some implementations, a first end of the stabilizer154is coupled to the impermeable layer150and a second end of the stabilizer154is coupled to a user's body (e.g., via adhesive or tape) or an apparatus occupied by the user (e.g., a bed or wheelchair) to stabilize the position of the assembly102relative to a user's urethral opening and/or the area surrounding the urethral opening. The stabilizer154can be a thin, pliable strip of material. For example, in some implementations the stabilizer154can include tape, gauze, cotton, cloth, or plastic. The stabilizer154can be any suitable length and/or width. In some implementations, the stabilizer154can be as thin as a single thread.

In some implementations, the impermeable layer150can define one or more vacuum relief openings158. Thus, in the event that a user's body envelopes the assembly102, the one or more vacuum relief openings158can prevent suction from increasing against the skin of the user, which may be uncomfortable or painful. Said another way, the one or more vacuum relief openings158can be located between two ends of the impermeable layer150such that at least one additional airflow path exists in the assembly102. The one or more vacuum relief openings158can be disposed at any suitable location on the impermeable layer150. For example, in some implementations, the one or more vacuum relief openings158can be disposed near the outlet120of the apparatus102. In some implementations, the one or more vacuum relief openings158can be disposed in a location that reduces the likelihood that the skin of the labia or the thigh of the user inadvertently covers the hole, such as a location near the outlet120.

In some implementations, urine collected by any of the systems and/or assemblies described herein can be sampled for analysis using urine strips. Urine test strips can be used to test a variety of health measures. Urine test strips can be configured to change color in response to being wetted with urine to indicate a particular measurement (i.e., the colors can correspond to known measurement scales). In some implementations, a urine test strip162can be inserted into the discharge line122such that urine flowing from the outlet120to the external receptacle160contacts the urine test strip162. The discharge line122can be transparent such that data on the urine test strip162can be read through a wall of the discharge line122. In some implementations, the urine test strip162can be disposed within the external receptacle160such that urine flowing into the external receptacle160contacts the urine test strip162. The external receptacle160can be at least partially transparent such that the urine test strip162can be read through a wall of the external receptacle160.

As an example,FIG.14is a schematic illustration of a portion of tubing line1022and a urine test strip1062affixed to the inside of the portion of tubing line1022. The portion of tubing line1022can be included in or form the entire discharge line (e.g., discharge line122) from an outlet of an assembly (e.g., outlet120) to an external receptacle (e.g., external receptacle160). The urine test strip1062can be secured within the tubing line1022by friction or by using any suitable adhesive. In some implementations, the tubing line1022can be a short tube segment (e.g., less than six inches) that is configured to form a portion of or all of a discharge line (e.g., discharge line122). For example, the tubing line1022can have a connector on each end (not shown) capable of connection with and removal from a line of tubing (e.g., discharge line122), an outlet (e.g., outlet120), and/or the external receptacle (e.g., external receptacle160). After urine has passed through the tubing line1022and the data has been read from the urine test strip1062, the tubing line1022and the urine test strip1062can be disposed of.

In some implementations, a camera, such as a camera built into a portable communication device (e.g., a smartphone, an iPhone, or the like) can be used to read the data on the urine test strip162. The camera can capture an image of the test strip and the image can be processed using, for example, a smartphone application. The data read from the urine test strip can be sent to a clinician for analysis and/or sent to a cloud-based address for physician access.

In some implementations, the system100can include a scale164. For example, the scale164can be disposed underneath the external receptacle160such that the scale is configured to measure the weight of fluid (e.g., urine) in the external receptacle160. The data indicating the weight of the fluid that has been delivered to the external receptacle160via the discharge line122can be measured at different time intervals and processed to determine how much urine, for example, has been voided by a user of the system100.

Although described as being intended for use by an adult female, in some implementations the system100can be used in adult, pediatric, male, female, and veterinary applications for animals of different species and sizes. In female applications, the assembly102can be placed between the legs or labia of the user and held snugly against the external urethra by the pressure of friction from the user's body, by the pressure of the legs or by such means as an undergarment, elastic strips, and/or adhesive tape. In male applications, the assembly102can be secured around the penis.

FIG.2is a perspective view of an assembly202with a portion of the assembly202shown in cut away. The assembly202includes a permeable support240and a reservoir210. As shown inFIG.2, the permeable support240and the reservoir210can be formed as a unitary structure. For example, the permeable support240and the reservoir210in combination can form a cylindrical container with closed ends. The cylindrical container with closed ends can define an interior volume. The permeable support240can define an inlet242in a sidewall of the permeable support240such that fluid can flow through the inlet242into the interior volume. The reservoir210can define an opening211and can be coupled to an outlet220such that the outlet220is in fluid communication with the opening211. Thus, fluid can flow from the interior volume, through the opening211, and through the outlet220.

The permeable support240can include one or more membrane supports244. The membrane supports244can be formed as struts that extend across the inlet242. Said another way, the membrane supports244can divide the inlet242into an array of distinct slot-shaped openings (or an array of slot-shaped openings can define the membrane supports). The membrane supports244can be used to support a permeable membrane (e.g., permeable membrane230shown inFIG.3). For example, the membrane supports244can maintain the shape of the permeable membrane230against a user's urethral opening and/or the area surrounding a user's urethral opening such that urine flowing from the urethral opening contacts and travels through the permeable membrane230. The membrane supports244can be formed in any suitable shape and/or thickness.

The permeable support240and the reservoir210can be formed of any suitable material. In some implementations, the permeable support140can be flexible. In some implementations, the permeable support140can be rigid. In some implementations, the permeable support240can be made of plastic, aluminum, a composite of plastic and aluminum, some other metal and/or a composite of plastic and another metal. Additionally, although not shown inFIG.2, in some implementations the permeable support240can be curved.

The assembly202can include a permeable membrane230.FIG.3is a perspective view of the assembly202with the permeable membrane230disposed on an outer surface of the permeable support240. In some implementations, the permeable membrane230can also be disposed on a portion of or on the entire outer surface of the reservoir210. The permeable membrane230can be at least partially supported by the membrane supports244(shown inFIG.2) such that the membrane supports244maintain the permeable membrane230against or near a urethral opening of a user.

The permeable membrane230can be formed of a material that is urine permeable and has wicking properties. The permeable membrane230can have a high absorptive rate and a high permeation rate such that urine can be rapidly wicked by the permeable membrane230and/or transported through the permeable membrane230. In some implementations, the permeable membrane230can be a ribbed knit fabric. In some implementations, the permeable membrane230can include and/or have the moisture-wicking characteristic of gauze, felt, terrycloth, thick tissue paper, and/or a paper towel. In some implementations, the permeable membrane230can be soft and/or minimally abrasive such that the permeable membrane230does not irritate the skin of the user. The permeable membrane230can be configured to wick fluid away from the urethral opening and/or the skin of the user such that the dampness of the skin of the user is lessened and infections are prevented. Additionally, the wicking properties of the permeable membrane230can help prevent urine from leaking or flowing beyond the assembly onto, for example, a bed. In some implementations, the permeable membrane130can be formed of fine denier polyester fibers coated with a thermoplastic water-based binder system. The tensile with the Webb direction can be, for example, about 45 lbs/inch2measured using an Instron test method. The weight per permeable membrane can be, for example, about 12 grams measured using the Mettle Gram Scale. The thickness per ten permeable membrane can be, for example, about 2.5″, measured using the Gustin-Bacon/Measure-Matic.

In some implementations, the permeable membrane230can be formed as a sock or sleeve that can be slid over the permeable support240. In some implementations, the permeable membrane230can be formed as a sheet that can be wrapped partially or completely around the permeable support240. The permeable membrane230can be secured in place with one or more securing elements252. In some implementations, the securing elements252can be impermeable and form a portion of or all of an impermeable layer (similar to impermeable layer150with reference to assembly100ofFIG.1). In some implementations, the securing elements252can include elastic bands (e.g., rubber bands), water-resistant adhesive tape, spring clips, hook and loop fasteners, zippers, snaps, and/or any other suitable securing element. In other implementations, the permeable membrane230can be secured in place via friction between the permeable membrane230and the permeable support240.

FIG.4is a schematic illustration the assembly202as part of a system200. The system200includes an external receptacle260and a vacuum source270. The external receptacle260can be the same or similar in structure and/or function as the external receptacle160described above with reference to the system100. The vacuum source270can be the same or similar in structure and/or function as the vacuum source170described above with reference to the system100. The assembly202can be fluidically coupled to the external receptacle260via a discharge line122. The external receptacle260can be fluidically coupled to the vacuum source270via a vacuum line224.

