Apparatus and methods for receiving discharged urine

Abstract

To provide a device that can collect urine from a person or animal, specifically a male, and minimizes contamination of a user and / or a peripheral area.SOLUTION: A system 100 suitable for collecting and transporting urine away from the body of a person or animal may include an assembly 102 having a fluid impermeable casing 150, a fluid permeable membrane 130, and a fluid permeable support 140. A reservoir 110 is defined by the fluid permeable support. The fluid permeable membrane can define a cavity 152. The casing can define an opening 132 such that the cavity is accessible via the opening. The assembly can also include an outlet 120 in fluidic communication with the reservoir. The assembly can be arranged such that a user's penis can be disposed through the opening with its urethral opening disposed within the cavity and such that a fluid can flow into a body from the urethral opening of the user's penis, collect in the reservoir, and flow out of the outlet.SELECTED DRAWING: Figure 1

Description

Technical Field

[0001] The present disclosure generally relates to systems, devices, and methods for collecting and transferring urine excreted from the body of a human or animal.

Background Art

[0002] This application claims priority to U.S. Patent Application No. 15 / 612,325, filed Jun. 2, 2017, entitled "Apparatus and Method for Receiving Excreted Urine," which is a continuation-in-part of U.S. Patent Application No. 15 / 221,106, filed Jul. 27, 2016, entitled "Male Urine Collection Device Using Suction Material," and U.S. Patent Application No. 15 / 238,427, filed Aug. 16, 2016, entitled "Use of Suction Material for Collecting and Transferring Urine from a Male." Each of the foregoing applications is hereby incorporated by reference in its entirety.

[0003] The embodiments described herein generally relate to collecting and transferring urine excreted from a human or animal. In various situations, a human or animal may have restricted or inhibited mobility, which can make the normal urination process difficult or impossible. For example, a person may experience or have a disability that inhibits mobility. A person may have restricted movement conditions, such as those experienced by pilots, drivers, and workers in hazardous areas. Additionally, urine collection may be required for monitoring purposes or clinical tests.

[0004] Urinary catheters, such as Foley catheters, can be used to address some of these situations, such as incontinence. However, unfortunately, urinary catheters can be uncomfortable and painful and can lead to complications such as infections. Additionally, in medical institutions and the like, urine bottles, which are containers used for the excrement of bedridden patients, may be used. However, urine bottles can be uncomfortable, leak easily, and can cause other hygiene problems.

[0005] Men who suffer the most severe consequences of urinary incontinence, such as discomfort, rash, and pain, are usually elderly and often bedridden. They require continuous assistance even to maintain a clean hygienic state. These patients often have the following characteristics. That is, they usually sleep on their backs, the size of the penis often shrinks with age, the swelling of the skin containing adipose tissue retracts the penis, and the penis often points upward while in the sleeping position, it becomes difficult for the patient to reach the penis, and it becomes difficult to operate the device, etc. The device for capturing urine should be designed with reference to these characteristics.

[0006] Available solutions usually involve a urine discharge port facing the distal end of the penis and are used while standing up (such as cups and funnels). Other designs, such as condom-style catheters, are often difficult for patients to operate, dimensionally incompatible, and do not stay in place reliably.

Prior Art Documents

Patent Documents

[0007]

Patent Document 1

Summary of the Invention

Problems to be Solved by the Invention

[0008] Therefore, there is a need for a device that can comfortably collect urine from a human or animal, particularly a male, and minimize soiling of the user and / or the surrounding area.

Means for Solving the Problems

[0009] An optimal system for collecting and transferring urine from a human or animal, particularly male urine, is disclosed. The disclosed system may include an assembly having a fluid-impermeable casing, a fluid-permeable support, a fluid-permeable membrane, and a tube. The fluid-impermeable casing can define an opening, an internal region, and a fluid outlet. The fluid-permeable support can define a reservoir. The support can be disposed within the internal region. The fluid-permeable membrane is disposed on the support and can cover at least a portion of the support. The fluid-permeable membrane can define at least a portion of a cavity. The tube can have a first end disposed within an elongated reservoir and may extend through the fluid outlet to a second fluid discharge end. The device is configured to place the urethral orifice of the user's penis within the cavity through the opening by receiving urine discharged from the urethral orifice through the membrane and the support into the reservoir, collecting the received urine from the reservoir through the tube, and discharging it from the fluid discharge end of the tube.

Brief Description of the Drawings

[0010]

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Modes for Carrying Out the Invention

[0011] A system is disclosed that is optimal for collecting and transferring urine from a human or animal, particularly a male body. In some embodiments, the disclosed system may include a fluid-impermeable casing, a fluid-permeable support, a fluid-permeable membrane, and a device having a tube. The fluid-impermeable casing can define an opening, an internal region, and a fluid outlet. The fluid-permeable support can define a reservoir. The support can be disposed within the internal region. The fluid-permeable membrane is disposed on the support and can cover at least a portion of the support. The fluid-permeable membrane can define at least a portion of a cavity. The tube can have a first end disposed within an elongate reservoir and extend through the fluid outlet to a second fluid discharge end. The device is configured to receive urine discharged from the urethral orifice through the membrane and the support and into the reservoir, collect the received urine from the reservoir through the tube, and discharge it from the fluid discharge end of the tube, by passing the user's penis through the opening and disposing the urethral orifice of the penis within the cavity.

[0012] In some embodiments, the method includes disposing a urine collection device in an operative relationship with the urethral orifice of a male user. The method may include disposing a urine collection device in an operative relationship with the urethral orifice of a male user. The urine collection device may include a fluid-impermeable casing, a fluid-permeable support, a fluid-permeable membrane, and a tube. The fluid-impermeable casing can define an opening, an interior region, and a fluid outlet. The fluid-permeable support can define a reservoir. The support can be disposed within the interior region. The fluid-permeable membrane may be disposed on the support and can cover at least a portion of the support. The fluid-permeable membrane can define at least a portion of a cavity. The tube can have a first end disposed within an elongate reservoir and may extend through the fluid outlet to a second fluid discharge end. The operative relationship may include disposing the user's penis through the opening of the casing and disposing the urethral orifice of the penis within the cavity. Urine discharged from the urethral orifice can be adapted to be received into the reservoir through the membrane and the support. The received urine can be collected from the reservoir through the tube and discharged from the fluid discharge end of the tube.

[0013] In some embodiments, the device may include a fluid-impermeable casing, a fluid-permeable support, a fluid-permeable membrane, and a tube. The fluid-impermeable casing can define an opening, an interior region, and a fluid outlet. The fluid-permeable support is disposed within the interior region and may have a first side facing the opening and a second side opposite the first side. The second side and the casing can together define a reservoir therebetween. The fluid-permeable membrane may be disposed on the support between the opening and the first side of the support. The fluid-permeable membrane and the casing can together define a cavity. The tube can have a first end disposed within the reservoir and may extend through the fluid outlet to a second fluid discharge end. The device may be configured to dispose the user's penis through the opening and dispose the urethral orifice of the penis within the cavity in order to receive urine discharged from the urethral orifice through the membrane and the support into the reservoir, collect the received urine from the reservoir through the tube, and discharge the urine from the fluid discharge end of the tube.

[0014] In some embodiments, the method may include disposing a urine collection device in an operative relationship with the urethral orifice of a male user. The urine collection device may include a fluid-impermeable casing, a fluid-permeable support, a fluid-permeable membrane, and a tube. The fluid-impermeable casing can define an opening, an internal region, and a fluid outlet. The fluid-permeable support may be disposed within the internal region and may have a first side facing the opening and a second side opposite the first side. The second side and the casing can together define a reservoir between the second side and the casing. The fluid-permeable membrane may be disposed on the support between the opening and the first side of the support. The fluid-permeable membrane and the casing can together define a cavity. The tube may have a first end disposed within the reservoir and may extend through the fluid outlet to a second fluid discharge end. The operative relationship may include disposing the penis of the user through the opening of the casing and disposing the urethral orifice of the penis within the cavity. Urine discharged from the urethral orifice may be received into the reservoir through the membrane and the support. The received urine can be collected from the reservoir through the tube and discharged from the fluid discharge end of the tube.

[0015] In some embodiments, when urine is being collected, the device can be used to collect urine flowing from the penis of a human or animal in a way that allows the urine to be easily transferred from the device. The device may include a chamber assembly in which a suction material is disposed around a porous material configured to form a chamber in which urine can be collected for transfer. The chamber may have a port for receiving a tube, whereby urine collected in the chamber can be transferred from the chamber by removing it from the chamber when a partial vacuum is applied into the chamber via the received tube. The dimensions and configuration of the chamber assembly may be determined so that opposite portions of the assembly can be fairly adjacent to define an opening that can be inserted through the head of the penis. A layer of impermeable material can be attached to the chamber assembly to cover one side of the opening, thereby providing a container for receiving the inserted head of the penis. When a partial vacuum is applied into the chamber via the tube, urine flowing from the penis can be removed from the container through the suction material and the porous material and placed into the chamber.

[0016] In some embodiments, when urine is being collected, a method can be used with a device to transfer urine from the device, and urine flowing from the penis of a human or animal can be collected. The device may include a flexible layer of porous material, a flexible wicking material disposed on one side of the layer of porous material, and a flexible layer of impermeable material. The flexible layer of impermeable material can be fixed to the peripheral edge on the other side of the layer of porous material to cover the other side of the porous material and define a chamber between the layer of porous material and the impermeable material that can collect and transfer urine. The chamber may have a port for receiving a tube, whereby when a partial vacuum is applied into the chamber via the received tube, the urine collected in the chamber can be transferred from the chamber by removing it from the chamber. The combination of the wicking material, the layer of porous material, and the layer of impermeable material may be sized and configured to provide a container for receiving the head of the penis. When a partial vacuum is applied into the chamber via the received tube, urine flowing from the penis can be removed from the container through the wicking material and the porous material and placed into the chamber.

[0017] As used herein, the singular forms “a,” “an,” and “the” are intended to include the plural forms as well, unless the context clearly dictates otherwise. Thus, for example, “a member” is intended to mean a single member or a combination of members, and “a material” is intended to mean one or more materials or a combination thereof.

[0018] The embodiments described in this specification can be formed or constructed from 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 nylon, polyester, polycarbonate, polyacrylate, ethylene-vinyl acetate and other acylated cellulose acetate polymers, non-degradable polyurethane, polystyrene, polyvinyl chloride, polyvinyl fluoride, poly(vinyl imidazole), chlorosulfonated polyolefin, polyethylene oxide, polyethylene terephthalate (PET), polytetrafluoroethylene (PTFE), and / or mixtures and copolymers thereof.

