WO2025193541A1 - Drainage port assemblies - Google Patents
Drainage port assembliesInfo
- Publication number
- WO2025193541A1 WO2025193541A1 PCT/US2025/018913 US2025018913W WO2025193541A1 WO 2025193541 A1 WO2025193541 A1 WO 2025193541A1 US 2025018913 W US2025018913 W US 2025018913W WO 2025193541 A1 WO2025193541 A1 WO 2025193541A1
- Authority
- WO
- WIPO (PCT)
- Prior art keywords
- collar
- connector
- drainage port
- port assembly
- state
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Pending
Links
Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F5/00—Orthopaedic methods or devices for non-surgical treatment of bones or joints; Nursing devices ; Anti-rape devices
- A61F5/44—Devices worn by the patient for reception of urine, faeces, catamenial or other discharge; Colostomy devices
- A61F5/4404—Details or parts
- A61F5/4407—Closure means other than valves
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F5/00—Orthopaedic methods or devices for non-surgical treatment of bones or joints; Nursing devices ; Anti-rape devices
- A61F5/44—Devices worn by the patient for reception of urine, faeces, catamenial or other discharge; Colostomy devices
- A61F5/4404—Details or parts
- A61F5/4405—Valves or valve arrangements specially adapted therefor ; Fluid inlets or outlets
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F5/00—Orthopaedic methods or devices for non-surgical treatment of bones or joints; Nursing devices ; Anti-rape devices
- A61F5/44—Devices worn by the patient for reception of urine, faeces, catamenial or other discharge; Colostomy devices
- A61F5/451—Genital or anal receptacles
- A61F5/453—Genital or anal receptacles for collecting urine or other discharge from male member
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F5/00—Orthopaedic methods or devices for non-surgical treatment of bones or joints; Nursing devices ; Anti-rape devices
- A61F5/44—Devices worn by the patient for reception of urine, faeces, catamenial or other discharge; Colostomy devices
- A61F5/451—Genital or anal receptacles
- A61F5/455—Genital or anal receptacles for collecting urine or discharge from female member
Definitions
- a person or animal may have limited or impaired mobility so typical urination processes are challenging or impossible. For example, a person may experience or have a disability that impairs mobility. A person may have restricted travel conditions such as those experienced by pilots, drivers, and workers in hazardous areas. Additionally, sometimes bodily fluids collection is needed for monitoring purposes or clinical testing.
- Urinary catheters such as a Foley catheter
- urinary catheters can be uncomfortable, painful, and can lead to complications, such as infections.
- bed pans which are receptacles used for the toileting of bedridden individuals, are sometimes used. However, bedpans can be prone to discomfort, spills, and other hygiene issues.
- a fluid collection assembly includes a fluid impermeable barrier defining a chamber, an opening, and a fluid outlet.
- the fluid impermeable barrier includes a proximal end region defining the opening and a distal end region defining the fluid outlet.
- the fluid collection assembly also includes at least one porous material disposed in the chamber and a drainage port assembly.
- the drainage port assembly includes a collar defining a collar passageway extending through at least a portion of the collar and a connector including an engagement portion attached to or integrally formed with the collar and a conduit attachment portion distinct from the engagement portion.
- the conduit attachment portion is configured to be attached to a conduit.
- the connector defines a connector passageway extending from the engagement portion to the conduit attachment portion.
- the connector is configured to move relative to the collar.
- the drainage port assembly attached to the distal end region of the fluid impermeable barrier and positioned to have the fluid outlet and a collar passageway extending through the collar aligned to allow bodily fluids received in the chamber to flow out of the chamber through the fluid outlet and into the collar passageway.
- a drainage port assembly in an embodiment, includes a collar defining a collar passageway extending through at least a portion of the collar and a connector including an engagement portion attached to or integrally formed with the collar and a conduit attachment portion distinct from the engagement portion.
- the conduit attachment portion is configured to be attached to a conduit.
- the connector defines a connector passageway extending from the engagement portion to the conduit attachment portion. The connector is configured to move relative to the collar.
- a method of using a drainage port assembly includes providing a drainage port assembly.
- the drainage port assembly includes a collar defining a collar passageway extending through at least a portion of the collar and a connector including an engagement portion attached to or integrally formed with the collar and a conduit attachment portion distinct from the engagement portion.
- the conduit attachment portion is configured to be attached to a conduit.
- the connector defines a connector passageway extending from the engagement portion to the conduit attachment portion.
- the connector is configured to move relative to the collar.
- the method also includes moving the connector relative to the collar.
- FIG. 1A is an isometric view of a fluid collection assembly including a drainage port assembly, according to an embodiment.
- FIG. IB is a cross-sectional view of the fluid collection assembly taken along plane 1B-1B.
- FIG. 1C is a cross-sectional view of the fluid collection assembly taken along plane 1B-1B with the drainage port assembly omitted.
- FIG. ID is a block diagram of a fluid collection system for fluid collection, according to an embodiment.
- FIG. 2A is an isometric view of a drainage port assembly, according to an embodiment.
- FIG. 2B is a cross-sectional view of the drainage port assembly taken along plane 2B-2B.
- FIGS. 3A and 3B are isometric views of a drainage port assembly exhibiting a first state and a second state, respectively, according to an embodiment.
- FIGS. 3C and 3D are cross-sectional views of the drainage port assembly taken along planes 3C-3C and 3D-3D, respectively.
- FIGS. 4A and 4B are isometric views of a drainage port assembly exhibiting a first state and a second state, respectively, according to an embodiment.
- FIGS. 4C and 4D are cross-sectional views of the drainage port assembly taken along planes 4C-4C and 4D-4D, respectively.
- FIG. 5A is an isometric view of a drainage port assembly, according to an embodiment.
- FIG. 5B is a cross-sectional view of the drainage port assembly taken along plane 5B-5B.
- FIG. 6A is an isometric view of a drainage port assembly, according to an embodiment.
- FIGS. 6B and 6C are cross-sectional views of the drainage port assembly in the first and second states taken along plane 6B-6B.
- FIG. 6D is a cross-sectional view of a portion of the drainage port assembly taken along plane 6D-6D.
- FIG. 7A is an isometric view of a drainage port assembly, according to an embodiment.
- FIG. 7B is a cross-sectional view of the drainage port assembly taken along plane 7B-7B.
- An example drainage port assembly includes a collar and a connector.
- the connector includes an engagement portion that is attached to or integrally formed with the collar and the conduit attachment portion that is distinct from the engagement portion.
- the engagement portion is configured to allow the conduit attachment portion to move relative to the collar.
- the collar and the connector define a collar passageway extending through the collar and a connector passageway extending through the connector, respectively.
- the movement of the conduit attachment portion relative to the collar switches the drainage port assembly between a first state and a second state, wherein the drainage port assembly permits flow of bodily fluids therethrough when in the first state (e.g., through the collar passageway and the connector passageway) and restricts the flow of the bodily fluids therethrough w hen in the second state.
- the drainage port assembly may form part of a fluid collection assembly.
- the fluid collection assembly may include a fluid impermeable barrier defining a chamber, an opening, and a fluid outlet.
- the fluid collection assembly may also include at least one porous material disposed in the chamber.
- the drainage port assembly may be attached to the fluid impermeable barrier.
- the collar may include at least one interfacing surface that is attached to the fluid impermeable barrier. The collar may be positioned on the fluid impermeable barrier such that the collar passageway is aligned with the fluid outlet thereby allowing bodily fluids received in the chamber to be removed from the chamber through the fluid outlet and through the collar and connector passageways of the drainage port assembly, for example, when the drainage port assembly is in the first state.
- the fluid collection assembly is positioned on an individual such that the opening of the fluid impermeable barrier is positioned adjacent to a urethral opening of an individual (e.g. , a female urethral opening or the urethral opening of a buried penis) or have a penis at least partially received through the opening and into the chamber.
- the individual may discharge one or more bodily fluids (e.g., urine, sweat, menstrual fluids, etc.) and the bodily fluids may be received into the chamber.
- the bodily fluids received in the chamber may be received by the porous material and may flow generally towards the fluid outlet.
- Bodily fluids that reach the fluid outlet may flow out of the chamber through the fluid outlet and into the collar and connector passageways of the drainage port assembly, for example, when the drainage port assembly is in the first state.
- the drainage port assembly may be connected to a conduit such that the bodily fluids that flow through the drainage port assembly enter the conduit and flow away from the fluid collection assembly through the conduit.
- a vacuum may be applied to the chamber using a vacuum source that is in fluid communication with the chamber via the conduit and the drainage port assembly.
- the vacuum source may facilitate moving the bodily fluids towards the fluid outlet and pulling the bodily fluids into the conduit via the fluid outlet and the collar and connector passageways of the drainage port assembly.
- the vacuum may also pull the bodily fluids received into the conduit into a fluid storage container.
- the drainage port assemblies disclosed herein are an improvement over conventional fluid outlets of conventional fluid collection assemblies.
- at least some conventional fluid collection assemblies either include a conduit directly attached to a fluid impermeable material thereof or to a rigid structure attached to the fluid impermeable material.
- the conduits extend from the conventional fluid collection assemblies in a fixed direction relative to the conventional fluid collection assemblies. For instance, during use, the fixed direction that the conduits extend from the conventional fluid collection assemblies may be towards the feet of the individual.
- the conduit may extend from the fluid collection assembly to a vacuum source and/or a fluid storage container.
- the conduit may need to have one or more bends formed therein for the conduit to reach the vacuum source and/or the fluid storage container.
- the fixed direction that the conduits extend from the conventional fluid collection assemblies may prevent the conduit from extending to the vacuum source and/or the fluid storage container in a direct path without forming one or more bends therein and, instead, may necessitate forming one or more tight or otherwise disadvantageous bends in the conduit for the conduit to reach the vacuum source and/or the fluid storage container.
- Such tight or otherwise disadvantageous bends in the conduit may cause the conduit to kink which, in turn, impedes removal of bodily fluids from the conventional fluid collection assemblies and increases the likelihood that the conventional fluid collection assemblies leak.
- the conduit may move during use of the fluid collection assembly, such as when the individual moves.
- the conduit may be initially arranged such that there are no kinks in the conduit.
- conduit to kink especially since the fixed direction that the conduit extends from the conventional fluid collection assemblies minimizes the ability for the conduit to accommodate such movement without kinking.
- the inability of the conduit to accommodate movement of the individual may also cause the conventional fluid collection assemblies to at least one of pull on the individual or cause the conventional fluid collection assemblies to twist, kink, or otherwise deform in a manner that may impede flow of the bodily fluids in the conventional fluid collection assemblies towards the fluid outlet.
- the drainage port assemblies disclosed herein are an improvement over such fluid collection assemblies since, as previously discussed, the connector of the drainage port assemblies disclosed herein can move relative to the collar.
- the movement of the connector relative to the collar allows the conduit to extend from the fluid collection assembly generally directly towards the fluid storage container and/or the vacuum source or may prevent or decrease the likelihood that the conduit needs to form tight or otherwise disadvantageous bends to reach the fluid storage container and/or the vacuum source.
- the movement of the connector relative to the collar decreases the likelihood that kinks form in the conduit.
- the movement of the connector relative to the collar allows the conduit to better accommodate movement of the individual without kinking the conduit, minimizes pulling on the individual, or twisting, kinking, or otherwise deforming the fluid collection assembly.
- Another issue associated with conventional fluid collection assemblies involves disconnecting the conventional fluid collection assemblies from a fluid storage container and/or a vacuum source.
- situations may arise during the operation of the conventional fluid collection assemblies that require disconnecting the conventional fluid collection assemblies from the fluid storage container and/or the vacuum source.
- Such situations include moving the patient from one location (e.g., room or building) to another location, replacing a faulty vacuum source, or emptying a full fluid storage container.
- disconnecting the conventional fluid collection assemblies from the fluid storage container and/or the vacuum source runs the risk of the individual discharging bodily fluids (e.g.. urinating) while the conventional fluid collection assemblies are disconnected.
- the bodily fluids discharged from the individual are received into the conventional fluid collection assemblies and either leak out the fluid outlet or the conduit extending from the fluid outlet. Disconnecting the conventional fluid collection assemblies from the fluid storage container and/or the vacuum source also runs into issues when used with individuals who can control the discharge of their bodily fluids since any bodily fluids that are present in the conventional fluid collection assemblies may still leak from the fluid outlet or the conduit extending from the fluid outlet.
- Some fluid collection assemblies attempt to resolve this issue by including a cap that is configured to cover the fluid outlet, the conduit extending from the outlet, or a rigid structure attached to the fluid outlet thereby restricting flow of the bodily fluids out of the fluid collection assemblies when disconnected from the fluid storage container and/or the vacuum source.
- a cap that is configured to cover the fluid outlet, the conduit extending from the outlet, or a rigid structure attached to the fluid outlet thereby restricting flow of the bodily fluids out of the fluid collection assemblies when disconnected from the fluid storage container and/or the vacuum source.
- the drainage port assemblies disclosed herein resolve this issue associated with conventional fluid collection assemblies.
- the drainage port assemblies disclosed herein are configured to allow the conduit attachment portion to rotate or otherwise move relative to the collar. Such movement of the conduit attachment portion relative to the collar may be leveraged to selectively permit or restrict the flow of bodily fluids through the drainage port assembly.
- the drainage port assembly may exhibit a first state that allows the bodily fluids to flow through the drainage port assembly and a second state that restricts flow of the bodily fluids through the drainage port assembly. Movement of the conduit attachment portion relative to the collar may be used to switch the drainage port assembly between these states thereby allowing the fluid collection assemblies to be detached from the fluid storage container or the vacuum source without the risk of leaking.
- the drainage port assemblies disclosed herein resolves the issue associated with disconnecting the fluid storage container and/or vacuum source without the associated issues with using a cap.
- FIG. 1A is an isometric view of a fluid collection assembly 100 including a drainage port assembly 144, according to an embodiment.
- FIG. IB is a cross-sectional view of the fluid collection assembly 100 taken along plane 1B-2B.
- FIG. 1C is a cross- sectional view of the fluid collection assembly 100 taken along plane 1B-1B with the drainage port assembly 144 omitted.
- the fluid collection assembly 100 is an example of a male fluid collection assembly though, in some embodiments, the fluid collection assembly 100 may be used to receive bodily fluids from a female urethral opening.
- the fluid collection assembly 100 includes a sheath 102 and a base 104.
- the base 104 is configured to be attached (e.g, permanently attached to or configured to be permanently attached) to the sheath 102.
- the base 104 is also configured to be attached to the region about the urethral opening (e.g, penis) of the individual.
- the sheath 102 includes a fluid impermeable barrier 106.
- the fluid impermeable barrier 106 at least partially defines a chamber 112 (e.g., interior region) and an opening 114.
- a chamber 112 e.g., interior region
- an opening 114 the interior surface(s) of the fluid impermeable barrier 106 at least partially defines the chamber 112 within the fluid collection assembly 100.
- the fluid impermeable barrier 106 temporarily stores the bodily fluids in the chamber 112.
- the fluid impermeable barrier 106 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.
- a fluid impermeable polymer e.g, silicone, polypropylene, polyethylene, polyethylene terephthalate, neoprene, a polycarbonate, etc.
- a metal film e.g, natural rubber, another suitable material, any other fluid impermeable material disclosed herein, or combinations thereof.
- the fluid impermeable barrier 106 substantially prevents the bodily fluids from passing through the fluid impermeable barrier 106.
- the fluid impermeable barrier 106 may be air permeable and fluid impermeable.
- the fluid impermeable barrier 106 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 of the fluid impermeable barrier 106 may be formed from a soft and/or smooth material, thereby reducing chaffing.
- the fluid impermeable barrier 106 may include one or more vacuum relief openings 137 that include a hole extending through the fluid impermeable barrier 106 and a water-impermeable, air permeable membrane covering the hole.
- the fluid impermeable barrier 106 may be relatively rigid.
- the fluid impermeable barrier 106 may be able to generally maintain a selected shape thereof (e.g, a generally planar or three-dimensional shape) when unsupported.
- the fluid impermeable barrier 106 may be at least partially formed from a top panel 122 and a bottom panel 124.
- the top panel 122 and the bottom panel 124 may be attached or integrally formed together (e.g, exhibits single piece construction, such as when the top panel 122 and the bottom panel 124 form a tubular structure or a folded sheet).
- the top panel 122 and the bottom panel 124 are distinct sheets.
- the fluid impermeable barrier 106 also defines a chamber 112 between the top panel 122 and the bottom panel 124, an opening 114 at a proximal end region 108 of the sheath 102. and a fluid outlet 116 at a distal end region 110 of the sheath 102.
- the sheath 102 also includes at least one porous material 118 disposed in the chamber 112.
- the inner surface(s) of the fluid impermeable barrier 106 (e.g.. inner surfaces of the top and bottom panels 122, 124) at least partially defines the chamber 112 within the fluid collection assembly 100.
- the fluid impermeable barrier 106 temporarily stores the bodily fluids in the chamber 112.
- the fluid impermeable barrier 106 may be formed from any of the fluid impermeable materials disclosed herein. As such, the fluid impermeable barrier 106 substantially prevents the bodily fluids from passing through the fluid impermeable barrier 106.
- At least one of the top panel 122 or the bottom panel 124 is formed from an at least partially transparent fluid impermeable material, such as polyethylene, polypropylene, polycarbonate, or polyvinyl chloride. Forming at least one of the top panel 122 or the bottom panel 124 from an at least partially transparent fluid impermeable material allows a person (e.g., medical practitioner) to examine the penis. In some embodiments, both the top panel 122 and the bottom panel 124 are formed from at least partially transparent fluid impermeable material.
- the chamber 112 may include a penis receiving area 130 that is configured to receive the penis of the individual when the penis extends into the chamber 112.
- the penis receiving area 130 may be defined by at least the porous material 118 and at least a portion of the at least partially transparent material of the top panel 122 and/or the bottom panel 124.
- the porous material 118 is positioned in the chamber 112 such that the porous material 118 is not positioned between the penis and at least a portion of the transparent portion of the top panel 122 and/or bottom panel 124 when the penis is inserted into the chamber 112 through the opening 1 14.
- the porous material 118 is generally not transparent and, thus, the portion of the at least partially transparent material of the top panel 122 and/or the bottom panel 124 that defines the penis receiving area 130 forms a window which allows the person to view into the penis receiving area 130 and examine the penis.
- the opening 114 defined by the fluid impermeable barrier 106 provides an ingress route for bodily fluids to enter the chamber 112 when the penis is a buried penis and allow the penis to enter the chamber 112 (e.g., the penis receiving area 130) when the penis is not buried.
- the opening 114 may be defined by the fluid impermeable barrier 106 (e.g., an inner edge of the fluid impermeable barrier 106).
- the opening 114 is formed in and extends through the fluid impermeable barrier 106 thereby enabling bodily fluids to enter the chamber 112 from outside of the fluid collection assembly 100.
- the fluid impermeable barrier 106 defines the fluid outlet 1 16 (shown in FIG. 1C).
- the fluid outlet 116 is a hole formed in the fluid impermeable barrier 106.
- the fluid outlet 116 may be formed at or near the distal end region 110 of the fluid impermeable barrier 106.
- the drainage port assembly 144 may be attached to the portions of the fluid impermeable barrier 106 that define the fluid outlet 116.
- the drainage port assembly 144 may include any of the drainage port assemblies disclosed herein.
- the drainage port assembly 144 may be attached to the fluid impermeable barrier 106 using any suitable technique.
- the portions of the fluid impermeable barrier 106 defining the fluid outlet 116 may be positioned (e.g., sandwiched) between a collar 145 and the annular base 149. That said, the portions of the fluid impermeable barrier 106 defining the fluid outlet 116 may be attached to the drainage port assembly 144 using other attachment techniques, such as an adhesive, welding, or sewing.
- the fluid outlet 116 may be aligned with the passageways of the drainage port assembly 144 such that bodily fluids may flow out of the chamber 112 through the fluid outlet 116 and the passageways of the drainage port assembly 144.
- the sheath 102 includes at least one porous material 118 disclosed in the chamber 112.
- the porous material 118 may direct the bodily fluids to one or more selected regions of the chamber 112, such as away from the penis and towards the fluid outlet 1 16.
- the porous material 1 18 may be formed from any of the porous materials disclosed herein.
- the porous material 118 may be formed from a single layer, two layers (e.g., a fluid permeable membrane extending across the opening 114 and a fluid permeable support since the fluid permeable membrane may be formed from a relatively foldable, flimsy, or otherwise easily deformable material), or three or more layers.
- the porous material 118 may be formed from a nonwoven material or a woven material (c.g.. spun nylon fibers).
- the porous material 118 may include at least one material exhibiting substantially no absorption, or at least one absorbent or adsorbent material.
- the porous material 118 may be configured to wick any bodily fluids away from the opening 114, thereby preventing the bodily fluids from escaping the chamber 112.
- 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 a portion of the porous material 118, such as not including adsorption of the bodily fluids into the fluid permeable support. Put another way, substantially no absorption or solubility 7 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.
- the term “substantially no absorption” may allow for nominal amounts of absorption and/or solubility of the bodily fluids into the porous material 118 (e.g, absorbency), such as less than about 30 wt% of the dry weight of the porous material 118, less than about 10 wt%, less than about 7 wt%, less than about 5 wt%, less than about 3 wt%, less than about 2 wt%, less than about 1 wt%, or less than about 0.5 wt% of the dry' weight of the porous material 118.
- the porous material 118 may also wick the bodily fluids generally towards an interior of the chamber 112, as discussed in more detail below.
- the porous material 118 may include at least one absorbent or adsorbent material.
- the fluid permeable membrane may be optional.
- the porous material 118 may include only the fluid permeable support.
- the fluid permeable support may be optionally omitted from the fluid collection assembly 7 100.
- the porous material 118 may only include the fluid permeable membrane.
- the porous material 118 may be hydrophobic.
- the porous material 118 may be hydrophobic when the porous material 118 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 porous material 118 may limit absorption, adsorption, and solubility 7 of the bodily 7 fluids in the porous material 118 thereby decreasing the volume of bodily fluids held in the porous material 118.
- at least a portion of the porous material 118 is hydrophobic or hydrophilic.
- the fluid permeable support is more hydrophobic (e.g.. exhibits a larger contact angle with water) than the fluid permeable membrane.
- the lower hydrophobicity 7 of the fluid permeable membrane may help the porous material 118 receive the bodily fluids from the urethral opening while the hydrophobicity of the fluid permeable support limits the bodily fluids that are retained in the porous material 118.
- the porous material 118 may include the fluid permeable membrane disposed in the chamber 112.
- the fluid permeable membrane may be positioned to at least extend across at least a portion (e.g. , all) of the opening 114.
- the fluid permeable membrane may be composed to wick the bodily fluids away from the opening 114, thereby preventing the bodily fluids from escaping the chamber 112.
- the fluid permeable membrane may include any material that may wick the bodily fluids.
- the fluid permeable membrane may include fabric, such as a gauze (e.g, a silk, linen, or cotton gauze), another soft fabric, another smooth fabric, a nonwoven material, or any of the other porous materials disclosed herein. Forming the fluid permeable membrane from gauze, soft fabric, and/or smooth fabric may reduce chaffing caused by the fluid collection assembly 100.
- the fluid collection assembly 100 may include the fluid permeable support disposed in the chamber 112.
- the fluid permeable support is configured to support the fluid permeable membrane, since the fluid permeable membrane may be formed from a relatively foldable, flimsy, or otherwise easily deformable material.
