Intermittent catheter systems and assemblies and methods of use thereof

Abstract

Disclosed herein is an intermittent catheter system comprising a rigid catheter housing (750) and an intermittent catheter (230). The catheter housing may include an inner sleeve (752), an outer sleeve (754) slidably mounted over the inner sleeve, and an end cap (756) configured to be located within an end of the outer sleeve and to facilitate both a first chamber (758) and a second chamber (760). The intermittent conduit system may have a storage state in which the conduit housing includes its maximum extended state with the intermittent conduit sealed within the first chamber. The intermittent catheter system may have an open state in which the catheter housing includes its maximum collapsed state in which the end cap ejects from the outer sleeve, exposing a funnel (236) of the intermittent catheter for removal of the intermittent catheter from the catheter housing.

Description

[0001] Priority

[0002] This application claims the benefit of priority of U.S. Provisional Application No. 63 / 427,030, filed on November 21, 2022, the entire disclosure of which is incorporated herein by reference.

[0003] Cross - References

[0004] This application is related to PCT / US2021 / 043771, filed on July 29, 2021, PCT / US2021 / 044021, filed on July 30, 2021, and PCT / US2021 / 049867, filed on September 10, 2021, the entire disclosure of each of these patents being incorporated herein by reference. Background Art

[0005] Users of urinary catheters, such as intermittent catheters, self - insert the catheter four to six times a day. However, catheterization using such intermittent catheters can be messy. In fact, existing intermittent catheters typically include water or lubricant in their packaging for lubricating the intermittent catheter prior to insertion, but such packaging is not configured to prevent the water or lubricant from being messy. Moreover, such packaging is not configured to prevent messes after catheterization, such as those involving the discharged urine. There is a need for an easy - to - use intermittent catheter that facilitates cleaning before and after use.

[0006] Disclosed herein are an intermittent catheter system and components and methods thereof that solve the foregoing problems. Summary of the Invention

[0007] In some embodiments, disclosed herein is also an intermittent catheter system that 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 configured to be located within the end of the outer sleeve opposite the closed end of the inner sleeve and to contribute to both a first chamber for a first containment and a second chamber for a second containment. The intermittent catheter includes a catheter tubing and a funnel over a proximal portion of the catheter tubing. 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, wherein the intermittent catheter is sealed within the first chamber. In the open state, the outer sleeve of the catheter housing slides over the inner sleeve of the catheter housing such that the catheter housing can be in its maximum collapsed state, wherein the end cap pops out of the outer sleeve and the funnel of the intermittent catheter is exposed for removing the intermittent catheter from the catheter housing.

[0008] In some embodiments, the end cap overlaps the open end of the inner sleeve, thereby providing a first chamber between the end cap cavity of the end cap and the inner sleeve cavity of the inner sleeve.

[0009] In some embodiments, an end cap gasket around the end cap and an inner sleeve gasket around the inner sleeve define the longitudinal boundaries of a second chamber between the inner surface of the outer sleeve and the outer surfaces of the end cap and the inner sleeve.

[0010] In some embodiments, the first chamber and the second chamber respectively provide a first containment and a second containment for any residual urine in or around the intermittent catheter, thereby preventing urine from leaking from the catheter housing in the storage state of the intermittent catheter system after use of the intermittent catheter.

[0011] In some embodiments, the end cap gasket and the inner sleeve gasket provide sufficient friction to maintain the storage state of the catheter housing, thereby avoiding inadvertently collapsing the open state of the uncapped catheter housing.

[0012] In some embodiments, toward the end of the outer sleeve opposite the end including the end cap, the inner circumference of the outer sleeve cavity of the outer sleeve gradually decreases in magnitude of the outer sleeve step. The inner sleeve includes an outer ridge configured to abut the outer sleeve step in the opposite end of the outer sleeve, thereby defining the maximum extended state of the catheter housing.

[0013] In some embodiments, toward the closed end of the inner sleeve, the outer circumference of the inner sleeve gradually increases in magnitude of the inner sleeve step. The taper of the inner circumference of the outer sleeve cavity of the outer sleeve is configured to constrain the inner sleeve from moving through the end of the outer sleeve including the end cap, thereby defining the maximum collapsed state of the catheter housing.

[0014] In some embodiments, when transitioning between the storage state and the open state of the catheter housing, the inner sleeve step in the outer circumference of the inner sleeve centers the inner sleeve within the outer sleeve.

[0015] In some embodiments, the intermittent catheter system further includes a lubricating coating on the catheter fitting of the intermittent catheter or a lubricant around the catheter fitting that is sealed within the first chamber in the storage state of the intermittent catheter system.

[0016] In some embodiments, the first chamber and the second chamber respectively provide a first containment and a second containment for the lubricant around the catheter fitting of the intermittent catheter, thereby preventing the lubricant from leaking from the catheter housing in the storage state of the intermittent catheter system before use of the intermittent catheter.

[0017] In some embodiments, the catheter housing is configured to collapse when the closed end of the inner sleeve is held against a surface and the outer sleeve slides 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.

[0018] In some embodiments, the funnel includes a plurality of ridges integrated into the outer surface of the funnel. These ridges are configured to be grasped as handles when removing the intermittent catheter from the catheter housing or draining urine.

[0019] In some embodiments, the catheter fitting includes a plurality of holes near the catheter tip. These holes are in fluid communication with the funnel opening.

[0020] In some embodiments, the intermittent catheter is configured for use by females.

[0021] Also disclosed herein is a method of an intermittent catheter system. In some embodiments, the method includes obtaining an 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 configured to be located within the end of the outer sleeve opposite the closed end of the inner sleeve and to contribute to both a first chamber for a first accommodation and a second chamber for a second accommodation. The intermittent catheter includes a catheter fitting and a funnel over a proximal portion of the catheter fitting. The catheter housing can be in its maximum extended state, where in the storage state of the intermittent catheter system, the intermittent catheter is sealed within the first chamber. The method further includes converting the intermittent catheter system to its open state. Converting the intermittent catheter system to its open state includes: grasping the outer sleeve of the catheter housing; holding the closed end of the inner sleeve of the catheter housing against a surface through 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 the funnel of the intermittent catheter. The method further includes removing the intermittent catheter from the catheter housing through the funnel of the intermittent catheter.

[0022] In some embodiments, when the outer sleeve is slid over the inner sleeve of the catheter housing, the funnel of the intermittent catheter causes the end cap to pop out of the outer sleeve of the catheter housing.

[0023] In some embodiments, the end cap overlaps the open end of the inner sleeve, thereby providing a first chamber between the end cap cavity of the end cap and the inner sleeve cavity of the inner sleeve.

[0024] In some embodiments, an end cap gasket around the end cap and an inner sleeve gasket around the inner sleeve define the longitudinal boundaries of the second chamber between the inner surface of the outer sleeve and the outer surfaces of the end cap and the inner sleeve.

[0025] In some embodiments, the first chamber and the second chamber respectively provide a first containment and a second containment for any lubricant around the catheter fitting of the intermittent catheter, thereby preventing leakage of the lubricant from the catheter housing in the stored state of the intermittent catheter system before use of the intermittent catheter.

[0026] In some embodiments, the method further comprises: inserting a distal portion of the catheter fitting 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 reforming the first chamber for the first containment of any residual urine in or around the intermittent catheter and the second chamber for the second containment of any urine leaking from the first chamber. Thus, reforming the first chamber and the second chamber prevents leakage of urine from the catheter housing in the stored state of the intermittent catheter system after use of the intermittent catheter.

[0027] These and other features of the concepts provided herein will become more apparent to those skilled in the art in view of the drawings and the following description, which more particularly describes specific embodiments of such concepts. BRIEF DESCRIPTION OF THE DRAWINGS

[0028] Figure 1 An exploded view of a first intermittent catheter system including a drainage assembly and a first rigid carrier housing, the first intermittent catheter system being in an unused state of the first intermittent catheter system, is shown.

[0029] Figure 2 An exploded view of a drainage assembly of a first intermittent catheter system according to some embodiments is shown. Figure 1 of the first intermittent catheter system is shown.

[0030] Figure 3 An exploded view of a first intermittent catheter system according to some embodiments in a used state of the first intermittent catheter system is shown.

[0031] Figure 4 An exploded view of a first intermittent catheter assembly including a first intermittent catheter and a storage sheath of a drainage assembly according to some embodiments is shown.

[0032] Figure 5 A side view of a first intermittent catheter according to some embodiments is shown.

[0033] Figure 6 A longitudinal cross-section of a first intermittent catheter according to some embodiments is shown.

[0034] Figure 7 An exploded view of a Figure 6Detailed view of a longitudinal section of a first intermittent catheter.

[0035] Figure 8 Side view of a first intermittent catheter assembly according to some embodiments.

[0036] Figure 9 Longitudinal section of a first intermittent catheter assembly according to some embodiments.

[0037] Figure 10 Shows a first intermittent catheter assembly according to some embodiments Figure 9 Detailed view of a longitudinal section of.

[0038] Figure 11 Shows a first intermittent catheter assembly according to some embodiments Figure 9 Another detailed view of a longitudinal section of.

[0039] Figure 12 Isometric view of a second intermittent catheter system in a storage state according to some embodiments.

[0040] Figure 13 Exploded view of a second intermittent catheter system according to some embodiments.

[0041] Figure 14 Side view of a second intermittent catheter system according to some embodiments.

[0042] Figure 15 Longitudinal section of a second intermittent catheter system according to some embodiments.

[0043] Figure 16 Side view of a second intermittent catheter of a second intermittent catheter system according to some embodiments.

[0044] Figure 17 Longitudinal section of a second intermittent catheter according to some embodiments.

[0045] Figure 18 Shows a second intermittent catheter according to some embodiments Figure 17 Detailed view of a longitudinal section of.

[0046] Figure 19 Side view of an outer sleeve of a first rigid catheter housing of a second intermittent catheter system according to some embodiments.

[0047] Figure 20 Longitudinal section of an outer sleeve of a first catheter housing according to some embodiments.

[0048] Figure 25AShows a cross-section of the outer sleeve of the first catheter housing according to some embodiments.

[0049] Figure 25B Shows another cross-section of the outer sleeve of the first catheter housing according to some embodiments.

