Intermittent-catheter systems and assemblies

Abstract

An intermittent-catheter system can include an intermittent-catheter assembly, a drainage bag, and a rigid carrying case for enclosing the intermittent-catheter assembly and drainage bag therein. The intermittent-catheter assembly can include an intermittent catheter including a funnel over a proximal end portion of a catheter tube. The funnel can include a funnel opening for voiding urine. The intermittent-catheter assembly can also include a storage sheath configured to enclose the catheter tube of the intermittent catheter therein. The carrying case can include a body having a closed bottom and an opening opposite the bottom, a flexible covering sealed around the opening, and a cap connected to the body by a hinge on a side of the carrying case. The flexible covering can include a flexible extension configured for grasping and opening the carrying case therewith by simultaneously pulling the flexible covering away from the opening of the body and lifting the cap.

Description

INTERMITTENT-CATHETER SYSTEMS AND ASSEMBLIES AS WELL ASMETHODS THEREOFPRIORITY

[0001] This application claims the benefit of priority to U.S. Provisional Patent Application No. 63 / 636,641, filed April 19, 2024, which is incorporated by reference in its entirety into this application.BACKGROUND

[0002] Users of urinary catheters such as intermittent catheters self-catheterize four to six times a day. However, catheterization with such intermittent catheters can be messy. Indeed, existing intermittent catheters often include water or lubricant in packages thereof for lubrication of the intermittent catheters prior to insertion, but such packages are not configured to keep the water or lubricant from making messes. That, and such packages are not configured to keep post-catheterization messes from occurring such as those involving voided urine. What is needed are simple-to-use intermittent catheters that facilitate cleanliness before and after use.

[0003] Disclosed herein are intermittent-catheter systems and assemblies as well as methods thereof that address the foregoing.SUMMARY

[0004] Disclosed herein is a an intermittent-catheter system including, in some embodiments, an intermittent-catheter assembly, a drainage bag, and a rigid carrying case enclosing the intermittent-catheter assembly and drainage bag therein. The intermittentcatheter assembly includes an intermittent catheter and a storage sheath. The intermittent catheter includes a catheter tube and a funnel over a proximal end portion of the catheter tube. The funnel has a funnel opening for voiding urine. The storage sheath and an end piece thereof is configured to enclose at least the catheter tube of the intermittent catheter therein. The drainage bag is optionally pre-connected to the funnel of the intermittent catheter, thereby forming a drainage assembly. The carrying case includes a body having a closed bottom and an opening opposite the bottom, a flexible covering sealed around the opening of the body, and a cap connected to the body by a living hinge on a side of the carrying case. The flexible covering includes a flexible extension configured for grasping and opening the carrying casetherewith by simultaneously pulling the flexible covering away from the opening of the body and lifting the cap.

[0005] In some embodiments, the flexible extension is a flexible extension tab.

[0006] In some embodiments, the flexible extension tab lies under a rigid extension tab of the cap such that a bottom side of the flexible extension tab and a top side of the rigid extension tab can be grasped together for simultaneously pulling the flexible covering away from the opening of the body and lifting the cap.

[0007] In some embodiments, the cap lacks an extension tab or some other lifting means intended for lifting the cap away from the opening of the body.

[0008] In some embodiments, the flexible extension is a flexible extension loop configured for insertion of a fingertip therethrough for simultaneously pulling the flexible covering away from the opening of the body and lifting the cap.

[0009] In some embodiments, the cap lacks an extension tab or some other lifting means intended for lifting the cap away from the opening of the body.

[0010] In some embodiments, the storage sheath extends between the end piece and the funnel of the intermittent catheter, thereby protecting the catheter tube from contamination as well as keeping any lubricious coating on or lubricant around the catheter tube contained within the storage sheath in an unused state of the intermittent-catheter assembly.

[0011] In some embodiments, the funnel of the intermittent catheter includes a tethered handle for pulling the intermittent-catheter assembly out of the carrying case.

[0012] In some embodiments, the handle is a finger loop configured for insertion of a fingertip therethrough for pulling the intermittent-catheter assembly out of the carrying case.

[0013] In some embodiments, the funnel of the intermittent catheter includes a tethered end cap for capping the funnel in a used state of the intermittent-catheter assembly.

[0014] In some embodiments, a distal portion of the end piece includes a plug configured to insert into the funnel opening of the funnel to form a leak-free, ouroboros-type, end-to-end closure in a used state of the intermittent-catheter assembly.

[0015] In some embodiments, a distal portion of the end piece includes a receptacle configured to accept therein an end portion of the funnel to form a leak-free, ouroboros-type, end-to-end closure in a used state of the intermittent-catheter assembly.

