Urine collection assembly comprising porous material and method of making urine collection assembly

Abstract

Embodiments relate to urine collection assemblies including a fluid impermeable barrier defining at least a chamber, at least one opening, and a fluid outlet, and a porous material disposed in the chamber. The porous material presents a cylindrical shape, is disposed within the chamber, and includes a porous support material and a hydrophilic cover sheet disposed over the porous support material. A seal is applied along the entire intersecting plane of the porous material, the seal configured to hold the porous material in a cylindrical shape. The urine collection assembly also includes a tube. The tube is disposed within the porous material and is in fluid communication with the fluid outlet. Embodiments also relate to methods of forming the urine collection assembly.

Description

BACKGROUND OF THE INVENTION

[0001] A person's ability to move may be restricted or impaired, making the typical process of urination challenging or impossible. For example, a person may experience or suffer from a disability that affects mobility. A person may have restricted movement conditions, such as those experienced by pilots, drivers, and workers in hazardous areas. Additionally, there are times when it is necessary to collect body fluids for monitoring or clinical testing purposes.

[0002] Urinary catheters (such as Foley catheters) can address some of these situations, such as incontinence. Unfortunately, urinary catheters can be uncomfortable, painful, and may lead to complications such as infections. Additionally, bedpans are sometimes used, which are containers for bedridden individuals to use the toilet. However, bedpans can be prone to discomfort, spills, and other hygiene issues. SUMMARY OF THE INVENTION

[0003] Embodiments relate to a urine collection assembly and a method of forming a urine collection assembly. In one embodiment, a method of forming a urine collection assembly may include cutting a tube and a porous material. The porous material may include a porous support material and a hydrophilic cover sheet disposed over the porous support material. The method may also include wrapping the porous support material and the hydrophilic cover around a clamping tool to form a cylinder. In one embodiment, the clamping tool may include pins extending from an outer surface of the clamping tool. The method may also include withdrawing the clamping tool from the wrapped porous material to form a channel within the porous material. In one embodiment, the method further includes inserting the tube into the channel to form a sub-assembly, and positioning the sub-assembly within a fluid-impermeable barrier.

[0004] In one embodiment, a method of forming a urine collection assembly is disclosed. The method may include forming a porous material that includes a first edge and a second edge opposite the first edge. The method may also include shaping the porous material into a cylinder that defines a channel extending along a centerline through the porous material. The method may also include sealing the first edge of the porous material to the second edge of the porous material. In one embodiment, the method further includes inserting the tube into the channel to form a sub-assembly, and positioning the sub-assembly within a fluid-impermeable barrier.

[0005] In one embodiment, a urine collection assembly is disclosed. The urine collection assembly includes a fluid-impermeable barrier that at least defines a chamber, at least one opening, and a fluid outlet. The urine collection assembly further includes a porous material formed in a cylindrical shape and disposed within the chamber. The porous material includes a porous support material, a hydrophilic cover sheet disposed over the porous support material, and a sealant applied along the entire intersecting plane of the porous material, the sealant configured to maintain the porous material in a cylindrical shape. The urine collection assembly further includes a tube. The tube is disposed within the porous material and the tube may be in fluid communication with the fluid outlet.

[0006] The features of any of the disclosed embodiments can be used in combination with each other without limitation. Additionally, other features and advantages of the present disclosure will become apparent to those of ordinary skill in the art by considering the following detailed description and the accompanying drawings. BRIEF DESCRIPTION OF THE DRAWINGS

[0007] The drawings illustrate several embodiments of the present disclosure, wherein like reference numerals refer to the same or similar elements or features shown in different views or embodiments in the drawings.

[0008] Figure 1A is an isometric view of a urine collection assembly including a porous material according to one embodiment.

[0009] Figure 1B is Figure 3 A schematic cross-sectional view of the urine collection assembly shown in A taken along plane β-β.

[0010] Figure 1C is Figure 3 A schematic cross-sectional view of the urine collection assembly shown in A taken along plane α-α.

[0011] Figure 1D is a side elevation view of a sub-assembly of a urine collection assembly according to one embodiment.

[0012] Figure 2 is a block diagram of a urine collection system including a urine collection assembly according to one embodiment.

[0013] Figure 3 is a flowchart of a method of forming a urine collection assembly according to one embodiment.

[0014] Figure 4 is a flowchart of a method of forming a urine collection assembly according to one embodiment.

[0015] Figure 5A is an isometric view of a clamping tool including a series of pins according to one embodiment.

[0016] Figure 5BCross-sectional schematic view of a clamping tool according to one embodiment. Detailed embodiments

[0017] Embodiments relate to a urine collection assembly and a method of forming a urine collection assembly. In some examples, the urine collection assembly may include a fluid-impermeable barrier that at least defines a chamber, at least one opening, and a fluid outlet. A porous material may be disposed within the chamber. The porous material may include a porous support material and a hydrophilic cover sheet disposed over the porous support material. The urine collection assembly may further include a tube. The porous material may be configured to surround the tube and the tube may be in fluid communication with the fluid outlet. Embodiments also relate to a urine collection system that includes such a urine collection assembly.

[0018] In use, the fluid collection assembly may be positioned such that the hydrophilic cover sheet is positioned adjacent to and in contact with the urethral orifice (e.g., vagina) of a female. A female may excrete one or more body fluids (e.g., urine). The excreted urine may be received into the porous material. The urine may flow through the porous material to the inlet of the tube, and the tube is positioned through an outlet defined by the fluid-impermeable barrier. Then, when removing urine from the fluid collection assembly, the urine may flow through the tube. In one embodiment, a vacuum may be provided from the tube to draw urine into the porous material and through the porous material to the inlet of the tube. The vacuum may also facilitate the flow of urine through the tube. The vacuum may be provided by a vacuum source in fluid communication with the tube.

