Conduits including at least one conduit porous material
The use of a conduit with conduit porous material in a fluid collection system addresses the discomfort and hygiene issues of traditional urinary catheters by enhancing flexibility and reducing kinking and collapse, thereby improving patient comfort and fluid collection efficiency.
Patent Information
- Application Number
- JP2025061137
- Authority / Receiving Office
- JP · JP
- Patent Type
- Applications
- Current Assignee / Owner
- Priority Date
- 2021-04-09
- Filing Date
- 2025-04-02
- Publication Date
- 2025-06-19
AI Technical Summary
Existing urinary catheters and urinals face issues such as discomfort, spillage, hygiene problems, discomfort, pain, and urinary tract infections, along with tubing that can kink or break.
A conduit with at least one conduit porous material is used in a fluid collection system, featuring a wall portion that defines an inlet, outlet, and passage, with the conduit porous material providing support and facilitating fluid flow.
The conduit system reduces the likelihood of collapse and kinking, enhances flexibility, and improves patient comfort, while maintaining effective fluid collection and removal.
Smart Images

Figure 2025092702000001_ABST
Abstract
Description
Technical Field
[0001] This application claims the benefit of U.S. Provisional Patent Application No. 63 / 172,975, filed Apr. 9, 2021, the disclosure of which is hereby incorporated by reference in its entirety.
Background Art
[0002] Patients may have limited mobility such that a typical urination process is difficult or impossible, or their mobility may be impaired. For example, a patient may have had surgery that impairs mobility or may have a physical disability that impairs mobility. In another example, a patient may have restricted travel conditions such as those experienced by pilots, drivers, and workers in hazardous areas. Additionally, fluid collection from a patient may be required for monitoring purposes or for clinical trials.
[0003] Urinary catheters such as urinals and Foley catheters can be used to address some of these situations (e.g., Patent Document 1). However, urinals and urinary catheters have several problems associated with them. For example, urinals can be prone to discomfort, spillage, and other hygiene problems. Urinary catheters can be uncomfortable, painful, and can cause urinary tract infections. Additionally, the tubing used with urinary catheters can be prone to kinking and breaking.
Prior Art Documents
Patent Documents
[0004]
Patent Document 1
Summary of the Invention
Problems to be Solved by the Invention
[0005] Accordingly, users and manufacturers of fluid collection assemblies continue to seek new and improved devices, systems, and methods for collecting urine. **Means for Solving the Problem**
[0006] Embodiments disclosed herein include a conduit comprising at least one conduit porous material, a fluid collection assembly and system comprising the conduit, and methods of using and forming the conduit. In one embodiment, a conduit for use in a fluid collection system for collecting one or more body fluids is disclosed. The conduit includes at least one wall portion that at least partially defines at least an inlet, an outlet, and a passage extending from the inlet to the outlet. The conduit also includes at least one conduit porous material disposed in at least a portion of the passage.
[0007] 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 that defines at least a chamber, at least one opening, and a fluid outlet. The fluid collection assembly also includes at least one assembly porous material disposed in the chamber. The fluid collection system also includes a conduit in fluid communication with the chamber. The conduit includes at least one wall portion that at least partially defines at least an inlet, an outlet, and a passage extending from the inlet to the outlet. The conduit also includes at least one conduit porous material disposed in at least a portion of the passage.
[0008] Features from any of the disclosed embodiments can be used in combination with each other without limitation. Additionally, other features and advantages of the present disclosure will become apparent to those skilled in the art by considering the following detailed description and the accompanying drawings.
[0009] The drawings illustrate several embodiments of the present disclosure, and like reference numerals refer to the same or similar elements or features in different figures or embodiments illustrated in the drawings. **Brief Description of the Drawings**
[0010]
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DETAILED DESCRIPTION OF THE INVENTION
[0011] Embodiments disclosed herein include conduits having at least one conduit porous material, fluid collection assemblies and systems including the conduits, and methods of using and forming the conduits. Exemplary conduits include at least one wall portion that at least partially defines at least an inlet, an outlet downstream of the inlet, and a passage extending from the inlet to the outlet. The conduit also includes at least one conduit porous material disposed in the passage. The conduit porous material may at least partially occupy the passage and may extend along at least a portion of the length of the conduit measured from the inlet to the outlet. The conduit may be configured for use in a fluid collection system for collecting one or more body fluids (e.g., urine, amniotic fluid, blood, etc.).
[0012] A pipeline including a pipeline porous material can be an improvement over a hollow pipeline without the pipeline porous material. The hollow pipeline can be used in a fluid collection system such as a fluid collection system including a vacuum source. The fluid collection system can include a fluid collection assembly configured to receive one or more body fluids from a patient. The hollow pipeline can be in fluid communication with both the fluid collection assembly and the vacuum source such that a vacuum pressure applied to the hollow pipeline by the vacuum source can remove body fluid from the fluid collection assembly. The hollow pipeline is configured to prevent its collapse when a vacuum pressure is applied, because the collapse of the hollow pipeline can sometimes inhibit the removal of body fluid from the fluid collection assembly. The hollow pipeline is configured to prevent its collapse by forming the hollow pipeline from at least one material having a Young's modulus (e.g., elastic modulus) and / or thickness that prevents the collapse of the hollow pipeline when a vacuum pressure is applied. For example, the hollow pipeline can be formed from transparent polyvinyl chloride, and its wall can exhibit a thickness greater than about 1.5 mm (e.g., the thickness measured parallel to its diameter). Even when the hollow pipeline is used in a fluid collection system without a vacuum source, the hollow pipeline may be formed from the same material as described above and / or may exhibit the same thickness to prevent collapse when a large mass is placed on it, which is noted.
[0013] When a hollow conduit is configured to prevent its collapse, the hollow conduit may exhibit limited flexibility. The limited flexibility of the hollow conduit can give rise to several problems. In one embodiment, due to its limited flexibility, the hollow conduit may exhibit a limited amount of bending without kinking. Similar to the collapse of the hollow conduit, kinking of the hollow conduit inhibits the removal of body fluid from the fluid collection assembly to which the hollow conduit is attached. The limited amount of bending of the hollow conduit can limit the locations where the conduit can be placed and may require a longer length. In one embodiment, the limited flexibility of the hollow conduit can make it difficult to align the fluid collection assembly around the urethral opening of a patient (e.g., an individual using the fluid collection assembly). For example, the hollow conduit may be at least partially disposed within the fluid collection assembly. The fluid collection assembly may be bent to conform to the shape of the urethral opening, which can minimize leakage of body fluid from the fluid collection assembly. However, the limited flexibility of the hollow conduit can resist bending of the fluid collection assembly, cause kinking when the fluid collection assembly is bent, or cause the fluid collection assembly to straighten or otherwise relieve the bend, at least one of which can occur.
[0014] As described above, a conduit that includes at least one conduit porous material disposed within the passageway solves at least some of the problems of the hollow conduits described above. In one embodiment, the conduit porous material provides support to the wall of the conduit, thereby reducing the likelihood that the conduit will collapse when a vacuum pressure is applied to the conduit. Accordingly, the conduits disclosed herein can be formed from a material having a Young's modulus that is less than that of a hollow conduit and / or a thickness that is less than that of a hollow conduit. The smaller Young's modulus and / or thickness of the conduits disclosed herein allows such conduits to exhibit greater flexibility than hollow conduits. Further, even if the conduits disclosed herein exhibit the same degree of flexibility as hollow conduits, the conduit porous material provides support to the wall of the conduit such that when bent, the conduit is less likely to kink compared to a hollow conduit. The increased flexibility and / or resistance to kinking of the conduits that include at least one conduit porous material may also enable such conduits to be more comfortable for a patient compared to hollow conduits.
[0015] FIG. 1 is a schematic cross-sectional view of a pipeline 100 according to an embodiment. The pipeline 100 includes at least one wall portion 102. The wall portion 102 defines at least an inlet 104, an outlet 106 downstream of the inlet 104, and a passage 108 extending from the inlet 104 to the outlet 106. The inlet 104 may be configured to be connected to a fluid collection assembly (not shown), to be disposed in a chamber of the fluid collection assembly, or to be in fluid communication with the fluid collection assembly in another way (e.g., via another pipeline). The outlet 106 is configured to be connected to a vacuum source (not shown) or to be in fluid communication with the vacuum source in another way (e.g., via another pipeline or a fluid storage container). The passage 108 forms a fluid flow path that can remove body fluid from the fluid collection assembly (not shown) and accumulate the removed body fluid in the fluid storage container. The pipeline 100 also includes at least one pipeline porous material 110 disposed in the passage 108 and at least partially occupying the passage 108. The pipeline porous material 110 provides a matrix through which body fluid can flow (e.g., by capillary action) and provides support for the wall portion 102 to suppress collapse or kinking of the pipeline 100.
[0016] The wall portion 102 can be formed from any suitable fluid-impermeable material. In one embodiment, the wall portion 102 can be formed from materials conventionally used to form a hollow conduit. In such an embodiment, the fluid-impermeable wall portion 102 can be formed from polyvinyl chloride. In one embodiment, the wall portion 102 can be formed from one or more materials having a Young's modulus smaller than that of polyvinyl chloride. Since the conduit porous material 110 provides support for the wall portion 102, the wall portion 102 can be formed from a material having a Young's modulus smaller than that of polyvinyl chloride. Examples of such materials include polyethylene (e.g., low-density polyethylene, high-density polyethylene, ultra-high molecular weight polyethylene), polypropylene, polytetrafluoroethylene, nitrile, nylon, ethylene vinyl acetate, thermoplastic elastomer, or combinations thereof. In one embodiment, the wall portion 102 can be formed from a material having a Young's modulus larger than that of polyvinyl chloride. In such an embodiment, the wall portion 102 can exhibit a thickness t measured perpendicular to the longitudinal axis 112 of the conduit 100, which allows the conduit 100 to exhibit flexibility less than that of a hollow conduit formed from polyvinyl chloride, or flexibility equal to that of the hollow conduit. In one embodiment, the wall portion 102 can be formed at least partially from a fluid-impermeable tape. In such an embodiment, the tape can be attached to the conduit porous material 110 by adhesion.
[0017] The wall portion 102 can exhibit a thickness t measured perpendicular to the longitudinal axis 112 of the conduit 100. The thickness of the wall portion 102 can be selected based on the desired flexibility of the conduit 100, the strength of the conduit porous material 110, and the Young's modulus of the one or more materials forming the wall portion 102.
[0018] In one embodiment, the wall portion 102 has a thickness t that is equal to or greater than the thickness of a hollow conduit conventionally used in a fluid collection system, for example, a thickness t of about 1.5 mm or more, about 1.6 mm or more, about 1.7 mm or more, about 1.8 mm or more, about 1.9 mm or more, about 2 mm or more, about 2.25 mm or more, about 2.5 mm or more, about 3 mm or more, or a thickness t in the range of about 1.5 mm to about 1.7 mm, about 1.6 mm to about 1.8 mm, about 1.7 mm to about 1.9 mm, about 1.8 mm to about 2 mm, about 1.9 mm to about 2.25 mm, about 2 mm to about 2.5 mm, or about 2.25 mm to about 3 mm. The wall portion 102 may have a thickness equal to or greater than that of a hollow conduit because the conduit porous material 110 suppresses the kinking of the conduit 100 compared to a hollow conduit, or because the wall portion 102 may be formed from a material having a Young's modulus smaller than that of polyvinyl chloride. Selecting the wall portion 102 to have a thickness t equal to or greater than that of a hollow conduit enables at least one of the conduit 100 to withstand the application of a greater vacuum pressure without collapsing, the wall portion 102 being formed from a material having a Young's modulus significantly smaller than that of polyvinyl chloride (i.e., the wall portion 102 can be formed from a more diverse material), the conduit porous material 110 being formed from one or more relatively thin materials (e.g., materials having a relatively low yield strength, a relatively low Young's modulus, and / or a relatively high porosity) such that the conduit porous material 110 does not provide significant support for the wall portion 102, the wall portion 102 being formed from a commonly used and relatively readily available hollow conduit, or the conduit 100 being used with inlets and outlets configured to be used with a hollow conduit.
[0019] In one embodiment, the wall portion 102 may exhibit a thickness t that is smaller than the hollow conduit. For example, the wall portion 102 may be about 0.05 mm or less, about 0.1 mm or less, about 0.15 mm or less, about 0.2 mm or less, about 0.25 mm or less, about 0.3 mm or less, about 0.35 mm or less, about 0.4 mm or less, about 0.45 mm or less, about 0.5 mm or less, about 0.6 mm or less, about 0.7 mm or less, about 0.8 mm or less, about 0.9 mm or less, about 1 mm or less, about 1.1 mm or less, about 1.2 mm or less, about 1.3 mm or less, about 1.4 mm or less, about 1.5 mm or less in thickness, or may exhibit a thickness in the range of about 0.05 mm to about 0.15 mm, about 0.1 mm to about 0.2 mm, about 0.15 mm to about 0.25 mm, about 0.2 mm to about 0.3 mm, about 0.25 mm to about 0.35 mm, about 0.3 mm to about 0.4 mm, about 0.35 mm to about 0.45 mm, about 0.4 mm to about 0.5 mm, about 0.45 mm to about 0.6 mm, about 0.5 mm to about 0.7 mm, about 0.6 mm to about 0.8 mm, about 0.7 mm to about 0.9 mm, about 0.8 mm to about 1 mm, about 0.9 mm to about 1.1 mm, about 1 mm to about 1.2 mm, about 1.1 mm to about 1.3 mm, about 1.2 mm to about 1.4 mm, or about 1.3 mm to about 1.5 mm. Even when the wall portion 102 may be formed from one or more materials that exhibit a Young's modulus smaller than that of polyvinyl chloride, the wall portion 102 disclosed herein may be able to exhibit such a small thickness because support for the wall portion 102 is provided by the conduit porous material 110.
[0020] In one embodiment, the wall portion 102 may be formed from a film. As used herein, the wall portion 102 is a "film" when the thickness t of the wall portion 102 is less than 0.75 mm, more particularly, when less than about 0.5 mm, or more particularly, when less than about 0.3 mm. When the wall portion 102 is a film, the flexibility of the conduit 100 is significantly increased compared to a hollow conduit. For example, when the wall portion 102 is a film, the wall portion 102 substantially prevents kinking and exhibits little or no resistance to bending of the fluid collection assembly.
[0021] As described above, the wall portion 102 defines the passage 108, and at least a portion of the passage 108 is occupied by at least one tubing porous material 110. The tubing porous material 110 can provide support against the wall portion 102 so as to suppress the collapse and kinking of the tubing 100 when a vacuum pressure is applied to the tubing 100 and when the tubing 100 is bent, respectively. Further, the tubing porous material 110 can feed body fluid drawn into the tubing 100 (e.g., via a vacuum pressure or capillary action) toward the outlet 106. The tubing porous material 110 can define a plurality of interconnected pores through which body fluid can flow therethrough.
