Intermittent catheter systems and assemblies and methods of use thereof

Abstract

The intermittent catheter system includes a rigid catheter housing (750) and an intermittent catheter (230). The catheter housing includes an inner sleeve (752), an outer sleeve (754) slidably mounted over the inner sleeve, and an end cap (756) seated within an end portion of the outer sleeve and contributing to both a primary chamber (758) and a secondary chamber (760). The intermittent catheter system can have a storage state in which the catheter housing includes its maximum extended state in which the intermittent catheter is sealed within the primary chamber. The intermittent catheter system can have an open state in which the catheter housing includes its maximum collapsed state in which the end cap pops out of the outer sleeve to expose the intermittent catheter funnel (236) for removal of the intermittent catheter from the catheter housing.

Description

[Technical Field]

[0001] The present disclosure relates to intermittent catheter systems and assemblies, and methods of use thereof. [Background technology]

[0002] Users of urinary catheters, such as intermittent catheters, self-catheterize four to six times per day. However, catheterization using such intermittent catheters can be prone to contamination. Indeed, existing intermittent catheters often include water or lubricant in their packaging to lubricate the intermittent catheter before insertion, but such packaging is not configured to keep the water or lubricant from contaminating it. Moreover, such packaging is not configured to prevent post-catheterization contamination, such as that associated with discharged urine. What is needed is an easy-to-use intermittent catheter that promotes cleanliness before and after use. Summary of the Invention

[0003] Disclosed herein are intermittent catheter systems and assemblies, and methods thereof, that address the foregoing. Also disclosed herein, in some embodiments, is an intermittent catheter system including a rigid catheter housing and an intermittent catheter. The catheter housing includes an inner sleeve, an outer sleeve slidably mounted over the inner sleeve, and an end cap. The end cap is seated within an end portion of the outer sleeve opposite the closed end portion of the inner sleeve and is configured to simultaneously contribute to both a primary chamber for primary containment and a secondary chamber for secondary containment. The intermittent catheter includes a catheter tube and a funnel on a proximal end portion of the catheter tube. The intermittent catheter system has a storage state and an open state. In the storage state, the catheter housing can be in its maximum extended state with the intermittent catheter sealed within the primary chamber. In the open state, the outer sleeve of the catheter housing slides over the inner sleeve of the catheter housing so that the catheter housing can be in its maximum collapsed state, and the end cap pops out of the outer sleeve, exposing the funnel of the intermittent catheter for removal from the catheter housing.

[0004] In some embodiments, the end cap overlaps the open end portion of the inner sleeve, thereby providing a primary chamber between the end cap cavity of the end cap and the inner sleeve cavity of the inner sleeve.

[0005] In some embodiments, an end cap gasket around the end cap and an inner sleeve gasket around the inner sleeve define the longitudinal limits of a secondary chamber between the inner surface of the outer sleeve and the outer surfaces of the end cap and inner sleeve.

[0006] In some embodiments, the primary and secondary chambers provide primary and secondary containment, respectively, for any residual urine in or around the intermittent catheter, thereby preventing urine leakage from the catheter housing when the intermittent catheter system is in a stored state after use of the intermittent catheter.

[0007] In some embodiments, the end cap gasket and inner sleeve gasket provide sufficient friction to maintain the catheter housing in its stored state, thereby preventing the catheter housing from unintentionally collapsing into an open state.

[0008] In some embodiments, the inner circumference of the outer sleeve cavity of the outer sleeve is graduated in size by an outer sleeve step toward the end portion of the outer sleeve opposite the end portion including the end cap, and the inner sleeve includes an external ridge configured to abut the outer sleeve step at the opposite end portion of the outer sleeve, thereby defining the maximum extension state of the catheter housing.

[0009] In some embodiments, the outer periphery of the inner sleeve increases in size gradually toward the closed end portion of the inner sleeve by an inner sleeve step, and the taper of the inner periphery of the outer sleeve cavity of the outer sleeve is configured to limit movement of the inner sleeve past the end portion of the outer sleeve, including the end cap, thereby defining the maximum collapsed state of the catheter housing.

[0010] In some embodiments, an inner sleeve step at the outer periphery of the inner sleeve centers the inner sleeve within the outer sleeve when transitioning the catheter housing between the stored and open positions.

[0011] In some embodiments, the intermittent catheter system further comprises a lubricious coating on or around the catheter tube of the intermittent catheter sealed within the primary chamber when the intermittent catheter system is in a stored state.

[0012] In some embodiments, the primary and secondary chambers provide primary and secondary containment, respectively, for lubricant around the catheter tube of the intermittent catheter, thereby preventing leakage of lubricant from the catheter housing when the intermittent catheter system is in a stored state prior to use of the intermittent catheter.

[0013] In some embodiments, the catheter housing is configured to collapse when the closed end portion of the inner sleeve is held against a surface and the outer sleeve is slid over the inner sleeve toward the surface, thereby exposing the funnel of the intermittent catheter for removal of the intermittent catheter from the catheter housing.

[0014] In some embodiments, the funnel includes a plurality of ridges integrated into the exterior surface of the funnel that are configured as handles so that the funnel can be grasped while removing the intermittent catheter from the catheter housing or draining urine.

[0015] In some embodiments, the catheter tube includes a plurality of eyelets proximate the catheter tip, the eyelets being in fluid communication with the funnel opening. In some embodiments, the intermittent catheter is configured for use by a female human.

[0016] Also disclosed herein is a method of an intermittent catheter system. In some embodiments, the method includes obtaining the intermittent catheter system in its storage state. The intermittent catheter system includes a rigid catheter housing and an intermittent catheter. The catheter housing includes an inner sleeve, an outer sleeve slidably mounted over the inner sleeve, and an end cap. The end cap is seated within an end portion of the outer sleeve opposite the closed end portion of the inner sleeve and is configured to simultaneously contribute to both a primary chamber for primary containment and a secondary chamber for secondary containment. The intermittent catheter includes a catheter tube and a funnel over a proximal end portion of the catheter tube. In the storage state of the intermittent catheter system, the catheter housing can be in its maximum extension state with the intermittent catheter sealed within the primary chamber. The method also includes transitioning the intermittent catheter system to its open state. Transitioning the intermittent catheter system to the open state includes grasping the outer sleeve of the catheter housing, holding the closed end portion of the inner sleeve of the catheter housing against the surface with the outer sleeve of the catheter housing, and sliding the outer sleeve of the catheter housing over the inner sleeve of the catheter housing toward the surface to expose a funnel of the intermittent catheter. The method also includes removing the intermittent catheter from the catheter housing by the funnel of the intermittent catheter.

[0017] In some embodiments, the funnel of the intermittent catheter pops the end cap out of the outer sleeve of the catheter housing when the outer sleeve is slid over the inner sleeve of the catheter housing.

[0018] In some embodiments, the end cap overlaps the open end portion of the inner sleeve, thereby providing a primary chamber between the end cap cavity of the end cap and the inner sleeve cavity of the inner sleeve.

[0019] In some embodiments, an end cap gasket around the end cap and an inner sleeve gasket around the inner sleeve define the longitudinal limits of a secondary chamber between the inner surface of the outer sleeve and the outer surfaces of the end cap and inner sleeve.

[0020] In some embodiments, the primary and secondary chambers provide primary and secondary containment, respectively, for any lubricant around the catheter tube of the intermittent catheter, thereby preventing leakage of the lubricant from the catheter housing when the intermittent catheter system is in a stored state prior to use of the intermittent catheter.

[0021] In some embodiments, the method includes inserting a distal end portion of the catheter tube into the urethra, draining urine from the bladder through the intermittent catheter, repositioning the intermittent catheter within the inner sleeve of the catheter housing, and repositioning the end cap within the end of the outer sleeve, thereby re-forming a primary chamber for primary containment of residual urine in or around the intermittent catheter and a secondary chamber for secondary containment of any urine that has leaked from the primary chamber. Re-forming the primary and secondary chambers in this manner prevents urine leakage from the catheter housing when the intermittent catheter system is stored after use.

[0022] These and other features of the concepts provided herein will become more apparent to those skilled in the art upon consideration of the accompanying drawings and the following description, which describe in more detail certain embodiments of such concepts. [Brief explanation of the drawings]

