Patent Publication Number: US-2021177643-A1

Title: External-Catheter Kits With Step-By Step Instructions, And Methods Thereof

Description:
PRIORITY 
     This application claims the benefit of priority to U.S. Provisional Application No. 62/688,186, filed Jun. 21, 2018, and to U.S. Provisional Application No. 62/675,633, filed May 23, 2018, each of which is incorporated by reference in its entirety into this application. 
    
    
     BACKGROUND 
     Hospitals around the country are understandably focusing their efforts on reducing risk of catheter-associated urinary tract infections (“CAUTIs”) in response to at least large penalties put in place by the Affordable Care Act (“ACA”). Steps taken to reduce the risk of such indwelling catheter-associated infections include implementation of a variety of prevention methodologies recommended by the Centers for Disease Control and Prevention (“CDC”), as well as decreasing utilization of indwelling catheters through use of non-indwelling catheter alternatives. With the use of non-indwelling catheter alternatives such as external catheters expected to rise, problems associated with application and management of such catheters once applied are also expected to rise. 
     Disclosed herein are external catheters, external catheter-related components, external-catheter kits with step-by-step instructions, and methods thereof providing a standardized system for application and management of such catheters. 
     SUMMARY 
     Disclosed herein is an external-catheter kit including, in some embodiments, one or more external catheters, a cleansing kit, and step-by-step instructions for using the external-catheter kit. The cleansing kit includes one or more individually wrapped towelettes for at least anatomical cleansing before application of any external catheter of the one or more external catheters. The step-by-step instructions for using the external-catheter kit include step-by-step instructions for the anatomical cleansing, external-catheter application, and external-catheter management subsequent to the external-catheter application. 
     In some embodiments, the external-catheter kit further includes a urine-drainage system. The urine-drainage system includes a urine-collection receptacle, urine-drainage tubing, and one or more connectors to fluidly connect an external catheter of the one or more external catheters to the urine-collection device. 
     In some embodiments, the urine-drainage system is at least partially preassembled in the external-catheter kit to minimize misconnections and misconnection-based contamination. The urine-drainage tubing is fluidly connected to the urine-collection receptacle in the partially preassembled urine-drainage system. 
     In some embodiments, the one or more external catheters are female external catheters (“FECs”). The one or more FECs are optionally individually wrapped. 
     In some embodiments, the external-catheter kit further includes an FEC urine-drainage system. The FEC urine-drainage system includes a urine-collection canister, a lid configured to cover the urine-collection canister, urine-drainage tubing, and one or more connectors to fluidly connect an FEC of the one or more FECs to the urine-collection canister. 
     In some embodiments, the FEC urine-drainage system is at least partially preassembled in the external-catheter kit to minimize misconnections and misconnection-based contamination. The urine-drainage tubing is fluidly connected to the urine-collection canister through the lid covering the urine-collection canister in the partially preassembled FEC urine-drainage system. 
     In some embodiments, the external-catheter kit further comprises a urine-privacy cover configured to form a sleeve for covering the urine-collection canister. The sleeve has a cut-out window configured to expose graduations on the urine-collection canister through the window of the sleeve while a remainder of the urine-collection canister is covered by the sleeve. 
     In some embodiments, the one or more external catheters are male external catheters (“MECs”). The one or more MECs are optionally individually wrapped. 
     In some embodiments, each MEC of the one or more MECs has a different size. The one or more MECs respectively represent at least the most common MEC size or sizes. 
     In some embodiments, the one or more MECs are five differently sized MECs. 
     In some embodiments, the external-catheter kit further includes an MEC sizer with up to at least five differently sized cutouts for determining an appropriate MEC size for a user or patient. 
     In some embodiments, each cutout of the cutouts has a differently colored border around the cutout in accordance with a color-based MEC size-indicator system. Each MEC of the one or more MECs has a different color in accordance with the MEC size-indictor system. 
     In some embodiments, the external-catheter kit further includes an MEC urine-drainage system. The MEC urine-drainage system includes a urine-collection bag, urine-drainage tubing, and a connector assembly to fluidly connect an MEC of the one or more MECs to the urine-collection bag. 
     In some embodiments, the urine-drainage bag is a bedside bag or a leg bag. 
     In some embodiments, the connector assembly includes a securable tubing connector having a urine-sampling port and a flexible, tubular bridge configured to connect to a flexible tubing connector of an MEC. Each tubing connector of the securable tubing connector and the flexible tubing connector is a bidirectional tubing connector. 
     In some embodiments, each tubing connector of the securable tubing connector and the flexible tubing connector has a tapered end portion configured to insert in an opposing end portion of the flexible bridge. The securable tubing connector has a non-tapered end portion configured to insert in an end portion of the urine-drainage tubing. The flexible tubing connector has a non-tapered end portion configured to insert in an end portion of any of the one or more MECs configured for urine drainage. 
     In some embodiments, the external-catheter kit further includes a securement device configured to secure the securable tubing connector of the connector assembly to a patient&#39;s leg. The securement device minimizes any longitudinal or transverse movement of the drainage tubing while in use. 
     In some embodiments, the MEC urine-drainage system is at least partially preassembled in the external-catheter kit to minimize misconnections and misconnection-based contamination. The urine-drainage tubing fluidly connects the connector assembly to the urine-drainage bag in the partially preassembled MEC urine-drainage system. 
     In some embodiments, the step-by-step instructions are provided in a booklet having a picture book format, integrated with packaging for the external-catheter kit, optionally, revealed as one or more components of the external-catheter kit are removed from the external-catheter kit, or a combination thereof. 
