Fluid collection assembly including a catheter with shape memory material

Abstract

A fluid collection assembly (100) includes a fluid-impermeable layer (102) that defines at least a chamber (104), at least one opening (106), and a fluid outlet (108). The fluid collection assembly also includes at least one porous material (110) disposed within the chamber and a multi-lumen conduit (114) disposed within the at least one porous material. The multi-lumen conduit includes a fluid lumen (147) and a shape memory lumen (149), with the shape memory material (150) held within the shape memory lumen by a limiting plug (154) and an end plug (152).

Description

[0001] Cross-references to related applications

[0002] This application claims priority to U.S. Provisional Patent Application No. 63 / 596,012, filed November 3, 2023, the disclosure of which is incorporated herein by reference in its entirety. Background Technology

[0003] People or animals may have limited or impaired mobility, making the routine urination process difficult or impossible. For example, an individual may experience or have a disability that affects their mobility. An individual may also be under conditions that restrict travel, such as those experienced by pilots, drivers, and workers in hazardous areas. Furthermore, in some cases, it is necessary to collect bodily fluids for monitoring or clinical testing.

[0004] Urinary catheters (such as Foley catheters) can address some of these situations, such as urinary incontinence. Unfortunately, catheters can cause discomfort and pain and may lead to complications such as infections. Additionally, bedpans are sometimes used; a bedpan is a container for bedridden individuals to use for toileting. However, bedpans are prone to discomfort, spills, and other hygiene problems. Summary of the Invention

[0005] Various embodiments relate to fluid collection assemblies, fluid collection systems including the same, and methods of using and forming the same. The fluid collection assembly includes a multi-lumen conduit having a shape memory material disposed within a shape memory lumen. In one embodiment, a fluid collection assembly is disclosed. The fluid collection assembly includes a fluid-impermeable layer defining a chamber within the fluid-impermeable layer, at least one opening through the fluid-impermeable layer, and a fluid outlet. The fluid collection assembly includes at least one porous material disposed within the chamber. The fluid collection assembly includes a conduit disposed within the at least one porous material, the conduit having a multi-lumen configuration having a fluid lumen and a shape memory lumen. The fluid collection assembly includes a shape memory material disposed within the shape memory lumen. The fluid collection assembly includes a limiting plug and an end plug disposed within the shape memory lumen, wherein the limiting plug and the end plug are disposed at opposite ends of the shape memory material within the shape memory lumen to prevent longitudinal movement of the shape memory material within the shape memory lumen.

[0006] In one embodiment, a fluid collection system is disclosed. The fluid collection system includes a fluid collection assembly. The fluid collection assembly includes a fluid-impermeable layer defining a chamber within the fluid-impermeable layer, at least one opening penetrating the fluid-impermeable layer, and a fluid outlet. The fluid collection assembly includes at least one porous material disposed within the chamber. The fluid collection assembly includes a conduit disposed within the at least one porous material, the conduit having a multi-cavity configuration having a fluid cavity and a shape memory cavity. The fluid collection assembly includes a shape memory material disposed within the shape memory cavity. The fluid collection assembly includes a limiting plug and an end plug disposed within the shape memory cavity, wherein the limiting plug and the end plug are disposed at opposite ends of the shape memory material within the shape memory cavity to prevent longitudinal movement of the shape memory material within the shape memory cavity. The fluid collection system also includes a fluid storage container and a vacuum source. The chamber, fluid storage container, and vacuum source of the fluid collection assembly are in fluid communication with each other, such that when one or more bodily fluids are present in the chamber, the suction provided by the vacuum source to the chamber of the fluid collection assembly removes the one or more bodily fluids from the chamber and stores the bodily fluids in the fluid storage container.

[0007] In one embodiment, a method for collecting bodily fluids using a fluid collection assembly is disclosed. The method includes: shaping the fluid collection assembly into a selected shape by bending a shape-memory material in a multi-lumen conduit of the fluid collection assembly. The method includes: positioning an opening of the fluid collection assembly adjacent to or on the wearer's urethra. The method includes: receiving the wearer's bodily fluids in the fluid collection assembly. The method further includes: receiving one or more bodily fluids from a urethral opening into the at least one porous material through the at least one opening.

[0008] Features of any of the disclosed embodiments can 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 upon consideration of the following detailed description and accompanying drawings. Attached Figure Description

[0009] The accompanying drawings illustrate several embodiments of the present disclosure, wherein the same reference numerals denote the same or similar elements or features in different views or embodiments shown in the drawings.

[0010] Figure 1A An isometric view of a fluid collection assembly according to one embodiment.

[0011] Figure 1B and Figure 1C respectively along Figure 1A The diagram shows a cross-sectional view of the fluid collection assembly taken from planes 1B-1B and 1C-1C.

[0012] Figure 1D According to one embodiment, from Figure 1C A cross-sectional schematic diagram of a portion of the fluid collection assembly, as shown in the box.

[0013] Figure 1E This is a cross-sectional view of a catheter according to one embodiment.

[0014] Figure 2A This is a cross-sectional schematic diagram of a fluid collection assembly according to one embodiment.

[0015] Figure 2B For the section cut along plane 2B-2B Figure 2A A cross-sectional schematic diagram of the fluid collection assembly.

[0016] Figure 3 This is a cross-sectional schematic diagram of a fluid collection assembly according to one embodiment.

[0017] Figure 4 This is a block diagram of a fluid collection system for fluid collection according to one embodiment. Detailed Implementation

[0018] Various embodiments relate to a fluid collection assembly including a multi-lumen conduit with a shape memory material disposed within at least one lumen, a fluid collection system including the same, and methods of using and forming thereof. An exemplary fluid collection assembly includes a fluid-impermeable layer (e.g., a fluid-impermeable barrier) that defines at least a chamber, at least one opening, and a fluid outlet. The fluid collection assembly also includes at least one porous material disposed within the chamber. The fluid collection assembly further includes a multi-lumen conduit with the shape memory material disposed within at least one lumen, wherein the shape memory material is contained therein via end plugs and retaining plugs within the lumen.

[0019] During use, the fluid collection assembly can be positioned on the individual such that the opening is located adjacent to the female or male urethral opening (i.e., on the penis). The individual may expel one or more bodily fluids, such as urine, blood, or sweat. The bodily fluids may flow into the chamber and be received into the porous material. The bodily fluids may be removed from the chamber via the fluid outlet. In one embodiment, a suction force may be applied to the chamber by a vacuum source to remove the bodily fluids from the chamber.

[0020] Shape memory material, disposed within a shape memory cavity and held therein by a retaining plug and end plugs, allows the fluid collection assembly to be bent, molded, or otherwise shaped into a selected configuration. The shape memory material disposed within the shape memory cavity and held therein by the retaining plug and end plugs allows for longitudinal movement within the shape memory cavity, providing superior malleability compared to shape memory material fixed longitudinally within the shape memory cavity. The end plugs and retaining plugs also prevent corrosion or contamination of the shape memory material by sealing it within the shape memory cavity. This configuration also prevents the wearer from feeling the presence of the shape memory material by placing it inside the conduit.

[0021] Figure 1A This is a perspective view of a fluid collection assembly 100 according to one embodiment. Figure 1B and Figure 1C respectively along Figure 1A The diagram shows a cross-sectional view of a fluid collection assembly 100 taken from planes 1B-1B and 1C-1C. This fluid collection assembly is an example of a fluid collection assembly configured to receive bodily fluids from the urethral orifice. The fluid collection assembly 100 includes a fluid-impermeable layer 102. The fluid-impermeable layer 102 defines at least a chamber 104, at least one opening 106, and a fluid outlet 108. The fluid collection assembly 100 also includes at least one porous material 110 disposed within the chamber 104 and extending across the opening 106. The porous material 110 includes at least one porous body material 138. The fluid collection assembly 100 also includes a catheter 114 having a multi-lumen configuration.

[0022] The fluid-impermeable layer 102 at least partially defines a chamber 104 (e.g., an interior region) and an opening 106. The fluid-impermeable layer 102 temporarily stores bodily fluids within the chamber 104. The fluid-impermeable layer 102 can be formed of any suitable fluid-impermeable material, such as fluid-impermeable polymers (e.g., silicone, polypropylene, polyethylene, polyethylene terephthalate, neoprene, polycarbonate, etc.), metal films, natural rubber, other suitable materials, any other fluid-impermeable materials disclosed herein, or combinations thereof. Thus, the fluid-impermeable layer 102 substantially prevents bodily fluids from passing through it. In one example, the fluid-impermeable layer 102 may be air-permeable but fluid-impermeable. In such an example, the fluid-impermeable layer 102 may be formed of a hydrophobic material defining a plurality of pores. At least one or more portions of at least the outer surface of the fluid-impermeable layer 102 may be formed of a soft and / or smooth material, thereby reducing friction on the wearer or user of the component.

