Fluid collection device having a fluid-permeable body in which a hydrophilic material is fixed to a nonwoven fabric material, and method for manufacturing it

Abstract

Embodiments disclosed herein are methods for manufacturing a fluid collector, related systems and apparatus. A method for manufacturing a fluid collector includes fixing a first layer, comprising a fluid-permeable nonwoven material, to a second layer using an adhesive to form a fluid-permeable body. The second layer comprises one or more of bamboo, cotton, and / or nonwoven hydrophilic materials. A method for manufacturing a fluid collector also includes placing the fluid-permeable body in a chamber at least partially defined by a fluid-impermeable barrier, so that the fluid-permeable body extends at least partially across the opening of the fluid-impermeable barrier.

Description

[Technical Field]

[0001] The present invention relates to a fluid collection device having a fluid-permeable body in which a hydrophilic material is fixed to a nonwoven fabric material, and to a method for manufacturing such a device. [Background technology]

[0002] Individuals may have limited or impaired mobility, making the normal urination process difficult or impossible. For example, an individual may have undergone surgery or have a disability that impairs mobility. In another example, an individual may have limited mobility conditions, such as those experienced by pilots, drivers, and workers in hazardous areas. Furthermore, fluid collection from an individual may be necessary for monitoring purposes or clinical trials.

[0003] Some of these situations can be addressed using a bedpan and a urinary catheter, such as a Foley catheter. However, bedpans and urinary catheters have several associated problems. For example, bedpans can be uncomfortable, cause pressure sores, spills, and other sanitary issues. Urinary catheters can be uncomfortable and painful and can also cause urinary tract infections.

[0004] Therefore, users and manufacturers of fluid collection devices continue to seek new and improved devices, systems, and methods for urine collection. [Prior art documents] [Patent Documents]

[0005] [Patent Document 1] International Publication No. 2023 / 014639 [Overview of the project] [Means for solving the problem]

[0006] Embodiments described herein include fluid collection devices and associated assemblies, systems, and methods for manufacturing them. In one embodiment, a method for manufacturing a fluid collection device is disclosed. The method includes fixing a first layer, comprising a fluid-permeable nonwoven material, to a second layer using an adhesive to form a fluid-permeable body, the second layer comprising one or more of bamboo, cotton, and / or nonwoven hydrophilic materials. The method includes placing the fluid-permeable body in a chamber at least partially defined by a fluid-impermeable barrier, so that the fluid-permeable body extends at least partially across the opening of the fluid-impermeable barrier.

[0007] In one embodiment, a method for manufacturing a fluid-permeable member for a fluid collection device is disclosed. The method includes fixing a first layer containing a fluid-permeable nonwoven material to a second layer to form a fluid-permeable body, the second layer containing one or more of bamboo, cotton, and / or nonwoven hydrophilic materials. The method includes winding the fluid-permeable body around a mandrel so that two opposing edges of the fluid-permeable body are adjacent longitudinally along the mandrel, and the fluid-permeable body forms a substantially cylindrical shape. The method includes fixing a metal member to the mandrel, the distal end of the metal member fixed to the mandrel close to the distal end of the fluid-permeable body, the proximal end of the metal member close to the proximal end of the fluid-permeable body, and the intermediate region of the metal member close to two opposing edges of the fluid-permeable body. The method includes thermally sealing at least the second layer of the fluid-permeable body at the two opposing edges of the fluid-permeable body. The method includes removing the metal component from the mandrel. The method also includes removing the mandrel from the fluid-permeable body.

[0008] In one embodiment, the fluid collection device includes a fluid-impermeable barrier that at least partially defines a chamber. The fluid-impermeable barrier includes an opening that fluid-communicates with the chamber, and an aperture that fluid-communicates with the chamber. The opening is positioned at least in close proximity to the user's urethra or is configured to receive the urethra into it. The fluid collection device includes a fluid-permeable body that is positioned or can be positioned within the chamber of the fluid-impermeable barrier, the fluid-permeable body extending at least partially across the opening. The fluid-permeable body includes an inner layer containing a fluid-permeable nonwoven material and an outer layer fixed to the inner layer with an adhesive and containing one or more of bamboo, cotton, and / or nonwoven hydrophilic materials.

[0009] Features from any of the disclosed embodiments may be used in combination with each other without limitation. Furthermore, other features and advantages of this disclosure will become apparent to those skilled in the art by considering the following detailed description and accompanying drawings.

[0010] The drawings illustrate several embodiments of the present disclosure, and the same reference numerals refer to the same or similar elements or features in different figures or embodiments shown in the drawings. [Brief explanation of the drawing]

[0011] [Figure 1A] This is an isometric view of a fluid collection device according to one embodiment. [Figure 1B] Figure 1A is a front view of a female user wearing the fluid collection device. [Figure 1C] Figure 1A is an exploded isometric view of the female fluid collection device. [Figure 1D] This is a cross-sectional view taken along line 1-1 of a female fluid collection device according to various embodiments, as shown in Figure 1A. [Figure 1E] This is a block diagram of a fluid collection system according to one embodiment. [Figure 2A] This is a side view of a fluid-permeable body of a fluid collection device wrapped around a mandrel, according to one embodiment. [Figure 2B]A side view of a metal member configured to be fixed to the mandrel of FIG. 2A according to one embodiment. [Figure 3] A flowchart of a method for manufacturing a fluid-permeable body for a fluid collection device according to one embodiment. [Figure 4] A flowchart of a method for manufacturing a fluid collection device according to one embodiment.

DETAILED DESCRIPTION OF THE INVENTION

[0012] A fluid collection device is used to collect fluids such as urine, vaginal secretions, penile secretions, seminal fluid, blood, sweat, or other body fluids from a user. In many embodiments, the fluid collection device includes a fluid-permeable member at least partially disposed within a chamber defined by a fluid-impermeable barrier. Methods for manufacturing a fluid collection device, particularly methods for manufacturing a fluid-permeable body, are disclosed herein. In at least one, some, or all of the embodiments disclosed herein, the method for manufacturing the fluid-permeable body of the fluid collection device provides the technical effect of significantly reducing labor and / or material costs during manufacturing. In at least one, some, or all of the embodiments disclosed herein, the fluid-permeable body includes an inner layer containing a fluid-permeable foam material and an outer layer fixed to the inner layer. The outer layer may include one or more of bamboo, cotton, and / or non-woven hydrophilic materials. The resulting fluid-permeable body provides the technical effect of a more comfortable fluid collection device in at least one, some, or all of the embodiments. The outer layer of the fluid-permeable body can provide a soft top liner that can draw in fluid due to the hydrophilicity of the outer layer, while the inner layer of the fluid-permeable foam material can include a hydrophobic material that can easily hold and transfer fluid under vacuum conditions, thereby keeping the fluid collection device dry during use and preventing skin irritation and / or skin damage associated with long-term use of a wet fluid collection device.

[0013] Figures 1A to 1D show fluid collection devices 100 according to several embodiments. Figure 1A is an isometric view of a fluid collection device 100 according to one embodiment. The fluid collection device 100 is an example of a female fluid collection device 100 configured to receive fluid from a woman. The fluid collection device 100 includes a fluid-impermeable barrier 102 and a fluid-permeable body 120 at least partially located within the fluid-impermeable barrier 102. Figure 1B is a front view of the fluid collection device 100 in use by a female user 150. When in use, the fluid-permeable body 120 of the fluid collection device is positioned at least in close proximity to the user 150's urethra. The fluid-permeable body 120 is located within a chamber 104 (shown in Figure 1D) of the fluid-impermeable barrier 102 of the fluid collection device 100 and is exposed to the user 150's urethra through an opening 106 of the fluid collection device 100. The fluid collection device 100 can be fixed to the user using any of the numerous fixing systems disclosed herein. The fluid received from the urethra into the chamber 104 of the fluid collection device 100 can be removed through the conduit 108.

[0014] The fluid-impermeable barrier 102 may include a first end region 125 and a second end region 127. The fluid-impermeable barrier 102 includes an internal boundary or edge 129 that at least partially defines the chamber 104 (e.g., the internal region shown in Figure 1C) and defines the opening 106. The fluid-impermeable barrier 102 has a substantially cylindrical shape between the first end region 125 and the second end region 127. In other embodiments, the fluid-impermeable barrier 102 may include other shapes, such as a substantially planar surface, a triangle, or one or more other suitable shapes. The opening 106 is formed within the fluid-impermeable barrier 102 and extends longitudinally through the fluid-impermeable barrier 102, thereby allowing fluid to flow from outside the fluid collector 100 into the chamber 104. The opening 106 may be configured to be located at least in close proximity to (for example, adjacent to, touching, or at the interface of) the opening of the female urethra, or to be positioned on the male penis.

