Patent Description:
The present disclosure generally relates to devices and systems for collecting urine discharged from the body of a user and carrying the urine away from the body.

Under various circumstances, a user may have limited or impaired mobility such that ordinary urinary functions and processes are rendered difficult (or impossible). For example, a person may have impaired mobility due to a disability or may be bedridden due to an injury or illness. In another example, a person may be subject to restricted occupational conditions under which the person has limited mobility. Also, for example, urine collection may be needed for monitoring purposes, such as for monitoring inputs and outputs in a clinical setting (e.g., in an intensive care unit, or for other clinical and/or laboratory testing).

Various approaches have been developed to address some of the problems or circumstances related to impaired or restricted urinary processes. However, prior approaches suffer from problems or limitations of their own. Internal urinary catheters, for example, can address problems arising from urinary incontinence or limited mobility, but urinary catheters can often be uncomfortable and can contribute to complications (for example, infections). Bed pans, as another example, are containers occasionally used for collecting urinary output of a bedridden person (such as a patient at a health care facility), but bed pans can contribute to patient discomfort, spillage, and issues related to sanitation or hygiene. An example of a urine collection device is provided in <CIT>.

Other more recent approaches to urinary collection have been developed, which include a urine collection device configured to be placed external to, but in contact with the body for collecting and directing a fluid receptacle. However, the recent approaches also present challenges, such as in maintaining the placement of the device in appropriate contact with the body of a user, resulting in potential leakage and patient discomfort.

The invention provides a urine collection device according to claim <NUM>. For better understanding of the invention, the present disclosure provides also further examples, not falling under the scope of the claims. In an example, a urine collection device is described. The urine collection device includes a covering defining a recessed receptacle, and a fluid collection assembly positioned in the recessed receptacle defined by the covering. The fluid collection assembly includes (i) a foam sleeve including a bore extending from a first end of the foam sleeve to a second end of the foam sleeve and (ii) a shape retaining element positioned in the bore of the foam sleeve. The shape retaining element is configured to conform the fluid collection assembly to a curved configuration for placement against a body of a user and maintain the curved configuration of the fluid collection assembly until the curved configuration is adjusted. The shape retaining element defines a passage extending from between a proximal end of the shape retaining element and a distal end of the shape retaining element. The fluid collection assembly also includes (iii) a tube extending through the passage defined by the shape retaining element.

The urine collection further includes a top sheet coupled to the covering. The top sheet and the covering define an internal chamber of the urine collection device. The top sheet is configured to draw urine into the internal chamber and toward the fluid collection assembly.

In another example, a method of making a urine collection device is described. The method includes forming a covering such that the covering defines a recessed receptacle and forming a fluid collection assembly. The fluid collection assembly includes (i) a foam sleeve including a bore extending from a first end of the foam sleeve to a second end of the foam sleeve and (ii) a shape retaining element positioned in the bore of the foam sleeve. The shape retaining element is configured to conform the fluid collection assembly to a curved configuration for placement against a body of a user and maintain the curved configuration of the fluid collection assembly until the curved configuration is adjusted. The shape retaining element defines a passage extending from between a proximal end of the shape retaining element and a distal end of the shape retaining element. The fluid collection assembly also includes (iii) a tube extending through the passage defined by the shape retaining element.

The method also includes positioning the fluid collection assembly in the recessed receptacle defined by the covering, wherein the fluid collection assembly; and coupling a top sheet to the covering with the fluid collection assembly positioned between the top sheet and the covering. The top sheet and the covering define an internal chamber of the urine collection device. The top sheet is configured to draw urine into the internal chamber and toward the fluid collection assembly.

In another example, a method, which does no fall under the scope of the invention, of collecting urine discharged from a body of a user is described. The method includes providing a urine collection device. The urine collection device includes a covering defining a recessed receptacle, and a fluid collection assembly positioned in the recessed receptacle defined by the covering. The fluid collection assembly includes (i) a foam sleeve including a bore extending from a first end of the foam sleeve to a second end of the foam sleeve and (ii) a shape retaining element positioned in the bore of the foam sleeve. The shape retaining element is configured to conform the fluid collection assembly to a curved configuration for placement against a body of a user and maintain the curved configuration of the fluid collection assembly until the curved configuration is adjusted. The shape retaining element defines a passage extending from between a proximal end of the shape retaining element and a distal end of the shape retaining element. The fluid collection assembly also includes (iii) a tube extending through the passage defined by the shape retaining element. The urine collection further includes a top sheet coupled to the covering. The top sheet and the covering define an internal chamber of the urine collection device. The top sheet is configured to draw urine into the internal chamber and toward the fluid collection assembly.

Additionally, the method includes positioning the urine collection device against the body of the user with the top sheet in operative relation with a urethral opening of the user. The method also includes receiving, through the top sheet and by the fluid collection assembly, urine discharged from the urethral opening. The method further includes evacuating the urine from the fluid collection assembly through the tube.

The features, functions, and advantages that have been discussed can be achieved independently in various embodiments or may be combined in yet other embodiments further details of which can be seen with reference to the following description and drawings.

The illustrative embodiments, however, as well as a preferred mode of use, further objectives and descriptions thereof, will best be understood by reference to the following detailed description of an illustrative embodiment of the present disclosure when read in conjunction with the accompanying drawings, wherein:.

Disclosed embodiments will now be described more fully hereinafter with reference to the accompanying drawings, in which some, but not all of the disclosed embodiments are shown. Indeed, several different embodiments may be described and should not be construed as limited to the embodiments set forth herein. Rather, these embodiments are described so that this disclosure will be thorough and complete and will fully convey the scope of the disclosure to those skilled in the art.

By the term "approximately" or "substantially" with reference to amounts or measurement values described herein, it is meant that the recited characteristic, parameter, or value need not be achieved exactly, but that deviations or variations, including for example, tolerances, measurement error, measurement accuracy limitations and other factors known to those of skill in the art, may occur in amounts that do not preclude the effect the characteristic was intended to provide.

Referring now to <FIG> a urine collection device <NUM> is shown according to an example. In particular, <FIG> depicts a perspective view of the urine collection device <NUM>, <FIG> depicts an exploded view of the urine collection device <NUM>, <FIG> depicts a first cross-sectional view of the urine collection device <NUM> through a line 1C-1C, and <FIG> depicts a second cross-sectional view of the urine collection device <NUM>.

As shown in <FIG>, the urine collection device <NUM> includes a covering <NUM>, a fluid collection assembly <NUM>, and a top sheet <NUM>. The fluid collection assembly <NUM> includes a foam sleeve <NUM>, a shape retaining element <NUM>, and a tube <NUM>. Additionally, the urine collection device <NUM> can include a fluid-impermeable barrier <NUM>, an anchor <NUM>, and/or a suction adapter <NUM>. These components of the urine collection device <NUM> will be further described below with respect to <FIG> and <FIG>, which depict additional aspects of the components of the urine collection device <NUM> shown in <FIG>.

