Fluid collection device with catheter comprising drainage holder

Abstract

Embodiments of the present disclosure include a fluid collection device including a fluid impermeable barrier defining at least a chamber, at least one opening, and a fluid outlet. The fluid collection device also includes a porous material disposed within the chamber, and a conduit in fluid communication with the chamber. The conduit has at least one tube wall at least partially defining an inlet, an outlet, and a passage extending from the inlet to the outlet. The catheter is provided with a drainage retainer for preventing clogging of the channel. The catheter may be configured for use in a fluid collection system to collect one or more bodily fluids (e.g., urine, amniotic fluid, blood, etc.

Description

Technical Background Patients may experience limited or impaired mobility, making the routine process of urination difficult or impossible. For example, patients may have mobility issues due to surgery or disability. Alternatively, patients may be in situations that restrict their movement, such as those faced by pilots, drivers, and workers in hazardous areas. Furthermore, fluid collection may be necessary for disease monitoring or clinical testing.

[0002] Bedpans and catheters, such as Foley catheters, can be used to address some of the aforementioned situations. However, both bedpans and catheters present several problems. For example, bedpans can cause patient discomfort, spills, and other hygiene issues. Catheters can cause discomfort, pain, and may lead to urinary tract infections. Furthermore, catheters used with urinary catheters are prone to bending and collapse.

[0003] Therefore, users and manufacturers of fluid collection components are constantly seeking new and improved urine collection devices, systems and methods. Summary of the Invention

[0004] Embodiments of this disclosure include: a catheter provided with a drainage retainer for preventing catheter blockage, a fluid collection assembly and system including the catheter, and methods of using and manufacturing thereof. In one embodiment, a fluid collection device for collecting one or more bodily fluids is disclosed. The fluid collection device may include a fluid-impermeable barrier defining at least a chamber, at least one opening, and a fluid outlet. The fluid collection device may also include a porous material disposed within the chamber, and a catheter in fluid communication with the chamber. The catheter includes at least one wall that at least partially defines an inlet, an outlet, and a channel extending from the inlet to the outlet. The catheter is also provided with a drainage retainer for preventing blockage of the channel.

[0005] In one embodiment, a fluid collection system is disclosed. The fluid collection system includes a fluid collection device. The fluid collection system also includes a fluid storage container configured to contain fluid, and a conduit for collecting one or more bodily fluids from the fluid collection device within the fluid collection system. The conduit includes at least one wall defining at least a partially defined inlet, an outlet, and a channel extending from the inlet to the outlet. The inlet is provided with a drainage retainer to prevent blockage of the channel. The fluid collection system also includes a vacuum source fluidly connected via the conduit to the fluid storage container and / or the fluid collection device, the vacuum source being configured to draw fluid from the fluid collection device to the fluid storage container via the conduit.

[0006] In one embodiment, a fluid collection method may include placing a fluid collection device at least adjacent to a user's urethra. The fluid collection device may include a fluid-impermeable barrier defining at least a chamber, at least one opening, and a fluid outlet. The fluid collection device may also include a porous material disposed within the chamber, and a catheter disposed within the chamber for collecting one or more bodily fluids. In some embodiments, the catheter may include at least one wall defining at least a partial inlet, an outlet, and a channel extending from the inlet to the outlet, wherein the inlet is provided with a drainage retainer to prevent blockage of the channel. The method may further include receiving fluid discharged by a user in the fluid collection device and receiving fluid discharged from the fluid collection device in a fluid collection container.

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

[0008] The accompanying drawings illustrate several embodiments of this disclosure, wherein the same reference numerals denote the same or similar parts or features in different views or embodiments of the drawings.

[0009] Figure 1A A side view of a fluid collection device according to an embodiment; Figure 1B According to one embodiment, along Figure 1A A cross-sectional schematic diagram of the fluid collection device taken from plane 1B-1B; Figure 1C According to one embodiment, along Figure 1A A cross-sectional schematic diagram of the fluid collection assembly taken from plane 1B-1B; Figure 2 This is a schematic cross-sectional view of a catheter according to one embodiment; Figures 3A to 3G This is a schematic cross-sectional view of various catheters taken along a plane parallel to the longitudinal axis of the catheter, according to different embodiments; Figure 3H According to one embodiment, along perpendicular to Figure 3G A schematic cross-sectional view of the catheter taken from a plane along its longitudinal axis. Figure 3I This is a schematic cross-sectional view of a catheter taken along a plane parallel to the longitudinal axis of the catheter, according to one embodiment. Figures 4A to 4C This is a schematic cross-sectional view of various catheters taken along a plane parallel to the longitudinal axis of the catheter, according to different embodiments; Figure 5This is a block diagram of a fluid collection system for fluid collection according to an embodiment; Figure 6 This is a flowchart of a fluid collection method according to an embodiment. Detailed Implementation

[0010] Embodiments of this disclosure include a fluid collection assembly and apparatus having a conduit, the conduit including at least one wall defining an inlet, an outlet, and a channel extending from the inlet to the outlet. The conduit may include a drainage retainer configured to prevent blockage of the channel. Embodiments also include a fluid collection system including the fluid collection assembly, and methods of using and manufacturing thereof. An exemplary assembly includes a conduit having at least partially defining an inlet and outlet, an outlet downstream of the inlet, and at least one wall defining a channel extending from the inlet to the outlet. The conduit also includes a drainage retainer configured to prevent blockage of the channel. The drainage retainer may be at least partially defined by the inlet and may extend along at least a portion of the length of the conduit from the inlet to the outlet. The conduit and assembly may be configured for use in a fluid collection system to collect one or more bodily fluids (e.g., urine, amniotic fluid, blood, etc.).

[0011] The fluid collection system may include a fluid collection assembly configured to receive one or more bodily fluids from a patient. The catheter may be in fluid communication with both the fluid collection assembly and a vacuum source, such that negative pressure applied to the catheter by the vacuum source can drain the bodily fluid from the fluid collection assembly. A drainage retainer disposed within the catheter is configured to prevent the catheter from being blocked or obstructed, for example, by preventing the catheter inlet from adhering to an internal non-fluid permeable membrane, or by preventing the catheter from collapsing when negative pressure is applied, both of which would impede the drainage of bodily fluid from the fluid collection assembly.

[0012] The inclusion of a drainage retainer in the tubing represents an improvement over tubing without this feature. Tubing without a drainage retainer may have an inlet that is flush with the inner surface of the fluid collection assembly, thus hindering fluid entry into the tubing. In some examples, fluid collection systems including a vacuum source, without a drainage retainer, will lose negative pressure suction and cause vacuum failure. Furthermore, vacuum failure or channel blockage can cause the fluid collection assembly to overfill, leading to leakage and / or spillage.

[0013] The conduit is configured to prevent collapse by preventing channel blockage. Furthermore, the conduit may be made of at least one material having a Young's modulus (e.g., elastic modulus) and / or wall thickness that prevents collapse under negative pressure. For example, the conduit may be made of transparent polyvinyl chloride with a wall thickness (e.g., measured along the diameter) greater than about 1.5 mm. It should be noted that even when the conduit is used in a fluid collection system that does not include a vacuum source, it may be made of the same material and / or have the same wall thickness to prevent blockage when using a gravity drainage system or other suitable drainage system.

[0014] The drainage retainer may have at least one or more openings configured to prevent catheter blockage. In some examples, the opening may employ a unique structural design, and / or additional components may be added to or connected to the catheter to ensure fluid flow. Poor fluid flow can cause numerous problems. For example, as mentioned earlier, blockage can damage the vacuum device and cause leakage. Furthermore, ensuring proper fluid flow through the drainage retainer allows for the manufacture of smaller, more discreet fluid collection assemblies. In one example, restricted or blocked fluid flow can make it difficult for the fluid collection assembly to fit snugly around the urethral opening of a patient (e.g., a user of the fluid collection assembly). For example, the catheter may be at least partially disposed within the fluid collection assembly. The fluid collection assembly can be bent to fit the shape of the urethral opening, thereby minimizing leakage of bodily fluids from the assembly. However, blockage or restricted fluid flow within the channel reduces vacuum suction and forces the user to bend, straighten, or otherwise adjust the fluid collection assembly to address the problem, resulting in a poorer fit.

