JP7810862B2 - URINE COLLECTION ASSEMBLY COMPRISING POROUS MATERIAL AND METHOD FOR MANUFACTURING URINE COLLECTION ASSEMBLY - Patent application - Google Patents

Description

The present invention relates to a urine collection assembly including a porous material and a method for manufacturing the urine collection assembly.

A person may have limited or impaired mobility, making the normal process of urination difficult or impossible. For example, the person may experience or be impaired in a way that impairs mobility. The person may have restricted mobility conditions, such as those experienced by pilots, drivers, and workers in hazardous areas. Additionally, collection of bodily fluids is sometimes necessary for monitoring purposes or clinical testing.

Urinary catheters, such as Foley catheters, can address some of these conditions, including incontinence. Unfortunately, urinary catheters can be uncomfortable, painful, and can lead to complications such as infection. In addition, bedpans, which are toilet containers for bedridden people, are sometimes used. However, bedpans can be prone to discomfort, overflow, and other hygiene issues.

International Publication No. 2022/125685 U.S. Patent Application Publication No. 2022/117775 U.S. Patent Application Publication No. 2022/265462

Embodiments relate to urine collection assemblies and methods of forming urine collection assemblies. In one embodiment, the 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 on the porous support material. The method may further include wrapping the porous support material and the hydrophilic cover around a gripping tool to form a cylinder. In one embodiment, the gripping tool may include a pin extending from an outer surface of the gripping tool. The method may also include withdrawing the gripping tool from the wrapped porous material to form a channel in the porous material. In one embodiment, the method further includes inserting a tube into the channel to form a subassembly and placing the subassembly within a fluid-impermeable barrier.

In one embodiment, a method of forming a urine collection assembly is disclosed. The method may include forming a porous material, the porous material including a first edge and a second edge opposite the first edge. The method may further include molding the porous material into a cylinder, the cylinder defining a channel extending through a centerline of 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 a tube into the channel to form a subassembly and disposing the subassembly in a fluid-impermeable barrier.

In one embodiment, a urine collection assembly is disclosed. The urine collection assembly includes a fluid-impermeable barrier defining at least a chamber, at least one opening, and a fluid outlet. The urine collection assembly also includes a cylindrically formed porous material disposed within the chamber. The porous material includes a porous support material and a hydrophilic cover sheet disposed on the porous support material, as well as a seal applied along all intersecting surfaces of the porous material, the seal being configured to maintain the porous material in a cylindrical shape. The urine collection assembly also includes a tube. The tube is disposed in the porous material, and the tube may be in fluid communication with the fluid outlet.

Features from any of the disclosed embodiments may be used in combination with each other, without limitation. Furthermore, other features and advantages of the present disclosure will become apparent to those skilled in the art upon consideration of the following detailed description and accompanying drawings.

The drawings illustrate several embodiments of the present disclosure, with the same reference numbers referring to the same or similar elements or features in different views or embodiments shown in the drawings.

FIG. 1 is a perspective view of a urine collection assembly including a porous material, according to one embodiment. 1B is a cross-sectional schematic view of the urine collection assembly shown in FIG. 1A taken along line β-β. 1B is a cross-sectional schematic view of the urine collection assembly shown in FIG. 1A taken along line α-α. FIG. 10 is a side view of a subassembly of a urine collection assembly, according to one embodiment. FIG. 1 is a block diagram of a urine collection system including a urine collection assembly, according to one embodiment. 1 is a flow diagram of a method of forming a urine collection assembly, according to one embodiment. 1 is a flow diagram of a method of forming a urine collection assembly, according to one embodiment. FIG. 1 is a perspective view of a gripper including a series of pins, according to one embodiment. 1 is a cross-sectional schematic view of a gripper according to one embodiment.

Embodiments relate to urine collection assemblies and methods of forming urine collection assemblies. In some examples, the urine collection assembly may include a fluid-impermeable barrier defining at least 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 on 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 including such a urine collection assembly.

During use, the fluid collection assembly can be positioned so that the hydrophilic cover sheet is positioned adjacent to and in contact with the female's urethral opening (e.g., vagina). The female may excrete one or more bodily fluids (e.g., urine). The excreted urine can be received within the porous material. The urine can flow through the porous material and to the inlet of a tube disposed through a fluid outlet defined by the fluid-impermeable barrier. The urine can then flow through the tube as it is removed from the fluid collection assembly. In one embodiment, a vacuum can be applied through the tube to draw the urine through the porous material and to the inlet of the tube. The vacuum can also facilitate the flow of urine through the tube. The vacuum can be applied from a vacuum source in fluid communication with the tube.