In use, the system200can be positioned such that the assembly202is abutting and/or near the urethral opening of the user. In particular, the assembly202can be positioned such that the inlet242and membrane supports244are facing the urethral opening such that urine exiting the urethral opening can travel through the permeable membrane230, through the inlet242, through the interior volume defined by the permeable support240and the reservoir210, and through the outlet220. The assembly202can be arranged relative to the urethral opening of the user such that gravity causes or assists urine entering the permeable support240in traveling to the reservoir210. Similarly as described above with reference to system100, the vacuum source270can assist and/or provide the pressure differential needed to draw fluid voided from the urethral opening into the inner volume of the assembly202, and then from the reservoir210into the external receptacle260. The vacuum source270can have a sufficiently high vacuum strength and air volume transport rate such that rapid air and liquid aspiration is maintained over a portion of or the entire permeable membrane230. Additionally, the inlet242can be sized and shaped such that the inlet242is larger than the area of the permeable membrane230that is configured to be wetted by urine flow in operation. Thus, the partial vacuum created by the vacuum source270in combination with the inlet242and the permeable membrane230can draw the urine contacting the permeable membrane230into the assembly202. In some implementations, however, the inlet242should not be distributed over too large of an area of the permeable support240because the partial vacuum strength may be reduced, thereby reducing the urine collection rate and the efficiency of the system200. The vacuum source270can be fluidically coupled to the external receptacle260via a vacuum line224such that gaseous fluid is drawn from the external receptacle260via the vacuum line224. As a result of the decrease in pressure within the external receptacle260caused by the drawing of gaseous fluid out of the external receptacle260, liquid and/or gaseous fluid can be drawn from the reservoir210, through the outlet220, through the discharge line222, and into the external receptacle260.

FIG.5is a schematic illustration of a system300. The system300includes an assembly302. The assembly302can be the same or similar in structure and/or function to the assembly102or the assembly202described above. The system300can include an external receptacle360and a vacuum source370. The external receptacle360can be the same or similar in structure and/or function as the external receptacle160and/or the external receptacle260described above. The vacuum source370can be the same or similar in structure and/or function as the vacuum source170and/or the vacuum source270described above.

As shown inFIG.5, the system300can include a chassis372. The vacuum source370can be mounted on the chassis372. A discharge pipe374and a vacuum intake pipe376can be mounted on or disposed within the chassis372. The discharge pipe374can be fluidically coupled to the assembly302via a discharge line322. The vacuum intake pipe376can be fluidically coupled to a vacuum line extending away from the chassis372. The chassis372can be mounted on and/or coupled to the external receptacle360. For example, in some implementations, the chassis can include helical threads configured to engage with helical threads on the external receptacle360such that the chassis372can engage with the external receptacle360.

In use, the system300can be positioned such that the assembly302is abutting and/or near the urethral opening of the user. In particular, the assembly302can be positioned such that one or more openings in the permeable support (not shown) of the assembly302face the urethral opening such that urine exiting the urethral opening can travel through a permeable membrane of the permeable support, through the one or more openings, through an interior volume defined by the permeable support and a reservoir of the assembly302, and through an outlet of the assembly302into the discharge line322. The assembly302can be arranged relative to the urethral opening of the user such that gravity causes urine entering the permeable support to travel to the reservoir. Similarly as described above with reference to system100and/or system200, the vacuum source370can assist and/or provide the pressure differential needed to draw fluid (e.g., urine) voided from the urethral opening into the inner volume of the assembly302, and then from the reservoir, through the discharge line322, and into the external receptacle360. The vacuum source370can have a sufficiently high vacuum strength and air volume transport rate such that rapid air and liquid aspiration is maintained over a portion of or the entire permeable membrane. The vacuum source370can be fluidically coupled to the external receptacle360via the vacuum intake pipe376such that gaseous fluid is drawn from the external receptacle360via the vacuum intake pipe376. The gaseous fluid can then be released from the system300via a vacuum line324. As a result of the decrease in pressure within the external receptacle360caused by the drawing of gaseous fluid out of the external receptacle360, liquid and/or gaseous fluid can be drawn from the assembly302, through the discharge line322, and into the external receptacle360.

In some implementations, rather than the permeable support and the reservoir being combined as a unitary or integral structure and shaped as a cylinder of constant diameter (e.g., permeable support240and reservoir210ofFIG.2), a permeable support and a reservoir can be formed as a unitary structure having any suitable shape, as shown inFIGS.6A-6C, which are schematic illustrations of various assembly shapes. For example, as shown inFIG.6A, an assembly402includes a permeable support440and a reservoir410. The permeable support440and the reservoir410are formed as a unitary structure having a curved shape. The permeable support440defines an inlet442and includes a number of membrane supports444. The membrane supports444extend across the inlet442. In other words, the membrane supports444divide the inlet442into a number of discrete inlet portions.

As shown inFIG.6B, an assembly502includes a permeable support540and a reservoir510. The permeable support540and the reservoir510are formed as a unitary structure having a straight shape with a larger diameter end portion. Thus, the reservoir510can have a larger diameter than the permeable support540. The permeable support540defines an inlet542and includes a number of membrane supports544. The membrane supports544extend across the inlet542. In other words, the membrane supports544divide the inlet542into a number of discrete inlet portions.

As shown inFIG.6C, an assembly602includes a permeable support640and a reservoir610. The permeable support640and the reservoir610are formed as a unitary structure having concave sides. The permeable support640defines an inlet642and includes a number of membrane supports644. The membrane supports644extend across the inlet642. In other words, the membrane supports644divide the inlet642into a number of discrete inlet portions.

FIG.7is a perspective view of an assembly702with a portion of the assembly702shown in cut away. The assembly702can be similar in structure and/or function to the assembly202described above with respect toFIG.2. For example, the assembly702includes a permeable support740and a reservoir710. The permeable support740and the reservoir710are formed as an integral, unitary cylindrical container with closed ends. The cylindrical container with closed ends defines an interior volume. The permeable support740can define an inlet742in a sidewall of the permeable support740such that fluid can flow through the inlet742into the interior volume. The permeable support740can include one or more membrane supports744. The membrane supports744can be the same or similar in structure and function to the membrane supports244described above with reference to the permeable support240.

Rather than including an outlet extending from a side of the reservoir710, the outlet720of the reservoir710can be formed as an elongated tube positioned within the reservoir710and extending through a portion of the reservoir710, through the permeable support740, and out a top end of the permeable support740. Thus, fluid can flow (e.g., via suction applied to the outlet720) from the interior volume, through the outlet720, and out the top of the apparatus702.

FIG.8is a perspective view of an assembly802. The assembly802can be similar in structure and/or function to the assembly702described above with respect toFIG.7. For example, the assembly802includes a permeable support840and a reservoir810. The permeable support840and the reservoir810are formed as an integral, unitary curved cylindrical container with closed ends. The cylindrical container with closed ends defines an interior volume. The permeable support840can define a number of inlets842in a sidewall844of the permeable support840such that fluid can flow through the number of inlets842into the interior volume. The sidewall844can support a permeable membrane, such as permeable membrane130described above with reference toFIG.1. In particular, the portions of the sidewall844defining and separating the number of inlets842can be the same or similar in structure and function to the membrane supports244described above with reference to the permeable support240. The assembly802can include an outlet820similar to the outlet720describe above with reference to the assembly702. For example, the outlet820can be formed as an elongated tube positioned within the reservoir810and extending through a portion of the reservoir810, through the permeable support840, and out a top end of the permeable support840. Thus, fluid can flow (e.g., via suction applied to the outlet820) from a urethral opening of a user, through the number of inlets842into the interior volume, to the reservoir810, through the outlet820, and out the top of the apparatus802.

In some implementations, the assembly802can include a permeable membrane (not shown) that includes a spray-on fabric, such as the spray-on fabric developed by Fabrican, Ltd. of London, England. The spray-on fabric can be applied to the exterior of the permeable support840and/or the reservoir810. The spray-on fabric can include a liquid suspension and can be applied via, for example, a spray gun or an aerosol can. The spray-on fabric can be formed by the cross-linking of fibers which adhere to the exterior of the permeable support840such that the spray-on fabric forms an instant non-woven fabric when applied to the exterior of the permeable support840and/or the reservoir810.

In some implementations, the assembly802can include a permeable membrane (not shown) similar in structure and function to any of the permeable membranes described above (such as, for example, permeable membrane230) can be secured to the permeable support840and/or the reservoir810. In some implementations, such as is shown inFIG.9, the assembly802can include a permeable membrane830covering a portion or all of the permeable support840and/or the reservoir810. The assembly802can also include an impermeable layer850. The permeable support840and the impermeable layer850can form, in combination, a sheath-like structure shaped and sized to be secured around at least a portion of the permeable support840and at least a portion of the reservoir810. The impermeable layer850can be disposed relative to the permeable support840, reservoir810, and permeable membrane830such that the permeable membrane830is configured for interfacing with a urethral opening and/or the area surrounding the urethral opening of a user and at least a portion of the number of inlets842are not covered by the impermeable layer850such that urine from the urethral opening can flow through the permeable membrane830, through the number of inlets842, and into the inner volume of the assembly802. The impermeable layer850can be disposed such that the impermeable layer850can direct fluid toward the reservoir810and reduce and/or prevent fluid from exiting the assembly802except via the outlet820.