[0050] Figure 26 Shows a second intermittent catheter assembly in an unused state according to some embodiments.

[0051] Figure 27 Shows an opening mechanism for opening the second intermittent catheter assembly according to some embodiments.

[0052] Figure 28 Shows a sealing mechanism for sealing the second intermittent catheter assembly after use according to some embodiments.

[0053] Figure 29 Shows a funnel of a third intermittent catheter of the second intermittent catheter assembly according to some embodiments, the funnel including a rigid insert.

[0054] Figure 30 Shows a drainage bag with an integrated foldable sealed disposal pocket in an unfolded state of the drainage bag according to some embodiments.

[0055] Figure 31 Shows a deployment mechanism for deploying the drainage bag from a folded state according to some embodiments.

[0056] Figure 32 Shows a first tear tab for forming a urine outlet for draining any urine from the drainage bag according to some embodiments.

[0057] Figure 33 Shows a second tear tab for forming a urine outlet for draining any urine from the drainage bag according to some embodiments.

[0058] Figure 34 Shows a third tear tab for forming a urine outlet for draining any urine from the drainage bag according to some embodiments.

[0059] Figure 35 Shows a pop-up nozzle with a stopper for a urine outlet for draining any urine from the drainage bag according to some embodiments.

[0060] Figure 36 Shows a peel cord for forming a urine outlet for draining any urine from the drainage bag according to some embodiments.

[0061] Figure 37Illustrated is a screw cap covered nozzle for a urine outlet for draining any urine from a drainage bag, according to some embodiments.

[0062] Figure 38 Illustrated is a hinged cap covered nozzle for a urine outlet for draining any urine from a drainage bag, according to some embodiments.

[0063] Figure 39 Illustrated is a first pair of peel seal tabs for forming a urine outlet for draining any urine from a drainage bag, according to some embodiments.

[0064] Figure 40 Illustrated is a second pair of peel seal tabs for forming a urine outlet for draining any urine from a drainage bag, according to some embodiments.

[0065] Figure 41 Illustrated is a membrane covered nozzle for a urine outlet for draining any urine from a drainage bag, according to some embodiments.

[0066] Figure 42 Illustrated is a piercing element for piercing a membrane covered nozzle for draining any urine from a drainage bag, according to some embodiments.

[0067] Figure 43 Illustrated is a peel seal adhesive sheet for opening a urine outlet for draining any urine from a drainage bag, according to some embodiments.

[0068] Figure 44 Illustrated is a drainage bag having a separable fold sealed disposal pouch, in an unfolded state of the drainage bag, according to some embodiments.

[0069] Figure 45 Illustrated is a drainage bag having a separable zip sealed disposal pouch, in an unfolded state of the drainage bag, according to some embodiments.

[0070] Figure 46 Illustrated is a second rigid carrier housing of a first intermittent catheter system, in a closed state of the second carrier housing, according to some embodiments.

[0071] Figure 47 Illustrated is the second carrier housing in an open state, according to some embodiments.

[0072] Figure 48 Illustrated is the front of a third rigid carrier housing of a first intermittent catheter system, in a closed state of the third carrier housing, according to some embodiments.

[0073] Figure 49Shows the rear of the third carrier housing in a closed state according to some embodiments.

[0074] Figure 50 Shows the third carrier housing in an open state according to some embodiments.

[0075] Figure 51 Shows an isometric view of a third intermittent catheter system according to some embodiments, the third intermittent catheter system including a third intermittent catheter assembly in a second catheter housing and an opening mechanism for opening the second catheter housing.

[0076] Figure 52 Shows a side view of an opening mechanism for opening the second catheter housing and removing the third intermittent catheter assembly from the second catheter according to some embodiments.

[0077] Figure 53 Shows an isometric view of a third intermittent catheter system according to some embodiments, the third intermittent catheter system including a third intermittent catheter assembly in a third catheter housing and an opening mechanism for opening the third catheter housing.

[0078] Figure 54 Shows a side view of an opening mechanism for opening the third catheter housing and removing the third intermittent catheter assembly from the third catheter according to some embodiments.

[0079] Figure 55 Shows an isometric view of a fourth intermittent catheter system according to some embodiments, the fourth intermittent catheter system including a third intermittent catheter assembly in a fourth rigid carrier housing and an opening mechanism for opening the fourth carrier housing.

[0080] Figure 56 Shows an isometric view of a fourth intermittent catheter system according to some embodiments, the fourth intermittent catheter system including a third intermittent catheter assembly in a fifth rigid carrier housing and an opening mechanism for opening the fifth carrier housing.

[0081] Figure 57 Shows an isometric view of a fifth intermittent catheter system including a first tray package according to some embodiments, the fifth intermittent catheter system being in an unused state of the fifth intermittent catheter system.

[0082] Figure 58 Shows an isometric view of a fifth intermittent catheter system including a drainage assembly according to some embodiments, the fifth intermittent catheter system being in an open state of the fifth intermittent catheter system.

[0083] Figure 59Shows a fixing mechanism for fixing a fifth intermittent catheter system during a catheterization procedure in a first tray package according to some embodiments.

[0084] Figure 60 Shows an isometric view of a fifth intermittent catheter system including a second tray package, the fifth intermittent catheter system being in an unused state of the fifth intermittent catheter system.

[0085] Figure 61 Shows a fixing mechanism for fixing a fifth intermittent catheter system during a catheterization procedure in a second tray package according to some embodiments.

[0086] Figure 62 Shows a front view of a third tray package of a fifth intermittent catheter system according to some embodiments, the third tray package being in an unused state of the third tray package.

[0087] Figure 63 Shows a rear view of a third tray package in an unused state according to some embodiments.

[0088] Figure 64 Shows an opening and resealing mechanism for opening a third tray package and resealing the third tray package after a catheterization procedure according to some embodiments.

[0089] Figure 61 Shows a front view of a sixth rigid carrier housing of a first intermittent catheter system according to some embodiments, the sixth rigid carrier housing being in an unused state of the sixth carrier housing.

[0090] Figure 62 Shows a front view of the sixth carrier housing in an open state of the sixth carrier housing according to some embodiments.

[0091] Figure 63 Shows a front view of the sixth carrier housing in a resealed state of the sixth carrier housing according to some embodiments.

[0092] Figure 64 Shows a rear view of the sixth carrier housing in an unused or resealed state of the sixth carrier housing according to some embodiments. Detailed Description

[0093] Before disclosing some specific embodiments 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 the specific embodiments disclosed herein may have components or features that can be easily separated from the specific embodiments, and these components or features can optionally be combined with or replace the components or features of any of the many other embodiments disclosed herein. In one example, unless the context otherwise indicates or there is some other reason, any intermittent catheter system disclosed herein can be modified to include a carrier housing, a tray package, or a catheter outer shell; a drainage assembly; an intermittent catheter assembly; an intermittent catheter; or any other component of another intermittent catheter system disclosed herein.

[0094] Regarding the terms used herein, it should also be understood that these terms are for the purpose of describing some specific embodiments, and these terms do not limit the scope of the concepts provided herein. Ordinal numbers (e.g., first, second, third, etc.) are generally used to distinguish or identify different features or steps in a group of features or steps, and do not provide a sequence or numerical limitation. For example, the "first", "second", and "third" features or steps do not necessarily occur in that order, and a specific embodiment including such features or steps is not necessarily limited to these three features or steps. Additionally, unless otherwise specified, any of the foregoing features or steps may further include one or more features or steps. For convenience, labels such as "left", "right", "top", "bottom", "front", "rear", etc. are used, and these labels are not intended to imply, for example, any particular fixed position, orientation, or direction. Instead, such labels are used to reflect, for example, relative position, orientation, or direction. The singular forms "a", "an", and "the" include plural references unless the context clearly dictates otherwise.

[0095] "Proximal" is used to indicate the part, segment, component, element, etc. of a medical device that is intended to be placed near or relatively close to the clinician when the medical device is used on a patient. For example, the "proximal part" or "proximal segment" of a medical device includes the part or segment of the medical device that is intended to be placed near the clinician when the medical device is used on a patient. Similarly, the "proximal length" of a medical device includes the length of the medical device that is intended to be placed near the clinician when the medical device is used on a patient. The "proximal end" of a medical device includes the end that is intended to be placed near the clinician when the medical device is used on a patient. The proximal part, proximal segment, or proximal length of a medical device need not include the proximal end of the medical device. In fact, the proximal part, proximal segment, or proximal length of a medical device can be shorter than the proximal end of the medical device. However, the proximal part, proximal segment, or proximal length of a medical device can include the proximal end of the medical device. If the context does not indicate that the proximal part, proximal segment, or proximal length of a medical device includes the proximal end of the medical device, or if it is considered advantageous in the following description, the "proximal part", "proximal segment", or "proximal length" can be modified to indicate that such part, segment, or length respectively includes the end part, end segment, or end length of the medical device to refer to the "proximal part", "proximal segment", or "proximal length" of the medical device.

[0096] "Distal" is used to indicate the part, segment, component, element, etc. of a medical device that is intended to be placed near the patient, relatively close to the patient, or even within the patient when the medical device is used on a patient. For example, the "distal part" or "distal segment" of a medical device includes the part or segment of the medical device that is intended to be placed near the patient, relatively close to the patient, or even within the patient when the medical device is used on a patient. Similarly, the "distal length" of a medical device includes the length of the medical device that is intended to be placed near the patient, relatively close to the patient, or even within the patient when the medical device is used on a patient. The "distal end" of a medical device is the end that is intended to be placed near the patient, relatively close to the patient, or even within the patient when the medical device is used on a patient. The distal part, distal segment, or distal length of a medical device need not include the distal end of the medical device. In fact, the distal part, distal segment, or distal length of a medical device can be shorter than the distal end of the medical device. However, the distal part, distal segment, or distal length of a medical device can include the distal end of the medical device. If the context does not indicate that the distal part, distal segment, or distal length of a medical device includes the distal end of the medical device, or if it is considered advantageous in the following description, the "distal part", "distal segment", or "distal length" can be modified to indicate that such part, segment, or length respectively includes the end part, end segment, or end length of the medical device to refer to the "distal part", "distal segment", or "distal length" of the medical device.