     In some embodiments, the packaging includes a wrap of a first sterilizable material around the components of the external-catheter kit or a tray of a second sterilizable material into which the components of the external-catheter kit are placed. The packaging further includes an outer packaging around the wrap or the tray. The outer packaging is configured for sterilizing the components of the external-catheter kit in the wrap or tray within the outer packaging with a sterilizing gas before sealing the external-catheter kit. 
     Also disclosed herein is an FEC kit including, in some embodiments, one or more FECs, a cleansing kit, and step-by-step instructions for using the FEC kit. The one or more FECs are optionally individually wrapped. The cleansing kit includes one or more individually wrapped towelettes for at least anatomical cleansing before application of any FEC of the one or more FECs. The step-by-step instructions for using the FEC kit include instructions for the anatomical cleansing, FEC application, and FEC management subsequent to the FEC application. 
     In some embodiments, the FEC kit further includes a urine-drainage system. The urine-drainage system includes a urine-collection canister, a lid configured to cover the urine-collection canister, urine-drainage tubing, and one or more connectors to fluidly connect an FEC of the one or more FECs to the urine-collection canister. 
     In some embodiments, the urine-drainage system is at least partially preassembled in the FEC kit to minimize misconnections and misconnection-based contamination. The urine-drainage tubing is fluidly connected to the urine-collection canister through the lid covering the urine-collection canister in the partially preassembled urine-drainage system. 
     In some embodiments, the FEC kit further includes a urine-privacy cover configured to form a sleeve for covering the urine-collection canister. The sleeve has a cut-out window configured to expose graduations on the urine-collection canister through the window of the sleeve while a remainder of the urine-collection canister is covered by the sleeve. 
     In some embodiments, the step-by-step instructions are provided in a booklet having a picture book format, integrated with packaging for the FEC kit, optionally, revealed as one or more components of the FEC kit are removed from the FEC kit, or a combination thereof. 
     In some embodiments, the packaging includes a wrap of a first sterilizable material around the components of the FEC kit or a tray of a second sterilizable material into which the components of the FEC kit are placed. The packaging further includes an outer packaging around the wrap or the tray. The outer packaging is configured for sterilizing the components of the FEC kit in the wrap or tray within the outer packaging with a sterilizing gas before sealing the FEC kit. 
     Also disclosed herein is an MEC kit including, in some embodiments, one or more MECs, a cleansing kit, and step-by-step instructions for using the MEC kit. The one or more MECs are optionally individually wrapped. The cleansing kit includes one or more individually wrapped towelettes for at least anatomical cleansing before application of any MEC of the one or more MECs. The step-by-step instructions for using the MEC kit include instructions for the anatomical cleansing, MEC application, and MEC management subsequent to the MEC application. 
     In some embodiments, each MEC of the one or more MECs has a same size and color. The color is part of a color-based MEC size-indicator system in which each size of MEC has a different color, optionally in accordance with an MEC sizer. 
     In some embodiments, the step-by-step instructions are provided in a booklet having a picture book format, integrated with packaging for the MEC kit, optionally, revealed as one or more components of the MEC kit are removed from the MEC kit, or a combination thereof. 
     In some embodiments, the packaging includes a wrap of a first sterilizable material around the components of the MEC kit or a tray of a second sterilizable material into which the components of the MEC kit are placed. The packaging further includes an outer packaging around the wrap or the tray. The outer packaging is configured for sterilizing the components of the MEC kit in the wrap or tray within the outer packaging with a sterilizing gas before sealing the MEC kit. 
     In some embodiments, each MEC of the one or more MECs has a same size and color. The color is part of a color-based MEC size-indicator system in which each size of MEC has a different color, optionally in accordance with an MEC sizer. The packaging includes either the wrap or tray, the outer packaging, or a combination thereof that matches the color of the one or more MECS. 
     Also disclosed herein is an MEC kit including, in some embodiments, an MEC sizer, a urine-drainage system, a cleansing kit, and step-by-step instructions for using the MEC kit. The MEC sizer has up to at least five differently sized cutouts for determining an appropriate MEC size for a user or patient. The urine-drainage system includes a urine-collection bag, urine-drainage tubing, and a connector assembly to fluidly connect an MEC to the urine-collection bag. The cleansing kit includes one or more individually wrapped towelettes for at least anatomical cleansing before MEC application. The step-by-step instructions for using the MEC kit include instructions for the anatomical cleansing, the MEC application, and MEC management subsequent to the MEC application. 
     In some embodiments, each cutout of the MEC sizer has a differently colored border around the cutout in accordance with a color-based MEC size-indicator system. 
     In some embodiments, the MEC kit further includes one or more MECs. The one or more MECs are optionally individually wrapped. Each MEC of the one or more MECs has a different size and color in accordance with the color-based MEC size-indicator system. The one or more MECs respectively represent at least the most common MEC size or sizes. 
     In some embodiments, the step-by-step instructions are further for identifying supplemental MEC kits including one or more supplemental MECs in accordance with the color-based MEC size-indictor system. The supplemental kits including the one or more supplemental MECs thereof and at least some packaging of the supplemental kits are individually colored to match the differently colored borders of the cutouts of the MEC sizer in accordance with the color-based MEC size-indicator system. 
     In some embodiments, the urine-drainage bag is a bedside bag or a leg bag. 
     In some embodiments, the connector assembly includes a securable tubing connector having a urine-sampling port and a flexible, tubular bridge configured to connect to a flexible tubing connector of an MEC. Each tubing connector of the securable tubing connector and the flexible tubing connector is a bidirectional tubing connector. 