[0023] [Figure 1] FIG. 1 is an exploded view of a first intermittent catheter system including a drainage assembly and a first rigid carrying case in an unused state of the first intermittent catheter system, according to some embodiments. [Figure 2]FIG. 2 is an exploded view of a drainage assembly of the first intermittent catheter system of FIG. 1, according to some embodiments. [Figure 3] FIG. 1 is an exploded view of the first intermittent catheter system in a used state of the first intermittent catheter system, according to some embodiments. [Figure 4] FIG. 10 is an exploded view of a first intermittent catheter assembly of a drainage assembly including a first intermittent catheter and a storage sheath, according to some embodiments. [Figure 5] FIG. 1 is a side view of a first intermittent catheter, according to some embodiments. [Figure 6] FIG. 1 is a longitudinal cross-sectional view of a first intermittent catheter, according to some embodiments. [Figure 7] FIG. 7 is a detailed view of a longitudinal cross section of the first intermittent catheter of FIG. 6, according to some embodiments. [Figure 8] FIG. 1 is a side view of a first intermittent catheter assembly, according to some embodiments. [Figure 9] FIG. 1 is a longitudinal cross-sectional view of a first intermittent catheter assembly, according to some embodiments. [Figure 10] FIG. 10 is a detailed longitudinal cross-sectional view of the first intermittent catheter assembly of FIG. 9, according to some embodiments. [Figure 11] FIG. 10 is another detailed view of the longitudinal cross section of the first intermittent catheter assembly of FIG. 9, according to some embodiments. [Figure 12] FIG. 1 is an isometric view of a second intermittent catheter system in a storage state, according to some embodiments. [Figure 13] FIG. 1 is an exploded view of a second intermittent catheter system, according to some embodiments. [Figure 14] FIG. 1 is a side view of a second intermittent catheter system, according to some embodiments. [Figure 15] FIG. 1 is a longitudinal cross-sectional view of a second intermittent catheter system, according to some embodiments. [Figure 16]FIG. 10 is a side view of a second intermittent catheter of a second intermittent catheter system, according to some embodiments. [Figure 17] FIG. 1B is a longitudinal cross-sectional view of a second intermittent catheter, according to some embodiments. [Figure 18] FIG. 18 is a detailed view of a longitudinal cross section of the second intermittent catheter of FIG. 17, according to some embodiments. [Figure 19] FIG. 10 is a side view of an outer sleeve of a first rigid catheter housing of a second intermittent catheter system, according to some embodiments. [Figure 20] FIG. 1B is a longitudinal cross-sectional view of an outer sleeve of a first catheter housing, according to some embodiments. [Figure 21] FIG. 10 is a transverse cross-sectional view of an outer sleeve of a first catheter housing, according to some embodiments. [Figure 22] FIG. 10 is another transverse cross-sectional view of the outer sleeve of the first catheter housing, according to some embodiments. [Figure 23] 1 illustrates a second intermittent catheter assembly in an unused state, according to some embodiments. [Figure 24] 10 illustrates a release mechanism for releasing the second intermittent catheter assembly, according to some embodiments. [Figure 25A] 10 illustrates a sealing mechanism for sealing the second intermittent catheter assembly after use, according to some embodiments. [Figure 25B] 14 illustrates a funnel of a third intermittent catheter of a second intermittent catheter assembly including a rigid insert, according to some embodiments. [Figure 26] 1 illustrates a drain bag with an integrated fold-and-seal processing pocket in the deployed state of the drain bag, according to some embodiments. [Figure 27] 10 illustrates a deployment mechanism for deploying the drainage bag from a folded state, according to some embodiments. [Figure 28]14A-14C show a first tear-away tab for creating a urine outlet for draining any urine from the drainage bag, according to some embodiments. [Figure 29] 13A-13C show a second tear-away tab for creating a urine outlet for draining any urine from the drainage bag, according to some embodiments. [Figure 30] 13A shows a third tear-away tab for creating a urine outlet for draining any urine from the drainage bag, according to some embodiments. [Figure 31] 13A-13C show a spout with a pop-up stopper for a urine outlet for draining any urine from the drainage bag, according to some embodiments. [Figure 32] 10 shows a ripcord for creating a urine outlet for draining any urine from the drainage bag, according to some embodiments. [Figure 33] 13A-13C show a spout covered with a screw cap for a urine outlet for draining any urine from the drainage bag, according to some embodiments. [Figure 34] 13A-13C show a hinged lid covered spout for a urine outlet for draining any urine from the drainage bag, according to some embodiments. [Figure 35] 14A-14C illustrate a first pair of peel seal tabs for creating a urine outlet for draining any urine from the drainage bag, according to some embodiments. [Figure 36] 10A-10C illustrate a second pair of peel seal tabs for creating a urine outlet for draining any urine from the drainage bag, according to some embodiments. [Figure 37] 10A-10C illustrate membrane-covered spouts for urine outlet for draining any urine from the drainage bag, according to some embodiments. [Figure 38] 10A-10C show a piercing element for piercing the membrane-covered spout to drain any urine from the drainage bag, according to some embodiments. [Figure 39] 10A-10C show peel-off seal stickers for opening the urine outlet to drain any urine from the drainage bag, according to some embodiments. [Figure 40]1 illustrates a drainage bag with a removable folded and sealed disposal pouch in the drainage bag's deployed state, according to some embodiments. [Figure 41] 1 illustrates a drainage bag with a removable zipper-sealed disposal pouch in the deployed state of the drainage bag, according to some embodiments. [Figure 42] 1 illustrates a second rigid carrying case of the first intermittent catheter system in a closed state of the second carrying case, according to some embodiments. [Figure 43] 1 illustrates a second carrying case in an open state according to some embodiments. [Figure 44] 10 illustrates a front view of the third rigid carrying case of the first intermittent catheter system with the third carrying case in a closed position, according to some embodiments. [Figure 45] 13 illustrates the rear of a third carrying case in a closed state, according to some embodiments. [Figure 46] 1 illustrates a third carrying case in an open state according to some embodiments. [Figure 47] FIG. 10 is an isometric view of a third intermittent catheter system including a third intermittent catheter assembly within a second catheter housing and an opening mechanism for opening the second catheter housing, according to some embodiments. [Figure 48] FIG. 10 is a side view of an opening mechanism for opening the second catheter housing and removing the third intermittent catheter assembly from the second catheter housing, according to some embodiments. [Figure 49] FIG. 10 is an isometric view of a third intermittent catheter system including a third intermittent catheter assembly within a third catheter housing and an opening mechanism for opening the third catheter housing, according to some embodiments. [Figure 50] FIG. 10 is a side view of an opening mechanism for opening the third catheter housing and removing the third intermittent catheter assembly from the third catheter housing, according to some embodiments. [Figure 51] FIG. 10 is an isometric view of a fourth intermittent catheter system including a third intermittent catheter assembly in a fourth rigid carrying case and an opening mechanism for opening the fourth carrying case, according to some embodiments. [Figure 52] FIG. 10 is an isometric view of a fourth intermittent catheter system including a third intermittent catheter assembly in a fifth rigid carrying case and an opening mechanism for opening the fifth carrying case, according to some embodiments. [Figure 53] FIG. 10 is an isometric view of a fifth intermittent catheter system including a first tray package in an unused state of the fifth intermittent catheter system, according to some embodiments. [Figure 54] FIG. 10 is an isometric view of a fifth intermittent catheter system including a drainage assembly in an open state of the fifth intermittent catheter system, according to some embodiments. [Figure 55] 10 illustrates a securing mechanism of the first tray package for securing the fifth intermittent catheter system during a catheter insertion procedure, according to some embodiments. [Figure 56] FIG. 10 is an isometric view of a fifth intermittent catheter system including a second tray package in an unused state of the fifth intermittent catheter system, according to some embodiments. [Figure 57] 10 illustrates a securing mechanism of the second tray package for securing the fifth intermittent catheter system during a catheter insertion procedure, according to some embodiments. [Figure 58] FIG. 10 shows a front view of the third tray package of the fifth intermittent catheter system in an unused state of the third tray package, according to some embodiments. [Figure 59] 10 illustrates a rear view of a third tray package in an unused state, according to some embodiments. [Figure 60] 10 illustrates an open-reseal mechanism for opening the third tray package after a catheter insertion procedure and resealing the third tray package, according to some embodiments. [Figure 61]FIG. 10 shows a front view of the sixth rigid carrying case of the first intermittent catheter system in an unused state of the sixth carrying case, according to some embodiments. [Figure 62] 10 illustrates a front view of the sixth carrying case in its open state, according to some embodiments. [Figure 63] 10 illustrates a front view of the sixth carrying case in a resealed state according to some embodiments. [Figure 64] 10 illustrates a rear view of the sixth carrying case in its unused or resealed state, according to some embodiments. DETAILED DESCRIPTION OF THE INVENTION

[0024] Before some specific embodiments are disclosed in more detail, it should be understood that the specific embodiments disclosed herein do not limit the scope of the concepts provided herein. It should also be understood that certain embodiments disclosed herein may have components or features that are readily separable from the specific embodiment and that can be combined or substituted in any way with components or features of any of the other embodiments disclosed herein. In certain examples, any intermittent catheter system disclosed herein can be modified to include a carrying case, tray package, or catheter housing, drainage assembly, intermittent catheter assembly, intermittent catheter, or any other component thereof of another intermittent catheter system disclosed herein, unless the context or reason suggests otherwise.

[0025] With regard to the terms used herein, it should also be understood that the terms are intended to describe certain specific embodiments and 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 within a group of features or steps and do not provide sequentiality or numerical limitations. For example, "first," "second," and "third" features or steps need not appear in that order, nor need a particular embodiment including such features or steps be limited to those three features or steps. In addition, any of the aforementioned features or steps can further include one or more additional features or steps unless otherwise indicated. Designations such as "left," "right," "top," "bottom," "front," "rear," and similar terms are used for convenience and are not intended to imply, for example, a specific, fixed position, orientation, or the like. Rather, such designations are used to reflect, for example, relative positions, orientation, or the like. The singular forms "a," "an," and "the" include plural references unless the context clearly dictates otherwise.

[0026] "Proximal" is used to refer to a portion, section, part, element, etc. of a medical device that is intended to be near or relatively near the clinician when the medical device is used on a patient. For example, a "proximal portion" or "proximal section" of a medical device includes a portion or section of the medical device that is intended to be near the clinician when the medical device is used on a patient. Similarly, a "proximal length" of a medical device includes a length of the medical device that is intended to be near the clinician when the medical device is used on a patient. A "proximal end" of a medical device is the end of the medical device that is intended to be near the clinician when the medical device is used on a patient. The proximal portion, section, or length of a medical device need not include the proximal end of the medical device. In fact, the proximal portion, section, or length of a medical device can be shorter than the proximal end of the medical device. However, the proximal portion, section, or length of a medical device may include the proximal end of the medical device. Where the context does not suggest that the proximal portion, proximal section, or proximal length of a medical device includes the proximal end of the medical device, or where deemed convenient in the following description, the terms "proximal portion," "proximal section," or "proximal length" may be modified to refer to the "proximal end portion," "proximal end section," or "proximal end length," respectively, of the medical device to indicate that such portion, section, or length includes the end, end section, or end length of the medical device.

[0027] "Distal" is used to refer to a portion, section, part, element, etc. of a medical device that is intended to be near, relatively near, or even within a patient when the medical device is used on a patient. For example, a "distal portion" or "distal section" of a medical device includes a portion or section of the medical device that is intended to be near, relatively near, or even within a patient when the medical device is used on a patient. Similarly, a "distal length" of a medical device includes a length of the medical device that is intended to be near, relatively near, or even within a patient when the medical device is used on a patient. A "distal end" of a medical device is an end of a medical device that is intended to be near, relatively near, or even within a patient when the medical device is used on a patient. A distal portion, section, or length of a medical device need not include the distal end of the medical device. In fact, a distal portion, section, or length of a medical device can be shorter than the distal end of the medical device. However, a distal portion, distal section, or distal length of a medical device may include the distal end of the medical device. Where the context does not suggest that a distal portion, distal section, or distal length of a medical device includes the distal end portion of the medical device, or where deemed convenient in the following description, the terms "distal portion," "distal section," or "distal length" may be modified to refer to a "distal end portion," "distal end portion section," or "distal end portion length," respectively, of a medical device to indicate that such portion, section, or length includes the end, end section, or end length of the medical device.

[0028] The unused condition of an intermittent catheter system or any component thereof refers to the intermittent catheter system or component thereof being described remaining in the packaging in which it was manufactured, distributed, or sold.

[0029] A used state of an intermittent catheter system or any component thereof indicates that the intermittent catheter system or component thereof being described is not in an unused state, i.e., the intermittent catheter system or component thereof is opened, unpackaged, prepared for use in such catheter insertion procedure, used in such catheter insertion procedure, etc.

[0030] The storage state of an intermittent catheter system, or any component thereof, may indicate that the described intermittent catheter system, or component thereof, has been opened, unpackaged, prepared for use in a catheter insertion procedure, used in such a catheter insertion procedure, etc., but is repackaged in some manner for storage until disposal is possible. Alternatively, the storage state of an intermittent catheter system, or any component thereof, may indicate that the described intermittent catheter system, or component thereof, remains in the packaging in which it was manufactured, distributed, or sold in an unused state. Thus, context should be used to inform any interpretation of the storage state of an intermittent catheter system, or component thereof.

[0031] A closed state of an intermittent catheter system, or any component thereof, indicates that the intermittent catheter system or component thereof being described is simply closed. Thus, the intermittent catheter system or component thereof being described may be in an unused state, a used state (but closed), or a stored state. Thus, context should be used to signal any interpretation of the closed state of an intermittent catheter system or component thereof beyond simply closed.

