Fluid collection devices including a coextruded shape memory material

Abstract

Examples relate to systems, devices, and methods for removing fluid from a fluid collection device using a vacuum source operably coupled thereto. The fluid collection devices include an extruded fluid impermeable barrier defining a chamber, at least one porous material disposed in the chamber, and a shape memory coextruded with the fluid impermeable barrier.

Description

FLUID COLLECTION DEVICES INCLUDING A COEXTRUDED SHAPE MEMORY MATERIALBACKGROUND

[0001] An individual may have limited or impaired mobility such that typical urination processes are challenging or impossible. For example, the individual may have surgery or a disability that impairs mobility. In another example, the individual may have restricted travel conditions such as those experience by pilots, drivers, and workers in hazardous areas. Additionally, fluid collection from the individual may be needed for monitoring purposes or clinical testing.

[0002] Bed pans and urinary catheters, such as a Foley catheter, may be used to address some of these circumstances. However, bed pans and urinary catheters have several problems associated therewith. For example, bed pans may be prone to discomfort, spills, and other hygiene issues. Urinary catheters be may be uncomfortable, painful, and may cause urinary tract infections.

[0003] Thus, users and manufacturers of fluid collection devices continue to seek new and improved devices, systems, and methods to collect urine.SUMMARY

[0004] Embodiments disclosed herein are related to devices, systems, and methods of using fluid collection devices having shape memory material therein. In an embodiment, a fluid collection device is disclosed. The fluid collection device includes a fluid impermeable barrier that is extruded and at least partially defines a chamber. The fluid impermeable barrier also defines an opening extending therethrough, the opening being configured to be positioned adjacent to a female urethra. The fluid collection device includes at least one porous material disposed in the chamber. The fluid collection device includes a shape memory material that is elongated and coextruded with the fluid impermeable barrier. The shape memory material is sized, shaped, and positioned to retain the shape memory material and the fluid impermeable barrier in a selected geometric configuration.

[0005] In another embodiment, a fluid collection device is disclosed. The fluid collection device includes a fluid impermeable barrier that is extruded and at least partially defines a chamber. The fluid impermeable barrier also defines an opening extending therethrough, the opening being configured to be positioned adjacent to a female urethra. The fluid collection device includes at least one porous material disposed in the chamber. The fluid collection device includes a shape memory material that is elongated and sized,shaped, and positioned to retain the shape memory material and the fluid impermeable barrier in a selected geometric configuration. The shape memory material is disposed on or within a region of the fluid impermeable barrier generally opposite to the opening. The shape memory material has a thickness of about 0.1 mm to about 0.6 mm and a width of about 3 mm to about 6.5 mm, and the region of the fluid impermeable barrier and the shape memory material have a combined thickness of about 2.5 mm or less.

[0006] In an embodiment, a method of forming a fluid collection device is disclosed. The method includes coextruding a fluid impermeable material and a shape memory material to form a fluid impermeable barrier at least partially defining a chamber and defining an opening extending through the fluid impermeable barrier, the shape memory material including a metal plate. The method also includes disposing at least one porous material within the chamber such that the at least one porous material extend across the opening.

[0007] Features from any of the disclosed embodiments may be used in combination with one another, without limitation. In addition, other features and advantages of the present disclosure will become apparent to those of ordinary skill in the art through consideration of the following detailed description and the accompanying drawings.BRIEF DESCRIPTION OF THE DRAWINGS

[0008] The drawings illustrate several embodiments of the present disclosure, wherein identical reference numerals refer to identical or similar elements or features in different views or embodiments shown in the drawings.

[0009] FIG. 1A is an isometric view of a fluid collection device, according to an embodiment.

[0010] FIG. IB is cross-sectional view of the fluid collection device taken along the plane A-A of FIG. 1A, according to an embodiment.

[0011] FIG. 1C is an isometric view of the fluid collection device of FIG. 1A, according to an embodiment.

[0012] FIG. 2 is a block diagram of a system for fluid collection, according to an embodiment.

[0013] FIG. 3 is a flow diagram of a method to collect fluid, according to an embodiment.DETAILED DESCRIPTION

[0014] Embodiments disclosed herein are related to devices, systems, and methods of using fluid collection devices and systems. The devices, systems, and methods of usingfluid collection devices and systems include at least one shape memory material for forming and maintaining the fluid collection device into a selected shape. The shape memory material may enable for selective manipulation of the fluid collection device to contour to the anatomical features of variously sized wearers. The shape memory material may include a plate, such as a metal plate, one or more metal rods, and / or one or more metal wires. In at least one, some, or all embodiments, the shape memory material is a metal coextruded with the fluid impermeable barrier. Coextruding the fluid impermeable barrier and the shape memory material results in the technical effects of more effective and efficient manufacture, increased strength, and / or greater wear resistance and / or selective shape retention of the region including the fluid impermeable barrier and the shape memory material. For example, coextrusion of a metal shape memory material and the fluid impermeable barrier allows for a manufacture of a multi-layer and multi-functional fluid collection device in a single pass, and also reduces the number of steps required to prepare a fluid collection device including a shape memory material.

[0015] The fluid collection devices disclosed herein include a fluid impermeable barrier that at least partially defines a chamber. The fluid impermeable barrier also defines an opening extending therethrough that is configured to be positioned adjacent to a female urethra. The fluid collection devices disclosed herein may include a porous material disposed in the chamber. The fluid collection devices disclosed herein include shape memory material carried by one or more components thereof, such as the fluid impermeable barrier, the porous material, or another component. The fluid collection devices also include a conduit having a channel extending between an inlet and outlet thereof. The inlet is configured to be coupled to a suction source and the outlet is configured to be fluidly coupled to a fluid storage (vessel or container).

[0016] The fluid collection devices disclosed herein are configured to collect fluid(s) from a wearer. The shape of the fluid collection device may be manipulated and at least temporarily maintained in a selected shape to provide a more comfortable and effective fit on the wearer. By shaping the fluid collection device with the shape memory material to match the anatomical shape of the wearer, more of the fluid may be collected and retained in the fluid collection device. For example, shaping the fluid collection device to match the anatomical shape of the wearer inhibits the fluid collection device from moving away from the groin of the wearer (e.g., when the wearer moves). Moving the fluid collection device away from the wearer increases the likelihood that fluid leaks from the fluidcollection device during use. As such, shaping the fluid collection device with the shape memory material to match the anatomical shape of the wear minimizes leaks.

[0017] The fluid collected by the fluid collection devices may include urine. The fluid(s) collected by the fluid collection devices may also include at least one of vaginal discharge, penile discharge, reproductive fluids, blood, sweat, or other bodily fluids. The fluid collection devices disclosed herein are configured to be used in fluid collection systems, which apply suction in the chamber to remove the fluid from the fluid collection device.