     In some embodiments, each tubing connector of the securable tubing connector and the flexible tubing connector has a tapered end portion configured to insert in an opposing end portion of the flexible bridge. The securable tubing connector has a non-tapered end portion configured to insert in an end portion of the urine-drainage tubing. The flexible tubing connector has a non-tapered end portion configured to insert in an end portion of any MEC configured for urine drainage. 
     In some embodiments, the MEC kit further includes a securement device configured to secure the securable tubing connector of the connector assembly to a patient&#39;s leg. The securement device minimizes any longitudinal or transverse movement of the drainage tubing while in use. 
     In some embodiments, the urine-drainage system is at least partially preassembled in the MEC kit to minimize misconnections and misconnection-based contamination. The urine-drainage tubing fluidly connects the connector assembly to the urine-drainage bag in the partially preassembled urine-drainage system. 
     In some embodiments, the step-by-step instructions are provided in a booklet having a picture book format, integrated with packaging for the MEC kit, optionally, revealed as one or more components of the MEC kit are removed from the MEC kit, or a combination thereof. 
     In some embodiments, the packaging includes a wrap of a first sterilizable material around the components of the MEC kit or a tray of a second sterilizable material into which the components of the MEC kit are placed. The packaging further includes an outer packaging around the wrap or the tray. The outer packaging is configured for sterilizing the components of the MEC kit in the wrap or tray within the outer packaging with a sterilizing gas before sealing the MEC kit. 
     Also disclosed herein is an MEC connector assembly for fluidly connecting an MEC to a urine-drainage system including, in some embodiments, a securable tubing connector, a flexible tubing connector, a flexible, tubular bridge between the securable tubing connector and the flexible tubing connector when the connector assembly is assembled. The securable tubing connector includes a urine-sampling port. The securable tubing connector is also configured for placement in a human body-adherable securement device. Each tubing connector of the securable tubing connector and the flexible tubing connector is a bidirectional tubing connector. The flexible tubing connector and the flexible bridge, together, are configured for comfortably connecting an MEC to a urine-drainage system. 
     In some embodiments, each tubing connector of the securable tubing connector and the flexible tubing connector has a tapered end portion configured to insert in an opposing end portion of the flexible bridge. 
     In some embodiments, the securable tubing connector has a non-tapered end portion configured to insert in an end portion of urine-drainage tubing of a urine-drainage system. 
     In some embodiments, the flexible tubing connector has a non-tapered end portion configured to insert in an open-ended portion of an MEC. 
     In some embodiments, the flexible tubing connector has a plurality of circumferential ridges on the non-tapered end portion configured to provide resistance to an MEC from slipping off the non-tapered end portion while the MEC is in use. 
     These and other features of the concepts provided herein will become more apparent to those of skill in the art in view of the accompanying drawings and following description, which disclose particular embodiments of such concepts in greater detail. 
    
    
     
       DRAWINGS 
         FIG. 1A  provides an MEC of a first style in accordance with some embodiments. 
         FIG. 1B  provides an MEC of a second style in accordance with some embodiments. 
         FIG. 1C  provides an MEC of a third style in accordance with some embodiments. 
         FIG. 1D  provides an MEC disposed over a plastic insert in accordance with some embodiments. 
         FIG. 2  provides an FEC in accordance with some embodiments. 
         FIG. 3A  provides a connector assembly for an MEC disposed in a securement device in accordance with some embodiments. 
         FIG. 3B  provides a cross-section of a connector assembly for an MEC disposed in a securement device in accordance with some embodiments. 
         FIG. 3C  provides a cross-section of a connector assembly for an MEC disposed in a securement device in accordance with some embodiments. 
         FIG. 3D  provides a close-up of a portion of the connector assembly of  FIG. 3B  in accordance with some embodiments. 
         FIG. 3E  provides a cross-section of a connector assembly for an MEC disposed in a securement device in accordance with some embodiments. 
         FIG. 4A  provides an FEC assembly fluidly connected to a house-vacuum system in accordance with some embodiments. 
         FIG. 4B  provides an FEC assembly fluidly connected to a standalone vacuum pump in accordance with some embodiments. 
         FIG. 5A  provides an MEC kit in accordance with some embodiments. 
         FIG. 5B  provides an MEC kit in accordance with some embodiments. 
         FIG. 6A  provides an FEC kit in accordance with some embodiments. 
         FIG. 6B  provides an FEC kit in accordance with some embodiments. 
     
    
    
     DESCRIPTION 
     Before some particular embodiments are disclosed in greater detail, it should be understood that the particular embodiments disclosed herein do not limit the scope of the concepts provided herein. It should also be understood that a particular embodiment disclosed herein can have features that can be readily separated from the particular embodiment and optionally combined with or substituted for features of any of a number of other embodiments disclosed herein. 
     Regarding terms used herein, it should also be understood the terms are for the purpose of describing some particular embodiments, and the terms do not limit the scope of the concepts provided herein. Ordinal numbers (e.g., first, second, third, etc.) are generally used to distinguish or identify different features or steps in a group of features or steps, and do not supply a serial or numerical limitation. For example, “first,” “second,” and “third” features or steps need not necessarily appear in that order, and the particular embodiments including such features or steps need not necessarily be limited to the three features or steps. Labels such as “left,” “right,” “front,” “back,” “top,” “bottom,” “clockwise,” “counter clockwise,” or other similar terms are used for convenience and are not intended to imply, for example, any particular fixed location, orientation, or direction. Instead, such labels are used to reflect, for example, relative location, orientation, or directions. Singular forms of “a,” “an,” and “the” include plural references unless the context clearly dictates otherwise. 