The impermeable layer850can include one or more extension portions856. The one or more extension portions856can extend away from the permeable membrane830and/or the permeable support840such that the one or more extension portions856can be gripped by a user or caregiver without contacting the permeable membrane830. Thus, the one or more extension portions856can be used to remove the permeable membrane830and the impermeable layer850from the permeable support840. In some implementations, the one or more extension portions856can be shaped as an elongated tab that extends along the length of the assembly802on one or more sides of the assembly802. Although not shown, in some implementations, the permeable membrane830and/or the impermeable layer850can include a handle (not shown). The handle can be shaped as a hoop and disposed on one end of the permeable membrane830and/or the impermeable layer850to assist in positioning and removing the permeable membrane830and/or the impermeable layer850from the permeable support840and/or the reservoir810.

In some implementations, the permeable membrane830can be formed as a sheath with a closed end such that the permeable membrane830can be pulled over the permeable support840and the reservoir810like a sock. For example, the permeable membrane830can be heat sealed on one end. In such implementations, the impermeable layer850can be secured to a portion of the side and/or bottom of the permeable membrane830. In other implementations, the permeable membrane830can be formed as a sheath with two open ends that can be pulled over the permeable support840and the reservoir810. In such implementations, the end of the permeable membrane830near the reservoir810can be left uncovered, and the impermeable layer850can be secured to a portion of the side and/or the bottom of the permeable membrane830. In some implementations, the permeable membrane830can be a piece of material smaller than the external surface area of the permeable support840. The permeable membrane830can be heat sealed to the impermeable layer850such that the combination of the permeable membrane830and the impermeable layer850form a sheath that can be secured to permeable support840and/or the reservoir810via, for example, pulling over the permeable support840and/or the reservoir810like a sock.

In some implementations, the assemblies described herein can include internal structures to direct fluid flow and/or provide structural support. Additionally, in some implementations, the assemblies described herein can include a first end cap and a second end cap. For example, the assemblies described herein can include the features shown and described with respect toFIGS.10-13.FIGS.10and11are a perspective view of a first end943A and perspective view of a second end943B, respectively, of a permeable support940. The permeable support940can include a tunnel946and a spine948. The tunnel can define a first chamber941C. The spine948can divide an inner volume of the permeable support940into a second channel941A and a third channel941B. The first chamber941C, the second channel941A, and the third channel941B can each run the length of the permeable support940and run parallel to one another. The spine948can be used to strengthen the permeable support940such that the permeable support940maintains an intended shape. The permeable support940can include one or more openings (not shown) in a sidewall of the permeable support940. The one or more openings can be aligned with the second channel941A and the third channel941B such that fluid can flow through the one or more openings into the second channel941A and the third channel941B. Although only one spine948is shown, in some implementations, the permeable support940can include additional spines such that the permeable support940is divided into additional channels. In some implementations, the permeable support940can be formed without a spine such that the permeable support940only defines one channel in addition to the third channel941C defined by the tunnel946.

FIG.12is a perspective view of a first end cap945configured to be coupled to the first end943A of the permeable support940. The first end cap945includes a first flange949A, a second flange949B, and a third flange949C. The third flange949C defines an opening941D through the first end cap945. The first flange949A, the second flange949B, and the third flange949C can be shaped and sized such that the first flange949A, the second flange949B, and the third flange949C can be coupled within the third chamber941B, the second chamber941A, and the first chamber941C, respectively. In some implementations, the first flange949A, the second flange949B, and the third flange949C can be shaped and sized such that the first flange949A, the second flange949B, and the third flange949C are configured to engage with the third chamber941B, the second chamber941A, and the first chamber941C, respectively.

FIG.13is a perspective view of a second end cap947configured to be coupled to the second end943B of the permeable support940. The second end cap947includes a first flange949D, a second flange949E, and a third flange949F. The first flange949D, the second flange949E, and the third flange949F can be shaped and sized such that the first flange949D, the second flange949E, and the third flange949F can be coupled within the second chamber941A, the first chamber941C, and the second chamber941B, respectively. In some implementations, the second end cap947can be shaped and sized such that the second end cap947can sealingly engage with the first chamber941C, the second chamber941A, and the third chamber941B to prevent fluid leakage.

In an assembled configuration in which the first end cap945is coupled to the first end943A of the permeable support940and the second end cap947is coupled to the second end943B of the permeable support940, the second end cap947and/or the permeable support940can define a reservoir910for collection of fluid (e.g., urine). The third flange949C of the first end cap945can define an outlet for fluid collected within the reservoir910. In some implementations, an external tube can be inserted through the first end cap945via the opening941D defined by the third flange949C and through the third channel941C defined by the tunnel946until an end of the external tube reaches fluid in the reservoir defined by the second end cap947and/or the permeable support940. The external tube can then be used to remove the fluid via suction. In some implementations, an external tube can be coupled to the first end cap945, rather than extended through the first end cap945and into the permeable support940. In such embodiments, suction can be applied via the external tube such that fluid (e.g., urine) in the reservoir910can be transported via suction through the first channel941C and out of the opening941D. Although not shown, in some implementations, the second flange949C of the first end cap945can extend from both sides of the first end cap945such that the second flange949C can form a male fitting for an external tube such that the external tube can be coupled to the second flange949C.

In some implementations, the tunnel946can be formed such that a gap exists between the end of the tunnel946and the face of the second end cap947such that the tunnel946does not prevent fluid from flowing from the second channel941A and/or the third channel941B into the first channel941C. In some implementations, the tunnel946is formed such that the gap between the tunnel946and the face of the second cap947is small such that a large amount of fluid does not accumulate in the reservoir910before reaching a height capable of being suctioned via the tunnel946.

In some implementations, the first end cap945and/or the second end cap947can be rigid. The first end cap945and/or the second end cap947can be, for example, injection molded and formed of plastic, such as ABS or nylon. In some implementations, the first end cap945and/or the second end cap947can be flexible. In some implementations, the first end cap945and/or the second end cap947can be made of any suitable material using any suitable process.

In some implementations, the permeable support940can be formed of a soft material, such as, for example, polyurethane, polyethylene, or synthetic rubber. The permeable support940can be formed via an extrusion process. In some implementations, the material used to form the permeable support940can be coiled during the extrusion process such that the permeable support940has a curved shape to improve the fit of the permeable support940and/or a permeable membrane coupled to the permeable support940with a user's urethral opening and/or the region of a user's body surround the urethral opening. In some implementations, the permeable support940can be formed via injection molding. In some implementations, the permeable support940can be rigid or flexible, and can be formed of any suitable material or combination of materials.

In some implementations, a stabilizer can be used to maintain any of the assemblies described herein in a particular position relative to a user's body. For example,FIG.15is a perspective view of an assembly1102. The assembly1102can be the same or similar in structure and function to the assembly202described above with reference toFIG.3. As shown inFIG.15, a stabilizer1154is coupled to the assembly1102such that the stabilizer1154can maintain the assembly1102in a certain position relative to a user's body. For example, in some situations of use, such as incontinence, disability that limits or impairs mobility, restricted travel conditions (e.g., conditions experienced by pilots, drivers, and/or workers in hazardous areas), monitoring purposes, or for clinical testing, the stabilizer1154can aid in maintaining the engagement between the assembly1102and the user's urethral opening and/or the area surrounding the urethral opening. In some implementations, the stabilizer1154can be coupled to or integrally formed with an impermeable layer of the assembly1102. In some implementations, a first end of the stabilizer1154can be coupled to an impermeable layer of the assembly1102and a second end of the stabilizer1154can be coupled to a user's body (e.g., via adhesive or tape) or to an apparatus occupied by the user (e.g., a bed or wheelchair) to stabilize the position of the assembly1102relative to a user's urethral opening and/or the area surrounding the urethral opening. The stabilizer1154can be a thin, pliable strip of material. For example, in some implementations the stabilizer1154can include tape, gauze, cotton, cloth, or plastic. The stabilizer1154can be any suitable length and/or width. In some implementations, the stabilizer1154can be as thin as a single thread. The stabilizer1154can be attached to the user's body or an apparatus occupied by the user via any suitable attachment mechanism, such as via skin-safe adhesive, tape, a hook, tying the stabilizer1154into a knot, or any other suitable attachment mechanism.