As shown in <FIG> and <FIG>, the urine collection device <NUM> includes a covering <NUM> that defines a recessed receptacle <NUM>. In general, the covering <NUM> can provide a fluid impermeable layer that can assist in retaining a fluid, such as urine, in the recessed receptacle <NUM>. In one example, the covering <NUM> can be made from a foam material such as, for instance, a polymer film, a fabric coated with a film, and/or an elastomeric polymer (e.g., silicone). Making the covering <NUM> from a foam material can beneficially provide for forming the covering <NUM> using a thermoforming process, which can help to improve manufacturing efficiency, improve manufacturing speed, improve manufacturing quality, and/or reduce manufacturing costs relative to other types of materials. However, in other examples, the covering <NUM> can be made from other materials and/or made by other manufacturing processes (e.g., vacuum forming, injection molding, and/or compression molding).

As shown in <FIG> and <FIG>, the covering <NUM> includes an upper peripheral edge <NUM>. The upper peripheral edge <NUM> can assist in coupling the covering <NUM> to the top sheet <NUM>. In <FIG> and <FIG>, the upper peripheral edge <NUM> defines a flange portion extending outwardly in a plane away from the recessed receptacle <NUM>. This can help to increase a surface area for coupling the covering <NUM> to the top sheet <NUM>. However, in other examples, the upper peripheral edge <NUM> can omit the flange portion (i.e., the upper peripheral edge can be entirely coplanar with a wall of the recessed receptacle <NUM>). This can reduce (or avoid) forming a seam <NUM> (shown in <FIG>) at an interface between the covering <NUM> and the top sheet <NUM>.

In <FIG>, the top sheet <NUM> is coupled to the covering <NUM> at the upper peripheral edge <NUM>. As examples, the top sheet <NUM> can be coupled to the covering <NUM> by heating sealing and/or welding (e.g., ultrasonic welding and/or radiofrequency welding) the top sheet <NUM> and the covering <NUM>. The top sheet <NUM> can additionally or alternatively be coupled to the covering <NUM> by an adhesive. For instance, in one implementation, a relatively thin layer of film and/or adhesive (e.g., a polyurethane adhesive and/or a polyethylene adhesive) can be applied to the covering <NUM> to the covering <NUM> before or after forming the recessed receptacle <NUM> in the covering <NUM> (e.g., before or after thermoforming), and prior to coupling the top sheet <NUM> to the covering <NUM>. In implementations in which the top sheet <NUM> is coupled to the covering <NUM> by the adhesive, welding, and/or heat sealing, the film and/or the adhesive can help to strengthen the coupling between the top sheet <NUM> and the covering <NUM> imparted by the heat sealing.

When the top sheet <NUM> is coupled to the covering <NUM>, the top sheet <NUM> and the covering <NUM> define an internal chamber <NUM> of the urine collection device <NUM> as shown in <FIG>. In general, the top sheet <NUM> can draw fluids such as urine into the internal chamber <NUM> and toward the fluid collection assembly <NUM>. For instance, the top sheet <NUM> can be formed of a material having a relatively high absorptive rate, a relatively high adsorption rate, and/or a relatively high permeation rate such that fluids such as urine can be rapidly wicked and drawn into the internal chamber <NUM> of the urine collection device <NUM> (and toward the fluid collection assembly <NUM>). As one example, the top sheet <NUM> can be made from an absorbent polyester mesh material (e.g., a jersey mesh material). As another example, the top sheet <NUM> can be made of a blend of polyester and spandex (e.g., a blend including approximately <NUM> percent polyester and approximately <NUM> percent spandex). In yet another example, the top sheet <NUM> can include a fibrous material that is configured to draw the urine toward the fluid collection assembly <NUM> under capillary action. In another example, the top sheet <NUM> can be formed from a material having a total weight of approximately <NUM> ounces per square yard (plus or minus approximately <NUM>%), a fiber that is a mechanically wicking yarn, a knit configured as a circular knit, a dimpled face, a wicking finish, and a width of approximately <NUM> inches to approximately <NUM> inches.

As shown in <FIG>, the urine collection device <NUM> can have a tapered section <NUM> at a distal end 100A of the urine collection device <NUM>. For instance, in <FIG> and <FIG>, the upper peripheral edge <NUM> of the covering <NUM> tapers inwardly toward a center axis <NUM> of the covering <NUM> such that the covering <NUM> includes a tapered portion <NUM> at a distal end 110A of the covering <NUM>. Similarly, as shown in <FIG>, the top sheet <NUM> can include a peripheral edge <NUM> that tapers inwardly in a manner similar to the tapered portion <NUM> of the covering <NUM>. The tapered section <NUM> of the urine collection device <NUM>, which is formed by the tapered portion <NUM> of the covering <NUM> and the tapered portion of the top sheet <NUM>, can help to improve patient comfort and assist in retaining the urine collection device <NUM> at a desired position on a user. For instance, in an example, the tapered section <NUM> can be sized and/or shaped to fit into gluteal folds and a perineum of a body of the user such that the urine collection device <NUM> remains in a relatively fixed position on the body of the user.

Additionally, within examples, the tapered section <NUM> can be wedge shaped to assist in retaining the urine collection device <NUM> in the gluteal folds and/or the perineum of the user. For instance, the wedge shape of the tapered section <NUM> can define an edge at the distal end 100A, the edge can have a length and a width, and the length can be greater than the width.

In one example, the tapered section <NUM> can have a length of approximately <NUM> inch to approximately <NUM> inches. In another example, the tapered section <NUM> can have a length of approximately <NUM> inches. These example lengths can additionally or alternatively assist in retaining the tapered shape in the gluteal folds and/or the perineum of the user.

Additionally or alternatively, example materials described herein with respect to components of the urine collection device <NUM> at the distal end 100A can provide the tapered section <NUM> with a flexibility that allows the tapered section <NUM> to conform to a shape of the gluteal folds and/or the perineum of the user when the tapered section <NUM> is positioned in the gluteal folds and/or the perineum of the user.

In <FIG>, the fluid collection assembly <NUM> is in the internal chamber <NUM> of the urine collection device <NUM> between the covering <NUM> and the top sheet <NUM>. Within examples, the recessed receptacle <NUM> of the covering <NUM> can facilitate positioning and retaining the fluid collection assembly <NUM> between the covering <NUM> and the top sheet <NUM> during a manufacturing process. In particular, the recessed receptacle <NUM> of the covering <NUM> can receive the fluid collection assembly <NUM>. For instance, in <FIG>, the recessed receptacle <NUM> can define a trough into which the fluid collection assembly <NUM> can be positioned. In one example, the recessed receptacle <NUM> of the covering <NUM> and the fluid collection assembly <NUM> can have respective sizes and/or shapes such that the covering <NUM> engages approximately <NUM> percent to approximately <NUM> percent of an outermost surface of the fluid collection assembly <NUM> (i.e., the outermost surface of the foam sleeve <NUM>). In another example, the recessed receptacle <NUM> of the covering <NUM> and the fluid collection assembly <NUM> can have respective sizes and/or shapes such that the covering <NUM> engages at least approximately <NUM> percent of the outermost surface of the fluid collection assembly <NUM>.

