Fluid collection device having a conduit including a flow retainer
Patent Information
- Authority / Receiving Office
- EP · EP
- Patent Type
- Applications
- Current Assignee / Owner
- PUREWICK CORP
- Filing Date
- 2023-08-29
- Publication Date
- 2026-07-08
AI Technical Summary
Existing fluid collection devices, such as bed pans and urinary catheters, face issues like discomfort, spills, hygiene problems, discomfort, pain, and the risk of urinary tract infections, along with conduits prone to kinking and collapsing.
The development of fluid collection devices featuring conduits with a flow retainer to prevent blockage, combined with a fluid impermeable barrier and porous material for efficient fluid collection and storage.
The solution effectively prevents blockages in the conduit, ensuring continuous fluid collection and reducing the risk of infections and discomfort, while maintaining the integrity of the fluid collection system.
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Figure US2023031433_06032025_PF_FP_ABST
Abstract
Description
FLUID COLLECTION DEVICE HAVING A CONDUIT INCLUDING A FLOW RETAINERBACKGROUND
[0001] A patient may have limited or impaired mobility such that typical urination processes are challenging or impossible. For example, the patient may have surgery or a disability that impairs mobility. Tn another example, the patient may have restricted travel conditions such as those experience by pilots, drivers, and workers in hazardous areas. Additionally, fluid collection from the patient may be needed for monitoring purposes or clinical testing.
[0002] Bed pans and urinary catheters, such as a Foley catheter, may be used to address some of these circumstances. However, bed pans and urinary catheters have several problems associated therewith. For example, bed pans may be prone to discomfort, spills, and other hygiene issues. Urinary catheters be may be uncomfortable, painful, and may cause urinary tract infections. Further, conduits used in association with urinary catheters may be prone to kinking and collapsing.
[0003] Thus, users and manufacturers of fluid collection assemblies continue to seek new and improved devices, systems, and methods to collect urine.SUMMARY
[0004] Embodiments disclosed herein include conduits including a flow retainer configured to prevent blockage of the conduit, fluid collection assemblies and systems including the same, and methods of using and forming the same. In an embodiment, a fluid collection device for collecting one or more bodily fluids is disclosed. The fluid collection device can include a fluid impermeable barrier defining at least a chamber, at least one opening, and a fluid outlet. The fluid collection device can also include a porous material disposed in the chamber and a conduit in fluid communication with the chamber. The conduit includes at least one wall at least partially defining at least an inlet, an outlet, and a passageway extending from the inlet to the outlet. The conduit also includes a flow retainer configured to prevent blockage of the passageway.
[0005] In an 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 hold a fluid and a conduit for use in the fluid collection system for collecting one or more bodily fluids from the fluid collection device. The conduit includes at least one wall at least partially defining at least an inlet, an outlet, and apassageway extending from the inlet to the outlet. The inlet includes a flow retainer configured to prevent blockage of the passageway. The fluid collection system also includes a vacuum source fluidly coupled to one or more of the fluid storage container or the fluid collection device via the conduit, the vacuum source configured to draw fluid from the fluid collection device via the conduit to the fluid storage container.
[0006] In an embodiment, a method to collect fluid can include positioning a fluid collection device at least proximate to a urethra of a user. The fluid collection device can include a fluid impermeable barrier defining at least a chamber, at least one opening, and a fluid outlet. The fluid collection device can further include a porous material disposed in the chamber and a conduit disposed in the chamber for collecting one or more bodily fluids. In some embodiments, the conduit can include at least one wall at least partially defining an inlet, an outlet, a passageway extending from the inlet to the outlet, wherein the inlet includes a flow retainer configured to prevent blockage of the passageway. The method can also include receiving fluid discharged from the user in the fluid collection device and receiving fluid discharged from the fluid collection device in a fluid collection container.
[0007] Features from any of the disclosed embodiments may be used in combination with one another, without limitation. In addition, other features and advantages of the present disclosure will become apparent to those of ordinary skill in the art through consideration of the following detailed description and the accompanying drawings.BRIEF DESCRIPTION OF THE DRAWINGS
[0008] The drawings illustrate several embodiments of the present disclosure, wherein identical reference numerals refer to identical or similar elements or features in different views or embodiments shown in the drawings.
[0009] FIG. 1A is a side view of a fluid collection device, according to an embodiment.
[0010] FIG IB is a cross-sectional schematic of the fluid collection device taken along plane IB- IB shown in FIG. 1A, according to an embodiment.
[0011] FIG. 1C is a cross-sectional schematic of the fluid collection assembly taken along plane IB- IB shown in FIG. 1A, according to an embodiment.
[0012] FIG. 2 is a cross-sectional schematic of a conduit, according to an embodiment.
[0013] FIGS. 3A to 3G are cross-sectional schematics of different conduits taken along a plane that parallel to a longitudinal axis of the conduits, according to different embodiments.
[0014] FIG. 3H is a cross-sectional schematic of the conduit shown in FIG. 3G taken along a plane that is perpendicular to a longitudinal axis of the conduit, according to an embodiment.
[0015] FIG. 31 is a cross-sectional schematic of a conduit taken along a plane that is parallel to a longitudinal axis of the conduit, according to an embodiment.
[0016] FIGS. 4A-4C are cross-sectional schematics of different conduits taken along a plane that is parallel to a longitudinal axis of the conduits, according to different embodiments.
[0017] FIG. 5 is a block diagram of a fluid collection system for fluid collection, according to an embodiment.
[0018] FIG. 6 is a flow chart of a method to collect fluid, according to an embodiment.DETAILED DESCRIPTION
[0019] Embodiments disclosed herein include fluid collection assemblies and devices having conduits including at least one wall at least partially defining at least an inlet, an outlet, and a passageway extending from the inlet to the outlet. The conduit can include a flow retainer configured to prevent blockage of the passageway. Embodiments also include fluid collection systems including the fluid collection assemblies, and methods of using and forming the same. An example assembly includes a conduit having at least one wall at least partially defining at least an inlet, and outlet downstream from the inlet, and a passageway extending from the inlet to the outlet. The conduit also includes a flow retainer configured to prevent blockage of the passageway. The flow retainer can be at least partially defined by the inlet and may extend along at least a portion of a length of the conduit measured from the inlet to the outlet. The conduit and assembly may be configured for use in a fluid collection system for collecting one or more bodily fluids (e.g., urine, amniotic fluid, blood, etc.).
[0020] The fluid collection system may include a fluid collection assembly that is configured to receive one or more bodily fluids from a patient. The conduit may be in fluid communication with both the fluid collection assembly and a vacuum source such that a vacuum pressure applied to the conduit by the vacuum source may remove the bodily fluids from the fluid collection assembly. The flow retainer disposed in the conduit is configured to prevent the conduit from being shut off or occluded, such as to prevent the inlet of the conduit from abutting the inside impermeable membrane, or to prevent collapse of the conduit when the vacuum pressure is applied therethrough, which may inhibit the removal of the bodily fluids from the fluid collection assembly.
[0021] The conduits including the flow retainer may be an improvement over a conduit that does not include the flow retainer. The conduits without a flow retainer can have the inlet flush with an interior surface of a fluid collection assembly, which can block fluid from entering the conduit. In some examples, a fluid collection system that includes a vacuum source. Without a flow retainer, the system can lose vacuum suction and cause the vacuum to fail. Further, loss of vacuum or blockage of the passageway can cause the fluid collection assembly to overfill and cause leakage and / or spills.