[0019] FIG. 1 is a schematic block diagram of system 100. System 100 includes assembly 102. Assembly 102 includes a permeable membrane 130, a permeable support 140, and an impermeable casing 150 (also referred to herein as an “impermeable layer”). The permeable membrane 130 and the permeable support 140 may be integrally referred to as a “chamber assembly”. The permeable support 140 defines a reservoir 110 (also referred to herein as a “chamber”). Assembly 102 also includes an outlet 120 (also referred to herein as a “port”) in fluid communication with reservoir 110. The permeable support 140 and the permeable membrane 130 can be arranged such that the permeable membrane 130 defines a cavity 152. The impermeable casing 150 defines an opening 132 such that it is accessible from outside assembly 100 to cavity 152. The impermeable casing 150 can direct fluid toward reservoir 110 and / or reduce and / or prevent fluid from exiting assembly 102 other than through outlet 120. In some implementations, assembly 102 can be arranged such that fluid enters cavity 152 through opening 132, passes through permeable membrane 130, passes through permeable support 140, and enters reservoir 110 and exits through outlet 120. In some implementations, assembly 102 may be arranged such that a user's penis can be inserted through the opening, whereby the user's urethral opening is disposed within cavity 152, and fluid flows from the user's urethral opening into cavity 152, passes through permeable membrane 130, passes through permeable support 140, enters reservoir 110, and exits through outlet 120. In some implementations, system 100 may include a discharge line 122 (also referred to herein as a “received tube”). Discharge line 122 may be fluidly coupled to an external container 160. External container 160 may be in fluid communication with a vacuum source 170 via a vacuum line 124. Both discharge line 122 and vacuum line 124 may include flexible tubes, such as, for example, flexible plastic tubes.

[0020] More specifically, the impermeable casing 150 can define an inner region accessible through the opening 132. The permeable membrane 130 and the permeable support 140 (and thus the reservoir 110) can be disposed within the inner region of the impermeable casing 150. The impermeable casing 150 can be of any suitable shape. For example, in some implementations, the impermeable casing 150 can be bowl-shaped. In some implementations, the impermeable casing 150 can include a bottom surface and at least one side wall. In some implementations, at least one side wall can define the opening 132 such that the opening 132 is on the opposite side of the bottom surface of the impermeable casing 150 and the inner region of the impermeable casing 150 is partitioned (co-defined) by the bottom surface, the side wall, and the opening 132. In some implementations, the impermeable casing 150 includes an upper surface that defines the opening 132 on the opposite side of the bottom surface. In some implementations, the side walls of the impermeable casing 150 are curved and continuous, such that the impermeable casing 150 has a rounded (e.g., circular or elliptical) outer perimeter. In some implementations, the impermeable casing 150 can be of any suitable shape and / or outer perimeter, such as rectangular, square, or triangular. In some implementations, as will be described in more detail below, one or more side walls can be concave such that at least a portion of the permeable membrane 130 and the permeable support 140 can be received therein.

[0021] In some embodiments, the impermeable casing 150 may be disposed around only a portion of the outside of the permeable membrane 130 and / or the permeable support 140. In some embodiments, the impermeable casing 150 may cover all of the outside of the chamber assembly (i.e., the permeable membrane 130 and / or the permeable support 140). In some embodiments, the impermeable casing 150 may be arranged to wrap around the outer surface of the permeable membrane 130 and / or the permeable support 140 and to cover a portion of the inside of the chamber assembly (i.e., the permeable membrane 130 and / or the permeable support 140). In some embodiments, the permeable membrane 130 and the permeable support 140 may be arranged to define a passageway with an open end (e.g., of a ring), and the impermeable casing 150 may be applied to one end and one side of the chamber assembly (i.e., the permeable membrane 130 and the permeable support 140) such that the cavity 152 is defined by the open end and the closed end. In some embodiments, the chamber assembly may define an opening 132 instead of the impermeable casing 150. In some embodiments, the portion of the impermeable casing 150 that closes one end of the cavity 152 and partially defines the cavity 152 may be of any suitable shape such that a part or all of the user's penis head can be disposed within the cavity 152. For example, a part of the impermeable casing 150 that closes one end of the cavity 152 may be curved, convex, or flat.

[0022] In some embodiments, the impermeable casing 150 may be attached to the chamber assembly (i.e., the permeable membrane 130 and the permeable support 140) by an adhesive. In some embodiments, the impermeable casing 150 may be attached to the chamber assembly by any suitable retaining mechanism, such as a retaining clip, or other fasteners. In some embodiments, the impermeable casing 150 may be pre-formed, and the chamber assembly may be inserted into the impermeable casing 150 and retained in a specific shape by the impermeable casing 150. In some embodiments, the impermeable casing 150 may be formed, for example, by an elongated strip of adhesive tape such that the chamber assembly can be maintained in a configuration that defines a cavity 152.

[0023] The impermeable layer 150 can be impermeable to fluids such as urine, for example. In some embodiments, the impermeable layer 150 can have the function of transporting fluids and can assist in directing the fluids towards the reservoir 110 and / or through the outlet 120 of the reservoir 110. In some embodiments, the impermeable layer 150 may be formed as an integral, unified structure. In other embodiments, the impermeable layer 150 may be a structure composed of multiple parts. The impermeable layer 150 may be a pre-formed (e.g., injection molded or blow molded) component. Alternatively, the impermeable layer 150 may be formed of a material such as an elongated strip of adhesive tape wrapped around at least a portion of the reservoir 110, a portion of the permeable support 140, and / or a portion of the permeable membrane 130. In some embodiments, the impermeable layer 150 may be formed of cardboard, pressure-sensitive paper, and / or coated paper. In some embodiments, the impermeable layer 150 may be flexible.

[0024] The permeable membrane 130 may be formed of a material having permeation characteristics with respect to fluids such as urine. The permeation characteristics may be suction, capillary action, diffusion, or other similar characteristics or processes, and are referred to herein as "permeability" or "suction". The permeable membrane 130 may have a high absorption rate and a high permeation rate, whereby urine can be quickly absorbed by the permeable membrane 130 and / or transported through the permeable membrane 130. In some implementations, the permeable membrane 130 may be flexible. In some implementations, the permeable membrane 130 may be a ribbed fabric. In some implementations, the permeable membrane 130 may be formed into a tubular sleeve so as to be disposed around the permeable support portion 140. In some implementations, the permeable membrane 130 may include and / or have a hygroscopic gauze, felt, terry cloth, thick tissue paper, and / or paper towel. In some implementations, the permeable membrane 130 may be soft and / or minimize friction so as not to irritate the user's skin. The permeable membrane 130 can be configured to suck fluid from the user's urethral opening and / or skin, thereby reducing the moisture of the user's skin and preventing infections. Further, the suction characteristics of the permeable membrane 130 can help prevent urine leakage or flow over the assembly (e.g., from the opening 132) onto the bed or the like. In some implementations, the permeable membrane 130 may be formed of thin-denier polyester fibers coated with a thermally flexible and aqueous binder system. For example, the tension can be about 45 pounds per square inch (when measured using the Instron test method). For example, the weight of the permeable membrane can be about 12 grams (when measured using a Mettler Toledo gram scale). For example, the thickness of every 10 permeable membranes can be about 2.5 inches (when measured using Gustin-Bacon / Measure-Matic).

[0025] The permeable support portion 140 can be positioned relative to the permeable membrane 130 so as to maintain the permeable membrane 130 in a specific shape and such that a fluid, such as urine, can pass through the permeable membrane 130, through the permeable support portion 140, and into the reservoir 110. In some implementations, the permeable support portion 140 may be ring-shaped, such that when the permeable support portion 140 is disposed within the impermeable casing 150, a cavity 152 is defined at the center of the ring-shaped permeable support portion 140. Alternatively, the outer surface of the permeable support portion 140 at the inner portion of the “ring” can define the cavity 152. When the permeable membrane 130 is disposed on the permeable support portion 140, the permeable membrane 130 can define a portion of the boundary of the cavity 152. When the permeable support portion 140 and the permeable membrane 130 are disposed within the impermeable casing 150, the cavity 152 can be aligned with the opening 132 of the impermeable casing 150. The reservoir 110 can be defined within or beside the permeable support portion 140 such that the reservoir 110 is an elongated ring-shaped reservoir.

[0026] In some embodiments, the permeable support portion 140 may be formed and / or shaped as a complete or continuous ring or circle. In some embodiments, the permeable support portion 140 may be formed and / or shaped as a discontinuous C-shape with gaps between the arcs and / or ends. In some embodiments, the permeable support portion 140 may be U-shaped. In some embodiments, the dimensions and configuration of the chamber assembly may be determined such that the opposite ends of the chamber assembly are fairly adjacent or proximate to define an opening that can be inserted through the head of the penis. In some embodiments, the permeable support portion 140 may be formed of a bendable tube having two ends. The bendable tube may be arranged to bring the two ends together (e.g., to form a C-shape), and the permeable support portion 140 may be fixed to be substantially circular in shape. In some embodiments, the outlet or port 120 may be positioned at the intersection of the two ends and placed in fluid communication with the elongated ring-shaped reservoir 110 defined by the permeable support portion 140. The discharge line 122 may be inserted through the outlet 120 (and thus through the impermeable casing 150 and the permeable support portion 140) to place it in fluid communication with the reservoir 110.

[0027] In some embodiments, the permeable support 140 may be formed as an elongated tube such that the reservoir 110 extends through a portion or the entire length of the elongated tube. Next, the permeable support 140 may be arranged and / or bent to form a ring such that the cavity 152 is defined at the center of the ring. In some embodiments, when the penis is disposed within the opening 132 of the impermeable casing 150, the inner diameter or other dimensions of the permeable support 140 may be determined such that the cavity 152 receives the user's penis, whereby the head of the penis can be disposed partially or completely within the cavity 152. Alternatively, the axis of the penis can be disposed within the opening 132, and the head of the penis can be disposed completely within the cavity 152, or the urethral opening of the head of the penis can be disposed within the cavity 152, and the opening 132 can surround a portion of the head and dispose this head partially within the cavity 152 and partially outside the cavity 152. In some embodiments, the cavity 152 may be sized to receive the head of the user's penis, whereby urine can be received within the cavity 152 from the urethral opening of the penis, through the permeable membrane 130 and / or through the permeable support 140, without splashing outside the opening 132.

[0028] In some embodiments, the permeable support 140 can be configured to maintain the permeable membrane 130 against the skin of the user's penis and / or near the user's urethral opening. For example, the permeable support 140 can be shaped and sized such that the cavity 152 is slightly larger than the head or tip of the user's penis. The permeable support 140 may include a portion that contacts the permeable membrane 130 having a curved or convex shape, whereby the permeable membrane 130 also curves or becomes convex. The permeable support 140 can support the permeable membrane 130 such that the permeable membrane 130 is stationary against the skin of the head or tip of the penis and guides the urethral opening towards the bottom surface of the impermeable casing 150, thereby creating a comfortable and at least partially enclosed boundary for engaging the area of the body near the urethral opening (e.g., the head and / or neck of the user's penis).

[0029] In some implementations, the permeable support 140 can be made of a rigid plastic. In some implementations, the permeable support 140 can be of any suitable shape and can be formed from any suitable material. For example, the permeable support 140 may be flexible. Additionally, the permeable support 140 may be formed of aluminum, a composite of plastic and aluminum, other materials, and / or a composite of plastic and another metal. In some implementations, the permeable support 140 may be formed of a natural material such as, for example, plant fibers (e.g., Greener Clean® manufactured by 3M). The natural material may include openings such that fluid can flow through the natural material. In some embodiments, the permeable support 140 may be cylindrical and can define a lumen. In some embodiments, the permeable support 140 may be formed of a perforated coated paper such as, for example, tubular wax paper.