[0016] In some embodiments, the body of the carrying case includes an internal post configured to hold the funnel of the intermittent catheter or the end piece of the storage sheath.

[0017] In some embodiments, the internal post extends from the bottom of the body toward the opening of the body.

[0018] In some embodiments, the internal post is integrated into a sidewall of the body toward the opening of the body. The internal post extends toward the opening of the body.

[0019] In some embodiments, the bottom of the body of the carrying case is curved opposite that including the internal post. Asymmetry in the bottom of the body imparted by such curving provides a visual or tactile indicator for orienting the carrying case for removing the intermittent-catheter assembly therefrom.

[0020] In some embodiments, the body of the carrying case is configured to enclose the drainage bag therein when the drainage bag is in a folded state.

[0021] In some embodiments, the drainage bag includes a disposal pocket in a pocketed end portion of the drainage bag opposite an inlet end portion of the drainage bag including a urine inlet. The disposal pocket is incorporated into a face of the drainage bag for folding the inlet end portion of the drainage bag into the disposal pocket for leak-free storage of the drainage bag until disposal.

[0022] In some embodiments, the drainage bag includes a handle extending from the pocketed end portion of the drainage bag. The handle is configured to facilitate unfolding the drainage bag from the folded state of the drainage bag.

[0023] In some embodiments, the intermittent catheter is configured for use by male humans or humans with non-specific anatomy.

[0024] 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 describe particular embodiments of such concepts in greater detail.BRIEF DESCRIPTION OF DRAWINGS

[0025] FIG. 1 illustrates an exploded view of an intermittent-catheter system including a drainage assembly and a rigid carrying case in an unused state of the intermittent-catheter system in accordance with some embodiments.

[0026] FIG. 2 illustrates an exploded view of the drainage assembly of the intermittentcatheter system of FIG. 1 in accordance with some embodiments.

[0027] FIG. 3 illustrates an exploded view of the intermittent-catheter system in a used state of the intermittent-catheter system in accordance with some embodiments.

[0028] FIG. 4 illustrates an exploded view of an intermittent-catheter assembly of the drainage assembly including an intermittent catheter and a storage sheath in accordance with some embodiments.

[0029] FIG. 5 illustrates a side view of the intermittent catheter in accordance with some embodiments.

[0030] FIG. 6 illustrates a longitudinal cross section of the intermittent catheter in accordance with some embodiments.

[0031] FIG. 7 illustrates a detailed view of the longitudinal cross section of the intermittent catheter of FIG. 6 in accordance with some embodiments.

[0032] FIG. 8 illustrates a side view of the intermittent-catheter assembly in accordance with some embodiments.

[0033] FIG. 9 illustrates a longitudinal cross section of the intermittent-catheter assembly in accordance with some embodiments.

[0034] FIG. 10 illustrates a detailed view of the longitudinal cross section of the intermittent-catheter assembly of FIG. 9 in accordance with some embodiments.

[0035] FIG. 11 illustrates another detailed view of the longitudinal cross section of the intermittent-catheter assembly of FIG. 9 in accordance with some embodiments.

[0036] FIG. 12 illustrates a funnel of the intermittent catheter including a tethered handle and a tethered end cap and in accordance with some embodiments.

[0037] FIG. 13 illustrates a drainage bag having an integrated fold-sealed disposal pocket in an unfolded state of the drainage bag in accordance with some embodiments.

[0038] FIG. 14 illustrates the carrying case in an unused state of the intermittentcatheter system in accordance with some embodiments.

[0039] FIG. 15 illustrates a cap of the carrying case lifted away from a body of the carrying case, wherein a flexible covering covers an opening in the body of the carrying case in accordance with some embodiments.

[0040] FIG. 16 illustrates both the cap and the flexible covering of the carrying case lifted away from the opening in the body of the carrying case in accordance with some embodiments.

[0041] FIG. 17 illustrates the carrying case in the unused state of the intermittentcatheter system, wherein the flexible covering includes a flexible extension loop in accordance with some embodiments.

[0042] FIG. 18 illustrates an internal post extending from a bottom of the body of the carrying case in accordance with some embodiments.

[0043] FIG. 19 illustrates the internal post integrated into a sidewall of the body of the carrying case in accordance with some embodiments.

[0044] FIG. 20 illustrates asymmetry in the body of the carrying case for orienting the carrying case when removing the intermittent-catheter assembly therefrom in accordance with some embodiments.

[0045] FIG. 21 further illustrates the asymmetry in the body of the carrying case for orienting the carrying case when removing the intermittent-catheter assembly therefrom in accordance with some embodiments.DESCRIPTION

[0046] 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 andoptionally combined with or substituted for features of any of a number of other embodiments disclosed herein.