[0032] The open state of the intermittent catheter system, or any component thereof, indicates that the described intermittent catheter system, or component thereof, is simply open. Accordingly, the described intermittent catheter system, or component thereof, is also in a used state, as described above. Indeed, regardless of whether the intermittent catheter system, or any component thereof, is prepared for use in a catheterization procedure or has been used in such a catheterization, the sterility of the intermittent catheter system is potentially compromised.

[0033] The carry case or tray package of the intermittent catheter system is generally configured to enclose therein one or more drainage bags, one or more intermittent catheter assemblies or intermittent catheters, and any other components for intermittent catheter insertion.

[0034] The catheter housing of the intermittent catheter system is generally configured to enclose one or more intermittent catheter assemblies or intermittent catheters therein. The catheter housing and any other components for intermittent catheterization, including the drainage bag, may be enclosed in a carrying case or tray package disclosed herein, or one of the user's choice.

[0035] Unless defined otherwise, all technical or scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art.

[0036] Male or unisex intermittent catheter system 1-11, 23, 24, 25A, 25B, and 26-64 illustrate various intermittent catheter systems or components thereof, according to several embodiments. Such intermittent catheter systems and components are configured for use by male humans or humans with non-specific anatomical structures.

[0037] In particular, the intermittent catheter system 100 is described below as a reference embodiment for describing various intermittent catheter systems and their components. It should be understood that other intermittent catheter systems or their components described below may not be described in as much detail as the reference embodiment, as such details may be gleaned from the description of the reference embodiment. Indeed, to reduce the burden of description, the descriptions of other intermittent catheter systems or their components often focus on differences between the intermittent catheter system 100 and its components and the reference embodiment, instead of repeating commonalities. Finally, as noted above, it should be understood that any intermittent catheter system disclosed herein may be modified to include a carrying case, tray package, or catheter housing, a drainage assembly, an intermittent catheter assembly, an intermittent catheter, or any other component thereof of another intermittent catheter system disclosed herein, unless context or reason suggests otherwise.

[0038] 1-11 illustrate an intermittent catheter system 100 according to some embodiments. In particular, Fig. 1 illustrates the intermittent catheter system 100 in an unused state, and Fig. 3 illustrates the intermittent catheter system 100 in a used state.

[0039] As shown, the intermittent catheter system 100 may include a drainage assembly 170 and a rigid carrying case selected from a variety of carrying cases described below. The drainage assembly 170 may include the intermittent catheter assembly 110 and a drainage bag 180, which may be pre-connected to the funnel 136 of the intermittent catheter 130 of the intermittent catheter assembly 110, as shown in FIG. 2. If the drainage bag 180 is not pre-connected to the funnel 136 of the intermittent catheter 130 as shown in FIG. 2, the drainage assembly 170 may instead be referred to as the drainage component of the intermittent catheter system 100 or another intermittent catheter system. Such a drainage component includes the intermittent catheter assembly 110 and its intermittent catheter 130. Each component of the intermittent catheter assembly 110, the drainage bag 180, and the carrying case 150 is described in more detail below.

[0040] 4-11 illustrate an intermittent catheter assembly 110 according to some embodiments. As shown, the intermittent catheter assembly 110 may include an intermittent catheter 130 and a sterility-maintaining enclosure 132 therefor.

[0041] The intermittent catheter 130 may include a catheter tube 134 and a funnel 136 on a proximal end portion of the catheter tube 134. The catheter tube 134 may include a plurality of eyelets 138 adjacent the catheter tip 140, and the funnel 136 may have a funnel opening 142 in fluid communication with the eyelets 138 by a lumen 143 through the intermittent catheter 130 for draining urine.

[0042] Sterility-maintaining enclosure 132 may include a storage sheath 144, an end cap 146 coupled to a distal end portion of storage sheath 144, and, optionally, a tamper-evident peelable seal covering cap 146 at least in an unused state of intermittent catheter assembly 110. Storage sheath 144 and end cap 146 are configured to enclose at least catheter tube 134 of intermittent catheter 130 therein to maintain its sterility in its unused state. Indeed, the storage sheath 144 may extend between the funnel 136 and the end cap 146 of the intermittent catheter 130, and the end cap 146 may extend over the distal end of the catheter tube 134, thereby protecting the catheter tube 134 from contamination and retaining any lubricious coating 135 on the catheter tube 134 or any lubricity around the catheter tube 134 contained within its sterility-maintaining enclosure 132 or storage sheath 144 in the unused state of the intermittent catheter assembly 110. However, it should be understood that the sterility-maintaining enclosure 132 may also dually function as a urine retention enclosure, thereby retaining any residual urine in or around the catheter tube 134 contained within the urine retention enclosure or its storage sheath 144 in the used state of the intermittent catheter assembly 110. Transitioning between the sterility maintenance enclosure 132 and the urine retention enclosure involves at least withdrawing the storage sheath 144 over the catheter tube 134, draining urine through the intermittent catheter 130, and advancing the storage sheath 144 back over the catheter tube 134.

[0043] In particular, the intermittent catheter assembly 110 may form a leak-tight, ulvo-type end-to-end closure in the unused state of the intermittent catheter assembly 110, in the used state of the intermittent catheter assembly 110, or both. Indeed, the distal portion of the end cap 146 may include a receptacle 148 configured to receive an end portion of the funnel 136 therein to form the end-to-end closure in either the unused or used state of the intermittent catheter assembly 110. Alternatively, the distal portion of the end cap 146 may include a plug (not shown) configured to be inserted into the funnel opening 142 of the funnel 136 to form the end-to-end closure in either the unused or used state of the intermittent catheter assembly 110. To assist in the formation of such an end-to-end closure, the end cap 146 may 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, funnel 136 does not need to have a separate end cap to close funnel 136 after use of intermittent catheter 130. Moreover, the formation of an end-to-end closure in the used state of intermittent catheter assembly 110 provides a convenient and compact configuration for intermittent catheter assembly 110 in its used state until it can be disposed of.

[0044] 23, 24, 25A, and 25B illustrate an intermittent catheter assembly 210 according to some embodiments. Such an intermittent catheter assembly 210 is an alternative to the intermittent catheter assembly 110.

[0045] As shown, the intermittent catheter assembly 210 may include an intermittent catheter 330, an introducer tip 332 on a distal end portion of the intermittent catheter 330, and a sterility-maintaining enclosure 334 therefor. Notably, the sterility-maintaining enclosure 334 of the intermittent catheter assembly 210 precludes pre-connection of the intermittent catheter assembly 210 and the drainage bag 180, such as in the unused state of the drainage assembly 170 described above, because, in the unused state of the intermittent catheter assembly 210, the introducer tip 332 and funnel 338 of the intermittent catheter 330 form a leak-tight, ulvo-bolic, end-to-end closure maintained by the tamper-evident package 336.

[0046] The intermittent catheter 330 may include a catheter tube 134 and a funnel 338 on a proximal end portion of the catheter tube 134. The catheter tube 134 may include a plurality of eyelets 340 proximate a catheter tip 342, and the funnel 338 may have a funnel opening 344 in fluid communication with the eyelets 340 by a lumen through the intermittent catheter 330 for draining urine. Furthermore, the funnel 338 may be formed from a polymer material ranging from a soft polymer material having a relatively low durometer to a hard polymer material having a relatively high durometer, although if the funnel 338 is formed from a soft polymer material, the funnel 338 may include a hard insert 346 inserted or otherwise disposed therein, as shown in Figures 25A and 25B.

[0047] The rigid insert 346 is configured with two levered semi-conical halves 348 to snap or clamp onto the introducer tip 332 in an unused state of the intermittent catheter assembly 210 as well as in an end-to-end closure in a used state of the intermittent catheter assembly 210. The rigid insert 346 may include interlocking features with the introducer tip 332, such as one or more semi-annular grooves, one or more semi-annular ridges, or some combination thereof, provided the interlocking features are complementary to those of the introducer tip 332. Advantageously, the rigid insert 346 may be configured such that when a distal end portion of the funnel 338 is pinched or squeezed distal to a pivot point 352 between the two semi-conical halves 348 of the rigid insert 346, the two semi-conical halves 348 of the rigid insert 346 will separate, allowing the introducer tip 332 to be separated or otherwise removed from the funnel 338 of the intermittent catheter 330.

[0048] The introducer tip 332 is configured for insertion into the urethral meatus, through which the catheter tube 134 of the intermittent catheter 330 is advanced. Such an introducer tip 332 has a larger diameter than the catheter tube 134, making catheter insertion using the introducer tip 332 easier for users with reduced dexterity. The introducer tip 332 may also be formed of a hard polymer material having a relatively high durometer compared to the catheter tube 134, thereby making catheter insertion using the introducer tip 332 easier for users with reduced dexterity. Notably, the hard polymer material of the introducer tip 332 also allows the two levered semi-conical halves 348 of the hard insert 346 to snap or clamp onto the introducer tip 332 in an unused state of the intermittent catheter assembly 210 as well as in an end-to-end closure in a used state of the intermittent catheter assembly 210. Further, such an introducer tip 332 may include interlocking features with the rigid insert 346, such as one or more annular grooves, one or more annular ridges, or some combination thereof, where the interlocking features are complementary to those of the rigid insert 346, and the interlocking features further enable the two levered semi-conical halves 348 of the rigid insert 346 to snap or clamp onto the introducer tip 332 in an end-to-end closure in an unused state of the intermittent catheter assembly 210 as well as in a used state of the intermittent catheter assembly 210.

[0049] Sterility-maintaining enclosure 334 may include a storage sheath 144 configured to enclose the entire intermittent catheter 330 therein to maintain its sterility in its unused state. Indeed, storage sheath 144 may extend from the distal end portion of funnel 338 around which the proximal end portion of storage sheath 144 is coupled, over the entire catheter tube 134, over the introducer tip 332 to which it may be coupled, over the proximal end portion of funnel 338, and back to the distal end portion of funnel 338. The distal end portion of the storage sheath 144 is bonded to the distal end portion of the funnel 338 or is otherwise covered by a tamper-evident package 336, thereby protecting the entire intermittent catheter 330 and introducer tip 332 from contamination and retaining any lubricious coating 135 on or around the catheter tube 134 contained within the sterility-maintaining enclosure 334 or its storage sheath 144 in the unused state of the intermittent catheter assembly 210.

[0050] The tamper-evident package 336 may include a ripcord or tear strip 354, such as one formed from the polymeric material of the storage sheath 144, between a weakened (e.g., scored, perforated, etc.) separation line in the storage sheath 144, the ripcord or tear strip 354 being configured to open the tamper-evident package 336 by pulling the ripcord or tear strip 354 across the storage sheath 144. As shown, the ripcord or tear strip 354 may include a handle 356 associated therewith, having any convenient shape of a variety of shapes, such as the ring-shaped handle 356 shown in FIG. 24. However, the ripcord or tear strip 354 need not include a handle 356 in some embodiments if additional length is provided for grasping with or wrapping around one or more fingers.

