At least one porous material attached to an impermeable barrier

Abstract

An exemplary liquid collection assembly comprises an impermeable barrier. The impermeable barrier defines at least a chamber, at least one opening, and a liquid outlet. The impermeable barrier further includes an upper panel and a bottom panel opposite the upper panel. The liquid collection assembly includes at least one porous material placed within the chamber. The at least one porous material includes an upper end region and a bottom end region. At least each edge of the bottom end region of the porous material is fixedly attached to the upper panel and the bottom panel.

Description

Technical Field

[0001] The present invention relates to at least one porous material attached to a liquid-impermeable barrier.

Background Art

[0002] A person or an animal may have limited or impaired mobility, making normal urination difficult or impossible. For example, a person may experience or have a disorder that impairs mobility. A person's movement conditions may be restricted, as experienced by pilots, drivers, and workers in hazardous areas. Additionally, fluid collection may be required for clinical trial purposes or health diagnosis.

Prior Art Documents

Patent Documents

[0003]

Patent Document 1

Patent Document 2

Patent Document 3

Patent Document 4

Patent Document 5

Patent Document 6

Patent Document 7

Patent Document 8

Patent Document 9

Patent Document 10

[0004] Urinary catheters, such as Foley catheters, can alleviate some of these conditions, including incontinence. However, urinary catheters can cause discomfort and pain, and can also lead to complications such as infection. In addition, urinals, which are containers used for urination by bedridden individuals, may be used. However, urinals are often inconvenient and can cause spills and other hygienic problems. [Means for solving the problem]

[0005] Embodiments disclosed herein relate to a liquid collection assembly comprising at least one porous material attached to an impermeable barrier, a liquid collection assembly comprising the same, and a method for manufacturing and using the same. In embodiments, a liquid collection assembly is disclosed. The liquid collection assembly comprises at least a chamber and an impermeable barrier defining at least one opening and a liquid outlet. The impermeable barrier comprises an upper panel and a bottom panel opposite the upper panel. The liquid collection assembly further comprises at least one porous material disposed within the chamber. The at least one porous material comprises an upper end region and a bottom end region. Each edge of at least the bottom end region of the at least one porous material is fixedly attached to the upper panel and the bottom panel by a porous material seal.

[0006] In an embodiment, a liquid collection system is disclosed. The liquid collection system comprises a liquid collection assembly. The liquid collection assembly comprises at least a chamber and an impermeable barrier defining at least one opening and a liquid outlet. The impermeable barrier includes an upper panel and a bottom panel opposite the upper panel. The liquid collection assembly further comprises at least one porous material disposed within the chamber. The at least one porous material includes an upper end region and a bottom end region. Each edge of at least the bottom end region of the at least one porous material is fixedly attached to the upper and bottom panels by a porous material seal. The liquid collection system further comprises a liquid storage container and a vacuum source. The chamber, liquid storage container, and vacuum source of the liquid collection assembly are in liquid communication with each other such that, when one or more bodily fluids are present in the chamber, one or more bodily fluids are removed from the chamber by suction provided to the chamber of the liquid collection assembly from the vacuum source and the bodily fluids are stored in the liquid storage container.

[0007] In an embodiment, a method for forming a liquid collection assembly is disclosed. The method comprises providing at least one porous material disposed within a chamber defined by an impermeable barrier. The impermeable barrier defines at least the chamber, at least one opening, and a liquid outlet. The impermeable barrier includes an upper panel and a bottom panel opposite the upper panel. The at least one porous material includes an upper end region and a bottom end region. The method further comprises fixing the at least one porous material to at least one of the upper panel or the bottom panel by a porous material seal.

[0008] In an embodiment, a method for collecting bodily fluids from a patient is disclosed. The method includes positioning at least one opening, defined by an impermeable barrier of a fluid collection assembly, adjacent to the patient's urethral orifice, or accommodating the patient's male genitalia through at least one opening into a chamber defined by an impermeable barrier. The impermeable barrier defines at least a chamber, at least one opening, and a fluid outlet. The impermeable barrier includes an upper panel and a bottom panel opposite the upper panel. The method further includes draining the bodily fluids into the chamber. The method further includes accommodating the bodily fluids in at least one porous material of a fluid collection assembly positioned within the chamber. The at least one porous material includes an upper end region and a bottom end region. Each edge of at least the bottom end region of the at least one porous material is fixedly attached to the upper and bottom panels by a porous material seal. The method additionally includes removing the bodily fluids from the chamber through the fluid outlet.

[0009] Features from any embodiment of the disclosure may be used in combination with each other, without limitation. Furthermore, by careful consideration of the following detailed description and accompanying drawings, other features and advantages of the disclosure will become apparent to those skilled in the art. [Brief explanation of the drawing]

[0010] The drawings illustrate several embodiments of the present disclosure, and like reference numerals indicate the same or similar elements or features of the disclosure in different drawings or in the embodiments shown in the drawings. [Figure 1A] Isometric projection top and bottom views of a liquid collection assembly according to an embodiment. [Figure 1B] Isometric projection top and bottom views of a liquid collection assembly according to an embodiment. [Figure 1C] Cross-sectional views of the liquid collection assembly taken along planes 1C-1C and 1D-1D. [Figure 1D] Cross-sectional views of the liquid collection assembly taken along planes 1C-1C and 1D-1D. [Figure 1E] An enlarged cross-sectional view of the liquid collection assembly taken from circle 1E of FIG. 1C before the porous material is attached to the upper and bottom panels. [Figure 1F] An enlarged cross-sectional view of the liquid collection assembly taken from circle 1E of FIG. 1C after the porous material is attached to the upper and bottom panels. [Figure 2A] Cross-sectional view of a method of forming a liquid collection assembly according to an embodiment. [Figure 2B] Cross-sectional view of the formed liquid collection assembly. [Figure 3] Isometric projection top view of different liquid collection assemblies having a porous material seal that extends only along a portion of the outer periphery of the porous material according to different embodiments. [Figure 4] Isometric projection top view of different liquid collection assemblies having a porous material seal that extends only along a portion of the outer periphery of the porous material according to different embodiments. [Figure 5A] Bottom view of a liquid collection assembly according to an embodiment. [Figure 5B] Cross-sectional view of the liquid collection assembly taken along plane 5B-5B shown in FIG. 5A. [Figure 6] Block diagram of a liquid collection system for liquid collection according to an embodiment.

Mode for Carrying Out the Invention

[0011] Embodiments disclosed herein relate to a liquid collection assembly comprising at least one porous material attached to an impermeable barrier, a liquid collection assembly comprising the same, and a method for manufacturing and using the same. An exemplary liquid collection assembly comprises an impermeable barrier. The impermeable barrier defines at least a chamber, at least one opening, and a liquid outlet. The impermeable barrier further comprises an upper panel and a bottom panel opposite the upper panel. The liquid collection assembly comprises at least one porous material disposed within the chamber. The at least one porous material comprises an upper end region and a bottom end region. At least each edge of the bottom end region of the porous material is fixedly attached to the upper panel and the bottom panel.

[0012] When in use, the fluid collection assembly may be positioned on the patient (i.e., the individual using the fluid collection assembly) such that the opening is positioned adjacent to the patient's urethral opening (e.g., female urethral opening or buried male genitalia) or the patient's male genitalia are positioned inside the chamber through the opening. The patient may discharge one or more bodily fluids (e.g., urine, sweat, blood, etc.). The bodily fluids discharged from the patient may enter the chamber and be received in the porous material. The bodily fluids received in the porous material may flow toward a liquid outlet or conduit inlet positioned inside the chamber. For example, suction may be provided to the chamber using a vacuum source that is in liquid communication with the chamber. Suction may cause the bodily fluids to preferentially flow toward the liquid outlet or conduit inlet. The bodily fluids may then be removed from the chamber by suction.

[0013] A liquid collection assembly disclosed herein, comprising a porous material attached to a panel of an impermeable barrier, is an improvement over conventional liquid collection assemblies. For example, some conventional liquid collection assemblies include a porous material placed within a chamber. Some conventional liquid collection assemblies simply place the porous material within the chamber without actually attaching it to the impermeable barrier. In such conventional liquid collection assemblies, the porous material can be maintained within the chamber by pressing it against the impermeable barrier or by selecting a porous material that is larger than the openings formed within the impermeable barrier. In other conventional liquid collection assemblies, one to several holes are formed in the porous material, and portions of the impermeable barrier adjacent to these holes can be attached to each other. In other conventional liquid collection assemblies, the porous material is physically attached to one side of the impermeable barrier but not to the other side. This simplifies the manufacture of the liquid collection assembly and prevents adhesives or other attachments from blocking or clogging the porous portions through the porous material through which bodily fluids flow.