[0022] The conduit porous material 110 can include any suitable conduit porous material. In one embodiment, the conduit porous material 110 can be formed from a fabric such as silk, linen, or cotton gauze. In one embodiment, the conduit porous material 110 can be a porous polymer (e.g., nylon, polyester, polyurethane, polyethylene, polypropylene, etc.) structure, a continuous foam, a spun nylon fiber, a natural material (e.g., cotton, wool, silk, or combinations thereof), a compressed gauze, paper, a terry fabric, pumice, any other suitable material, or combinations thereof. In one embodiment, the conduit porous material 110 can be formed from spun nylon fibers. In one embodiment, the conduit porous material 110 can be formed from a nonwoven material such as at least one of a card web, a needle punched web, an airlaid web, a spunlace web, a vertical lap nonwoven, a horizontal lap nonwoven, or an intersecting lap nonwoven. The nonwoven can be formed from fibers including at least one of polyester, polypropylene, polyurethane, polyolefin, polycarbonate, polyvinyl chloride, polyacrylic acid, nylon, other synthetic fibers, one or more natural fibers (e.g., low grade cotton lint), hollow fibers, or combinations thereof. Such nonwovens can exhibit high porosity that allows body fluids to flow therethrough and can provide sufficient support to the wall portion 102 to prevent collapse and kinking of the conduit 100. Examples of nonwoven materials are disclosed in U.S. Provisional Patent Application No. 63 / 134,754, filed Jan. 7, 2021, the disclosure of which is hereby incorporated by reference in its entirety.
[0023] The conduit porous material 110 can exhibit a porosity in the range of about 20% or more, about 30% or more, about 40% or more, about 50% or more, about 60% or more, about 65% or more, about 70% or more, about 75% or more, about 80% or more, about 85% or more, about 90% or more, about 95% or more, or from about 20% to about 40%, from about 30% to about 50%, from about 40% to about 60%, from about 50% to about 65%, from about 60% to about 70%, from about 65% to about 75%, from about 70% to about 80%, from about 75% to about 85%, from about 80% to about 90%, from about 85% to about 95%, or from about 90% to about 99%. Generally, by reducing the porosity of the conduit porous material 110, the amount of support provided by the conduit porous material 110 to the wall portion 102 can be increased. In other words, by reducing the porosity of the conduit porous material 110, the possibility that the conduit 100 collapses or twists when a vacuum pressure is applied can be reduced. However, reducing the porosity of the conduit porous material 110 also reduces the flow rate of the body fluid flowing through the conduit 100. Therefore, the porosity of the conduit porous material 110 can be selected by taking a balance of the performance of the conduit porous material 110 to provide support to the wall portion 102 while allowing the body fluid to flow internally.
[0024] The conduit porous material 110 at least partially occupies the cross-sectional area of the passageway 108, and the cross-sectional area of the passageway 108 is obtained along a plane perpendicular to the longitudinal axis 112 of the conduit 100. The amount of the cross-sectional area of the passageway 108 occupied by the conduit porous material 110 may depend on the method used to form the conduit 100. In one embodiment, the conduit porous material 110 substantially completely occupies the cross-sectional area of the passageway 108. In such an embodiment, the conduit 100 can be formed, for example, by co-extruding the wall portion 102 and the conduit porous material 110, or by directly disposing the wall portion 102 on the conduit porous material 110. For example, when the wall portion 102 is a tape disposed on the conduit porous material 110 by adhesion, or when the wall portion 102 covers the outer surface of the conduit porous material 110, the wall portion 102 can be directly disposed on the conduit porous material 110. It is noted that when the wall portion 102 is formed as a coating on the conduit porous material 110, the wall portion 102 can extend partially into the conduit porous material 110. In one embodiment, the conduit porous material 110 only partially occupies the cross-sectional area of the passageway 108 (for example, the conduit porous material 110 has a cross-sectional area smaller than the cross-sectional area of the passageway 108). In such an embodiment, the conduit 100 can be formed, for example, by inserting the conduit porous material 110 into a hollow conduit. To minimize the friction caused by the conduit porous material 110 contacting the surface of the hollow conduit during insertion, the conduit porous material 110 inserted into the hollow conduit can have a cross-sectional area smaller than the cross-sectional area of the hollow conduit. It is noted that when the wall portion 102 is formed (e.g., wound) around the conduit porous material 110, or when the conduit porous material 110 is inserted into the passageway 108 of the hollow conduit, the conduit porous material 110 can substantially occupy the cross-sectional area of the passageway 108 (such insertion may be more difficult than when the conduit porous material 110 has a cross-sectional area smaller than the passageway 108). It is noted that the conduit 100 can be formed using methods other than those disclosed above, such as disposing the conduit porous material 110 in a hollow conduit and then heat-shrinking the hollow conduit, or coating the conduit porous material 110 with a fluid-impermeable material that forms the wall portion 102.
[0025] In one embodiment, the conduit 100 can be configured such that there is no risk of the conduit 100 collapsing when exposed to an expected vacuum pressure. As used herein, vacuum pressure refers to gauge pressure, i.e., the differential pressure between a location external to and spaced from the fluid collection assembly to which the passageway 108 and the conduit 100 are attached and a location within the passageway. During use, the vacuum pressure applied to the passageway 108 can be from about 1 kPa to about 40 kPa, depending on the vacuum source fluidly coupled to the fluid collection assembly 1040. Thus, the wall portion 102 and the porous material 110 can be selected to withstand such vacuum pressures of from about 1 kPa to about 5 kPa, from about 2.5 kPa to about 7.5 kPa, from about 5 kPa to about 10 kPa, from about 7.5 kPa to about 12.5 kPa, from about 10 kPa to about 15 kPa, from about 12.5 kPa to about 17.5 kPa, from about 15 kPa to about 20 kPa, from about 17.5 kPa to about 22.5 kPa, from about 20 kPa to about 25 kPa, from about 22.5 kPa to about 27.5 kPa, from about 25 kPa to about 30 kPa, from about 27.5 kPa to about 32.5 kPa, from about 30 kPa to about 35 kPa, from about 32.5 kPa to about 37.5 kPa, or from about 35 kPa to about 40 kPa. In some embodiments, the vacuum pressure can be greater than about 40 kPa.
[0026] The performance of the conduit 100 that resists collapse when a vacuum pressure is applied to the passage 108 depends on several factors. Generally, by increasing the Young's modulus of the material forming the wall portion 102, increasing the Young's modulus of the material forming the conduit porous material 110, increasing the thickness of the wall portion 102, increasing the density of the conduit porous material 110, and decreasing the porosity of the conduit porous material 110, it becomes possible to apply a larger vacuum pressure to the passage 108 without significantly increasing the likelihood of the conduit 100 collapsing. However, increasing the Young's modulus of the material forming the wall portion 102, increasing the Young's modulus of the material forming the conduit porous material 110, increasing the thickness of the wall portion 102, increasing the density of the conduit porous material 110, and decreasing the voids in the passage 108 decrease the flexibility of the conduit 100. Therefore, the selection of the composition of the wall portion 102, the composition of the conduit porous material 110, the thickness of the wall portion 102, the density of the conduit porous material 110, and the amount of voids can be selected by balancing the need to increase the flexibility of the conduit 100 while preventing the vacuum pressure from collapsing the conduit 100.
[0027] The conduit porous material 110 is from about 5 kg / m 3 to about 10 kg / m 3 from about 7.5 kg / m 3 to about 12.5 kg / m 3 from about 10 kg / m 3 to about 15 kg / m 3 from about 12.5 kg / m 3 to about 17.5 kg / m 3 from about 15 kg / m 3 to about 20 kg / m 3 from about 17.5 kg / m 3 to about 22.5 kg / m 3 from about 20 kg / m 3 to about 25 kg / m 3 from about 22.5 kg / m 3 to about 27.5 kg / m 3 from about 25 kg / m 3 to about 30 kg / m 3 from about 27.5 kg / m 3 to about 32.5 kg / m 3, from about 30 kg / m 3 to about 35 kg / m 3 , about 32.5 kg / m 3 to about 37.5 kg / m 3 , about 35 kg / m 3 to about 37.5 kg / m 3 , about 35 kg / m 3 to about 40 kg / m 3 , about 37.5 kg / m 3 to about 42.5 kg / m 3 , about 40 kg / m 3 to about 45 kg / m 3 , about 42.5 kg / m 3 to about 47.5 kg / m 3 , or about 45 kg / m 3 to about 50 kg / m 3 can be selected to exhibit a density of. Generally, by increasing the density of the conduit porous material 110, the possibility that the conduit 100 collapses when a vacuum pressure is applied decreases. However, by increasing the density of the conduit porous material 110, the flow rate of the body fluid flowing through it also decreases, and the flexibility of the conduit 100 also decreases. Therefore, the density of the conduit porous material 110 can be selected by taking a balance between the need to increase the flexibility of the conduit 100 and prevent the vacuum pressure from collapsing the conduit 100. The density of the conduit porous material 110 can also be selected based on the Young's modulus and thickness of the wall portion 102. By increasing the Young's modulus and / or thickness of the wall portion 102, it becomes possible for the conduit porous material 110 to exhibit a lower density, and vice versa. It is noted that the voids in the passage 108 depend at least in part on the density of the conduit porous material 110 and whether the porous material 110 occupies substantially all of the cross-sectional area of the passage 108.
[0028] Generally, an average person excretes urine at a rate from about 6 ml / s to about 50 ml / s, such as from about 10 ml / s to about 25 ml / s. The rate at which a person urinates can vary, for example, based on the person's physique and age. To prevent the fluid collection assembly to which the conduit 100 is attached from becoming supersaturated with body fluid (which can cause leakage), the conduit porous material 110 can be selected to exhibit a flow rate comparable to the rate at which an average person excretes urine. For example, the conduit porous material 110 can be selected to exhibit a flow rate greater than about 6 ml / s, greater than about 10 ml / s, greater than about 20 ml / s, greater than about 30 ml / s, greater than about 40 ml / s, greater than about 50 ml / s, or in the range from about 6 ml / s to about 10 ml / s, from about 8 ml / s to about 12 ml / s, from about 10 ml / s to about 15 ml / s, from about 12.5 ml / s to about 17.5 ml / s, from about 15 ml / s to about 20 ml / s, from about 17.5 ml / s to about 22.5 ml / s, from about 20 ml / s to about 25 ml / s, from about 22.5 ml / s to about 27.5 ml / s, from about 25 ml / s to about 30 ml / s, from about 27.5 ml / s to about 35 ml / s, from about 30 ml / s to about 40 ml / s, from about 35 ml / s to about 45 ml / s, or from about 40 ml / s to about 50 ml / s. As used herein, the flow rate is at least one of when the conduit porous material 110 is saturated with body fluid or when it is not saturated with body fluid, and when any vacuum pressure disclosed herein is applied to the passage 108, or when no vacuum pressure is applied to the passage 108 (e.g., the body fluid flows only by suction and / or gravity), and can refer to the flow rate of the body fluid in the conduit porous material 110.
[0029] The pipeline 100 is shown as having a breakage portion between the inlet 104 and the outlet 106. The breakage portion indicates that the pipeline 100 may assume any length. In one embodiment, the pipeline 100 may have a length of about 1 cm or more, about 15 cm or more, about 30 cm or more, about 45 cm or more, about 60 cm or more, about 75 cm or more, about 90 cm or more, about 105 cm or more, about 120 cm or more, about 150 cm or more, about 180 cm or more, 210 cm or more, about 240 cm or more, about 265 cm or more, about 300 cm or more, or a length in the range of about 1 cm to about 30 cm, about 15 cm to about 45 cm, about 30 cm to about 60 cm, about 45 cm to about 75 cm, about 60 cm to about 90 cm, about 75 cm to about 105 cm, about 90 cm to about 120 cm, about 105 cm to about 150 cm, about 120 cm to about 180 cm, about 150 cm to about 210 cm, about 180 cm to about 240 cm, about 210 cm to about 265 cm, or about 240 cm to about 300 cm. For example, when the pipeline 100 forms a bendable L-shaped connector between a hollow pipeline and another hollow pipeline or a fluid collection assembly, the pipeline 100 may have a length of about 1 cm to about 15 cm. When the pipeline 100 is mainly disposed only in the fluid collection assembly, the pipeline 100 may have a length of about 10 cm to about 40 cm. Or when the pipeline 100 extends significantly far from the fluid collection assembly, the pipeline 100 may have a length greater than about 35 cm.
[0030] The passageway 108 may exhibit a maximum lateral dimension L measured perpendicular to the longitudinal axis 112. D may exhibit. The maximum lateral dimension L D may be the diameter of the passageway 108 when the passageway 108 exhibits an overall cylindrical shape. The maximum lateral dimension L Dcan be selected to be in the range of about 4 mm or more, about 5 mm or more, about 6 mm or more, about 7 mm or more, about 8 mm or more, about 9 mm or more, about 10 mm or more, about 12 mm or more, about 14 mm or more, about 16 mm or more, about 18 mm or more, about 20 mm or more, about 25 mm or more, or from about 4 mm to about 6 mm, from about 5 mm to about 7 mm, from about 6 mm to about 8 mm, from about 7 mm to about 9 mm, from about 8 mm to about 10 mm, from about 9 mm to about 12 mm, from about 10 mm to about 14 mm, from about 12 mm to about 16 mm, from about 14 mm to about 18 mm, from about 16 mm to about 20 mm, or from about 18 mm to about 25 mm. Maximum transverse dimension L D can be selected based on a number of factors. In one embodiment, the maximum transverse dimension L D can be selected based on the desired flow rate of body fluid in the passageway 108, and increasing the maximum transverse dimension L D increases the flow rate (e.g., Q = A * v, where Q is the flow rate, A is the cross-sectional area, and v is the velocity of the body fluid in the passageway 108). In one embodiment, the maximum transverse dimension L D can be selected based on the device. As used herein, one or more devices refers to one or more devices that may include at least one inlet and / or outlet of a fluid collection assembly, a fluid storage container, a vacuum source, or a hollow conduit to which the conduits disclosed herein are attached, attachable, or configured to be attached. For example, if the conduit 100 forms a female attachment portion with a device, the maximum transverse dimension L D can be selected to be slightly smaller than, equal to, or slightly larger than the dimensions of the device (e.g., the conduit 100 expands). Similarly, when the conduit 100 forms a male attachment portion with a device, the maximum transverse dimension L D can be selected to be smaller than the dimensions of the device. However, it is noted that the conduit 100 can be configured to be attached to an adapter (e.g., the adapter 326 illustrated in FIG. 3) that allows the conduit 100 to be attached to the device even if the dimensions of the conduit 100 are significantly different from the dimensions of the device.
[0031] In one embodiment, the conduit porous material 110 is formed from the same porous material as the porous material (hereinafter referred to as "assembly porous material") used in a fluid collection assembly configured to receive the conduit 100. Forming the conduit porous material 110 from the same material as the assembly porous material can facilitate the manufacture of the conduit 100. For example, the assembly porous material is readily available, and thus, the manufacture of a fluid collection system including the fluid collection assembly and the conduit 100 does not require the use of limited storage space to store two different porous materials. In one example, by forming the conduit porous material 110 and the assembly porous material from the same material, the conduit porous material 110 can be formed, at least in part, from scraps of the assembly porous material generated during the manufacture of the fluid collection assembly, and vice versa. In one example, by forming the conduit porous material 110 and the assembly porous material from the same material, the conduit porous material 110 and the assembly porous material can be integrally formed with each other, as illustrated in FIG. 9.