[0022] The conduit is configured to prevent collapse thereof by preventing blockage of the passageway. Further, the conduit can be manufactured from at least one material exhibiting a Young’s modulus (e.g., modulus of elasticity) and / or a thickness that prevent the collapse of the conduit when the vacuum pressure is applied thereto. For example, the conduit may be formed from transparent polyvinyl chloride and the wall thereof may exhibit a thickness (e.g. , measured parallel to the diameter thereof) that is greater than about 1.5 mm. It is noted that the conduit may be formed from the same material and / or exhibit the same thickness discussed above even when the conduit is used in a fluid collection system that does not include a vacuum source to prevent blockage thereof when using either a gravity drain system or other suitable disposal system.
[0023] The flow retainer may exhibit at least one or a series of openings configured to prevent the blockage of the conduit. In some examples, the opening can have a unique structural design and or additional components included and / or connected to the conduit to ensure flow. Lack of flow may create several issues. In an example, blockage can cause damage to the vacuum and leaks as described above. Further, ensuring proper flow with a flow retainer can enable the manufacture of smaller and more discreet fluid collection assemblies. In an example, the limited flow or blockage may make conforming the fluid collection assembly to the region about the urethral opening of the patient (e.g., an individual using the fluid collection assembly) difficult. For instance, the 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 may minimize bodily fluids from leaking from the fluid collection assembly. However, blockage or flow restrictions into the passageway may reduce the vacuum and also cause the user to bend or straighten or otherwise unbend the fluid collection assembly to correct the issue, which can result in a worse fit.
[0024] As previously discussed, the conduits that include flow retainer disposed in passageway can resolve at least some of the issues of the hollow conduit discussed above.As such, the conduits and flow retainers disclosed herein may be formed from a material exhibiting a Young’s modulus that is less than and / or a thickness that is less than the conduit. The lower Young’s modulus and / or thickness of the conduits disclosed herein allows the conduits disclosed herein to exhibit a flexibility that is greater than the hollow conduit. Further, even if the conduits disclosed herein include shapes and features that provides support to the flow retainer to prevent blockage of the passageway when compared to conduits without a flow retaining feature.
[0025] FIG. 1A is an isometric view of a portion of a fluid collection system 122 that includes a fluid collection assembly 140 that is in fluid communication with a conduit 100, according to an embodiment. FIG. IB is a cross-sectional schematic of the fluid collection assembly 140 taken along plane 1B-1B shown in FIG. 1A, according to an embodiment. The fluid collection assembly 140 is an example of a fluid collection device for receiving and collecting bodily fluids from a female or male. The fluid collection assembly 140 includes a fluid impermeable barrier 142 defining 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 in the chamber 146. The conduit 100 is disposed through the fluid outlet 148 such that an inlet 104 of the conduit 100 is disposed in the chamber 146. Except as otherwise disclosed herein, the conduit 100 may be the same or substantially similar to any of the conduits disclosed herein.
[0026] The fluid impermeable barrier 142 at least partially defines a chamber 146 (e.g. , interior region) and an opening 144. For example, the interior surface(s) 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 the bodily fluids in the chamber 146. The fluid impermeable barrier 142 may be formed of any suitable fluid impermeable material(s), such as a fluid impermeable polymer (e.g. , silicone, polypropylene, polyethylene, polyethylene terephthalate, neoprene, a polycarbonate, etc.), a metal film, natural rubber, another suitable material, any other fluid impermeable material disclosed herein, or combinations thereof. As such, the fluid impermeable barrier 142 substantially prevents the bodily fluids from passing through the fluid impermeable barrier 142. In an example, the fluid impermeable barrier 142 may be air permeable and fluid impermeable. In such an example, the fluid impermeable barrier 142 may be formed of a hydrophobic material that defines a plurality of pores. At least one or more portions of at least an outer surface 154 of the fluid impermeable barrier 142 may be formed from a soft and / or smooth material, thereby reducing chaffing.
[0027] In some examples, the fluid impermeable barrier 142 may be tubular (ignoring the opening), such as substantially cylindrical (as shown), oblong, prismatic, or flattened tubes. During use, the outer surface 154 of the fluid impermeable barrier 142 may contact the patient. The fluid impermeable barrier 142 may be sized and shaped to fit between the labia and / or the gluteal cleft between the legs of a female user.
[0028] The opening 144 provides an ingress route for fluids to enter the chamber 146. The opening 144 may be defined by the fluid impermeable barrier 142 such as by an inner edge of the fluid impermeable barrier 142. For example, the opening 144 is formed in and extends through the fluid impermeable barrier 142, from the outer surface 154 to the inner surface 152, thereby enabling bodily fluids to enter the chamber 146 from outside of the fluid collection assembly 140. The opening 144 may be an elongated hole in the fluid impermeable barrier 142. For example, the opening 144 may be defined as a cut-out in the fluid impermeable barrier 142. The opening 144 may be located and shaped to be positioned adjacent to a female urethra.
[0029] The fluid collection assembly 140 may be positioned proximate to the female urethral opening and the bodily fluids may enter the chamber 146 of the fluid collection assembly 140 via the opening 144. The fluid collection assembly 140 is configured to receive the bodily fluids into the chamber 146 via the opening 144. When in use, the opening 144 may have an elongated shape that extends from a first location below the urethral opening (e.g., at or near the anus or bottom of the vaginal opening) to a second location above the urethral opening (e.g., at or near the top of the vaginal opening or the pubic hair).
[0030] The opening 144 may have an elongated shape because the space between the legs of a female is relatively small, thereby only permitting the flow of the bodily fluids along a path that corresponds to the elongated shape of the opening f44 (e.g. , longitudinally extending opening). The opening 144 in the fluid impermeable barrier 142 may exhibit a length that is measured along the longitudinal axis of the fluid collection assembly 140 that may be at least about 10% of the length of the fluid collection assembly 140, such as about 10% to about 30%, about 25% to about 40%, about 30% to about 60%, about 50% to about 75%, about 65% to about 85%, or about 75% to about 95% of the length of the fluid collection assembly 140.
[0031] The opening 144 in the fluid impermeable barrier 142 may exhibit a width that is measured transverse to the longitudinal axis of the fluid collection assembly 140 that may be at least about 10% of the circumference of the fluid collection assembly 140, suchas about 10% to about 30%, about 25% to about 40%, about 30% to about 60%, about 50% to about 75%, about 65% to about 85%, or about 75% to about 100% of the circumference of the fluid collection assembly 140. The opening 144 may exhibit a width that is greater than 70% of the circumference of the fluid collection assembly 140 since the vacuum (e.g., suction) through the conduit 100 pulls the fluid through the porous material 150 and into the conduit 100. In some examples, the opening 144 may be vertically oriented (e.g., having a major axis parallel to the longitudinal axis of the fluid collection assembly 140). In some examples (not shown), the opening 144 may be horizontally oriented (e.g., having a major axis perpendicular to the longitudinal axis of the fluid collection assembly 140). In an example, the fluid impermeable barrier 142 may be configured to be attached to the patient, such as adhesively attached (e.g., with a hydrogel adhesive) to the patient. According to an example, a suitable adhesive is a hydrogel layer.
[0032] In some examples, the fluid impermeable barrier 142 may define a fluid outlet 148 sized to receive the conduit 100. The at least one conduit 100 may be disposed in the chamber 146 via the fluid outlet 148. The fluid outlet 148 may be sized and shaped to form an at least substantially fluid tight seal against the conduit 100 or the at least one tube thereby substantially preventing the bodily fluids from escaping the chamber 146.
[0033] The fluid impermeable barrier 142 may include markings thereon, such as one or more markings to aid a user in aligning the fluid collection assembly 140 on the patient. For example, a line on the fluid impermeable barrier 142 (e.g., opposite the opening 144) may allow a healthcare professional to align the opening 144 over the urethra of the patient. In examples, the markings may include one or more of alignment guide or an orientation indicator, such as a stripe or hashes. Such markings may be positioned to align the fluid collection assembly 140 to one or more anatomical features such as a pubic bone, etc.