[0014] In the conventional liquid collection assemblies disclosed above, there may be a gap formed between the porous material and the impermeable barrier. When suction is provided to the chamber of such a liquid collection assembly, it is preferable that the suction provided to the chamber from the vacuum source removes air from such gaps instead of the bodily fluid held within the porous material. In some cases, removing air from the gap causes the impermeable barrier to be drawn into the porous material, thereby eliminating the gap and facilitating the flow of bodily fluid from the porous material. Alternatively, removing air from the gap may at least simply draw more air into the gap, thereby preventing the impermeable barrier from being drawn into the porous material. Removal of air from the gap, and when the impermeable barrier is drawn into the porous material by suction, air rather than bodily fluid is preferentially drawn into the chamber, may cause folds or wrinkles to form in the impermeable barrier. Removal of air from the gap may further slow down the suction of the impermeable barrier into the porous material. Any of these problems may prevent or inhibit the removal of bodily fluid from the porous material and the chamber. These problems are particularly pronounced in conventional male fluid collection assemblies with thin, brittle, impermeable barriers, and / or when conventional fluid collection assemblies are configured to lie flat when placed on a flat surface.

[0015] Another problem related to at least some of the conventional liquid collection assemblies described above is that the porous material is not retained relative to the liquid outlet or conduit inlet. For example, the porous material in at least some of the liquid collection assemblies described above may come into contact with the liquid outlet or conduit inlet of a conventional liquid collection assembly before use. However, the movement of the liquid collection assembly during use may cause the porous material to bend, be pulled, or otherwise move away from the liquid outlet or conduit inlet. Such movement may create a gap between the porous material and the liquid outlet or conduit inlet, through which suction supplied to the chamber may remove air instead of bodily fluids. Also, if the porous material moves away from the liquid outlet or conduit inlet, the suction may pull the impermeable barrier toward the liquid outlet or conduit inlet, especially if the impermeable barrier is made of a thin and brittle material, or if the liquid collection assembly is configured to lie flat on a flat surface. When an impermeable barrier is pulled toward a liquid outlet or conduit inlet, the impermeable barrier can at least partially block the liquid outlet or conduit inlet, thereby preventing or at least inhibiting the removal of bodily fluids from the chamber.

[0016] The liquid collection assemblies disclosed herein, which include a porous material attached to a panel of an impermeable barrier, are improved over conventional liquid collection assemblies because they prevent or at least suppress the formation of gaps. For example, in the liquid collection assemblies disclosed herein, at least a portion of the porous material is attached to both sides of the surrounding impermeable barrier. Such attachments hold the impermeable barrier against the porous material, thereby preventing the formation of gaps. Such attachments also hold the porous material against the liquid outlet or conduit inlet, thereby preventing the impermeable barrier from moving toward the liquid outlet or conduit inlet.

[0017] Figures 1A and 1B are isometric top and bottom views of the fluid collection assembly 100 according to an embodiment, respectively. Figures 1C and 1D are cross-sectional views of the fluid collection assembly 100 along planes 1C-1C and 1D-1D, respectively. The fluid collection assembly 100 is an example of a male fluid collection assembly, but in some embodiments, the fluid collection assembly 100 may be used to collect bodily fluids from the female urethral opening. The fluid collection assembly 100 has a sheath 102 and a base 104. The base 104 is configured to attach to the sheath 102 (e.g., permanently attached or configured to be permanently attached). The base 104 is also configured to attach to the area around the individual's urethral opening (e.g., male genitalia).

[0018] The sheath 102 has an impermeable barrier 106 formed at least partially from an upper panel 108 and a bottom panel 110. The impermeable barrier 106 further defines a chamber 112 between the upper panel 108 and the bottom panel 110, an opening 114 in the base end region 116 of the sheath 102, and a liquid outlet 118 in the tip region 120 of the sheath 102. The sheath 102 further includes at least one porous material 122 disposed within the chamber 112.

[0019] The upper panel 108 and the bottom panel 110 may be attached to each other or integrally formed (e.g., having a single-piece configuration). In embodiments, as shown, the upper panel 108 and the bottom panel 110 are separate sheets. In such embodiments, the upper and bottom panels 108, 110 may be attached to each other along the edges 111 using one or more panel seals 113 (shown in bold in Figures 1C to 1F). The panel seals 113 include ultrasonic ("US") welding, high-frequency ("RF") welding, adhesive, or other suitable attachments that attach the upper and bottom panels 108, 110 in a manner that prevents or at least restricts the flow of bodily fluids between the upper and bottom panels 108, 110.

[0020] The inner surfaces of the impermeable barrier 106 (e.g., the inner surfaces of the upper and lower panels 108, 110) at least partially define the chamber 112 within the liquid collection assembly 100. The impermeable barrier 106 temporarily stores bodily fluids within the chamber 112. The impermeable barrier 106 substantially prevents bodily fluids from passing through the impermeable barrier 106.

[0021] The impermeable barrier 106 may be formed from any suitable impermeable material(s), such as an impermeable polymer (e.g., silicone, polypropylene, polyethylene, polyethylene terephthalate, neoprene, polycarbonate, etc.), a metal film, natural rubber, other suitable materials, any other impermeable material disclosed herein, or a combination thereof. Thus, the impermeable barrier 106 substantially prevents bodily fluids from passing through it. In one example, the impermeable barrier 106 may be both permeable and impermeable. In such an example, the impermeable barrier 106 may be made of a hydrophobic material defining a plurality of pores. At least one portion of at least the outer surface 124 of the impermeable barrier 106 may be made of a soft and / or smooth material. This reduces abrasion.

[0022] In some embodiments, at least one of the upper panel 108 or the bottom panel 110 is formed from a partially transparent, impermeable material such as polyethylene, polypropylene, polycarbonate, or polyvinyl chloride. Forming at least one of the upper panel 108 or the bottom panel 110 from a partially transparent, impermeable material allows an individual (e.g., a doctor) to examine the male genitalia. In some embodiments, both the upper panel 108 and the bottom panel 110 are formed from a partially transparent, impermeable material. Choosing to form at least one of the upper panel 108 or the bottom panel 110 from a partially transparent, impermeable material allows the male genitalia to be examined without removing the entire liquid collection assembly 100 from the area surrounding the male genitalia. For example, the chamber 112 may have a genital accommodating area 126 configured to accommodate the individual's male genitalia when the male genitalia extend into the chamber 112. The male genital area 126 may be defined by at least the porous material 122 and at least a portion of the partially transparent material of the upper panel 108 and / or the bottom panel 110. In other words, when the male genitalia is inserted into the chamber 112 through the opening 114, the porous material 122 may be positioned within the chamber 112 such that it is not positioned between the male genitalia and at least a portion of the transparent portion of the upper panel 108 and / or the bottom panel 110. The porous material 122 is generally opaque, and therefore the portion of the partially transparent material of the upper panel 108 and / or the bottom panel 110 defining the male genital area 126 forms a window that allows an individual to look into the male genital area 126 and examine the male genitalia.

[0023] In embodiments, the liquid-impermeable barrier 106 may include one or more vents 115. The vents 115 may allow air to enter the chamber 112 and flow toward the liquid outlet 118. Such airflow may facilitate the flow of bodily fluid toward the liquid outlet 118. The vents 115 may include air-permeable and water-impermeable filters to prevent bodily fluid from leaking out of the chamber 112 through the vents 115.

[0024] The opening 114, defined by the impermeable barrier 106, provides an entry path for bodily fluids to enter the chamber 112 when the penis is buried, and for the penis to enter the chamber 112 (e.g., the penis-receiving area 126) when the penis is not buried. The opening 114 may be defined by the impermeable barrier 106 (e.g., the inner edge of the impermeable barrier 106). For example, the opening 114 is formed within the impermeable barrier 106 and extends through it. This allows bodily fluids to enter the chamber 112 from outside the liquid collection assembly 100.

[0025] The impermeable barrier 106 defines a liquid outlet 118 sized to accommodate a conduit 128. The conduit 128 may be at least partially located within the chamber 112, or otherwise be in liquid communication with the chamber 112 through the liquid outlet 118. The liquid outlet 118 may be sized and shaped to form at least substantially a liquid-tight seal with respect to the conduit 128. This substantially prevents the body fluid from escaping from the chamber 112.

[0026] In an embodiment, the impermeable barrier 106 includes a cap 130 that forms a liquid outlet 118. The cap 130 exhibits greater rigidity than the upper and lower panels 108, 110. The high rigidity of the cap 130 facilitates the attachment of the conduit 128 to the liquid outlet 118 (e.g., by crimp fit) than if the conduit 128 were directly attached to the upper and lower panels 108, 110. The cap 130 may include a connecting portion 132 configured to be attached to the upper and lower panels 108, 110. The cap 130 may also include a conduit portion 134 extending from the connecting portion 132 configured to be attached to the conduit 128. The cap 130 defines a passage 136 extending through the connecting portion 132 and the conduit portion 134, which allows bodily fluids to flow through the cap 130 so that the bodily fluids can be removed from the chamber 112 into the conduit 128. The cap 130 may include a flange 138 extending into the chamber 112 from the connection portion 132. The flange 138 may extend adjacent to the bottom panel 110. The flange 138 may provide a location where the porous material 122 can be attached to the cap 130 via a porous material sealing portion 148.