In some implementations, the permeable membrane can include a web of flexible porous material. For example, as shown inFIG.16, a permeable support1240can be formed of a web of flexible porous material and shaped such that the permeable support1240defines a channel1240B. The flexible porous material can be, for example, spun plastic fibers. The spun plastic fibers can be, for example, spun polyester fibers such as is used in a typical scouring pad. The permeable support1240can have a tubular shape. The permeable support1240can be shaped such that the permeable support1240is cylindrical or non-cylindrical. As shown inFIG.17, which is a cross-section of the permeable support1240shown inFIG.16taken along the line17-17, the channel1240B can be shaped and configured to receive an outlet tube1220.

As shown inFIG.18, a permeable membrane1230can be coupled to the permeable support1240. The permeable membrane1230can be the same or similar in structure and/or function to any of the permeable membranes described herein. The permeable support1240can have a first closed end1243A and a second closed end1243B. The second closed end1243B and the bottom of the permeable support1240can collectively form a reservoir1210to collect fluid that enters the channel1240B via the permeable membrane1230and the permeable support1240. The outlet tube1220can be inserted into the channel1240B such that fluid that travels into the permeable support1240can be removed from the permeable support1240via the channel1240B and the outlet tube1220(via, for example, a vacuum source).

In some implementations, a web of flexible porous material can be in the form of a flexible sheet rolled or folded into a tubular shape. For example, as shown inFIG.19, a permeable support1340can include a flexible sheet formed of a web of flexible porous material and rolled or folded such that the permeable support1340defines a channel1340B. The flexible porous material can be, for example, spun plastic fibers. The spun plastic fibers can be, for example, spun polyester fibers such as is used in a typical scouring pad. The permeable support1340can be made to have a tubular shape by rolling a first end of the flexible sheet towards a second end of the flexible sheet such that the first end and the second end meet along an intersection plane identified by1340A. The permeable support1340can then be secured in this shape using securing elements1352. The securing elements1352can include any suitable securing element, such as, for example, adhesive or glue. In some implementations, rather than using one or more separate securing elements1352, the permeable support1340can be secured in a rolled or folded configuration via compression from a permeable membrane (e.g., the permeable membrane1330described below). The permeable support1340can be shaped such that the permeable support1340is cylindrical or non-cylindrical. As shown inFIG.20, which is a cross-section of the permeable support1340shown inFIG.19taken along the line20-20, the channel1340B can be shaped and configured to receive an outlet tube1320.

As shown inFIG.21, a permeable membrane1330can be coupled to the permeable support1340. The permeable membrane1330can be the same or similar in structure and/or function to any of the permeable membranes described herein. For example, the permeable membrane1330can include a wicking material wrapped around the permeable support1340. In some implementations, the permeable membrane1330can include a wicking material attached or sprayed onto the web of flexible porous material prior to folding the web into the tubular shape. The permeable support1340can have a first closed end1343A and a second closed end1343B. The second closed end1343B and the bottom of the permeable support1340can collectively form a reservoir1310to collect fluid that enters the channel1340B via the permeable membrane1330and the permeable support1340. The outlet tube1320can be inserted into the channel1340B such that fluid that travels into the permeable support1340can be removed from the permeable support1340via the channel1340B and the outlet tube1320(via, for example, a vacuum source).

FIGS.22-26are various views of an assembly1402shown in a variety of configurations. As shown inFIGS.22-24, which are a front view, back view, and side view of an assembly1402, respectively, in some implementations, the permeable support1440can be shaped as a flexible sheet. The flexible sheet can be formed of a porous flexible web of spun plastic fibers, such as, for example, spun polyester fibers such as is used in a typical scouring pad. In some implementations, polyester fibers are used due to their ability to remain odor free. In some implementations, the flexible sheet can be formed of any suitable type of fibers. An outlet tube1420can be attached to the permeable support1440via any suitable attachment mechanism. For example, the outlet tube1420can be attached to the permeable support1440via securement elements1452, such as, for example, adhesive tape.

The assembly1402can include an impermeable layer1450. As shown inFIG.25, which is a side view of the assembly1402including the impermeable layer1450, the impermeable layer1450can be coupled to the permeable support1440such that fluid traveling through the permeable support1440can be directed toward an end of the outlet tube1420. The impermeable layer1450can, in combination with the permeable support1440, define a reservoir1410for collection of fluid that has entered the assembly1402via the permeable support1440and traveled to the bottom of the assembly1402. For example, the bottom end of the impermeable layer1450and/or the bottom end of the permeable support1440can be a closed end such that fluid does not exit the assembly1402except via the outlet tube1420(via, for example, a vacuum source).

The assembly1402can also include a permeable membrane1430. As shown inFIG.26, which is a front view of the assembly1402, the permeable membrane1430can be disposed on the outer surface of the permeable support1440or on the outer surface of the permeable support1440and the backing1450. The permeable membrane1430can be the same or similar to any of the permeable membranes described herein.

In some implementations, the reservoir, the impermeable layer, and/or a portion of the outlet can be formed as an integral, one piece structure. For example,FIGS.27and28are a top view and a cross-sectional side view, respectively, of an impermeable casing1504. The impermeable casing1504includes an impermeable layer1550, an outlet1520, and a reservoir1510. The outlet1520and the reservoir1510are coupled together by the impermeable layer1550. The impermeable layer1550defines an elongated opening1504A. The outlet1520can be configured to receive tubing such that fluid can be removed from an interior of the impermeable casing1504via the tubing. The impermeable casing1504can be formed of a flexible and compliant, impermeable material, such as, for example, silicone and/or another polymer. Additionally, the impermeable casing1504can be curved such that, in a configuration in which the impermeable casing1504includes a permeable membrane and/or a permeable support, the impermeable casing1504can expose the permeable membrane for a comfortable and secure interface for engagement with a user's urethral opening.

In some implementations, the impermeable casing1504can be configured to contain a permeable membrane disposed over a permeable support. For example,FIG.29is a top view of a permeable support1540. The permeable support1540can define a number of inlets1542. The inlets1542can be symmetrical or non-symmetrical across the permeable support1540. In some implementations, the permeable support1540can be formed of a porous spun plastic or plastic netting material. The permeable support1540can be flexible and compliant. In some implementations, the permeable support1540can be formed of flexible polypropylene, nylon, polyester, another plastic, a natural material, and/or any other suitable material. As shown inFIG.30, the permeable support1540can be folded or rolled into a tubular shape. As shown inFIG.31, the permeable support1540can be covered with a permeable membrane1530. For example, the permeable support1540can form a flexible framework over which the permeable membrane1530can fit snugly.

The permeable support1540in combination with the permeable membrane1530can be disposed within the interior of the impermeable casing1504such that the permeable support1540can maintain the permeable membrane1530against or near a source of moisture (e.g., a urethral opening) through the elongated opening1504A. The permeable membrane1530and the permeable support1540can be positioned within the impermeable casing1504using any suitable method. For example, in some implementations, the permeable membrane1530can be pulled over or wrapped around the permeable support1540. The combination of the permeable membrane1530and the permeable support1540can then be inserted through the elongated opening1504A of the impermeable casing1504and the impermeable casing1504can be stretched and/or otherwise maneuvered such that the impermeable casing1504surrounds the permeable membrane1530except in the area of the elongated opening1504A.

In some implementations, the permeable membrane1530(e.g., a tubular gauze) can first be disposed over a hollow plastic pipe (not shown). The pipe covered with the permeable membrane1530can be inserted through the opening1520of the impermeable casing1504such that the permeable membrane1530is positioned within the impermeable casing1504. The permeable support1540can then be formed into a configuration such that the permeable support1540can function as a hollow framework for the permeable membrane1530(e.g., a tubular or cylindrical shape as shown inFIG.30). The permeable support1540can then be inserted through the pipe and/or the opening1520such that the permeable support1540is coextensive and arranged within the permeable membrane1530. The pipe can then be removed from the permeable membrane1530and the permeable support1540via the opening1520while the permeable membrane1530and the permeable support1540are grasped such that the permeable membrane1530and the permeable support1540remain within the impermeable casing1504.

In some implementations, the permeable membrane1530(e.g., a tubular gauze) can first be disposed over a hollow plastic pipe (not shown). The permeable support1540can then be formed into a configuration such that the permeable support1540can function as a hollow framework for the permeable membrane1530(e.g., a tubular or cylindrical shape as shown inFIG.30). The permeable support1540can then be inserted through the pipe such that the permeable support1540is coextensive and arranged within the permeable membrane1530. The pipe can then be removed from the permeable membrane1530and the permeable support1540while the permeable membrane1530and the permeable support1540are grasped such that the permeable membrane1530and the permeable support1540remain within the impermeable casing1504. If the permeable membrane1530is longer than necessary, such as if the permeable membrane1530is longer than the permeable support1540, the permeable membrane1530can be cut (e.g., with scissors) to the desired length. The permeable membrane1530in combination with the permeable support1540can then be inserted into the impermeable casing1504via the elongated opening1504A.