- the fluid permeable support may be positioned such that the fluid permeable membrane is disposed between the fluid permeable support and the fluid impermeable barrier 106.
- the fluid permeable support may support and maintain the position of the fluid permeable membrane.
- the fluid permeable support may 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.
- the fluid permeable membrane material(s) may be utilized in a more dense or rigid form than in the fluid permeable membrane when used as the fluid permeable support.
- the fluid permeable support may be formed from any fluid permeable material that is less deformable than the fluid permeable membrane.
- the fluid permeable support may include a porous polymer (e.g., nylon, polyester, polyurethane, polyethylene, polypropylene, etc.) structure or an open cell foam, such as spun nylon fiber.
- the fluid permeable support may include a nonwoven material.
- the fluid permeable support 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.
- the fluid permeable support may be formed from fabric, felt, gauze, or combinations thereof.
- the fluid permeable membrane may include first layer and a second layer.
- the first layer may be positioned to generally receive bodily fluid before the second layer.
- the first layer may include hydrophilic polypropylene or hydrophilic polyethylene (e.g, polypropylene or polyethylene including a polyethylene glycol fatty acid ester surfactant or otherwise treated to be hydrophilic) and the second layer may include bamboo.
- the first layer and the second layer may have a synergistic effect that allows the first layer to quickly receive bodily fluids therein, move the bodily fluids from the first layer into the second layer, and maintain the first layer relatively dry.
- the hydrophilicity of the first layer allows the first layer to quickly receive bodily fluids, such as to initially receive bodily fluids that are discharged from the urethral opening of the individual.
- the bamboo second layer may exhibit a hydrophilicity that is greater than (z.e., exhibits a contact angle with water that is less than) the first layer.
- the greater hydrophilicity’ of the bamboo second layer pulls bodily fluids from the first layer and into the second layer, thereby facilitating quick transfer of bodily fluids from the first layer to the second layer.
- the greater hydrophilicity of the bamboo second layer also helps dry the first layer since the hydrophilic pull from the bamboo second layer removes most of the bodily fluids from the first layer.
- the dry first layer minimizes discomfort caused by using a fluid collection assembly including the porous material, minimizes skin degradation caused by the bodily fluids, and allows the fluid collection assembly including the porous material to be used for longer periods of time (e.g., greater than 24 hours).
- the first layer and the second layer may be positioned adjacent to a polyethylene terephthalate (“PET”) fluid permeable support since the bamboo second layer is able to transfer bodily fluids quickly and effectively into the PET fluid permeable support thereby preventing the first and second layers from becoming saturated with bodily fluids.
- PET polyethylene terephthalate
- the PET fluid permeable support is able to quickly move substantially all of the bodily fluids towards a fluid outlet such that the PET fluid permeable support is substantially dry a short period of time after receiving the bodily fluids.
- the dry PET fluid permeable support facilitates drying of the particular first and second layers of this example.
- the PET fluid permeable support may include a nonwoven material and, more particularly a vertical lapped nonwoven material, since such nonwoven materials facilitate drawing fluids into the PET fluid permeable support from the bamboo second layer and improve flow of the bodily fluids in the PET fluid permeable support towards the fluid outlet thereby facilitating dry ing of the porous material 118.
- first layer and/or the second layer may include porous materials other than hydrophilic polypropylene/polyethylene and bamboo, respectively, as discussed in more detail herein. Further, the first layer and/or the second layer may be used with an inner fluid permeable support other than PET, as discussed in more detail herein.
- porous material 118 are disclosed in PCT International Application No. PCT/US2022/011281 fded on January 5, 2022, PCT International Application No. PCT/US2022/042719 filed on September 7, 2022, PCT International Application No. PCT/US2022/042725 filed on September 7, 2022, U.S. Provisional Patent Application No. 63/241,564 filed on September 8, 2021.
- the porous material 118 may be a sheet. Forming the porous material 118 as a sheet may facilitate the manufacturing of the fluid collection assembly 100. For example, forming the porous material 118 as a sheet allows the top panel 122, the bottom panel 124, and the porous material 118 to each be sheets . During the manufacturing of the fluid collection assembly 100, the top panel 122, the bottom panel 124, and the porous material 118 may be stacked and then attached to each other in the same manufacturing step. For instance, the porous material 118 may exhibit a shape that is the same size or, more preferably, slightly smaller than the size of the top panel 122 and the bottom panel 124.
- attaching the top panel 122 and the bottom panel 124 together along the outer edges thereof may also attach the porous material 1 18 to the top panel 122 and the bottom panel 124.
- the porous material 118 may be slightly smaller than the top panel 122 and the bottom panel 124 such that the top panel 122 and/or the bottom panel 124 extend around the porous material 118 such that the porous material 118 does not form a passageway through the fluid impermeable barrier 106 through which the bodily fluids may leak.
- attaching the porous material 118 to the top panel 122 and/or the bottom panel 124 may prevent the porous material 118 from significantly moving in the chamber 112, such as preventing the porous material 118 from bunching together near the fluid outlet 116.
- the porous material 118 may be attached to the top panel 122 or the bottom panel 124 (e.g., via an adhesive) before or after attaching the top panel 122 to the bottom panel 124.
- the porous material 118 may merely be disposed in the chamber 112 without attaching the porous material 118 to at least one of the top panel 122 or the bottom panel 124.
- the porous material 118 may exhibit shapes other than a sheet, such as a hollow generally cylindrical shape.
- the porous material 118 may include a passageway extending therethrough that allows a nonburied penis to extend through the porous material 118 when the penis receiving area 130 is between the porous material 118 and the top panel 122.
- the sheath 102 is substantially flat when the penis is not in the penis receiving area 130 and the sheath 102 is resting on a flat surface.
- the sheath 102 is substantially flat because the fluid impermeable barrier 106 is formed from the top panel 122 and the bottom panel 124 instead of a generally tubular fluid impermeable barrier.
- the porous material 118 may be a sheet, which also causes the sheath 102 to be substantially flat.
- the sheath 102 may also be substantially flat because the fluid collection assembly 100 may not include relatively rigid rings or caps that exhibit a rigidity that is greater than the portions of the fluid impermeable barrier 106 thereabout, since such rings and caps may inhibit the sheath 102 being substantially flat.
- the sheath 102 is described as being substantially flat because at least one of the porous material 118 may cause a slight bulge to form in the sheath 102 depending on the thickness of the porous material 118, the fluid outlet 116 and/or conduit 142 may cause a bulge thereabout, or the base 104 may pull on portions of the sheath 102 thereabout. It is also noted that the sheath 102 may also be compliant and, as such, the sheath 102 may not be substantially flat during use since, during use, the sheath 102 may rest on anon-flat surface (e.g., may rest on the testicles, the perineum, and/or between the thighs) and the sheath 102 may conform to the surface of these shapes.
- anon-flat surface e.g., may rest on the testicles, the perineum, and/or between the thighs
- the ability of the sheath 102 to be substantially flat when the penis is not in the penis receiving area 130 and the sheath 102 is resting on a flat surface allows the fluid collection assembly 100 to be used with a buried and a non-buried penis.
- the penis does not extend into the penis receiving area 130 which causes the sheath 102 to lie relatively flat across the aperture 120 of the base 104.
- the porous material 118 extends across the opening 114 and the aperture 120 and is in close proximity to the buried penis.
- the porous material 118 prevents or inhibits pooling of bodily fluids discharged from the buried penis against the skin of the individual since the porous material 118 will receive and remove at least a significant portion of the bodily fluids that would otherwise pool against the skin of the individual.
- the skin of the individual remains dry thereby improving comfort of using the fluid collection assembly 100 and preventing skin degradation.
- the fluid collection assembly 100 may still be used with a non-buried penis since the nonburied penis can still be received into the penis receiving area 130, even when the penis is fully erect.
- the ability of the sheath 102 to be substantially flat allows the fluid collection assembly 100 to be used more discretely than if the sheath 102 was not substantially flat, thereby avoiding possibly embarrassing scenarios.
- the porous material 118 occupies substantially all of the chamber 112 and the penis receiving area 130 is collapsed (shown as being non-collapsed in FIGS. IB and 1C for illustrative purposes to show the penis receiving area 130).
- the sheath 102 may not define a region that is constantly unoccupied by the porous material 118.
- the porous material 118 occupies substantially all of the chamber 112. the bodily fluids discharged into the chamber 112 are unlikely to pool for significant periods of time since pooling of the bodily fluids may cause sanitation issues, cause an odor, and/or may cause the skin of the individual to remain in contact with the bodily fluids, which may cause discomfort and skin degradation.
- the top panel 122, the bottom panel 124, and the porous material 118 may be selected to be relatively flexible.
- the top panel 122, the bottom panel 124, and the porous material 118 are relatively flexible when the top panel 122, the bottom panel 124, and the porous material 118, respectively, are unable to maintain their shape when unsupported.
- the flexibility of the top panel 122, the bottom panel 124, and the porous material 118 may allow the sheath 102 to be substantially flat, as discussed above.
- the flexibility of the top panel 122, the bottom panel 124, and the porous material 118 may also allow the sheath 102 to conform to the shape of the penis even when the size and shape of the penis changes (e.g., becomes erect) and to minimize any unoccupied spaces in the chamber 112 in which bodily fluids may pool.
- at least the top panel 122 may be relatively rigid. The top panel
- the 122 is relatively rigid when the top panel 122 maintains a shape thereof when a vacuum applied to the chamber 112.
- the vacuum applied to the chamber 112 may be (in either absolute or gauge) about 40 kPa or less, about 30 kPa or less, about 20 kPa or less, or about 5 kPa to about 15 kPa.
- the relative rigidity of the top panel 122 prevents the collapse of the top panel 122 during use.
- at least some conventional male fluid collection assemblies are formed from non-rigid panel(s) (e.g., flimsy and compliant panel(s)). When a vacuum is applied to the conventional male fluid collection assemblies, air in the conventional fluid collection assemblies is removed and the non-rigid panel(s) collapse.
- the collapsed panels may cover the urethral opening of the penis thereby preventing or at least inhibiting the individual from discharging urine into the conventional male fluid collection assemblies.
- the relatively rigid top panel 122 is unlikely to collapse when a vacuum is applied to the chamber 112.
- the relative rigidity of the top panel 122 prevents the top panel 122 from covering the urethral opening of the penis.
- the relatively rigid top panel 122 may still be flexible and soft thereby allowing the fluid collection assembly 100 to be comfortable to use.
- the fluid collection assembly 100 is configured to rest on top of the thighs of the individual during use.
- the relatively rigid top panel 122 may still be able to allow the fluid collection assembly 100 to fall between the thighs of the individual when the individual opens the individual’s thighs thereby preventing uncomfortable pulling on the area about the penis if the fluid collection assembly 100 was not flexible.
- the relatively rigid top panel 122 may easily collapse if the individual closed the individual's thighs after the fluid collection assembly 100 fell between the thigs to prevent the top panel 122 from uncomfortably pressing into the thighs of the individual.
- the top panel 122 may be relatively rigid because the top panel 122 has one or more three-dimensional structures formed therein.
- the three-dimensional structures may be formed in the top panel 122, for example, using a thermoforming technique since thermosetting is able to form the three-dimensional structures quickly, cheaply, and efficiently.
- the three-dimensional structures may resist bending of which, in turn, increases the rigidity of the top panel 122.
- the three-dimensional structures may include, for example, a bulge, one or more reinforcement structures, one or more fold lines, any other suitable three-dimensional structure, or combinations thereof. It is noted that the three-dimensional structures may be formed using other techniques, such as by selectively varying a thickness of the top panel 122, adding a material to the top panel 122, or via any other suitable technique.
- the fluid collection assembly 100 includes a base 104 that is configured to be attached to the sheath 102.
- the base 104 is configured to be permanently attached to the sheath 102.
- the base 104 is configured to be permanently attached to the sheath 102 when, for example, the fluid collection assembly 100 is provided with the base 104 permanently attached to the sheath 102, or the base 104 is provided without being permanently attached to the sheath 102 but is configured to be permanently attached to the sheath 102 at some point in the future.
- Permanently attached means that the sheath 102 cannot be detached from the base 104 without damaging at least one of the sheath 102 or the base 104, using a blade to separate the sheath 102 from the base 104, and/or using chemicals to dissolve the adhesive that attaches the sheath 102 to the base 104.
- the base 104 may be permanently attached to the sheath 102 using an adhesive, sewing, heat sealing, RF welding, or US welding.
- the base 104 is configured to be reversibly attached to the sheath 102.
- the base 104 is integrally formed with the sheath 102.
- the base 104 includes an aperture 120.
- the base 104 is permanently attached to the distal end region 110 of the sheath 102 such that the aperture 120 is aligned with the opening 114.
- the base 104 is sized, shaped, and made of a material to be coupled to the skin that surrounds the penis (e.g, mons pubis, thighs, testicles, and/or perineum) and have the penis disposed therethrough.
- the base 104 may define an aperture 120 configured to have the penis positioned therethrough.
- the base 104 may exhibit the general shape or contours of the skin surface that the base 104 is configured to be coupled with.
- the base 104 may be flexible, thereby allowing the base 104 to conform to any shape of the skin surface and mitigate the base 104 pulling on the skin surface.
- the base 104 may extend laterally past the sheath 102, thereby increasing the surface area of the skin of the individual to which the fluid collection assembly 100 may be attached compared to a substantially similar fluid collection assembly 100 that did not include a base.
- the fluid collection assembly 100 includes the conduit 142.
- the inlet of the conduit 142 may be located near the distal end region 110 of the sheath 102 which is expected to be the gravimetrically low point of the chamber 112 when worn by an individual. Locating the inlet at or near the distal end region 110 of the sheath 102 enables the conduit 142 to receive more of the bodily fluids than if the inlet of the conduit 142 was located elsewhere and reduces the likelihood of pooling (e.g., pooling of the bodily fluids may cause microbe growth and foul odors).
- the fluid collection assembly 100 is merely one example of a fluid collection assembly that may include any of the drainage port assemblies disclosed herein.
- Other examples of fluid collection assemblies that may include any of the drainage port assemblies disclosed herein are disclosed in U.S. Patent No. 10,973,678 filed on June 2, 2017, U.S. Patent No. 10,390,989 filed on September 8, 2016, U.S. Patent No. 10,226,376 filed on June 3, 2017, PCT Patent Application No. PCT/US2021/039866 filed on June 30, 2021, U.S. Patent Application No. 16/433,773 filed on June 6, 2019, U.S. Provisional Patent Application No. 63,564.696 filed on March 13, 2024, and U.S. Provisional Patent Application No.
- FIG. ID is a block diagram of a fluid collection system 192 for fluid collection, according to an embodiment.
- the fluid collection system 192 includes a fluid collection assembly 100, a fluid storage container 180, and a vacuum source 182.
- the fluid collection assembly 100 may be the same or substantially similar to any of the fluid collection assemblies disclosed herein.
- the fluid collection assembly 100, the fluid storage container 180, and the vacuum source 182 may be fluidly coupled to each other via one or more conduits 142.
- fluid collection assembly 100 may be operably coupled to one or more of the fluid storage container 180 or the vacuum source 182 via the conduit 142.
- the bodily fluids collected in the fluid collection assembly 100 may be removed from the fluid collection assembly 100 via the conduit 142 which protrudes into the fluid collection assembly 100.
- an inlet of the conduit 142 may extend into the fluid collection assembly 100, such as to a reservoir therein.
- the outlet of the conduit 142 may extend into the fluid collection assembly 100 or the vacuum source 182.
- Suction force may be introduced into the chamber of the fluid collection assembly 100 via the inlet of the conduit 142 responsive to suction (e.g., vacuum) force applied at the outlet of the conduit 142.
- suction force may be applied to the outlet of the conduit 142 by the vacuum source 182 either directly or indirectly.
- the suction force may be applied indirectly via the fluid storage container 180.
- the outlet of the conduit 142 may be disposed within the fluid storage container 180 and an additional conduit 142 may extend from the fluid storage container 180 to the vacuum source 182. Accordingly, the vacuum source 182 may apply suction to the fluid collection assembly 100 via the fluid storage container
- the suction force may be applied directly via the vacuum source 182.
- the outlet of the conduit 142 may be disposed within the vacuum source 182.
- An additional conduit 142 may extend from the vacuum source 182 to a point outside of the fluid collection assembly 100. such as to the fluid storage container 180.
- the vacuum source 182 may be disposed between the fluid collection assembly 100 and the fluid storage container 180.
- the fluid storage container 180 is sized and shaped to retain bodily fluids therein.
- the fluid storage container 180 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.
- the conduit 142 may extend from the fluid collection assembly 100 and attach to the fluid storage container 180 at a first point therein.
- An additional conduit 142 may attach to the fluid storage container 180 at a second point thereon and may extend and attach to the vacuum source 182.
- a vacuum e.g., suction
- Bodily fluids, such as urine may be drained from the fluid collection assembly 100 using the vacuum source 182.
- the vacuum source 182 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 182 may provide a vacuum or suction to remove bodily fluids from the fluid collection assembly 100.
- the vacuum source 182 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).
- the vacuum source 182 may be sized and shaped to fit outside of, on, or within the fluid collection assembly 100.
- FIG. 2A is an isometric view of a drainage port assembly 244, according to an embodiment.
- FIG. 2B is a cross-sectional view of the drainage port assembly 244 taken along plane 2B-2B.
- the drainage port assembly 244 exhibits a three-piece construction. As illustrated, the drainage port assembly 244 includes a collar 245, a connector 247, and an optional annular base 249.
- the collar 245 is configured to be attached to the fluid impermeable barrier e.g., the fluid impermeable barrier 106 of FIGS. 1A-1C) and to be moveably (e.g., rotatably) attached to the connector 247. As such, the collar 245 allows the connector 247 to be indirectly rotatably attached to the fluid impermeable barrier.
- the annular base 249 is configured to interact with the collar 245 to attach the drainage port assembly 244 to the fluid impermeable barrier, for example, by sandwiching the fluid impermeable barrier between the collar 245 and the annular base 249.
- the collar 245 may exhibit any suitable structure that allows the collar 245 to be both attached to the fluid impermeable barrier of the fluid collection assembly and the connector 247 while also allowing the connector 247 to move relative to the collar 245.
- the collar 245 includes a central structure 253 and a laterally-extending structure 255 that extends from the central structure 253 in a lateral (e.g., radial) direction relative to the central axis 257 of the collar 245.
- the central structure 253 is configured to be moveably attached to the connector 247.
- the central structure 253 may be rotatably attached to the connector 247 using any suitable technique, as will be discussed in more detail below.
- the size, shape, and structure of the central structure 253 may be selected based on the technique used to moveably attach the connector 247 to the central structure 253.
- the central structure 253 is configured to be attached to the connector 247 using at least one pin 201.
- the connector 247 is configured to rotate about the central structure 253 in a single rotation axis (e.g., the roll, yaw, or pitch axis depending on the orientation of the drainage port assembly 244).
- the opening of the collar passageway 261 through which the connector 247 extends may exhibit a generally rectangular shape (e.g., a rectangular shape with opposing rounded edges) to accommodate rotation of the connector 247.
- the central structure 253 may be moveably attached to the connector 247 using a ball and socket structure, any of the other structures disclosed herein, or any other suitable structure.
- the connector 247 may be configured to rotate or otherwise move about the central structure 253 in a single axis, which simplifies operation of the drainage port assembly 244 and minimizes the likelihood that the connector 247 inadvertently moves during operation (e.g., movement that may cause the kinking of the conduit).
- the direction that that connector 247 moves relative to the central structure 253 may be selected based on the embodiment in which the drainage port assembly 244 is used.
- the connector 247 is configured to move (e.g. , rotate) such that the connector 247 can point generally towards the feet of the individual or head of the individual.
- the connector 247 may be configured to point generally towards the proximal end region and the distal end region of the fluid collection assembly including the drainage port assembly 244, depending on the orientation of the fluid collection assembly on the individual. Being able to point the connector 247 generally towards the feet or head of the individual may be beneficial when the fluid storage container and/or the vacuum source is positioned in a direction that is generally towards the feet of the individual (e.g., attached to a foot of a bed) or towards the head of the individual (e.g. , a wall mounted vacuum source located behind the bed).
- the connector 247 is configured to move (e.g., rotate) such that the connector can point generally tow ards either side of the individual.
- the connector 247 may be beneficial when the fluid storage container and/or the vacuum source is positioned in a direction that is generally towards the side of the individual (e.g., attached to a side of a bed or on a nightstand).
- the connector 247 may be configured to rotate or otherwise move about the central structure 253 in multiple directions, such as the connector 347 illustrated in FIGS. 3A-3D.
- the collar 245 also includes a laterally-extending structure 255.
- the laterally-extending structure 255 extends laterally outwardly from a central axis 257 of the collar 245.
- the laterally-extending structure 255 may extend from or near a proximal end 279 of the collar 245 (z. c.. an end of the collar 245 that is closest to the individual and/or the fluid impermeable barrier during use) of the central structure 253 in a lateral (e.g., radial) direction relative to the central axis 257.
- the laterally-extending structure 255 increases the surface area of the collar 245 that may be attached to the fluid impermeable barrier which, in turn, better secures the drainage port assembly 244 to the fluid impermeable barrier. Such improved securement of the drainage port assembly 244 to the fluid impermeable barrier may be important since forces may be applied to the drainage port assembly 244 that may try to detach the drainage port assembly
- the laterally-extending structure 255 may increase the surface area of the collar 245 by at least about 2 cm 2 than if the collar 245 did not include the laterally-extending structure 255. such as increasing the surface area of the collar 245 by at least about 2.5 cm 2 , at least about 5 cm 2 , at least about 7.5 cm 2 , at least about 20 cm 2 , at least about 25 cm 2 , at least about 20 cm 2 , at least about 25 cm 2 , at least about 30 cm 2 , at least about 40 cm 2 , at least about 50 cm 2 , at least about 60 cm 2 , or at least about 70 cm 2 .
- the central structure 253 and the laterally-extending structure may increase the surface area of the collar 245 by at least about 2 cm 2 than if the collar 245 did not include the laterally-extending structure 255. such as increasing the surface area of the collar 245 by at least about 2.5 cm 2 , at least about 5 cm 2 , at least about 7.5 cm 2 , at least about 20 cm 2 , at least about 25 cm
- the collar 245 may cause the collar 245 to exhibit a generally top hat shape, as shown. That said, the collar 245 may exhibit a structure other than the structure illustrated in FIGS. 2A-2C.
- the later lly -extending structure 255 may be omitted when the central structure 253 exhibits a surface area that is sufficiently large to be attached to the fluid impermeable barrier without needing the laterally-extending structure 255.
- the collar 245 may cause the collar 245 to exhibit a generally top hat shape, as shown. That said, the collar 245 may exhibit a structure other than the structure illustrated in FIGS. 2A-2C.
- the later lly -extending structure 255 may be omitted when the central structure 253 exhibits a surface area that is sufficiently large to be attached to the fluid impermeable barrier without needing the laterally-extending structure 255.
- the collar 245 may cause the collar 245 to exhibit a generally top hat shape, as shown. That said, the collar 245 may exhibit a structure other than the structure illustrated
- the central structure 253 or the laterally-extending structure 255 may exhibit a shape other than the shapes illustrated in FIGS. 2A-2C.
- the central structure 253 may exhibit a tapered shape, a generally rectangular prism shape, or any other suitable shape.
- the laterally-extending structure 255 may exhibit a generally square disclike shape, a tapered shape, or another other suitable shape.