[0027] In some embodiments, the liquid outlet 118 may be formed from an unattached or unintegrated portion of the upper panel 108 and the bottom panel 110. In such embodiments, the impermeable barrier 106 may not include a cap 130, which may facilitate the manufacture of the liquid collection assembly 100, reduce the number of parts used to form the liquid collection assembly 100, and shorten the time required to manufacture the liquid collection assembly 100. Without a cap 130, it may be difficult to secure the conduit 128 to the liquid outlet 118 by a tie fit, but it may still be possible to attach the conduit 128 to the liquid outlet 118. Thus, the conduit 128 may be attached to the liquid outlet 118 (e.g., to the upper and bottom panels 108, 110) by adhesive, welding, or other means. Attaching the conduit 128 to the liquid outlet 118 may prevent leakage and prevent the conduit 128 from unintentionally detaching from the liquid outlet 118. In one example, the conduit 128 may be attached to the liquid outlet 118 in the same manufacturing steps as attaching the upper and lower panels 108 and 110 to each other.

[0028] As described above, the sheath 102 includes at least one porous material 122 placed within the chamber 112. The porous material 122 can guide bodily fluids toward one or more selected areas of the chamber 112, for example, toward the fluid outlet 118 away from the male genitalia. In one example, the porous material 122 may be made of a single layer (illustrated), two layers (e.g., a permeable outer layer extending across the entire opening 114 and a permeable inner layer, since the permeable outer layer may be formed from a relatively brittle, brittle, or other deformable material), or three or more layers. If the porous material 122 includes multiple layers, the multiple layers can be bonded together using adhesives, interlocking of fibers between different layers, or other suitable techniques. Bonding multiple layers of the porous material 122 can prevent the formation of gaps between the layers such that air could be drawn in instead of bodily fluids by the suction provided to the chamber 112. In one example, the porous material 122 may be formed from a nonwoven or woven material (e.g., spun nylon fibers). In one example, the porous material 122 may include at least one material that is substantially non-absorbent, or at least one absorbent or adsorbent material.

[0029] In an embodiment, the porous material 122 may be a substantially flat sheet. Forming the porous material 122 as a sheet may facilitate the manufacture of the liquid collection assembly 100. For example, by forming the porous material 122 as a sheet, the upper panel 108, the bottom panel 110, and the porous material 122 can each be made as sheets. During the manufacture of the liquid collection assembly 100, the upper panel 108, the bottom panel 110, and the porous material 122 may be laminated in the same manufacturing step and then attached to each other. For example, the porous material 122 may be the same size as the upper panel 108 and the bottom panel 110, or more preferably slightly smaller. Thus, by attaching the upper panel 108 and the bottom panel 110 to each other along their outer edges, the porous material 122 can also be attached to the upper panel 108 and the bottom panel 110. The porous material 122 may be slightly smaller than the upper panel 108 and / or bottom panel 110 so that the porous material 122 does not form a passage through which bodily fluids can leak through the impermeable barrier 106, and the upper panel 108 and / or bottom panel 110 spread out around the porous material 122. Attaching the porous material 122 to the upper panel 108 and / or bottom panel 110 can prevent the porous material 122 from moving significantly within the chamber 112, for example, preventing it from solidifying near the liquid outlet 118. In one example, the porous material 122 may be attached to the upper panel 108 or bottom panel 110 (e.g., via an adhesive) before or after attaching the upper panel 108 to the bottom panel 110. In one example, the porous material 122 may simply be placed in the chamber 112 without attaching it to at least one of the upper panel 108 or bottom panel 110. In the embodiment, the porous material 122 may have a shape other than a sheet, such as a hollow, substantially cylindrical shape.

[0030] In embodiments, the porous material 122 may be configured to draw up bodily fluids through the opening 114, thereby preventing the fluids from escaping from the chamber 112. Permeability as referred to herein may be suction, capillary action, diffusion, or other similar properties or processes, and is described herein as “permeation” and / or “suction.” Such “suction” and / or “permeation” properties do not necessarily involve the absorption of bodily fluids into any part of the porous material 122, such as the adsorption of bodily fluids into a permeable inner layer. In other words, even after the material has been exposed to bodily fluids and removed from them for some time, substantially no absorption or dissolution of the bodily fluids into the material may occur. While it is desirable that no absorption or dissolution occurs at all, the expression “substantially no absorption” may allow for small amounts of absorption and / or dissolution of bodily fluids into the porous material 122 (e.g., absorbent). This amount is less than about 30 weight percent, less than about 20 weight percent, less than about 10 weight percent, less than about 7 weight percent, less than about 5 weight percent, less than about 3 weight percent, less than about 2 weight percent, less than about 1 weight percent, less than about 0.5 weight percent, etc., of the dry weight of the porous material 122. As will be described in more detail below, the porous material 122 can also generally draw up bodily fluids toward the interior of the chamber 112. In embodiments, the porous material 122 may have at least one absorbent or adsorbent material.

[0031] In embodiments, the porous material 122 may include a permeable outer layer placed within the chamber 112. The permeable outer layer may cover at least a portion (e.g., all) of the opening 114. The permeable outer layer may be configured to draw up bodily fluids from the opening 114, thereby preventing bodily fluids from escaping from the chamber 112. In embodiments, the permeable outer layer may include any material capable of drawing up bodily fluids. For example, the permeable outer layer may include cloth such as gauze (e.g., silk, linen, or cotton gauze), other flexible cloth, other smooth cloth, nonwoven material (e.g., warp-layered nonwoven material), or any other porous material disclosed herein. Forming the permeable outer layer with gauze, flexible cloth, and / or smooth cloth can reduce friction that occurs in the liquid collection assembly 100.

[0032] The liquid collection assembly 100 may include a permeable inner layer positioned within the chamber 112. The permeable inner layer is configured to support the permeable outer layer, because the permeable outer layer may be formed from a relatively brittle, brittle, or otherwise deformable material. For example, the permeable inner layer may be positioned such that the permeable outer layer is located between the permeable inner layer and the impermeable barrier 106. Thus, the permeable inner layer can support and maintain the position of the permeable outer layer. The permeable inner layer may include any material capable of drawing up, absorbing, adsorbing, or otherwise transporting body fluids, such as any permeable outer layer material described herein. For example, when used as a permeable inner layer, one or more permeable outer layer materials may be available in a higher density or higher rigidity form than the permeable outer layer. The permeable inner layer may be formed from any permeable material that is less deformable than the permeable outer layer. For example, the permeable inner layer may include a porous polymer structure (e.g., nylon, polyester, polyurethane, polyethylene, polypropylene, etc.) or an open-cell foam such as spun nylon fibers. In some examples, the permeable inner layer may include a nonwoven material such as a warp-stacked nonwoven material. In some examples, the permeable inner layer may be formed from a natural material such as cotton, wool, silk, or a combination thereof. In such examples, the material may be coated, such as a water-repellent coating, to prevent or limit the absorption of liquid into the material. In some examples, the permeable inner layer may be formed from cloth, felt, gauze, or a combination thereof.

[0033] In some examples, the permeable outer layer may be optional. For example, the porous material 122 may consist only of a permeable inner layer. In some examples, the permeable inner layer may be optionally omitted from the liquid collection assembly 100. For example, the porous material 122 may consist only of a permeable outer layer. Other examples of porous materials that may be included in the liquid collection assembly 100 are disclosed in Patent Document 1 filed June 30, 2021, Patent Document 2 filed January 5, 2022, Patent Document 3 filed September 7, 2022, Patent Document 4 filed September 7, 2022, Patent Document 5 filed September 8, 2021, Patent Document 6 filed February 7, 2022, and Patent Document 7 filed February 7, 2022. Each disclosure is incorporated herein by reference in its entirety.

[0034] In embodiments, at least a portion of the porous material 122 (e.g., one or more permeable outer layers, or in particular, a permeable inner layer) may be hydrophobic. The porous material 122 may be hydrophobic if its contact angle with water (the main component of body fluids) is greater than about 90°, such as in the range of 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 body fluids within the porous material 122. Therefore, the amount of body fluid held within the porous material 122 is reduced. In embodiments, at least a portion of the porous material 122 may be hydrophobic or hydrophilic. In embodiments, the permeable inner layer is more hydrophobic than the permeable outer layer (e.g., has a larger contact angle with water). If the permeable outer layer has low hydrophobicity, the porous material 122 may be able to more easily contain bodily fluids from the urethral opening. On the other hand, if the permeable inner layer is hydrophobic, the amount of bodily fluids that can be retained within the porous material 122 is limited.