[0030] The permeable support portion 140 can define one or more openings (e.g., an array of openings) to enable the flow of fluid from the permeable membrane 130 to the reservoir 110. In some implementations, the permeable support portion 140 may be formed as a curved tube or a curved cylinder having one or more openings. In some implementations, the permeable support portion 140 can include a membrane support (e.g., a crossbar) extending across the opening, whereby the opening is divided into an array of separate slot-shaped openings. The membrane support can be used to support the permeable membrane 130. For example, the membrane support can maintain the shape of the permeable membrane 130 against the skin of the user's penis and / or near the user's urethral orifice, whereby urine flowing out from the urethral orifice contacts the permeable membrane 130 and moves through the permeable membrane 130. In some implementations, the permeable support portion 140 can define several openings having various shapes, such as a plurality of circular openings. In some implementations, the permeable support portion 140 may be formed as a curved or ring-shaped cylinder of spun plastic (e.g., non-woven permeable nylon and polyester webbing), whereby the permeable support portion 140 can have many openings. For example, a rectangular portion of spun plastic can be bent cylindrically and curved into a ring or U-shape for use in the assembly 102. In some implementations, the permeable support portion 140 can be made of a porous material. For example, the permeable support portion 140 may be a ring-shaped tubular enclosure of porous glass defining a frit. In other implementations, the permeable support portion 140 can define an opening in the sidewall of the permeable support portion 140, and this sidewall may be covered by a mesh screen defining many smaller openings. In some embodiments, the reservoir 110 can include any space defined within the permeable support portion 140 and / or an opening (e.g., a space within a porous material or a space defined within a spun plastic material).

[0031] The reservoir 110 may be of any suitable shape and / or any diameter (or other dimension) suitable for receiving and moving urine during use of the system 100. In some implementations, the size of the reservoir 110 may be determined such that a large or small amount of urine can be collected and temporarily held until the urine can be removed from the reservoir 110 via the outlet 120. For example, the size of the reservoir 110 may be determined such that the reservoir 110 is configured to hold a small amount of urine that may be released due to incontinence. In some implementations, the size of the reservoir 110 may be determined such that the reservoir 110 is configured to hold a large amount of urine that may be released while emptying a full bladder. In some implementations, the size of the reservoir 110 may be determined such that the reservoir 110 collects and holds a small or large amount of urine while simultaneously removing the urine via a pump such as, for example, gravity and / or a vacuum source 170. Alternatively, the reservoir 110 may function as a sump, and the size of the reservoir 110 may be determined such that the reservoir 110 may form a portion of the passageway for urine to pass through the reservoir 110 from the permeable membrane 130 through the permeable support 140 and out the outlet 120. Temporary urine stagnation may occur within the reservoir 110 under conditions where the flow rate of urine entering the assembly 102 through the permeable membrane 130 is greater than the flow rate through the discharge line 122. Thus, the size of the reservoir 110 may be determined such that the reservoir 110 accommodates a volume that can temporarily accumulate fluid due to the difference in flow rates entering and leaving the assembly 102. Although the outlet 120 is shown as extending from the side of the reservoir 110, in some implementations, the outlet 120 may extend from the bottom of the reservoir 110.

[0032] In some implementations, assembly 102 may optionally include a cushion assembly 180. The cushion assembly 180 may include a membrane layer 182 and a support layer 184 (also referred to herein as a "base of the porous material"). The membrane layer 182 may be formed of a material similar or identical to the permeable membrane 130 and may have properties similar or identical to the permeable membrane 130. For example, the membrane layer 182 may be configured to draw fluid (e.g., urine) away from the user's urethral opening when the user's urethral opening is positioned near or in contact with the membrane layer 182. The membrane layer 182 may also be permeable such that fluid (e.g., urine) passes through the membrane layer 182 and flows to the permeable membrane 130 and / or the permeable support 140, into the reservoir 110, and out through the outlet 120. The support layer 184 may be formed of a material similar or identical to the permeable support 140 and may have properties similar or identical to the permeable support 140. For example, the support layer 184 may be configured to maintain the membrane layer 182 near or in contact with the user's glans penis when the user's glans penis is disposed within the cavity 152 of the assembly 102. The support layer 184 may also be permeable such that fluid (e.g., urine) passes through the membrane layer 182, through the support layer 184, and flows to the permeable membrane 130 and / or the permeable support 140, into the reservoir 110, and out through the outlet 120. The cushion assembly 180 can be disposed within the impermeable casing 150 such that the cushion assembly 180 forms a boundary (e.g., the bottom of the cavity 152) of the cavity 152. The cushion assembly 180 can be positioned along the bottom surface of the impermeable casing 150 such that the user's penis contacts the cushion assembly 180 and / or to reduce splashing when urine flowing from the user's urethral opening and into the cavity 152 enters the cushion assembly 180. In some implementations, the cushion assembly 180 (specifically, the membrane layer 182) may be disposed within the impermeable casing 150 in contact with the permeable membrane 130.

[0033] The outer container 160 can collect the fluid exiting the reservoir 110 through the outlet 120 via the discharge line 122. The outer container 160 may be a sealed container. In some implementations, the outer container 160 may be disposable. In some implementations, the outer container 160 may be configured to be sterilized and reused.

[0034] In some implementations, gravity can be used to cause the fluid in the reservoir 110 to follow a fluid flow path from the reservoir 110 to the outer container 160 (i.e., a fluid flow path including the outlet 120 and the discharge line 122). In some implementations, the vacuum source 170 can assist and / or provide the pressure differential necessary to remove fluid from the user's urethral orifice, place it into the permeable support 140, place it into the reservoir 110, and place it from the reservoir 110 into the outer container 160. The vacuum source 170 can be in fluid communication with the outer container 160 via the vacuum line 124, whereby gaseous fluid is removed from the outer container 160 via the vacuum line 124. As a result of the pressure reduction in the outer container 160 caused by removing the gaseous fluid from the outer container 160, liquid and / or gaseous fluid can be removed from the reservoir 110, passed through the outlet 120, and passed through the discharge line 122 into the outer container 160. In some implementations, the vacuum source 170 can apply a large suction force to capture all or substantially all of the urine discharged by the user in various positions (e.g., when a male user is lying on his side or on his back).

[0035] The vacuum source 170 can have a fairly high vacuum force and air volume transfer rate, whereby rapid suction of air and liquid is maintained across a portion or all of the permeable membrane 130. In some implementations, one or more openings of the permeable support 140 are distributed over an area that is slightly larger than the area of the permeable membrane 130 configured to be wetted by the urine flow during operation. Thus, the partial vacuum created by the vacuum source 170, together with one or more openings of the permeable support 140 and the permeable membrane 130, can draw urine in contact with the permeable membrane 130 into the assembly 102, specifically the reservoir 110. However, in some implementations, a reduction in the partial vacuum force can reduce the urine collection volume and the efficiency of the system 100, so one or more openings of the permeable support 140 need not be distributed over an area larger than necessary for the permeable support 140.

[0036] In some implementations, the vacuum source 170 may be a pump configured to be readily available, inexpensive, relatively quiet, and / or operate continuously. For example, the vacuum source 170 may be a submersible aeration pump. The vacuum line 124 can be attached to the intake port of the submersible aeration pump (rather than the discharge port of the aeration), whereby the gaseous fluid is taken into the submersible aeration pump from the external container 160 via the vacuum line 124. In some implementations, the required static vacuum pressure of the system 100 is at a free flow rate of about 10 to 100 cubic centimeters per second and about 3 to 10 feet of water column (10% to 30% of 1 atmosphere, 80 to 250 mmHg). In some implementations, the required static vacuum pressure of the system 100 varies depending on the size of the user and the expected volume of urine from the user and / or through the system 100. In some implementations, the discharge line 122 may have a diameter of about 0.25 inches, and the vacuum source 170 can be configured to flow about 500 cubic centimeters of urine through the discharge line 122 into the external container 160 over the normal urination time of the user, typically 10 to 20 seconds, but in a shorter or longer range, for example, in the range of 5 to 90 seconds. In some implementations, the vacuum source 170 may include a wall-mounted vacuum system such as those found in hospitals. In some implementations, the wall-mounted vacuum system can be configured to apply a vacuum pressure of, for example, about 20 mmHg to about 40 mmHg. In some implementations, the vacuum source 170 can be powered by 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 system 100 while moving via a wheelchair or a motor vehicle, the vacuum source 170 can be powered by DC power.

[0037] In some implementations, urine collected by any of the systems and / or assemblies described herein can be sampled using a urine strip for analysis. Urine test strips can be used to test various health diagnostic measurements. The urine test strip can be configured to change color in response to being wetted with urine to represent a particular measurement value (i.e., the color can correspond to a known measurement scale). In some implementations, a urine test strip (not shown) can be inserted into the discharge line 122 such that urine flowing from the outlet 120 to the external container 160 contacts the urine test strip. The discharge line 122 may be transparent so that data on the urine test strip can be read through the wall of the discharge line 122. In some implementations, the urine test strip can be disposed within the external container 160 such that urine flowing into the external container 160 contacts the urine test strip. The external container 160 may be at least partially transparent so that data on the urine test strip can be read through the wall of the external container 160.

[0038] In some implementations, a camera, such as a camera incorporated into a mobile communication device (e.g., smartphone, iPhone (registered trademark), etc.), can be used to read the data on the urine test strip. The camera can capture an image of the test strip, and this image can be processed using, for example, a smartphone application. The data read from the urine test strip may be sent to a clinician for analysis and / or sent to a cloud-based address for access by a physician.

[0039] In some implementations, the system 100 may include a scale (not shown). For example, the scale 164 can be disposed below the external container 160 and configured to measure the weight of the fluid (e.g., urine) within the external container 160. Data representing the weight of the fluid delivered to the external container 160 via the discharge line 122 is measured and processed at different time intervals to determine, for example, the amount of urine discharged by a user of the system 100.

[0040] Although described with the intention of being used by adult males, in some embodiments, system 100 can be used for veterinary applications for adults, children, males, females, and animals of different species and sizes. In female applications, assembly 102 can be placed between the user's legs or between the labia and comfortably held against the external urethral orifice by frictional pressure from the user's body, pressure between the legs, or underwear, elastic strips, and / or adhesive tape. In male applications, assembly 102 can be positioned such that the user's penis is disposed within assembly 102 (e.g., within cavity 152 formed within assembly 102). A male user can use assembly 102 in any suitable position, such as while lying on his back, side, sitting, or standing. In some embodiments, during urination, the head of the male user's penis can be positioned in contact with permeable membrane 130 and / or membrane layer 182. In some embodiments, during urination, the head of the male user's penis can be disposed at least partially within cavity 152 but not positioned in contact with permeable membrane 130 and / or membrane layer 182.