[0097] An indication of the unused state of an intermittent catheter system or any of its components indicates that the described intermittent catheter system or its component remains in the packaged state as manufactured, distributed, or sold.

[0098] An indication of the used state of an intermittent catheter system or any of its components indicates that the described intermittent catheter system or its component is not in the unused state; that is, the intermittent catheter system or its component has been opened, unpackaged, prepared for use in a catheterization procedure, used in such a catheterization procedure, etc.

[0099] An indication of the stored state of an intermittent catheter system or any of its components indicates that the described intermittent catheter system or its component has been opened, unpackaged, prepared for use in a catheterization procedure, used in such a catheterization procedure, etc., but has been repackaged in some way for storage until disposal can occur. Alternatively, an indication of the stored state of an intermittent catheter system or any of its components can indicate that the described intermittent catheter system or its component remains in the packaged state as manufactured, distributed, or sold in the unused state. Thus, context should be used to inform any interpretation of the stored state of an intermittent catheter system or any of its components.

[0100] An indication of the closed state of an intermittent catheter system or any of its components indicates that the described intermittent catheter system or its component is simply closed. Thus, the described intermittent catheter system or its component can be in the unused state, the used state (but closed), or the stored state. Thus, context should be used to inform any interpretation of the closed state of an intermittent catheter system or any of its components, not just the fact of being closed.

[0101] An indication of the open state of an intermittent catheter system or any of its components indicates that the described intermittent catheter system or its component is simply open. Thus, the described intermittent catheter system or its component is also in the used state, as described above. In fact, the sterility of the intermittent catheter system is potentially compromised whether or not the intermittent catheter system or any of its components has been prepared for use in a catheterization procedure or used in such a catheterization procedure.

[0102] The carrier housing or tray packaging of an 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 catheterization.

[0103] The catheter housing of an intermittent catheter system is generally configured to enclose therein one or more intermittent catheter assemblies or intermittent catheters. The catheter housing and any other components for intermittent catheterization (including drainage bags) can be enclosed in the carrier housing or tray packaging disclosed herein or something selected by the user.

[0104] Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this disclosure pertains.

[0105] Male or unisex intermittent catheter system

[0106] Figures 1 to 11 、 Figure 23 、 Figure 24 、 Figure 25A 、 Figure 25B 、 Figures 26 to 64 illustrates various intermittent catheter systems or components thereof in accordance with some embodiments. Such intermittent catheter systems and components are configured for use by males or humans with non-specific anatomies.

[0107] Notably, the intermittent catheter system 100 is set forth immediately below as a reference embodiment for purposes of describing various intermittent catheter systems and their components. It should be understood that other intermittent catheter systems or components thereof set forth below may not be described in as much detail as the reference embodiment, as such details may be gathered from the description of the reference embodiment. Indeed, for purposes of reducing the illustrative burden, the description of other intermittent catheter systems or components thereof typically focuses on the differences from the reference embodiment of the intermittent catheter system 100 and its components, rather than reiterating commonalities. Finally, as noted above, it should be understood that any intermittent catheter system disclosed herein may be modified to include a carrier housing, a tray package, or a catheter sheath; a drainage assembly; an intermittent catheter assembly; an intermittent catheter; or any other component thereof of another intermittent catheter system disclosed herein, unless the context otherwise indicates or there is another reason therefor.

[0108] Figures 1 to 11 illustrates an intermittent catheter system 100 in accordance with some embodiments. Notably, Figure 1 illustrates the intermittent catheter system 100 in an unused state of the intermittent catheter system 100, Figure 3 illustrates the intermittent catheter system 100 in a used state of the intermittent catheter system 100.

[0109] As shown, the intermittent catheter system 100 may include a drainage assembly 170 and a rigid carrier housing selected from various carrier housings set forth below. The drainage assembly 170 may in turn include an intermittent catheter assembly 110 and a drainage bag 180, and the drainage bag 180 may be pre-connected to the funnel 136 of the intermittent catheter 130 of the intermittent catheter assembly 110, as Figure 2 shown. If the drainage bag 180 is not as Figure 2Regarding the funnel 136 pre-connected to the intermittent catheter 130 as shown, the drainage assembly 170 may alternatively be referred to as the drainage component of the intermittent catheter system 100 or another intermittent catheter system, as the case may be. 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 carrier housing 150 is elaborated in more detail below.

[0110] Figures 4 to 11 An intermittent catheter assembly 110 according to some embodiments is shown.

[0111] As shown, the intermittent catheter assembly 110 may include an intermittent catheter 130 and a sterility-maintaining enclosure 132 therefor.

[0112] The intermittent catheter 130 may include a catheter tube fitting 134 and a funnel 136 above the proximal portion of the catheter tube fitting 134. The catheter tube fitting 134 may include a plurality of holes 138 near the catheter tip 140, and the funnel 136 may have a funnel opening 142 that is in fluid communication with the holes 138 through the lumen 143 of the intermittent catheter 130 for urine drainage.

[0113] The sterility-maintaining enclosure 132 may include a storage sheath 144, an end cap 146 coupled to the distal portion of the storage sheath 144, and optionally, a tamper-evident peelable seal on the cap 146 at least in the unused state of the intermittent catheter assembly 110. The storage sheath 144 and the end cap 146 are configured to enclose at least the catheter tube fitting 134 of the intermittent catheter 130 therein to maintain its sterility in its unused state. In fact, the storage sheath 144 may extend between the funnel 136 of the intermittent catheter 130 and the end cap 146, and the end cap 146 may extend over the distal end of the catheter tube fitting 134, thereby protecting the catheter tube fitting 134 from contamination and, in the unused state of the intermittent catheter assembly 110, keeping any lubricating coating 135 on the catheter tube fitting 134 or any lubricant around the catheter tube fitting 134 contained within the sterility-maintaining enclosure 132 or its storage sheath 144. However, it should be understood that the sterility-maintaining enclosure 132 may also serve as a urine retention enclosure, whereby in the used state of the intermittent catheter assembly 110, any residual urine in or around the catheter tube fitting 134 is contained within the urine retention enclosure or its storage sheath 144. Switching between the sterility-maintaining enclosure 132 and the urine retention enclosure involves at least retracting the storage sheath 144 over the catheter tube fitting 134, draining urine through the intermittent catheter 130, and advancing the storage sheath 144 backward over the catheter tube fitting 134.

[0114] Notably, the intermittent catheter assembly 110 can form a leak - free, ouroboros - type, end - to - end enclosure in the unused state of the intermittent catheter assembly 110, the used state of the intermittent catheter assembly 110, or both. In fact, the distal portion of the end cap 146 can include a receptacle 148 configured to receive therein the end of the funnel 136 to form an end - to - end enclosure in the unused or used state of the intermittent catheter assembly 110. Alternatively, the distal portion of the end cap 146 can include a plug (not shown) configured to be inserted into the funnel opening 142 of the funnel 136 to form an end - to - end enclosure in the unused or used state of the intermittent catheter assembly 110. To facilitate the formation of such an end - to - end enclosure, the end cap 146 can include a flange 153 configured to facilitate the manipulation of the intermittent catheter assembly 110 when forming an end - to - end enclosure in the used state of the intermittent catheter assembly 110. Advantageously, the funnel 136 does not require a separate end cap to close the funnel 136 after use of the intermittent catheter 130. Moreover, forming an end - to - end enclosure in the used state of the intermittent catheter assembly 110 provides a convenient and compact form of the used state of the intermittent catheter assembly 110 until disposal can occur.

[0115] Figure 23 , Figure 24 , Figure 25A and Figure 25B An intermittent catheter assembly 210 is shown in accordance with some embodiments. Such an intermittent catheter assembly 210 is an alternative to the intermittent catheter assembly 110.

[0116] As shown, the intermittent catheter assembly 210 can include an intermittent catheter 330, a guidewire tip 332 on the distal 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 eliminates the need for 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 the guidewire tip 332 of the intermittent catheter 330 and the funnel 338 form a leak - free, ouroboros - type, end - to - end enclosure in the unused state of the intermittent catheter assembly 210, which is maintained by the tamper - evident packaging 336.

[0117] The intermittent catheter 330 may include a catheter fitting 134 and a funnel 338 over the proximal portion of the catheter fitting 134. The catheter fitting 134 may include a plurality of apertures 340 near the catheter tip 342, and the funnel 338 may have a funnel opening 344 that is in fluid communication with the apertures 340 through the lumen of the intermittent catheter 330 for urine drainage. Additionally, the funnel 338 may be formed of a polymeric material ranging from a soft polymeric material having a relatively low hardness to a rigid polymeric material having a relatively high hardness; however, when the funnel 338 is formed of a soft polymeric material, the funnel 338 may include a rigid insert 346 inserted or otherwise disposed therein, as Figure 25A and Figure 25B shown.

[0118] The rigid insert 346 is configured to have two lever-style semi-conical halves 348 to snap or clamp onto the introducer tip 332 in an end-to-end encapsulation in both the unused state and the 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-circular grooves, one or more semi-circular ridges, or some combination thereof, provided that the interlocking features are complementary to the interlocking features of the introducer tip 332. Advantageously, the rigid insert 346 may be configured such that when the distal portion of the funnel 338 is pinched or squeezed distally towards the 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 separate, thereby allowing the introducer tip 332 to be separated or otherwise removed from the funnel 338 of the intermittent catheter 330.

[0119] The distal end 332 of the introducer is configured to be inserted into the urethral orifice, and the catheter tubing 134 of the intermittent catheter 330 is advanced through the distal end 332 of the introducer. Such a distal end 332 of the introducer has a larger diameter than the catheter tubing 134, making it easier for users with low dexterity to insert the catheter using the distal end 332 of the introducer. The distal end 332 of the introducer can also be formed of a rigid polymer material having a relatively high hardness compared to the catheter tubing 134, which further makes it easier for users with low dexterity to insert the catheter using the distal end 332 of the introducer. Notably, the rigid polymer material of the distal end 332 of the introducer also enables the two lever-like semi-conical halves 348 of the rigid insert 346 to snap or clamp onto the distal end 332 of the introducer in the end-to-end encapsulation of the intermittent catheter assembly 210 in both its unused state and its used state. Additionally, such a distal end 332 of the introducer can include interlocking features with the rigid insert 346, such as one or more annular grooves, one or more annular ridges, or some combination thereof, as long as the interlocking features are complementary to the interlocking features of the rigid insert 346, and the interlocking features also enable the two lever-like semi-conical halves 348 of the rigid insert 346 to snap or clamp onto the distal end 332 of the introducer in the end-to-end encapsulation of the intermittent catheter assembly 210 in both its unused state and its used state.