[0035] The porous material 122 includes an upper region 140 and a lower region 142. The upper region 140 is located adjacent to (e.g., covering) the opening 114, or in other forms, closer to the opening 114 defined by the impermeable barrier 106 than the lower region 142. The lower region 142 may be located adjacent to the liquid outlet 118 or the entrance of a conduit located through the liquid outlet 118, or in other forms, closer to the liquid outlet 118 or the entrance of a conduit located through the liquid outlet 118. The upper region 140 includes a portion of the porous material 122 within the portion of the chamber 112 defined by the base region 116 of the impermeable barrier 106, and a portion of the porous material 122 extending over the entire opening 114. The lower region 142 includes a portion of the porous material 122 within the portion of the chamber 112 defined by the tip region 120. In one example, the bottom region 142 is adjacent to and / or near the edge 113 of the cap 130 and the impermeable barrier 106 extending from the cap 130, the edge 113 of the impermeable barrier 106 that is not parallel to the longitudinal axis. In one example, the bottom region 142 may extend about 5 cm or less from the bottom end of the porous material 122. These ranges include approximately 5 mm or less, approximately 7.5 mm or less, approximately 1 cm or less, approximately 1.25 cm or less, approximately 1.5 cm or less, approximately 2 cm or less, approximately 2.5 cm or less, approximately 3 cm or less, approximately 3.5 cm or less, approximately 4 cm or less, or from approximately 5 mm to approximately 1 cm, from approximately 7.5 mm to approximately 1.25 cm, from approximately 1 cm to approximately 1.5 cm, from approximately 1.25 cm to approximately 2 cm, from approximately 1.5 cm to approximately 2.5 cm, from approximately 2 cm to approximately 3 cm, from approximately 2.5 cm to approximately 3.5 cm, from approximately 3 cm to approximately 4 cm, or from approximately 3.5 cm to approximately 5 cm. The porous material may further include an intermediate region 144 extending between the upper region 140 and the bottom region 142.

[0036] The porous material 122 may include at least one top surface 150 and at least one bottom surface 152 opposite to the top surface 150. The top surface 150 may extend adjacent to and abut against the upper panel 108 (if the gap is removed), and the bottom surface 152 may extend adjacent to and abut against the bottom panel 110. The porous material 122 may include one or more edges 154 around the porous material 122 that extend from the top surface 150 to the bottom surface 152.

[0037] As described above, at least a portion of the porous material 122 is attached to the upper panel 108 and the bottom panel 110. By attaching the porous material 122 to both the upper and bottom panels 108 and 110, it is preferable to prevent or at least suppress the formation of a gap between the porous material 122 and the upper and bottom panels 108 and 110, thereby allowing air to be removed from the gap by suction through this gap, rather than drawing air or bodily fluids out of the porous material 122.

[0038] For example, Figure 1E is an enlarged cross-sectional view of the liquid collection assembly 100 taken from circle 1E in Figure 1C, before the porous material 122 is attached to the upper and lower panels 108, 110. Because the porous material 122 is not attached to the upper and lower panels 108, 110, the upper and lower panels 108, 110 and the porous material 122 can move freely relative to each other. For example, Figure 1E shows the upper panel 108 curving to separate from the porous material 122 to form a first gap 146a, the porous material 122 moving to separate from the lower panel 110 and flange 138 to form a second gap 146b, and the porous material 122 moving to separate from the liquid outlet 118 (for example, moving to separate from the entrance of the passage 136 defined by the cap 130).

[0039] Figure 1E also shows the main liquid flow A (circumstantially indicated using arrow A) through the chamber 112 when suction is applied to the chamber 112 before the porous material 122 is attached to the top and bottom panels 108, 110. As shown in the figure, the main liquid flow A moves around the porous material 122 so that the suction provided to the chamber 112 preferably removes air from the first and second gaps 146a, 146b rather than removing air and bodily fluids from the porous material 122. The main air flow A slows down, or at least suppresses, the removal of bodily fluids from the chamber 112. It should be noted that even if the porous material 122 is attached to only one of the top or bottom panels 108, 110, one of the first or second gaps 146a, 146b can be formed, respectively, so that air is removed from the gap rather than removing air and bodily fluids from the porous material 122 rather than removing air and bodily fluids from the porous material 122, even in this case. Furthermore, the main airflow A may pull the upper panel 108 toward the liquid outlet 118 (i.e., toward the third gap 146c), thereby causing the upper panel 108 to at least partially block the liquid outlet 118. Note that the flange 138 prevents or at least restrains the bottom panel 110 from being pulled toward the liquid outlet 118 (e.g., toward the third gap 146c). However, in the absence of the flange 138, the main airflow A may pull the bottom panel 110 toward the liquid outlet 118 so that the bottom panel 110 blocks the liquid outlet 118 at least partially.

[0040] Figure 1F is an enlarged cross-sectional view of the liquid collection assembly 100 taken from circle 1E in Figure 1C, after the porous material 122 has been attached to the upper and lower panels 108, 110. The porous material 122 is attached to the upper and lower panels 108, 110 using one or more porous material seals 148 (schematically shown as lines in Figures 1A and 1B, and as thick lines in Figures 1C-1F). Because the porous material 122 is attached to the upper and lower panels 108, 110, the upper and lower panels 108, 110 and the porous material 122 cannot move freely relative to each other, at least in the vicinity of the porous material seals 148. Thus, the porous material seals 148 prevent or at least suppress the formation of gaps as shown in Figure 1E. For example, Figure 1F shows the main liquid flow B (schematically shown using arrow B) through the chamber 112, caused by suction provided to the chamber 112. As shown in the figure, the main liquid flow B flows through at least a portion of the porous material 122. The main liquid flow B extending through the porous material 122 draws air from the porous material 122 (if at least a portion of the pores of the porous material 122 are occupied by air), thereby promoting the flow of bodily fluid through the porous material 122 toward the liquid outlet 118. The main liquid flow B extending through the porous material 122 further draws bodily fluid from the porous material 122 if at least a portion of the pores of the porous material 122 are occupied by bodily fluid.

[0041] It should be noted that a gap may be formed between the porous material 122 and at least one of the upper panel 108 or the bottom panel 110 downstream of the porous material sealing portion 148 (i.e., between the porous material sealing portion 148 and the opening 114). Such a gap may include, for example, the male genitalia accommodating area 126. The main liquid flow B flows primarily through the gap downstream of the porous material sealing portion 148, and rather than flowing through the portion of the porous material 122 downstream of the porous material sealing portion 148, it may preferentially remove air from the gap downstream of the porous material sealing portion 148. However, unlike the first, second, and third gaps 146a, 146b, and 146c, the removal of air from the gap downstream of the porous material sealing portion 148 does not prevent or suppress the removal of bodily fluids from the porous material 122. This is because the main liquid flow B still flows through a portion of the porous material 122. For example, the main liquid flow B still flows through the porous material 122 surrounding the porous material seal 148, thereby removing the bodily fluid from that portion of the porous material 122. Since the bodily fluid contains water, it bonds to each other via hydrogen bonds. Therefore, removing the bodily fluid from the portion of the porous material 122 adjacent to the porous material seal 148 draws in additional bodily fluid from the portion of the porous material 122 adjacent to the porous material seal 148. Furthermore, removing air from the gap downstream of the porous material seal 148 generally reduces the volume of such gaps. A reduction in the volume of the gap downstream of the porous material seal 148 prevents or suppresses the unfavorable accumulation of bodily fluid in the gap, promoting the favorable containment of the bodily fluid within the porous material 122.

[0042] Note that in the descriptions of Figures 1E and 1F, it is stated and illustrated that because the inlet of conduit 128 does not extend into the chamber 112, the bodily fluids and main liquid flow flow towards the liquid outlet 118. However, note that if conduit 128 is located inside the chamber 112, the bodily fluids and main liquid flow will flow towards the inlet of conduit 128 and into it.

[0043] The porous material seal 148 may include a suitable seal for attaching the porous material 122 to the upper and bottom panels 108, 110 so as to prevent, or at least restrict, movement between the upper and bottom panels 108, 110 and the porous material 122. The porous material seal 148 may also prevent, or at least restrict, airflow through the porous material seal 148 so as to prevent the formation of a channel through which air can flow without passing through the porous material 122. The porous material seal 148 may be formed using any suitable technique (i.e., the porous material 122 can be attached to the upper and bottom panels 108, 110). In one example, the porous material seal 148 may include an adhesive (e.g., a silicone adhesive, a hydrogel adhesive, a hot melt adhesive, or any other suitable adhesive) for attaching the porous material 122 to the upper and bottom panels 108, 110. The adhesive must be configured to prevent or limit its spread into the porous material 122, as the adhesive spreading into the porous material 122 could block or clog the pores of the porous material 122 through which bodily fluids could flow. The spread of the adhesive into the porous material 122 can be prevented or suppressed by controlling at least one of the following: the amount of adhesive, the contact angle between the adhesive and the porous material 122, or the pressure applied when bonding the upper and lower panels 108, 110 and the porous material 122. In one example, the porous material seal 148 may be formed using thermal welding, US welding, RF welding, or other suitable welding. Since the weld may block or clog the pores of the porous material 122 through which bodily fluids could flow, the formation of the weld can be controlled to limit the distance the weld extends into the porous material 122. In one example, the porous material seal 148 may be formed by stitching extending through, or at least partially through, the porous material 122. Unlike the adhesive or welded joints described above, stitching minimizes the blockage of the pores in the porous material 122. It should be noted that the porous material seal 148 may be formed by a technique other than adhesive, welding, or stitching, or by a combination of the above techniques. For example, since the distance of the weld that can extend into the porous material 122 is limited, and the strength of the weld is limited, the porous material seal 148 may be formed from a weld reinforced with stitching.