[0047] 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. In addition, any of the foregoing features or steps can, in turn, further include one or more features or steps unless indicated otherwise. Labels such as “left,” “right,” “top,” “bottom,” “front,” “back,” and the like 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.

[0048] “Proximal” is used to indicate a portion, section, piece, element, or the like of a medical device intended to be near or relatively nearer to a clinician when the medical device is used on a patient. For example, a “proximal portion” or “proximal section” of the medical device includes a portion or section of the medical device intended to be near the clinician when the medical device is used on the patient. Likewise, a “proximal length” of the medical device includes a length of the medical device intended to be near the clinician when the medical device is used on the patient. A “proximal end” of the medical device is an end of the medical device intended to be near the clinician when the medical device is used on the patient. The proximal portion, the proximal section, or the proximal length of the medical device need not include the proximal end of the medical device. Indeed, the proximal portion, the proximal section, or the proximal length of the medical device can be short of the proximal end of the medical device. However, the proximal portion, the proximal section, or the proximal length of the medical device can include the proximal end of the medical device. Should context not suggest the proximal portion, the proximal section, or the proximal length of the medical device includes the proximal end of the medical device, or if it is deemed expedient in the following description, “proximal portion,” “proximal section,” or “proximal length” can be modified to indicate such a portion, section, or length includes an end portion, an end section, or an endlength of the medical device for a “proximal end portion,” a “proximal end section,” or a “proximal end length” of the medical device, respectively.

[0049] “Distal” is used to indicate a portion, section, piece, element, or the like of a medical device intended to be near, relatively nearer, or even in a patient when the medical device is used on the patient. For example, a “distal portion” or “distal section” of the medical device includes a portion or section of the medical device intended to be near, relatively nearer, or even in the patient when the medical device is used on the patient. Likewise, a “distal length” of the medical device includes a length of the medical device intended to be near, relatively nearer, or even in the patient when the medical device is used on the patient. A “distal end” of the medical device is an end of the medical device intended to be near, relatively nearer, or even in the patient when the medical device is used on the patient. The distal portion, the distal section, or the distal length of the medical device need not include the distal end of the medical device. Indeed, the distal portion, the distal section, or the distal length of the medical device can be short of the distal end of the medical device. However, the distal portion, the distal section, or the distal length of the medical device can include the distal end of the medical device. Should context not suggest the distal portion, the distal section, or the distal length of the medical device includes the distal end of the medical device, or if it is deemed expedient in the following description, “distal portion,” “distal section,” or “distal length” can be modified to indicate such a portion, section, or length includes an end portion, an end section, or an end length of the medical device for a “distal end portion,” a “distal end section,” or a “distal end length” of the medical device, respectively.

[0050] An unused state of the intermittent-catheter system or any component thereof indicates the intermittent-catheter system or component thereof being described remains packaged as manufactured, distributed, or sold.

[0051] A used state of the intermittent-catheter system or any component thereof indicates the intermittent-catheter system or component thereof being described is not in an unused state; that is, the intermittent-catheter system or the component thereof is opened, unpackaged, prepared for use in a catheterization procedure, used in such a catheterization procedure, or the like.

[0052] A storage state of the intermittent-catheter system or any component thereof indicates the intermittent-catheter system or component thereof being described has beenopened, unpackaged, prepared for use in a catheterization procedure, used in such a catheterization procedure, or the like but repackaged in some manner for storage until disposal is possible. Alternatively, the storage state of an intermittent-catheter system or any component thereof can indicate the intermittent-catheter system or component thereof being described remains packaged as manufactured, distributed, or sold per the unused state. Therefore, context should be used to inform any interpretation of the storage state of the intermittent-catheter system or component thereof.

[0053] A closed state of the intermittent-catheter system or any component thereof indicates the intermittent-catheter system or component thereof being described is simply closed. As such, the intermittent-catheter system or component thereof being described can be in an unused state, a used state (but closed), or a storage state. Therefore, context should be used to inform any interpretation of the closed state of the intermittent-catheter system or component thereof beyond simply being closed.

[0054] An opened state of the intermittent-catheter system or any component thereof indicates the intermittent-catheter system or component thereof being described is simply opened. As such, the intermittent-catheter system or component thereof being described is also in a used state, as above. Indeed, whether or not the intermittent-catheter system or any component thereof has been prepared for use in a catheterization procedure or used in such a catheterization procedure, sterility of the intermittent-catheter system is potentially compromised.

[0055] A carrying case of the intermittent-catheter system is generally configured to enclose therein one or more intermittent-catheter assemblies or intermittent catheters, one or more drainage bags, optionally, independently pre-connected to the one-or-more intermittentcatheter assemblies or intermittent catheters to form one or more drainage assemblies, and any other components for intermittent catheterization.