[0120] The sterility-maintaining encapsulation 334 can include a storage sheath 144 configured to encapsulate the entire intermittent catheter 330 therein to maintain its sterility in its unused state. In fact, the storage sheath 144 can extend from the distal portion of the funnel 338, and the proximal portion of the storage sheath 144 is coupled around the distal portion to the entire catheter tubing 134, to the distal end 332 of the introducer where it can be coupled, to the proximal portion of the funnel 338, and back to the distal portion of the funnel 338. The distal portion of the storage sheath 144 is coupled to or otherwise covers the distal portion of the funnel 338 through a tamper-evident package 336, thereby protecting the entire intermittent catheter 330 and the distal end 332 of the introducer from contamination and maintaining any lubricating coating 135 on the catheter tubing 134 or any lubricant around the catheter tubing 134 within the sterility-maintaining encapsulation 334 or its storage sheath 144 in the unused state of the intermittent catheter assembly 210.

[0121] The tamper-evident package 336 can include a pull cord or tear strip 354 located between weakened (e.g., scored, perforated, etc.) separation lines of the storage sheath 144, such as a pull cord or tear strip formed from the polymer material of the storage sheath 144 itself, wherein the pull cord or tear strip 354 is configured to be pulled across the storage sheath 144 to open the tamper-evident package 336. As shown, the pull cord or tear strip 354 can include a handle 356 coupled thereto, the handle having any convenient shape of a variety of shapes, such as Figure 24 the annular handle 356 shown; however, in some embodiments, the pull cord or tear strip 354 need not include a handle 356 if provided with additional length for grasping or winding around one or more fingers.

[0122] The sterility-maintaining enclosure 334 can also serve as a urine retention enclosure, whereby in the deployed state of the intermittent catheter assembly 210, any residual urine in or around the catheter tubing 134 is retained within the urine retention enclosure or its storage sheath 144. In fact, after using the intermittent catheter 330 to drain urine, as the catheter tubing 134 of the intermittent catheter 330 is advanced through the distal end 332 of the introducer, the storage sheath 144 gathers around the distal portion of the funnel 338, and the storage sheath 144 can be repositioned over the intermittent catheter 330 and the distal end 332 of the introducer, as in the non-deployed state of the intermittent catheter assembly 210. Additionally, the distal end 332 of the introducer can be inserted into the funnel 338 including the rigid insert 346 such that in the end-to-end enclosure in the deployed state of the intermittent catheter, the two levered semi-conical halves 348 of the rigid insert 346 snap or clamp onto the distal end 332 of the introducer, whereby any residual urine in or around the catheter tubing 134 is retained within the urine retention enclosure or its storage sheath 144.

[0123] Figure 1 、 Figure 2 and Figures 26 to 41 illustrate various drainage bags or components thereof according to some embodiments. It should be noted that while such drainage bags are described herein as components of male or ambidextrous intermittent catheter systems, it should be understood that the female intermittent catheter systems described below can include Figure 1 、 Figure 2 and Figures 26 to 41 any of the drainage bags.

[0124] As shown, the drainage bag 180 can be a collapsible drainage bag that includes a urine drainage device for draining any urine from the drainage bag 180 and a disposal device for disposing of the drainage bag 180.

[0125] The drainage bag 180 can be in a folded state when the drainage assembly 170 or the drainage component is in an unused state, which provides a compact form of the drainage bag 180 until it is used during a catheterization procedure. During Figure 27 the shown folded state of the drainage bag 180, the drainage bag 180 can include: one or more folds along the width such that the drainage bag 180 has a shorter length in the folded state than in the unfolded state of the drainage bag 180; one or more folds along the length such that the drainage bag 180 has a shorter width in the folded state than in the unfolded state of the drainage bag 180; or some combination thereof. However, it should be understood that in the unused state of the drainage bag, the drainage bag 180 can be folded into any convenient geometric shape (e.g., square, rectangle, triangle, etc.) to fit within the rigid packaging described herein. The folded state of the drainage bag 180 can be maintained by a strip 182 that extends from a longitudinal end of the drainage bag 180 and also includes a urine inlet 184 to which the intermittent catheter 130 of the intermittent catheter assembly 110 is connected. The strip 182 can include a handle 183 and an adhesive strip or patch 185 for adhering to the folded portion of the drainage bag 180 to maintain the folded state of the drainage bag 180. After the strip 182 adhered to the folded portion of the drainage bag 180 is peeled off therefrom, the drainage bag 180 can be unfolded according to the unfolding mechanism for unfolding the drainage bag 180, as Figure 27 shown. It is noted that the drainage bag 180 can include a handle 186 that extends from the other longitudinal end of the drainage bag 180 opposite the end including the urine inlet 184. The handle 186 is configured to facilitate the unfolding of the drainage bag 180 from its folded state.

[0126] Figures 28 to 39 Various urine drainage devices for draining any urine from the drainage bag 180 are shown according to some embodiments.

[0127] As shown, the urine drainage device is opposite the strip 182 in the longitudinal end of the drainage bag 180 and also includes the urine inlet 184. Such urine drainage devices can include a tear tab 188, a peel cord 190, a peel seal tab 192, or a peel seal adhesive sheet 194 for forming a urine outlet or a nozzle 195 selected from various nozzles for the urine outlet.

[0128] Figures 28 to 30 An example of a tear tab 188 for forming a urine outlet is provided, where Figure 28 the tear tab 188 includes a handle 196 configured to directly pull the tear tab 188 across a weakened (e.g., scored, perforated, etc.) separation line of the drainage bag 180 starting from a starting notch 198 to form a urine outlet; Figure 29The tear tab 188 includes a handle 202 configured to pull the tear tab 188 out of the drain bag 180 (e.g., away from the longitudinal end of the drain bag 180 including the tear tab 188) and across the weakened separation line starting from the starting notch 198 to form a urine outlet; Figure 30 The handleless tear tab 188 is configured to directly pull the tear tab 188 across the weakened separation line of the drainage bag 180 starting from the starting notch 198 to form a urine outlet.

[0129] Similarly, Figure 32 An example of a ripcord 190 for forming a urine outlet is provided, wherein Figure 32 The detachable cord 190 includes an annular handle 204 coupled thereto for pulling the detachable cord 190 across the separation line of the drainage bag 180 under which the detachable cord 190 is embedded to form a urine outlet. It is worth noting that the handle 204 coupled to the detachable cord 190 can be any convenient shape; however, in some embodiments, the detachable cord 190 need not include a handle 204 if additional length is provided for grasping or wrapping around one or more fingers.

[0130] Figure 35 and Figure 36 An example of a peel-off sealing tab 192 for forming a urine outlet is provided, wherein Figure 35 The peel seal tabs 192 include a handle 206 configured to pull the peel seal tabs 192 away from the drain bag 180 (e.g., away from the front and back of the drain bag 180) starting from a small separation between the peel seal tabs 192 to form a urine outlet; Figure 36 The handleless peel-off sealing tab 192 is configured to be used to pull the peel-off sealing tab 192 away from the drain bag 180 (e.g., away from the front and back of the drain bag 180) starting from a small separation between the peel-off sealing tabs 192 to form a urine outlet. Notably, the peel-off sealing tab 192 is configured to reseal the urine outlet when the peel-off sealing tab 192 is pressed back together; however, in some embodiments, the peel-off sealing tab 192 may be only a peel-off tab without the ability to reseal when pressed together.

[0131] Similarly, Figure 39 An example of a peel-off seal adhesive sheet 194 for forming a urine outlet is provided, wherein Figure 39The stemless peel seal adhesive sheet 194 is configured to pull the peel seal adhesive sheet 194 away from the drainage bag 180 (e.g., away from the front or back of the drainage bag 180) to form a urine outlet. Notably, the peel seal adhesive sheet 194 is configured to reseal the urine outlet when the peel seal adhesive sheet 194 is pressed back onto the drainage bag 180 over the urine outlet; however, in some embodiments, the peel seal adhesive sheet 194 can be merely a peel sheet without the ability to reseal when pressed onto the drainage bag 180 over the urine outlet.

[0132] Figure 31 , Figure 33 , Figure 34 and Figure 37 Examples of various nozzles for the urine outlet are provided, where Figure 31 the nozzle 195 of Figure 31 includes a pop - stop 208 for a resealable pop - up stop - equipped nozzle, Figure 33 the nozzle 195 of Figure 33 includes a screw cap 211 for a resealable screw - cap - covered nozzle, Figure 34 the nozzle 195 of Figure 34 includes a hinged cap 212 for a resealable hinged - cap - covered nozzle, Figure 37 the nozzle 195 of Figure 37 includes a membrane 214 (e.g., plastic film, foil film, composite film of the foregoing films, etc.) for a membrane - covered nozzle. Notably, Figure 38 Examples of a piercing element 216 with a piercing end are provided, the piercing end being for piercing the membrane 214 of the membrane - covered nozzle for draining any urine from the drainage bag 180. As shown, such a piercing element 216 can be tethered to the drainage bag 180 with a tether 218 for keeping the piercing element 216 together with the drainage bag 180. Further, as shown, the piercing element 216 can be an end - open tube whose length is sufficient to extend into the nozzle 195 beyond any debris of the membrane 214 attached to the lip of the nozzle 195, thereby providing a smooth surface through the urine outlet for draining any urine therefrom. Alternatively, the piercing element 216 can be an end - closed tube having a closed end opposite the piercing end of the piercing element 216, thereby providing a stop for resealing the membrane - covered nozzle.

[0133] Figure 26 , Figure 40 and Figure 41 Illustrate various disposal devices for disposing of the drainage bag 180 according to some embodiments.