[0023] Opening 106 provides an entry path for bodily fluids into chamber 104. Opening 106 may be defined by a fluid-impermeable layer 102, for example, by the inner edge of the fluid-impermeable layer 102. For example, opening 106 is formed in and extends through the fluid-impermeable layer 102, thereby allowing bodily fluids to enter chamber 104 from the outside of the fluid collection assembly 100.

[0024] In some examples, a fluid-impermeable layer 102 may define a fluid outlet 108, which is sized to receive a catheter 114. At least one catheter 114 may be disposed within a chamber 104 via the fluid outlet 108. The size and shape of the fluid outlet 108 may be adapted to form at least substantially a fluid seal with the catheter 114 (e.g., a drainage tube), thereby substantially preventing the leakage of bodily fluids from the chamber 104.

[0025] As previously described, the fluid collection assembly 100 includes a porous material 110 disposed within the chamber 104. The porous material 110 may cover at least a portion (e.g., all) of the opening 106. At least one porous material 110 may include one or more of foam, spun fibers, vertical nonwoven materials, textile materials, quilted materials, etc. At least one porous material 110 may include a porous body material 138, and optionally include a porous membrane material disposed above the porous body material. Figure 2A and Figure 2B ).

[0026] At least one porous material 110 may be formed from any suitable natural material (e.g., fiber, fabric, foam) or synthetic material (e.g., fiber, fabric, foam). In some embodiments, at least one porous material 110 may include open-cell foam, carded web, spun fibers (e.g., spun nylon fibers), nonwoven fibers, textile fibers, etc. For example, the porous host material 138 may include open-cell foam or vertical nonwoven material. In one embodiment, at least one porous material 110 (e.g., porous host material 138) may be formed from synthetic fibers or foam, such as polymer fibers or foam. Examples of synthetic fibers or foams include polyester, polyethylene, polypropylene, polyurethane (e.g., viscoelastic PU), latex, silicone, nylon, etc. In some embodiments, at least one porous material 110 may be formed from natural fibers, which may have better sustainability and biodegradability compared to synthetic fibers. Examples of natural fibers include cellulose, cotton, bamboo fiber, wool, etc.

[0027] In some embodiments, open-cell foam can be used in porous material 110 (e.g., porous bulk material 138). The density and porosity of the open-cell foam can be selected to provide the desired fluid transport volume and rate through it. For example, the density of the open-cell foam can be at least 40 kg / m³. 3 For example, about 40 kg / m3 Approximately 500 kg / m 3 Approximately 50 kg / m 3 Approximately 400 kg / m 3 Approximately 50kg / m 3 Approximately 200 kg / m 3 Approximately 200 kg / m 3 Approximately 400 kg / m 3 or less than 500 kg / m 3 The porosity of the open-cell foam can be at least about 15 pores per inch (PPI), for example, about 20 PPI to about 120 PPI, about 20 PPI to about 50 PPI, about 50 PPI to about 100 PPI, or less than about 120 PPI. The material of the open-cell foam can be selected to have the desired surface properties (e.g., hydrophilicity or hydrophobicity) and structural properties (e.g., flexural stiffness). As will be described in more detail below, the open-cell foam can include any of a variety of different materials, such as rubber, one or more polymers, etc.

[0028] Typically, the average person's urination rate is from about 6 ml / s to about 50 ml / s, for example, from about 10 ml / s to about 25 ml / s. Individual urination rates may vary, for example, depending on an individual's body size and age. The porous material 110 can be selected to capture and transport bodily fluids at a rate comparable to the rate at which an individual excretes bodily fluids to prevent leakage. For example, at least one porous material 110 can be selected to capture and transport bodily fluids at rates greater than about 6 ml / s, greater than about 10 ml / s, greater than about 30 ml / s, about 6 ml / s to about 50 ml / s, about 6 ml / s to about 20 ml / s, about 20 ml / s to about 40 ml / s, about 6 ml / s to about 15 ml / s, about 15 ml / s to about 25 ml / s, less than about 50 ml / s, or less than about 30 ml / s.

[0029] In some embodiments, at least one porous material 110 (e.g., porous host material 138) may be configured to wick and / or otherwise transport any bodily fluid away from the opening 106, thereby preventing the bodily fluid from escaping from the chamber 104. Permeability as referred to herein may be wicking, capillary action, diffusion, or other similar properties or processes, and is referred to herein as “permeable” and / or “wicking.” Such “wicking” and / or “permeable” properties may not include the adsorption of bodily fluid into at least a portion of the at least one porous material 110. In other words, after the at least one porous material 110 is exposed to bodily fluid and removed from the bodily fluid for a period of time, the bodily fluid is substantially not adsorbed or dissolved into the at least one porous material 110. Although the absence of adsorption or dissolution is desired, the term "substantially non-adsorbent" allows a nominal amount of bodily fluid to adsorb and / or dissolve into at least one porous material 110 (e.g., adsorbent), for example, less than about 30 wt%, less than about 20 wt%, less than about 10 wt%, less than about 7 wt%, less than about 5 wt%, less than about 3 wt%, less than about 2 wt%, less than about 1 wt%, or less than about 0.5 wt% of the dry weight of at least one porous material 110. In one embodiment, at least one porous material 110 may comprise at least one adsorbent or absorbent material.

[0030] In one embodiment, at least one porous material 110 may be hydrophobic. At least one porous material 110 may be hydrophobic when the contact angle between at least one porous material 110 and water is about 90° to about 120°, about 105° to about 135°, about 120° to about 150°, about 135° to about 165°, or greater than 150°. Compared to at least one porous material 110 being hydrophilic, at least one hydrophobic porous material 110 can more rapidly transport the bodily fluids it receives.

[0031] Nevertheless, in one embodiment, at least one porous material 110 may be hydrophilic. The hydrophilicity of at least one porous material 110 allows it to rapidly capture bodily fluids, thereby preventing or at least inhibiting bodily fluid leakage due to the large-scale expulsion of bodily fluids in a short period. At least one porous material 110 may be hydrophilic when the contact angle between the at least one porous material 110 and water (the main component of bodily fluids) is about 0° to about 90°, about 0° to about 15°, about 15° to about 30°, about 30° to about 45°, about 45° to about 60°, about 60° to about 90°, about 10° to about 40°, about 40° to about 80°, less than about 90°, less than about 60°, or less than about 30°. Generally, increasing the hydrophilicity of at least one porous material 110 (i.e., reducing the contact angle between the vertical nonwoven material and water) increases the amount of bodily fluid that the at least one porous material 110 can receive within a certain time. However, increasing the hydrophilicity of at least one porous material 110 increases the amount of bodily fluid retained in the at least one porous material 110 after receiving bodily fluid. Therefore, the hydrophilicity of at least one porous material 110 can be selected based on a balance between the need for rapid bodily fluid reception and the simultaneous maintenance of dryness of the at least one porous material 110. For example, at least one porous material 110 included in a fluid collection assembly 100 configured for short-term use with an individual with a large bladder may exhibit greater hydrophilicity than at least one porous material 110 in a fluid collection assembly 100 configured for long-term use with an individual with a medium to small bladder. It should be noted that at least some conventional fluid collection assemblies are selected to be hydrophobic to improve their fluid transport. However, it has been unexpectedly found that even when the vertical nonwoven material is hydrophilic, the vertical nonwoven material still exhibits rapid fluid transport.

[0032] In one embodiment, the hydrophobicity or hydrophilicity of at least one porous material 110 may be an inherent property of the material (e.g., fiber) used to form the at least one porous material 110. In one embodiment, the hydrophobicity or hydrophilicity of the at least one porous material 110 may be altered by at least one of the following methods: adding impurities or functional groups to the at least one porous material 110, otherwise treating the at least one porous material 110, or coating the at least one porous material 110 with a material exhibiting different hydrophobicity or hydrophilicity than the at least one porous material 110.

[0033] Figure 1D According to one embodiment, from Figure 1CThe diagram shows a cross-sectional view of a portion of the fluid collection assembly 100, captured by the frame. As shown, at least one porous material 110 may comprise a vertical nonwoven material. The vertical nonwoven material is formed from a folded nonwoven web 118. The folded nonwoven web 118 may comprise a plurality of folds 120 and a plurality of intermediate portions 122 extending between the folds 120. The folded nonwoven web 118 may comprise an outer surface adjacent to the fluid-impermeable layer 102 and an opposing inner surface (e.g., defining an aperture for a receiving conduit 114). The folds 120 may extend substantially parallel to the outer and inner surfaces of the folded nonwoven web 118. The intermediate portions 122 may extend between the outer and inner surfaces of the folded nonwoven web 118. In one embodiment, a folded nonwoven mesh 118 may be positioned within a chamber 104 such that the fold 120 extends substantially parallel to the longitudinal (e.g., central) axis 116 of the fluid collection assembly 100 (e.g., substantially parallel to the longitudinal axis of the porous material 110), and / or extends circumferentially when the porous material 110 is substantially cylindrical. A folded nonwoven mesh 118 may be positioned within a chamber 104 such that a middle portion 122 extends substantially parallel to the longitudinal axis 116 of the fluid collection assembly 100 (e.g., substantially parallel to the longitudinal axis of the porous material 110), and / or extends radially when the porous material 110 is substantially cylindrical.