[0041] Figure 2 is a top view of assembly 202. Figure 3 is a cross-sectional view of assembly 202 taken along line 3-3 of Figure 2. Assembly 202 includes a permeable membrane 230, a permeable support 240, and a cushion assembly 280. The permeable membrane 230 and the permeable support 240 may be integrally referred to as a "chamber assembly". The permeable membrane 230, the permeable support 240, and the cushion assembly 280 are disposed within an impermeable casing 250 (also referred to herein as an "impermeable layer"). The permeable membrane 230, the permeable support 240, the cushion assembly 280, and the impermeable casing 250 may have the same or similar structures and / or functions as the permeable membrane 130, the permeable support 140, the cushion assembly 180, and the impermeable casing 150 described above with reference to system 100. For example, the permeable support 240 defines a reservoir 210 (also referred to herein as a "channel"). The impermeable casing 250 defines an opening 232 (also referred to herein as a "port"). Assembly 202 also includes an outlet 220 in fluid communication with reservoir 210.

[0042] The permeable support portion 240 and the permeable membrane 230 can be arranged such that the permeable support portion 240 and / or the permeable membrane 230 together define a cavity 252 within the permeable membrane 230. The impermeable casing 250 can direct fluid towards the reservoir 210 and / or reduce and / or prevent fluid from exiting the assembly 202 except through the outlet 220. In some implementations, the assembly 202 can be arranged such that fluid enters the cavity 252 through the opening 232, passes through the permeable membrane 230, passes through the permeable support portion 240, and enters the reservoir 210 and flows out through the outlet 220. In some implementations, the assembly 202 may be arranged such that a user's penis can be inserted through the opening 232, whereby the user's urethral orifice is disposed within the cavity 252, fluid flows from the user's urethral orifice into the cavity 252, passes through the permeable membrane 230, passes through the permeable support portion 240, and enters the reservoir 210 and flows out through the outlet 220. A discharge line 222 (e.g., a tube) (also referred to herein as the "received tube") can extend through the outlet 220. A first end (not shown) of the drain line 222 may be positioned within the reservoir 210, and the drain line 222 extends through the permeable support portion 240, the permeable membrane 230, and the impermeable casing 250, whereby fluid within the reservoir 210 can be moved from the assembly 202 via the drain line 222. A second end of the discharge line 222 may be fluidly connected to an external container (e.g., the external container 160). The external container may be fluidly connected to a vacuum source (e.g., the vacuum source 170) via a vacuum line (e.g., the vacuum line 124). Both the discharge line 222 and the vacuum line may include a flexible tube, such as a flexible plastic tube, for example.

[0043] More specifically, the impermeable casing 250 can define an inner region accessible through the opening 232. The permeable membrane 230 and the permeable support 240 (and thus the reservoir 210) can be disposed within the inner region of the impermeable casing 250. The impermeable casing 250 can be of any suitable shape. For example, in some implementations, the impermeable casing 250 can be bowl-shaped. As shown in FIG. 3, the impermeable casing 250 can include a bottom surface and side walls. The side walls can define the opening 232 such that the opening 232 is on the opposite side of the bottom surface of the impermeable casing 250 and the inner region of the impermeable casing 250 is partitioned (integrally defined) by the bottom surface, the side walls, and the opening 232. The side walls of the impermeable casing 250 can be curved and continuous such that the impermeable casing 250 has a rounded (e.g., circular or elliptical) outer perimeter. As shown in FIG. 3, one or more of the side walls can be concave such that the side walls can receive at least a portion of the permeable membrane 230 and the permeable support 240.

[0044] The impermeable layer 250 can be impermeable to fluids such as urine, for example. In some implementations, the impermeable layer 250 can have a function of transferring fluid and can assist in directing the fluid toward the reservoir 210 and / or through the outlet 220 of the reservoir 210. In some implementations, the impermeable layer 250 can be formed as an integral, unified structure. In other implementations, the impermeable layer 250 can be a structure of multiple components. The impermeable layer 250 can be a preformed (e.g., injection molded or blow molded) component. Alternatively, the impermeable layer 250 can be formed of a material such as an elongated strip of adhesive tape wrapped around at least a portion of the reservoir 210, a portion of the permeable support 240, and / or a portion of the permeable membrane 230. In some embodiments, the impermeable layer 250 can be formed of cardboard, pressure-sensitive paper, and / or coated paper. In some embodiments, the impermeable layer 250 can be flexible.

[0045] The permeable membrane 230 may be formed of a material having permeation characteristics with respect to fluids such as urine. The permeation characteristics may be suction, capillary action, diffusion, or other similar characteristics or processes, and are referred to herein as "permeability" and / or "suction". The permeable membrane 230 may have a high absorption rate and a high permeation rate, whereby urine can be rapidly absorbed by the permeable membrane 230 and / or transferred through the permeable membrane 230. In some implementations, the permeable membrane 230 may be flexible. In some implementations, the permeable membrane 230 may be a ribbed fabric. In some implementations, the permeable membrane 230 may be shaped like a tubular sleeve so as to be disposed around the permeable support 240. In some implementations, the permeable membrane 230 may include and / or have a hygroscopic gauze, felt, terry cloth, thick tissue paper, and / or paper towel. In some implementations, the permeable membrane 230 may be soft and / or minimize friction so as not to irritate the user's skin. The permeable membrane 230 can be configured to suck up fluid from the user's urethral opening and / or skin, thereby reducing the moisture of the user's skin and preventing infections. Additionally, the suction characteristics of the permeable membrane 230 can help prevent urine leakage or flowing over the assembly (e.g., from the opening 232) onto, for example, the bed. In some implementations, the permeable membrane 130 may be formed of fine-denier polyester fibers coated with a thermally flexible and aqueous binder system. For example, the tension can be, for example, about 45 pounds per square inch (when measured using the Instron test method). For example, the weight of the permeable membrane can be, for example, about 12 grams (when measured using a Mettler Toledo gram scale). For example, the thickness of every 10 permeable membranes can be, for example, about 2.5 inches (when measured using Gustin-Bacon / Measure-Matic).

[0046] The permeable support portion 240 can be positioned relative to the permeable membrane 230 so as to maintain the permeable membrane 230 in a specific shape and so that fluid, such as urine for example, can pass through the permeable membrane 230 and through the permeable support portion 240 and into the reservoir 210. As shown in FIG. 2, the permeable support portion 240 can be in the shape of a ring, such that when the permeable membrane 230 is disposed on the permeable support portion 240 and the permeable support portion 240 is disposed within the impermeable casing 250, a cavity 252 is defined at the center of the ring-shaped permeable support portion 240 and the permeable membrane 230. Alternatively, the outer surface of the permeable membrane 230 in the inner portion of the “ring” can define the cavity 252. As shown in FIGS. 2 and 3, the cavity 252 can be aligned with the opening 232 of the impermeable casing 250. The reservoir 210 can be defined within the permeable support portion 240 such that the reservoir 210 is an elongated ring-shaped reservoir.

[0047] In some implementations, the permeable support portion 240 may be formed and / or shaped as a complete or continuous ring or circle. In some implementations, the permeable support portion 240 may be formed and / or shaped as an arc. In some implementations, the dimensions and configuration of the chamber assembly may be determined such that the opposite ends of the chamber assembly are fairly adjacent or proximate to define an opening that can be inserted through the glans penis. In some implementations, the permeable support portion 240 may be formed as a bendable tube having two ends. The bendable tube may be arranged such that the two ends are joined (e.g., to form a C-shape), and the permeable support portion 240 may be fixed to be substantially circular in shape. In some implementations, the outlet or port 220 can be positioned at the intersection of the two ends and placed in fluid communication with the elongated ring-shaped reservoir 210 defined by the permeable support portion 240. A discharge line 222 may be inserted through the outlet 220 (and thus through the impermeable casing 250 and the permeable support portion 240) to place the discharge line 222 in fluid communication with the reservoir 210.

[0048] In some embodiments, the permeable support 240 may be formed as an elongated tube, whereby the reservoir 210 extends through part or all of the elongated tube. Next, the permeable support 240 may be arranged and / or bent to form a ring, whereby the permeable support 240 defines a cavity 252 at the center of the ring. In some embodiments, when disposing the penis within the opening 232 of the impermeable casing 250, the inner diameter or other dimensions of the permeable support 240 may be determined such that the cavity 252 receives the user's penis, whereby the head of the penis can be disposed partially or fully within the cavity. In another way, the axis of the penis can be disposed within the opening 232, and the head of the penis can be disposed fully within the cavity 252, or the urethral opening of the head of the penis can be disposed within the cavity 252, and this head can be disposed partially within the cavity 252 and partially outside the cavity 252 such that the opening 232 surrounds part of the head. In some embodiments, the cavity 252 may be dimensioned to receive the head of the user's penis, whereby urine can be received within the cavity 252 from the urethral opening of the penis, through the permeable membrane 230 and / or through the permeable support 240, without splashing outside the opening 232.

[0049] In some embodiments, the permeable support 240 can be configured to maintain the permeable membrane 230 against the skin of the user's penis and / or near the user's urethral opening. For example, the permeable support 240 can be shaped and sized such that the cavity 252 is slightly larger than the head or tip of the user's penis. The permeable support 240 may include a portion that contacts the permeable membrane 230 having a curved or convex shape, whereby the permeable membrane 230 also curves or becomes convex. The permeable support 240 can support the permeable membrane 230 such that the permeable membrane 230 remains stationary against the skin of the head or tip of the penis and guides the urethral opening towards the bottom surface of the impermeable casing 250, thereby creating a comfortable and at least partially enclosed boundary for engaging the area of the body near the urethral opening (e.g., the head and / or neck of the user's penis).

[0050] In some implementations, the permeable support 240 can be made of a rigid plastic. In some implementations, the permeable support 240 can be of any suitable shape and can be formed from any suitable material. For example, the permeable support 240 may be flexible. Further, the permeable support 240 may 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 support 240 may be formed of a natural material such as, for example, plant fibers (e.g., Greener Clean® manufactured by 3M). The natural material may include openings so that fluid can flow through the natural material. In some embodiments, the permeable support 240 may be cylindrical and can define a lumen. In some embodiments, the permeable support 240 may be formed of a perforated coated paper such as tubular wax paper.

[0051] The permeable support portion 240 can define one or more openings (e.g., an array of openings) to enable fluid flow from the permeable membrane 230 to the reservoir 210. In some implementations, the permeable support portion 240 may be formed as a curved tube or a curved cylinder having one or more openings. In some implementations, the permeable support portion 240 can include a membrane support (e.g., a crossbar) extending across the opening, whereby the opening is divided into an array of separate slot-like openings. The membrane support can be used to support the permeable membrane 230. For example, the membrane support can maintain the shape of the permeable membrane 230 against the skin of the user's penis and / or near the user's urethral orifice, whereby urine flowing out of the urethral orifice contacts the permeable membrane 230 and moves through the permeable membrane 230. In some implementations, the permeable support portion 240 can define several openings having various shapes, such as a plurality of circular openings. In some implementations, the permeable support portion 240 may be formed as a curved shape of spun plastic (e.g., non-woven permeable nylon and polyester webbing) or a ring-shaped cylinder, whereby the permeable support portion 240 can have many openings. For example, a rectangular portion of spun plastic may be bent or wound cylindrically and then curved into a ring for use in the assembly 202. In some implementations, the permeable support portion 240 can be made of a porous material. For example, the permeable support portion 240 may be a ring-shaped tubular enclosure of porous glass defining a frit. In other implementations, the permeable support portion 240 can define an opening in the sidewall of the permeable support portion 240, and this sidewall may be covered by a mesh screen defining many smaller openings. In some embodiments, the reservoir 210 can include any space defined within the permeable support portion 240 and / or openings (e.g., a space within a porous material or a space defined within a spun plastic material).