Conventional fluid collection assemblies may include a porous material positioned to initially receive bodily fluids from an individual using the conventional fluid collection assembly. Such porous materials may be hydrophobic or configured to wick bodily fluids into the conventional fluid collection assembly. However, many conventional porous materials positioned to initially receive bodily fluids from an individual may be ineffective at capturing urine discharged from the individual, increasing the likelihood that the bodily fluids will leak from the fluid collection assembly. Furthermore, many conventional porous materials have been found to remain wet after an individual has discharged bodily fluids, which may prevent conventional fluid collection assemblies from being used for extended periods of time (e.g., more than 12 hours) without causing deterioration to the individual's skin, which may result in significant discomfort.

The urine collection assembly and the porous material disposed therein may alleviate at least some of these problems associated with the porous materials of conventional fluid collection assemblies. For example, the hydrophilic cover sheet may be configured to form a sealing layer when the hydrophilic cover sheet becomes wet, facilitating vacuum function within the assembly. The porous support material may effectively receive bodily fluids, thereby preventing or at least inhibiting leakage of the bodily fluids. The hydrophilic cover sheet may also be configured to dry more quickly than conventional porous materials after receiving bodily fluids, thereby allowing the urine collection assembly to be used for an extended period of time (e.g., for a period of more than about 24 hours, e.g., about 24 to about 36 hours, about 30 to about 42 hours, or about 36 to about 48 hours). The hydrophilic cover sheet may effectively receive bodily fluids and remain dry due to at least one or more of the hydrophilic or porous properties of the material comprising the cover sheet, as described in more detail below.

The porous support material encourages urine to flow toward the tube inlet and remove urine from the urine collection assembly. The porous support material may include a 3D structure configured to encourage such fluid flow, for example, through at least one of the hydrophobicity, thickness, or areal density of the porous support material, as described in more detail below.

FIG. 1A is a perspective view of a urine collection assembly 100 according to one embodiment. FIG. 1B is a cross-sectional schematic view of the urine collection assembly 100 taken along the plane β-β shown in FIG. 1A. The urine collection assembly 100 is an example of a female urine collection assembly for receiving and collecting bodily fluids (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 may be formed from any suitable fluid-impermeable material(s), such as a fluid-impermeable polymer (such as silicone, polypropylene, polyethylene, polyethylene terephthalate, neoprene, polycarbonate, etc.), natural rubber, another suitable material, other fluid-impermeable materials disclosed herein, or a combination thereof. Thus, the fluid-impermeable barrier 102 substantially prevents bodily fluids from passing through the fluid-impermeable barrier 102. In one example, the fluid-impermeable barrier 102 may be air-permeable and fluid-impermeable. At least one or more portions of the outer surface 106 of the fluid-impermeable barrier 102 may be formed from a soft and/or smooth material to thereby reduce chafing.

In some examples, the fluid-impermeable barrier 102 may be tubular, such as substantially cylindrical (as shown), or an oval, prismatic, or flat tube. In some examples, the outer surface 106 of the fluid-impermeable barrier 102 may contact an individual during use. The fluid-impermeable barrier 102 may be sized and shaped to fit between the labia and/or intergluteal cleft between the legs of a female user.

The opening 104 may provide an entrance for urine to enter the urine collection assembly 100. The opening 104 may be defined by the fluid-impermeable barrier 102, for example, by an inner edge of the fluid-impermeable barrier 102, thereby allowing urine to enter the urine collection assembly 102 through the opening 104.

The opening 104 may be an elongated hole in the fluid-impermeable barrier 102. For example, the opening 104 may be defined as a cutout in the fluid-impermeable barrier 102 extending from the distal end region 108 to the proximal end region 110. The opening 104 may be positioned and shaped to be located adjacent to the female urethral opening. The opening 104 may have an elongated shape because the space between a woman's legs is relatively small when her legs are closed, thereby allowing bodily fluids to flow only along a path corresponding to the elongated shape of the opening 104 (e.g., a longitudinally extending opening 104).

The fluid-impermeable barrier 102 at least partially defines a chamber 112. For example, the inner surface(s) 122 of the fluid-impermeable barrier 102 at least partially define the chamber 112 within the urine collection assembly 100. The fluid-impermeable barrier 102 temporarily stores bodily fluids within the chamber 112. The urine collection assembly 100 also includes a porous material 114 disposed within the chamber 112. The urine collection assembly 100 can be positioned near a female urethral opening such that urine can enter the chamber 112 of the urine collection assembly 100 through the opening 104. The urine collection assembly 100 is configured to receive bodily fluids into the chamber 112 through the opening 104. In use, the opening 104 may have an elongated shape extending from a first position below the urethral opening to a second position above the urethral opening.