In some implementations, the permeable membrane1530can be attached to the permeable support1540via an adhesive or adhesive tape. In some implementations, the permeable membrane1530can be attached to the permeable support1540via compression from the impermeable casing1504. For example, the permeable membrane1530can be wrapped around the permeable support1540and inserted into the impermeable casing1504such that the impermeable casing1504applies compression to the permeable membrane1530and the permeable support1540such that the permeable membrane1530and the permeable support1540each maintain their shape and attachment to each other. In some implementations, the permeable membrane1530can be secured to the permeable support1540by compression as a result of the permeable membrane1530having elastic properties. For example, the permeable membrane1530can include tubular compression gauze that can be applied to the permeable support1540as a sleeve.

FIG.32is a cross-sectional illustration of an assembly1602. The assembly1602includes an impermeable casing1604. The impermeable casing1604can be the same or similar in structure and/or function to the impermeable casing1504described above with respect toFIGS.27and28. For example, the impermeable casing1604can include a reservoir1610, an impermeable backing1650, and an outlet1620. Additionally, the assembly1602can include a permeable membrane1630and a permeable support1640. The permeable membrane1630and the permeable support1640can be the same or similar in structure and function to and of the permeable membranes and permeable supports, respectively, described herein. For example, the permeable membrane1630can be a ribbed knit fabric sleeve and the permeable support1640can be formed of spun plastic (e.g., non-woven permeable webbing) shaped as a tube. Thus, the assembly1602can be pliable and/or flexible such that the assembly1602can conform to differently shaped and/or sized users to ensure effective and secure placement of the assembly1602. The assembly1602can include a tube1621associated with the outlet1620such that fluid in the reservoir1610can be removed through the tube1621and out of the outlet1620via, for example, a vacuum source (not shown).

FIG.33is a cross-sectional side view of the assembly1602engaged with a female body. As shown inFIG.33, the assembly1602can be arranged near the urethra such that the elongated opening1604A of the assembly1602is facing the urethral opening. Additionally, the assembly1602can be placed between the labia of the user and held snugly against or near the urethra by the pressure of friction from the user's body. Additionally, as shown inFIG.33, the assembly1602can be curved such that the assembly1602provides a comfortable and secure interface for engagement with a user's urethral opening and the surrounding area of the user's body, with the elongated opening on the inside of the curve. Thus, upon the voiding of urine from the user's body, the urine can flow into the assembly1602via the elongated opening1604A, the permeable membrane1630, and an inlet of the permeable support1640. The urine can then flow to the reservoir1610of the assembly1602due to gravity and/or suction provided by a vacuum source via the tube1621. The suction provided by the vacuum source can then draw the urine from the reservoir1610, through the tube1621, and out of the assembly1602.

The assembly1602can have any suitable dimension such that the assembly1602can be configured to engage with the urethral opening and/or the area surrounding the urethral opening of users of different sizes and/or anatomical structures. For example, in some embodiments, the impermeable casing1604can range from about 7 inches to about 8 inches in length (i.e. from a tip of the reservoir1610to the opening in the outlet1620). In some embodiments, such as for larger patients, the impermeable casing1604can range from about 9 inches to about 10 inches in length. In some embodiments, such as for smaller adult patients or children, the impermeable casing1604can range from about 3 inches to about 5 inches in length. In some embodiments, the impermeable casing1604can range from about 3 inches to about 10 inches in length. The elongated opening1604A can range from about 5 inches to about 6 inches in length. In some embodiments, the diameter of the impermeable casing1604can be about 1 inch. In some embodiments, the diameter of the impermeable casing1604can range from about 0.5 inches to about 1.5 inches in diameter. The elongated opening1604A can have a width of about 1 inch and a depth of about 0.5 inches relative to the height (i.e. diameter) of the impermeable casing1604. The permeable support1640can have a diameter of about 0.875 inches. The outlet1620can be about 0.25 inches long and about 0.5 inches wide. The opening of the outlet1620can have a diameter of about 0.375 inches. Additionally, the tube1621can have a diameter of about 0.375 inches.

Additionally, the assembly1602can include any suitable curve such that the assembly1602can engage with a user's urethral opening and/or area surrounding the urethral opening. For example, in some embodiments, the assembly1602and/or the impermeable casing1604can have an angle of curvature of about 40°. In some embodiments, the assembly1602and/or the impermeable casing1604can have an angle of curvature of about 60°. In some embodiments, the assembly1602and/or the impermeable casing1604can have a radius of curvature ranging from about 6 inches to about 10 inches.

In some embodiments, the permeable membrane1630and/or the permeable support1640can be disposed fully within the impermeable casing1604such that the permeable membrane1630and/or the permeable support1640does not extend through the elongated opening1604A. In some embodiments, the permeable membrane1630and/or the permeable support1640can be disposed within the impermeable casing1604such that a portion of the permeable membrane1630and/or a portion of the permeable support1640extends through the elongated opening1604A.

FIG.34is an exploded view of the components of an assembly1802. The assembly1802can be the same or similar in structure and/or function to the assembly1602described above. For example, the assembly1802includes an impermeable casing1804. The impermeable casing1804can be the same or similar in structure and/or function to the impermeable casing1604and/or the impermeable casing1504. The impermeable casing1804can include a reservoir1810, an impermeable backing1850, and an outlet1820. Additionally, the assembly1802can include a permeable membrane1830and a permeable support1840. The permeable membrane1830and the permeable support1840can be the same or similar in structure and function to and of the permeable membranes and permeable supports, respectively, described herein. For example, the permeable membrane1830can be a ribbed knit fabric sleeve and the permeable support1840can be formed of a flexible sheet of spun plastic (e.g., non-woven permeable webbing) that can be folded or rolled such that the permeable support1840is shaped as a tube. Thus, the assembly1802can be pliable and/or flexible such that the assembly1802can conform to differently shaped and/or sized users to ensure effective and secure placement of the assembly1802. The assembly1802can include a tube1821associated with the outlet1820such that fluid in the reservoir1810can be removed through the tube1821and out of the outlet1820via, for example, a vacuum source (not shown).

As shown inFIG.35, which is a side view of the assembly1802in an assembly configuration, the permeable support1840can be folded or rolled such that its shape is changed from a sheet to a tube. The permeable membrane1830can be pulled over the permeable support1840. The combination of the permeable membrane1830and the permeable support1840can then be inserted through the elongated opening1804A of the impermeable casing1804and the impermeable casing1804can be stretched and/or otherwise maneuvered such that the impermeable casing1804surrounds the permeable membrane1830except in the area of the elongated opening1804A. The tubing1821can be inserted through the outlet1820such that it is disposed within a channel defined by the permeable support1840with one end in the reservoir1810. In some implementations, the tubing1821can be inserted into a channel defined by the permeable support1840prior to inserting the permeable support1840and the permeable membrane1830through the elongated opening1804A. The tubing1821can be threaded through the elongated opening1804A and through the opening1820, and the reservoir1810of the impermeable backing1804can be pulled around the opposite end of the tubing1821, the permeable support1840, and the permeable membrane1830.

In some implementations, an impermeable layer can define one or more vacuum relief openings. For example,FIG.40is a back view of an impermeable casing2004. The impermeable casing2004can be the same or similar to the impermeable casing1804shown in and described with reference toFIGS.34and35. The impermeable casing2004can include a reservoir2010, an impermeable backing2050, and an outlet2020. The impermeable casing can also include a vacuum relief opening2058. Thus, in the event that a user's body envelopes an assembly including the impermeable layer2050, such as an assembly the same or similar to assembly1802, the one or more vacuum relief openings2058can prevent suction from increasing against the skin of the user, which may be uncomfortable or painful. For example, the impermeable casing2004can define an elongated opening (not shown) the same or similar to the elongated opening1804A described above. The vacuum relief opening2058can be located between two ends of the impermeable casing2004such that at least one additional airflow path exists in the assembly in the event that the user's body obstructs a portion of or the entire elongated opening. Although shown as being located near the outlet2020, the vacuum relief opening2058can be disposed at any suitable location on the impermeable layer2050. In some implementations, the one or more vacuum relief openings2058can be disposed in a location that reduces the likelihood that the skin of the labia or the thigh of the user inadvertently covers the hole, such as a location near the outlet2020. Additionally, the impermeable casing2004can include any suitable number of vacuum relief openings2058.