[0052] The reservoir 210 may be of any suitable shape and / or of any diameter (or other dimension) suitable for receiving and moving urine during use of the system including the assembly 202. In some implementations, the size of the reservoir 210 may be determined such that the reservoir 210 can collect and temporarily hold large or small amounts of urine until the urine can be removed from the reservoir 210 via the outlet 220. For example, the size of the reservoir 210 may be determined such that the reservoir 210 is configured to hold a small amount of urine that may be released due to incontinence. In some implementations, the size of the reservoir 210 may be determined such that the reservoir 210 is configured to hold a large amount of urine that may be released while emptying a full bladder. In some implementations, the size of the reservoir 110 may be determined such that the reservoir 210 collects and holds small or large amounts of urine while simultaneously removing the urine via a pump such as, for example, gravity and / or a vacuum source 270. Alternatively, the reservoir 210 may function as a sump, and the size of the reservoir 210 may be determined such that the reservoir 210 may form a portion of a passage for urine to pass through the permeable membrane 230, through the permeable support 240, and out of the outlet 220 through the reservoir 210. Temporary urine stagnation may occur within the reservoir 210 under conditions where the flow rate of urine entering the assembly 202 through the permeable membrane 230 is greater than the flow rate through the discharge line 222. Accordingly, the size of the reservoir 110 may be determined such that the reservoir 210 accommodates a volume that can temporarily accumulate fluid due to the difference in flow rates entering and exiting the assembly 202.

[0053] Although the outlet 220 is shown as extending from the side of the reservoir 210, in some implementations, the outlet 220 may extend from the bottom of the reservoir 210.

[0054] The cushion assembly 280 may include a membrane layer 282 and a support layer 284 (also referred to herein as the "base of the porous material"). The membrane layer 282 may be formed of a material similar or identical to the permeable membrane 230 and may have properties similar or identical to the permeable membrane 230. For example, the membrane layer 282 may be configured to draw fluid (e.g., urine) away from the user's urethral orifice when the user's urethral orifice is positioned near or in contact with the membrane layer 282. The membrane layer 282 may also be permeable such that fluid (e.g., urine) flows through the membrane layer 282, through the permeable membrane 230 and / or the permeable support 240, into the reservoir 210, and out through the outlet 220. The support layer 284 may be formed of a material similar or identical to the permeable support 240 and may have properties similar or identical to the permeable support 240. For example, the support layer 284 may be configured to maintain the membrane layer 282 in proximity to or in contact with the user's glans penis when the user's glans penis is disposed within the cavity 252 of the assembly 202. The support layer 284 may also be permeable such that fluid (e.g., urine) flows through the membrane layer 282, through the support layer 284, through the permeable membrane 230 and / or the permeable support 240, into the reservoir 210, and out through the outlet 220. The cushion assembly 280 may be disposed within the impermeable casing 250 such that the cushion assembly 280 forms the boundary (e.g., the bottom of the cavity 252) of the cavity 252. The cushion assembly 280 may be positioned along the bottom surface of the impermeable casing 250 such that the user's penis contacts the cushion assembly 280 and / or to reduce splashing of urine flowing from the user's urethral orifice into the cavity 252 and into the cushion assembly 280. In some implementations, the cushion assembly 280 (specifically, the membrane layer 282) may be disposed within the impermeable casing 250 in contact with the permeable membrane 230.

[0055] Figure 4 is a flowchart showing a method of collecting urine from a user using an assembly according to one embodiment. Method 300 optionally includes, at 302, fluidly coupling the discharge end of the tube of the urine collection device to a fluid container. Method 300 further optionally includes, at 304, fluidly coupling the discharge end of the tube of the urine collection device to a vacuum source.

[0056] At 306, method 300 further includes disposing the head of the penis of a male user (e.g., a human or an animal) through an opening into a cavity at least partially defined by a membrane of the urine collection device such that the urine collection device is disposed in an operative relationship with the urethral orifice of the user. The urine collection device can be similar or analogous in structure and / or function to any of the urine collection devices described herein, such as, for example, assembly 102 of FIG. 1 and / or assembly 202 of FIG. 2. For example, the urine collection device may include a fluid-impermeable casing, a fluid-permeable support, a fluid-permeable membrane, and a tube. The fluid-impermeable casing can define an opening, an interior region, and a fluid outlet. The fluid-permeable support can define a reservoir. The fluid-permeable support can also be disposed within the inner region of the fluid-impermeable casing. The fluid-permeable membrane can be disposed on the support and cover at least a portion of the support. The fluid-permeable membrane can at least partially define a cavity aligned with the opening defined in the fluid-impermeable casing. The tube can have a first end disposed within the elongate reservoir and extend through the fluid outlet to a second fluid discharge end. The assembly can be arranged such that fluid flows from the urethral orifice of the user's penis into the cavity, is collected in the reservoir through the fluid-permeable membrane and the fluid-permeable support, and exits through the outlet.

[0057] At 308, method 300 further includes enabling urine discharged from the penis to be received through the membrane, through the support, into the cavity, and into the reservoir.

[0058] At 310, method 300 also further includes enabling the received urine to be retrieved from the reservoir through the tube and discharged from the fluid discharge end of the tube.

[0059] Method 300 optionally includes, at 312, enabling the collected urine to be collected in a fluid container.

[0060] Method 300 optionally includes, at 314, removing the urine collection device from the user's penis. Thus, the urine collection device can capture and transfer urine from the user without the need to attach a catheter to the urethral orifice of the user's penis. In some implementations, urine can flow against gravity during collection.

[0061] Finally, method 300 optionally includes, at 316, disposing the head of the user's penis through the opening into the cavity of the urine collection device so as to dispose the second urine collection device in a relationship acting on the user's urethral orifice.

[0062] FIG. 5 is a schematic block diagram of system 400. System 400 includes assembly 402. Assembly 402 includes a permeable membrane 430, a permeable support 440, and an impermeable casing 450 (also referred to herein as an “impermeable layer”). The permeable support 440 and the impermeable casing 450 together define a reservoir 410 (also referred to herein as a “chamber”). Assembly 402 also includes an outlet 420 (also referred to herein as a “port”) in fluid communication with reservoir 410. The permeable support 440 and the permeable membrane 430 can be arranged such that the permeable membrane 430 defines a cavity 452 within the impermeable casing 450. The impermeable casing 450 defines an opening 432 to provide access to cavity 452 from outside of assembly 402. The impermeable casing 450 can direct fluid toward reservoir 410 and / or reduce and / or prevent fluid from exiting assembly 402 other than through outlet 420. In some implementations, assembly 402 can be arranged such that fluid enters cavity 452 through opening 432, passes through permeable membrane 430, passes through permeable support 440, and enters reservoir 410 and exits through outlet 420. In some implementations, assembly 402 can be arranged such that a user's penis can be inserted through opening 432, whereby the user's urethral orifice is disposed within cavity 452 and fluid flows from the user's urethral orifice into cavity 452, passes through permeable membrane 430, passes through permeable support 440, and enters reservoir 410 and exits through outlet 420. In some implementations, system 400 may include a discharge line 422 (also referred to herein as a “received tube”). Discharge line 422 may be fluidly coupled to an external container 460. External container 460 may be in fluid communication with a vacuum source 470 via a vacuum line 424. Both discharge line 422 and vacuum line 424 may include flexible tubes, such as flexible plastic tubes for example.

[0063] More specifically, the impermeable casing 450 can define an inner region accessible through the opening 432. The permeable membrane 430 and the permeable support 440 can be disposed within the inner region of the impermeable casing 450. The impermeable casing 450 can be of any suitable shape. For example, in some implementations, the impermeable casing 450 can be bowl-shaped. In some implementations, the impermeable casing 450 can include a bottom surface and at least one side wall. In some implementations, the opening 432 can be on the side opposite the bottom surface of the impermeable casing 450. In some implementations, the opening 432 can be of any suitable shape and / or size. In some implementations, the impermeable casing 450 can optionally include a lip portion 456, whereby the opening 432 is at least partially partitioned and defined by the lip portion 456. The lip portion 456 can surround the opening 432 partially or entirely. In some implementations, the lip portion 456 can be shaped and sized such that it can reduce the possibility of urine flowing out from the opening 432 and / or reduce the risk of urine splashing through the opening 432.

[0064] In some embodiments, the opening 432 has a width and / or extension of a size similar to the diameter of the user's penis. In some embodiments, the opening 432 has a width and / or extension longer than the diameter of the user's penis. In some embodiments, the opening 432 may be, for example, circular or elliptical. In some embodiments, the opening 432 may be of any suitable shape. Similarly, the impermeable casing 450 may be of any suitable shape and / or outer peripheral shape, such as, for example, rectangular, square, triangular, circular, elliptical, or irregular shape. For example, the opening 432 (and the impermeable casing 450) may have a rounded or semi-circular first portion and a second portion tapered from a first side adjacent to the first portion having a width from the first width to a second width narrower than the first width. In some embodiments, the shape of the opening 432 may be the same as or similar to the outer peripheral shape of the upper portion of the impermeable casing 450.

[0065] In some embodiments, the permeable support 440 may have a bottom side with a peripheral edge. The peripheral edge may be fixed to the impermeable casing 450. In some embodiments, the peripheral edge may be fixed (e.g., by an adhesive) to a portion of the impermeable casing 450 adjacent to the upper edge of the impermeable casing 450. In some embodiments, the impermeable casing 450 may extend upward beyond the location where the peripheral edge of the permeable support 540 is attached. In some embodiments, the impermeable casing 450 may be attached to the permeable support 440 by any suitable holding mechanism, such as, for example, a retaining clip or other fastener. In some embodiments, the permeable support 440 and the permeable membrane 430 may be positioned within the impermeable casing without using an additional coupling mechanism.

[0066] The impermeable layer 450 may be impermeable to fluids such as urine, for example. In some implementations, the impermeable layer 450 can have the function of transferring fluid and can assist in guiding the fluid towards the reservoir 410 and / or through the outlet 420 of the reservoir 410. In some implementations, the impermeable layer 450 may be formed as an integral, unified structure. In other implementations, the impermeable layer 450 may be a structure composed of multiple components. The impermeable layer 450 may be a preformed (e.g., injection molded or blow molded) component. Alternatively, the impermeable layer 450 may be formed of a material such as an elongated strip of adhesive tape wrapped around at least a portion of the reservoir 410, a portion of the permeable support 440, and / or a portion of the permeable membrane 430. In some embodiments, the impermeable layer 450 may be formed of cardboard, pressure-sensitive paper, and / or coated paper. In some embodiments, the impermeable layer 450 may be flexible.