[0034] The vertical nonwoven material comprises a plurality of fibers 124. In one embodiment, the nonwoven web 118 forming the vertical nonwoven material may include a plurality of generally oriented fibers 124. The generally oriented fibers 124 can improve the ability of the vertical nonwoven material to capture and transport bodily fluids. The generally oriented fibers 124 can also improve the mechanical properties of the vertical nonwoven material. As used herein, fibers 124 are “generally aligned” when a certain percentage of fibers 124 are substantially parallel to each other. The certain percentage of fibers 124 means at least about 70% of fibers 124, more preferably at least about 80% of fibers 124, more preferably 90% of fibers 124, and even more preferably at least about 95% of fibers 124. The fibers 124 are substantially parallel to each other when the certain percentage of fibers 124 are parallel to each other ±30°, more preferably ±20°, more preferably ±10°, and even more preferably ±5°.

[0035] The nonwoven web 118 may be disposed within the chamber 104 such that the fibers 124 in the fold 120 are generally oriented circumferentially, and the fibers 124 in the intermediate portion 122 are generally oriented radially. Without being bound by theory, the circumferential orientation of the fibers 124 in the fold 120 allows body fluids initially received by the vertical nonwoven material to preferentially diffuse circumferentially, and the radial orientation of the fibers 124 in the intermediate portion allows body fluids initially to preferentially diffuse radially into the porous material 110. This initial circumferential and radial diffusion of the body fluids allows for rapid dispersion of the body fluids within a large volume of the vertical nonwoven material, thereby enabling the vertical nonwoven material to quickly capture and transport the body fluids. It should be noted that the fibers 124 do not impede the flow of body fluids in a direction generally parallel to the longitudinal axis 116, especially after the fibers 124 have been wetted. Furthermore, dispersing the body fluids within the vertical nonwoven material increases the surface area of ​​any body fluids that may remain in the vertical nonwoven material after removal from the porous material 110. A larger surface area facilitates the evaporation of residual body fluids as air flows through the porous material 110. In one embodiment, the fibers 124 are randomly oriented, or may be oriented in relation to... Figure 1D The different orientations shown.

[0036] In one embodiment, as shown, folding the nonwoven web 118 can result in the formation of a gap 125 extending generally parallel to the longitudinal axis 116. The gap 125 can facilitate fluid flow in a direction generally parallel to the longitudinal axis 116. However, the nonwoven web 118 can be folded or compressed by the fluid-impermeable layer 102 to reduce the size of the gap 125, thereby preventing the accumulation of bodily fluids within the chamber 104. For example, the nonwoven web 118 can be folded or compressed by the fluid-impermeable layer 102 such that the size of the gap 125, measured perpendicular to the longitudinal axis 116, 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.

[0037] As previously described, the vertical nonwoven material can be formed from at least one folded nonwoven web 118. The vertical nonwoven material can be formed from any suitable nonwoven web. In one embodiment, the nonwoven web includes at least one carding web. The carding web includes a plurality of fibers 124, which may be oriented in a generally similar direction. The generally similar orientation of the fibers 124 in the carding web makes the carding web anisotropic. For example, the strength of the carding web is greatest when the force applied to it is generally parallel to the fiber 124; however, the strength of the carding web decreases as the force applied to it becomes increasingly oblique or perpendicular to the fiber orientation. Therefore, the carding web may need to be positioned within the chamber 104 to mitigate forces applied to it that are not generally parallel to the fiber 124 orientation, or the bonding between the fibers 124 may need to be increased (e.g., thermal or chemical) to prevent undesirable wear of the carding web.

[0038] In one embodiment, the nonwoven web 118 may include at least one needled web. The needled web may be formed from a sheet comprising a plurality of fibers 124. The sheet may include a plurality of randomly oriented fibers 124 (e.g., fibers 124 are generally parallel to a plane and randomly oriented within the plane), or may include generally oriented fibers 124 (e.g., a combed web), because the orientation of the fibers 124 can better facilitate the flow of bodily fluids therein. A plurality of needles (e.g., a plurality of barbed needles) are inserted into the sheet in a direction generally parallel to the thickness of the sheet, thereby causing portions of the fibers 124 to become entangled and interlocked with each other.

[0039] In one embodiment, the nonwoven web 118 may include at least one air-laid web. The air-laid web may have a plurality of randomly oriented fibers 124. The plurality of random fibers 124 may have sufficiently large lengths such that the fibers 124 are entangled with each other without being bonded together, or the fibers 124 may be bonded together. Due to the random orientation of the fibers 124, the air-laid web tends to be isotropic and exhibits a high porosity. Similarly, due to the random orientation of the fibers 124, the air-laid web can exhibit a high bulkiness. The air-laid web may be formed from fibers 124 that cannot be combed (e.g., short fibers).

[0040] In one embodiment, the nonwoven web 118 may include at least one hydroentangled web. The hydroentangled web is formed by providing a sheet containing randomly oriented fibers 124 or by providing a carded web. A high-pressure water jet, generally parallel to the thickness of the sheet, is directed toward the sheet. Similar to needle-punched web, the high-pressure water jet causes some of the fibers 124 to migrate from the outside of the sheet to its interior, thereby forming a columnar structure. Therefore, the hydroentangled web can have similar functionality to needle-punched web, i.e., the hydroentangled web can be more isotropic than a carded web and includes divots.

[0041] While carded webs, needle-punched webs, air-laid webs, and hydroentangled webs are preferred nonwoven webs included in vertical nonwoven materials, vertical nonwoven materials may also include one or more nonwoven webs other than carded webs, needle-punched webs, air-laid webs, and hydroentangled webs. For example, vertical nonwoven materials may include wet-laid webs, spunbond nonwoven webs, or meltblown nonwoven webs.

[0042] The folded nonwoven web 118 can be formed from a sheet. When the sheet is placed on a horizontal plane surface, the fold 120 can extend parallel to the horizontal plane surface, and the middle portion 122 can extend vertically from the horizontal plane surface. Subsequently, the folded nonwoven web 118 can be rolled up to form a cylindrical folded nonwoven web 118.

[0043] In some embodiments, the vertical nonwoven material may include a material without fibers. For example, a foam may be used instead of the nonwoven web 118. The foam may have similar or the same dimensions, shape, and folding manner as the folded nonwoven web 118 to form a porous body of the porous material 110. For example, the foam may include an open-cell foam folded to have a plurality of folds 120 and a plurality of intermediate portions 122 extending between the folds 120 to form the vertical nonwoven material. In such examples, the foam may include foams of any polymer disclosed herein, such as polyurethane, polyethylene, polyethylene terephthalate, polyether, etc. Body fluids can move toward a reservoir or under vacuum force (e.g., the inlet of conduit 114) through the open-cell structure of the foam.

[0044] Suitable vertical nonwoven materials for porous material 110 and their properties are disclosed in International Patent Application No. PCT / US2022 / 042719, filed September 7, 2022, and U.S. Provisional Patent Application No. 63 / 241,575, filed September 8, 2021, the disclosures of which are incorporated herein by reference in their entirety for any purpose.

[0045] The porous material 110 can exhibit a thickness T greater than about 1 mm, for example, in the range of about 1 mm to about 30 mm, about 1 mm to about 10 mm, about 10 mm to about 20 mm, about 20 mm to about 30 mm, about 5 mm to about 15 mm, about 15 mm to about 25 mm, less than about 30 mm, or less than about 20 mm. Increasing the thickness T of the porous material 110 generally increases the volume of bodily fluid that can be temporarily stored in the porous material 110 and provides greater flexibility in selecting the density and basis weight of the porous material 110. However, the thickness T of the porous material 110 may be limited by the size and functionality of the fluid collection assembly 100. For example, the thickness T of the porous material 110 may be selected such that the porous material 110 can be combined with other components (such as porous membrane material 236) that can also be disposed within the chamber 104. Figure 2B (or catheter 114) are placed together in chamber 104.