[0044] The top surface 150 may be attached to the upper panel 108 using a first porous material seal, and the bottom surface 152 may be attached to the bottom panel 110 using a second porous material seal. In embodiments, the first porous material seal and the second porous material seal are identical (for example, the first and second porous material seals are formed using the same adhesive, the same type of welding, or by stitching extending through the porous material). In embodiments, the first porous material seal and the second porous material seal are different. The first porous material seal and the second porous material seal may be different for various reasons. For example, one of the first or second porous material seal may be formed during the manufacture of the liquid collection assembly 100, and the other of the first or second porous material seal may be formed during the modification of the liquid collection assembly 100.

[0045] As described above, the upper panel 108 and the bottom panel 110 are attached to each other using the panel sealing portion 113 when the upper panel 108 and the bottom panel 110 are separate. In an embodiment, the panel sealing portion 113 and the porous material sealing portion 148 may be separate from each other. The panel sealing portion 113 and the porous material sealing portion 148 may be separate from each other if they are visually distinguishable or formed as separate parts. In one example, the panel sealing portion 113 and the porous material sealing portion 148 are separate when they are spaced apart. In one example, the panel sealing portion 113 and the porous material sealing portion 148 are separate because the mounting portion used to form the panel sealing portion 113 is different from the mounting portion used to form the porous material sealing portion 148. For example, in such an example, the panel seal portion 113 is formed by a first weld (e.g., hot welding, US welding, RF welding, etc.), and the porous material seal portion 148 is formed by at least one of a second weld different from the first weld, by using an adhesive, or by using stitching. In one example, if the panel seal portion 113 is formed before or after the porous material seal portion 148, the panel seal portion 113 is separate from the porous material seal portion 148.

[0046] The panel seal portion 113 and the porous material seal portion 148 may be separate from each other for various reasons. In one example, the impermeable barrier 106 and the porous material 122 may be formed from different materials that require different mounting techniques. In one example, the porous material 122 is formed from a porous material that needs at least some of its pores to remain open in order to function, while the impermeable barrier 106 does not. Therefore, in such an example, the panel seal portion 113 may be formed using a technique that may block the pores of the porous material 122.

[0047] In one embodiment, the porous material sealing portion 148 is used to attach substantially the entire upper surface 150 to the upper panel 108 and / or substantially the entire bottom surface 152 to the bottom panel 110. In such an embodiment, gaps are less likely to form between the surface of the porous material 122 and the upper panel 108 and / or bottom panel 110. Furthermore, attaching substantially the entire upper surface 150 and / or bottom surface 152 to their respective panels enhances the attachment between them.

[0048] In the embodiment, as shown in the figure, only a portion of the top surface 150 is attached to the upper panel 108 and / or only a portion of the bottom surface 152 is attached to the bottom panel 110 via the porous material sealing portion 148. For example, only a portion of the edge 154 of the top surface 150 of the porous material 122, or a portion near thereto, is attached to the upper panel 108 and / or only a portion of the edge 154 of the bottom surface 152 of the porous material 122, or a portion near thereto, is attached to the bottom panel 110. In such an example, the porous material sealing portion 148 still ensures that the main liquid flow flows through at least a portion of the porous material 122, while at the same time allowing the liquid collection assembly 100 to include certain gaps, such as the penis-receiving area 126. Furthermore, by attaching only a portion of the top surface 150 to the upper panel 108 and / or only a portion of the bottom surface 152 to the bottom panel 110, the likelihood of the porous material sealing portion 148 at least partially blocking the pores of the porous material 122 is reduced. Furthermore, attaching only a portion of the top surface 150 to the upper panel 108 and / or only a portion of the bottom surface 152 to the bottom panel 110 may be easier than attaching substantially the entire top surface 150 to the upper panel 108 and / or substantially the entire bottom surface 152 to the bottom panel 110, respectively.

[0049] In embodiments, as shown, if only a portion of the top surface 150 is attached to the upper panel 108 at or near the edge 154 of the porous material 122, and / or if only a portion of the bottom surface 152 is attached to the bottom panel 110, the porous material seal 148 may extend along at least substantially the entire periphery of the porous material 122. In such embodiments, since there is no path for the liquid flow to bypass the porous material seal 148, the liquid flow in the chamber 112 generated by suction must flow through the porous material 122. Such a liquid flow maximizes the vacuum-assisted suction of bodily fluids through the porous material 122. However, as will be further explained with reference to Figures 3 and 4, the porous material seal 148 does not need to extend along the entire circumference of the porous material 122.

[0050] The timing of the formation of the porous material seal 148 is arbitrary. In one example, the porous material seal 148 is formed at least partially before the panel seal 113 is formed (i.e., before the upper and bottom panels 108, 110 are attached) (i.e., the porous material 122 is attached to one or both of the upper panel 108 or the bottom panel 110). In such an example, the formation of the porous material seal 148 may be easier because it is easier to access the porous material 122 before the panel seal 113 is formed. In one example, the porous material seal 148 may be formed at least partially at the same time as the panel seal 113. In such an example, if the porous material seal 148 and the panel seal 113 have the same type of attachment, it may be advantageous to form the porous material seal 148 and the panel seal 113 substantially simultaneously. In one example, at least a portion of the porous material seal 148 may be formed after the panel seal 113 is formed. In such examples, the porous material seal 148 can be formed during the modification of a conventional liquid collection assembly. By modifying a conventional liquid collection assembly to incorporate the porous material seal 148, on-site customization based on the needs and / or preferences of the patient or caregiver becomes possible, and inventory management can be simplified due to the reduced number of liquid collection assembly types.

[0051] In embodiments, the porous material 122 may abut against the inlet of the liquid outlet 118. If at least one of the following is the case, where substantially the entire top surface 150 is attached to the upper panel 108, substantially the entire bottom surface 152 is attached to the bottom panel 110, the top surface 150 is attached to the upper 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, the porous material seal 148 can maintain the porous material 122 relative to the inlet of the liquid outlet 118. Maintaining the porous material 122 relative to the inlet of the liquid outlet 118 can prevent the formation of the third gap 146c shown in Figure 1E. In other words, by maintaining the porous material 122 relative to the inlet of the liquid outlet 118, it is possible to prevent the upper panel 108 and / or the bottom panel 110 from being pulled toward the inlet of the liquid outlet 118 by suction, so that the upper panel 108 and / or the bottom panel 110 at least partially block the inlet of the liquid outlet 118. In embodiments, the porous material 122 does not abut the inlet of the liquid outlet 118. In such embodiments, the impermeable barrier 106 may be sufficiently rigid so that the upper panel 108 and / or the bottom panel 110 are less likely to be pulled toward the inlet of the liquid outlet 118 by suction. The gap between the porous material 122 and the inlet of the liquid outlet 118 substantially forms an extension of the conduit 128 extending from the inlet of the liquid outlet 118 to the porous material 122. In embodiments, the porous material 122 does not extend into or through the liquid outlet 118.

[0052] Generally, when the male genitalia are not present in the male genitalia housing area 126, the sheath 102 is substantially flat and rests on a flat surface. The sheath 102 is substantially flat because the impermeable barrier 106 is not a substantially tubular impermeable barrier, but is formed from an upper panel 108 and a bottom panel 110. As mentioned above, the porous material 122 may be in sheet form, in which case the sheath 102 will also be substantially flat. The sheath 102 may also be substantially flat because the liquid collection assembly 100 may not contain a relatively rigid ring or cap that exhibits higher rigidity than the surrounding impermeable barrier 106 portion (such a ring or cap may prevent the sheath 102 from being substantially flat). It should be noted that the description of the sheath 102 as substantially flat is because, depending on the thickness of the porous material 122, at least one of the porous material 122 may form a slight bulge in the sheath 102, causing a bulge around the liquid outlet 118 and / or conduit 128, or causing the base 104 to pull on the outer portion of the sheath 102. Furthermore, it should be noted that the sheath 102 may be conforming in shape, and therefore, the sheath 102 may not be substantially flat during use, as it may be placed on an uneven surface during use (e.g., between the testicles, perineum, and / or thighs), and the sheath 102 may conform to the shape of these surfaces.

[0053] The fluid collection assembly 100 can be used with both buried and unburied penises because, when the penis is not within the penis-receiving area 126 and the sheath 102 is placed on a flat surface, the sheath 102 can become substantially flat. For example, when the fluid collection assembly 100 is used with a buried penis, the penis does not extend into the penis-receiving area 126. This allows the sheath 102 to be placed relatively flat across the entire opening 156 of the base 104. When the sheath 102 is placed relatively flat across the entire opening 156, the porous material 122 extends across the entire openings 114 and 156, and is in close proximity to the buried penis. Therefore, the porous material 122 prevents or suppresses the accumulation of bodily fluids discharged from the buried penis against the individual's skin. This is because the porous material 122 receives or removes at least a large portion of the bodily fluids that could accumulate against the individual's skin. Therefore, the individual's skin remains dry, the usability of the fluid collection assembly 100 is improved, and skin damage is prevented. On the other hand, unlike other conventional fluid collection assemblies configured for use with retracted penises, the fluid collection assembly 100 can also be used with unretracted penises. This is because even when an unretracted penis is fully erect, it can be accommodated in the penis-receiving area 126. Furthermore, because the sheath 102 can be nearly flat, the fluid collection assembly 100 can be used more flexibly to individual situations compared to when the sheath 102 is not nearly flat. Thus, various situations that could be embarrassing are prevented.

