WO2021211799A1

WO2021211799A1 - Fluid collection assemblies including a vaginal implants

Info

Publication number: WO2021211799A1
Application number: PCT/US2021/027422
Authority: WO
Inventors: Melody Mei Hee KURODA; David R. Schiff; Sharon D. WEST; Vladlena Belozerova; Breanna Stachowski; Justin BECHSTEIN; Alana CLERKIN; Trisha ECKARD
Original assignee: Purewick Corporation
Priority date: 2020-04-17
Filing date: 2021-04-15
Publication date: 2021-10-21

Abstract

Embodiments disclosed herein are related to fluid collection assemblies, methods of using the same, and systems including the same. An example fluid collection assembly includes a fluid impermeable barrier defining an opening, a chamber, and a fluid outlet. The fluid collection assembly also includes at least one porous material disposed in the chamber. The fluid collection assembly further includes at least one vaginal implant coupled to the fluid impermeable barrier. The vaginal implant is configured to maintain the opening of the fluid impermeable barrier adjacent to a urethral opening of a individual when the vaginal implant is disposed in the vagina of the individual.

Description

FLUID COLLECTION ASSEMBLIES INCLUDING A VAGINAL IMPLANTS

CROSS-REFERENCE TO RELATED APPLICATIONS [0001] This application claims priority to U.S. Provisional Patent Application No. 63/011,571 filed on April 17, 2020, the disclosure of which is incorporated herein, in its entirety, by this reference.

BACKGROUND

[0002] A person or animal may have limited or impaired mobility such that 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.

[0003] Urinary catheters, such as a Foley catheter, can be used to 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

[0004] Embodiments disclosed herein are related to fluid collection assemblies, methods of using the same, and systems including the same. In an embodiment, a fluid collection assembly is disclosed. The fluid collection assembly includes a fluid impermeable barrier defining an opening, a chamber, and a fluid outlet. The fluid collection assembly also includes a vaginal implant coupled to the fluid impermeable barrier. The vaginal implant is configured to be positioned in a vagina and secure the opening of the fluid impermeable barrier adjacent to a urethral opening.

[0005] In an embodiment, a fluid collection system is disclosed. The fluid collection system includes a fluid collection assembly. The fluid collection assembly includes a fluid impermeable barrier defining an opening, a chamber, and a fluid outlet. The fluid collection assembly also includes a vaginal implant coupled to the fluid impermeable barrier. The vaginal implant is configured to be positioned in a vagina and secure the opening of the fluid impermeable barrier adjacent to a urethral opening. The fluid collection system also includes a fluid storage container in fluid communication with the fluid collection assembly and a vacuum device in fluid communication with the fluid collection assembly and the fluid storage container. The fluid collection assembly, the fluid storage container, and the vacuum device are configured to remove one or more bodily fluids from the chamber of the fluid collection assembly and deposit the bodily fluids in the fluid storage container when a suction force provided from the vacuum device is applied to the chamber of the fluid collection assembly.

[0006] In an embodiment, a method is disclosed. The method includes positioning an opening defined by a fluid impermeable barrier adjacent to a urethral opening of an individual. The fluid impermeable barrier also defines a chamber and a fluid outlet. The method further includes positioning a vaginal implant coupled to the fluid impermeable barrier in a vagina of the individual to secure the opening of the fluid impermeable barrier adjacent to the urethral opening of the individual.

[0007] Features from any of the disclosed embodiments may be used in combination with one another, without limitation. In addition, other features and advantages of the present disclosure will become apparent to those of ordinary skill in the art through consideration of the following detailed description and the accompanying drawings.

BRIEF DESCRIPTION OF THE DRAWINGS [0008] The drawings illustrate several embodiments of the present disclosure, wherein identical reference numerals refer to identical or similar elements or features in different views or embodiments shown in the drawings.

[0009] FIG. 1 is an isometric view of a fluid collection assembly, according to an embodiment.

[0010] FIG. 2 is an isometric view of the fluid collection assembly during use, according to an embodiment.

[0011] FIGS. 3A and 3B are schematic side views of the fluid collection assembly during use, according to an embodiment.

[0012] FIG. 4 is a block diagram of a system for fluid collection, according to an embodiment.

DETAIFED DESCRIPTION

[0013] Embodiments disclosed herein are related to fluid collection assemblies, methods of using the same, and systems including the same. An example fluid collection assembly includes a fluid impermeable barrier defining at least one opening, a chamber, and a fluid outlet. The fluid collection assembly also includes at least one porous material disposed in the chamber. The fluid collection assembly further includes at least one vaginal implant coupled to the fluid impermeable barrier. The vaginal implant is configured to maintain the opening of the fluid impermeable barrier adjacent to a urethral opening of a individual when at least a portion of the vaginal implant is temporarily (i.e., not permanently) positioned in the vagina of the individual.

