An individual may have limited or impaired mobility such that typical urination processes are challenging or impossible. For example, the individual may have surgery, a disability, or other medical condition that impairs mobility. In another example, the individual may have restricted travel conditions such as those experienced by pilots, drivers, and workers in hazardous areas. Additionally, fluid collection from the individual may be needed for monitoring purposes or clinical testing.
Bed pans and urinary catheters, such as a Foley catheter, can be used to address some of these circumstances. However, bed pans and urinary catheters have several problems associated therewith. For example, bed pans can be prone to discomfort, pressure ulcers spills, and other hygiene issues. Urinary catheters be can be uncomfortable, painful, and can cause urinary tract infections.
Thus, users and manufacturers of fluid collection devices continue to seek new and improved devices, systems, and methods to collect urine.
Embodiments of the invention relate to fluid collection devices, system, and methods having a multiport valve assembly therein. In an embodiment, a fluid collection device is disclosed. The fluid collection device includes a fluid impermeable barrier at least partially defining an interior chamber and an opening through which the interior chamber is exposed to an external environment. The fluid collection device includes a fluid permeable body positioned at least partially within the interior chamber to extend across at least a portion of the opening and configured to wick fluid away from the opening. The fluid collection device includes a conduit extending into the interior chamber. The fluid collection device includes a multiport valve assembly disposed within the interior chamber.
In an embodiment, a fluid collection system is disclosed. The system includes a fluid collection device including a fluid impermeable barrier, a fluid permeable body, a conduit, and a multiport valve assembly. The system includes a fluid storage container fluidly connected to the fluid collection device via the conduit, the fluid storage container being configured to store fluids therein. The system includes a vacuum source fluidly connected to the fluid storage container, the vacuum source being configured to provide vacuum force into the interior chamber via the fluid storage container and the conduit.
In an embodiment, a method to collect bodily fluid is disclosed. The method includes positioning a fluid collection device including a fluid impermeable barrier, a fluid permeable body, a conduit, and a multiport valve assembly adjacent to a urethra of a wearer. The method includes receiving fluid from the urethra into the fluid collection device. The method includes removing the fluid from the fluid collection device via the conduit.
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.
Embodiments of the invention relate to fluid collection devices having a fluid impermeable barrier, a fluid permeable body, a conduit, and a multiport valve assembly as well as systems and methods for collecting fluid using the same.
The drawings illustrate several embodiments of the invention, wherein identical reference numerals refer to identical or similar elements or features in different views or embodiments shown in the drawings.
Embodiments disclosed herein relate to fluid collection devices designed to be placed near the urethra of a wearer and allow selection between a plurality of ports (e.g., valves) of a multiport valve assembly therein to collect fluid, such as urine, from the wearer and remove the fluid through one of the plurality of ports. Methods of using the fluid collection devices and systems including the fluid collection devices are also disclosed. Example fluid collection devices include a fluid impermeable barrier defining an interior chamber for collecting fluids. The fluid collection devices include a fluid permeable body at least partially disposed within the interior chamber. The fluid permeable body includes at least one permeable (e.g., porous) material for collecting and passing fluids therethrough, such as a wicking material (e.g., foam or spun plastic fibers). The fluid collection body may include a relatively soft fluid permeable membrane disposed over a fluid permeable support material, to interface with the flesh of a wearer. One or more of the fluid impermeable barrier or the fluid permeable body are sized and shaped to fit the wearer near the urethra such as one or more of over the vagina or between the legs of the wearer. The fluid collection devices include a multiport valve assembly within the interior chamber.
The multiport valve assembly allows a user (e.g., wearer, medical professional, etc.) to select a valve among a plurality of valves along a longitudinal length of the fluid collection device through which urine collected in the device is removed. Such a configuration allows for selective use of ports in different portions of the interior chamber based on the position of the wearer. For example, in a sitting position, fluid may pool in a medial portion of the interior chamber, whereas in a supine position or a reclined position, the fluid may pool in a second end region of the interior chamber.
The fluid impermeable barrier 102 at least partially defines the interior chamber 104 and opening 106. For example, the inner surface(s) 105 of the fluid impermeable barrier 102 at least partially defines the interior chamber 104 within the fluid collection device 100. The fluid impermeable barrier 102 at least temporarily retains the fluid(s) in the interior chamber 104. The fluid impermeable barrier 102 may be formed of any suitable fluid impermeable material(s), such as a fluid impermeable polymer (e.g., silicone, polypropylene, polyethylene, polyethylene terephthalate, thermoplastic elastomer(s), a polycarbonate, etc.), a metal film, natural rubber, another suitable material, or combinations thereof. As such, the fluid impermeable barrier 102 substantially prevents the fluid(s) from passing therethrough. In an example, the fluid impermeable barrier 102 may be air permeable and liquid impermeable. In such an example, the fluid impermeable barrier 102 may be formed of a hydrophobic material that defines a plurality of pores that are air permeable but not liquid permeable. In an example, one or more portions of at least an outer surface of the fluid impermeable barrier 102 may be formed from a soft and/or smooth material, thereby reducing chaffing.