     Unless defined otherwise, all technical and scientific terms used herein have the same meaning as commonly understood by those of ordinary skill in the art. 
     Hospitals around the country are understandably focusing their efforts on reducing risk of CAUTIs in response to at least large penalties put in place by the ACA. Steps taken to reduce the risk of such indwelling catheter-associated infections include implementation of a variety of prevention methodologies recommended by the CDC, as well as decreasing utilization of indwelling catheters through use of non-indwelling catheter alternatives. With the use of non-indwelling catheter alternatives such as external catheters expected to rise, problems associated with application and management of such catheters once applied are also expected to rise. 
     Disclosed herein are external catheters, external catheter-related components, external-catheter kits with step-by-step instructions, and methods thereof providing a standardized system for application and management of such catheters. 
     Male External Catheter (MEC) 
       FIGS. 1A-1D  show a number of MECs in accordance with some embodiments. Such MECs can have sheaths of latex, non-latex such as silicone, or non-latex and non-silicone such as polyurethane. Non-latex sheaths such as silicone sheaths provide breathability over latex sheaths. Such MECs can also include adhesive for self-adhering sheaths. MECs without self-adhering sheaths use adjustable straps over the MECs in lieu of adhesive. 
       FIG. 1A  provides an unrolled MEC  110 A of a first style in accordance with some embodiments. 
     As shown, the MEC  110 A has a more traditional sheath length (e.g., a sheath length of about 3″) and placement of a band of adhesive  112  along a length of a silicone sheath. The adhesive can be a hydrocolloid adhesive integrated into a lining of the sheath about a medial section of the MEC  110 A. A width of the band of the adhesive  112  can be about 1.75″ along the medial section of the MEC  110 A. The combination of the silicon sheath and the hydrocolloid adhesive provides a supple, breathable MEC  110 A that wicks away moisture when worn. 
       FIG. 1B  provides an unrolled MEC  110 B of a second style in accordance with some embodiments. 
     As shown, the MEC  110 B has a shorter sheath length (e.g., a sheath length of about 1.5″) and forward placement of the band of adhesive  112  along a length of a silicone sheath. The adhesive can be a hydrocolloid adhesive integrated into a lining of the sheath about a medial section of the MEC  110 B. The width of the band of the adhesive  112  can be about 1.75″ along the medial section of the MEC  110 B, which provides a maximum amount of adhesive over the length of the sheath. The combination of the silicon sheath and the hydrocolloid adhesive provides a supple, breathable MEC  110 B that wicks away moisture when worn. 
       FIG. 1C  provides an unrolled MEC  110 C of a third style in accordance with some embodiments. 
     As shown, the MEC  110 C has a more traditional sheath length (e.g., a sheath length of about 3″) and forward placement of a band of adhesive  112  along a length of a silicone sheath. The adhesive can be a hydrocolloid adhesive integrated into a lining of the sheath about a medial section of the MEC  110 C. The width of the band of the adhesive  112  can be about 3.00″ along the medial section of the MEC  110 C, which provides a maximum amount of adhesive over the length of the sheath compared to the MEC  110 A. The combination of the silicon sheath and the hydrocolloid adhesive provides a supple, breathable MEC  110 C that wicks away moisture when worn. 
       FIG. 1D  provides a rolled MEC such as any MEC of MECs,  110 A,  110 B, and  110 C disposed over a plastic insert  111  in accordance with some embodiments. 
     As shown, a rolled MEC such as any MEC of MECs,  110 A,  110 B is disposed over the plastic insert  111  to maintain structural integrity of the MEC prior to use. Any MEC described herein can be packaged with such a plastic insert, which is easily removed by pulling the MEC away from the plastic insert as shown. 
     Each MEC of the MECs  110 A,  110 B, and  110 C is manufactured with an inner diameter selected from 25 mm (“small”), 29 mm (“medium”), 32 mm (“intermediate”), 36 mm (“large”), and 41 mm (“extra-large”) to ensure a proper fit. 
     Each MEC of the MECs  110 A,  110 B, and  110 C of a same size can be manufactured with a common color by way of a dye added to the raw material for manufacturing the same-sized MECs. As set forth herein, each MEC of the MECs  110 A,  110 B, and  110 C can include a flexible connector  384 , which flexible connector  384  can have the same color as the MEC into which it is inserted. The color is part of a color-based MEC size-indicator system in which each size of MEC has a different color, optionally in accordance with an MEC sizer. (See the MEC sizer  560  of  FIG. 5B .) Alternatively, an MEC attachment colored in accordance with the color-based MEC size-indicator system can be used to indicate an associated MEC size. For example, a colored band can be placed around an MEC or one or more MEC-related components to indicate an associated MEC size. 
     The hydrocolloid adhesive of each MEC of the MECs  110 A,  110 B, and  110 C maintains adhesion while maintaining skin integrity without skin maceration. 
     Female External Catheter (FEC) 
       FIG. 2  provides an FEC  210  in accordance with some embodiments. 
     As shown, the FEC  210  includes gauze  212  covering an aperture in an elongate body  214 . The aperture is fluidly connected to urine-drainage tubing  216 , which is configured for connection to urine-drainage tubing of a urine-drainage system. (See the urine-drainage tubing  642  of  FIG. 6B  and the urine-drainage system  440  of  FIGS. 4A and 4B .) The gauze  212  is configured to collect urine over a length and width of the aperture in the elongate body  214 , and when the FEC  210  is connected to a light vacuum source (e.g., 40 mm Hg), the urine is wicked away through the aperture and the urine-drainage tubing  216 . 