[0014] The fluid collection assembly is configured to be disposed against the individual such that the opening of the fluid impermeable barrier is disposed adjacent to at least the urethral opening of the individual. The vaginal implant may be disposed through the vaginal opening and into the vagina to secure the fluid collection assembly to the individual and maintain the opening adjacent to the urethral opening. After securing the fluid collection assembly, the individual may discharge, either controllably or uncontrollably, bodily fluids (e.g., urine) from the urethral opening. The porous material may remove the bodily fluids from the individual and move the bodily fluids through the opening and the chamber to the fluid outlet. The bodily fluids may be removed from the chamber via the fluid outlet by using at least one gravity (e.g., the fluid outlet is located at the gravimetric low point of the chamber) or a suction force provided by a vacuum which suctions the bodily fluids from the chamber.

[0015] FIG. 1 is an isometric view of a fluid collection assembly 100, according to an embodiment. The fluid collection assembly 100 includes a fluid impermeable barrier 102 defining an opening 104, a chamber 106, and a fluid outlet 108. The fluid collection assembly 100 also includes at least one porous material 110 (e.g., contoured porous material) disposed in the chamber 106. The fluid collection assembly 100 further includes a vaginal implant 112 and a conduit 114 attached to or integrally formed with the fluid outlet 108.

[0016] The fluid impermeable barrier 102 may be formed of any suitable fluid imporous material(s), such as a fluid impermeable polymer (e.g., silicone, polypropylene, polyethylene, polyethylene terephthalate, a polycarbonate, etc.), a metal film, natural rubber, another suitable material, or combinations thereof. As such, the fluid impermeable barrier 102 substantially prevents the bodily fluids from passing through the fluid impermeable barrier 102. In an example, the fluid impermeable barrier 102 may be air permeable and fluid impermeable. In such an example, the fluid impermeable barrier 102 may be formed of a hydrophobic material that defines a plurality of pores. At least a surface of the fluid impermeable barrier 102 that may contact the individual may be formed from a soft and/or smooth material ( e. g. , silicone), thereby reducing chaffing. In an embodiment, the fluid impermeable barrier 102 may be formed from a flexible material, such as silicone, which allows the fluid impermeable barrier 102 to be bent into a shape that conforms the anatomy of the individual. In an embodiment, as illustrated, the fluid impermeable barrier 102 may be at least partially transparent which allows the presence of bodily fluids in the chamber 106 to be easily detected.

[0017] The fluid impermeable barrier 102 includes an outer surface 116 and an inner surface 118 defining the chamber 106. In an embodiment, the outer surface 116 and the inner surface 118 may exhibit a generally curved shape (e.g., generally semi-spherical shape or a generally funnel-like shape). In such an example, the chamber 106 may exhibit a generally curved shape. The generally curved outer surface 116 may allow a portion of the fluid impermeable barrier 102 to be positioned underneath the labia (e.g., at least one of the labia majora or the labia minora) which allows the labia to secure the fluid impermeable barrier 102 against the vulva such that the opening 104 is adjacent to the urethral opening of the individual (as shown in FIG. 2). In an embodiment, at least one of the outer surface 116 or the inner surface 118 of the fluid impermeable barrier 102 may exhibit a non-curved shape, such as a generally conical or fustrum shape.

[0018] In an embodiment, the outer and inner surfaces 116, 118 of the fluid impermeable barrier 102 may exhibit the same or substantially shapes. In an embodiment, not shown, the outer surface 116 and the inner surface 118 may exhibit different shapes. For example, the outer surface 116 may exhibit a generally curved shape (e.g., a generally spherical shape) and the inner surface 118 may exhibit a generally conical shape. In an embodiment, the gap between the outer surface 116 and the inner surface 118 may be substantially completely occupied by the material(s) that form the fluid impermeable barrier 102. In an embodiment, the gap between the outer surface 116 and the inner surface 118 may be at least partially occupied by a fluid, such as air or saline. In such an embodiment, the fluid may facilitate bending of the fluid impermeable barrier 102 when positioning the fluid impermeable barrier 102 underneath the labia of the individual.