In some examples, the fluid impermeable barrier 102 may be tubular (ignoring the opening), such as substantially cylindrical, oblong, prismatic, a flattened tube, or any other extruded shape. The fluid impermeable barrier 102 may be sized and shaped to fit between the legs of a wearer. During use, an outer surface 103 of the fluid impermeable barrier 102 may at least partially contact the wearer, such as the thighs of the wearer.
The opening 106 provides an ingress route for fluids to enter the interior chamber 104. The opening 106 may be defined by the fluid impermeable barrier 102, such as by an inner edge of the fluid impermeable barrier 102. For example, the opening 106 is formed in and extends through the fluid impermeable barrier 102, from the outer surface 103 to the inner surface 105, thereby enabling fluid(s) to enter the interior chamber 104 from outside of the fluid collection device 100. The opening 106 may be located and shaped to be positioned adjacent to a wearer's urethra while the device is in use. At least a portion of porous material(s) of the fluid permeable body 115 disposed in the interior chamber 104 may be exposed through the opening 106 to allow fluids to move inwardly into the interior chamber 104, such as via one or more of permeation, suction, or wicking.
The fluid collection device 100 may be positioned proximate to the urethra and urine may enter the interior chamber 104 via the opening 106. When in use, the opening 106 may be elongated, extending from a first location below the urethra to a second location above the urethra (e.g., at or near the top of the vaginal opening or the pubic region). The opening 106 may exhibit an elongated shape because the space between the legs of a wearer is relatively narrow when the legs of the wearer are closed, thereby only permitting the flow of the fluid(s) along a path that corresponds to the elongated shape of the opening 106 (e.g., longitudinally extending opening).
The opening 106 in the fluid impermeable barrier 102 may exhibit a length that is measured along the longitudinal axis of the fluid collection device 100 that may be at least about 10% of the length of the fluid collection device 100, such as about 25% to about 50%, about 40% to about 60%, about 50% to about 75%, about 65% to about 85%, or about 75% to about 95% of the length of the fluid collection device 100. The opening 106 in the fluid impermeable barrier 102 may exhibit a width that is measured transverse to the longitudinal axis of the fluid collection device 100 and may be at least about 10% of the circumference of the fluid collection device 100, such as about 25% to about 50%, about 40% to about 60%, about 50% to about 75%, about 65% to about 85%, or about 75% to about 100% of the circumference of the fluid collection device 100. The opening 106 may exhibit a width that is greater than 50% of the circumference of the fluid collection device 100 since the vacuum (e.g., suction) through the conduit 108 pulls the fluid through the fluid permeable body 115 and into the conduit 108. The opening 106 may be longitudinally oriented (e.g., having a major axis parallel to the longitudinal axis of the device 100). In some examples, the opening 106 may be laterally oriented (e.g., having a major axis perpendicular to the longitudinal axis of the device 100).
The fluid collection device 100 includes the fluid permeable body 115 disposed in the interior chamber 104. The fluid permeable body 115 may extend across at least a portion (e.g., all) of the opening 106. At least a portion of the fluid permeable body 115 may be exposed to an environment outside of the interior chamber 104 through the opening 106. The fluid permeable body 115 may wick and/or allow transport of any fluid away from the opening 106, thereby preventing the fluid from escaping the interior chamber 104.
The fluid permeable body 115 includes one or more porous materials. The fluid permeable body 115 may include one or more of a fluid permeable membrane 118 or a fluid permeable support 120. In some examples, the fluid permeable support 120 and the fluid permeable membrane 118 may be made of solely porous material(s). At least a portion of the porous material of the fluid permeable body 115 may be a wicking material configured to wick, draw, and/or allow transport any of the bodily fluids away from the opening 106, thereby preventing bodily fluids from escaping the interior chamber 104. The porous material may not include absorption of the bodily fluids into at least a portion of the porous material. Put another way, substantially no absorption or solubility of the bodily fluids into the porous material may take place after the porous material is exposed to the bodily fluids. While no absorption 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 (e.g., absorbency), such as about 30 wt % of the dry weight of the porous 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 porous material. In some examples, the porous material may include at least one absorbent or adsorbent material.