[0015] As described above, catheters including a drainage retainer disposed within the channel can solve at least some of the problems associated with hollow catheters. Therefore, the catheters and drainage retainers disclosed herein can be made of materials with a Young's modulus lower than and / or a wall thickness less than that of conventional hollow catheters. The lower Young's modulus and / or thinner wall thickness of the catheters described herein allow them to have superior flexibility compared to conventional hollow catheters. Furthermore, compared to catheters without a drainage retainer, even with the appropriate shape and structure, the catheters of this disclosure provide support for the drainage retainer, thereby preventing channel blockage.

[0016] Figure 1A This is a partial perspective view of a fluid collection system 122 according to an embodiment, which includes a fluid collection assembly 140 in fluid communication with a conduit 100. Figure 1B According to one embodiment, along Figure 1AThe diagram shows a cross-sectional view of a fluid collection assembly 140 taken along plane 1B-1B. The fluid collection assembly 140 is an example of a fluid collection device for receiving and collecting bodily fluids from a woman or man. The fluid collection assembly 140 includes a fluid-impermeable barrier 142 that defines at least an opening 144, a chamber 146, and a fluid outlet 148. The fluid collection assembly 140 also includes at least one porous material 150 disposed within the chamber 146. A conduit 100 is disposed through the fluid outlet 148 such that the inlet 104 of the conduit 100 is located within the chamber 146. Unless otherwise stated herein, the conduit 100 may be identical or substantially similar to any conduit disclosed herein.

[0017] A fluid-impermeable barrier 142 at least partially defines a chamber 146 (e.g., an internal region) and an opening 144. For example, the inner surface 152 of the fluid-impermeable barrier 142 at least partially defines the chamber 146 within the fluid collection assembly 140. The fluid-impermeable barrier 142 temporarily stores bodily fluids within the chamber 146. The fluid-impermeable barrier 142 can be made of any suitable fluid-impermeable material, such as fluid-impermeable polymers (e.g., silicone rubber, polypropylene, polyethylene, polyethylene terephthalate, neoprene rubber, polycarbonate, etc.), metal films, natural rubber, other suitable materials, any other fluid-impermeable materials disclosed herein, or combinations thereof. Thus, the fluid-impermeable barrier 142 substantially prevents bodily fluids from penetrating. In one example, the fluid-impermeable barrier 142 may be permeable to air but impermeable to liquid. In such examples, the fluid-impermeable barrier 142 may be made of a hydrophobic material forming multiple micropores. At least one or more areas of the outer surface 154 of the fluid impermeable barrier 142 may be made of a soft and / or smooth material, thereby reducing frictional discomfort.

[0018] In some examples, the fluid-impermeable barrier 142 may be tubular (openings omitted), such as generally cylindrical (as shown), oblong, prismatic, or flattened tubular. During use, the outer surface 154 of the fluid-impermeable barrier 142 may come into contact with the patient. The size and shape of the fluid-impermeable barrier 142 may be configured to fit the gluteal cleft region between the labia and / or between the legs of a female user.

[0019] Opening 144 provides an inflow passage for fluid to enter chamber 146. Opening 144 may be defined by a fluid-impermeable barrier 142, for example, by the inner edge of the fluid-impermeable barrier 142. For example, opening 144 is formed in the fluid-impermeable barrier 142 and extends from the outer surface 154 to the inner surface 152, thereby allowing bodily fluid to enter chamber 146 from outside the fluid collection assembly 140. Opening 144 may be an elongated orifice on the fluid-impermeable barrier 142. For example, opening 144 may be defined as a cut in the fluid-impermeable barrier 142. The location and shape of opening 144 may be configured to be adjacent to the female urethra.

[0020] The fluid collection assembly 140 can be placed near the female urethral opening, and bodily fluids can enter the chamber 146 of the fluid collection assembly 140 through the opening 144. The fluid collection assembly 140 is configured to receive bodily fluids into the chamber 146 through the opening 144. In use, the opening 144 can be elongated, extending from a first position below the urethral opening (e.g., near the anus or vaginal opening) to a second position above the urethral opening (e.g., above the vaginal opening or near pubic hair).

[0021] The opening 144 is designed in a narrow, elongated shape because the space between a woman's legs is relatively small, thus allowing bodily fluids to flow only along paths corresponding to the narrow shape of the opening 144 (e.g., a longitudinally extending opening). The length of the opening 144 on the fluid impermeable barrier 142, measured along the longitudinal axis of the fluid collection assembly 140, may be at least about 10% of the length of the fluid collection assembly 140, for example, about 10% to 30%, about 25% to 40%, about 30% to 60%, about 50% to 75%, about 65% to 85%, or about 75% to 95% of the assembly length.

[0022] The opening 144 on the fluid-impermeable barrier 142, the width of which is measured along a direction perpendicular to the longitudinal axis of the fluid collection assembly 140, may be at least about 10% of the circumference of the fluid collection assembly 140, for example, about 10% to 30%, about 25% to 40%, about 30% to 60%, about 50% to 75%, about 65% to 85%, or about 75% to 100% of the circumference of the fluid collection assembly 140. Because a vacuum (e.g., suction) generated via the conduit 100 draws fluid through the porous material 150 into the conduit 100, the width of the opening 144 may be greater than 70% of the circumference of the fluid collection assembly 140. In some examples, the opening 144 may be vertically oriented (e.g., its major axis is parallel to the longitudinal axis of the fluid collection assembly 140). In other examples (not shown), the opening 144 may be horizontally oriented (e.g., its major axis is perpendicular to the longitudinal axis of the fluid collection assembly 140). In one example, the fluid-impermeable barrier 142 may be configured to adhere to a patient, for example, by means of an adhesive (e.g., using a hydrogel adhesive). According to one example, the suitable adhesive is a hydrogel layer.

[0023] In some examples, the fluid impermeable barrier 142 may be sized to accommodate a fluid outlet 148 of the conduit 100. At least one conduit 100 may be disposed within the chamber 146 through the fluid outlet 148. The size and shape of the fluid outlet 148 may be configured to form a substantially fluid-tight structure with the conduit 100 or at least one fitting, thereby substantially preventing leakage of bodily fluids from the chamber 146.

[0024] The fluid-impermeable barrier 142 may include markings, such as one or more, to help a user align and position the fluid collection assembly 140 on a patient. For example, a line on the fluid-impermeable barrier 142 (e.g., located opposite the opening 144) may facilitate a medical professional aligning the opening 144 with the patient's urethra. The markings may include, for example, one or more alignment guide marks or orientation indicators, such as stripes or hash marks. The position of such markings may be configured to align the fluid collection assembly 140 with one or more anatomical structures, such as the pubis.

[0025] The fluid collection assembly 140 includes a porous material 150 disposed within a chamber 146. The porous material 150 may cover at least a portion (e.g., all) of an opening 144. The porous material 150 may include a fluid-permeable membrane 156 and a fluid-permeable support 158. The porous material 150 is exposed to the environment outside the chamber 146 through the opening 144. In one embodiment, the porous material 150 may be configured to divert any bodily fluids away from the opening 144, thereby preventing bodily fluids from overflowing from the chamber 146. Permeability characteristics mentioned herein may include capillary conduction, capillary action, diffusion, or other similar characteristics or processes, collectively referred to herein as “permeable” and / or “conducting”. Such “conducting” and / or “permeable” characteristics may not include the absorption of bodily fluids into at least a portion of the diverting material, for example, the adsorption of bodily fluids into the fluid-permeable support 158. In other words, after the material has been in contact with and out of contact for a period of time, the bodily fluids are not substantially absorbed or dissolved by the material. While the goal is to achieve complete non-absorption and non-dissolution, the term "substantially non-absorbent" still allows for trace amounts of bodily fluids absorbed and / or dissolved in the channeling material (e.g., hygroscopicity), for example, less than about 30 wt%, less than about 20 wt%, less than about 10 wt%, less than about 7 wt%, less than about 5 wt%, less than about 3 wt%, less than about 2 wt%, less than about 1 wt%, or less than about 0.5 wt% of the dry weight of the channeling material. The channeling material may also guide bodily fluids substantially toward the interior of chamber 146, as will be described in more detail below. In one embodiment, porous material 150 may comprise at least one absorbent or adsorbent material.