[0056] 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.Intermittent-catheter systems

[0057] FIGS. 1-21 illustrate the intermittent-catheter system 100 or components thereof in accordance with some embodiments. Such an intermittent-catheter system 100 and itscomponents are configured for use by male humans or humans with non-specific anatomy. Notably, FIGS. 14 and 17 illustrate the intermittent-catheter system 100 in an unused state of the intermittent-catheter system 100, and FIGS. 1 and 3 illustrate the intermittent-catheter system 100 in a used state of the intermittent-catheter system 100.

[0058] As shown, the intermittent-catheter system 100 can include a rigid carrying case 150 and either a drainage assembly 170 or one or more drainage components of the drainage assembly 170. The drainage assembly 170 can include an intermittent-catheter assembly 110 and a drainage bag 180, which drainage bag 180 is optionally pre-connected to the funnel 136 of the intermittent catheter 130 of the intermittent-catheter assembly 110 as shown. If the drainage bag 180 is not pre-connected to the funnel 136 of the intermittent catheter 130, the drainage assembly 170 can instead be referred to as the foregoing drainage components of the intermittent-catheter system 100. When the drainage bag 180 is not included in the intermittentcatheter system 100, such drainage components can include the intermittent-catheter assembly 110 or the intermittent catheter 130 thereof. Each component of the intermittent-catheter assembly 110, the drainage bag 180, and the carrying case 150 is set forth in more detail below.

[0059] FIGS. 4-12 illustrate the intermittent-catheter assembly 110 in accordance with some embodiments.

[0060] As shown, the intermittent-catheter assembly 110 can include an intermittent catheter 130 and a sterility-preserving enclosure 132 therefor.

[0061] The intermittent catheter 130 can include a catheter tube 134 and a funnel 136 over a proximal end portion of the catheter tube 134. The catheter tube 134 can include a plurality of eyelets 138 proximate a catheter tip 140, and the funnel 136 can have a funnel opening 142 in fluid communication with the eyelets 138 by way of a lumen 143 through the intermittent catheter 130 for voiding urine. Notably, the funnel 136 can include a tethered handle 252 for pulling the intermittent-catheter assembly 110 out of the carrying case 150. As shown in FIG. 12, such a handle 252 can be a finger loop configured for insertion of a fingertip therethrough for pulling the intermittent-catheter 110 assembly out of the carrying case 150.

[0062] The sterility-preserving enclosure 132 can include a storage sheath 144, an end piece 146 coupled to a distal end portion of the storage sheath 144, and, optionally, a tamperproof, peelable seal (not shown) over the cap 146 in at least the unused state of the intermittentcatheter assembly 110. The storage sheath 144 and end piece 146 are configured to enclose atleast the catheter tube 134 of the intermittent catheter 130 therein to preserve its sterility in the unused state thereof. Indeed, the storage sheath 144 can extend between the funnel 136 of the intermittent catheter 130 and the end piece 146, and the end piece 146 can extend over a distal end of the catheter tube 134, thereby protecting the catheter tube 134 from contamination as well as keeping any lubricious coating 135 on the catheter tube 134 or any lubricant around the catheter tube 134 contained within the sterility-preserving enclosure 132 or storage sheath 144 thereof in the unused state of the intermittent-catheter assembly 110. However, it should be understood that the sterility -preserving enclosure 132 can also double as a urine-retaining enclosure, thereby keeping any residual urine in or around the catheter tube 134 contained within the urine-retaining enclosure or storage sheath 144 thereof in the used state of the intermittent-catheter assembly 110. Transitioning between the sterility-preserving enclosure 132 and the urine-retaining enclosure involves at least withdrawing the storage sheath 144 over the catheter tube 134, voiding urine through the intermittent catheter 130, and advancing the storage sheath 144 back over the catheter tube 134.

[0063] Notably, the intermittent-catheter assembly 110 can form a leak-free, ouroboros-type, end-to-end closure in the unused state of the intermittent-catheter assembly 110, the used state of the intermittent-catheter assembly 110, or both. Indeed, a distal portion of the end piece 146 can include a receptacle 148 configured to accept therein an end portion of the funnel 136 to form the end-to-end closure in the unused or used state of the intermittentcatheter assembly 110. Alternatively, the distal portion of the end piece 146 can include a plug (not shown) configured to insert into the funnel opening 142 of the funnel 136 to form the end- to-end closure in the unused or used state of the intermittent-catheter assembly 110. To assist in forming such an end-to-end closure, the end piece 146 can include a flange 153 configured to facilitate handling of the intermittent-catheter assembly 110 when forming the end-to-end closure in the used state of the intermittent-catheter assembly 110. Advantageously, the funnel 136 need not have a separate end cap to close the funnel 136 after use of the intermittent catheter 130 in such embodiments. That, and formation of the end-to-end closure in the used state of the intermittent-catheter assembly 110 provides a convenient, compact form of the used state of the intermittent-catheter assembly 110 until disposal is possible. However, in some embodiments, the intermittent-catheter assembly 110 can alternatively or additionally include a separate end cap 254 tethered to the funnel 136 for closing the funnel 136 in the used state of the intermittent-catheter assembly 110, which end cap 254 some users might prefer for itssimplicity. Advantageously, such an end cap 254 cannot be misplaced in that it is tethered to the funnel 136.