The fluid permeable membrane 118 may include any fluid permeable material that may wick the fluid. In some examples, the fluid permeable membrane 118 may be formed from a synthetic material such as polymer fibers or a natural material, such as cotton, wool, bamboo, silk, or combinations thereof. For example, the fluid permeable membrane 118 may include fabric, such as a gauze (e.g., a silk, linen, bamboo, or cotton gauze), another soft fabric, or another smooth fabric. The fluid permeable membrane 118 may include spun plastic fibers (e.g., nylon), such as a spun plastic mat or bed. Forming the fluid permeable membrane 118 from gauze, soft fabric, and/or smooth fabric may reduce chaffing caused by alternative materials.
The fluid permeable membrane 118 is disposed in the interior chamber 104. The fluid permeable membrane 118 may extend across at least a portion (e.g., all) of the opening 106. The fluid permeable membrane 118 may wick fluid inwardly away from the opening 106, thereby preventing fluid from escaping the interior chamber 104.
The fluid permeable body 115 may include the fluid permeable support 120 disposed in the interior chamber 104. The fluid permeable support 120 is positioned and composed to support the fluid permeable membrane 118 since the fluid permeable membrane 118 may be formed from a foldable, flimsy, or otherwise easily deformable material. For example, the fluid permeable support 120 may be positioned such that the fluid permeable membrane 118 is disposed between at least a portion of the fluid permeable support 120 and the fluid impermeable barrier 102. As such, the fluid permeable support 120 may support and maintain the position of the fluid permeable membrane 118 thereon. The fluid permeable support 120 may include any material that may wick the fluid, such as any of the fluid permeable membrane materials disclosed herein. For example, the fluid permeable support 120 may be formed from any fluid permeable material that is less deformable than the fluid permeable membrane 118, such as any of the materials disclosed herein for the fluid permeable membrane 118, in a more dense or rigid form. In some examples, the fluid permeable support 120 may include a porous polymer (e.g., nylon, polyester, polyurethane, polyethylene, polypropylene, etc.) structure, an open cell foam, or spun plastic fibers (e.g., nylon fibers). In some examples, the fluid permeable membrane 118 may include gauze and the fluid permeable support may include spun nylon fibers. In some examples, the fluid permeable support 120 may be formed from fabric, felt, gauze, or combinations thereof. In some examples, the fluid permeable support 120 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 120 may be omitted from the fluid collection device 100. In some examples, the fluid permeable membrane 118 may be optional. For example, the fluid permeable body 115 may include only the fluid permeable support 120.
In some embodiments, the fluid permeable support 120 may have a greater permeability or a greater ability to wick fluids than the fluid permeable membrane 118, such as to move the fluid inwardly from the outer surface of the fluid collection device 100. In some examples, the permeability or the wicking ability of the fluid permeable support 120 and the fluid permeable membrane 118 may be substantially the same.
The fluid permeable membrane 118 and the fluid permeable support 120 may at least substantially completely fill the portions of the interior chamber 104 that are not occupied by the conduit 108. In another example, the fluid permeable membrane 118 and the fluid permeable support 120 may not substantially completely fill the portions of the interior chamber 104 that are not occupied by the conduit 108. In such an example, the fluid collection device 100 includes a reservoir 122 in the interior chamber 104.
The conduit 108 extends into the interior chamber 104. The conduit 108 may be at least partially disposed in the interior chamber 104. The conduit 108 (e.g., a drainage tube) includes an inlet and outlet positioned downstream from the inlet. The conduit 108 may extend into the interior chamber 104 to any point therein. For example, the conduit 108 may be inserted into the interior chamber 104 at a first end region 125 of the fluid collection device 100 and extend therethrough into the first end region 125 or to the second end region 127. The conduit 108 may extend into the fluid impermeable barrier 102 from the first end region 125 through to the reservoir 122 in the second end region 127 such that the inlet of the conduit 108 is in fluid communication with the reservoir 122. The fluid collected in the reservoir 122 may be removed from the interior chamber 104 via the conduit 108.
In some examples, the conduit 108 may enter the interior chamber 104 in the second end region 127 and an inlet of the conduit 108 may be disposed in the second end region 127. The inlet(s) or ports may be a portion of the multiport valve assembly 130. The reservoir 122 may be disposed in the second end region 127 in any of the embodiments disclosed herein. The inlet(s) may be disposed within the fluid permeable support 120 such between the first end region 125 and the second end region 127. Fluids may be removed from the interior chamber 104 via the inlet(s) when suction is applied in the conduit 108.