[0026] In one embodiment, the porous material 150 may include a fluid-permeable membrane 156 disposed within the chamber 146. The fluid-permeable membrane 156 may cover at least a portion (e.g., all) of the opening 144. The fluid-permeable membrane 156 may be configured to divert bodily fluids away from the opening 144, thereby preventing bodily fluids from leaking out of the chamber 146.

[0027] In one embodiment, the fluid-permeable membrane 156 may comprise any material capable of conducting fluid. For example, the fluid-permeable membrane 156 may comprise fabrics such as gauze (e.g., silk gauze, linen gauze, or cotton gauze), other soft fabrics, other smooth fabrics, or any other porous material disclosed herein. Using gauze, soft fabrics, and / or smooth fabrics to fabricate the fluid-permeable membrane 156 can reduce frictional discomfort to the human body caused by the fluid collection assembly 140.

[0028] The fluid collection assembly 140 may include a fluid-permeable support 158 ​​disposed within the chamber 146. Since the fluid-permeable membrane 156 may be made of a foldable, thin, or deformable material, the fluid-permeable support 158 ​​is configured to support the fluid-permeable membrane 156. For example, the fluid-permeable support 158 ​​may be positioned such that the fluid-permeable membrane 156 is located between the fluid-permeable support 158 ​​and the fluid-impermeable barrier 142. Therefore, the fluid-permeable support 158 ​​supports and secures the position of the fluid-permeable membrane 156. The fluid-permeable support 158 ​​also provides a fluid-retaining matrix, such as water bound by hydrogen bonds. When a negative pressure is applied to the matrix, fluid can be drawn through it. The fluid-permeable support 158 ​​may include any material capable of achieving conduction, absorption, adsorption, or other bodily fluid transport effects, such as any of the fluid-permeable membrane materials described above. For example, when used as the fluid-permeable support 158, it may be formed of any fluid-permeable material with less deformability than the fluid-permeable membrane 156. For example, the fluid-permeable support 158 ​​may comprise a porous polymer structure (such as nylon, polyester, polyurethane, polyethylene, polypropylene, etc.) or an open-cell foam, such as spun nylon fibers. In some examples, the fluid-permeable support 158 ​​may be made of natural materials, such as cotton, wool, silk, or combinations thereof. In such examples, the material may have a coating, such as a hydrophobic coating, to prevent or limit fluid absorption by the material. In some examples, the fluid-permeable support 158 ​​may be made of fabric, felt, gauze, or combinations thereof.

[0029] In some examples, the fluid-permeable membrane 156 is optional. For example, the porous material 150 may only include the fluid-permeable support 158. In other examples, the fluid collection assembly 140 may also selectively omit the fluid-permeable support 158. For example, the porous material 150 may only include the fluid-permeable membrane 156.

[0030] In one embodiment, the fluid-permeable support 158 ​​may be hydrophobic. The fluid-permeable support 158 ​​is hydrophobic when the contact angle between itself and water (a major component of body fluids) is greater than about 90°, for example, the contact angle range may be about 90° to 120°, about 105° to 135°, about 120° to 150°, about 135° to 175°, or about 150° to 180°. The hydrophobicity of the fluid-permeable support 158 ​​can limit the absorption, adsorption, and dissolution of body fluids within it, thereby reducing the amount of body fluid retained in the porous material 150. In one embodiment, the fluid-permeable membrane 156 is hydrophobic or hydrophilic. In one embodiment, the hydrophobicity of the fluid-permeable support 158 ​​is higher than that of the fluid-permeable membrane 156 (e.g., a larger contact angle with water). The lower hydrophobicity of the fluid-permeable membrane 156 helps the porous material 150 receive bodily fluids from the urethral opening, while the hydrophobicity of the fluid-permeable support 158 ​​limits the amount of bodily fluids retained in the porous material 150.

[0031] In one embodiment, the porous material 150 includes a nonwoven material to replace at least one of the fluid-permeable membrane 156 or the fluid-permeable support, or as an additional structure to at least one of the fluid-permeable membrane 156 or the fluid-permeable support. Examples of nonwoven materials included in the porous material 150 are disclosed in U.S. Provisional Patent Application No. 63 / 134,754, filed January 7, 2021, the disclosure of which is previously incorporated herein by reference.

[0032] The porous material 150 can at least substantially completely fill the area of ​​the chamber 146 not occupied by the conduit 100. In some examples, the porous material 150 may not completely fill the area of ​​the chamber 146 not occupied by the conduit 100. In such examples, the fluid collection assembly 140 includes a reservoir or collection tank 160 disposed within the chamber 146. Figure 1B ).

[0033] The reservoir 160 may be a substantially unfilled area within the chamber 146. The reservoir 160 may be formed between one or both of the fluid-impermeable barrier 142 and the fluid-permeable membrane 156 and the fluid-permeable support 158. Body fluid within the chamber 146 may flow through the fluid-permeable membrane 156 and / or the fluid-permeable support 158 ​​to the reservoir 160. The reservoir 160 may temporarily store body fluid therein.

[0034] Bodily fluids within chamber 146 can flow through the fluid-permeable membrane 156 and / or the fluid-permeable support 158 ​​to the reservoir 160. A fluid-impermeable barrier 142 retains the bodily fluids within the reservoir 160. Although the reservoir 160 is illustrated in the distal region 162, it can also be located at any location within chamber 146, such as the proximal region 164. The reservoir 160 can be positioned within chamber 146 at a location designed to be in a low gravitational position when the fluid collection assembly is worn.

[0035] In some examples (not shown), the fluid collection assembly 140 may include multiple reservoirs, for example: a first reservoir located in chamber 146 closest to the inlet of catheter 100 (e.g., distal region 162), and a second reservoir located in or near proximal region 164 within chamber 146. In another example, the fluid-permeable support 158 ​​is spaced apart from at least a portion of the catheter 100, and the reservoir 160 may be a gap between the fluid-permeable support 158 ​​and the catheter 100.

[0036] The catheter 100 may be at least partially disposed within the chamber 146. The catheter 100 may be used to drain bodily fluids from the chamber 146. The catheter 100 includes at least one wall 102 or barrier defining an inlet 104, an outlet (not shown) downstream of the inlet 104, and a channel 108. The inlet 104 may be provided with a drainage retainer 110 configured to prevent blockage of the channel 108. The outlet of the catheter 100 is operatively coupled to a vacuum source, such as a vacuum pump, to extract fluid from the chamber 146 through the catheter 100. For example, the catheter 100 may extend from a proximal region 164 into a fluid-impermeable barrier 142 and extend to a distal region 162 near a reservoir 160, such that the inlet 104 is in fluid communication with the reservoir 160. The catheter 100 fluidly connects the chamber 146 to a fluid storage container (not shown) or a vacuum source (not shown).

[0037] The conduit 100 extends through channels in the porous material 150. In one embodiment, the conduit 100 extends from the fluid outlet 148 through the channels to a location near or within the reservoir 160. In some embodiments, the inlet 104 may not extend into the reservoir 160, but rather may be located inside the porous material 150 (fluid-permeable membrane 156 and / or fluid-permeable support 158) or at its end 166. For example, one end of the conduit 100 may be flush with or recessed within the fluid-permeable membrane 156 and / or fluid-permeable support 158. Body fluids collected in the fluid collection assembly 140 may be drained from the chamber 146 through the conduit 100.