[0015] The fluid collector 100 may be positioned at least in close proximity to the opening of the female urethra or on the penis, and urine may flow into the internal region of the fluid collector 100 through the opening 106. The fluid collector 100 is configured to receive fluid into the chamber 104 through the opening 106. For example, the opening 106 may have an elongated shape and be configured to extend from a first location below the urethral opening (e.g., the perineum, anus or its vicinity, below the vaginal opening) to a second location above the urethral opening (e.g., the pubic bone or its vicinity). In some embodiments, the opening 106 may have an elongated shape so that during use, about one-third of the opening 106 is above the urethra and about two-thirds of the opening is below the urethra. The opening 106 may have an elongated shape due to the relatively small space between the woman's legs, thereby allowing fluid flow only along a path corresponding to the elongated shape of the opening 106. For example, the opening may extend longitudinally along a fluid-impermeable barrier. The opening 106 of the fluid-impermeable barrier 102 may have a width measured laterally with respect to the longitudinal direction, and this width may be at least about 10% around the fluid collector 100, for example, about 25% to about 50%, about 40% to about 60%, about 50% to about 75%, about 65% to about 85%, or about 75% to about 100% around the fluid collector 100. The opening 106 may have a width greater than 50% around the fluid collector 100, because the vacuum (e.g., suction) through the conduit 108 draws the fluid into the conduit 108. In some embodiments, the opening 106 may be vertical (e.g., having a principal axis parallel to the longitudinal axis of the device 100). In some embodiments (not shown), the opening 106 may be horizontal (e.g., having a principal axis perpendicular to the longitudinal axis of the device 100). In some embodiments, an internal boundary or edge 129 of the fluid-impermeable barrier 102 defines an opening 106. The edge 129 may include two opposing arcuate portions, which continue to the outer circumference or periphery of a substantially cylindrical fluid-impermeable barrier 102. In one embodiment, the fluid-impermeable barrier 102 may be configured to be attached to an individual, for example, by adhesive bonding to the individual (e.g., using a hydrogel adhesive).

[0016] The fluid-impermeable barrier 102 can also temporarily store fluid within the chamber 104. For example, the fluid-impermeable barrier 102 may be formed from any suitable fluid-impermeable material, such as fluid-impermeable polymers (e.g., silicone, polypropylene, polyethylene, polyethylene terephthalate, polycarbonate, etc.), polyurethane films, thermoplastic elastomers (TPEs), rubber, thermoplastic polyurethanes, other suitable materials, or combinations thereof. Thus, the fluid-impermeable barrier 102 substantially prevents fluid from flowing out of the portion of the chamber 104 separated from the opening 106. The fluid-impermeable barrier 102 is flexible, thereby allowing it to bend or curve when the fluid collection device 100 is positioned relative to the wearer's body. Examples of fluid-impermeable barriers include, but are not limited to, those containing at least one of VersaflexCL2000X TPE, DynaflexG6713TPE, or Silpuran6000 / 05A / B silicone.

[0017] In one embodiment, the fluid-impermeable barrier 102 may be air-permeable. In such an embodiment, the fluid-impermeable barrier 102 may be formed from a hydrophobic material defining a plurality of pores. In one embodiment, at least one or more portions of the outer surface of the fluid-impermeable barrier 102 may be formed from a soft and / or smooth material to reduce abrasion. The fluid-impermeable barrier 102 may include markings, for example, one or more markings thereon, to help the user position the device 100 on the wearer. For example, a line on the fluid-impermeable barrier 102 (e.g., opposite the opening 106) may allow a healthcare professional to position the opening 106 on the wearer's urethra. In an example, the markings may include one or more alignment guides or directional indicators, for example, stripes or hashes. Such markings may be positioned to position the device 100 on one or more anatomical features, such as the pubic bone.

[0018] The fluid collection device 100 may include a fluid-permeable body 120 or layer positioned within the chamber 104. The fluid-permeable body 120 may cover or extend across at least a portion (e.g., all) of the opening 106. The fluid-permeable body 120 may be configured to draw fluid away from the opening 106 or to draw it in by other means, thereby preventing the fluid from escaping from the chamber 104. The fluid-permeable body 120 may also draw fluid generally into the interior of the chamber 104, as will be described in more detail below. A portion of the fluid-permeable body 120 may define a portion of the outer surface of the fluid collection device 100. In particular, a portion of the fluid-permeable body 120 defining a portion of the outer surface of the fluid collection device 100 may be a portion of the fluid-permeable body 120 exposed by the opening 106, which is defined by a fluid-impermeable barrier 102 that comes into contact with the user. Furthermore, the portion of the fluid permeable device that defines a part of the outer surface of the fluid collection device 100 does not need to be covered with gauze or other wicking material at the opening.

[0019] The fluid-permeable body 120 may be configured to draw up and / or transport fluid from the opening 106 toward the reservoir 122 and / or the inlet 110 of the conduit 108. The fluid-permeable body 120 may contain any material that can draw up fluid. The permeability properties referred to herein may be wicking, capillary action, diffusion, or other similar properties or processes, and are referred herein to as “permeability” and / or “wicking.” Such “wicking” or other physical properties may exclude absorption into the fluid-permeable body 120 and do not involve the absorption of body fluids into the fluid-permeable body 120. In other words, substantially the absorption or solubility of body fluids into the material cannot occur for a period of time after the material has been exposed to and separated from the body fluids. When it is desirable that there is no absorption or solubility, the term “substantially non-absorbent” may allow the nominal amount of body fluid absorption and / or solubility into the fluid permeable body 120 (e.g., absorption) to be 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 1% by weight, or less than about 0.5% by weight of the dry weight of the fluid permeable body 120. In one embodiment, the fluid permeable body 120 may include at least one absorbent or adsorbent material.

[0020] The fluid-permeable body 120 may include a unidirectional fluid-transport fabric. This allows the fluid-permeable body 120 to remove fluid from the area around the female urethra, thereby keeping the urethra dry. Figure 1D is a cross-sectional view of the fluid collection device 100 cut along line 1-1 in Figure 1A. The fluid-permeable body 120 may allow fluid to flow, generally, toward the reservoir 122 (shown in Figure 1D) and / or the inlet 110 of the conduit 108 within the chamber 104. In some embodiments, the fluid-permeable body 120 may include two or more layers of fluid-permeable material. For example, the fluid-permeable body 120 may include an inner layer 120a and an outer layer 120c fixed to the inner layer 120a.

[0021] In some embodiments, the inner layer 120a of the fluid-permeable body 120 may be a porous layer containing a nonwoven fluid-permeable material, the nonwoven fluid-permeable material including, for example, one or more of polyester, nylon, polypropylene, polyethylene, cellulose, and / or combinations thereof. In some embodiments, the inner layer may include foam materials, such as nonwoven fluid-permeable foam materials, synthetic fibers, and / or hydrophobic materials. In some embodiments, the nonwoven material of the inner layer 120a may include vertical nonwoven material or conventional fiber-laminated foam. For example, the inner layer 120a (as vertical or conventional fiber-laminated foam) may include polyester nonwoven foam, polypropylene nonwoven foam, nylon nonwoven foam, polyurethane foam, PVC foam, spacer fabric, and any combination thereof. For example, vertical nonwoven material includes a nonwoven web folded vertically. In one embodiment, the vertical nonwoven material may be hydrophobic, such that the vertical nonwoven material has a contact angle with water of approximately 90° to approximately 120°, approximately 105° to approximately 135°, approximately 120° to approximately 150°, approximately 135° to approximately 165°, or 150° or more.

[0022] Generally, increasing the density of a vertical nonwoven material increases its strength. However, increasing the density of a vertical nonwoven material may decrease its porosity, reducing the amount of bodily fluid that can be temporarily stored in the inner layer 120a and potentially decreasing the flow rate of bodily fluid through the vertical nonwoven material. Therefore, the density of the vertical nonwoven material can be selected based on a balance between the desired strength, porosity, and the flow rate of bodily fluid through the vertical nonwoven material.

[0023] In an embodiment of the inner layer 120a containing a vertical nonwoven fabric material, the inner layer has a surface density of approximately 100 g / m². 2 / cm ~ approx. 250g / m 2 / cm, approx. 100g / m 2 / cm ~ approx. 175g / m 2 / cm, approx. 175g / m 2 / cm ~ approx. 250g / m 2 / cm, approx. 100g / m 2 / cm to approximately 150 g / m 2 / cm, approximately 150 g / m 2 / cm to approximately 200 g / m 2 / cm, approximately 200 g / m 2 / cm to approximately 250 g / m 2 / cm, approximately 100 g / m 2 / cm to approximately 125 g / m 2 / cm, approximately 125 g / m 2 / cm to approximately 150 g / m 2 / cm, approximately 150 g / m 2 / cm to approximately 175 g / m 2 / cm, approximately 175 g / m 2 / cm, approximately 175 g / m 2 / cm to approximately 200 g / m 2 / cm, approximately 200 g / m 2 / cm to approximately 225 g / m 2 / cm, or approximately 225 g / m 2 / cm to approximately 250 g / m 2 / cm may indicate.

[0024] The vertical nonwoven material of the inner layer 120a may contain fibers. The average length, average transverse dimension, and average aspect ratio of the fibers in the inner layer 120a may be selected based on a number of factors. For example, increasing the aspect ratio of the fibers in the inner layer 120a (e.g., increasing the average length) may increase the mechanical bonding of the fibers in the inner layer 120a. For example, increasing the aspect ratio of the fibers in the inner layer 120a promotes entanglement of the fibers in the inner layer 120a, increasing the strength and durability of the vertical nonwoven material. The entanglement of the fibers in the inner layer 120a may also eliminate or minimize other bonding techniques applied to the vertical nonwoven material, such as thermal, chemical bonding, or other mechanical bonding (e.g., further entanglement caused by needle punching or high-pressure water jetting). However, increasing the aspect ratio of the fibers in the inner layer 120a may make it more difficult to disperse the fibers in the inner layer 120a (e.g., difficulty in achieving uniformity of the vertical nonwoven material). Furthermore, increasing the aspect ratio may limit the types of nonwoven webs that can form the vertical nonwoven material. For example, fibers in the inner layer 120a with a large average length (e.g., a large aspect ratio) may not be usable in card webs and must be used in airlaid webs. In one example, decreasing the aspect ratio may reduce the entanglement of the fibers in the inner layer 120a, which may necessitate further bonding of the fibers in the inner layer 120a. Therefore, the average length, average transverse dimension, and average aspect ratio of the fibers 124 may be selected based on the desired strength, the mechanical bonding between the fibers in the inner layer 120a, the amount of processing required for the vertical nonwoven material (e.g., whether further processing to enhance bonding via heat is desirable), the type of nonwoven web containing the fibers, and the uniformity of the fibers.