The conduit 108 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 108 may include silicon or latex. In some examples, the conduit 108 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 108 to be flexible. The conduit 108 may be at least partially transparent. In some examples, one or more portions of the conduit 108 may be frosted or opaque (e.g., black) to obscure visibility of the fluid(s) therein.
The fluid impermeable barrier 102, the fluid permeable membrane 118 and the fluid permeable support 120 may be sized and shaped to have the conduit 108 at least partially disposed in the interior chamber 104. For example, at least one of the fluid permeable membrane 118 and the fluid permeable support 120 may be configured to form a space that accommodates the conduit 108. The fluid impermeable barrier 102 may define an aperture sized to receive the conduit 108. The conduit 108 may be disposed in the interior chamber 104 via the aperture. The aperture may be sized and shaped to form an at least substantially fluid tight seal against the conduit 108, thereby substantially preventing the fluid(s) from escaping the interior chamber 104. The fluid collected in the fluid collection device 100 may be removed from the interior chamber 104 via the conduit 108.
The porous material of the fluid permeable body 115 (e.g., fluid permeable membrane 118 and the fluid permeable support 120) may not substantially completely fill the portions of the interior chamber 104 that are not occupied by the conduit 108. In such examples, the fluid collection device 100 includes the reservoir 122 therein. The reservoir 122 is a substantially unoccupied portion of the interior chamber 104. The reservoir 122 may be defined between the fluid impermeable barrier 102 and the porous material of the fluid permeable body 115 (e.g., one or both of the fluid permeable membrane 118 and the fluid permeable support 120). The fluid(s) emitted by the wearer may be wicked into the interior chamber 104 by the porous material of the fluid permeable body 115 and may flow through the fluid permeable membrane 118 and/or fluid permeable support 120 to the reservoir 122. The fluid impermeable barrier 102 may retain the fluid(s) in the reservoir 122. The reservoir 122 may be located in a portion of the fluid collection device expected to be positioned in a gravimetrically low point of the fluid collection device when worn by a person. In such examples, the location of the openings the multiport valve assembly including the conduit 108 and the reservoir 122 at the gravimetrically low point of the fluid collection device allows the fluids collected in the interior chamber 104 to drain into the reservoir 122 when the device is positioned on the wearer. For instance, the fluid(s) in the porous material of the fluid permeable body 115 may flow in any direction due to capillary forces. However, the fluid(s) may exhibit a preference to flow in the direction of gravity, especially when at least a portion of the porous material of the fluid permeable body 115 is saturated with the fluid(s). Accordingly, one or more of the inlet or the reservoir 122 may be located in the second end region 127. While depicted in the second end region 127, a reservoir 122 may be located in any portion of the interior chamber 104 such as the first end region 125 or an intermediate portion therebetween. In such examples, the conduit 108 may extend into the reservoir 122, such as through one or more of the porous material of the fluid permeable body 115 or fluid impermeable barrier 102 in the first end region 125.
Other embodiments of fluid impermeable barriers, fluid permeable membranes, fluid permeable supports, cavities, conduits and their shapes and configurations useful for the fluid collection devices described herein are disclosed in U.S. patent application Ser. No. 15/612,325 filed on Jun. 2, 2017; U.S. patent application Ser. No. 15/260,103 filed on Sep. 8, 2016; and U.S. Pat. No. 10,226,376 filed on Jun. 1, 2017, the disclosure of each of which is incorporated herein, in its entirety, by this reference.
Referring to
In some embodiments, the multiport valve assembly 130 is rotationally alignable. Sets of the holes in the conduit 108 and sheath 132 align depending upon the rotational position of the sheath 132 with respect to the conduit 108. Such alignment allows fluid to be removed from a medial portion of the interior chamber 104 or the second end region of the interior chamber 104. In some embodiments, to align to form a port or inlet in the interior chamber 104, the sets of holes in the conduit 108 and sheath 132 are longitudinally spaced by the same (first) distance but located on circumferentially different portions as explained below. The terminal end of the conduit 108 (portion of conduit 108 within the interior chamber 104) defines a first plurality of holes thereon. The sheath 132 defines a second plurality of holes therein. The first plurality of holes and the second plurality of holes are spaced to align only one of the first plurality of holes with only one of the second plurality of holes for a selected orientation of the terminal end of the conduit 108 with respect to the sheath 132.