[0018] FIG. 1A is an isometric view of a fluid collection device 100, according to an embodiment. FIG. IB is cross-sectional view of the fluid collection device 100 taken along the plane A-A of FIG. 1A, according to an embodiment. The fluid collection device 100 is an example of a female fluid collection device for receiving and collecting fluid(s) from a female. The fluid collection device 100 includes a fluid impermeable barrier 102, porous material 115 e.g., wicking material) disposed in a chamber within the fluid impermeable barrier 102, at least one shape memory material 130, and an optional conduit 108 at least partially disposed within the chamber.

[0019] The fluid impermeable barrier 102 at least partially defines a chamber 104 (e.g. , interior region) and an opening 106. For example, the interior surface(s) 103 of the fluid impermeable barrier 102 at least partially defines the chamber 104 within the fluid collection device 100. The fluid impermeable barrier 102 temporarily stores the fluid(s) in the chamber 104. The fluid impermeable barrier 102 may be formed of any suitable fluid impermeable material(s), such as a fluid impermeable polymer (e.g., silicone, polypropylene, polyethylene, polyethylene terephthalate, a polycarbonate, etc.), a metal film, natural rubber, another suitable material, or combinations thereof. As such, the fluid impermeable barrier 102 substantially prevents the fluid(s) from passing through the fluid impermeable barrier 102. In an example, the fluid impermeable barrier 102 may be air permeable and fluid impermeable. In such an example, the fluid impermeable barrier 102 may be formed of a hydrophobic material that defines a plurality of pores. At least one or more portions of at least an outer surface 105 of the fluid impermeable barrier 102 may be formed from a soft and / or smooth material, thereby reducing chaffing.

[0020] In some examples, the fluid impermeable barrier 102 may be tubular (ignoring the opening), such as substantially cylindrical (as shown), oblong, prismatic, or flattened tubes. During use, the outer surface 105 of the fluid impermeable barrier 102 may contactthe wearer. The fluid impermeable barrier 102 may be sized and shaped to fit in the gluteal cleft between the legs of a female wearer.

[0021] The opening 106 provides an ingress route for fluids to enter the chamber 104. The opening 106 may be defined by the fluid impermeable barrier 102 such as by an inner edge of the fluid impermeable barrier 102. For example, the opening 106 is formed in and extends through the fluid impermeable barrier 102, from the outer surface 105 to the inner surface 103, thereby enabling fluid(s) to enter the chamber 104 from outside of the fluid collection device 100. The opening 106 may be an elongated hole in the fluid impermeable barrier 102. For example, the opening 106 may be defined as a cut-out in the fluid impermeable barrier 102. The opening 106 may be located and shaped to be positioned adjacent to a female urethra.

[0022] The fluid collection device 100 may be positioned proximate to the female urethra and urine may enter the chamber of the fluid collection device 100 via the opening 106. The fluid collection device 100 is configured to receive the fluid(s) into the chamber 104 via the opening 106. When in use, the opening 106 may have an elongated shape that extends from a first location below the urethral opening (e.g., at or near the anus or the vagina] opening) to a second location above the urethral opening (e.g., at or near the top of the vaginal opening or the pubic hair).

[0023] The opening 106 may have an elongated shape because the space between the legs of a female is relatively small when the legs of the female are closed, thereby only permitting the flow of the fluid(s) along a path that corresponds to the elongated shape of the opening 106 (e.g., longitudinally extending opening). The opening 106 in the fluid impermeable barrier 102 may exhibit a length that is measured along the longitudinal axis of the fluid collection device 100 that may be at least about 10% of the length of the fluid collection device 100, such as 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 95% of the length of the fluid collection device 100.

[0024] The opening 106 in the fluid impermeable barrier 102 may exhibit a width that is measured transverse to the longitudinal axis of the fluid collection device 100 that may be at least about 10% of the circumference of the fluid collection device 100, such as 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% of the circumference of the fluid collection device 100. The opening 106 may exhibit a width that is greater than 50% of the circumference of the fluid collection device 100 since the vacuum (e.g., suction) through the conduit 108 pullsthe fluid through the porous material 115 and into the conduit 108. In some examples, the opening 106 may be vertically oriented (e.g., having a major axis parallel to the longitudinal axis of the device 100). In some examples (not shown), the opening 106 may be horizontally oriented e.g., having a major axis perpendicular to the longitudinal axis of the device 100). In an example, the fluid impermeable barrier 102 may be configured to be attached to the wearer, such as adhesively attached (e.g., with a hydrogel adhesive) to the wearer. According to an example, a suitable adhesive is a hydrogel layer.

[0025] In some examples, the fluid impermeable barrier 102 may define an aperture 124 sized to receive the conduit 108. The at least one conduit 108 may be disposed in the chamber 104 via the aperture 124. The aperture 124 may be sized and shaped to form an at least substantially fluid tight seal against the conduit 108 or the at least one tube thereby substantially preventing the fluid(s) from escaping the chamber 104.

[0026] The fluid impermeable barrier 102 may include markings (not shown) thereon, such as one or more markings to aid a wearer in aligning 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 align the opening 106 over the urethra of the wearer. In examples, the markings may include one or more of alignment guide or an orientation indicator, such as a stripe or hashes. Such markings may be positioned to align the device 100 to one or more anatomical features such as a pubic bone, etc.

[0027] The fluid collection device 100 includes porous material 115 disposed in the chamber 104. The porous material 115 may cover at least a portion (e.g. , all) of the opening 106. The porous material 115 is exposed to the environment outside of the chamber 104 through the opening 106. The porous material 115 may be configured to move any fluid away from the opening 106, thereby preventing the fluid from escaping the chamber 104. The permeable properties referred to herein may be wicking, capillary action, diffusion, or other similar properties or processes, and are referred to herein as “permeable” and / or “wicking.” Such “wicking” may not include absorption of fluid into the porous material. Put another way, substantially no absorption of fluid into the material may take place after the material is exposed to the fluid and removed from the fluid for a time. While no absorption is desired, the term “substantially no absorption” may allow for nominal amounts of absorption of fluid into the porous material (e.g. , absorbency), such as less than about 10 wt% of the dry weight of the porous material, less than about 7 wt%, less than about 5 wt%, less than about 3 wt%, less than about 2 wt%, less than about 1 wt%, or less than about 0.5 wt% of the dry weight of the porous material. The porous material 115 mayalso wick the fluid generally towards an interior of the chamber 104, as discussed in more detail below. The porous material 115 may include one or more of a fluid permeable membrane 118 or a fluid permeable support 120. However, in some embodiments, it is noted that the porous material 115 may include an absorption material (e.g., hydrophilic material) instead of a wicking material.