[0032] In one embodiment, as shown, the conduit porous material 110 extends over at least substantially the entire length of the conduit 100. In other words, the conduit porous material 110 extends from the inlet 104 or near it to the outlet 106 or near it. Thus, the conduit porous material 110 provides support to substantially all of the wall portion 102. In one embodiment, the conduit porous material 110 extends only along a portion of the overall length of the conduit 100, which minimizes the amount of conduit porous material 110 required to form the conduit 100. In such an embodiment, the conduit porous material 110 can be positioned at a portion of the conduit 100 that is expected to exhibit sharp bends during use. In such an example, the conduit porous material 110 can be disposed from the inlet 104 or near it and can extend a distance of about 15 cm to about 60 cm (e.g., from about 30 cm to about 45 cm) from the inlet 104, because only such portions of the conduit 100 are likely to have sharp bends formed therein. In one example, a portion of the conduit 100 is disposed in a chamber of the fluid collection assembly, and the conduit porous material 110 can be omitted from at least some of the portion of the conduit 100 disposed in the chamber of the fluid collection assembly, because the fluid collection assembly can limit the bending of such portions of the conduit 100.
[0033] In one embodiment, the conduit porous material 110 does not extend outwardly from the inlet 104 and / or the outlet 106. For example, any portion of the conduit porous material 110 that extends outwardly from the inlet 104 and / or the outlet 106 cannot provide support to the wall portion 102. Further, any portion of the conduit porous material 110 that extends outwardly from the inlet 104 and / or the outlet 106 can make it difficult to connect the conduit 100 to the device, because such portions of the conduit porous material 110 can interfere with the creation of a connection between the inlet 104 and / or the outlet 106 and the device (e.g., a fluid collection assembly, another conduit, a fluid storage container, etc.) and are required to be positioned within the device.
[0034] The wall portion 102 can be configured such that the conduit 100 can exhibit a certain average radius of curvature without kinking. The average radius of curvature that the wall portion 102 can exhibit without kinking can be about 0.25 cm or less, about 0.5 cm or less, about 0.75 cm or less, about 1 cm or less, about 1.25 cm or less, about 1.5 cm or less, about 1.75 cm or less, about 2 cm or less, about 2.5 cm or less, about 3 cm or less, or can be in the range of about 0.25 cm to about 0.75 cm, about 0.5 cm to about 1 cm, about 0.75 cm to about 1.25 cm, about 1 cm to about 1.5 cm, about 1.25 cm to about 1.75 cm, about 1.5 cm to about 2 cm, about 1.75 cm to about 2.5 cm, or about 2 cm to about 3 cm. The average radius of curvature that the wall portion 102 can exhibit without kinking can depend on the thickness of the wall portion 102, the material forming the wall portion 102, and the strength of the porous material 110.
[0035] In one embodiment, the conduit 100 can include a shape memory material (e.g., steel, copper, or aluminum wire) disposed on or attached to the conduit 100. The shape memory material is configured to maintain the shape of the conduit 100. For example, the shape memory material can maintain the bent shape of the conduit 100. Examples of shape memory materials that can be attached to or disposed on the conduit 100 are disclosed in International Application No. PCT / US2020 / 042262 filed on July 16, 2020, and U.S. Provisional Patent Application No. 63 / 094,646 filed on October 21, 2020, the entire disclosures of each of which are hereby incorporated by reference into the present application.
[0036] The conduit disclosed herein may exhibit any suitable cross-sectional shape along a plane perpendicular to the longitudinal axis of the conduit. FIGS. 2A through 2D are schematic cross-sectional views of various conduits along a plane perpendicular to the longitudinal axis of the conduit, according to various embodiments. Unless otherwise disclosed herein, the conduits shown in FIGS. 2A through 2D are the same as, or substantially similar to, any of the conduits disclosed herein. For example, the conduits shown in FIGS. 2A through 2D include at least one wall portion 202a that defines a passageway 208a and at least one conduit porous material 210a disposed in at least a portion of the passageway.
[0037] Referring to FIG. 2A, conduit 200a includes at least one wall portion 202a that defines a passageway 208a and at least one conduit porous material 210a. The conduit porous material 210a is formed from a sheet. For example, the conduit porous materials disclosed herein are often provided in the form of a sheet.
[0038] The sheet of the conduit porous material 210a can be rolled up so that the conduit porous material 210a presents an overall circular cross-sectional shape. In one embodiment, as shown, the sheet of the conduit porous material 210a is rolled up such that the opposing edges 214a of the conduit porous material 210a are adjacent to each other or positioned proximal to each other. In such an embodiment, the conduit porous material 210a may form a central gap 216a at its center. Optionally, the conduit porous material 210a may also present an outer gap 218a between the opposing edges 214a of the conduit porous material 210a. When the edges 214a of the conduit porous material 210a are adjacent to each other (e.g., in contact), the central gap 216a and the outer gap 218a cannot be directly connected. When the edges 214a of the conduit porous material 210a are proximal to each other (e.g., slightly separated), the central gap 216a and the outer gap 218a can be directly connected. The central gap 216a and the outer gap 218a increase the voids in the passage 208a through which body fluid can flow, thereby increasing the flow rate of the body fluid through the passage 208a. In some examples, the conduit 200a may include additional porous material configured to be disposed in at least one of the central gap 216a or the outer gap 218a. The additional porous material may provide additional support to the conduit porous material 210a, thereby increasing the performance of the conduit 100 that resists crushing and twisting. In one embodiment not shown, the sheet of the conduit porous material 210a can be spirally wound around itself, thereby omitting at least one of the central gap 216a or the outer gap 218a or minimizing their sizes as compared to bending the conduit porous material 210a as illustrated in FIG. 2A. Therefore, the conduit porous material 210a can be strengthened by spirally winding the conduit porous material 210a, but the flow rate of the body fluid through the passage 208a may be reduced as compared to bending the conduit porous material 210a as illustrated in FIG. 2A.
[0039] In some embodiments, regardless of whether the conduit porous material 210a is simply bent or spirally wound, when measured along a plane perpendicular to the longitudinal axis of the conduit 200a, the conduit porous material 210a may initially exhibit a cross-sectional area smaller than the cross-sectional area of the passage 208a. In such embodiments, the conduit porous material 210a may be disposed within a hollow conduit to form the conduit 200a. After disposing the conduit porous material 210a within the hollow conduit, the conduit porous material 210a is slightly relaxed from its bend or unwound from its coil such that the conduit porous material 210a presses against the wall portion 202a. In some embodiments, as previously described herein, the conduit porous material 210a may be bent or wound. After bending or winding the conduit porous material 210a, for example, a fluid-impermeable tape or coating may be applied to the conduit porous material 210a to form the wall portion 202a around the conduit porous material 210a.
[0040] Referring to FIG. 2B, the conduit 200b includes at least one wall portion 202b that defines the passage 208b. The wall portion 202b and the passage 208b may exhibit an overall circular cross-sectional shape when measured along a plane generally perpendicular to the longitudinal axis (not shown) of the conduit 200b. The conduit 200b also includes at least one conduit porous material 210b disposed within the passage 208b. In one example, the at least one conduit porous material 210b may exhibit an overall circular cross-sectional shape that corresponds to or is smaller than the overall circular cross-sectional shape of the passage 208b.
[0041] Generally, the device is configured to be attached to a hollow conduit having an overall circular cross-sectional shape measured perpendicular to the longitudinal axis of the hollow conduit. The overall circular cross-sectional shapes of conduit 200a shown in FIG. 2A and conduit 200b shown in FIG. 2B may allow conduits 200a, 200b to be directly attached (i.e., without an adapter) to such a device depending on the dimensions of conduits 200a, 200b (e.g., the maximum lateral dimension of its passageway). However, the conduits disclosed herein may exhibit any overall non-circular cross-sectional shape, because such conduits can be attached to the device using an adapter, or because the device is configured to be directly attached to a conduit having an overall non-circular cross-sectional shape. For example, FIG. 2C shows a conduit 200c having an overall elongated (e.g., oval or egg-shaped) cross-sectional shape, and FIG. 2D shows a conduit 200d having an overall rectangular (e.g., square) cross-sectional shape. The conduits disclosed herein may also exhibit any other suitable non-circular cross-sectional shape, such as an overall hexagonal cross-sectional shape or an overall triangular cross-sectional shape.
[0042] FIG. 3 is a schematic cross-sectional view of a fluid collection system 322 according to one embodiment. The fluid collection system 322 includes a conduit 300. Unless otherwise disclosed herein, the conduit 300 can include any of the conduits disclosed herein. The fluid collection system 322 also includes a device 324. As described above, the device 324 can include an outlet of a fluid collection assembly, an inlet or outlet of a fluid storage container, an inlet or outlet of a vacuum source, and an inlet or outlet of a hollow conduit. The fluid collection system 322 also includes an adapter 326. The adapter 326 extends between and is configured to be attached to the device 324 and the conduit 300. In one embodiment, the adapter 326 includes a conduit portion 328 configured to be attached to the conduit 300. The adapter 326 can be configured to be attached to the conduit 300 using any suitable technique. In one example, the conduit portion 328 is configured to be press-fitted onto the conduit 300 when the conduit 300 exhibits sufficient rigidity to maintain the connection. When the conduit portion 328 is configured to be press-fitted onto the conduit 300, one or more of the ends of the conduit portion 328 or the conduit 300 can be tapered, which can facilitate the press fit therebetween. Further, when the conduit portion 328 is configured to be press-fitted onto the conduit 300, the conduit portion 328 can be reversibly attached to the conduit, which allows the conduit 300 and the adapter 326 to be provided separately. Providing the conduit 300 separately allows the conduit 300 to be used with various devices (e.g., devices that can be directly attached to the conduit 300 or devices that can be indirectly attached via the adapter 326). In one example, the conduit portion 328 is permanently attached to the conduit 300 (e.g., attached by adhesion or welded). For example, when the conduit 300 does not exhibit sufficient rigidity to maintain a press-fit attachment between the conduit portion 328 and the conduit 300, the conduit portion 328 can be permanently attached to the conduit 300.By permanently attaching the pipeline 300 to the pipeline portion 328, only the indirect attachment of the pipeline 300 to the device 324 becomes possible, and the attachment of the pipeline 300 to a device to which the pipeline 300 can be directly attached is prevented. The pipeline portion 328 can be configured to form a male attachment portion with the pipeline 300 (for example, the pipeline 300 is disposed within the pipeline portion 328), or can be configured to form a female attachment portion with the pipeline 300 (for example, the pipeline portion 328 is disposed within the pipeline 300).
[0043] In one embodiment, the adapter 326 is integrally formed with the wall portion 302 of the pipeline 300 and does not include the pipeline portion 328. Instead, the adapter 326 is a portion of the wall portion 302 that exhibits one or more characteristics different from the remaining portion of the wall portion 302. The different characteristics of the adapter 326 facilitate the attachment of the adapter 326 to the device 324. For example, the different characteristics can include increased rigidity (e.g., increased thickness), a cross-sectional shape different from that of the remaining portion of the wall portion 302, or at least one of different one or more dimensions. The increased rigidity can facilitate press-fitting the pipeline 300 directly onto the device 324. The different cross-sectional shape and / or different one or more dimensions can correspond to the cross-sectional shape and / or one or more dimensions of the device 324 (e.g., equal to, slightly larger than, or slightly smaller than these).
[0044] The adapter 326 includes a device portion 330 configured to be attached to the device 324. Generally, the device portion 330 is configured to be reversibly attached (e.g., press-fitted) to the device 324. However, the device portion 330 may be configured to be permanently attached to the device 324. The device portion 330 can be configured to form a male attachment portion with the device (for example, the device 324 is disposed within the device portion 330), or can be configured to form a female attachment portion with the device 324 (for example, the device portion 330 is disposed within the device 324).
[0045] In some embodiments, the cross-sectional shape and / or one or more dimensions of conduit 300 are each different from the cross-sectional shape and / or one or more dimensions of device 324. In such embodiments, adapter 326 includes an intermediate portion 332. Intermediate portion 332 varies the cross-sectional shape and / or one or more dimensions of adapter 326 as it extends from conduit portion 328 toward device portion 330. For example, as shown, one or more dimensions of conduit 300 may be larger than those of device 324, and intermediate portion 332 may be tapered, thereby reducing one or more dimensions of adapter 326 as it extends from conduit portion 328 toward device portion 330.
[0046] Adapter 326 includes one or more adapter walls 327 that form conduit portion 328, device portion 330, and intermediate portion 332. Adapter walls 327 also define at least one adapter passage 329 configured to allow body fluid to flow between conduit 300 and device 324 through adapter 326. Adapter walls 327 are formed from a fluid-impermeable material to prevent body fluid from leaking through adapter walls 327. In one example, adapter walls 327 may be formed from any of the fluid-impermeable materials disclosed herein. In one example, adapter walls 327 may be formed from a material having high rigidity to enable adapter 326 to be press-fitted onto conduit 300 and / or device 324. Examples of such materials having high rigidity include polyvinyl chloride formed without a plasticizer, metal, or any other suitable material.
[0047] It is noted that conduit 300 may be connected to device 324 without adapter 326. In one example, conduit 300 may be sized and shaped to connect directly to device 324. In one example, conduit 300 may exhibit a rigidity such that conduit 300 can be press-fitted onto device 324. In one example, conduit 300 may be fastened to device 324 with tape.
[0048] In FIGS. 1 - 3, the pipeline shown is shown to include a pipeline porous material disposed only in its passageway. In other words, the pipelines shown in FIGS. 1 - 3 do not include the pipeline porous material extending therefrom. However, in some embodiments (shown in FIGS. 4A - 6B), the pipeline porous material may extend outward from the passageway of the pipeline.
[0049] FIGS. 4A and 4B show a method of forming a pipeline 400 that includes a pipeline porous material 410 extending outward from a passageway 408 (shown in FIG. 4C) according to one embodiment. In particular, FIG. 4A is a top elevation view of the pipeline porous material 410 before forming the pipeline 400, and FIG. 4B is an isometric view of the pipeline 400 formed using the pipeline porous material 410. Unless otherwise disclosed herein, the pipeline 400 can be the same as or substantially similar to any of the pipelines disclosed herein.
[0050] Referring to FIG. 4A, the pipeline porous material 410 can be provided as a sheet, such as a generally rectangular sheet. Optionally, the pipeline porous material 410 can have one or more cuts 433 formed therein. The cuts 433 are schematically shown using dashed lines. The cuts 433 divide the pipeline porous material 410 into a first portion 434 and a second portion 435. The first portion 434 can form at least a portion of the pipeline porous material 410 that extends outward from the passageway 408 of the pipeline 400 (illustrated in FIG. 4C), and the second portion 435 can form at least a portion of the pipeline porous material 410 that is disposed in the passageway 408 of the pipeline 400.
[0051] Referring to FIG. 4B, the conduit 400 can be formed by rolling up, gathering in one place, or otherwise collecting the second portion 435 of the conduit porous material 410. The cut 433 allows the second portion 435 to be rolled up, gathered in one place, or otherwise collected without substantially disturbing the first portion 434. The wall portion 402 can be formed around the second portion 435, or the second portion 435 can be positioned within a passage 408 defined by one or more pre-formed wall portions 402. Accordingly, at least a portion of the first portion 434 can extend from the wall portion 402 of the conduit 400. As will be discussed in more detail below, the first portion 434 can be positioned in a chamber of the fluid collection assembly, which can facilitate the removal of body fluid from the chamber.