[0025] Generally, the average person urinates at a rate of approximately 6 ml / s to 50 ml / s, for example, approximately 10 ml / s to 25 ml / s. A person's urination rate can vary depending on their physique and age. The vertical nonwoven material of the inner layer 120a may be selected to capture and transport bodily fluids at a rate corresponding to the rate at which an individual expels bodily fluids in order to prevent leakage. For example, the vertical nonwoven material may transport bodily fluids at rates exceeding approximately 6 ml / s, exceeding approximately 10 ml / s, exceeding approximately 20 ml / s, exceeding approximately 30 ml / s, exceeding approximately 40 ml / s, exceeding approximately 50 ml / s, or approximately 6 ml / s to approximately 10 ml / s, approximately 8 ml / s to approximately 12 ml / s, approximately 10 ml / s to approximately 15 ml / s, approximately 12.5 ml / s to approximately 17.5 ml / s, approximately 15 ml / s to approximately 20 ml / s, and approximately 1 It can be selected to capture and transport at speeds of approximately 7.5 ml / s to 22.5 ml / s, 20 ml / s to 25 ml / s, 22.5 ml / s to 27.5 ml / s, 25 ml / s to 30 ml / s, 27.5 ml / s to 35 ml / s, 30 ml / s to 40 ml / s, 35 ml / s to 45 ml / s, or 40 ml / s to 50 ml / s.

[0026] The rate at which a vertical nonwoven material captures and transports bodily fluids can depend on many factors. For example, the rate at which a vertical nonwoven material captures and transports bodily fluids may depend inversely to the density and basis weight of the vertical nonwoven material, as the density and / or basis weight of the vertical nonwoven material increase, the rate at which the vertical nonwoven material captures and transports bodily fluids may decrease, or vice versa. For example, the rate at which a vertical nonwoven material captures and transports bodily fluids may depend on the material forming the fibers of the inner layer 120a (e.g., the hydrophobicity of the material). For example, the rate at which a vertical nonwoven material captures and transports bodily fluids may increase with increasing thickness T, because increasing thickness T increases the cross-sectional area over which the bodily fluids can flow. For example, the rate at which a vertical nonwoven material captures and transports bodily fluids may depend on the type of nonwoven web (e.g., card web, needle punch web, etc.), because each type of nonwoven web may exhibit different rates at which the vertical nonwoven material captures and transports bodily fluids.

[0027] In some embodiments, the vertical nonwoven material is formed from a folded nonwoven web. The folded nonwoven web may include a plurality of folded portions and a plurality of intermediate portions extending between the folded portions. The folded nonwoven web may include an outer surface adjacent to a fluid-impermeable layer and an inner surface on the opposite side (e.g., defining a bore for receiving the conduit 108). The folded portions may extend substantially parallel to the outer and inner surfaces of the folded nonwoven web. The intermediate portions may extend between the outer and inner surfaces of the folded nonwoven web. In one embodiment, the folded nonwoven web may be placed in a chamber, and as a result, the folded portions extend substantially parallel to the longitudinal axis (e.g., center) of the fluid collection assembly (e.g., substantially parallel to the longitudinal axis of the porous material) and / or circumferentially if the porous material exhibits a substantially cylindrical shape. The folded nonwoven web may be positioned within the chamber such that the middle portion extends substantially parallel to the longitudinal axis of the fluid collection assembly (for example, substantially parallel to the longitudinal axis of the porous material), and / or extends radially if the porous material has a substantially cylindrical shape.

[0028] As described above, in some embodiments, the inner layer 120a comprises a vertical nonwoven material containing a plurality of fibers. In one embodiment, the nonwoven web forming the vertical nonwoven material may contain a plurality of substantially oriented fibers. The substantially oriented fibers can improve the vertical nonwoven material's ability to trap and transport bodily fluids. The substantially oriented fibers can also improve the mechanical properties of the vertical nonwoven material. As used herein, fibers are “substantially aligned” when a certain percentage of the fibers are substantially parallel to one another. A certain percentage of fibers means at least about 70%, more preferably at least about 80%, more preferably 90%, and even more preferably at least about 95% of the fibers. Fibers are substantially parallel to one another when a certain percentage of the fibers are parallel to one another at an angle of ±30°, more preferably ±20°, more preferably ±10°, or even more preferably ±5°.

[0029] The nonwoven fabric material 118 of the inner layer 120a may be arranged in the chamber 104 such that the fibers in the folded portion are generally oriented circumferentially and the fibers in the intermediate portion are generally oriented radially. Although not bound by theory, the circumferential orientation of the fibers in the folded portion may cause the bodily fluid received by the vertical nonwoven fabric material to be preferentially dispersed circumferentially first, and the radial orientation of the fibers in the intermediate portion may cause the bodily fluid to be preferentially dispersed radially first within the porous material. Dispersing the bodily fluid first circumferentially and then radially allows the bodily fluid to be quickly dispersed throughout the large volume of the vertical nonwoven fabric material, thereby enabling the vertical nonwoven fabric material to quickly capture and transport the bodily fluid. It should be noted that the fibers do not obstruct the flow of bodily fluid in a direction substantially parallel to the longitudinal axis, especially after the fibers have been wetted. Furthermore, dispersing the bodily fluid throughout the vertical nonwoven fabric material increases the surface area of ​​bodily fluid that may remain in the vertical nonwoven fabric material after the bodily fluid has been removed from the porous material. Due to the large surface area, the evaporation of residual bodily fluids is promoted by the airflow passing through the porous material. In one embodiment, the fibers may be randomly oriented or oriented in a manner different from that shown above.

[0030] In one embodiment, a gap extending substantially parallel to the longitudinal axis may be formed by folding the nonwoven web. The gap may facilitate fluid flow in a direction substantially parallel to the longitudinal axis. However, the nonwoven web may be folded or compressed by the fluid-impermeable barrier 102 to minimize the size of the gap and prevent the accumulation of bodily fluids in the chamber 104. For example, the nonwoven web may be folded or compressed by the fluid-impermeable barrier 102 so that the gap is less than about 1 mm, less than about 0.75 mm, less than about 0.5 mm, or less than about 0.25 mm in dimensions measured perpendicular to the longitudinal axis.

[0031] As described above, a vertical nonwoven material can be formed from at least one folded nonwoven web. A vertical nonwoven material can be formed from any suitable nonwoven web. In one embodiment, the nonwoven web includes at least one card web. The card web includes a plurality of fibers that may be oriented in substantially the same direction. The substantially same orientation of the fibers in the card web makes the card web anisotropic. For example, the strength of the card web is maximum when the force applied to it is substantially parallel to the fibers, but the strength of the card web decreases as the force applied to it becomes more oblique or perpendicular to the orientation of the fibers. Therefore, the card web may need to be placed in the chamber 104 to mitigate forces applied to the card web that are not substantially parallel to the orientation of the fibers, or further bonding between the fibers (e.g., thermal or chemical action) may be required to prevent undesirable wear of the card web. The initial flow of bodily fluid through the card web may vary depending on whether the bodily fluid flows parallel, oblique, or perpendicular to the orientation of the fibers. Therefore, by selecting a nonwoven web to include a card web, it becomes possible to select the strength and flow properties of the porous material based on the orientation of the fibers. Although the fibers are generally oriented, the orientation of each fiber may vary slightly, which results in sufficiently high porosity of the card web so that the card web exhibits any of the densities, thicknesses, basis weights, and flow rates disclosed herein.

[0032] In one embodiment, the nonwoven web may include at least one needle-punched web. The needle-punched web may be formed from a sheet containing multiple fibers. The sheet may contain multiple randomly oriented fibers (e.g., fibers are substantially parallel to the plane or randomly oriented to the plane) or substantially oriented fibers (e.g., a card web) because the orientation of the fibers can better facilitate the flow of bodily fluids through it. Multiple needles (e.g., multiple barbed needles) are inserted into the sheet in a direction substantially parallel to the thickness of the sheet, thereby entangling and intertwining some of the fibers. For example, the insertion of needles into the sheet causes some of the fibers to be reoriented and move from the surface of the sheet to the interior of the sheet to form columns. The entanglement of fibers caused by the insertion of needles can sufficiently entangle the fibers and bind them together without requiring additional bonding. Due to the entanglement of fibers, the needle-punched web may exhibit more isotropic properties compared to a card web, thereby potentially eliminating the need for specific orientation within the chamber 104 or additional bonding of fibers. The needle-punched web may exhibit good flow properties. For example, needles extending into a sheet can form divots, which facilitate the vertical flow of bodily fluids through the needle-punched web.

[0033] In one embodiment, the nonwoven web may comprise at least one airlaid web. The airlaid web may exhibit a plurality of randomly oriented fibers. The plurality of random fibers may be long enough that they do not need to intertwine and bond together, or the fibers may be bonded together. Due to the random orientation of the fibers, the airlaid web tends to be isotropic and exhibit high porosity. Similarly, due to the random orientation of the fibers, the airlaid web may exhibit high loft. The airlaid web may be formed from fibers that cannot be carded (e.g., short fibers).