As shown in
As shown in
While two sets of holes (e.g., medial and distal) are disclosed with respect to
Further alignment schemes may be utilized in multiport valve assemblies. For example, a conduit and sheath having a selective longitudinal alignment for the holes thereon may be utilized to control application of vacuum force in the interior chamber of a fluid collection device in specific locations therein.
The multiport valve assembly 230 includes a terminal end of the conduit 208, the terminal end of the conduit 208 defining a first plurality of holes thereon. The multiport valve assembly 130 include the sheath concentrically disposed over the terminal end of the conduit 108 within the interior chamber, the sheath defining a second plurality of holes therein. The first plurality of holes and the second plurality of holes are spaced to align only one of the first plurality of holes with only one of the second plurality of holes for a selected orientation of the terminal end of the conduit 208 with respect to the sheath 232. The first plurality of holes include a conduit distal hole 211 on a first side of the conduit 208 at a second end region of a fluid collection device and a conduit medial hole 209 on the first side of the conduit 208 and longitudinally spaced from the conduit distal hole 211 by a first distance. The second plurality of holes include a sheath distal hole 235 on a first side of the sheath 232 at a second end region of the fluid collection device and a sheath medial hole 233 on the first side of sheath 232 and longitudinally spaced from the sheath distal hole 235 by a second distance that is different than the first distance. The conduit 208 is longitudinally movable within and with respect to the sheath 232. The difference of the first distance and the second distance may be greater than the diameter of the holes in the conduit 208 and sheath 232. Accordingly, when the conduit 208 is moved longitudinally in the sheath 232, the distal holes or the medial holes may align and the other of the distal holes or the medial holes may not overlap such that vacuum applied through conduit 208 is only applied to the interior chamber of the fluid collection device through one set of holes.
As shown in
The fluid impermeable barrier 202 is similar or identical to the fluid impermeable barrier 102 in one or more aspects. The fluid impermeable barrier 202 at least partially defines the interior chamber 204 and opening 106. For example, the inner surface(s) 205 of the fluid impermeable barrier 202 at least partially defines the interior chamber 204 within the fluid collection device 200. The fluid impermeable barrier 202 at least temporarily retains the fluid(s) in the interior chamber 204. The fluid impermeable barrier 202 may include a bulbous portion 255 in the medial region between the first end region 125 and the second end region 127. The bulbous portion 255 may form at least a portion of a reservoir 223 in the medial region of the interior chamber 204.
The fluid permeable body 115 may fill at least some of the interior chamber 204. The fluid permeable body 115 may not fill all of the unoccupied portions of the interior chamber 204. In such examples, the fluid collection device 200 includes one or more reservoirs 122 or 223 therein. The reservoir 122 may be located in the second end region 127 as disclosed above with respect to the fluid collection device 100. Such a reservoir is useful when the second end region is located at a gravimetrically low point of the fluid collection device 200 such as when the wearer is in a supine, laying, or reclining position.
The reservoir 223 may be located in the medial region of the of interior chamber 204, such as substantially opposite the opening 106. The reservoir 223 may be located between the sheath 232 and fluid impermeable barrier 202 opposite the opening 106. The reservoir 223 may not include one or more of the fluid permeable membrane 118 or the fluid permeable support 120 therein. In some examples (not shown), the reservoir 223 may include an empty space between a substantially cylindrical fluid permeable body 115 and the bulbous portion 255. Such examples with reservoirs located in the medial portion may be particularly useful when a wearer is in a sitting position, such as when the fluid collection device is bent and the medial portion is at a gravimetrically low point of the device.
In some examples (not shown), no reservoir 223 may be included. In such examples, the bulbous portion 255 may allow fluids to gather in the medial region such that use of a medial port to remove the same would be desirable. For example, the fluid permeable body may fill at least some of the space depicted as the reservoir 223 in
The fluid collection device 200 includes the multiport valve assembly 230 disclosed above. The multiport valve assembly 230 may be used to select a medial port in the medial region (e.g., aligned medial holes 209 and 233) or the distal port 236 (e.g., aligned distal holes 211 and 235) as shown. For example, the conduit 208 may be moved toward the second end region 127 with respect to the sheath 232 to align the conduit medial hole 209 with the sheath medial hole 233 to form a medial port (not shown). The sheath 232 may be fixed relative to the fluid permeable body 215 and fluid impermeable barrier 202. Accordingly, the conduit 208 may move within the sheath 232 to align the holes thereon.
In some examples, the fluid collection devices disclosed herein may include an alignment assembly to align the conduit with the sheath to ensure alignment of the holes thereon to provide egress for fluids collected in the device. Various alignment assemblies may be utilized with a multiport valve assembly.