[0038] Positioning the inlet 104 at or near the intended low gravity location of the chamber 146 when worn by the patient allows the catheter 100 to collect more fluid and reduces the likelihood of fluid stasis (e.g., fluid stasis can lead to microbial growth and odor) compared to positioning the inlet 104 elsewhere. For example, fluid in the fluid-permeable membrane 156 and fluid-permeable support 158 ​​can flow in any direction due to capillary action. However, in the absence of vacuum suction, fluid tends to flow more in the direction of gravity, especially when the fluid-permeable membrane 156 and / or fluid-permeable support 158 ​​are at least partially saturated with fluid. Therefore, one or more of the inlet 104, drainage retainer 110, or reservoir 160 can be positioned within the fluid collection assembly 140 at the intended low gravity location when worn by the patient, such as the distal region 162.

[0039] As described in more detail below, catheter 100 is configured to be connected to and extend at least partially therebetween one or more of a fluid storage container (not shown) and a vacuum source (not shown). In one example, catheter 100 is configured to be directly connected to a vacuum source (not shown). In this example, catheter 100 may extend outward from fluid impermeability barrier 142 by at least one foot, at least two feet, at least six feet, or at least ten feet. In another example, catheter 100 is configured not to be directly connected to at least one of the fluid storage container (not shown) and the vacuum source (not shown). In some examples, the catheter is secured to the patient's skin by a catheter fixation device, such as the STATLOCK® catheter fixation device from CRBard, including, but not limited to, the types disclosed in U.S. Patent Nos. 6,117,163, 6,123,398, and 8,211,063, the entire disclosure of which is incorporated herein by reference.

[0040] The inlet 104 and outlet of the conduit 100 are configured to fluidly communicate (e.g., directly or indirectly) a vacuum source (not shown) with a chamber 146 (e.g., a reservoir 160). When the vacuum source ( Figure 5 When a negative pressure / suction is applied within the catheter 100, bodily fluid within the chamber 146 (e.g., at the distal region 162, such as within the reservoir 160) can be drawn into the inlet 104 and discharged through the catheter 100 from the fluid collection assembly 140. The vacuum source may include a pump or other suitable mechanism. In some examples, the catheter may be made frosted or opaque (e.g., black) to conceal the internal bodily fluid and prevent it from being seen.

[0041] As described above, catheter 100 can be configured to be inserted into chamber 146 at least. In one example, catheter 100 may be placed within chamber 146 such that the tip of catheter 100 is spaced from components of fluid impermeable barrier 142 or other possible portions of fluid collection assembly 140 that may partially obstruct or block inlet 104. Furthermore, inlet 104 of catheter 100 may be biased relative to tip 166 of porous material 150 such that inlet 104 is closer to proximal region 164 of fluid collection assembly 140 than tip 150. However, when inlet 104 of catheter 100 is not biased, drainage retainer 110 prevents catheter 100 from forming a seal with fluid impermeable barrier 142 or other components and allows catheter 100 to aspirate bodily fluids through drainage retainer 110. For example, catheter 100 can directly draw bodily fluids from porous material 150, and due to hydrogen bonding, water is retained in porous material 150, allowing the catheter to extract more bodily fluids from porous material 150. In some examples, the inlet 104 of catheter 100 can extend into reservoir 160, for example, to the end of fluid-impermeable barrier 142 within chamber 146. Without drainage retainer 110, catheter 100 may become at least partially blocked when inlet 104 comes into contact with fluid-impermeable barrier 142.

[0042] The drainage retainer 110 may be oriented in a selected direction (e.g., facing), such as opposite to the opening 144. This configuration allows the drainage retainer 110 to face or be near the lower part of gravity of the chamber 146 when the fluid collection assembly 140 is worn, such as when the wearer or user is in a supine, lying, or standing position. In some examples, the inlet 104 may be closed to allow only fluid to flow into the catheter 100 through the drainage retainer 110.

[0043] The catheter 100 may have one or more markings (not shown) on its exterior, positioned to facilitate insertion of the catheter 100 into the chamber 146 and to ensure accurate positioning of the inlet 104 within the chamber 146. For example, the catheter 100 may include one or more markings to prevent insertion that is too deep or too shallow, thereby avoiding obstruction or blockage of the inlet 104 by the fluid impermeability barrier 142. In another example, the catheter 100 may include one or more markings to facilitate proper rotation of the catheter 100 relative to the chamber 146, thereby ensuring that at least one drainage retainer 110 faces a selected direction, such as away from the inlet 144. The one or more markings may include lines, dots, labels, or any other suitable identifier.

[0044] Other embodiments of fluid-impermeable barriers, fluid-permeable membranes, fluid-permeable supports, chambers, and their shapes and configurations have been disclosed in U.S. Patent Application No. 15 / 612,325, filed June 2, 2017; U.S. Patent Application No. 15 / 260,103, filed September 8, 2016; and U.S. Patent No. 10,390,989, filed September 8, 2016. The entire contents of all the foregoing documents are incorporated herein by reference.

[0045] In some examples, the drainage retainer may extend beyond the end of the porous material. For example, the catheter 100 may be at least partially disposed within the reservoir 160, and the end of the catheter (such as inlet 104) and the drainage retainer 110 may extend into or be disposed within the reservoir 160.

[0046] Figure 1C According to one embodiment, along Figure 1A The diagram shows a cross-sectional view of the fluid collection assembly 140 taken from plane 1B-1B. The conduit 100c may be similar to or identical to conduit 100 in one or more aspects. As shown, conduit 100c may not include inlet 104. In this type of example, the end (e.g., distal end) of conduit 100c may be closed, for example, by using a wall similar to or identical to at least one tube wall 102. The drainage retainer 110 may serve as the sole pathway for fluid flow through conduit 108. In this type of example, the drainage retainer 110 may be considered as an inlet. The drainage retainer 110 may be positioned away from outlet 144, for example, at a 180° angle opposite to opening 144. The drainage retainer 110 may be spaced at a distance from the end of the conduit, for example, at least 1 mm, at least 5 mm, at least 1 cm from the end of conduit 100c, or the distance may range from 1 mm to 3 cm, 1 mm to 1 cm, 1 mm to 5 mm, 5 mm to 1 cm, 1 cm to 3 cm, or less than 3 cm or less than 1.5 cm. By spaced apart from the end of the catheter 100c, the drainage retainer prevents blockage caused by the fluid impermeability barrier within the dome-shaped reservoir 160 or by external force compressing the reservoir 160. Simultaneously, by holding the drainage retainer 110 close to the end of the reservoir, it is maintained near the low gravity position of the fluid collection assembly, ensuring smooth fluid aspiration.

[0047] In some embodiments (not shown), the distal end of the catheter (e.g., inlet 104) may be disposed within the reservoir 160, while the drainage retainer 110 may be disposed within a channel (e.g., in contact with the porous material 150). By spaced apart from the distal end of the catheter and located within the pores of the porous material, the drainage retainer 110 maintains contact with the porous material at or near the distal end of the fluid collection assembly, while preventing clogging due to the dome shape of the reservoir or the compressive forces applied thereto. The porous material 150 provides structural support to prevent the drainage retainer 110 from being squeezed shut or otherwise blocked.

[0048] Figure 2 This is a schematic cross-sectional view of a catheter 200 according to one embodiment. The catheter 200 includes at least one wall 202. The wall 202 defines at least an inlet 204, an outlet 206 downstream of the inlet 204, and a channel 208 extending from the inlet 204 to the outlet 206. The inlet 204 may be configured to connect to a fluid collection assembly (not shown), be disposed within a chamber of the fluid collection assembly, or otherwise fluidly communicate with the fluid collection assembly (e.g., via another catheter). The outlet 206 is configured to connect to a vacuum source (not shown), or otherwise fluidly communicate with a vacuum source (e.g., via another catheter or a fluid storage container). The channel 208 forms a fluid flow path for drawing bodily fluid from the fluid collection assembly (not shown) and delivering the drawn bodily fluid to a fluid storage container. The catheter 200 also includes a drainage retainer 210 disposed in at least one wall 202, which defines the inlet 204 and / or at least partially occupies the channel 208. Drainage retainer 210, which will be described in more detail below, is configured to prevent blockage of channel 208 due to occlusion at inlet 204, viscous fluid or solids.