[0134] As shown, the disposal device can be a disposal pocket 220 or a disposal pouch 222 that is either integrally incorporated in the other longitudinal end of the drainage bag 180 opposite the end including the urine inlet 184 or removably attached thereto.

[0135] Figure 26 An example of a disposal pocket 220 is provided that is incorporated into the front of the drainage bag 180 for folding the longitudinal end of the drainage bag 180, including the urine inlet 184, into the disposal pocket 220 to achieve the use state of the drainage bag 180. However, the disposal pocket 220 can alternatively be incorporated into the back of the drainage bag 180 for folding the longitudinal end of the drainage bag 180, including the urine inlet 184, into the disposal pocket 220. Optionally, the disposal pocket can be pleated with pleats 224 or otherwise include additional polymeric material of the drainage bag 180 for expanding the disposal pocket 220 to accommodate therein the longitudinal end of the drainage bag 180, including the urine inlet 184. Additionally, the disposal pocket 220 can include a folding extension 226 formed from the polymeric material of the disposal pocket for sealing the longitudinal end of the drainage bag 180, including the urine inlet 184, within the disposal pocket 220 to achieve a substantially or completely leak-free use state of the drainage bag 180. Notably, the folding extension 226 of the disposal pocket 220 can include a handle 228 to facilitate folding the folding extension 226 over the back of the drainage bag 180 when the disposal pocket 220 is incorporated into the front of the drainage bag 180 or folding the folding extension over the front of the drainage bag 180 when the disposal pocket 220 is incorporated into the back of the drainage bag 180. Additionally, the folding extension 226 of the disposal pocket 220 can include an adhesive strip or patch 232 configured to seal the folding extension 226 to the back or front of the drainage bag 180 to achieve a substantially or completely leak-free use state of the drainage bag 180.

[0136] Figure 40 and Figure 41 An example of a disposal pouch 222 is provided that is removably attached to the other longitudinal end of the drainage bag 180 opposite the end including the urine inlet 184 for enclosing the drainage bag 180 within the disposal pouch 222 to achieve the use state of the drainage bag 180. Similar to the tear tab 188 for forming the urine outlet, the drainage bag 180 can be configured to directly pull the disposal pouch 222 across a weakened (e.g., scored, perforated, etc.) separation line starting from one of two notches 235 between the disposal pouch 222 and the remaining or main portion of the drainage bag 180 to separate the disposal pouch 222 from the remaining or main portion of the drainage bag 180. As Figure 40As shown, the disposal pouch 222 may include a folded extension 226 formed from the polymeric material of the drainage bag 180 for sealing the drainage bag 180 within the disposal pouch 222 after enclosing the remaining or major portion of the drainage bag 180 therein to achieve a substantially or completely leak - free use state of the drainage bag 180. Notably, the folded extension 226 of the disposal pouch 222 may include a handle 228 to facilitate folding the folded extension 226 over the opposite face of the drainage bag 180. Additionally, the folded extension 226 of the disposal pouch 222 may include an adhesive strip or patch 232 configured to seal the folded extension 226 over the opposite face of the drainage bag 180 to achieve a substantially or completely leak - free use state of the drainage bag 180. As Figure 41 shown, the disposal pouch 222 may alternatively include a zipper 237 instead of the folded extension 226 for sealing the drainage bag 180 within the disposal pouch 222 after enclosing the remaining or major portion of the drainage bag 180 therein to achieve a substantially or completely leak - free use state of the drainage bag 180.

[0137] Figure 1 , Figure 3 , Figures 42 to 46 and Figures 61 to 64 illustrate various rigid carrier housings 150, 250, 350, and 650 of an intermittent catheter system 100 according to some embodiments. Notably, such carrier housings 150, 250, 350, and 650 may be reusable such that the intermittent catheter system 100 can be made whole again or formed into a unit after use with one or more supplementary packages, each supplementary package including at least the drainage assembly 170 or its drainage components.

[0138] Regarding Figure 1 , Figure 3 , Figure 42 and Figure 43The load-bearing housings 150 and 250, each of the load-bearing housings 150 and 250 includes a main body 152 and a covering thereon, such as a cap 154, for enclosing at least the drainage assembly 170 or its drainage components therein in an unused state. Although not shown, it should be understood that the intermittent catheter system 100 may also include a covering on the main body 152, similar to the coverings described below for the tray packages 1050, 1150, and 1250 in the intermittent catheter system 500; however, such coverings should be considered tamper-proof packages for showing that the intermittent catheter system 100 remains in an unused state when the tamper-proof package remains intact. As shown, the main body 152 and the cap 154 may be connected to each other by one or more hinges 156, such as one or more active hinges, one or more self-closing spring hinges, etc., independently on the sub-longitudinal sides of each of the load-bearing housings 150 and 250. In addition, each of the load-bearing housings 150 and 250 may independently include a clamp 158, a rigid extension extending from the cap 154, such as a tab or handle having a through-hole on its sub-longitudinal side opposite to the side including one or more hinges 156, a pull strip 160, etc. In one example, the load-bearing housing 150 may include one or more active hinges on one sub-longitudinal side of the load-bearing housing 150 and a clamp 158 on the other sub-longitudinal side of the load-bearing housing 150, as Figure 1 and Figure 3 shown. In another example, the load-bearing housing 250 may include one or more self-closing spring hinges on one sub-longitudinal side of the load-bearing housing 250 and a pull strip 160 on the other sub-longitudinal side of the load-bearing housing 250, as Figure 42 and Figure 43 shown. Additionally, each of the load-bearing housings 150 and 250 may independently include a gasket 162 between the main body 152 and the cap 154, whereby the load-bearing housing 150 or 250 (as appropriate) is configured to provide enhanced secondary containment for any residual urine leaking from the intermittent catheter assembly 110 in the used state of the intermittent catheter assembly 110. In fact, with such a configuration, the load-bearing housing 150 or 250 is further configured to enclose at least the intermittent catheter assembly 110 therein in the used state of the intermittent catheter assembly 110.

[0139] Regarding Figures 44 to 46The carrier housing 350, which also includes a body 152 and a covering thereon, such as a cap 154, for at least enclosing therein at least the drainage assembly 170 or its drainage components in an unused state. As shown, the body 152 and the cap 154 may be connected to each other by one or more hinges 156 on the main longitudinal side of the carrier housing 350 (which is different from the carrier housing 150 or 250). Additionally, in contrast to the carrier housing 150 or 250, the front of the body 152 of the carrier housing 350 may have a shorter length than the rear of the body 152, thereby providing a larger opening in the body 152 for better access to the components of the intermittent catheter system 100 within the carrier housing 350. Complementarily, the front of the cap 154 of the carrier housing 350 may have a longer length than its rear. Further, the carrier housing 350 may include a snap member 164 on the main longitudinal side of the carrier housing 350 opposite the longitudinal side including one or more hinges 156. In fact, the snap member 164 may extend from the front of the cap 154 such that it extends over the front of the body 152 of the carrier housing 350, in which case it may snap into a retainer 166 in the front of the carrier housing 350 for fastening the cap 154 and the body 152 together, as Figure 44 shown. Although not shown, the carrier housing 350 may further include a gasket 162 between the body 152 and the cap 154 if the cap 154 is not formed of a rubber material. In any case, the carrier housing 350 is configured to provide a second containment for any residual urine leaking from the intermittent catheter assembly 110 in the use state of the intermittent catheter assembly 110. In fact, with such a configuration, the carrier housing 350 is further used to enclose at least the intermittent catheter assembly 110 therein in the use state of the intermittent catheter assembly 110.

[0140] Regarding Figures 61 to 64 the carrier housing 650, which also includes a body 152 and a covering thereon, such as a lid 168, for at least enclosing therein at least the drainage assembly 170 or its drainage components in an unused state. As shown, the body 152 and the lid 168 may be connected to each other by one or more hinges 156 on the main longitudinal side of the carrier housing 650. Similar to the carrier housing 350, the front of the body 152 of the carrier housing 650 may have a shorter length than the rear of the body 152, thereby providing a larger opening in the body 152 for better access to the components of the intermittent catheter system 100 within the carrier housing 650. However, as Figure 62As shown, the carrier housing 650 may further include a cutout 172 that connects to the aforementioned opening in the front, thereby providing an even larger opening in the body 152 for even better access to the components of the intermittent catheter system 100 that are within the carrier housing 650. Complementarily, the front of the lid of the carrier housing 650 may be shaped to have an extension 174 that overlaps with its opening and the cutout 172 in the body 152 of the carrier housing 650. Additionally, the carrier housing 650 may include a hinged snap 176 on the main longitudinal side of the carrier housing 650 that is opposite the longitudinal side that includes one or more hinges 156. The hinged snap 176 may be used to indicate the unused state or the used state of the intermittent catheter system 100. In fact, in the unused state of the intermittent catheter system 100, the hinged snap 176 may be exactly on the extension 174 of the lid 168, as Figure 61 shown. In the used state of the intermittent catheter system 100, the hinged snap 176 may extend from the extension 174 of the lid 168 on the front of the body 152 of the carrier housing 650. In this case, it may snap into a retainer 178 in the front of the carrier housing 650 for fastening the cap 154 and the body 152 together, as Figure 63 shown. Although not shown, if the cap 154 is not formed of a rubber material, the carrier housing 650 may further include a gasket 162 between the body 152 and the cap 154. In any case, the carrier housing 650 is configured to provide a second containment for any residual urine that leaks from the intermittent catheter assembly 110 in the used state of the intermittent catheter assembly 110. In fact, with such a configuration, the carrier housing 650 is further used to enclose at least the intermittent catheter assembly 110 therein in the used state of the intermittent catheter assembly 110.

[0141] It is worth noting that when carrying the intermittent catheter system 100 independently or otherwise on the back, rigid packages (such as the rigid packages of the carrier housings 150, 250, 350, and 650) provide better protection than soft packages; however, such rigid packages may be more difficult to pack into a suitcase, etc., especially when packing such a suitcase tightly.

[0142] Figures 53 to 60 An intermittent catheter system 500 according to some embodiments is shown. It is worth noting that Figure 53 、 Figure 56 、 Figure 58 and Figure 59 show the intermittent catheter system 500 in the unused state of the intermittent catheter system 500, Figure 54 、 Figure 55 、 Figure 57 and Figure 60The intermittent catheter system 500 in a state of use of the intermittent catheter system 500 is shown.