     While the FEC  210  is primarily configured for female external catheterization, there is a need for a vacuum-assisted external catheter such as the FEC  210  for small, buried (i.e., hidden beneath anatomical structures such as the abdomen, thigh, or scrotum), or inverted male anatomies. As such, the FEC  210 , or a modified version thereof, can also be used for male external catheterization if needed. 
     MEC-Related Components 
       FIG. 3A  provides a connector assembly  380  for an MEC such as the MEC  110 A,  110 B, or  110 C disposed in a securement device  370  in accordance with some embodiments.  FIGS. 3B, 3C, and 3E  provide various cross-sections of the connector assembly  380  assembly disposed in the securement device  370  in accordance with some embodiments.  FIG. 3D  provides a close-up of a portion of the connector assembly  380  of  FIG. 3B  in accordance with some embodiments. 
     As shown, the connector assembly  380  includes a securable tubing connector  382  and a flexible, tubular bridge  386  between the securable tubing connector  382  and a flexible tubing connector  384  of an MEC when the connector assembly  380  is assembled. The securable tubing connector  382  includes a urine-sampling port  388 . 
     Each tubing connector of the securable tubing connector  382  and the flexible tubing connector  384  is a bidirectional tubing connector. Each tubing connector of the securable tubing connector  382  and the flexible tubing connector  384  also has a tapered end portion configured to insert in an opposing end portion of the flexible bridge  386 . The securable tubing connector  382  has a non-tapered end portion configured to insert in an end portion of urine-drainage tubing of a urine-drainage system. The flexible tubing connector  384  has a non-tapered end portion configured to insert in an open-ended portion of any MEC configured for urine drainage. 
     The flexible tubing connector  384  and the flexible bridge  386 , together, are configured for comfortably and fluidly connecting an MEC to a urine-drainage system making the connector assembly  380  part of the urine-drainage system in some embodiments. (See urine-drainage system  540  of  FIG. 5B .) The flexible tubing connector  384  can have a number of circumferential ridges on the non-tapered end portion configured to provide resistance to an MEC from slipping off the non-tapered end portion while the MEC is in use. 
     The securable tubing connector  382  is also configured for placement in a human body-adherable securement device such as the securement device  370 . The securement device  370  can include, but is not limited to, a StatLock® device (C. R. Bard, Inc., Murray Hill, N.J., USA) or the like. 
     FEC-Related Components 
       FIG. 4A  provides the FEC  210  fluidly connected to a house-vacuum system  490 A in accordance with some embodiments.  FIG. 4B  provides the FEC  210  fluidly connected to a standalone vacuum pump  490 B in accordance with some embodiments. 
     As shown, the FEC  210  is fluidly connected to a light vacuum source (e.g., 40 mm Hg) such as the house-vacuum system  490 A or the standalone vacuum pump  490 B by way of a urine-drainage system  440 . The urine-drainage system includes a urine-collection canister  644 , a lid  646  configured to cover the urine-collection canister  644 , and urine-drainage tubing  642  as shown and described in reference to  FIG. 6B . When the FEC  210  is connected to the light vacuum source, urine can be wicked away through the aperture and the urine-drainage tubing  216  of the FEC  210 . 
     External-Catheter Kits 
     External-catheter kits can include starter kits and supplemental kits, which external-catheter kits standardize external catheterization and minimize procedural variation for better outcomes. Starter kits generally include most, if not all, single-use and multi-use components needed for an anatomical cleansing, an external-catheter application, and some external-catheter management subsequent to the external-catheter application. Supplemental kits generally include single-use components to supplement the commonly used single-use components of the starter kits. That said, due to the different styles and sizes of MECs, a starter kit for external male catheterization optionally includes one or more MECs. When such a starter kit does not include one or more MECs, a supplemental kit including the one or more MECs complements and completes the starter kit. Such starter and supplemental kits are described in more detail below. 
     Beginning with supplemental kits for external catheterization, such external-catheter kits include, in some embodiments, one or more external catheters, a cleansing kit, and step-by-step instructions for using the external-catheter kit. The cleansing kit includes one or more individually wrapped towelettes (e.g., castile soap wipes) for at least anatomical cleansing before application of any external catheter of the one or more external catheters. The cleansing kit optionally further includes one or more pairs of exam gloves for at least the anatomical cleansing. The step-by-step instructions for using the external-catheter kit include step-by-step instructions for the anatomical cleansing, external-catheter application, and external-catheter management subsequent to the external-catheter application. 
     Adverting to starter kits for external catheterization, such external-catheter kits further include (i.e., in addition to the components of the supplemental kits) a urine-drainage system. The urine-drainage system includes a urine-collection receptacle, urine-drainage tubing, and one or more connectors to fluidly connect an external catheter of the one or more external catheters to the urine-collection device. The urine-drainage system is at least partially preassembled in the external-catheter kit to minimize misconnections and misconnection-based contamination, which can result from mishandling components of the urine-drainage system. The urine-drainage tubing is fluidly connected to the urine-collection receptacle in the partially preassembled urine-drainage system. 
     Whether a starter kit or a supplemental kit for external catheterization, the step-by-step instructions for using the external-catheter kit are provided in a booklet having a picture book format. A booklet allows the step-by-step instructions to be conveniently set at some distance away from the external-catheter kit. Alternatively, the step-by-step instructions are integrated with packaging for the external-catheter kit. Optionally, the integrated instructions are revealed as one or more components of the external-catheter kit are removed from the external-catheter kit. Step-by-step instructions in a combination of a booklet and integrated with the packaging can also be provided in the external-catheter kit. Labels for components of the external-catheter kit are used in conjunction with the step-by-step instructions. Such labels can be on the components or packaging for the components. 