[0019] Traditional fluid collection assemblies may include a porous material that is positioned to initially receive body fluids from an individual using such a traditional fluid collection assembly. Such porous materials are hydrophobic or otherwise configured to wick body fluids into the traditional fluid collection assembly. However, many traditional porous materials positioned to initially receive body fluids from an individual may not effectively capture the urine excreted by the individual, which increases the likelihood of leakage of body fluids from the fluid collection assembly. In addition, it has been found that many traditional porous materials remain wet after an individual excretes body fluids, which prevents traditional fluid collection assemblies from being used for long periods of time (e.g., periods exceeding 12 hours) without causing damage to the skin of the individual, and skin damage can be extremely uncomfortable.

[0020] A urine collection assembly and a porous material disposed therein can address at least some of the problems associated with porous materials of conventional fluid collection assemblies. For example, a hydrophilic cover sheet is configured to form a seal layer when the hydrophilic cover sheet becomes wet to facilitate a vacuum function within the assembly. The porous support material can effectively receive body fluid, such that the porous material can prevent or at least inhibit leakage of body fluid. The hydrophilic cover sheet can also be configured to dry faster than conventional porous materials after receiving body fluid, which allows the urine collection assembly to be used over a long period of time (such as a period greater than about 24 hours, for example, about 24 hours to about 36 hours, about 30 hours to about 42 hours, or about 36 hours to about 48 hours). For example, due to at least one or more of the hydrophilicity of the material including the cover sheet or the nature of the porous material, the hydrophilic cover sheet can effectively receive body fluid and remain dry, as discussed in more detail below.

[0021] The porous support material facilitates the flow of urine towards the inlet of the tube, thereby removing urine from the urine collection assembly. The porous support material can include a 3D structure that is configured to facilitate such fluid flow due to, for example, at least one or more of the hydrophobicity, thickness, or surface density of the porous support material, as discussed in more detail below.

[0022] Figure 1A is an isometric view of a urine collection assembly 100 according to one embodiment. Figure 1B is Figure 1A A schematic cross-sectional view taken along plane β-β of the urine collection assembly 100 shown in. The urine collection assembly 100 is an example of a female urine collection assembly for receiving and collecting body fluid (e.g., urine) from a female. The urine collection assembly 100 includes a fluid-impermeable barrier 102. The fluid-impermeable barrier includes an opening 104 defined by a fluid-impermeable outer surface 106. The fluid-impermeable barrier 102 can be formed of any suitable fluid-impermeable material, such as a fluid-impermeable polymer (e.g., silicone, polypropylene, polyethylene, polyethylene terephthalate, neoprene, polycarbonate, etc.), natural rubber, another suitable material, any other fluid-impermeable material disclosed herein, or a combination thereof. Thus, the fluid-impermeable barrier 102 substantially prevents body fluid from passing through the fluid-impermeable barrier 102. In one example, the fluid-impermeable barrier 102 can be air-permeable and fluid-impermeable. At least a portion or portions of the outer surface 106 of the fluid-impermeable barrier 102 can be formed of a soft and / or smooth material to reduce abrasion.

[0023] In some examples, the fluid-impermeable barrier 102 can be tubular, such as generally cylindrical (as shown); or rectangular, prismatic, or flat tube. In some examples, during use, the outer surface 106 of the fluid-impermeable barrier 102 can contact the individual. The size and shape of the fluid-impermeable barrier 102 can be designed to fit between the labia and / or the cleft of the buttocks of a female user.

[0024] The opening 104 can provide an entrance for urine to enter the urine collection assembly 100. The opening 104 can be defined by the fluid-impermeable barrier 102 (e.g., by the inner edge of the fluid-impermeable barrier 102), so that urine can enter the urine collection assembly 102 through the opening 104.

[0025] The opening 104 can be an elongated hole in the fluid-impermeable barrier 102. For example, the opening 104 can be defined as an incision in the fluid-impermeable barrier 102 that extends from the distal region 108 to the proximal region 110. The opening 104 can be located and shaped to be adjacent to the female urethral orifice. Since the space between a female's legs is relatively small when the legs are closed, the opening 104 can have an elongated shape, so as to allow body fluids to flow only along a path corresponding to the elongated shape of the opening 104 (e.g., the longitudinally extending opening 104).

[0026] The fluid-impermeable barrier 102 at least partially defines a chamber 112. For example, the inner surface 122 of the fluid-impermeable barrier 102 at least partially defines a chamber 112 within the urine collection assembly 100. The fluid-impermeable barrier 102 temporarily stores body fluids in the chamber 112. The urine collection assembly 100 further includes a porous material 114 disposed in the chamber 112. The urine collection assembly 100 can be positioned near the female urethral orifice, and urine can enter the chamber 112 of the urine collection assembly 100 via the opening 104. The urine collection assembly 100 is configured to receive body fluids into the chamber 112 via the opening 104. In use, the opening 104 can have an elongated shape that extends from a first position below the urethral orifice to a second position above the urethral orifice.

[0027] The urine collection assembly 100 can further include a tube 116 disposed through a fluid outlet 118 defined by the fluid-impermeable barrier 102, such that the inlet 120 of the tube 116 is disposed in the chamber 112. In some examples, the fluid-impermeable barrier 102 can define a fluid outlet 116 sized to receive the tube 116. The tube 116 can be disposed in the chamber 112 via the fluid outlet 118. The size and shape of the fluid outlet 118 can be designed to form at least a substantially fluid-tight seal with the tube 116, thereby substantially preventing body fluids from escaping from the chamber 112.