[0064] FIGS. 1, 2, and 13 illustrate the drainage bag 180 or components thereof in accordance with some embodiments.

[0065] As shown, the drainage bag 180 can include a urine-drainage means for draining any urine from the drainage bag 180 and a disposal means for disposing the drainage bag 180. Such a urine-drainage means can include a tear tab 188, but it should be understood the urinedrainage means can alternatively include a rip cord, peal-and-seal tabs, a peal-and-seal sticker, or the like for creating and optionally resealing a urine outlet.

[0066] While not shown, the drainage bag 180 can be in a folded state in the unused state of the drainage assembly 170 or the drainage components, which provides a compact form of the drainage bag 180 until it is used during a catheterization procedure. In the folded state of the drainage bag 180, the drainage bag 180 can include one or more folds along a width such that the drainage bag 180 has a shorter length in the folded state than in an unfolded state of the drainage bag 180, one or more folds along a length such that the drainage bag 180 has a shorter width in the folded state than in the unfolded state of the drainage bag 180, or some combination thereof. However, it should be understood that the drainage bag 180 can be folded into any convenient geometric shape (e.g., squares, rectangles, triangles, etc.) in the unused state of the drainage bag to suit its packaging in the rigid package set forth herein. The folded state of the drainage bag 180 can be maintained by a strap 182 extending from an inlet end portion of the drainage bag 180 also including a urine inlet 184 to which the intermittent catheter 130 of the intermittent-catheter assembly 110 connects. The strap 182 can include a handle 183 and an adhesive strip or patch 185 for adhering to a folded portion of the drainage bag 180 to maintain the folded state of the drainage bag 180. After peeling the strap 182 adhered to the folded portion of the drainage bag 180 away therefrom, the drainage bag 180 can be unfolded in accordance with an unfolding mechanism for unfolding the drainage bag 180. Notably, the drainage bag 180 can include a handle 186 extending from the pocketed end portion of the drainage bag 180 opposite the inlet end portion of the drainage bag 180. The handle 186 is configured to facilitate unfolding the drainage bag 180 from the folded state of the drainage bag 180.

[0067] FIG. 13 illustrates a disposal means for disposing the drainage bag 180 in accordance with some embodiments.

[0068] As shown, the disposal means can be a disposal pouch or pocket 220 respectively integrated in a pocketed end portion of the drainage bag 180 opposite the inlet end portion of the drainage bag 180 including the urine inlet 184.

[0069] FIG. 13 provides an example of the disposal pocket 220 incorporated into an anterior face of the drainage bag 180 for folding the inlet end portion of the drainage bag 180 into the disposal pocket 220 for a used state of the drainage bag 180. However, the disposal pocket 220 can alternatively be incorporated into a posterior face of the drainage bag 180 for folding the inlet end portion of the drainage bag 180 into the disposal pocket 220. Optionally, the disposal pocket can be pleated with pleats 224 or otherwise include additional polymeric material of the drainage bag 180 for expanding the disposal pocket 220 to accommodate the inlet end portion of the drainage bag 180 therein. Further, the disposal pocket 220 can include a fold-over extension 226 formed of the polymeric material of the disposal pocket for sealing the inlet end portion of the drainage bag 180 in the disposal pocket 220 for a substantially or entirely leak-free used state of the drainage bag 180. Notably, the fold-over extension 226 of the disposal pocket 220 can include a handle 228 to facilitate folding the fold-over extension 226 over the posterior face of the drainage bag 180, if the disposal pocket 220 is incorporated into the anterior face of the drainage bag 180, or the anterior face of the drainage bag 180, if the disposal pocket 220 is incorporated into the posterior face of the drainage bag 180. Further, the fold-over extension 226 of the disposal pocket 220 can include an adhesive strip or patch 232 configured to seal the fold-over extension 226 over the posterior or anterior face of the drainage bag 180 for the substantially or entirely leak-free used state of the drainage bag 180 until disposal.

[0070] FIGS. 1, 3, and 14-21 and illustrate the rigid carrying case 150 or components thereof in accordance with some embodiments. Notably, such a carrying case 150 can be reusable such that the intermittent-catheter system 100 can be completed or made whole again after use with one or more supplemental packages, each of which includes at least the drainage assembly 170 or the one-or-more drainage components thereof.