The urine collection assembly 100 may further include a tube 116 disposed through a fluid outlet 118 defined by the fluid-impermeable barrier 102, such that an inlet 120 for the tube 116 is disposed within the chamber 112. In some examples, the fluid-impermeable barrier 102 may define a fluid outlet 118 sized to receive the tube 116. The tube 116 may be disposed within the chamber 112 via the fluid outlet 118. The fluid outlet 118 may be sized and shaped to form at least a substantially fluid-tight seal with the tube 116, thereby substantially preventing bodily fluids from leaking from the chamber 112.

As previously mentioned, porous material 114 is disposed within chamber 112. Porous material 114 may be formed into and exhibit a generally cylindrical shape. In one embodiment, porous material 114 may be provided in a sheet. In such an embodiment, porous material 114 may be wrapped around a generally cylindrical shape with its opposing edges touching each other, as further described below.

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 that is not occupied by the tube 116. In some examples, the porous material 114 may not substantially completely fill the portion of the chamber 112 that is not occupied by the tube 116. In such examples, the urine collection assembly 100 includes a reservoir 124 or sump disposed within the chamber 112.

The reservoir 124 or 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 within the chamber 112 may flow through the porous material 114 to the reservoir 124. The reservoir 124 or sump may hold bodily fluids therein. Although shown in the distal end region 108, the reservoir 124 or sump may be located in any portion of the chamber 112, such as the proximal end region 110. The reservoir 124 or sump may be located in a portion of the chamber 112 that is designed to be located at a gravimetrically low point on the urine collection assembly 100 when the urine collection assembly 100 is in use.

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 within the chamber 112, with the hydrophilic cover sheet 128 positioned closer to the individual's urethral opening than the porous support material 126. For example, the hydrophilic cover sheet 128 may extend across the opening 104 and be exposed to the exterior of the urine collection assembly 100. In this manner, the hydrophilic cover sheet 128 may contact the individual's vaginal region when the urine collection assembly 100 is positioned adjacent to the vaginal region. The porous material 114 may also be positioned such that the porous support material 126 defines a bore configured to receive the tube 116 when the urine collection assembly 100 is assembled.

The tube 116 may be at least partially disposed within the chamber 112. The tube 116 may 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 from the inlet 120, and a passageway. The outlet of the tube may be operably connected to a vacuum source, such as a vacuum pump, to draw fluid from the chamber 112 through the tube 116. For example, the tube 116 may extend from the proximal end region 110 into the fluid-impermeable barrier 102 and extend to the distal end region 108 to a point proximate a reservoir 124 therein, thereby placing the inlet 120 in fluid communication with the reservoir 124. The tube 116 fluidly connects the chamber 112 to a fluid storage container (not shown) or a vacuum source (not shown).

The porous material 114 may surround the tube 116. In one embodiment, the tube 116 extends from the fluid outlet 118 through the porous material 114 to a position proximate the reservoir 124 and near the distal end region 108. In such an embodiment, the inlet 120 may not extend into the reservoir 124; instead, the inlet 120 may be located within or at the end of the porous material 114. In one embodiment, the tube 116 is at least partially located within the reservoir 124, with the inlet 120 extending into or located within the reservoir 124. Thus, the inlet 120 of the tube 116 may be flush with the porous material 114, behind the reservoir 124 or sump, or may extend into the reservoir 124. Urine collected within the urine collection assembly 100 may be removed from the chamber 112 via the tube 116.

By placing the inlet 120 at or near a location that is expected to be a gravimetric low point in the chamber 112 when worn by an individual, the tube 116 is able to receive more urine than if the tube inlet 120 were located elsewhere, reducing the likelihood of urine pooling (which can lead to microbial growth and foul odors). The tube inlet 120 and the outlet of the tube 116 are configured to fluidly couple (e.g., directly or indirectly) a vacuum source (not shown) to the chamber 112 (e.g., reservoir 124). When the vacuum source (shown in FIG. 2) applies vacuum/suction within the tube 116, urine within the chamber 112 is drawn into the inlet 120 (e.g., at the distal end region 108, such as within the reservoir 124) and can be expelled from the urine collection assembly 100 via the tube 116.

In one example, the hydrophilic cover sheet 128 can receive urine in direct contact with the anatomical region. The hydrophilic cover sheet 128 can draw urine into the porous material 114, thereby allowing the hydrophilic cover sheet 128 to effectively receive bodily fluids. The hydrophilic cover sheet 128 can also distribute urine through the hydrophilic cover sheet 128, thereby allowing the hydrophilic cover sheet 128 to receive a large amount of urine in a relatively short period of time and promoting the transfer of urine from the hydrophilic cover sheet 128 to the porous support material 126. The hydrophilic cover sheet 128 can include a nonwoven structure. In some examples, the hydrophilic cover sheet 128 can include cloth gauze.

