At least one porous material attached to a fluid impermeable barrier

Abstract

An exemplary bodily fluid collection assembly includes a fluid-impermeable barrier. The fluid-impermeable barrier defines at least one chamber, at least one opening, and a fluid outlet. The fluid-impermeable barrier also includes a top panel and a bottom panel opposite the top panel. The bodily fluid collection assembly further includes at least one porous material disposed within the chamber. The at least one porous material includes a top region and a bottom region. The edge of at least the bottom region of the porous material is securely connected to the top panel and the bottom panel.

Description

Background Technology

[0001] Humans or animals may have limited or impaired mobility, making the routine process of urination difficult or impossible. For example, some people may have impaired mobility due to disability; pilots, drivers, and workers in hazardous areas may face limited mobility. In addition, human bodily fluids may sometimes need to be collected for health monitoring or clinical testing.

[0002] Urinary catheters, such as the Foley catheter, can be used to manage conditions like urinary incontinence. Unfortunately, catheters can cause discomfort, pain, and may lead to complications such as infection. Bedpans, containers for bedridden patients, are sometimes used. However, bedpans can also cause discomfort, leakage, and other hygiene problems. Summary of the Invention

[0003] The embodiments disclosed herein relate to a fluid collection assembly comprising at least one porous material attached to a fluid-impermeable barrier, a fluid collection assembly including the same, and methods of manufacturing and using the same. In one embodiment, a fluid collection assembly is disclosed. The fluid collection assembly includes a fluid-impermeable barrier defining at least one chamber, at least one opening, and a fluid outlet. The fluid-impermeable barrier includes a top panel and a bottom panel opposite to the top panel. The fluid collection assembly further includes at least one porous material disposed within the chamber. The at least one porous material includes a top region and a bottom region. The edge of the bottom region of the at least one porous material is sealed and fixedly connected to the top panel and the bottom panel by a porous material seal.

[0004] 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 barrier defining at least one chamber, at least one opening, and a fluid outlet. The fluid-impermeable barrier includes a top panel and a bottom panel opposite the top panel. The fluid collection assembly also includes at least one porous material disposed within the chamber. The at least one porous material includes a top region and a bottom region. The edge of the bottom region of the at least one porous material is sealed and fixedly connected to the top and bottom panels by the porous material. The fluid collection system also includes a fluid storage container and a vacuum source. The chamber of the fluid collection assembly, the fluid storage container, and the vacuum source are in fluid communication with each other, such that when one or more bodily fluids are present in the chamber, suction provided by the vacuum source to the chamber of the fluid collection assembly can remove the one or more bodily fluids from the chamber and transport them to the fluid storage container.

[0005] In one embodiment, a method of forming a fluid collection assembly is disclosed. The method includes: providing at least one porous material disposed within a cavity defined by a fluid-impermeable barrier. The fluid-impermeable barrier defines at least the cavity, at least one opening, and a fluid outlet. The fluid-impermeable barrier includes a top panel and a bottom panel opposite the top panel. The at least one porous material includes a top region and a bottom region. The method further includes: securing the at least one porous material to at least one of the top panel or the bottom panel using a porous material seal.

[0006] In one embodiment, a method for collecting bodily fluids from a patient is disclosed. The method includes: positioning at least one opening defined by a fluid-impermeable barrier of a fluid collection assembly near the patient's urethral opening, or receiving the patient's penis through the at least one opening and extending it into a chamber defined by the fluid-impermeable barrier. The fluid-impermeable barrier defines at least the chamber, the at least one opening, and a fluid outlet. The fluid-impermeable barrier includes a top panel and a bottom panel opposite the top panel. The method further includes: draining bodily fluids into the chamber. The method further includes: receiving the bodily fluids through at least one porous material of the fluid collection assembly disposed within the chamber. The at least one porous material includes a top region and a bottom region, and the edge of at least the bottom region of the at least one porous material is sealed and fixedly connected to the top panel and the bottom panel by a porous material seal. The method further includes: draining the bodily fluids from the chamber through the fluid outlet.

[0007] The technical features of any embodiment of this disclosure can be combined with each other without limitation. Furthermore, other features and advantages of this disclosure will be readily apparent to those skilled in the art upon reading the following detailed description and accompanying drawings. Attached Figure Description

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

[0009] Figure 1A and Figure 1B The images are a top and bottom isometric view of a fluid collection assembly according to an embodiment. Figure 1C and Figure 1D These are cross-sectional views of the fluid collection assembly taken along plane 1C-1C and plane 1D-1D, respectively. Figure 1E for Figure 1C A partially enlarged cross-sectional view of the fluid collection assembly shown in circle 1E in front of the porous material installed on the top and bottom panels; Figure 1F for Figure 1C The enlarged cross-sectional view of the fluid collection assembly shown in circle 1E after the porous material is installed on the top and bottom panels; Figure 2A A cross-sectional view of a method for forming a fluid collection assembly in one embodiment; Figure 2B A cross-sectional view of the molded fluid collection assembly; Figure 3 and Figure 4 Top isometric view of different fluid collection assemblies in different embodiments, wherein the porous material seal is provided only along the outer edge of the porous material in different embodiments; Figure 5A This is a bottom plan view of the fluid collection assembly in one embodiment; Figure 5B For along Figure 5A A cross-sectional view of the fluid collection assembly along plane 5B-5B is shown. Figure 6 This is a block diagram of a fluid collection system for fluid collection in one embodiment. Detailed Implementation

[0010] The embodiments disclosed herein relate to a fluid collection assembly including at least one porous material attached to a fluid-impermeable barrier, a fluid collection device including the assembly, and methods for preparing and using the same. An exemplary fluid collection assembly includes a fluid-impermeable barrier defining at least a chamber, at least one opening, and a fluid outlet. The fluid-impermeable barrier also includes a top panel and a bottom panel disposed opposite the top panel. The fluid collection assembly further includes at least one porous material disposed within the chamber, the porous material having a top region and a bottom region. At least an edge of the bottom region of the porous material is fixedly connected to the top panel and the bottom panel.

[0011] During use, the fluid collection assembly can be worn by a patient (i.e., the user of the fluid collection assembly) by aligning the opening with the patient's urethral opening (such as the female urethral opening or the urethral opening of a concealed penis), or by allowing the patient's penis to pass through the opening into the chamber. The patient may expel one or more bodily fluids (such as urine, blood, sweat, etc.). The expelled bodily fluids can enter the chamber and be absorbed by the porous material. The bodily fluids absorbed by the porous material can flow to a fluid outlet or to a catheter inlet located within the chamber. For example, suction can be applied to the chamber through a vacuum source in fluid communication with the chamber. The suction can cause the bodily fluids to preferentially flow to the fluid outlet or the catheter inlet. The suction can then remove the bodily fluids from the chamber.

[0012] The fluid collection assemblies disclosed herein, which include porous material attached to a fluid-impermeable barrier panel, represent improvements over conventional fluid collection assemblies. For example, some conventional fluid collection assemblies include porous material disposed within a chamber. In some conventional fluid collection assemblies, the porous material is merely placed within the chamber without being physically attached to the fluid-impermeable barrier. In such conventional fluid collection assemblies, the porous material can be held within the chamber by adhering it tightly to the fluid-impermeable barrier and / or by selecting a porous material with dimensions larger than the openings on the fluid-impermeable barrier. In other conventional fluid collection assemblies, one or more pores may be formed on the porous material, and portions of the fluid-impermeable barrier adjacent to these pores may be interconnected. In still other conventional fluid collection assemblies, the porous material is physically attached to one side of the fluid-impermeable barrier rather than both sides to simplify the manufacturing process of the fluid collection assembly and to prevent adhesives or other connectors from clogging or obstructing the flow of bodily fluids through the porous material.

[0013] The conventional fluid collection assembly disclosed above may have a gap formed between a porous material and a fluid-impermeable barrier. When suction is applied to the chamber of such a fluid collection assembly, the suction provided to the chamber from a vacuum source preferentially draws air from the gap rather than bodily fluids stored in the porous material. Sometimes, drawing air from the gap causes the fluid-impermeable barrier to be drawn into and adhere to the porous material, thereby eliminating the gap and promoting the outflow of bodily fluids from the porous material. In other cases, drawing air from the gap may only result in more air being drawn into the gap, thus preventing the fluid-impermeable barrier from adhering to the porous material. When the fluid-impermeable barrier is drawn into and adheres to the porous material, drawing air from the gap may also create wrinkles or creases on the fluid-impermeable barrier; in this case, suction preferentially draws air from the chamber rather than bodily fluids through the porous material. Furthermore, drawing air from the gap may further delay the adsorption and adhesion of the fluid-impermeable barrier to the porous material. Any of the above problems may hinder or inhibit the outflow of bodily fluids from the porous material and the chamber. These problems are particularly pronounced in the use of traditional male fluid collection components that include thin, fluid-impermeable barriers and / or are designed to flatten when laid flat on a surface.