[0046] The rate at which the porous material 110 captures and transports bodily fluids can depend on several factors. For example, the rate at which a vertical nonwoven material captures and transports bodily fluids can be inversely proportional to the density and basis weight of the vertical nonwoven material, wherein increasing the density and / or basis weight of the vertical nonwoven material can decrease the rate at which it captures and transports bodily fluids, and vice versa. In one example, the rate at which the porous material 110 captures and transports bodily fluids can depend on the material forming the porous material 110 (e.g., the hydrophilicity of the material). As the thickness T increases, the rate at which the porous material 110 captures and transports bodily fluids can increase because increasing the thickness T increases the cross-sectional area through which the bodily fluids can flow.

[0047] See you again Figure 1A-1C In one embodiment, as shown, the porous material 110 may comprise only or substantially only a porous body material 138. In such an embodiment, the porous body material 138 may define a pore configured to receive a conduit 114, and the porous body material 138 extends from the pore to a fluid-impermeable layer 102. When the porous material 110 comprises only or substantially only the porous body material 138, the entire porous material 110 is capable of rapidly capturing and transporting bodily fluids. As will be described in more detail below, the porous material 110 may include at least one additional material, such as a porous membrane material, although such additional materials may reduce the ability of the porous material 110 to capture and / or transport at least one bodily fluid.

[0048] The fluid collection assembly 100 may include a collection section for collecting bodily fluids. The collection section may be an occupied or unoccupied portion of the chamber 104. The collection section may be a portion of the chamber 104 located at or near the inlet of the catheter 114. The porous material 110 may at least substantially completely fill the unoccupied portion of the chamber 104. In some examples, the porous material 110 may not substantially completely fill the unoccupied portion of the chamber 104. In such examples, the fluid collection assembly 100 includes a reservoir 126 (e.g., a collection section) disposed within the chamber 104.

[0049] As shown, the reservoir 126 (collection section) can be a substantially unoccupied portion of the chamber 104. The reservoir 126 can be defined between the fluid-impermeable layer 102 and the porous material 110. Bodily fluids located within the chamber 104 can flow into the reservoir 126 through the porous material 110. The reservoir 126 can retain bodily fluids therein. The fluid-impermeable layer 102 can retain bodily fluids in the reservoir 126. Although depicted as being located in the distal region 132, the reservoir 126 can also be located in any part of the chamber 104, such as the proximal region 134. The reservoir 126 can be located in the portion of the chamber 104 designed to be at the lowest point of gravity of the fluid collection assembly 100 when worn.

[0050] Although the reservoir 126 or collection portion is depicted as the part of chamber 104 not occupied by the porous material 110, the reservoir 126 or collection portion may be occupied by the porous material 110 and still function as a reservoir or collection portion. For example, the porous material 110 may substantially fill the part of chamber 104 not occupied by the catheter 114, and the reservoir 126 may be the distal region of the chamber or any other portion of chamber 104 configured to retain bodily fluids therein during or before removal via the catheter 114.

[0051] In some examples (not shown), the fluid collection assembly 100 may include multiple reservoirs, such as a first reservoir located in the portion of chamber 104 closest to the inlet of conduit 114 (e.g., distal region 132) and a second reservoir located in the portion of chamber 104 located in or adjacent to proximal region 134. In another example, the porous material 110 is spaced apart from at least a portion of conduit 114, and the reservoir 126 may be the space between the porous material 110 and conduit 114.

[0052] Figure 1E This is a cross-sectional view of the catheter 114 according to one embodiment. See also... Figure 1B , Figure 1C and Figure 1E The conduit 114 includes a fluid lumen 147 and a shape memory lumen 149. The conduit 114 includes an outer wall 146 and an inner wall 148, which at least partially define the fluid lumen 147 and the shape memory lumen 149, respectively. The outer wall 146 and the inner wall 148 of the conduit 114 may be made of polymers, such as silicone, polyvinyl chloride (PVC), polyethylene, thermoplastic polyurethane, thermoplastic elastomers (e.g., synthetic rubber), etc. The Shore A hardness of the conduit 114 may be at least 40, for example, about 40 to about 95, about 50 to about 95, about 40 to about 60, about 60 to about 80, about 75 to about 95, less than 95, or less than 75. The length of the conduit 114 may be at least 1 meter, for example, about 1 m to about 5 m, about 1 m to about 3 m, about 2 m to about 4 m, or less than 5 m.

[0053] The catheter 114 may be at least partially disposed within the chamber 104. The catheter 114 may be used to remove bodily fluids from the chamber 104. The catheter 114 includes at least one wall (e.g., outer wall 146) defining an inlet 112, an outlet (not shown) downstream of the inlet 112, and a passage between the two.

[0054] The outlet of conduit 114 is operatively connected to a vacuum source, such as a vacuum pump, to extract fluid from chamber 104 through conduit 114. For example, conduit 114 may extend from proximal region 134 into fluid-impermeable layer 102 and may extend to distal region 132 to a point near reservoir 126 therein, such that inlet 112 is in fluid communication with reservoir 126. Conduit 114 fluidly connects chamber 104 to a fluid storage container (not shown) or a vacuum source (not shown). In some embodiments, inlet 112 may be located in or near fluid-impermeable layer 102 in distal region 132.

[0055] The conduit 114 extends through a pore in the porous material 110. In one embodiment, the conduit 114 extends from the fluid outlet 108 through the pore to a position near the reservoir 126. In such an embodiment, the inlet 112 may not extend into the reservoir 126, but rather may be located within or at the end of the porous material 110. For example, the end of the conduit 114 may extend co-exist with or be recessed within the porous material 110. In one embodiment, the conduit 114 is at least partially located within the reservoir 126, and the inlet 112 may extend into or be located within the reservoir 126. In one embodiment, the inlet 112 may be located posterior to the reservoir 126. Bodily fluids collected in the fluid collection assembly 100 may be removed from the chamber 104 via the conduit 114.

[0056] Compared to placing the inlet 112 in other locations, placing the inlet 112 at or near a position in the chamber 104 that is expected to be a low point of gravity when worn by an individual allows the conduit 114 to receive more bodily fluid and reduces the likelihood of accumulation (e.g., accumulation of bodily fluid can lead to microbial growth and foul odor). For example, bodily fluid in the porous material 110 can flow in any direction due to capillary action. However, bodily fluid tends to flow in the direction of gravity, especially when at least a portion of the porous material 110 is saturated with bodily fluid. Therefore, one or more of the inlet 112 or the reservoir 126 can be located in the fluid collection assembly 100 at a position that is expected to be a low point of gravity when worn by an individual, such as the distal region 132.

[0057] The inlet 112 and outlet of the conduit 114 are configured to fluidly connect (e.g., directly or indirectly) a vacuum source (not shown) to a chamber 104 (e.g., a reservoir 126). When the vacuum source ( Figure 4 When a vacuum / suction force is applied within the conduit 114, bodily fluids in the chamber 104 (e.g., bodily fluids in the distal region 132, such as those in the reservoir 126) can be drawn into the inlet 112 and extracted from the fluid collection assembly 100 via the conduit 114. In some examples, the conduit 114 may be frosted or opaque (e.g., black) to obscure the visibility of the bodily fluids therein.

[0058] As previously described, the catheter 114 may be configured to be at least insertable into the chamber 104. In one example, the catheter 114 may be positioned within the chamber 104 such that the distal end of the catheter 114 is spaced apart from the fluid-impermeable layer 102 or other components of the fluid collection assembly 100 that may at least partially obstruct or block the inlet 112. Furthermore, the inlet 112 of the catheter 114 may be biased relative to the distal end of the porous material 110 such that the inlet 112 is closer to the proximal region 134 of the fluid collection assembly 100 than the distal end of the porous material 110. By biasing the inlet 112 relative to the distal end of the porous material 110 in this manner, the inlet 112 can receive bodily fluids directly from the porous material 110, and due to hydrogen bonding, more bodily fluids can be introduced from the porous material 110 into the catheter 114.

[0059] The multi-cavity configuration may include a fluid cavity 147 for conveying fluid and at least one shape memory cavity 149 for accommodating shape memory material 150 therein.

[0060] The dimensions and shape of the fluid cavity 147 are adapted to allow bodily fluids to flow through it. For example... Figure 1E As shown, the fluid cavity 147 may be larger than the shape memory cavity 149. For example, the inner diameter (or major dimension) of the fluid cavity 147 may be at least about 0.1 inches (2.5 mm), such as about 0.1 inches to about 0.5 inches (12.7 mm), about 0.15 inches (3.8 mm) to about 0.35 inches (8.9 mm), about 0.25 inches (6.3 mm) to about 0.4 inches (10.2 mm), or less than about 0.5 inches.