[0051] The sterility-maintaining enclosure 334 may also double as a urine retention enclosure, thereby retaining any residual urine in or around the catheter tube 134 housed within the urine retention enclosure or its storage sheath 144 in the used state of the intermittent catheter assembly 210. Indeed, after use of the intermittent catheter 330 to drain urine, which binds the storage sheath 144 around the distal end portion of the funnel 338 as the catheter tube 134 of the intermittent catheter 330 is advanced through the introducer tip 332, the storage sheath 144 may be repositioned over the intermittent catheter 330 and introducer tip 332, as in the unused state of the intermittent catheter assembly 210. Additionally, the introducer tip 332 can be inserted into a funnel 338 containing a rigid insert 346 so that the two levered semi-conical halves 348 of the rigid insert 346 snap or clamp onto the introducer tip 332 in an end-to-end closure in the used state of the intermittent catheter, thereby retaining any residual urine in or around the catheter tube 134 contained within its urine retention enclosure or storage sheath 144.

[0052] Figures 1, 2, and 26-41 illustrate various drainage bags or components thereof according to several embodiments. In particular, although such drainage bags are described herein as components of male or unisex intermittent catheter systems, it should be understood that the female intermittent catheter systems described below may include any of the drainage bags of Figures 1, 2, and 26-41.

[0053] As shown, the drain bag 180 may be a collapsible drain bag that includes a urine drainage means for draining urine from the drain bag 180 and a disposal means for discarding the drain bag 180.

[0054] The drainage bag 180 may be in a folded state in the unused state of the drainage assembly 170 or drainage components, thereby providing a compact configuration for the drainage bag 180 until use during a catheter insertion procedure. In the folded state of the drainage bag 180 shown in FIG. 27 , the drainage bag 180 may include one or more folds along a 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, 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 may be folded into any convenient geometric shape (e.g., square, rectangular, triangular, etc.) in the unused state of the drainage bag to fit into packaging within the rigid packages described herein. The collapsed state of the drainage bag 180 may be maintained by a strap 182 extending from a longitudinal end portion of the drainage bag 180 that also includes a urinary inlet 184 to which the intermittent catheter 130 of the intermittent catheter assembly 110 connects. The strap 182 may include a handle 183 and an adhesive strip or patch 185 that is attached to the folded portion of the drainage bag 180 to maintain the collapsed state of the drainage bag 180. After peeling the strap 182 from the folded portion of the drainage bag 180, the drainage bag 180 may be unfolded according to the unfolding mechanism for unfolding the drainage bag 180 shown in FIG. 27 . In particular, the drainage bag 180 may include a handle 186 extending from another longitudinal end portion of the drainage bag 180 opposite the one that includes the urinary inlet 184. The handle 186 is configured to facilitate unfolding the drainage bag 180 from its collapsed state.

[0055] 28-39 show various urine drainage means for draining urine from the drainage bag 180, according to some embodiments. As shown, the urinary relief means is located at a longitudinal end portion of the relief bag 180, opposite the strap 182, which also includes a urinary inlet 184. Such urinary relief means may include a tear tab 188, a ripcord 190, a peel seal tab 192, or a peel seal sticker 194 to form a urinary outlet or a spout 195 selected from a variety of spouts for the urinary outlet.

[0056] 28-30 provide examples of tear tabs 188 for creating a urine outlet, where the tear tab 188 in FIG. 28 includes a handle 196 configured to pull the tear tab 188 directly across a weakened (e.g., scored, perforated, etc.) separation line in the drainage bag 180 starting from the initiation notch 198 to create a urine outlet; the tear tab 188 in FIG. 29 includes a handle 202 configured to pull the tear tab 188 away from the drainage bag 180 (e.g., away from a longitudinal end portion of the drainage bag 180 including the tear tab 188) and across a weakened separation line starting from the initiation notch 198 to create a urine outlet; and the handleless tear tab 188 in FIG. 30 is configured to pull the tear tab 188 directly across a weakened separation line in the drainage bag 180 starting from the initiation notch 198 to create a urine outlet.

[0057] Similarly, Figure 32 provides one example of a ripcord 190 for creating a urine outlet, the ripcord 190 of Figure 32 including a ring-shaped handle 204 coupled to the ripcord 190 for pulling the ripcord 190 across the parting line of the drainage bag 180 in which the ripcord 190 is embedded to create a urine outlet. Notably, the handle 204 coupled to the ripcord 190 can be any convenient shape, although in some embodiments, the ripcord 190 need not include a handle 204 if additional length is provided for grasping with or wrapping around one or more fingers.

[0058] 35 and 36 provide examples of peel seal tabs 192 for creating a urine outlet, where the peel seal tab 192 in FIG. 35 includes a handle 206 configured to start with a small separation between the peel seal tabs 192 and pull the peel seal tab 192 away from the drain bag 180 (e.g., away from the front and rear surfaces of the drain bag 180) to create a urine outlet, and the handle-less peel seal tab 192 in FIG. 36 is configured to start with a small separation between the peel seal tabs 192 and pull the peel seal tab 192 away from the drain bag 180 (e.g., away from the front and rear surfaces of the drain bag 180) to create a urine outlet. In particular, the peel seal tabs 192 are configured to reseal the urine outlet when the peel seal tabs 192 are pushed back together. However, in some embodiments, the peel seal tabs 192 can be simply peel tabs that do not have the ability to reseal when pushed together.

[0059] Similarly, Figure 39 provides an example of a peel seal sticker 194 for creating a urine outlet, where the handle-less peel seal sticker 194 of Figure 39 is configured to create a urine outlet by pulling the peel seal sticker 194 away from the drain bag 180 (e.g., away from the front or back of the drain bag 180). In particular, the peel seal sticker 194 is configured to reseal the urine outlet when the peel seal sticker 194 is pushed back onto the drain bag 180 over the urine outlet. However, in some embodiments, the peel seal sticker 194 can simply be a peel sticker that does not have the ability to reseal when pressed onto the drain bag 180 over the urine outlet.

[0060] Figures 31, 33, 34, and 37 provide examples of various spouts for urine outlets, with spout 195 in Figure 31 including a pop-up stopper 208 for a spout with a resealable pop-up stopper, spout 195 in Figure 33 including a screw cap 211 for a spout covered with a resealable screw cap, spout 195 in Figure 34 including a hinged lid 212 for a spout covered with a resealable hinged lid, and spout 195 in Figure 37 including a membrane 214 (e.g., a plastic membrane, a foil membrane, the composite membranes mentioned above, etc.) for a membrane-covered spout. In particular, Figure 38 provides an example of a piercing element 216 having a piercing end portion for piercing the membrane 214 of a membrane-covered spout to drain urine from the drainage bag 180. As shown, such a piercing element 216 may be tethered to the drainage bag 180 with a tether 218 for holding the piercing element 216 to the drainage bag 180. Further, as shown, the piercing element 216 may be an open-ended tube having a length sufficient to extend into the spout 195 beyond any broken pieces of the membrane 214 attached to the lip of the spout 195, thereby providing a smooth surface through which urine can drain therefrom. Alternatively, the piercing element 216 may be a closed-ended tube having a closed end opposite the piercing end portion of the piercing element 216, thereby providing a stopper for resealing the membrane-covered spout.

[0061] 26, 40, and 41 show various disposal means for disposing of the drain bag 180, according to some embodiments. As shown, the disposal means may be a disposal pocket 220 or disposal pouch 222, respectively, integral with or removably attached to another longitudinal end portion of the drain bag 180 opposite the portion containing the urine inlet 184.

[0062] 26 provides an example of a processing pocket 220 incorporated into the front of the drain bag 180 for folding the longitudinal end portion of the drain bag 180 including the urine inlet 184 into the processing pocket 220 for the used state of the drain bag 180. However, the processing pocket 220 may alternatively be incorporated into the rear of the drain bag 180 for folding the longitudinal end portion of the drain bag 180 including the urine inlet 184 into the processing pocket 220. Optionally, the processing pocket may be pleated with pleats 224 or may otherwise include additional polymeric material of the drain bag 180 to expand the processing pocket 220 to accommodate the longitudinal end portion of the drain bag 180 including the urine inlet 184. Additionally, the processing pocket 220 may include a fold extension 226 formed from the polymeric material of the processing pocket for sealing a longitudinal end portion of the drain bag 180, including the urine inlet 184, within the processing pocket 220, for a substantially or completely leak-proof used state of the drain bag 180. In particular, the fold extension 226 of the processing pocket 220 may include a handle 228 for facilitating folding the fold extension 226 onto the rear surface of the drain bag 180 if the processing pocket 220 is incorporated into the front surface of the drain bag 180, or onto the front surface of the drain bag 180 if the processing pocket 220 is incorporated into the rear surface of the drain bag 180. Additionally, the fold extension 226 of the processing pocket 220 may include an adhesive strip or patch 232 configured to seal the fold extension 226 onto the rear or front surface of the drain bag 180 for a substantially or completely leak-proof used state of the drain bag 180.

[0063] 40 and 41 provide an example of a processing pouch 222 removably attached to the other longitudinal end portion of the drainage bag 180 opposite the end portion including the urine inlet 184 for enclosing the drainage bag 180 within the processing pouch 222 for a used state of the drainage bag 180. Similar to the tear tab 188 for creating the urine outlet, the drainage bag 180 may be configured to separate the processing pouch 222 from the remainder or main portion of the drainage bag 180 by pulling the processing pouch 222 directly across a weakened (e.g., cut, perforated, etc.) separation line between the processing pouch 222 and the remainder or main portion of the drainage bag 180, starting from one of two notches 235. 40 , the processing pouch 222 may include a fold extension 226 formed from the polymeric material of the drainage bag 180 for sealing the drainage bag 180 within the processing pouch 222 after enclosing the remaining or main portion of the drainage bag 180 therein for a substantially or completely leak-free used state of the drainage bag 180. In particular, the fold extension 226 of the processing pouch 222 may include a handle 228 on the side opposite the drainage bag 180 for facilitating folding the fold extension 226. Furthermore, the fold extension 226 of the processing pouch 222 may include an adhesive strip or patch 232 configured to seal the fold extension 226 on the side opposite the drainage bag 180 for a substantially or completely leak-free used state of the drainage bag 180. As shown in FIG. 41, the processing pouch 222 may alternatively include a zipper 237 instead of the fold-over extension 226 to seal the drainage bag 180 within the processing pouch 222 after enclosing the remaining or main portion of the drainage bag 180 therein for a substantially or completely leak-proof used state of the drainage bag 180.

[0064] 1, 3, 42-46, and 61-64 illustrate various rigid carrying cases 150, 250, 350, and 650 for the intermittent catheter system 100, according to some embodiments. Notably, such carrying cases 150, 250, 350, and 650 may be reusable such that the intermittent catheter system 100 may be reassembled or reassembled after use with one or more auxiliary packages, each of which includes at least the evacuation assembly 170 or evacuation components thereof.