[0014] Another problem, at least partially related to the conventional fluid collection assemblies discussed above, is that the porous material fails to maintain contact with the fluid outlet or conduit inlet. For example, the porous material in at least a portion of the aforementioned fluid collection assemblies may be in contact with the fluid outlet or conduit inlet of a conventional fluid collection assembly before use. However, movement of the fluid collection assembly during use may cause the porous material to bend, be stretched, or otherwise displace away from the fluid outlet or conduit inlet. Such movement may create a gap between the porous material and the inlet of the fluid outlet or conduit inlet, resulting in air being drawn away instead of bodily fluids when suction is applied to the chamber. Furthermore, moving the porous material away from the fluid outlet or conduit inlet may cause suction to pull the fluid impermeable barrier toward the fluid outlet or conduit inlet, especially if the fluid impermeable barrier is made of a thin material or the fluid collection assembly is designed to flatten on a flat surface. Pulling the fluid impermeable barrier toward the fluid outlet or conduit inlet may cause the fluid impermeable barrier to at least partially block the fluid outlet or conduit inlet, thereby hindering or at least inhibiting the drainage of bodily fluids from the chamber.

[0015] The fluid collection assembly disclosed herein, comprising porous material attached to a fluid-impermeable barrier panel, represents an improvement over conventional fluid collection assemblies because it prevents or at least inhibits gap formation. For example, the fluid collection assembly disclosed herein includes at least a portion of porous material attached to corresponding locations on both sides of the fluid-impermeable barrier. This attachment allows the fluid-impermeable barrier to adhere tightly to the porous material, thereby preventing gap formation. This attachment also maintains the porous material in contact with the fluid outlet or conduit inlet, thus preventing the fluid-impermeable barrier from shifting towards the fluid outlet or conduit inlet.

[0016] Figure 1A and Figure 1B These are top and bottom isometric views of a fluid collection assembly 100 according to one embodiment. Figure 1C and Figure 1D The images show cross-sectional views of the fluid collection assembly 100 taken along planes 1C-1C and 1D-1D, respectively. The fluid collection assembly 100 is an example of a male fluid collection assembly, although in some embodiments, it can also be used to receive bodily fluids from a female urethral opening. The fluid collection assembly 100 includes a sheath 102 and a base 104. The base 104 is configured to attach (e.g., permanently attached or configured to be permanently attached) to the sheath 102. The base 104 is also configured to attach to an area surrounding an individual's urethral opening (e.g., the penis).

[0017] The sheath 102 includes a fluid-impermeable barrier 106 formed at least partially by a top panel 108 and a bottom panel 110. The fluid-impermeable barrier 106 also defines a chamber 112 between the top panel 108 and the bottom panel 110, an opening 114 in a proximal region 116 of the sheath 102, and a fluid outlet 118 in a distal region 120 of the sheath 102. The sheath 102 also includes at least one porous material 122 disposed within the chamber 112.

[0018] The top panel 108 and the bottom panel 110 may be joined or integrally formed (e.g., presented as a single piece). In one embodiment, as shown, the top panel 108 and the bottom panel 110 are separate sheets. In such embodiments, the top panel 108 and the bottom panel 110 may be sealed along the edge 111 by one or more panels 113 (in... Figures 1C to 1F (shown in bold) are interconnected. Panel seal 113 may include ultrasonic welding, radio frequency welding, adhesive or any other suitable means of joining the top panel 108 and the bottom panel 112 together in a manner that prevents or at least inhibits the flow of bodily fluids between the top panel 108 and the bottom panel 110.

[0019] The inner surface of the fluid impermeable barrier 106 (e.g., the inner surfaces of the top panel 108 and the bottom panel 110) at least partially defines a chamber 112 within the fluid collection assembly 100. The fluid impermeable barrier 106 temporarily stores bodily fluids within the chamber 112. The fluid impermeable barrier 106 substantially prevents bodily fluids from passing through the fluid impermeable barrier 106.

[0020] The fluid-impermeable barrier 106 can be formed of any suitable fluid-impermeable material, such as fluid-impermeable polymers (e.g., silicone, polypropylene, polyethylene, polyethylene terephthalate, neoprene rubber, polycarbonate, etc.), metal films, natural rubber, other suitable materials, any other fluid-impermeable materials disclosed herein, or combinations thereof. Therefore, the fluid-impermeable barrier 106 substantially prevents bodily fluids from permeating through it. In one example, the fluid-impermeable barrier 106 may be permeable to air but impermeable to liquids. In such examples, the fluid-impermeable barrier 106 may be formed of a hydrophobic material defining a plurality of pores. At least one or more portions of at least one outer surface 124 of the fluid-impermeable barrier 106 may be formed of a soft and / or smooth material to reduce friction.

[0021] In one embodiment, at least one of the top panel 108 or the bottom panel 110 is formed of a fluid-impermeable material that is at least partially transparent, such as polyethylene, polypropylene, polycarbonate, or polyvinyl chloride. Using a fluid-impermeable material to form at least one of the top panel 108 or the bottom panel 110 allows a person (e.g., a medical practitioner) to examine the penis. In some embodiments, both the top panel 108 and the bottom panel 110 are formed of a fluid-impermeable material that is at least partially transparent. Selecting at least one of the top panel 108 or the bottom panel 110 formed of a fluid-impermeable material that is at least partially transparent allows for examination of the penis without removing the entire fluid collection assembly 100 from the area surrounding the penis. For example, the chamber 112 may include a penis receiving area 126 configured to receive an individual's penis when the penis is inserted into the chamber 112. The penis receiving area 126 is defined by at least a porous material 122 and at least a portion of the at least partially transparent material of the top panel 108 and / or the bottom panel 110. In other words, the porous material 122 is located within the chamber 112 such that when the penis is inserted into the chamber 112 through the opening 114, the porous material 122 is not positioned between the penis and the transparent portions of the top panel 108 and / or the bottom panel 110. The porous material 122 is generally opaque; therefore, the portion of the at least partially transparent material of the top panel 108 and / or the bottom panel 110 defining the penis receiving area 126 forms a window that allows a person to observe the interior of the penis receiving area 126 and examine the penis.

[0022] In one embodiment, the fluid-impermeable barrier 106 may include one or more vents 115. Vents 115 may allow air to enter chamber 112 and flow to fluid outlet 118. The airflow may facilitate the flow of bodily fluids to fluid outlet 118. Vents 115 may include air-permeable but water-impermeable filters to prevent leakage of bodily fluids from chamber 112 through vents 115.

[0023] An opening 114, defined by a fluid-impermeable barrier 106, provides a pathway for bodily fluids to enter chamber 112 (when the penis is implanted) and allows the penis to enter chamber 112 (e.g., penis receiving area 126) when the penis is not implanted. The opening 114 may be defined by a fluid-impermeable barrier 106 (e.g., the inner edge of the fluid-impermeable barrier 106). For example, the opening 114 is formed on and extends through the fluid-impermeable barrier 106, thereby allowing bodily fluids to enter chamber 112 from the outside of the fluid collection assembly 100.

[0024] A fluid-impermeable barrier 106 defines a fluid outlet 118 sized to receive the catheter 128. The catheter 128 may be at least partially disposed within the chamber 112, or may be in fluid communication with the chamber 112 via the fluid outlet 118. The fluid outlet 118 is sized and shaped to form a seal with the catheter 128 that is at least substantially leak-proof, thereby substantially preventing the leakage of bodily fluids from the chamber 112.

[0025] In one embodiment, the fluid-impermeable barrier 106 includes a cap 130 forming a fluid outlet 118. The cap 130 has greater rigidity than the top panel 108 and the bottom panel 110. The increased rigidity of the cap 130 facilitates connecting the conduit 128 to the fluid outlet 118 (e.g., via an interference fit) compared to directly connecting the conduit 128 to the top panel 108 and the bottom panel 110. The cap 130 may include a connection portion 132 configured to connect to the top panel 108 and the bottom panel 110. The cap 130 may also include a conduit portion 134 extending from the connection portion 132, configured to connect to the conduit 128. The cap 130 defines a channel 136 through the connection portion 132 and the conduit portion 134, allowing bodily fluid to flow through the cap 130, thereby allowing bodily fluid to drain from the chamber 112 into the conduit 128. The cap 130 may include a flange 138 extending from the connection portion 132 into the chamber 112. The flange 138 may extend near the bottom panel 110. The flange 138 may provide a location where the porous material 122 can be attached to the cap 130 through the porous material seal 148.

[0026] In one embodiment, the fluid outlet 118 may be formed from unconnected or non-integral portions of the top panel 108 and the bottom panel 110. In such embodiments, the fluid impermeability barrier 106 may not include the cap 130, which helps simplify the manufacture of the fluid collection assembly 100, reduces the number of parts required to form the fluid collection assembly 100, and may shorten the time required to manufacture the fluid collection assembly 100. However, the absence of the cap 130 may make it difficult to secure the conduit 128 to the fluid outlet 118 using an interference fit; however, it should be noted that connecting the conduit 128 to the fluid outlet 118 is still feasible. Therefore, the conduit 128 may be connected to the fluid outlet 118 (e.g., to the top panel 108 and the bottom panel 110) using adhesives, welding, or other methods of joining fluid outlet 118 together. Connecting the conduit 128 to the fluid outlet 118 prevents leakage and avoids accidental detachment of the conduit 128 from the fluid outlet 118. In one example, conduit 128 can be connected to fluid outlet 118 in the same manufacturing step that joins top panel 108 and bottom panel 110 together.