[0028] The fluid collection device 100 may include the fluid permeable membrane 118 disposed in the chamber 104. The fluid permeable membrane 118 may cover at least a portion e.g., all) of the opening 106. The fluid permeable membrane 118 may be composed to wick fluid away from the opening 106, thereby preventing the fluid from escaping the chamber 104.

[0029] The fluid permeable membrane 118 may include any material that may wick the fluid. For example, the fluid permeable membrane 118 may include fabric, such as a gauze (e.g. , a silk, linen, or cotton gauze), another soft fabric, or another smooth fabric. Forming the fluid permeable membrane 118 from gauze, soft fabric, and / or smooth fabric may reduce chaffing caused by the fluid collection device 100.

[0030] The fluid collection device 100 may include the fluid permeable support 120 disposed in the chamber 104. The fluid permeable support 120 is configured to support the fluid permeable membrane 118 since the fluid permeable membrane 118 may be formed from a relatively foldable, flimsy, or otherwise easily deformable material. For example, the fluid permeable support 120 may be positioned such that the fluid permeable membrane 118 is disposed between the fluid permeable support 120 and the fluid impermeable barrier 102. As such, the fluid permeable support 120 may support and maintain the position of the fluid permeable membrane 118. The fluid permeable support 120 may include any material that may wick the fluid, such as any of the fluid permeable membrane materials disclosed herein above. For example, the fluid permeable membrane material(s) may be utilized in a more dense or rigid form than in the fluid permeable membrane 118 when used as the fluid permeable support 120. The fluid permeable support 120 may be formed from any fluid permeable material that is less deformable than the fluid permeable membrane 118. For example, the fluid permeable support 120 may include a porous polymer (e.g., nylon, polyester, polyurethane, polyethylene, polypropylene, etc.) structure or an open cell foam. In some examples, the fluid permeable support 120 may be formed from a natural material, such as cotton, wool, silk, or combinations thereof. In such examples, the material may have a coating to prevent or limit absorption of fluid into the material, such as a water repellent coating. In some examples, the fluid permeable support 120 may be formed fromfabric, felt, gauze, or combinations thereof. In some examples, the fluid permeable membrane 118 may be optional. For example, the porous material 115 may include only the fluid permeable support 120. In some examples, the fluid permeable support 120 may be optionally omitted from the fluid collection device 100. For example, the porous material 115 may only include the fluid permeable membrane 118.

[0031] The fluid permeable support 120 may have a greater ability to wick fluids than the fluid permeable membrane 118, such as to move the fluid inwardly from the outer surface of the fluid collection device 100. In some examples, the wicking ability of the fluid permeable support 120 and the fluid permeable membrane 118 may be substantially the same.

[0032] In some embodiments, the fluid permeable support 120 may be a porous layer that includes a non-woven fluid permeable material, such as one or more of polyester, nylon, polypropylene, polyethylene, cellulose, and / or combinations thereof. Descriptions and aspects of non-woven material and configurations thereof are disclosed in PCT Patent Application No. PCT / US23 / 24805, filed on June 8, 2023 the disclosure of which is incorporated herein, in its entirety, by this reference. In some embodiments, the fluid permeable membrane 1 18 includes one or more of a bamboo material, a cotton material, and / or a non-woven hydrophilic material. More specifically, the fluid permeable membrane may include one or more of the bamboo material, the cotton material, a nonwoven polypropylene hydrophilic material, a non-woven polyethylene hydrophilic material, a non-woven polyester hydrophilic material, and / or combinations thereof (such as a bamboo / cotton mixed material).

[0033] The fluid permeable membrane 118 and the fluid permeable support 120 may at least substantially completely fill the portions of the chamber 104 that are not occupied by the conduit 108. In some examples, the fluid permeable membrane 118 and the fluid permeable support 120 may not substantially completely fill the portions of the chamber 104 that are not occupied by the conduit 108. In such an example, the fluid collection device 100 includes a reservoir or sump 122 (FIG. IB) disposed in the chamber 104.

[0034] The reservoir 122 is a substantially unoccupied portion of the chamber 104. The reservoir 122 may be defined between the fluid impermeable barrier 102 and one or both of the fluid permeable membrane 118 and fluid permeable support 120. The fluid(s) that are in the chamber 104 may flow through the fluid permeable membrane 118 and / or fluid permeable support 120 to the reservoir 122. The reservoir 122 may retain of the fluid(s) therein.

[0035] The fluid(s) that are in the chamber 104 may flow through the fluid permeable membrane 118 and / or fluid permeable support 120 to the reservoir 122. The fluid impermeable barrier 102 may retain the fluid(s) in the reservoir 122. While depicted in the second end region 127, the reservoir 122 may be located in any portion of the chamber 104 such as the first end region 125. The reservoir 122 may be located in a portion of the chamber 104 that is designed to be located in a gravimetrically low point of the fluid collection device when the device is worn.

[0036] In some examples (not shown), the fluid collection device 100 may include multiple reservoirs, such as a first reservoir that is located at the portion of the chamber 104 closest to the inlet 110 (e.g., second end region 127) and a second reservoir that is located at the portion of the of the chamber 104 that is closest to the outlet 112 of the conduit 108 (e.g., first end region 125). In another example, the fluid permeable support 120 is spaced from at least a portion of the conduit, and the reservoir 122 may be the space between the fluid permeable support 120 and the conduit.

[0037] The conduit 108 may be at least partially disposed in the chamber 104. The conduit 108 may be used to remove fluid form the chamber 104. The conduit 108 (e.g., a tube) includes an inlet 1 10 and an outlet 1 12 positioned downstream from the inlet 110. The outlet 112 may be operably coupled to a suction source, such as a vacuum pump for withdrawing fluid form the chamber through the conduit 108. For example, the conduit 108 may extend into the fluid impermeable barrier 102 from the first end region 125 and may extend to the second end region 127 to a point proximate to the reservoir 122 therein such that the inlet 110 is in fluid communication with the reservoir 122. The conduit 108 fluidly couples the chamber 104 with the fluid storage container (not shown) or the vacuum source (not shown).

[0038] The conduit 108 may include a flexible material such as plastic tubing (e.g., medical tubing). Such plastic tubing may include a thermoplastic elastomer, polyvinyl chloride, ethylene vinyl acetate, polytetrafluoroethylene, etc., tubing. In some examples, the conduit 108 may include silicon or latex. In some examples, the conduit 108 may include one or more portions that are resilient, such as to by having one or more of a diameter or wall thickness that allows the conduit to be flexible.