The alignment assembly 1050 may be connected to the fluid impermeable barrier 102 and the conduit 108. For example, the alignment assembly 1050 may be disposed around the conduit 108 on the first end of the fluid impermeable barrier. The alignment assembly 1050 may include a fixed collar 1051 and an inner collar 1052 disposed within the fixed collar 1051. The fixed collar 1051 and the inner collar 1052 may be formed of an at least semi-rigid material such as a polymer, metal, or the like. Suitable polymers may include any of the polymers disclosed herein for the fluid impermeable barrier 102 or the conduit 108. For example, suitable polymers may include one or more of polyether ether ketone (“PEEK”), polypropylene, polyethylene, polyethylene terephthalate, thermoplastic elastomer(s), a polycarbonate, or the like.
The fixed collar 1051 may be operably coupled to the fluid impermeable barrier 102 such as via adhesive, welding, crimp, tension fit, or the like. The inner collar 1052 may be operably coupled to the terminal end of the conduit 108, the inner collar 1052 being disposed within the fixed collar 1051. Accordingly, rotation of the inner collar 1052 with respect to the fixed collar 1051 rotates the conduit with respect to the sheath (and the rest of the fluid collection device 1000). The fixed collar 1051 and the inner collar 1052 may have markings to align the conduit distal hole with the sheath distal hole and the conduit medial hole with the sheath medial hole. The markings on the fixed collar 1051 may correspond to the position of the sheath distal hole and the sheath medial hole on the sheath and the markings on the inner collar 1052 may correspond to the location of the conduit distal hole and the conduit medial hole on the conduit. For example, the fixed collar 1051 may have a first marking 1053 indicating the circumferential position of the holes on the sheath and the inner collar 1052 may have at least a second marking 1054 indicating the circumferential position of the conduit distal hole and the conduit medial hole. When aligned circumferentially, the first marking 1053 and the at least a second marking 1054 indicate that the sheath holes are in circumferential alignment with one of the conduit distal hole and the conduit medial hole. A 180° rotation would align the other of the conduit distal hole and the conduit medial hole.
The alignment assembly 1050 may include a locking mechanism 1060 to at least temporarily retain position of the inner collar 1052 relative to the fixed collar 1051. Locking mechanism 1060 may include one or more notches 1061 facing inward on the fixed collar 1051 and one or more notches 1062 facing outward on the inner collar 1052. The one or more notches 1061 and 1062 may be in alignment with the holes in the conduit and the sheath. For example, a first notch 1061 on the inner collar 1052 may circumferentially align with the conduit distal hole and the second notch 1062 on the inner collar 1052 (e.g., 180° from the first notch) may circumferentially align with the conduit medial hole. One of the notches 1061 on the fixed collar 1051 may circumferentially align with the sheath distal hole and the sheath medial hole. The one or more notches 1061 and 1062 may be in longitudinal alignment such that when the inner collar 1052 is rotated with respect to the fixed collar 1051, the notches 1061 and 1062 may align circumferentially. The respective notches may be aligned with the respective markings to indicate what position the multiport valve assembly is currently holding.
The locking mechanism 1060 may include a pin, ball, a spring, or any other means of holding notches in place with respect to each other. For example and as shown in
In some examples, the locking mechanism 1060 may include a spring loaded locking mechanism, such as having a spring loaded pin, ball, or other structure which is positioned, sized, and shaped to automatically bias into a notch to retain the inner collar 1052 relative to the fixed collar 1051. As noted herein, the locking mechanism 1060 can be positioned to lock into position when the markings on the inner collar 1052 are aligned with the markings on the fixed collar 1051.
The alignment assembly 1050 and the locking mechanism 1060 may be used with the circumferentially alignable multiport valve assembly 30 of
Alignment assemblies useful for the multiport valve assemblies disclosed herein may include longitudinal alignment assemblies. For example, an alignment assembly may provide an indication of, or retain the conduit relative to the sheath to when sets of holes thereon are aligned.
The inner collar 1352 is longitudinally movable with respect to the fixed collar 1351. The conduit medial hole and the conduit distal holes on the conduit are spaced from each other by a first distance and the sheath medial hole and medial distal hole on the sheath are spaced by a second distance that is different than the first distance. The inner collar 1352 is longitudinally movable in the fixed collar 1351 by the difference between the first distance and the second distance. The difference between the first distance and the second distance may be larger than the diameter of the holes in the sheath and conduit. Accordingly, when the holes (e.g., distal or medial) that are not aligned do not overlap and are therefore sealed when the other holes (e.g., medial or distal) are aligned.