[0027] As previously described, the sheath 102 includes at least one porous material 122 disposed within the chamber 112. The porous material 122 can guide bodily fluids to one or more selected areas of the chamber 112, for example, away from the penis and towards the fluid outlet 118. In one example, the porous material 122 may consist of a single layer (as shown), a double layer (e.g., a fluid-permeable outer layer covering the opening 114 and a fluid-permeable inner layer, since the fluid-permeable outer layer may be formed of a relatively foldable, thin, or deformable material), or three or more layers. If the porous material 122 comprises multiple layers, the multiple layers can be joined together by an adhesive, entanglement between fibers of different layers, or any other suitable technique. Joining the multiple layers of the porous material 122 together prevents the formation of gaps between the layers, thereby avoiding suction on the chamber 112 that draws air rather than bodily fluids from these gaps. In one example, the porous material 122 may be formed of a nonwoven or woven material (e.g., spun nylon fibers). In another example, the porous material 122 may include at least one substantially non-absorbent material, or at least one absorbent or adsorbent material.

[0028] In one embodiment, the porous material 122 may be a substantially planar sheet. Forming the porous material 122 into a sheet simplifies the manufacture of the fluid collection assembly 100. For example, forming the porous material 122 into a sheet allows each of the top panel 108, the bottom panel 110, and the porous material 122 to be sheet-like. During the manufacture of the fluid collection assembly 100, the top panel 108, the bottom panel 110, and the porous material 122 may be stacked first and then connected to each other in the same manufacturing step. For example, the shape and dimensions of the porous material 122 may be the same as, or more preferably, slightly smaller than, the dimensions of the top panel 108 and the bottom panel 110. Therefore, when the top panel 108 and the bottom panel 110 are joined together along their outer edges, the porous material 122 can also be attached to the top panel 108 and the bottom panel 110 simultaneously. The porous material 122 is slightly smaller than the top panel 108 and the bottom panel 110, thereby extending and enclosing the periphery of the porous material 122, so that the porous material 122 does not form channels in the fluid impermeable barrier 106 that could lead to leakage of bodily fluids. Furthermore, attaching the porous material 122 to the top panel 108 and / or the bottom panel 110 prevents significant movement of the porous material 122 within the chamber 112, for example, preventing the porous material 122 from accumulating near the fluid outlet 118. In one example, the porous material 122 may be attached to the top panel 108 or the bottom panel 110 before or after the top panel 108 is attached to the bottom panel 110 (e.g., by adhesive). In another example, the porous material 122 may also be placed simply within the chamber 112 without being attached to at least one of the top panel 108 or the bottom panel 110. In one embodiment, the porous material 122 may also take on other non-sheet shapes, such as a substantially hollow cylinder.

[0029] In one embodiment, the porous material 122 may be configured to prevent bodily fluid from escaping from the chamber 112 by drawing any bodily fluid away from the opening 114. The term "permeable" as used herein may include wicking, capillary action, diffusion, or other similar properties or processes, referred to herein as "permeable" and / or "wicking." Such "wicking" and / or "permeable" properties may not include the absorption of bodily fluid by at least a portion of the porous material 122, for example, the adsorption of bodily fluid by a fluid-permeable inner layer. In other words, when the material is exposed to and detached from bodily fluid for a period of time, the bodily fluid is substantially not absorbed or dissolved by the material. While no absorption or dissolution is ideal, the term "substantially no absorption" allows for nominal amounts (e.g., absorbance) of bodily fluids that are minimally absorbed and / or dissolved by the porous material 122, 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 the porous material 122. As discussed in more detail below, the porous material 122 may also substantially wick bodily fluids into the interior of the chamber 112. In one embodiment, the porous material 122 may comprise at least one absorbent or adsorbent material.

[0030] In one embodiment, the porous material 122 may include a fluid-permeable outer layer disposed within the chamber 112. The fluid-permeable outer layer may cover at least a portion (e.g., all) of the opening 114. The fluid-permeable outer layer is configured to draw bodily fluids away from the opening 114 through wicking, thereby preventing leakage of bodily fluids from the chamber 112. In one embodiment, the fluid-permeable outer layer may include any suitable material capable of wicking bodily fluids. For example, the fluid-permeable outer layer may include fabrics such as gauze (e.g., silk, linen, or cotton gauze), other soft fabrics, other smooth fabrics, nonwoven materials (e.g., vertically combed nonwoven materials), or any other porous material disclosed herein. Using gauze, soft fabrics, and / or smooth fabrics to form the fluid-permeable outer layer can reduce skin friction caused by the fluid collection assembly 100.

[0031] The fluid collection assembly 100 may include a fluid-permeable inner layer disposed within a chamber 112. The fluid-permeable inner layer is configured to support a fluid-permeable outer layer, as the outer layer may be formed of a relatively foldable, thin, or easily deformable material. For example, the fluid-permeable inner layer may be positioned such that the fluid-permeable outer layer is located between the fluid-permeable inner layer and the fluid-impermeable barrier 106. In this way, the fluid-permeable inner layer supports and holds the position of the fluid-permeable outer layer. The fluid-permeable inner layer may include any material capable of allowing the transport of bodily fluids by wicking, absorption, adsorption, or other means, such as any of the fluid-permeable outer layer materials disclosed above. For example, when used as a fluid-permeable inner layer, the same fluid-permeable outer layer material may be used in a denser or more rigid form than in the fluid-permeable outer layer material. The fluid-permeable inner layer may be formed of any fluid-permeable material that is less deformable than the fluid-permeable outer layer. For example, a fluid-permeable inner layer may comprise a porous polymer structure (such as nylon, polyester, polyurethane, polyethylene, polypropylene, etc.) or an open-cell foam, such as spun nylon fibers. In some examples, the fluid-permeable inner layer may comprise a nonwoven material, such as a vertically carded nonwoven material. In other examples, the fluid-permeable inner layer may be formed from natural materials, such as cotton, wool, silk, or combinations thereof. In these examples, the material may have a coating, such as a waterproof coating, to prevent or limit the absorption of liquids by the material. In some examples, the fluid-permeable inner layer may be formed from fabrics, felts, gauze, or combinations thereof.

[0032] In some examples, the fluid-permeable outer layer is optional. For example, the porous material 122 may consist only of a fluid-permeable inner layer. In some examples, the fluid-permeable inner layer may be selectively omitted from the fluid collection assembly 100. For example, the porous material 122 may consist only of a fluid-permeable outer layer. Examples of other porous materials that may be included in the fluid collection assembly 100 are disclosed in PCT patent application No. PCT / US2021 / 039866, filed June 30, 2021; PCT international application No. PCT / US2022 / 011281, filed January 5, 2022; PCT international application No. PCT / US2022 / 042719, filed September 7, 2022; PCT international application No. PCT / US2022 / 042725, filed September 7, 2022; U.S. provisional patent application No. 63 / 241,564, filed September 8, 2021; PCT international application No. PCT / US2022 / 015418, filed February 7, 2022; and PCT international application No. [missing information - likely a date or date]. The disclosures of each of these applications, PCT / US2022 / 015420, are incorporated herein by reference in their entirety.

[0033] In one embodiment, at least a portion of the porous material 122 (e.g., one or more of the fluid-permeable outer layer, or more specifically, the fluid-permeable inner layer) may be hydrophobic. The porous material 122 is hydrophobic when the contact angle between the porous material 122 and water (a major component of bodily fluids) is greater than about 90°, for example, the contact angle ranges from about 90° to about 120°, about 105° to about 135°, about 120° to about 150°, about 135° to about 175°, or about 150° to about 180°. The hydrophobicity of the porous material 122 can limit the absorption, adsorption, and dissolution of bodily fluids in the material, thereby reducing the amount of bodily fluid retained in the porous material 122. In one embodiment, at least a portion of the porous material 122 is hydrophobic or hydrophilic. In one embodiment, the fluid-permeable inner layer is more hydrophobic than the fluid-permeable outer layer (e.g., with a larger contact angle with water). The low hydrophobicity of the fluid-permeable outer layer helps the porous material 122 receive bodily fluids from the urethral opening, while the hydrophobicity of the fluid-permeable inner layer limits the amount of bodily fluids retained in the porous material 122.