[0028] As described above, the porous material 114 is disposed in the chamber 112. The porous material 114 may be formed and presented in a generally cylindrical shape. In one embodiment, the porous material 114 may be provided in the form of a sheet. In such an embodiment, the porous material 114 may be rolled into a generally cylindrical shape with its opposite edges in contact with each other, as further described in the method described below.

[0029] In some examples, the porous material 114 may be cut to a length that at least substantially completely fills the portion of the chamber 112 not occupied by the tube 116. In some examples, the porous material 114 may not substantially completely fill the portion of the chamber 112 not occupied by the tube 116. In such examples, the urine collection assembly 100 includes a reservoir 124 or a sump disposed in the chamber 112.

[0030] The reservoir 124 or the sump may be a substantially unoccupied portion of the chamber 112. The reservoir 124 may be defined between the fluid-impermeable barrier 102 and the porous material 114. Urine in the chamber 112 may flow through the porous material 114 to the reservoir 124. The reservoir 124 or the sump may retain body fluid therein. Although the reservoir 124 or the sump is illustrated as being located in the distal region 108, the reservoir 124 or the sump may be located in any part of the chamber 112, such as the proximal region 110. The reservoir 124 or the sump may be located in a portion of the chamber 112 that is designed to be at the low point of the gravity analysis of the urine collection assembly 100 during use of the urine collection assembly 100.

[0031] In some examples, the porous material 114 may include a porous support material 126 and a hydrophilic cover sheet 128 disposed on the porous support material 126. The porous material 114 may be disposed in the chamber 112 such that the hydrophilic cover sheet 128 is positioned closer to the urethral orifice of the individual than the porous support material 126. For example, the hydrophilic cover sheet 128 may extend across the opening 104 and be exposed to the outside of the urine collection assembly 100. Thus, when the urine collection assembly 100 is positioned adjacent to the vaginal area, the hydrophilic cover sheet 128 may contact the vaginal area of the individual. When assembling the urine collection assembly 100, the porous material 114 may also be positioned such that the porous support material 126 defines a hole configured to receive the tube 116.

[0032] The tube 116 can be at least partially disposed within the chamber 112. The tube 116 can be used to remove urine from the chamber 112. The tube 116 includes at least one wall that defines an inlet 120, an outlet (not shown) downstream of the inlet 120, and a passageway. The outlet of the tube can be operably coupled to a vacuum source, such as a vacuum pump, for withdrawing fluid from the chamber 112 through the tube 116. For example, the tube 116 can extend from the proximal region 110 into the fluid-impermeable barrier 102 and can extend into the distal region 108 to a point near the reservoir 124 such that the inlet 120 is in fluid communication with the reservoir 124. The tube 116 fluidly couples the chamber 112 to a fluid storage container (not shown) or a vacuum source (not shown).

[0033] The porous material 114 can surround the tube 116. In one embodiment, the tube 116 extends from the fluid outlet 118, through the porous material 114, to a location near the reservoir 124 and in the vicinity of the distal region 108. In such an embodiment, the inlet 120 may not extend into the reservoir 124, but rather the inlet 120 can be disposed within the porous material 114 or at the terminus of the porous material 114. In one embodiment, the tube 116 is at least partially disposed within the reservoir 124 and the inlet 120 can extend into or be positioned within the reservoir 124. Thus, the inlet 120 of the tube 116 can be located behind the reservoir 124 or the sump, flush with the porous material 114, or extend into the reservoir 124. Urine collected within the urine collection assembly 100 can be removed from the chamber 112 via the tube 116.

[0034] Positioning the inlet 120 at or near the gravity analysis low point of the chamber 112 as expected during individual wear enables the tube 116 to receive more urine than if the tube inlet 120 were located elsewhere and reduces the likelihood of accumulation (e.g., urine accumulation can lead to microbial growth and foul odors). The tube inlet 120 and the tube outlet 116 are configured to fluidly couple (e.g., directly or indirectly) a vacuum source (not shown) to the chamber 112 (e.g., the reservoir 124). When the vacuum source (as Figure 2 shown) applies a vacuum / suction in the tube 116, urine in the chamber 112 (e.g., at the distal region 108 such as in the reservoir 124, etc.) can be drawn into the inlet 120 and discharged from the urine collection assembly 100 via the tube 116.

[0035] In one example, the hydrophilic cover sheet 128 can directly contact the anatomical area and receive urine. The hydrophilic cover sheet 128 can draw urine into the porous material 114, enabling the hydrophilic cover sheet 128 to effectively receive body fluids. Additionally, the hydrophilic cover sheet 128 distributes urine through the hydrophilic cover sheet 128, which allows the hydrophilic cover sheet 128 to receive a large amount of urine in a relatively short period of time and facilitates the transfer of urine from the hydrophilic cover sheet 128 to the porous support material 126. The hydrophilic cover sheet 128 can include a non-woven fabric structure. In some examples, the hydrophilic cover sheet 128 can include a fabric gauze.

[0036] The hydrophilic cover sheet 128 can be selected to exhibit a surface density between about 10 g / m 2 and about 200 g / m 2 . In some examples, the surface density of the hydrophilic cover sheet 128 can be about 75 g / m 2 to about 125 g / m 2 , about 100 g / m 2 to about 150 g / m 2 , about 125 g / m 2 to about 175 g / m 2 , or about 150 g / m 2 to about 200 g / m 2 . The surface density of the hydrophilic cover sheet 128 depends on the density and thickness of the hydrophilic cover sheet 128. Thus, the surface density of the hydrophilic cover sheet 128 can be selected for the same reasons as the thickness of the hydrophilic cover sheet 128.