[0067] The permeable membrane 430 may be formed of a material having permeation characteristics with respect to fluids such as urine. The permeation characteristics may be suction, capillary action, diffusion, or other similar characteristics or processes, and are referred to herein as "permeable" and / or "suction". The permeable membrane 430 may have a high absorption rate and a high permeation rate, whereby urine can be rapidly absorbed by the permeable membrane 430 and / or transferred through the permeable membrane 430. In some implementations, the permeable membrane 430 may be flexible. In some implementations, the permeable membrane 430 may be a ribbed fabric. In some implementations, the permeable membrane 430 may include and / or have a hygroscopic gauze, felt, terry cloth, thick tissue paper, and / or paper towel. In some implementations, the permeable membrane 430 may be soft and / or minimize friction so as not to irritate the user's skin. The permeable membrane 430 can be configured to suck up and release fluid from the user's urethral opening and / or skin, thereby reducing the moisture of the user's skin and preventing infections. In addition, the suction characteristics of the permeable membrane 430 can help prevent urine leakage or flow onto, for example, the bed (such as outside the opening 432) beyond the assembly. In some implementations, the permeable membrane 430 may be formed of thin-denier polyester fibers coated with a thermally flexible and aqueous binder system. The tension can be, for example, about 45 pounds per square inch (when measured using the Instron test method). The weight of the permeable membrane can be, for example, about 12 grams (when measured using the metric gram method). The thickness of every 10 permeable membranes can be, for example, about 2.5 inches (when measured using Gustin-Bacon / Measure-Matic).

[0068] The permeable support portion 440 can be positioned relative to the permeable membrane 430 so as to maintain the permeable membrane 430 in a specific shape and so that fluid, such as urine, can pass through the permeable membrane 430 and through the permeable support portion 440 and into the reservoir 410. In some implementations, the permeable membrane 430 may be disposed on the upper side as the first side of the permeable support portion 440, and the bottom side as the second side of the permeable support portion 440 can define the boundary of the reservoir 410. In some implementations, the permeable support portion 440 may be of a concave shape such that when the permeable support portion 440 is disposed within the impermeable casing 450, the cavity 452 forms the bottom of the concave shape. When the permeable membrane 430 is disposed on the permeable support portion 440, the permeable membrane 430 can define a part of the bottom boundary and / or the side boundary of the cavity 452. When the permeable support portion 440 and the permeable membrane 430 are disposed within the impermeable casing 450, the cavity 452 can be aligned with the opening 432 of the impermeable casing 450. The reservoir 410 may be defined by the permeable support portion 440 and the impermeable casing 450 such that the reservoir 410 is concave and of any suitable shape and / or dimensions.

[0069] In some embodiments, the permeable support portion 440 and / or the permeable membrane 430 may be of any suitable shape and / or size. In some embodiments, the permeable support portion 440 and / or the permeable membrane 430 may be of the same or similar shape and dimensions. In some embodiments, the permeable support portion 440 and / or the permeable membrane 430 may be shaped such that the outer periphery of the permeable support portion 440 and / or the permeable membrane 430 is the same or similar to the outer periphery of the upper portion of the impermeable casing 450 and / or the opening 432. In some embodiments, the dimensions of the permeable support portion 440 and / or the permeable membrane 430 may be sized such that the cavity 452 can receive the user's penis and the head of the penis can be partially or wholly disposed within the cavity 452 (i.e., the shaft of the penis is disposed within the opening 432 and the head of the penis is fully disposed within the cavity 452, or the urethral opening of the head of the penis is disposed within the cavity 452 and the head is disposed partially inside and partially outside the cavity 452 such that the opening 432 surrounds a part of the head). In some embodiments, the cavity 452 may be sized to receive the head of the user's penis, whereby urine can be received within the cavity 452 from the urethral opening of the penis, through the permeable membrane 430 and / or the permeable support portion 440, without splashing outside the opening 432.

[0070] In some embodiments, the permeable support portion 440 can be configured to maintain the permeable membrane 430 against the skin of the user's penis and / or near the user's urethral orifice. For example, the permeable support portion 440 can be shaped and sized such that the cavity 452 is slightly larger than the head or tip of the user's penis. The permeable support portion 440 can include a portion that contacts the permeable membrane 430 and has a curved or convex shape, whereby the permeable membrane 430 is also curved or convex. The permeable support portion 440 can support the permeable membrane 430 such that the permeable membrane 430 is stationary against the skin of the head or tip of the penis and guides the urethral orifice toward the bottom surface of the impermeable casing 450, thereby creating a comfortable and at least partially enclosed boundary for engaging the area of the body near the urethral orifice (e.g., the head and / or neck of the user's penis).

[0071] In some embodiments, the permeable support portion 440 can be made of rigid plastic. In some embodiments, the permeable support portion 440 can be of any suitable shape and can be formed from any suitable material. For example, the permeable support portion 440 can be flexible. Additionally, the permeable support portion 440 can be formed of aluminum, a composite of plastic and aluminum, some other metal, and / or a composite of plastic and another metal. In some embodiments, the permeable support portion 440 can 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 such that fluid can flow through the natural material. In some embodiments, the permeable support portion 440 can be formed of a perforated coated paper such as tubular wax paper.

[0072] The permeable support portion 440 can define one or more openings (e.g., an array of openings) to enable the flow of fluid from the permeable membrane 430 to the reservoir 410. In some implementations, the permeable support portion 440 can include membrane support portions (e.g., crossbars) that extend across the openings, whereby the openings are divided into an array of discrete slot-shaped openings. The membrane support portions can be used to support the permeable membrane 430. For example, the membrane support portions can maintain the shape of the permeable membrane 430 against the skin of the user's penis and / or near the user's urethral orifice, whereby urine flowing out of the urethral orifice contacts the permeable membrane 430 and moves through the permeable membrane 130. In some implementations, the permeable support portion 440 can define several openings having various shapes, such as a plurality of circular openings. In some implementations, the permeable support portion 440 may be formed as a spun plastic (e.g., non-woven permeable nylon and polyester webbing), whereby the permeable support portion 440 can have many openings. In some implementations, the permeable support portion 440 can be made of a porous material. For example, the permeable support portion 440 may be a container of porous glass that defines a frit. In other implementations, the permeable support portion 440 can define the openings of the permeable support portion 440, and these openings may be covered by a mesh screen that defines many smaller openings. In some embodiments, the reservoir 410 can include any space defined within the permeable support portion 440 and / or openings (e.g., a space within a porous material or a space defined within a spun plastic material).

[0073] The reservoir 410 may be of any suitable shape and / or of any diameter (or other dimension) suitable for receiving and moving urine during use of the system 400. In some implementations, the reservoir 410 may be sized such that a large or small amount of urine can be collected and temporarily held until it can be removed from the reservoir 410 via the outlet 420. For example, the reservoir 410 may be sized such that it is configured to hold a small amount of urine that may be released due to incontinence. In some implementations, the reservoir 410 may be sized such that it is configured to hold a large amount of urine that may be released while emptying a full bladder. In some implementations, the reservoir 410 may be sized such that it is configured to collect and hold a small or large amount of urine while simultaneously removing the urine via a pump such as, for example, gravity and / or a vacuum source 470. Alternatively, the reservoir 410 may function as a sump, and the reservoir 410 may be sized such that it may form a portion of a passage for urine to pass from the permeable membrane 430 through the permeable support 440 and out of the reservoir 410 via the outlet 420. Temporary urine stagnation may occur within the reservoir 410 under conditions where the flow rate of urine entering the assembly 402 through the permeable membrane 430 is greater than the flow rate through the discharge line 422. Thus, the reservoir 410 may be sized to accommodate a volume that can temporarily accumulate fluid due to differences in the flow rates entering and leaving the assembly 402.

[0074] Although the outlet 420 is shown as extending from the side of the reservoir 410, in some implementations, the outlet 420 may extend from the bottom of the reservoir 410.

[0075] The outer container 460 can collect the fluid exiting the reservoir 410 through the outlet 420 via the discharge line 422. The outer container 460 may be a sealed enclosure. In some implementations, the outer container 460 may be disposable. In some implementations, the outer container 460 may be configured to be sterilized and reused.

[0076] In some implementations, gravity can cause the fluid in the reservoir 410 to follow a fluid path from the reservoir 410 to the outer container 460 (i.e., the fluid path including the outlet 420 and the discharge line 422). In some implementations, the vacuum source 470 can assist and / or provide the pressure differential necessary to remove the fluid from the user's urethral orifice, place it into the permeable support 440, place it into the reservoir 410, and place it from the reservoir 410 into the outer container 460. The vacuum source 470 can be in fluid communication with the outer container 460 via a vacuum line 424, whereby gaseous fluid is removed from the outer container 460 via the vacuum line 424. As a result of the pressure reduction in the outer container 460 caused by removing the gaseous fluid from the outer container 460, liquid and / or gaseous fluid can be removed from the reservoir 410, passed through the outlet 420, and passed through the discharge line 422 into the outer container 460. In some implementations, the vacuum source 470 can apply a large suction force to capture all or substantially all of the urine discharged by the user in various positions (e.g., when a male user is lying on his side or on his back).

[0077] The vacuum source 470 can have a fairly high vacuum force and air volume transfer rate, thereby maintaining rapid suction of air and liquid across a portion or all of the permeable membrane 430. In some implementations, one or more openings of the permeable support 440 are distributed over an area that is slightly larger than the area of the permeable membrane 430 configured to be wetted by the urine flow during operation. Thus, the partial vacuum created by the vacuum source 470, together with one or more openings of the permeable support 440 and the permeable membrane 430, can draw the urine in contact with the permeable membrane 430 into the assembly 402, specifically the reservoir 410. However, in some implementations, one or more openings of the permeable support 440 need not be distributed over too large an area of the permeable support 440, because the partial vacuum force would decrease and thus the urine collection volume and the efficiency of the system 400 could be reduced.

[0078] In some implementations, the vacuum source 470 can be similar or analogous in structure and / or function to the vacuum source 170 described above in connection with the system 100 shown in FIG. 1. In some implementations, urine collected by any of the systems and / or assemblies described herein can be sampled for analysis using the urine strips described above in a similar manner in connection with the system 100 shown in FIG. 1. In some implementations, the external container 460 can be similar or analogous in structure and / or function to the external container 160 described above in connection with the system 100 shown in FIG. 1.

[0079] Although described with the intention of being used by adult males, in some implementations, system 400 can be used for veterinary applications for adults, children, males, females, and animals of different species and sizes. In female applications, assembly 402 can be placed between the user's legs or between the labia and held comfortably against the external urethral orifice by frictional pressure from the user's body, pressure between the legs, or underwear, elastic strips, and / or adhesive tape. In male applications, assembly 402 can be positioned such that the user's penis is disposed within assembly 402 (e.g., within a cavity formed within assembly 402). A male user can use assembly 402 in any suitable position, such as while lying on his back, side, sitting, or standing. In some implementations, during urination, the head of the male user's penis can be positioned in contact with the permeable membrane 430. In some implementations, during urination, the head of the male user's penis can be disposed at least partially within cavity 452 but not positioned in contact with the permeable membrane 430.