The hydrophilic cover sheet 128 may be selected to exhibit an areal density of ^from about 10 g/m to about 200 g/ ^m . In some examples, the areal density of the hydrophilic cover sheet 128 may be ^from about 75 g/m ^to about 125 g/m, ^from about 100 g/m to about 150 g/ ^m , ^from about 125 g/m ^to about 175 g/m, or from about 150 g/ ^m to about 200 g/ ^m . The areal density of the hydrophilic cover sheet 128 is a function of the density and thickness of the hydrophilic cover sheet 128. Thus, the areal density of the hydrophilic cover sheet 128 may be selected for any reason similar to the thickness of the hydrophilic cover sheet 128.

The hydrophilic cover sheet 128 may have a thickness 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, e.g., 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 enable the hydrophilic cover sheet 128 to effectively receive urine by reducing the distance that urine must flow through the hydrophilic cover sheet 128. The thickness of the hydrophilic cover sheet 128 may also allow the hydrophilic cover sheet 128 to dry quickly because it allows the hydrophilic cover sheet 128 to retain only a relatively small amount of urine at a time. The relatively small amount of urine present on the hydrophilic cover sheet 128 may be easily removed (e.g., evaporated) into the atmosphere or by airflow caused 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 near the urethral opening, because hydrophilic materials tend to retain urine and remain wet. Therefore, conventional material selection for fluid collection assemblies tends to use hydrophobic materials because they do not retain large amounts of fluid. However, hydrophobic materials may not be able to effectively receive bodily fluids, such as urine.

It should be noted that, in general, reducing the thickness of the hydrophilic cover sheet 128 increases the efficiency with which the hydrophilic cover sheet 128 receives bodily fluids and increases the rate at which the hydrophilic cover sheet 128 dries. However, reducing the thickness of the hydrophilic cover sheet 128 also decreases the durability of the hydrophilic cover sheet 128 and may limit the diffusion of urine into the hydrophilic cover sheet 128 in a direction generally parallel to the longitudinal axis β-β, which may promote the flow of urine from the hydrophilic cover sheet 128 into the porous support material 126.

As previously mentioned, 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 fibers, 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 Ser. No. 15/612,325, filed June 2, 2017, U.S. patent application Ser. No. 15/260,103, filed September 8, 2016, U.S. patent application Ser. No. 10,390,989, filed September 8, 2016, U.S. provisional patent application Ser. No. 63/067,542, filed August 19, 2020, and U.S. patent application Ser. No. 16/433,773, filed June 6, 2019, the disclosures of each of which are incorporated herein by reference in their entirety.

The thickness of the porous support material 126 may be about 20 mm or less, e.g., 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, which may reduce the flow of urine therethrough, thereby reducing the amount of urine that can be temporarily stored in the porous material 114. Reducing the amount of urine that can be temporarily stored in the porous material 114 may increase the likelihood of urine leakage therethrough.

The porous support material 126 may be selected ^to exhibit an areal density of about 150 g/m ^to about 800 g/m ^, about 150 g/m ^to about 200 g/m, ^about 200 g/m to about 300 g/ ^{m ,} about 300 g/ ^m to about 400 g/m, ^about 400 g/m to about 500 g/ ^{m ,} about 500 g/ ^m to about 600 g/m, about 600 g/ ^m to about 700 g/m ^, or about 700 g/ ^m to about 800 g/ ^m . The areal density of the porous support material 126 is a function of the density and thickness of the porous support material 126. Thus, the areal density of the porous support material 126 may be selected for any reason similar to the thickness of the porous support material 126 .

In some embodiments, the porous material 114 may further include a support layer 130. The support layer 130 may be disposed between the porous support material 126 and the hydrophilic cover sheet 128. The support layer 130 may be configured to form a path for bodily fluid flow. In one embodiment, the support layer 130 is formed from a plurality of fibers, such as a plurality of microfilaments. In one example, the plurality of fibers may be aligned in a first direction, which generally extends from the porous support material 126 to the hydrophilic cover sheet 128 (e.g., aligned generally perpendicular to the longitudinal axis β-β). Aligning the fibers in the first direction allows the support layer 130 to more securely attach the porous support material 126 and the hydrophilic cover sheet 128. Additionally, urine may be slightly more likely to flow in a direction parallel to the fibers. Thus, aligning the fibers in the second direction may allow urine to pass through the support layer 130 more quickly than if the fibers were oriented in another direction, thereby causing urine to flow through a greater portion of the support layer 130 than if the fibers were aligned in another direction. By allowing urine to flow through a greater portion of the support layer 130, a greater amount of urine may pass through the porous material 114 at any one time, reducing the likelihood of urine leaking through the porous material 114.