[0049] The tube wall 202 can be made of any suitable fluid-impermeable material. In one embodiment, the tube wall 202 can be made of a conventional material commonly used in the manufacture of hollow conduits. In this embodiment, the tube wall 202 can be made of polyvinyl chloride (PVC). In one embodiment, the tube wall 202 can be made of one or more materials with a Young's modulus lower than that of PVC. Since the drainage retainer 210 is disposed inside and / or through the tube wall 202, thus weakening the structural support of at least a portion of the tube wall 202, the tube wall 202 can also be made of a material with a Young's modulus similar to that of PVC. Examples of such materials include polyethylene (such as low-density polyethylene, high-density polyethylene, and ultra-high molecular weight polyethylene), polypropylene, polytetrafluoroethylene, nitrile rubber, nylon, ethylene-vinyl acetate copolymer, thermoplastic elastomers, or combinations thereof. In one embodiment, the tube wall 202 can be made of a material with a Young's modulus higher than that of PVC. In this embodiment, the tube wall 202 can have a thickness such that the conduit 200 exhibits less or equal flexibility than a conduit made of PVC.

[0050] The tube wall 202 may have a thickness t measured along a direction perpendicular to the longitudinal axis 212 of the conduit 200. The thickness of the tube wall 202 may be selected based on the required flexibility of the conduit 200, the conduit strength, the effect of the drainage retainer 210, and the Young's modulus of the material constituting the tube wall 202. The tube wall 202 may have a thickness comparable to or greater than that of conventional conduits because, compared to conventional conduits, at least one location of the drainage retainer 210 removes a portion of the material from the conduit 200, or the tube wall 202 may be made of a material with a Young's modulus lower than that of polyvinyl chloride. Choosing a thickness t of the tube wall 202 comparable to or greater than that of conventional conduits allows the conduit 200 to prevent collapse under vacuum pressure while also enabling the delivery of fluids with higher viscosity or containing more solid particles.

[0051] In one embodiment, the tube wall 202 may have a thickness t greater than that of a conventional conduit. For example, the thickness of the tube wall 202 may be about 0.05 mm and above, about 0.1 mm and above, about 0.15 mm and above, about 0.2 mm and above, about 0.25 mm and above, about 0.3 mm and above, about 0.35 mm and above, about 0.4 mm and above, about 0.45 mm and above, about 0.5 mm and above, about 0.6 mm and above, about 0.7 mm and above, about 0.8 mm and above, about 0.9 mm and above, about 1 mm and above, about 1.1 mm and above, about 1.2 mm and above, about 1.3 mm and above, about 1.4 mm and above, about 1.5 mm and above; or within the range of about 0.05 mm. Approximately 0.15mm, approximately 0.1mm to 0.2mm, approximately 0.15mm to 0.25mm, approximately 0.2mm to 0.3mm, approximately 0.25mm to 0.35mm, approximately 0.3mm to 0.4mm, approximately 0.35mm to 0.45mm, approximately 0.4mm to 0.5mm, approximately 0.45mm to 0.6mm, approximately 0.5mm to 0.7mm, approximately 0.6mm to 0.8mm, approximately 0.7mm to 0.9mm, approximately 0.8mm to 1mm, approximately 0.9mm to 1.1mm, approximately 1mm to 1.2mm, approximately 1.1mm to 1.3mm, approximately 1.2mm to 1.4mm, or approximately 1.3mm to 1.5mm. The tube wall 202 described herein can be of this thickness because the tube wall 202 needs to provide support for the drainage retainer 210 of the catheter, even when the tube wall 202 is made of a material with a Young's modulus higher than that of polyvinyl chloride.

[0052] In general, the average person's urination rate is approximately 6 ml / s to 50 ml / s, for example, approximately 10 ml / s to 25 ml / s. Individual urination rates may vary, depending on factors such as body size and age. The flow rate of the catheter drainage retainer 210 and / or inlet 204 can be selected to be comparable to the average person's urination rate to prevent the fluid collection components (such as fluid collection devices) connected to the catheter 200 from becoming saturated with excess body fluid, thus preventing leakage. For example, the flow rate of the catheter drainage retainer 210 can be selected to be greater than approximately 6 ml / s, greater than approximately 10 ml / s, greater than approximately 20 ml / s, greater than approximately 30 ml / s, greater than approximately 40 ml / s, greater than approximately 50 ml / s, or within the following ranges: approximately 6 ml / s to 10 ml / s, approximately 8 ml / s to 12 ml / s, approximately 10 ml / s to 15 ml / s, approximately 12.5 ml / s to 17.5 ml / s. The flow rate is approximately 15 ml / s to 20 ml / s, approximately 17.5 ml / s to 22.5 ml / s, approximately 20 ml / s to 25 ml / s, approximately 22.5 ml / s to 27.5 ml / s, approximately 25 ml / s to 30 ml / s, approximately 27.5 ml / s to 35 ml / s, approximately 30 ml / s to 40 ml / s, approximately 35 ml / s to 45 ml / s, or approximately 40 ml / s to 50 ml / s. As used herein, flow rate refers to the body fluid flow rate of the catheter drainage retainer 210 when the catheter drainage retainer 210 is immersed in body fluid, not immersed in body fluid, under vacuum pressure, or when no vacuum pressure is applied to the channel 208 (e.g., body fluid flows solely by capillary flow and / or gravity).

[0053] The conduit 200 is shown disconnected between the inlet 204 and the outlet 206. This disconnection indicates that the conduit 200 can have any length. In one example, the conduit 200 can have the following lengths: approximately 1 cm and above, approximately 15 cm and above, approximately 30 cm and above, approximately 45 cm and above, approximately 60 cm and above, approximately 75 cm and above, approximately 90 cm and above, approximately 105 cm and above, approximately 120 cm and above, approximately 150 cm and above, approximately 180 cm and above, approximately 210 cm and above, approximately 240 cm and above, approximately 265 cm and above, approximately 300 cm and above; or Within the following ranges: approximately 1cm to 30cm, approximately 15cm to 45cm, approximately 30cm to 60cm, approximately 45cm to 75cm, approximately 60cm to 90cm, approximately 75cm to 105cm, approximately 90cm to 120cm, approximately 105cm to 150cm, approximately 120cm to 180cm, approximately 150cm to 210cm, approximately 180cm to 240cm, approximately 210cm to 265cm, and approximately 240cm to 300cm. For example, when conduit 200 forms a bendable joint between conduit 200 and another conduit or fluid collection assembly, its length can be approximately 1cm to 15cm; when conduit 200 is mainly located only inside the fluid collection assembly, its length can be approximately 10cm to 40cm; when conduit 200 extends a long distance outward from the fluid collection assembly, its length can be greater than approximately 35cm.

[0054] Channel 208 can have a maximum lateral dimension L D When channel 208 is cylindrical in shape, the maximum lateral dimension L is... D This refers to the diameter of channel 208. Maximum lateral dimension L D Available sizes are: approximately 4mm and above, approximately 5mm and above, approximately 6mm and above, approximately 7mm and above, approximately 8mm and above, approximately 9mm and above, approximately 10mm and above, approximately 12mm and above, approximately 14mm and above, approximately 16mm and above, approximately 18mm and above, approximately 20mm and above, and approximately 25mm and above; or within the following ranges: approximately 4mm to 6mm, approximately 5mm to 7mm, approximately 6mm to 8mm, approximately 7mm to 9mm, approximately 8mm to 10mm, approximately 9mm to 12mm, approximately 10mm to 14mm, approximately 12mm to 16mm, approximately 14mm to 18mm, approximately 16mm to 20mm, or approximately 18mm to 25mm. Maximum lateral dimension L D The choice can be based on a variety of factors. In one example, the maximum lateral dimension L D The selection can be made based on the desired flow rate of the body fluid within channel 208. Under the premise of a constant fluid flow velocity through the catheter, the maximum lateral dimension L can be increased. DThis can increase 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 fluid within channel 208). In another example, the maximum lateral dimension L... D The selection is based on the device. As used herein, a device refers to a device in which the conduit described herein is connected, connectable, or configured to be connected, and may include an inlet and / or outlet of at least one of a fluid collection assembly (such as a fluid collection device), a fluid storage container, a vacuum source, or a hollow conduit. For example, when conduit 200 is connected to the device as a female connector, the maximum lateral dimension L D It can be selected to be slightly smaller than the device size (e.g., the catheter 200 is expandable), equal to the device size, or slightly larger than the device size. Furthermore, when the catheter 200 forms a male connector connection with the device, the maximum lateral dimension L... D It can be selected to be smaller than the device size.