[0143] As shown, the intermittent catheter system 500 may include a drainage assembly 170 or its drainage component, similar to the intermittent catheter system 100 described above. However, instead of the rigid carrier housings 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 package member) selected from at least the tray packages (or tray package members) 1050, 1150, and 1250 described below.

[0144] Regarding Figures 53 to 55 the tray package 1050, the tray package 1050 includes: a tray 1052 having a rectangular shape defined by a longitudinal cross-section of the tray 1052; a cover 1054 on an originally open face of the tray 1052 for enclosing at least the drainage assembly 170 or its drainage component therein in an unused state; and a securing mechanism for securing the intermittent catheter system 500 during a catheterization procedure. As shown, the tray 1052 may include a lip 1056 around the tray 1502 and a lip extension 1058 extending from the lip 1056 at a longitudinal end 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; however, a cover extension 1060 of the cover 1054 extending over the lip extension 1058 of the tray 1052 is significantly not sealed to the lip extension 1058. In fact, such a cover extension 1060 of the cover 1054 (which may be a tab or a 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 for accessing the components of the intermittent catheter system 500 within the tray package 1050. When the cover extension 1060 of the cover 1054 is as Figure 53 and Figure 54When the annular handle 1062 as shown is in place, one can pass a finger through the hole in the handle 1062 and bend the rigid yet flexible lip extension 1058 of the tray 1052 towards the base of the tray 1052 to separate the handle 1062 from the lip extension 1058 for grasping the handle 1062. Additionally, the lip extension 1058 of the tray 1052 can include an integrated clamp 1064 for a securing mechanism, and the integrated clamp 1064 is used to conveniently clamp the tray 1052 and thus the intermittent catheter system 500 to the user's shirt during a catheterization procedure. Finally, since the cover 1054 can be resealed to the tray 1052 via a resealable seal around the lip 1056 of the tray 1052, the tray package 1050 is configured to provide a secondary containment for any residual urine leaking from the intermittent catheter assembly 110 in the used state of the intermittent catheter assembly 110. In fact, with such a configuration, the tray package 1050 is further configured to enclose at least the intermittent catheter assembly 110 therein in the used state of the intermittent catheter assembly 110.

[0145] Regarding Figure 56 and Figure 57 the tray package 1150, the tray package 1150 includes: a tray 1052 (e.g., a circular tray or an oval tray) having an oval shape defined by the longitudinal cross-section of the tray 1052; a cover 1054 on the originally open face of the tray 1052 for enclosing at least the drainage assembly 170 or its drainage components therein in the unused state; and a securing mechanism for securing the intermittent catheter system 500 during a catheterization procedure. Similar to the rectangular tray 1052, the oval tray 1052 can include a lip 1056 around the tray 1052 and a lip extension 1058 extending from the lip 1056 of the tray 1052, and the lip extension 1058 can also include an integrated clamp 1064 for conveniently clamping the tray 1052 and thus the intermittent catheter system 500 to the user's shirt during a catheterization procedure. However, differently, the clamp 1064 of the oval tray 1052 is advantageously centered in the lip extension 1058 of the tray 1052 rather than being offset to one side as in the rectangular tray 1052. The cover 1054 can be sealed to the tray 1052 via a resealable seal around the lip 1056 of the tray 1052. Although not shown, the cover 1054 of the tray package 1150 can include an unsealed cover extension, similar to the cover extension 1060 of the tray package 1050; however, when the tray package 1150 includes such a cover extension, it extends at least over the tongue 1066 of the clamp 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 Figure 53 andFigure 54 For the annular handle portion 1062 shown, a finger can be used to bend the rigid but flexible tongue 1066 of the clamp 1064 towards the base of the tray 1052 to separate the cover extension 1060 from the lip extension 1058, to facilitate grasping the cover extension 1060 and at least partially peeling the cover 1054 from the tray 1052, thereby for accessing the components within the tray package 1150 of the intermittent catheter system 500. Finally, since the cover 1054 can be resealed to the tray 1052 by a resealable seal around the lip 1056 of the tray 1052, the tray package 1150 is configured to provide a secondary containment for any residual urine leaking from the intermittent catheter assembly 110 in the state of use of the intermittent catheter assembly 110. In fact, with such a configuration, the tray package 1150 is further configured to enclose at least the intermittent catheter assembly 110 therein in the state of use of the intermittent catheter assembly 110.

[0146] Regarding Figures 58 to 60The tray package 1250, which also includes a tray 1052 (e.g., a circular or oval tray) having an elliptical shape defined by the longitudinal cross-section of the tray 1052, but different in that the flange 1056 surrounding the tray 1052 has a teardrop shape. Additionally, the tray package 1250 includes: a cover 1054, which is on the originally open face of the tray 1052 and is used to enclose at least the drainage assembly 170 or its drainage components therein in the unused state; and a fixing mechanism for fixing the intermittent catheter system 500 during the catheterization procedure. The flange 1056 surrounding the tray 1052 includes a flange extension 1058 extending from the flange 1056 of the tray 1052, but the flange extension 1058 tapers to a point, thereby giving the teardrop-shaped flange 1056 its shape. The pointed flange extension 1058 may include an integrated clamp 1064 for conveniently clamping the tray 1052 and thus the intermittent catheter system 500 to the user's shirt during the catheterization procedure. Notably, the clamp 1064 of the tray 1052 is pointed, and due to the length of the pointed flange extension 1058, such a pointed clamp 1064 can have a deeper bite and thus a stronger grip on the user's shirt than the clamp 1064 of the tray packages 1050 or 1150. Additionally, the pointed clamp 1064 may be made of a different, more rigid material than the remainder of the tray 1052, such as a metal clamp overmolded into a polymer tray, thereby further strengthening the grip of the pointed clamp 1064. Finally, the pointed clamp 1064 of the tray 1052 is advantageously centered within the pointed flange extension 1058 of the tray 1052, rather than being offset to one side as in the rectangular tray 1052. The cover 1054 may be sealed to the tray 1052 by a resealable seal around the flange 1056 of the tray 1052. Although the cover 1054 may include an unsealed cover extension extending over the pointed flange extension 1058, similar to the cover extension 1060 of the tray package 1050, but Figure 58 the tray package 1250 is alternatively shown as having a triangular handle 1068 oriented opposite to the pointed flange extension 1058 to facilitate gripping the handle 1068 and at least partially peeling the cover 1054 from the tray 1052, thereby for accessing the components of the intermittent catheter system 500 within the tray package 1250. Finally, since the cover 1054 can be resealed to the tray 1052 by a resealable seal around the flange 1056 of the tray 1052, the tray package 1250 is configured to provide a secondary containment for any residual urine leaking from the intermittent catheter assembly 110 in the used state of the intermittent catheter assembly 110. In fact, with such a configuration, the tray package 1250 is further configured to enclose at least the intermittent catheter assembly 110 therein in the used state of the intermittent catheter assembly 110.

[0147] Notably, when carried independently or otherwise borne, such as an intermittent catheter system 500, rigid packages (such as the rigid packages of tray packages 1050, 1150, and 1250) provide better protection than soft packages; however, such rigid packages may be more difficult to pack into a suitcase or the like, especially when tightly packing such a suitcase.

[0148] Figure 51 and Figure 52 illustrates an intermittent catheter system 400 according to some embodiments. Notably, Figure 51 and Figure 52 illustrates an intermittent catheter system 400 according to an opening mechanism for opening a rigid carrier housing 450 or 550 of the intermittent catheter system 400 and thereby converting the intermittent catheter system 400 from its stored state to an open state and vice versa.

[0149] As shown, the intermittent catheter system 400 may include a drainage assembly 170 or its drainage component, similar to the intermittent catheter system 100 described above. However, instead of the rigid carrier housings 150, 250, 350, or 650 that passively enclose the drainage assembly 170 or its drainage component in its unused or used state for the intermittent catheter system 100, the carrier housings 450 and 550 interact with at least the intermittent catheter assembly 310.

[0150] Regarding Figure 51A carrier housing 450, the carrier housing 450 including a main body 452 and a covering thereon, such as a lid 454, for at least enclosing therein at least the drainage assembly 170 or its drainage components in an unused state. As shown, the main body 452 and the lid 454 may be connected to each other by a longitudinal movable hinge 456 on the main longitudinal side of the carrier housing 450, and the main body 452 and the lid 454 thereby provide a clamshell opening for unobstructed access to the components of the intermittent catheter system 500 for removal from the carrier housing 450, as shown. Additionally, the carrier housing 450 may include a storage plate 458 having a pair of appropriately sized posts 460 extending therefrom, the pair of posts being configured to mount the intermittent catheter assembly 310 thereon in an unused state of the intermittent catheter assembly 310 or in a 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 one of the 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 one of the pair of posts 460. Thus, the storage plate 458 and its pair of posts 460 may protect the catheter tubing 134 from contamination and, in an unused state of the intermittent catheter assembly 310, maintain any lubricating coating 135 on the catheter tubing 134 or any lubricant surrounding the catheter tubing 134 within the sterility-maintaining enclosure 466 or its storage sheath 144. Further, in a used state of the intermittent catheter assembly 310, the storage plate 458 and its pair of posts 460 may retain any residual urine in or around the catheter tubing 134 within the urine-retaining enclosure or its storage sheath 144. The carrier housing 450 may in turn be configured to have a gasket similar to the gasket 162 and the like described above to provide enhanced secondary containment, particularly for any residual urine that may leak from the intermittent catheter assembly 310 in a used state of the intermittent catheter assembly 310.

