An individual may have limited or impaired mobility such that typical urination processes are challenging or impossible. For example, the individual may have surgery or a disability 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, may be used to address some of these circumstances. However, bed pans and urinary catheters have several problems associated therewith. For example, bed pans may be prone to discomfort, spills, and other hygiene issues. Urinary catheters may be uncomfortable, painful, and may 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 disclosed herein are related to fluid collection devices having a multi-part adhesive cover, and related systems and methods. In an embodiment, a fluid collection device includes a fluid impermeable barrier having a first portion, a second portion, and a chamber defined between the first portion and the second portion. The first portion of the fluid impermeable barrier includes an outer surface and an inner surface and defines an opening sized to receive a penis therethrough. The fluid collection device also includes a fluid permeable body positioned at least partially within the chamber. The fluid collection device also includes an attachment system secured to the outer surface of the fluid impermeable barrier. The attachment system includes one or more adhesive regions extending at least partially around the opening such that portions of the one or more adhesive regions are positioned on at least opposing sides of the opening. The one or more adhesive regions are configured to adhere to skin of a user. The attachment system also includes two adhesive covers removably secured to the one or more adhesive regions and positioned such that the opening is positioned between the two adhesives covers.
In an embodiment, a method of collecting fluid such as urine includes positioning a penis of a user at least partially in a chamber defined by a fluid collection device and through an opening defined by a first portion of a fluid impermeable barrier of the fluid collection device. The fluid impermeable barrier includes a second portion and a chamber defined between the first portion and the second portion of the fluid impermeable barrier. The fluid collection device includes a fluid permeable body positioned at least partially within the chamber. The method includes removing a first adhesive cover from a first adhesive region secured to an outer surface of the first portion of the fluid impermeable barrier. The first adhesive region extends at least partially around the opening such that the first adhesive region is positioned at least partially between the opening and a first side portion of the fluid impermeable barrier. The method includes adhering the first adhesive region to at least one of pelvic, suprapubic, or abdominal skin of the user on a first side of the penis. The method includes, after adhering the first adhesive region to the at least one of pelvic, suprapubic, or abdominal skin of the user on the first side of the penis, removing a second adhesive cover from a second adhesive region secured to the outer surface of the first portion of the impermeable barrier. The second adhesive region extends at least partially around the opening such that the second adhesive region is positioned at least partially between the opening and a second side portion of the fluid impermeable barrier opposite to the first side portion. The method includes adhering the second adhesive region to at least one of pelvic, suprapubic, or abdominal skin of the user on a second side of the penis.
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.
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.
Embodiments disclosed herein are related to fluid collection devices having a multi-part adhesive cover, and related systems and methods of use. Conventional fluid collection devices may include an adhesive and a single adhesive cover or backing removably secured to the adhesive. The adhesive may be configured to secure the fluid collection device to the user, such as securing the adhesive to skin on at least one of a pelvic, a suprapubic, or an abdominal region around the penis of the user. The single adhesive cover of conventional fluid collection devices may extend around opposing portions of the opening into the fluid collection device. Thus, to secure the fluid collection device to the user, the entire single adhesive cover of a conventional fluid collection device may need to be removed before the fluid collection device is positioned on the user. Placement and securement of the adhesive with the entire adhesive cover removed may be difficult and uncomfortable for both the user and the caregiver. For example, a non-erect penis tends to lay to the side and to get the penis through the opening of the fluid collection device, a hand of the user or caregiver is required to hold the top of the penis. This holding of the top of the penis may become difficult when the hand holding the penis is not able to go through the opening of the fluid collection device with the penis. When the hand lets go of the penis, the penis may flop to the side and come in contact with the uncovered adhesive. The hand assisting in securing the fluid collection device to the user also may come in contact with the uncovered adhesive. The uncovered adhesive, then, may adhere or stick to the hand and/or the penis rather than (or in addition to) the skin around the penis, without the penis actually going through the opening of the fluid collection device as intended.