[0034] The fluid collection assembly 140 includes porous material 150 disposed in the chamber 146. The porous material 150 may cover at least a portion (e.g., all) of the 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 of the chamber 146 through the opening 144. In an embodiment, the porous material 150 may be configured to wick any bodily fluids away from the opening 144, thereby preventing the bodily fluids from escaping the chamber 146. The permeable properties referred to herein may be wicking, capillary action, diffusion, or other similar properties or processes, and are referred to herein as “permeable” and / or “wicking.” Such “wicking” and / or “permeable” properties may not include absorption of the bodily fluids into at least aportion of the wicking material, such as not include adsorption of the bodily fluids into the fluid permeable support 158. Put another way, substantially no absorption or solubility of the bodily fluids into the material may take place after the material is exposed to the bodily fluids and removed from the bodily fluids for a time. While no absorption or solubility is desired, the term “substantially no absorption” may allow for nominal amounts of absorption and / or solubility of the bodily fluids into the wicking material (e.g., absorbency), such as less than about 30 wt% of the dry weight of the wicking material, 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 wicking material. The wicking material may also wick the bodily fluids generally towards an interior of the chamber 146, as discussed in more detail below. In an embodiment, the porous material 150 may include at least one absorbent or adsorbent material.
[0035] In an embodiment, the porous material 150 may include the fluid permeable membrane 156 disposed in 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 composed to wick the bodily fluids away from the opening 144, thereby preventing the bodily fluids from escaping the chamber 146.
[0036] In an embodiment, the fluid permeable membrane 156 may include any material that may wick the bodily fluids. For example, the fluid permeable membrane 156 may include fabric, such as a gauze (e.g. , a silk, linen, or cotton gauze), another soft fabric, another smooth fabric, or any of the other porous materials disclosed herein. Forming the fluid permeable membrane 156 from gauze, soft fabric, and / or smooth fabric may reduce chaffing caused by the fluid collection assembly 140.
[0037] The fluid collection assembly 140 may include the fluid permeable support 158 disposed in the chamber 146. The fluid permeable support 158 is configured to support the fluid permeable membrane 156 since the fluid permeable membrane 156 may be formed from a relatively foldable, flimsy, or otherwise easily deformable material. For example, the fluid permeable support 158 may be positioned such that the fluid permeable membrane 156 is disposed between the fluid permeable support 158 and the fluid impermeable barrier 142. As such, the fluid permeable support 158 may support and maintain the position of the fluid permeable membrane 156. The fluid permeable support 158 also provides a matrix to hold fluids, such as water via hydrogen bonding thereto. When a vacuum is applied to the matrix the fluid may be pulled through the matrix. The fluid permeable support 158may include any material that may wick, absorb, adsorb, or otherwise allow fluid transport of the bodily fluids, such as any of the fluid permeable membrane materials disclosed herein above. For example, the fluid permeable membrane material(s) may be utilized in a more dense or rigid form than in the fluid permeable membrane 156 when used as the fluid permeable support 158. The fluid permeable support 158 may be formed from any fluid permeable material that is less deformable than the fluid permeable membrane 156. For example, the fluid permeable support 158 may include a porous polymer (e.g., nylon, polyester, polyurethane, polyethylene, polypropylene, etc.) structure or an open cell foam, such as spun nylon fiber. In some examples, the fluid permeable support 158 may be formed from a natural material, such as cotton, wool, silk, or combinations thereof. In such examples, the material may have a coating to prevent or limit absorption of fluid into the material, such as a water repellent coating. In some examples, the fluid permeable support 158 may be formed from fabric, felt, gauze, or combinations thereof.
[0038] In some examples, the fluid permeable membrane 156 may be optional. For example, the porous material 150 may include only the fluid permeable support 158. In some examples, the fluid permeable support 158 may be optionally omitted from the fluid collection assembly 140. For example, the porous material 150 may only include the fluid permeable membrane 156.
[0039] In an embodiment, the fluid permeable support 158 may be hydrophobic. The fluid permeable support 158 may be hydrophobic when the fluid permeable support 158 exhibits a contact angle with water (a major constituent of bodily fluids) that is greater than about 90°, such as in ranges of about 90° to about 120°, about 105° to about 135°, about 120° to about 150°, about 135° to about 175°, or about 150° to about 180°. The hydrophobicity of the fluid permeable support 158 may limit absorption, adsorption, and solubility of the bodily fluids in the fluid permeable support 158 thereby decreasing the amount of bodily fluids held in the porous material 150. In an embodiment, the fluid permeable membrane 156 is hydrophobic or hydrophilic. In an embodiment, the fluid permeable support 158 is more hydrophobic e.g., exhibits a larger contact angle with water) than the fluid permeable membrane 156. The lower hydrophobicity of the fluid permeable membrane 156 may help the porous material 150 receive the bodily fluids from the urethral opening while the hydrophobicity of the fluid permeable support 158 limits the bodily fluids that are retained in the porous material 150.
[0040] In an embodiment, the porous material 150 includes a non woven material instead of or in addition to at least one of the fluid permeable membrane 156 or the fluidpermeable support. Examples of nonwoven materials that may be included in the porous material 150 are disclosed in U.S. Provisional Patent Application No. 63 / 134,754 filed on January 7, 2021, the disclosure of which was previously incorporated herein.
[0041] The porous material 150 may at least substantially completely fill the portions of the chamber 146 that are not occupied by the conduit 100. In some examples, the porous material 150 may not substantially completely fill the portions of the chamber 146 that are not occupied by the conduit 100. In such an example, the fluid collection assembly 140 includes a reservoir or sump 160 (FIG. IB) disposed in the chamber 146.
[0042] The reservoir 160 may be a substantially unoccupied portion of the chamber 146. The reservoir 160 may be defined between the fluid impermeable barrier 142 and one or both of the fluid permeable membrane 156 and fluid permeable support 158. The bodily fluids that are in the chamber 146 may flow through the fluid permeable membrane 156 and / or fluid permeable support 158 to the reservoir 160. The reservoir 160 may retain of the bodily fluids therein.
[0043] The bodily fluids that are in the chamber 146 may flow through the fluid permeable membrane 156 and / or fluid permeable support 158 to the reservoir 160. The fluid impermeable barrier 142 may retain the bodily fluids in the reservoir 160. While depicted in the distal end region 162, the reservoir 160 may be located in any portion of the chamber 146 such as the proximal end region 164. The reservoir 160 may be located in a portion of the chamber 146 that is designed to be located in a gravimetrically low point of the fluid collection assembly when the fluid collection assembly is worn.
[0044] In some examples (not shown), the fluid collection assembly 140 may include multiple reservoirs, such as a first reservoir that is located at the portion of the chamber 146 closest to the inlet of the conduit 100 (e.g., distal end region 162) and a second reservoir that is located at the portion of the of the chamber 146 that is at or near proximal end region 164). In another example, the fluid permeable support 158 is spaced from at least a portion of the conduit 100, and the reservoir 160 may be the space between the fluid permeable support 158 and the conduit 100.
[0045] The conduit 100 may be at least partially disposed in the chamber 146. The conduit 100 may be used to remove the bodily fluids from the chamber 146. The conduit 100 includes at least one wall 102 or barrier defining an inlet 104, an outlet (not shown) downstream from the inlet 104, and a passageway 108. The inlet 104 may include a flow retainer 110 configured to prevent blockage of the passageway 108. The outlet of the conduit 100 may be operably coupled to a vacuum source, such as a vacuum pump forwithdrawing fluid from the chamber 146 through the conduit 100. For example, the conduit 100 may extend into the fluid impermeable barrier 142 from the proximal end region 164 and may extend to the distal end region 162 to a point proximate to the reservoir 160 therein such that the inlet 104 is in fluid communication with the reservoir 160. The conduit 100 fluidly couples the chamber 146 with the fluid storage container (not shown) or the vacuum source (not shown).