     The packaging of either a starter kit or a supplemental kit for external catheterization can include a wrap of a first sterilizable material (e.g., Central Supply Room [“CSR”] wrap) around the components of the external-catheter kit. Alternatively, the packaging can include a tray of a second sterilizable material (e.g., a moldable plastic) into which the components of the external-catheter kit are placed. The labels for the components of the external-catheter kit used in conjunction with the step-by-step instructions can be on the wrap or the tray. The packaging can further include an outer packaging around the wrap or the tray. The outer packaging can be configured for sterilizing the components of the external-catheter kit in the wrap or tray within the outer packaging with a sterilizing gas before sealing the external-catheter kit. That said, the external-catheter kit need not be sterilized. 
     Male External-Catheter Kits 
     Again, external-catheter kits, which include MEC kits, can include starter kits and supplemental kits. Starter kits for male external catheterization generally include most, if not all, single-use and multi-use components needed for an anatomical cleansing, an MEC application, and some external-catheter management subsequent to the MEC application. Supplemental kits for male external catheterization generally include single-use components to supplement the commonly used single-use components of the starter kits. That said, due to the different styles and sizes of MECs, a starter kit for external male catheterization optionally includes one or more MECs. When such a starter kit does not include one or more MECs, a supplemental kit including the one or more MECs complements and, therefore, completes the starter kit. Such starter and supplemental kits are described in more detail below. 
     Beginning with supplemental kits for male external catheterization,  FIG. 5A  provides such an MEC kit  500 A in accordance with some embodiments. 
     As shown, the MEC kit  500 A includes one or more MECs  510 , a cleansing kit  520 , and step-by-step instructions  530  for using the MEC kit  500 A. The one or more MECs  510  are optionally individually wrapped. The cleansing kit  520  includes one or more individually wrapped towelettes  522  (e.g., castile soap wipes) for at least anatomical cleansing before application of any MEC of the one or more MECs  510 . The cleansing kit  520  optionally further includes one or more pairs of exam gloves  524  for at least the anatomical cleansing. The step-by-step instructions  530  for using the MEC kit  500 A include instructions for the anatomical cleansing, MEC application, and MEC management subsequent to the MEC application. 
     Each MEC of the one or more MECs  510  of the MEC kit  500 A has a same size and color. Each MEC of the MECs  510  can include the flexible connector  384 , which flexible connector  384  can have the same color as the MEC into which it is inserted. The color is part of a color-based MEC size-indicator system in which each size of MEC has a different color, optionally in accordance with an MEC sizer. Alternatively, an MEC attachment colored in accordance with the color-based MEC size-indicator system can be used to indicate an associated MEC size. For example, a colored band can be placed around an MEC or one or more MEC-related components to indicate an associated MEC size. The packaging of the MEC kit  500 A, which is described in more detail below, includes either a wrap or a tray, outer packaging, or a combination thereof (e.g., outer packaging around the wrap or the tray). Such packaging can match the color of the one or more MECs  510  (or attachments) in accordance with the color-based MEC size-indicator system. 
     Adverting to starter kits for male external catheterization,  FIG. 5B  provides such an MEC kit  500 B in accordance with some embodiments. 
     As shown, the MEC kit  500 B includes one or more, optionally, individually wrapped, MECs  510 ; however, such MECs are optional in starter kits for male external catheterization due to the different styles and sizes of MECs. When such a starter kit includes the one or more MECs  510 , each MEC of the one or more MECs  510  has a different size. Furthermore, each MEC of the one or more MECs  510  can have a different color in accordance with a color-based MEC size-indicator system. (Note that each MEC of the one or more MECs  510  of the MEC kit  500 A has a same size and color.) Alternatively, an MEC attachment colored in accordance with the color-based MEC size-indicator system can be used to indicate an associated MEC size. For example, a colored band can be placed around an MEC or one or more MEC-related components to indicate an associated MEC size. The one or more MECs  510  respectively represent at least the most common MEC size or sizes. That said, the one or more MECs can be five differently sized MECs corresponding to an MEC sizer  560 . 
     The MEC kit  500 B further includes (i.e., in addition to the components of the MEC kit  500 A) an MEC sizer  560 . The MEC sizer  560  has up to at least five differently sized cutouts for determining an appropriate MEC size for a user or patient. Each cutout  562  of the cutouts of the MEC sizer  560  can have a differently colored border  564  around the cutout  562  in accordance with a color-based MEC size-indicator system. The MEC sizer  560  can be used to select an MEC of the one or more differently sized MECs  510 , if present, or the MEC sizer  560  can be used to select a supplemental kit for male external catheterization such as the MEC kit  500 A. 
     The MEC kit  500 B further includes a urine-drainage system  540 . The urine-drainage system  540  includes a urine-collection bag  544 , urine-drainage tubing  542 , and a connector assembly  380  to fluidly connect an MEC to the urine-collection bag  544 . The urine-collection bag  544  is a bedside bag or a leg bag. 