[0034] In one embodiment, a nonwoven web may include at least one spunlace web. The spunlace web is formed by supplying a sheet or card web containing randomly oriented fibers. A high-pressure water jet, substantially parallel to the thickness of the sheet, is directed onto the sheet. Similar to a needle-punched web, the high-pressure water jet moves some of the fibers from the outside to the inside of the sheet, forming columns. Thus, a spunlace web can function similarly to a needle-punched web, i.e., a spunlace web may be more isotropic than a card web and contain divots. However, a spunlace web may exhibit at least one of a lower density, a greater thickness, or a lower basis weight than a needle-punched web. Therefore, a spunlace web may be more delicate (e.g., less durable or softer) than a needle-punched web. A more delicate spunlace web may be more comfortable in contact with the patient's skin than a needle-punched web.

[0035] For example, the vertical nonwoven material of the inner layer 120a may include a wet-laid web, even though the wet-laid web may exhibit lower durability compared to other nonwoven webs disclosed herein. For example, the vertical nonwoven material may include a spunbond or melt-blown nonwoven web, even though such a nonwoven web may have too low porosity for certain applications.

[0036] In one embodiment, the nonwoven web does not include horizontal or cross-wrap nonwoven material. The horizontal or cross-wrap nonwoven material includes a folded nonwoven web that differs from the vertical nonwoven material described above. Due to the different folding structures of the horizontal and cross-wrap nonwoven materials, it has been found that the horizontal and cross-wrap nonwoven materials are significantly slower at capturing and / or transporting bodily fluids than the corresponding vertical nonwoven material (e.g., the same material, hydrophilicity, basis weight, density, etc.). In one embodiment, the nonwoven web includes horizontal or cross-wrap nonwoven material.

[0037] A folded nonwoven web can be formed from a sheet. When the sheet is placed on a horizontal surface, the folded portion may extend parallel to the horizontal plane, while the intermediate portion may extend perpendicular to the horizontal plane. Next, the folded nonwoven web can be rolled up to form a cylindrical folded nonwoven web.

[0038] In one embodiment, the inner layer 120a comprises only or substantially only vertical nonwoven material. In such an embodiment, the vertical nonwoven material may define a bore configured to receive a conduit 108, and the vertical nonwoven material extends from the bore to a fluid-impermeable barrier 102. When the inner layer 120a comprises only or substantially only vertical nonwoven material, the entire inner layer 120a can rapidly capture and transport bodily fluids. However, it should be noted that the inner layer 120a may include at least one additional material, even if such additional material may reduce at least one of the inner layer 120a's ability to capture and / or transport bodily fluids. Other embodiments and aspects of nonwoven materials and their configurations are disclosed in PCT Patent Application No. PCT / US22 / 42719, filed on 7 September 2022, which is incorporated herein by reference in its entirety.

[0039] The thickness of the inner layer 120a (measured from the bore to the adhesive 120b) may be approximately 2mm to 25mm, 2mm to 10mm, 7mm to 15mm, 12mm to 20mm, 17mm to 25mm, 2mm to 7mm, 5mm to 10mm, 7mm to 12mm, 10mm to 15mm, 12mm to 17mm, 15mm to 20mm, 17mm to 22mm, or 20mm to 25mm.

[0040] The fluid-permeable body 120 also includes an outer layer 120c fixed to the inner layer 120a. The outer layer 120c may include one or more of bamboo, cotton, and / or nonwoven hydrophilic materials. In particular, the outer layer 120c may include one or more of bamboo, cotton, nonwoven polypropylene hydrophilic material, nonwoven polyethylene hydrophilic material, nonwoven polyester hydrophilic material, and / or a combination thereof (e.g., bamboo / cotton blend).

[0041] The outer layer 120c can be formed as a sheet or liner material in many embodiments. For example, the thickness of the outer layer 120c (measured from the adhesive 120b to the outer surface of the fluid permeable body 120) may be about 0.1 mm to about 0.4 mm, 0.125 mm to about 0.4 mm, about 0.1 mm to about 0.25 mm, about 0.25 mm to about 0.4 mm, about 0.1 mm to about 0.2 mm, about 0.2 mm to about 0.3 mm, about 0.3 mm to about 0.4 mm, about 0.1 mm to about 0.15 mm, about 0.15 mm to about 0.2 mm, about 0.2 mm to about 0.25 mm, about 0.25 mm to about 0.3 mm, about 0.3 mm to about 0.35 mm, or about 0.35 mm to about 0.4 mm.

[0042] The outer layer 120c may exhibit a surface density of approximately 10gsm to 100gsm, 10gsm to 55gsm, 55gsm to 100gsm, 10gsm to 20gsm, 20gsm to 30gsm, 30gsm to 40gsm, 40gsm to 50gsm, 50gsm to 60gsm, 60gsm to 70gsm, 70gsm to 80gsm, 80gsm to 90gsm, or 90gsm to 100gsm.

[0043] The inner layer 120a can be fixed to the outer layer 120c using an adhesive at 120c. The adhesive may include one or more hot-melt adhesives, such as polyurethane, acrylic, and / or polyester nonwoven web adhesives. In some embodiments, the particle size of the hot-melt adhesive may be in the range of about 1.0 μm to about 10 μm.

[0044] In many embodiments, the fluid-permeable body 120 is formed in a substantially cylindrical shape, resulting in the inner layer 120a and the outer layer 120c being concentric with each other. The outer layer 120c can cover or extend across at least a portion (e.g., all) of the opening 106 when the fluid-permeable body 120 is placed inside the chamber 104 of the fluid-impermeable barrier 102.

[0045] The fluid collection device 100 also includes a conduit 108 that is at least partially located within the chamber 104. The conduit 108 (e.g., a tube) has an inlet 110 at a second end region 127 of the fluid-impermeable barrier 102 and an outlet 112 at a first end region 125 of the fluid-impermeable barrier 102 located downstream of the inlet 110. The conduit 108 provides fluid communication between the internal region of the chamber 104 and a fluid storage container (not shown) or a portable vacuum source (not shown). For example, the conduit 108 can directly or indirectly fluidically couple the internal region of the chamber 104 and / or the reservoir 122 to the fluid storage container or portable vacuum source.

[0046] In the illustrated embodiment, the fluid permeable body 120 defines a bore 202 that extends through the fluid permeable body 120 from a first body end 121 of the fluid permeable body 120 to a second body end 123 of the fluid permeable body 120 distal to the first body end 121. In other embodiments, the bore 202 extends only partially into the fluid permeable body from the first body end 121 of the fluid permeable body 120.

[0047] In the illustrated embodiment, the conduit 108 is at least partially located within the chamber 104 and interfaces with at least a portion of the bore 202 of the fluid-permeable body 120. For example, the conduit 108 may extend from a first end region 125 (e.g., near the outlet 112) into the fluid-impermeable barrier 102 and through the bore 202 to a second end region 127 (e.g., opposite the first end region 125) to a point close to the reservoir 122, so that the inlet 110 is in fluid communication with the reservoir 122. For example, in the illustrated embodiment, the inlet 110 extends beyond the second body end 123 and is located within the reservoir 122. However, in other embodiments, the inlet 110 may be located flush with the second body end 123 of the fluid-permeable body 120 that partially defines the reservoir 122, or behind the second body end 123. In some embodiments, the second body end 123 extends to the second end region 127, substantially filling the chamber 104 and covering the inlet 110. The fluid collected in the fluid collector 100 can be removed from the interior region of the chamber 104 via the conduit 108. The conduit 108 may include a flexible material such as a plastic tube (e.g., a medical tube). Such plastic tubes may include thermoplastic elastomers, polyvinyl chloride, ethylene vinyl acetate, polytetrafluoroethylene, and the like. In some embodiments, the conduit 108 may include silicone or latex.

[0048] In some embodiments, the conduit 108 is fixed to and / or embedded in the conduit 108, according to one embodiment, with a shape memory material 109, such as a shape memory polymer or metal (e.g., shape memory metal), attached to and / or embedded in the conduit 108. The shape memory material 109 may extend longitudinally along the conduit 108. In many embodiments, the shape memory material 109 is configured to bend and / or mold the conduit 108 and the fluid collector 100 to conform to the unique shape of the user's body.

[0049] A suitable shape memory material is configured to take on an intermediate or permanent shape in response to a stimulus. Stimuli may include external physical forces (e.g., bending forces), heat, electrical bias, or magnetic fields. While the term “shape memory” is used herein to describe some “shape memory materials,” it should be understood that in some examples, materials modified by the term “shape memory” may not necessarily return to a pre-selected shape upon application of a stimulus, as understood in the conventional definition of “shape memory material.” Rather, at least some of the shape memory materials disclosed herein may simply retain a selected shape, regardless of subsequent stimuli, when bent, set, or hardened into a particular shape and / or cooled into a particular shape. Shape memory materials may be returned to their original shape or changed into a new shape upon application of a stimulus. For example, a metal wire bent into a first shape may be used as a shape memory material, and the metal wire may then be changed to a second shape by physical force applied to it or by heating.