[0037] The hydrophilic cover sheet 128 may exhibit a thickness that is significantly less than the thickness of the porous support material 126. For example, the thickness of the hydrophilic cover sheet 128 may be about 400 μm or less, such as about 350 μm or less, about 300 μm or less, about 250 μm or less, about 200 μm or less, about 150 μm or less, about 100 μm or less, or in the range of about 50 μm to about 150 μm, about 100 μm to about 200 μm, about 150 μm to about 250 μm, about 200 μm to about 300 μm, or about 250 μm to about 400 μm. The thickness of the hydrophilic cover sheet 128 may allow the hydrophilic cover sheet 128 to effectively receive urine because the distance that urine needs to flow through the hydrophilic cover sheet 128 is reduced. The thickness of the hydrophilic cover sheet 128 may also allow the hydrophilic cover sheet 128 to dry quickly because the thickness of the hydrophilic cover sheet 128 only allows the hydrophilic cover sheet 128 to hold a relatively small amount of urine at any given time. The relatively small amount of urine present in the hydrophilic cover sheet 128 can be easily removed (e.g., evaporated) into the atmosphere or removed by an air flow induced by a vacuum applied to the chamber 112 of the fluid collection assembly 100. Conventional material selection for fluid collection assemblies avoids the use of hydrophilic materials, especially in the portion close to the urethral orifice, because hydrophilic materials tend to retain urine and remain wet. Thus, conventional material selection for fluid collection assemblies tends to use hydrophobic materials because hydrophobic materials do not retain large amounts of fluid. However, hydrophobic materials may not be effective in receiving body fluids such as urine.

[0038] It should be noted that, generally, reducing the thickness of the hydrophilic cover sheet 128 will improve the efficiency of the hydrophilic cover sheet 128 in receiving body fluids and increase the speed at which the hydrophilic cover sheet 128 dries. However, reducing the thickness of the hydrophilic cover sheet 128 will also reduce the durability of the hydrophilic cover sheet 128 and will also limit the diffusion of urine into the hydrophilic cover sheet 128 in a direction generally parallel to the longitudinal axis β-β, which in turn can facilitate the flow of urine from the hydrophilic cover sheet 128 into the porous support material 126.

[0039] As described above, the porous material 114 includes a porous support material 126. In one example, the porous support material 126 is a woven fabric. In some examples, the porous support material 126 may include at least one of polyester, polypropylene, polyethylene, nylon, spun nylon fiber, vertically woven bamboo, cotton, or cellulose. Further examples of fluid collection assemblies that may include the porous materials disclosed herein are disclosed in: U.S. Patent Application No. 15 / 612,325, filed June 2, 2017; U.S. Patent Application No. 15 / 260,103, filed September 8, 2016; U.S. Patent No. 10,390,989, filed September 8, 2016; U.S. Provisional Patent Application No. 63 / 067,542, filed August 19, 2020; and U.S. Patent Application No. 16 / 433,773, filed June 6, 2019, the disclosures of each of which are incorporated herein by reference in their entirety.

[0040] The porous support material 126 may exhibit a thickness of about 20 mm or less, such as about 15 mm or less, about 10 mm or less, about 5 mm or less, about 2 mm or less, or in the range of about 2 mm to about 5 mm, about 5 mm to about 10 mm, about 10 mm to about 15 mm, or about 15 mm to about 20 mm. In some embodiments, the porous support material 126 may be hydrophobic and may reduce the urine flow therethrough, which in turn may reduce the volume of urine that may be temporarily stored in the porous material 114. Reducing the volume of urine temporarily stored in the porous material 114 may increase the likelihood of urine leakage therefrom.

[0041] The porous support material 126 may be selected to exhibit a surface density of about 150 g / m 2 to about 800 g / m 2 、about 150 g / m 2 to about 200 g / m 2 、about 200 g / m 2 to about 300 g / m 2 、about 300 g / m 2 to about 400 g / m 2 、about 400 g / m 2 to about 500 g / m 2 、about 500 g / m 2 to about 600 g / m 2 、about 600 g / m 2 to about 700 g / m 2 or about 700 g / m 2 to about 800 g / m 2。The surface density of the porous support material 126 depends on the density and thickness of the porous support material 126. Thus, the surface density of the porous support material 126 can be selected for the same reasons as the thickness of the porous support material 126.

[0042] In some embodiments, the porous material 114 may further include a support layer 130. The support layer 130 may be located between the porous support material 126 and the hydrophilic cover sheet 128. The support layer 130 may be configured to form channels for body fluid flow. In one embodiment, the support layer 130 is formed by a plurality of fibers (such as a plurality of microfilaments). In one example, the plurality of fibers may be arranged along a first direction, where the first direction generally extends from the porous support material 126 to the hydrophilic cover sheet 128 (e.g., generally perpendicular to the longitudinal axis β-β). Arranging the fibers along the first direction may allow the support layer 130 to attach the porous support material 126 and the hydrophilic cover sheet 128 together more firmly. Additionally, urine may be more likely to flow in a direction parallel to the fibers. Thus, compared to when the fibers are arranged in other directions, arranging the fibers along the second direction may cause urine to be withdrawn through the support layer 130 more quickly, which results in a greater percentage of urine flowing into the support layer 130 than when the fibers are arranged in other directions. Causing a greater percentage of urine to flow into the support layer 130 may result in a greater volume of urine flowing through the porous material 114 at any given time and reduce the likelihood of urine leakage from the porous material 114.