     The connector assembly  380  includes a securable tubing connector  382  having a urine-sampling port  388  and a flexible, tubular bridge  386  configured to connect to a flexible tubing connector  384  of an MEC. (See  FIGS. 3A-3E .) The connector assembly  380  is configured by way of the flexible bridge  386  to comfortably connect to a flexible tubing connector  384  of an MEC of the one or more MECs  510 , thereby fluidly connecting the MEC to the urine-collection bag  544  by way of the urine-drainage tubing  542 . Each tubing connector of the securable tubing connector  382  and the flexible tubing connector  384  is a bidirectional tubing connector. Each tubing connector of the securable tubing connector  382  and the flexible tubing connector  384  also has a tapered end portion configured to insert in an opposing end portion of the flexible bridge  386 . The securable tubing connector  382  has a non-tapered end portion configured to insert in an end portion of the urine-drainage tubing  542 . The flexible tubing connector  384  has a non-tapered end portion configured to insert in an end portion of any MEC configured for urine drainage. 
     The urine-drainage system  540  is at least partially preassembled in the MEC kit  500 B to minimize misconnections and misconnection-based contamination. The urine-drainage tubing  542  fluidly connects the connector assembly  380  to the urine-drainage bag  544  in the partially preassembled urine-drainage system  540 . 
     The MEC kit  500 B further includes a securement device  370  configured to secure the securable tubing connector  382  of the connector assembly  380  to a patient&#39;s leg. The securement device  370  minimizes any longitudinal or transverse movement of the urine-drainage tubing  542  while in use. Such a securement device can include, but is not limited to, a StatLock® device (C. R. Bard, Inc., Murray Hill, N.J., USA) or the like. 
     Whether a starter kit or a supplemental kit for male external catheterization, the step-by-step instructions for using the MEC kit are provided in a booklet having a picture book format. A booklet allows the step-by-step instructions to be conveniently set at some distance away from the MEC kit. Alternatively, the step-by-step instructions are integrated with packaging for the MEC kit. Optionally, the integrated instructions are revealed as one or more components of the MEC kit are removed from the MEC kit. Step-by-step instructions in a combination of a booklet and integrated with the packaging can also be provided in the MEC kit. Labels for components of the MEC kit are used in conjunction with the step-by-step instructions. Such labels can be on the components or packaging for the components. 
     The step-by-step instructions, particularly those in starter kits for male external catheterization, are further for identifying supplemental kits for male external catheterization that include one or more supplemental MECs in accordance with the color-based MEC size-indictor system. The supplemental kits including the one or more supplemental MECs thereof and at least some packaging of the supplemental kits are individually colored to match the differently colored borders of the cutouts of the MEC sizer  560  in accordance with the color-based MEC size-indicator system. 
     The packaging of either a starter kit or a supplemental kit for male external catheterization can include a wrap of a first sterilizable material (e.g., CSR wrap) around the components of the MEC kit. Alternatively, the packaging can include a tray of a second sterilizable material (e.g., a moldable plastic) into which the components of the MEC kit are placed. The labels for the components of the MEC kit used in conjunction with the step-by-step instructions can be on the wrap or the tray. The packaging can further include an outer packaging around the wrap or the tray. The outer packaging can be configured for sterilizing the components of the MEC kit in the wrap or tray within the outer packaging with a sterilizing gas before sealing the MEC kit. That said, the MEC kit need not be sterilized. 
     While not shown in either  FIG. 5A or 5B , a starter kit or a supplemental kit for male external catheterization can further include a visual duration indicator configured to indicate when a predetermined amount of time has elapsed since connecting an MEC to the urine-collection bag  544 . This is useful for reminding a user or patient to replace the MEC after the predetermined amount of time has elapsed. The predetermined amount of time can be at least 4 hours, 8 hours, 12 hours, 16 hours, 20 hours, or 24 hours. The predetermined amount of time can be no more than 24 hours, 20 hours, 16 hours, 12 hours, 8 hours, or 4 hours. As such, the predetermined amount of time can be at least 4 hours and no more than 24 hours, including at least 8 hours and no more than 20 hours, such as at least 8 hours and no more than 16 hours, or, for example, about 12 hours. 
     The visual duration indicator is configured for activation and, thereby, starting the predetermined amount of time during one or more steps of a procedure for connecting the MEC to the urine-collection bag  544 . Activation can include, but is not limited to, peeling an adhered backing off a component of MEC kit  500 A or  500 B or breaking a fluid-filled blister on a component of MEC kit  500 A or  500 B (e.g., an MEC attachment colored in accordance with the color-based MEC size-indicator system) to start a process of chemical migration, chemical reaction, or a combination thereof resulting in a discernable visual endpoint indicating the predetermined amount of time has elapsed. Subsequent to activation of the visual duration indicator prior to or at the time of connecting the MEC to the urine-collection bag  544 , the visual duration indicator will change color (e.g., lighter color, different color, no color) after the predetermined amount of time has elapsed reminding the user or patient to replace the MEC. 
     Female External-Catheter Kits 
     Again, external-catheter kits, which include FEC kits, can include starter kits and supplemental kits. Starter kits for female external catheterization generally include most, if not all, single-use and multi-use components needed for an anatomical cleansing, an FEC application, and some external-catheter management subsequent to the FEC application. Supplemental kits for female external catheterization generally include single-use components to supplement the commonly used single-use components of the starter kits. 
     Beginning with supplemental kits for female external catheterization,  FIG. 6A  provides such an FEC kit  600 A in accordance with some embodiments. 
     As shown, the FEC kit  600 A includes one or more FECs  610 , a cleansing kit  620 , and step-by-step instructions  630  for using the FEC kit  600 A. The one or more FECs  610  are optionally individually wrapped. The cleansing kit  620  includes one or more individually wrapped towelettes  622  (e.g., castile soap wipes) for at least anatomical cleansing before application of any FEC of the one or more FECs  610 . The cleansing kit  620  optionally further includes one or more pairs of exam gloves  624  for at least the anatomical cleansing. The step-by-step instructions  630  for using the FEC kit  600 A include instructions for the anatomical cleansing, FEC application, and FEC management subsequent to the FEC application. 