[0071] As shown, the carrying case 150 includes a body 152 and a rigid covering such as a cap 154, wherein the body 152 has a closed bottom 256 and a body opening 258 oppositethe bottom 256 of the body 152 with the cap 154 configured to fit over the body opening 258, thereby providing an enclosure for enclosing therein at least the drainage assembly 170 or the one-or-more drainage components thereof in an unused state of the intermittent-catheter system 100. The body 152 and the cap 154 can be connected to each other by one or more hinges 156 such as one or more living hinges, one or more self-closing spring hinges, or the like on a major or minor longitudinal side of the carrying case.

[0072] The body 152 of the carrying case 150 can include an internal post 260 configured to hold the funnel 136 of the intermittent catheter 130 or the end piece 146 of the storage sheath 144 in at least the unused state of the intermittent-catheter system 100. Such an internal post 260 can extend from the bottom 256 of the body 152 toward the body opening 258 of the body 152 as shown in FIG. 18. Optionally, the internal post 260 is spaced from a sidewall of the body 152 with a connecting spacer 262 providing clearance from the sidewall for holding the funnel 136 of the intermittent catheter 130 or the end piece 146 of the storage sheath 144. In addition, being that the spacer 262 is connected to both the internal post 260 and the sidewall of the body 152, the spacer 262 is configured to provide structural support to the internal post 260, particularly for multiple uses of the internal post 260 to hold the funnel 136 of the intermittent catheter 130 or the end piece 146 of the storage sheath 144. Alternatively, the internal post 260 can be integrated into the sidewall of the body 152 instead of the bottom 256 of the body 152 as shown in FIG. 19. Such an internal post 260 can also extend toward the body opening 258 of the body 152, but a free end of the internal post 260 can be closer to the body opening 258 of the body 152 while maintaining a same internal volume within the body 152. Notably, as shown in FIGS. 20 and 21 the bottom 256 of the body 152 can be curved for a curved portion 264 opposite that including the internal post 260. Further, the bottom 256 of the body 152 including the internal post 260 can be pointed for a pointed portion 266, a point of which can extend up the minor longitudinal side of the body 152 including the internal post 260 to the body opening 258 of the body 152. Asymmetry in the bottom 256 of the body 152 imparted by portions thereof including the curved and pointed portions 264 and 266 provides a visual or tactile indicator for orienting the carrying case 150 for removing the intermittentcatheter assembly 110 therefrom. This can be particularly helpful for users with one or more impairments.

[0073] The carrying case 150 can also include a cap-based clip 158, a rigid extension 268 extending from the cap 154 such as a tab or a handle with an optional through hole, or thelike on its minor longitudinal side opposite that including the one-or-more hinges 156. In an example, the carrying case 150 can include the one-or-more living hinges on one minor longitudinal side of the carrying case 150 and the rigid extension 268 in the form of a tab extending from the cap 154 on the other minor longitudinal side of the carrying case 150 as shown in FIGS. 14-16, 20, and 21. However, it should be understood that the cap 154 need not include the clip 158, the rigid extension 268, or the like on the minor longitudinal side of the carrying case 150 opposite the one-or-more hinges 156 when the carrying case 150 includes some other cap-lifting means intended for lifting the cap 154 away from the body opening 258 of the body 152. Indeed, in some embodiments, the cap 154 lacks the clip 158, the rigid extension 268, or the like, the carrying case 150 alternatively including the flexible extension 272 set forth below, which can be configured for grasping and opening the carrying case 150 therewith by simultaneously pulling the flexible covering 270 away from the body opening 258 of the body 152 and lifting the cap 154.

[0074] The intermittent-catheter system 100 can further include a flexible covering 270 over the body opening 258 of the body 152 such as sealed around the body opening 258 of the body 152, for example, bonded to a perimeter around the body opening 258 of the body 152. Such a flexible covering 270 should be considered tamper-proof packaging for showing that the intermittent-catheter system 100 remains in an unused state when the tamper-proof packaging remains intact. The flexible covering 270 can include a flexible extension 272 such as an extension tab (see FIGS. 14-16) or an extension loop (see FIG. 17) configured for grasping and opening the carrying case 150 therewith by simultaneously pulling the flexible covering 270 away from the body opening 258 of the body 152 and lifting the cap 154. In an example, the flexible extension 272 is the extension tab of FIGS 14-16, which can lie under and, optionally, be bonded to the rigid extension 268 of the cap 154 such that a bottom side of the flexible extension 272 and a top side of the rigid extension 268 can be grasped together for simultaneously pulling the flexible covering 270 away from the body opening 258 of the body 152 and lifting the cap 154. In another example, the flexible extension 272 is the extension loop of FIG. 17, which is configured for insertion of a fingertip therethrough for simultaneously pulling the flexible covering 270 away from the body opening 258 of the body 152 and lifting the cap 154.