[0043] The support layer 130 may be formed of a hydrophilic material and / or a hydrophobic material. In one example, the support layer 130 may be formed of a hydrophilic material. As previously mentioned, the porous material of traditional fluid collection assemblies may not be formed of a hydrophilic material because such materials typically retain body fluids. However, when the porous support material 126 exhibits hydrophobicity, the hydrophobicity can limit the urine retained by the support layer 130. When the support layer 130 is hydrophilic, the support layer 130 may generally exhibit less hydrophilicity than the hydrophilic cover sheet 128. In one example, the support layer 130 may be formed of a hydrophobic material that exhibits any hydrophobicity disclosed herein. In such an example, the support layer 130 may exhibit less hydrophobicity than the porous support material 126 to facilitate the flow of body fluid from the hydrophilic cover sheet 128 to the support layer 130. In some embodiments, the support layer 130 may be omitted from the porous material 114 and not included in the urine collection assembly 100.

[0044] The porous support material 126, the hydrophilic cover sheet 128, and / or the support layer 130 can be formed of any suitable material. In one example, at least one of the porous support material 126, the hydrophilic cover sheet 128, or the support layer 130 can include a substrate coated with a material. In such an example, the coating material can exhibit different hydrophilic or hydrophobic properties from the substrate. In one example, at least one of the porous support material 126, the hydrophilic cover sheet 128, and the support layer 130 can be formed of at least one material that has been treated to alter its hydrophilic or hydrophobic properties.

[0045] In some examples, the porous material 114 disclosed herein can include one or more additional layers. The porous material 114 and / or any of its components can be configured to wick urine away from the opening 104, thereby preventing urine from escaping the chamber 112. The permeable properties referred to herein can be wicking, capillary action, diffusion, or other similar properties or processes, and are referred to herein as "permeable" and / or "wicking". Such "wicking" and / or "permeable" properties may not include the absorption of body fluids into at least a portion of the porous material 114. In other words, when the material is exposed to urine and removed from the urine for a period of time, body fluids are substantially not absorbed or dissolved into the material. Although not desired to be absorbed or dissolved, the term "substantially non-absorbent" can allow for a nominal amount (e.g., absorbency) of urine and / or body fluid absorption and / or dissolution into the porous material 114, such as less than about 30 wt% of the dry weight of the porous material 114, less than about 20 wt%, less than about 10 wt%, less than about 7 wt%, less than about 5 wt%, less than about 3 wt%, less than about 2 wt%, less than about 1 wt%, or less than about 0.5 wt% of the dry weight of the porous material 114. The porous material 114 can also wick body fluids generally towards the interior of the chamber 112, as described in more detail below. In one embodiment, the porous material 114 can include at least one absorbent or adsorbent material.

[0046] Figure 1C is Figure 3Schematic cross-sectional view of the urine collection assembly shown in A taken along plane α-α. The porous material 114 is shown wrapped around the tube 116 in a cylindrical shape and sealed. In some embodiments, the porous material 114 can be sealed with an adhesive seal 132 and disposed within the fluid-impermeable barrier 102. In some embodiments, the seal can be formed by ultrasonic welding. In some embodiments, the material of the seal 132 can be formed from a polymeric adhesive (such as an epoxy, acrylate, or silicone material). The adhesive seal 132 can include a curing temperature below about 200 °C. The seal material can have a coefficient of thermal expansion below about 50 ppm / °C. In some examples, the seal 132 is moisture-proof or moisture-resistant. The seal 132 is provided for holding the side edges of the porous material 114 together. The seal 132 can be applied to the porous support material 126, the hydrophilic cover sheet 128, and / or the support layer 130. Generally, the seal 132 is applied to all components of the porous material 114. In some examples, the edges of the porous material 114 can overlap, and the seal 132 can be applied to the top and bottom surfaces of the edges as needed to fix the shape of the porous material 114.

[0047] Figure 1D Side view of the sub-assembly 134 of the urine collection assembly 100 according to one embodiment. The sub-assembly 134 can include a tube 116, and the porous material 114 is wrapped around the tube 116 in a cylindrical shape. The sub-assembly 134 at least includes a porous support material 126 and a hydrophilic cover sheet 128 disposed on the porous support material 126. The seal 132 can be applied over the entire length of the sub-assembly 134. The adhesive material of the seal 132 can be applied to the opposing surfaces of the edge of the porous material 114 and cured by exposure to radiation or entrained heat, radiation, air, or other suitable curing media. The seal 132 can be formed from a non-toxic adhesive, by plastic welding, by ultrasonic welding, or from a material including but not limited to a polymeric or non-woven tape. The seal 132 can be applied without damaging or affecting the component properties of the porous material 114. The seal 132 can include multiple layers. In some examples, the layers can include different drying and / or adhesive properties. In some examples, the first adhesive layer can be rapidly curing, while another adhesive layer can be waterproof or fluid-resistant. In some embodiments, the side edges of the porous material 114 can be cut into an interlocking pattern (such as a zigzag or staggered pattern) to enhance the strength of the seal 132. The pattern can be a repeating pattern or a non-repeating pattern.