     Adverting to starter kits for female external catheterization,  FIG. 6B  provides such an FEC kit  600 B in accordance with some embodiments. 
     As shown, the FEC kit  600 B further includes (i.e., in addition to the components of the FEC kit  600 A) a urine-drainage system  440  (see  FIGS. 4A and 4B ). The urine-drainage system  440  includes a urine-collection canister  644 , a lid  646  configured to cover the urine-collection canister  644 , urine-drainage tubing  642 , and one or more connectors such as connector  643  to fluidly connect an FEC of the one or more FECs  610  to the urine-collection canister  644 . 
     The urine-drainage system  440  is at least partially preassembled in the FEC kit  600 B to minimize misconnections and misconnection-based contamination. The urine-drainage tubing  642  is fluidly connected to the urine-collection canister  644  through the lid  646  covering the urine-collection canister  644  in the partially preassembled urine-drainage system  440 . 
     The FEC kit  600 B further includes a urine-privacy cover  648  configured to form a sleeve for covering the urine-collection canister  644 . The sleeve has a cut-out window  649  configured to expose graduations on the urine-collection canister  644  through the window  649  of the sleeve while a remainder of the urine-collection canister  644  is covered by the sleeve. 
     While not shown, the FEC kit  600 B can further include a securement device configured to secure the urine-drainage tubing  642  of the urine-drainage system  440  to a patient&#39;s leg or another portion of the patient&#39;s body. The securement device minimizes any longitudinal or transverse movement of the urine-drainage tubing  642  while in use. Such a securement device can include, but is not limited to, a StatLock® device (C. R. Bard, Inc., Murray Hill, N.J., USA) or the like. 
     Whether a starter kit or a supplemental kit for female external catheterization, the step-by-step instructions for using the FEC kit are provided in a booklet having a picture book format. A booklet allows the step-by-step instructions to be conveniently set at some distance away from the FEC kit. Alternatively, the step-by-step instructions are integrated with packaging for the FEC kit. Optionally, the integrated instructions are revealed as one or more components of the FEC kit are removed from the FEC kit. Step-by-step instructions in a combination of a booklet and integrated with the packaging can also be provided in the FEC kit. Labels for components of the FEC kit are used in conjunction with the step-by-step instructions. Such labels can be on the components or packaging for the components. 
     The packaging of either a starter kit or a supplemental kit for female external catheterization can include a wrap of a first sterilizable material (e.g., CSR wrap) around the components of the FEC kit. Alternatively, the packaging can include a tray of a second sterilizable material (e.g., a moldable plastic) into which the components of the FEC kit are placed. The labels for the components of the FEC kit used in conjunction with the step-by-step instructions can be on the wrap or the tray. The packaging can further include an outer packaging around the wrap or the tray. The outer packaging can be configured for sterilizing the components of the FEC kit in the wrap or tray within the outer packaging with a sterilizing gas before sealing the FEC kit. That said, the FEC kit need not be sterilized. 
     While not shown in either  FIG. 6A or 6B , a starter kit or a supplemental kit for female external catheterization can further include a visual duration indicator configured to indicate when a predetermined amount of time has elapsed since connecting an FEC to the urine-collection canister  644 . This is useful for reminding a user or patient to replace the FEC after the predetermined amount of time has elapsed. The predetermined amount of time can be at least 4 hours, 8 hours, 12 hours, 16 hours, 20 hours, or 24 hours. The predetermined amount of time can be no more than 24 hours, 20 hours, 16 hours, 12 hours, 8 hours, or 4 hours. As such, the predetermined amount of time can be at least 4 hours and no more than 24 hours, including at least 8 hours and no more than 20 hours, such as at least 8 hours and no more than 16 hours, or, for example, about 12 hours. 
     The visual duration indicator is configured for activation and, thereby, starting the predetermined amount of time during one or more steps of a procedure for connecting the FEC to the urine-collection canister  644 . Activation can include, but is not limited to, peeling an adhered backing off a component of FEC kit  600 A or  600 B or breaking a fluid-filled blister on a component of FEC kit  600 A or  600 B to start a process of chemical migration, chemical reaction, or a combination thereof resulting in a discernable visual endpoint indicating the predetermined amount of time has elapsed. Subsequent to activation of the visual duration indicator prior to or at the time of connecting the FEC to urine-collection canister  644 , the visual duration indicator will change color after the predetermined amount of time has elapsed reminding the user or patient to replace the FEC. 
     Methods 
     Methods of external catheters, external catheter-related components, or external-catheter kits include methods of making or using the external catheters, external catheter-related components, or external-catheter kits. For example, methods of making the external-catheter kits include kitting the components of the external-catheter kits, optionally sterilizing the components of the external-catheter kits, and sealing the external-catheter kits. For example, methods of using the external-catheter kits include opening the external-catheter kits and following the step-by-step instructions provided in the external-catheter kits, thereby following a standardized system for application and management of external catheters with minimized procedural variation. 
     While some particular embodiments have been disclosed herein, and while the particular embodiments have been disclosed in some detail, it is not the intention for the particular embodiments to limit the scope of the concepts provided herein. Additional adaptations and/or modifications can appear to those of ordinary skill in the art, and, in broader aspects, these adaptations and/or modifications are encompassed as well. Accordingly, departures may be made from the particular embodiments disclosed herein without departing from the scope of the concepts provided herein.