[0055] As described above, the tube wall 202 defines a channel 208, and at least a portion of the channel 208 is kept open and unobstructed by the drainage retainer 210. When negative pressure is applied to the catheter 200 and the catheter inlet 204 is pressed against a surface or otherwise obstructed, the drainage retainer 210 can prevent the catheter 200 from collapsing or bending. The drainage retainer 210 can also guide bodily fluids aspirated into the catheter 200 (e.g., through negative pressure or capillary action) to the outlet 206. The drainage retainer 210 may have multiple openings and / or structures through which bodily fluids can flow.

[0056] See Figure 3A The catheter 300a includes at least one wall 302a defining a channel 308a, an inlet 304a, and at least one drainage retainer 310a. The drainage retainer 310a may include a cut formed by the inlet 304a. In other words, a portion of the catheter 300a is cut away at the inlet 304a, thereby forming an irregular surface at the inlet 304a. For example, the catheter 300a may have an arcuate section cut away at the inlet 304a to ensure that the channel 308a at or near the inlet 304a is not blocked when the inlet 304a is against an impermeable surface.

[0057] Figure 3B A catheter 300b with a structure similar to catheter 300a is shown. Catheter 300b includes at least one wall 302b defining a channel 308b, an inlet 304b, and at least one drainage retainer 310b. The drainage retainer 310b may include a tapered inlet 304b. In other words, a portion of catheter 300b is cut away at the inlet 304b to form a tapered edge or pointed inlet 304b. For example, catheter 300b may be obliquely cut away at the inlet 304b, which similarly ensures that the channel 308b at or near the inlet 304b is not blocked when the inlet 304b rests against an impermeable surface.

[0058] Figure 3C Another example of the drainage retainer 310c is shown. Figure 3C A catheter 300c is shown, comprising at least one tube wall 302c defining a channel 308c, an inlet 304c, and a drainage retainer 310c. In this example, the drainage retainer 310c may be formed by cutting a portion of the tube wall 302c to create a semi-circular notch. In some examples, the drainage retainer 310c may be located at or near the inlet 304c. In other words, the inlet 304c forms a first opening, and the drainage retainer 310c also forms an opening in the tube wall 302c. For example, the distance between the drainage retainer 310c and the inlet 304c can be selected as being directly at the inlet, approximately 1 mm or less, approximately 5 mm or less, approximately 6 mm or less, approximately 7 mm or less, approximately 8 mm or less, approximately 9 mm or less, approximately 10 mm or less, approximately 12 mm or less, approximately 14 mm or less, approximately 16 mm or less, approximately 18 mm or less, approximately 20 mm or less, approximately 25 mm or less, or within the following ranges: approximately 4 mm to 6 mm, approximately 5 mm to 7 mm, approximately 6 mm to 8 mm, approximately 7 mm to 9 mm, approximately 8 mm to 10 mm, approximately 9 mm to 12 mm, approximately 10 mm to 14 mm, approximately 12 mm to 16 mm, approximately 14 mm to 18 mm, approximately 16 mm to 20 mm, or approximately 18 mm to 25 mm.

[0059] Reference Figure 3DIn some examples, the catheter 300d includes at least one wall 302d defining a channel 308d, an inlet 304d, and a drainage retainer 310d. In this example, the drainage retainer 310d may include a series of semi-circular cuts extending from or near the inlet 304d to or near the outlet (not shown). In other words, the inlet 304d forms a first opening, while the drainage retainer 310d forms a series of openings on the at least one wall. In examples where the catheter 300d is disposed within an elongated fluid collection assembly or device, this series of semi-circular cuts provides a greater flow rate and reduces the probability of blockage compared to other configurations. The spacing of this series of semi-circular cut-out drainage retainers 310d can be set to approximately 4 mm and below, approximately 5 mm and below, approximately 6 mm and below, approximately 7 mm and below, approximately 8 mm and below, approximately 9 mm and below, approximately 10 mm and below, approximately 12 mm and below, approximately 14 mm and below, approximately 16 mm and below, approximately 18 mm and below, approximately 20 mm and below, approximately 25 mm and below, or within the following ranges: approximately 4 mm to 6 mm, approximately 5 mm to 7 mm, approximately 6 mm to 8 mm, approximately 7 mm to 9 mm, approximately 8 mm to 10 mm, approximately 9 mm to 12 mm, approximately 10 mm to 14 mm, approximately 12 mm to 16 mm, approximately 14 mm to 18 mm, approximately 16 mm to 20 mm, or approximately 18 mm to 25 mm. In some examples, this series of semi-circular cut-out drainage retainers 310d is only provided on a single surface or in a single direction of at least one tube wall 302d. In other examples, the series of semi-circular cut-out drainage retainers 310d can be distributed circumferentially along the tube wall 302d. One advantage of placing the semi-circular cut-out drainage retainer 310d only on one side or a single surface is that it avoids the negative pressure device drawing in air and failing to extract fluid from the component, which could lead to fluid retention and potentially cause infection and / or require more frequent component replacement.

[0060] Drainage retainers 110, 210, 310a, 310b, 310c, or 310d may be oriented away from the opening of the fluid collection assembly containing the catheter. In these embodiments, the position and orientation of the drainage retainer are set at the lowest point of gravity of the fluid collection assembly and in the corresponding direction. By placing the drainage retainer on one side or a single surface of the catheter, air is prevented from being drawn into the assembly by the vacuum device (thus preventing the extraction of fluid).

[0061] Figure 3EA catheter 300e with a structure similar to catheter 300a is shown. Catheter 300e includes at least one wall 302e defining a channel 308e, an inlet 304e, and at least one drainage retainer 310e. The drainage retainer 310e may include a serrated edge defining the inlet 304e. In other words, a portion of catheter 300e at the inlet 304e is cut away to form a serrated but uniform edge surrounding the inlet 304e, with a series of pointed extensions. For example, catheter 300e is cut with multiple bevels at the inlet 304e to ensure that the channel 308e at or near the inlet 304e is not blocked when the inlet 304e is abutted against an impermeable surface.

[0062] Figure 3F A catheter 300f with a structure similar to catheter 300e is shown. Catheter 300f includes at least one wall 302f defining a channel 308f, an inlet 304f, and at least one drainage retainer 310f. The drainage retainer 310f may include a wavy inlet 304f. In other words, a portion of catheter 300f at the inlet 304f is cut away to form a wavy edge or inlet 304f with a smooth, extended structure that does not easily trap solid particles. For example, catheter 300f may have a series of arcuately extending patterned structures cut into the inlet 304f, which similarly ensures that the channel 308f at or near the inlet 304f is not blocked when the inlet 304f rests against an impermeable surface.

[0063] Figure 3G Another exemplary drainage retainer 310g is shown. Figure 3GThe diagram illustrates a catheter 300g comprising at least one wall 302g defining a channel 308g, an inlet 304g, and a drainage retainer 310g. In this embodiment, the drainage retainer 310g may include a semi-circular cutout or extension extending from a portion of the wall 302g and beyond the inlet 304g. In other words, the drainage retainer 310g includes an annular protrusion extending from the inlet end of the catheter 300g. The drainage retainer 310g may comprise a polymer, metal, or other at least semi-rigid material. The drainage retainer 310g forms a gap between the inlet 304g and other components of the fluid collection device housing the catheter 300g (e.g., a fluid-impermeable barrier). In some examples, the drainage retainer 310g may be positioned distal to or further distal to the inlet 304g. For example, the distance from the tip of the drainage retainer 310g to the inlet 304g can be set to be directly at the inlet, about 1 mm or less, about 5 mm or less, about 6 mm or less, about 7 mm or less, about 8 mm or less, or within the following ranges: about 4 mm to 6 mm, about 5 mm to 7 mm, about 6 mm to 8 mm, about 7 mm to 9 mm, or about 8 mm to 10 mm. In some embodiments, the drainage retainer may include a thread that is wrapped around (e.g., in a circular or spiral shape) around the conduit.