[0048] Figure 2FIG. 0 is a block diagram of a urine collection system 200 with a urine collection assembly 202 according to one embodiment. The urine collection system 200 includes a urine collection assembly 202, a urine storage container 206, and a vacuum source 208. The urine collection assembly 202 can be the same as or substantially similar to any fluid collection assembly disclosed herein. The urine collection assembly 202, the urine storage container 206, and the vacuum source 208 can be fluidly coupled to each other via one or more tubes 204. For example, the urine collection assembly 202 can be operably coupled to one or more of the urine storage container 206 or the vacuum source 208 via the tube 204. Urine collected in the urine collection assembly 202 can be removed from the urine collection assembly 202 via the tube 204 extending into the urine collection assembly 202. For example, the inlet of the tube 204 can extend into the urine collection assembly 202, such as into a reservoir therein. The outlet of the tube 204 can extend into the urine collection assembly 202 or the vacuum source 208. In response to a suction force (e.g., vacuum) applied at the outlet of the tube 204, the suction force can be introduced into the chamber of the urine collection assembly 202 via the inlet of the tube 204.

[0049] The suction force can be applied to the outlet of the tube 204 directly or indirectly by the vacuum source 208. The suction force can be applied indirectly via the urine storage container 206. For example, the outlet of the tube 204 can be disposed within the urine storage container 206, and an additional tube 204 can extend from the urine storage container 206 to the vacuum source 208. Thus, the vacuum source 208 can apply suction to the urine collection assembly 202 via the urine storage container 206. The suction force can be applied directly via the vacuum source 208. For example, the outlet of the tube 204 can be disposed within the vacuum source 208. An additional tube 204 can extend from the vacuum source 208 to an external point of the urine collection assembly 202, such as to the urine storage container 206. In such an example, the vacuum source 208 can be disposed between the urine collection assembly 202 and the urine storage container 206.

[0050] The size and shape of the urine storage container 206 can be designed to retain body fluid therein. The urine storage container 206 can include a bag (e.g., a drainage bag), a bottle, or a cup (e.g., a collection jar) or any other enclosed container for storing body fluid (e.g., urine). In some examples, the tube 204 can extend from the urine collection assembly 202 and be coupled to the urine storage container 206 at a first point therein. An additional tube 204 can be coupled to the urine storage container 206 at a second point thereon and can extend and be attached to the vacuum source 208. Thus, the urine collection assembly 202 can be evacuated (e.g., suctioned) via the urine storage container 206. The vacuum source 208 can be used to drain body fluid (e.g., urine) from the urine collection assembly 202. In some examples, the urine storage container 206 can include a scale or gauge to measure the amount of urine collected.

[0051] The vacuum source 208 can include one or more of a manual vacuum pump, an electric vacuum pump, a diaphragm pump, a centrifugal pump, a positive displacement pump, a magnetic drive pump, a peristaltic pump, or any pump configured to generate a vacuum. The vacuum source 208 can provide a vacuum or suction to remove body fluid from the urine collection assembly 202. In some examples, the vacuum source 208 can be powered by one or more power cords (e.g., connected to a power outlet), one or more batteries, or even a manual power source (e.g., a manually operated vacuum pump). The vacuum source 208 disclosed herein can also include one or more switches, buttons, plugs, remote controls, or any other device suitable for activating the vacuum source 208.

[0052] A method of forming a urine collection system (e.g., urine collection system 200) can include forming and / or fabricating a urine collection assembly 202 and fluidly connecting the urine collection assembly 202 to a urine storage container 206 and a vacuum source 208 such that when urine is present in the chamber, suction provided from the vacuum source 208 to chamber 118 of the urine collection assembly 202 removes urine from the urine collection assembly 202.

[0053] Figure 3 FIG. 8 is a flow chart of a method 300 of forming a urine collection assembly (e.g., urine collection assembly 100) according to one embodiment. In some examples, the method can include an action 302 of cutting a tube and a porous material. In some embodiments, the tube and the porous material can be die cut. In other embodiments, the tube and / or the porous material can be laser cut. Laser cutting works by directing the output of a high-power laser. The focused laser beam can be directed onto the porous material and / or the tube, and then the material and / or the tube will melt, burn, evaporate, or be blown away by an air stream, leaving an edge with a surface finish. A die is a preformed tool that works with a press to process materials into the desired size and shape. In some embodiments, the porous material is die cut to facilitate the rapid manufacture / assembly of the urine collection assembly. Die cutting is the process of using a machine to mass-produce cut-out shapes. The die cutting machine can be of a manual or industrial design. In some examples, the entire process of cutting the tube and / or the porous material is automated, so more shapes can be produced at a faster speed. In some embodiments, the tube and the porous material can be cut simultaneously. In other embodiments, the tube and the porous material can be cut separately. The porous material can at least include a porous support material and a hydrophilic cover sheet disposed above the porous support material. In some examples, the porous material can also include a support layer. The support layer can be positioned between the porous support material and the hydrophilic cover sheet.

[0054] The method may further include operation 304: wrapping a porous material including at least a porous support material and a hydrophilic cover around a clamping tool to form a cylinder. The clamping tool may include pins extending from an outer surface of the clamping tool to extend into the porous material and form the porous material into a cylinder. The method may further include operation 306 of sealing the hydrophilic cover sheet. Operation 306 may be optional if a seal is required or preferred before assembling the urine collection assembly. In some embodiments, the hydrophilic cover sheet may be sealed with tape or glue to maintain the porous material in a cylindrical shape. In some examples, an adhesive may be pre-applied before wrapping the porous material around the clamping tool. The hydrophilic cover sheet is configured to extend across an opening of a fluid-impermeable barrier of the urine collection assembly, and the hydrophilic cover sheet is configured to draw urine into the urine collection assembly.

[0055] The method may further include operation 308: withdrawing the clamping tool from the wrapped porous support material to form a channel within the porous support material. Method 300 further includes operation 310 of inserting a tube into the channel to form a sub-assembly. The sub-assembly includes the tube with the porous material wrapped around it in a cylindrical shape. The porous material includes a porous support material and a hydrophilic cover sheet disposed above the porous support material. The hydrophilic cover sheet may be sealed. The method may further include operation 312 of positioning the sub-assembly into a fluid-impermeable barrier. The fluid-impermeable barrier may include a chamber, at least one opening, and a fluid outlet, and the sub-assembly is configured to be disposed within the chamber and the tube extends through the fluid outlet.