[0039] As shown in FIG. IB, the end of the conduit 108 may extend through a bore in the fluid permeable membrane 118 and / or fluid permeable support 120, such as into the reservoir 122. For example, the inlet 110 may be extend into or be positioned in the reservoir 122. In the illustrated embodiment, the conduit 108 is at least partially disposedin the reservoir 122. In some examples (not shown), the conduit 108 may enter the chamber 104 in the second end region and the inlet 110 of the conduit 108 may be disposed in the second end region (e.g., in the reservoir 122). The fluid collected in the fluid collection device 100 may be removed from the chamber 104 via the conduit 108.

[0040] In some examples, the inlet 110 may not extend into the reservoir 122. In such examples, the inlet 110 may be disposed within the porous material 115 (fluid permeable membrane 118 and / or fluid permeable support 120) or at a terminal end thereof. For example, an end of the conduit 108 may be coextensive with or recessed within the fluid permeable membrane 118 and / or fluid permeable support 120.

[0041] Locating the inlet 110 at or near a location expected to be the gravimetrically low point of the chamber 104 when worn by a wearer enables the conduit 108 to receive more of the fluid(s) than if inlet 110 was located elsewhere and reduce the likelihood of pooling (e.g., pooling of the fluid(s) may cause microbe growth and foul odors). For instance, the fluid(s) in the fluid permeable membrane 118 and the fluid permeable support 120 may flow in any direction due to capillary forces. However, the fluid(s) may exhibit a preference to flow in the direction of gravity, especially when at least a portion of the fluid permeable membrane 118 and / or the fluid permeable support 120 is saturated with the fluid(s). Accordingly, one or more of the inlet 110 or the reservoir 122 may be located in the fluid collection device in a position expected to be the gravimetrically low point in the fluid collection device when worn by a wearer, such as the second end region 127.

[0042] In an example, the conduit 108 is configured to be at least insertable into the chamber 104. In such an example, the conduit 108 may include one or more markers (not shown) on an exterior thereof that are located to facilitate insertion of the conduit 108 into the chamber 104. For example, the conduit 108 may include one or more markings thereon that are configured to prevent over or under insertion of the conduit 108, such as when the conduit 108 defines an inlet 110 that is configured to be disposed in or adjacent to the reservoir 122. In another example, the conduit 108 may include one or more markings thereon that are configured to facilitate correct rotation of the conduit 108 relative to the chamber 104. The one or more markings may include a line, a dot, a sticker, or any other suitable marking.

[0043] As described in more detail below, the conduit 108 is configured to be coupled to, and at least partially extend between, one or more of the fluid storage container (not shown) and the vacuum source (not shown). In an example, the conduit 108 is configured to be directly connected to the vacuum source (not shown). In such an example, the conduit108 may extend from the fluid impermeable barrier 102 by at least one foot, at least two feet, at least three feet, or at least six feet. In another example, the conduit 108 is configured to be indirectly connected to at least one of the fluid storage container (not shown) and the vacuum source (not shown). In some examples, the conduit is secured to a wearer’s skin with a catheter securement device, such as a STATLOCK® catheter securement device available from C. R. Bard, Inc., including but not limited to those disclosed in U.S. Patent Nos. 6,117,163; 6,123,398; and 8,211,063, the disclosures of which are all incorporated herein by reference in their entirety.

[0044] The inlet 110 and the outlet 112 are configured to fluidly couple (e.g., directly or indirectly) the vacuum source (not shown) to the chamber 104 e.g., the reservoir 122). As the vacuum source (FIG. 14) applies a vacuum / suction in the conduit 108, the fluid(s) in the chamber 104 (e.g., at the second end region such as in the reservoir 122) may be drawn into the inlet 110 and out of the fluid collection device 100 via the conduit 108. In some examples, the conduit may be frosted or opaque (e.g., black) to obscure visibility of the fluid(s) therein.

[0045] The fluid collection device 100 includes a shape memory material 130. The shape memory material may be sized, shaped, and positioned in the fluid collection device to cause at least a portion of the fluid collection device 100 to retain a selected shape (e.g., geometric configuration). In an embodiment, the shape memory material 130 is configured to be bent, shaped, or otherwise deformed (hereafter collectively referred to as “shape,” “shaped,” or “shaping”). In an example, the shape memory material 130 is configured to be shaped along an entire length thereof. Allowing the shape memory material 130 to be shaped along the entire length thereof may allow the fluid collection device 100 to exhibit a shape that substantially corresponds to the anatomical features of the wearer. In an example, the shape memory material 130 is configured to be shaped at one or more selected location thereof. In such an example, the selected locations of the shape memory material 130 may be preferentially shaped relative to the rest of the shape memory material 130. While configuring the shape memory material 130 to be shaped at the selected location may inhibit the fluid collection device 100 from exhibiting a shape that substantially corresponds to the anatomical features of the wearer, it may facilitate shaping of the fluid collection device 100, especially for less experienced wearers. In an embodiment, the shape memory material may not be configured to be shaped. Instead, the shape memory material may exhibit a selected shape that corresponds or substantially corresponds to the anatomical feature of the wearer. In such an embodiment, the shape memory material 130may be more rigid and / or resilient than the rest of the fluid collection device 100 thereby causing at least a portion of the fluid collection device 100 to correspond to the selected shape of the shape memory material 130.

[0046] The shape memory material 130 may include a shape memory polymer or a metal (e.g., shape memory metal). In an example, the shape memory material includes a metal material such as aluminum, copper, aluminum alloy, brass, or combinations thereof. Generally, the shape memory materials are composed to adopt an intermediate or permanent shape in response to a stimuli. The stimuli may include an external physical force (e.g. , bending force), heat, electrical bias, or a magnetic field. While the term “shape memory” is used to describe some of the “shape memory materials” herein, it should be understood that, in some examples, the material modified by the term “shape memory” may not necessarily need to return to a preselected shape upon application of a stimuli, as understood as the classical definition of the “shape memory material.” Rather, at least some of the shape memory materials herein may simply hold a selected shape when bent, set, or cured into a specific shape and / or when cooled in a specific shape, regardless of the stimuli applied thereto after. The shape memory materials may be returned to the original shape or changed to a new shape by application of stimuli. For example, a metal wire bent to a first shape may be utilized as the shape memory material, whereinafter the metal wire may be modified to a second shape via physical force applied thereto or via heating. However, in some embodiments, the shape memory materials may exhibit a selected shape, as discussed above and application of the stimuli may cause the shape memory material to deform (e.g. , elastically deform or bend) into an intermediate shape. In such embodiments, the shape memory material may return to the initial shape upon removal of the stimuli such that the shape memory material does not maintain the intermediate shape.