- the collar 245 defines a collar passageway 261 that extends through the collar 245.
- the collar passageway 261 extends through the central structure 253 and the laterally-extending structure 255.
- the collar passageway 261 forms a passageway through the collar 245 that allows the bodily fluids to flow through the collar 245.
- the collar passageway 261 may also allow the collar 245 to receive a portion of the connector 247, as will be discussed in more detail below.
- the collar 245 includes one or more interior surfaces 263 that define the collar passageway 261.
- the collar passageway 261 may exhibit a first portion and a second portion.
- the first portion may extend from the proximal end 279 of the collar 245 and may form an inlet of the collar passageway 261.
- the second portion may extend from or near the first portion to the distal end 275 of the collar 245.
- the second portion is configured to receive a portion of the connector 247.
- the second portion is configured to receive the engagement portion 265 of the connector 247.
- the second portion of the collar passageway 261 may exhibit a size and shape that corresponds to the size and shape of the portion of the connector 247 that is received thereby.
- the first portion exhibits a first maximum lateral dimension (“first dimension'’) Di at or near the proximal end 279 and the second portion exhibits a second maximum lateral dimension (“second dimension”) D2. wherein the first and second dimensions Di, D2 are measured parallel to each other.
- the second dimension D2 may be at or near the distal end 275.
- Each of the first and second dimensions Di and D2 are measured between opposing portions of the interior surfaces 263.
- the second dimension D2 is selected to allow the collar passageway 261 to receive at least a portion of the connector 247.
- the second dimension D2 may be selected to correspond to a maximum lateral dimension of the connector 247 measured in the same direction as the second dimension D2.
- the first dimension Di is smaller than the second dimension D2.
- the smaller first dimension Di prevents or at least inhibits movement of the connector 247 into the first portion of the collar passageway 261.
- the smaller first dimension Di may help maintain the connector 247 in the second portion of the collar passageway 261 thereby keeping the connector 247 moveably attached to the collar 245.
- the first dimension Di is equal to or greater than the second dimension D2.
- the connector 247 includes an engagement portion 265 and a conduit attachment portion 248.
- the engagement portion 265 is configured to be received or otherwise rotatably attached to the collar 245 when the drainage port assembly 244 is completely assembled.
- the conduit attachment portion 248 is distinct and separate from the engagement portion 265 and includes the portions of the connector 247 that are configured to be attached to a conduit.
- the conduit attachment portion 248 may form the outlet 252 of the drainage port assembly 244.
- at least a portion of the engagement portion 265 and a corresponding portion of the conduit attachment portion 248 are spaced from each other.
- the connector 247 may include an intermediate portion 269 extending between the engagement portion
- the engagement portion 265 and the engagement portion 265, the conduit attachment portion 248. and the intermediate portion 269 may be distinguishable from each other by exhibiting different shapes, a step therebetween (e.g, a sudden dimension change), or by which portion of the connector 247 can be positioned or are otherwise configured to be positionable within the collar passageway 261, which portion of the connector 247 can receive or are otherwise configured to receive a conduit, or which portions of the connector 247 are not positioned or positionable within the collar passageway 261 and cannot receive a conduit.
- the engagement portion 265 and the conduit attachment portion 248 are not spaced from each other.
- the engagement portion 265 and the conduit attachment portion 248 may be distinguishable from each other by exhibiting different shapes, a step therebetween (e , a sudden dimension change), or by which portion of the connector 247 can be positioned or are otherwise configured to be positionable within the collar passageway 261 and/or which portion of the connector 247 can receive or are otherwise configured to receive a conduit.
- the connector 247 also defines a connector passageway 271 extending through the connector 247 such that bodily fluids may How through the connector 247 to the conduit attached to the conduit attachment portion 248.
- the connector passageway 271 may extend from and through the engagement portion 265, through the intermediate portion (if included in the connector 247). and through conduit attachment portion 248.
- the engagement portion 265 and the conduit attachment portion 248 may exhibit any suitable orientation relative to each other.
- the engagement portion 265 c.g.. a central axis of the engagement portion 265 exhibits an orientation that is generally parallel and aligned with the conduit attachment portion 248 (e.g, a central axis of the conduit attachment portion 248).
- This parallel orientation of the engagement portion 265 relative to the conduit attachment portion 248 may minimize turbulent flow of the bodily fluids through the connector passageway 271 which, in turn, increases the volume of bodily fluids that may be removed through the drainage port assembly 244 over a given period of time.
- the engagement portion 265 e.g.
- a central axis of the engagement portion 265) exhibits an orientation that is generally oblique or perpendicular to the conduit attachment portion 248 (e.g.. a central axis of the conduit attachment portion 248).
- the orientation of the engagement portion 265 relative to the conduit attachment portion 248 may minimize the distance that the connector 247 extends above a fluid impermeable barrier which, in turn, may minimize interference between the connector 247 and bedding or clothing disposed above the drainage port assembly 244.
- the engagement portion 265 exhibits a structure that allows the engagement portion 265 to be rotatably attached to the collar 245.
- the shape of the engagement portion 265 is configured to be disposed in the collar passageway 261.
- the engagement portion 265 exhibits a size and shape that allows the engagement portion 265 to rotate in the collar passageway 261 (e.g, may exhibit a size and shape that corresponds to a size and shape of the interior surfaces 263 defining the second portion of the collar passageway 261).
- the engagement portion 265 may exhibit a generally cylindrical shape, wherein the height of the cylindrical shape of the engagement portion 265 is generally oriented and centered on the pin 201.
- the engagement portion 265 may exhibit other shapes, such as a generally spherical shape.
- the connector 247 may be moveably attached to the collar 245 using any suitable technique.
- the connector 247 may be snap fastened to the collar 245.
- the snap fastening includes forcing the engagement portion 265 over a portion of the collar passageway 261 exhibiting a lateral dimension that is slightly smaller than the corresponding lateral dimension of the engagement portion 265.
- the engagement portion 265 may be snap fastened to the collar 245 by forcing the engagement portion 265 through the distal end 275 of the collar 245, wherein the distal end 275 of the collar 245 exhibits a lateral dimension that is smaller than a corresponding lateral dimension of the engagement portion 265.
- Forcing the engagement portion 265 over the distal end 275 of the collar 245 may position the engagement portion 265 in the second portion of the collar passageway 261.
- the smaller first dimension Di of the collar passageway 261 maintains the engagement portion 265 in the second portion of the collar passageway 261.
- the engagement portion 265 may be snap fastened to the collar 245 by forcing the engagement portion 265 through the first portion of the collar passageway 261. wherein the first dimension Di is smaller than a corresponding lateral dimension of the engagement portion 265.
- Forcing the engagement portion 265 through the first portion of the collar passageway 261 may position the engagement portion 265 in the second portion of the collar passageway 261.
- a smaller lateral dimension of the collar passageway 261 at the distal end 275 maintains the engagement portion 265 in the second portion of the collar passageway 261.
- the pin 201 may be attached to the collar 245 and the engagement portion 265 after positioning the engagement portion 265 in the collar passageway 261.
- the connector 247 is not snap fastened to the collar 245. In such an embodiment, the connector 247 may only be attached to the collar 245 using the pin 201.
- the collar passageway 261 and the connector passageway 271 are configured to remain in fluid communication with each other regardless of the position of the connector 247 relative to the collar 245.
- the collar passageway 261 and the connector passageway 271 are configured to remain in fluid communication with each other regardless if the connector 247 is positioned as far forward as possible, positioned as far backwards as possible, or in some intermediate positioned therebetween.
- the collar passageway 261 and the connector passageway 271 are in fluid communication with each other when the inlet of the connector passageway 271 and the immediately adjacent portion of the collar passageway 261 (e g., the outlet of the first position of the collar passageway 261) at least partially overlap thereby allowing bodily fluids to flow from the collar passageway 261 and into the connector passageway 271. It is noted that several structural factors determine whether the collar passageway 261 and the connector passageway 271 remain in fluid communication. These structural factors include one or more of the lateral dimension of the connector passageway 271 at the inlet thereof, the lateral dimension of the collar passageway 261 adjacent to the inlet of the connector passageway 271, or the maximum amount of movement that the connector 247 may move relative to the collar 245. As such, these structural factor(s) may be selected to ensure that the collar passageway 261 and the connector passageway 271 remain in fluid communication.
- the conduit attachment portion 248 is configured to be attached to a conduit.
- the conduit attachment portion 248 may include any suitable structure that allows the conduit attachment portion 248 to be attached to the conduit.
- the conduit attachment portion 248 may be a male connector having a tapered shape (e.g., truncated conical shape), wherein a lateral dimension of the tapered shape increases with increasing distance from the outlet 252.
- the conduit attachment portion 248 may be a female connector, include one or more threads configured to engage with the conduit, or any other suitable structure.
- the drainage port assembly 244 may include an annular base 249.
- the annular base 249 is configured, with the collar 245, to attach the drainage port assembly 244 to the fluid impermeable barrier.
- the annular base 249 is configured to have a portion of the fluid impermeable barrier that defines the fluid outlet positioned between the annular base 249 and the collar 245.
- attaching the annular base 249 to the collar 245 also secures the drainage port assembly 244 to the fluid impermeable barrier.
- the annular base 249 defines a base passageway 291 extending therethrough. The base passageway 291 allows bodily fluids to flow through the annular base 249 and into the collar passageway 261 and the connector passageway 271.
- the annular base 249 may exhibit any suitable shape.
- the annular base 249 may exhibit a generally disk-like shape (e g., a generally planar shape).
- the annular base 249 may include a raised structure (e.g., a raised structure that is configured to be at least partially disposed in the collar passageway 261) and a laterally -extending structure that extends laterally away from the raised structure.
- the annular base 249 may exhibit a generally top hat-like shape. Examples of annular bases exhibiting a generally top hat-like shape are disclosed in U.S.
- the annular base 249 is configured to be attached to the fluid impermeable barrier.
- the annular base 249 is configured to be attached to the fluid impermeable barrier by positioning (e.g., sandwiching) the fluid impermeable barrier between the laterally-extending structure 255 of the collar 245 and the annular base 249.
- the laterally-extending structure 255 of the collar 245 may include at least one first interfacing surface 287 and the annular base 249 may include at least one second interfacing surface 288.
- the first interfacing surface 287 and the second interfacing surface 288 may be configured to face and be positioned adjacent to each other after the drainage port assembly 244 is assembled.
- the first interfacing surface 287 may form the proximal end 279 of the collar 245, be positioned proximate to the proximal end 279 of the collar 245 (as shown), or otherwise face generally away from the distal end 275 of the collar 245 and the second interfacing surface 288 may generally face towards the distal end of the first interfacing surface 287 and the second interfacing surface 288 allow the fluid impermeable barrier to be positioned therebetween thereby securing the drainage port assembly 244 to the fluid impermeable barrier.
- the first and second interfacing surfaces 287, 288 exhibit non-planar surfaces (e.g., complementary non-planar surfaces).
- the non-planar first and second interfacing surfaces 287, 288 increase the surface area of the first and second interfacing surfaces 287, 288.
- the increased surface area of the first and second interfacing surfaces 287, 288 causes the first and second interfacing surfaces 287, 288 to contact a greater surface area of the fluid impermeable barrier which, in turn, improves the attachment between the first and second interfacing surfaces 287, 288 and the fluid impermeable barrier.
- the non-planar first and second interfacing surfaces 287, 288 may also create a tortuous path therebetween.
- the tortuous path may prevent or at least inhibit bodily fluids leaking between the first and second interfacing surfaces 287, 288 and the fluid impermeable barrier.
- at least one of the first and second interfacing surfaces 287, 288 are planar.
- the annular base 249 may be attached to the collar 245 using any suitable technique.
- the annular base 249 may snap fasten to the collar 245.
- the collar 245 may include at least one proximally-extending structure 203 extending from the laterally-extending structure 255.
- the proximally-extending structure 203 may include a single annular structure extending more than 50% to completely around a lateral periphery of the laterally-extending structure 255 or may include a plurality of structures forming a discontinuous annular structure.
- proximally-extending structure 203 may include one or more protrusions 205 extending laterally inwardly from or near the proximal end of the proximally -extending structure 203.
- the protrusions 205 reduce the lateral dimension of a portion of the collar 245 to be less than a corresponding dimension of the annular base 249.
- the annular base 249 may be forced over the protrusions 205 to position the annular base 249 between the first interfacing surface 287 and the protrusions 205.
- the protrusions 205 may then help maintain the position of the annular base 249 between the first interfacing surface 287 and the protrusions 205 thereby snap fastening the annular base 249 to the collar 245.
- the annular base 249 may be snap fastened to the collar 245 using other structures, examples of which are disclosed below or in U.S. Provisional Application No. 63/711,445 filed on October 24, 2024, the disclosure of which was previously incorporated herein.
- At least one of the protrusions 205 includes a tapered or curved surface 207 generally facing in a proximal direction (as shown) or the lateral edges of the annular base 249 include a tapered or curved surface 209 generally facing a distal direction (as shown).
- the tapered or curved surfaces 207, 209 may facilitate moving the annular base 249 over the protrusions 205. It is noted that any of the structure disclosed herein that may be snap fastened together may include similar tapered or curved surfaces to facilitate moving one element over another.
- the annular base 249 may be attached to the collar 245 using a non-snap fastening technique.
- the annular base 249 may be attached to the collar 245 using an interference fit when the fluid impermeable barrier is positioned between the collar 245 and the annular base 249.
- the collar 245 and the annular base 249 may be attached to each other and/or the fluid impermeable barrier therebetween using an adhesive, stitching, or any other suitable technique.
- the attachment between the collar 245 and the annular base 249 prevents or at least inhibits rotation of the collar 245 relative to the annular base 249. Preventing rotation between the collar 245 and the annular base 249 may minimize wear between the collar 245, the annular base 249, and the fluid impermeable barrier therebetween. In an example, friction between the collar 245 and the annular base 249 prevents or at least inhibits rotation of the collar 245 relative to the annular base 249.
- the friction may be caused by portions of the collar 245 and the annular base 249 contacting each other (e.g, contact caused by and/or between the lower protrusion 283 and the base protrusion 284) and/or the contact between the collar 245, the annular base 249, and the fluid impermeable barrier therebet een.
- the attachment between the collar 245 and the annular base 249 allows rotation of the collar 245 and the annular base 249, which may make it easier for the connector 247 to rotate relative to the fluid impermeable barrier and may still allow the connector 247 to rotate relative to the fluid impermeable barrier if rotation of the connector 247 relative to the collar 245 is prevented
- the drainage port assembly 244 may include a seal to prevent or at least inhibit bodily fluids from leaking through the drainage port assembly 244.
- the seal may prevent at least one of bodily fluids leaking between the collar 245 and the connector 247 or between the collar 245 and the annular base 249.
- the seal may include any structure that may prevent or at least inhibit bodily fluids from leaking through the drainage port assembly 244.
- the seal may include a crab claw seal, an O-ring positioned between two components of the drainage port assembly 244, or any other suitable seal.
- FIGS. 3A and 3B are isometric views of a drainage port assembly 344 exhibiting a first state and a second state, respectively, according to an embodiment.
- FIGS. 3C and 3D are cross-sectional views of the drainage port assembly 344 taken along planes 3C-3C and 3D-3D, respectively.
- the drainage port assembly 344 is the same as or substantially similar to any of the drainage port assemblies disclosed herein.
- the drainage port assembly 344 includes a collar 345 and a connector 347 moveably attached to the collar 345.
- the drainage port assembly 344 is switchable between a first state and a second state.
- the drainage port assembly 344 may exhibit the first state when the connector 347 exhibits a first position (e.g., orientation) relative to the collar 345 and the second state when the connector 347 exhibits a second position (e.g, orientation) relative to the collar 345.
- the connector 347 is in the first position when moved as far to the right as possible (e.g, as far to one side as possible) and the second position when moved as far to the left as possible (e.g. , as far to an opposing side as possible).
- the connector 347 may be in the first position when moved to the far left, the forwardmost position, the backward most position, an intermediate position (e.g, an intermediate position between the far left and far right positions or between the forward most and backward most positions), or any other position.
- the connector 347 may be in the second position when moved to the far right, the forwardmost position, the backward most position, an intermediate position (e.g. an intermediate position between the far left and far right positions or between the forward most and backward most positions), or any other position.
- the collar passageway 361 and the connector passageway 371 are in fluid communication with each other when the drainage port assembly 344 is in the first state.
- the collar passageway 361 and the connector passageway 371 are in fluid communication with each other because the inlet of the connector passagew ay 371 at least partially overlaps with (e.g. , is coextensive with, as shown) an adjacent portion of the collar passagew ay 361 (e.g, the outlet of the first portion of the collar passageway 361). Since the inlet of the connector passageway 371 and the adj acent portion of the collar passageway 361 overlap, bodily fluids may freely flow from the collar passageway 361 to the connector passageway 371.
- the collar passageway 361 and the connector passageway 371 are in fluid communication with each other even when only a portion of the inlet of the connector passageway 371 overlaps with the adjacent portion of the collar passageway 361 since the partial overlap still allow s bodily fluids to flow from the collar passageway 361 to the connector passageway 371.
- the collar passageway 361 and the connector passageway 371 are not in fluid communication with each other when the drainage port assembly 344 is in the second state.
- the collar passageway 361 and the connector passageway 371 are not in fluid communication with each other because the inlet of the connector passageway 371 does not overlap with an adjacent portion of the collar passageway 361. Since the inlet of the connector passageway 371 and the adjacent portion of the collar passageway 361 do not overlap, bodily fluids are restricted from flowing from the collar passageway 361 to the connector passagew ay 371. It is noted that negligible quantities of bodily fluids may leak between the collar 345 and the connector 347 thereby allowing negligible quantities of the bodily fluids to flow between the passageways even when the drainage port assembly 344 is in the second state.
- the collar passagew ay 361 and the connector passageway 371 are and are not in fluid communication with each other when the drainage port assembly 344 is in the first state and the second state, respectively.
- the orientation of and pathway followed by the collar passageway 361 and the connector passageway 371 relative to each other are selected to allow" these passageways to be in fluid communication with each other when the connector 347 is in the first position.
- the connector passageway 371 exhibits a bend 313 thereof.
- the bend 313 allows the connector passageway 371 to extend to the collar passageway 361 when the connector 347 is oriented at an angle relative to a central axis of the collar passageway 361, and the connector 347 is in the first position and the collar passageway 361 is centrally positioned.
- the bend 313 also allows the inlet of the connector passageway 371 to not overlap the adjacent portion of the collar passageway 361 when the drainage port assembly 344 is in the second state.
- the inlet of the connector passageway 371 and the adjacent portion of the collar passageway 361 exhibit sufficient size (e.g, lateral dimension) such that the passageways are and are not in fluid communication with each other when the drainage port assembly 344 is in the first state and the second state, respectively.
- FIGS. 4A and 4B are isometric views of a drainage port assembly 444 exhibiting a first state and a second state, respectively, according to an embodiment.
- FIGS. 4C and 4D are cross-sectional views of the drainage port assembly 444 taken along planes 4C-4C and 4D-4D, respectively.
- the drainage port assembly 444 is the same as or substantially similar to any of the drainage port assemblies disclosed herein.
- the drainage port assembly 444 includes a collar 445 and a connector 447 moveably attached to the collar 445.
- the collar 445 and the connector 447 are attached together using a ball-socket type structure.
- the engagement portion 465 exhibits a generally spherical shape and the central structure 453 exhibits a socket type structure defining a spherical pocket configured to receive the generally spherical shape of the engagement portion 465.
- the ball-socket type structure of the collar 445 and the connector 447 allows the connector 447 to exhibit two more degrees of freedom.
- the connector 447 may be configured to move in two or more of the yaw, pitch, or roll directions relative to the collar 445.
- Allowing the connector 447 to move in two or more directions relative to the collar 445 may facilitate attaching and detaching a conduit to the connector 447.
- the individual attaching the conduit to the conduit attachment portion 448 may find it beneficial for the conduit attachment portion 448 to be oriented in some beneficial direction. It is noted that the beneficial direction may include the conduit attachment portion 448 generally pointing towards the individual or some other direction.
- the beneficial direction may vary from individual to individual.
- the individual attaching or detaching the conduit may have various positions relative to the drainage port assembly 444 (e.g, located on one side or an opposing side of the drainage port assembly 444) and/or various individuals may attach or detach the conduit from the conduit attachment portion 448. Allowing the connector 447 to exhibit two or more degrees of freedom increases the likelihood that the conduit attachment portion 448 can be oriented in the beneficial direction regardless of the position of the individual or the individual attaching or detaching the conduit.
- the central structure 453 of the collar 445 defines at least one cutout.
- the cutout of the central structure 453 is the outlet of the central structure 453 through which a portion of the connector 447 (e.g, the conduit attachment portion 448 or an intermediate structure 469) may extend out of the collar passageway 461 (e.g., the pocket that receives the engagement portion 465).
- the cutout is larger than the portion of the connector 447 extending therethrough thereby allowing the connector 447 to exhibit two or more degrees of freedoms.
- the cutout may exhibit two lateral dimensions measured perpendicular to a central axis 457 of the collar 445 and perpendicular to each other. These two lateral dimensions of the cutout may be larger than the lateral dimensions of the portion of the connector 447 extending therethrough measured parallel to these two lateral dimensions of the cutout.
- the drainage port assembly 444 may be configured to switch between a first state and a second state depending on the position of the connector 447 relative to the cutout. For example, the drainage port assembly 444 may exhibit the first state (FIGS. 4A and 4C) when the connector 447 exhibits a first position in the cutout (e.g, the conduit attachment portion 448 extends in a first direction) and the drainage port assembly 444 may exhibit the second state (FIGS. 4B and 4D) when the connector 447 exhibits a second position in the cutout (e.g., the conduit attachment portion 448 extends in a second direction).
- the collar 445 includes a single cutout.
- the collar 445 includes a plurality of cutouts, such as a first cutout 415 and a second cutout 417.
- the drainage port assembly 444 may exhibit the first state when a portion of the connector 447 extends through the first cutout 415 and the second state when the portion of the connector 447 extends through the second cutout 417.
- the second cutout 417 is larger than the first cutout 415. The larger size of the second cutout 417 allows for greater movement of the connector 447 while attaching or detaching the conduit.
- the larger size of the second cutout 417 allows the conduit attachment portion 448 to exhibit a variety of directions such that the conduit attachment portion 448 is more likely to exhibit the previously discussed beneficial direction regardless of the position of the individual relative to the drainage port assembly 444 or the individual who is attaching or detaching the conduit.
- the smaller size of the first cutout 415 limits movement of the connector 447 when the drainage port assembly 444 is in the first state which, in turn, decreases the likelihood that the drainage port assembly 444 inadvertently switches from the first state to the second state during use, for instance, when the individual wearing the fluid collection assembly including the drainage port assembly 444 moves.
- the first cutout 415 exhibits a size that is substantially similar to the size of the portion of the connector 447 extending therethrough.
- the intersection of the first and second cutouts 415, 417 exhibits a first lateral dimension that is slightly smaller than a second lateral dimension of the portion of the connector 447 measured parallel to the first lateral dimension.
- the difference between the first and second lateral dimensions should be sufficiently small that the inherent flexibility of the portion of the collar 445 defining the intersection of the first and second cutouts 415, 417 and the flexibility of the portion of the connector 447 extending through the cutouts allows the connector 447 to move between the first and second cutouts 415. 417 without damaging the collar 445 or the connector 447.