[0054] If the sheath 102 is substantially flat, the porous material 122 will be present throughout substantially the entire chamber 112, and the male genital area 126 will be compressed (in Figures 1C and 1D, for illustrative purposes, the male genital area 126 is shown in an uncompressed state). In other words, the sheath 102 does not need to define areas where the porous material 122 is not always present. Since the retention of bodily fluids can cause sanitary problems, produce foul odors, and / or cause discomfort and skin damage due to prolonged contact of the bodily fluids with the individual's skin, the presence of the porous material 122 throughout substantially the entire chamber 112 makes it less likely for bodily fluids discharged into the chamber 112 to remain for a long time.

[0055] As described above, the upper panel 108, the bottom panel 110, and the porous material 122 may be selected to be relatively flexible. The upper panel 108, the bottom panel 110, and the porous material 122 are relatively flexible if they cannot maintain their shape without support. The flexibility of the upper panel 108, the bottom panel 110, and the porous material 122 allows the sheath 102 to be made nearly flat, as described above. The flexibility of the upper panel 108, the bottom panel 110, and the porous material 122 further allows the shape of the sheath 102 to conform to the shape of the penis even if the size and shape of the penis change (e.g., when erect). This minimizes any voids in the chamber 112 where bodily fluids may accumulate.

[0056] As described above, the liquid collection assembly 100 has a base 104 configured to be attached to the sheath 102. For example, the base 104 is configured to be permanently attached to the sheath 102. For example, if the liquid collection assembly 100 is provided with a base 104 that is permanently attached to the sheath 102, or if the base 104 is not permanently attached to the sheath 102 but is configured to be permanently attached to the sheath 102 at some point in the future, then the base 104 is configured to be permanently attached to the sheath 102. Permanently attached means that the sheath 102 cannot be removed from the base 104 without damaging at least one of the sheath 102 or the base 104 by using a blade to separate the sheath 102 from the base 104 and / or by using chemicals to dissolve the adhesive that attaches the sheath 102 to the base 104. The base 104 may be permanently attached to the sheath 102 by adhesive, stitching, heat sealing, RF welding, or US welding. In one embodiment, the base 104 is configured to be detachably attached to the sheath 102. In another embodiment, the base 104 is integrally formed with the sheath 102.

[0057] The base 104 has an opening 156. The base 104 is permanently attached to the tip region 120 of the sheath 102 so that the opening 156 is aligned with the opening 114.

[0058] The base 104 is made of a material, size, shape, and material such that it can be attached to the skin surrounding the male genitalia (e.g., the pubic mound, thigh, testicles, and / or perineum), and the male genitalia are positioned inside it. For example, the base 104 may define an opening 156 configured to accommodate the male genitalia. In one example, the base 104 may have a general shape or contour of the skin surface to which the base 104 is configured to attach. The base 104 may be flexible. This allows the base 104 to conform to any shape of the skin surface and minimizes the pulling of the base 104 across the skin surface. The base 104 may extend laterally through the sheath 102. This increases the surface area of ​​an individual's skin to which the liquid collection assembly 100 can be attached, compared to a substantially similar liquid collection assembly 100 without a base.

[0059] As described above, the fluid collection assembly 100 includes a conduit 128. The inlet of the conduit 128 may be located near the tip region 120 of the sheath 102, which is expected to be the lowest point in the direction of gravity of the chamber 112 when worn by an individual. If the cap 130 is located in or near the tip region 120, the inlet of the conduit 128 may be located near the tip region 120 of the sheath 102. By positioning the inlet in or near the tip region 120 of the sheath 102, the conduit 128 can receive more bodily fluids and the possibility of accumulation is reduced compared to when the inlet of the conduit 128 is located elsewhere (for example, accumulation of bodily fluids can lead to microbial growth and foul odor).

[0060] As described above, the panel seal portion 113 and the porous material seal portion 148 of the liquid collection assembly 100 shown in Figures 1A to 1F are separate from each other. However, the panel seal portion and the porous material seal portion of the liquid collection assembly disclosed herein may be the same. That is, the panel seal portion and the porous material seal portion disclosed herein may not be separate. Figure 2A is a cross-sectional view of a method for forming a liquid collection assembly 200 according to an embodiment. Figure 2B is a cross-sectional view of the liquid collection assembly 200 after formation. Unless otherwise described herein, the liquid collection assembly 200 is the same as or substantially the same as any of the liquid collection assemblies disclosed herein. For example, the liquid collection assembly 200 comprises an impermeable barrier 206 including an upper panel 208 and a bottom panel 210. The liquid collection assembly 200 also comprises at least one porous material 222.

[0061] The liquid collection assembly 200 is formed by providing an upper panel 208, a bottom panel 210, and a porous material 222. The upper panel 208 and the bottom panel 210 include a rim 211. The porous material 222 includes an upper surface 250, a bottom surface 252, and a rim 254. The porous material 222 is positioned between the upper panel 208 and the bottom panel 210 such that the upper surface 250 of the porous material 222 is adjacent to the upper panel 208 and the bottom surface 252 is adjacent to the bottom panel 210.

[0062] The edges 211 of the upper and lower panels 208, 210 can be joined by applying a force C (circumstantially indicated by arrows). The edges 254 of the porous material 222 can be clamped and compressed together with the edges 211 of the upper and lower panels 208, 210 once they are joined. It should be noted that the porous material 222 may have a width smaller than the width of the upper and lower panels 208, 210 so that when force C is applied to the upper and lower panels 208, 210, parts of the upper and lower panels 208, 210 come into direct contact with each other, and other parts of the upper and lower panels 208, 210 come into direct contact with the porous material 222. The edges 211 of the upper and lower panels 208, 210 and the surrounding areas can be attached to each other and to the porous material 222 to form a panel-porous material seal 213. The panel-porous material seal 213 can be formed using any of the techniques disclosed herein. For example, the panel and the porous material seal 213 may be formed using welding, adhesive, stitching, or any other suitable mounting technique. Note that the panel and the porous material seal 213 may extend substantially along the entire periphery of the porous material 222, or along a portion of the periphery of the porous material 222, as will be described in more detail below.

[0063] With the panel and porous material seal 213, only one seal needs to be formed in the liquid collection assembly 200 instead of two separate seals, thus allowing for faster and simpler manufacturing of the liquid collection assembly 200 compared to the liquid collection assembly 100 shown in Figures 1A to 1F. On the other hand, the compressed porous material 222 imparts stress to the panel and porous material seal 213 that attempts to continuously break it, thus creating a gap between the upper panel 208 and the bottom panel 210, increasing the possibility of bodily fluid leakage. Furthermore, depending on the technique used to form the panel and porous material seal 213, the panel and porous material seal 213 may at least partially block more pores in the porous material 222, thereby potentially reducing the amount of bodily fluid that can flow through and be temporarily stored in the porous material 222 compared to the porous material 122 in Figures 1A to 1F, assuming the initial volumes of the porous material 122 and the porous material 222 are the same.

[0064] Referring again to Figures 1A and 1B, the porous material seal 148 extends substantially along the entire outer periphery of the porous material 122. However, the porous material seal disclosed herein, including the panel and the porous material seal, may extend only along a portion of the outer periphery of the porous material. Figures 3 and 4 are isometric top views of different liquid collection assemblies according to different embodiments, having a porous material seal extending only along a portion of the outer periphery of the porous material. The liquid collection assemblies shown in Figures 3 and 4 are identical or substantially similar to any of the liquid collection assemblies disclosed herein unless otherwise specified herein.

[0065] Referring to Figure 3, only a portion of the bottom edge region of the porous material (hidden by the upper panel 308 and not shown) is attached to the upper panel 308 and the bottom panel (hidden and not shown). In Figure 3, the porous material sealing portion 348 that attaches the lower edge region of the porous material to the upper panel 308 and the bottom panel is schematically shown by lines. The portion of the bottom edge region of the porous material attached to the upper panel 308 and the bottom panel includes the portion of the porous material adjacent to the liquid outlet 318 (e.g., the cap 330), the portion of the porous material adjacent to the edge of the impermeable barrier 306 extending from the liquid outlet 318 (e.g., the edge 311 of the impermeable barrier 306 that is not parallel to the longitudinal axis of the impermeable barrier 306), or any other portion of the bottom edge region. In one example, only the edge of the porous material or a portion of the bottom edge region of the porous material near it is attached to the upper panel 308 and the bottom panel. The bottom edge region of the porous material can be attached to the upper panel 308 and the bottom panel using any of the techniques disclosed herein. For example, a portion of the bottom edge region of the porous material can be attached to the upper panel 308 and the bottom panel using a porous material seal 348 separate from the panel seal 313.