[0034] The porous material 122 includes a top region 140 and a bottom region 142. The top region 140 is located adjacent to (e.g., covering) the opening 114, or closer to the opening 114 defined by the fluid impermeable barrier 106 than the bottom region 142. The bottom region 142 is located adjacent to the fluid outlet 118, or closer to the fluid outlet 118 or a catheter inlet placed through the fluid outlet 118. The top region 140 includes a portion of the porous material 122 located within a portion of the chamber 112 defined by the proximal region 116 of the fluid impermeable barrier 106, and a portion of the porous material 122 extending across the opening 114. The bottom region 142 includes a portion of the porous material 122 located within a portion of the chamber 112 defined by the distal region 120. In one example, the bottom region 142 is adjacent to and / or near the cap 130 and the edge 113 of the fluid impermeable barrier extending from the cap 130 and not parallel to the longitudinal axis of the fluid impermeable barrier 106. In one example, the bottom region 142 may extend from the bottom end of the porous material 122 by about 5 cm or less, for example, about 5 mm or less, about 7.5 mm or less, about 1 cm or less, about 1.25 cm or less, about 1.5 cm or less, about 2 cm or less, about 2.5 cm or less, about 3 cm or less, about 3.5 cm or less, about 4 cm or less, or within the range of about 5 mm to about 1 cm, about 7.5 mm to about 1.25 cm, about 1 cm to about 1.5 cm, about 1.25 cm to about 2 cm, about 1.5 cm to about 2.5 cm, about 2 cm to about 3 cm, about 2.5 cm to about 3.5 cm, about 3 cm to about 4 cm, or about 3.5 cm to about 5 cm. The porous material may also include an intermediate region 144 extending between the top region 140 and the bottom region 142.

[0035] The porous material 122 includes at least one top surface 150 and a bottom surface 152 opposite to the top surface 150. The top surface 150 may extend to and be in contact with the top panel 108 (when any gaps are eliminated), and the bottom surface 152 may extend to and be in contact with the bottom panel 110. The porous material 122 may also include one or more edges 154 extending from the top surface 150 to the bottom surface 152 around the periphery of the porous material 122.

[0036] As previously described, at least a portion of the porous material 122 is attached to the top panel 108 and the bottom panel 110. Attaching the porous material 122 to both the top panel 108 and the bottom panel 110 simultaneously prevents or at least inhibits the formation of gaps between the porous material 122 and the top panel 108 and the bottom panel 110, through which suction would preferentially draw air rather than from the porous material 122.

[0037] For example, Figure 1E Before the porous material 122 is connected to the top panel 108 and the bottom panel 110, from Figure 1C The enlarged cross-sectional view of the fluid collection assembly 100 taken at circle 1E. Since the porous material 122 is not connected to the top panel 108 and the bottom panel 110, the top panel 108, the bottom panel 110, and the porous material 122 can move freely relative to each other. For example, Figure 1E The top panel 108 is shown to bend outward away from the porous material 122 to form a first gap 146a; the porous material 122 is moved away from the bottom panel 108 and the flange 138 to form a second gap 146b; and the porous material 122 is moved away from the fluid outlet 118 (e.g., away from the inlet of the channel 136 defined by the cap 130).

[0038] Figure 1E The diagram also schematically illustrates the dominant fluid flow A (schematically indicated by arrow A) through chamber 112 if suction is applied to chamber 112 before the porous material 122 is attached to the top panel 108 and the bottom panel 110. As shown, the dominant fluid flow A flows around the porous material 122, so the suction applied to chamber 112 preferentially draws air from the first gap 146a and the second gap 146b, rather than from the porous material 122 itself. The dominant airflow A delays or at least hinders the drainage of bodily fluids from chamber 112. It should be noted that attaching the porous material 122 to only one of the top panel 108 or the bottom panel 110 will still allow the formation of one of the first gap 146a or the second gap 146b, respectively, so the suction applied to chamber 112 will still preferentially draw air from these gaps, rather than from the porous material 122 itself. Furthermore, the dominant airflow A may pull the top panel 108 toward the fluid outlet 118 (i.e., into the third gap 146c), potentially causing the top panel 108 to at least partially block the fluid outlet 118. It should be noted that the flange 138 prevents or at least inhibits the bottom panel 110 from being pulled toward the fluid outlet 118 (e.g., into the third gap 146c). However, without the flange 138, the dominant airflow A might pull the bottom panel 110 toward the fluid outlet 118, potentially causing the bottom panel 110 to at least partially block the fluid outlet 118.

[0039] Figure 1F After the porous material 122 is connected to the top panel 108 and the bottom panel 110, from Figure 1C A magnified cross-sectional view of the fluid collection assembly 100 taken at circle 1E. Porous material 122 is used to seal 148 with one or more porous materials (in...). Figure 1A and 1B The text is presented schematically using lines. Figures 1C to 1F(Shown in bold) It is connected to the top panel 108 and the bottom panel 110. Because the porous material 122 is attached to the top panel 108 and the bottom panel 110, the top panel 108, bottom panel 110, and porous material 122 cannot move freely relative to each other in at least the region near the porous material seal 148. Therefore, the porous material seal 148 prevents or at least inhibits... Figure 1E The formation of the gap shown.

[0040] For example, Figure 1F The dominant fluid flow B (indicated by arrow B) through chamber 112, caused by suction applied to chamber 112, is schematically shown. As shown, the dominant fluid flow B flows through at least a portion of porous material 122. The dominant fluid flow B flowing through porous material 122 draws air from porous material 122 (when the pores of porous material 122 are at least partially occupied by air), thereby promoting the flow of bodily fluid through porous material 122 and toward fluid outlet 118. When the pores of porous material 122 are at least partially occupied by bodily fluid, the dominant fluid flow B flowing through porous material 122 also draws bodily fluid from porous material 122.

[0041] It should be noted that downstream of the porous material seal 148 (i.e., between the porous material seal 148 and the opening 114), a gap may still form between the porous material 122 and the top or bottom panel 108. Such a gap may include, for example, a penis receiving area 126. The dominant fluid flow B may primarily flow through the gap downstream of the porous material seal 148 and preferentially draw air from the gap downstream of the porous material seal 148, rather than flowing through a portion of the porous material 122 downstream of the porous material seal 148. However, unlike the first gap 146a, the second gap 146b, and the third gap 146c, drawing air from the gap downstream of the porous material seal 148 does not prevent or inhibit the removal of bodily fluids from the porous material 122, because the dominant fluid flow B still flows through a portion of the porous material 122. For example, the dominant fluid flow B may still flow through the porous material 122 surrounding the porous material seal 148, thereby removing any bodily fluids from that portion of the porous material 122. Because bodily fluids contain water, they are bonded together by hydrogen bonds. Therefore, removing bodily fluid from the portion of porous material 122 adjacent to the porous material seal 148 will draw more bodily fluid into that portion of porous material 122. Furthermore, evacuating air from the gaps downstream of the porous material seal 148 typically reduces the volume of these gaps. This reduction in the gap volume downstream of the porous material seal 148 prevents or inhibits undesirable accumulation of bodily fluid in the gaps and promotes efficient reception of bodily fluid into the porous material 122.

[0042] It is important to note that Figure 1E and 1FThe description mentions and shows that bodily fluids and the dominant fluid flow toward the fluid outlet 118 because the inlet of the catheter 128 does not extend into the chamber 112. However, it should be noted that if the catheter 128 were located inside the chamber 112, the bodily fluids and the dominant fluid flow would be toward and into the inlet of the catheter 128.

[0043] The porous material seal 148 may include a suitable sealing method that attaches the porous material 122 to the top panel 108 and bottom panel 110 in a manner that prevents or at least inhibits relative movement between the top panel 108 and bottom panel 110 and the porous material 122. The porous material seal 148 may also prevent or at least inhibit airflow directly through the seal to prevent the porous material seal 148 from forming a channel through which air can pass without passing through the porous material 122. The porous material seal 148 (i.e., attaching the porous material 122 to the top panel 108 and bottom panel 110) may be formed using any suitable technique. In one example, the porous material seal 148 may include an adhesive (e.g., silicone adhesive, hydrogel adhesive, hot melt adhesive, or any other suitable adhesive) that can be used to attach the porous material 122 to the top panel 108 and bottom panel 110. The adhesive should be configured to prevent or limit the penetration of the adhesive into the interior of the porous material 122, as adhesive penetrating deep into the interior of the porous material 122 may clog or even impede the flow of bodily fluids through the pores of the porous material 122. Controlling at least one of the following factors—the amount of adhesive used, the contact angle between the adhesive and the porous material 122, or the pressure applied to the top panel 108, bottom panel 110, and porous material 122 when these components are bonded together—can prevent or inhibit adhesive penetration into the porous material 122. In another example, the porous material seal 148 can be formed by thermal welding, ultrasonic welding, radio frequency welding, or any other suitable welding method. The formation of the weld can be controlled to limit the distance the weld penetrates into the porous material 122, as welding may block or impede the pores of the porous material 122 for the flow of bodily fluids. In one example, the porous material seal 148 can be formed by a suture that penetrates or at least partially penetrates the porous material 122. Unlike the adhesives or welds discussed above, sutures may offer minimal obstruction to the pores of the porous material 122. It is worth noting that the porous material seal 148 can also be formed using techniques other than adhesives, welding, or sutures, or a combination of the above techniques may be used. For example, the porous material seal 148 can be formed by welding and reinforced with stitching because the limited distance the weld penetrates into the porous material 122 restricts the weld strength.