- the smaller first lateral dimension inhibits accidentally moving the connector 447 between the first and second cutouts 415, 417 during use of the drainage port assembly 444.
- the smaller first lateral dimension may also provide tactile feedback indicating when the connector 447 moves between the first and second cutouts 415. 417. which may be beneficial when the individual moving the connector 447 cannot see the connector 447 (e.g, the drainage port assembly 444 is under a blanket to maintain the dignity of the individual using the fluid collection assembly including the drainage port assembly 444).
- the drainage port assembly 444 may exhibit the second state when a portion of the connector 447 extends through the first cutout 415 and the first state when the portion of the connector 447 extends through the second cutout 417.
- FIG. 5A is an isometric view of a drainage port assembly 544, according to an embodiment.
- FIG. 5B is a cross-sectional view of the drainage port assembly 544 taken along plane 5B-5B. Except as otherwise disclosed herein, the drainage port assembly 544 is the same as or substantially similar to any of the drainage port assemblies disclosed herein.
- the drainage port assembly 544 includes a collar 545 and a connector 547.
- the connector 547 includes a conduit attachment portion 548, an engagement portion 565 that is configured to allow the conduit attachment portion 548 to move relative to the collar 545. and an optional intermediate portion 569.
- the engagement portion 565 is configured to elastically deform thereby allowing the conduit attachment portion 548 to move relative to the collar 545.
- the engagement portion 565 is configured to elastically deform because the engagement portion 565 exhibits an average thickness that is less than a minimum thickness of the collar 545, a minimum thickness of the conduit attachment portion 548, and a minimum thickness of the optional intermediate portion 569.
- the engagement portion 565 may exhibit an average thickness of about 2 mm or less, about 1.5 mm or less, about 1 mm or less, about 750 pm or less, about 500 pm or less, about 400 pm or less, about 300 pm or less, about 250 pm or less, or in ranges of about 250 pm to about 500 pm. about 400 pm to about 750 pm, about 500 pm to about 1 mm, about 750 pm to about 1.5 mm, or about 1 mm to about 2 mm.
- the average thickness of the engagement portion 565 may be less than the minimum thickness of the collar 545, the conduit attachment portion 548, and the optional intermediate portion 569 by about 250 pm to about 500 pm, about 400 pm to about 750 pm, or about 500 pm to about 1 mm.
- the smaller average thickness of the engagement portion 565 allows the engagement portion 565 to preferentially deform when a load is applied to the conduit attachment portion 548 that causes the conduit attachment portion 548 to pivot about the engagement portion 565.
- the smaller average thickness of the engagement portion 565 may allow the connector 547 and/or the drainage port assembly 544 as a whole to be integrally formed (e.g., exhibit single piece construction) which may facilitate manufacturing of the drainage port assembly 544, for instance, using an injection molding technique.
- the engagement portion 565 is configured to elastically deform because the engagement portion 565 includes a material exhibiting a stiffness (e.g. , modulus of elasticity) that is lower than the material forming the collar 545, the conduit attachment portion 548, and the optional intermediate portion 569.
- the lower stiffness allows the engagement portion 565 to preferentially deform when a load is applied to the conduit attachment portion 548 that causes the conduit attachment portion 548 to pivot about the engagement portion 565.
- Forming the engagement portion 565 from a material exhibiting a lower stiffness may cause the connector 547 and/or the drainage port assembly 544 to exhibit a multiple-piece construction which may complicate manufacturing of the drainage port assembly 544 since the pieces of the drainage port assembly 544 need to be attached together.
- the collar 545 does not include a central structure. Instead, the collar 545 only includes the laterally-extending structure 549 and the engagement portion 565 extends from (e.g., is attached to or integrally formed with) the laterally-extending structure 549. In an embodiment, not shown, the collar 545 includes a central structure and the engagement portion 565 extends from the central structure.
- FIG. 6A is an isometric view of a drainage port assembly 644, according to an embodiment.
- FIGS. 6B and 6C are cross-sectional views of the drainage port assembly 644 in the first and second states taken along plane 6B-6B.
- FIG. 6D is a cross-sectional view of a portion of the drainage port assembly 644 taken along plane 6D-6D. Except as otherwise disclosed herein, the drainage port assembly 644 is the same as or substantially similar to any of the drainage port assemblies disclosed herein.
- the drainage port assembly 644 includes a collar 645, a connector 647, and an optional annular base 649.
- the connector 647 is configured to move up (i.e.. distally) and down (e.g., proximally) relative to the collar 645. Movement of the connector 647 up and down relative to the collar 645 may switch the drainage port assembly 644 from a first state to a second state, and vice versa.
- the collar 645 defines a collar passageway 661.
- the collar passageway 661 is configured to receive a portion of the connector 647.
- the collar passageway 661 defines a fluid flow path 619.
- the fluid flow path 619 is a portion of the collar passageway 661 that is not occupied by the connector 647 and is in fluid communication with the chamber of the fluid collection assembly when the drainage port assembly 644 is in the first state.
- the connector 647 defines an inlet 621.
- the inlet 621 of the connector 647 and the fluid flow path 619 are in fluid communication with each other.
- at least a portion of the inlet 621 overlaps with the fluid flow path 619 such that bodily fluids in the fluid flow path 619 may flow through the inlet 621.
- the drainage port assembly 644 is in the second state, the inlet 621 and the fluid flow path 619 are not in fluid communication with each other. In other words, the inlet 621 does not overlap with the fluid flow path 619 thereby restricting flow of the bodily fluids from the fluid flow path 619 to the inlet 621.
- the inlet 621 is located on a lateral side of the connector 647.
- the fluid flow 7 path 619 may extend along a portion of the lateral side of the connector 647 such that the fluid flow path 619 may be adjacent to the inlet 621 when the drainage port assembly 644 is in the first state.
- At least one of at least a portion of the interior surfaces 663 of the collar 645 or at least a portion of the outer surfaces 690 of the connector 647 may exhibit different cross-sectional shapes.
- a portion of the interior surfaces 663 may defines a generally circular cross- sectional shape with a cutout defining the fluid flow path 619 and/or a portion of the outer surfaces 690 of the connector 647 adjacent to the fluid flow path 619 when the drainage port assembly 644 is in the first state may exhibit a truncated circular cross-sectional shape.
- the fluid flow path 619 may be formed using other techniques, such as forming a passageway through the walls of the collar 645.
- the inlet 621 is located on the proximal side of the connector 647.
- the collar 645 may defined an L-shaped member extending proximally from the rest of the collar 645, with the horizontal portion of the L-shape member configured to abut the distal end of the connector 647 and cover the inlet 621 when the drainage port assembly 644 is in the first state.
- the collar 645 and the connector 647 may include one or more features that are configured to limit movement of the connector 647 relative to the collar 645. Limiting the movement of the connector 647 may prevent the collar 645 and the connector 647 from becoming detached from each other and overlapping the fluid flow path 619 and the inlet 621 when the drainage port assembly 644 is in the first state.
- the connector 647 may include a protrusion 623.
- the protrusion 623 e.g. , annular protrusion
- the protrusion 623 may be positioned at a proximal end of the conduit attachment portion 648 or the optional intermediate portion (not shown).
- the protrusion 623 may cause the maximum lateral dimension of the connector 647 to be larger than a minimum lateral dimension of the distal end 675 of the collar 645. As such, the protrusion 623 may abut the distal end 675 of the collar 645 thereby preventing further downward motion of the connector 647 relative to the collar 645.
- a portion of the interior surfaces 663 of the collar 645 and a portion of the outer surfaces 690 of the engagement portion 665 may include a tapered, stepped, curved, or other surface that increases the maximum dimension of the outer surfaces 690 and the interior surfaces 663. These tapered, stepped, curved or other surfaces may abut each other and prevent further upward motion of the connector 647 relative to the collar 645.
- the connector 647 may include a laterally- extending portion 625 at a proximal end thereof.
- the laterally-extending portion 625 may exhibit a lateral dimension that is greater than the lateral dimension of the collar passageway 661 or a base passageway 691.
- the greater lateral dimension of the laterally- extending portion 625 may cause the laterally-extending portion 625 to abut the portion of the collar 645 defining the collar passageway 661 or the portion of the annular base 649 defining the base passageway 691 and prevent further upward motion of the connector 647 relative to the collar 645.
- the connector 647 may exhibit a first position relative to the collar 645 when the drainage port assembly 644 exhibits the first state and a second position relative to the collar 645 when the drainage port assembly 644 exhibits the second state.
- the connector 647 may exhibit the first position when the connector 647 is moved downwardly (e.g., exhibits a proximally -most position) and the second position when the connector 647 is moved upwardly (e.g., exhibits a distally-most position).
- attaching and detaching the conduit from the conduit attachment portion 648 may switch the drainage port assembly 644 from the first state to the second state.
- attaching the conduit to the conduit attachment portion 648 may apply a downward force on the connector 647 thereby moving the connector 647 to the first position and detaching the conduit from the conduit attachment portion 648 may apply an upward force to the connector 647 thereby moving the connector 647 to the second position.
- the drainage port assembly 644 may exhibit the first state when a conduit is attached to the conduit attachment portion 648 and fluid flow through the drainage port assembly 644 is desired and may exhibit the second state when a conduit is not attached to the conduit attachment portion 648 and fluid flow through the drainage port assembly 644 is not desired.
- the connector 647 may exhibit the first position when the connector 647 is moved upwardly and the second position when the connector 647 is moved downwardly.
- FIG. 7A is an isometric view- of a drainage port assembly 744, according to an embodiment.
- FIG. 7B is a cross-sectional view of the drainage port assembly 744 taken along plane 7B-7B. Except as otherwise disclosed herein, the drainage port assembly 744 is the same as or substantially similar to any of the drainage port assemblies disclosed herein.
- the drainage port assembly 744 includes a collar 745, a connector 747, and an optional annular base 749.
- the engagement portion 765 of the connector 747 is configured to elastically deform, thereby allowing the conduit attachment portion 748 to rotate (e.g., pivot) relative to the collar 745.
- the engagement portion 765 is configured to allow the conduit attachment portion 748 to move up and down and maintain an upwards or downwards position relative to the collar 745.
- the engagement portion 765 includes a generally accordion-like structure. In other words, the engagement portion 765 includes one or more peaks 727 and one or more valleys 729.
- Collapsing the engagement portion 765 allows the conduit attachment portion 748 to move downwardly (e.g., proximally). Due to the accordion-like structure of the engagement portion 765, the engagement portion 765 can maintain the collapsed state thereof.
- Expanding the engagement portion 765 allows the conduit attachment portion 748 to move upwardly (e.g. distally). Due to the accordion-like structure of the engagement portion 765, the engagement portion 765 can maintain the expanded state thereof.
- the engagement portion 765 may exhibit a compliant structure other than the accordion-like structure that allows the engagement portion 765 to move the conduit attachment portion 748 upwardly and downwardly while maintaining the conduit attachment portion 748 in the upward or downward position.
- the engagement portion 765 may form a generally convex semi -spherical shape when the conduit attachment portion 748 is positioned upwardly and a generally concave semi-spherical shape when the conduit attachment portion 748 is positioned downwardly.
- the drainage port assembly 744 may be configured to switch between a first state and a second state responsive to moving the conduit attachment portion 748 downwardly and upwardly.
- the connector 747 includes one or more support 731 extending inwardly and proximally from the inner surface 790 of the connector 747.
- the supports 731 may include at least one radially inwardly extending support and a distally vertically extending support.
- the connector 747 may include a plug 733 at a proximal end of the supports 731. The plug 733 may exhibit a lateral dimension that is greater than the inlet 721 of the connector 747.
- the plug 733 may cover and prevent fluid flow- through the inlet 721 when the plug 733 abuts the inlet 721.
- the plug 733 may move relative to the inlet 721 as the conduit attachment portion 748 moves upwardly and downwardly thereby allowing movement of the conduit attachment portion 748 to switch the drainage port assembly 744 between the first and second states.
- the plug 733 may cover the inlet 721 when the connector 747 is in the first position (e.g., the conduit attachment portion 748 is in an upward position) and may move away from the inlet 721 when the connector 747 is in the second position (e.g, the conduit attachment portion 748 is in a downward position).
- the drainage port assembly 744 may exhibit the first state w hen a conduit is attached to the conduit attachment portion 748 and fluid flow through the drainage port assembly
- the plug 733 may be located on a proximal side of the inlet 721.
- the connector 747 may exhibit the first position when the connector
- the plug 733 may be positioned on a distal side of the inlet 721.
- supports 731 and the plug 733 illustrated in FIG. 7B may be used in any of the drainage port assemblies disclosed herein (e.g, the drainage port assembly 644 of FIGS. 6A-6D).
- the drainage port assembly 744 may include any of the structures disclosed herein that allow the drainage port assembly 744 to switch between the first and second states, such as any of the structures disclosed in the discussion of the drainage port assembly 644 of FIGS. 6A-6D.
- the collar 745 may be attached to the annular base 749 using any suitable technique. In an embodiment, the collar 745 may snap fasten to the annular base 749.
- the annular base 749 may include at least one distally-extending structure 703 extending from the laterally-extending structure 786 of the annular base 749.
- the distally-extending structure 703 may include a single annular structure extending more than 50% to completely around a lateral periphery of the laterally-extending structure 786 or may include a plurality of structures forming a discontinuous annular structure. It is noted that selecting the distally-extending structure 703 to include a discontinuous annular structure may facilitate flexing of the distally-extending structure 703 during attachment of the collar 745.
- the distally-extending structure 703 may include one or more protrusions 705 extending laterally inwardly from or near the distal end of the distally-extending structure 703.
- the protrusions 705 reduce the lateral dimension of a portion of the annular base 749 to be less than a corresponding dimension of the collar 745.
- the collar 745 may be forced over the protrusions 705 to position the collar 745 between the second interfacing surface 788 of the annular base 749 and the protrusions 705.
- the protrusions 705 may then help maintain the position of the collar 745 between the second interfacing surface 788 and the protrusions 705 thereby snap fastening the collar 745 to the annular base 749.
- the collar 745 may be snap fastened to the annular base 749 using other structures, examples of which are disclosed above or in U.S. Provisional Application No. 63/711,445 filed on October 24, 2024, the disclosure of which was previously incorporated herein.
- At least one of the protrusions 705 includes a tapered or curved surface 707 facing in a distal direction (as shown) or the lateral edges of the collar 745 include a tapered or curv ed surface 709 facing a proximal direction (as shown).
- the tapered or curved surfaces 707, 709 may facilitate moving the collar 745 over the protrusions 705.
- Terms of degree indicate structurally or functionally insignificant variations.
- 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 7 .
- the term of degree indicates that the shape being modified by the term of degree has the appearance of the disclosed shape.
- the term of degree may be used to indicate that the shape may have rounded comers instead of sharp comers, curved edges instead of straight edges, one or more protrusions extending therefrom, is oblong, is the same as the disclosed shape, etc.
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Abstract
An example drainage port assembly includes a collar and a connector, The connector includes an engagement portion that is attached to or integrally formed with the collar and the conduit attachment portion that is distinct from the engagement portion. The engagement portion is configured to allow the conduit attachment portion to move relative to the collar. The collar and the connector define a collar passageway extending through the collar and a connector passageway extending through the connector, respectively. In some embodiments, the movement of the conduit attachment portion relative to the collar switches the drainage port assembly between a first state and a second state, wherein the drainage port assembly permits flow of bodily fluids therethrough when in the first state (e.g., through the collar passageway and the connector passageway) and restricts the flow of the bodily fluids therethrough w hen in the second state.
Description
DRAINAGE PORT ASSEMBLIES
CROSS-REFERENCE TO RELATED APPLICATIONS
[0001] This application claims priority to U.S. Provisional Application No. 63/564,696 filed on March 13, 2024; U.S. Provisional Application No. 63/711,445 filed on October 24, 2024; and U.S. Provisional Application No. 63/711,438 filed on October 24, 2024, the disclosure of each of which is incorporated herein, in its entirety', by this reference.
[0002]
BACKGROUND
[0003] A person or animal may have limited or impaired mobility so typical urination processes are challenging or impossible. For example, a person may experience or have a disability that impairs mobility. A person may have restricted travel conditions such as those experienced by pilots, drivers, and workers in hazardous areas. Additionally, sometimes bodily fluids collection is needed for monitoring purposes or clinical testing.
[0004] Urinary catheters, such as a Foley catheter, can address some of these circumstances, such as incontinence. Unfortunately, urinary catheters can be uncomfortable, painful, and can lead to complications, such as infections. Additionally, bed pans, which are receptacles used for the toileting of bedridden individuals, are sometimes used. However, bedpans can be prone to discomfort, spills, and other hygiene issues.
SUMMARY
[0005] Embodiments disclosed herein related to drainage port assemblies, fluid collection assemblies and systems including the same, and methods of making and using the same. In an embodiment, a fluid collection assembly is disclosed. The fluid collection assembly includes a fluid impermeable barrier defining a chamber, an opening, and a fluid outlet. The fluid impermeable barrier includes a proximal end region defining the opening and a distal end region defining the fluid outlet. The fluid collection assembly also includes at least one porous material disposed in the chamber and a drainage port assembly. The drainage port assembly includes a collar defining a collar passageway extending through at least a portion of the collar and a connector including an engagement portion attached to or integrally formed with the collar and a conduit attachment portion distinct from the engagement portion. The conduit attachment portion is configured to be attached to a conduit. The connector defines a connector passageway extending from the engagement
portion to the conduit attachment portion. The connector is configured to move relative to the collar. The drainage port assembly attached to the distal end region of the fluid impermeable barrier and positioned to have the fluid outlet and a collar passageway extending through the collar aligned to allow bodily fluids received in the chamber to flow out of the chamber through the fluid outlet and into the collar passageway.
[0006] In an embodiment, a drainage port assembly is disclosed. The drainage port assembly includes a collar defining a collar passageway extending through at least a portion of the collar and a connector including an engagement portion attached to or integrally formed with the collar and a conduit attachment portion distinct from the engagement portion. The conduit attachment portion is configured to be attached to a conduit. The connector defines a connector passageway extending from the engagement portion to the conduit attachment portion. The connector is configured to move relative to the collar.
[0007] In an embodiment, a method of using a drainage port assembly is disclosed. The method includes providing a drainage port assembly. The drainage port assembly includes a collar defining a collar passageway extending through at least a portion of the collar and a connector including an engagement portion attached to or integrally formed with the collar and a conduit attachment portion distinct from the engagement portion. The conduit attachment portion is configured to be attached to a conduit. The connector defines a connector passageway extending from the engagement portion to the conduit attachment portion. The connector is configured to move relative to the collar. The method also includes moving the connector relative to the collar.
[0008] 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
[0009] 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. [0010] FIG. 1A is an isometric view of a fluid collection assembly including a drainage port assembly, according to an embodiment.
[0011] FIG. IB is a cross-sectional view of the fluid collection assembly taken along plane 1B-1B.
[0012] FIG. 1C is a cross-sectional view of the fluid collection assembly taken along plane 1B-1B with the drainage port assembly omitted.
[0013] FIG. ID is a block diagram of a fluid collection system for fluid collection, according to an embodiment. [0014] FIG. 2A is an isometric view of a drainage port assembly, according to an embodiment.
[0015] FIG. 2B is a cross-sectional view of the drainage port assembly taken along plane 2B-2B.
[0016] FIGS. 3A and 3B are isometric views of a drainage port assembly exhibiting a first state and a second state, respectively, according to an embodiment.
[0017] FIGS. 3C and 3D are cross-sectional views of the drainage port assembly taken along planes 3C-3C and 3D-3D, respectively.
[0018] FIGS. 4A and 4B are isometric views of a drainage port assembly exhibiting a first state and a second state, respectively, according to an embodiment. [0019] FIGS. 4C and 4D are cross-sectional views of the drainage port assembly taken along planes 4C-4C and 4D-4D, respectively.
[0020] FIG. 5A is an isometric view of a drainage port assembly, according to an embodiment.
[0021] FIG. 5B is a cross-sectional view of the drainage port assembly taken along plane 5B-5B.
[0022] FIG. 6A is an isometric view of a drainage port assembly, according to an embodiment.
[0023] FIGS. 6B and 6C are cross-sectional views of the drainage port assembly in the first and second states taken along plane 6B-6B. [0024] FIG. 6D is a cross-sectional view of a portion of the drainage port assembly taken along plane 6D-6D.
[0025] FIG. 7A is an isometric view of a drainage port assembly, according to an embodiment.
[0026] FIG. 7B is a cross-sectional view of the drainage port assembly taken along plane 7B-7B.
DETAILED DESCRIPTION
[0027] Embodiments disclosed herein related to drainage port assemblies, fluid collection assemblies and systems including the same, and methods of making and using the same. An example drainage port assembly includes a collar and a connector. The
connector includes an engagement portion that is attached to or integrally formed with the collar and the conduit attachment portion that is distinct from the engagement portion. The engagement portion is configured to allow the conduit attachment portion to move relative to the collar. The collar and the connector define a collar passageway extending through the collar and a connector passageway extending through the connector, respectively. In some embodiments, the movement of the conduit attachment portion relative to the collar switches the drainage port assembly between a first state and a second state, wherein the drainage port assembly permits flow of bodily fluids therethrough when in the first state (e.g., through the collar passageway and the connector passageway) and restricts the flow of the bodily fluids therethrough w hen in the second state.
[0028] The drainage port assembly may form part of a fluid collection assembly. The fluid collection assembly may include a fluid impermeable barrier defining a chamber, an opening, and a fluid outlet. The fluid collection assembly may also include at least one porous material disposed in the chamber. The drainage port assembly may be attached to the fluid impermeable barrier. For example, the collar may include at least one interfacing surface that is attached to the fluid impermeable barrier. The collar may be positioned on the fluid impermeable barrier such that the collar passageway is aligned with the fluid outlet thereby allowing bodily fluids received in the chamber to be removed from the chamber through the fluid outlet and through the collar and connector passageways of the drainage port assembly, for example, when the drainage port assembly is in the first state.
[0029] During use, the fluid collection assembly is positioned on an individual such that the opening of the fluid impermeable barrier is positioned adjacent to a urethral opening of an individual (e.g. , a female urethral opening or the urethral opening of a buried penis) or have a penis at least partially received through the opening and into the chamber. After the fluid collection assembly is positioned, the individual may discharge one or more bodily fluids (e.g., urine, sweat, menstrual fluids, etc.) and the bodily fluids may be received into the chamber. The bodily fluids received in the chamber may be received by the porous material and may flow generally towards the fluid outlet. Bodily fluids that reach the fluid outlet may flow out of the chamber through the fluid outlet and into the collar and connector passageways of the drainage port assembly, for example, when the drainage port assembly is in the first state. The drainage port assembly may be connected to a conduit such that the bodily fluids that flow through the drainage port assembly enter the conduit and flow away from the fluid collection assembly through the conduit. In an embodiment, a vacuum may be applied to the chamber using a vacuum source that is in fluid communication with
the chamber via the conduit and the drainage port assembly. The vacuum source may facilitate moving the bodily fluids towards the fluid outlet and pulling the bodily fluids into the conduit via the fluid outlet and the collar and connector passageways of the drainage port assembly. The vacuum may also pull the bodily fluids received into the conduit into a fluid storage container.