[0019] The porous material 110 may exhibit a shape that generally corresponds to

(e.g., is the same or substantially the same as) or is different than the shape of the inner surface 118 of the fluid impermeable barrier 102. In embodiments where the porous material 110 exhibits a shape that is different than the shape of the inner surface 118, the fluid collection assembly 100 includes a support that maintains the shape of the porous material 110 and the position of the porous material 110 in the chamber 106. The conical support may be formed from a fluid impermeable material (e.g., any of the materials that may form the fluid impermeable barrier 102 discussed herein) or a porous material (e.g., any of the materials that may form the porous material 110 disclosed herein). A gap may be present between the support 119 and the inner surface 118. The gap may form a fluid reservoir, as discussed in more detail below. In some embodiment, the fluid collection assembly 100 does not include a support and, instead, the porous material 110 is able to maintain the shape thereof and the portions of the porous material 110 that contact the inner surface 118 of the fluid impermeable barrier 102 may maintain the position of the porous in the chamber 106.

[0020] In an embodiment, the porous material 110 disposed in the chamber 106 may exhibit a generally conical shape which may facilitate flowing the bodily fluids towards the fluid outlet 108. In an embodiment, the porous material 110 exhibits a non- conical shape, such as when the porous material 100 occupies substantially all of the chamber 106.

[0021] As previously discussed, the fluid impermeable barrier 102 defines the chamber 106. The chamber 106 is configured to have at least a portion of the porous material 110 disposed therein and to temporarily store the bodily fluids therein. The fluid impermeable barrier 102 also defines the opening 104. The opening 104 is configured to be positioned adjacent to the urethral opening and has a size sufficient to completely enclose the urethral opening. The opening 104 provides an ingress route for the bodily fluids to enter the chamber 106.

[0022] The fluid impermeable barrier 102 also forms and defines a fluid outlet

108. The fluid outlet 108 is an passageway formed in the fluid impermeable barrier 102 that is in fluid communication with the chamber 106. As such, the fluid outlet 108 may be used to remove bodily fluids from the chamber 106. The fluid outlet 108 may be located at or near a gravimetric low point of the chamber 106 (e.g. , when the individual is lying and/or sitting) to prevent pooling of the bodily fluids in the chamber 106. The fluid outlet 108 may be sized to receive a conduit 114 or may be integrally formed with the conduit 114. The conduit 114 may be disposed in the chamber or otherwise in fluid communication with the chamber 106 via the fluid outlet 108. The fluid outlet 108 may be sized and shaped to form an at least substantially fluid tight seal against the conduit 114 when the conduit 114 is not integrally formed with the fluid outlet 108 thereby substantially preventing the bodily fluids from escaping the chamber. [0023] The fluid impermeable barrier 102 is configured to support one or more components of the fluid collection assembly 100. For example, the fluid impermeable barrier 102 may be configured to allow the porous material 110 to be disposed in the chamber 106. The fluid impermeable barrier 102 may include one or more support pillars (not shown) to prevent the chamber 106 from collapsing, the opening 104 from closing, or the fluid outlet 108 from closing. In an embodiment, the support pillars may include increasing the thickness of the fluid impermeable barrier 102 in selected regions thereof to increase the strength of the fluid impermeable barrier 102. In an embodiment, the support pillars may include attaching a material, such a metal wires, to the rest of the fluid impermeable barrier 102 to increase the strength of the fluid impermeable barrier 102. [0024] In an embodiment, the fluid collection assembly 100 may include an adhesive layer attached to the fluid impermeable barrier 102. The adhesive layer may be used to attach the fluid collection assembly 100 to the vulva of the individual.

[0025] As previously discussed, the fluid collection assembly 100 includes porous material 110 disposed in the chamber 106. The porous material 110 may cover at least a portion (e.g., all) of the opening 104, extend outwardly from the opening 104, or extending inwardly from the opening 104. The porous material 110 is exposed to the environment outside of the chamber 106 through the opening 104. The permeable properties referred to herein may be wicking, capillary action, absorption, diffusion, or other similar properties or processes, and are referred to herein as “permeable” and/or “porous.” The porous material 110 may also wick the bodily fluids generally towards an interior of the chamber 106, as discussed in more detail below. The porous material 110 may include one or more of a fluid permeable membrane or a fluid permeable support. [0026] In an embodiment, at least a portion of the porous material 110 may be a wicking material configured to wick and/or allow flow of any of the bodily fluids away from the opening 104, thereby preventing bodily fluids from escaping the chamber 106. The porous material 110 may not include absorption of the bodily fluids into the wicking material. Put another way, substantially no absorption of the bodily fluids into the porous material 110 may take place after the wicking material is exposed to the bodily fluids. While no absorption is desired, the term “substantially no absorption” may allow for nominal amounts of absorption of the bodily fluids into the porous material 110 (e.g., absorbency), such as about 30 wt% of the dry weight of the wicking material, about 20 wt%, about 10 wt%, about 7 wt%, about 5 wt%, about 3 wt%, about 2 wt%, about 1 wt%, or about 0.5 wt% of the dry weight of the wicking material. [0027] The fluid collection assembly 100 may include the fluid permeable membrane disposed in the chamber 106. The fluid permeable membrane may cover at least a portion (e.g., all) of the opening 104. The fluid permeable membrane may be composed to pull/push the bodily fluids away from the opening 104, thereby promoting fluid flow into the chamber 106, prevent fluid remaining on the vulva of the individual, and preventing the bodily fluids from escaping the chamber 106.