[0066] By attaching only a portion of the bottom edge region of the porous material to the upper panel 308 and the bottom panel, the size of the porous material sealing portion 348 can be reduced compared to the porous material sealing portion 148 shown in Figures 1A to 1F, which may facilitate the manufacturing of the liquid collection assembly 300. Furthermore, by attaching only a portion of the bottom edge region to the upper panel 308 and the bottom panel, the amount of pores that are accidentally blocked by adhesives or welding used to form the porous material sealing portion 348 is reduced compared to the case where more porous material is attached to the upper panel 308 and the bottom panel.

[0067] In some embodiments, the panel seal 313 and the porous material seal 348 are separate. In such embodiments, at least a portion of the liquid flow generated by the suction supplied to the chamber may flow between the panel seal 313 and the porous material seal 348. The liquid flow between the panel seal 313 and the porous material seal 348 may reduce the vacuum-assisted suction of bodily fluids in the porous material compared to the vacuum-assisted suction of bodily fluids in the porous material 122 shown in Figures 1C to 1F. On the other hand, because the path that forces the liquid to flow around the porous material seal 348 is winding, the reduction in vacuum-assisted suction of bodily fluids in the porous material may be negligible or negligible.

[0068] Referring to Figure 4, the bottom edge region of the porous material and at least a portion of the intermediate portion (hidden by the upper panel 408 and not shown) are attached to the upper panel 408 and the bottom panel (hidden and not shown) via the porous material sealing portion 448. In this embodiment, the upper edge region of the porous material is not attached to the upper panel 408 and the bottom panel. In this embodiment, a portion of the upper edge region of the porous material may be attached to the upper panel 408 and the bottom panel.

[0069] By attaching a portion of the bottom edge region and at least a portion of the intermediate portion of the porous material to the upper panel 408 and the bottom panel, the size of the porous material seal 448 can be reduced compared to the porous material seal 148 shown in Figures 1C, 1D, and 1F, which may facilitate the manufacture of the liquid collection assembly 400. Furthermore, by attaching the bottom edge region and a portion of the intermediate portion to the upper panel 408 and the bottom panel, the amount of pores that are accidentally blocked by adhesives or welding used to form the porous material seal 448 is reduced compared to the case where more porous material is attached to the upper panel 408 and the bottom panel.

[0070] In one example, a portion of the bottom edge region of the porous material and an intermediate portion of the porous material near or adjacent to the edge are attached to the upper panel 408 and the bottom panel. The portion of the bottom edge region of the porous material may be attached to the upper panel 408 and the bottom panel using any of the techniques disclosed herein. For example, the portion of the bottom edge region of the porous material may be attached to the upper panel 408 and the bottom panel using a porous material seal 448 separate from the panel seal 413.

[0071] In some embodiments, the panel seal 313 and the porous material seal 348 are separate. In such embodiments, at least a portion of the liquid flow generated by suction supplied to the chamber may flow between the panel seal 313 and the porous material seal 348. The liquid flow between the panel seal 313 and the porous material seal 348 may reduce the vacuum-assisted suction of body fluids in the porous material compared to the vacuum-assisted suction of body fluids in the porous material 122 shown in Figures 1C to 1F. On the other hand, the reduction in vacuum-assisted suction of body fluids in the porous material of the liquid collection assembly 400 may be smaller than the reduction in vacuum-assisted suction of body fluids in the porous material of the liquid collection assembly 300 shown in Figure 3.

[0072] Figure 5A is a bottom view of the liquid collection assembly 500 according to an embodiment. Figure 5B is a cross-sectional view of the liquid collection assembly 500 along the line 5B-5B shown in Figure 5A. Although the liquid collection assembly 500 is an example of a liquid collection assembly for men, it should be noted that the liquid collection assembly 500 may also be used for women. Unless otherwise described herein, the liquid collection assembly 500 is identical or substantially the same as any of the liquid collection assemblies disclosed herein. Furthermore, any of the features of the liquid collection assembly 500 may be used in conjunction with any of the liquid collection assemblies disclosed herein.

[0073] The liquid collection assembly 500 comprises an impermeable barrier 506. The impermeable barrier 506 may be identical or substantially the same as any of the impermeable barriers disclosed herein. The impermeable barrier 506 includes an upper panel 508 and a bottom panel 510. The impermeable barrier 506 at least partially defines an opening 514 and a chamber 512 that communicates the opening 514 with the liquid within the liquid collection assembly 500. In some embodiments, the bottom panel of the impermeable barrier 506 may define the opening 514. The impermeable barrier 506 includes a proximal region 516 (e.g., one or more wings configured to be attached to a patient) and a tip region 520. The opening 514 may be located close to the proximal region 516 of the impermeable barrier 506 or closer than the tip region 520. The impermeable barrier 506 is defined such that the liquid outlet 518 can be located adjacent to or closer to the tip region 520 than to the proximal region 516. In some embodiments, the impermeable barrier 506 narrows between the proximal region 516 and the tip region 520. For example, the impermeable barrier 506 (and chamber 512) may have a substantially triangular front shape, with the tip region 520 located at the narrow end or tip of a triangular outline. The impermeable barrier 506 may have a shape substantially complementary to the chamber 512, such as a substantially triangular front shape. The impermeable barrier 506 may include a substantially flexible impermeable material such as an impermeable polymer (e.g., silicone, polypropylene, polyethylene, polyethylene terephthalate, polycarbonate, etc.), a polyurethane film, a thermoplastic elastomer, an oil, another suitable material, or a combination thereof. In some embodiments, the impermeable barrier includes a paper-like or bag-like impermeable material and / or an impermeable fabric.

[0074] The liquid collection assembly 500 further includes a porous material 522 located within the chamber 512 and extending at least partially between the tip region 520 and the base region 516. The porous material 522 may have a shape substantially complementary to the shape of the chamber of the impermeable barrier 506. In some embodiments, the porous material 522 is spaced apart from the edge 511 of the impermeable barrier 506 that extends at least partially between the tip region 520 and the base region 516. In some embodiments, the porous material 522 is positioned to abut the edge 511 of the impermeable barrier 506 so that the impermeable barrier 506 holds liquid within the porous material 522 from the opening 514 to the liquid outlet 518.

[0075] The liquid collection assembly 500 comprises at least one porous material 522. The porous material 522 may be identical or substantially identical to any of the porous materials disclosed herein. The porous material 522 removes liquid from the area surrounding the male genitalia, drying that area and the urethra. The porous material 522 allows the liquid to flow overall toward the inlet 558 of the conduit 528. The porous material 522 may be attached to the upper panel 508 and bottom panel 510 of the impermeable barrier 506 using any of the techniques disclosed herein. For example, the porous material 522 may be attached to the upper panel 508 and bottom panel 510 using a porous material seal 548. In some embodiments, the bottom end region 542 of the porous material 522 has a shape substantially complementary to the tip region 520.

[0076] The liquid collection assembly 500 further comprises a conduit 528 extending into the chamber 512 and having an end located close to the tip region 520 of the impermeable barrier 506. As shown in Figure 5B, the conduit 528 has an inlet 558 near the end 218 of the conduit 528. Referring again to Figure 5A, when a vacuum is applied to the conduit 528, bodily fluids contained within the porous material 522 may flow to the tip region 520 for collection and storage. The conduit 528 may extend into the chamber 512 through the liquid outlet 518 of the impermeable barrier 506. In some embodiments, a first portion of the conduit 528, including the inlet 558, may be fixedly connected to the impermeable barrier 506 close to the liquid outlet 518, and a second portion of the conduit 528 may be detachably fixed or connected to the liquid collection assembly 500 close to the liquid outlet 518. The fluid outlet 518 may be located close to the tip region 520 of the impermeable barrier 506. In some embodiments, the inlet 558 of the conduit 528 is located between the tip region 520 and the fluid outlet 518. In some embodiments, there is no fluid outlet 518, and the conduit 528 may be led out of the chamber 512 through the opening 514. Patent Document 8 describes an embodiment of a fluid collection assembly for a male extracorporeal catheter, the embodiment of which can be used in any embodiment disclosed herein, and the disclosure is incorporated in whole by reference.

[0077] Other examples of liquid collection assemblies that may include the porous material attached to an impermeable barrier are Patent Document 9 filed on April 13, 2023, Patent Document 10 filed on November 3, 2020, Patent Document 11 filed on October 13, 2022, Patent Document 12 filed on October 12, 2022, Patent Document 13 filed on May 23, 2022, Patent Document 14 filed on March 28, 2022, and 2019 This is disclosed in Patent Document 15, issued on August 13, 2019; Patent Document 16, filed on January 30, 2018; Patent Document 17, issued on August 13, 2019; Patent Document 18, filed on June 6, 2019; Patent Document 19, filed on November 24, 2021; Patent Document 20, filed on December 22, 2022; Patent Document 21, filed on February 24, 2023; and Patent Document 22, filed on September 1, 2021. The contents of each disclosure are incorporated in their entirety herein by reference.