One or more of the fixed collar 1351 and the inner collar 1352 may have markings 1353 or 1354 thereon to align the conduit distal hole with the sheath distal hole and the conduit medial hole with the sheath medial hole of the multiport valve assembly of a fluid collection device including the alignment assembly 1350. The markings on the inner collar 1352 may correspond to the location of the conduit distal hole and the conduit medial hole on the conduit of a multiport valve assembly connected thereto. As shown, the marking 1353 may indicate the position of the conduit medial hole and the marking 1354 may indicate the position of the conduit distal hole. As shown in
The alignment assembly 1350 may include a locking mechanism to at least temporarily retain the position of the inner collar 1352 and conduit relative to the fixed collar 1351 and the sheath. The locking mechanism for the alignment assembly 1350 may be similar or identical to the locking mechanism 1060 (
The alignment assembly 1350 may include a spring loaded locking mechanism configured to retain the inner collar 1352 relative to the fixed collar 1351 when the sheath distal hole is aligned with the conduit distal hole, the sheath medial hole is aligned with the conduit medial hole, or when the markings on the fixed collar and/or inner collar indicate one of the foregoing. For example, the ball, a pin, or the like may be spring loaded to be biased into a notch when the inner collar 1352 is move longitudinally with respect to the fixed collar 1351.
The alignment assembly 1350 and the locking mechanism may be used with the longitudinally alignable multiport valve assembly 230 of
The port in a medial portion of a fluid collection device may be more useful than a port in the second end region of the fluid collection device or vice versa when the wearer is in a specific position. For example, the gravimetrically low point of the fluid collection device may change depending upon the positioning of the wearer.
Any of the fluid collection devices disclosed herein may be used in
Any of the fluid collection devices disclosed herein may be used in systems for collecting fluids such as urine and vaginal discharge from a wearer.
The fluid collection device 1701 may be similar or identical to any of the fluid collection devices disclosed herein. For example, the fluid collection device 1701 may include a fluid impermeable barrier, a fluid permeable body, and an alignment assembly as disclosed herein. The fluid collection device may include any of the alignment assemblies disclosed herein. The fluid collection device 1701 may include the conduit 108 including at least one inlet (e.g., distal and medial holes) and an outlet as disclosed herein. The outlet may be fluidly coupled to the fluid storage container 1719 and the inlet(s) may be positioned in the fluid collection device 1701 such as in a portion of the interior chamber therein selected to be at a gravimetrically low point of the fluid collection device 1701 when worn by a user (e.g., reservoir(s)).
The conduit 108 is coupled to and at least partially extends between one or more of the fluid storage container 1719 and the vacuum source 1729. Accordingly, the vacuum source 1729 may be fluidly connected to the fluid storage container 1719 via the conduit 108. In an example, the conduit 108 is directly connected to the vacuum source 1729. In some examples, the conduit 108 may be indirectly connected to at least one of the fluid storage container 1719 and the vacuum source 1729. In some examples, the conduit 108 may be 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. Pat. Nos. 6,117,163; 6,123,398; and 8,211,063, the disclosures of which are all incorporated herein by reference in their entirety.
Fluid (e.g., urine or other bodily fluids) collected in the fluid collection device 1701 may be removed from the fluid collection device 1701 via the conduit 108. Vacuum or suction force may be applied to remove fluid from the fluid collection device via the conduit either directly or indirectly. The vacuum force may be applied indirectly via the fluid storage container 1719. For example, the second open end of the conduit 108 may be disposed within the fluid storage container 1719 and an additional conduit 108 may extend from the fluid storage container 1719 to the vacuum source 1729. Accordingly, the vacuum source 1729 may indirectly apply vacuum or suction force into the fluid collection device 1701 (e.g., chamber therein) via the fluid storage container 1719 and conduit 108. As the fluid is drained from the interior chamber of the fluid collection device 1701, the fluid may travel through the first section of conduit 108 to the fluid storage container 1719 where it may be retained. The fluid storage container 1719 is constructed to store fluids therein. The fluid storage container 1719 may be a substantially rigid container, such as a jar, a canister, or the like. The fluid storage container may include a bag in some examples.
The vacuum source 1729 may include one or more of a vacuum pump, a wall-mounted vacuum line, or a hand pump. For example, the vacuum source 1729 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. In examples, the vacuum source 1729 may be a portable vacuum source 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).
Any of the fluid collection devices or systems disclosed herein may be utilized to collect one or more fluids from a wearer of the fluid collection device.