[0028] The fluid permeable membrane may include any material that may be permeable to the bodily fluids. For example, the fluid permeable membrane may include fabric, such as a gauze (e.g., a silk, linen, or cotton gauze), a nonwoven material, paper, another soft fabric, or another smooth fabric. Forming the fluid permeable membrane from gauze, soft fabric, and/or smooth fabric may reduce chaffing caused by the fluid collection assembly 100 and makes wearing the fluid collection assembly more comfortable. In an embodiment, the fluid permeable membrane may define a plurality of perforations or may be continuous (e.g., does not define perforations therein).

[0029] The fluid collection assembly 100 may include the fluid permeable support disposed in the chamber 106. The fluid permeable support is configured to support the fluid permeable membrane and maintain the shape of the chamber 106 since the fluid impermeable barrier 102 and 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 opening 104. As such, the fluid permeable support may support and maintain the position of the fluid permeable membrane and the shape of the chamber 106. The fluid permeable support may include any material that may be permeable to 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 porous 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 (e.g., spun fibers such as spun nylon fibers, nonwoven material) or a foam (e.g., an open cell foam). 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 the bodily fluids 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.

[0030] In some examples, the fluid permeable membrane may be optional. For example, the porous material 110 may include only the fluid permeable support. In some examples, the fluid permeable support may be optionally omitted from the fluid collection assembly 100. For example, the porous material 110 may only include the fluid permeable membrane. In some examples, the porous material 110 may include an additional layer (e.g., absorbent layer) instead of or in addition to the fluid permeable membrane and the fluid permeable support.

[0031] In an embodiment, the fluid permeable membrane and/or the fluid permeable support are wicking materials. In such an embodiment, the fluid permeable support may have a greater ability to wick the bodily fluids than the fluid permeable membrane, such as to move the bodily fluids inwardly from the 116 of the fluid collection assembly 100. In some examples, the wicking ability of the fluid permeable support and the fluid permeable membrane may be substantially the same. In an embodiment, the fluid permeable membrane and/or the fluid permeable support are non- wicking materials (e.g., absorbent materials).

[0032] In an embodiment, not shown, the fluid permeable membrane and the fluid permeable support may at least substantially completely fill the portions of the chamber 106 that are not occupied by the conduit 114. In an embodiment, as previously discussed, the fluid permeable membrane and the fluid permeable support may not substantially completely fill the portions of the chamber 106 that are not occupied by the conduit 114. In such an embodiment, the fluid collection assembly 100 includes the fluid reservoir (not shown) disposed in the chamber 106.

[0033] The fluid reservoir is a substantially unoccupied portion of the chamber

106. The fluid reservoir may be defined between the fluid impermeable barrier 102 and one or both of the fluid permeable membrane and fluid permeable support. The bodily fluids that are in the chamber 106 may flow through the fluid permeable membrane and/or fluid permeable support to the fluid reservoir. The fluid reservoir may retain of the bodily fluids therein. The bodily fluids that are in the chamber 106 may flow through the fluid permeable membrane and/or fluid permeable support and, optionally, to the fluid reservoir. The fluid impermeable barrier 102 may retain the bodily fluids in the fluid reservoir. The fluid reservoir may be located in a portion of the chamber 106 that is designed to be located in a gravimetrically low point of the fluid collection assembly when the device is worn.

[0034] As previously discussed, the fluid collection assembly 100 includes a vaginal implant 112. The vaginal implant 112 includes an anchor 124 and a band 126. The band 126 extends from or near the fluid impermeable barrier 102 to the anchor 124 thereby attaching the anchor 124 to the fluid impermeable barrier. In an embodiment, the vaginal implant 112 includes a a connection 128 at an end of the band 126 that is opposite the anchor 124. The connection 128 may include a ring (as shown), one or more ribs extending from the band 126, or other structure that extends around at least a portion the fluid impermeable barrier 102 thereby attaching the vaginal implant 112 to the fluid impermeable barrier. The connection 128 may extend around a portion of the fluid impermeable barrier 102 that is adjacent or at least proximate to the opening 104 to decrease the distance that the band 126 extends from the anchor 124 and to better control the position of the opening 104 against the vulva however, the connection 128 may be spaced from the opening 104. In an example, the connection 128 may be attached to the fluid impermeable barrier 102 using an adhesive or via an interference fit. The connection 128 may also form a lip extending from at least a portion of the fluid impermeable barrier 102 which may help secure the fluid impermeable barrier 102 beneath the labia. The connection 128 may be formed from a flexible material (e.g., silicone) and/or a smooth material to make the connection 128 more comfortable against the labia and to prevent chaffing of the labia. The connection 128 may cover only a portion of the outer surface 116 of the fluid impermeable barrier 102 or cover substantially all of the outer surface 116. In an embodiment, the connection 128 is omitted from the vaginal implant 112 and the band 126 is directly attached to the fluid impermeable barrier 102 (e.g., via an adhesive, ultrasonic weld, etc.) or the band 126 may be integrally formed with the fluid impermeable barrier 102.