[0030] The drainage port assemblies disclosed herein are an improvement over conventional fluid outlets of conventional fluid collection assemblies. For example, at least some conventional fluid collection assemblies either include a conduit directly attached to a fluid impermeable material thereof or to a rigid structure attached to the fluid impermeable material. In such an example, the conduits extend from the conventional fluid collection assemblies in a fixed direction relative to the conventional fluid collection assemblies. For instance, during use, the fixed direction that the conduits extend from the conventional fluid collection assemblies may be towards the feet of the individual. The conduit may extend from the fluid collection assembly to a vacuum source and/or a fluid storage container. The conduit may need to have one or more bends formed therein for the conduit to reach the vacuum source and/or the fluid storage container. The fixed direction that the conduits extend from the conventional fluid collection assemblies may prevent the conduit from extending to the vacuum source and/or the fluid storage container in a direct path without forming one or more bends therein and, instead, may necessitate forming one or more tight or otherwise disadvantageous bends in the conduit for the conduit to reach the vacuum source and/or the fluid storage container. Such tight or otherwise disadvantageous bends in the conduit may cause the conduit to kink which, in turn, impedes removal of bodily fluids from the conventional fluid collection assemblies and increases the likelihood that the conventional fluid collection assemblies leak. [0031] Further, the conduit may move during use of the fluid collection assembly, such as when the individual moves. For example, the conduit may be initially arranged such that there are no kinks in the conduit. However, movement of the individual after initially arranging the conduit may cause the conduit to kink, especially since the fixed direction that the conduit extends from the conventional fluid collection assemblies minimizes the ability for the conduit to accommodate such movement without kinking. Also, the inability of the conduit to accommodate movement of the individual may also cause the conventional fluid collection assemblies to at least one of pull on the individual or cause the conventional fluid collection assemblies to twist, kink, or otherwise deform in a manner that may impede
flow of the bodily fluids in the conventional fluid collection assemblies towards the fluid outlet.
[0032] The drainage port assemblies disclosed herein are an improvement over such fluid collection assemblies since, as previously discussed, the connector of the drainage port assemblies disclosed herein can move relative to the collar. The movement of the connector relative to the collar allows the conduit to extend from the fluid collection assembly generally directly towards the fluid storage container and/or the vacuum source or may prevent or decrease the likelihood that the conduit needs to form tight or otherwise disadvantageous bends to reach the fluid storage container and/or the vacuum source. As such, the movement of the connector relative to the collar decreases the likelihood that kinks form in the conduit. Also, the movement of the connector relative to the collar allows the conduit to better accommodate movement of the individual without kinking the conduit, minimizes pulling on the individual, or twisting, kinking, or otherwise deforming the fluid collection assembly. [0033] Another issue associated with conventional fluid collection assemblies involves disconnecting the conventional fluid collection assemblies from a fluid storage container and/or a vacuum source. For example, situations may arise during the operation of the conventional fluid collection assemblies that require disconnecting the conventional fluid collection assemblies from the fluid storage container and/or the vacuum source. Such situations include moving the patient from one location (e.g., room or building) to another location, replacing a faulty vacuum source, or emptying a full fluid storage container. With individuals who are unable to control discharge of their bodily fluids, disconnecting the conventional fluid collection assemblies from the fluid storage container and/or the vacuum source runs the risk of the individual discharging bodily fluids (e.g.. urinating) while the conventional fluid collection assemblies are disconnected. The bodily fluids discharged from the individual are received into the conventional fluid collection assemblies and either leak out the fluid outlet or the conduit extending from the fluid outlet. Disconnecting the conventional fluid collection assemblies from the fluid storage container and/or the vacuum source also runs into issues when used with individuals who can control the discharge of their bodily fluids since any bodily fluids that are present in the conventional fluid collection assemblies may still leak from the fluid outlet or the conduit extending from the fluid outlet.
[0034] Some fluid collection assemblies attempt to resolve this issue by including a cap that is configured to cover the fluid outlet, the conduit extending from the outlet, or a rigid
structure attached to the fluid outlet thereby restricting flow of the bodily fluids out of the fluid collection assemblies when disconnected from the fluid storage container and/or the vacuum source. Examples of such caps are disclosed in U.S. Provisional Patent Application No. 63,564,696 filed on March 13, 2024, and U.S. Provisional Application No. 63/711,445 filed on October 24, 2024, the discloses of each of which were previously incorporated herein.
[0035] Some of the drainage port assemblies disclosed herein resolve this issue associated with conventional fluid collection assemblies. As previously discussed, the drainage port assemblies disclosed herein are configured to allow the conduit attachment portion to rotate or otherwise move relative to the collar. Such movement of the conduit attachment portion relative to the collar may be leveraged to selectively permit or restrict the flow of bodily fluids through the drainage port assembly. For example, the drainage port assembly may exhibit a first state that allows the bodily fluids to flow through the drainage port assembly and a second state that restricts flow of the bodily fluids through the drainage port assembly. Movement of the conduit attachment portion relative to the collar may be used to switch the drainage port assembly between these states thereby allowing the fluid collection assemblies to be detached from the fluid storage container or the vacuum source without the risk of leaking. As such, the drainage port assemblies disclosed herein resolves the issue associated with disconnecting the fluid storage container and/or vacuum source without the associated issues with using a cap.
[0036] The drainage port assemblies disclosed herein and the fluid collection assemblies including such drainage port assemblies may be an improvement over conventional fluid collection assemblies for other reasons, as discussed in more detail below. [0037] FIG. 1A is an isometric view of a fluid collection assembly 100 including a drainage port assembly 144, according to an embodiment. FIG. IB is a cross-sectional view of the fluid collection assembly 100 taken along plane 1B-2B. FIG. 1C is a cross- sectional view of the fluid collection assembly 100 taken along plane 1B-1B with the drainage port assembly 144 omitted. The fluid collection assembly 100 is an example of a male fluid collection assembly though, in some embodiments, the fluid collection assembly 100 may be used to receive bodily fluids from a female urethral opening. The fluid collection assembly 100 includes a sheath 102 and a base 104. The base 104 is configured to be attached (e.g, permanently attached to or configured to be permanently attached) to
the sheath 102. The base 104 is also configured to be attached to the region about the urethral opening (e.g, penis) of the individual.
[0038] The sheath 102 includes a fluid impermeable barrier 106. The fluid impermeable barrier 106 at least partially defines a chamber 112 (e.g., interior region) and an opening 114. For example, the interior surface(s) of the fluid impermeable barrier 106 at least partially defines the chamber 112 within the fluid collection assembly 100. The fluid impermeable barrier 106 temporarily stores the bodily fluids in the chamber 112. The fluid impermeable barrier 106 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 106 substantially prevents the bodily fluids from passing through the fluid impermeable barrier 106. In an example, the fluid impermeable barrier 106 may be air permeable and fluid impermeable. In such an example, the fluid impermeable barrier 106 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 of the fluid impermeable barrier 106 may be formed from a soft and/or smooth material, thereby reducing chaffing. In an embodiment, the fluid impermeable barrier 106 may include one or more vacuum relief openings 137 that include a hole extending through the fluid impermeable barrier 106 and a water-impermeable, air permeable membrane covering the hole. In an embodiment, the fluid impermeable barrier 106 may be relatively rigid. That is, the fluid impermeable barrier 106 may be able to generally maintain a selected shape thereof (e.g, a generally planar or three-dimensional shape) when unsupported. [0039] The fluid impermeable barrier 106 may be at least partially formed from a top panel 122 and a bottom panel 124. The top panel 122 and the bottom panel 124 may be attached or integrally formed together (e.g, exhibits single piece construction, such as when the top panel 122 and the bottom panel 124 form a tubular structure or a folded sheet). In an embodiment, as illustrated, the top panel 122 and the bottom panel 124 are distinct sheets. The fluid impermeable barrier 106 also defines a chamber 112 between the top panel 122 and the bottom panel 124, an opening 114 at a proximal end region 108 of the sheath 102. and a fluid outlet 116 at a distal end region 110 of the sheath 102. The sheath 102 also includes at least one porous material 118 disposed in the chamber 112.
[0040] The inner surface(s) of the fluid impermeable barrier 106 (e.g.. inner surfaces of the top and bottom panels 122, 124) at least partially defines the chamber 112 within the fluid collection assembly 100. The fluid impermeable barrier 106 temporarily stores the bodily fluids in the chamber 112. The fluid impermeable barrier 106 may be formed from any of the fluid impermeable materials disclosed herein. As such, the fluid impermeable barrier 106 substantially prevents the bodily fluids from passing through the fluid impermeable barrier 106.
[0041] In an embodiment, at least one of the top panel 122 or the bottom panel 124 is formed from an at least partially transparent fluid impermeable material, such as polyethylene, polypropylene, polycarbonate, or polyvinyl chloride. Forming at least one of the top panel 122 or the bottom panel 124 from an at least partially transparent fluid impermeable material allows a person (e.g., medical practitioner) to examine the penis. In some embodiments, both the top panel 122 and the bottom panel 124 are formed from at least partially transparent fluid impermeable material. Selecting at least one of the top panel 122 or the bottom panel 124 to be formed from an at least partially transparent impermeable material allows the penis to be examined without detaching the entire fluid collection assembly 100 from the region about the penis. For example, the chamber 112 may include a penis receiving area 130 that is configured to receive the penis of the individual when the penis extends into the chamber 112. The penis receiving area 130 may be defined by at least the porous material 118 and at least a portion of the at least partially transparent material of the top panel 122 and/or the bottom panel 124. In other words, the porous material 118 is positioned in the chamber 112 such that the porous material 118 is not positioned between the penis and at least a portion of the transparent portion of the top panel 122 and/or bottom panel 124 when the penis is inserted into the chamber 112 through the opening 1 14. The porous material 118 is generally not transparent and, thus, the portion of the at least partially transparent material of the top panel 122 and/or the bottom panel 124 that defines the penis receiving area 130 forms a window which allows the person to view into the penis receiving area 130 and examine the penis.
[0042] The opening 114 defined by the fluid impermeable barrier 106 provides an ingress route for bodily fluids to enter the chamber 112 when the penis is a buried penis and allow the penis to enter the chamber 112 (e.g., the penis receiving area 130) when the penis is not buried. The opening 114 may be defined by the fluid impermeable barrier 106 (e.g., an inner edge of the fluid impermeable barrier 106). For example, the opening 114
is formed in and extends through the fluid impermeable barrier 106 thereby enabling bodily fluids to enter the chamber 112 from outside of the fluid collection assembly 100.
[0043] The fluid impermeable barrier 106 defines the fluid outlet 1 16 (shown in FIG. 1C). The fluid outlet 116 is a hole formed in the fluid impermeable barrier 106. The fluid outlet 116 may be formed at or near the distal end region 110 of the fluid impermeable barrier 106. The drainage port assembly 144 may be attached to the portions of the fluid impermeable barrier 106 that define the fluid outlet 116. The drainage port assembly 144 may include any of the drainage port assemblies disclosed herein. The drainage port assembly 144 may be attached to the fluid impermeable barrier 106 using any suitable technique. In an example, the portions of the fluid impermeable barrier 106 defining the fluid outlet 116 may be positioned (e.g., sandwiched) between a collar 145 and the annular base 149. That said, the portions of the fluid impermeable barrier 106 defining the fluid outlet 116 may be attached to the drainage port assembly 144 using other attachment techniques, such as an adhesive, welding, or sewing. The fluid outlet 116 may be aligned with the passageways of the drainage port assembly 144 such that bodily fluids may flow out of the chamber 112 through the fluid outlet 116 and the passageways of the drainage port assembly 144.
[0044] As previously discussed, the sheath 102 includes at least one porous material 118 disclosed in the chamber 112. The porous material 118 may direct the bodily fluids to one or more selected regions of the chamber 112, such as away from the penis and towards the fluid outlet 1 16. The porous material 1 18 may be formed from any of the porous materials disclosed herein. In an example, the porous material 118 may be formed from a single layer, two layers (e.g., a fluid permeable membrane extending across the opening 114 and a fluid permeable support since the fluid permeable membrane may be formed from a relatively foldable, flimsy, or otherwise easily deformable material), or three or more layers. In an example, the porous material 118 may be formed from a nonwoven material or a woven material (c.g.. spun nylon fibers). In an example, the porous material 118 may include at least one material exhibiting substantially no absorption, or at least one absorbent or adsorbent material. [0045] In an embodiment, the porous material 118 may be configured to wick any bodily fluids away from the opening 114, thereby preventing the bodily fluids from escaping the chamber 112. 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 a portion of the porous material 118, such as not including adsorption of the bodily fluids into the fluid permeable support. Put another way, substantially no absorption or solubility7 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 porous material 118 (e.g, absorbency), such as less than about 30 wt% of the dry weight of the porous material 118, less than about 10 wt%, less than about 7 wt%, less than about 5 wt%, less than about 3 wt%, less than about 2 wt%, less than about 1 wt%, or less than about 0.5 wt% of the dry' weight of the porous material 118. The porous material 118 may also wick the bodily fluids generally towards an interior of the chamber 112, as discussed in more detail below. In an embodiment, the porous material 118 may include at least one absorbent or adsorbent material.
[0046] In some examples, the fluid permeable membrane may be optional. For example, the porous material 118 may include only the fluid permeable support. In some examples, the fluid permeable support may be optionally omitted from the fluid collection assembly7 100. For example, the porous material 118 may only include the fluid permeable membrane.
[0047] In an embodiment, at least a portion of the porous material 118 (e.g., one or more of the fluid permeable membrane or, more preferably, the fluid permeable support) may be hydrophobic. The porous material 118 may be hydrophobic when the porous material 118 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 porous material 118 may limit absorption, adsorption, and solubility7 of the bodily7 fluids in the porous material 118 thereby decreasing the volume of bodily fluids held in the porous material 118. In an embodiment, at least a portion of the porous material 118 is hydrophobic or hydrophilic. In an embodiment, the fluid permeable support is more hydrophobic (e.g.. exhibits a larger contact angle with water) than the fluid permeable membrane. The lower hydrophobicity7 of the fluid permeable membrane may help the porous material 118 receive the bodily fluids from the urethral opening while the hydrophobicity of the fluid permeable support limits the bodily fluids that are retained in the porous material 118.
[0048] In an embodiment, the porous material 118 may include the fluid permeable membrane disposed in the chamber 112. The fluid permeable membrane may be positioned to at least extend across at least a portion (e.g. , all) of the opening 114. The fluid permeable membrane may be composed to wick the bodily fluids away from the opening 114, thereby preventing the bodily fluids from escaping the chamber 112.
[0049] In an embodiment, the fluid permeable membrane may include any material that may wick the bodily fluids. For example, the fluid permeable membrane may include fabric, such as a gauze (e.g, a silk, linen, or cotton gauze), another soft fabric, another smooth fabric, a nonwoven material, or any of the other porous materials disclosed herein. Forming the fluid permeable membrane from gauze, soft fabric, and/or smooth fabric may reduce chaffing caused by the fluid collection assembly 100.
[0050] The fluid collection assembly 100 may include the fluid permeable support disposed in the chamber 112. The fluid permeable support is configured to support the fluid permeable membrane, since the fluid permeable membrane may be formed from a relatively foldable, flimsy, or otherwise easily deformable material. For example, the fluid permeable support may be positioned such that the fluid permeable membrane is disposed between the fluid permeable support and the fluid impermeable barrier 106. As such, the fluid permeable support may support and maintain the position of the fluid permeable membrane. The fluid permeable support may 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 when used as the fluid permeable support. The fluid permeable support may be formed from any fluid permeable material that is less deformable than the fluid permeable membrane. For example, the fluid permeable support 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 may include a nonwoven material. In some examples, the fluid permeable support 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 may be formed from fabric, felt, gauze, or combinations thereof.
[0051] In a particular example, the fluid permeable membrane may include first layer and a second layer. The first layer may be positioned to generally receive bodily fluid
before the second layer. The first layer may include hydrophilic polypropylene or hydrophilic polyethylene (e.g, polypropylene or polyethylene including a polyethylene glycol fatty acid ester surfactant or otherwise treated to be hydrophilic) and the second layer may include bamboo. In such an example, the first layer and the second layer may have a synergistic effect that allows the first layer to quickly receive bodily fluids therein, move the bodily fluids from the first layer into the second layer, and maintain the first layer relatively dry. For instance, the hydrophilicity of the first layer allows the first layer to quickly receive bodily fluids, such as to initially receive bodily fluids that are discharged from the urethral opening of the individual. However, the bamboo second layer may exhibit a hydrophilicity that is greater than (z.e., exhibits a contact angle with water that is less than) the first layer. The greater hydrophilicity’ of the bamboo second layer pulls bodily fluids from the first layer and into the second layer, thereby facilitating quick transfer of bodily fluids from the first layer to the second layer. The greater hydrophilicity of the bamboo second layer also helps dry the first layer since the hydrophilic pull from the bamboo second layer removes most of the bodily fluids from the first layer. The dry first layer minimizes discomfort caused by using a fluid collection assembly including the porous material, minimizes skin degradation caused by the bodily fluids, and allows the fluid collection assembly including the porous material to be used for longer periods of time (e.g., greater than 24 hours). In this particular example, the first layer and the second layer may be positioned adjacent to a polyethylene terephthalate (“PET”) fluid permeable support since the bamboo second layer is able to transfer bodily fluids quickly and effectively into the PET fluid permeable support thereby preventing the first and second layers from becoming saturated with bodily fluids. Further, the PET fluid permeable support is able to quickly move substantially all of the bodily fluids towards a fluid outlet such that the PET fluid permeable support is substantially dry a short period of time after receiving the bodily fluids. The dry PET fluid permeable support facilitates drying of the particular first and second layers of this example. It is noted that the PET fluid permeable support may include a nonwoven material and, more particularly a vertical lapped nonwoven material, since such nonwoven materials facilitate drawing fluids into the PET fluid permeable support from the bamboo second layer and improve flow of the bodily fluids in the PET fluid permeable support towards the fluid outlet thereby facilitating dry ing of the porous material 118. That said, the first layer and/or the second layer may include porous materials other than hydrophilic polypropylene/polyethylene and bamboo, respectively, as discussed in more detail herein. Further, the first layer and/or the second
layer may be used with an inner fluid permeable support other than PET, as discussed in more detail herein.
[0052] Other examples of the porous material 118 are disclosed in PCT International Application No. PCT/US2022/011281 fded on January 5, 2022, PCT International Application No. PCT/US2022/042719 filed on September 7, 2022, PCT International Application No. PCT/US2022/042725 filed on September 7, 2022, U.S. Provisional Patent Application No. 63/241,564 filed on September 8, 2021. PCT International Application No. PCT/US2022/015418 filed on February 7, 2022, PCT International Application No. PCT/US2022/015420 filed on February' 7, 2022, and PCT Patent Application No. PCT/US2021/039866 filed on June 30, 2021, the disclosures of each of which are incorporated herein, in their entireties, by this reference.
[0053] In an embodiment, the porous material 118 may be a sheet. Forming the porous material 118 as a sheet may facilitate the manufacturing of the fluid collection assembly 100. For example, forming the porous material 118 as a sheet allows the top panel 122, the bottom panel 124, and the porous material 118 to each be sheets . During the manufacturing of the fluid collection assembly 100, the top panel 122, the bottom panel 124, and the porous material 118 may be stacked and then attached to each other in the same manufacturing step. For instance, the porous material 118 may exhibit a shape that is the same size or, more preferably, slightly smaller than the size of the top panel 122 and the bottom panel 124. As such, attaching the top panel 122 and the bottom panel 124 together along the outer edges thereof may also attach the porous material 1 18 to the top panel 122 and the bottom panel 124. The porous material 118 may be slightly smaller than the top panel 122 and the bottom panel 124 such that the top panel 122 and/or the bottom panel 124 extend around the porous material 118 such that the porous material 118 does not form a passageway through the fluid impermeable barrier 106 through which the bodily fluids may leak. Also, attaching the porous material 118 to the top panel 122 and/or the bottom panel 124 may prevent the porous material 118 from significantly moving in the chamber 112, such as preventing the porous material 118 from bunching together near the fluid outlet 116. In an example, the porous material 118 may be attached to the top panel 122 or the bottom panel 124 (e.g., via an adhesive) before or after attaching the top panel 122 to the bottom panel 124. In an example, the porous material 118 may merely be disposed in the chamber 112 without attaching the porous material 118 to at least one of the top panel 122 or the bottom panel 124. In an embodiment, the porous material 118 may exhibit shapes other than a sheet, such as a hollow generally cylindrical shape. In an embodiment, the
porous material 118 may include a passageway extending therethrough that allows a nonburied penis to extend through the porous material 118 when the penis receiving area 130 is between the porous material 118 and the top panel 122.
[0054] Generally, the sheath 102 is substantially flat when the penis is not in the penis receiving area 130 and the sheath 102 is resting on a flat surface. The sheath 102 is substantially flat because the fluid impermeable barrier 106 is formed from the top panel 122 and the bottom panel 124 instead of a generally tubular fluid impermeable barrier. Further, as previously discussed, the porous material 118 may be a sheet, which also causes the sheath 102 to be substantially flat. The sheath 102 may also be substantially flat because the fluid collection assembly 100 may not include relatively rigid rings or caps that exhibit a rigidity that is greater than the portions of the fluid impermeable barrier 106 thereabout, since such rings and caps may inhibit the sheath 102 being substantially flat. It is noted that the sheath 102 is described as being substantially flat because at least one of the porous material 118 may cause a slight bulge to form in the sheath 102 depending on the thickness of the porous material 118, the fluid outlet 116 and/or conduit 142 may cause a bulge thereabout, or the base 104 may pull on portions of the sheath 102 thereabout. It is also noted that the sheath 102 may also be compliant and, as such, the sheath 102 may not be substantially flat during use since, during use, the sheath 102 may rest on anon-flat surface (e.g., may rest on the testicles, the perineum, and/or between the thighs) and the sheath 102 may conform to the surface of these shapes.
[0055] The ability of the sheath 102 to be substantially flat when the penis is not in the penis receiving area 130 and the sheath 102 is resting on a flat surface allows the fluid collection assembly 100 to be used with a buried and a non-buried penis. For example, when the fluid collection assembly 100 is being used with a buried penis, the penis does not extend into the penis receiving area 130 which causes the sheath 102 to lie relatively flat across the aperture 120 of the base 104. When the sheath 102 lies relatively flat across the aperture 120, the porous material 118 extends across the opening 114 and the aperture 120 and is in close proximity to the buried penis. As such, the porous material 118 prevents or inhibits pooling of bodily fluids discharged from the buried penis against the skin of the individual since the porous material 118 will receive and remove at least a significant portion of the bodily fluids that would otherwise pool against the skin of the individual. Thus, the skin of the individual remains dry thereby improving comfort of using the fluid collection assembly 100 and preventing skin degradation. However, unlike other conventional fluid collection assemblies that are configured to be used with buried penises,
the fluid collection assembly 100 may still be used with a non-buried penis since the nonburied penis can still be received into the penis receiving area 130, even when the penis is fully erect. Additionally, the ability of the sheath 102 to be substantially flat allows the fluid collection assembly 100 to be used more discretely than if the sheath 102 was not substantially flat, thereby avoiding possibly embarrassing scenarios.