[0075] While not shown, the carrying case 150 can include a gasket between the body 152 and the cap 154 such as under the flexible covering 270 in the unused state of theintermittent catheter system 100, the carrying case 150 thereby configured to provide enhanced secondary containment for any residual urine that leaks from the intermittent-catheter assembly 110 in the used state of the intermittent-catheter assembly 110. Indeed, with such a configuration, the carrying case 150 is further configured for enclosing therein at least the intermittent-catheter assembly 110 in a used state of the intermittent-catheter assembly 110.

[0076] Notably, rigid packaging such as that of the carrying case 150 offers better protection than soft packaging when the intermittent-catheter system 100 or the like is independently carried or otherwise toted; however, such rigid packaging can be more difficult than soft packaging to pack into luggage or the like, particularly when tightly packing such luggage.Methods

[0077] As set forth below, methods can include methods of using the intermittentcatheter systems and assemblies disclosed herein; however, it should be understood that those methods can be further discerned from description of the intermittent-catheter systems and assemblies and how they are configured to function. Likewise, additional methods can be discerned from description of the intermittent-catheter systems and assemblies and how they are configured to function.

[0078] For example, a method of an intermittent-catheter system 100 can include removing the drainage assembly 170 or the one-or-more drainage components thereof in the unused state of the drainage assembly 170 from the rigid carrying case 150.

[0079] As set forth above, the drainage assembly can include the intermittent-catheter assembly 110 and the drainage bag 180.

[0080] Briefly, as to the intermittent-catheter assembly 110, the intermittent-catheter assembly 110 can include the intermittent catheter 130 and the sterility-preserving enclosure 132. The intermittent catheter 130 can include the catheter tube 134 and the funnel 136 over the proximal end portion of the catheter tube 134. The funnel 136 can have the funnel opening 142 for voiding urine. The sterility-preserving enclosure 132 can include the storage sheath 144 and the end piece 146. The storage sheath 144 and the end piece 146 can be configured to enclose at least the catheter tube 134 of the intermittent catheter 130 therein. As to the drainagebag 180, the drainage bag 180 is optionally pre-connected to the funnel 136 of the intermittent catheter 130.

[0081] The method can also include inserting the distal end portion of the catheter tube 134 into a urethra; voiding urine from a bladder into the drainage bag 180 through the intermittent catheter 130; and enclosing at least the intermittent-catheter assembly 110 in the used state of the intermittent-catheter assembly 110 in the carrying case 150.

[0082] The method can also include inserting the end portion of the funnel 136 into the receptacle 148 of the distal portion of the end piece 146 to form the leak-free, ouroboros-type, end-to-end closure in the used state of the intermittent-catheter assembly 110. Alternatively, the method can include inserting the plug (not shown) of the distal portion of the end piece 146 into the funnel opening 142 of the funnel 136 to form the leak-free, ouroboros-type, end-to- end closure in the used state of the intermittent-catheter assembly 110. Regardless, the storage sheath 144 can extend between the end piece 146 and the funnel 136 of the intermittent catheter 130 in the used state of the intermittent-catheter assembly 110, thereby keeping any residual urine in or around the catheter tube 134 contained within the storage sheath 144 in the used state of the intermittent-catheter assembly 110.

[0083] The method can also include removing the strap 182 adhered to the folded portion of the drainage bag 180 maintained in the folded state of the drainage bag 180 by the strap 182. The strap 182 can extend from the inlet end portion of the drainage bag 180 including the urine inlet 184.

[0084] The method can also include unfolding the drainage bag 180. As set forth above, the folded state of the drainage bag 180 can include the one-or-more folds along the width such that the drainage bag 180 has a shorter length in the folded state than in the unfolded state of the drainage bag 180, the one-or-more folds along the length such that the drainage bag 180 has a shorter width in the folded state than in the unfolded state of the drainage bag 180, or some combination thereof.

[0085] The method can also include draining the urine from the drainage bag 180; and folding the inlet end portion of the drainage bag 180 into the disposal pocket 220 incorporated into the face of the drainage bag 180 for the used state of the drainage assembly 170. Notably, the disposal pocket 220 is in the pocketed end portion of the drainage bag 180 opposite the inlet end portion of the drainage bag 180 including the urine inlet 184.

[0086] 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 or modifications can appear to those of ordinary skill in the art, and, in broader aspects, these adaptations 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.