[0035] The anchor 124 is configured to be disposed in the vagina of the individual. The anchor 124 is flexible to facilitate insertion into, securement to, and removal from the vagina. For example, as illustrated in FIG. 1, the anchor 124 may exhibit an initial shape (shown solid) having a first width and a deformed shape (shown faded) having a second width that is less than the first width. The anchor 124 may be bent from the initial shape into a deformed shape. The anchor 124 may be inserted into the vagina while the anchor 124 exhibits the deformed shape. The reduced with of the anchor 124 may facilitate insertion of the anchor 124 into the vagina through the vaginal opening. It is noted that a lubricant may be applied to the anchor 124 and, optionally, at least a portion of the band 126 prior to inserting the anchor 124 into the vagina. At least a portion of the band 126 may also be inserted into the vagina. Once the anchor 124 is positioned (e.g., correctly positioned) in the vagina, the anchor 124 is allowed to return to the initial shape. For example, the anchor 124 may be initially bent into the deformed shape by applying a load to the anchor 124 (e.g., pitched with a hand) and the anchor 124 may return to the initial shape by removing the load from the anchor 124. When the anchor 124 returns to the initial shape, the anchor 124 presses against the walls of the vagina thereby securing the anchor 124 in the vagina. Securing the anchor 124 in the vagina may at least partially secure or help maintain the opening 104 around the urethral opening. To remove the anchor 124, the band 126 may be pulled to remove the anchor 124. Due to the rounded edges of the anchor 124, there may not be a need to bend the anchor 124 into the deformed shape thereof to remove the anchor 124. However, removing the anchor 124 may include deforming the anchor 124, for example, by applying a load to the anchor 124. It is noted that the band 126 may be positioned at least one of in the vagina or between and/or beneath the labia which causes the band 126 to at least partially secure or help maintain the opening 104 around the urethral opening.

[0036] As shown, the anchor 124 may exhibit a generally ring-like shape which may facilitate deforming the anchor 124 and prevent the anchor 124 from uncomfortably digging into the vaginal walls. However, it is noted that the anchor 124 may exhibit other shapes, such as a disk or a ball-like shape (e.g., a generally spherical shape or an oblong ball-like shape). When the anchor 124 exhibits a ball-like shape or any other 3- dimensional shape, bending the anchor 124 may include decreasing the volume of (e.g., compressing) the anchor 124 thereby reducing the anchor 124 from the first width to the second width, as discussed above.

[0037] In an embodiment, the vaginal implant 112 may form a spring that stores mechanical energy. For example, the vaginal implant 112 may exhibit a relaxed shape. The anchor 124 may be spaced from the opening 104 of the fluid impermeable barrier 102 by a first distance when the vaginal implant 112 is in the relaxed shape. The fluid collection assembly 100 is configured such that positioning the anchor 124 in the vagina and positioning the opening of the fluid impermeable barrier 102 against to the urethral opening changes the vaginal implant 112 to a loaded shape. The anchor 124 is spaced from the opening 104 by a second distance that is greater or less than the first distance when the vaginal implant 112 is in the loaded shape. The increased second distance causes the opening 104 to press harder against the portion of the vulva proximate to the urethral opening and the anchor 124 to press against the vaginal wall since the vaginal implant 112 wants to return to the relaxed shape. Pressing the opening 104 and anchor harder against the portion of the vulva proximate to the urethral opening reduces the likelihood that the fluid collection assembly 100 leaks. Further, pressing the opening 104 and the anchor 124 harder against the vulva and the vaginal wall, respectively, may secure the fluid collection assembly 100 against the individual (e.g., prevent movement of the opening 104 away from the urethral opening) and prevent movement of the fluid collection assembly 100. In an example, the band 126 may form the spring the maintains the position of the anchor 124 relative to the opening 104 when the vaginal implant 112 is in the relaxed state and cause the opening 104 and the anchor 124 to press against the individual when the vaginal implant 112 is in the loaded state. In such an example, the band 126 may include a metal wire or strip (e.g., a metal wire or strip within a polymer shell) or other material that is elastic.