[0151] Regarding Figure 52The load-bearing housing 550 includes a main body 552 and a covering thereon, such as a lid 554, for at least enclosing therein at least the drainage assembly 170 or its drainage components in an unused state. As shown, the main body 552 and the lid 554 may be operably connected to each other by a low dexterity-friendly push-open lid opening mechanism (e.g., a cam and follower mechanism) in the longitudinal ends of the load-bearing housing 550, wherein the lid 554 is configured to separate from the main body 552 when the outer surface of the lid 554 is pressed into the main body 552, thereby providing an opening for accessing the components of the intermittent catheter system 500 to remove them from the load-bearing housing 550, as shown. Additionally, the inner surface of the lid 554 may be configured as a storage plate 458, the storage plate having a pair of appropriately sized posts 460 extending therefrom, the pair of posts being configured to mount the intermittent catheter assembly 310 thereon in an unused state or in a used state of the intermittent catheter assembly 310. In fact, as described above, the funnel 462 of the intermittent catheter assembly 310 may be mounted on the first post 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 the second post of the pair of posts 460. Thus, the storage plate 458 and its pair of posts 460 may protect the catheter tubing 134 from contamination and, in an unused state of the intermittent catheter assembly 310, retain any lubricating coating 135 on the catheter tubing 134 or any lubricant surrounding the catheter tubing 134 within the sterility-maintaining enclosure 466 or its storage sheath 144. Additionally, in a used state of the intermittent catheter assembly 310, the storage plate 458 and its pair of posts 460 may retain any residual urine in or around the catheter tubing 134 within the urine-retaining enclosure or its storage sheath 144. The load-bearing housing 550 may in turn be configured to have a gasket similar to the gasket 162 and the like described above to provide enhanced secondary containment, particularly for any residual urine that may leak from the intermittent catheter assembly 310 in a used state of the intermittent catheter assembly 310.

[0152] Notably, when carrying the intermittent catheter system 500 or the like independently or otherwise on the back, a rigid package (such as the rigid package of the load-bearing housing 450 or 550) provides better protection than a soft package; however, such rigid packages may be more difficult to pack into a suitcase or the like, particularly when tightly packing such a suitcase.

[0153] Figures 47 to 50 An intermittent catheter system 300 is shown according to some embodiments. Notably, Figures 47 to 50Each figure therein shows an intermittent catheter system 300 according to an opening mechanism for opening a rigid catheter housing 850 or 950 of the intermittent catheter system 300 and thereby converting the intermittent catheter system 300 from its stored state to an open state and vice versa.

[0154] As shown, the intermittent catheter system 300 can include the intermittent catheter assembly 310 described above, and it is noted that there is no drainage bag 180 or other large-volume drainage component. Further, instead of the rigid carrier housings 150, 250, 350 or 650 of the intermittent catheter system 100 that passively enclose at least the intermittent catheter assembly 310 in its unused or used state, the catheter housings 850 and 950 interact with at least the intermittent catheter assembly 310.

[0155] From Figure 49 and Figure 50Starting with the catheter housing 950, the catheter housing 950 includes a body 952 and a covering thereon, such as a lid 954 having an optional open loop 956, etc. The catheter housing 950 is configured to enclose at least an intermittent catheter assembly 310 therein in an unused state. As shown, the body 952 and the lid 954 can be connected to each other by a movable hinge 958 in the longitudinal ends of the catheter housing 950, and the body 952 and the lid 954 thus provide a partition-type 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 can include a storage plate 458, and the storage plate can be configured to be located within the longitudinal end of the catheter housing 950 opposite the movable hinge 958 or integrated into the inner surface of the secondary side of the catheter housing 950 opposite the movable hinge 958. Notably, the secondary side of the catheter housing 950 including the storage plate 458 can also be connected to the body 952 by a movable hinge 960, such that the secondary side of the catheter housing 950 can be folded away from the remainder of the body 952, such as folded down onto the outer surface, for low dexterity-friendly removal of the intermittent catheter assembly 310 from the catheter housing 950. Similarly, the storage plate 458 can have a pair of appropriately sized posts 460 extending therefrom, and the pair of posts are configured to mount the intermittent catheter assembly 310 thereon in an unused state of the intermittent catheter assembly 310 or in a used state of the intermittent catheter assembly 310. In fact, the funnel 462 of the intermittent catheter assembly 310 can be mounted on the first post of the pair of posts 460 extending from the storage plate 458, and the end cap 464 of the intermittent catheter assembly 310 can be mounted on the second post of the pair of posts 460. Thus, the storage plate 458 and its pair of posts 460 can protect the catheter tubing 134 from contamination and, in an unused state of the intermittent catheter assembly 310, maintain any lubricating coating 135 on the catheter tubing 134 or any lubricant surrounding the catheter tubing 134 within the sterility-maintaining encapsulation 466 or its storage sheath 144. Additionally, in a used state of the intermittent catheter assembly 310, the storage plate 458 and its pair of posts 460 can hold any residual urine in or around the catheter tubing 134 within the urine-retaining encapsulation or its storage sheath 144. The catheter housing 950 can further be configured to have a gasket similar to the gasket 162, etc., described above, to provide enhanced secondary containment, particularly for any residual urine that may leak from the intermittent catheter assembly 310 in a used state of the intermittent catheter assembly 310.

[0156] Regarding Figure 47 and Figure 48a catheter housing 850, the catheter housing 850 including a body 852 and a covering thereon, such as a cap 854 having an optional open loop 856, etc., the catheter housing 850 being configured to enclose at least an intermittent catheter assembly 310 therein in an unused state. As shown, the body 852 and the cap 854 can be connected to each other by a living hinge 858 in the longitudinal ends of the catheter housing 850, the body 852 and the cap 854 thereby providing a partition-type 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 can include a separate or two-piece storage plate 860, the storage plate being distributed between the body piece and the cap piece at the longitudinal end of the catheter housing 850 opposite the longitudinal end including the living hinge 858. Such a storage plate 860 can be integrated into the separate inner surface of the separate or two-piece secondary side of the catheter housing 850 opposite the side including the living hinge 858. Each piece of the separate or two-piece storage plate 860 can have appropriately sized posts extending therefrom to effect a pair of posts 862, the pair of posts being configured to mount the intermittent catheter assembly 310 thereon in an unused state of the intermittent catheter assembly 310 or in a used state of the intermittent catheter assembly 310. In fact, the funnel 462 of the intermittent catheter assembly 310 can be mounted on the first post of the pair of posts 862 extending from the first piece of the separate or two-piece storage plate 860, and the end cap 464 of the intermittent catheter assembly 310 can be mounted on the second post of the pair of posts 862 extending from the second piece of the separate or two-piece storage plate 860. Thus, the separate or two-piece storage plate 860 and its pair of posts 862 can protect the catheter fitting 134 from contamination and, in an unused state of the intermittent catheter assembly 310, keep any lubricating coating 135 on the catheter fitting 134 or any lubricant around the catheter fitting 134 contained within the sterility-maintaining enclosure 466 or its storage sheath 144. It is noted that when the catheter housing 850 is opened according to an opening mechanism for opening the catheter housing 850, the separate or two-piece storage plate 860 is separated such that the first piece and the second piece of the separate or two-piece storage plate 860 are opposite each other, thereby providing unobstructed access to the intermittent catheter assembly 310 for removal from the catheter housing 850 for use or for re-placement in the catheter housing 850 after use. Regarding the latter, in a used state of the intermittent catheter assembly 310, the separate or two-piece storage plate 860 and its pair of posts 862 can keep any residual urine in or around the catheter fitting 134 contained within the urine retention enclosure or its storage sheath 144. The catheter housing 850 can further be configured to have a gasket, such as the gasket 162 described above, etc., to provide enhanced secondary containment, particularly for any residual urine that may leak from the intermittent catheter assembly 310 in a used state of the intermittent catheter assembly 310.

[0157] Notably, when carried independently or otherwise strapped to the body, such as an intermittent catheter system 300, a rigid package (such as the rigid packages of catheter housings 850 or 950) provides better protection than a soft package; however, such rigid packages may be more difficult to pack into a suitcase, etc., especially when packing such a suitcase tightly.

[0158] Method of male or unisex intermittent catheter system

[0159] As described below, the methods can include methods of using the intermittent catheter systems and components disclosed herein; however, it should be understood that these methods can be further discerned from the description of the intermittent catheter systems and components and how they are configured to function. Similarly, additional methods can be discerned from the description of the intermittent catheter systems and components and how they are configured to function.

[0160] For example, a method of the intermittent catheter system 100 can include removing the drainage assembly 170 from the rigid carrying housing 150 in an unused state of the drainage assembly 170.

[0161] As described above, the drainage assembly can include an intermittent catheter assembly 110 and a drainage bag 180.

[0162] Briefly, with respect to the intermittent catheter assembly 110, the intermittent catheter assembly 110 can include an intermittent catheter 130 and a sterility-maintaining enclosure 132. The intermittent catheter 130 can include a catheter tube member 134 and a funnel 136 over a proximal portion of the catheter tube member 134. The funnel 136 can have a funnel opening 142 for discharging urine. The sterility-maintaining enclosure 132 can include a storage sheath 144 and an end cap 146. The storage sheath 144 and the end cap 146 can be configured to enclose at least the catheter tube member 134 of the intermittent catheter 130 therein.

[0163] With respect to the drainage bag 180, the drainage bag 180 is optionally pre-connected to the funnel 136 of the intermittent catheter 130.

[0164] The method can further include inserting a distal portion of the catheter tube member 134 into the urethra; discharging urine from the bladder into the drainage bag 180 through the intermittent catheter 130; and enclosing at least the intermittent catheter assembly 110 in the carrying housing 150 in a used state of the intermittent catheter assembly 110.

[0165] The method may further include inserting an end of the funnel 136 into a container 148 in a distal portion of the end cap 146 to form a leak - free, ouroboros - type, end - to - end encapsulation in the use state of the intermittent catheter assembly 110. Alternatively, the method may include inserting a plug (not shown) in the distal portion of the end cap 146 into the funnel opening 142 of the funnel 136 to form a leak - free, ouroboros - type, end - to - end encapsulation in the use state of the intermittent catheter assembly 110. In any case, in the use state of the intermittent catheter assembly 110, the storage sheath 144 may extend between the end cap 146 of the intermittent catheter 130 and the funnel 136, thereby retaining any residual urine in or around the catheter fitting 134 within the storage sheath 144 in the use state of the intermittent catheter assembly 110.

[0166] The method may further include removing a strip 182 adhered to a folded portion of the drainage bag 180, the drainage bag being maintained in a folded state of the drainage bag 180 by the strip 182. The strip 182 may extend from a longitudinal end of the drainage bag 180 that includes a urine inlet 184.