[0050] In one embodiment, the shape memory material may include a metal, such as an elemental metal, an alloy, or a shape memory alloy. Suitable shape memory metals may include standard steel, stainless steel, carbon alloy steel, heat-treated steel, aluminum, silver, copper, iron, nickel, zinc, tin, beryllium, etc. Suitable shape memory alloys may include stainless steel, galvanized steel, aluminum alloys, nickel-titanium alloys such as Nitinol, Ni-Ti-Cu, Ni-Ti, Co, copper-based alloys such as Cu-Zn-Al, Cu-Al-Ni, Cu-Al-Sn, Co-Cr-Ni-Mo alloys such as Elgiloy®, or other alloys having shape memory properties. In certain embodiments, the shape memory material includes 18-20 gauge steel wire. As described above, the shape memory metal or alloy may simply be a metal or alloy that can be molded into a selected configuration. In some examples, the shape memory metal or alloy may return to its original shape when an external stimulus is applied. In some cases, the outer surface of shape memory metals can be coated with a polymer, anodized, passivated, or otherwise treated to prevent corrosion.

[0051] Shape memory polymers ("SMPs") are polyurethane-based SMPs that may include, for example, copolymers (e.g., copolyesters, polyurethanes, polyether esters, etc.) containing one or more blocks of poly(ε-caprolactone), polyethylene terephthalate (PET), polyethylene oxide (PEO), polyethylene glycol (PEG), polystyrene, polymethyl methacrylate (PMMA), polybutyl methacrylate (PBMA), poly(N,N-butadiene), poly(N-methyl-N-oxazoline), polytetrahydrofuran, or poly(butylene terephthalate); thermoplastic polymers (e.g., polyetheretherketone (PEEK), nylon, acetal, polytetrafluoroethylene (PTFE), polysulfone, polynorvonene, other deformable polymers, or other shape memory polymers.

[0052] The fluid-impermeable barrier 102 can store fluid in an internal reservoir 122. The reservoir 122 may be an unoccupied portion of the chamber 104 where no other material is present. In some embodiments, the reservoir 122 is at least partially defined by the fluid-permeable body 120 and the fluid-impermeable barrier 102. For example, in one embodiment, the reservoir 122 may be located in the portion of the chamber 104 closest to the inlet 110 (e.g., a second end region). Thus, in the embodiment of Figure 1D, the reservoir 122 is defined by the second body end 123 of the fluid-permeable body 120 and the second end region 127 of the fluid-impermeable barrier 102. However, the reservoir 122 may be located at a different position within the chamber 104. For example, the reservoir 122 may be located at the end of the chamber 104 closest to the outlet 112. In these embodiments and other embodiments, the conduit 108 may extend through the first end region 125 of the fluid-impermeable barrier 102 to the reservoir 122, but not through the fluid-permeable body 120. Therefore, in these embodiments and other embodiments, the fluid-permeable body 120 may not have a bore. In another embodiment, the fluid collector 100 may include a plurality of reservoirs, for example, a first reservoir located in the portion of the chamber 104 closest to the inlet 110 (e.g., a second end region), and a second reservoir located in the portion of the chamber 104 closest to the outlet 112 (e.g., a first end region). In another example, the fluid-permeable body 120 is separated from at least a portion of the conduit 108, and the reservoir 122 may be the space between the fluid-permeable body 120 and the conduit 108. In some embodiments, the fluid-permeable body 120 fills or occupies substantially the entire chamber 104, which includes filling or occupying substantially the entire reservoir 122 between the inlet 110 and the second end region 127 of the fluid-impermeable barrier 102.Reservoirs, fluid-impermeable barriers, fluid-permeable membranes, fluid-permeable bodies, chambers, and other embodiments of their shapes and configurations 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, and U.S. Patent Application No. 15 / 611,587 filed June 1, 2017, the disclosures of each application being incorporated herein by reference in their entirety.

[0053] The fluid-impermeable barrier 102 and the fluid-permeable body 120 may be configured such that the conduit 108 is at least partially located within the chamber 104. For example, the fluid-permeable body 120 may be configured to form a space for accommodating the conduit 108, such as a bore 202. In another example, the fluid-impermeable barrier 102 may define an aperture 124 sized to accommodate the conduit 108 (e.g., at least one tube). At least one conduit 108 may be located within the chamber 104 via the aperture 124. The aperture 124 may be configured to form at least a substantially fluid-tight seal to the conduit 108 or at least one tube, thereby substantially preventing fluid from leaking out of the chamber 104.

[0054] In some embodiments, as shown in Figure 1D, the conduit 108 may penetrate the fluid-permeable body 120 and extend at least partially into the reservoir 122. In some embodiments, the conduit 108 may not extend into the reservoir 122 (or the conduit 108 may not be present in the reservoir 122) by penetrating the fluid-permeable body 120 and terminating at or before the second body end 123 of the fluid-permeable body 120. For example, the end of the conduit 108 (e.g., the inlet 110) may be substantially flush with or coplanar with the second body end 123 of the fluid-permeable body 120. In other embodiments, the end of the conduit 108 may be recessed from the second body end 123 of the fluid-permeable body 120. The end of the conduit 108 (e.g., the inlet 110) may also be selectively movable between a state in which it partially extends into the reservoir 122 (as shown in Figure 1D) and a state in which it is recessed from or flush with the second body end 123 of the fluid-permeable body.

[0055] When fixed to the fluid collection device 100, the conduit 108 is configured to be in fluid communication with one or more fluid storage containers and portable vacuum sources, and to extend at least partially between them. For example, the conduit 108 may be configured to be fluidly coupled with one or more fluid storage containers and portable vacuum sources, and to extend at least partially between them. In one embodiment, the conduit 108 is configured to be directly connected to a portable vacuum source. In such an example, the conduit 108 may extend at least 1 foot, at least 2 feet, at least 3 feet, or at least 6 feet from the fluid-impermeable barrier 102. In another example, the conduit 108 is configured to be indirectly connected to at least one of the fluid storage containers or portable vacuum sources. In some examples, the conduit may be made of frosted glass or opaque (e.g., black) to reduce the visibility of the fluid inside. In some embodiments, the conduit is secured to the wearer's skin by a catheter fixation device, such as the STATLOCK® catheter fixation device available from CRBard, Inc., which includes, but is not limited to, those disclosed in U.S. Patents 6,117,163, 6,123,398, and 8,211,063, all of which are incorporated herein by reference.

[0056] The inlet 110 and outlet 112 are configured to provide fluid communication (e.g., directly or indirectly) between a portable vacuum source (not shown) and a chamber 104 (such as a reservoir 122). For example, the inlet 110 and outlet 112 of the conduit 108 may be configured to fluidly couple the portable vacuum source to the reservoir 122 directly or indirectly. In one embodiment, the inlet 110 and / or outlet 112 may form a male connector. In another example, the inlet 110 and / or outlet 112 may form a female connector. In one embodiment, the inlet 110 and / or outlet 112 may include ribs configured to facilitate secure coupling. In one embodiment, the inlet 110 and / or outlet 112 may form a tapered shape. In one embodiment, the inlet 110 and / or outlet 112 may include a rigid material or a flexible material.

[0057] By positioning the inlet 110 at or near a gravimetrically low point in the chamber 104, the conduit can receive more fluid than if the inlet 110 were located elsewhere, reducing the possibility of stagnation (for example, fluid stagnation can lead to microbial growth and foul odors). For example, fluid within the fluid-permeable body 120 can flow in any direction due to capillary forces. However, the fluid may show a preference for flowing in the direction of gravity, especially when at least a portion of the fluid-permeable body 120 is saturated with fluid.

[0058] When a portable vacuum source applies vacuum / suction to the conduit 108, fluid(s) within the chamber 104 (e.g., in the first end region 125, the second end region 127, or in the reservoir 122 located at any other intermediate position within the chamber 104) may be drawn into the inlet 110 and discharged from the fluid collection device 100 via the conduit 108.

[0059] In one embodiment, the conduit 108 is configured to be insertable into at least the chamber 104. In such an embodiment, the conduit 108 may include one or more markers 131 (shown in Figure 1A) on its exterior, which are configured to facilitate the insertion of the conduit 108 into the chamber 104. For example, the conduit 108 may include one or more markings configured to prevent over-insertion or under-insertion of the conduit 108, for example, when the conduit 108 defines an inlet 110 configured to be located in or adjacent to the reservoir 122. In another embodiment, the conduit 108 may include one or more markings configured to facilitate the correct rotation of the conduit 108 into the chamber 104. In one embodiment, the one or more markings may include lines, dots, stickers, or any other suitable markings. In the example, the conduit 108 may extend from a first end region (e.g., near the outlet 112) into the fluid-impermeable barrier 102 to a second end region (e.g., opposite the first end region) to a point near the reservoir 122, so that the inlet 110 is in fluid communication with the reservoir 122. In some embodiments (not shown), the conduit 108 may enter a second end region, and the inlet 110 may be located in the second end region (e.g., inside the reservoir 122). The fluid collected in the fluid collection device 100 can be removed from the interior region of the chamber 104 via the conduit 108. The conduit 108 may include a flexible material such as a plastic tube (e.g., a medical tube), as disclosed herein. In some examples, the conduit 108 may include one or more resilient portions, which is due to having one or more diameters or wall thicknesses that allow the conduit to be flexible.

[0060] In one embodiment, one or more components of the fluid collection device 100 may include antimicrobial materials, such as antibacterial materials, in locations where the fluid collection device may come into contact with the wearer or the wearer's bodily fluids. The antimicrobial materials may include antimicrobial coatings, such as nitrofurazone coatings or silver coatings. The antimicrobial materials can prevent microbial growth, such as microbial growth caused by fluid stagnation or retention. In one embodiment, one or more components of the fluid collection device 100 (e.g., an impermeable barrier 102, a conduit 108, etc.) may include odor blocking or absorbing materials, such as cyclodextrin-containing materials or thermoplastic elastomer (TPE) polymers.