The relative sizes and/or shapes of the recessed receptacle <NUM> and the fluid collection assembly <NUM> can help manufacturing processes by assisting in retaining the fluid collection assembly <NUM> in a desired position relative to the covering <NUM> while one or more manufacturing operations are performed (e.g., such as coupling the top sheet <NUM> to the covering <NUM> and/or the manufacturing operations described below). The relative sizes and/or shapes of the recessed receptacle <NUM> and the fluid collection assembly <NUM> can additionally or alternatively help to provide the fluid impermeable layer of the covering <NUM> over a surface area that is suitable for retaining fluid, such as urine, within the urine collection device <NUM> during use.

As shown in <FIG> and <FIG>, the covering <NUM> can also include a channel <NUM> that extends from the recessed receptacle <NUM> to an opening <NUM> at a proximal end 110B of the covering <NUM>. The upper peripheral edge <NUM> can extend continuously around a periphery of the covering <NUM>, except at the opening <NUM>. The channel <NUM> can receive the tube <NUM> to provide egress of fluid, such as urine, in a proximal direction out of the internal chamber <NUM>. As shown in <FIG>, the channel <NUM> can have a depth that is less than a depth of the recessed receptacle <NUM>. This can help to more closely conform the covering <NUM> to the fluid collection assembly <NUM> based on a position of the tube <NUM> in the fluid collection assembly <NUM> (i.e., the position of the tube <NUM> relative to the outermost surface of the foam sleeve <NUM>).

Additionally, as shown in <FIG> and <FIG>, the covering <NUM> can include one or more vent apertures <NUM> extending through the covering <NUM> (e.g., in the recessed receptacle <NUM> adjacent to the proximal end 110B of the covering <NUM>). The one or more vent apertures <NUM> can be configured to allow air to pass between the internal chamber <NUM> and an external environment in the event that the urine collection device <NUM>. This can help to mitigate relatively high pressures being applied to the patient in the evet that the urine collection device <NUM> fully suctioned to the user. The one or more vent apertures <NUM> can be formed during or after forming the covering <NUM>, and after placing the top sheet <NUM> (e.g., by mechanically punching the vent apertures <NUM> in the covering <NUM> and/or by laser cutting the vent apertures <NUM> in the covering <NUM>). Although the urine collection device <NUM> includes two vent apertures <NUM> in the illustrated example, the urine collection device <NUM> can include a different quantity of vent apertures <NUM> in other examples (e.g., one vent aperture <NUM>, three vent apertures <NUM>, four vent apertures <NUM>, etc.).

As noted above, when the urine collection device <NUM> is assembled as shown in <FIG>, the fluid collection assembly <NUM> is positioned in the recessed receptacle <NUM> defined by the covering <NUM>. <FIG> depicts the fluid collection assembly <NUM> including the foam sleeve <NUM>, the shape retaining element <NUM>, and the tube <NUM>. As shown in <FIG> and <FIG>, the foam sleeve <NUM> includes a bore <NUM> extending from a first end 116A of the foam sleeve <NUM> to a second end 116B of the foam sleeve <NUM>. The shape retaining element <NUM> is positioned in the bore <NUM> of the foam sleeve <NUM>. The shape retaining element <NUM> defines a passage <NUM> extending from between a distal end 118A of the shape retaining element <NUM> and a proximal end 118B of the shape retaining element <NUM>. The tube <NUM> extends through the passage <NUM> defined by the shape retaining element <NUM>.

As shown in <FIG>, the foam sleeve <NUM> can help to reduce a contact pressure of the tube <NUM> and/or the shape retaining element <NUM> on a body of a user.

The foam sleeve <NUM> can be made from any suitable material and has suitable shape that allows for collecting fluid (e.g., urine) and/or directing fluid flow into the internal chamber <NUM> of the urine collection device <NUM>. As one example, the foam sleeve <NUM> can be made from a reticulated foam material (e.g., VOLARA® Type EO foam, which is currently manufactured by Sekisui Voltek having a place of business in Lawrence, Massachusetts). In one implementation, the foam sleeve <NUM> can have a pore size between approximately <NUM> pores per inch (PPI) and approximately <NUM> PPI (e.g., approximately <NUM> PPI), a density between approximately <NUM> pounds per cubic feet and approximately <NUM> pounds per cubic feet (e.g., approximately <NUM> pounds per cubic feet), a tensile strength of at least approximately <NUM> pounds per square inch (PSI) (e.g., approximately <NUM> PSI), an elongation of at least approximately <NUM> percent (e.g., approximately <NUM> percent), a tear of at least approximately <NUM> pounds per inch (e.g., approximately <NUM> pounds per inch), a compression load deflection (CLD) <NUM>%R of at least approximately <NUM> PSI (e.g., approximately <NUM> PSI), a CLD <NUM>%R of at least approximately <NUM> PSI (e.g., approximately <NUM> PSI), and/or a compression set <NUM>% of less than approximately <NUM> percent (e.g., approximately <NUM> percent).

In one example, the foam sleeve <NUM> can be formed by first positioning the shape retaining element <NUM> between a first sheet of foam and a second sheet of foam. After positioning the shape retaining element between the first sheet of foam and the second sheet of foam, the first sheet of foam can be coupled to the second sheet of foam on opposing sides of the shape retaining element. For instance, in one implementation, the first sheet of foam and the second sheet of foam can be heat sealed to each other (e.g., via a C-shaped heat sealing tool). After coupling the first sheet of foam to the second sheet of foam, cutting the first sheet of foam and the second sheet of foam on the opposing sides of the shape retaining element <NUM> to form the foam sleeve <NUM> with the shape retaining element <NUM> positioned in the bore <NUM> of the foam sleeve <NUM>. This process can help to rapidly and/or efficiently manufacture the foam sleeve <NUM>. However, in another example, the foam sleeve <NUM> can be formed by an extrusion process.

In <FIG>, the foam sleeve <NUM> can extend into the tapered section <NUM> of the urine collection device <NUM>). For instance, as shown in <FIG> and <FIG>, the foam sleeve <NUM> extends into the tapered portion <NUM> at the distal end 110A of the covering <NUM> to a position proximate to and/or abutting with the distal end 110A of the covering <NUM>. This can help to mitigate (or prevent) the urine collection device <NUM> collapsing at the distal end 100A and, thus, assist with retaining the urine collection device <NUM> at a desired position on a body of a user.