The support layer 130 may be formed from either a hydrophilic material and/or a hydrophobic material. In one example, the support layer 130 may be formed from a hydrophilic material. As mentioned above, the porous material of conventional fluid collection assemblies may not be formed from a hydrophilic material because hydrophilic materials generally retain bodily fluids. However, if the porous support material 126 exhibits hydrophobicity, that hydrophobicity limits the amount of urine that can be retained by the support layer 130. If the support layer 130 is hydrophilic, it may generally exhibit a lower hydrophilicity than the hydrophilic cover sheet 128. In one example, the support layer 130 may be formed from a hydrophobic material that exhibits any of the hydrophobic properties disclosed herein. In such an example, the support layer 130 may exhibit a lower hydrophobicity than the porous support material 126, promoting the flow of bodily fluids 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 be included in the urine collection assembly 100.

The porous support material 126, the hydrophilic cover sheet 128, and/or the support layer 130 may be formed from 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 may include a base material coated with a material. In such an example, the coating material may exhibit different hydrophilicity or hydrophobicity than the base material. In one example, at least one of the porous support material 126, the hydrophilic cover sheet 128, and the support layer 130 may be formed from at least one material that has been treated to alter its hydrophilicity or hydrophobicity.

In some examples, the porous material 114 disclosed herein may include one or more additional layers. The porous material 114 and/or any of its components may be configured to wick urine away from the opening 104, thereby preventing urine from leaking out of the chamber 112. The permeability properties referred to herein may be wicking, capillary action, diffusion, or other similar properties or processes, and are referred to herein as "permeability" and/or "wicking." Such "wicking" and/or "permeability" properties may not include absorption of bodily fluids into at least a portion of the porous material 114. In other words, substantially no absorption or solubility of bodily fluids into the material may occur for a period of time after the material has been exposed to and removed from urine. While no absorption or solubility is desirable, the term "substantially no absorption" may mean that a nominal amount of absorption and/or solubility (e.g., absorbency) of urine and/or bodily fluids into the porous material 114 may be acceptable, such as less than about 30% by weight, less than about 20% by weight, less than about 10% by weight, less than about 7% by weight, less than about 5% by weight, less than about 3% by weight, less than about 2% by weight, less than about 1% by weight, or less than about 0.5% by weight of the dry weight of the porous material 114. The porous material 114 may also wick bodily fluids generally toward the interior of the chamber 112, as described in more detail below. In one embodiment, the porous material 114 may include at least one absorbent or absorbing material.

1C is a cross-sectional schematic view taken along the α-α plane of the urine collection assembly shown in FIG. 1A. The porous material 114 is cylindrically wrapped around the tube 116 and sealed. In some embodiments, the porous material 114 may be sealed with an adhesive seal 132 and disposed within the fluid-impermeable barrier 102. In some embodiments, the seal may be formed by ultrasonic welding. In some embodiments, the material of the seal 132 may be formed from a polymer adhesive, such as an epoxy, acrylate, or silicone material. The adhesive seal 132 may have a cure temperature of less than about 200°C. The seal material may exhibit a coefficient of thermal expansion of less than about 50 ppm per degree Celsius. In some examples, the seal 132 is moisture-proof or moisture-resistant. The seal 132 is provided to hold the side edges of the porous material 114 together. The seal 132 may 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 instances, the edges of the porous material 114 may overlap, and the seal 132 may be applied to the upper and lower surfaces of the edges as needed to lock the porous material 114 into shape.

FIG. 1D is a side view of a subassembly 134 of the urine collection assembly 100, according to one embodiment. The subassembly 134 may include the tube 116 with the porous material 114 wrapped around the tube 116 in a cylindrical shape. The subassembly 134 includes at least the porous support material 126 and a hydrophilic cover sheet 128 disposed on the porous support material 126. A seal 132 may be applied along the entire length of the subassembly 134. The adhesive material of the seal 132 may be applied to the surface opposite the edge of the porous material 114 and may be cured by exposure to radiant or entrained heat, radiation, air, or other suitable curing medium. The seal 132 may be formed by materials including, but not limited to, non-toxic adhesives, plastic welding, ultrasonic welding, or polymer or nonwoven tape. The seal 132 may be applied without damaging or affecting the properties of the components of the porous material 114. The seal 132 may include multiple layers. In some examples, the layers may include different drying and/or adhesive properties. In some examples, a first adhesive layer may be fast-setting, while another adhesive layer may be waterproof or fluid-resistant. In some embodiments, the side edges of the porous material 114 may be cut in an interlocking pattern (e.g., zigzag or interdigitations) to increase the strength of the seal 132. The pattern may be a repeating or non-repeating pattern.