[0064] Figure 3H It shows Figure 3G The diagram shows a cross-section of the conduit 300g taken along a plane parallel to its longitudinal axis. As shown, fluid can flow into the inlet 304g from between the flow retainer 310g and the inlet 304g. In some examples, the flow retainer 310g ensures that the inlet 304g is not blocked when it is in close contact with an impermeable surface.

[0065] In some examples, the flow retainer may include a screen or filter configured to connect to the inlet of the conduit. (Reference) Figure 3IThe conduit 300i includes at least one wall 302i defining a channel 308i, an inlet 304i, and at least one flow retainer 310i connected to the inlet 304i. The flow retainer 310i may include a filter configured to alter the flow path of fluid entering the inlet 304i. In some examples, the flow retainer 310i may include a filter configured to prevent solid matter from entering the channel 308i. In other words, the conduit 300i may include a filter attached to the inlet 304i at the inlet 304i. For example, the conduit 300i may be connected to the inlet 304i by an adhesive, interference fit, or other suitable connection method. In some examples, the flow retainer 310i may include the same material as the conduit 300i (e.g., polyvinyl chloride). In other examples, the flow retainer 310i may include different materials, such as metal or membrane materials. For example, the flow retainer 310i may include a plastic housing and a metal filter disposed within the housing. In some examples, the flow retainer 310i may also include a membrane disposed within the housing. The membrane can be configured to separate different fluids and / or filter smaller particles through a filter screen.

[0066] The filtration device may include spunbond plastic, such as a fluid-permeable support material. This filtration device prevents the inlet from forming a seal against the inner wall of a fluid-impermeable barrier, while allowing fluid to flow through it, for example, through a fluid-permeable support material (such as a filter device) positioned above the inlet.

[0067] In some examples, catheters can be used in fluid collection systems to collect one or more bodily fluids. (Reference) Figure 4A The conduit 400a may include a wall 402a that at least partially defines an inlet 404a, an outlet (not shown), and a channel 408a. In some examples, the fluid flow direction at the outlet is parallel to the conduit 400a, while the fluid flow direction at the inlet 404a is perpendicular to the longitudinal direction 406 of the conduit 400a. In other words, the inlet 404a acts as a flow retainer by its own orientation. In some examples, the channel 408a may also include a filter 410 disposed therein. In some embodiments, the filter 410 may be disposed above the inlet 404a; while in other embodiments, such as Figure 4A As shown, filter 410 may be disposed inside channel 408a. In some examples, inlet 404a may have an approximately circular cross-sectional shape. The shape or size of inlet 404a may be configured to maximize the flow rate into channel 408a and prevent channel 408a from becoming clogged. For example, inlet 404a may be circular, rectangular, serrated, or any other shape.

[0068] Figure 4BA conduit 400b similar to conduit 400a is shown. Conduit 400b includes at least one wall 402b defining a channel 408b and an inlet 404b. The inlet 404b may include a series of inlets 404b that can further increase the flow rate into the channel 408b. In other words, conduit 400a may include a series of semi-circular cuts as inlets 404b leading to an outlet (not shown) or located near an outlet. That is, the inlets 404b define a first opening 404b1 and a second opening 404b2. In the example where conduit 400b is disposed within an elongated fluid collection assembly or device, this series of semi-circular cuts can provide a greater flow rate and reduce the probability of clogging compared to other examples. The spacing between this series of semi-circular cut-in inlets 404b can be approximately millimeters or less, approximately 5 mm or less, approximately 6 mm or less, approximately 7 mm or less, approximately 8 mm or less, approximately 9 mm or less, approximately 10 mm or less, approximately 12 mm or less, approximately 14 mm or less, approximately 16 mm or less, approximately 18 mm or less, approximately 20 mm or less, approximately 25 mm or less, or range from approximately 4 mm to approximately 6 mm, approximately 5 mm to approximately 7 mm, approximately 6 mm to approximately 8 mm, approximately 7 mm to approximately 9 mm, approximately 8 mm to approximately 10 mm, approximately 9 mm to approximately 12 mm, approximately 10 mm to approximately 14 mm, approximately 12 mm to approximately 16 mm, approximately 14 mm to approximately 18 mm, approximately 16 mm to approximately 20 mm, or approximately 18 mm to approximately 25 mm. In some examples, this series of semi-circular cut-in inlets 404b is provided only on a single surface or in a single direction of at least one pipe wall 402b. In other examples, this series of semi-circular cut-in inlets 404b may be arranged circumferentially around the pipe wall 402b.

[0069] The orientation of inlets 404a or 404b can be configured to face away from the opening of the fluid collection assembly containing the conduit. In such examples, inlets 404a and 404b are positioned and oriented at a low gravitational point and orientation within the fluid collection assembly. By placing the inlets on one side or a single surface of the conduit, it prevents a vacuum from drawing air (rather than sucking in liquid) from the assembly.

[0070] Figure 4C A catheter 400c similar to catheter 400b is shown, but it includes a series of inlet 404c openings arranged circumferentially around the tube wall 402c. One advantage of arranging a series of semi-circular inlet 404c openings on a single side or surface is that it prevents air from being drawn into the assembly by a vacuum, which could otherwise cause fluid stagnation, potentially leading to infection and / or requiring more frequent assembly replacements.

[0071] Figure 5This is a block diagram of a fluid collection system 500 for fluid collection according to one embodiment. The system 500 includes a fluid collection assembly 502, a fluid storage container 504, and a vacuum source 506. The fluid collection assembly 502, the fluid storage container 504, and the vacuum source 506 are fluidly connected to each other via one or more conduits. For example, as shown, the conduits may include a first conduit 508a extending from the fluid collection assembly 502 to the fluid storage container 504, and a second conduit 508b extending from the fluid storage container 504 to the vacuum source 506.

[0072] In one embodiment, the first conduit 508a can be any of the conduit (e.g., tubing) embodiments described above. In one example, the conduit may include a flow retainer configured to prevent conduit blockage. In one example, the flow retainer may be located at the inlet of the conduit, or may be configured as the inlet of the conduit. In one embodiment, the second conduit 508b does not include a flow retainer. However, the second conduit may include a filter or screen as described above. In one embodiment, the fluid collection system 500 may include at least one other conduit (not shown) in addition to the first conduit 508a and / or the second conduit 508b. In one example, the first conduit 508a may be in direct fluid communication with the fluid collection assembly 502 and extends only from the fluid collection assembly 502 to a portion of the distance between the fluid collection assembly 502 and the fluid storage container 504. Thus, the fluid collection system 500 may include a conduit connected to the outlet of the first conduit 508a and extending from the first conduit 508a to the fluid storage container 504.

[0073] The fluid collection assembly 502 may be similar to or identical to any fluid collection assembly or device disclosed herein in one or more respects. The shape and size of the fluid collection assembly 502 may be positioned adjacent to a female urethral orifice or for a male urethral orifice to pass through (e.g., to accommodate a penis). For example, the fluid collection assembly 502 may include a fluid-impermeable barrier that at least partially defines a chamber (e.g., an internal region) of the fluid collection assembly 502. This fluid-impermeable barrier also defines at least one opening extending through the fluid-impermeable barrier from the external environment. This opening may be positioned adjacent to a female urethral orifice or for a male urethral orifice to pass through. The fluid collection assembly 502 may include a porous material disposed within the chamber, such as one or more fluid-permeable supports and fluid-permeable membranes. The fluid collection assembly 502 includes any one or more fixations disclosed herein.