[0044] The top surface 150 can be sealed to the top panel 108 using a first porous material seal, and the bottom surface 152 can be sealed to the bottom panel 110 using a second porous material seal. In one embodiment, the first and second porous material seals are identical (e.g., they are formed using the same adhesive, the same type of welding, or through-hole stitching). In another embodiment, the first and second porous material seals are different. The first and second porous material seals may differ for various reasons. For example, one of the first and second porous material seals may be formed during the manufacture of the fluid collection assembly 100, while the other may be formed during the modification of the fluid collection assembly 100.

[0045] As previously described, when the top panel 108 and the bottom panel 110 are different components, they are connected together by a panel seal 113. In one embodiment, the panel seal 113 and the porous material seal 148 can be independent of each other. The panel seal 113 and the porous material seal 148 are considered independent when they are visually distinguishable or formed independently. For example, if the panel seal 113 and the porous material seal 148 are spatially separated, then they are independent. In one example, the panel seal 113 and the porous material seal 148 can also be considered independent because the connection method used to form the panel seal 113 is different from the connection method used to form the porous material seal 148. Specifically, in such examples, panel seal 113 may be formed by a first type of welding (e.g., thermal welding, ultrasonic welding, radio frequency welding, etc.), while porous material seal 148 may be formed by a second type of welding, different from the first type, using adhesives or stitching, etc. Furthermore, if panel seal 113 is formed earlier or later than porous material seal 148, then panel seal 113 is independent of porous material seal 148.

[0046] Panel seal 113 and porous material seal 148 can be independent of each other for a variety of reasons. For example, the fluid impermeable barrier 106 and porous material 122 can be made of different materials, requiring different bonding techniques. For instance, porous material 122 may require at least some pores to remain open to function properly, while fluid impermeable barrier 106 does not. Therefore, in such examples, panel seal 113 may be formed using techniques that would block the pores of porous material 122.

[0047] In one embodiment, a porous material seal 148 can be used to connect nearly the entire top surface 150 to the top panel 108, or nearly the entire bottom surface 152 to the bottom panel 110. In such embodiments, it is difficult to form a gap between the surface of the porous material 122 and the top panel 108 and / or the bottom panel 110. Furthermore, connecting nearly the entire top surface 150 and / or the bottom surface 152 to the respective panels can enhance the connection strength between them.

[0048] In one embodiment, as shown, the porous material seal 148 connects at least a portion of the top surface 150 to the top panel 108 and / or only a portion of the bottom surface 152 to the bottom panel 110. For example, only a portion of the top surface 150 at or near the edge 154 of the porous material 122 is connected to the top panel 108, and / or only a portion of the bottom surface 152 at or near the edge 154 of the porous material 122 is connected to the bottom panel 110. In such examples, the porous material seal 148 still ensures that the dominant fluid flow passes through at least a portion of the porous material 122, while allowing the fluid collection assembly 100 to retain some gaps, such as the penis receiving area 126. Furthermore, connecting only a portion of the top surface 150 to the top panel 108 and / or a portion of the bottom surface 152 to the bottom panel 110 reduces the likelihood that the porous material seal 148 will at least partially block the pores of the porous material 122. In addition, it may be easier to connect only a portion of the area than to connect almost all of the top surface 150 to the top panel 108 and / or to connect almost all of the bottom surface 152 to the bottom panel 110.

[0049] In one embodiment, as shown, when only the portion of the top surface 150 at or near the edge 154 of the porous material 122 is attached to the top panel 108, or the portion of the bottom surface 152 at or near the edge 154 of the porous material 122 is attached to the bottom panel 110, the porous material seal 148 can extend along almost the entire outer periphery of the porous material 122. In such embodiments, the fluid flow within the chamber 112 caused by suction must flow through the porous material 122 because there is no flow path that bypasses the porous material seal 148. This fluid flow maximizes the vacuum assistance used for wicking of bodily fluids through the porous material 122. Nevertheless, as Figure 3 and Figure 4 As will be discussed in more detail, the porous material seal 148 does not need to extend along the entire outer periphery of the porous material 122.

[0050] The porous material seal 148 can be formed at any suitable time. In one example, the porous material seal 148 is at least partially formed (i.e., the porous material 122 is attached to one or both of the top panel 108 or the bottom panel 110) before the panel seal 113 is formed (i.e., before the top panel 108 and the bottom panel 110 are joined together). Such examples may facilitate the formation of the porous material seal 148 because the porous material 122 may be more easily accessed before the panel seal 113 is formed. In one example, the porous material seal 148 can be at least partially formed simultaneously with the panel seal 113. In such examples, it may be advantageous for the porous material seal 148 and the panel seal 113 to be formed substantially simultaneously when they are joined in the same manner. In one example, at least a portion of the porous material seal 148 can be formed after the panel seal 113 is formed. In such examples, the porous material seal 148 can be formed during the retrofitting of a conventional fluid collection assembly. Retrofitting conventional fluid collection components to include a porous material seal 148 allows for on-site customization to meet the needs and / or preferences of patients or caregivers, and simplifies inventory management due to fewer types of fluid collection components.

[0051] In one embodiment, the porous material 122 may conform to the inlet of the fluid outlet 118. The porous material seal 148 can hold the porous material 122 in position conforming to the inlet of the fluid outlet 118 when at least one of the following conditions is met: nearly the entire top surface 150 is attached to the top panel 108; nearly the entire bottom surface 152 is attached to the bottom panel 110; the top surface 150 is attached to the top panel 108 at or near the edge 154 of the porous material 122; or the bottom surface 152 is attached to the bottom panel 110 at or near the edge 154 of the porous material 122. Maintaining the porous material 122 in contact with the inlet of the fluid outlet 118 prevents… Figure 1E The formation of the third gap 146c shown. In other words, keeping the porous material 122 in contact with the inlet of the fluid outlet 118 prevents suction from pulling the top panel 108 and / or the bottom panel 110 toward the inlet of the fluid outlet 118, thereby causing the top panel 108 and / or the bottom panel 110 to at least partially block the inlet. In one embodiment, the porous material 122 does not conform to the inlet of the fluid outlet 118. In such embodiments, the fluid impermeable barrier 106 may be sufficiently rigid to make it unlikely that suction will pull the top panel 108 and / or the bottom panel 110 toward the inlet of the fluid outlet 118. The gap between the porous material 122 and the inlet of the fluid outlet 118 effectively forms an extension of the conduit 128 between the inlet of the fluid outlet 118 and the porous material 122. In one embodiment, the porous material 122 does not extend into or through the fluid outlet 118.

[0052] Typically, when the penis is not located within the penile receiving area 126 and the sheath 102 lies flat on a flat surface, the sheath 102 is substantially flat. The sheath 102 is substantially flat because the fluid-impermeable barrier 106 is formed by the top panel 108 and the bottom panel 110, rather than a conventional tubular fluid-impermeable barrier. Furthermore, as previously mentioned, the porous material 122 can be sheet-like, which also contributes to the substantially flattening of the sheath 102. The substantially flattening of the sheath 102 can also be due to the fluid collection assembly 100 not including relatively rigid rings or caps with a rigidity greater than that of the surrounding fluid-impermeable barrier 106 portion, as such rings and caps could prevent the sheath 102 from exhibiting a substantially flattened shape.

[0053] It should be noted that the sheath 102 is described as "substantially flat" because, depending on the thickness of the porous material 122, a portion of the porous material 122 may cause a slight bulge in the sheath 102; the fluid outlet 118 and / or conduit 128 may create a bulge around it; or the base 104 may pull on portions of the sheath 102 around it. It should also be noted that the sheath 102 may also be compliant, and therefore, during use, the sheath 102 may not remain substantially flat, as it may be placed on non-flat surfaces (e.g., between the testicles, perineum, and / or thighs), and the sheath 102 will conform to the shape of these surfaces.

[0054] When the penis is not placed within the penis receiving area 126 and the sheath 102 lies flat on a flat surface, the substantially flat sheath 102 allows the fluid collection assembly 100 to be used with both implanted and unimplanted penises. For example, when the fluid collection assembly 100 is used with an implanted penis, the penis is not inserted into the penis receiving area 126, resulting in the sheath 102 spreading relatively flat over the opening 156 of the base 104. When the sheath 102 is relatively flat over the opening 156, the porous material 122 extends across the openings 114 and 156 and is closely adjacent to the implanted penis. Therefore, the porous material 122 can prevent or inhibit the accumulation of bodily fluids drained from the implanted penis on the patient's skin, as the porous material 122 receives and removes most of the bodily fluids that would otherwise accumulate on the skin. As a result, the patient's skin remains dry, thereby improving the comfort of using the fluid collection assembly 100 and preventing skin deterioration. However, unlike conventional fluid collection assemblies designed for implanted penises, the fluid collection assembly 100 can still be used with unimplanted penises, as the unimplanted penis can still be accommodated within the penis receiving area 126, even when the penis is fully erect. Furthermore, the substantially flat sheath 102 makes the use of the fluid collection assembly 100 more discreet than when the sheath 102 is not substantially flat, thus avoiding potentially embarrassing situations.