[0061] In any embodiment disclosed herein, the conduit 108 may include, or be operably coupled to, a flow meter (not shown) for measuring the flow of fluid therein, one or more fixing devices (e.g., StatLock fixing devices, not shown) or fittings for fixing the conduit 108 to one or more components of the system or apparatus disclosed herein (e.g., a portable vacuum source or a fluid storage container), or one or more valves for controlling the flow of fluid in the system and apparatus herein. In one embodiment, at least one of the portions of the conduit 108 of the fluid collection device or system herein may be formed from an opaque material at least partially to obscure the fluid present therein. For example, a first section of the conduit 108 disclosed herein may be formed from an opaque or translucent material, while a second section of the conduit 108 may be formed from a transparent or translucent material. In some examples, the first section may include a transparent or translucent material. Unlike opaque or nearly opaque materials, translucent materials allow users of the apparatus and systems described herein to visually identify the fluid or problem obstructing the fluid flow in the conduit 108.

[0062] In any of the examples, systems, or apparatus disclosed herein, the fluid collection system may include a humidity sensor (not shown) located inside the chamber of the fluid collection device. In such examples, the humidity sensor may be operably coupled to a controller or directly to a portable vacuum source and may provide an electrical signal indicating whether or not moisture is detected in one or more parts of the chamber. The humidity sensor(s) may provide an indication that moisture is present, in which case the controller or portable vacuum device may instruct to begin suction into the chamber and remove the fluid from there. Suitable humidity sensors may include capacitance sensors, volume sensors, potential sensors, resistance sensors, frequency-domain reflectance sensors, time-domain reflectance sensors, or any other suitable humidity sensors. In practice, the humidity sensor may detect the humidity inside the chamber and provide a signal to the controller or portable vacuum source to operate the portable suction device.

[0063] Figure 1E is a block diagram of a fluid collection system 10 according to one embodiment. The system 10 may include a fluid collection device 12, a fluid storage container 14, and a portable vacuum source 16. The fluid collection device 12 may include any of the fluid collection devices disclosed herein, such as fluid collection device 100. The fluid collection device 12, the fluid storage container 14, and the portable vacuum source 16 may be fluidically coupled to one or more conduits 17. The conduits 17 may include any of the conduits disclosed herein, such as conduit 108. The fluid collection device 12 may be operably coupled to one or more fluid storage containers 14 or portable vacuum sources via the conduits 17. Fluid collected in the fluid collection device 12 (e.g., urine, or other bodily fluids) may be removed from the fluid collection device 12 via the conduits 17, which protrude into the internal region of the fluid collection device 12. For example, the first open end of the conduit 17 may extend into the fluid collection device 12, to its reservoir. The second open end of the conduit 17 may extend into the fluid storage container 14 or the portable vacuum source 16. Suction force may be introduced into the internal region of the fluid collection device 12 via the first open end of the conduit 17 in response to a suction force (e.g., vacuum) applied to the second end of the conduit 17. Suction force may be applied directly or indirectly to the second open end of the conduit 17 by the portable vacuum source 16.

[0064] The suction force may be applied indirectly through the fluid storage container 14. For example, the second open end of the conduit 17 may be located inside the fluid storage container 14, and an additional conduit 17 may extend from the fluid storage container 14 to the portable vacuum source 16. Thus, the portable vacuum source 16 can apply suction to the fluid collector 12 through the fluid storage container 14. The suction force may also be applied directly through the fluid storage container 14. For example, the second open end of the conduit 17 may be located inside the portable vacuum source 16. An additional conduit 17 may extend from the portable vacuum source 16 to an outside point of the fluid collector 12, such as the fluid storage container 14. In such an example, the portable vacuum source 16 may be located between the fluid collector 12 and the fluid storage container 14.

[0065] The fluid collection device 12 may be shaped and sized to be positioned adjacent to or near the female urethra. The fluid collection member of the fluid collection device 12 may include a fluid-impermeable barrier that at least partially defines the chamber of the fluid collection device 12 (e.g., the internal region of the fluid collection device). As described in more detail above, the fluid collection device 12 may include a fluid-impermeable barrier that is more flexible and thinner than that of conventional fluid collection devices. The fluid-impermeable barrier also defines an opening that penetrates from the external environment. The opening may be positioned on the fluid collection member to be aligned adjacent to or near the female urethra. The fluid collection member of the fluid collection device 12 may include a fluid-permeable body disposed within the fluid-impermeable barrier. The fluid-permeable body may include a fluid-permeable membrane and a fluid-permeable support disposed within the fluid-permeable membrane. The conduit 17 can extend into the fluid collection device 12, passing through one or more fluid-impermeable barriers, fluid-permeable membranes, or fluid-permeable supports at its first end region, to a second end region of the fluid collection member of the fluid collection device 12. An exemplary fluid collection device used in the systems and methods of this specification is described in more detail below.

[0066] In some embodiments, the fluid storage container 14 may include a bag (e.g., a drainage bag), a bottle or cup (e.g., a collection jar), or other sealed container for storing bodily fluids such as urine. In some examples, a conduit 17 may extend from the fluid collection device 12 and be attached to the fluid storage container 14 at a first point therein. An additional conduit 17 may be attached to the fluid storage container 14 at a second point and may extend to a portable vacuum source 16. For example, the fluid storage container 14 may include a container fluidically coupled to a first conduit section, the first conduit section also fluidically coupled to a fluid collection member of the fluid collection device 12. The container may be fluidically coupled to a second section of the conduit 17, the second section also fluidly coupled to a portable vacuum source. In such an example, the portable vacuum source 16 can supply vacuum / suction to the fluid collection member via the container, thereby providing suction force within the chamber of the fluid collection member. Therefore, a vacuum (such as suction) can be drawn in through the fluid storage container 14 and then through the fluid collection device 12. Once the fluid is discharged from the chamber, it can move through the first section of the conduit to the fluid storage container, where it can be retained. Fluids such as urine can be discharged from the fluid collection device 12 using a portable vacuum source 16.

[0067] In some embodiments, the portable vacuum source 16 can be located inside or on the fluid collector 12. In such examples, a conduit 17 may extend from the fluid collector and be attached to the portable vacuum source 16 at a first point therein. An additional conduit 17 may be attached to the portable vacuum source 16 at a second point therein, extending from the fluid collector 12 and attached to the fluid storage container 14. Thus, a vacuum (e.g., suction) can be drawn through the fluid collector 12 via the fluid storage container 14.

[0068] The portable vacuum source 16 may include one or more of the following: a manual vacuum pump, an electric vacuum pump, a diaphragm pump, a centrifugal pump, a positive displacement pump, a magnetically driven pump, a peristaltic pump, or any pump configured to generate a vacuum. The portable vacuum source 16 may supply vacuum or suction to remove fluid from the fluid collection member of the fluid collection device 12. In some examples, the portable vacuum source 16 may be powered by one or more of the following: one or more power cords (e.g., connected to a power socket), one or more batteries, or a manual power source (e.g., a manual vacuum pump). In some examples, the portable vacuum source 16 may be sized and shaped to fit outside, on top of, or inside the fluid collection device 12. For example, the portable vacuum source 16 may include one or more small pumps or one or more micropumps. The portable vacuum source 16 disclosed herein may include one or more of the following: a switch, a button, a plug, a remote control, or any other device suitable for operating the portable vacuum source 16. It should be understood that the portable vacuum source 16 disclosed herein can provide a portable means for supplying suction or vacuum, thereby enabling the use of the apparatus and systems herein outside of hospital or care facility environments where vacuum lines are piped into the patient's room or where a large vacuum source (e.g., larger or heavier than the patient can easily carry) is installed. For example, the portable vacuum source may be small and lightweight enough for a user (e.g., the patient) or caregiver (e.g., a nurse) to carry while the user is on the move.

[0069] Moving forward in the drawings, Figure 2A is a side view of the fluid permeable body 120 of the fluid collector 100 wrapped around a mandrel 210, and Figure 2B is a side view of a metal member 250 configured to be fixed to the mandrel 210 of Figure 2A, according to one embodiment. The mandrel 210 and the metal member 250 may be used to manufacture the fluid collector 100 and / or the fluid permeable body 120, as will be described in more detail below. The mandrel 210 may include a rod or cylinder having any of the various mandrel configurations and materials. In some embodiments, the mandrel 210 includes outer diameters of about 0.5 cm to about 2 cm, about 0.5 cm to about 1.5 cm, about 0.5 cm to about 1 cm, about 0.75 cm to about 1.25 cm, about 1 cm to about 1.5 cm, about 0.5 cm, about 0.75 cm, about 1 cm, about 1.25 cm, or about 1.5 cm.

[0070] The metal member 250 may include a body of metal cord(s) or metal wire and an electric wire 260 electrically connected to the metal member 250. In some embodiments, the metal member 250 includes a proximal end region 252, an intermediate region 254, and a distal end region 256. The proximal end region 252 and / or the distal end region 256 may be angled (e.g., perpendicular) with respect to the intermediate region 254. The proximal end region 252 and the distal end region 256 may be spaced apart from each other by a length substantially equal to the longitudinal length of the fluid permeable body 120 when wrapped around the mandrel 210. The metal member 250 may be configured to be detachably fixed to the mandrel 210. For example, one or more (e.g., both) of the proximal end region 252 and / or the distal end region 256 may be configured to be fixed to the mandrel 210. When fixed to the mandrel, at least one (e.g., all) of the proximal end region 252, distal end region 256, and / or intermediate region 254 may contact the opposite edge or end of the fluid permeable body 120 wrapped around the mandrel 210. When activated, the metal member 250 may be configured so that at least one (e.g., all) of the proximal end region 252, distal end region 256, and / or intermediate region 254 thermally seal or fix together the opposite edge or end of the fluid permeable body 120. Thus, the metal member 250 may be configured to heat to a temperature sufficient to thermally seal the edge of at least the outer layer 120c of the fluid permeable body 120.