[0047] In an embodiment, the shape memory material may include metal, such as an elemental metal, an alloy, or shape memory alloy. Suitable shape memory metals may include standard steels, stainless steel, carbon alloy steel, head treated steel, aluminum, silver, copper, iron, nickel, zinc, tin, beryllium, or the like. Suitable shape memory alloys may include stainless steel; galvanized steel; aluminum alloys; nickel- titanium alloys, such as Nitinol, Ni-Ti-Cu, Ni-Ti, Co, or the like; copper-based alloys such as Cu-Zn-Al, Cu-Al- Ni, Cu-Al-Sn, or the like; Co-Cr-Ni-Mo alloys (e.g., Elgiloy®) or the like; or any other alloy having shape memory characteristics. As explained above, the shape memory metals or alloys may merely be metals or alloys that may be shaped to a selected configuration. In some examples, the shape memory metals or alloys may return to a primary shape whenan external stimuli is applied thereto. In some examples, the outer surface of the shape memory metal may be coated with a polymer, anodized, passivated, or otherwise treated to prevent corrosion.

[0048] Shape memory polymers (“SMPs”) may include polyurethane-based SMPs such as a copolymer (e.g., copolyester, polyurethane, polyetherester, etc.) including blocks of one or more of poly(E-caprolactone), polyethyleneterephthalate (PET), polyethyleneoxide (PEO), polyethylene glycol (PEG), polystyrene, polymethylmethacrylate (PMMA), Polybutylmethacrylate (PBMA), poly(N,N-butadiene), poly(N-methyl-N-oxazoline), polytetrahydrofuran, or poly(butylene terephthalate); thermoplastic polymers such as polyether ether ketone (PEEK), nylon, acetal, polytetrafluoroethylene (PTFE), polypropylene, polyethylene, acrylonitrile butadiene styrene (ABS), polysulphone, or the like; Polynorbonene; other deformable polymers; or any other shape memory polymer.

[0049] As shown in FIG. IB, the shape memory material 130 may be located in the fluid impermeable barrier 102, such as being incorporated into the fluid impermeable barrier 102. For example, the shape memory material 130 (e.g., an elongated metal plate) may be coextruded or insert molded with the fluid impermeable barrier 102. Accordingly, in an embodiment, the shape memory material 130 may comprise a shape memory metal (e.g., aluminum, copper, etc.) coextruded or insert molded into the fluid impermeable barrier 102. While reference herein is made to a shape memory material 130 including a metal plate, one or more embodiments of the fluid collection device 100 may include a shape memory material 130 including one or more metal rods or one or more metal wires coextruded with the fluid impermeable barrier 102 and extending longitudinally within the fluid impermeable barrier 102. Coextruding the fluid impermeable barrier and the shape memory material results in the technical effects of more effective and efficient manufacture, increased strength, and / or greater wear resistance and / or selective shape retention of the region including the fluid impermeable barrier 102 and the shape memory material 130. For example, coextrusion of a metal shape memory material 130 and the fluid impermeable barrier 102 allows for a manufacture of a multi-layer and multi-functional fluid collection device 100 in a single pass, and also reduces the number of steps required to prepare a fluid collection device including a shape memory material.

[0050] In some examples, the shape memory material 130 may only be disposed in one or more discrete portions of the fluid impermeable barrier 102. For example, the fluid impermeable barrier 102 may be at least partially constructed of shape memory material130 longitudinally extending along the bottom surface (e.g., substantially opposite the opening) of the fluid collection device 100.

[0051] The length of the shape memory material 130 (e.g. , the elongated metal) may be at least 10% of the longitudinal length of the fluid collection device, such as 10% to 100%, 30% to 100%, 10% to 40%, 30% to 60%, 60% to 90%, 40% to 80%, 50% to 100%, less than 100%, or less than 70% of the length of the fluid collection device.

[0052] In some embodiments, the shape memory material 130 includes a width of about 3 mm to about 6.5 mm, about 3 mm to about 4.5 mm, about 4 mm to about 5.5 mm, about 5 mm to about 6.5 mm, about 3 mm to about 3.75 mm, about 3.5 mm to about 4.25 mm, about 4 mm to about 4.75 mm, about 4.5 mm to about 5.25 mm, about 5 mm to about 5.75 mm, about 5.5 mm, to about 6.25 mm, about 3 mm, about 3.5 mm, about 4 mm, about 4.5 mm, about 5 mm, about 5.5 mm, about 6 mm, or about 6.5 mm.

[0053] In some embodiments, the shape memory material 130 includes a thickness of about 0.1 mm to about 0.6 mm, about 0. 1 mm to about 0.4 mm, about 0.3 mm to about 0.6 mm, about 0. 1 mm to about 0.3 mm, about 0.2 mm to about 0.4 mm, about 0.3 mm to about 0.5 mm, about 0.4 mm to about 0.6 mm, about 0. 1 mm, about 0.2 mm, about 0.3 mm, about 0.4 mm, about 0.5 mm, about 0.6 mm, less than about 0.6 mm, less than about 0.5 mm, less than about 0.4 mm, less than about 0.3 mm, or less than about 0.2 mm.

[0054] In some examples, the shape memory material may be incorporated into the fluid impermeable barrier, such as located external to the chamber and within the fluid impermeable barrier. Returning to FIG. IB, the shape memory material 130 may be coextruded or inserted molded within the fluid impermeable barrier 102. Accordingly, the shape memory material 130 may be isolated within the fluid impermeable barrier 102. The shape memory material 130 may extend from the first end region 125 to the second end region 127. Accordingly, the shape memory material 130 on the fluid collection device 100 may be formed to, and maintain, a selected shape. By locating the shape memory material 130 within the fluid impermeable barrier 102, the shape memory material 130 may not provide a perceptible feel on the skin of the wearer when in use and the shape memory material 130 may be isolated from the fluids in the chamber 104.

[0055] Coextruding the fluid impermeable barrier 102 and the shape memory material 130 results in the fluid impermeable barrier 102 surrounding the shape memory material 130. Accordingly, in some embodiments, substantially all of the shape memory material 130 may interface the fluid impermeable barrier 102 after the shape memory material 130 and the fluid impermeable barrier 102 are coextruded. For example, when coextruded, theshape memory material 130 may interface a first portion of the fluid impermeable barrier 102 that separates the shape memory material 130 from the chamber 104 (e.g., the first portion of the fluid impermeable barrier 102 interfaces the shape memory material 130 and includes a portion of the inner surface 103 of the fluid impermeable barrier 102 defining the chamber 104 and opposite to the shape memory material 130). Also, when coextruded, the shape memory material 130 may interface a second portion of the fluid impermeable barrier 102 that separates the shape memory material 130 from the outside of the fluid collection device 130 (e.g., the second portion of the fluid impermeable barrier 102 interfaces the shape memory material 130 and includes a portion of the outer surface 105 of the fluid impermeable barrier 102 opposite to the shape memory material 130).