[0055] When the sheath 102 is substantially flattened, the porous material 122 occupies almost all the space of the chamber 112, and the penis-accommodating area 126 is in a collapsed state. Figure 1C and Figure 1D (The image is schematically drawn in an uncollapsed state to show the penile receiving area 126). In other words, the sheath 102 does not define an area that is not permanently occupied by the porous material 122. When the porous material 122 occupies almost all the space of the chamber 112, bodily fluids drained into the chamber 112 are unlikely to accumulate for a long time, as accumulation of bodily fluids can lead to hygiene problems, odor, and / or keep the patient's skin in continuous contact with bodily fluids, causing discomfort and worsening of skin conditions.

[0056] As previously discussed, the top panel 108, bottom panel 110, and porous material 122 can be made relatively flexible. The top panel 108, bottom panel 110, and porous material 122 are relatively flexible when they cannot maintain their shape in an unsupported state. The flexibility of the top panel 108, bottom panel 110, and porous material 122 allows the sheath 102 to be substantially flat, as described above. The flexibility of the top panel 108, bottom panel 110, and porous material 122 also allows the sheath 102 to adapt to the shape of the penis, even when the size and shape of the penis change (e.g., during erection), and minimizes unoccupied space within the chamber 112 where bodily fluids may accumulate.

[0057] As previously discussed, the fluid collection assembly 100 includes a base 104 configured to connect to a sheath 102. For example, the base 104 is configured to be permanently connected to the sheath 102. The base 104 may be considered permanently connected to the sheath 102 if, for example, the base 104 is already permanently connected to the sheath 102 when the fluid collection assembly 100 is provided; or if the base 104 is not permanently connected to the sheath 102 when provided, but is configured to be permanently connected to the sheath 102 at some future point in time. A permanent connection means that the sheath 102 cannot be separated from the base 104 without damaging at least one of the sheath 102 or the base 104, requiring the sheath 102 to be cut from the base 104 using a tool, and / or the adhesive connecting the sheath 102 and the base 104 to be dissolved using a chemical solvent. The base 104 may be permanently connected to the sheath 102 by adhesive, sewing, heat sealing, radio frequency welding, or ultrasonic welding. In one embodiment, the base 104 is configured to be reversibly connected to the sheath 102. In another embodiment, the base 104 and the sheath 102 are integrally formed.

[0058] The base 104 includes an aperture 156. The base 104 is permanently connected to the distal region 120 of the sheath 102 such that the aperture 156 is aligned with the opening 114.

[0059] The size, shape, and material of the base 104 enable it to conform to the skin surrounding the penis (e.g., pubis, thigh, testicles, and / or perineum) and allow the penis to pass through it. For example, the base 104 may define an opening 156 configured to allow the penis to pass through it. In one example, the base 104 may present a general shape or contour of the skin surface to which the base 104 is attached. The base 104 may be flexible, thereby enabling it to conform to any shape of the skin surface and reducing the pulling force of the base 104 on the skin surface. The base 104 may extend laterally beyond the sheath 102, thereby increasing the surface area on which the fluid collection assembly 100 can adhere to the user's skin compared to a substantially similar fluid collection assembly 100 that does not include the base.

[0060] As previously discussed, the fluid collection assembly 100 includes a catheter 128. The inlet of catheter 128 may be located near the distal region 120 of sheath 102, which is intended to be the lowest point of chamber 112 in the direction of gravity when worn by an individual. The inlet of catheter 128 may be located near the distal region 120 of sheath 102 when cap 130 is located at or near the distal region 120. Positioning the inlet at or near the distal region 120 of sheath 102 allows catheter 128 to receive more fluid than if the inlet of catheter 128 were located elsewhere, and reduces the likelihood of fluid buildup (e.g., fluid buildup can lead to microbial growth and foul odor).

[0061] As discussed earlier, Figure 1A-1F The panel seal 113 and the porous material seal 148 in the illustrated body fluid collection assembly 100 are independent of each other. However, the panel seal and the porous material seal in the body fluid collection assembly disclosed herein may be the same. That is, the panel seal and the porous material seal disclosed herein may not be independent of each other. Figure 2A This is a cross-sectional view of a method for forming a body fluid collection assembly 200 according to one embodiment. Figure 2B This is a cross-sectional view of the formed body fluid collection assembly 200. Unless otherwise disclosed herein, the body fluid collection assembly 200 is identical or substantially similar to any body fluid collection assembly disclosed herein. For example, the body fluid collection assembly 200 includes a fluid-impermeable barrier 206 comprising a top panel 208 and a bottom panel 210. The body fluid collection assembly 200 also includes at least one porous material 222.

[0062] The body fluid collection assembly 200 is formed by providing a top panel 208, a bottom panel 210, and a porous material 222. The top panel 208 and bottom panel 210 include edges 211. The porous material 222 includes a top surface 250, a bottom surface 252, and an edge 254. The porous material 222 is positioned between the top panel 208 and the bottom panel 210 such that the top surface 250 of the porous material 222 is adjacent to the top panel 208, and the bottom surface 252 is adjacent to the bottom panel 210.

[0063] When force C (indicated schematically by an arrow) is applied, the edges 211 of the top panel 208 and the bottom panel 210 can be agglomerated together. As the edges 211 of the top panel 208 and the bottom panel 210 are agglomerated, the edges 254 of the porous material 222 may be squeezed together and compressed. It is noteworthy that the width of the porous material 222 may be smaller than the width of the top panel 208 and the bottom panel 210; therefore, applying force C to the top panel 208 and the bottom panel 210 will cause a portion of the top panel 208 and the bottom panel 210 to be in direct contact with each other, while another portion of the top panel 208 and the bottom panel 210 will be in direct contact with the porous material 222. The edges 211 of the top panel 208 and the bottom panel 210 and their surrounding areas can be joined together and connected to the porous material 222, thereby forming a panel and porous material seal 213. The panel and porous material seal 213 can be formed using any of the techniques disclosed herein. For example, the panel and porous material seal 213 can be formed by welding, adhesives, stitching, or any other suitable joining technique. It is worth noting that the panel and porous material seal 213 may extend along almost the entire outer periphery of the porous material 222, or, as will be discussed in detail below, along a portion of the outer periphery of the porous material 222.

[0064] and Figure 1A-1F Compared to the illustrated fluid collection assembly 100, the panel and porous material seal 213 can accelerate and simplify the manufacturing process of the fluid collection assembly 200 because the fluid collection assembly 200 only requires forming one seal instead of two separate seals. However, the compressed porous material 222 generates a stress on the panel and porous material seal 213, which continuously attempts to break the seal, thereby increasing the likelihood of a gap forming between the top panel 208 and the bottom panel 210, from which fluid may leak. It is further noteworthy that, according to the technique used to form the panel and porous material seal 213, the panel and porous material seal 213 may at least partially block the pores of more porous material 222, thus, assuming that the initial volumes of porous material 122 and porous material 222 are the same, compared to... Figure 1A-1F Compared to porous material 122, the amount of body fluid that can flow through and be temporarily stored in porous material 222 is reduced.

[0065] review Figure 1Aand 1B The porous material seal 148 extends almost the entire outer edge of the porous material 122. However, the porous material seal disclosed herein, which includes a panel and a porous material seal, may extend only a portion of the outer edge of the porous material. Figure 3 and Figure 4 These are top isometric views of various bodily fluid collection assemblies according to different embodiments, each having a porous material seal extending only along a portion of the outer edge of the porous material. Unless otherwise disclosed herein, Figure 3 and Figure 4 The body fluid collection assembly shown is the same as or substantially similar to any body fluid collection assembly disclosed herein.

[0066] refer to Figure 3 Only the bottom region of the porous material (not shown in the figure, obscured by the top panel 308) is connected to the top panel 308 and the bottom panel (not shown in the figure, obscured). The porous material seal 348 connecting the bottom region of the porous material to the top panel 308 and the bottom panel can be... Figure 3 A line is schematically shown in the diagram. The portion of the porous material bottom region connected to the top panel 308 and the bottom panel includes a portion of porous material adjacent to the fluid outlet 318 (e.g., cap 330), a portion of porous material adjacent to the edge of the fluid impermeable barrier 306 extending from the fluid outlet 318 (e.g., the edge 311 of the volume impermeable barrier 306 not parallel to the longitudinal axis of the fluid impermeable barrier 306), or any other portion of the bottom region. In one example, only the portion of the porous material bottom region located at or near the porous material edge is connected to the top panel 308 and the bottom panel. The bottom region of the porous material can be connected to the top panel 308 and the bottom panel using any of the techniques disclosed herein. For example, this portion of the porous material bottom region can be connected to the top panel 308 and the bottom panel using a porous material seal 348 independent of the panel seal 313.

[0067] Only a portion of the bottom area of ​​the porous material is connected to the top panel 308 and the bottom panel, with Figure 1A-1F Compared to the porous material seal 148 shown, reducing the size of the porous material seal 348 helps simplify the manufacture of the bodily fluid collection assembly 300. Furthermore, connecting only a portion of the bottom region to the top panel 308 and bottom panel reduces the number of pores that may be accidentally blocked by adhesives, welding, etc., used to form the porous material seal 348, compared to connecting more porous material regions to the top panel 308 and bottom panel.