[0052] In one embodiment, the first portion 434 can remain in an overall sheet-like configuration (e.g., the first portion 434 is not folded, rolled up, gathered in one place, or otherwise collected). In one embodiment, the first portion 434 can be folded back onto the wall portion 402 of the conduit 400. For example, FIG. 4C is a schematic cross-sectional view of the conduit 400 when the first portion 434 of the conduit porous material 410 is folded back onto the wall portion 402 according to one embodiment. The first portion 434 can be folded back such that at least a portion of the first portion 434 contacts at least a portion of the outer surface 436 of the wall portion 402. It has been found that the wall portion 402 of the conduit 400 is most likely to be crushed at or near the inlet 404 of the conduit 400. However, unexpectedly, it has been found that folding the first portion 434 of the conduit porous material 410 onto the wall portion 402 of the conduit 400 suppresses the crushing of the wall portion 402 at or near the inlet 404. Further, folding the conduit porous material 410 onto the wall portion 402 can reduce the amount of assembly porous material included in the fluid collection assembly to which the conduit 400 is attached.
[0053] It should be noted that FIGS. 4A-4C merely show one or more methods of forming a conduit that includes a portion of the conduit porous material extending from the passageway. In one embodiment, the conduit porous material 410 may not have a notch. In one embodiment, the conduit porous material 410 may exhibit a non-rectangular sheet-like shape, such as a shape that includes a sheet-like portion attached to a cylindrical-shaped portion.
[0054] The wall portion of the conduit and the portion of the conduit porous material extending from the passageway may exhibit a shape other than the shapes shown in FIGS. 4A-4C. For example, FIG. 5 is a schematic cross-sectional view of a conduit 500 that includes a first portion 534 of a conduit porous material 510 extending from a passageway 508 of the conduit 500, according to one embodiment. Unless otherwise disclosed herein, the conduit 500 may be the same as or substantially similar to any of the conduits disclosed herein. The first portion 534 may be configured to at least partially or substantially occupy a portion of the chamber not occupied by the assembly porous material. Accordingly, the first portion 534 may exhibit an overall hemispherical shape, valve shape, or other shape corresponding to a portion of the chamber not occupied by the assembly porous material. In one embodiment, the first portion 534 may exhibit a maximum lateral dimension D1 (e.g., diameter) that is greater than the maximum lateral dimension D2 of the wall portion 502 of the conduit 500, which may help the conduit porous material 510 better occupy the portion of the chamber not occupied by the assembly porous material. As discussed in more detail below, the shape of the first portion 534 may facilitate the flow of body fluid from the assembly porous material to the conduit porous material 510.
[0055] The conduit 500 can be formed using any suitable method. In one embodiment, the conduit 500 can be formed in the same manner as the conduit 400 shown in FIGS. 4A - 4C, except that the first portion 534 is gathered, shaped, or otherwise brought together in one place to form a shape that at least partially or substantially occupies the portion of the chamber not occupied by the assembly porous material. In one embodiment, the conduit porous material 510 can be provided to generally exhibit a hemispherical shape, a valve shape, or any suitable shape.
[0056] FIGS. 6A and 6B illustrate a method of forming a conduit 600 that includes a conduit porous material 610 extending outwardly from a passageway (not shown, unclear). In particular, FIG. 6A is a top elevation view of the conduit porous material 610 prior to forming the conduit 600, and FIG. 6B is an isometric view of the conduit 600 formed using the conduit porous material 610. Unless otherwise disclosed herein, the conduit 600 can be the same as or substantially similar to any of the conduits disclosed herein.
[0057] Referring to FIG. 6A, the conduit porous material 610 can be provided as a sheet, such as a generally rectangular sheet. The conduit porous material 610 can have one or more cuts 633 formed therein. The cuts 633 are schematically shown using dashed lines. The conduit porous material 610 can have one or more first cuts 633 formed therein that form a first portion 634 and a second portion 635. At least a portion of the first portion 634 is configured to extend from the wall portion 602 of the conduit 600, and at least a portion of the second portion 635 is configured to be disposed within the passage of the conduit 600. The conduit porous material 610 can also include one or more second cuts 633 formed therein that separate the first portion 634 into a plurality of regions (e.g., a first region 637 and a second region 638). The plurality of regions can form different distinct flow paths through which body fluid can flow through the conduit porous material 610 therein. The plurality of regions can also enable the conduit porous material 610 to receive body fluid from different locations in the chamber of the fluid collection assembly. In one embodiment, the first and second cuts 633a, 633b are not parallel to each other (e.g., are perpendicular).
[0058] Referring to FIG. 6B, at least a portion of the second portion 635 can be rounded, gathered in one place, or otherwise grouped together. The rounded, gathered, or otherwise grouped portion of the second portion 635 can be disposed in a passage defined by the already formed wall portion 602, or the wall portion 602 can be formed around such a portion of the second portion 635. In one embodiment, the wall portion 602 can form a primary branch 639 that includes the first portion 635 disposed in the passage defined thereby. The wall portion 602 can also include one or more secondary branches 641 extending from the primary branch 639. For example, the wall portion 602 can include a secondary branch 641 for each region of the first portion 634. The secondary branch 641 can define a passage that includes a portion of the first portion 634 disposed therein. Each of the secondary branches 641 can define an inlet 604, and the remaining portion of the first portion 634 that is not disposed in the passage defined by the secondary branch 641 can extend from the inlet 604. The secondary branch 641 can minimize the diffusion of the vacuum pressure through all of the first portion 634, thereby concentrating the vacuum pressure on the uncovered portion of the conduit porous material 610. In one embodiment, each of the secondary branches 641 can extend from the primary branch 639 at the same distance. In one embodiment, at least one of the secondary branches 641 can extend from the primary branch 639 at a different distance from at least one other secondary branch 641.
[0059] As described above, the conduit disclosed herein can be used with a fluid collection assembly. FIG. 7A is an isometric view of a portion of a fluid collection system 722 that includes a fluid collection assembly 740 in fluid communication with a conduit 700, according to one embodiment. FIG. 7B is a schematic cross-sectional view of the fluid collection system 722 along plane 7B-7B illustrated in FIG. 7A, according to one embodiment. The fluid collection assembly 740 is an example of a female fluid collection assembly for receiving and collecting body fluid from a female. The fluid collection assembly 740 includes at least a fluid-impermeable barrier 742 that defines an opening 744, a chamber 746, and a fluid outlet 748. The fluid collection assembly 740 also includes at least one assembly porous material 750 disposed in the chamber 746. The conduit 700 is disposed through the fluid outlet 748 such that an inlet 704 of the conduit 700 is disposed in the chamber 746. Unless otherwise disclosed herein, the conduit 700 can be the same as, or substantially similar to, any of the conduits disclosed herein.
[0060] The fluid-impermeable barrier 742 at least partially defines a chamber 746 (e.g., an internal region) and an opening 744. For example, the inner surface 752 of the fluid-impermeable barrier 742 at least partially defines the chamber 746 within the fluid collection assembly 740. The fluid-impermeable barrier 742 temporarily stores body fluid in the chamber 746. The fluid-impermeable barrier 742 can be formed of any suitable one or more fluid-impermeable materials such as a fluid-impermeable polymer (e.g., silicone, polypropylene, polyethylene, polyethylene terephthalate, neoprene, polycarbonate, etc.), a metal film, natural rubber, other suitable materials, any other fluid-impermeable material disclosed herein, or combinations thereof. Thus, the fluid-impermeable barrier 742 substantially prevents body fluid from passing through the fluid-impermeable barrier 742. In one embodiment, the fluid-impermeable barrier 742 can be air-permeable and fluid-impermeable. In such an embodiment, the fluid-impermeable barrier 742 can be formed of a hydrophobic material that defines a plurality of pores. At least one or more portions of at least the outer surface 754 of the fluid-impermeable barrier 742 can be formed of a soft and / or smooth material, thereby reducing abrasion.
[0061] In some embodiments, the fluid-impermeable barrier 742 can be tubular (ignoring the opening), such as a tube having a substantially cylindrical shape, an oval shape, a prismatic shape, or a flat shape (as shown). In use, the outer surface 754 of the fluid-impermeable barrier 742 can contact the patient. The fluid-impermeable barrier 742 can have a size and shape that fits between the labia and / or between the buttocks of a female user's legs.
[0062] The aperture 744 provides an entry path for fluid to enter the chamber 746. The aperture 744 can be defined by a fluid-impermeable barrier 742, such as by the inner edge of the fluid-impermeable barrier 742. For example, the aperture 744 is formed in the fluid-impermeable barrier 742 and extends through the fluid-impermeable barrier 742 from the outer surface 754 to the inner surface 752, thereby enabling body fluid to enter the chamber 746 from outside the fluid collection assembly 740. The aperture 744 can be an elongated hole in the fluid-impermeable barrier 742. For example, the aperture 744 can be defined as a notch in the fluid-impermeable barrier 742. The aperture 744 can be positioned and shaped so as to be adjacent to a female urethra.
[0063] The fluid collection assembly 740 can be positioned proximal to the female urethral orifice, and body fluid can enter the chamber 746 of the fluid collection assembly 740 through the aperture 744. The fluid collection assembly 740 is configured to receive body fluid into the chamber 746 through the aperture 744. In use, the aperture 744 can have an elongated shape extending from a first location below the urethral orifice (e.g., the location of the anus or vaginal orifice or near thereto) to a second location above the urethral orifice (e.g., the upper part of the vaginal orifice or the location of the pubic hair or near thereto).
[0064] When a female's legs are closed, the space between the legs is relatively small, so the aperture 744 can have an elongated shape, thereby permitting only the flow of body fluid along a path corresponding to the elongated shape of the aperture 744 (e.g., an aperture extending longitudinally). The aperture 744 of the fluid-impermeable barrier 742 can exhibit a length measured along the longitudinal axis of the fluid collection assembly 740, and this length can be at least about 10% of the length of the fluid collection assembly 740, such as from about 10% to about 30%, from about 25% to about 40%, from about 30% to about 60%, from about 50% to about 75%, from about 65% to about 85%, or from about 75% to about 95% of the length of the fluid collection assembly 740.
[0065] The opening 744 of the fluid-impermeable barrier 742 may exhibit a width measured across the longitudinal axis of the fluid collection assembly 740, and this length may be at least about 10% of the perimeter of the fluid collection assembly 740, such as from about 10% to about 30%, from about 25% to about 40%, from about 30% to about 60%, from about 50% to about 75%, from about 65% to about 85%, or from about 75% to about 100% of the perimeter of the fluid collection assembly 740. The opening 744 may exhibit a width greater than 70% of the perimeter of the fluid collection assembly 740, because a vacuum (e.g., suction) through the conduit 700 draws fluid into the conduit 700 through the assembly porous material 750. In some embodiments, the opening 744 may be oriented vertically (e.g., having a major axis parallel to the longitudinal axis of the fluid collection assembly 740). In some embodiments (not shown), the opening 744 may be oriented horizontally (e.g., having a major axis perpendicular to the longitudinal axis of the fluid collection assembly 740). In one embodiment, the fluid-impermeable barrier 742 may be configured to be attached to the patient, such as by adhesion (e.g., by a hydrogel adhesive). According to one embodiment, a suitable adhesive is a hydrogel layer.
[0066] In some embodiments, the fluid-impermeable barrier 742 may define a fluid outlet 748 sized to receive the conduit 700. At least one conduit 700 may be disposed in the chamber 746 via the fluid outlet 748. The fluid outlet 748 may have a size and shape to form at least a substantially liquid-tight seal with the conduit 700 or at least one tube, thereby substantially preventing body fluid from escaping from the chamber 746. It is noted that the fluid outlet 748 may have a size and shape to form at least a substantially liquid-tight seal with an adapter (e.g., adapter 326 of FIG. 3).
[0067] The fluid-impermeable barrier 742 may include markings, such as one or more markings that assist a user in aligning the fluid collection assembly 740 over a patient. For example, a line on the fluid-impermeable barrier 742 (e.g., on the opposite side of the opening 744) may enable a healthcare provider to align the opening 744 over the patient's urethra. In an embodiment, the markings may include one or more of alignment guides or direction indicators, such as stripes or hash marks. Such markings may be positioned to align the fluid collection assembly 740 with one or more anatomical features, such as the pubic bone.
[0068] The fluid collection assembly 740 includes an assembly porous material 750 disposed in the chamber 746. The assembly porous material 750 can cover at least a portion (e.g., all) of the opening 744. The assembly porous material 750 can include a fluid permeable membrane 756 and a fluid permeable support 758. The assembly porous material 750 is exposed to the environment outside the chamber 746 via the opening 744. In one embodiment, the assembly porous material 750 can be configured to draw up any body fluid away from the opening 744, thereby preventing the body fluid from escaping from the chamber 746. The property of permeability referred to herein can be suction, capillary action, diffusion, or other similar properties or processes, and is referred to herein as "permeability" and / or "suction". Such "suction" and / or "permeability" properties may not include the absorption of body fluid into at least a portion of the suction material, for example, may not include the adsorption of body fluid into the fluid permeable support 758. In other words, after the material is exposed to body fluid and removed from the body fluid for a while, substantially no absorption or solubility of the body fluid into the material can occur. Although absorption or solubility is not desired, the term "substantially no absorption" can allow for only a small amount of absorption and / or solubility (e.g., absorbency) of body fluid into the suction material, such as 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 suction material. As discussed in more detail below, the suction material can also draw up body fluid entirely towards the inside of the chamber 746. In one embodiment, the assembly porous material 750 can include at least one absorbent or adsorbent material.
[0069] In one embodiment, the assembly porous material 750 can include a fluid permeable membrane 756 disposed in the chamber 746. The fluid permeable membrane 756 can cover at least a portion (e.g., all) of the opening 744. The fluid permeable membrane 756 can be configured to draw up body fluid away from the opening 744, thereby preventing the body fluid from escaping from the chamber 746.
[0070] In one embodiment, the fluid permeable membrane 756 can include any material capable of wicking body fluid. For example, the fluid permeable membrane 756 can include a fabric such as gauze (e.g., silk, linen, or cotton gauze), other soft fabrics, other smooth fabrics, or any of the other porous materials disclosed herein. By forming the fluid permeable membrane 756 from gauze, soft fabric, and / or smooth fabric, abrasion caused by the fluid collection assembly 740 can be reduced.