[0056] In some embodiments, the shape memory material 130 is positioned directly between two portions (e.g., the first portion and the second portion) of the fluid impermeable barrier 102 each having a thickness of about 1.5 mm or less or 1 mm or less. In some embodiments, the region of the fluid impermeable barrier 102 having the shape memory material 130 disposed between two portions and the shape memory material have a combined thickness of about 3 mm or less, such as a combined thickness of about 1 mm to about 3 mm, about 1 mm to about 2 mm, about 1 .5 mm to about 2.5 mm, about 2 mm to about 3 mm, less than about 3 mm, less than about 2.5 mm, less than about 2 mm, or less than about 1.5 mm.

[0057] While the region of the fluid collection device 100 including the shape memory material 130 shown in FIG. IB appears to be thicker than other regions of the fluid impermeable barrier 102, in many embodiments, even with the shape memory material 130 disposed between portions of only some of the fluid impermeable barrier 102, the fluid impermeable barrier 102 includes a substantially uniform thickness throughout the fluid impermeable barrier 102. For example, a selected portion of the fluid impermeable barrier 102 having the shape memory material 130 absent therefrom may include a thickness that is substantially equal to a selected region of the fluid impermeable barrier 102 that is coextruded with the shape memory material 130 (e.g., a region of the fluid impermeable barrier having the shape memory material 130 disposed between two portions of the fluid impermeable barrier 102). Accordingly, the fluid impermeable barrier 102 may include a substantially uniform thickness between the region of the fluid impermeable barrier 102 including the shape memory material 130 and one or more regions of the fluid impermeable barrier 102 having the shape memory material absent therefrom.

[0058] While being shown as being only in the lower half (e.g. , back portion) of the fluid impermeable barrier 102, the shape memory material 130 may be disposed in the lateral portions or in the upper half (e.g., front, wearer-facing portion) of the fluid impermeable barrier 102 or may be an at least partial tube concentrically disposed within the fluid impermeable barrier 102.

[0059] In an embodiment, the shape memory material 130 may initially (i.e., before shaping the plate) exhibit one or more bends therein e.g., the plate is an at least partial tube). For example, as illustrated, the plate may exhibit a bend in the direction that is parallel to the width. The bend in the plate may be configured to correspond to the shape of the fluid collection device. For example, at least some of the fluid collection devices disclosed herein exhibit a generally cylindrical shape and the bend in the plate may correspond to the curvature of the generally cylindrical shape of the fluid collection device. However, the bend in the plate may make shaping the plate more difficult. In an embodiment, the plate may be substantially planar. In an embodiment, the plate may have one or more openings or perforations therein. For example, depending on the location of the plate in the fluid collection device, the one or more openings or perforations may allow fluid to flow to through the plate. The one or more openings or perforations may also decrease the weight of the plate. The one or more openings or perforations may also weaken the plate thereby facilitating shaping of the plate to form regions of the plate that are preferentially shaped relative to other regions of the plate. The plate may provide support to the fluid collection device thereby allowing the fluid collection device to better maintain the desired shape thereof.

[0060] FIG. 1C is an isometric view of the fluid collection device 100 of FIG. 1A, according to an embodiment. FIG. 1C shows the fluid collection device 100 in a second shape which differs from the first shape shown in FIG. 1A. As shown, the fluid collection device 100 may be shaped to contour to the anatomy of a wearer using the fluid collection device 100 to improve comfort over conventional devices and to remain in position during use. The fluid collection device 100 may be manipulated to contour to the anatomy in the groin region of a wearer. For example, the second end region 127 may be shaped upwardly such that the fluid collection device 100 maintains a generally arcuate shape with the first end region 125 and the second end region being disposed above a medial portion therebetween. In such examples, the second end region may be positioned in the gluteal cleft of the wearer, the second end region may be positioned against the upper vaginal or pubic area of the wearer, and the portion therebetween may be shaped to contour theanatomy of the wearer. The shape in the device may be more or less arcuate depending on the size and shape of the wearer. Accordingly, the devices disclosed herein may be utilized with a variety of differently sized wearers.

[0061] Additionally, the fluid collection device 100 may be returned to an original shape (e.g., a substantially straight cylinder) or manipulated into a third shape after being manipulated and used in the second shape. Such manipulation may be performed by applying a stimuli, such as any of those disclosed herein.

[0062] In an example, one or more components (e.g., fluid impermeable barrier 102, conduit 108, the porous material 115, etc.) of the fluid collection device 100 may include an odor blocking or absorbing material such as a cyclodextrine-containing material or a thermoplastic elastomer (TPE) polymer.

[0063] Other embodiments of fluid impermeable barriers, fluid permeable membranes, fluid permeable supports, chambers, and their shapes and configurations are disclosed in U.S. Patent Application No. 15 / 612,325 filed on June 2, 2017; U.S. Patent Application No. 15 / 260,103 filed on September 8, 2016; and U.S. Patent No. 10,225,376 filed on June 1, 2017, the disclosure of each of which is incorporated herein, in its entirety, by this reference.

[0064] FIG. 2 is a block diagram of a system 201 for fluid collection, according to an embodiment. The system 201 includes a fluid collection device 200, a fluid storage container 207, and a vacuum source 209. The fluid collection device 200, the fluid storage container 207, and the vacuum source 209 may be fluidly coupled to each other via one or more conduits 108. For example, fluid collection device 200 may be operably coupled to one or more of the fluid storage container 207 or the vacuum source 209 via the conduit 108. Fluid (e.g., urine or other bodily fluids) collected in the fluid collection device 200 may be removed from the fluid collection device 200 via the conduit 108 which protrudes into the fluid collection device 200. For example, an inlet of the conduit 108 may extend into the fluid collection device 200, such as to a reservoir therein. The outlet of the conduit 108 may extend into the fluid collection device 200 or the vacuum source 209. Suction force may be introduced into the chamber of the fluid collection device 200 via the inlet of the conduit 108 responsive to suction (e.g., vacuum) force applied at the outlet of the conduit 108.