[0068] In one embodiment, the panel seal 313 and the porous material seal 348 are independent of each other. In this embodiment, at least a portion of the fluid flow generated by the suction applied to the chamber can flow between the panel seal 313 and the porous material seal 348. Figure 1C-1FCompared to vacuum-assisted wicking of bodily fluids within the porous material 122, fluid flow between the panel seal 313 and the porous material seal 348 may reduce the vacuum-assisted wicking effect of bodily fluids within the porous material. However, since the fluid must travel a tortuous path to bypass the porous material seal 348, the reduction in the vacuum-assisted wicking effect of bodily fluids within the porous material may be negligible or slight.

[0069] refer to Figure 4 The bottom region of the porous material and at least a portion of the middle portion (not shown in the figure, obscured by the top panel 408) are connected to the top panel 408 and the bottom panel (not shown in the figure, obscured) via a porous material seal 448. In one embodiment, the top region of the porous material is not connected to the top panel 408 and the bottom panel. In another embodiment, a portion of the top region of the porous material may also be connected to the top panel 408 and the bottom panel.

[0070] The bottom region and at least a portion of the middle part of the porous material are connected to the top panel 408 and the bottom panel, with Figure 1C , 1D Compared to the porous material seal 148 shown in 1F, reducing the size of the porous material seal 448 facilitates the manufacture of the body fluid collection assembly 400. Furthermore, connecting the bottom region and the middle portion to the top panel 408 and the bottom panel reduces the number of pores that may be accidentally blocked by adhesives, welding, etc., used to form the porous material seal 448, compared to connecting more of the porous material to the top panel 408 and the bottom panel.

[0071] In one example, portions of the porous material at or near the edge of the porous material's bottom and middle sections are connected to the top panel 408 and the bottom panel. These portions of the porous material's bottom region can be connected to the top panel 408 and the bottom panel using any of the techniques disclosed herein. For example, these portions of the porous material's bottom region can be connected to the top panel 408 and the bottom panel using a porous material seal 448, which is separate from the panel seal 413.

[0072] In one embodiment, the panel seal 313 and the porous material seal 348 are independent of each other. In this embodiment, at least a portion of the fluid flow generated by the suction applied to the chamber can flow between the panel seal 313 and the porous material seal 348. Figure 1C-1F Compared to vacuum-assisted wicking of body fluid within the porous material 122 shown, fluid flow between the panel seal 313 and the porous material seal 348 may reduce the vacuum-assisted wicking effect of body fluid within the porous material. However, the reduction in the vacuum-assisted wicking effect of the porous material in the body fluid collection assembly 400 is less than... Figure 3 The reduction in the vacuum-assisted wicking effect of the porous material in the fluid collection assembly 300 shown is less significant.

[0073] Figure 5A This is a bottom plan view of a body fluid collection assembly 500 according to one embodiment. Figure 5B It is along Figure 5A The diagram shows a cross-sectional view of the body fluid collection assembly 500 taken along plane 5B-5B. The body fluid collection assembly 500 is an example of a male body fluid collection assembly, but it should be noted that the body fluid collection assembly 500 can also be used for females. Unless otherwise disclosed herein, the body fluid collection assembly 500 is identical or substantially similar to any body fluid collection assembly disclosed herein. Furthermore, any features of the body fluid collection assembly 500 can be used in any body fluid collection device disclosed herein.

[0074] The body fluid collection assembly 500 includes a fluid-impermeable barrier 506. The fluid-impermeable barrier 506 may be identical or substantially similar to any fluid-impermeable barrier disclosed herein. The fluid-impermeable barrier 506 includes a top panel 508 and a bottom panel 510. The fluid-impermeable barrier 506 at least partially defines an opening 514 and a chamber 512 within the body fluid collection assembly 500 in fluid communication with the opening 514. In some embodiments, the bottom panel of the fluid-impermeable barrier 506 may define the opening 514. The fluid-impermeable barrier 506 includes a proximal region 516 (e.g., configured to connect to one or more flaps of a patient) and a distal region 520. The opening 514 may be closer to the proximal region 516 of the fluid-impermeable barrier 506 than the distal region 520. The fluid-impermeable barrier 506 also defines a fluid outlet 518, which may be closer to the distal region 520 than the proximal region 516. In some embodiments, the fluid-impermeable barrier 506 gradually narrows between a proximal region 516 and a distal region 520. For example, the fluid-impermeable barrier 506 (and the chamber 512) may have a generally triangular frontal profile, with the distal region 520 located at the narrow end or apex of the triangular profile. The fluid-impermeable barrier 506 may have a shape that is substantially complementary to the chamber 512, such as a generally triangular frontal profile. The fluid-impermeable barrier 506 may comprise a generally flexible fluid-impermeable material, such as a fluid-impermeable polymer (e.g., silicone, polypropylene, polyethylene, polyethylene terephthalate, polycarbonate, etc.), a polyurethane film, a thermoplastic elastomer, an oil, other suitable materials, or combinations thereof. In some embodiments, the fluid-impermeable barrier comprises a paper or bag-like fluid-impermeable material and / or a fluid-impermeable fabric.

[0075] The fluid collection assembly 500 also includes a porous material 522 located within a chamber 512 and extending at least partially between a distal region 520 and a proximal region 516. The shape of the porous material 522 may be substantially complementary to the chamber shape of the fluid impermeable barrier 506. In some embodiments, the porous material 522 is spaced apart from an edge 511 of the fluid impermeable barrier 506 that extends at least partially between the distal region 520 and the proximal region 516. In some embodiments, the porous material 522 is positioned close to the edge 511 of the fluid impermeable barrier 506 such that the fluid impermeable barrier 506 can retain fluid in the porous material 522, allowing it to flow from the opening 514 to the fluid outlet 518.

[0076] The fluid collection assembly 500 includes at least one porous material 522. The porous material 522 may be the same as or substantially similar to any porous material disclosed herein. The porous material 522 can remove fluid from the area surrounding the penis, thereby keeping said area and urethra dry. The porous material 522 allows fluid to flow substantially toward the inlet 558 of the conduit 528. The porous material 522 can be attached to the top panel 508 and bottom panel 510 of the fluid-impermeable barrier 506 using any of the techniques disclosed herein. For example, the porous material 522 can be attached to the top panel 508 and bottom panel 510 using a porous material seal 548. In some embodiments, the shape of the bottom region 542 of the porous material 522 is substantially complementary to the distal region 520.

[0077] The body fluid collection assembly 500 also includes a catheter 528 extending into the chamber 512 and having one end near a distal region 520 adjacent to a fluid impermeable barrier 506. For example... Figure 2B As shown, catheter 528 includes an inlet 558 near the end 218 of catheter 528. Return Figure 2AWhen a vacuum is applied to the catheter 528, the bodily fluid received by the porous material 522 can flow to the distal region 520 and collect for removal. The catheter 528 can pass through the fluid outlet 518 of the fluid-impermeable barrier 506 and extend into the chamber 512. In some embodiments, a first portion of the catheter 528, including an inlet 558, can be fixedly connected to the fluid-impermeable barrier 506 near the fluid outlet 518, and a second portion of the catheter 528 can be detachably fixed or connected to the bodily fluid collection device 500 near the fluid outlet 518. The fluid outlet 518 can be located near the distal region 520 of the fluid-impermeable barrier 506. In some embodiments, the inlet 558 of the catheter 528 is located between the distal region 520 and the fluid outlet 518. In some embodiments, the fluid outlet 518 may not be provided, and the catheter 528 may exit the chamber 512 through the opening 514. U.S. Provisional Patent 63 / 067,542 describes embodiments of a male external urinary catheter fluid collection assembly, and all aspects thereof can be used in any embodiment disclosed herein, the entire disclosure of which is incorporated herein by reference.

[0078] Other examples of body fluid collection components that may include porous materials attached to fluid-impermeable barriers are disclosed in the following patent documents: U.S. Patent Application No. 18 / 299,788, filed April 13, 2023; U.S. Patent No. 11,376,152, filed November 3, 2020; U.S. Patent Application No. 17 / 996,155, filed October 13, 2022; U.S. Patent Application No. 17 / 996,064, filed October 12, 2022; U.S. Patent Application No. 17 / 664,487, filed May 23, 2022; PCT International Patent Application No. PCT / US2022 / 022111, filed March 28, 2022; U.S. Patent Application No. 10,376,407, granted August 13, 2019; and U.S. Patent Application No. 10,376,407, filed January 30, 2018. U.S. Patent No. 10,376,406, granted August 13, 2019; U.S. Patent Application No. 16 / 478,180, filed June 6, 2019; U.S. Patent Application No. 17 / 614,173, filed November 24, 2021; U.S. Patent Application No. 18 / 003,029, filed December 22, 2022; U.S. Patent Application No. 18 / 042,842, filed February 24, 2023; and U.S. Patent Application No. 17 / 446,654, filed September 1, 2021. The disclosures of these patent documents are incorporated herein by reference in their entirety.