[0065] 1, 3, 42, and 43, each of the carrying cases 150 and 250 includes a main body 152 and a cover thereover, such as a cap 154, for enclosing at least the evacuation assembly 170 or evacuation components thereof therein in an unused state. Although not shown, it should be understood that the intermittent catheter system 100 may further include a cover over the main body 152, similar to those described below for the tray packages 1050, 1150, and 1250 in the intermittent catheter system 500. However, such a cover should be considered a tamper-evident package to indicate that the intermittent catheter system 100 remains in an unused state when the tamper-evident package remains intact. As shown, body 152 and cap 154 ​​may be independently connected to one another by one or more hinges 156, such as one or more living hinges or one or more self-closing spring hinges, on the minor longitudinal side of each carrying case 150 and 250. Additionally, each carrying case 150 and 250 may independently include a clip 158, a rigid extension from cap 154, such as a tab or handle with a through hole, and a pull strap 160, on its minor longitudinal side opposite the side including one or more hinges 156. In one example, carrying case 150 may include one or more living hinges on one minor longitudinal side of carrying case 150 and a clip 158 on the other minor longitudinal side of carrying case 150, as shown in FIGS. In another example, the carrying case 250 may include one or more self-closing spring hinges on one small longitudinal side of the carrying case 250 and a pull strap 160 on the other small longitudinal side of the carrying case 250, as shown in Figures 42 and 43.Additionally, each of carrying cases 150 and 250 may independently include a gasket 162 between body 152 and cap 154, with carrying case 150 or 250, as the case may be, configured to provide enhanced secondary containment for any residual urine that leaks from intermittent catheter assembly 110 in its used state. Indeed, in such a configuration, carrying case 150 or 250 is further configured to enclose at least intermittent catheter assembly 110 therein in its used state.

[0066] With respect to the carrying case 350 of FIGS. 44-46 , the carrying case 350 also includes a body 152 and an overlying cover, such as a cap 154, for enclosing at least the evacuation assembly 170 or its evacuation components therein when unused. As shown, the body 152 and cap 154 ​​may be connected to one another by one or more hinges 156 on a major longitudinal side of the carrying case 350, unlike the carrying case 150 or 250. In further contrast to the carrying case 150 or 250, the front of the body 152 of the carrying case 350 may have a shorter length than the rear of the body 152, thereby providing a larger opening in the body 152 for greater access to the components of the intermittent catheter system 100 within the carrying case 350. Complementarily, the front of the cap 154 ​​of the carrying case 350 may have a longer length than the rear of the same. Additionally, the carrying case 350 may include a catch 164 on a large longitudinal side of the carrying case 350 opposite the side including the one or more hinges 156. Indeed, the catch 164 may extend from the front of the cap 154 ​​so as to extend over the front of the body 152 of the carrying case 350 and may catch a keeper 166 on the front of the carrying case 350 to secure the cap 154 ​​and body 152 together, as shown in FIG. 44 . Although not shown, the carrying case 350 may also include a gasket 162 between the body 152 and the cap 154 ​​if the cap 154 ​​is not formed of a rubberized material. In any event, the carrying case 350 is configured to provide secondary containment for any residual urine that leaks from the intermittent catheter assembly 110 when the intermittent catheter assembly 110 is in a used state. Indeed, in such a configuration, the carrying case 350 is further intended to enclose at least the intermittent catheter assembly 110 therein in its used state.

[0067] With respect to the carrying case 650 of FIGS. 61-64 , the carrying case 650 also includes a body 152 and a cover thereon, such as a lid 168, for enclosing at least the evacuation assembly 170 or evacuation components thereof therein when unused. As shown, the body 152 and the lid 168 may be connected to one another by one or more hinges 156 on the major longitudinal sides of the carrying case 650. Similar to the carrying case 350, the front of the body 152 of the carrying case 650 may have a shorter length than the rear of the body 152, thereby providing a larger opening in the body 152 for greater access to the components of the intermittent catheter system 100 within the carrying case 650. However, as shown in FIG. 62 , the carrying case 650 may also include a notch 172 on the front that is connected to the aforementioned opening, thereby providing a larger opening in the body 152 for even greater access to the components of the intermittent catheter system 100 within the carrying case 650. Complementarily, the front of the lid of the carrying case 650 may be molded with an extension 174 to overlap the opening in the body 152 of the carrying case 650 and its notch 172. Additionally, the carrying case 650 may include a hinged catch 176 on a large longitudinal side of the carrying case 650 opposite the side containing the one or more hinges 156, which may be used to indicate an unused state of the intermittent catheter system 100 or a used state of the intermittent catheter system 100. Indeed, in the unused state of the intermittent catheter system 100, the hinged catch 176 may be directly above the extension 174 of the lid 168, as shown in FIG. In the used state of the intermittent catheter system 100, the hinged catch 176 may extend from the extension 174 of the lid 168 onto the front of the body 152 of the carrying case 650 and may catch a keeper 178 in the front of the carrying case 650 to secure the cap 154 ​​and body 152 together, as shown in FIG. 63. Although not shown, the carrying case 650 may also include a gasket 162 between the body 152 and the cap 154 ​​if the cap 154 ​​is not formed of a rubberized material.In any event, the carrying case 650 is configured to provide secondary containment for any residual urine that leaks from the intermittent catheter assembly 110 in its used state. Indeed, in such a configuration, the carrying case 650 is further intended to enclose at least the intermittent catheter assembly 110 therein in its used state.

[0068] Although rigid packages such as those of carrying cases 150, 250, 350, and 650 provide better protection than flexible packages, particularly when intermittent catheter system 100 or the like is transported or otherwise carried independently, such rigid packages may be more difficult to pack into luggage or the like than flexible packages, particularly when packing such luggage securely.

[0069] Figures 53-60 illustrate an intermittent catheter system 500 according to some embodiments. In particular, Figures 53, 56, 58, and 59 illustrate the intermittent catheter system 500 in an unused state, and Figures 54, 55, 57, and 60 illustrate the intermittent catheter system 500 in a used state.

[0070] As shown, the intermittent catheter system 500 may include a drainage assembly 170 or drainage components thereof, similar to the intermittent catheter system 100 described above. However, instead of the rigid carrying case 150, 250, 350, or 650 of the intermittent catheter system 100, the intermittent catheter system 500 may include a rigid tray package (or rigid tray packaging) selected from at least tray packages (or tray packaging) 1050, 1150, and 1250 described below.

[0071] 53-55 , the tray package 1050 includes a tray 1052 having a rectangular shape as defined by a longitudinal cross-section of the tray 1052, a cover 1054 covering an otherwise open face of the tray 1052 for enclosing at least the evacuation assembly 170 or its evacuation components therein in an unused state, and a securing mechanism for securing the intermittent catheter system 500 during a catheter insertion procedure. As shown, the tray 1052 may include a lip 1056 around the tray 1052 and a lip extension 1058 extending from the lip 1056 at a longitudinal end portion of the tray 1052. The cover 1054 may be sealed to the tray 1052 by a resealable seal around the lip 1056 of the tray 1052, although a cover extension 1060 of the cover 1054 extending over the lip extension 1058 of the tray 1052 is not specifically sealed to the lip extension 1058. Indeed, such cover extension 1060 of the cover 1054, which may be a tab or handle 1062 as shown, is advantageously not sealed to the lip extension 1058 of the tray 1052 to facilitate grasping the cover extension 1060 and at least partially peeling the cover 1054 from the tray 1052, thereby accessing the components of the intermittent catheter system 500 within the tray package 1050. If the cover extension 1060 of the cover 1054 is a ring-shaped handle 1062, such as shown in FIGS. 53 and 54 , the rigid yet flexible lip extension 1058 of the tray 1052 may be bent with a finger through a hole in the handle 1062 toward the base of the tray 1052 to grasp the handle 1062 and separate it from the lip extension 1058. Additionally, the lip extension 1058 of the tray 1052 may include an integrated clip 1064 for a securing mechanism, which is for conveniently clipping the tray 1052, and thus the intermittent catheter system 500, to a user's shirt during the catheter insertion procedure.Finally, the cover 1054 can be resealed to the tray 1052 by a resealable seal around the lip 1056 of the tray 1052, such that the tray package 1050 is configured to provide secondary containment for any residual urine that leaks from the intermittent catheter assembly 110 in its used state. Indeed, in such a configuration, the tray package 1050 is further configured to enclose at least the intermittent catheter assembly 110 therein in its used state.

[0072] 56 and 57 , the tray package 1150 includes a tray 1052 (e.g., a circular tray or an oval tray) having an oval shape as defined by a longitudinal cross-section of the tray 1052, a cover 1054 covering an otherwise open face of the tray 1052 for enclosing at least the drainage assembly 170 or its drainage components therein in an unused state, and a securing mechanism for securing the intermittent catheter system 500 during a catheter insertion procedure. Similar to the rectangular tray 1052, the oval tray 1052 may include a lip 1056 around the tray 1052 and a lip extension 1058 extending from the lip 1056 of the tray 1052, which may also include an integral clip 1064 for conveniently clipping the tray 1052, and thus the intermittent catheter system 500, to a user's shirt during a catheter insertion procedure. Unlike this, however, the clip 1064 of the oval tray 1052 is advantageously centered on the lip extension 1058 of the tray 1052, rather than offset to one side of it as in the rectangular tray 1052. The cover 1054 may be sealed to the tray 1052 by a resealable seal around the lip 1056 of the tray 1052. Also, although not shown, the cover 1054 of the tray package 1150 may include an unsealed cover extension similar to that of the cover extension 1060 of the tray package 1050; however, when the tray package 1150 includes such a cover extension, the cover extension extends over at least the tongue 1066 of the clip 1064 in the lip extension 1058 of the tray 1052. Whether the cover extension 1060 of the cover 1054 is a tab or a handle such as the ring-shaped handle 1062 shown in Figures 53 and 54, the hard but flexible tongue 1066 of the clip 1064 can be bent with a finger toward the base of the tray 1052 to separate the cover extension 1060 from the lip extension 1058, gripping the cover extension 1060 and at least partially peeling the cover 1054 from the tray 1052, thereby facilitating access to the components of the intermittent catheter system 500 within the tray package 1150.Finally, the cover 1054 can be resealed to the tray 1052 by a resealable seal around the lip 1056 of the tray 1052, such that the tray package 1150 is configured to provide 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, in such a configuration, the tray package 1150 is further configured to enclose at least the intermittent catheter assembly 110 therein in the used state of the intermittent catheter assembly 110.