To facilitate positioning the foam sleeve <NUM> in the tapered portion <NUM> at the distal end 110A of the covering <NUM>, the foam sleeve <NUM> can include a chamfer <NUM> at the tapered portion <NUM> of the covering <NUM>. The chamfer <NUM> and the bore <NUM> of the foam sleeve <NUM> are further shown in <FIG> depicts a side view of the foam sleeve <NUM>, <FIG> depicts a top view of the foam sleeve <NUM>, and <FIG> depicts a plan view of the first end 116A of the foam sleeve <NUM>. As shown in <FIG>, the chamfer <NUM> can reduce a size of the foam sleeve <NUM> such that the foam sleeve <NUM> can fit in the tapered portion <NUM> of the covering <NUM>.

The shape retaining element <NUM> is configured to conform the fluid collection assembly <NUM> to a curved configuration for placement against a body of a user and maintain the curved configuration of the fluid collection assembly <NUM> until the curved configuration is adjusted. This can help to adjust a shape of the urine collection device <NUM> based on a shape of the user's anatomy and thereby improve collecting and diverting urine from the user into the internal chamber <NUM> of the urine collection device <NUM>. The shape retaining element <NUM> can additionally or alternatively facilitate adjusting the shape of the urine collection device <NUM> based on a shape of the user's anatomy to improve user comfort.

In one example, the shape retaining element <NUM> can include a plurality of linking segments <NUM> that are moveably coupled to each other. For instance, <FIG> depicts the shape retaining element <NUM> including the linking segments <NUM>, <FIG> depicts a representative one of the linking segments <NUM>, and <FIG> depicts a cross-sectional view of the linking segment <NUM> in <FIG> according to an example. As shown in <FIG>, the linking segments <NUM> are arranged sequentially along a longitudinal direction of the shape retaining element <NUM>. As shown in <FIG>, each of the linking segments <NUM> has a first portion 152A, a second portion 152B, and a third portion 152C. Each of the first portion 152A, the second portion 152B, and the third portion 152C is hollow or has at least an open portion for passing the tube <NUM> therethrough. The first portion 152A includes a spherically shaped body with an opening therein. The first portion 152A is connected to a second portion 152B having a cylindrical shape and a passage therethrough for passing the tube <NUM>. The second portion 152B is connected to the third portion 152C having a semi-spherical shape and forming a hollow cup. The first portion 152A (the spherical shape) of one segment <NUM> is configured to fit within the hollow cup of the third portion 152C of an immediately successive segment <NUM>.

In this way, the linked segments <NUM> include a series of individual segments linked to (e.g., by snapping together) a successive individual segment, wherein each segment <NUM> is moveable relative to the successive segment as the first portion 152A moves within the hollow cup of the third portion 152C. Further, the shape retaining element <NUM> can be manipulated by a person (e.g., a healthcare provider or a user) in various directions and is configured to retain its shape following the manipulation. As such, a curvature of urine collection device <NUM> is adjustable, for example, to fit the anatomical curvature of a particular user.

The linking segments <NUM> can collectively define the passage <NUM> extending between the distal end 118A and the proximal end 118B of the shape retaining element <NUM>. As shown in <FIG>, <FIG>, and <FIG>, the tube <NUM> extends through the passage <NUM> defined by the shape retaining element <NUM>. The tube <NUM> is configured to allow a vacuum (e.g. a pressure lower than ambient air pressure) to be produced in the internal chamber <NUM> of the urine collection device <NUM> when suction is applied to the tube <NUM>. In this way, fluid (e.g., urine) collected in the internal chamber <NUM> of the urine collection device <NUM> can be evacuated from the urine collection device <NUM> through the tube <NUM>.

As shown in <FIG> and <FIG>, the tube <NUM> includes a distal end 120A in the internal chamber <NUM> at the distal end 100A of the urine collection device <NUM> and a proximal end 120B that extends proximally from the internal chamber <NUM> at the proximal end 100B of the urine collection device <NUM>. More specifically, as shown in <FIG>, the tube <NUM> extends distally from the shape retaining element <NUM> into the tapered portion <NUM> at the distal end 110A of the covering <NUM>. In this way, the tube <NUM> can be in fluid communication with the distal end 100A of the urine collection device <NUM>. As such, when fluid (e.g., urine) is received in the internal chamber <NUM>, the fluid can flow down (e.g., under gravity and/or vacuum pressure) and enter the distal end 120A of the tube <NUM>.

As shown in <FIG> and <FIG>, the tube <NUM> can include a plurality of apertures <NUM> at a distal portion of the tube <NUM>. Providing a plurality of apertures <NUM> at the distal portion of the tube <NUM> can help to enhance air flow into the tapered section <NUM> at the distal end 110A of the urine collection device <NUM> and/or inhibit (or prevent) a vacuum lock, which would prevent the flow of fluid (e.g., urine) through the tube <NUM>.

Additionally, as shown in <FIG> and <FIG>, the distal end 120A of the tube <NUM> can be approximately flush with the first end 116A of the foam sleeve <NUM>. In <FIG>, the distal end 118A of the shape retaining element <NUM> is located proximal to the distal end 120A of the tube <NUM>. This can help to expose the apertures <NUM> to enhance air flow and/or receive fluid into the tube <NUM>. In one example, the distal end 118A of the shape retaining element <NUM> can be approximately <NUM> inches from the distal end 120A of the tube <NUM>.

Within examples, the tube <NUM> can be a flexible material to facilitate directing the tube <NUM> away from the user's body. It can be beneficial to direct the tube <NUM> away from the user's body (e.g., off the side of a bed) to reduce (or prevent) the tube <NUM> from accidental pulling and leakage resulting from such pulling (e.g., due to the tube <NUM> accidentally decoupling from another drain tube at the suction adapter <NUM>). This may also be beneficial in that the tube <NUM> can be routed to either side of the bed and this can provide greater flexibility in positioning additional equipment (e.g., the equipment described below with respect to <FIG>) relative to the user. Additionally, in implementations in which the suction adapter <NUM> is made of a relatively hard material (e.g., a relatively hard plastic), directing the tube <NUM> and the suction adapter <NUM> away from the user's body can enhance user comfort.

As examples, the tube <NUM> can have a length that is greater than approximately six inches. Additionally, in one example, the tube <NUM> can have a durometer of approximately <NUM> Shore A, an inner diameter of approximately <NUM> inches, and an outer diameter of approximately <NUM> inches. These example durometer and dimension parameters of the tube <NUM> can achieve the benefits associated with the flexibility of the tube <NUM> described above. However, the tube <NUM> can have a different hardness and/or different dimensions in other examples. For instance, the tube <NUM> can have a durometer between approximately <NUM> Shore A and approximately <NUM> Shore A in another example.