[0071] The fluid collection assembly 740 may include a fluid-permeable support 758 disposed in the chamber 746. Since the fluid-permeable membrane 756 can be formed from a material that is relatively easy to fold, thin, or otherwise easily deformable, the fluid-permeable support 758 is configured to support the fluid-permeable membrane 756. For example, the fluid-permeable support 758 can be positioned such that the fluid-permeable membrane 756 is disposed between the fluid-permeable support 758 and the fluid-impermeable barrier 742. Thus, the fluid-permeable support 758 can support the fluid-permeable membrane 756 and maintain the position of the fluid-permeable membrane 756. The fluid-permeable support 758 can include any material that can draw up, absorb, adsorb, or otherwise enable fluid transport of body fluid, such as any of the fluid-permeable membrane materials disclosed above herein. For example, one or more fluid-permeable membrane materials can be utilized in a form having a higher density or higher rigidity than in the case of the fluid-permeable membrane 756 when used as the fluid-permeable support 758. The fluid-permeable support 758 can be formed from any fluid-permeable material that is less deformable than the fluid-permeable membrane 756. For example, the fluid-permeable support 758 can include a porous polymer (e.g., nylon, polyester, polyurethane, polyethylene, polypropylene, etc.) structure, or an open-cell foam such as span nylon fibers. In some embodiments, the fluid-permeable support 758 can be formed from natural materials such as cotton, wool, silk, or combinations thereof. In such embodiments, the material can have a coating that prevents or limits the absorption of fluid into the material, such as a water-repellent coating. In some embodiments, the fluid-permeable support 758 can be formed from a fabric, felt, gauze, or combinations thereof.
[0072] In some embodiments, the fluid-permeable membrane 756 can be optional. For example, the assembly porous material 750 can include only the fluid-permeable support 758. In some embodiments, the fluid-permeable support 758 can optionally be omitted from the fluid collection assembly 740. For example, the assembly porous material 750 can include only the fluid-permeable membrane 756.
[0073] In one embodiment, the fluid-permeable support 758 may be hydrophobic. The fluid-permeable support 758 may be hydrophobic when presenting a contact angle with water (a major component of body fluid) greater than about 90°, such as in the range from about 90° to about 120°, from about 105° to about 135°, from about 120° to about 150°, from about 135° to about 175°, from about 150° to about 180°. The hydrophobicity of the fluid-permeable support 758 may limit the absorption, adsorption, and solubility of body fluid in the fluid-permeable support 758, thereby reducing the amount of body fluid retained in the assembly porous material 750. In one embodiment, the fluid-permeable membrane 756 may be hydrophobic or hydrophilic. In one embodiment, the fluid-permeable support 758 has a greater hydrophobicity (e.g., presents a greater contact angle with water) than the fluid-permeable membrane 756. The lower hydrophobicity of the fluid-permeable membrane 756 may help the assembly porous material 750 receive body fluid from the urethral orifice while restricting the body fluid retained in the assembly porous material 750 by the hydrophobicity of the fluid-permeable support 758.
[0074] In one embodiment, the assembly porous material 750 includes a nonwoven material instead of or in addition to at least one of the fluid-permeable membrane 756 or the fluid-permeable support. Examples of nonwoven materials that may be included in the assembly porous material 750 are disclosed in U.S. Provisional Patent Application No. 63 / 134,754, filed on January 7, 2021, the disclosure of which is hereby incorporated by reference into this application.
[0075] The assembly porous material 750 may at least substantially completely fill the portion of the chamber 746 not occupied by the conduit 700. In some examples, the assembly porous material 750 may not substantially completely fill the portion of the chamber 746 not occupied by the conduit 700. In such examples, the fluid collection assembly 740 includes a reservoir 760 (FIG. 1B) disposed in the chamber 746.
[0076] The reservoir 760 is a substantially unoccupied portion of the chamber 746. The reservoir 760 can be defined between the fluid-impermeable barrier 742 and one or both of the fluid-permeable membrane 756 and the fluid-permeable support 758. Body fluid within the chamber 746 can flow through the fluid-permeable membrane 756 and / or the fluid-permeable support 758 into the reservoir 760. The reservoir 760 can hold body fluid therein.
[0077] Body fluid within the chamber 746 can flow through the fluid-permeable membrane 756 and / or the fluid-permeable support 758 into the reservoir 760. The fluid-impermeable barrier 742 can hold body fluid within the reservoir 760. Although the reservoir 760 is depicted in the distal end region 762, the reservoir 760 can be located in any portion of the chamber 746, such as the proximal end region 764. The reservoir 760 can be located in a portion of the chamber 746 that is designed to be at a gravimetrically low point of the fluid collection assembly when the fluid collection assembly is worn.
[0078] In some embodiments (not shown), the fluid collection assembly 740 can include a plurality of reservoirs, such as a first reservoir located in a portion of the chamber 746 closest to the inlet of the conduit 700 (e.g., the distal end region 762), and a second reservoir located in a portion of the chamber 746 in or near the proximal end region 764. In another embodiment, the fluid-permeable support 758 is spaced from at least a portion of the conduit 700, and the reservoir 760 can be the space between the fluid-permeable support 758 and the conduit 700.
[0079] The conduit 700 can be at least partially disposed within the chamber 746. The conduit 700 can be used to remove body fluid from the chamber 746. The conduit 700 includes at least one wall portion 702 that defines an inlet 704, an outlet (not shown) downstream of the inlet 704, and a passageway 708. The passageway 708 can be at least partially occupied by at least one conduit porous material 710. The outlet of the conduit 700 can be operatively coupled to a vacuum source, such as a vacuum pump, to draw fluid from the chamber 746 through the conduit 700. For example, the conduit 700 can extend into the fluid-impermeable barrier 742 from the proximal end region 764 and then extend to the distal end region 762 and to a point proximal to the reservoir 760 therein such that the inlet 704 is in fluid communication with the reservoir 760. The conduit 700 fluidly couples the chamber 746 to a fluid storage container (not shown) or a vacuum source (not shown).
[0080] The conduit 700 can extend through the pores of the assembly porous material 750. In one embodiment, the conduit 700 extends from the fluid outlet 748, through the pores, to a location proximal to the reservoir 760. In such an embodiment, the inlet 704 need not extend into the reservoir 760. Instead, the inlet 704 can be disposed within or at the terminal end 766 of the assembly porous material 750 (fluid permeable membrane 756 and / or fluid permeable support 758). For example, the end of the conduit 700 can have the same outer extension as the fluid permeable membrane 756 and / or fluid permeable support 758 or can be recessed within the fluid permeable membrane 756 and / or fluid permeable support 758. In one embodiment, the conduit 700 is at least partially disposed within the reservoir 760 and the inlet 704 can extend into or be positioned within the reservoir 760. Body fluid collected by the fluid collection assembly 740 can be removed from the chamber 746 via the conduit 700.
[0081] By positioning the inlet 704 at or near a location that is expected to be a gravimetrically low point of the chamber 746 when worn by the patient, the conduit 700 can receive more body fluid and reduce the likelihood of storage than when the inlet 704 is located elsewhere (e.g., body fluid storage can cause bacterial growth and odor). For example, body fluid in the fluid permeable membrane 756 and the fluid permeable support 758 can flow in any direction by capillary force. However, the body fluid may exhibit a preferential tendency to flow in the direction of gravity, particularly when at least a portion of the fluid permeable membrane 756 and / or the fluid permeable support 758 is saturated with body fluid. Therefore, one or more of the inlet 704 or the reservoir 760 can be located in the fluid collection assembly 740 at a location that is expected to be a gravimetrically low point in the fluid collection assembly 740, such as the distal end region 762, when worn by the patient.
[0082] As will be described in more detail below, the conduit 700 is configured to be coupled to and at least partially extend between one or more of a fluid storage container (not shown) and a vacuum source (not shown). In one embodiment, the conduit 700 is configured to be directly connected to a vacuum source (not shown). In such an embodiment, the conduit 700 can extend from the fluid impermeable barrier 742 by at least 1 foot, at least 2 feet, at least 3 feet, or at least 6 feet. In another embodiment, the conduit 700 is configured to be indirectly connected to at least one of a fluid storage container (not shown) and a vacuum source (not shown). In some embodiments, the conduit is fixed to the patient's skin by a catheter fixation device, such as a STATLOCK® catheter fixation device available from C.R.Bard, Inc., including but not limited to those disclosed in U.S. Patent Nos. 6,117,163, 6,123,398, and 8,211,063, the entire disclosures of which are hereby incorporated by reference in their entirety.
[0083] The inlet 704 and outlet of the conduit 700 are configured to fluidly couple (e.g., directly or indirectly) a vacuum source (not shown) to the chamber 746 (e.g., reservoir 760). When a vacuum source (FIG. 21) applies a vacuum / suction to the conduit 700, body fluid in the chamber 746 (e.g., body fluid in the distal end region 762 such as reservoir 760) can be drawn into the inlet 704 and out of the fluid collection assembly 740 via the conduit 700. In some embodiments, the conduit can be bead blasted so that body fluid therein is not clearly visible, or can be opaque (e.g., black).
[0084] As described above, the conduit 700 can be configured to be insertable at least within the chamber 746. In one embodiment, the conduit 700 can be positioned within the chamber 746 such that the terminal end 720 of the conduit 700 is spaced from the fluid impermeable barrier 742 or other components of the fluid collection assembly 740 that could at least partially block or occlude the inlet 704. Further, the inlet 704 of the conduit 700 can be offset relative to the terminal end 766 of the assembly porous material 750 such that the inlet 704 is closer to the proximal end region 764 of the fluid collection assembly 740 than the terminal end 766 of the assembly porous material 750. By offsetting the inlet 704 relative to the terminal end 766 of the assembly porous material 750 in this manner, the inlet 704 can directly receive body fluid from the assembly porous material 750, and thanks to hydrogen bonding, draw more body fluid from the assembly porous material 750.
[0085] The conduit 700 may include, on its exterior, one or more markers (not shown) positioned to facilitate insertion of the conduit 700 into the chamber 746 and proper placement of the inlet 704 within the chamber 746. For example, the conduit 700 may include, on it, one or more markings configured to prevent over-insertion or under-insertion of the conduit 700, such as to prevent a fluid-impermeable barrier 742 from blocking or closing the inlet 704. In another embodiment, the conduit 700 may include, on it, one or more markings configured to facilitate accurate rotation of the conduit 700 relative to the chamber 746. The one or more markings may include lines, dots, stickers, or any other suitable markings.
[0086] Other embodiments of fluid-impermeable barriers, fluid-permeable membranes, fluid-permeable supports, chambers, and their shapes and configurations are disclosed in U.S. Patent Application No. 15 / 612,325, filed Jun. 2, 2017, U.S. Patent Application No. 15 / 260,103, filed Sep. 8, 2016, and U.S. Patent No. 10,390,989, filed Sep. 8, 2016, the entire disclosures of each of which are hereby incorporated by reference into this application.
[0087] FIG. 8 is a schematic cross-sectional view of a portion of a fluid collection system 822 according to one embodiment. The fluid collection system 822 includes a fluid collection assembly 840 and a conduit 800 in fluid communication with the fluid collection assembly 840. Unless otherwise disclosed herein, the conduit 800 is the same as or substantially similar to any of the conduits disclosed herein. For example, the conduit 800 includes at least one wall portion 802 that defines an inlet 804, an outlet (not shown), and a passageway 808. The conduit 800 includes at least one conduit porous material 810 disposed in the passageway 808. Unless otherwise disclosed herein, the fluid collection assembly 840 is the same as or substantially identical to any of the fluid collection assemblies disclosed herein. For example, the fluid collection assembly 840 includes a fluid impermeable barrier 842 that defines at least one opening 844, a chamber 846, and a fluid outlet 848. The fluid collection assembly 840 also includes at least one assembly porous material 850 disposed in the chamber 846.
[0088] The fluid outlet 848 is formed in or near the distal end region 862 instead of in or near the proximal end region (not shown) of the fluid collection assembly 840. For example, the fluid outlet 848 can be formed in or near a reservoir (not shown) when the chamber 846 includes the reservoir 860, and / or can be formed at or near a point where the weight measurement of the fluid collection assembly 840 is expected to be lower. Thus, the distance that the conduit 800 needs to extend within the chamber 846 such that the inlet 804 of the conduit 800 is at or near the reservoir 860 and / or at or near the gravimetrically lower point of the chamber 846 is significantly reduced compared to when the fluid outlet 848 is formed in or near the proximal end region. In some embodiments, the assembly porous material 850 can be formed without holes formed therein, or the distance that the holes extend through the assembly porous material 850 can be reduced compared to the holes formed in the assembly porous material 850 shown in FIG. 7B, which can increase the volume of body fluid that can be retained within the assembly porous material 850. The conduit 800 can be arranged such that, through the fluid outlet 848, the inlet 804 of the conduit 800 is adjacent to or within the assembly porous material 850.
[0089] The high flexibility of the conduit 800 can allow the fluid outlet 848 to be located in or near the distal end region 862 of the fluid collection assembly 840. For example, the conduit 800 extending outward from the fluid outlet 848 may need to be bent at or near the fluid outlet 848 when the patient is wearing clothing or when the patient is lying down. Similar bends formed in conventional hollow conduits are prone to kinking when similar bending is required, or can be pushed into the clothing or bed.
[0090] FIG. 9 is a schematic cross-sectional view of a portion of a fluid collection system 922 according to one embodiment. The fluid collection system 922 includes a fluid collection assembly 940 and a conduit 900 in fluid communication with the fluid collection assembly 940. Unless otherwise disclosed herein, the conduit 900 is the same as or substantially similar to any of the conduits disclosed herein. Unless otherwise disclosed herein, the fluid collection assembly 940 is the same as or substantially the same as any of the fluid collection assemblies disclosed herein. For example, the fluid collection assembly 940 includes a fluid-impermeable barrier 942 that defines at least one opening 944, a chamber 946, and a fluid inlet 948. The fluid inlet 948 can be formed at or near the distal end region 962 (as shown) or at another portion of the fluid collection assembly 940. The fluid collection assembly 940 also includes at least one assembly porous material 950 disposed in the chamber 946.
[0091] In one embodiment, at least a portion of the wall 902 of the conduit 900 is integrally formed with the fluid-impermeable barrier 942 of the fluid collection assembly 940. Forming the wall 902 integrally with the fluid-impermeable barrier 942 can reduce the complexity of forming the fluid collection system 922 because there are fewer parts for assembly included in the fluid collection assembly 922. Forming the wall 902 integrally with the fluid-impermeable barrier 942 can make it easier to align and accurately position the conduit 900 relative to the fluid collection assembly 940. In one embodiment not shown, the conduit 900 is separate from the fluid-impermeable barrier 942 and is attached to the fluid-impermeable barrier 942.
[0092] In one embodiment, the conduit 900 extends along at least a portion of the fluid-impermeable barrier 942, which obviates the need to form pores within the assembly porous material 950. In one embodiment, the fluid-impermeable barrier 942 forms at least a portion (e.g., all) of the wall 902 of the conduit 900 and defines at least a portion of the passageway 908. In such an embodiment, the conduit 900 can be defined by at least one inner wall 902a and at least one outer wall 902b. At least one of the inner wall 902a or the outer wall 902b is formed by the fluid-impermeable barrier 942. In one example, one of the inner or outer walls 902a, 902b is separate from the fluid-impermeable barrier 942. In such an example, the inner or outer wall 902a, 902b is separate from the fluid-impermeable barrier 942 and can be formed from at least one fluid-impermeable layer attached to the fluid-impermeable barrier 942. In one embodiment, the conduit 900 extends so as to be spaced apart from the remaining portion of the fluid-impermeable barrier 942.
[0093] In one embodiment, the porous material 950 occupies substantially all of the chamber 946, and the chamber 946 does not define a reservoir.