[0079] Figure 6This is a block diagram of a body fluid collection system 660 for collecting body fluids according to one embodiment. The body fluid collection system 660 includes a body fluid collection assembly 600, a body fluid storage container 662, and a vacuum source 664. The body fluid collection assembly 600 may be identical or substantially similar to any body fluid collection assembly disclosed herein. The body fluid collection assembly 600, the body fluid storage container 662, and the vacuum source 664 may be fluidly connected via one or more conduits 628. For example, the body fluid collection assembly 600 may be operatively connected to the body fluid storage container 662 and / or the vacuum source 664 via conduits 628. Body fluid collected in the body fluid collection assembly 600 may be removed via conduits 628 extending into the body fluid collection assembly 600. For example, the inlet of the conduit 628 may extend into the body fluid collection assembly 600, for example, to one of its storage areas. The outlet of the conduit 628 may extend into the body fluid collection assembly 600 or the vacuum source 664. In response to a suction force (e.g., vacuum) applied at the outlet end of catheter 628, the suction force can be introduced into the chamber of fluid collection assembly 600 through the inlet of catheter 628.

[0080] Suction force can be applied directly or indirectly to the outlet end of the conduit 628 by a vacuum source 664. Suction force can also be applied indirectly through the body fluid storage container 662. For example, the outlet of the conduit 628 can be located inside the body fluid storage container 662, while another auxiliary conduit 628 can extend from the body fluid storage container 662 to the vacuum source 664. Correspondingly, the vacuum source 664 can apply suction force to the body fluid collection assembly 600 through the body fluid storage container 662. Suction force can also be applied directly by the vacuum source 664. For example, the outlet of the conduit 628 can be directly located inside the vacuum source 664. Another auxiliary conduit 628 can extend from the vacuum source 664 to a specific location outside the body fluid collection assembly 600, such as reaching the body fluid storage container 662. In such examples, the vacuum source 664 can be located between the body fluid collection assembly 600 and the body fluid storage container 662.

[0081] The body fluid storage container 662 is sized and shaped to accommodate body fluids. The body fluid storage container 662 can be a bag (such as a drainage bag), a bottle, or a cup (such as a collection container), or any other closed container for storing body fluids such as urine. In some examples, a catheter 628 may extend from the body fluid collection assembly 600 and connect to the body fluid storage container 662 at a first connection point. Another additional catheter 628 may connect to the body fluid storage container 662 at a second connection point and connect to a vacuum source 664. Therefore, a vacuum (e.g., aspiration) can be applied to the body fluid collection assembly 600 through the body fluid storage container 662. Body fluids, such as urine, can be drained from the body fluid collection assembly 600 using the vacuum source 664.

[0082] Vacuum source 664 may include one or more of the following: a manual vacuum pump, an electric vacuum pump, a diaphragm pump, a centrifugal pump, a positive displacement pump, a magnetically driven pump, a peristaltic pump, or any pump capable of generating a vacuum. Vacuum source 664 can provide a vacuum or suction force to remove bodily fluids from bodily fluid collection assembly 600. In some examples, vacuum source 664 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). In some examples, the size and shape of vacuum source 664 may be designed to conform to the exterior, above, or interior of bodily fluid collection assembly 600. For example, vacuum source 664 may include one or more micropumps or one or more micro-pumps. Vacuum source 664 disclosed herein may include one or more of the following control devices: a switch, a button, a plug, a remote control, or any other device suitable for activating vacuum source 664.

[0083] While various aspects and embodiments have been disclosed herein, other aspects and embodiments are also included. The various aspects and embodiments disclosed herein are for illustrative purposes only and are not intended to be limiting.

[0084] Degree terms (such as “about,” “basically,” “general,” etc.) indicate structural or functional differences that are not significant. In one example, when a degree term is used with a term indicating quantity, the degree term should be interpreted as representing ±10%, ±5%, or ±2% of that quantity term. In another example, when a degree term is used to modify a shape, the degree term indicates that the modified shape has the appearance of the disclosed shape. For example, a degree term could be used to indicate that the shape may have rounded corners instead of sharp corners, curved edges instead of straight edges, extend with one or more protrusions, be elliptical, or be identical to the disclosed shape, etc.

Claims

1. A body fluid collection assembly, comprising: A fluid-impermeable barrier defining at least one chamber, at least one opening, and a fluid outlet, the fluid-impermeable barrier comprising a top panel and a bottom panel opposite the top panel; At least one porous material disposed within the cavity, the at least one porous material comprising a top region and a bottom region; The edge of at least the bottom region of the at least one porous material is fixedly connected to the top panel and the bottom panel by a porous material seal.

2. The body fluid collection assembly according to claim 1, wherein the top panel is independent of the bottom panel, and wherein the edge of the top panel is connected to the corresponding edge of the bottom panel by a panel seal.

3. The body fluid collection assembly according to claim 2, wherein the porous material seal is the same as the panel seal.

4. The body fluid collection assembly according to claim 2, wherein the porous material seal and the panel seal are independent and separate from each other.

5. The body fluid collection assembly according to any one of claims 2 or 4, wherein the porous material seal and the panel seal comprise different types of connection methods.

6. The body fluid collection assembly according to claim 1, wherein the top panel and the bottom panel are integrally formed.

7. The body fluid collection assembly according to any one of claims 1 to 6, wherein only the bottom region of the at least one porous material is connected to the top panel and the bottom panel.

8. The body fluid collection assembly according to any one of claims 1 to 7, wherein the top region of the at least one porous material is not connected to the top panel and the bottom panel.

9. The body fluid collection assembly according to any one of claims 1 to 7, wherein the edges of the at least one porous material are substantially entirely fixedly attached to the top panel and the bottom panel.

10. The body fluid collection assembly according to any one of claims 1 to 9, wherein the porous material seal maintains contact between the at least one porous material and the fluid outlet or the inlet of the conduit.

11. The body fluid collection assembly according to any one of claims 1 to 10, wherein the porous material sealing comprises an adhesive for attaching the at least one porous material to the top panel and / or the bottom panel.

12. The body fluid collection assembly according to any one of claims 1 to 11, wherein the porous material seal comprises a weld connecting the at least one porous material to the top panel and / or the bottom panel.

13. The body fluid collection assembly according to any one of claims 1 to 12, wherein the porous material seal comprises a stitching portion connecting the at least one porous material to the top panel and / or the bottom panel.

14. The body fluid collection assembly according to any one of claims 1 to 14, wherein at least the bottom region of the at least one porous material is sealed to the top panel using a first porous material and sealed to the bottom panel using a second porous material, wherein, The first porous material seal is different from the second porous material seal.

15. A body fluid collection system, comprising: Body fluid collection assembly according to any one of claims 1 to 14; A container for storing bodily fluids; as well as A vacuum source; The chamber of the body fluid collection assembly, the body fluid storage container, and the vacuum source are in fluid communication with each other, such that when one or more body fluids are present in the chamber, the suction force applied from the vacuum source to the chamber of the body fluid collection assembly removes the one or more body fluids from the chamber and stores them in the body fluid storage container.

16. A method of forming a body fluid collection assembly, the method comprising: Provided is at least one porous material disposed within a cavity defined by a fluid-impermeable barrier, the fluid-impermeable barrier defining at least the cavity, at least one opening, and a fluid outlet, the fluid-impermeable barrier including a top panel and a bottom panel opposite the top panel, the at least one porous material including a top region and a bottom region; and At least one porous material is securely attached to the top panel and / or the bottom panel using a porous material seal.

17. The method according to claim 16, wherein, Using a porous material seal to securely attach the at least one porous material to the top panel and / or the bottom panel includes: using the porous material seal to securely attach the at least one porous material to both the top panel and the bottom panel.

18. The method according to claim 16, wherein, Providing at least one porous material disposed within the cavity comprises: providing at least one porous material located between the top panel and the bottom panel, wherein the top panel and the bottom panel are not yet connected together; and The process of using the porous material to seal and fix the at least one porous material to the top panel and / or the bottom panel includes: fixing the edge of the top panel to the bottom panel, and simultaneously attaching the at least one porous material to both the top panel and the bottom panel.

19. The method of claim 16, wherein: Providing at least one porous material disposed within the cavity includes: providing at least one porous material already attached to one of the top panel or the bottom panel; and Attaching the at least one porous material to at least one of the top panel or the bottom panel includes: attaching the at least one porous material to the other of the top panel or the bottom panel.

20. A method for collecting bodily fluids from a patient, the method comprising: The fluid collection assembly has at least one opening defined by a fluid impermeable barrier, placed near the patient's urethral opening, or accommodating the patient's penis through the at least one opening into a chamber defined by the fluid impermeable barrier, the fluid impermeable barrier defining at least the chamber, the at least one opening, and a fluid outlet, the fluid impermeable barrier including a top panel and a bottom panel opposite the top panel; Expel bodily fluids from the chamber; The body fluid is received into at least one porous material of the body fluid collection assembly disposed within the chamber, the at least one porous material comprising a top region and a bottom region, wherein the edge of at least the bottom region of the at least one porous material is fixedly connected to the top panel and the bottom panel by a porous material seal; and The bodily fluid is removed from the chamber through the fluid outlet.

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