[0071] Figure 3 is a flow diagram of a method 300 for manufacturing a fluid-permeable body for a fluid collection device according to one embodiment. Method 300 can form any embodiment of the fluid-permeable body 120 described above. In one embodiment, method 300 includes a step 302 to form a fluid-permeable body by fixing a first layer to a second layer. In some embodiments, method 300 may include a step 304 to wrap the fluid-permeable body around a mandrel, so that two opposing edges of the fluid-permeable body are adjacent longitudinally along the mandrel, and the fluid-permeable body forms a substantially cylindrical shape with the first layer as the inner layer and the second layer as the outer layer. In some embodiments, Method 300 may also include a step 306 for fixing a metal member to a mandrel, such that the distal end region of the metal member is fixed to the mandrel close to the distal end of the fluid permeable body, the proximal end region of the metal member is close to the proximal end of the fluid permeable body, and the intermediate region of the metal member is close to two opposing edges of the fluid permeable body. In some embodiments, Method 300 may also include a step 308 for thermally sealing at least a second layer of the fluid permeable body at two opposing edges of the fluid permeable body. In some embodiments, Method 300 may include a step 310 for removing the metal member from the mandrel and a step 312 for removing the mandrel from the fluid permeable body. The steps of Method 300 are for illustrative purposes only. For example, the steps of Method 300 may be performed in a different order, divided into multiple steps, modified, supplemented, or combined.

[0072] In method 300, the first layer may include any material or configuration of the inner layer 120a described above, and the second layer may include any material or configuration of the outer layer 120c described above. For example, the first layer may include a fluid-permeable (e.g., porous) nonwoven fabric material, and the second layer may include one or more bamboo, cotton, and / or nonwoven hydrophilic materials. In some embodiments, the second layer may include one or more bamboo, cotton, nonwoven polypropylene hydrophilic material, nonwoven polyethylene hydrophilic material, and / or nonwoven polyester hydrophilic material. In some embodiments, the surface density of the second layer is about 10 gsm to about 100 gsm. In some embodiments, the fluid-permeable nonwoven fabric material of the first layer includes a vertical nonwoven foam material, for example, a vertical nonwoven foam material containing one or more polyester, nylon, polypropylene, polyethylene, and / or cellulose. The first layer has a density of about 100 g / m². 2 / cm ~ approx. 250g / m 2 The second layer may have a surface density of approximately 0.125 mm to approximately 0.4 mm, and the first layer may have a thickness of approximately 2 mm to approximately 25 mm.

[0073] In some embodiments, step 302, which involves fixing a first layer to a second layer to form a fluid-permeable body, includes hot-melt bonding the first layer to the second layer using a hot-melt adhesive, the hot-melt adhesive being one or more polyurethane, acrylic, and / or polyester nonwoven web adhesives. For example, in an assembly process, the first layer may be placed on a conveyor belt line and a hot-melt adhesive web may be applied to the first layer. The hot-melt adhesive may be one or more thermoplastic resins, polyurethane, acrylic, and / or polyester nonwoven web adhesives. In some embodiments, the hot-melt adhesive may include particles that are sprayed onto the first layer on the conveyor line. Thus, in some embodiments, method 300 may include spraying hot-melt adhesive particles onto the first layer. The particle size of the hot melt adhesive may include approximately 1.0 μm to 10.0 μm, approximately 1.0 μm to 5.0 μm, approximately 5.0 μm to 10.0 μm, approximately 1.0 μm to 3.0 μm, approximately 3.0 μm to 5.0 μm, approximately 5.0 μm to 7.0 μm, or approximately 7.0 μm to 9.0 μm.

[0074] The second layer may be applied on top of the hot melt adhesive web in the conveyor belt line, so that the hot melt adhesive web is positioned between the first and second layers. Once the hot melt adhesive web is positioned between the first and second layers in the conveyor line, the conveyor belt is passed over rollers or through hot rollers on the conveyor line, melting the hot melt adhesive web and fixing the first layer to the second layer.

[0075] A hot roller can apply a predetermined temperature to the assembly of the first layer, the hot melt adhesive, and the second layer. In some embodiments, the hot roller applies temperatures of about 60°C to about 140°C, about 60°C to about 100°C, about 100°C to about 140°C, about 60°C to about 80°C, about 80°C to about 100°C, about 100°C to about 120°C, or about 100°C to about 140°C.

[0076] As described above, method 300 may include a step 304 of winding the fluid permeable body around a mandrel, so that the two opposing edges of the fluid permeable body are adjacent longitudinally along the mandrel, and the fluid permeable body forms a substantially cylindrical shape with the first layer as the inner layer and the second layer as the outer layer. Figure 2A shows an example in which the fluid permeable body 120 is wound around a mandrel 210 so that the two opposing edges 220 of the fluid permeable body are adjacent longitudinally along the mandrel 210, and the fluid permeable body 120 forms a substantially cylindrical shape. The bore 202 is formed through the substantially cylindrical fluid permeable body 120.

[0077] As described above, in some embodiments, method 300 may also include a step 306 of fixing a metal member to a mandrel, such that the distal end region of the metal member is fixed to the mandrel close to the distal end of the fluid permeable body, the proximal end region of the metal member is close to the proximal end of the fluid permeable body, and / or the intermediate region of the metal member is close to two opposing edges of the fluid permeable body. Figure 2B shows, for example, a metal member 250 including a proximal end region 252, an intermediate region 254, and a distal end region 256.

[0078] In step 306, the metal member 250 may be fixed to the mandrel 210 and / or the fluid permeable body 120 positioned around the mandrel 210. For example, at least one (e.g., both) of the proximal end region 252 and / or distal end region 256 of the metal member 250 may be fixed to the mandrel 210 and / or the fluid permeable body 120. The proximal end region 252 and / or distal end region 256 may be mechanically fixed to the mandrel 210. The distal end region 256 of the metal member 250 may be fixed to the mandrel 210 in close proximity to or adjacent to two opposing edges 220 of the distal end of the fluid permeable body 120, the proximal end region 252 of the metal member 250 may be fixed to the mandrel 210 in close proximity to or adjacent to two opposing edges 220 of the proximal end of the fluid permeable body 120, and / or the intermediate region 254 of the metal member 250 may be positioned in close proximity to two opposing edges of the fluid permeable body 120 between the proximal and distal ends.

[0079] In some embodiments, the metal member 250 clamps the fluid permeable body 120, so that the distal end region 256 of the metal member 250 is close to or adjacent to two opposing edges 220 at the distal end of the fluid permeable body 120, the proximal end region 252 of the metal member 250 is close to or adjacent to two opposing edges 220 at the proximal end of the fluid permeable body 120, and / or the intermediate region 254 of the metal member 250 is close to two opposing edges of the fluid permeable body 120 between the proximal and distal ends.

[0080] In some embodiments, method 300 may also include step 308 of thermally sealing at least a second layer of the fluid permeable body at two opposing ends of the fluid permeable body. For example, a metal member 250 may be activated by a wire 260 and heated to a predetermined temperature. When heated, the distal end region 256 of the metal member 250 may thermally seal at least a portion of the two opposing edges 220 of the distal end of the fluid permeable body 120, the proximal end region 252 of the metal member 250 may thermally seal at least a portion of the two opposing edges 220 of the proximal end of the fluid permeable body 120, and / or the intermediate region 254 of the metal member 250 may thermally seal at least a portion of the two opposing edges of the fluid permeable body 120 between the proximal and distal ends of the fluid permeable body 120. In some embodiments, when the metal member 250 is activated, the metal member 250 can thermally seal the opposing edges of the second layer (e.g., the outer layer) together.

[0081] In some embodiments, steps 306 and 308 are omitted from method 300. Instead, method 300 may include the step of securing two opposing edges of the fluid-permeable body together using adhesive or double-sided tape.

[0082] The steps of Method 300 are for illustrative purposes only. For example, the steps of Method 300 may be performed in a different order, divided into multiple steps, modified, supplemented, or combined.

[0083] Figure 4 is a flow diagram of a method 400 for manufacturing a fluid collector according to one embodiment. Method 400 can form any embodiment of the fluid-permeable body 120 and / or fluid collector 100 described above. Method 400 may include a step 402 for forming a fluid-permeable body by fixing a first layer to a second layer. Method 400 may also include a step 404 for placing the fluid-permeable body in a chamber at least partially defined by a fluid-impermeable barrier, the fluid-permeable body extending at least partially across the opening of the fluid-impermeable barrier.

[0084] Step 402, which involves fixing the first layer to the second layer to form a fluid-permeable body, may include any embodiment of step 302, which involves fixing the first layer to the second layer to form a fluid-permeable body, as described above in relation to Method 300. In Method 400, the first layer may include any embodiment or material of the first layer in Method 300 or the inner layer 120a of the fluid collector 100. In Method 400, the second layer may include any embodiment or material of the second layer in Method 300 or the outer layer 120c of the fluid collector 100. Furthermore, Method 400 may include any embodiment of Method 300 described above in forming a fluid-permeable body. For example, Method 400 may include one or more (e.g., all) of steps 304, 306, 308, 310, and / or 312 of Method 300.