FIG. 2 is a block diagram of a urine collection system 200 for 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 may be the same as or substantially similar to any of the fluid collection assemblies disclosed herein. The urine collection assembly 202, the urine storage container 206, and the vacuum source 208 may be fluidly coupled to one another via one or more tubes 204. For example, the urine collection assembly 202 may 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 may be removed from the urine collection assembly 202 via the tube 204, which may protrude into the urine collection assembly 202. For example, the inlet of the tube 204 may extend into the urine collection assembly 202, e.g., to a reservoir therein. The outlet of the tube 204 may extend to the urine collection assembly 202 or to a vacuum source 208. A suction force may be introduced into the chamber of the urine collection assembly 202 via the inlet of the tube 204 in response to suction (e.g., vacuum) force applied to the outlet of the tube 204.

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

The urine storage container 206 may be sized and shaped to hold bodily fluids therein. The urine storage container 206 may include a bag (e.g., a drainage bag), a bottle or cup (e.g., a collection jar), or other sealed container for collecting bodily fluids such as urine. In some examples, a tube 204 extends from the urine collection assembly 202 and is connected to the urine storage container 206 at a first point therein. An additional tube 204 may be connected to the urine storage container 206 at a second point therein and may be attached to a vacuum source 208. Thus, a vacuum (e.g., suction) may be drawn into the urine collection assembly 202 through the urine storage container 206. Bodily fluids such as urine may be evacuated from the urine collection assembly 202 using the vacuum source 208. In some examples, the urine storage container 206 may have a scale or gauge to measure the amount of urine collected.

The vacuum source 208 may 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 may provide a vacuum or suction to remove bodily fluids from the urine collection assembly 202. In some examples, the vacuum source 208 may be powered by one or more of a power cord (e.g., connected to a power socket), one or more batteries, or even a manual power source (e.g., a manual vacuum pump). The vacuum sources 208 disclosed herein may further include one or more of a switch, a button, a plug, a remote control, or any other device suitable for activating the vacuum source 208.

A method of forming a urine collection system, such as urine collection system 200, may include forming and/or manufacturing 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 if urine is present in the chamber, the urine is removed from the urine collection assembly 202 by suction applied from the vacuum source 208 to the chamber 118 of the urine collection assembly 202.

FIG. 3 is a flow diagram of a method 300 for forming a urine collection assembly (e.g., urine collection assembly 100), according to one embodiment. In some examples, the method may include operation 302 of cutting the tubing and porous material. In some embodiments, the tubing and porous material may be die-cut. In other embodiments, the tubing and/or porous material may be laser-cut. Laser cutting operates by directing the output of a high-power laser. A focused laser beam may be directed at the porous material and/or tubing, which then melts, burns, vaporizes, or is blown away by a gas jet, leaving a surface-finished edge. A die is a pre-formed tool that works in conjunction with a press to manipulate the material into a desired size and shape. In some embodiments, the porous material is die-cut to facilitate rapid manufacturing/assembly of the urine collection assembly. Die-cutting is a process that uses machinery to mass-produce cutout shapes. The die cutter may be manual or industrially designed. In some examples, the entire process of cutting the tube and/or porous material may be automated to produce more shapes at a faster rate. The tube and porous material may be cut simultaneously in some embodiments. In other embodiments, the tube and porous material may be cut separately. The porous material may include at least a porous support material and a hydrophilic cover sheet disposed on the porous support material. In some examples, the porous material may further include a support layer. The support layer may be disposed between the porous support material and the hydrophilic cover sheet.

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

The method may also include operation 308 of withdrawing the gripper from the wrapped porous support material to form a channel in the porous support material. Method 300 further includes operation 310 of inserting a tube into the channel to form a subassembly. The subassembly includes a tube in which the porous material is wrapped cylindrically around the tube. The porous material includes the porous support material and a hydrophilic cover sheet disposed on the porous support material. The hydrophilic cover sheet may be sealed. The method may also include operation 312 of disposing the subassembly within a fluid-impermeable barrier. The fluid-impermeable barrier may include a chamber, at least one opening, and a fluid outlet, wherein the subassembly is configured to be disposed within the chamber and the tube extends through the fluid outlet.