At least one, some, or all embodiments of fluid collection devices described herein may include one or more adhesive regions and two (or more) adhesive covers removably secured to the one or more adhesive regions. This configuration of one or more adhesive regions and two or more adhesive covers results in the technical effect of securing the one or more adhesive regions to the skin of the user one at a time, and reducing the chance that the one or more adhesive regions secure to undesired locations, such as a hand or the penis itself. For example, a penis may be inserted through the opening in the fluid collection device before any of the two or more adhesive covers are removed from the one or more adhesive regions. Because the one or more adhesive regions remain covered while the penis is inserted through the opening, the one or more adhesive regions will not adhere to the penis or the gloves as the penis is inserted through the opening of the fluid collection device. Once the penis is inserted through the opening, the user or caregiver may remove a first adhesive from a first portion of the one or more adhesive regions and secure that first portion of the one or more adhesive regions to the skin of the user before removing the second adhesive cover. Once the first portion of the one or more adhesive regions is secured to the user, the user or caregiver may then remove the second adhesive cover from a second portion of the one or more adhesive regions and then secure that second portion of the one or more adhesive regions to the skin of the user. The first and second portions of the one or more adhesive regions may be at least partially positioned on opposite sides of the opening in the fluid collection device effective to secure the fluid collection device to the user with the penis extending through the opening.
The suction force may be applied to the outlet of the tube 17 by the vacuum source 16 either directly or indirectly. The suction force may be applied indirectly via the fluid collection container 14. For example, the outlet of the tube 17 may be disposed within or fluidly coupled to an interior region of the fluid collection container 14 and an additional tube 17 may extend from the fluid collection container 14 to the vacuum source 16. Accordingly, the vacuum source 16 may apply suction to the fluid collection device 12 via the fluid collection container 14. The suction force may be applied directly via the vacuum source 16. For example, the outlet of the tube 17 may be disposed within the vacuum source 16. An additional tube 17 may extend from the vacuum source 16 to a point outside of the fluid collection device 12, such as to the fluid collection container 14. In such examples, the vacuum source 16 may be disposed between the fluid collection device 12 and the fluid collection container 14.
The fluid collection container 14 is sized and shaped to retain a fluid therein. The fluid collection container 14 may include a bag (e.g., drainage bag), a bottle or cup (e.g., collection jar), or any other enclosed container for storing bodily fluid(s) such as urine. In some examples, the tube 17 may extend from the fluid collection device 12 and attach to the fluid collection container 14 at a first point therein. An additional tube 17 may attach to the fluid collection container 14 at a second point thereon and may extend and attach to the vacuum source 16. Accordingly, a vacuum (e.g., suction) may be drawn through fluid collection device 12 via the fluid collection container 14. Fluid, such as urine, may be drained from the fluid collection device 12 using the vacuum source 16.
The vacuum source 16 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 source configured to produce a vacuum (e.g., negative pressure). The vacuum source 16 may provide a vacuum or suction to remove fluid from the fluid collection device 12. In some examples, the vacuum source 16 may be powered by one or more of a power cord (e.g., connected to a power socket), one or more batteries, or even manual power (e.g., a hand operated vacuum pump). In some examples, the vacuum source 16 may be sized and shaped to fit outside of, on, or within the fluid collection device 12. For example, the vacuum source 16 may include one or more miniaturized pumps or one or more micro pumps. The vacuum sources disclosed herein may include one or more of a switch, a button, a plug, a remote, or any other device suitable to activate the vacuum source 16. Aspects of the fluid collection system 10 may be included in any of the fluid collection systems described herein. For example, the fluid collection device 12 may include any of the fluid or urine collection devices described herein.
The urine collection device 200 also includes a fluid permeable body 210 positioned within the chamber 204 and extending at least partially between the distal end region 205 and the proximal end region 203. The fluid permeable body 210 may be shaped generally complementary to the shape of the chamber of the fluid impermeable barrier 202. In some embodiments, the fluid permeable body 210 is spaced from the edges of the fluid impermeable barrier 202. In some embodiments, the fluid permeable body 210 is positioned to abut the edges of the fluid impermeable barrier 202 such that fluid impermeable barrier 202 retains fluid in the fluid permeable body 210 from the opening 206 to the distal end region 205.