[0078] Figure 6 is a block diagram of a liquid collection system 660 for liquid collection according to an embodiment. The liquid collection system 660 includes a liquid collection assembly 600, a liquid storage container 662, and a vacuum source 664. The liquid collection assembly 600 may be identical or substantially the same as any of the liquid collection assemblies disclosed herein. The liquid collection assembly 600, the liquid storage container 662, and the vacuum source 664 may be liquid-coupled to each other via one or more conduits 628. For example, the liquid collection assembly 600 may be operationally coupled to one or more of the liquid storage container 662 and the vacuum source 664 via the conduits 628. Bodily fluids collected in the liquid collection assembly 600 may be removed from the liquid collection assembly 600 via conduits 628 protruding into the liquid collection assembly 600. For example, the inlet of the conduit 628 may extend into the liquid collection assembly 600, such as into a storage area inside it. The outlet of the conduit 628 may extend into the liquid collection assembly 600 or the vacuum source 664. Depending on the suction force (e.g., vacuum) applied to the outlet of the conduit 628, a suction force may be introduced into the chamber of the liquid collection assembly 600 through the inlet of the conduit 628.

[0079] A suction force can be applied directly or indirectly to the outlet of the conduit 628 by the vacuum source 664. The suction force can also be applied indirectly via the liquid storage container 662. For example, the outlet of the conduit 628 may be located inside the liquid storage container 662, and an additional conduit 628 may extend from the liquid storage container 662 to the vacuum source 664. Thus, the vacuum source 664 can apply suction to the liquid collection assembly 600 via the liquid storage container 662. The suction force can also be applied directly via the vacuum source 664. For example, the outlet of the conduit 628 may be located inside the vacuum source 664. An additional conduit 628 may extend from the vacuum source 664 to a part outside the liquid collection assembly 600, such as the liquid storage container 662. In such an example, the vacuum source 664 may be located between the liquid collection assembly 600 and the liquid storage container 662.

[0080] The fluid storage container 662 may be of a size and shape that allows it to hold bodily fluids inside. The fluid storage container 662 may include a bag (e.g., a drainage bag), a bottle or cup (e.g., a collection bottle), or other sealed container for storing bodily fluids such as urine. In some examples, a conduit 628 may extend from the fluid collection assembly 600 and be attached at a first point inside the fluid storage container 662. An additional conduit 628 may be attached at a second point on the fluid storage container 662, extending to and attached to a vacuum source 664. Thus, a vacuum (e.g., suction) can be extracted through the fluid storage container 662 and through the fluid collection assembly 600. Bodily fluids such as urine can be discharged from the fluid collection assembly 600 using the vacuum source 664.

[0081] The vacuum source 664 may include one or more manual vacuum pumps, electric vacuum pumps, diaphragm pumps, centrifugal pumps, displacement pumps, magnetically driven pumps, peristaltic pumps, or any pump configured to generate a vacuum. The vacuum source 664 may provide vacuum or suction to remove bodily fluids from the liquid collection assembly 600. In some examples, the vacuum source 664 may be powered by one or more power cords (e.g., plugged into an outlet), one or more batteries, or even a manual power source (e.g., a manual vacuum pump). In some examples, the vacuum source 664 may be sized and shaped to fit outside, on top of, or inside the liquid collection assembly 600. For example, the vacuum source 664 may include one or more small pumps or one or more micropumps. The vacuum source 664 disclosed herein may include one or more switches, buttons, plugs, remote controls, or any other devices suitable for operating the vacuum source 664.

[0082] While various embodiments of the model have been disclosed herein, other embodiments and models are also conceivable. The various embodiments and models disclosed herein are for illustrative purposes only and are not intended to be limiting.

[0083] Terms expressing degree (e.g., "approximately," "roughly," "generally," etc.) indicate variations that are not structurally or functionally significant. In one example, when a term expressing degree is included in a term expressing quantity, the term expressing degree is understood to be ±10%, ±5%, or +2% of the term expressing quantity. In one example, when a term expressing degree is used to modify a shape, the term expressing degree indicates that the shape modified by the term expressing degree has the appearance of the disclosed shape. For example, terms expressing degree may be used to indicate that the shape may have rounded corners instead of sharp corners, curved edges instead of straight edges, one or more projections extending from them, be elliptical, or be identical to the disclosed shape.

Claims

1. An impermeable barrier comprising an upper panel and a bottom panel opposite the upper panel, defining at least a chamber, at least one opening, and a liquid outlet, A chamber comprising an upper end region and a lower end region, and at least one porous material disposed within the chamber, Equipped with, Each edge of at least the bottom edge region of the at least one porous material is fixedly attached to the upper panel and the bottom panel by a porous material sealing portion. A liquid collection assembly characterized by the following features.

2. The upper panel is separate from the bottom panel. Each edge of the upper panel is attached to the corresponding edge of the bottom panel by a panel sealing portion. The liquid collection assembly according to claim 1.

3. The porous material sealing portion and the panel sealing portion are the same. The liquid collection assembly according to claim 2.

4. The porous material sealing portion and the panel sealing portion are separate and spaced apart from each other. The liquid collection assembly according to claim 2.

5. The porous material sealing portion and the panel sealing portion include different types of mounting portions. The liquid collection assembly according to any one of claims 2 or 4.

6. The upper panel and the bottom panel are integrally formed with each other. The liquid collection assembly according to claim 1.

7. Only the bottom edge region of the at least one porous material is attached to the upper panel and the bottom panel. The liquid collection assembly according to any one of claims 1 to 6.

8. The upper end region of the at least one porous material is not attached to the upper panel and the bottom panel. The liquid collection assembly according to any one of claims 1 to 7.

9. Substantially the entire edge of each of the at least one porous material is fixedly attached to the upper panel and the bottom panel. The liquid collection assembly according to any one of claims 1 to 7.

10. The porous material sealing portion maintains contact between the at least one porous material and the liquid outlet or the inlet of the conduit. The liquid collection assembly according to any one of claims 1 to 9.

11. The porous material sealing portion includes an adhesive for attaching the at least one porous material to at least one of the upper panel or the bottom panel. The liquid collection assembly according to any one of claims 1 to 10.

12. The porous material sealing portion includes welding to attach the at least one porous material to at least one of the upper panel or the bottom panel. The liquid collection assembly according to any one of claims 1 to 11.

13. The porous material sealing portion includes sewing the at least one porous material to at least one of the upper panel or the bottom panel. The liquid collection assembly according to any one of claims 1 to 12.

14. At least the bottom edge region of the at least one porous material is attached to the upper panel using a first porous material sealing portion and to the bottom panel using a second porous material sealing portion. The first porous material sealing portion is different from the second porous material sealing portion. The liquid collection assembly according to any one of claims 1 to 13.

15. A liquid collection assembly according to any one of claims 1 to 14, Liquid storage container and Equipped with a vacuum source, If one or more bodily fluids are present in the chamber, the one or more bodily fluids are removed from the chamber by suction provided to the chamber of the liquid collection assembly from the vacuum source. The chamber, the liquid storage container, and the vacuum source of the liquid collection assembly are in liquid communication with each other so that the bodily fluid is stored in the liquid storage container. A liquid collection system characterized by the following features.

16. A method for forming a liquid collection assembly, To provide at least one porous material having an upper end region and a lower end region, disposed within a chamber defined by an impermeable barrier including an upper panel and a lower panel opposite the upper panel, defining at least a chamber, at least one opening, and a liquid outlet, The at least one porous material is fixedly attached to at least one of the upper panel or the bottom panel by a porous material sealing portion. A method characterized by including the following.

17. Attaching the at least one porous material to at least one of the upper panel or the bottom panel by a porous material sealing portion includes attaching the at least one porous material to both the upper panel and the bottom panel using the porous material sealing portion. The method according to 16, characterized by...

18. Providing at least one porous material disposed within the chamber includes providing the at least one porous material disposed between the upper panel and the bottom panel, wherein the upper panel and the bottom panel are not attached to each other. Attaching the at least one porous material to at least one of the upper panel or the bottom panel by the porous material sealing portion includes attaching each edge of the upper panel to the bottom panel and attaching the at least one porous material to the upper panel and the bottom panel simultaneously. The method according to 16, characterized by...

19. Providing at least one porous material disposed within the chamber includes providing the at least one porous material attached to either the upper panel or the bottom panel, Attaching the at least one porous material to at least one of the upper panel or the bottom panel includes attaching the at least one porous material to the other of the upper panel or the bottom panel. The method according to 16, characterized by...

20. A method for collecting bodily fluids from a patient, A liquid collection assembly defines at least a chamber, at least one opening, and a liquid outlet, and the at least one opening, defined by an impermeable barrier including an upper panel and a bottom panel opposite the upper panel, is positioned adjacent to the patient's urethral opening, or the patient's male genitalia are housed within the chamber defined by the impermeable barrier through the at least one opening. To discharge bodily fluids into the aforementioned chamber, The liquid collection assembly comprises at least one porous material disposed within the chamber and including an upper end region and a lower end region, wherein each edge of at least the lower end region of the at least one porous material is fixedly attached to the upper panel and the lower panel by a porous material sealing portion, and the liquid is contained within the at least one porous material. To remove the bodily fluid from the chamber through the liquid outlet, A method characterized by including the following.

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