In another example, the tube <NUM> can have a kink distance of approximately <NUM> as determined in accordance with a test conducted in accordance with the standard provided by "BS EN <NUM>:<NUM> Catheters - Test methods for kinking of single lumen catheters and medical tubing". In another example, the tube <NUM> can have a kink distance less than approximately <NUM> as determined in accordance with a test conducted in accordance with the standard provided by "BS EN <NUM>:<NUM> Catheters - Test methods for kinking of single lumen catheters and medical tubing". In yet another example, the tube <NUM> can have a kink distances less than approximately <NUM> as determined in accordance with a test conducted in accordance with the standard provided by "BS EN <NUM>:<NUM> Catheters - Test methods for kinking of single lumen catheters and medical tubing". As noted above, the urine collection device <NUM> can also include a suction adapter <NUM>. The suction adapter <NUM> can include a stepped tapering to help couple the tube <NUM> to a suction tube of a vacuum device. Providing the suction adapter <NUM> with a shape that tapers inwardly along a direction from the distal end 110A toward the proximal end 100B can help to couple the suction adapter <NUM> with a relatively wide variety of different tubes (e.g., a drain tube as described below with respect to <FIG>) having differently sized tube diameters. As such, the tapered shape of the suction adapter <NUM> can help to make the urine collection device <NUM> more universally compatible with other equipment in a healthcare environment. In other examples, the suction adapter <NUM> can additionally or alternatively include a thread, a hose barb, and/or a Luer lock for coupling with the tube of the suction tube of the vacuum device.

Although the suction adapter <NUM> is shown in <FIG> as a male-type component that is configured to be received by a female-type component (e.g., an open end of a drain tube), the suction adapter <NUM> can alternatively be provided as a female-type component that is configured to couple with a male-type component of other equipment in a healthcare environment. For example, the suction adapter <NUM> can include a socket in which a male-type adapter of a drain tube can be inserted and retained.

Additionally, as noted above, the urine collection device <NUM> can also include a fluid-impermeable barrier <NUM>. As shown in <FIG>, the fluid-impermeable barrier <NUM> is coupled to a distal portion of the covering <NUM> (e.g., at the tapered portion <NUM> of the covering <NUM>). The fluid-impermeable barrier <NUM> and the distal portion of the covering <NUM> can define a fluid-impermeable chamber. In this way, the fluid-impermeable barrier <NUM> can assist in retaining the fluid (e.g., urine) in the internal chamber <NUM> of the urine collection device <NUM>. Additionally or alternatively, the fluid-impermeable barrier <NUM> can help to provide a barrier against fecal contamination.

As examples, the fluid-impermeable barrier <NUM> can be made from a fluid-impermeable material such as, for instance, a foam, silicone, urethane, and/or other types of impermeable elastomeric polymers. In some implementations, the fluid-impermeable barrier <NUM> can be made from a material that is the same as a material of the covering <NUM>. In other implementations, the fluid-impermeable barrier <NUM> can be made from a material that is different than a material of the covering <NUM>.

As shown in <FIG>, the anchor <NUM> is coupled to a proximal portion of the covering <NUM>. The anchor <NUM> includes an adhesive configured to couple the urine collection device <NUM> to the user. In this way, the anchor <NUM> is configured to secure the urine collection device <NUM> to the user in a position in which the urine collection device <NUM> can collect and divert the fluid (e.g., urine) into the internal chamber <NUM> of the urine collection device <NUM>.

Within examples, the anchor <NUM> can have a shape that can conform to a surface area of a pelvic region of the user without pulling or pinching the skin or otherwise causing discomfort. The anchor <NUM> can have any suitable shape for securing the urine collection device <NUM> to the body of a user (e.g., and remain secured to the user despite motion by the user, moisture accumulation on the body, and/or passage of time).

In <FIG>, the anchor <NUM> includes a first arm 124A and a second arm 124B laterally extending from a center portion 124C. In this arrangement, when the anchor <NUM> is secured to the user via the adhesive, the center portion 124C can be located at a middle area of the user's pelvic area and/or abdomen so that the first arm 124A and the second arm 124B extend to areas adjacent to the middle area of the user's pelvic area and/or abdomen. This can help to improve stability of the urine collection device <NUM> secured to the user.

In one example, the first arm 124A and the second arm 124B can include the adhesive, whereas the center portion 124C can omit the adhesive. This can additionally or alternatively assist in reducing (or minimizing) an extent to which the adhesive adheres to hair of the user. Omitting the adhesive at the center portion 124C also can be beneficial for users that do not have hair at the middle area of the user's pelvic area and/or abdomen as omitting the adhesive at the center portion 124C reduces an amount of adhesive on the user's skin and, thus, improves patient comfort. In one implementation, the center portion 124C omitting the adhesive can be, for instance, approximately <NUM> inches wide.

In another example, the first arm 124A, the second arm 124B, and the center portion 124C can include the adhesive such that the adhesive can adhere to the user at the first arm 124A, the second arm 124B, and/or the center portion 124C of the anchor <NUM>. In these examples, the anchor <NUM> can include a liner that can initially cover the adhesive prior to coupling the anchor <NUM> to the user, and be removed to expose the adhesive to facilitate coupling the anchor <NUM> to the user.

In some examples, the tube <NUM> can be coupled to the anchor <NUM>. This can help to mitigate (or prevent) the tube <NUM> from migrating from a desired position in the internal chamber <NUM> relative to the distal end 110A of the covering <NUM>. In other examples, the tube <NUM> can be additionally or alternatively coupled to the shape retaining element <NUM>.

Referring now to <FIG>, a simplified diagram of a system <NUM> for collecting urine is depicted according to an example embodiment. As shown in <FIG>, the system <NUM> includes the urine collection device <NUM> described above. Additionally, the system <NUM> includes a drain tube <NUM>, a waste collection reservoir <NUM>, and a vacuum device <NUM>.

A first end <NUM> of the drain tube <NUM> is coupled to the suction adapter <NUM> of the urine collection device <NUM>. For example, the drain tube <NUM> can include a thread, a Luer lock, and/or other feature for coupling the drain tube <NUM> to the suction adapter <NUM>. Within examples, the drain tube <NUM> can be a flexible material to facilitate directing the drain tube away from the user's body. It can be beneficial to direct the drain tube <NUM> away from the user's body (e.g., off the side of a bed) to reduce (or prevent) the drain tube <NUM> from accidental pulling and leakage resulting from such pulling.

The waste collection reservoir <NUM> is coupled to a second end <NUM> of the drain tube <NUM> to receive the urine from the drain tube <NUM>. In one example, the waste collection reservoir <NUM> can be a leg bag, a drainage bag, or other container. In another example, the waste collection reservoir <NUM> can include a hanger and/or another structure for coupling the waste collection reservoir <NUM> to a patient support surface <NUM> (e.g., a bed and/or a wheelchair) used by the patient.

In some examples, the waste collection reservoir <NUM> can be a sealed container. This can, for example, reduce (or minimize) a risk of spillage and/or contamination. In some examples, the waste collection reservoir <NUM> can be disposable. In other examples, the waste collection reservoir <NUM> can be reusable. For instance, the waste collection reservoir <NUM> can be configured to be sterilized after a use and reused.