[0080] FIG. 6 is a top view of assembly 502. FIG. 7 is a cross-sectional view of assembly 502 taken along line 7-7 of FIG. 6. Assembly 502 includes a permeable membrane 530, a permeable support 540, and an impermeable casing 550 (also referred to herein as an “impermeable layer”). The permeable membrane 530 and the permeable support 540 are disposed within the impermeable casing 550. The permeable membrane 530, the permeable support 540, and the impermeable casing 550 may have the same or similar structures and / or functions as the permeable membrane 430, the permeable support 440, and the impermeable casing 450 described above with reference to system 400. For example, the permeable support 540 and the impermeable casing 550 together define a reservoir 510 (also referred to herein as a “chamber”). The impermeable layer 550 defines an opening 532. Assembly 502 also includes an outlet 520 (also referred to herein as a “port”) in fluid communication with the reservoir 510.

[0081] The permeable support portion 540 and the permeable membrane 530 can be arranged such that the impermeable membrane 550 and the permeable support portion 540, and / or the permeable membrane 530, together define the cavity 552 within the permeable membrane 530. The impermeable casing 550 can direct fluid towards the reservoir 510 and / or reduce and / or prevent fluid from exiting the assembly 502 other than through the outlet 520. In some implementations, the assembly 502 can be arranged such that fluid enters the cavity 552 through the opening 532, passes through the permeable membrane 530, passes through the permeable support portion 540, and enters the reservoir 510, and then flows out through the outlet 520. In some implementations, the assembly 502 can be arranged such that the user's penis can be inserted through the opening 532, whereby the user's urethral orifice is disposed within the cavity 552, fluid flows from the user's urethral orifice into the cavity 552, passes through the permeable membrane 530, passes through the permeable support portion 540, and enters the reservoir 510, and then flows out through the outlet 520. The discharge line 522 (e.g., a tube, also referred to herein as the "received tube") can extend through the outlet 520. As shown in FIG. 7, the first end of the drain line 522 can be positioned within the reservoir 510, and the drain line 522 extends through the impermeable casing 550, whereby fluid within the reservoir 510 can be moved from the assembly 502 via the drain line 522. The second end of the discharge line 522 can be fluidly connected to an external container (e.g., the external container 460). The external container can be fluidly connected to a vacuum source (e.g., the vacuum source 470) via a vacuum line (e.g., the vacuum line 424). Both the discharge line 522 and the vacuum line can include a flexible tube, such as a flexible plastic tube, for example.

[0082] More specifically, the impermeable casing 550 can define an inner region accessible through the opening 532. The permeable membrane 530 and the permeable support 540 can be disposed within the inner region of the impermeable casing 550. The impermeable casing 550 can be of any suitable shape. For example, in some implementations, the impermeable casing 550 can be bowl-shaped. As shown in FIG. 7, the impermeable casing 550 can include a curved or concave bottom surface on the opposite side of the opening 532. As shown in FIGS. 6 and 7, the impermeable casing 550 can include a lip portion 556 surrounding the opening 532. The lip portion 556 can define the opening 532 such that the opening 532 is on the opposite side of the bottom surface of the impermeable casing 550 and the inner region of the impermeable casing 550 is partitioned (and co-defined) by the curved or concave bottom surface of the impermeable casing 550, the lip portion 556, and the opening 532. The lip portion 556 can be shaped and sized such that it can reduce the possibility of urine flowing out from the opening 532 and / or reduce the risk of urine splashing through the opening 532. In some implementations, the opening 532 has a width and / or extension similar to the diameter of the user's penis. In some implementations, the opening 532 has a width and / or extension longer than the diameter of the user's penis. In some implementations, the opening 532 can be of an irregular shape. For example, as shown in FIG. 6, the opening 532 (and the impermeable casing 550) can have a rounded or semi-circular first portion and a second portion tapered from a first side adjacent to the first portion having a first width to a second width narrower than the first width.

[0083] As shown in FIG. 7, the permeable support portion 540 may have a bottom side with a peripheral edge portion 542. The peripheral edge portion 542 may be fixed (e.g., with an adhesive) to the inner wall of the impermeable casing 550. In some implementations, the reservoir 510 formed by the permeable support portion 540 and the impermeable casing 550 is sized to collect and / or move urine, and the cavity 552 is sized to accommodate a part or all of the user's penis within the cavity 552. The peripheral edge portion 542 may be fixed at one or more locations (or continuously along the peripheral edge). In some implementations, the impermeable casing 550 may be attached to the permeable support portion 540 with any suitable holding mechanism, such as a retaining clip or other fastening means. In some implementations, the permeable support portion 540 and the permeable membrane 530 may be positioned within the impermeable casing without using an additional coupling mechanism.

[0084] The impermeable layer 550 may be impermeable to fluids such as urine, for example. In some implementations, the impermeable layer 550 can have a function of transferring fluid and can assist in directing the fluid towards the reservoir 510 and / or through the outlet 520 of the reservoir 510. In some implementations, the impermeable layer 550 may be formed as an integral and unified structure. In other implementations, the impermeable layer 550 may be a structure composed of multiple parts. The impermeable layer 550 may be a pre-formed (e.g., injection molded or blow molded) component. Alternatively, the impermeable layer 550 may be formed of a material such as an elongated strip of adhesive tape wrapped around at least a portion of the reservoir 510, a portion of the permeable support portion 540, and / or a portion of the permeable membrane 530. In some embodiments, the impermeable layer 550 may be formed of cardboard, pressure-sensitive paper, and / or coated paper. In some embodiments, the impermeable layer 550 may be flexible.

[0085] The permeable membrane 530 may be formed of a material having permeation characteristics with respect to fluids such as urine. The permeation characteristics may be suction, capillary action, diffusion, or other similar characteristics or processes, and are referred to herein as "permeability" and / or "suction". The permeable membrane 530 may have a high absorption rate and a high permeation rate, whereby urine can be rapidly absorbed by the permeable membrane 530 and / or transferred through the permeable membrane 530. In some implementations, the permeable membrane 530 may be flexible. In some implementations, the permeable membrane 530 may be a ribbed fabric. In some implementations, the permeable membrane 530 may include and / or have a hygroscopic gauze, felt, terry cloth, thick tissue paper, and / or paper towel. In some implementations, the permeable membrane 530 may be soft and / or minimize friction so as not to irritate the user's skin. The permeable membrane 530 can be configured to suck up and release fluid from the user's urethral opening and / or skin, thereby reducing the moisture of the user's skin and preventing infections. In addition, the suction characteristics of the permeable membrane 530 can help prevent urine leakage or flow over the assembly (e.g., outside the opening 532) onto, for example, the bed. In some implementations, the permeable membrane 530 may be formed of fine denier polyester fibers coated with a thermally flexible and aqueous binder system. The tension in the weft direction, when measured using the Instron test method, can be, for example, about 45 pounds per square inch. The weight per permeable membrane, when measured using the metric gram method, can be, for example, about 12 grams. The thickness of every 10 permeable membranes, when measured using Gustin-Bacon / Measure-Matic, can be, for example, about 2.5 inches.

[0086] The permeable support portion 540 can be positioned relative to the permeable membrane 530 so as to maintain the permeable membrane 530 in a specific shape and so that a fluid, such as urine, can pass through the permeable membrane 530 and through the permeable support portion 540 and into the reservoir 510. In some implementations, the permeable membrane 530 may be disposed on a first upper side of the permeable support portion 540, and a second bottom side of the permeable support portion 540 can define a boundary of the reservoir 510. As shown in FIG. 7, the permeable support portion 540 can be of a concave shape such that when the permeable membrane 530 is disposed on the permeable support portion 540 and when the permeable membrane 530 and the permeable support portion 540 are disposed within the impermeable casing 550, the cavity 552 has a concave bottom. When the permeable support portion 540 and the permeable membrane 530 are disposed within the impermeable casing 550, the cavity 552 can be aligned with the opening 532 of the impermeable casing 550. The reservoir 510 can be defined by the permeable support portion 540 and the impermeable casing 550 such that the reservoir 510 is concave and of any suitable shape and / or dimensions.

[0087] In some embodiments, the permeable support portion 540 and / or the permeable membrane 530 may be of any suitable shape and / or size. In some embodiments, the permeable support portion 540 and / or the permeable membrane 530 may be of the same or similar shape and dimensions. In some embodiments, the permeable support portion 540 and / or the permeable membrane 530 may be shaped such that the outer periphery of the permeable support portion 540 and / or the permeable membrane 530 is the same or similar to the outer periphery of the upper portion of the impermeable casing 550 and / or the opening 532. In some embodiments, the dimensions of the permeable support portion 540 and / or the permeable membrane 530 may be sized such that the cavity 552 can receive the user's penis and the head of the penis can be disposed partially or completely within the cavity 552 (i.e., the axis of the penis is disposed within the opening 532 and the head of the penis is disposed completely within the cavity 552, or the urethral opening of the head of the penis is disposed within the cavity 552, with a portion of the head within the cavity 552 and a portion of the head outside the cavity 552, and the opening 532 is sized to surround a portion of the head). In some embodiments, the cavity 552 may be sized to receive the head of the user's penis, such that urine can be received within the cavity 552 from the urethral opening of the penis, through the permeable membrane 530 and / or the permeable support portion 540, without splashing outside the opening 532.

[0088] In some embodiments, the permeable support 540 can be configured to maintain the permeable membrane 530 against the skin of the user's penis and / or near the user's urethral orifice. For example, the permeable support 540 can be shaped and sized such that the cavity 552 is slightly larger than the head or tip of the user's penis. The permeable support 540 can include a portion that contacts the permeable membrane 530 and has a curved or convex shape, whereby the permeable membrane 530 is also curved or convex. The permeable support 540 can support the permeable membrane 530 such that the permeable membrane 530 is stationary against the skin of the head or tip of the penis and directs the urethral orifice towards the bottom surface of the impermeable casing 550, thereby creating a comfortable and at least partially enclosed boundary for engaging the area of the body near the urethral orifice (e.g., the head and / or neck of the user's penis).

[0089] In some embodiments, the permeable support 540 can be made of rigid plastic. In some embodiments, the permeable support 540 can be of any suitable shape and can be formed from any suitable material. For example, the permeable support 540 can be flexible. Additionally, the permeable support 540 can be formed of aluminum, a composite of plastic and aluminum, some other metal, and / or a composite of plastic and another metal. In some embodiments, the permeable support 540 can be formed of a natural material such as, for example, plant fibers (e.g., Greener Clean (registered trademark) manufactured by 3M). The natural material can include openings such that fluid can flow through the natural material. In some embodiments, the permeable support 540 can be formed of a perforated coated paper such as tubular wax paper.