[0065] The suction force may be applied to the outlet of the conduit 108 by the vacuum source 209 either directly or indirectly. The suction force may be applied indirectly via the fluid storage container 207. For example, the outlet of the conduit 108 may be disposedwithin the fluid storage container 207 and an additional conduit 108 may extend from the fluid storage container 207 to the vacuum source 209. Accordingly, the vacuum source 209 may apply suction to the fluid collection device 200 via the fluid storage container 207. The suction force may be applied directly via the vacuum source 209. For example, the outlet of the conduit 108 may be disposed within the vacuum source 209. An additional conduit 108 may extend from the vacuum source 209 to a point outside of the fluid collection device 200, such as to the fluid storage container 207. In such examples, the vacuum source 209 may be disposed between the fluid collection device 200 and the fluid storage container 207.

[0066] The fluid collection device 200 may be similar or identical to any of the fluid collection devices disclosed herein (e.g. , 100 and 300-1500) in one or more aspects. The fluid collection device 200 may be shaped and sized to be positioned adjacent to a female urethra. For example, the fluid collection device 200 may include a fluid impermeable barrier at least partially defining a chamber (e.g., interior region) of the fluid collection device 200. The fluid impermeable barrier also defines an opening extending therethrough from the external environment. The opening may be positioned adjacent to a female urethra. The fluid collection device 200 may include a fluid permeable membrane disposed within the fluid impermeable barrier. The fluid collection device 200 may include porous material disposed in the chamber such as one or more of a fluid permeable support and a fluid permeable membrane. The fluid collection device 200 includes the shape memory material on or incorporated in one or more components thereof. The shape memory material is sized, shaped, and positioned to retain a selected geometric configuration as disclosed herein. The conduit 108 may extend into the fluid collection device 200 at a first end (e.g. , proximal) region, through one or more of the fluid impermeable barrier, fluid permeable membrane, or the fluid permeable support to a second end (e.g., distal) region of the fluid collection device 200. The conduit 108 includes an inlet and an outlet, the outlet being fluidly coupled to the fluid storage container and the inlet being positioned in a portion of the chamber selected to be at a gravimetrically low point of the fluid collection device when worn.

[0067] The fluid storage container 207 is sized and shaped to retain a fluid therein. The fluid storage container 207 may include a bag (e.g., drainage bag), a bottle or cup (e.g., collection jar), or any other enclosed container for storing bodily fluid(s) such as urine. In some examples, the conduit 108 may extend from the fluid collection device 200 and attach to the fluid storage container 207 at a first point therein. An additional conduit 108 mayattach to the fluid storage container 207 at a second point thereon and may extend and attach to the vacuum source 209. Accordingly, a vacuum (e.g., suction) may be drawn through fluid collection device 200 via the fluid storage container 207. Fluid, such as urine, may be drained from the fluid collection device 200 using the vacuum source 209.

[0068] The vacuum source 209 may include one or more of a manual vacuum pump, and electric vacuum pump, a diaphragm pump, a centrifugal pump, a displacement pump, a magnetically driven pump, a peristaltic pump, or any pump configured to produce a vacuum. The vacuum source 209 may provide a vacuum or suction to remove fluid from the fluid collection device 200. In some examples, the vacuum source 209 may be powered by one or more of a power cord (e.g., connected to a power socket), one or more batteries, or even manual power (e.g., a hand operated vacuum pump). In some examples, the vacuum source 209 may be sized and shaped to fit outside of, on, or within the fluid collection device 200. For example, the vacuum source 209 may include one or more miniaturized pumps or one or more micro pumps. The vacuum sources 209 disclosed herein may include one or more of a switch, a button, a plug, a remote, or any other device suitable to activate the vacuum source 209.

[0069] FIG. 3 is a flow diagram of a method 300 of forming a fluid collection device, according to an embodiment. The fluid collection device formed according to embodiments of the method 300 may include any of the fluid collection devices disclosed herein. In some embodiment, the method 300 includes coextruding 310 a fluid impermeable material and a shape memory material to form a fluid impermeable barrier at least partially defining a chamber and defining an opening extending through the fluid impermeable barrier, the shape memory material including a metal plate, rod, or wire. In some embodiments, the method 300 includes disposing 320 at least one porous material within the chamber such that the at least one porous material extend across the opening.

[0070] In some embodiments of the method 300, the metal plate, rod, or wire includes aluminum, copper, aluminum alloy, brass, or combinations thereof. Coextruding 310 may include coextruding the fluid impermeable material and the shape memory material to form the fluid impermeable barrier with the shape memory material disposed on or within a region of the fluid impermeable barrier generally opposite to the opening. The shape memory material may have a thickness of about 0.1 mm to about 0.6 mm. Coextruding 310 may include coextruding the fluid impermeable material and the shape memory material to form the fluid impermeable barrier with the shape memory material disposed directly between two portions of the fluid impermeable barrier having a thickness of about 1 mmor less. The region of the fluid impermeable barrier and the shape memory material may have a combined thickness of about 2.5 mm or less.

[0071] In some embodiments, coextruding 310 the fluid impermeable material and the shape memory material to form the fluid impermeable barrier includes coextruding the fluid impermeable barrier and one or more metal rods or wires to form the fluid impermeable barrier. More particularly, coextruding 310 the fluid impermeable barrier and one or more metal rods or wires to form the fluid impermeable barrier includes coextruding the fluid impermeable barrier and one or more metal rods or wires to form the fluid impermeable barrier having a substantially uniform thickness throughout the fluid impermeable barrier.

[0072] In some embodiments of the method 300, the shape memory material has a width of about 3 mm to about 6.5 mm. In some embodiments of the method 300, the shape memory material has a length that is about 50% to about 100% of a longitudinal length of the fluid impermeable barrier. In some embodiments of the method 300, the at least on porous material includes a vertical non-woven foam and wicking material covering the vertical non-woven foam across at least the opening of the fluid impermeable barrier, the wicking material including a bamboo or hydrophilic polypropylene material.

[0073] As used herein, the term “about” or “substantially” refers to an allowable variance of the term modified by “about” by ±10% or ±5%. Further, the terms “less than,” “or less,” “greater than”, “more than,” or “or more” include as an endpoint, the value that is modified by the terms “less than,” “or less,” “greater than,” “more than,” or “or more.”

[0074] While various aspects and embodiments have been disclosed herein, other aspects and embodiments are contemplated. The various aspects and embodiment disclosed herein are for purposes of illustration and are not intended to be limiting.

Claims

CLAIMSWhat is claimed is:

1. A fluid collection device, comprising: a fluid impermeable barrier that is extruded and at least partially defines a chamber, the fluid impermeable barrier also defining an opening extending therethrough, the opening configured to be positioned adjacent to a female urethra; at least one porous material disposed in the chamber; and a shape memory material that is elongated and coextruded with the fluid impermeable barrier, the shape memory material being sized, shaped, and positioned to retain the shape memory material and the fluid impermeable barrier in a selected geometric configuration.