In some implementations, rather than including an impermeable casing, an assembly can include an impermeable backing that includes adhesive tape. For example,FIG.36is an exploded view of an assembly1702. The assembly1702includes a reservoir1710, a permeable support1740, a permeable membrane1730, and a tube1721. The assembly1702can be similar in structure and/or function to the assembly1602described above with reference toFIGS.32and33. For example, the permeable membrane1730and the permeable support1740can be the same or similar to any of the permeable membranes and permeable supports described herein. For example, the permeable support1740can be a flexible sheet of spun plastic (e.g., non-woven permeable webbing). Thus, the assembly1702can be pliable and/or flexible such that the assembly1702can conform to differently shaped and/or sized users to ensure effective and secure placement of the assembly1702. In some implementations, the permeable membrane1730can be a ribbed knit fabric sleeve. Additionally, the tube1721can be associated with an outlet (e.g., the outlet1720inFIG.38) for drawing fluid out of the reservoir1710and into an external receptacle (such as external receptacle160shown and described with respect toFIG.1). The reservoir1710can include a flexible cap and can be configured to be attached to the permeable membrane1730and/or the permeable support via an impermeable backing (e.g., the impermeable backing1750inFIG.28).

As shown inFIG.37, which is a side view of a partially assembled assembly1702, the permeable support1840can be folded or rolled such that its shape is changed from a sheet to a tube. The permeable support1840can then be inserted into the reservoir1710(e.g., a flexible cap). The tube1721can be inserted through a channel formed by the permeable support1840and into the reservoir1710.

As shown inFIG.38, the assembly1702can include an impermeable backing1750that includes adhesive tape. The impermeable backing1750can include two securing portions1752A and1752B connected by a backing portion1753. The securing portions1752A and1752B in combination with the backing portion1753can define an elongated opening1704A through which a fluid (e.g., urine) can travel into the assembly1702. Additionally, the securing portion1752A can be used to secure the reservoir1710to the backing portion1753, the permeable membrane1730, and/or the permeable support1740(shown inFIGS.36and37). In some implementations, the securing portion1752B in combination with the tube1721can form a portion of or all of the outlet1720. Thus, the impermeable backing1750can direct fluid flow through the assembly1702such that fluid that enters the permeable membrane1730and the permeable support1740via the elongated opening1704A does not exit the assembly1702except via the tube1721. In use, the fluid can flow due to gravity and/or suction toward the reservoir1710and be contained by the reservoir1710and the impermeable backing1750. The tube1721can then be used to draw the fluid out of the assembly1702(via, for example, a vacuum source). Additionally, the impermeable backing1750can assist in limiting the area of the permeable membrane1730experiencing suction from a vacuum source such that the pressure differential is stronger and fluid can be drawn through the permeable membrane1730efficiently.

FIG.39is a flowchart illustrating a method of using an assembly to collect urine from a user, according to an embodiment. The method1900optionally includes, at1902, fluidically coupling the discharge end of the tube of the urine collecting apparatus to a fluid receptacle. Method1900optionally further includes, at1904, fluidically coupling the discharge end of the tube of the urine collecting apparatus to a source of vacuum. Method1900further includes, at1906, disposing in operative relationship with the urethral opening of a female user (e.g. human or animal) the urine collecting apparatus. The urine collecting apparatus can be the same or similar in structure and/or function to any of the urine collecting apparatus described herein, such as, for example, the assembly102inFIG.1. For example, the urine collecting apparatus can include a fluid impermeable casing, a fluid permeable support, a fluid permeable membrane, and a tube. The fluid impermeable casing can have a fluid reservoir at a first end and a fluid outlet at a second end. A longitudinally extending fluid impermeable layer can be coupled to the fluid reservoir and the fluid outlet and can define a longitudinally elongated opening between the fluid reservoir and the fluid outlet. The fluid permeable support can be disposed within the casing with a portion extending across the elongated opening. The fluid permeable membrane can be disposed on the support and can cover at least the portion of the support that extends across the elongated opening, so that the membrane is supported on the support and disposed across the elongated opening. The tube can have a first end disposed in the reservoir and a second fluid discharge end. The tube can extend behind at least the portion of the support and the portion of the membrane disposed across the elongated opening and can extend through the fluid outlet to the second fluid discharge end. The operative relationship can include the opening being adjacent to the urethral opening of the female user.

The method1900also includes, at1908, allowing urine discharged from the urethral opening to be received through the opening of the fluid impermeable layer, the membrane, the support, and into the reservoir.

The method1900also includes, at1910, allowing the received urine to be withdrawn from the reservoir via the tube and out of the fluid discharge end of the tube.

The method1900optionally includes, at1912, removing the urine collecting apparatus from the operative relationship with the urethral opening of the user.

Finally, the method1900optionally includes, at1914, disposing a second urine collecting apparatus in operative relationship with the urethral opening of the user.

In some embodiments, the support and casing can be cylindrical and can have a curved shape with the elongated opening disposed on the inside of the curve. The disposing can include disposing the urine collecting apparatus with the elongated opening adjacent the urethral opening of the user and oriented with the reservoir proximal to the user's anus and the outlet disposed above the urethral opening.

In some embodiments, an assembly (such as, for example, the assembly1602shown inFIG.32) can have a curved shape that is defined or maintained at least in part by a shape-retaining member. In some embodiments, the shape-retaining member can be implemented as a tube with an intake end positioned within a reservoir such that the tube extends from the reservoir and through at least a portion of a permeable support, similar to, for example, the tube1621shown with respect toFIGS.32and33, that has a precurved shape such that at least a portion of an assembly including the tube will also have a similar or corresponding precurved shape. For example, as shown inFIG.41, a tube2121is precurved. The tube2121can be the same or similar in structure and/or function to any of the tubes described herein, such as the tube1621, the tube1721, and/or the tube1821. The tube2121can be precurved to any suitable curved shape (e.g., any suitable angle of curvature) such that, for example, an assembly including the tube2121can engage with a user's urethral opening and/or an area surrounding the urethral opening.

In some implementations, the tube2121can be initially formed such that it has an uncurved (i.e., straight) overall shape. The tube2121can then be curved via, for example, heat setting. Said another way, the tube2121can be formed of a stiff or rigid material, such as a stiff plastic, in a straight shape. The tube2121can be heated such that the tube2121is softened, and then the tube2121can be bent to a predefined curved shape. After being curved, the tube2121can be cooled such that the tube2121hardens.

In some implementations, the tube2121can be precurved by initially forming the tube2121such that the tube2121has a straight shape and then bending the tube2121beyond the elastic limit of the tube2121such that the tube2121has a preset curve. For example, the tube2121can be formed of a material such as metal that will retain a curved shape after being bent to the curved shape.

In some embodiments, an assembly (such as, for example, the assembly1602shown inFIG.32) can have a curved shape that is defined or maintained at least in part by a shape-retaining member that is separate from the tube that has an intake end in the reservoir. Thus, the assembly can have both a tube and a separate shape-retaining element for maintaining the assembly or a portion of the assembly in a precurved shape. For example, as shown inFIG.42, a shape-retaining element2251can have a precurved shape. The shape-retaining element2251can be formed of, for example, a strip of semi-rigid material. The shape-retaining element2251can be attached to any suitable portion of the assembly. For example, in some implementations, the shape-retaining element2251can be attached to an inner surface of an impermeable layer, such as impermeable layer1650. In some implementations, the shape-retaining element2251can be disposed between an impermeable layer (e.g., the impermeable layer1650) and a permeable support (e.g., the permeable support1640) and/or a permeable membrane (e.g., the permeable membrane1630). In some implementations, the shape-retaining element2251can be attached to an outer surface of an impermeable layer (e.g., the impermeable layer1650) or can be imbedded in an impermeable layer (e.g., the impermeable layer1650).

In some embodiments, a tube with an intake end positioned within a reservoir such that the tube extends from the reservoir and through at least a portion of a permeable support, similar to, for example, the tube1621shown with respect toFIGS.32and33, can have a beveled intake end (i.e. a beveled reservoir end). As shown inFIG.43, a tube2321includes a beveled intake end2323. The tube2321can be the similar in structure and/or function to any of the tubes described herein, such as, for example, the tube1621, the tube1721, the tube1821and/or the tube2121. The beveled intake end2323can prevent blockage of the tube2321in operation. For example, the beveled intake end2323can increase the size of an intake opening2325of the tube2321such that the intake opening2325is less likely to be blocked by an obstruction. Additionally, the beveled intake end2323can prevent the tube2323from becoming obstructed at the intake end by the material forming the reservoir. For example, in assemblies in which the reservoir is formed by a flexible and/or pliable material as part of a casing, such as the reservoir1810of casing1804inFIG.35, the suction resulting from the vacuum through the tube1821and/or force applied to the outside of the reservoir may cause the material of the reservoir1810to move toward the intake end of the tube1821and obstruct and/or seal the intake end of the tube1821, preventing the flow of fluid through the intake end of the tube1821. A beveled intake end of the tube2321can prevent this obstruction from occurring due to the angled tip. Even if a portion of a reservoir (e.g.,1810) flexes into contact with the distal end of the tube2321, the intake opening2325can remain at least partially or completely unobstructed.