[0056] When the sheath 102 is substantially flat, the porous material 118 occupies substantially all of the chamber 112 and the penis receiving area 130 is collapsed (shown as being non-collapsed in FIGS. IB and 1C for illustrative purposes to show the penis receiving area 130). In other words, the sheath 102 may not define a region that is constantly unoccupied by the porous material 118. When the porous material 118 occupies substantially all of the chamber 112. the bodily fluids discharged into the chamber 112 are unlikely to pool for significant periods of time since pooling of the bodily fluids may cause sanitation issues, cause an odor, and/or may cause the skin of the individual to remain in contact with the bodily fluids, which may cause discomfort and skin degradation. [0057] As previously discussed, the top panel 122, the bottom panel 124, and the porous material 118 may be selected to be relatively flexible. The top panel 122, the bottom panel 124, and the porous material 118 are relatively flexible when the top panel 122, the bottom panel 124, and the porous material 118, respectively, are unable to maintain their shape when unsupported. The flexibility of the top panel 122, the bottom panel 124, and the porous material 118 may allow the sheath 102 to be substantially flat, as discussed above. The flexibility of the top panel 122, the bottom panel 124, and the porous material 118 may also allow the sheath 102 to conform to the shape of the penis even when the size and shape of the penis changes (e.g., becomes erect) and to minimize any unoccupied spaces in the chamber 112 in which bodily fluids may pool. [0058] In an example, at least the top panel 122 may be relatively rigid. The top panel
122 is relatively rigid when the top panel 122 maintains a shape thereof when a vacuum applied to the chamber 112. The vacuum applied to the chamber 112 may be (in either absolute or gauge) about 40 kPa or less, about 30 kPa or less, about 20 kPa or less, or about 5 kPa to about 15 kPa. The relative rigidity of the top panel 122 prevents the collapse of the top panel 122 during use. For example, at least some conventional male fluid collection assemblies are formed from non-rigid panel(s) (e.g., flimsy and compliant panel(s)). When a vacuum is applied to the conventional male fluid collection assemblies, air in the conventional fluid collection assemblies is removed and the non-rigid panel(s) collapse. The collapsed panels may cover the urethral opening of the penis thereby preventing or at
least inhibiting the individual from discharging urine into the conventional male fluid collection assemblies. However, unlike the conventional male fluid collection assemblies, the relatively rigid top panel 122 is unlikely to collapse when a vacuum is applied to the chamber 112. When the top panel 122 defines a portion of the penis receiving area 130, the relative rigidity of the top panel 122 prevents the top panel 122 from covering the urethral opening of the penis.
[0059] It is noted that the relatively rigid top panel 122 may still be flexible and soft thereby allowing the fluid collection assembly 100 to be comfortable to use. For example, the fluid collection assembly 100 is configured to rest on top of the thighs of the individual during use. However, the relatively rigid top panel 122 may still be able to allow the fluid collection assembly 100 to fall between the thighs of the individual when the individual opens the individual’s thighs thereby preventing uncomfortable pulling on the area about the penis if the fluid collection assembly 100 was not flexible. Further, the relatively rigid top panel 122 may easily collapse if the individual closed the individual's thighs after the fluid collection assembly 100 fell between the thigs to prevent the top panel 122 from uncomfortably pressing into the thighs of the individual.
[0060] The top panel 122 may be relatively rigid because the top panel 122 has one or more three-dimensional structures formed therein. The three-dimensional structures may be formed in the top panel 122, for example, using a thermoforming technique since thermosetting is able to form the three-dimensional structures quickly, cheaply, and efficiently. The three-dimensional structures may resist bending of which, in turn, increases the rigidity of the top panel 122. The three-dimensional structures may include, for example, a bulge, one or more reinforcement structures, one or more fold lines, any other suitable three-dimensional structure, or combinations thereof. It is noted that the three-dimensional structures may be formed using other techniques, such as by selectively varying a thickness of the top panel 122, adding a material to the top panel 122, or via any other suitable technique.
[0061] As previously discussed, the fluid collection assembly 100 includes a base 104 that is configured to be attached to the sheath 102. For example, the base 104 is configured to be permanently attached to the sheath 102. The base 104 is configured to be permanently attached to the sheath 102 when, for example, the fluid collection assembly 100 is provided with the base 104 permanently attached to the sheath 102, or the base 104 is provided without being permanently attached to the sheath 102 but is configured to be permanently attached to the sheath 102 at some point in the future. Permanently attached means that the
sheath 102 cannot be detached from the base 104 without damaging at least one of the sheath 102 or the base 104, using a blade to separate the sheath 102 from the base 104, and/or using chemicals to dissolve the adhesive that attaches the sheath 102 to the base 104. The base 104 may be permanently attached to the sheath 102 using an adhesive, sewing, heat sealing, RF welding, or US welding. In an embodiment, the base 104 is configured to be reversibly attached to the sheath 102. In an embodiment, the base 104 is integrally formed with the sheath 102.
[0062] The base 104 includes an aperture 120. The base 104 is permanently attached to the distal end region 110 of the sheath 102 such that the aperture 120 is aligned with the opening 114.
[0063] The base 104 is sized, shaped, and made of a material to be coupled to the skin that surrounds the penis (e.g, mons pubis, thighs, testicles, and/or perineum) and have the penis disposed therethrough. For example, the base 104 may define an aperture 120 configured to have the penis positioned therethrough. In an example, the base 104 may exhibit the general shape or contours of the skin surface that the base 104 is configured to be coupled with. The base 104 may be flexible, thereby allowing the base 104 to conform to any shape of the skin surface and mitigate the base 104 pulling on the skin surface. The base 104 may extend laterally past the sheath 102, thereby increasing the surface area of the skin of the individual to which the fluid collection assembly 100 may be attached compared to a substantially similar fluid collection assembly 100 that did not include a base.
[0064] As previously discussed, the fluid collection assembly 100 includes the conduit 142. The inlet of the conduit 142 may be located near the distal end region 110 of the sheath 102 which is expected to be the gravimetrically low point of the chamber 112 when worn by an individual. Locating the inlet at or near the distal end region 110 of the sheath 102 enables the conduit 142 to receive more of the bodily fluids than if the inlet of the conduit 142 was located elsewhere and reduces the likelihood of pooling (e.g., pooling of the bodily fluids may cause microbe growth and foul odors).
[0065] It is noted that the fluid collection assembly 100 is merely one example of a fluid collection assembly that may include any of the drainage port assemblies disclosed herein. Other examples of fluid collection assemblies that may include any of the drainage port assemblies disclosed herein are disclosed in U.S. Patent No. 10,973,678 filed on June 2, 2017, U.S. Patent No. 10,390,989 filed on September 8, 2016, U.S. Patent No. 10,226,376 filed on June 3, 2017, PCT Patent Application No. PCT/US2021/039866 filed
on June 30, 2021, U.S. Patent Application No. 16/433,773 filed on June 6, 2019, U.S. Provisional Patent Application No. 63,564.696 filed on March 13, 2024, and U.S. Provisional Patent Application No. 63/683,428 filed on August 15, 2024, the disclosure of each of which is incorporated herein, in its entirety, by this reference. [0066] FIG. ID is a block diagram of a fluid collection system 192 for fluid collection, according to an embodiment. The fluid collection system 192 includes a fluid collection assembly 100, a fluid storage container 180, and a vacuum source 182. The fluid collection assembly 100 may be the same or substantially similar to any of the fluid collection assemblies disclosed herein. The fluid collection assembly 100, the fluid storage container 180, and the vacuum source 182 may be fluidly coupled to each other via one or more conduits 142. For example, fluid collection assembly 100 may be operably coupled to one or more of the fluid storage container 180 or the vacuum source 182 via the conduit 142. The bodily fluids collected in the fluid collection assembly 100 may be removed from the fluid collection assembly 100 via the conduit 142 which protrudes into the fluid collection assembly 100. For example, an inlet of the conduit 142 may extend into the fluid collection assembly 100, such as to a reservoir therein. The outlet of the conduit 142 may extend into the fluid collection assembly 100 or the vacuum source 182. Suction force may be introduced into the chamber of the fluid collection assembly 100 via the inlet of the conduit 142 responsive to suction (e.g., vacuum) force applied at the outlet of the conduit 142. [0067] The suction force may be applied to the outlet of the conduit 142 by the vacuum source 182 either directly or indirectly. The suction force may be applied indirectly via the fluid storage container 180. For example, the outlet of the conduit 142 may be disposed within the fluid storage container 180 and an additional conduit 142 may extend from the fluid storage container 180 to the vacuum source 182. Accordingly, the vacuum source 182 may apply suction to the fluid collection assembly 100 via the fluid storage container
180. The suction force may be applied directly via the vacuum source 182. For example, the outlet of the conduit 142 may be disposed within the vacuum source 182. An additional conduit 142 may extend from the vacuum source 182 to a point outside of the fluid collection assembly 100. such as to the fluid storage container 180. In such examples, the vacuum source 182 may be disposed between the fluid collection assembly 100 and the fluid storage container 180.
[0068] The fluid storage container 180 is sized and shaped to retain bodily fluids therein. The fluid storage container 180 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 conduit 142 may extend from the fluid collection assembly 100 and attach to the fluid storage container 180 at a first point therein. An additional conduit 142 may attach to the fluid storage container 180 at a second point thereon and may extend and attach to the vacuum source 182. Accordingly, a vacuum (e.g., suction) may be drawn through fluid collection assembly 100 via the fluid storage container 180. Bodily fluids, such as urine, may be drained from the fluid collection assembly 100 using the vacuum source 182.
[0069] The vacuum source 182 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 182 may provide a vacuum or suction to remove bodily fluids from the fluid collection assembly 100. In some examples, the vacuum source 182 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 182 may be sized and shaped to fit outside of, on, or within the fluid collection assembly 100. For example, the vacuum source 182 may include one or more miniaturized pumps or one or more micro pumps. The vacuum sources 182 disclosed herein may include one or more of a switch, a button, a plug, a remote, or any other device suitable to activate the vacuum source 182. [0070] FIG. 2A is an isometric view of a drainage port assembly 244, according to an embodiment. FIG. 2B is a cross-sectional view of the drainage port assembly 244 taken along plane 2B-2B. The drainage port assembly 244 exhibits a three-piece construction. As illustrated, the drainage port assembly 244 includes a collar 245, a connector 247, and an optional annular base 249. The collar 245 is configured to be attached to the fluid impermeable barrier e.g., the fluid impermeable barrier 106 of FIGS. 1A-1C) and to be moveably (e.g., rotatably) attached to the connector 247. As such, the collar 245 allows the connector 247 to be indirectly rotatably attached to the fluid impermeable barrier. The annular base 249 is configured to interact with the collar 245 to attach the drainage port assembly 244 to the fluid impermeable barrier, for example, by sandwiching the fluid impermeable barrier between the collar 245 and the annular base 249.
[0071] The collar 245 may exhibit any suitable structure that allows the collar 245 to be both attached to the fluid impermeable barrier of the fluid collection assembly and the connector 247 while also allowing the connector 247 to move relative to the collar 245. In a particular embodiment, as shown, the collar 245 includes a central structure 253 and a
laterally-extending structure 255 that extends from the central structure 253 in a lateral (e.g., radial) direction relative to the central axis 257 of the collar 245.
[0072] The central structure 253 is configured to be moveably attached to the connector 247. The central structure 253 may be rotatably attached to the connector 247 using any suitable technique, as will be discussed in more detail below. The size, shape, and structure of the central structure 253 may be selected based on the technique used to moveably attach the connector 247 to the central structure 253. In an embodiment, the central structure 253 is configured to be attached to the connector 247 using at least one pin 201. In such an embodiment, the connector 247 is configured to rotate about the central structure 253 in a single rotation axis (e.g., the roll, yaw, or pitch axis depending on the orientation of the drainage port assembly 244). To facilitate rotation of the connector 247 in a single axis, when viewed from above, the opening of the collar passageway 261 through which the connector 247 extends may exhibit a generally rectangular shape (e.g., a rectangular shape with opposing rounded edges) to accommodate rotation of the connector 247. In an embodiment, the central structure 253 may be moveably attached to the connector 247 using a ball and socket structure, any of the other structures disclosed herein, or any other suitable structure.
[0073] In an embodiment, the connector 247 may be configured to rotate or otherwise move about the central structure 253 in a single axis, which simplifies operation of the drainage port assembly 244 and minimizes the likelihood that the connector 247 inadvertently moves during operation (e.g., movement that may cause the kinking of the conduit). The direction that that connector 247 moves relative to the central structure 253 may be selected based on the embodiment in which the drainage port assembly 244 is used. In an example, the connector 247 is configured to move (e.g. , rotate) such that the connector 247 can point generally towards the feet of the individual or head of the individual. In such an example, the connector 247 may be configured to point generally towards the proximal end region and the distal end region of the fluid collection assembly including the drainage port assembly 244, depending on the orientation of the fluid collection assembly on the individual. Being able to point the connector 247 generally towards the feet or head of the individual may be beneficial when the fluid storage container and/or the vacuum source is positioned in a direction that is generally towards the feet of the individual (e.g., attached to a foot of a bed) or towards the head of the individual (e.g. , a wall mounted vacuum source located behind the bed). In an example, the connector 247 is configured to move (e.g., rotate) such that the connector can point generally tow ards either side of the individual.
Being able to point the connector 247 generally towards the sides of the individual may be beneficial when the fluid storage container and/or the vacuum source is positioned in a direction that is generally towards the side of the individual (e.g., attached to a side of a bed or on a nightstand). In an embodiment, the connector 247 may be configured to rotate or otherwise move about the central structure 253 in multiple directions, such as the connector 347 illustrated in FIGS. 3A-3D.
[0074] As previously discussed, the collar 245 also includes a laterally-extending structure 255. The laterally-extending structure 255 extends laterally outwardly from a central axis 257 of the collar 245. In particular, the laterally-extending structure 255 may extend from or near a proximal end 279 of the collar 245 (z. c.. an end of the collar 245 that is closest to the individual and/or the fluid impermeable barrier during use) of the central structure 253 in a lateral (e.g., radial) direction relative to the central axis 257. The laterally-extending structure 255 increases the surface area of the collar 245 that may be attached to the fluid impermeable barrier which, in turn, better secures the drainage port assembly 244 to the fluid impermeable barrier. Such improved securement of the drainage port assembly 244 to the fluid impermeable barrier may be important since forces may be applied to the drainage port assembly 244 that may try to detach the drainage port assembly
244 from the fluid impermeable barrier during use. For example, the laterally-extending structure 255 may increase the surface area of the collar 245 by at least about 2 cm2 than if the collar 245 did not include the laterally-extending structure 255. such as increasing the surface area of the collar 245 by at least about 2.5 cm2, at least about 5 cm2, at least about 7.5 cm2, at least about 20 cm2, at least about 25 cm2, at least about 20 cm2, at least about 25 cm2, at least about 30 cm2, at least about 40 cm2, at least about 50 cm2, at least about 60 cm2, or at least about 70 cm2. [0075] In an embodiment, the central structure 253 and the laterally-extending structure
255 may cause the collar 245 to exhibit a generally top hat shape, as shown. That said, the collar 245 may exhibit a structure other than the structure illustrated in FIGS. 2A-2C. For example, the later lly -extending structure 255 may be omitted when the central structure 253 exhibits a surface area that is sufficiently large to be attached to the fluid impermeable barrier without needing the laterally-extending structure 255. In such an example, the collar
245 may exhibit a generally cylindrical or tapered conical shape. In another example, one or more of the central structure 253 or the laterally-extending structure 255 may exhibit a shape other than the shapes illustrated in FIGS. 2A-2C. For instance, the central structure 253 may exhibit a tapered shape, a generally rectangular prism shape, or any other suitable
shape. Similarly, the laterally-extending structure 255 may exhibit a generally square disclike shape, a tapered shape, or another other suitable shape.
[0076] The collar 245 defines a collar passageway 261 that extends through the collar 245. For example, the collar passageway 261 extends through the central structure 253 and the laterally-extending structure 255. The collar passageway 261 forms a passageway through the collar 245 that allows the bodily fluids to flow through the collar 245. The collar passageway 261 may also allow the collar 245 to receive a portion of the connector 247, as will be discussed in more detail below. The collar 245 includes one or more interior surfaces 263 that define the collar passageway 261. [0077] The collar passageway 261 may exhibit a first portion and a second portion.
The first portion may extend from the proximal end 279 of the collar 245 and may form an inlet of the collar passageway 261. The second portion may extend from or near the first portion to the distal end 275 of the collar 245. The second portion is configured to receive a portion of the connector 247. For example, the second portion is configured to receive the engagement portion 265 of the connector 247. As such, the second portion of the collar passageway 261 may exhibit a size and shape that corresponds to the size and shape of the portion of the connector 247 that is received thereby.
[0078] The first portion exhibits a first maximum lateral dimension (“first dimension'’) Di at or near the proximal end 279 and the second portion exhibits a second maximum lateral dimension (“second dimension”) D2. wherein the first and second dimensions Di, D2 are measured parallel to each other. The second dimension D2 may be at or near the distal end 275. Each of the first and second dimensions Di and D2 are measured between opposing portions of the interior surfaces 263. The second dimension D2 is selected to allow the collar passageway 261 to receive at least a portion of the connector 247. As such, the second dimension D2 may be selected to correspond to a maximum lateral dimension of the connector 247 measured in the same direction as the second dimension D2. In an embodiment, as shown, the first dimension Di is smaller than the second dimension D2. The smaller first dimension Di prevents or at least inhibits movement of the connector 247 into the first portion of the collar passageway 261. In other words, the smaller first dimension Di may help maintain the connector 247 in the second portion of the collar passageway 261 thereby keeping the connector 247 moveably attached to the collar 245. In an embodiment, the first dimension Di is equal to or greater than the second dimension D2.
[0079] The connector 247 includes an engagement portion 265 and a conduit attachment portion 248. The engagement portion 265 is configured to be received or otherwise rotatably attached to the collar 245 when the drainage port assembly 244 is completely assembled. The conduit attachment portion 248 is distinct and separate from the engagement portion 265 and includes the portions of the connector 247 that are configured to be attached to a conduit. The conduit attachment portion 248 may form the outlet 252 of the drainage port assembly 244. In some embodiments, as shown, at least a portion of the engagement portion 265 and a corresponding portion of the conduit attachment portion 248 are spaced from each other. In such embodiments, the connector 247 may include an intermediate portion 269 extending between the engagement portion
265 and the engagement portion 265, the conduit attachment portion 248. and the intermediate portion 269 may be distinguishable from each other by exhibiting different shapes, a step therebetween (e.g, a sudden dimension change), or by which portion of the connector 247 can be positioned or are otherwise configured to be positionable within the collar passageway 261, which portion of the connector 247 can receive or are otherwise configured to receive a conduit, or which portions of the connector 247 are not positioned or positionable within the collar passageway 261 and cannot receive a conduit. In some embodiments, not shown, the engagement portion 265 and the conduit attachment portion 248 are not spaced from each other. In such embodiments, the engagement portion 265 and the conduit attachment portion 248 may be distinguishable from each other by exhibiting different shapes, a step therebetween (e , a sudden dimension change), or by which portion of the connector 247 can be positioned or are otherwise configured to be positionable within the collar passageway 261 and/or which portion of the connector 247 can receive or are otherwise configured to receive a conduit. The connector 247 also defines a connector passageway 271 extending through the connector 247 such that bodily fluids may How through the connector 247 to the conduit attached to the conduit attachment portion 248. For example, the connector passageway 271 may extend from and through the engagement portion 265, through the intermediate portion (if included in the connector 247). and through conduit attachment portion 248. [0080] The engagement portion 265 and the conduit attachment portion 248 may exhibit any suitable orientation relative to each other. In an example, as shown, the engagement portion 265 (c.g.. a central axis of the engagement portion 265) exhibits an orientation that is generally parallel and aligned with the conduit attachment portion 248 (e.g, a central axis of the conduit attachment portion 248). This parallel orientation of the
engagement portion 265 relative to the conduit attachment portion 248 may minimize turbulent flow of the bodily fluids through the connector passageway 271 which, in turn, increases the volume of bodily fluids that may be removed through the drainage port assembly 244 over a given period of time. In an example, not shown, the engagement portion 265 (e.g. , a central axis of the engagement portion 265) exhibits an orientation that is generally oblique or perpendicular to the conduit attachment portion 248 (e.g.. a central axis of the conduit attachment portion 248). In such an example, the orientation of the engagement portion 265 relative to the conduit attachment portion 248 may minimize the distance that the connector 247 extends above a fluid impermeable barrier which, in turn, may minimize interference between the connector 247 and bedding or clothing disposed above the drainage port assembly 244.
[0081] The engagement portion 265 exhibits a structure that allows the engagement portion 265 to be rotatably attached to the collar 245. The shape of the engagement portion 265 is configured to be disposed in the collar passageway 261. In other words, the engagement portion 265 exhibits a size and shape that allows the engagement portion 265 to rotate in the collar passageway 261 (e.g, may exhibit a size and shape that corresponds to a size and shape of the interior surfaces 263 defining the second portion of the collar passageway 261). For example, the engagement portion 265 may exhibit a generally cylindrical shape, wherein the height of the cylindrical shape of the engagement portion 265 is generally oriented and centered on the pin 201. In an embodiment, the engagement portion 265 may exhibit other shapes, such as a generally spherical shape.
[0082] The connector 247 may be moveably attached to the collar 245 using any suitable technique. In an embodiment, the connector 247 may be snap fastened to the collar 245. The snap fastening includes forcing the engagement portion 265 over a portion of the collar passageway 261 exhibiting a lateral dimension that is slightly smaller than the corresponding lateral dimension of the engagement portion 265. In an example, the engagement portion 265 may be snap fastened to the collar 245 by forcing the engagement portion 265 through the distal end 275 of the collar 245, wherein the distal end 275 of the collar 245 exhibits a lateral dimension that is smaller than a corresponding lateral dimension of the engagement portion 265. Forcing the engagement portion 265 over the distal end 275 of the collar 245 may position the engagement portion 265 in the second portion of the collar passageway 261. The smaller first dimension Di of the collar passageway 261 maintains the engagement portion 265 in the second portion of the collar passageway 261. In an example, the engagement portion 265 may be snap fastened to the
collar 245 by forcing the engagement portion 265 through the first portion of the collar passageway 261. wherein the first dimension Di is smaller than a corresponding lateral dimension of the engagement portion 265. Forcing the engagement portion 265 through the first portion of the collar passageway 261 may position the engagement portion 265 in the second portion of the collar passageway 261. A smaller lateral dimension of the collar passageway 261 at the distal end 275 maintains the engagement portion 265 in the second portion of the collar passageway 261. The pin 201 may be attached to the collar 245 and the engagement portion 265 after positioning the engagement portion 265 in the collar passageway 261. In an embodiment, the connector 247 is not snap fastened to the collar 245. In such an embodiment, the connector 247 may only be attached to the collar 245 using the pin 201.
[0083] The collar passageway 261 and the connector passageway 271 are configured to remain in fluid communication with each other regardless of the position of the connector 247 relative to the collar 245. For example, referring to the orientation of drainage port assembly 244 illustrated in FIG. 2A, the collar passageway 261 and the connector passageway 271 are configured to remain in fluid communication with each other regardless if the connector 247 is positioned as far forward as possible, positioned as far backwards as possible, or in some intermediate positioned therebetween. The collar passageway 261 and the connector passageway 271 are in fluid communication with each other when the inlet of the connector passageway 271 and the immediately adjacent portion of the collar passageway 261 (e g., the outlet of the first position of the collar passageway 261) at least partially overlap thereby allowing bodily fluids to flow from the collar passageway 261 and into the connector passageway 271. It is noted that several structural factors determine whether the collar passageway 261 and the connector passageway 271 remain in fluid communication. These structural factors include one or more of the lateral dimension of the connector passageway 271 at the inlet thereof, the lateral dimension of the collar passageway 261 adjacent to the inlet of the connector passageway 271, or the maximum amount of movement that the connector 247 may move relative to the collar 245. As such, these structural factor(s) may be selected to ensure that the collar passageway 261 and the connector passageway 271 remain in fluid communication.