[0038] In an embodiment, the vaginal implant 112 may be made from any of the materials discussed above regarding the fluid impermeable barrier 102. In an embodiment, the vaginal implant 112 may be formed from a metal (e.g., a metal within a polymer shell), composite, or any other suitable polymer.

[0039] As previously discussed, the fluid collection assembly 100 may include a conduit 114. The conduit 114 may include a flexible material such as plastic tubing (e.g., medical tubing). Such plastic tubing may include a thermoplastic elastomer, polyvinyl chloride, ethylene vinyl acetate, polytetrafluoroethylene, etc., tubing. In some examples, the conduit 114 may include silicon or latex. In some examples, the conduit 114 may include one or more portions that are resilient, such as to by having one or more of a diameter or wall thickness that allows the conduit 114 to be flexible.

[0040] In an example, the conduit 114 is configured to be at least insertable into the chamber 106. In such an example, the conduit 114 may include one or more markers (not shown) on an exterior thereof that are located to facilitate insertion of the conduit 114 into the chamber 106. For example, the conduit 114 may include one or more markings thereon that are configured to prevent over or under insertion of the conduit 114, such as when the conduit 114 defines an inlet that is configured to be disposed in or adjacent to the reservoir. In another example, the conduit 114 may include one or more markings thereon that are configured to facilitate correct rotation of the conduit 114 relative to the chamber 106. The one or more markings may include a line, a dot, a sticker, or any other suitable marking.

[0041] As described in more detail below, the conduit 114 is configured to be coupled to, and at least partially extend between, one or more of the fluid storage container (not shown) and the vacuum device (not shown). In an example, the conduit 114 is configured to be directly connected to the vacuum device (not shown). In such an example, the conduit 114 may extend from the fluid impermeable barrier 102 by at least one foot, at least two feet, at least three feet, or at least six feet. In another example, the conduit 114 is configured to be indirectly connected to at least one of the fluid storage container (not shown) and the vacuum device (not shown). In some examples, the conduit 114 is secured to a wearer’s skin with a catheter securement device, such as a STATLOCK® catheter securement device available from C. R. Bard, Inc., including but not limited to those disclosed in U.S. Patent Nos. 6,117,163; 6,123,398; and 8,211,063, the disclosures of which are all incorporated herein by reference in their entirety.

[0042] The inlet and the outlet of the conduit 114 are configured to fluidly couple (e.g., directly or indirectly) the vacuum device (not shown) to the chamber 106 (e.g., the reservoir). As the vacuum device (FIG. 4) applies a vacuum/suction in the conduit 114, the bodily fluids in the chamber 106 may be drawn into the conduit 114 and out of the fluid collection assembly 100. In some examples, the conduit 114 may be frosted or opaque (e.g., black) to obscure visibility of the bodily fluids therein.

[0043] FIG. 2 is an isometric view of the fluid collection assembly 100 during use, according to an embodiment. The fluid impermeable barrier 102 may be positioned on the vulva (partially obscured) of an individual 230 such that the opening 104 (shown in FIG. 1) of the fluid impermeable barrier 102 is positioned adjacent to the urethral opening. For example, the fluid impermeable barrier 102 may be positioned to be at least partially underneath and between the labia 232 of the individual 230. The band 126 of the vaginal implant 112 extends from the fluid impermeable barrier 102 such that at least a portion of the vaginal implant 112 (e.g., the anchor 124 and at least a portion of the band 126) is positioned in the vagina. The portions of the vaginal implant 112 in the vagina are shown using phantom lines.

[0044] FIGS. 3A and 3B are schematic side views of the fluid collection assembly 100 during use, according to an embodiment. FIG. 3A illustrates the relative position of the fluid collection assembly 100 when the individual 330 is lying down, according to an embodiment. As shown, when the individual 330 is lying down, the fluid outlet 108 of the fluid collection assembly 100 may be above a portion of the opening 104. Thus, the fluid collection assembly 100 may require a suction force to remove bodily fluids from the chamber 106. FIG. 3B illustrates the relative position of the fluid collection assembly 100 when the individual 330 is sitting up, according to an embodiment. As shown, when the individual 330 is sitting up, the fluid outlet 108 of the fluid collection assembly 100 may be below the opening 104. Thus, any bodily fluids that are in the chamber 106 may flow to the fluid outlet 108 and out of the chamber 106 due to gravity without the use of a suction force. It is noted that a suction force may be used to remove bodily fluids from the chamber 106 even when the individual 330 is sitting up.