[0046] The conduit 100 may extend through a bore in the porous material 150. In an embodiment, the conduit 100 extends from the fluid outlet 148, through the bore, to a location that is proximate to or in the reservoir 160. In some embodiments, the inlet 104 may not extend into the reservoir 160 and, instead, the inlet 104 may be disposed within the porous material 150 (fluid permeable membrane 156 and / or fluid permeable support 158) or at a terminal end 166 thereof. For example, an end of the conduit 100 may be coextensive with or recessed within the fluid permeable membrane 156 and / or fluid permeable support 158. The bodily fluids collected in the fluid collection assembly 140 may be removed from the chamber 146 via the conduit 100.
[0047] Locating the inlet 104 at or near a location expected to be the gravimetrically low point of the chamber 146 when worn by a patient enables the conduit 100 to receive more of the bodily fluids than if inlet 104 was located elsewhere and reduce the likelihood of pooling (e.g., pooling of the bodily fluids may cause microbe growth and foul odors). For instance, the bodily fluids in the fluid permeable membrane 156 and the fluid permeable support 158 may flow in any direction due to capillary forces. However, absent a vacuum force, the bodily fluids may exhibit a preference to flow in the direction of gravity, especially when at least a portion of the fluid permeable membrane 156 and / or the fluid permeable support 158 is saturated with the bodily fluids. Accordingly, one or more of the inlet 104, flow retainer 110, or the reservoir 160 may be located in the fluid collection assembly 140 in a position expected to be the gravimetrically low point in the fluid collection assembly 140 when worn by a patient, such as the distal end region 162.
[0048] As described in more detail below, the conduit 100 is configured to be coupled to, and at least partially extend between, one or more of the fluid storage container (not shown) and the vacuum source (not shown). In an example, the conduit 100 is configured to be directly connected to the vacuum source (not shown). In such an example, the conduit 100 may extend from the fluid impermeable barrier 142 by at least one foot, at least two feet, at least six feet, or at least ten feet. In another example, the conduit 100 is configured to be indirectly connected to at least one of the fluid storage container (not shown) and thevacuum source (not shown). In some examples, the conduit is secured to a patient’s skin with a catheter securement apparatus, such as a STATLOCK® catheter securement apparatus 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 disclosures of which are all incorporated herein by reference in their entirety.
[0049] The inlet 104 and the outlet of the conduit 100 are configured to fluidly couple (e.g., directly or indirectly) the vacuum source (not shown) to the chamber 146 (e.g., the reservoir 160). As the vacuum source (FIG. 5) applies a vacuum / suction in the conduit 100, the bodily fluids in the chamber 146 e.g., at the distal end region 162 such as in the reservoir 160) may be drawn into the inlet 104 and out of the fluid collection assembly 140 via the conduit 100. The vacuum source can include a pump or other suitable mechanism. In some examples, the conduit may be frosted or opaque (e.g., black) to obscure visibility of the bodily fluids therein.
[0050] As previously discussed, the conduit 100 may be configured to be at least insertable into the chamber 146. In an example, the conduit 100 may be positioned in the chamber 146 such that a terminal end of the conduit 100 is spaced from the fluid impermeable barrier 142 or other components of the fluid collection assembly 140 that may at least partially obstruct or block the inlet 104. Further, the inlet 104 of the conduit 100 may be offset relative to a terminal end 166 of the porous material 150 such that the inlet 104 is closer to the proximal end region 164 of the fluid collection assembly 140 than the terminal end of the porous material 150. However, when the inlet 104 of the conduit 100 is not offset, the flow retainer 110 prevents the conduit 100 from sealing to the fluid impermeable barrier 142 or other components and allows the conduit 100 to receive bodily fluids through the flow retainer 110. For example, the conduit 100 may receive bodily fluids directly from the porous material 150 and, due to hydrogen bonding retaining water in the porous material 150, may pull more bodily fluids from the porous material 150. In some examples, the inlet 104 of the conduit 100 may extend into the reservoir 160 such as to the terminal end of the fluid impermeable barrier 142 in the chamber 146. Without the flow retainer 110, the conduit 100 may become at least partially occluded when the inlet 104 contacts the fluid impermeable barrier 142.
[0051] The flow retainer 110 may be oriented in (e.g., facing) a selected direction, such as a direction opposite the opening 144. Such a configuration orients the flow retainer 110 in or near the gravimetrically low point of the chamber 146 when the fluid collection assembly 140, such as when a wearer or user is supine, laying, or standing. In someexamples, the inlet 104 may be closed to only allow fluid to flow into the conduit 100 via the flow retainer 110.
[0052] The conduit 100 may include one or more markers (not shown) on an exterior thereof that are located to facilitate insertion of the conduit 100 into the chamber 146 and correct placement of the inlet 104 in the chamber 146. For example, the conduit 100 may include one or more markings thereon that are configured to prevent over or under insertion of the conduit 100, such as to prevent the fluid impermeable barrier 142 from obstructing or blocking the inlet 104. In another example, the conduit 100 may include one or more markings thereon that are configured to facilitate correct rotation of the conduit 100 relative to the chamber 146 to ensure the at least one flow retainer 110 is facing a selected direction, such as away from the opening 144. The one or more markings may include a line, a dot, a sticker, or any other suitable marking.
[0053] 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 on June 2, 2017; U.S. Patent Application No. 15 / 260,103 filed on September 8, 2016; and U.S. Patent No. 10,390,989 filed on September 8, 2016, the disclosure of each of which is incorporated herein, in its entirety, by this reference.
[0054] In some examples, the flow retainer may extend past the terminal end of the porous material. For example, the conduit 100 may be at least partially disposed in the reservoir 160 and the terminal end of the conduit (e.g., inlet 104) and flow retainer 110 may extend into or be positioned in the reservoir 160.
[0055] FIG. 1C is a cross-sectional schematic of the fluid collection assembly 140 taken along plane IB- IB shown in FIG. 1A, according to an embodiment. The conduit 100c may be similar or identical to the conduit 100 in one or more aspects. As shown, the conduit 100c may not include the inlet 104. In such examples, the terminal end (e.g., distal end) of the conduit 100c may be closed off, such as by a wall similar or identical to the at least one wall 102. The flow retainer 110 may be the only route of fluid flow through the conduit 108. In such examples, the flow retainer 110 can be considered the inlet. The flow retainer 110 may face away from the opening 144, such as 180 degrees away from the opening 144. The flow retainer 110 may be spaced from the terminal end of the conduit by a distance, such as at least 1 mm away from the terminal end of the conduit 100c, at least 5 mm, at least 1 cm, 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, less than 3 cm, or less than 1.5 cm from the terminal end of the conduit 100c.By spacing the flow retainer 110 from the terminal end of the conduit 100c, the flow retainer may be prevented from becoming occluded by contact with the (domed shape of the) fluid impermeable barrier in the reservoir 160 or by compression of the reservoir 160 from external forces. By keeping the flow retainer 110 relatively near the terminal end of the reservoir, the flow retainer may be maintained close to a gravimetrically low point of the fluid collection assembly to ensure fluid intake therethrough.
[0056] In some embodiments (not shown), the terminal end of the conduit (e.g., inlet 140) may be disposed in the reservoir 160 and the flow retainer 110 may be disposed within the bore (e.g., in contact with the porous material 150). By spacing the flow retainer 110 from the terminal end of the conduit and within the bore of the porous material, the flow retainer 110 may be maintained in contact with the porous material at or near the distal end of the fluid collection assembly and prevented from becoming occluded by the domed shape of the reservoir or compressive forces applied thereto. The porous material 150 may provide structural support to keep the flow retainer 110 from being pinched shut or otherwise blocked.