[0094] FIG. 10 is a schematic cross-sectional view of a portion of a fluid collection system 1022 including a conduit 1000 in fluid communication with a fluid collection assembly 1040, according to one embodiment. Unless otherwise disclosed herein, conduit 1000 is the same as, or substantially similar to, any of the conduits disclosed herein. For example, conduit 1000 may include at least one wall portion 1002 that defines at least an inlet 1004, an outlet (not shown), and a passageway 1008. Conduit 1000 also includes a conduit porous material 1010 disposed within passageway 1008. Unless otherwise disclosed herein, fluid collection assembly 1040 is the same as, or substantially similar to, any of the fluid collection assemblies disclosed herein. For example, fluid collection assembly 1040 may include a fluid-impermeable barrier 1042 that defines an opening 1044, a chamber 1046, and a fluid outlet 1048. Fluid collection assembly 1040 may also include at least one assembly porous material 1050 disposed within chamber 1046.
[0095] At least a portion of conduit porous material 1010 and assembly porous material 1050 are integrally formed with each other (e.g., exhibit a single-piece construction). By integrally forming conduit porous material 1010 and assembly porous material 1050 with each other, a gap can be prevented from forming between conduit porous material 1010 and assembly porous material 1050, which can inhibit the flow of body fluid from assembly porous material 1050 to conduit porous material 1010.
[0096] The fluid collection assembly disclosed herein may include a conduit having conduit porous material extending outwardly from its wall. For example, FIG. 11 is a schematic cross-sectional view of a portion of a fluid collection system 1122 including a conduit 1100 in fluid communication with a fluid collection assembly 1140 according to one embodiment. Unless otherwise disclosed herein, conduit 1100 is the same as, or substantially similar to, any of the conduits disclosed herein. For example, conduit 1100 may include at least one wall 1102 defining at least an inlet 1104, an outlet (not shown), and a passageway 1108. Conduit 1100 also includes conduit porous material 1110 disposed partially within passageway 1108. Unless otherwise disclosed herein, fluid collection assembly 1140 is the same as, or substantially similar to, any of the fluid collection assemblies disclosed herein. For example, fluid collection assembly 1140 may include a fluid impermeable barrier 1142 defining a chamber 1146 and at least one assembly porous material disposed within chamber 1146.
[0097] Conduit porous material 1110 may include a first portion 1134 extending outwardly from passageway 1108 (e.g., from inlet 1104) and a second portion 1135 disposed within passageway 1108. The first portion 1134 may be folded over the wall 1102 of conduit 1100. For example, the first portion 1134 may be folded to cover all or substantially all of the outer surface 1136 of wall 1102. When fluid collection assembly 1140 includes assembly porous material 1150, the first portion 1134 may support assembly porous material 1150. Assembly porous material 1150 and the first portion 1134 of conduit porous material 1110 may contact each other to minimize the formation of a gap therebetween.
[0098] During operation, the fluid collection assembly 1150 may receive body fluid into the chamber 1146 through the opening 1144. The body fluid may be received into the assembly porous material 1150 and may flow into the first portion 1134 of the conduit porous material 1110. The body fluid may then flow from the first portion 1134 into the second portion 1135, where the vacuum pressure applied to the conduit 1100 sucks the body fluid through the conduit 1100. The hydrogen bonds between the water molecules of the body fluid draw additional body fluid from the first portion 1134 into the second portion 1135 of the body fluid being sucked through the second portion 1135 of the conduit porous material 1110. Further, the hydrogen bonds draw the body fluid in the second portion 1135 into the first portion 1134 of the conduit porous material 1110 from the assembly porous material 1150. It is noted that any gap between the assembly porous material 1150 and the first portion 1134 may break the hydrogen bonds between the water molecules in the assembly porous material 1150 and the first portion 1134. The lack of hydrogen bonds may prevent the body fluid from being drawn from the assembly porous material 1150 into the conduit porous material 1110. Instead, the flow of body fluid from the assembly porous material 1150 into the conduit porous material 1110 may rely on suction and gravity, which may be slower. The hydrogen bonds between the water molecules and the direct contact between the conduit porous material 1110 and the assembly porous material 1150 reduce the need to position the inlet 1104 of the conduit 1100 at or near the point where the weight measurement of the chamber 1146 is expected to be low. The first portion 1134 may also facilitate the alignment of the conduit 1100 in the chamber 1146.
[0099] FIG. 12 is a schematic cross-sectional view of a portion of a fluid collection system 1222 that includes a conduit 1200 in fluid communication with a fluid collection assembly 1240, according to one embodiment. Unless otherwise disclosed herein, conduit 1200 is the same as, or substantially similar to, any of the conduits disclosed herein. For example, conduit 1200 may include at least one wall portion 1202 that defines at least an inlet 1204, an outlet (not shown), and a passageway 1208. Conduit 1200 also includes a conduit porous material 1210 disposed partially within passageway 1208. Unless otherwise disclosed herein, fluid collection assembly 1240 is the same as, or substantially similar to, any of the fluid collection assemblies disclosed herein. For example, fluid collection assembly 1240 may include a fluid-impermeable barrier 1242 and at least one assembly porous material 1250.
[0100] Conduit porous material 1210 may include a first portion 1234 that extends outwardly from passageway 1208 and a second portion 1235 disposed within passageway 1208. The first portion 1234 may be folded back onto the wall portion 1202 of conduit 1200. For example, the first portion 1234 may be folded back to cover only a portion of the outer surface 1236 of wall portion 1202. Assembly porous material 1250 may be configured to define a notch or otherwise receive and abut the first portion 1234 such that, in response to body fluid being drawn from the first portion 1234 into the second portion 1235, body fluid is drawn from assembly porous material 1250 into the first portion 1234. Hydrogen bonding between water molecules and direct contact between conduit porous material 1210 and assembly porous material 1250 reduce the need to position the inlet 1204 of conduit 1200 at or near a point where the weight measurement of chamber 1246 is expected to be low. The first portion 1234 may also facilitate alignment of conduit 1200 within chamber 1246.
[0101] FIG. 13 is a schematic cross-sectional view of a portion of a fluid collection system 1322 including a conduit 1300 in fluid communication with a fluid collection assembly 1340, according to one embodiment. Unless otherwise disclosed herein, conduit 1300 is the same as, or substantially similar to, any of the conduits disclosed herein. For example, conduit 1300 may include at least one wall portion 1302 that defines at least an inlet 1304, an outlet (not shown), and a passageway 1308. Conduit 1300 also includes a conduit porous material 1310 disposed partially within passageway 1308. Unless otherwise disclosed herein, fluid collection assembly 1340 is the same as, or substantially similar to, any of the fluid collection assemblies disclosed herein. For example, fluid collection assembly 1340 may include a fluid impermeable barrier 1342 that defines a chamber 1346 and at least one assembly porous material 1350 disposed within chamber 1346.
[0102] Conduit porous material 1310 includes a first portion 1334 extending from inlet 1304 and a second portion 1335 disposed within passageway 1308. The first portion 1334 has a shape configured to at least partially or substantially completely occupy a portion of chamber 1346 not occupied by assembly porous material 1350 and the remainder of conduit 1300. In other words, the first portion 1334 may prevent chamber 1346 from forming a reservoir or may inhibit the volume of the reservoir.
[0103] The first portion 1334 may facilitate the flow of body fluid from the assembly porous material 1350 into the passageway 1308 of the conduit 1300. For example, as described above, the hydrogen bonds between water molecules may draw body fluid from the assembly porous material 1350 into the first portion 1334 of the conduit porous material 1350 and then into the second portion 1335 of the conduit porous material 1350. When the chamber 1346 defines a reservoir, at least some of the body fluid may enter the reservoir. The body fluid cannot be removed from the reservoir until the body fluid in the reservoir reaches an amount sufficient to reach the inlet 1304 of the conduit 1300. Thus, it is noted that the presence of the reservoir may inhibit the rapid removal of substantially all of the body fluid from the chamber 1346, but the reservoir may increase the amount of body fluid stored in the chamber 1346. Further, at least substantially occupying the portion of the chamber 1346 that does not include the assembly porous material 1350 by the conduit 1300 inhibits the twisting and / or crushing of such a portion of the chamber 1346 during use of the fluid collection assembly 1340. The hydrogen bonds between water molecules, the direct contact between the conduit porous material 1310 and the assembly porous material 1350, and the reduced volume of any unoccupied portion of the chamber 1346 reduce the need to position the inlet 1304 of the conduit 1300 at or near the point where the weight measurement of the chamber 1346 is expected to be low. The first portion 1334 may also facilitate the alignment of the conduit 1300 in the chamber 1346.
[0104] FIG. 14 is a schematic cross-sectional view of a portion of a fluid collection system 1422 that includes a conduit 1400 in fluid communication with a fluid collection assembly 1440. Unless otherwise disclosed herein, conduit 1400 is the same as or substantially similar to any of the conduits disclosed herein. For example, conduit 1400 may include at least one wall portion 1402 that defines at least an inlet 1404, an outlet (not shown), and a passageway 1408. Conduit 1400 also includes a conduit porous material 1410 disposed partially within passageway 1408. Unless otherwise disclosed herein, fluid collection assembly 1440 is the same as or substantially similar to any of the fluid collection assemblies disclosed herein. For example, fluid collection assembly 1440 may include a fluid-impermeable barrier 1442 that defines a chamber 1446 and at least one assembly porous material 1450 disposed within chamber 1446.
[0105] Conduit 1400 is substantially similar to conduit 600 shown in FIG. 6B. For example, the first portion 1434 of conduit porous material 1410 may include a plurality of discrete regions that form different pathways through which body fluid can flow. Wall portion 1402 may also include a primary branch 1439 and one or more secondary branches 1441 extending therefrom. The plurality of regions of the first portion 1434 enables conduit 1400 to remove body fluid from a plurality of different regions of chamber 1446. This may also inhibit the storage of body fluid in the non-occupied portions of chamber 1446. Hydrogen bonding between water molecules and direct contact between conduit porous material 1410 and assembly porous material 1450 reduce the need to position inlet 1404 of conduit 1400 at or near a point where the weight measurement of chamber 1446 is expected to be low. The plurality of regions may also facilitate the alignment of conduit 1400 within chamber 1446.
[0106] In one embodiment, as shown, chamber 1446 includes reservoir 1460. Reservoir 1460 may include portions that are not substantially occupied between multiple regions of the first portion 1434 of conduit porous material 1410. However, since the multiple regions of the first portion 1434 inhibit storage, the multiple regions facilitate removal of body fluid from reservoir 1460. In one embodiment, assembly porous material 1450 at least partially occupies the space between the multiple regions of the first portion 1434, further inhibiting storage of body fluid in such unoccupied space.
[0107] The conduits disclosed herein can be included in a fluid collection system that includes a male fluid collection assembly configured to receive body fluid from a male (e.g., from the penis). For example, FIG. 15A is an isometric view of a portion of a fluid collection system 1522 that includes a conduit 1500 in fluid communication with a fluid collection assembly 1540, according to one embodiment. FIG. 15B is a schematic cross-sectional view of the fluid collection assembly 1540 along plane 15B-15B shown in FIG. 15A, according to one embodiment. Fluid collection assembly 1540 is an example of a male fluid collection assembly, but in some embodiments, fluid collection assembly 1540 can be used to receive body fluid from a female urethral orifice. Unless otherwise disclosed herein, conduit 1500 is the same as, or substantially similar to, any of the conduits disclosed herein. For example, conduit 1500 can include at least one wall portion 1502 that defines at least an inlet 1504, an outlet (not shown), and a passageway 1508. Conduit 1500 also includes conduit porous material 1510 disposed in passageway 1508. Unless otherwise disclosed herein, fluid collection assembly 1540 is the same as, or substantially similar to, any of the fluid collection assemblies disclosed herein. For example, fluid collection assembly 1540 can include a fluid-impermeable barrier 1542 that defines an opening 1544, a chamber 1546, and a fluid outlet 1548. Fluid collection assembly 1540 can also include at least one assembly porous material 1550 disposed in chamber 1546.
[0108] The fluid collection assembly 1540 includes a sheath 1570 and a base portion 1572. The base portion 1572 is configured to be attached to the sheath 1570 (e.g., permanently attached or configured to be permanently attached). The base portion 1572 is also configured to be attached to an area around the patient's urethral orifice (e.g., the penis).
[0109] The sheath 1570 includes a fluid-impermeable barrier 1542 that is at least partially formed from a first panel 1574 and a second panel 1576. The first panel 1574 and the second panel 1576 can be attached to each other or integrally formed (e.g., exhibit a single-piece construction). In one embodiment, as shown, the first panel 1574 and the second panel 1576 are separate sheets. The fluid-impermeable barrier 1542 defines a chamber 1546 between the first panel 1574 and the second panel 1576, an opening 1544 in the proximal end region 1564 of the sheath 1570, and a fluid outlet 1548 in the distal end region 1562 of the sheath 1570. The sheath 1570 also includes at least one assembly porous material 1550 disposed in the chamber 1546.
[0110] One or more inner surfaces of the fluid-impermeable barrier 1542 (e.g., the inner surfaces of the first and second panels 1574, 1576) at least partially define the chamber 1546 within the fluid collection assembly 1540. The fluid-impermeable barrier 1542 temporarily stores body fluid in the chamber 1546. The fluid-impermeable barrier 1542 can be formed from any of the fluid-impermeable materials disclosed herein. Thus, the fluid-impermeable barrier 1542 substantially prevents body fluid from passing through the fluid-impermeable barrier 1542.
[0111] In one embodiment, at least one of the first panel 1574 or the second panel 1576 is formed from at least partially transparent fluid-impermeable material such as polyethylene, polypropylene, polycarbonate, or polyvinyl chloride. By forming at least one of the first panel 1574 or the second panel 1576 from at least partially transparent fluid-impermeable material, it becomes possible for a person (e.g., a doctor) to examine the penis. In some embodiments, both the first panel 1574 and the second panel 1576 are formed from at least partially transparent fluid-impermeable material. By selecting to form at least one of the first panel 1574 or the second panel 1576 from at least partially transparent impermeable material, it becomes possible to examine the penis without removing the fluid collection assembly 1540 entirely from the area around the penis. For example, the chamber 1546 may include a penis receiving area 1578 configured to receive an individual's penis when the penis extends within the chamber 1546. The penis receiving area 1578 may be defined at least by at least a portion of the assembly porous material 1550 and at least a portion of the at least partially transparent material of the first panel 1574 and / or the second panel 1576. In other words, the assembly porous material 1550 is positioned within the chamber 1546 such that when the penis is inserted into the chamber 1546 through the opening 1544, the assembly porous material 1550 is not positioned between the penis and at least a portion of the transparent portion of the first panel 1574 and / or the second panel 1576. The assembly porous material 1550 is not entirely transparent, and thus the portion of the at least partially transparent material of the first panel 1574 and / or the second panel 1576 that defines the penis receiving area 1578 forms a window that allows a person to look into the penis receiving area 1578 and examine the penis.