In some examples, the subassembly may be formed with a channel therein, and the tube may be inserted after the porous material is disposed within the fluid-impermeable barrier. The subassembly may be inserted into the fluid-impermeable barrier through an opening. In some examples, the tube may be inserted into the opening and pass through a fluid outlet in the fluid-impermeable barrier. In other examples, the tube may be inserted through the fluid outlet and then inserted into a channel formed in the subassembly. In some examples, assembly of the urine collection assembly and/or subassembly may be automated.

FIG. 4 is a flow diagram 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 operation 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 from a porous support material and a hydrophilic cover sheet that is in sheet form and bonded to the porous material. The porous material sheet may include a first lateral edge and a second lateral edge opposite the first lateral edge. The sheet may include other edges, as the sheet may be cut into any suitable shape, including a square or rectangle. Operation 402 of forming the porous material may also include bonding the porous support material and the hydrophilic cover sheet, where the hydrophilic cover sheet is disposed on the porous support material.

Method 400 may also include operation 404 of forming the porous material into a cylinder, the cylinder defining a channel extending through a centerline of the porous material. In some examples, the porous material may be formed into the cylinder by wrapping the porous material around a gripper. The gripper may include a pin extending from an outer surface of the gripper that extends into the porous material and rolls the gripper to form the porous material into the cylinder. The gripper may then be removed to form the channel.

The method may also include operation 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 using adhesive 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 the outer surface of the first edge of the porous material to the inner surface of the first edge of the porous material. In other words, the seal may be applied along the entire intersecting surface 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.

Method 400 further includes operation 408 of inserting a tube into the channel to form a subassembly. The subassembly includes a tube with a porous material wrapped and sealed cylindrically around the tube. The method may also include operation 410 of placing the subassembly within a fluid-impermeable barrier. The fluid-impermeable barrier may include a chamber, at least one opening, and a fluid outlet, with the subassembly configured to be placed within the chamber and the tube extending through the fluid outlet.

In some examples, the subassembly may be formed with a channel therein, and the tube may be inserted after the porous material is disposed within the fluid-impermeable barrier. The subassembly may be inserted into the fluid-impermeable barrier through an opening. In some examples, the tube may be inserted into the opening and pass through a fluid outlet in the fluid-impermeable barrier. In other examples, the tube may be inserted through the fluid outlet and then inserted into a channel formed in the subassembly. In some examples, assembly of the urine collection assembly and/or subassembly may be automated.

FIG. 5A is a perspective view of a gripping tool 500 including a series of pins 502 according to one embodiment, and FIG. 5B is a cross-sectional schematic view of the gripping tool 500 according to one embodiment, taken along the plane α-α shown in FIG. 5A. In some examples, the gripping tool 500 includes pins 502 extending from its outer surface. The pins 502 are configured to be inserted into the porous material, penetrate the hydrophilic cover sheet, and insert into the porous support material, facilitating wrapping of the porous material into a cylindrical shape. In assembling the urine collection assembly, the pins 502 of the gripping tool 500 can be attached to the porous material, wrapping the porous material 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 is then removed from the porous material, leaving a cylindrical porous material with a channel therein large enough to allow insertion of a tube (e.g., tube 116).

In some embodiments, the gripper 500 may be formed from at least one of metal, plastic, or wood. The gripper 500 may be rigid and may control the wrapping of the porous support material and hydrophilic cover around the gripper 500 to form a cylinder. The pins 502 may include a series of pins 502 extending from the gripper 500 at least the length of the cut porous material. The gripper 500 may further include a portion that does not include the pin(s) 502, which may serve as a handle for the gripper 500 or for attachment to a machine during the process of forming the subassembly.

5B, the pin(s) 502 may include a series of pins arranged around the gripper. The pin(s) 502 may be formed from at least one of metal, plastic, or wood. The pin(s) may be formed from a rigid material strong enough to be inserted through the porous material. In some examples, the pin(s) 502 may be flexible and aid in withdrawing the gripper 500 from the subassembly. In some examples, the pin(s) 502 may be configured to bend when the gripper 500 is withdrawn. In other examples, the pin(s) 502 may be retracted into the gripper 500 to aid in withdrawal. The pin(s) 502 may extend from the outer surface of the tube a sufficient length to extend through the hydrophilic cover sheet and into the porous support material. In some embodiments, the pin(s) 502 may exhibit a length 504 of about 5 mm to about 10 mm.

While various aspects and embodiments are disclosed herein, other aspects and embodiments are contemplated. The various aspects and embodiments disclosed herein are for illustrative purposes and are not intended to be limiting.