[0073] 58-60 , the tray package 1250 also includes a tray 1052 having an oval shape defined by a longitudinal cross-section of the tray 1052 (e.g., a circular tray or an oval tray), but, unlike the tray 1052, a lip 1056 around the tray 1052 has a teardrop shape. In addition, the tray package 1250 includes a cover 1054 covering an otherwise open face of the tray 1052 for enclosing at least the drainage assembly 170 or its drainage components therein in an unused state, and a securement mechanism for securing the intermittent catheter system 500 during a catheter insertion procedure. The lip 1056 around the tray 1052 includes a lip extension 1058 extending from the lip 1056 of the tray 1052, the lip extension 1058 being pointed, thereby giving the teardrop-shaped lip 1056 its shape. The pointed lip extension 1058 may include an integral clip 1064 for conveniently clipping the tray 1052, and thus the intermittent catheter system 500, to a user's shirt during a catheterization procedure. In particular, the clip 1064 of the tray 1052 is pointed, and due to the length of the pointed lip extension 1058, such pointed clip 1064 may have a deeper bite and therefore a stronger grip on the user's shirt than the clip 1064 of the tray package 1050 or 1150. Additionally, the pointed clip 1064 may be made of a different, stronger material than the rest of the tray 1052, such as a metal clip overmolded onto a polymer tray, thereby further enhancing the grip of the pointed clip 1064. Finally, the pointed clip 1064 of the tray 1052 is advantageously centered relative to the pointed lip extension 1058 of the tray 1052, rather than offset to one side of it as in a rectangular tray 1052. The cover 1054 may be sealed to the tray 1052 by a resealable seal around a lip 1056 of the tray 1052 .Also, the cover 1054 may include an unsealed cover extension similar to that of the cover extension 1060 of the tray package 1050 that extends over the pointed lip extension 1058, although the tray package 1250 in FIG. 58 is instead shown with a triangular handle 1068 oriented opposite the pointed lip extension 1058 for grasping the handle 1068 and at least partially peeling the cover 1054 from the tray 1052, thereby facilitating access to the components of the intermittent catheter system 500 within the tray package 1250. Finally, because the cover 1054 may be resealed to the tray 1052 by a resealable seal around the lip 1056 of the tray 1052, the tray package 1250 is configured to thereby provide secondary containment for any residual urine that leaks from the intermittent catheter assembly 110 in a used state of the intermittent catheter assembly 110. Indeed, in such a configuration, the tray package 1250 is further configured to enclose at least the intermittent catheter assembly 110 therein in its used state.

[0074] Rigid packages such as those of tray packages 1050, 1150, and 1250 provide better protection than flexible packages, particularly when intermittent catheter system 500 or the like is transported or otherwise carried independently; however, such rigid packages may be more difficult than flexible packages to pack into luggage or the like, particularly when packing such luggage securely.

[0075] Figures 51 and 52 illustrate an intermittent catheter system 400 according to some embodiments. In particular, Figures 51 and 52 illustrate the intermittent catheter system 400 with an opening mechanism for opening the rigid carrying case 450 or 550 of the intermittent catheter system 400, thereby transitioning the intermittent catheter system 400 from its storage state to its open state, or vice versa.

[0076] As shown, the intermittent catheter system 400 may include a drainage assembly 170 or drainage components thereof, similar to the intermittent catheter system 100 described above. However, instead of the rigid carrying cases 150, 250, 350, or 650 of the intermittent catheter system 100 passively enclosing the drainage assembly 170 or its drainage components in its unused or used state, the carrying cases 450 and 550 interact with at least the intermittent catheter assembly 310.

[0077] 51 , the carrying case 450 includes a body 452 and an overlying cover, such as a lid 454, for enclosing at least the evacuation assembly 170 or evacuation components thereof therein in an unused state. As shown, the body 452 and the lid 454 may be connected to one another by a longitudinal living hinge 456 on a major longitudinal side of the carrying case 450, whereby the body 452 and the lid 454 provide a clamshell-type opening for unobstructed access to the components of the intermittent catheter system 500 for removal from the carrying case 450, as shown. Additionally, the carrying case 450 may include a storage plate 458 having a pair of suitably sized posts 460 extending therefrom configured to mount the intermittent catheter assembly 310 thereon in either the unused state of the intermittent catheter assembly 310 or the used state of the intermittent catheter assembly 310. In fact, the funnel 462 of the intermittent catheter assembly 310 may be mounted on a first of a pair of posts 460 extending from the storage plate 458, and the end cap 464 of the sterility-maintaining enclosure 466 of the intermittent catheter assembly 310 may be mounted on a second of the pair of posts 460. Thus, the storage plate 458 and its pair of posts 460 may protect the catheter tube 134 from contamination and may retain any lubricious coating 135 on the catheter tube 134 or any lubricant around the catheter tube 134 housed in its sterility-maintaining enclosure 466 or storage sheath 144 when the intermittent catheter assembly 310 is in an unused state. Furthermore, the storage plate 458 and its pair of posts 460 may retain residual urine in or around the catheter tube 134 housed in its urine retention enclosure or storage sheath 144 when the intermittent catheter assembly 310 is in a used state. The carrying case 450 may then be configured with a gasket, such as the gasket 162 described above, to provide enhanced secondary containment for any residual urine that may leak from the intermittent catheter assembly 310, particularly in a used state of the intermittent catheter assembly 310.

[0078] 52 , the carrying case 550 includes a body 552 and an overlying cover, such as a lid 554, for enclosing at least the evacuation assembly 170 or evacuation components thereof therein when unused. As shown, the body 552 and the lid 554 may be operatively connected to one another at the longitudinal ends of the carrying case 550 by an easy-to-use push-open lid opening mechanism (e.g., a cam follower mechanism) that requires little dexterity, and the lid 554 is configured to separate from the body 552 when an outer surface of the lid 554 is pressed into the body 552, thereby providing an opening for accessing the components of the intermittent catheter system 500 for removal from the carrying case 550, as shown. Additionally, the inner surface of the lid 554 may be configured as a storage plate 458 having a pair of suitably sized posts 460 extending therefrom configured to mount the intermittent catheter assembly 310 thereon, either in the unused state of the intermittent catheter assembly 310 or in the used state of the intermittent catheter assembly 310. Indeed, as described above, the funnel 462 of the intermittent catheter assembly 310 may be mounted on a first of the pair of posts 460 extending from the storage plate 458, and the end cap 464 of the intermittent catheter assembly 310 may be mounted on a second of the pair of posts 460. Thus, the storage plate 458 and its pair of posts 460 may protect the catheter tube 134 from contamination and may retain any lubricity coating 135 on the catheter tube 134 or any lubricity around the catheter tube 134 housed within its sterility-maintaining enclosure 466 or storage sheath 144 in the unused state of the intermittent catheter assembly 310. Additionally, the storage plate 458 and its pair of posts 460 may retain residual urine in or around the catheter tube 134 contained within its urine retention enclosure or storage sheath 144 in the used state of the intermittent catheter assembly 310.The carrying case 550 may then be configured with a gasket, such as the gasket 162 described above, to provide enhanced secondary containment for any residual urine that may leak from the intermittent catheter assembly 310, particularly in a used state of the intermittent catheter assembly 310.

[0079] Hard packaging such as that of carrying case 450 or 550 may provide better protection than soft packaging, particularly when intermittent catheter system 500 or the like is transported or otherwise carried independently; however, such hard packaging may be more difficult than soft packaging to pack into luggage or the like, particularly when packing such luggage securely.

[0080] Figures 47-50 illustrate an intermittent catheter system 300 according to some embodiments. In particular, each of Figures 47-50 illustrates the intermittent catheter system 300 with an opening mechanism for opening the rigid catheter housing 850 or 950 of the intermittent catheter system 300, thereby transitioning the intermittent catheter system 300 from its stored state to its open state, or vice versa.

[0081] As shown, intermittent catheter system 300 may include, among other things, the intermittent catheter assembly 310 described above without drainage bag 180 or other bulky drainage components. Furthermore, instead of the rigid carrying case 150, 250, 350, or 650 of intermittent catheter system 100 passively enclosing at least intermittent catheter assembly 310 in its unused or used state, catheter housings 850 and 950 interact with at least intermittent catheter assembly 310.

[0082] 49 and 50, the catheter housing 950 includes a body 952 and an overlying cover, such as a lid 954, having an optional opening loop 956 or the like, for enclosing at least the intermittent catheter assembly 310 therein in an unused state. As shown, the body 952 and the lid 954 may be connected to one another by living hinges 958 within longitudinal end portions of the catheter housing 950, whereby the body 952 and the lid 954 provide a clapperboard-shaped opening for unobstructed access to at least the intermittent catheter assembly 310 for removal from the catheter housing 950, as shown. Additionally, the catheter housing 950 may include a storage plate 458 configured to seat within a longitudinal end portion of the catheter housing 950 opposite the living hinge 958, or may be integrated into the inner surface of a short side of the catheter housing 950 opposite the living hinge 958. Notably, the short side of the catheter housing 950 including the storage plate 458 may also be connected to the body 952 by a living hinge 960, such that the short side of the catheter housing 950 may be folded away from the remainder of the body 952, such as folded onto the exterior, for reduced dexterity in removing the intermittent catheter assembly 310 from the catheter housing 950. Again, the storage plate 458 may have a pair of suitably sized posts 460 extending therefrom configured to mount the intermittent catheter assembly 310 thereon, either in the unused state of the intermittent catheter assembly 310 or in the used state of the intermittent catheter assembly 310. In fact, the funnel 462 of the intermittent catheter assembly 310 may be mounted on a first post of a pair of posts 460 extending from the storage plate 458, and the end cap 464 of the intermittent catheter assembly 310 may be mounted on a second post of the pair of posts 460.Thus, the storage plate 458 and its pair of posts 460 may protect the catheter tube 134 from contamination and may retain any lubricity coating 135 on the catheter tube 134 or any lubricity around the catheter tube 134 housed within its sterility-maintaining enclosure 466 or storage sheath 144 in the unused state of the intermittent catheter assembly 310. Furthermore, the storage plate 458 and its pair of posts 460 may retain residual urine in or around the catheter tube 134 housed within its urine retention enclosure or storage sheath 144 in the used state of the intermittent catheter assembly 310. The catheter housing 950 may then be configured with a gasket, such as the gasket 162 described above, to provide enhanced secondary containment for any residual urine that may leak from the intermittent catheter assembly 310, particularly in the used state of the intermittent catheter assembly 310.

[0083] 47 and 48 , the catheter housing 850 includes a body 852 and an overlying cover, such as a lid 854, having an optional opening loop 856 or the like, for enclosing at least the intermittent catheter assembly 310 therein in an unused state. As shown, the body 852 and the lid 854 may be connected to one another by a living hinge 858 within a longitudinal end portion of the catheter housing 850, whereby the body 852 and the lid 854 provide a clapperboard-shaped opening for unobstructed access to at least the intermittent catheter assembly 310 for removal from the catheter housing 850, as shown. Additionally, the catheter housing 850 may include a split or two-piece storage plate 860 distributed between the body and lid portions at a longitudinal end portion of the catheter housing 850 opposite the end portion including the living hinge 858. Such a storage plate 860 may be integrated into the inner split surface of the shorter side of the split or two-piece catheter housing 850 opposite the side containing the living hinge 858. Each piece of the split or two-piece storage plate 860 may have a pair of suitably sized posts 862 extending therefrom configured to mount the intermittent catheter assembly 310 thereon, either in the unused state of the intermittent catheter assembly 310 or in the used state of the intermittent catheter assembly 310. Indeed, the funnel 462 of the intermittent catheter assembly 310 may be mounted on a first post of the pair of posts 862 extending from the first piece of the split or two-piece storage plate 860, and the end cap 464 of the intermittent catheter assembly 310 may be mounted on a second post of the pair of posts 862 extending from the second piece of the split or two-piece storage plate 860.Thus, the split or two-piece storage plate 860 and its pair of posts 862 may protect the catheter tube 134 from contamination and may retain any lubricity coating 135 on the catheter tube 134 or any lubricity around the catheter tube 134 contained within its sterility-maintaining enclosure 466 or storage sheath 144 in an unused state of the intermittent catheter assembly 310. In particular, upon opening the catheter housing 850 in accordance with the opening mechanism for opening the catheter housing 850, the split or two-piece storage plate 860 separates such that the first and second pieces of the split or two-piece storage plate 860 face each other, thereby providing unobstructed access to the intermittent catheter assembly 310 for removal from the catheter housing 850 for use or for repositioning within the catheter housing 850 after use. Regarding the latter, the split or two-piece storage plate 860 and its pair of posts 862 may retain residual urine in or around the catheter tube 134 housed within its urine retention enclosure or storage sheath 144 in the used state of the intermittent catheter assembly 310. The catheter housing 850 may then be configured with a gasket, such as the gasket 162 described above, to provide enhanced secondary containment for any residual urine that may leak from the intermittent catheter assembly 310, particularly in the used state of the intermittent catheter assembly 310.