[0057] FIG. 2 is a cross-sectional schematic of a conduit 200, according to an embodiment. The conduit 200 includes at least one wall 202. The wall 202 defines at least an inlet 204, and outlet 206 downstream from the inlet 204, and a passageway 208 extending from the inlet 204 to the outlet 206. The inlet 204 may be configured to be connected to, disposed in a chamber of, or otherwise in fluid communication with (e.g. , via another conduit) a fluid collection assembly (not shown). The outlet 206 is configured to be connected to or otherwise in fluid communication with (e.g., via another conduit or a fluid storage container) a vacuum source (not shown). The passageway 208 forms a fluid flow path that may remove bodily fluids from a fluid collection assembly (not shown) and deposit the removed bodily fluids in a fluid storage container. The conduit 200 also a flow retainer 210 disposed in the at least one wall 202, defining the inlet 204, and / or and at least partially occupying the passageway 208. The flow retainer 210 is described in greater detail below and is configured to prevent blockage of the passageway 208 from occlusion at the inlet 204, viscous fluids, or solids.
[0058] The wall 202 may be formed from any suitable fluid impermeable material. In an embodiment, the wall 202 may be formed from a material that is conventionally used to form hollow conduits. In such an embodiment, the fluid impermeable wall 202 may be formed from polyvinyl chloride. In an embodiment, the wall 202 may be formed from one or more materials exhibiting a Young’s modulus that is less than polyvinyl chloride. Thewall 202 may be formed from a material exhibiting a Young’s modulus that is similar to polyvinyl chloride because the flow retainer 210 is disposed in and / or through the wall 202 and thus removes support from at least a portion of the wall 202. Examples of such materials include polyethylene (e.g. , low density polyethylene, high density polyethylene, and ultrahigh molecular weight polyethylene), polypropylene, polytetrafluoroethylene, nitrile, nylon, ethylene vinyl acetate, a thermoplastic elastomer, or combinations thereof. In an embodiment, the wall 202 may be formed from a material exhibiting a Young’s modulus that is greater the polyvinyl chloride. In such an embodiment, the wall 202 may exhibit a thickness that allows the conduit 200 to exhibit a flexibility that is less than or equal to a conduit that is formed from polyvinyl chloride.
[0059] The wall 202 may exhibit a thickness t measured perpendicular to the longitudinal axis 212 of the conduit 200. The thickness of the wall 202 may be selected based on the desired flexibility of the conduit 200, the strength of the conduit, the effect of the flow retainer 210, and the Young’s modulus of the material(s) that form the wall 202. The wall 202 may exhibit a thickness that is comparable to or greater than a conventional conduit because at least one of the flow retainer 210 features removes a portion of the conduit 200 compared to the conventional conduit or the wall 202 may be formed from a material exhibiting a Young’s modulus that is less than polyvinyl chloride. Selecting the wall 202 to exhibit a thickness t that is comparable to or greater than the conventional conduit allows at least one of the conduit 200 to have vacuum pressures applied thereto without collapsing, and also can accommodate more viscous fluids or larger solid content.
[0060] In an embodiment, the wall 202 may exhibit a thickness t that is greater than the conventional conduit. For example, the wall 202 may exhibit a thickness that is about 0.05 mm or greater, about 0.1 mm or greater, about 0.15 mm or greater, about 0.2 mm or greater, about 0.25 mm or greater, about 0.3 mm or greater, about 0.35 mm or greater, about 0.4 mm or greater, about 0.45 mm or greater, about 0.5 mm or greater, about 0.6 mm or greater, about 0.7 mm or greater, about 0.8 mm or greater, about 0.9 mm or greater, about 1 mm or greater, about 1.1 mm or greater, about 1.2 mm or greater, about 1.3 mm or greater, about 1.4 mm or greater, about 1.5 mm or greater, or in ranges 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 about1.2 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. The wall 202 disclosed herein may be able to exhibit such thicknesses because of the support required to the conduit flow retainer 210 from the wall 202, even when the wall 202 may be formed from material(s) that exhibit a Young’s modulus that is greater than polyvinyl chloride.
[0061] Generally, the average person discharges urine at a rate of about 6 ml / s to about 50 ml / s, such as at a rate of about 10 ml / s to about 25 ml / s. The rate at which the person urinate may vary, such as based on the size of the person and the age of the person. The conduit flow retainer 210 and / or inlet 204 may be selected to exhibit a flow rate that is comparable to the rate at which the average person discharges urine to prevent oversaturation of the fluid collection assembly (e.g., fluid collection device) to which the conduit 200 is attached with bodily fluids which may cause leaks. For example, the conduit flow retainer 210 may be selected to exhibit a flow rate that is 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 ranges of about 6 ml / s to about 10 ml / s, about 8 ml / s to about 12 ml / s, about 10 ml / s to about 15 ml / s, about 12.5 ml / s to about 17.5 ml / s, about 15 ml / s to about 20 ml / s, about 17.5 ml / s to about 22.5 ml / s, about 20 ml / s to about 25 ml / s, about 22.5 ml / s to about 27.5 ml / s, about 25 ml / s to about 30 ml / s, about 27.5 ml / s to about 35 ml / s, about 30 ml / s to about 40 ml / s, about 35 ml / s to about 45 ml / s, or about 40 ml / s to about 50 ml / s. As used herein, the flow rate may refer to the flow rate of the bodily fluids in the conduit flow retainer 210 when the conduit flow retainer 210 is at least one of immersed with the bodily fluids, not immersed with the bodily fluids, under a vacuum pressure, or when no vacuum pressure is applied to the passageway 208 (e.g. , the bodily fluids flow only due to wicking and / or gravity).
[0062] The conduit 200 is illustrated with a break between the inlet 204 and the outlet 206. The break indicates that the conduit 200 may exhibit any length. In an example, the conduit 200 may exhibit a length that is about 1 cm or greater, about 15 cm or greater, about 30 cm or greater, about 45 cm or greater, about 60 cm or greater, about 75 cm or greater, about 90 cm or greater, about 105 cm or greater, about 120 cm or greater, about 150 cm or greater, about 180 cm or greater, 210 cm or greater, about 240 cm or greater, about 265 cm or greater, about 300 cm or greater, or in ranges 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 180cm to about 240 cm, about 210 cm to about 265 cm, or about 240 cm to about 300 cm. For example, the conduit 200 may exhibit a length of about 1 cm to about 15 cm when the conduit 200 forms a bendable elbow connector between the conduit 200 and another conduit or a fluid collection assembly, a length of about 10 cm to about 40 cm when the conduit 200 is predominately disposed only in a fluid collection assembly, or a length greater than about 35 cm when the conduit 200 extends a significantly distance from the fluid collection assembly.