[0090] The permeable support portion 540 can define one or more openings (e.g., an array of openings) to enable the flow of fluid from the permeable membrane 530 to the reservoir 510. In some implementations, the permeable support portion 540 can include membrane support portions (e.g., crossbars) that extend across the openings, whereby the openings are divided into an array of discrete slot-shaped openings. The membrane support portions can be used to support the permeable membrane 530. For example, the membrane support portions can maintain the shape of the permeable membrane 530 against the skin of the user's penis and / or near the user's urethral orifice, whereby urine flowing out of the urethral orifice contacts the permeable membrane 530 and moves through the permeable membrane 130. In some implementations, the permeable support portion 540 can define several openings having various shapes, such as a plurality of circular openings. In some implementations, the permeable support portion 540 may be formed as a spun plastic (e.g., non-woven permeable nylon and polyester webbing), whereby the permeable support portion 540 can have many openings. In some implementations, the permeable support portion 540 can be formed from a porous material. For example, the permeable support portion 540 may be a receptacle of porous glass that defines a frit. In other implementations, the permeable support portion 540 can define an opening of the permeable support portion 540, and this opening may be covered by a mesh screen that defines many smaller openings. In some embodiments, the reservoir 510 can include any space defined within the permeable support portion 540 and / or the openings (e.g., a space within a porous material or a space defined within a spun plastic material).

[0091] The reservoir 510 may be of any suitable shape and / or of any diameter (or other dimension) suitable for receiving and moving urine during use of the system including the assembly 502. In some implementations, the size of the reservoir 510 may be determined such that the reservoir 510 can collect and temporarily hold a large or small amount of urine until the urine is removed from the reservoir via the outlet 520. For example, the size of the reservoir 510 may be determined such that the reservoir 510 is configured to hold a small amount of urine that may be released due to incontinence. In some implementations, the size of the reservoir 510 may be determined such that the reservoir 510 is configured to hold a large amount of urine that may be released while emptying a full bladder. In some implementations, the size of the reservoir 510 may be determined such that the reservoir 510 collects and holds a small or large amount of urine while simultaneously removing the urine via a pump such as, for example, gravity and / or a vacuum source 570. In another way, the reservoir 510 may function as a liquid reservoir and the size of the reservoir 510 may be determined such that the reservoir 510 may form a portion of a passage for urine to pass from the permeable membrane 530 through the permeable support 540 and through the reservoir 510 to the outlet 520. Temporary urine stagnation may occur within the reservoir 510 under conditions where the flow rate of urine entering the assembly 502 through the permeable membrane 530 is greater than the flow rate through the discharge line 522. Thus, the size of the reservoir 110 may be determined such that the reservoir 510 accommodates a volume that can temporarily accumulate fluid due to the difference in flow rates entering and exiting the assembly 502.

[0092] Figure 8 is a flowchart illustrating a method of using an assembly for collecting urine from a user, according to one embodiment. Method 600 optionally includes, at 602, fluidly coupling a discharge end of a tube of a urine collection device to a fluid container. Method 600 further optionally includes, at 604, fluidly coupling a discharge end of a tube of the urine collection device to a vacuum source.

[0093] Method 600 further includes, at 606, disposing the head of a male user's (e.g., human or animal) penis through an opening into a cavity defined by a fluid permeable membrane and a casing of a urine collection device, such that the urine collection device is disposed in an operative relationship with the user's urethral orifice. The urine collection device can be, for example, any urine collection device described herein, such as assembly 402 of FIG. 5 and / or assembly 502 of FIGS. 6 and 7, and can be similar or analogous in structure and / or function. For example, the urine collection device may include a fluid impermeable casing, a fluid permeable support, a fluid permeable membrane, and a tube. The fluid impermeable casing can define an opening, an interior region, and a fluid outlet. The fluid permeable support can have a first side and a second side. The second side of the fluid permeable support and the fluid impermeable casing can together define a reservoir. The fluid permeable support can also be disposed within the interior region of the fluid impermeable casing. The fluid permeable membrane can be disposed on the first side of the support and cover at least a portion of the support. The fluid permeable membrane and the casing can together define a cavity. The tube can have a first end disposed within an elongate reservoir and extend through the fluid outlet to a second fluid discharge end. The assembly can be arranged such that fluid flows from the user's penile urethral orifice into the cavity, is collected in the reservoir through the fluid permeable membrane and the fluid permeable support, and exits through the outlet.

[0094] Method 600 further includes, at 608, receiving urine discharged from the penis into the cavity and enabling it to be received through the membrane and through the support into the reservoir.

[0095] Method 600 also further includes, at 610, collecting the received urine from the reservoir through the tube and enabling it to exit from the fluid discharge end of the tube.

[0096] Method 600 optionally further includes, at 612, enabling the collected urine to be collected in a fluid container.

[0097] Method 600 optionally includes, at 614, removing the urine collection device from the user's penis. Thus, the urine collection device can capture and transfer urine from the user without the need to attach a catheter to the urethral opening of the user's penis. In some implementations, urine can flow against gravity during collection.

[0098] Finally, method 600 optionally includes, at 616, disposing the head of the user's penis through the opening into the cavity of the urine collection device and disposing the second urine collection device in an operative relationship with the user's urethral opening.

[0099] Although various embodiments of the systems, methods, and devices have been described above, it should be understood that they are presented by way of example only and not limitation. The methods and steps described above represent specific events occurring in a specific order, and those skilled in the art having the benefit of this disclosure should recognize that the order of the specific steps may be changed and such changes would follow the variations of the invention. Further, the specific steps may be executed simultaneously as parallel processes where possible, as well as executed in the order as described above. Although embodiments have been shown and described in detail, it should be understood that various changes may be made in form and detail.

[0100] For example, while various embodiments have been described as having combinations of detailed features and / or components, other embodiments are possible having any combination, or sub - combination, of any features and / or components from any of the embodiments described herein. Further, the specific configuration of various components may also vary. For example, the size and specific shape of various components may provide the functions described herein while differing from the embodiments shown.

Claims

1. A fluid collection device comprising: A fluid-impermeable layer including a first portion defining an opening into which the penis is inserted and a second portion on the opposite side of the first portion forming the bottom surface of the fluid collection device, wherein the opening has a size and dimensions such that it can receive at least the head of a male penis, and the fluid-impermeable layer forms an internal region of the fluid collection device; A fluid-permeable membrane disposed in the internal region of the fluid collection device between the first portion and the second portion of the fluid-impermeable layer, the fluid-permeable membrane surrounding at least a portion of the opening into which the penis is inserted; An outlet which is an outlet of the fluid-impermeable layer and is configured to enable the transfer of fluid in the internal region of the fluid collection device away from the fluid collection device; A container extending from the opening into the internal region of the fluid collection device and at least partially defined by the first portion of the fluid-impermeable layer and the fluid-permeable membrane, the container having a shape such that it can receive at least the head of the penis inserted through the opening; Comprising The first portion of the fluid-impermeable layer has a shape such that the fluid collection device has a contour that tapers at least partially along the opening and continues to taper beyond the opening. A fluid collection device characterized by the above.

2. The fluid collection device according to claim 1, Wherein the container is configured to take out the fluid flowing from the head of the penis through the permeable membrane to the outlet when the male is lying on his back and the penis is disposed in the container. A fluid collection device characterized by the above.

3. The fluid collection device according to claim 1 or 2, Wherein the container is a void between the first portion of the fluid-impermeable layer and the fluid-permeable membrane. A fluid collection device characterized by the above.

4. The fluid collection device according to any one of claims 1 to 3, Further comprising a chamber disposed on the opposite side of the container within the internal region of the fluid collection device, the chamber being disposed between the fluid-permeable membrane and the second portion of the fluid-impermeable layer. A fluid collection device characterized by the above.

5. The fluid collection device according to claim 4, Wherein the chamber is a void located between the fluid-permeable membrane and the second portion of the fluid-impermeable layer. A fluid collection device, characterized in that... **Claim 6** The fluid collection device according to any one of claims 1 to 5, further comprising an additional fluid-permeable layer fixed to the opposite side of the opening of the fluid-impermeable layer. A fluid collection device, characterized in that... **Claim 7** The fluid collection device according to claim 6, wherein the additional fluid-permeable layer contains polytetrafluoroethylene. A fluid collection device, characterized in that... **Claim 8** The fluid collection device according to any one of claims 1 to 7, wherein the permeable membrane contains polyester. A fluid collection device, characterized in that... **Claim 9** The fluid collection device according to any one of claims 1 to 8, wherein the opening includes a first semi-circular region and a second region narrower than the first semi-circular region, and the second region has a tapered shape that changes from a first width adjacent to the first semi-circular region to a second width smaller than the first width. A fluid collection device, characterized in that... **Claim 10** The fluid collection device according to any one of claims 1 to 9, wherein the second portion of the fluid-impermeable layer has a generally curved concave shape as a whole. A fluid collection device, characterized in that... **Claim 11** The fluid collection device according to any one of claims 1 to 10, wherein the outlet includes a tube that is in fluid communication with the container in the internal region of the fluid collection device and extends outward from the fluid-impermeable layer. A fluid collection device, characterized in that... **Claim 12** A fluid collection system, comprising the fluid collection device according to any one of claims 1 to 11, and a vacuum source fluidly connected to the outlet. A fluid collection system, characterized in that it comprises... **Claim 13** The system according to claim 12, further comprising a fluid container fluidly connected to the outlet. A system, characterized in that... **Claim 14** A fluid collection device, comprising an impermeable material having a recess, an opening provided in the impermeable material, a first layer of permeable material, a second layer of permeable material at least partially located between the first layer of permeable material and at least a part of the impermeable material, and a chamber of voids spaced from the opening of the impermeable material and at least partially located in the recess of the impermeable material, the chamber being located between and defined by a part of the second layer of permeable material and at least some of the recess of the impermeable material. A tube that extends at least partially through the impermeable material into a chamber of a void located within the recess, the tube being configured to transport fluid from the chamber through the tube. Comprising The first layer of the permeable material and the second layer of the permeable material are located between the opening and the chamber of the void. A fluid collection device characterized by this.

15. The fluid collection device according to claim 14, A container at least partially defined by the first layer of the permeable material, having a shape that can receive at least the head of the penis, and configured to take out fluid flowing from the head of the penis into the chamber through the first layer of the permeable material and the second layer of the permeable material when the head of the penis is disposed within the container. A fluid collection device characterized by further comprising this.

16. The fluid collection device according to claim 14, The first layer of the permeable material includes a suction material, The second layer of the permeable material includes a web of spun material. A fluid collection device characterized by this.

17. The fluid collection device according to claim 14, Further comprising an opening in the impermeable material located approximately opposite the chamber. A fluid collection device characterized by this.

18. The fluid collection device according to claim 17, A part of the first layer of the permeable material is located on the opposite side of the opening and is adjacent to the part of the second layer of the permeable material that defines the chamber. A fluid collection device characterized by this.

19. The fluid collection device according to claim 17, The impermeable material includes a lip portion that at least partially surrounds the opening. A fluid collection device characterized by this.

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