The vacuum device <NUM> can apply a vacuum pressure to the drain tube <NUM> to assist in directing the urine from the suction adapter <NUM> to the waste collection reservoir <NUM>. For instance, the vacuum device <NUM> can include an air pump or other vacuum source, which is coupled to the waste collection reservoir <NUM> by an air tube <NUM>. In one example, the air tube <NUM> can also be made of a flexible material.

In some examples, the vacuum device <NUM> can be a wall vacuum integrated into a room of a medical facility. In other examples, the vacuum device <NUM> can be integrated with the patient support surface <NUM>. For instance, the vacuum device <NUM> can be integrated with a bed in a medical facility.

Within some examples, the system can also include an occlusion clip for selectively controlling the flow of urine in the drain tube. For instance, the occlusion clip can provide for stopping the flow of urine in the drain tube to facilitate changing and/or emptying the waste collection reservoir.

In use, the urine collection device <NUM> can be attached to the user. For example, the urine collection device <NUM> can be against the body of the user with the top sheet <NUM> in operative relation with a urethral opening of the user. In an example, this can include positioning the urine collection device <NUM> in a vertical orientation relative to a urethral opening of a female user. Additionally, positioning the urine collection device <NUM> relative to the user can include adjusting a curvature of the urine collection device <NUM> (e.g., by bending the shape retaining element <NUM>) to conform a shape of the urine collection device <NUM> to a shape of the user.

After positioning the urine collection device <NUM> relative to the user, the urine collection device <NUM> can be secured to the user with an adhesive on an anchor <NUM> of the urine collection device <NUM>. Additionally or alternatively, the urine collection device <NUM> can be secured to the user by engaging the distal end 100A of the urine collection device <NUM> (i.e., the tapered section <NUM>) with a portion of the user's anatomy.

The drain tube <NUM> can be coupled to the suction adapter <NUM> at the first end <NUM> and the waste collection reservoir <NUM> at the second end <NUM>. The vacuum device <NUM> can also be connected to the waste collection reservoir <NUM> by the air tube <NUM>. The vacuum device <NUM> can then be operated to apply the vacuum pressure at the suction adapter <NUM> (e.g., via the air tube <NUM>, the waste collection reservoir <NUM>, and the drain tube <NUM>).

In this arrangement, the urine collection device <NUM> can receive, through the top sheet <NUM> and by the fluid collection assembly <NUM>, urine discharged from the urethral opening of the user. The urine can flow through the foam sleeve <NUM> and toward the distal end 120A of the tube <NUM>. The urine can then be evacuated from the fluid collection assembly <NUM> through the tube <NUM>.

Referring now to <FIG>, a process for manufacturing the urine collection device <NUM> is shown according to an example. As shown in <FIG>, the recessed receptacle <NUM> can be formed in a sheet of foam to form the covering <NUM>. In one example, a thermoforming machine can apply thermal energy while pressing the sheet of foam into a mold in the shape of the recessed receptacle <NUM> to form the covering <NUM>. In <FIG>, the sheet of foam includes a single recessed receptacle <NUM>. However, in other examples, the thermoforming machine can form a plurality of recessed receptacles <NUM> in the sheet of foam and the sheet of foam can remain uncut between the recessed receptacles <NUM>. This can help to more rapidly and/or efficiently manufacture a plurality of urine collection devices <NUM> by providing for simultaneous performance one or more operations of the manufacturing process described herein on the urine collection devices <NUM>.

The process can also include inserting the tube <NUM> in the passage <NUM> of the shape retaining element <NUM>. For instance, <FIG> shows the tube <NUM> inserted in the passage <NUM> of the shape retaining element <NUM>. As shown in <FIG>, the distal end 120A of the tube <NUM> extends distally past the distal end 118A of the shape retaining element <NUM>. Additionally, in <FIG>, the suction adapter <NUM> is coupled to the proximal end 120B of the tube <NUM>.

To assemble the fluid collection assembly <NUM>, the shape retaining element <NUM> and the tube <NUM> are positioned in the bore <NUM> of the foam sleeve <NUM> as shown in <FIG>. In one example, this can include positioning the shape retaining element <NUM> and the tube <NUM> between a first sheet of foam and a second sheet of foam and then coupling the first sheet of foam to the second sheet of foam on opposing sides of the shape retaining element <NUM> and the tube <NUM>. For instance, in one implementation, a heat sealer machine can apply thermal energy and/or pressure to the first sheet of foam and the second sheet of form on the opposing sides of the shape retaining element <NUM> and the tube <NUM> to form a heat seal. The heat sealer can include, for example, a C-shaped tool to form the heat seal on the opposing sides of the shape retaining element <NUM> and the tube <NUM>. After coupling the first sheet of foam to the second sheet of foam, a machine can cut the first sheet of foam and the second sheet of foam on the opposing sides of the shape retaining element to form the foam sleeve <NUM> with the shape retaining element <NUM> positioned in the bore <NUM> of the foam sleeve <NUM> and the tube <NUM> positioned in the passage <NUM> of the shape retaining element <NUM>.

As shown in <FIG>, after forming the recessed receptacle <NUM> in the covering <NUM> and forming the fluid collection assembly <NUM>, the fluid collection assembly <NUM> can be positioned in the recessed receptacle <NUM> of the covering <NUM>. Also, as shown in <FIG>, the tube <NUM> can be positioned in the channel <NUM> of the covering <NUM> such that the tube <NUM> extends proximally from the covering <NUM>.

After positioning the fluid collection assembly <NUM> in the recessed receptacle <NUM> of the covering <NUM>, the top sheet <NUM> can be positioned on the covering <NUM> and the fluid collection assembly <NUM> such that the fluid collection assembly <NUM> is between the covering <NUM> and the top sheet <NUM> as shown in <FIG>. In <FIG>, the fluid-impermeable barrier <NUM> is coupled to the top sheet <NUM> prior to positioning the top sheet <NUM> on the covering <NUM> and the fluid collection assembly <NUM>. For example, the fluid-impermeable barrier <NUM> can be coupled to the top sheet <NUM> by an adhesive, welding the fluid-impermeable barrier <NUM> to the top sheet <NUM>, and/or melting the fluid-impermeable barrier <NUM> into the top sheet <NUM>.

In this example, the fluid-impermeable barrier <NUM> overlaps a portion of the top sheet <NUM>. However, in another example, the fluid-impermeable barrier <NUM> can extend from the top sheet <NUM> such that the fluid-impermeable barrier <NUM> dos not overlap with the top sheet <NUM> (e.g., the top sheet <NUM> may be omitted at the tapered portion <NUM> of the covering <NUM>.