[0063] The passageway 208 may exhibit a maximum lateral dimension LD. The maximum lateral dimension LD may be the diameter of the passageway 208 when the passageway 208 exhibits a generally cylindrical shape. The maximum lateral dimension LD may be selected to be about 4 mm or greater, about 5 mm or greater, about 6 mm or greater, about 7 mm or greater, about 8 mm or greater, about 9 mm or greater, about 10 mm or greater, about 12 mm or greater, about 14 mm or greater, about 16 mm or greater, about 18 mm or greater, about 20 mm or greater, about 25 mm or greater, or in ranges of about 4 mm to about 6 mm, about 5 mm to about 7 mm, about 6 mm to about 8 mm, about 7 mm to about 9 mm, about 8 mm to about 10 mm, about 9 mm to about 12 mm, about 10 mm to about 14 mm, about 12 mm to about 16 mm, about 14 mm to about 18 mm, about 16 mm to about 20 mm, or about 18 mm to about 25 mm. The maximum lateral dimension LD may be selected based on a number of factors. In an example, the maximum lateral dimension LD may be selected based on the desired flow rate of bodily fluids in the passageway 208, wherein increasing the maximum lateral dimension LD increases the flow rate assuming a constant velocity of fluid flow through the conduit (e.g., Q=A*v where Q is the flow rate, A is the cross-sectional area, and v is the velocity of the bodily fluids in the passageway 208). In an example, the maximum lateral dimension LD is selected based on the device. As used herein, the device(s) refers to the device(s) to which the conduits disclosed herein are, can be, or are configured to be attached to and may include the inlet and / or outlet of at least one of a fluid collection assembly (e.g., fluid collection device), a fluid storage container, a vacuum source, or a hollow conduit. For instance, the maximum lateral dimension LD may be selected to be slightly smaller (e.g., the conduit 200 expands), equal to, or slightly larger than the dimension of the device if the conduit 200 forms a female attachment with the device. Also, the maximum lateral dimension LD may be selected to be smaller than the dimension of the device when the conduit 200 forms a male attachment with the device.
[0064] As previously discussed, the wall 202 defines a passageway 208 and at least a portion of the passageway 208 is kept clear from blockage by the flow retainer 210. The flow retainer 210 may inhibit collapse and kinking of the conduit 200 when a vacuum pressure is applied to the conduit 200 and when the conduit inlet 204 is pressed against a surface or otherwise obstructed. The flow retainer 210 may also direct the bodily fluids that are pulled into the conduit 200 (e.g., via the vacuum pressure or capillary action) towards the outlet 206. The flow retainer 210 may define a plurality openings and / or features through which the bodily fluids may flow.
[0065] Referring to FIG. 3A, the conduit 300a includes at least one wall 302a defining a passageway 308a and an inlet 304a at least one flow retainer 310a. The flow retainer 310a can include a notch defined by the inlet 304a. In other words, a portion of the conduit 300a at the inlet 304a is cutout to form an irregular surface at the inlet 304a. For example, the conduit 300a has an arch cut from the inlet 304a, which ensures that the passageway 308a at or near the inlet 304a is not blocked when the inlet 304a is disposed against an impermeable surface.
[0066] FIG. 3B shows a conduit 300b that is similar to the conduit 300a. The conduit 300b includes at least one wall 302b defining a passageway 308b and an inlet 304b at least one flow retainer 310b. The flow retainer 310b can include a tapered inlet 304b. In other words, a portion of the conduit 300b at the inlet 304b is cutout to form a tapered edge or a pointed inlet 304b. For example, the conduit 300b has an angle cut from the inlet 304b, which again ensures that the passageway 308b at or near the inlet 304b is not blocked when the inlet 304b is disposed against an impermeable surface.
[0067] Another example flow retainer 310c is shown in FIG. 3C. FIG. 3C shows a conduit 300c that includes at least one wall 302c defining a passageway 308c and an inlet 304c and the flow retainer 310c. In this example, the flow retainer 310c can include a semicircular cutout of a portion of the at least one wall 302c. In some examples the flow retainer 310c can be disposed at or near the inlet 304c. In other words, the inlet 304c defines a first opening and the flow retainer 310c defines an opening in the at least one wall 302c. For example, The distance from the flow retainer 310c to the inlet 304c may be selected to be disposed 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, about 9 mm or less, about 10 mm or less, about 12 mm or less, about 14 mm or less, about 16 mm or less, about 18 mm or less, about 20 mm or less, about 25 mm or less r, or in ranges of about 4 mm to about 6 mm, about 5 mm to about 7 mm, about 6 mm to about 8 mm, about 7 mm to about 9 mm, about 8 mmto about 10 mm, about 9 mm to about 12 mm, about 10 mm to about 14 mm, about 12 mm to about 16 mm, about 14 mm to about 18 mm, about 16 mm to about 20 mm, or about 18 mm to about 25 mm.
[0068] Referring to FIG. 3D, in some examples, a conduit 300d that includes at least one wall 302d defining a passageway 308d and an inlet 304d and the flow retainer 310d. In this example, the flow retainer 310d can include a series of semicircular cutouts extending from or near the inlet 304d to or near the outlet (not shown). In other words, the inlet 304d defines a first opening and the flow retainer 310d defines a series of openings in the at least one wall. In an example where the conduit 300d is disposed within an elongated fluid collection assembly or device, the series of semicircular cutouts can provide a greater flow rate and less probability of clogging than other examples. The series of semicircular cutout flow retainers 3 lOd can be spaced apart a distance of about mm or less, about 5 mm or less, about 6 mm or less, about 7 mm or less, about 8 mm or less, about 9 mm or less, about 10 mm or less, about 12 mm or less, about 14 mm or less, about 16 mm or less, about 18 mm or less, about 20 mm or less, about 25 mm or less r, or in ranges of about 4 mm to about 6 mm, about 5 mm to about 7 mm, about 6 mm to about 8 mm, about 7 mm to about 9 mm, about 8 mm to about 10 mm, about 9 mm to about 12 mm, about 10 mm to about 14 mm, about 12 mm to about 16 mm, about 14 mm to about 18 mm, about 16 mm to about 20 mm, or about 18 mm to about 25 mm. In some examples, the series of semicircular cutout flow retainers 310d are disposed only on a single surface or direction of the at least one wall 302d. In other examples, the series of semicircular cutout flow retainers 310d can be disposed about the perimeter of the wall 302d. One benefit of having the series of semicircular cutout flow retainers 310d disposed on a singular side or surface is to prevent the vacuum from potentially drawing air and not withdrawing the liquid fluid from the assembly, which would result in stagnant liquid and could cause infections and / or more frequent replacement of the assembly.
[0069] The flow retainer 110, 210, 310a, 310b, 310c, or 310d may be oriented in a direction facing away from the opening of the fluid collection assembly containing the conduit. In such examples, the flow retainer is positioned and oriented to be positioned in a gravimetrically low point and direction of the fluid collection assembly. By positioning the flow retainer on a single side or surface of the conduit, the vacuum may be prevented from drawing air (not withdrawing the liquid) from the assembly.
[0070] FIG. 3E shows a conduit 300e that is similar to the conduit 300a. The conduit 300e includes at least one wall 302e defining a passageway 308e and an inlet 304e at leastone flow retainer 310e. The flow retainer 310e can include a serrated edge defining the inlet 304e. In other words, a portion of the conduit 300e at the inlet 304e is cutout to form a jagged, but uniform edge having a series of pointed extensions surrounding the inlet 304e. For example, the conduit 300e has a series of angles cut from the inlet 304e, which again ensures that the passageway 308e at or near the inlet 304e is not blocked when the inlet 304e is disposed against an impermeable surface.
[0071] FIG. 3F shows a conduit 300f that is similar to the conduit 300e. The conduit 300f includes at least one wall 302f defining a passageway 308f and an inlet 304f at least one flow retainer 310f. The flow retainer 3 lOf can include a wavy inlet 304f. In other words, a portion of the conduit 300f at the inlet 304f is cutout to form a wavy edge or an inlet 304f that has smooth extensions that would not trap solid particles as easily. For example, the conduit 300f has a pattern with a series of curved extensions cut from the inlet 304f, which again ensures that the passageway 3O8f at or near the inlet 304f is not blocked when the inlet 304f is disposed against an impermeable surface.