The fluid permeable body 210 can be configured to wick and/or allow transport of fluid away from the opening 206, thereby preventing the fluid from escaping the chamber 204. The fluid permeable body 210 also can wick and/or allow transport of the fluid generally towards a sump 219 (shown in
The fluid permeable body 210 can include a one-way fluid movement fabric. As such, the fluid permeable body 210 can remove fluid from the area around the penis, thereby leaving the area and urethra dry. The fluid permeable body 210 can enable the fluid to flow generally towards the sump 219 and the tube 208 within the chamber 204. The fluid permeable body 210 can include a porous or fibrous material, such as hydrophilic polyolefin. In some embodiments, the fluid permeable body 210 consists of or consists essentially of a porous or fibrous material, such as hydrophilic polyolefin. Examples of polyolefin that can be used in the fluid permeable body 210 include, but are not limited to, polyethylene, polypropylene, polyisobutylene, ethylene propylene rubber, ethylene propylene diene monomer, or combinations thereof. Moreover, the fluid permeable body 210 can be manufactured according to various manufacturing methods, such as molding, extrusion, or sintering. The fluid permeable body 210 can include varying densities or dimensions.
In some embodiments, the fluid permeable body 210 can include two or more layers of fluid permeable materials. For example, the fluid permeable body 210 can include a fluid permeable membrane covering or wrapped around a fluid permeable support, with both the fluid permeable membrane and the fluid permeable support being disposed in the chamber 204. The fluid permeable membrane can cover or extend across at least a portion (e.g., all) of at least the side of the fluid permeable support facing the penis of the user. The fluid permeable membrane and the fluid permeable support can be configured to wick any fluid away from the opening 206, thereby preventing the fluid from escaping the chamber 204 and promoting removal of the fluid through the tube 208.
The fluid permeable membrane and the fluid permeable support also can wick and/or allow transport of the fluid generally towards an interior of the chamber 204, such as the sump 219. The fluid permeable membrane can include any material that can wick the fluid. For example, the fluid permeable membrane can include fabric, such as a gauze (e.g., a silk, linen, polymer based materials such as polyester, or cotton gauze), nylon (such as a spun nylon fibers), another soft fabric (e.g., jersey knit fabric or the like), or another smooth fabric (e.g., rayon, satin, or the like). Forming the fluid permeable membrane from gauze, soft fabric, and/or smooth fabric can reduce chaffing caused by the urine collection device 200. Other embodiments of fluid permeable membranes and fluid permeable supports 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; U.S. patent application Ser. No. 15/611,587 filed on Jun. 1, 2017; PCT Patent Application No. PCT/US19/29608, filed on Apr. 29, 2019, the disclosure of each of which is incorporated herein, in its entirety, by this reference. In many embodiments, the fluid permeable body 210 includes a fluid permeable support including a porous spun nylon fiber structure and a fluid permeable wicking membrane including gauze at least partially enclosing the spun nylon fiber structure. For example, the fluid permeable body 210 may include a gauze or other wicking fabric positioned to contact the skin of the user. In some embodiments, the gauze or other wicking fabric is wrapped around a body of spun nylon fibers material and/or covering both sides of a substantially planar spun nylon fibers material. In some embodiments, the gauze or other wicking fabric covers the side of substantially planar spun nylon fibers material that is oriented towards the skin of the user.
The urine collection device 200 also includes a tube 208 extending into the chamber 204 and having an end positioned proximate to the distal end region 205 of the fluid impermeable barrier 202. A sump may be defined as the region or area between the tube opening and the distal end region 205 of the fluid impermeable barrier 202. Fluid discharged on the fluid permeable body 210 may flow to and pool in the sump for removal when a vacuum is applied on the tube 208. The tube 208 may extend through an aperture 212 in a top portion of the fluid impermeable barrier 202 and into the chamber 204. The aperture 212 may be positioned proximate to the distal end region 205 of fluid impermeable barrier 202. In some embodiments, the end of the tube 208 and/or the tube opening are positioned between the distal end region 205 and the aperture 212. In some embodiments, the aperture 212 is absent, and the tube 208 may exit the chamber 204 through the opening 206. U.S. Provisional Patent 63/067,542 describes embodiments of male external catheter urine collection devices, aspects of which may be used in any of the embodiments disclosed herein, the disclosure of which are incorporated in their entirety by this reference.