[0045] It is noted that FIGS. 3A and 3B are merely examples of the relative position of the fluid collection assembly 100 when the individual 330 is in different positions. As such, the relative position of the fluid collection assembly 100 may be different than what is shown in FIGS. 3A and 3B. The relative position of the fluid collection assembly 100 may be different, for example, due to the different anatomy of different individuals, the fluid collection assembly 100 may be positioned differently on the individual 330, or the fluid outlet 108 may not be centrally located on the fluid impermeable barrier 102 (e.g., the inner surface 118 may exhibit an off-centered conical shape).

[0046] The fluid collection assemblies disclosed herein may are discussed as being used to collect bodily fluids from a female. However, it is noted that the principles discussed herein may be used to collect bodily fluids from a male (e.g., from a penis). In an example, any of the fluid collection assemblies disclosed herein may be used to collect bodily fluids from a penis. In such an example, the openings of the fluid collection assemblies may be configured to be positioned adjacent to the penis and the vaginal implant may be configured to be positioned around the testicles or in the anus.

[0047] FIG. 4 is a block diagram of a system 490 for fluid collection, according to an embodiment. The system 490 includes a fluid collection assembly 400, a fluid storage container 492, and a vacuum device 464. The fluid collection assembly 400, the fluid storage container 492, and the vacuum device 464 may be fluidly coupled to each other via one or more conduits 412. For example, fluid collection assembly 400 may be operably coupled to one or more of the fluid storage container 492 or the vacuum device 464 via the conduit 412. However, as previously discussed, the vacuum device 464 and the fluid storage container 492 may be integrally formed together. The bodily fluids collected in the fluid collection assembly 400 may be removed from the fluid collection assembly 400 via the conduit 412 which protrudes into the fluid collection assembly 400. For example, an inlet of the conduit 412 may extend into the fluid collection assembly 400, such as to a fluid reservoir therein. The outlet of the conduit 412 may extend into the fluid collection assembly 400 or the vacuum device 464. Suction force may be introduced into the chamber of the fluid collection assembly 400 via the inlet of the conduit 412 responsive to suction (e.g., vacuum) force applied at the outlet of the conduit 412.

[0048] The suction force may be applied to the outlet of the conduit 412 by the vacuum device 464 either directly or indirectly. The suction force may be applied indirectly via the fluid storage container 492. For example, the outlet of the conduit 412 may be disposed within the fluid storage container 492 and an additional conduit 412 may extend from the fluid storage container 492 to the vacuum device 464. Accordingly, the vacuum device 464 may apply suction to the fluid collection assembly 400 via the fluid storage container 492. The suction force may be applied directly via the vacuum device 464. For example, the outlet of the conduit 412 may be disposed within the vacuum device 464. An additional conduit 412 may extend from the vacuum device 464 to a point outside of the fluid collection assembly 400, such as to the fluid storage container 492. In such examples, the vacuum device 464 may be disposed between the fluid collection assembly 400 and the fluid storage container 492.

[0049] The fluid collection assembly 400 may be similar or identical to any of the fluid collection assemblies disclosed herein in one or more aspects. The fluid collection assembly 400 may be shaped and sized to be positioned adjacent to a female urethra or have a male urethra positioned therethrough (e.g., receive a penis therein). For example, the fluid collection assembly 400 may include a fluid impermeable barrier at least partially defining a chamber (e.g., interior region) of the fluid collection assembly 400. The fluid impermeable barrier also defines an opening extending therethrough from the external environment. The opening may be positioned adjacent to a female urethra or have a male urethra positioned therethrough. The fluid collection assembly 400 may include a fluid permeable membrane disposed within the fluid impermeable barrier. The fluid collection assembly 400 may include at least one porous material disposed in the chamber such as one or more of a fluid permeable support and a fluid permeable membrane.

[0050] The fluid storage container 492 is sized and shaped to retain the bodily fluids therein. The fluid storage container 492 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 412 may extend from the fluid collection assembly 400 and attach to the fluid storage container 492 at a first point therein. An additional conduit 412 may attach to the fluid storage container 492 at a second point thereon and may extend and attach to the vacuum device 464. Accordingly, a vacuum (e.g., suction) may be drawn through fluid collection assembly 400 via the fluid storage container 492. The bodily fluids, such as urine, may be drained from the fluid collection assembly 400 using the vacuum device 464.

[0051] The vacuum device 464 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 device 464 may provide a vacuum or suction to remove the bodily fluids from the fluid collection assembly 400. In some examples, the vacuum device 464 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 device 464 may be sized and shaped to fit outside of, on, or within the fluid collection assembly 400. For example, the vacuum device 464 may include one or more miniaturized pumps or one or more micro pumps. The vacuum devices 464 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 device 464.

[0052] 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.