Claims

CLAIMSWhat is claimed is:

1. An intermittent-catheter system, comprising: an intermittent-catheter assembly including: an intermittent catheter including a catheter tube and a funnel over a proximal end portion of the catheter tube, the funnel having a funnel opening for voiding urine; and a storage sheath having an end piece, the storage sheath and the end piece configured to enclose at least the catheter tube of the intermittent catheter therein; and a drainage bag optionally pre-connected to the funnel of the intermittent catheter, thereby forming a drainage assembly; and a rigid carrying case enclosing the intermittent-catheter assembly and drainage bag therein, the carrying case including: a body having a closed bottom and an opening opposite the bottom; a flexible covering sealed around the opening of the body; and a cap connected to the body by a living hinge on a side of the carrying case, the flexible covering including a flexible extension configured for grasping and opening the carrying case therewith by simultaneously pulling the flexible covering away from the opening of the body and lifting the cap.

2. The intermittent-catheter system of claim 1, wherein the flexible extension is a flexible extension tab.

3. The intermittent-catheter system of claim 2, wherein the flexible extension tab lies under a rigid extension tab of the cap such that a bottom side of the flexible extension tab and a top side of the rigid extension tab can be grasped together for simultaneously pulling the flexible covering away from the opening of the body and lifting the cap.

4. The intermittent-catheter system of claim 2, wherein the cap lacks an extension tab or some other lifting means intended for lifting the cap away from the opening of the body.

5. The intermittent-catheter system of claim 1, wherein the flexible extension is a flexible extension loop configured for insertion of a fingertip therethrough for simultaneously pulling the flexible covering away from the opening of the body and lifting the cap.

6. The intermittent-catheter system of claim 5, wherein the cap lacks an extension tab or some other lifting means intended for lifting the cap away from the opening of the body.

7. The intermittent-catheter system of any of claims 1-6, wherein the storage sheath extends between the end piece and the funnel of the intermittent catheter, thereby protecting the catheter tube from contamination as well as keeping any lubricious coating on or lubricant around the catheter tube contained within the storage sheath in an unused state of the intermittent-catheter assembly.

8. The intermittent-catheter system of any of the preceding claims, wherein the funnel of the intermittent catheter includes a tethered handle for pulling the intermittentcatheter assembly out of the carrying case.

9. The intermittent-catheter system of claim 8, wherein the handle is a finger loop configured for insertion of a fingertip therethrough for pulling the intermittent-catheter assembly out of the carrying case.

10. The intermittent-catheter system of any of the preceding claims, wherein the funnel of the intermittent catheter includes a tethered end cap for capping the end piece in a used state of the intermittent-catheter assembly.

11. The intermittent-catheter system of any of claims 1-9, wherein a distal portion of the end piece includes a plug configured to insert into the funnel opening of the funnel to form a leak-free, ouroboros-type, end-to-end closure in a used state of the intermittent-catheter assembly.

12. The intermittent-catheter system of any of claims 1-9, wherein a distal portion of the end piece includes a receptacle configured to accept therein an end portion of the funnel to form a leak-free, ouroboros-type, end-to-end closure in a used state of the intermittentcatheter assembly.

13. The intermittent-catheter system of any of the preceding claims, wherein the body of the carrying case includes an internal post configured to hold the funnel of the intermittent catheter or the end piece of the storage sheath.

14. The intermittent-catheter system of claim 13, wherein the internal post extends from the bottom of the body toward the opening of the body.

15. The intermittent-catheter system of claim 13, wherein the internal post is integrated into a sidewall of the body toward the opening of the body, the internal post extending toward the opening of the body.

16. The intermittent-catheter system of any of claims 13-15, wherein the bottom of the body of the carrying case is curved opposite that including the internal post, asymmetry in the bottom of the body imparted thereby providing a visual or tactile indicator for orienting the carrying case for removing the intermittent-catheter assembly therefrom.

17. The intermittent-catheter system of any of the preceding claims, wherein the body of the carrying case is configured to enclose the drainage bag therein when the drainage bag is in a folded state.

18. The intermittent-catheter system of claim 17, wherein the drainage bag includes a disposal pocket in a pocketed end portion of the drainage bag opposite an inlet end portion of the drainage bag including a urine inlet, the disposal pocket incorporated into a face of the drainage bag for folding the inlet end portion of the drainage bag into the disposal pocket for leak-free storage of the drainage bag until disposal.

19. The intermittent-catheter system of claim 18, wherein the drainage bag includes a handle extending from the pocketed end portion of the drainage bag, the handle configured to facilitate unfolding the drainage bag from the folded state of the drainage bag.

20. The intermittent-catheter system of any of the preceding claims, wherein the intermittent catheter is configured for use by male humans or humans with non-specific anatomy.

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