[0056] In some examples, a channel may be formed therein within the sub-assembly, and the tube may be inserted after the porous material is disposed within the fluid-impermeable barrier. The sub-assembly may be inserted into the fluid-impermeable barrier through the opening. In some examples, the tube may be inserted into the opening and through the fluid outlet in the fluid-impermeable barrier. In other examples, the tube may be inserted into the channel formed within the sub-assembly after being inserted through the fluid outlet. In some examples, the assembly of the urine collection assembly and / or the sub-assembly may be automated.

[0057] Figure 4FIG. 400 is a flow chart of a method 400 of forming a urine collection assembly (e.g., urine collection assembly 100) according to one embodiment. In some examples, the method may include an act 402 of forming a porous material including a first edge and a second edge. The second edge may be opposite the first edge. In other words, the porous material may be assembled into a sheet from a porous support material and a hydrophilic cover sheet coupled to the porous material. The sheet of porous material may include a first side edge and a second side edge opposite the first side edge. The sheet may include other edges as the sheet may be cut into any suitable shape, including a square or a rectangle. The act 402 of forming the porous material may also include coupling the porous support material and the hydrophilic cover sheet such that the hydrophilic cover sheet is disposed over the porous support material.

[0058] The method 400 may also include an act 404 of shaping the porous material into a cylinder that defines a channel extending along a center line through the porous material. In some examples, the porous material may be shaped by wrapping the porous material around a clamping tool to form the cylinder. The clamping tool may include pins extending from an outer surface of the clamping tool so as to extend into the porous material, and rolling the clamping tool to shape the porous material into a cylinder. The clamping tool may then be removed to form the channel.

[0059] The method may also include an act 406 of sealing a first edge of the porous material to a second edge of the porous material. In some examples, the hydrophilic cover sheet may be sealed with tape or glue. In some embodiments, sealing the first edge of the porous material to the second edge of the porous material may include applying a polymer adhesive to at least the first edge of the porous material. In some embodiments, the seal may extend from an outer surface of the first edge of the porous material to an inner surface of the first edge of the porous material. In other words, the seal may be applied along the entire intersection plane of the porous material. The adhesive may be configured to hold the porous material in a cylindrical shape. In some embodiments, sealing the first edge of the porous material to the second edge of the porous material may include ultrasonically welding the first edge of the porous material to the second edge of the porous material.

[0060] The method 400 further includes an act 408 of inserting a tube into the channel to form a subassembly. The subassembly includes the tube wrapped with the porous material, the porous material being sealed around the tube in a cylindrical shape. The method may also include an act 410 of positioning the subassembly into a fluid-impermeable barrier. The fluid-impermeable barrier may include a chamber, at least one opening, and a fluid outlet, and the subassembly is configured to be disposed in the chamber and the tube extends through the fluid outlet.

[0061] In some examples, a sub-component may form channels therein and a tube may be inserted after a porous material is disposed within a fluid-impermeable barrier. The sub-component may be inserted through an opening into the fluid-impermeable barrier. In some examples, the tube may be inserted into the opening and through a fluid outlet in the fluid-impermeable barrier. In other examples, the tube may be inserted into a channel formed in the sub-component after being inserted through the fluid outlet. In some examples, the assembly of the urine collection component and / or the sub-component may be automated.

[0062] Figure 5A is an isometric view of a gripping tool 500 including a series of pins 502 according to one embodiment, while Figure 5B is a schematic cross-sectional view of the gripping tool 500 taken along the Figure 5A plane α-α shown. In some examples, the gripping tool 500 includes pins 502 extending from an outer surface. The pins 502 are configured to be inserted into the porous material, through the hydrophilic cover sheet and into the porous support material to facilitate wrapping the porous material into a cylindrical shape. When assembling the urine collection component, the pins 502 of the gripping tool 500 may be attached to the porous material and the porous material may be wound around the gripping tool 500 to form a cylindrical shape. In some examples, the porous material is wrapped in a single layer and sealed with an adhesive. The gripping tool 500 may then be removed from the porous material, leaving a cylindrical-shaped porous material having channels therein that are large enough for inserting a tube (e.g., tube 116).

[0063] In some embodiments, the gripping tool 500 may be formed of at least one of metal, plastic, or wood. The gripping tool 500 may be rigid to control the wrapping of the porous support material and the hydrophilic cover around the gripping tool 500 to form a cylinder. The pins 502 may include a series of pins 502 extending from the gripping tool 500 by at least the length of the cut porous material. The gripping tool 500 may also include portions thereon that do not include pins 502 for attachment to a machine or to serve as a handle for the gripping tool 500 during the process of forming the sub-component.

[0064] In some examples, as Figure 5BAs shown, the pins 502 can include a series of pins disposed around the perimeter of the holding tool. The pins 502 can be formed of at least one of metal, plastic, or wood. The pins can be made of a rigid material strong enough to be inserted through the porous material. In some examples, the pins 502 can be flexible to assist in withdrawing the holding tool 500 from the subassembly. In some examples, the pins 502 can be configured to bend when the holding tool 500 is withdrawn. In other examples, the pins 502 can retract into the interior of the holding tool 500 to assist in withdrawal. The pins 502 can extend far enough from the outer surface of the tube to penetrate into the hydrophilic cover sheet and extend into the porous support material. In some embodiments, the pins 502 can have a length 504 of about 5 mm to about 10 mm.