[0061] The shape memory cavity 149 is sized and shaped to accommodate the shape memory material 150 therein. For example, the inner diameter (or principal dimension) of the shape memory cavity 149 may be at least about 0.03 inches (0.76 mm), such as about 0.03 inches to about 0.1 inches (2.5 mm), about 0.03 inches to about 0.05 inches (1.3 mm), about 0.05 inches to about 0.07 inches (1.8 mm), or less than about 0.1 inches. Although the shape memory cavity 149 is depicted as being located at the lowest point of gravity of the conduit 114 (e.g., at the bottom of the fluid cavity 147), the shape memory cavity 149 may be located at any point in the fluid cavity 147, such as the side (e.g., at the 3 o'clock or 9 o'clock position) or the top (e.g., at the 12 o'clock position).

[0062] See you again Figure 1B and Figure 1CThe shape memory cavity 149 may contain shape memory material 150 in discrete portions of the longitudinal length of the conduit 114, such as the portion of the shape memory cavity 149 located within the longitudinal length of the fluid impermeable layer 102. The shape memory material 150 may include elements configured to allow the shape of the fluid collection assembly to be controllably changed and / or maintained in a selected shape.

[0063] At least one shape memory material 150 prevents or at least inhibits leakage of bodily fluids from the fluid collection assembly 100. For example, bodily fluids may leak from the fluid collection assembly because initially the fluid collection assembly 100 may not conform well to the anatomy of the wearer (e.g., a user) around the urethral opening. Poor conformation can result in gaps between the porous material 110 and the area around the urethral opening. These gaps may provide locations where bodily fluids can flow through without being received by the porous material 110, and / or locations where bodily fluids can leave the porous material 110. To reduce or eliminate these gaps, the fluid collection assembly 100 includes a shape memory material 150 disposed within a shape memory lumen 149. The shape memory material 150 is configured to be manipulated (e.g., bent or otherwise shaped) to give the fluid collection assembly 300 a shape that matches the shape of the patient's anatomy and conforms to the anatomy of the wearer's area around the urethral opening (e.g., the vaginal region). In other words, the shape memory material 150 enables the fluid collection assembly 100 to achieve a more precise, anatomically conformal fit to the area around the urethral opening compared to conventional fluid collection devices.

[0064] The dimensions, shape, and position of the shape memory material 150 within the fluid collection assembly 100 are adapted to maintain at least a portion of the fluid collection assembly 100 in a selected shape (e.g., geometric configuration). The shape memory material 150 is configured to be bent, shaped, or otherwise deformed (collectively, "shape," "forming," or "shaping"). The shape memory material 150 may be configured to be shaped along its entire length. Allowing the shape memory material 150 to be shaped along its entire length allows the fluid collection assembly 100 to present a shape substantially corresponding to the patient's anatomical features. For example, the shape memory material 150 may present a first shape (e.g., an initial shape), and when the shape memory material 150 presents the first shape, the fluid collection assembly 100 may present a first configuration (i.e., a generally linear shape). The shape memory material 150 may be operated to present a second shape different from the first shape, and when the shape memory material 150 presents the second shape, the fluid collection assembly 100 may present a second configuration (e.g., a generally curved cylinder). The second configuration of the fluid collection assembly 100 may correspond more to the shape of the area around the urethral orifice than the first configuration.

[0065] Shape memory material 150 may include shape memory polymers or metals (e.g., shape memory metals). Typically, shape memory material 150 is configured to take on an intermediate or permanent shape in response to a stimulus. For example, shape memory material 150 may present a first shape (e.g., an initial shape) and may switch from the first shape to a second shape, different from the first shape, upon external stimulus. Shape memory material 150 may also switch back from the second shape to the first shape in response to a stimulus, or switch to a third shape, different from the first and second shapes.

[0066] The stimulus may include external physical forces (e.g., bending forces), heat, electrical bias, or magnetic fields. While the term “shape memory” is used to describe some of the “shape memory materials” herein, it should be understood that in some examples, a material modified by the term “shape memory” does not necessarily need to be understood as returning to a pre-selected shape after the application of a stimulus, as is typically defined for a “shape memory material.” Rather, at least some of the shape memory materials disclosed herein may retain a selected shape only when bent, shaped, or cured into a particular shape, and / or when cooled in that particular shape, regardless of any subsequent stimulus applied thereto. A shape memory material can be restored to its original shape or transformed into a new shape by the application of a stimulus. For example, a wire bent into a first shape may be used as shape memory material 150, which can then be changed into a second shape by applying a physical force or by heating. However, in some embodiments, shape memory material 150 may present a selected shape, as described above, and the application of a stimulus may deform the shape memory material (e.g., elastically deform or bend) into an intermediate shape. In such an implementation, when the stimulus is removed, the shape memory material 150 can revert to a first initial shape, such that the shape memory material 150 does not retain the intermediate shape.

[0067] Shape memory material 150 is distinct from conduit 114 (e.g., it is independently movable). Shape memory material 150 may include rods, filaments, cables, or other structures disposed within shape memory lumen 149. Shape memory material 150 may have a cylindrical shape, an extruded oval shape, or a polygonal extruded shape. The dimensions of shape memory material 150 may be adapted for installation within shape memory lumen 149. For example, the diameter (or major dimension) of shape memory material 150 may be at least about 0.03 inches, such as about 0.03 inches to about 0.1 inches, about 0.03 inches to about 0.05 inches, about 0.05 inches to about 0.07 inches, less than about 0.15 inches, or less than about 0.1 inches. In some embodiments, shape memory material 150 may include filaments of 12 gauge (2.05 mm) to 20 gauge (0.81 mm), such as 14 gauge (1.63 mm) filaments. The shape memory material 150 may be smaller than the shape memory cavity 149, for example, at least 0.001 inch (25.4 μm), 0.001 inch to 0.1 inch, 0.001 inch to 0.01 inch (254 μm), 0.01 inch to 0.04 inch, or 0.04 inch to 0.1 inch smaller than the shape memory cavity 149. Such examples may provide selected fits between the shape memory material 150 and the shape memory cavity 149, such as sliding fits, sliding fits, running fits, loose fits, etc., thereby allowing the shape memory material 150 to move relative to the shape memory cavity 149 (e.g., along the longitudinal direction).

[0068] In some examples, the shape memory material 150 may be slightly larger than the shape memory cavity 149, for example, by 0.001 inches to 0.01 inches. Such examples can provide a tight fit between the shape memory material 150 and the shape memory cavity 149, so that the shape memory material 150 does not move relative to the shape memory cavity 149.

[0069] In one embodiment, the shape memory material 150 may include a metal, such as a pure metal, an alloy, or a shape memory alloy. Suitable shape memory metals may include aluminum, silver, copper, iron, nickel, zinc, tin, beryllium, etc. Suitable shape memory alloys may include alloys of any of the shape memory metals disclosed herein, such as standard steel, stainless steel, carbon alloy steel, heat-treated steel, galvanized steel, aluminum alloys, nickel alloys, nickel-titanium alloys (e.g., Nitinol, Ni-Ti-Cu, Ni-Ti, Co, etc.), copper, copper-based alloys (e.g., brass, Cu-Zn-Al, Cu-Al-Ni, Cu-Al-Sn, etc.), Co-Cr-Ni-Mo alloys (e.g., Elgiloy®, etc.), or any other alloy having shape memory properties. As explained above, the shape memory metal or alloy may also simply be a metal or alloy that can be molded into a selected configuration. In some examples, the shape memory metal or alloy may recover its initial shape when an external stimulus is applied to it. In some examples, the outer surface of the shape memory metal may be polymer-coated, anodized, passivated, or otherwise treated to prevent corrosion. In some examples, shape memory metals may undergo annealing, tempering, or other heat treatments. Such heat treatments can reduce the brittle fracture of shape memory materials 150 and improve their ductility.

[0070] Shape memory polymers (SMPs) may include: polyurethane-based SMPs, such as copolymers containing one or more of the following blocks (e.g., copolyesters, polyurethanes, polyether esters, etc.): 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 polybutylene terephthalate; thermoplastic polymers such as polyetheretherketone (PEEK), nylon, acetal, polytetrafluoroethylene (PTFE), polypropylene, polyethylene, acrylonitrile-butadiene-styrene copolymer (ABS), polysulfone, etc.; polynorbornene; other deformable polymers; or any other shape memory polymer.

[0071] The shape memory material 150 can be held within the shape memory cavity 149 by one or more plugs disposed at or near its (opposite) longitudinal ends. The plugs may include a retaining plug 154 and an end plug 152. The size, shape, and position of the plugs are adapted to be installed within the shape memory cavity 149 and to prevent the shape memory material 150 from moving (longitudinally) across the plugs within the shape memory cavity 149. For example, the retaining plug 154 and the end plug 152 may be disposed within the shape memory cavity 149 at opposite ends of the shape memory material 150 to prevent longitudinal movement of the shape memory material 150 within the shape memory cavity 149.