[0112] The opening 1544 defined by the fluid-impermeable barrier 1542 provides an entry path for fluid to enter the chamber 1546 when the penis is an embedded penis and allows the penis to enter the chamber 1546 (e.g., the penis receiving area 1578) when the penis is not embedded. The opening 1544 can be defined by the fluid-impermeable barrier 1542 (e.g., the inner edge of the fluid-impermeable barrier 1542). For example, the opening 1544 is formed in and extends through the fluid-impermeable barrier 1542, thereby allowing body fluid to enter the chamber 1546 from the outside of the fluid collection assembly 1540.
[0113] The fluid-impermeable barrier 1542 defines a fluid outlet 1548 sized to receive the conduit 1500. The conduit 1500 can be at least partially disposed within the chamber 1546 or otherwise in fluid communication with the chamber 1546 via the fluid outlet 1548. The fluid outlet 1548 can have a size and shape to form at least a substantially liquid-tight seal with respect to the conduit 1500, thereby substantially preventing body fluid from escaping from the chamber 1546. In one embodiment, the fluid outlet 1548 can be formed from portions of a first panel 1574 and a second panel 1576 that are not attached to or integrally formed with each other. In such an embodiment, the fluid-impermeable barrier 1542 need not include a cap that exhibits greater rigidity than portions of the fluid-impermeable barrier 1542 around it, which can facilitate the manufacture of the fluid collection assembly 1540, can reduce the number of parts used to form the fluid collection assembly 1540, and can reduce the time required to manufacture the fluid collection assembly 1540. It is noted that the absence of a cap can make it difficult to use an interference fit to secure the conduit 1500 to the fluid outlet 1548, but it is still possible to attach the conduit 1500 to the fluid outlet 1548. Thus, the conduit 1500 can be attached to the fluid outlet 1548 (e.g., the first and second panels 1574, 1576) using adhesion, welding, or otherwise joined to the fluid outlet 1548. Attaching the conduit 1500 to the fluid outlet 1548 can prevent leakage and prevent the conduit 1500 from being accidentally separated from the fluid outlet 1548. In one example, the conduit 1500 can be attached to the fluid outlet 1548 in the same manufacturing step that attaches the first and second panels 1574, 1576 to each other.
[0114] As described above, the sheath 1570 includes at least one assembly porous material 1550 disposed in the chamber 1546. The assembly porous material 1550 can deliver body fluid to one or more selected regions of the chamber 1546, such as a region spaced apart from the penis and a region towards the fluid outlet 1548. The assembly porous material 1550 can be formed from any of the porous materials disclosed herein. In one embodiment, the assembly porous material 1550 can be formed from a single layer, two layers (e.g., a fluid permeable membrane and a fluid permeable support extending across the opening 1544, as the fluid permeable membrane can be formed from a material that is relatively easy to fold, thin, or otherwise easily deformable), or three or more layers. In one embodiment, the assembly porous material 1550 can be formed from a non-woven material or a woven material (e.g., spannylon fibers). In one embodiment, the assembly porous material 1550 can include at least one material that is substantially non-absorbent, or at least one absorbent or adsorbent material.
[0115] In one embodiment, the assembly porous material 1550 can be a sheet. Forming the assembly porous material 1550 as a sheet can facilitate the manufacture of the fluid collection assembly 1540. For example, by forming the assembly porous material 1550 as a sheet, each of the first panel 1574, the second panel 1576, and the assembly porous material 1550 can be made into a sheet. During the manufacture of the fluid collection assembly 1540, the first panel 1574, the second panel 1576, and the assembly porous material 1550 can be laminated and then attached to each other in the same manufacturing step. For example, the assembly porous material 1550 can have a shape that is the same size as or, more preferably, slightly smaller than the sizes of the first panel 1574 and the second panel 1576. Thus, by attaching the first panel 1574 and the second panel 1576 to each other along their outer edges, the assembly porous material 1550 can also be attached to the first panel 1574 and the second panel 1576. The assembly porous material 1550 can be slightly smaller than the first panel 1574 and / or the second panel 1576 such that the first panel 1574 and / or the second panel 1576 extends around the assembly porous material 1550 so that the assembly porous material 1550 does not form passages through which body fluid can leak through the fluid-impermeable barrier 1542. Similarly, by attaching the assembly porous material 1550 to the first panel 1574 and / or the second panel 1576, the assembly porous material 1550 can be prevented from moving significantly within the chamber 1546, such as preventing the assembly porous material 1550 from bunching up near the fluid outlet 1548. In one example, the assembly porous material 1550 can be attached (e.g., by adhesion) to the first panel 1574 or the second panel 1576 before or after attaching the first panel 1574 to the second panel 1576. In one example, the assembly porous material 1550 can simply be placed in the chamber 1546 without attaching the assembly porous material 1550 to at least one of the first panel 1574 or the second panel 1576.In one embodiment, the assembly porous material 1550 can exhibit a shape other than a sheet, such as a hollow and generally cylindrical shape.
[0116] Generally, when the penis is not in the penile receiving area 1578 and the sheath 1570 is placed on a flat surface, the sheath 1570 is substantially flat. The fluid-impermeable barrier 1542 is formed from the first panel 1574 and the second panel 1576 rather than from an overall cylindrical fluid-impermeable barrier, so the sheath 1570 is substantially flat. Further, as described above, the assembly porous material 1550 can be a sheet, which also makes the sheath 1570 substantially flat. The fluid collection assembly 1540 need not include a relatively rigid ring or cap that exhibits greater rigidity than the surrounding portion of the fluid-impermeable barrier 1542, because such a ring or cap can sometimes prevent the sheath 1570 from being substantially flat. Although the sheath 1570 has been described as being substantially flat, it is noted that, depending on the thickness of the assembly porous material 1550, the assembly porous material 1550 can cause a slight bulge to form in the sheath 1570, the fluid outlet 1548 and / or the conduit 1500 can cause a bulge around it, or the base portion 1572 can pull on the surrounding portion of the sheath 1570, at least one of these being the case. It is also noted that the sheath 1570 is flexible, and thus the sheath 1570 can sometimes not be substantially flat during use, because during use, the sheath 1570 can be placed on a non-flat surface (for example, it can be placed between the testicles, perineum, and / or thighs), and the sheath 1570 can conform to the surfaces of these shapes.
[0117] The performance of the sheath 1570, which is substantially flat when the penis is absent from the penile receiving area 1578 and the sheath 1570 is placed on a flat surface, enables the fluid collection assembly 1540 to be used with both an implanted penis and a non-implanted penis. For example, when the fluid collection assembly 1540 is being used with an implanted penis, the penis does not extend into the penile receiving area 1578, whereby the sheath 1570 assumes a relatively flat state across the aperture 1580 of the base portion 1572. When the sheath 1570 is in a relatively flat state across the aperture 1580, the assembly porous material 1550 extends across the opening 1544 and the aperture 1580 and is in close proximity to the implanted penis. Thus, the assembly porous material 1550 prevents or inhibits the pooling of body fluids discharged from the implanted penis against the individual's skin, because the assembly porous material 1550 receives and removes at least a majority of the body fluids that would otherwise pool against the individual's skin. Accordingly, the individual's skin remains dry, thereby improving the comfort of using the fluid collection assembly 1540 and preventing skin degradation. However, unlike other conventional fluid collection assemblies configured to be used with an implanted penis, the fluid collection assembly 1540 can still be used with a non-implanted penis because the non-implanted penis can still be received within the penile receiving area 1578 even when the penis is fully erect. Additionally, the performance of the sheath 1570 being substantially flat enables the fluid collection assembly 1540 to be used more discretely than if the sheath 1570 were not substantially flat, thereby avoiding potentially cumbersome situations.
[0118] When the sheath 1570 is substantially flat, the assembly porous material 1550 occupies substantially all of the chamber 1546, and the penile receiving area 1578 is collapsed (for illustrative purposes of showing the penile receiving area 1578, it is shown in FIG. 15B in an uncollapsed state). In other words, the sheath 1570 need not define an area that is not always occupied by the assembly porous material 1550. When the assembly porous material 1550 occupies substantially all of the chamber 1546, there is no likelihood of long-term retention of body fluid discharged into the chamber 1546, because retention of body fluid can pose a hygiene problem, can cause an unpleasant odor, and / or can leave the individual's skin in contact with the body fluid, resulting in discomfort and skin deterioration.
[0119] As described above, the first panel 1574, the second panel 1576, and the assembly porous material 1550 can be selected to have relatively high flexibility. When the first panel 1574, the second panel 1576, and the assembly porous material 1550 cannot maintain their shapes when not supported respectively, the first panel 1574, the second panel 1576, and the assembly porous material 1550 have relatively high flexibility. As described above, the high flexibility of the first panel 1574, the second panel 1576, and the assembly porous material 1550 can enable the sheath 1570 to be substantially flat. The high flexibility of the first panel 1574, the second panel 1576, and the assembly porous material 1550 can also enable the sheath 1570 to conform to the shape of the penis even when the size and shape of the penis change (e.g., when erect), minimizing any unoccupied space within the chamber 1546 where body fluid can be retained.
[0120] As described above, the fluid collection assembly 1540 includes a base portion 1572 configured to be attached to the sheath 1570. For example, the base portion 1572 is configured to be permanently attached to the sheath 1570. For example, the base portion 1572 is configured to be permanently attached to the sheath 1570 when the fluid collection assembly 1540 includes the base portion 1572 permanently attached to the sheath 1570, or the base portion 1572 is not provided in a permanently attached state to the sheath 1570 but is configured to be permanently attached to the sheath 1570 at a future point in time. Permanently attached means that the sheath 1570 cannot be separated from the base portion 1572 without damaging at least one of the sheath 1570 or the base portion 1572 using a blade to separate the sheath 1570 from the base portion 1572 and / or using a chemical to dissolve the adhesive attaching the sheath 1570. The base portion 1572 can be permanently attached to the sheath 1570 using an adhesive, sewing, heat sealing, RF welding, or US welding. In one embodiment, the base portion 1572 is configured to be reversibly attached to the sheath 1570. In one embodiment, the base portion 1572 is integrally formed with the sheath 1570.
[0121] As described above, the base portion 1572 includes an aperture 1580. The base portion 1572 is permanently attached to the first end region 120 of the sheath 1570 such that the aperture 1580 is aligned with the opening 1544.
[0122] The base portion 1572 is coupled to the skin that surrounds the penis (e.g., the mons pubis, thighs, testicles, and / or perineum), has a size and shape such that the penis is disposed therein, and is made of such a material. For example, the base portion 1572 may define an aperture 1580 configured such that the penis is positioned therethrough. In one embodiment, the base portion 1572 may present the overall shape or contour of the skin surface to which the base portion 1572 is coupled. The base portion 1572 may have high flexibility, thereby enabling the base portion 1572 to conform to any shape of the skin surface and relieving the tension of the skin surface by the base portion 1572. The base portion 1572 may extend laterally beyond the sheath 1570, thereby increasing the surface area of the skin of the individual to which the fluid collection assembly 1540 can be attached as compared to a substantially similar fluid collection assembly 1540 that does not include the base portion.
[0123] As described above, the fluid collection assembly 1540 includes a conduit 1500. The conduit 1500 can be the same as or substantially similar to any of the conduits disclosed herein. For example, the conduit 1500 includes a conduit porous material 1510 disposed in a passage 1508. The conduit porous material 1510 can be separate from the assembly porous material 1550 (as shown), or can be integrally formed with the assembly porous material 1550 (as shown in FIGS. 10 and 17).
[0124] The inlet 1504 of the conduit 1500 can be located near the distal end region 1562 of the sheath 1570 that is expected to be the gravimetrically lower point of the chamber 1546 when worn by the patient. By positioning the inlet 1504 at or near the distal end region 1562 of the sheath 1570, the conduit 1500 can receive and store more body fluid than when the inlet of the conduit 1500 is located elsewhere, reducing the possibility of storage (e.g., storage of body fluid can cause bacterial growth and bad odor).
[0125] The conduit 1500 is shown as extending from the distal end region 1562 of the sheath 1570 in a direction generally parallel to the longitudinal axis of the sheath 1570 when the sheath 1570 is placed on a flat surface. However, due to the high flexibility of the conduit 1500, the conduit 1500 may extend from the distal end region 1562 at an angle that is not generally parallel to the longitudinal axis of the sheath 1570. For example, FIG. 16 is a schematic cross-sectional view of a portion of a fluid collection system 1622 that includes a conduit 1600 in fluid communication with a fluid collection assembly 1640, according to one embodiment. Unless otherwise disclosed herein, the conduit 1600 and the fluid collection assembly 1640 are each identical or substantially similar to any of the conduits and fluid collection assemblies disclosed herein. The fluid collection assembly 1640 includes a sheath 1670, and a fluid outlet 1648 is defined at or near the distal end region 1662 of the sheath 1670. The fluid outlet 1648 is configured to allow the conduit 1600 to extend from the sheath 1670 in a direction that is not parallel to the longitudinal axis 1612 of the sheath 1670 when the sheath 1670 is placed on a flat surface (e.g., a perpendicular or diagonal direction). For example, the fluid outlet 1648 may include at least one wall portion 1682 configured to abut the conduit 1600. The wall portion 1682 may extend from the remainder of the sheath 1670 in a direction that is not parallel to the longitudinal axis 1612 of the sheath 1670, thereby causing the conduit 1600 to extend from the sheath 1670 in a similar direction. Since the conduit 1600 may be bent for the reasons already disclosed herein, the conduit 1600 may extend from the sheath 1670 in a direction that is not parallel to the longitudinal axis of the sheath 1670.
[0126] The fluid-impermeable barrier of the male fluid collection assembly disclosed herein can form at least a portion of the wall of the conduit attached thereto (e.g., define at least a portion of the passageway). For example, FIG. 17 is a schematic cross-sectional view of a portion of a fluid collection system 1722 that includes a conduit 1700 in fluid communication with a fluid collection assembly 1740, according to one embodiment. Unless otherwise disclosed herein, conduit 1700 and fluid collection assembly 1740 are each identical or substantially similar to any of the conduits and fluid collection assemblies disclosed herein. It is noted that FIGS. 15B through 16 are schematic side cross-sectional views of at least a portion of the fluid collection system, while FIG. 17 is a schematic top cross-sectional view of a portion of fluid collection system 1722.
[0127] Similar to the fluid collection system 922 shown in FIG. 9, conduit 1700 extends along at least a portion of fluid-impermeable barrier 1742. Conduit 1700 can extend along lateral side 1784 of fluid collection assembly 1740 to prevent the weight of conduit 1700 from bearing on the patient's penis, which can increase patient discomfort. In one embodiment (not shown), conduit 1700 is separate from fluid-impermeable barrier 1742 and is attached to fluid-impermeable barrier 1742. In one embodiment, fluid-impermeable barrier 1742 forms at least a portion (e.g., all) of wall 1702 of conduit 1700 and defines at least a portion of passageway 1708. In such an embodiment, conduit 1700 can be defined by at least one inner wall 1702a and at least one outer wall 1702b. In one example, one of the inner or outer walls 1702a, 1702b is separate from fluid-impermeable barrier 1742. In such an example, the inner or outer wall 1702a, 1702b separate from fluid-impermeable barrier 1742 can be formed from at least one fluid-impermeable layer attached to fluid-impermeable barrier 1742.