In some embodiments, an assembly can include a casing that includes a channel defined in a sidewall of the casing, instead of the tube extending within the casing, as disclosed in many of the previous embodiments. For example,FIG.44Ais a cross-sectional side view of a casing2404. The casing2404can be similar in structure and/or function to any of the casings described herein, such as, for example, the casing1604shown inFIG.32. For example, casing2404can include a reservoir2410and an impermeable backing2450. The casing2404can include a closed end2499opposite the reservoir2410. In some embodiments, as shown inFIG.44A, the casing2404can include an impermeable external wall2451, such that the impermeable backing2450and the external wall2451collectively define a channel2490. For example,FIG.44B, which is a schematic illustration of a cross-section of the casing2404taken along the line44B-44B inFIG.44A, shows the channel2490defined between the external wall2451and the impermeable backing2450. The impermeable backing2450can define an opening2480such that the channel2490can be in fluidic communication with the reservoir2410via the opening2480. For example,FIG.44C, which is a schematic illustration of a cross-section of the casing2404taken along the line44C-44C inFIG.44A, shows the opening2480defined in the impermeable backing2450such that fluid can flow from the reservoir2410, through the opening2480, and into the channel2490. AlthoughFIGS.44A-44Dshow the opening2480disposed at the point of line44C-44C (i.e., near or in the reservoir2410), in some embodiments one or more openings similar in structure and/or function to opening2480can be disposed at one or more other positions along the impermeable backing2450that are suitable for forming a fluidic connection between the channel2490and the reservoir2410.FIG.44D, which is a schematic illustration of a bottom view of the impermeable backing2450(i.e., without the external wall2451attached), similarly shows the opening2480defined in the impermeable backing2450near the reservoir2410.

The channel2490can extend along the length of the casing2404, as shown, from the opening2480to an outlet2420such that fluid in the reservoir2410can be removed via the opening2480through the channel2490via, for example, a vacuum source (not shown) coupled to the outlet2420. Although shown as having a crescent shape, the channel2490can be formed in any suitable shape. For example, the channel2490can be tubular. In some implementations, as shown inFIG.44A, a tube2429can be coupled to or integrally formed with the casing2404such that the tube2429defines an additional length of the channel2490and thus the outlet2420is disposed at a distance from the impermeable backing2450. In some implementations, the outlet2420may be disposed proximal to the closed end2499of the casing. In some implementations, the tube2429and the other components of the casing2404can be formed as an integral, one-piece structure, as shown inFIG.44A. In some implementations, the external wall2451at least partially defining the channel2490and/or the tube2429can be separately formed and attached to the impermeable backing2450and/or the closed end of the casing2499via, for example, adhesive or tape.

The casing2404can be made from material similar in structure and/or function to any of the casings described herein, such as, for example, the casing1504shown inFIG.27, the casing1604inFIG.32and/or the casing1804shown inFIG.35, such that the assembly can withstand the pressure differential needed to draw fluid voided from the urethral opening of a user into a permeable support (not shown) housed within the casing2404and into the reservoir2410without collapsing. The casing2404, the channel2490and/or the tube2429may include spines or other suitable structures to reinforce their structural integrity. The casing2404, and in particular the impermeable backing2450and the external wall2451defining the channel2470, can be made of a material and formed so as to be able to withstand the pressure differential needed to remove collected fluid from the reservoir2410through the channel2490via the opening2480, through the outlet2420, and into an external receptacle (not shown). Thus, the impermeable backing2450and the external wall2451can be made of a material sufficiently strong or rigid such that the channel2490can remain open and unobstructed when coupled to a vacuum source.

In some embodiments, rather than the channel being collectively defined by an external wall and an impermeable backing, the assembly can include an external tube defining a channel. For example,FIG.45is a cross-sectional illustration of an assembly2500. The assembly2500can include a casing2504. The casing2504can be similar in structure and/or function to any of the casings described herein, such as, for example, the casing2404shown inFIG.44A. For example, casing2504can include a reservoir2510and an impermeable backing2550. The casing2504can include a closed end2599opposite the reservoir2510. The impermeable backing2550and/or the reservoir2510can define an opening2580. The assembly2500can include an outlet tube2528defining a lumen. The outlet tube2528can be disposed on the casing2504such that the outlet tube2528extends from the opening2580and the lumen of the outlet tube2528is in fluid communication with the opening2580and the reservoir2510. The outlet tube2528may be made of flexible or rigid material. The casing2504and the outlet tube2528can be formed together as an integral piece or formed separately and connected using any suitable coupling mechanism such as, for example, tube fittings, adhesive, and/or tape. Although in the embodiment shown inFIG.45the opening2580is disposed in the reservoir2510, in other embodiments one or more openings similar in structure and/or function to the opening2580can be disposed at other position(s) along the impermeable backing, and an outlet tube such as the outlet tube2528can be coupled to each of the one or more openings.

In some implementations, the assembly2500can include an external tube2522defining a channel. The outlet tube2528can be coupled to the external tube2522such that the channel of the external tube2522is in fluidic communication with the lumen of the outlet tube2528(and, thus, the reservoir2510). The outlet tube2528can have any suitable length for fluidically coupling the reservoir2510with the external tube2522. The outlet tube2528can be secured to the external tube2522using any suitable coupling mechanism such as, for example, a leak-proof tube connecting apparatus, adhesive, and/or tape. In some implementations, the external tube2522can be fluidically coupled to a vacuum source (not shown) such that fluid can be evacuated from the reservoir2510via suction created by the vacuum source. The outlet tube2528(and the casing2504if formed integrally with tube2528) can be made from material similar in structure and/or function to any of the casings described herein, such as, for example, the casing2404shown inFIG.44A, such that the assembly can withstand the pressure differential needed to draw urine voided from the urethral opening of a user into a permeable support (not shown) housed within the casing2504, into the reservoir2510, through the outlet tube2528via the opening2580, and through the external tube2522connected to an external receptacle (not shown).

In some embodiments, rather than including a permeable membrane disposed on a permeable support, the permeable support can be formed of a material that provides the functions of both the permeable membrane and the permeable support. For example,FIGS.46and47are a side view and an exploded view, respectively, of an assembly2602, according to an embodiment. The assembly2602includes a permeable support2640, a tube2621, and a casing2604. The permeable support2640can be formed of a material that includes the at least some of the features and/or provides at least some of the functions of both the permeable membrane and permeable support of embodiments described above. The assembly2602can otherwise be the same or similar in structure and/or function to the any of the embodiments described above. For example, the impermeable casing2604can be the same or similar in structure and/or function to the impermeable casings1504,1604,1804,2004,2404, and/or2504. The impermeable casing2604can include a reservoir2610, an impermeable backing2650, and an outlet2620. Additionally, the impermeable casing2604can define an elongated opening2604A.

As noted above, the permeable support2640can be the same or similar in function to the permeable membranes and/or the permeable supports, respectively, described in the previous embodiments. The permeable support2640, however, can be formed of a single material that meets the functional requirements and/or includes the functional benefits of the materials of both the permeable membranes and the permeable supports of the previous embodiments. Specifically, the material of which permeable support2640is formed can have sufficient structural integrity to serve as a permeable support for the casing2604, sufficient porosity and/or permeability to allow urine to pass freely through the permeable support2640, and/or sufficient loft and resiliency to extend to or out of the elongated opening2604A. The permeable support2640can also be sufficiently pliable and/or flexible such that the assembly2602can conform to differently shaped and/or sized users to ensure effective and secure placement of the assembly2602.

In addition, the material of which the permeable support2640is formed can have an exterior surface that provides the same functions as the permeable membranes of the previous embodiments. Thus, the permeable support2640can be urine permeable and can have wicking properties. Specifically, the permeable support2640can have a high absorptive rate and a high permeation rate such that urine can be rapidly absorbed and/or transported therethrough. The permeable support2640can be soft and/or minimally abrasive such that it does not irritate the skin of the user. Additionally, the permeable support2640can wick fluid away from the urethral opening and/or the skin of the user such that the dampness of the skin of the user is lessened and infections are prevented. The permeable support2640can also be sufficiently permeable and/or have sufficient wicking ability to help prevent urine from leaking or flowing beyond the assembly onto, for example, a bed.

The material of which the permeable support2640is formed can be in the form of a flexible sheet rolled or folded into a tubular form, for example, as shown inFIG.47and in the illustration inFIG.48. Alternatively, the permeable support2640can be formed as a cylinder such that the permeable support2640has the desired shape without rolling or folding. The permeable support2640can be made from, for example, polyester, recycled polyester fleece, and/or nylon knit mesh. The permeable support2640can be secured within a hollow casing (for example, the casing2604shown inFIGS.46and47) by inserting the permeable support2640into the casing via an elongated opening of the casing (e.g., elongated opening2604A of the casing2604). In some implementations, the permeable support2640may be affixed to a casing such as the casing2604by using any suitable means, such as, for example, using adhesive, glue, and/or tape.