[0072] The retaining plug 154 and end plug 152 may be made of an elastic material, such as a polymer, epoxy resin, rubber, metal, wood, etc. Suitable polymers may include PVC, polycarbonate, polyethylene, polypropylene, polyacetal, polytetrafluoroethylene, acrylic acid, or any polymer disclosed herein. For example, the retaining plug 154 and end plug 152 may be made of heat-sealable PVC. The retaining plug 154 and end plug 152 may also be made of any metallic material disclosed herein. In such examples, the retaining plug 154 and end plug 152 may be annealed, tempered, or otherwise heat-treated. The retaining plug 154 and end plug 152 may be made of an adhesive, such as an adhesive barrier formed in the shape memory cavity 149. The adhesive may be a UV-curable adhesive, a catalyst-curable adhesive, a thermosetting adhesive, etc. The main dimensions of the retaining plug 154 and end plug 152 may be designed to provide a press fit, interference fit, fixed fit, similar fit, forced fit, or any other tight fit within the shape memory cavity 149. For example, the maximum external dimensions of the retaining plug 154 and the end plug 152 may be about 0.001 inches to 0.03 inches, about 0.001 inches to about 0.01 inches, about 0.01 inches to about 0.02 inches, or less than about 0.03 inches, smaller than the internal dimensions of the shape memory cavity 149. The retaining plug 154 and the end plug 152 may match the shape of the shape memory cavity 149, such as being cylindrical, extruded oval, extruded polygonal, etc. In some examples, one or more portions of the retaining plug 154 and the end plug 152 may have a tapered shape, such as cylindrical, circular, etc. The length of the retaining plug 154 and the end plug 152 may be at least about 0.05 inches (0.13 cm), such as about 0.05 inches to about 0.2 inches (0.51 cm), about 0.1 inches (0.25 cm) to about 0.25 inches (0.64 cm), or less than about 0.25 inches.

[0073] End plug 152 may be positioned (longitudinally) within shape memory cavity 149 at the furthest point within shape memory cavity 149 to which shape memory material 150 can extend. For example, end plug 152 may be positioned within shape memory cavity 149 at or near inlet 112. End plug 152 may be spaced from inlet 112 by at least about 0.01 inches, about 0.01 inches to about 0.25 inches, or less than about 0.5 inches. The size, shape, and position of end plug 152 are adapted to retain shape memory material 150 within shape memory cavity 149 by preventing shape memory material 150 from dislodging from the distal end of shape memory cavity 149. Thus, end plug 152 is held in place within shape memory cavity 149, for example, by mating with shape memory cavity 149, adhesive, or welding.

[0074] The retainer 154 can be positioned (longitudinally) within the shape memory cavity 149 at the nearest proximal site within the shape memory cavity 149 to which the shape memory material 150 can extend. For example, the retainer 154 can be located at a site within the shape memory cavity 149 located within the chamber 104, within the fluid outlet 108, or even outside the fluid outlet 108 (e.g., closer to the wearer or user than the fluid-impermeable layer).

[0075] In some embodiments, the retaining plug 154 may be disposed at a point in the shape memory cavity 149 located outside the fluid outlet 108 (e.g., closer to the wearer or user than the fluid-impermeable layer 102). The size, shape, and position of the retaining plug 154 are adapted to retain the shape memory material 150 in the distal region of the shape memory cavity 149 by preventing the shape memory material 150 from sliding to a proximal region of the shape memory cavity 149 that is closer to or near the region located in or near the fluid-impermeable layer 102. Thus, the retaining plug 154 is held in place within the shape memory cavity 149, for example, by means of mating with the shape memory cavity 149, adhesive, or welding.

[0076] The space within the shape memory cavity 149 between the end plug 152 and the retaining plug 154 may be longer than the shape memory material 150 to allow the shape memory material 150 to move in a selected amount therein. For example, the space within the shape memory cavity 149 between the end plug 152 and the retaining plug 154 may be at least about 0.1 inches longer than the shape memory material 150, such as about 0.1 inches to about 1 inch (2.5 cm), about 0.1 inches to about 0.3 inches (0.76 cm), 0.15 inches (0.38 cm) to 0.35 inches (0.89 cm), 0.3 inches to 0.6 inches (1.52 cm), about 0.5 inches (1.27 cm) to 1 inch, less than 1 inch, or less than 0.5 inches. Such a space allows the shape memory material 150 to move longitudinally within the shape memory cavity 149 in a selected amount. Due to the presence of this space and the ability of the shape memory material 150 to slide within the shape memory cavity 149, the shape memory material 150 possesses the ability to move within the shape memory cavity 149. This allows for better bending (radial bending, kinking, etc.) of the shape memory material 150, the conduit 114, and the fluid collection assembly 100 compared to when the shape memory material 150 is fixed relative to the shape memory cavity 149. This improved bending is due to the reduced tensile force during bending of the shape memory material 150 when it is not adhered to the inner surface of the shape memory cavity 149.

[0077] As described above, the end plug 152 and the retaining plug 154 can be held within the shape memory cavity 149 by adhesive, mating (fitting between the plug and the cavity), or welding (e.g., melting). The retaining plug 154 can be adhesively applied before being positioned within the shape memory cavity 149. After the retaining plug 154 is positioned and the adhesive has cured or dried, the shape memory material 150 can be disposed within the shape memory cavity 149, allowing the shape memory material to slide or move longitudinally therein. The end plug 152 can be adhesively applied before being positioned within the shape memory cavity 149, thereby providing a selected amount of space between the plug and the shape memory material 150.

[0078] The porous materials of the fluid collection components disclosed herein may include both a porous (fluid-permeable) body and a porous membrane. Figure 2A This is a cross-sectional schematic diagram of a fluid collection assembly 200 according to one embodiment. Figure 2B For along Figure 2A The diagram shows a cross-sectional view of the fluid collection assembly 200 taken along plane 2B-2B. The fluid collection assembly 200 includes a porous material 210 having a porous host material 238 and a porous membrane material 236 disposed thereon. Unless otherwise disclosed herein, the fluid collection assembly 200 may be similar to or identical to any fluid collection assembly disclosed herein. For example, the fluid collection assembly 200 may include a fluid-impermeable layer 102 defining at least a chamber 104, at least one opening 106, and a fluid outlet 108. The fluid collection assembly 200 includes a conduit 114 having a shape memory material 150, an end plug 152, and a limiting plug 154. Furthermore, at least one porous host material 238 of the porous material 210 may be the same as or substantially similar to any porous material 110 disclosed herein, for example, the same as or substantially similar to any porous host material 138 disclosed herein (e.g., polyurethane foam, spun nylon fiber, or vertical nonwoven material). In one embodiment, the porous host material 238 may support the porous membrane material 236 disposed thereon, while in other embodiments, the porous membrane material 236 may be supported by the fluid-impermeable layer 102 or other components.

[0079] The porous membrane material 236 may comprise any suitable porous material, such as a porous sheet. In one example, the porous membrane material 236 may comprise gauze (e.g., silk gauze, linen gauze, or cotton gauze), other soft fabrics, other smooth fabrics, horizontally laid nonwoven materials, cross-laid nonwoven materials, porous polymer structures (e.g., nylon, polyester, polyurethane, polyethylene, polypropylene, etc.) or open-cell foams (e.g., spun nylon fibers), or any other suitable porous material. The porous membrane material 236 may be formed from natural fibers, which may be more sustainable and biodegradable than synthetic fibers. Examples of natural fibers include cellulose, cotton, bamboo, wool, etc. In some examples, the fibers (e.g., gauze) of the porous membrane material 236 may comprise a blend of natural and synthetic fibers. For example, the porous membrane material 236 may comprise bamboo fiber and polypropylene fiber. In one example, the porous membrane material 236 may comprise a hydrophobic material (e.g., a material with a water contact angle greater than 90°).

[0080] In one example, the porous membrane material 236 (e.g., gauze, vertical nonwoven material, or quilted material) may exhibit different densities, basis weights, thicknesses, average fiber lengths, average fiber transverse dimensions, average fiber aspect ratios, or different rates (the rate at which the porous membrane material 236 captures and transports body fluids) from the porous host material 238.

[0081] In some examples, the porous membrane material may include a three-dimensional mesh material (3D mesh material). The 3D mesh material may include a top layer, a fiber layer, and a bottom layer. The top layer includes a mesh fabric. The mesh fabric may include polyester, polypropylene, nylon, cellulose, cotton, bamboo, any other material, or any combination of the above materials. The top layer may be hydrophilic. This hydrophilicity may originate from the material itself or from a coating applied thereto. By using a hydrophilic material in the top layer, moisture is preferentially carried away from the wearer's skin of the fluid collection assembly 200. The top layer may include pores formed in the mesh. Larger pores allow urine to enter the underlying porous material (e.g., the fiber layer or porous host material 238) more quickly. The fiber layer includes multiple fibers, such as spun plastic fibers. The fiber layer may include polyester fibers, nylon fibers, or cellulose fibers. The fiber layer may be bonded to the top layer by one or more methods such as adhesives, welding (e.g., fusion). The fiber layer is configured to separate the top layer from the bottom layer and allow urine to move from the top layer to the bottom layer without retaining urine. The bottom layer includes a mesh fabric. The mesh fabric may include polyester, polypropylene, nylon, cellulose, cotton, bamboo, any other material, or any combination of the foregoing. The underlayer may be hydrophobic. This hydrophobicity may originate from the material itself or from a coating applied thereto. The underlayer includes pores formed in the mesh. The pores in the top layer may be larger than those in the underlayer. The underlayer may be bonded to the fiber layer in the same manner as the top layer.