[0084] Hard packaging such as that of catheter housing 850 or 950 may provide better protection than soft packaging, particularly when intermittent catheter system 300 or the like is transported or otherwise carried independently; however, such hard packaging may be more difficult than soft packaging to pack into luggage or the like, particularly when packing such luggage securely.

[0085] Method for male or unisex intermittent catheter system As described below, methods may include methods of using the intermittent catheter systems and assemblies disclosed herein, although it should be understood that these methods may be further identified from the description of the intermittent catheter systems and assemblies and how they are configured to function. Similarly, additional methods may be identified from the description of the intermittent catheter systems and assemblies and how they are configured to function.

[0086] For example, the method of the intermittent catheter system 100 may include removing the evacuation assembly 170 from the rigid carrying case 150 when the evacuation assembly 170 is in an unused state.

[0087] As described above, the drainage assembly may include the intermittent catheter assembly 110 and the drainage bag 180. Briefly, with regard to the intermittent catheter assembly 110, the intermittent catheter assembly 110 may include an intermittent catheter 130 and a sterility-maintaining enclosure 132. The intermittent catheter 130 may include a catheter tube 134 and a funnel 136 on a proximal end portion of the catheter tube 134. The funnel 136 may have a funnel opening 142 for draining urine. The sterility-maintaining enclosure 132 may include a storage sheath 144 and an end cap 146. The storage sheath 144 and the end cap 146 may be configured to enclose at least the catheter tube 134 of the intermittent catheter 130 therein.

[0088] With regard to drainage bag 180, drainage bag 180 is optionally pre-connected to funnel 136 of intermittent catheter 130. The method may also include inserting a distal end portion of the catheter tube 134 into the urethra, draining urine from the bladder through the intermittent catheter 130 into a drainage bag 180, and enclosing at least the intermittent catheter assembly 110 in a carrying case 150 in a used state of the intermittent catheter assembly 110.

[0089] The method may also include inserting an end portion of the funnel 136 into a receptacle 148 in a distal portion of the end cap 146 to form a leak-tight, ulvo-osseous, end-to-end closure in the used state of the intermittent catheter assembly 110. Alternatively, the method may include inserting a plug (not shown) in a distal portion of the end cap 146 into the funnel opening 142 of the funnel 136 to form a leak-tight, ulvo-osseous, end-to-end closure in the used state of the intermittent catheter assembly 110. In either case, the storage sheath 144 may extend between the end cap 146 and the funnel 136 of the intermittent catheter 130 in the used state of the intermittent catheter assembly 110, thereby retaining 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.

[0090] The method may also include detaching a strap 182 that is adhered to a folded portion of the drainage bag 180 that is maintained in the folded state by the strap 182. The strap 182 may extend from a longitudinal end portion of the drainage bag 180 that includes the urine inlet 184.

[0091] The method may also include unfolding the drain bag 180. As described above, the collapsed state of the drain bag 180 may include one or more folds along a width such that the drain bag 180 has a shorter length in the collapsed state than in the unfolded state of the drain bag 180, one or more folds along a length such that the drain bag 180 has a shorter width in the collapsed state than in the unfolded state of the drain bag 180, or some combination thereof.

[0092] The method may also include draining urine from the drain bag 180 and folding a longitudinal end portion of the drain bag 180 including the urine inlet 184 into a processing pocket 220 integrated into the face of the drain bag 180 for a used state of the drain assembly 170. In particular, the processing pocket 220 is at the other longitudinal end portion of the drain bag 180 opposite the end portion including the urine inlet 184. Alternatively, the method may include draining urine from the drain bag 180, removing a processing pouch 222 attached to the other longitudinal end portion of the drain bag 180 opposite the end portion including the urine inlet 184, and enclosing the drain bag 180 within the processing pouch 222 for a used state of the drain assembly 170.

[0093] Female Intermittent Catheter System 12-22 illustrate an intermittent catheter system 200 or components thereof according to some embodiments. Such an intermittent catheter system 200 and its components are configured for use by a female human.

[0094] As shown, the intermittent catheter system 200 may include an intermittent catheter 230 and a rigid catheter housing 750. The intermittent catheter system 200 may have a storage state and an open state. In the storage state, the catheter housing 750 may be in its maximum extended state with the intermittent catheter 230 sealed within the primary chamber 758, as described below. In the open state, the outer sleeve 754 of the catheter housing 750 is slid over the inner sleeve 752 of the catheter housing 750 such that the catheter housing 750 may be in its maximum collapsed state, with the end cap 756 popping out of the outer sleeve 754 and the funnel 236 of the intermittent catheter 230 exposed for removal of the intermittent catheter 230 from the catheter housing 750. However, it should be understood that the open state of the intermittent catheter system 200 may include the outer sleeve 754 of the catheter housing 750 being slid over the inner sleeve 752 of the catheter housing 750 in its intermediate collapsed state, with the end cap 756 partially popping out of the outer sleeve 754 and the funnel 236 of the intermittent catheter 230 partially exposed.

[0095] 16-18 illustrate an intermittent catheter 230 according to some embodiments. The intermittent catheter 230 may include a catheter tube 234 and a funnel 236 on a proximal end portion of the catheter tube 234. The catheter tube 234 may include a plurality of eyelets 238 proximate the catheter tip 240, and the funnel 236 may have a funnel opening 242 in fluid communication with the eyelets 238 by a lumen 243 through the intermittent catheter 230 for draining urine. Additionally, the funnel 236 may include a plurality of ridges integrated into the exterior surface of the funnel 236 configured as a handle so that the funnel 236 can be grasped while removing the intermittent catheter 230 from the catheter housing 750 or draining urine.

[0096] 12-15 and 19-22 show a catheter housing 750 according to some embodiments. The catheter housing 750 may include an inner sleeve 752, an outer sleeve 754 slidably mounted over the inner sleeve 752, and an end cap 756. As shown in Figure 12, the catheter housing 750 is configured to collapse when the closed end portion of the inner sleeve 752 is held against a surface and the outer sleeve 754 is slid over the inner sleeve 752 toward the surface, thereby exposing the funnel 236 of the intermittent catheter 230 for removal of the intermittent catheter 230 from the catheter housing 750.

[0097] As shown, end cap 756 may be a swivel cap including a pair of extension arms 757, each of which includes a post 759 configured for insertion into a complementary through-hole in the open end portion of inner sleeve 752. Notably, such an end cap 756 contributes to secondary chamber 760, described below, but does not contribute to primary chamber 758. Alternatively, end cap 756 may approximate a single-ended cylinder (e.g., a cylinder with a single closed end) that simultaneously contributes to both primary chamber 758 and secondary chamber 760. (See FIG. 15, where post 759 on each extension arm of pair of extension arms 757 is shown in dashed outline to indicate its presence or absence according to whether it is a swivel cap or a single-ended cylinder.) Indeed, if end cap 756 approximates a single-ended cylinder, end cap 756 may be configured to seat within the end portion of outer sleeve 754 opposite the closed end portion of inner sleeve 752 and simultaneously contribute to both primary chamber 758 and secondary chamber 760. End cap 756 may overlap the open end portion of inner sleeve 752 with an interference fit, such as a clearance fit, to provide primary chamber 758 between end cap cavity 762 of end cap 756 and inner sleeve cavity 764 of inner sleeve 752. Regardless of whether the end cap 756 is a swivel cap or approximates a single-ended cylinder, an end cap gasket 766 (e.g., a single end cap gasket) around the end cap 756 and an inner sleeve gasket 768 (e.g., a single inner sleeve gasket) around the inner sleeve 752 may define the longitudinal limits of the secondary chamber 760 between the inner surface of the outer sleeve 754 and the outer surfaces of the end cap 756 and inner sleeve 752. In particular, the end cap gasket 766 and the inner sleeve gasket 768 provide sufficient friction to maintain the catheter housing 750 in a stored state under typical usage scenarios, thereby avoiding unintentional collapse of the catheter housing 750 into an open state.

[0098] The primary chamber 758 and the secondary chamber 760 provide primary and secondary containment, respectively, for containing or otherwise retaining any lubricious coating 135 on the catheter tube 234 or any lubricant around the catheter tube 234 of the intermittent catheter 230, thereby preventing leakage of lubricant from the catheter housing 750 when the intermittent catheter system 200 is in a stored state prior to use of the intermittent catheter 230. The primary chamber 758 and the secondary chamber 760 also provide primary and secondary containment, respectively, for any residual urine in or around the intermittent catheter 230, thereby preventing leakage of urine from the catheter housing 750 when the intermittent catheter system 200 is in a stored state after use of the intermittent catheter 230 and after it has been returned to the catheter housing 750 for storage until the entire intermittent catheter system 200 can be discarded.

[0099] Again, the catheter housing 750 may be configured to collapse from a maximum extended state in the storage state of the intermittent catheter system 200 to a maximum collapsed state in the open state of the intermittent catheter system 200 when the closed end portion of the inner sleeve 752 is held against a surface and the outer sleeve 754 is slid over the inner sleeve 752 toward the surface. With respect to the maximum extended state of the catheter housing 750, the inner circumference of the outer sleeve cavity 769 of the outer sleeve 754 is graduated in size by the outer sleeve step 770 toward the end portion of the outer sleeve 754 opposite the end portion including the end cap 756 (i.e., the distal end portion of the outer sleeve 754 according to the nomenclature used for the intermittent catheter 230). Additionally, the inner sleeve 752 includes an external ridge 772 configured to abut the outer sleeve step 770 at the opposite end portion (i.e., distal end portion) of the outer sleeve 754, thereby defining the maximum extended state of the catheter housing 750. For the maximum collapsed state of the catheter housing 750, the outer circumference of the inner sleeve 752 increases in size gradually toward the closed end portion of the inner sleeve 752 (i.e., the distal end portion of the inner sleeve 752 according to the nomenclature used for the intermittent catheter 230) due to the inner sleeve step 774. The taper of the inner circumference of the outer sleeve cavity 769 of the outer sleeve 754 distal to the outer sleeve step 770 is configured to limit upward movement of the inner sleeve 752 past the end portion of the outer sleeve 754 including the end cap 756 (i.e., the proximal end portion of the outer sleeve 754 according to the nomenclature used for the intermittent catheter 230), thereby defining the maximum collapsed state of the catheter housing 750. Advantageously, the inner sleeve step 774 on the outer periphery of the inner sleeve 752 also centers the inner sleeve 752 within the outer sleeve 754 when transitioning between the maximum extended state of the catheter housing 750 in the storage state of the intermittent catheter system 200 and the maximum collapsed state of the catheter housing 750 in the open state of the intermittent catheter system 200.