Terms of degree (e.g., "about," "substantially," "generally," etc.) indicate variations that are structurally or functionally insignificant. In one example, when a term of degree is included in a term indicating a quantity, the term of degree is interpreted to mean ±10%, ±5%, or +2% of the term indicating a quantity. In one example, when a term of degree is used to modify a shape, the term of degree indicates that the shape modified by the term of degree has the appearance of the disclosed shape. For example, the term of degree may be used to indicate that a shape may have rounded corners instead of sharp corners, curved edges instead of straight edges, and that one or more protrusions extending therefrom are rectangular, similar to the disclosed shape, etc.

Claims (26)

1. A method of forming a urine collection assembly, comprising:
Cutting the tube and the porous material, wherein the porous material comprises:
a first edge and a second edge opposite the first edge;
a porous support material ;
a hydrophilic cover sheet disposed on the porous support material;
wrapping the porous material around a gripping tool to form a cylinder, the gripping tool including a pin extending from an outer surface of the gripping tool;
withdrawing the gripping tool from the wrapped porous material to form a channel in the porous material;
sealing the first edge of the porous material to the second edge of the porous material;
inserting the tube into the channel to form a subassembly;
placing the subassembly within a fluid-impermeable barrier;
method. The method of claim 1, further comprising the step of sealing the hydrophilic cover sheet. The method of claim 2, wherein the step of sealing the hydrophilic cover sheet includes sealing the hydrophilic cover sheet with adhesive tape or glue. The method of claim 1 , wherein cutting the tube and the porous material comprises die cutting or laser cutting. The method of claim 1 , wherein the tube and the porous material are cut simultaneously. The method of claim 1 , wherein the gripping tool is formed from at least one of metal, plastic, or wood. The method of claim 1 , wherein the pin extends from the outer surface of the tube about 5 mm to about 10 mm. The method of claim 1 , wherein the pins include a series of pins extending from the gripper, the series of pins extending along the gripper and along at least the length of the cut porous material. The method of claim 1 , wherein the pins include a series of pins arranged around the circumference of the gripper. The method of claim 1 , wherein the pin is formed from at least one of metal, plastic, or wood. 10. The method of claim 1, wherein the fluid-impermeable barrier includes a chamber, at least one opening, and a fluid outlet, the subassembly configured to be disposed within the chamber, and the tube extending through the fluid outlet. 12. The method of claim 11, wherein the hydrophilic cover sheet extends across the at least one opening in the fluid-impermeable barrier, the hydrophilic cover sheet being configured to draw urine into the urine collection assembly and direct it towards a tube. 1. A method of forming a urine collection assembly, comprising:
forming a porous material, the porous material including a first edge and a second edge opposite the first edge;
forming the porous material into a cylinder, the cylinder defining 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;
placing the subassembly within a fluid-impermeable barrier;
method. The step of forming the porous material comprises:
The method of claim 13, comprising bonding a porous support material to a hydrophilic cover sheet, said hydrophilic cover sheet being disposed on said porous support material. 14. The method of claim 13, wherein sealing the first edge of the porous material to the second edge of the porous material comprises applying a polymer adhesive to at least the first edge of the porous material. 14. The method of claim 13, wherein sealing the first edge of the porous material to the second edge of the porous material comprises ultrasonically welding the first edge of the porous material to the second edge of the porous material. a fluid-impermeable barrier defining at least a chamber, at least one opening, and a fluid outlet;
a porous material exhibiting a cylindrical shape disposed within the chamber,
porous support material,
a hydrophilic cover sheet disposed on the porous support material; and
a porous material including a seal applied along all intersecting surfaces of the porous material, the seal configured to hold the porous material in a cylindrical shape;
a tube disposed within the porous material and in fluid communication with the fluid outlet.
Urine collection assembly. The urine collection assembly of claim 17, wherein the hydrophilic cover sheet has a thickness of about 400 μm or less. 18. A urine collection assembly according to claim 17 , wherein the porous support material exhibits a thickness of between about 2 mm and about 20 mm. 18. The urine collection assembly of claim 17 , wherein the porous support material comprises at least one of polyester, polypropylene, polyethylene, nylon, spun nylon fibers, woven fabric, vertically woven bamboo, cotton, or cellulose. 18. The urine collection assembly of claim 17 , wherein the porous support material exhibits an areal density of from about 150 g/m ² to about 800 g/m ² . 18. The urine collection assembly of claim 17 , further comprising a support layer disposed between the porous support material and the hydrophilic cover sheet. 18. The urine collection assembly of claim 17 , wherein the hydrophilic cover sheet comprises a nonwoven structural material. 18. The urine collection assembly of claim 17 , wherein the hydrophilic cover sheet exhibits an areal density of from about 10 g/m ² to about 200 g/m ² . 18. The urine collection assembly of claim 17 , wherein the seal comprises adhesive tape or glue. 18. The urine collection assembly of claim 17 , wherein the seal comprises an ultrasonic weld.