2. The fluid collection device of claim 1, wherein the at least one shape memory material includes a shape memory polymer or a shape memory metal.

3. The fluid collection device of any of claims 1-2, wherein the at least one shape memory material includes aluminum, copper, aluminum alloy, brass, or combinations thereof.

4. The fluid collection device of any of claims 1 -3, wherein the shape memory material coextruded with the fluid impermeable barrier is disposed on or within a region of the fluid impermeable barrier generally opposite to the opening.

5. The fluid collection device of claim 4, wherein the shape memory material has a thickness of about 0. 1 mm to about 0.6 mm.

6. The fluid collection device of claim 5, wherein the shape memory material is positioned directly between two portions of the fluid impermeable barrier having a thickness of about 1 mm or less.

7. The fluid collection device of any of claims 4-6, wherein the region of the fluid impermeable barrier and the shape memory material having a combined thickness of about 2.5 mm or less, and wherein the fluid impermeable barrier includes a substantially uniform thickness between the region including the shape memory material and one or more regions of the fluid impermeable barrier having the shape memory material absent therefrom.

8. The fluid collection device of any of claims 1-7, wherein the shape memory material has a width of about 3 mm to about 6.5 mm.

9. The fluid collection device of any of claims 1-3, wherein the shape memory material includes one or more rods or wires coextruded with the fluid impermeable barrier.

10. The fluid collection device of claim 9, wherein the fluid impermeable barrier includes a substantially uniform thickness throughout the fluid impermeable barrier.

11. The fluid collection device of any of claims 1-10, wherein the shape memory material has a length that is about 50% to about 100% of a longitudinal length of the fluid impermeable barrier.

12. The fluid collection device of any of claims 1-11, wherein the at least one porous material includes a vertical non-woven foam and wicking material covering the vertical non-woven foam across at least the opening of the fluid impermeable barrier, the wicking material including a bamboo or hydrophilic polypropylene material.

13. A fluid collection device, comprising: a fluid impermeable barrier that is extruded and at least partially defines a chamber, the fluid impermeable barrier also defining an opening extending therethrough, the opening configured to be positioned adjacent to a female urethra; at least one porous material disposed in the chamber; and a shape memory material that is elongated and sized, shaped, and positioned to retain the shape memory material and the fluid impermeable barrier in a selected geometric configuration, wherein the shape memory material is disposed on or within a region of the fluid impermeable barrier generally opposite to the opening, the shape memory material having a thickness of about 0. 1 mm to about 0.6 mm and a width of about 3 mm to about 6.5 mm, and the region of the fluid impermeable barrier and the shape memory material having a combined thickness of about 2.5 mm or less, wherein the fluid impermeable barrier includes a substantially uniform thickness between the region including the shape memory material and one or more regions of the fluid impermeable barrier having the shape memory material absent therefrom.

14. The fluid collection device of claim 13, wherein the at least one shape memory material includes an elongated metal plate.

15. The fluid collection device of claim 14, wherein the elongated metal plate includes aluminum, copper, aluminum alloy, brass, or combinations thereof.

16. The fluid collection device of any of claims 13-15, wherein the shape memory material is positioned directly between two portions of the fluid impermeable barrier having a thickness of about 1 mm or less.

17. The fluid collection device of any of claims 13-16, wherein the shape memory material has a length that is about 50% to about 100% of a longitudinal length of the fluid impermeable barrier.

18. The fluid collection device of any of claims 13-17, wherein the shape memory material is coextruded or insert molded with the fluid impermeable barrier.

19. The fluid collection device of any of claims 13-18, wherein the at least one porous material includes a vertical non-woven foam and wicking material covering the vertical non-woven foam across at least the opening of the fluid impermeable barrier, the wicking material including a bamboo or hydrophilic polypropylene material.

20. A fluid collection system, comprising: a fluid storage container configured to hold a fluid; the fluid collection device of any one of claims 1-17; and a vacuum source fluidly coupled to one or more of the fluid storage container or the fluid collection device via the conduit, the vacuum source configured to draw fluid from the fluid collection device via the conduit.

21. A method of forming a fluid collection device, the method comprising: coextruding a fluid impermeable material and a shape memory material to form a fluid impermeable barrier at least partially defining a chamber and defining an opening extending through the fluid impermeable barrier; and disposing at least one porous material within the chamber such that the at least one porous material extend across the opening.

22. The method of claim 21, wherein the shape memory material includes metal plate of aluminum, copper, aluminum alloy, brass, or combinations thereof.

23. The method of any of claims 21-22, wherein coextruding the fluid impermeable material and the shape memory material to form the fluid impermeable barrier includes coextruding the fluid impermeable material and the shape memory material to form the fluid impermeable barrier with the shape memory material disposed on or within a region of the fluid impermeable barrier generally opposite to the opening.

24. The method of claim 23, wherein the shape memory material has a thickness of about 0.1 mm to about 0.6 mm.

25. The method of claim 24, wherein coextruding the fluid impermeable material and the shape memory material to form the fluid impermeable barrier with the shape memory material disposed on or within a region of the fluid impermeable barrier generally opposite to the opening includes coextruding the fluid impermeable material and the shape memory material to form the fluid impermeable barrier with the shape memory material disposed directly between two portions of the fluid impermeable barrier having a thickness of about 1 mm or less.

26. The method of any of claims 23-25, wherein the region of the fluid impermeable barrier and the shape memory material having a combined thickness of about 2.5 mm or less, and wherein the fluid impermeable barrier includes a substantially uniform thickness between the region including the shape memory material and one or more regions of the fluid impermeable barrier having the shape memory material absent therefrom.

27. The method of any of claims 21-26, wherein the shape memory material has a width of about 3 mm to about 6.5 mm.

28. The method of any of claims 21-33, wherein coextruding the fluid impermeable material and the shape memory material to form the fluid impermeable barrier includes coextruding the fluid impermeable barrier and one or more metal rods or wires to form the fluid impermeable barrier.

29. The method of claim 28, wherein coextruding the fluid impermeable barrier and one or more metal rods or wires to form the fluid impermeable barrier includes coextruding the fluid impermeable barrier and one or more metal rods or wires to form the fluid impermeable barrier having a substantially uniform thickness throughout the fluid impermeable barrier.

30. The method of any of claims 21 -29, wherein the shape memory material has a length that is about 50% to about 100% of a longitudinal length of the fluid impermeable barrier.

31. The method of any of claims 21-30, wherein the at least on porous material includes a vertical non-woven foam and wicking material covering the vertical non-woven foam across at least the opening of the fluid impermeable barrier, the wicking material including a bamboo or hydrophilic polypropylene material.

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