[0084] As previously discussed, the conduit attachment portion 248 is configured to be attached to a conduit. The conduit attachment portion 248 may include any suitable structure that allows the conduit attachment portion 248 to be attached to the conduit. In an example, as shown, the conduit attachment portion 248 may be a male connector having
a tapered shape (e.g., truncated conical shape), wherein a lateral dimension of the tapered shape increases with increasing distance from the outlet 252. In an example, the conduit attachment portion 248 may be a female connector, include one or more threads configured to engage with the conduit, or any other suitable structure. [0085] As previously discussed, the drainage port assembly 244 may include an annular base 249. The annular base 249 is configured, with the collar 245, to attach the drainage port assembly 244 to the fluid impermeable barrier. In particular, the annular base 249 is configured to have a portion of the fluid impermeable barrier that defines the fluid outlet positioned between the annular base 249 and the collar 245. As such, attaching the annular base 249 to the collar 245 also secures the drainage port assembly 244 to the fluid impermeable barrier. The annular base 249 defines a base passageway 291 extending therethrough. The base passageway 291 allows bodily fluids to flow through the annular base 249 and into the collar passageway 261 and the connector passageway 271.
[0086] The annular base 249 may exhibit any suitable shape. In an example, as shown. the annular base 249 may exhibit a generally disk-like shape (e g., a generally planar shape). In an example, the annular base 249 may include a raised structure (e.g., a raised structure that is configured to be at least partially disposed in the collar passageway 261) and a laterally -extending structure that extends laterally away from the raised structure. In such an embodiment, the annular base 249 may exhibit a generally top hat-like shape. Examples of annular bases exhibiting a generally top hat-like shape are disclosed in U.S.
Provisional Patent Application No. 63/71 1,438 filed on October 24, 2024, the disclosure of which was previously incorporated herein.
[0087] The annular base 249 is configured to be attached to the fluid impermeable barrier. In an embodiment, the annular base 249 is configured to be attached to the fluid impermeable barrier by positioning (e.g., sandwiching) the fluid impermeable barrier between the laterally-extending structure 255 of the collar 245 and the annular base 249. For example, the laterally-extending structure 255 of the collar 245 may include at least one first interfacing surface 287 and the annular base 249 may include at least one second interfacing surface 288. The first interfacing surface 287 and the second interfacing surface 288 may be configured to face and be positioned adjacent to each other after the drainage port assembly 244 is assembled. For example, the first interfacing surface 287 may form the proximal end 279 of the collar 245, be positioned proximate to the proximal end 279 of the collar 245 (as shown), or otherwise face generally away from the distal end 275 of the collar 245 and the second interfacing surface 288 may generally face towards the distal end
of the first interfacing surface 287 and the second interfacing surface 288 allow the fluid impermeable barrier to be positioned therebetween thereby securing the drainage port assembly 244 to the fluid impermeable barrier. [0088] In an embodiment, the first and second interfacing surfaces 287, 288 exhibit non-planar surfaces (e.g., complementary non-planar surfaces). The non-planar first and second interfacing surfaces 287, 288 increase the surface area of the first and second interfacing surfaces 287, 288. The increased surface area of the first and second interfacing surfaces 287, 288 causes the first and second interfacing surfaces 287, 288 to contact a greater surface area of the fluid impermeable barrier which, in turn, improves the attachment between the first and second interfacing surfaces 287, 288 and the fluid impermeable barrier. The non-planar first and second interfacing surfaces 287, 288 may also create a tortuous path therebetween. The tortuous path may prevent or at least inhibit bodily fluids leaking between the first and second interfacing surfaces 287, 288 and the fluid impermeable barrier. In an embodiment, as shown, at least one of the first and second interfacing surfaces 287, 288 are planar.
[0089] The annular base 249 may be attached to the collar 245 using any suitable technique. In an embodiment, the annular base 249 may snap fasten to the collar 245. For example, as shown, the collar 245 may include at least one proximally-extending structure 203 extending from the laterally-extending structure 255. The proximally-extending structure 203 may include a single annular structure extending more than 50% to completely around a lateral periphery of the laterally-extending structure 255 or may include a plurality of structures forming a discontinuous annular structure. It is noted that selecting the proximally-extending structure 203 to include a discontinuous annular structure may facilitate flexing of the proximally-extending structure 203 during attachment of the annular base 249 to the collar 245. The proximally-extending structure 203 may include one or more protrusions 205 extending laterally inwardly from or near the proximal end of the proximally -extending structure 203. The protrusions 205 reduce the lateral dimension of a portion of the collar 245 to be less than a corresponding dimension of the annular base 249. To attach the annular base 249 to the collar 245, the annular base 249 may be forced over the protrusions 205 to position the annular base 249 between the first interfacing surface 287 and the protrusions 205. The protrusions 205 may then help maintain the position of the annular base 249 between the first interfacing surface 287 and the protrusions 205 thereby snap fastening the annular base 249 to the collar 245. The
annular base 249 may be snap fastened to the collar 245 using other structures, examples of which are disclosed below or in U.S. Provisional Application No. 63/711,445 filed on October 24, 2024, the disclosure of which was previously incorporated herein.
[0090] In an embodiment, at least one of the protrusions 205 includes a tapered or curved surface 207 generally facing in a proximal direction (as shown) or the lateral edges of the annular base 249 include a tapered or curved surface 209 generally facing a distal direction (as shown). The tapered or curved surfaces 207, 209 may facilitate moving the annular base 249 over the protrusions 205. It is noted that any of the structure disclosed herein that may be snap fastened together may include similar tapered or curved surfaces to facilitate moving one element over another.
[0091] It is noted that the annular base 249 may be attached to the collar 245 using a non-snap fastening technique. In an example, the annular base 249 may be attached to the collar 245 using an interference fit when the fluid impermeable barrier is positioned between the collar 245 and the annular base 249. In an example, the collar 245 and the annular base 249 may be attached to each other and/or the fluid impermeable barrier therebetween using an adhesive, stitching, or any other suitable technique.
[0092] In an embodiment, the attachment between the collar 245 and the annular base 249 prevents or at least inhibits rotation of the collar 245 relative to the annular base 249. Preventing rotation between the collar 245 and the annular base 249 may minimize wear between the collar 245, the annular base 249, and the fluid impermeable barrier therebetween. In an example, friction between the collar 245 and the annular base 249 prevents or at least inhibits rotation of the collar 245 relative to the annular base 249. The friction may be caused by portions of the collar 245 and the annular base 249 contacting each other (e.g, contact caused by and/or between the lower protrusion 283 and the base protrusion 284) and/or the contact between the collar 245, the annular base 249, and the fluid impermeable barrier therebet een. In an embodiment, the attachment between the collar 245 and the annular base 249 allows rotation of the collar 245 and the annular base 249, which may make it easier for the connector 247 to rotate relative to the fluid impermeable barrier and may still allow the connector 247 to rotate relative to the fluid impermeable barrier if rotation of the connector 247 relative to the collar 245 is prevented
(e.g. , the connector 247 becomes jammed against the collar 245).
[0093] In an embodiment, now shown, the drainage port assembly 244 may include a seal to prevent or at least inhibit bodily fluids from leaking through the drainage port assembly 244. For example, the seal may prevent at least one of bodily fluids leaking
between the collar 245 and the connector 247 or between the collar 245 and the annular base 249. The seal may include any structure that may prevent or at least inhibit bodily fluids from leaking through the drainage port assembly 244. In an example, the seal may include a crab claw seal, an O-ring positioned between two components of the drainage port assembly 244, or any other suitable seal.
[0094] As previously discussed, some of the drainage port assemblies disclosed herein may be switchable between a first state where bodily fluids can flow through the drainage port assembly, and a second state where bodily fluids cannot flow through the drainage port assembly. FIGS. 3A and 3B are isometric views of a drainage port assembly 344 exhibiting a first state and a second state, respectively, according to an embodiment. FIGS. 3C and 3D are cross-sectional views of the drainage port assembly 344 taken along planes 3C-3C and 3D-3D, respectively. Except as otherwise disclosed herein, the drainage port assembly 344 is the same as or substantially similar to any of the drainage port assemblies disclosed herein. For example, the drainage port assembly 344 includes a collar 345 and a connector 347 moveably attached to the collar 345.
[0095] The drainage port assembly 344 is switchable between a first state and a second state. The drainage port assembly 344 may exhibit the first state when the connector 347 exhibits a first position (e.g., orientation) relative to the collar 345 and the second state when the connector 347 exhibits a second position (e.g, orientation) relative to the collar 345. In the illustrated embodiment, the connector 347 is in the first position when moved as far to the right as possible (e.g, as far to one side as possible) and the second position when moved as far to the left as possible (e.g. , as far to an opposing side as possible). That said, depending on the orientation of the drainage port assembly 344, the connector 347 may be in the first position when moved to the far left, the forwardmost position, the backward most position, an intermediate position (e.g, an intermediate position between the far left and far right positions or between the forward most and backward most positions), or any other position. Similarly, depending on the orientation of the drainage port assembly 344, the connector 347 may be in the second position when moved to the far right, the forwardmost position, the backward most position, an intermediate position (e.g. an intermediate position between the far left and far right positions or between the forward most and backward most positions), or any other position.
[0096] Referring to FIG. 3C, the collar passageway 361 and the connector passageway 371 are in fluid communication with each other when the drainage port assembly 344 is in the first state. The collar passageway 361 and the connector passageway 371 are in fluid
communication with each other because the inlet of the connector passagew ay 371 at least partially overlaps with (e.g. , is coextensive with, as shown) an adjacent portion of the collar passagew ay 361 (e.g, the outlet of the first portion of the collar passageway 361). Since the inlet of the connector passageway 371 and the adj acent portion of the collar passageway 361 overlap, bodily fluids may freely flow from the collar passageway 361 to the connector passageway 371. It is noted that the collar passageway 361 and the connector passageway 371 are in fluid communication with each other even when only a portion of the inlet of the connector passageway 371 overlaps with the adjacent portion of the collar passageway 361 since the partial overlap still allow s bodily fluids to flow from the collar passageway 361 to the connector passageway 371.
[0097] Referring to FIG. 3D, the collar passageway 361 and the connector passageway 371 are not in fluid communication with each other when the drainage port assembly 344 is in the second state. The collar passageway 361 and the connector passageway 371 are not in fluid communication with each other because the inlet of the connector passageway 371 does not overlap with an adjacent portion of the collar passageway 361. Since the inlet of the connector passageway 371 and the adjacent portion of the collar passageway 361 do not overlap, bodily fluids are restricted from flowing from the collar passageway 361 to the connector passagew ay 371. It is noted that negligible quantities of bodily fluids may leak between the collar 345 and the connector 347 thereby allowing negligible quantities of the bodily fluids to flow between the passageways even when the drainage port assembly 344 is in the second state.
[0098] Several factors determine w hether the collar passagew ay 361 and the connector passageway 371 are and are not in fluid communication with each other when the drainage port assembly 344 is in the first state and the second state, respectively. In an example, the orientation of and pathway followed by the collar passageway 361 and the connector passageway 371 relative to each other are selected to allow" these passageways to be in fluid communication with each other when the connector 347 is in the first position. For instance, in the illustrated embodiment, the connector passageway 371 exhibits a bend 313 thereof. The bend 313 allows the connector passageway 371 to extend to the collar passageway 361 when the connector 347 is oriented at an angle relative to a central axis of the collar passageway 361, and the connector 347 is in the first position and the collar passageway 361 is centrally positioned. The bend 313 also allows the inlet of the connector passageway 371 to not overlap the adjacent portion of the collar passageway 361 when the drainage port assembly 344 is in the second state. In another example, the inlet of the
connector passageway 371 and the adjacent portion of the collar passageway 361 exhibit sufficient size (e.g, lateral dimension) such that the passageways are and are not in fluid communication with each other when the drainage port assembly 344 is in the first state and the second state, respectively. [0099] FIGS. 4A and 4B are isometric views of a drainage port assembly 444 exhibiting a first state and a second state, respectively, according to an embodiment. FIGS. 4C and 4D are cross-sectional views of the drainage port assembly 444 taken along planes 4C-4C and 4D-4D, respectively. Except as otherwise disclosed herein, the drainage port assembly 444 is the same as or substantially similar to any of the drainage port assemblies disclosed herein. For example, the drainage port assembly 444 includes a collar 445 and a connector 447 moveably attached to the collar 445.
[00100] The collar 445 and the connector 447 are attached together using a ball-socket type structure. For example, the engagement portion 465 exhibits a generally spherical shape and the central structure 453 exhibits a socket type structure defining a spherical pocket configured to receive the generally spherical shape of the engagement portion 465.
Unlike the drainage port assemblies illustrated in FIGS. 2A-3D, the ball-socket type structure of the collar 445 and the connector 447 allows the connector 447 to exhibit two more degrees of freedom. For example, the connector 447 may be configured to move in two or more of the yaw, pitch, or roll directions relative to the collar 445. [00101] Allowing the connector 447 to move in two or more directions relative to the collar 445 may facilitate attaching and detaching a conduit to the connector 447. For example, the individual attaching the conduit to the conduit attachment portion 448 may find it beneficial for the conduit attachment portion 448 to be oriented in some beneficial direction. It is noted that the beneficial direction may include the conduit attachment portion 448 generally pointing towards the individual or some other direction. It is also noted that the beneficial direction may vary from individual to individual. During use, the individual attaching or detaching the conduit may have various positions relative to the drainage port assembly 444 (e.g, located on one side or an opposing side of the drainage port assembly 444) and/or various individuals may attach or detach the conduit from the conduit attachment portion 448. Allowing the connector 447 to exhibit two or more degrees of freedom increases the likelihood that the conduit attachment portion 448 can be oriented in the beneficial direction regardless of the position of the individual or the individual attaching or detaching the conduit.
[00102] In an embodiment, the central structure 453 of the collar 445 defines at least one cutout. As used in this embodiment, the cutout of the central structure 453 is the outlet of the central structure 453 through which a portion of the connector 447 (e.g, the conduit attachment portion 448 or an intermediate structure 469) may extend out of the collar passageway 461 (e.g., the pocket that receives the engagement portion 465). Generally, the cutout is larger than the portion of the connector 447 extending therethrough thereby allowing the connector 447 to exhibit two or more degrees of freedoms. For example, the cutout may exhibit two lateral dimensions measured perpendicular to a central axis 457 of the collar 445 and perpendicular to each other. These two lateral dimensions of the cutout may be larger than the lateral dimensions of the portion of the connector 447 extending therethrough measured parallel to these two lateral dimensions of the cutout.
[00103] The drainage port assembly 444 may be configured to switch between a first state and a second state depending on the position of the connector 447 relative to the cutout. For example, the drainage port assembly 444 may exhibit the first state (FIGS. 4A and 4C) when the connector 447 exhibits a first position in the cutout (e.g, the conduit attachment portion 448 extends in a first direction) and the drainage port assembly 444 may exhibit the second state (FIGS. 4B and 4D) when the connector 447 exhibits a second position in the cutout (e.g., the conduit attachment portion 448 extends in a second direction). [00104] In an embodiment, the collar 445 includes a single cutout. In an embodiment, as shown, the collar 445 includes a plurality of cutouts, such as a first cutout 415 and a second cutout 417. The drainage port assembly 444 may exhibit the first state when a portion of the connector 447 extends through the first cutout 415 and the second state when the portion of the connector 447 extends through the second cutout 417. In an example, the second cutout 417 is larger than the first cutout 415. The larger size of the second cutout 417 allows for greater movement of the connector 447 while attaching or detaching the conduit. In other words, the larger size of the second cutout 417 allows the conduit attachment portion 448 to exhibit a variety of directions such that the conduit attachment portion 448 is more likely to exhibit the previously discussed beneficial direction regardless of the position of the individual relative to the drainage port assembly 444 or the individual who is attaching or detaching the conduit. The smaller size of the first cutout 415 limits movement of the connector 447 when the drainage port assembly 444 is in the first state which, in turn, decreases the likelihood that the drainage port assembly 444 inadvertently switches from the first state to the second state during use, for instance, when the individual
wearing the fluid collection assembly including the drainage port assembly 444 moves. In a particular example, the first cutout 415 exhibits a size that is substantially similar to the size of the portion of the connector 447 extending therethrough. In a particular example, as shown in the intersection of the first and second cutouts 415, 417 exhibits a first lateral dimension that is slightly smaller than a second lateral dimension of the portion of the connector 447 measured parallel to the first lateral dimension. The difference between the first and second lateral dimensions should be sufficiently small that the inherent flexibility of the portion of the collar 445 defining the intersection of the first and second cutouts 415, 417 and the flexibility of the portion of the connector 447 extending through the cutouts allows the connector 447 to move between the first and second cutouts 415. 417 without damaging the collar 445 or the connector 447. The smaller first lateral dimension inhibits accidentally moving the connector 447 between the first and second cutouts 415, 417 during use of the drainage port assembly 444. The smaller first lateral dimension may also provide tactile feedback indicating when the connector 447 moves between the first and second cutouts 415. 417. which may be beneficial when the individual moving the connector 447 cannot see the connector 447 (e.g, the drainage port assembly 444 is under a blanket to maintain the dignity of the individual using the fluid collection assembly including the drainage port assembly 444). It is noted that the drainage port assembly 444 may exhibit the second state when a portion of the connector 447 extends through the first cutout 415 and the first state when the portion of the connector 447 extends through the second cutout 417.
[00105] It is noted that the collar 445 may include three or more cutouts. For example, the three or more cutouts may allow the connector 447 to be oriented in various different directions when in the first state. [00106] FIG. 5A is an isometric view of a drainage port assembly 544, according to an embodiment. FIG. 5B is a cross-sectional view of the drainage port assembly 544 taken along plane 5B-5B. Except as otherwise disclosed herein, the drainage port assembly 544 is the same as or substantially similar to any of the drainage port assemblies disclosed herein. For example, the drainage port assembly 544 includes a collar 545 and a connector 547.
[00107] The connector 547 includes a conduit attachment portion 548, an engagement portion 565 that is configured to allow the conduit attachment portion 548 to move relative to the collar 545. and an optional intermediate portion 569. The engagement portion 565
is configured to elastically deform thereby allowing the conduit attachment portion 548 to move relative to the collar 545.
[00108] In an embodiment, the engagement portion 565 is configured to elastically deform because the engagement portion 565 exhibits an average thickness that is less than a minimum thickness of the collar 545, a minimum thickness of the conduit attachment portion 548, and a minimum thickness of the optional intermediate portion 569. For instance, the engagement portion 565 may exhibit an average thickness of about 2 mm or less, about 1.5 mm or less, about 1 mm or less, about 750 pm or less, about 500 pm or less, about 400 pm or less, about 300 pm or less, about 250 pm or less, or in ranges of about 250 pm to about 500 pm. about 400 pm to about 750 pm, about 500 pm to about 1 mm, about 750 pm to about 1.5 mm, or about 1 mm to about 2 mm. The average thickness of the engagement portion 565 may be less than the minimum thickness of the collar 545, the conduit attachment portion 548, and the optional intermediate portion 569 by about 250 pm to about 500 pm, about 400 pm to about 750 pm, or about 500 pm to about 1 mm. The smaller average thickness of the engagement portion 565 allows the engagement portion 565 to preferentially deform when a load is applied to the conduit attachment portion 548 that causes the conduit attachment portion 548 to pivot about the engagement portion 565. The smaller average thickness of the engagement portion 565 may allow the connector 547 and/or the drainage port assembly 544 as a whole to be integrally formed (e.g., exhibit single piece construction) which may facilitate manufacturing of the drainage port assembly 544, for instance, using an injection molding technique.
[00109] In an embodiment, the engagement portion 565 is configured to elastically deform because the engagement portion 565 includes a material exhibiting a stiffness (e.g. , modulus of elasticity) that is lower than the material forming the collar 545, the conduit attachment portion 548, and the optional intermediate portion 569. The lower stiffness allows the engagement portion 565 to preferentially deform when a load is applied to the conduit attachment portion 548 that causes the conduit attachment portion 548 to pivot about the engagement portion 565. Forming the engagement portion 565 from a material exhibiting a lower stiffness may cause the connector 547 and/or the drainage port assembly 544 to exhibit a multiple-piece construction which may complicate manufacturing of the drainage port assembly 544 since the pieces of the drainage port assembly 544 need to be attached together.
[00110] In an embodiment, as shown, the collar 545 does not include a central structure. Instead, the collar 545 only includes the laterally-extending structure 549 and the
engagement portion 565 extends from (e.g., is attached to or integrally formed with) the laterally-extending structure 549. In an embodiment, not shown, the collar 545 includes a central structure and the engagement portion 565 extends from the central structure. [00111] FIG. 6A is an isometric view of a drainage port assembly 644, according to an embodiment. FIGS. 6B and 6C are cross-sectional views of the drainage port assembly 644 in the first and second states taken along plane 6B-6B. FIG. 6D is a cross-sectional view of a portion of the drainage port assembly 644 taken along plane 6D-6D. Except as otherwise disclosed herein, the drainage port assembly 644 is the same as or substantially similar to any of the drainage port assemblies disclosed herein. For example, the drainage port assembly 644 includes a collar 645, a connector 647, and an optional annular base 649.
[00112] The connector 647 is configured to move up (i.e.. distally) and down (e.g., proximally) relative to the collar 645. Movement of the connector 647 up and down relative to the collar 645 may switch the drainage port assembly 644 from a first state to a second state, and vice versa. For example, the collar 645 defines a collar passageway 661. The collar passageway 661 is configured to receive a portion of the connector 647. The collar passageway 661 defines a fluid flow path 619. The fluid flow path 619 is a portion of the collar passageway 661 that is not occupied by the connector 647 and is in fluid communication with the chamber of the fluid collection assembly when the drainage port assembly 644 is in the first state. The connector 647 defines an inlet 621. When the drainage port assembly 644 is in the first state, the inlet 621 of the connector 647 and the fluid flow path 619 are in fluid communication with each other. In other words, at least a portion of the inlet 621 overlaps with the fluid flow path 619 such that bodily fluids in the fluid flow path 619 may flow through the inlet 621. When the drainage port assembly 644 is in the second state, the inlet 621 and the fluid flow path 619 are not in fluid communication with each other. In other words, the inlet 621 does not overlap with the fluid flow path 619 thereby restricting flow of the bodily fluids from the fluid flow path 619 to the inlet 621. That said, it is noted that negligible quantities of the bodily fluids may leak from the fluid flow path 619 into the inlet 621 even when the drainage port assembly 644 is in the second state. [00113] In an embodiment, as shown, the inlet 621 is located on a lateral side of the connector 647. In such an embodiment, the fluid flow7 path 619 may extend along a portion of the lateral side of the connector 647 such that the fluid flow path 619 may be adjacent to the inlet 621 when the drainage port assembly 644 is in the first state. To allow the fluid flow path 619 to extend along a portion of the lateral side of the connector 647, at least one
of at least a portion of the interior surfaces 663 of the collar 645 or at least a portion of the outer surfaces 690 of the connector 647 may exhibit different cross-sectional shapes. For example, a portion of the interior surfaces 663 may defines a generally circular cross- sectional shape with a cutout defining the fluid flow path 619 and/or a portion of the outer surfaces 690 of the connector 647 adjacent to the fluid flow path 619 when the drainage port assembly 644 is in the first state may exhibit a truncated circular cross-sectional shape. It is noted that the fluid flow path 619 may be formed using other techniques, such as forming a passageway through the walls of the collar 645.