[0072] Another example flow retainer 310g is shown in FIG. 3G. FIG. 3G shows a conduit 300g that includes at least one wall 302g defining a passageway 308g and an inlet 304g and the flow retainer 310g. In this example, the flow retainer 310g can include a semicircular cutout or extension that extends from a portion of the at least one wall 302g beyond the inlet 304g. In other words, the flow retainer 310g includes a looped extension extending from the outlet of the conduit 300g. The flow retainer 310g can include polymer, metal, or any other at least semi-rigid material. The flow retainer 310g provides clearance between the inlet 304g and other portions of a fluid collection device containing the conduit 300g, such as the fluid impermeable barrier. In some examples the flow retainer 310g can be disposed past or more distal to the inlet 304g. For example, the distance from the apex of the flow retainer 310g to the inlet 304g may be selected to be disposed 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 in ranges of about 4 mm to about 6 mm, about 5 mm to about 7 mm, about 6 mm to about 8 mm, about 7 mm to about 9 mm, or about 8 mm to about 10 mm. In some examples, the flow retainer can include wires disposed (e.g., circled or spiraled) around the conduit.
[0073] FIG. 3H shows a cross-sectional schematic of the conduit 300g shown in FIG. 3G taken along a plane that is parallel to a longitudinal axis of the conduit 300g. As shown, the fluid can flow into the inlet 304g from between the flow retainer 310g and the inlet304g. In some examples, the flow retainer 310g ensures the inlet 304g is not blocked when the inlet 304g is disposed against an impermeable surface.
[0074] In some examples, the flow retainer can include a strainer or filter configured to couple to the inlet of the conduit. Referring to FIG. 31, the conduit 300i includes at least one wall 302i defining a passageway 3O8i and an inlet 304i at least one flow retainer 3 lOi connected to the inlet 304i. The flow retainer 3 lOi can include a strainer configured to alter the flow path of the fluid entering the inlet 304i. In some examples, the flow retainer 3 lOi can include a filter configured to block solids from entering the passageway 308i. In other words, the conduit 300i at the inlet 304i can include a filter apparatus attached to the inlet 304i. For example, the conduit 300i can have the flow retainer 3 lOi connected to the inlet 304i by an adhesive, an interference fit, or other suitable attachment method to couple the flow retainer 3 lOi to the inlet 304i. In some examples, the flow retainer 3 lOi can include the same material as the conduit 300i (e.g., polyvinyl chloride). In other examples, the flow retainer 3 lOi can include a different material, such as a metal or membrane material. For example, the flow retainer 3 lOi can include a plastic housing and a metal strainer disposed within the housing. In some examples, the flow retainer 310i can further include a membrane disposed within the housing. The membrane can be configured to separate different fluids and / or filter smaller particulates that passed through the strainer.
[0075] The filter apparatus can include spun plastic, such as the fluid permeable support material. The filter apparatus can prevent the inlet from becoming sealed against the inside of the fluid impermeable barrier, while also allowing the flow of fluids therethrough, such as through the fluid permeable support material (e.g., filter apparatus) disposed over the inlet.
[0076] In some examples, a conduit can be used in a fluid collection system for collecting one or more bodily fluids. Referring to FIG. 4A, a conduit 400a can include a wall 402a at least partially defining an inlet 404a and an outlet (not shown) and a passageway 408a. In some examples, the flow of bodily fluids at the outlet is parallel with the conduit 400a and the flow of bodily fluids 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 the orientation of the inlet 404a. In some examples, the passageway 408 can further include a filter 410 disposed therein. The filter 410 can be disposed over the inlet 404a in some embodiments and in other embodiments, the filter can be disposed within the passageway 408a, as shown in FIG. 4A. In some examples, the inlet 404a can exhibit a generally circular cross-sectional shape. The shape or size of the inlet 404a can beconfigured to maximize flow into the passageway 408a and to prevent blockage of the passageway 408a. For example, the inlet 404a may be circular, rectangular, serrated, or any other shape.
[0077] FIG. 4B shows a conduit 400b that is similar to the conduit 400a. The conduit 400b includes at least one wall 402b defining a passageway 408b and an inlet 404b. The inlet 404b can include a series of inlets 404b that can further increase flow into the passageway 408b. In other words, the conduit 400a can include a series of semicircular cutouts as the inlet 404b to or near the outlet (not shown). In other words, the inlet 404b defines a first opening 404b 1 and also a second opening 404b2. In an example where the conduit 400b is disposed within an elongated fluid collection assembly or device, the series of semicircular cutouts can provide a greater flow rate and less probability of clogging than other examples. The series of semicircular cutout inlets 404b can be spaced apart a distance of about mm or less, about 5 mm or less, about 6 mm or less, about 7 mm or less, about 8 mm or less, about 9 mm or less, about 10 mm or less, about 12 mm or less, about 14 mm or less, about 16 mm or less, about 18 mm or less, about 20 mm or less, about 25 mm or less r, or in ranges of about 4 mm to about 6 mm, about 5 mm to about 7 mm, about 6 mm to about 8 mm, about 7 mm to about 9 mm, about 8 mm to about 10 mm, about 9 mm to about 12 mm, about 10 mm to about 14 mm, about 12 mm to about 16 mm, about 14 mm to about 18 mm, about 16 mm to about 20 mm, or about 18 mm to about 25 mm. In some examples, the series of semicircular cutout inlets 404b are disposed only on a single surface or direction of the at least one wall 402b. In other examples, the series of semicircular cutout inlets 404b can be disposed about the perimeter of the wall 402b.
[0078] The inlet 404a or 404b may be oriented in a direction facing away from the opening of the fluid collection assembly containing the conduit. In such examples, the inlet 404a and 404b is positioned and oriented to be positioned in a gravimetrically low point and direction of the fluid collection assembly. By positioning the inlet on a single side or surface of the conduit, the vacuum may be prevented from drawing air (not withdrawing the liquid) from the assembly.
[0079] FIG. 4C shows a conduit 400c that is similar to the conduit 400b, but includes a series of inlet 404c opening disposed about the perimeter of a wall 402c. One benefit of having the series of semicircular cutout inlets 404c disposed on a singular side or surface is to prevent the vacuum from potentially drawing air and not withdrawing the liquid fluid from the assembly, which would result in stagnant liquid and could cause infections and / or more frequent replacement of the assembly.
[0080] FIG. 5 is a block diagram of a fluid collection system 500 for fluid collection, according to an 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 may be fluidly coupled to each other via one or more conduits. For example, as illustrated, 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.
[0081] In an embodiment, the first conduit 508a can be any of the conduit (e.g., tube) embodiments described above. In an example, the conduit can include a flow retainer configured to prevent blockage of the conduit. In an example, the flow retainer can be located at the inlet of the conduit or can be configured as the inlet of the conduit. In an embodiment, the second conduit 508b does not include a flow retainer. However, the second conduit can include a filter or a strainer as described above. In an 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 an example, the first conduit 508a may be in direct fluid communication with the fluid collection assembly 502 and may extend from the fluid collection assembly 502 only part of the distance between the fluid collection assembly 502 and the fluid storage container 504. As such, the fluid collection system 500 may include a conduit that is connected to the outlet of the first conduit 508a and extends from the first conduit 508a to the fluid storage container 504.
[0082] The fluid collection assembly 502 may be similar or identical to any of the fluid collection assemblies or devices disclosed herein in one or more aspects. The fluid collection assembly 502 may be shaped and sized to be positioned adjacent to a female urethral opening or have a male urethral opening positioned there through (e.g., receive a penis therein). For example, the fluid collection assembly 502 may include a fluid impermeable barrier at least partially defining a chamber (e.g., interior region) of the fluid collection assembly 502. The fluid impermeable barrier also defines at least one opening extending there through from the external environment. The opening may be positioned adjacent to a female urethral opening or have a male urethral opening positioned there through. The fluid collection assembly 502 may include 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 502 includes one or more of any of the securement bodies disclosed herein.