[0128] Similar to the fluid collection system 1022 shown in FIG. 10, at least a portion of the conduit porous material 1710 and the assembly porous material 1750 are integrally formed with each other (e.g., exhibit a single-piece construction). For example, at least a portion of the conduit porous material 1710 and the assembly porous material 1750 can be formed from the same sheet with a notch or a portion removed, allowing a portion of the wall 1702 and / or the fluid impermeable barrier 1742 to be formed between a portion of the conduit porous material 1710 and the assembly porous material 1750.
[0129] The male fluid collection assembly disclosed herein can be used with a conduit that includes a portion of the conduit porous material extending from its inlet. For example, FIG. 18 is a schematic cross-sectional view of a portion of a fluid collection system 1822 that includes a conduit 1800 in fluid communication with a fluid collection assembly 1840, according to one embodiment. Unless otherwise disclosed herein, the conduit 1800 and the fluid collection assembly 1840 are each the same as, or substantially similar to, any of the conduits and fluid collection assemblies disclosed herein. The conduit 1800 includes a conduit porous material 1810 that includes a first portion 1834 and a second portion 1835. At least a portion of the first portion 1834 extends outwardly from the passage 1808 (e.g., from the inlet 1804), and at least a portion of the second portion 1835 is disposed in the passage 1808. In one embodiment, the first portion 1834 can be folded back, which can prevent the conduit 1800 from collapsing at or near the inlet 1804, as described above. The conduit porous material 1810 can abut the assembly porous material 1850 and facilitate the drawing of body fluid from the assembly porous material 1850 to the conduit porous material 1810 via hydrogen bonding. The conduit porous material 1810 can prevent the twisting and / or collapsing of the chamber 1846, facilitate the alignment of the conduit 1800, and, as described above, reduce the need to have the inlet 1804 of the conduit 1800 located at or near a point where the weight measurement of the chamber 1846 is expected to be low.
[0130] FIG. 19 is a schematic cross-sectional view of a portion of a fluid collection system 1922 that includes a conduit 1900 in fluid communication with a fluid collection assembly 1940, according to one embodiment. Unless otherwise disclosed herein, conduit 1900 and fluid collection assembly 1940 are each identical or substantially similar to any of the conduits and fluid collection assemblies disclosed herein. Conduit 1900 includes a conduit porous material 1910 that includes a first portion 1934 and a second portion 1935. At least a portion of the first portion 1934 extends outwardly from passageway 1908, and at least a portion of the second portion 1935 is disposed in passageway 1908. The first portion 1934 may be configured to substantially occupy a portion of chamber 1946 near the inlet 1904 of conduit 1900. For example, the first portion 1934 may be configured to substantially occupy a portion of chamber 1946 that is not occupied by assembly porous material 1950 or that forms a portion of penile receiving area 1978. The conduit porous material 1910 may inhibit twisting and / or crushing of chamber 1946, facilitate alignment of conduit 1900, and, as described above, reduce the need to have an inlet 1904 of conduit 1900 positioned at or near a point where the weight measurement of chamber 1946 is expected to be low.
[0131] FIG. 20 is a schematic cross-sectional view of a portion of a fluid collection system 2022 including a conduit 2000 in fluid communication with a fluid collection assembly 2040, according to one embodiment. Unless otherwise disclosed herein, conduit 2000 and fluid collection assembly 2040 are each the same as or substantially similar to any of the conduits and fluid collection assemblies disclosed herein. Conduit 2000 includes a conduit porous material 2010 that includes a first portion 2034 and a second portion 2035. At least a portion of the first portion 2034 extends outwardly from passageway 2008, and at least a portion of the second portion 2035 is disposed within passageway 2008. The first portion 2034 may include a plurality of regions. The wall 2002 of conduit 2000 may also include a primary branch 2039 and one or more secondary branches 2041 extending from primary branch 2039. The plurality of regions 2034 may enable conduit 2000 to receive body fluid from a plurality of different locations in chamber 2046. In one embodiment, the plurality of regions 2034 may extend sufficiently within chamber 2046 such that the plurality of regions surround any penile side disposed within chamber 2046. In such an embodiment, the plurality of regions 2034 may increase the likelihood that body fluid discharged from the penis is directly received by conduit porous material 2010, which may enable the assembly porous material 2050 to be omitted from fluid collection assembly 2040. Conduit porous material 2010 may inhibit twisting and / or crushing of chamber 2046, facilitate alignment of conduit 2000, and, as described above, reduce the need to have an inlet 2004 of conduit 2000 positioned at or near a point where the weight measurement of chamber 2046 is expected to be low.
[0132] The tubing disclosed herein can be used with fluid collection assemblies other than the fluid collection assemblies shown in FIGS. 7A through 20. For example, the tubing disclosed herein can be used with a Foley catheter, a condom-type male catheter, or a wound dressing. Other examples of fluid collection assemblies to which the tubing disclosed herein can be attached are disclosed in U.S. Patent Application No. 16 / 433,773, filed Jun. 6, 2019, the disclosure of which is hereby incorporated by reference in its entirety. It is also noted that at least some of the fluid collection assemblies can be used for wound treatment to receive one or more body fluids (e.g., blood, etc.) from a wound.
[0133] FIG. 21 is a block diagram of a fluid collection system 2122 for fluid collection, according to one embodiment. The system 2122 includes a fluid collection assembly 2140, a fluid storage container 2190, and a vacuum source 2192. The fluid collection assembly 2140, the fluid storage container 2190, and the vacuum source 2192 can be fluidly coupled to each other via one or more tubing. For example, as shown, the tubing can include a first tubing 2194a extending from the fluid collection assembly 2140 to the fluid storage container 2190 and a second tubing 2194b extending from the fluid storage container 2190 to the vacuum source 2192.
[0134] In one embodiment, the first tubing 2194a includes at least one tubing porous material. In one example, the tubing porous material can be disposed throughout the first tubing 2194a (e.g., extending from the inlet or near the inlet of the first tubing 2194a to the outlet or near the outlet of the first tubing 2194a). In one example, the tubing porous material can be disposed only in a portion of the first tubing 2194a. In one embodiment, the second tubing 2194b includes at least one tubing porous material. Similar to the first tubing 2194a, the tubing porous material of the second tubing 2194b can be disposed throughout the second tubing 2194b or only in a portion of the second tubing 2194b. In one embodiment, one of the first or second tubings 2194a, 2194b can include a hollow tubing.
[0135] In one embodiment, the fluid collection system 2122 may include at least one hollow conduit (not shown) in addition to the first conduit 2194a and / or the second conduit 2194b. In one example, the first conduit 2194a may be in direct fluid communication with the fluid collection assembly 2140 and may extend from the fluid collection assembly 2140 for only a portion of the distance between the fluid collection assembly 2140 and the fluid storage container 2190. Thus, the fluid collection system 2122 may include a hollow conduit extending from the first conduit 2194a to the fluid storage container 2190 that is connected to the outlet of the first conduit 2194a.
[0136] The fluid collection assembly 2140 may be similar or identical to any of the fluid collection assemblies disclosed herein in one or more aspects. The fluid collection assembly 2140 may have a shape and size such that it is positioned adjacent to a female urethral orifice or such that a male urethral orifice is positioned therethrough (e.g., such that it receives a penis therein). For example, the fluid collection assembly 2140 may include a fluid-impermeable barrier that at least partially defines a chamber (e.g., an internal region) of the fluid collection assembly 2140. The fluid-impermeable barrier also defines at least one opening that extends therethrough from the external environment. The opening may be positioned adjacent to a female urethral orifice or such that a male urethral orifice is positioned therethrough. The fluid collection assembly 2140 may include a porous material disposed in the chamber, such as one or more of a fluid-permeable support and a fluid-permeable membrane. The fluid collection assembly 2140 includes one or more of any of the fixators disclosed herein.
[0137] The fluid storage container 2190 has a size and shape such that it holds body fluid therein. The fluid storage container 2190 can include a bag (e.g., a drainage bag), a bottle or cup (e.g., a collection jar), or any other sealed container for storing body fluid such as urine. In some embodiments, the first conduit 2194a can extend from the fluid collection assembly 2140 and can be attached to the fluid storage container 2190 at a first point of the fluid storage container 2190. The second conduit 2194b can be attached to the fluid storage container 2190 at a second point on the fluid storage container 2190 and can extend to and be attached to the vacuum source 2192. Thus, a vacuum (e.g., suction) can be drawn through the fluid collection assembly 2140 via the fluid storage container 2190. Fluid such as urine can be discharged from the fluid collection assembly 2140 using the vacuum source 2192.
[0138] The vacuum source 2192 can include one or more of a manual vacuum pump, an electric vacuum pump, a diaphragm pump, a centrifugal pump, a displacement pump, a magnetic drive pump, a peristaltic pump, or any pump configured to create a vacuum. The vacuum source 2192 can provide a vacuum or suction to remove fluid from the fluid collection assembly 2140. In some embodiments, the vacuum source 2192 can be powered by one or more of a power cord (e.g., one connected to a power socket), one or more batteries, or manual power (e.g., a manually operated vacuum pump). In some embodiments, the vacuum source 2192 can have a size and shape that fits outside of, on, or within the fluid collection assembly 2140. For example, the vacuum source 2192 can include one or more small pumps or one or more micropumps. The vacuum source 2192 can include one or more of a switch, a button, a plug, a remote controller, or any other device suitable for operating the vacuum source 2192.
[0139] Although various aspects and embodiments have been disclosed in this specification, other aspects and embodiments are contemplated. The various aspects and embodiments disclosed in this specification are for purposes of illustration and not intended to be limiting.
[0140] Terms indicating degree (e.g., "about," "substantially," "wholly," etc.) indicate variations that are not structurally or functionally critical. In one example, when a term indicating degree is included with a term indicating quantity, the term indicating degree is interpreted to mean ±10%, ±5%, or +2% of the term indicating quantity. In one example, when a term indicating degree is used to modify a shape, the term indicating degree indicates that the shape modified by the term indicating degree has the appearance of the disclosed shape. For example, the term indicating degree can be used to indicate that the shape may have rounded corners instead of sharp corners, may have curved edges instead of straight edges, one or more protrusions extending therefrom are oval in shape, is the same as the disclosed shape, and the like.
Claims
1. 1. A conduit for use in a fluid collection system for collecting one or more bodily fluids, comprising: At least one wall portion, the wall portion having at least The entrance and The exit, a passageway extending from the inlet to the outlet; At least one wall at least partially defining at least one conduit porous material disposed in at least a portion of the passageway, the at least one conduit porous material extending from at least at or near the inlet to at or near the outlet and defining at least one of a central gap in a center of the at least one conduit porous material or an outer gap between opposing edges of the at least one conduit porous material; A pipeline comprising:
2. 10. The conduit of claim 1, wherein the at least one wall comprises polyvinyl chloride.
3. 10. The conduit of claim 1, wherein the at least one wall is formed from a film.
4. 10. The conduit of claim 1, wherein the at least one conduit porous material comprises spun nylon.
5. 2. The conduit of claim 1, wherein said at least one conduit porous material is disposed only in said passageway.
6. 2. The conduit of claim 1, wherein the at least one conduit porous material includes a first portion and a second portion, at least a portion of the first portion not disposed in the passageway, and at least a portion of the second portion disposed in the passageway.
7. 7. The conduit of claim 6, wherein the first portion is generally hemispherical or bulb shaped.
8. 7. A conduit according to claim 6, wherein said first portion presents a maximum lateral dimension which is greater than a maximum lateral dimension of said at least one wall.
9. 7. The conduit of claim 6, wherein the first portion includes a plurality of regions that define different and separate flow paths for the one or more bodily fluids to flow.
10. 10. The conduit of claim 9, wherein the at least one wall portion includes a primary branch and one or more secondary branches, the passages of the primary branch including at least a portion of the second portion of the at least one conduit porous material disposed therein, the passages of the one or more secondary branches including portions of one or more regions of the first portion of the at least one conduit porous material disposed therein, and each of the one or more secondary branches defining the inlet.
11. 10. The conduit of claim 1, wherein at least a portion of the at least one conduit porous material comprises a rolled sheet.
12. 10. The conduit of claim 1, wherein at least a portion of said at least one conduit porous material has a generally circular cross-sectional shape.
13. 2. The conduit of claim 1, wherein the conduit is capable of exhibiting bends therein exhibiting a mean radius of curvature of about 2 cm without kinking.
14. 1. A fluid collection system comprising:
1. A fluid collection assembly comprising: a fluid impermeable barrier defining at least a chamber, at least one opening, and a fluid outlet; At least one assembly porous material disposed in the chamber; a fluid collection assembly including: a conduit in fluid communication with the chamber, At least one wall portion, the wall portion having at least The entrance and The exit, a passageway extending from the inlet to the outlet; At least one wall at least partially defining at least one conduit porous material separate from the at least one assembly porous material, the at least one conduit porous material disposed in at least a portion of the passageway, the at least one conduit porous material extending from at least at or near the inlet to at or near the outlet, and defining at least one of a central gap in a center of the at least one conduit porous material or an outer gap between opposing edges of the at least one conduit porous material; A pipeline including 1. A fluid collection system comprising:
15. 15. The fluid collection system of claim 14, wherein the fluid-impermeable barrier defines a reservoir, the inlet of the conduit is positioned adjacent to the reservoir, and the conduit extends through the fluid outlet.
16. 16. The fluid collection system of claim 15, wherein the fluid-impermeable barrier includes a distal end region and a proximal end region opposite the distal end region, the reservoir is defined at least in part by the distal end region of the fluid-impermeable barrier, and the fluid outlet is at or near the distal end region of the fluid-impermeable barrier.
17. 15. The fluid collection system of claim 14, wherein the conduit occupies substantially all of the chamber not occupied by the at least one assembly porous material.
18. 15. The fluid collection system of claim 14, wherein the fluid-impermeable barrier defines a reservoir, the fluid-impermeable barrier including a distal end region and a proximal end region opposite the distal end region, the reservoir being defined at least in part by the distal end region of the fluid-impermeable barrier, and the fluid outlet is at the proximal end region of the fluid-impermeable barrier.
19. 15. The fluid collection system of claim 14, wherein the fluid impermeable barrier extends along a longitudinal axis and the conduit extends from the fluid outlet generally parallel to the longitudinal axis.
20. 15. The fluid collection system of claim 14, wherein the fluid impermeable barrier extends along a longitudinal axis and the conduit extends from the fluid outlet at an angle that is not generally parallel to the longitudinal axis.
21. 15. The fluid collection system of claim 14, wherein the fluid impermeable barrier of the fluid collection assembly forms at least a portion of the at least one wall of the conduit.
22. 15. The fluid collection system of claim 14, wherein the conduit extends along at least one lateral surface of the fluid impermeable barrier.
23. 15. The fluid collection system of claim 14, further comprising an adapter, the adapter including a line segment adapted to be attached to the inlet of the line.
24. 2. The pipeline of claim 1, The at least one conduit porous material defines both the central gap and the outer gap.
25. 25. A conduit according to claim 24, The conduit porous material is a rolled sheet of material disposed within the hollow conduit.
26. 26. A conduit according to claim 25, The outer gap has an outwardly expanding sector-like cross section and the central gap has a circular cross section.
27. 27. The conduit of claim 26, The center gap and the outer gap are directly connected,pipe.
28. 27. The conduit of claim 26, A conduit in which the center gap and the outer gap are not directly connected.
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