[00114] In an embodiment, not shown, the inlet 621 is located on the proximal side of the connector 647. In such an embodiment, the collar 645 may defined an L-shaped member extending proximally from the rest of the collar 645, with the horizontal portion of the L-shape member configured to abut the distal end of the connector 647 and cover the inlet 621 when the drainage port assembly 644 is in the first state.
[00115] In an embodiment, the collar 645 and the connector 647 may include one or more features that are configured to limit movement of the connector 647 relative to the collar 645. Limiting the movement of the connector 647 may prevent the collar 645 and the connector 647 from becoming detached from each other and overlapping the fluid flow path 619 and the inlet 621 when the drainage port assembly 644 is in the first state. In an example, the connector 647 may include a protrusion 623. The protrusion 623 (e.g. , annular protrusion) may be positioned at a proximal end of the conduit attachment portion 648 or the optional intermediate portion (not shown). The protrusion 623 may cause the maximum lateral dimension of the connector 647 to be larger than a minimum lateral dimension of the distal end 675 of the collar 645. As such, the protrusion 623 may abut the distal end 675 of the collar 645 thereby preventing further downward motion of the connector 647 relative to the collar 645. In an embodiment, a portion of the interior surfaces 663 of the collar 645 and a portion of the outer surfaces 690 of the engagement portion 665 may include a tapered, stepped, curved, or other surface that increases the maximum dimension of the outer surfaces 690 and the interior surfaces 663. These tapered, stepped, curved or other surfaces may abut each other and prevent further upward motion of the connector 647 relative to the collar 645. In an embodiment, the connector 647 may include a laterally- extending portion 625 at a proximal end thereof. The laterally-extending portion 625 may exhibit a lateral dimension that is greater than the lateral dimension of the collar passageway 661 or a base passageway 691. The greater lateral dimension of the laterally- extending portion 625 may cause the laterally-extending portion 625 to abut the portion of
the collar 645 defining the collar passageway 661 or the portion of the annular base 649 defining the base passageway 691 and prevent further upward motion of the connector 647 relative to the collar 645.
[00116] The connector 647 may exhibit a first position relative to the collar 645 when the drainage port assembly 644 exhibits the first state and a second position relative to the collar 645 when the drainage port assembly 644 exhibits the second state. In an embodiment, the connector 647 may exhibit the first position when the connector 647 is moved downwardly (e.g., exhibits a proximally -most position) and the second position when the connector 647 is moved upwardly (e.g., exhibits a distally-most position). In such an embodiment, attaching and detaching the conduit from the conduit attachment portion 648 may switch the drainage port assembly 644 from the first state to the second state. For example, attaching the conduit to the conduit attachment portion 648 may apply a downward force on the connector 647 thereby moving the connector 647 to the first position and detaching the conduit from the conduit attachment portion 648 may apply an upward force to the connector 647 thereby moving the connector 647 to the second position.
As such, the drainage port assembly 644 may exhibit the first state when a conduit is attached to the conduit attachment portion 648 and fluid flow through the drainage port assembly 644 is desired and may exhibit the second state when a conduit is not attached to the conduit attachment portion 648 and fluid flow through the drainage port assembly 644 is not desired. In an embodiment, the connector 647 may exhibit the first position when the connector 647 is moved upwardly and the second position when the connector 647 is moved downwardly.
[00117] FIG. 7A is an isometric view- of a drainage port assembly 744, according to an embodiment. FIG. 7B is a cross-sectional view of the drainage port assembly 744 taken along plane 7B-7B. Except as otherwise disclosed herein, the drainage port assembly 744 is the same as or substantially similar to any of the drainage port assemblies disclosed herein. For example, the drainage port assembly 744 includes a collar 745, a connector 747, and an optional annular base 749.
[00118] Similar to the drainage port assembly 544 illustrated in FIGS. 5A and 5B. the engagement portion 765 of the connector 747 is configured to elastically deform, thereby allowing the conduit attachment portion 748 to rotate (e.g., pivot) relative to the collar 745. However, the engagement portion 765 is configured to allow the conduit attachment portion 748 to move up and down and maintain an upwards or downwards position relative to the collar 745. For example, the engagement portion 765 includes a generally accordion-like
structure. In other words, the engagement portion 765 includes one or more peaks 727 and one or more valleys 729. Collapsing the engagement portion 765 (e.g., bringing adjacent peaks 727 and/or valleys 729 together) allows the conduit attachment portion 748 to move downwardly (e.g., proximally). Due to the accordion-like structure of the engagement portion 765, the engagement portion 765 can maintain the collapsed state thereof.
Expanding the engagement portion 765 (e.g.. moving adjacent peaks 727 and/or valleys 729 further apart) allows the conduit attachment portion 748 to move upwardly (e.g. distally). Due to the accordion-like structure of the engagement portion 765, the engagement portion 765 can maintain the expanded state thereof. [00119] It is noted that the engagement portion 765 may exhibit a compliant structure other than the accordion-like structure that allows the engagement portion 765 to move the conduit attachment portion 748 upwardly and downwardly while maintaining the conduit attachment portion 748 in the upward or downward position. For example, relative to an individual positioned above the drainage port assembly 744, the engagement portion 765 may form a generally convex semi -spherical shape when the conduit attachment portion 748 is positioned upwardly and a generally concave semi-spherical shape when the conduit attachment portion 748 is positioned downwardly.
[00120] The drainage port assembly 744 may be configured to switch between a first state and a second state responsive to moving the conduit attachment portion 748 downwardly and upwardly. In an embodiment, as shown, the connector 747 includes one or more support 731 extending inwardly and proximally from the inner surface 790 of the connector 747. For example, as shown, the supports 731 may include at least one radially inwardly extending support and a distally vertically extending support. The connector 747 may include a plug 733 at a proximal end of the supports 731. The plug 733 may exhibit a lateral dimension that is greater than the inlet 721 of the connector 747. As such, the plug 733 may cover and prevent fluid flow- through the inlet 721 when the plug 733 abuts the inlet 721. The plug 733 may move relative to the inlet 721 as the conduit attachment portion 748 moves upwardly and downwardly thereby allowing movement of the conduit attachment portion 748 to switch the drainage port assembly 744 between the first and second states. In an example, as shown, the plug 733 may cover the inlet 721 when the connector 747 is in the first position (e.g., the conduit attachment portion 748 is in an upward position) and may move away from the inlet 721 when the connector 747 is in the second position (e.g, the conduit attachment portion 748 is in a downward position). As such, the drainage port assembly 744 may exhibit the first state w hen a conduit is attached
to the conduit attachment portion 748 and fluid flow through the drainage port assembly
744 is desired and may exhibit the second state when a conduit is not attached to the conduit attachment portion 748 and fluid flow through the drainage port assembly 744 is not desired. In such an example, the plug 733 may be located on a proximal side of the inlet 721. In an example, the connector 747 may exhibit the first position when the connector
747 is moved upwardly and the second position when the connector 747 is moved downwardly. In such an example, the plug 733 may be positioned on a distal side of the inlet 721.
[00121] It is noted that supports 731 and the plug 733 illustrated in FIG. 7B may be used in any of the drainage port assemblies disclosed herein (e.g, the drainage port assembly 644 of FIGS. 6A-6D). Similarly, the drainage port assembly 744 may include any of the structures disclosed herein that allow the drainage port assembly 744 to switch between the first and second states, such as any of the structures disclosed in the discussion of the drainage port assembly 644 of FIGS. 6A-6D. [00122] The collar 745 may be attached to the annular base 749 using any suitable technique. In an embodiment, the collar 745 may snap fasten to the annular base 749. For example, as shown, the annular base 749 may include at least one distally-extending structure 703 extending from the laterally-extending structure 786 of the annular base 749. The distally-extending structure 703 may include a single annular structure extending more than 50% to completely around a lateral periphery of the laterally-extending structure 786 or may include a plurality of structures forming a discontinuous annular structure. It is noted that selecting the distally-extending structure 703 to include a discontinuous annular structure may facilitate flexing of the distally-extending structure 703 during attachment of the collar 745. The distally-extending structure 703 may include one or more protrusions 705 extending laterally inwardly from or near the distal end of the distally-extending structure 703. The protrusions 705 reduce the lateral dimension of a portion of the annular base 749 to be less than a corresponding dimension of the collar 745. To attach the collar
745 to the annular base 749, the collar 745 may be forced over the protrusions 705 to position the collar 745 between the second interfacing surface 788 of the annular base 749 and the protrusions 705. The protrusions 705 may then help maintain the position of the collar 745 between the second interfacing surface 788 and the protrusions 705 thereby snap fastening the collar 745 to the annular base 749. The collar 745 may be snap fastened to the annular base 749 using other structures, examples of which are disclosed above or in
U.S. Provisional Application No. 63/711,445 filed on October 24, 2024, the disclosure of which was previously incorporated herein.
[00123] In an embodiment, at least one of the protrusions 705 includes a tapered or curved surface 707 facing in a distal direction (as shown) or the lateral edges of the collar 745 include a tapered or curv ed surface 709 facing a proximal direction (as shown). The tapered or curved surfaces 707, 709 may facilitate moving the collar 745 over the protrusions 705.
[00124] 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.
[00125] Terms of degree (e. , "about." “substantially,’7 “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 quantity7. 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 comers instead of sharp comers, curved edges instead of straight edges, one or more protrusions extending therefrom, is oblong, is the same as the disclosed shape, etc.
Claims
1. A fluid collection assembly, comprising: a fluid impermeable barrier defining a chamber, an opening, and a fluid outlet, the fluid impermeable barrier including a proximal end region defining the opening and a distal end region defining the fluid outlet; at least one porous material disposed in the chamber; and a drainage port assembly including: a collar defining a collar passageway extending through at least a portion of the collar; and a connector including an engagement portion attached to or integrally formed with the collar and a conduit attachment portion distinct from the engagement portion, the conduit attachment portion configured to be attached to a conduit, the connector defining a connector passageway extending from the engagement portion to the conduit attachment portion, the connector configured to move relative to the collar; wherein the drainage port assembly attached to the distal end region of the fluid impermeable barrier and positioned to have the fluid outlet and a collar passageway extending through the collar aligned to allow bodily fluids received in the chamber to flow out of the chamber through the fluid outlet and into the collar passageway.
2. The fluid collection assembly of claim 1, wherein the drainage port assembly is configured to switch between a first state and a second state as the conduit attachment portion moves relative to the collar, wherein the drainage port assembly permits flow of bodily fluids therethrough when in the first state and restricts flow of the bodily fluids therethrough when in the second state.
3. The fluid collection assembly of claim 2, wherein the connector is configured to rotate relative to the collar, and wherein rotating the connector relative to the collar switches the drainage port assembly between a first state and a second state.
4. The fluid collection assembly of claim 3, wherein the collar defines a collar passageway extending therethrough, the collar passageway and the connector passageway are in fluid communication with each other when the drainage port assembly is in the first state, the collar passageway and the connector passageway are not in fluid communication with each other when the drainage port assembly exhibits the second state.
5. The fluid collection assembly of any one of claims 3 or 4, wherein the engagement portion of the connector is attached to the collar via at least one pin, wherein the connectors rotate about the pin.
6. The fluid collection assembly of any one of claims 3 or 4, wherein the engagement portion of the connector exhibits a generally spherical structure, and the collar defines a socket configured to receive the engagement portion.
7. The fluid collection assembly of claim 6, wherein the socket of the collar defines a first cutout and a second cutout, the drainage port assembly exhibits the first state when the connector extends through the first cutout, and the drainage port assembly exhibits the second state when the connector extends through the second cutout.
8. The fluid collection assembly of claim 7, wherein a portion of the connector through the first cutout or the second cutout exhibits a first lateral dimension, the first cutout exhibiting a second lateral dimension that is equal to or slightly larger than a first lateral dimension of the cutout portion, and the second cutout exhibiting a third lateral dimension that is significantly larger than a first lateral dimension, wherein the first, second, and third lateral dimensions are measured parallel to each other.
9. The fluid collection assembly of any one of claims 7 or 8, wherein a portion of the connector through the first cutout or the second cutout exhibits a first lateral dimension and an intersection between the first cutout and the second cutout exhibits a second lateral dimension that is slightly smaller than the first lateral dimension, wherein the first and second lateral dimensions are measured parallel to each other.
10. The fluid collection assembly of any one of claims 3 or 4, wherein the conduit attachment portion is configured to move upwardly and downwardly relative to the collar, and wherein moving the conduit attachment portion upwardly and downwardly switches the drainage port assembly between the first state and the second state.
11. The fluid collection assembly of claim 10, wherein moving the connector upwardly switches the drainage port assembly from the first state to the second state and moving the connector downwardly switches the drainage port assembly from the second state to the first state.
12. The fluid collection assembly of any one of claims 3 or 4, wherein the engagement portion of the connector is configured to preferentially elastically deform.
13. The fluid collection assembly of any one of claims 3-12, further comprising a plug extending from the connector, the plug configured to be spaced from an inlet of the
connector when the drainage port assembly is in the first state and abut and cover the inlet of the connector when the drainage port assembly is in the second state.
14. The fluid collection assembly of any one of claims 1-13, wherein the connector is configured to rotate relative to the collar.
15. The fluid collection assembly of claim 14, wherein the engagement portion of the connector is attached to the collar via at least one pin, wherein the connectors rotate about the pin.
16. The fluid collection assembly of any one of claims 1-15, wherein the engagement portion extends away from the collar, the engagement portion exhibiting at least one of: an average thickness that is less than a minimum thickness of at least one of the collar, the conduit attachment portion, or an optional intermediate portion of the connector extending from the engagement portion to the conduit attachment portion; or a stiffness that is less than a stiffness of at least one of the collar, the conduit attachment portion, or the optional intermediate portion.
17. The fluid collection assembly of claim 16, wherein the engagement portion includes one or more peaks and one or more valleys.
18. The fluid collection assembly of any one of claims 1-17, further comprising an annular base defining a base passageway extending through the annular base, the annular base configured to be attached to the collar.
19. A drainage port assembly, comprising: a collar defining a collar passageway extending through at least a portion of the collar; and a connector including an engagement portion attached to or integrally formed with the collar and a conduit attachment portion distinct from the engagement portion, the conduit attachment portion configured to be attached to a conduit, the connector defining a connector passageway extending from the engagement portion to the conduit attachment portion, the connector configured to move relative to the collar.
20. The drainage port assembly of claim 19, wherein the drainage port assembly is configured to switch between a first state and a second state as the conduit attachment portion moves relative to the collar, wherein the drainage port assembly permits flow' of bodily fluids therethrough when in the first state and restricts flow of the bodily fluids therethrough when in the second state.
21. The drainage port assembly of claim 20, wherein the connector is configured to rotate relative to the collar, and wherein rotating the connector relative to the collar switches the drainage port assembly between a first state and a second state.
22. The drainage port assembly of claim 21, wherein the collar defines a collar passageway extending therethrough, the collar passageway and the connector passageway are in fluid communication with each other when the drainage port assembly is in the first state, the collar passageway and the connector passageway are not in fluid communication with each other when the drainage port assembly exhibits the second state.
23. The drainage port assembly of any one of claims 21 or 22, wherein the engagement portion of the connector is attached to the collar via at least one pin, wherein the connectors rotate about the pin.
24. The drainage port assembly of any one of claims 21 or 22, wherein the engagement portion of the connector exhibits a generally spherical structure, and the collar defines a socket configured to receive the engagement portion.
25. The drainage port assembly of claim 24, wherein the socket of the collar defines a first cutout and a second cutout, the drainage port assembly exhibits the first state when the connector extends through the first cutout, and the drainage port assembly exhibits the second state when the connector extends through the second cutout.
26. The drainage port assembly of claim 25, wherein a portion of the connector through the first cutout or the second cutout exhibits a first lateral dimension, the first cutout exhibiting a second lateral dimension that is equal to or slightly larger than a first lateral dimension of the cutout portion, and the second cutout exhibiting a third lateral dimension that is significantly larger than a first lateral dimension, wherein the first, second, and third lateral dimensions are measured parallel to each other.
27. The drainage port assembly of any one of claims 25 or 26, wherein a portion of the connector through the first cutout or the second cutout exhibits a first lateral dimension and an intersection between the first cutout and the second cutout exhibits a second lateral dimension that is slightly smaller than the first lateral dimension, wherein the first and second lateral dimensions are measured parallel to each other.
28. The drainage port assembly of any one of claims 21 or 22, wherein the conduit attachment portion is configured to move upwardly and downw ardly relative to the collar, and wherein moving the conduit attachment portion upwardly and downwardly switches the drainage port assembly between the first state and the second state.
29. The drainage port assembly of claim 28, wherein moving the connector upwardly switches the drainage port assembly from the first state to the second state and moving the connector downwardly switches the drainage port assembly from the second state to the first state.
30. The drainage port assembly of any one of claims 21 or 22, wherein the engagement portion of the connector is configured to preferentially elastically deform.
31. The drainage port assembly of any one of claims 21-30. further comprising a plug extending from the connector, the plug configured to be spaced from an inlet of the connector when the drainage port assembly is in the first state and abut and cover the inlet of the connector when the drainage port assembly is in the second state.
32. The drainage port assembly of any one of claims 19-31, wherein the connector is configured to rotate relative to the collar.
33. The drainage port assembly of claim 32, wherein the engagement portion of the connector is attached to the collar via at least one pin, wherein the connectors rotate about the pin.
34. The drainage port assembly of any one of claims 19-33, wherein the engagement portion extends away from the collar, the engagement portion exhibiting at least one of: an average thickness that is less than a minimum thickness of at least one of the collar, the conduit attachment portion, or an optional intermediate portion of the connector extending from the engagement portion to the conduit attachment portion; or a stiffness that is less than a stiffness of at least one of the collar, the conduit attachment portion, or the optional intermediate portion.
35. The drainage port assembly of claim 34, wherein the engagement portion includes one or more peaks and one or more valleys.
36. The drainage port assembly of any one of claims 19-35, further comprising an annular base defining a base passageway extending through the annular base, the annular base configured to be attached to the collar.
37. A method of using a drainage port assembly, the method comprising: providing a drainage port assembly, the drainage port assembly including: a collar defining a collar passageway extending through at least a portion of the collar; a connector including an engagement portion attached to or integrally formed with the collar and a conduit attachment portion distinct from the engagement portion, the
conduit attachment portion configured to be attached to a conduit, the connector defining a connector passageway extending from the engagement portion to the conduit attachment portion, the connector configured to move relative to the collar; and moving the connector relative to the collar.
38. The method of claim 37, wherein moving the connector relative to the collar switches the drainage port assembly between a first state and a second state, and wherein the drainage port assembly permits flow of bodily fluids therethrough when in the first state and restricts flow of the bodily fluids therethrough when in the second state.
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| US202463564696P | 2024-03-13 | 2024-03-13 | |
| US63/564,696 | 2024-03-13 | ||
| US202463711438P | 2024-10-24 | 2024-10-24 | |
| US202463711445P | 2024-10-24 | 2024-10-24 | |
| US63/711,438 | 2024-10-24 | ||
| US63/711,445 | 2024-10-24 |
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| WO2025193541A1 true WO2025193541A1 (en) | 2025-09-18 |
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| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| PCT/US2025/018909 Pending WO2025193540A1 (en) | 2024-03-13 | 2025-03-07 | Drainage port assemblies, fluid collection assemblies and systems including the same |
| PCT/US2025/018913 Pending WO2025193541A1 (en) | 2024-03-13 | 2025-03-07 | Drainage port assemblies |
| PCT/US2025/018907 Pending WO2025193539A1 (en) | 2024-03-13 | 2025-03-07 | Fluid collection assemblies including one or more three- dimensional structures |
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| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| PCT/US2025/018909 Pending WO2025193540A1 (en) | 2024-03-13 | 2025-03-07 | Drainage port assemblies, fluid collection assemblies and systems including the same |
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| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| PCT/US2025/018907 Pending WO2025193539A1 (en) | 2024-03-13 | 2025-03-07 | Fluid collection assemblies including one or more three- dimensional structures |
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| WO (3) | WO2025193540A1 (en) |
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|---|---|---|---|---|
| US4280498A (en) * | 1979-10-22 | 1981-07-28 | Hollister Incorporated | Valved drain assembly for urostomy pouch |
| EP0680296B1 (en) * | 1992-03-04 | 1997-05-14 | Coloplast A/S | A collection bag for urine from urine-incontinent and urostomy-operated humans as well as an outlet valve system therefor |
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| US20230240884A1 (en) * | 2022-01-28 | 2023-08-03 | Purewick Corporation | Male fluid collection assemblies and systems, methods of using, and methods of manufacturing the same |
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|---|---|---|---|---|
| FR2826704A1 (en) * | 2001-06-29 | 2003-01-03 | Dan Bismuth | Rotary pipe coupling e.g. for compressed air or water pipe has rotary component with two ring seals and groove for circlip |
| AU2019221663B2 (en) | 2018-02-14 | 2021-07-08 | Sage Products Llc | Devices and systems for urine collection |
| MX2023000064A (en) * | 2020-07-02 | 2023-02-01 | Purewick Corp | Male fluid collection assemblies and systems, methods of using, and methods of manufacturing the same. |
| AU2021409949B2 (en) * | 2020-12-23 | 2025-04-10 | Sage Products Llc | Devices and systems for urine collection |
| US20240108491A1 (en) * | 2021-02-08 | 2024-04-04 | Purewick Corporation | Pivotable fluid collection device tubing connectors and related systems and methods |
| EP4475805A1 (en) * | 2022-02-07 | 2024-12-18 | Purewick Corporation | Fluid collection assemblies including at least one of polyurethane or polyethylene foam background |
-
2025
- 2025-03-07 WO PCT/US2025/018909 patent/WO2025193540A1/en active Pending
- 2025-03-07 WO PCT/US2025/018913 patent/WO2025193541A1/en active Pending
- 2025-03-07 WO PCT/US2025/018907 patent/WO2025193539A1/en active Pending
Patent Citations (6)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US4280498A (en) * | 1979-10-22 | 1981-07-28 | Hollister Incorporated | Valved drain assembly for urostomy pouch |
| EP0680296B1 (en) * | 1992-03-04 | 1997-05-14 | Coloplast A/S | A collection bag for urine from urine-incontinent and urostomy-operated humans as well as an outlet valve system therefor |
| US10226376B2 (en) | 2014-03-19 | 2019-03-12 | Purewick Corporation | Apparatus and methods for receiving discharged urine |
| US10390989B2 (en) | 2014-03-19 | 2019-08-27 | Purewick Corporation | Apparatus and methods for receiving discharged urine |
| US10973678B2 (en) | 2016-07-27 | 2021-04-13 | Purewick Corporation | Apparatus and methods for receiving discharged urine |
| US20230240884A1 (en) * | 2022-01-28 | 2023-08-03 | Purewick Corporation | Male fluid collection assemblies and systems, methods of using, and methods of manufacturing the same |
Also Published As
| Publication number | Publication date |
|---|---|
| WO2025193539A1 (en) | 2025-09-18 |
| WO2025193540A1 (en) | 2025-09-18 |
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