The attachment system 250 also includes two or more adhesive covers 252a, 252b removably secured to the one or more adhesive regions 254 and positioned such that the opening 206 is positioned between the two or more adhesives covers 252a, 252b. The two or more adhesive covers 252a, 252b may together cover substantially all of the one or more adhesive regions 254 such that the one or more adhesive regions 254 do not adhere to skin, gloves, etc., while the one or more covers 252a, 252b are removably secured to the one or more adhesive regions 254. Positioning of the two or more adhesives covers 252a, 252b on opposing sides or portions of the opening 206 allows a penis to be inserted into the opening 206 with the two or more adhesives covers 252a, 252b secured to the one or more adhesive regions 254. Once the penis has been inserted into the opening 206, the two or more adhesives covers 252a, 252b may be individually removed from the one or more adhesive regions 254 and secured to the skin of the user surrounding the penis one at a time, as described in greater detail in relation to
In some embodiments, the attachment system 250 is substantially horseshoe-shaped. Returning to
The one or more adhesive regions 254 may include a single continuous adhesive material including one or more (e.g., two) adhesive regions, areas, or portions. In some embodiments, the one or more adhesive regions 254 include two separate adhesive regions spaced from one another, each of the two adhesive covers 252a, 252b removably secured to a different one of the two adhesive regions.
Other attachment systems may include other configurations and shapes.
Turning specifically to
The act 510 may include positioning a penis of a user at least partially in a chamber defined by a fluid collection device and through an opening defined by a first portion of a fluid impermeable barrier of the fluid collection device. The fluid collection device may include any fluid collection device described herein, such as the urine collection device 200. The fluid impermeable barrier may include a second portion and a chamber defined between the first portion and the second portion of the fluid impermeable barrier and the fluid collection device may include a fluid permeable body positioned at least partially within the chamber.
The act 520 may include removing a first adhesive cover from a first adhesive region secured to an outer surface of the first portion of the fluid impermeable barrier. The first adhesive cover and the first adhesive region may be part of any of the attachment systems described herein, such as the attachment system 250, 310, 320, 330, 340, 350. The first adhesive region may extend at least partially around the opening such that the first adhesive region is positioned at least partially between the opening and a first side portion of the fluid impermeable barrier. In some embodiments, the act 520 of removing a first adhesive cover from a first adhesive region may include removing the first adhesive cover from the first adhesive region secured to the outer surface of the first portion of the fluid impermeable barrier between the opening and the first side portion of the fluid impermeable barrier and also between the opening and a distal end region of the fluid impermeable barrier.
The act 530 may include adhering the first adhesive region to skin of the user around or proximate to the base of the penis. For example, the act 530 may include adhering the first adhesive region to a first region of at least one of pelvic, suprapubic, or abdominal skin to the side of the penis.
The act 540 may include, after adhering the first adhesive region to at least one of pelvic, suprapubic, or abdominal skin of the user on the first side of the penis, removing a second adhesive cover from a second adhesive region secured to the outer surface of the first portion of the impermeable barrier. The second adhesive region may extend at least partially around the opening such that the second adhesive region is positioned at least partially between the opening and a second side portion of the fluid impermeable barrier opposite to the first side portion. In some embodiments, the act 540 of removing a second adhesive cover from a second adhesive region may include removing the second adhesive cover from the second adhesive region secured to the outer surface of the first portion of the fluid impermeable barrier between the opening and the second side portion of the fluid impermeable barrier and also between the opening and the distal end region of the fluid impermeable barrier.
The act 550 may include adhering the second adhesive region to skin of the user around or proximate to the base of the penis. For example, the act 550 may include adhering the second adhesive region to a second region of at least one of pelvic, suprapubic, or abdominal skin to the side of the penis such that the penis is positioned between the first region of pelvic skin and the second region of the at least one of pelvic, suprapubic, or abdominal skin.
The acts of the method 500 described above are for illustrative purposes. For example, the acts of the method 500 can be performed in different orders, split into multiple acts, modified, supplemented, or combined. In an embodiment, one or more of the act of the method 500 can be omitted from the method 500. Any of the acts of the method 500 can include using any of the portable urine collection systems disclosed herein.
As used herein, the term “about” or “substantially” refers to an allowable variance of the term modified by “about” or “substantially” by ±10% or ±5%. Further, the terms “less than,” “or less,” “greater than,” “more than,” or “or more” include, as an endpoint, the value that is modified by the terms “less than,” “or less,” “greater than,” “more than,” or “or more.”
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.
This application claims priority to U.S. Provisional Patent Application No. 63/165,273 filed on Mar. 24, 2021, the disclosure of which is incorporated herein, in its entirety, by this reference.
Filing Document | Filing Date | Country | Kind |
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PCT/US2022/021103 | 3/21/2022 | WO |
Number | Date | Country | |
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63165273 | Mar 2021 | US |