[0085] In some embodiments, Method 400 further includes inserting a conduit through a bore of a fluid-permeable body. The conduit may include a shape-memory material fixed thereto and / or embedded therein, such as a shape-memory material 109. Method 400 may further include inserting a conduit through an aperture of a fluid-impermeable barrier.

[0086] The steps of Method 400 are for illustrative purposes only. For example, the steps of Method 400 may be performed in a different order, divided into multiple steps, modified, supplemented, or combined.

[0087] As used herein, the terms “about” or “substantially” refer to an acceptable variation of up to ±10% or ±5% of the term modified by “about.” Furthermore, the terms “less than,” “less than or equal to,” “greater than,” “greater than,” or “greater than or equal to” include, as an endpoint, the value modified by the terms “less than,” “less than or equal to,” “greater than,” “greater than,” or “greater than or equal to.”

[0088] Various aspects and embodiments are disclosed herein, but other aspects and embodiments are conceivable. The various aspects and embodiments disclosed herein are for illustrative purposes only and are not intended to limit the scope.

Claims

1. A method for manufacturing a fluid collection device, A fluid-permeable body is formed by fixing a first layer containing a fluid-permeable nonwoven fabric material to a second layer using an adhesive, wherein the second layer contains one or more of bamboo material, cotton material, and / or nonwoven hydrophilic material. The fluid-permeable body is placed in a chamber at least partially defined by a fluid-impermeable barrier, so that the fluid-permeable body extends at least partially across the opening of the fluid-impermeable barrier. Methods that include...

2. The method according to claim 1, wherein the second layer comprises one or more of the bamboo material, the cotton material, a nonwoven polypropylene hydrophilic material, a nonwoven polyethylene hydrophilic material, and / or a nonwoven polyester hydrophilic material.

3. The method according to claim 1 or 2, wherein the second layer has a surface density of about 10 gsm to about 100 gsm.

4. The method according to any one of claims 1 to 3, wherein the fluid-permeable nonwoven material of the first layer includes a vertical nonwoven foam material.

5. The method according to claim 4, wherein the vertical nonwoven foam material comprises one or more of polyester, nylon, polypropylene, polyethylene, and / or cellulose.

6. The first layer is approximately 100 g / m² ２ / cm ~ approx. 250g / m ２ The method according to any one of claims 1 to 5, comprising a surface density of / cm.

7. The method according to any one of claims 1 to 6, wherein the second layer has a thickness of about 0.125 mm to about 0.4 mm, and the first layer has a thickness of about 2 mm to about 25 mm.

8. The method according to any one of claims 1 to 7, wherein fixing a first layer containing a fluid-permeable nonwoven fabric material to a second layer using an adhesive to form a fluid-permeable body includes hot-melt bonding the first layer to the second layer using the hot-melt adhesive containing one or more thermoplastic resins, polyurethanes, acrylics, and / or polyester nonwoven fabric web adhesives.

9. The method according to claim 8, further comprising spraying the hot melt adhesive onto the first layer, and then hot-melt bonding the first layer to the second layer using the hot melt adhesive placed between the first layer and the second layer.

10. The method according to any one of claims 1 to 9, further comprising winding the fluid-permeable body around an axis and fixing the two edges of the fluid-permeable body together so that the fluid-permeable body becomes substantially cylindrical, the first layer becomes an inner layer, the second layer becomes an outer layer concentric with the inner layer, and the fluid-impermeable barrier becomes substantially cylindrical.

11. The fluid-permeable body is wrapped around a mandrel, so that the two opposing edges of the fluid-permeable body are adjacent to each other in the longitudinal direction along the mandrel, and the fluid-permeable body forms a substantially cylindrical shape. The metal member is fixed to the mandrel such that the distal end of the metal member is close to the distal end of the fluid permeable body and fixed to the mandrel, the proximal end of the metal member is close to the proximal end of the fluid permeable body, and the intermediate region of the metal member is close to the two opposing edges of the fluid permeable body. At least the second layer of the fluid permeable body is thermally sealed at the two opposing edges of the fluid permeable body. Removing the aforementioned metal member from the mandrel, and Removing the mandrel from the fluid-permeable body, The method according to any one of claims 1 to 9, further comprising:

12. Inserting a conduit through a bore of the fluid-permeable body, wherein the conduit includes a shape-memory material fixed thereto and / or embedded therein, Inserting the conduit through the aperture of the fluid-impermeable barrier, The method according to any one of claims 1 to 11, further comprising:

13. A method for manufacturing a fluid permeable member for a fluid collection device, A first layer containing a fluid-permeable nonwoven fabric material is fixed to a second layer to form a fluid-permeable body, wherein the second layer contains one or more of bamboo material, cotton material, and / or nonwoven hydrophilic material. The fluid-permeable body is wrapped around a mandrel, so that the two opposing edges of the fluid-permeable body are adjacent to each other in the longitudinal direction along the mandrel, and the fluid-permeable body forms a substantially cylindrical shape. The metal member is fixed to the mandrel such that the distal end of the metal member is close to the distal end of the fluid permeable body and fixed to the mandrel, the proximal end of the metal member is close to the proximal end of the fluid permeable body, and the intermediate region of the metal member is close to the two opposing edges of the fluid permeable body. At least the second layer of the fluid permeable body is thermally sealed at the two opposing edges of the fluid permeable body. Removing the aforementioned metal member from the mandrel, and Removing the mandrel from the fluid-permeable body, Methods that include...

14. The method according to claim 12, wherein the second layer comprises one or more of the bamboo material, the cotton material, a nonwoven polypropylene hydrophilic material, a nonwoven polyethylene hydrophilic material, and / or a nonwoven polyester hydrophilic material.

15. The method according to claim 12 or 13, wherein the second layer has a surface density of about 10 gsm to about 100 gsm.

16. The method according to any one of claims 12 to 14, wherein the fluid-permeable nonwoven material of the first layer includes a vertical nonwoven foam material.

17. The method according to claim 15, wherein the vertical nonwoven foam material comprises one or more of polyester, nylon, polypropylene, polyethylene, and / or cellulose.

18. The first layer is approximately 100 g / m² ２ Approximately 250 g / m per cm ２ The method according to any one of claims 12 to 16, comprising a surface density of / cm.

19. The method according to any one of claims 12 to 17, wherein the second layer has a thickness of about 0.125 mm to about 0.4 mm, and the first layer has a thickness of about 2 mm to about 25 mm.

20. The method according to any one of claims 12 to 18, wherein fixing a first layer containing a fluid-permeable nonwoven fabric material to a second layer to form a fluid-permeable body includes hot-melt bonding the first layer to the second layer using a hot-melt adhesive containing one or more polyurethane, acrylic, and / or polyester nonwoven web adhesives.

21. The method according to claim 20, further comprising spraying the hot melt adhesive onto the first layer, and then hot-melt bonding the first layer to the second layer using the hot melt adhesive placed between the first layer and the second layer.

22. A fluid-impermeable barrier defining at least partially a chamber, the fluid-impermeable barrier including an opening that fluid-communicates with the chamber, and an aperture that fluid-communicates with the chamber, wherein the opening is positioned at least in close proximity to the user's urethra or configured to receive the urethra into the fluid-impermeable barrier, and A fluid permeable body disposed within the chamber of the fluid-impermeable barrier and extending at least partially across the opening, comprising an inner layer containing a fluid-permeable nonwoven fabric material and an outer layer fixed to the inner layer with an adhesive and containing one or more of bamboo, cotton, and / or nonwoven hydrophilic materials, A fluid collection device equipped with the following features.

23. The fluid collection device according to claim 20, wherein the outer layer comprises one or more of the bamboo material, the cotton material, a nonwoven polypropylene hydrophilic material, a nonwoven polyethylene hydrophilic material, and / or a nonwoven polyester hydrophilic material.

24. The fluid collection device according to claim 20 or 21, wherein the outer layer has a surface density of about 10 gsm to about 100 gsm.

25. The fluid collection device according to any one of claims 20 to 22, wherein the fluid-permeable nonwoven fabric material of the inner layer includes a vertical nonwoven foam material.

26. The fluid collection device according to claim 23, wherein the vertical nonwoven foam material comprises one or more of polyester, nylon, polypropylene, polyethylene, and / or cellulose.

27. The inner layer is approximately 100 g / m² ２ / cm ~ approx. 250g / m ２ A fluid collection device according to any one of claims 20 to 24, comprising a surface density of / cm.

28. The fluid collection device according to any one of claims 20 to 25, wherein the outer layer has a thickness of about 0.125 mm to about 0.4 mm, and the inner layer has a thickness of about 2 mm to about 25 mm.

29. The fluid collection apparatus according to any one of claims 20 to 26, wherein the adhesive comprises a hot melt adhesive comprising one or more thermoplastic resins, polyurethanes, acrylics, and / or polyester nonwoven web adhesives.

30. The fluid collection device according to any one of claims 20 to 27, wherein the fluid-impermeable barrier is substantially cylindrical, the fluid-permeable body is substantially cylindrical, and the inner layer and the outer layer of the fluid-permeable body are concentric with each other.

31. The fluid collection device according to any one of claims 20 to 28, further comprising a conduit extending through the aperture into the chamber of the fluid-impermeable barrier and at least partially into the fluid-permeable body.

32. The fluid collection device according to claim 29, wherein the conduit includes a shape memory material fixed thereto and / or embedded therein.

33. The fluid collection device according to claim 30, wherein the shape memory material comprises one or more metal wires, metal alloy wires, and / or plastic reinforced fibers.

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