[0065] Although various aspects and embodiments have been disclosed herein, other aspects and embodiments are also contemplated. The various aspects and embodiments disclosed herein are for illustrative purposes only and are not intended to be limiting.

[0066] Degree terms (e.g., "about", "substantially", "generally", etc.) denote variations that are not significant in structure or function. In one example, when a degree term is used with a term denoting an indicated quantity, the degree term is interpreted as denoting ±10%, ±5%, or ±2% of the term denoting the indicated quantity. In one example, when a degree term is used to modify a shape, the degree term indicates that the shape modified by the degree term has the appearance of the disclosed shape. For example, a degree term can be used to indicate that the shape may have rounded corners instead of sharp corners, curved edges instead of straight edges, one or more protrusions extending therefrom, be rectangular, be the same as the disclosed shape, etc.

Claims

1. A method of forming a urine collection assembly, the method comprising: A cut tube and a porous material, the porous material comprising: a porous support material; and a hydrophilic cover sheet disposed above the porous support material; Wrapping the porous material around a clamping tool to form a cylinder, the clamping tool including pins extending from an outer surface of the clamping tool; Withdrawing the clamping tool from the wrapped porous material to form a channel within the porous material; Inserting the tube into the channel to form a subassembly; and Positioning the subassembly within a fluid-impermeable barrier.

2. The method according to claim 1, further comprising sealing the hydrophilic cover sheet.

3. The method according to claim 2, wherein, Sealing the hydrophilic cover sheet includes sealing the hydrophilic cover sheet with tape or glue.

4. The method according to any one of claims 1 to 3, wherein, Cutting the tube and the porous material includes die-cutting or laser cutting.

5. The method according to any one of claims 1 to 4, wherein, The tube and the porous material are cut simultaneously.

6. The method according to any one of claims 1 to 5, wherein, The clamping tool is formed of at least one of metal, plastic, or wood.

7. The method according to any one of claims 1 to 6, wherein, The pins extend from the outer surface of the tube by about 5 mm to about 10 mm.

8. The method according to any one of claims 1 to 7, wherein, The pins include a series of pins extending from the clamping tool, the series of pins extending along at least a length of the cut porous material.

9. The method according to any one of claims 1 to 8, wherein, The pins include a series of pins disposed around a circumference of the clamping tool.

10. The method according to any one of claims 1 to 9, wherein, The pins are formed of at least one of metal, plastic, or wood.

11. The method according to any one of claims 1 to 10, wherein, The fluid-impermeable barrier includes a chamber, at least one opening, and a fluid outlet, and the subassembly is configured to be disposed within the chamber and the tube extends through the fluid outlet.

12. The method according to claim 11, wherein, The hydrophilic cover sheet extends across the opening of the fluid-impermeable barrier, and the hydrophilic cover sheet is configured to draw urine into the urine collection assembly and toward the tube.

13. A method of forming a urine collection assembly, the method comprising: Forming a porous material, the porous material including a first edge and a second edge opposite the first edge; Shaping the porous material into a cylinder that defines a channel extending through a centerline of the porous material; Sealing the first edge of the porous material to the second edge of the porous material; Inserting a tube into the channel to form a subassembly; And Positioning the subassembly within a fluid-impermeable barrier.

14. The method according to claim 13, wherein, Forming the porous material includes: Coupling a porous support material with a hydrophilic cover sheet such that the hydrophilic cover sheet is disposed above the porous support material.

15. The method according to claim 13 or 14, wherein Sealing the first edge of the porous material to the second edge of the porous material includes applying a polymer adhesive to at least the first edge of the porous material.

16. The method according to claim 13 or 14, wherein Sealing the first edge of the porous material to the second edge of the porous material includes ultrasonically welding the first edge of the porous material to the second edge of the porous material.

17. A urine collection assembly, comprising: A fluid-impermeable barrier that at least defines a chamber, at least one opening, and a fluid outlet; A porous material presenting a cylindrical shape, which is disposed within the chamber, the porous material comprising: a porous support material; a hydrophilic cover sheet disposed above the porous support material; and a seal applied along an entire intersection plane of the porous material, the seal being configured to maintain the porous material in a cylindrical shape; and a tube, wherein the tube is disposed within the porous material and is in fluid communication with the fluid outlet.

18. The urine collection assembly according to claim 17, wherein The hydrophilic cover sheet exhibits a thickness of about 400 μm or less.

19. The urine collection assembly according to claim 17 or 18, wherein The porous support material exhibits a thickness of about 2 mm to about 20 mm.

20. The urine collection assembly according to any one of claims 17 to 19, wherein The porous support material includes at least one of polyester, polypropylene, polyethylene, nylon, spun nylon fiber, woven fabric, vertically woven bamboo, cotton, or cellulose.

21. The urine collection assembly according to any one of claims 17 to 20, wherein The porous support material exhibits a surface density of about 150 g / m 2 to about 800 g / m 2 .

22. The urine collection assembly according to any one of claims 17 to 21, further comprising a support layer disposed between the porous support material and the hydrophilic cover sheet.

23. The urine collection assembly according to any one of claims 17 to 22, wherein The hydrophilic cover sheet includes a non-woven structural material.

24. The urine collection assembly according to any one of claims 17 to 23, wherein The hydrophilic cover sheet exhibits a surface density of about 10 g / m 2 to about 200 g / m 2 .

25. The urine collection assembly according to any one of claims 17 to 24, wherein The seal includes tape or glue.

26. The urine collection assembly according to any one of claims 17 to 24, wherein The seal includes ultrasonic welding.

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