[0074] The fluid storage container 504 is sized and shaped to contain bodily fluids. The fluid storage container 504 may include a bag (e.g., a drainage bag), a bottle or cup (e.g., a collection can), or any other closed container for storing bodily fluids such as urine. In some examples, a first conduit 508a may extend from the fluid collection assembly 502 and connect to it at a first connection point on the fluid storage container 504. A second conduit 508b may connect to the fluid storage container 504 at a second connection point and extend to and connect to a vacuum source 506. Thus, a vacuum (e.g., suction) can be drawn through the fluid storage container 504 via the fluid collection assembly 502. Fluids, such as urine, can be drained from the fluid collection assembly 502 using the vacuum source 506.

[0075] Vacuum source 506 may include one or more of a manual vacuum pump, an electric vacuum pump, a diaphragm pump, a centrifugal pump, a positive displacement pump, a magnetically driven pump, a peristaltic pump, or any pump configured to generate a vacuum. Vacuum source 506 can provide a vacuum or suction to remove fluid from fluid collection assembly 502. In some examples, vacuum source 506 may be powered by one or more of a power cord (e.g., connected to a power outlet), one or more batteries, or even manual power (e.g., a manually operated vacuum pump). In some examples, the size and shape of vacuum source 506 may be designed to be positioned externally, above, or internally to fluid collection assembly 502. For example, vacuum source 506 may include one or more micropumps or one or more micro-pumps. Vacuum source 506 may include one or more of a switch, button, plug, remote control, or any other means suitable for activating vacuum source 506.

[0076] Figure 6This is a flowchart of a method 600 for collecting fluid according to one embodiment. Method 600 includes a step 602 of positioning a fluid collection device at least near a user's urethra, and a step 604 of receiving fluid discharged from the user in the fluid collection device. Method 600 also includes a step 606 of receiving fluid discharged from the fluid collection device in a fluid collection container. In some embodiments, method 600 may further include applying a vacuum to a first conduit in fluid communication with the fluid collection device using a pump to effectively draw fluid from the fluid collection device into the fluid collection container. Method 600 may include any fluid collection system and / or device described herein or incorporated herein by reference. For example, a fluid collection assembly or device may include: a fluid-impermeable barrier defining at least a chamber, at least one opening, and a fluid outlet; a porous material disposed within the chamber; and a conduit in fluid communication with the chamber. The conduit may include at least one wall defining at least a partially defined inlet, an outlet, and a channel extending from the inlet to the outlet, wherein the inlet includes a flow retainer configured to prevent channel blockage. In many embodiments, the direction of fluid flow at the outlet of the fluid collection device is parallel to the conduit, while the direction of fluid flow at the inlet is perpendicular to the conduit.

[0077] It should be understood that the steps of method 600 described above are for illustrative purposes only. For example, the steps of method 600 may be performed in a different order, broken down into multiple steps, modified, supplemented, or combined. In one embodiment, one or more steps in method 600 may be omitted. Any step in method 600 may include the use of any fluid collection system or component disclosed herein.

[0078] In this document, the terms “about” or “substantially” mean that the term they modify is allowed a deviation range of ±10% or ±5%. Furthermore, when the terms “less than,” “or less,” “greater than,” “more than,” or “or greater” include endpoint values, their endpoints are the numerical values ​​they modify.

[0079] While several aspects and embodiments have been disclosed herein, other aspects and embodiments are also considered. The various aspects and embodiments disclosed herein are for illustrative purposes only and are not intended to be limiting.

[0080] Degree terms (such as "about," "basically," "generally," etc.) indicate structurally or functionally negligible variations. In one example, when a degree term is used with a term indicating quantity, the degree term is interpreted as ±10%, ±5%, or ±2% of that quantity term. In one example, when a degree term is used to modify a shape, the degree term indicates that the shape modified by the degree term has the appearance of the disclosed shape. For example, a degree term may be used to indicate that the shape may have rounded corners instead of sharp corners, curved edges instead of straight edges, one or more protrusions extending from it, be elliptical, or be the same as the disclosed shape, etc.

Claims

1. A fluid collection device, comprising: A fluid-impermeable barrier defining at least one chamber, at least one opening, and a fluid outlet; Porous material disposed within the cavity; as well as A conduit in fluid communication with the chamber, the conduit comprising: At least one pipe wall, the pipe wall at least partially defining: Entrance; Exports; and A channel extending from the inlet to the outlet, wherein the inlet includes a drainage retainer configured to prevent blockage of the channel.

2. The apparatus according to claim 1, characterized in that, The at least one pipe wall comprises polyvinyl chloride.

3. The apparatus according to any one of claims 1 or 2, characterized in that, The drainage retainer includes a groove defined by the inlet.

4. The apparatus according to claim 1, characterized in that, The drainage retainer includes at least one semi-circular cut on a portion of the at least one tube wall.

5. The apparatus according to claim 1, characterized in that, One or more of the drainage retainers or the inlet extend beyond the distal end of the porous material.

6. The apparatus according to claim 1, characterized in that, The drainage retainer includes a tapered inlet.

7. The apparatus according to claim 1, characterized in that, The drainage retainer includes a serrated edge at the inlet.

8. The apparatus according to any one of claims 1 to 7, characterized in that, The outlet defines a first opening on at least one tube wall, the drainage retainer defines a second opening on at least one tube wall, and the end of the catheter is closed.

9. The apparatus according to claim 1, characterized in that, The drainage retainer includes a filter screen configured to be connected to the inlet of the catheter.

10. The apparatus according to claim 9, characterized in that, The drainage retainer and the catheter are made of the same material.

11. The apparatus according to claim 9, characterized in that, The drainage retainer is made of a different material than the catheter.

12. The apparatus according to claim 1, characterized in that, The drainage retainer includes an annular extension extending from the outlet of the catheter.

13. A fluid collection system, comprising: A fluid storage container, configured to contain fluid; Fluid collection device; A catheter for use in the fluid collection system to collect one or more bodily fluids from the fluid collection device, the catheter comprising: At least one pipe wall, said at least one pipe wall at least partially defining at least: Entrance; Exports; and A channel extending from the inlet to the outlet, wherein the conduit includes a drainage retainer configured to prevent blockage of the channel; and A vacuum source, which is fluidly connected via the conduit to one or more of the fluid storage container or the fluid collection device, the vacuum source being configured to draw fluid from the fluid collection device to the fluid storage container via the conduit.

14. The system according to claim 13, characterized in that, A filter is also installed inside the inlet.

15. The system according to any one of claims 13 or 14, characterized in that, The entrance has a generally circular cross-sectional shape.

16. A method for collecting fluid, the method comprising: The fluid collection device is located at least in the vicinity of the user's urethra, wherein the fluid collection device comprises: A fluid-impermeable barrier that defines at least the chamber, at least one opening, and a fluid outlet; The porous material disposed within the cavity; and A conduit in fluid communication with the chamber, the conduit comprising: At least one pipe wall, the pipe wall at least partially defining: Entrance; Exports; and A channel extending from the inlet to the outlet, wherein the inlet includes a drainage retainer configured to prevent blockage of the channel; The fluid collection device receives fluid discharged from the user; and The fluid discharged from the fluid collection device is received in the fluid collection container.

17. The method according to claim 16, characterized in that, The fluid impermeable barrier defines a reservoir, and the inlet of the conduit is located adjacent to the reservoir, the conduit extending through the fluid outlet.

18. The method according to claim 16, wherein, The fluid impermeable barrier includes a distal region and a proximal region opposite to the distal region, the liquid reservoir is at least partially defined by the distal region of the fluid impermeable barrier, and the fluid outlet is located at or near the distal region of the fluid impermeable barrier.

19. The method of claim 16, wherein, The catheter essentially occupies all the space within the cavity that is not occupied by the porous material.

20. The method of claim 16, further comprising using a pump to generate negative pressure via a conduit in fluid communication with the fluid collection device to effectively draw fluid from the fluid collection device into the fluid collection container.

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