[0082] In one embodiment, as shown, a porous membrane material 236 is disposed on the outer surface of at least one porous host material 238 (e.g., between the fluid-impermeable layer 102 and the porous host material 138), such that the porous membrane material 236 extends across the opening 106 and contacts the individual during use. The porous membrane material 236 may be disposed on the porous host material 238 to make the fluid collection assembly 200 more comfortable to use and / or improve the capture of bodily fluids. In one example, the individual may find direct contact between the porous host material 238 and a sensitive area of ​​the vagina uncomfortable, for example, due to the surface roughness of the foam or fibers protruding from the porous host material 238. In such an example, the porous membrane material 236 may comprise a material that is smoother or otherwise more comfortable than the porous host material 238 (e.g., gauze). In one example, as previously described, the hydrophilicity of the porous host material 238 may be limited to facilitate the removal of bodily fluids therefrom. However, limiting the hydrophilicity of the porous host material 238 may limit its ability to capture body fluids. Therefore, the porous membrane material 236 can be selected to exhibit greater hydrophilicity than the porous host material 238 (i.e., a smaller contact angle with water than the porous host material 238), thereby allowing the porous membrane material 236 to capture body fluids more quickly than the porous host material 238. When the porous membrane material 236 exhibits greater hydrophilicity than the porous host material 238, it can also exhibit a significantly smaller thickness than the porous host material 238. The smaller thickness of the porous membrane material 236 reduces the volume of body fluid retained in the porous membrane material 236 that needs to be evaporated by the air flowing through the chamber 204.

[0083] In one embodiment, the porous membrane material 236 may be positioned between the porous body material 238 and the conduit 114, either on the outer surface of the porous body material 238 or on the outer surface of the porous body material 238.

[0084] In some examples, the porous membrane material may include a three-dimensional mesh material (3D mesh material). The 3D mesh material may include a top layer, a fiber layer, and a bottom layer. The top layer includes a mesh fabric. The mesh fabric may include polyester, polypropylene, nylon, cellulose, cotton, bamboo, any other material, or any combination of the above materials. The top layer may be hydrophilic. This hydrophilicity may originate from the material itself or from a coating applied thereto. By using a hydrophilic material in the top layer, moisture is preferentially carried away from the wearer's skin of the fluid collection assembly 200. The top layer may include pores formed in the mesh. Larger pores allow urine to enter the underlying porous material (e.g., the fiber layer or porous host material 238) more quickly. The fiber layer includes multiple fibers, such as spun plastic fibers. The fiber layer may include polyester fibers, nylon fibers, or cellulose fibers. The fiber layer may be bonded to the top layer by one or more methods such as adhesives, welding (e.g., fusion). The fiber layer is configured to separate the top layer from the bottom layer and allow urine to move from the top layer to the bottom layer without retaining urine. The bottom layer includes a mesh fabric. The mesh fabric may include polyester, polypropylene, nylon, cellulose, cotton, bamboo, any other material, or any combination of the foregoing. The underlayer may be hydrophobic. This hydrophobicity may originate from the material itself or from a coating applied thereto. The underlayer includes pores formed in the mesh. The pores in the top layer may be larger than those in the underlayer. The underlayer may be bonded to the fiber layer in the same manner as the top layer.

[0085] like Figure 2A and Figure 2B As shown, the shape memory lumen 149 of the catheter 114 can be positioned at the lowest point of gravity of the catheter 114 (e.g., the bottom of the catheter 114). Different positions and configurations of the shape memory lumen and the shape memory material therein can be utilized. For example, the catheter may include multiple shape memory lumens disposed therein. Figure 3 This is a cross-sectional view of a fluid collection assembly 300 according to one embodiment. The fluid collection assembly 300 may be similar to or the same as any fluid collection assembly disclosed herein in one or more aspects. For example, as shown, the fluid collection assembly 300 includes a fluid-impermeable layer 102, a porous material 210 disposed in the fluid-impermeable layer 102, and a conduit 314 disposed in the porous material 210. The fluid collection assembly 300 may include a shape memory material (…). Figure 1B ), end plug ( Figure 1B ) and limit plug ( Figure 1B ).

[0086] The catheter 314 may be similar to or identical to the catheter 114 in one or more aspects, such as size, components, materials, and performance. For example, the catheter 314 may include a fluid lumen 347 and a plurality of shape memory lumens 349a and 349b. The fluid lumen 347 may be similar to or identical to the fluid lumen 147 in one or more aspects. For example, the fluid lumen 147 may be the largest lumen on the multi-lumen catheter 314.

[0087] Multiple shape memory cavities 349a and 349b may be similar to or identical to shape memory cavity 149 in one or more aspects, such as size, shape, or performance. Multiple shape memory cavities may include at least two shape memory cavities as shown in the figure, such as two to 20 shape memory cavities, less than 10 shape memory cavities, or less than 5 shape memory cavities.

[0088] As described above regarding catheter 114, shape memory lumens 349a and 349b are defined by the outer and inner walls of catheter 314. Shape memory lumens 349a and 349b can be located at any point in the fluid lumen 147, such as on the side (e.g., at the 3 o'clock or 9 o'clock position), at the top and bottom (e.g., at the 12 o'clock and 6 o'clock positions), near the bottom (e.g., at the 5 o'clock and 7 o'clock positions), or at any other suitable location within the fluid lumen 347.

[0089] As described with respect to fluid collection assemblies 100 and 200, each of the plurality of shape memory cavities may include shape memory material, end plugs, and limiting plugs. Such embodiments may provide a more rigid fluid collection assembly, or allow the use of narrower shape memory material and shape memory conduits compared to embodiments having a single shape memory conduit and shape memory material therein. In some embodiments, shape memory material, end plugs, and limiting plugs may be included in only selected portions of the plurality of shape memory cavities.

[0090] In some examples, the conduit may include a shape memory material co-extruded into the outer wall of the conduit. For example, one or more wires may be co-extruded with the outer wall to form the conduit. In such examples, the shape memory material may include any shape memory material and its properties disclosed above. Suitable co-extruded conduits or drainage tubes, shape memory materials, and their properties for use in the fluid collection assemblies described herein are disclosed in U.S. Patent Application No. 17 / 451,719, filed October 19, 2021, and U.S. Provisional Patent Application No. 63 / 094,626, filed October 21, 2020, the disclosures of which are incorporated herein by reference in their entirety for any purpose.

[0091] Figures 1A to 3The fluid collection assembly shown is an example of a fluid collection assembly particularly suitable for collecting bodily fluids from women (e.g., from the female urethral opening), obese men, men with a concealed penis, or men with a micropenis. However, the porous materials disclosed herein, as well as the conduits comprising shape memory materials, can be used in fluid collection assemblies in which the penis can be inserted. Examples of male fluid collection assemblies that may include the porous materials described herein and conduits comprising shape memory materials are disclosed in PCT Patent Application No. PCT / US2021 / 039866, filed June 30, 2021, and U.S. Patent Application No. 16 / 433,773, filed June 6, 2019, the disclosures of which are incorporated herein by reference in their entirety for any purpose.

[0092] Figure 4 This is a block diagram of a fluid collection system 450 for fluid collection according to one embodiment. The fluid collection system 450 includes a fluid collection assembly 400, a fluid storage container 452, and a vacuum source 454. The fluid collection assembly 400 may be the same as or substantially similar to any fluid collection assembly disclosed herein. The fluid collection assembly 400, the fluid storage container 452, and the vacuum source 454 may be fluidly connected to each other via one or more conduits 414. For example, the fluid collection assembly 400 may be operatively connected to one or more of the fluid storage container 452 or the vacuum source 454 via conduits 414. Bodily fluids collected in the fluid collection assembly 400 may be removed from the fluid collection assembly 400 via conduits 414 extending into the fluid collection assembly 400. For example, the inlet of the conduit 414 may extend into the fluid collection assembly 400, for example, into a reservoir therein. The outlet of the conduit 414 may extend into the fluid collection assembly 400 or the vacuum source 454. In response to a suction force (e.g., vacuum) applied at the outlet of the conduit 414, the suction force can be introduced into the chamber of the fluid collection assembly 400 via the inlet of the conduit 414.