After positioning the top sheet <NUM> on the covering <NUM> and the fluid collection assembly <NUM>, the top sheet <NUM> can be coupled to the covering <NUM> as shown in <FIG>. For example, a heat sealing machine can apply thermal energy and/or pressure to the top sheet <NUM> and the covering <NUM> (e.g., at the upper peripheral edge <NUM> shown in <FIG>) to heat seal the top sheet <NUM> to the covering <NUM>. The top sheet <NUM> and the covering <NUM> can then be cut to form the seam <NUM> around the periphery of the urine collection device <NUM> at an interface between the covering <NUM> and the top sheet <NUM>.

In this example, because the fluid-impermeable barrier <NUM> is coupled to the top sheet <NUM> prior to coupling the top sheet <NUM> to the covering <NUM>, the process of coupling the top sheet <NUM> to the covering <NUM> simultaneously couples the fluid-impermeable barrier <NUM> to the covering <NUM>.

Additionally, as noted above, the upper peripheral edge <NUM> defines a flange portion extending outwardly in a plane away from the recessed receptacle <NUM>. This can help to increase a surface area for coupling the covering <NUM> to the top sheet <NUM> (e.g., at the peripheral edge <NUM> of the top sheet <NUM>). Additionally, the upper peripheral edge <NUM> of the covering <NUM> and the peripheral edge <NUM> of the top sheet <NUM> can help to inhibit leakage. For instance, when urine is applied to a central area of the top sheet <NUM> and the foam sleeve <NUM> at a rate that exceeds a rate of absorption for the top sheet <NUM> and the foam sleeve <NUM>, the excess urine waiting to be absorbed may spread out toward the upper peripheral edge <NUM> and the peripheral edge <NUM>. The upper peripheral edge <NUM> and the peripheral edge <NUM> can act as gutters that direct the excess urine down toward less saturated portions of the top sheet <NUM> and the foam sleeve <NUM> and toward the distal end 120A of the tube <NUM> where the urine can be suctioned. In this way, the upper peripheral edge can inhibit (or prevent) the urine from leaking off the sides.

In one example, the upper peripheral edge <NUM> and the peripheral edge <NUM> can have a width of approximately <NUM> inches to provide the gutter function for directing the urine down toward the distal end 120A of the tube <NUM>. Additionally, as noted above, the top sheet <NUM> and the foam sleeve <NUM> can extend downward to the distal end 120A of the tube <NUM>, which can help to direct the urine to the position at which it can be more effectively suctioned away from the urine collection device <NUM>.

In an example implementation, the upper peripheral edge <NUM> and/or the peripheral edge <NUM> can form a slightly concave shape to help provide the gutter function (e.g., the concavity can face the user). For instance, the top sheet <NUM> can be kept under tension before sealing the upper peripheral edge <NUM> and the peripheral edge <NUM> such that the top sheet <NUM> pulls the upper peripheral edge <NUM> and the peripheral edge <NUM> inward once the profile of the urine collection device <NUM> is cut.

As shown in <FIG>, the anchor <NUM> can be coupled to the covering <NUM> at the proximal end 110B of the covering <NUM>. In an example, the anchor <NUM> can be coupled to the covering <NUM> by an adhesive. Also, in some examples, the anchor <NUM> can additionally be coupled to the tube <NUM> to help mitigate (or prevent) movement of the tube <NUM> in an axial direction relative to the covering <NUM>. In this arrangement, the tube <NUM> can be adhered to the covering <NUM> and/or the top sheet <NUM> such that the tube <NUM> is sandwiched between (i) the covering <NUM> and/or the top sheet <NUM>, and (ii) the anchor <NUM>. As shown in <FIG>, the process can result in the urine collection device <NUM> described above according to an example.

Additionally, in the example described above, the one or more vent apertures <NUM> can be formed during or after forming the covering <NUM>, and after placing the top sheet <NUM> (e.g., by mechanically punching the vent apertures <NUM> in the covering <NUM> and/or by laser cutting the vent apertures <NUM> in the covering <NUM>).

In the example described above, the fluid-impermeable barrier <NUM> is coupled to the top sheet <NUM> prior to coupling the top sheet <NUM> to the covering <NUM>. Additionally, in the example illustrated in <FIG> and <FIG>, the fluid-impermeable barrier <NUM> is co-extensive with the top sheet <NUM> on lateral sides of the urine collection device <NUM> (i.e., the fluid-impermeable barrier <NUM> does not extend past the top sheet <NUM> to overlap with portions of the covering <NUM> that are not overlapped by the top sheet <NUM>). However, in another example, the fluid-impermeable barrier <NUM> can be coupled to top sheet <NUM> and the covering <NUM> after the top sheet <NUM> is coupled to the covering <NUM>, and/or the fluid-impermeable barrier <NUM> can extend past the top sheet <NUM> to wrap substantially around the covering <NUM>.

As an example, <FIG> depicts the urine collection device <NUM>, except with a fluid-impermeable barrier <NUM> instead of the fluid-impermeable barrier <NUM> shown in <FIG> and <FIG>. As shown in <FIG>, the fluid-impermeable barrier <NUM> wraps around the distal end 100A of the urine collection device <NUM> such that the fluid-impermeable barrier <NUM> covers the seam <NUM> at the distal end 100A. Covering the seam <NUM> at the distal end 100A with the fluid-impermeable barrier <NUM> can help to improve patient comfort.

Additionally, in the examples described above, the tube <NUM> can be coupled to the anchor <NUM> and/or the shape retaining element <NUM> to help (or prevent) the tube <NUM> from migrating from a desired position in the internal chamber <NUM> relative to the distal end 110A of the covering <NUM>. In another example, the tube <NUM> can be additionally or alternatively coupled to another component of the urine collection device <NUM> to help maintain the position of the tube <NUM>. For instance, <FIG> depicts an example in which the urine collection device <NUM> further includes a retention collar <NUM> coupled to the tube <NUM> to help maintain the position of the tube <NUM>. As shown in <FIG>, the retention collar <NUM> can be located adjacent to the distal end 120A (shown in <FIG>) of the tube <NUM> and have a size that is greater than a size of the passage <NUM> (shown in <FIG>) defined by the shape retaining element <NUM> (e.g., the retention collar <NUM> can be a flange that extends outwardly from the tube <NUM>). In this arrangement, when the tube <NUM> is positioned in the passage <NUM> of the shape retaining element <NUM>, the retention collar <NUM> can engage the shape retaining element <NUM> (i.e., as a stop) to inhibit or prevent proximal movement of the tube <NUM> relative to the shape retaining element <NUM>.

Referring now to <FIG>, a flowchart for a process <NUM> of making a urine collection device is shown according to an example. As shown in <FIG>, at block <NUM>, the process <NUM> includes forming a covering such that the covering defines a recessed receptacle. At block <NUM>, the process <NUM> includes forming a fluid collection assembly including a foam sleeve, a shape retaining element, and a tube.