Block 1810 of positioning any of the fluid collection devices disclosed herein adjacent to a urethra of a wearer may include utilizing any of the fluid collection devices disclosed herein. For example, the fluid collection device 1701 includes any of the alignment assemblies disclosed herein. Positioning any of the fluid collection devices disclosed herein adjacent to a urethra of a wearer may include positioning the opening on, around or over the labia or vulva of the wearer. Positioning any of the fluid collection devices disclosed herein adjacent to a urethra of a wearer may include positioning the second end region of the fluid collection device against or near the perineal region of the wearer with the first end region against or near the pubic region of the wearer.
Positioning any of the fluid collection devices disclosed herein adjacent to a urethra of a wearer may include positioning the opening of the fluid collection device over, on, or in contact with the urethra of the wearer. Positioning any of the fluid collection devices disclosed herein adjacent to a urethra of a wearer may include positioning the fluid collection device on the wearer effective to locate a medial port or a distal port of the multiport valve assembly at a gravimetrically low point of the fluid collection device.
Block 1820 of receiving fluid from the urethra into the fluid collection device may include receiving the fluid into fluid permeable body, such as via the opening. Receiving fluid from the urethra into the fluid collection device may include wicking or otherwise allowing the fluid to flow into the interior chamber of the fluid collection device via the fluid permeably body (e.g., fluid permeable membrane and fluid permeable support). Receiving fluid from the urethra into the fluid collection device may include may include flowing the fluid towards a portion of the interior chamber of the fluid collection device that is fluidly coupled to one or more of a gravimetrically low portion of the fluid chamber, a port (e.g., an inlet) of a conduit or multiport valve assembly, or a reservoir.
Block 1830 of removing the fluid from the fluid collection device via the conduit may include removing at least some of the fluid from the interior chamber of the fluid collection device. Removing the fluid from the fluid collection device via the conduit may include removing at least some of the fluid from the fluid permeable body of the fluid collection device. Removing the fluid from the fluid collection device via the conduit may include applying a vacuum in the interior chamber, such as via any of the vacuum sources disclosed herein. In such examples, the removing may include activating the vacuum source. Removing the fluid from the fluid collection device via the conduit may include removing the fluid into a fluid storage container.
The method 1800 may include selecting a port (e.g., inlet or valve) of the multiport valve assembly. Selecting a port of the multiport valve assembly rotating the conduit with respect to or relative to the sheath, such as rotating the conduit inside of the sheath to align a conduit distal hole with a sheath distal hole or a conduit medial hole with a sheath medial hole. Selecting a port of the multiport valve assembly may include moving the conduit longitudinally with respect to the sheath, such as moving the conduit inside of the sheath to align a conduit distal hole with a sheath distal hole or a conduit medial hole with a sheath medial hole.
Selecting a port of the multiport valve assembly may include aligning markings on an alignment assembly, which causes the conduit to move with respect to the sheath either rotationally or longitudinally. Selecting a port of the multiport valve assembly may include aligning a locking mechanism on the alignment assembly, which causes the conduit to move with respect to the sheath either rotationally or longitudinally, effective to lock the alignment assembly and the conduit with respect to the sheath when the distal holes or the medial holes are aligned.
Selecting a port of the multiport valve assembly may be carried out prior to, contemporaneously with, or after positioning any of the fluid collection devices disclosed herein adjacent to a urethra of a wearer.
The method 1800 may include collecting the fluid(s) that are removed from the fluid collection device, such as in the fluid storage container. The method may include one or more of testing or quantifying the amount of fluid removed.
The fluid collection devices, systems, and methods disclosed herein provide for secure attachment of fluid collection devices to collect fluids emitted from a wearer, which prevents leakage and soiling of the wearer's clothing, bedding, and care takers.
As used herein, the term “about” or “substantially” refers to an allowable variance of the term modified by “about” by ±10% or ±5%. Further, the terms “less than,” “or less,” “greater than”, “more than,” or “or more” include as an endpoint, the value that is modified by the terms “less than,” “or less,” “greater than,” “more than,” or “or more.”
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. Additionally, the words “including,” “having,” and variants thereof (e.g., “includes” and “has”) as used herein, including the claims, shall be open ended and have the same meaning as the word “comprising” and variants thereof (e.g., “comprise” and “comprises”).
This application claims priority to U.S. Provisional Patent Application No. 63/241,328 filed on 7 Sep. 2021, the disclosure of which is incorporated herein, in its entirety, by this reference.
Number | Date | Country | |
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63241328 | Sep 2021 | US |