[0053] Terms of degree (e.g., “about,” “substantially,” “generally,” etc.) indicate structurally or functionally insignificant variations. In an example, when the term of degree is included with a term indicating quantity, the term of degree is interpreted to mean ± 10%, ±5%, or +2% of the term indicating quantity. In an example, when the term of degree is used to modify a shape, the term of degree indicates that the shape being modified by the term of degree has the appearance of the disclosed shape. For instance, the term of degree may be used to indicate that the shape may have rounded corners instead of sharp corners, curved edges instead of straight edges, one or more protrusions extending therefrom, is oblong, is the same as the disclosed shape, etc.

Claims

CLAIMS We claim:

1. A fluid collection assembly, comprising: a fluid impermeable barrier defining: an opening; a chamber; and a fluid outlet; and a vaginal implant coupled to the fluid impermeable barrier, the vaginal implant configured to be positioned in a vagina and secure the opening of the fluid impermeable barrier adjacent to a urethral opening.

2. The fluid collection assembly of claim 1, wherein the fluid impermeable barrier includes at least one outer surface that exhibits a generally semi-spherical shape.

3. The fluid collection assembly of any one of claims 1 or 2, wherein the fluid impermeable barrier includes at least one inner surface that exhibits a generally conical or frustum shape.

4. The fluid collection assembly of any one of claims 1-3, wherein the vaginal implant includes an anchor and a band extend from or near the fluid impermeable barrier to the anchor.

5. The fluid collection assembly of claim 4, wherein the band is directly attached to the fluid impermeable barrier.

6. The fluid collection assembly of claim 4, wherein the vaginal implant further includes a connection extending at least partially around the fluid impermeable barrier.

7. The fluid collection assembly of claim 6, wherein the connection includes a ring or one or more ribs extending from the band.

8. The fluid collection assembly of any one of claims 6 or 7, wherein the connection forms a lip extending from at least one outer surface of the fluid impermeable barrier.

9. The fluid collection assembly of any one of claims 4-7, wherein the anchor exhibits a ring-like shape.

10. The fluid collection assembly of any one of claims 4-8, wherein the anchor is deformable between an initial shape and a deformed shape, wherein a width of the anchor in the initial shape is greater than a width of the anchor in the deformed shape.

11. The fluid collection assembly of any one of claims 4-9, wherein vaginal implant exhibits a relaxed state and a loaded state, wherein a distance from the anchor to the opening when the vaginal implant is in the loaded state is greater or less than a distance from the anchor to the opening when the vaginal implant is in the relaxed state.

12. The fluid collection assembly of any one of claims 1-10, further comprising at least one porous material disposed in the chamber.

13. The fluid collection assembly of claim 11, wherein the at least one porous material includes a fluid permeable membrane disposed over a fluid permeable support.

14. A fluid collection system, comprising: the fluid collection assembly of any one of claims 1-11; a fluid storage container in fluid communication with the fluid collection assembly; and a vacuum device in fluid communication with the fluid collection assembly and the fluid storage container; wherein the fluid collection assembly, the fluid storage container, and the vacuum device are configured to remove one or more bodily fluids from the chamber of the fluid collection assembly and deposit the bodily fluids in the fluid storage container when a suction force provided from the vacuum device is applied to the chamber of the fluid collection assembly.

15. A method, comprising: positioning an opening defined by a fluid impermeable barrier adjacent to a urethral opening of an individual, the fluid impermeable barrier defining a chamber and a fluid outlet; and positioning a vaginal implant coupled to the fluid impermeable barrier in a vagina of the individual to secure the opening of the fluid impermeable barrier adjacent to the urethral opening of the individual.

16. The method of claim 14, wherein positioning the vaginal implant in the vagina of the individual includes deforming an anchor of the vaginal implant from an initial shape to a deformed shape and inserting the anchor into the vaginal while the anchor exhibits the deformed shape, wherein a width of the anchor in the initial shape is greater than a width of the anchor in the deformed shape.

17. The method of any one of claims 14 or 15, wherein the vaginal implant exhibits a relaxed state before positioning the vaginal implant in the vagina of the individual and a loaded state after positioning the vaginal implant in the vagina, wherein a distance from the anchor to the opening when the vaginal implant is in the loaded state is greater or less than a distance from the anchor to the opening when the vaginal implant is in the relaxed state.

18. The method of any one of claims 14-16, further comprising discharging one or more bodily fluids from the urethral opening of the individual and receiving the one or more bodily fluids into the chamber.

19. The method of any one of claims 14-17, further comprising removing one or more bodily fluids from the chamber of the fluid collection assembly and depositing the bodily fluids in a fluid storage container when a suction force provided from a vacuum device is applied to the chamber.