The foam sleeve includes a bore extending from a first end of the foam sleeve to a second end of the foam sleeve. The shape retaining element is positioned in the bore of the foam sleeve. The shape retaining element is configured to conform the fluid collection assembly to a curved configuration for placement against a body of a user and maintain the curved configuration of the fluid collection assembly until the curved configuration is adjusted. The shape retaining element defines a passage extending from between a proximal end of the shape retaining element and a distal end of the shape retaining element. The tube extends through the passage defined by the shape retaining element.

At block <NUM>, the process <NUM> includes positioning the fluid collection assembly in the recessed receptacle defined by the covering, wherein the fluid collection assembly. At block <NUM>, the process <NUM> includes coupling a top sheet to the covering with the fluid collection assembly positioned between the top sheet and the covering. The top sheet and the covering define an internal chamber of the urine collection device. The top sheet is configured to draw urine into the internal chamber and toward the fluid collection assembly.

<FIG> depict additional aspects of the process <NUM> according to further examples. As shown in <FIG>, forming the covering at block <NUM> can include thermoforming the recessed receptacle in a sheet of foam at block <NUM>.

As shown in <FIG>, forming the fluid collection assembly at block <NUM> can include (i) positioning the shape retaining element between a first sheet of foam and a second sheet of foam at block <NUM>, (ii) after positioning the shape retaining element between the first sheet of foam and the second sheet of foam at block <NUM>, coupling the first sheet of foam to the second sheet of foam on opposing sides of the shape retaining element at block <NUM>, and (iii) after coupling the first sheet of foam to the second sheet of foam at block <NUM>, cutting the first sheet of foam and the second sheet of foam on the opposing sides of the shape retaining element to form the foam sleeve with the shape retaining element positioned in the bore of the foam sleeve at block <NUM>.

As shown in <FIG>, coupling the first sheet of foam to the second sheet of foam at block <NUM> can include heat sealing the first sheet of foam to the second sheet of foam at block <NUM>.

As shown in <FIG>, forming the fluid collection assembly at block <NUM> can include forming a chamfer at a distal end of the foam sleeve at block <NUM>.

As shown in <FIG>, forming the covering at block <NUM> can include forming a tapered portion at a distal end of the covering at block <NUM>. Also, in <FIG>, positioning the fluid collection assembly in the recessed receptacle defined by the covering at block <NUM> can include positioning the chamfer in the tapered portion of the covering at block <NUM>.

As shown in <FIG>, forming the fluid collection assembly at block <NUM> can include inserting the tube in the shape retaining element such that the tube extends distally from the shape retaining element at block <NUM>.

As shown in <FIG>, the process <NUM> can further include coupling a fluid-impermeable barrier to a distal portion of the covering to form a fluid-impermeable chamber between the fluid-impermeable barrier and the distal portion of the covering at block <NUM>.

As shown in <FIG>, the process <NUM> can also include coupling an anchor to a proximal portion of the covering at block <NUM>. The anchor can include an adhesive configured to couple the urine collection device to a patient.

As shown in <FIG>, the process <NUM> can also include coupling the tube to the anchor to inhibit proximal movement of the tube relative to the shape retaining element at block <NUM>.

As shown in <FIG>, the process <NUM> can further include applying a layer of adhesive to the covering at block <NUM> prior to coupling the top sheet to the covering at block <NUM>. Additionally, in <FIG>, coupling the top sheet to the covering at block <NUM> can include coupling the top sheet to the covering via the layer of adhesive at block <NUM>.

As shown in <FIG>, coupling the top sheet to the covering at block <NUM> can include coupling the top sheet to the covering via the layer of adhesive and heat sealing the top sheet and the covering at block <NUM>.

Referring now to <FIG>, a flowchart for a process <NUM> of collecting urine discharged from a body of a user is shown according to an example. As shown in <FIG>, at block <NUM>, the process <NUM> includes providing a urine collection device. The urine collection device includes a covering defining a recessed receptacle, and a fluid collection assembly positioned in the recessed receptacle defined by the covering. The fluid collection assembly includes (i) a foam sleeve including a bore extending from a first end of the foam sleeve to a second end of the foam sleeve and (ii) a shape retaining element positioned in the bore of the foam sleeve. The shape retaining element is configured to conform the fluid collection assembly to a curved configuration for placement against a body of a user and maintain the curved configuration of the fluid collection assembly until the curved configuration is adjusted. The shape retaining element defines a passage extending from between a proximal end of the shape retaining element and a distal end of the shape retaining element. The fluid collection assembly also includes (iii) a tube extending through the passage defined by the shape retaining element. The urine collection further includes a top sheet coupled to the covering. The top sheet and the covering define an internal chamber of the urine collection device. The top sheet is configured to draw urine into the internal chamber and toward the fluid collection assembly.

At block <NUM>, the process <NUM> includes positioning the urine collection device against the body of the user with the top sheet in operative relation with a urethral opening of the user. At block <NUM>, the process <NUM> includes receiving, through the top sheet and by the fluid collection assembly, urine discharged from the urethral opening. At block <NUM>, the process <NUM> includes evacuating the urine from the fluid collection assembly through the tube.

<FIG> depict additional aspects of the process <NUM> according to further examples. As shown in <FIG>, positioning the urine collection device against the body of the user at block <NUM> can include positioning the fluid collection assembly in a vertical orientation relative to a urethral opening of a female user at block <NUM>.

As shown in <FIG>, the process <NUM> can also include securing the urine collection device to the user with an adhesive on an anchor of the urine collection device at block <NUM>.

As shown in <FIG>, the process <NUM> can further include securing the urine collection device to the user by engaging a distal end of the urine collection device with a portion of the user's anatomy at block <NUM>.

Claim 1:
A urine collection device (<NUM>), comprising:
a covering (<NUM>) defining a recessed receptacle (<NUM>), wherein the covering comprises an upper peripheral edge (<NUM>);
a fluid collection assembly (<NUM>) positioned in the recessed receptacle defined by the covering, wherein the fluid collection assembly comprises:
a foam sleeve (<NUM>) comprising a bore (<NUM>) extending from a first end (116A) of the foam sleeve to a second end (116B) of the foam sleeve,
a shape retaining element (<NUM>) positioned in the bore of the foam sleeve, wherein the shape retaining element is configured to conform the fluid collection assembly to a curved configuration for placement against a body of a user and maintain the curved configuration of the fluid collection assembly until the curved configuration is adjusted, wherein the shape retaining element defines a passage (<NUM>) extending from between a distal end (118A) of the shape retaining element and a proximal end (118B) of the shape retaining element,
a tube (<NUM>) extending through the passage defined by the shape retaining element; and
a top sheet (<NUM>) coupled to the upper peripheral edge of the covering,
wherein the top sheet and the covering define an internal chamber (<NUM>) of the urine collection device, and
wherein the top sheet is configured to draw urine into the internal chamber and toward the fluid collection assembly.