In use, once inserted and positioned against the impermeable backing2650, the assembly2602may be positioned relative to a user such that the surface of the permeable support2640contacts the urethral opening of the user. Urine can be drawn through the permeable support2640such that the urine collects in the reservoir2610. The urine can then be drawn from the reservoir2610via the tube2621and through the outlet2620using, for example, an external vacuum source (not shown). The material of which permeable support2640is formed may be compressible. The material can also have sponge-like properties such that the material can maintain shape when wet, thereby maintaining contact with the user during a urination event via a slight protrusion of the permeable support2640outside the casing2604via the elongated opening2604A. While the permeable support2640is shown with casing2604inFIGS.46and47for illustration purposes, the permeable support2640can be used in conjunction with any of the assemblies or casings shown or described herein, such as, for example, the assembly802ofFIG.9, the assembly ofFIG.18, the casing1504ofFIG.27, the casing1604ofFIG.32, the casing1804ofFIGS.34-35, the assembly1702ofFIGS.37-38, the casing2004ofFIG.40, the casing2404ofFIG.44A, and/or the casing2504inFIG.45.

In some embodiments, rather than including an outlet tube as shown and described with respect to assembly2500inFIG.45, an assembly can include an outlet tube inserted partially into the reservoir and extending away from the assembly. For example,FIG.49Ais a lengthwise cross-sectional view of an assembly2702. The assembly2702can include a casing2704, a permeable support2740, and a permeable membrane2730. The assembly2702can be similar in structure and/or function to any of the assemblies described herein, such as, for example, the assembly102shown and described with respect toFIG.1, the assembly1802shown and described with respect toFIG.35, and/or the assembly2602shown and described with respect toFIG.46. Specifically, the casing2704can be similar in structure and/or function to any of the casings described herein, such as, for example, the casing1504shown and described with respect toFIGS.27and28, the casing1804shown and described with respect toFIG.34, the casing2004shown and described with respect toFIG.40, the casing2404shown and described with respect toFIG.44Aand/or the casing2504shown and described with respect toFIG.45. The casing2704can include, for example, an impermeable backing2750, a reservoir2710, a closed end2799opposite the reservoir2710, and an opening2780defined by the impermeable backing2750and/or the reservoir2710. The casing2704can be made with or without a precurved form. For example, in some implementations, the casing2704can be precurved such that the casing2704is concave or convex. Although shown as including a separate permeable membrane2730and permeable support2740, in some embodiments the assembly2702can include a permeable support2740made of a material such that the permeable support2740can include some or all of the functions of any of the permeable membranes described herein. In such embodiments, the assembly2702can include only a permeable support and not a separate permeable membrane disposed on the permeable support.

The assembly2702can include an outlet tube2726that can be inserted into the casing2704through the opening2780such that the inserted open end of the tube2726can be disposed within the reservoir2710. In such an arrangement, a lumen of the tube2726can be in fluidic communication with the reservoir. An exemplary casing2704with a mounted outlet tube2726is shown in cross-sectional view inFIG.49B. The outlet tube2726can be made of flexible or rigid material. As shown inFIG.49Band in the cross-sectional view taken along line49C-49C shown inFIG.49C, the outlet tube2726can extend along the outside of and away from the casing2704. The outlet tube2726can have any suitable length such that the outlet tube2726is suitable for the extraction of fluid from the reservoir2710. The outlet tube2726can be secured to the casing2704through any leak-proof coupling mechanism, for example by using pressure insertion through the opening2780, or by using the stiction properties of the tube2726and the casing2704. In some implementations, the outlet tube2726can be secured to the casing2704due to the reservoir end of the outlet tube2726having a larger diameter than the opening2880A. In some implementations, the outlet tube2726can be secured to the casing2704via, for example, a leak-proof fastening mechanism such as, for example, adhesive and/or tape. In some implementations, the outlet tube2726can be directly coupled to an external receptacle (e.g., the external receptacle160) such that urine collected in the reservoir can be transported to the external receptacle via the outlet tube2726. In some implementations, the outlet tube2726can be coupled to an external receptacle via another tube (not shown) coupled to the outlet tube2726. In some implementations, a vacuum source can be used to assist in drawing fluid from the reservoir2710via the outlet tube2726.

AlthoughFIG.49Ashows the opening2780disposed in or near the reservoir2710, in other embodiments one or more openings similar in structure and/or function to the opening2780can be disposed at one or more other positions along the length of the impermeable backing2750as well as laterally along the width of the impermeable backing2750such that a tube such as the outlet tube2726can be inserted and secured in each of the one or more openings of the casing2704. For example, as shown inFIG.50A, the assembly2802includes a first tube2826A and a second tube2826B. The assembly2802can be similar in structure and/or function to any of the assemblies described herein. For example, the assembly2802can include a casing2804defining an elongated opening2804A, an impermeable backing2850, a reservoir2810, and a closed end2899opposite the reservoir end.FIG.51shows a shallow angled perspective view of the assembly2802with the first tube2826A and the second tube2826B coupled to the casing2804. As shown inFIGS.50A and51, the casing2804can define a first opening2880A and a second opening2880B (shown inFIG.51) defined in the impermeable backing2850through which the first tube2826A and the second tube2826B, respectively, can be inserted. For example, as shown in phantom inFIG.50A, the reservoir end of the tube2826A can be inserted through the opening2880A into the reservoir2810. The portion of each of the first tube2826A and the second tube2826B disposed within the casing can be of any suitable length that allows proper extraction of fluid collected in the reservoir without any obstruction to the open tips of the first tube2826A and the second tube2826B. The open tips of the first tube2826A and the second tube2826B can be disposed within the reservoir2810such that fluid can flow from the reservoir2810during use without obstruction or interference by the casing2804with the assistance of, for example, vacuum suction or gravity.

In some implementations, the two openings2880A and2880B can be disposed at any suitable location along the length and width of the casing2804such that there may be sufficient spatial separation between the reservoir ends of the first tube2826A and the second tube2826B for maximal and effective extraction of urine collected in the reservoir2810during use of the assembly2802. Additionally, the two openings2880A and2880B may be positioned such that proper coupling between the first tube2826A, the second tube2826B, and the casing can be ensured.

The assembly2802can be fashioned such that the outlet tubes2826A and2826B extend along the outside of the casing2804as shown inFIG.50B, which is a cross-sectional view taken along the line50B-50B inFIG.50A. The assembly2802can include a permeable support2840and a permeable membrane2830, and can be positioned such that a portion of the permeable membrane2830extends through the elongated opening2804A and against or near the urethral opening of the user. In some implementations, the tubes2826A and2826B can be directly coupled to an external receptacle (e.g., the external receptacle160) such that urine collected in the reservoir can be transported to the external receptacle via the tubes2826A and2826B. In some implementations, the tubes2826A and2826B can be coupled to an external receptacle via an external tube2822(shown inFIG.51) coupled to the tubes2826A and2826B. The tubes2826A and2826B can be connected to the external tube2822using any coupling mechanism that allows leak-proof connection, such as, for example, tube fittings, adhesive, or tape. In some implementations, a vacuum source can be used to assist in drawing fluid from the reservoir2810via the tubes2826A and2826B. The positioning, structure and material of the tubes2826A and2826B, external tube2822, and the casing2804can be such that the assembly2802allows for free flow of fluid from a urethral opening of a user, through the permeable membrane2830, through the permeable support2840, into the reservoir2810, through the openings2880A and2880B, and through the tubes2826A and2826without obstruction of the open reservoir ends of the tubes2826A and2826B. Additionally, the assembly2802can withstand the pressure differential due to the application of vacuum suction to draw out the fluid (e.g., urine) collected in the reservoir2810. The assembly2802can also simultaneously be sufficiently pliable and/or flexible to conform to the size and shape of different users to ensure effective transfer of voided urine.

Although the assembly2802is shown to include a permeable support2840(indicated by the dot pattern) and a permeable membrane2830(indicated by a cross pattern) inFIG.50B, in other embodiments the assembly may include a permeable support2840made of material such that it serves the functions of both the permeable support and the permeable membrane. Such a permeable support2840can be similar in structure and/or function to permeable support2640in assembly2602. For example, the permeable support2840can have an exterior surface with wicking properties, a high absorptive rate, and/or a high permeation rate such that urine can be rapidly absorbed and/or transported therethrough. Further, the permeable support2840can be soft and/or minimally abrasive such that the exterior surface of the permeable support2840does not irritate the skin of the user. The permeable support2840can also be made of a material that can wick fluid away from the urethral opening and/or the skin of the user such that the dampness of the skin of the user is lessened and infections are prevented.

While various embodiments of the 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.