[0083] The fluid storage container 504 is sized and shaped to retain the bodily fluids therein. The fluid storage container 504 may include a bag (e.g., drainage bag), a bottle or cup (e.g., collection jar), or any other enclosed container for storing bodily fluids such as urine. In some examples, the first conduit 508a may extend from the fluid collection assembly 502 and attach to the fluid storage container 504 at a first point therein. The second conduit 508b may attach to the fluid storage container 504 at a second point thereon and may extend and attach to the vacuum source 506. Accordingly, a vacuum (e.g., suction) may be drawn through fluid collection assembly 502 via the fluid storage container 504. Fluid, such as urine, may be drained from the fluid collection assembly 502 using the vacuum source 506.
[0084] The vacuum source 506 may include one or more of a manual vacuum pump, and electric vacuum pump, a diaphragm pump, a centrifugal pump, a displacement pump, a magnetically driven pump, a peristaltic pump, or any pump configured to produce a vacuum. The vacuum source 506 may provide a vacuum or suction to remove fluid from the fluid collection assembly 502. In some examples, the vacuum source 506 may be powered by one or more of a power cord (e.g., connected to a power socket), one or more batteries, or even manual power (e.g., a hand operated vacuum pump). In some examples, the vacuum source 506 may be sized and shaped to fit outside of, on, or within the fluid collection assembly 502. For example, the vacuum source 506 may include one or more miniaturized pumps or one or more micro pumps. The vacuum source 506 may include one or more of a switch, a button, a plug, a remote, or any other device suitable to activate the vacuum source 506.
[0085] FIG. 6 a flow chart of a method 600 to collect fluid, according to an embodiment. The method 600 includes an act 602 of positioning a fluid collection device at least proximate to a urethra of a user and an act 604 of receiving fluid discharged from the user in a fluid collection device. The method 600 also includes an act 606 of receiving fluid discharged from the fluid collection device in a fluid collection container. In some embodiments, the method 600 may further include using a pump to pull a vacuum on a first conduit in fluid communication with the fluid collection device effective to draw fluid from the fluid collection device and into the fluid collection container. The method 600 may include any of the fluid collection systems and / or devices described or incorporated by reference herein. For example, the 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 in the chamber, and a conduit in fluid communication with thechamber. The conduit may include at least one wall at least partially defining an inlet, an outlet, and a passageway extending from the inlet to the outlet, wherein the inlet includes a flow retainer configured to prevent blockage of the passageway. In many embodiments, the flow of bodily fluids at the outlet of the fluid collection device is parallel with the conduit and the flow of bodily fluids at the inlet is perpendicular to the conduit.
[0086] It should be appreciated that the acts of the method 600 described above are for illustrative purposes. For example, the acts of the method 600 can be performed in different orders, split into multiple acts, modified, supplemented, or combined. In an embodiment, one or more of the acts of the method 600 can be omitted from the method 600. Any of the acts of the method 600 can include using any of the fluid collection systems or assemblies disclosed herein.
[0087] As used herein, the term “about” or “substantially” refers to an allowable variance of the term modified by “about” or “substantially” by ±10% or ±5%. Further, the terms “less than,” “or less,” “greater than,” “more than,” or “or more” include, as an endpoint, the value that is modified by the terms “less than,” “or less,” “greater than,” “more than,” or “or more.”
[0088] While various aspects and embodiments have been disclosed herein, other aspects and embodiments are contemplated. The various aspects and embodiments disclosed herein are for purposes of illustration and are not intended to be limiting.
[0089] Terms of degree (e.g., “about,” “substantially,” “generally,” etc.) indicate structurally or functionally insignificant variations. In an example, when the term of degree is included with a term indicating quantity, the term of degree is interpreted to mean ± 10%, ±5%, or +2% of the term indicating quantity. In an example, when the term of degree is used to modify a shape, the term of degree indicates that the shape being modified by the term of degree has the appearance of the disclosed shape. For instance, the term of degree may be used to indicate that the shape may have rounded corners instead of sharp corners, curved edges instead of straight edges, one or more protrusions extending therefrom, is oblong, is the same as the disclosed shape, etc.
Claims
CLAIMSWe claim:
1. A fluid collection device, comprising: a fluid impermeable barrier defining at least a chamber, at least one opening, and a fluid outlet; a porous material disposed in the chamber; and a conduit in fluid communication with the chamber, the conduit including: at least one wall at least partially defining: an inlet; an outlet; and a passageway extending from the inlet to the outlet, wherein the inlet includes a flow retainer configured to prevent blockage of the passageway.
2. The device of claim 1, wherein the at least one wall includes polyvinyl chloride.
3. The device of any one of claims 1 or 2, wherein the flow retainer includes a notch defined by the inlet.
4. The device of claim 1, wherein the flow retainer includes at least one semicircular cutout of a portion of the at least one wall.
5. The device of claim 1, wherein one or more of the flow retainer or the inlet extends past a distal end of the porous material.
6. The device of claim 1, wherein the flow retainer includes a tapered inlet.
7. The device of claim 1, wherein the flow retainer includes a serrated edge at the inlet.
8. The device of any one of claims 1-7, wherein the outlet defines a first opening and the flow retainer defines a second opening in the at least one wall, and a terminal end of the conduit is closed.
9. The device of claim 1 , wherein the flow retainer includes a strainer configured to couple to the inlet of the conduit.
10. The device of claim 9, wherein the flow retainer and the conduit are constructed of the same material.
11. The device of claim 9, wherein the flow retainer includes a different material than the conduit.
12. The device of claim 1 , wherein the flow retainer includes a looped extension extending from the outlet of the conduit.
13. A fluid collection system, comprising: a fluid storage container configured to hold a fluid; a fluid collection device; a conduit for use in the fluid collection system for collecting one or more bodily fluids from the fluid collection device, the conduit comprising: at least one wall at least partially defining at least: an inlet; an outlet; and a passageway extending from the inlet to the outlet, wherein the conduit includes a flow retainer configured to prevent blockage of the passageway; and a vacuum source fluidly coupled to one or more of the fluid storage container or the fluid collection device via the conduit, the vacuum source configured to draw fluid from the fluid collection device via the conduit to the fluid storage container.
14. The system of claim 13, wherein the inlet further includes a filter disposed therein.
15. The system of any of claims 13 or 14, wherein the inlet exhibits a generally circular cross-sectional shape.
16. A method to collect fluid, the method comprising; positioning a fluid collection device at least proximate to a urethra of a user, wherein the fluid collection device includes: a fluid impermeable barrier defining at least a chamber, at least one opening, and a fluid outlet; a porous material disposed in the chamber; and a conduit in fluid communication with the chamber, the conduit including: at least one wall at least partially defining: an inlet; an outlet; and a passageway extending from the inlet to the outlet, wherein the inlet includes a flow retainer configured to prevent blockage of the passageway; receiving fluid discharged from the user in the fluid collection device; andreceiving fluid discharged from the fluid collection device in a fluid collection container.
17. The method of claim 16, wherein the fluid impermeable barrier defines a reservoir and the inlet of the conduit is positioned adjacent to the reservoir, the conduit extending through the fluid outlet.
18. The method of claim 16, wherein the fluid impermeable barrier includes a distal end region and a proximal end region opposite the distal end region, wherein a reservoir is at least partially defined 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.
19. The method of claim 16, wherein the conduit occupies substantially all of the chamber that is not occupied by the porous material.
20. The method of claim 16, further comprising using a pump to pull a vacuum through the conduit in fluid communication with the fluid collection device effective to draw fluid from the fluid collection device and into the fluid collection container.