[0100] Method for female intermittent catheter system As described below, methods may include methods of using the intermittent catheter systems and assemblies disclosed herein, although it should be understood that these methods may be further identified from the description of the intermittent catheter systems and assemblies and how they are configured to function. Similarly, additional methods may be identified from the description of the intermittent catheter systems and assemblies and how they are configured to function.

[0101] For example, a method of the intermittent catheter system 200 may include obtaining the intermittent catheter system 200 in its storage state. As described above, the intermittent catheter system 200 may include a rigid catheter housing 750 and an intermittent catheter 230.

[0102] Briefly, with regard to the catheter housing 750, the catheter housing 750 may include an inner sleeve 752, an outer sleeve 754 slidably mounted over the inner sleeve 752, and an end cap 756. The end cap 756 seats within the end portion of the outer sleeve 754 opposite the closed end portion of the inner sleeve 752 and may be configured to simultaneously contribute to both a primary chamber 758 for primary containment and a secondary chamber 760 for secondary containment. In effect, the end cap 756 overlaps the open end portion of the inner sleeve 752, thereby providing the primary chamber 758 between an end cap cavity 762 of the end cap 756 and an inner sleeve cavity 764 of the inner sleeve 752. An end cap gasket 766 around the end cap 756 and an inner sleeve gasket 768 around the inner sleeve 752 then define the longitudinal limits of the secondary chamber 760 between the inner surface of the outer sleeve 754 and the outer surfaces of the end cap 756 and inner sleeve 752. Again, the primary chamber 758 and secondary chamber 760 provide primary and secondary containment, respectively, for any lubricant around the catheter tube 234 of the intermittent catheter 230, thereby preventing leakage of lubricant from the catheter housing 750 when the intermittent catheter system 200 is in a stored state prior to use of the intermittent catheter 230.

[0103] With respect to the intermittent catheter 230, the intermittent catheter 230 may include a catheter tube 234 and a funnel 236 on a proximal end portion of the catheter tube 234. The catheter housing 750 may be in its maximum extended state with the intermittent catheter 230 sealed within the primary chamber 758 in a storage state of the intermittent catheter system 200.

[0104] The method may also include transitioning the intermittent catheter system 200 to its open state. Transitioning the intermittent catheter system 200 to the open state includes grasping the outer sleeve 754 of the catheter housing 750, holding a closed end portion of the inner sleeve 752 of the catheter housing 750 against a surface with the outer sleeve 754 of the catheter housing 750, and sliding the outer sleeve 754 of the catheter housing 750 over the inner sleeve 752 of the catheter housing 750 toward the surface to expose the funnel 236 of the intermittent catheter 230. The funnel 236 of the intermittent catheter 230 pops the end cap 756 out of the outer sleeve 754 of the catheter housing 750 as the outer sleeve 754 is slid over the inner sleeve 752 of the catheter housing 750.

[0105] The method may also include removing the intermittent catheter 230 from the catheter housing 750 by the funnel 236 of the intermittent catheter 230. The method may also include inserting the distal end portion of the catheter tube 234 into the urethra, draining urine from the bladder through the intermittent catheter 230, repositioning the intermittent catheter 230 within the inner sleeve 752 of the catheter housing 750, and repositioning the end cap 756 within the end of the outer sleeve 754, thereby re-forming a primary chamber 758 for primary containment of any residual urine in or around the intermittent catheter 230, and a secondary chamber 760 for secondary containment of urine that has leaked from the primary chamber 758. Re-forming the primary chamber 758 and the secondary chamber 760 in this manner prevents urine leakage from the catheter housing 750 when the intermittent catheter system 200 is in a stored state after use of the intermittent catheter 230.

[0106] Although some specific embodiments are disclosed herein, and the specific embodiments are disclosed in some detail, the specific embodiments are not intended to limit the scope of the concepts provided herein. Additional improvements or modifications may be apparent to those skilled in the art, and the broader aspects encompass these as well. Thus, departures may be made from the specific embodiments disclosed herein without departing from the scope of the concepts provided herein.

Claims

1. 1. An intermittent catheter system, comprising: a rigid catheter housing; and an intermittent catheter; The rigid catheter housing comprises: an inner sleeve; an outer sleeve slidably mounted on the inner sleeve; an end cap seated within an end portion of the outer sleeve opposite the closed end portion of the inner sleeve, the end cap configured to simultaneously contribute to both a primary chamber for primary containment and a secondary chamber for secondary containment; Including, the intermittent catheter includes a catheter tube and a funnel on a proximal end portion of the catheter tube; The intermittent catheter system comprises: a storage state, in which the catheter housing is in its maximum extension state and the intermittent catheter is sealed within the primary chamber; an open state in which the outer sleeve of the catheter housing is slid over the inner sleeve of the catheter housing such that the catheter housing is in its maximum collapsed state, the end cap pops out of the outer sleeve, and the funnel of the intermittent catheter is exposed for removal of the intermittent catheter from the catheter housing. Intermittent catheter system.

2. 2. The intermittent catheter system of claim 1, wherein the end cap overlaps the open end portion of the inner sleeve, thereby providing the primary chamber between an end cap cavity of the end cap and an inner sleeve cavity of the inner sleeve.

3. 3. The intermittent catheter system of claim 1, wherein an end cap gasket around the end cap and an inner sleeve gasket around the inner sleeve define the longitudinal limits of the secondary chamber between the inner surface of the outer sleeve and the outer surfaces of the end cap and the inner sleeve.

4. 4. The intermittent catheter system of claim 1, wherein the primary chamber and the secondary chamber provide the primary containment and the secondary containment, respectively, for any residual urine in or around the intermittent catheter, thereby preventing urine leakage from the catheter housing when the intermittent catheter system is in the stored state after use of the intermittent catheter.

5. 4. The intermittent catheter system of claim 3, wherein the end cap gasket and the inner sleeve gasket provide sufficient friction to maintain the catheter housing in the stored state, thereby avoiding unintentional collapse of the catheter housing into the open state.

6. 6. The intermittent catheter system of claim 3, wherein the inner circumference of the outer sleeve cavity of the outer sleeve is stepped down in size by an outer sleeve step toward the end portion of the outer sleeve opposite the end portion including the end cap, and the inner sleeve includes an external ridge configured to abut the outer sleeve step at the opposite end portion of the outer sleeve, thereby defining the maximum extension state of the catheter housing.

7. 7. The intermittent catheter system of claim 6, wherein the outer periphery of the inner sleeve increases in size gradually toward the closed end portion of the inner sleeve by an inner sleeve step, and the taper of the inner periphery of the outer sleeve cavity of the outer sleeve is configured to limit movement of the inner sleeve through the end portion of the outer sleeve including the end cap, thereby defining the maximum collapsed state of the catheter housing.

8. 8. The intermittent catheter system of claim 7, wherein the inner sleeve step at the outer periphery of the inner sleeve centers the inner sleeve within the outer sleeve when transitioning the catheter housing between the stored state and the open state.

9. 9. The intermittent catheter system of claim 1, further comprising a lubricant coating on or around the catheter tube of the intermittent catheter sealed within the primary chamber in the storage state of the intermittent catheter system.

10. 10. The intermittent catheter system of claim 9, wherein the primary and secondary chambers respectively provide the primary and secondary containment for lubricant around the catheter tube of the intermittent catheter, thereby preventing leakage of lubricant from the catheter housing when the intermittent catheter system is in a stored state prior to use of the intermittent catheter.

11. 11. The intermittent catheter system of claim 1, wherein the catheter housing is configured to collapse when the closed end portion of the inner sleeve is held against a surface and the outer sleeve is slid over the inner sleeve toward the surface, thereby exposing the funnel of the intermittent catheter for removal of the intermittent catheter from the catheter housing.

12. 12. The intermittent catheter system of claim 1, wherein the funnel includes a plurality of ridges integrated into an outer surface of the funnel, the ridges configured as a handle so that the funnel can be grasped while removing the intermittent catheter from the catheter housing or draining urine.

13. 13. The intermittent catheter system of claim 1, wherein the catheter tube includes a plurality of eyelets proximate the catheter tip, the eyelets being in fluid communication with the funnel opening.

14. 14. The intermittent catheter system of claim 1, wherein the intermittent catheter is configured for use by a female human.

15. 1. A method for an intermittent catheter system, comprising: obtaining the intermittent catheter system in its stored state; the intermittent catheter system includes a rigid catheter housing and an intermittent catheter; The rigid catheter housing comprises: an inner sleeve; an outer sleeve slidably mounted on the inner sleeve; an end cap seated within an end portion of the outer sleeve opposite the closed end portion of the inner sleeve and configured to simultaneously contribute to both a primary chamber for primary containment and a secondary chamber for secondary containment; Including, the intermittent catheter includes a catheter tube and a funnel on a proximal end portion of the catheter tube; the catheter housing is in its maximum extended state with the intermittent catheter sealed within the primary chamber in the storage state of the intermittent catheter system. To obtain and transitioning the intermittent catheter system to its open state, grasping the outer sleeve of the catheter housing; holding a closed end portion of an inner sleeve of the catheter housing against a surface with the outer sleeve of the catheter housing; and sliding the outer sleeve of the catheter housing over the inner sleeve of the catheter housing toward the surface to expose a funnel of the intermittent catheter. To transfer and and removing the intermittent catheter from the catheter housing by the funnel of the intermittent catheter. Methods for intermittent catheter systems.

16. 16. The method of claim 15, wherein the funnel of the intermittent catheter pops the end cap out of the outer sleeve of the catheter housing when the outer sleeve is slid over the inner sleeve of the catheter housing.

17. 17. The method of claim 15 or 16, wherein the end cap overlaps the open end portion of the inner sleeve, thereby providing the primary chamber between an end cap cavity of the end cap and an inner sleeve cavity of the inner sleeve.

18. 18. The method of any one of claims 15 to 17, wherein an end cap gasket around the end cap and an inner sleeve gasket around the inner sleeve define the longitudinal limits of the secondary chamber between the inner surface of the outer sleeve and the outer surfaces of the end cap and inner sleeve.

19. 19. The method of any one of claims 15 to 18, wherein the primary and secondary chambers provide the primary and secondary containment, respectively, for any lubricant around the catheter tube of the intermittent catheter, thereby preventing leakage of lubricant from the catheter housing in the stored state of the intermittent catheter system prior to use of the intermittent catheter.

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