[0093] A suction force can be applied directly or indirectly to the outlet of the conduit 414 by a vacuum source 454. The suction force can also be applied indirectly via a fluid storage container 452. For example, the outlet of the conduit 414 can be located within the fluid storage container 452, and an additional conduit 414 can extend from the fluid storage container 452 to the vacuum source 454. Therefore, the vacuum source 454 can apply a suction force to the fluid collection assembly 400 via the fluid storage container 452. Alternatively, the suction force can be applied directly via the vacuum source 454. For example, the outlet of the conduit 414 can be located within the vacuum source 454. An additional conduit 414 can extend from the vacuum source 454 to a point outside the fluid collection assembly 400, such as extending to the fluid storage container 452. In such examples, the vacuum source 454 can be located between the fluid collection assembly 400 and the fluid storage container 452.

[0094] The fluid storage container 452 is sized and shaped to retain bodily fluids therein. The fluid storage container 452 may include a bag (e.g., a drainage bag), a bottle or cup (e.g., a collection can), or any other closed container for storing bodily fluids (e.g., urine). In some examples, a catheter 414 may extend from the fluid collection assembly 400 and be attached to the fluid storage container 452 at a first point. An additional catheter 414 may be attached to the fluid storage container 452 at a second point and may extend and be attached to a vacuum source 454. Therefore, a vacuum (e.g., aspiration) can be drawn into the fluid collection assembly 400 via the fluid storage container 452. Bodily fluids (e.g., urine) can be drained from the fluid collection assembly 400 using the vacuum source 454.

[0095] Vacuum source 454 may include one or more of the following: a manual vacuum pump, an electric vacuum pump, a diaphragm pump, a centrifugal pump, a displacement pump, a magnetically driven pump, a peristaltic pump, a wall-mounted vacuum line, or any pump configured to generate a vacuum. Vacuum source 454 can provide a vacuum or suction force to remove bodily fluids from fluid collection assembly 400. In some examples, vacuum source 454 may be powered by one or more of the following: a power cord (e.g., connected to a power outlet), one or more batteries, or even manual power (e.g., a manually operated vacuum pump). Vacuum source 454 may be a portable vacuum source. In some examples, vacuum source 454 is sized and shaped to be mounted externally to, on, or within fluid collection assembly 400. For example, vacuum source 454 may include one or more miniaturized pumps or one or more micropumps. Vacuum source 454 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 activating vacuum source 454.

[0096] In one embodiment, a method of collecting bodily fluids using a fluid collection assembly includes: forming the fluid collection assembly into a selected shape by bending a shape memory material in a multi-lumen conduit of the fluid collection assembly; positioning an opening of the fluid collection assembly adjacent to or on the wearer's urethra; and receiving the wearer's bodily fluids in the fluid collection assembly (e.g., a device).

[0097] The fluid collection assembly may include any of the fluid collection assemblies disclosed herein. Forming the fluid collection assembly into a selected shape by bending the shape memory material in the multi-lumen catheter of the fluid collection assembly may include bending the fluid collection assembly into a generally arcuate shape that conforms to one or more surfaces of the wearer's body near the urethra along the sagittal plane.

[0098] Positioning the opening of the fluid collection component adjacent to or on the wearer's urethra may include positioning the opening of the fluid collection component on or above the wearer's labia. Positioning the opening of the fluid collection component adjacent to or on the wearer's urethra may also include positioning the opening of the fluid collection component on or above the wearer's penis (e.g., micropenis, concealed penis).

[0099] Receiving a wearer's bodily fluids in a fluid collection assembly may include receiving and collecting urine through an opening into a porous material of the fluid collection assembly. This collection may include delivering the bodily fluids through the porous material toward an inlet of a multi-lumen catheter.

[0100] The method may include: removing bodily fluid from a chamber of a fluid collection assembly. Removing bodily fluid from a chamber of a fluid collection assembly may include: applying a vacuum force to the chamber using a vacuum source via a conduit (e.g., the fluid interior of a conduit). Removing bodily fluid from a chamber of a fluid collection assembly may include: storing the removed bodily fluid in a fluid storage container.

[0101] The method may include using the techniques or methods disclosed herein.

[0102] While various aspects and implementations have been disclosed herein, other aspects and implementations are conceivable. The various aspects and implementations disclosed herein are for illustrative purposes and are not intended to be limiting.

[0103] Degree terms (such as "about," "basically," "roughly," etc.) indicate no significant change in structure or function. For example, when a degree term is included with a term indicating quantity, the degree term is interpreted as ±10%, ±5%, or ±2% of the term indicating quantity. For example, when a degree term is used to modify a shape, the degree term indicates that the shape modified by the degree term has the appearance of the disclosed shape. For example, a degree term can be used to indicate that a shape may have rounded corners instead of sharp corners, curved edges instead of straight edges, one or more protrusions extending from it, be oblong, or be the same as the disclosed shape, etc.

Claims

1. A fluid collection assembly, comprising: Fluid-impermeable layers are limited to the following: The chamber is located within the fluid-impermeable layer; Passing through at least one opening in the fluid-impermeable layer; as well as Fluid outlet; At least one porous material disposed in the chamber; A conduit disposed in the at least one porous material, the conduit comprising a multi-lumen configuration having a fluid lumen and a shape memory lumen; Shape memory material, disposed within the shape memory cavity; and A limiting plug and an end plug are disposed in the shape memory cavity, wherein the limiting plug and the end plug are disposed at opposite ends of the shape memory material in the shape memory cavity to prevent the shape memory material from moving longitudinally within the shape memory cavity.

2. The fluid collection assembly according to claim 1, wherein, The at least one porous material defines a hole configured to receive the conduit.

3. The fluid collection assembly according to any one of claims 1 to 2, wherein, The at least one porous material includes polyurethane foam.

4. The fluid collection assembly according to any one of claims 1 to 2, wherein, The at least one porous material includes a three-dimensional mesh material.

5. The fluid collection assembly according to any one of claims 1 to 4, wherein, The at least one porous material includes a porous host material and a porous membrane material disposed on the porous host material.

6. The fluid collection assembly according to claim 5, wherein, The porous host material includes polymer foam, and the porous membrane material includes gauze.

7. The fluid collection assembly according to claim 5, wherein, The porous body material includes at least one vertical nonwoven material.

8. The fluid collection assembly according to any one of claims 1 to 7, wherein, The at least one vertical nonwoven material includes at least one of polyester, polypropylene, polyurethane, nylon, cellulose, cotton, or bamboo.

9. The fluid collection assembly according to any one of claims 1 to 8, wherein, The shape memory cavity is smaller than the fluid cavity.

10. The fluid collection assembly according to any one of claims 1 to 9, wherein, The shape memory cavity is located at the lowest point of gravity within the fluid cavity.

11. The fluid collection assembly according to any one of claims 1 to 10, wherein, The shape memory material includes metals or shape memory polymers.

12. The fluid collection assembly of claim 11, wherein, The metal includes copper alloys or nickel alloys.

13. The fluid collection assembly according to any one of claims 1 to 12, wherein, The limiting plug and the end plug are made of polymer, adhesive or metal.

14. The fluid collection assembly according to any one of claims 1 to 13, wherein, The limiting plug and the end plug have shapes that are complementary to the inner wall shape of the catheter defining the shape memory lumen.

15. The fluid collection assembly according to any one of claims 1 to 14, wherein: The limiting plug is positioned at a single point within the longitudinal length of the fluid-impermeable layer within the shape memory cavity; and The end plug is disposed within the shape memory lumen at the distal region of the catheter.

16. The fluid collection assembly according to any one of claims 1 to 13, wherein, The distance between the limiting plug and the end plug is at least 0.25 cm longer than the length of the shape memory material.

17. A fluid collection system, comprising: The fluid collection assembly according to any one of claims 1 to 16; Fluid storage containers; as well as Vacuum source; The chamber, the fluid storage container, and the vacuum source of the fluid collection assembly are in fluid communication with each other, such that when one or more bodily fluids are present in the chamber, the vacuum source provides suction to the chamber of the fluid collection assembly to remove the one or more bodily fluids from the chamber and store the bodily fluids in the fluid storage container.

18. The fluid collection system according to claim 17, wherein, The vacuum source includes a wall-mounted vacuum line or a portable vacuum source.

19. A method for collecting bodily fluids using a fluid collection assembly, the method comprising: The fluid collection assembly is formed into a selected shape by bending the shape memory material in the multi-lumen conduit of the fluid collection assembly according to any one of claims 1 to 16; The opening of the fluid collection assembly is positioned adjacent to or on the wearer's urethra; as well as The wearer's bodily fluids are collected in the fluid collection assembly.

20. The method of claim 19, further comprising removing bodily fluids from the fluid collection assembly.

Images