[0167] The method may further include unfolding the drainage bag 180. As described above, the folded state of the drainage bag 180 may include: one or more folds along the width such that the drainage bag 180 has a shorter length in the folded state than in the unfolded state of the drainage bag 180; one or more folds along the length such that the drainage bag 180 has a shorter width in the folded state than in the unfolded state of the drainage bag 180; or some combination thereof.

[0168] The method may further include draining urine from the drainage bag 180; and folding a longitudinal end of the drainage bag 180 that includes the urine inlet 184 into a disposal pocket 220 incorporated into a face of the drainage bag 180 to achieve the use state of the drainage assembly 170. Notably, the disposal pocket 220 is located in the other longitudinal end of the drainage bag 180 opposite the longitudinal end that includes the urine inlet 184. Alternatively, the method may include draining urine from the drainage bag 180; removing a disposal pouch 222 attached to the other longitudinal end of the drainage bag 180 opposite the longitudinal end that includes the urine inlet 184; and enclosing the drainage bag 180 in the disposal pouch 222 to achieve the use state of the drainage assembly 170.

[0169] Female intermittent catheter system

[0170] Figures 12 to 22 An intermittent catheter system 200 or components thereof according to some embodiments are shown. Such an intermittent catheter system 200 and its components are configured for use by females.

[0171] As shown, the intermittent catheter system 200 can include an intermittent catheter 230 and a rigid catheter housing 750.

[0172] The intermittent catheter system 200 can have a storage state and an open state. In the storage state, the catheter housing 750 can be in its maximum extended state, wherein the intermittent catheter 230 is sealed within a first chamber 758 described below. In the open state, the outer sleeve 754 of the catheter housing 750 slides over the inner sleeve 752 of the catheter housing 750 such that the catheter housing 750 can be in its maximum collapsed state, wherein the end cap 756 pops out from the outer sleeve 754 and the funnel 236 of the intermittent catheter 230 is 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 can include the outer sleeve 754 of the catheter housing 750 sliding over the inner sleeve 752 of the catheter housing 750 in its intermediate collapsed state, wherein the end cap 756 partially pops out from the outer sleeve 754 and the funnel 236 of the intermittent catheter 230 is partially exposed.

[0173] Figures 16 to 18 An intermittent catheter 230 is shown according to some embodiments.

[0174] The intermittent catheter 230 can include a catheter fitting 234 and a funnel 236 over the proximal portion of the catheter fitting 234. The catheter fitting 234 can include a plurality of holes 238 near the catheter tip 240, and the funnel 236 can have a funnel opening 242 that is in fluid communication with the holes 238 through the lumen 243 of the intermittent catheter 230 for draining urine. Additionally, the funnel 236 can include a plurality of ridges integrated into the outer surface of the funnel 236 that are configured to be grasped as a handle when removing the intermittent catheter 230 from the catheter housing 750 or when draining urine.

[0175] Figures 12 to 15 and Figures 19 to 22 A catheter housing 750 is shown according to some embodiments.

[0176] The catheter housing 750 can include an inner sleeve 752, an outer sleeve 754 slidably mounted over the inner sleeve 752, and an end cap 756. As Figure 12 shown, the catheter housing 750 is configured to collapse when the closed end of the inner sleeve 752 remains against a surface and the outer sleeve 754 slides on 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.

[0177] As shown, the end cap 756 can be a rotating cap that includes a pair of extending arms 757, where each of the pair of extending arms 757 includes a post 759 configured to be inserted into a complementary through-hole in the open end of the inner sleeve 752. Notably, such an end cap 756 contributes to the subsequent second chamber 760 but not to the first chamber 758. Alternatively, the end cap 756 can approximate a single-ended cylinder (e.g., a cylinder with a single closed end) that contributes to both the first chamber 758 and the second chamber 760. (See Figure 15 , where, depending on the rotating cap or single-ended cylinder, the post 759 of each of the pair of extending arms 757 is shown in dashed outline to indicate its presence or absence.) In fact, when the end cap 756 approximates a single-ended cylinder, the end cap 756 can be configured to be located within the end of the outer sleeve 754 opposite the closed end of the inner sleeve 752 and contribute to both the first chamber 758 and the second chamber 760. The end cap 756 can overlap the open end of the inner sleeve 752 with an interference fit (such as a clearance fit) to provide the first chamber 758 between the end cap cavity 762 of the end cap 756 and the inner sleeve cavity 764 of the inner sleeve 752. Regardless of whether the end cap 756 is a rotating 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 can define the longitudinal boundaries of the second chamber 760 between the inner surface of the outer sleeve 754 and the outer surfaces of the end cap 756 and the inner sleeve 752. Notably, the end cap gasket 766 and the inner sleeve gasket 768 provide sufficient friction to maintain the storage state of the catheter housing 750 under typical use scenarios, thereby preventing inadvertent collapse to the open state of the catheter housing 750.

[0178] The first chamber 758 and the second chamber 760 respectively provide a first containment and a second containment for containing or otherwise holding any lubricating coating 135 on the catheter fitting 234 of the intermittent catheter 230 or any lubricant around the catheter fitting 234 of the intermittent catheter 230, thereby preventing leakage of the lubricant from the catheter housing 750 in the storage state of the intermittent catheter system 200 prior to use of the intermittent catheter 230. The first chamber 758 and the second chamber 760 also respectively provide a first containment and a second containment for any residual urine in or around the intermittent catheter 230, thereby preventing leakage of urine from the catheter housing 750 in the storage state of the intermittent catheter system 200 after use and returning the intermittent catheter 230 to the catheter housing 750 for storage until the entire intermittent catheter system 200 can be disposed of.

[0179] Similarly, the catheter housing 750 can 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 of the inner sleeve 752 is held against a surface and the outer sleeve 754 slides toward the surface over the inner sleeve 752. With respect to the maximum extended state of the catheter housing 750, toward the end of the outer sleeve 754 opposite the end including the end cap 756 (i.e., the distal portion of the outer sleeve 754 in terms of the terminology used for the intermittent catheter 230), the inner circumference of the outer sleeve cavity 769 of the outer sleeve 754 gradually decreases in magnitude of the outer sleeve step 770. Additionally, the inner sleeve 752 includes an outer ridge 772 configured to abut the outer sleeve step 770 in the opposite end (i.e., the distal end) of the outer sleeve 754, thereby defining the maximum extended state of the catheter housing 750. With respect to the maximum collapsed state of the catheter housing 750, toward the closed end of the inner sleeve 752 (i.e., the distal portion of the inner sleeve 752 in terms of the terminology used for the intermittent catheter 230), the outer circumference of the inner sleeve 752 gradually increases in magnitude of 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 restrain the inner sleeve 752 from moving upward through the end of the outer sleeve 754 including the end cap 756 (i.e., the proximal portion of the outer sleeve 754 in terms of the terminology used for the intermittent catheter 230), thereby defining the maximum collapsed state of the catheter housing 750. Advantageously, 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, the inner sleeve step 774 in the outer circumference of the inner sleeve 752 also centers the inner sleeve 752 within the outer sleeve 754.

[0180] Method of female intermittent catheter system

[0181] As described below, the methods can include methods of using the intermittent catheter systems and components disclosed herein; however, it should be understood that these methods can be further discerned from the description of the intermittent catheter systems and components and how they are configured to function. Similarly, additional methods can be discerned from the description of the intermittent catheter systems and components and how they are configured to function.

[0182] For example, a method of the intermittent catheter system 200 can include obtaining the intermittent catheter system 200 in its storage state.

[0183] As described above, the intermittent catheter system 200 can include a rigid catheter housing 750 and an intermittent catheter 230.

[0184] In short, with respect 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 may be configured to be located within the end of the outer sleeve 754 opposite the closed end of the inner sleeve 752 and, at the same time, contribute to both a first chamber 758 for a first accommodation and a second chamber 760 for a second accommodation. In fact, the end cap 756 overlaps the open end of the inner sleeve 752, thereby providing the first chamber 758 between the end cap cavity 762 of the end cap 756 and the inner sleeve cavity 764 of the inner sleeve 752. In addition, an end cap gasket 766 around the end cap 756 and an inner sleeve gasket 768 around the inner sleeve 752 define the longitudinal boundaries of the second chamber 760 between the inner surface of the outer sleeve 754 and the outer surfaces of the end cap 756 and the inner sleeve 752. Similarly, the first chamber 758 and the second chamber 760 respectively provide a first accommodation and a second accommodation for any lubricant around the catheter fitting 234 of the intermittent catheter 230, thereby preventing leakage of the lubricant from the catheter housing 750 in the stored state of the intermittent catheter system 200 before use of the intermittent catheter 230.

[0185] With respect to the intermittent catheter 230, the intermittent catheter 230 may include a catheter fitting 234 and a funnel 236 over the proximal portion of the catheter fitting 234. The catheter housing 750 may be in its maximum extended state, wherein in the stored state of the intermittent catheter system 200, the intermittent catheter 230 is sealed within the first chamber 758.

[0186] The method may further include converting the intermittent catheter system 200 to its open state. Converting the intermittent catheter system 200 to its open state includes: grasping the outer sleeve 754 of the catheter housing 750; holding the closed end of the inner sleeve 752 of the catheter housing 750 against a surface through 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. When sliding the outer sleeve 754 over the inner sleeve 752 of the catheter housing 750, the funnel 236 of the intermittent catheter 230 causes the end cap 756 to pop out of the outer sleeve 754 of the catheter housing 750.

[0187] The method may further include removing the intermittent catheter 230 from the catheter housing 750 through the funnel 236 of the intermittent catheter 230.

[0188] The method may further include: inserting a distal portion of the catheter fitting 234 into the urethra; discharging 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 reforming a first chamber 758 for a first containment of any residual urine in or around the intermittent catheter 230 and a second chamber 760 for a second containment of any urine leaking from the first chamber 758. Thus, reforming the first chamber 758 and the second chamber 760 prevents urine from leaking from the catheter housing 750 in the stored state of the intermittent catheter system 200 after use of the intermittent catheter 230.

[0189] Although some specific embodiments have been disclosed herein and although these specific embodiments have been disclosed in considerable detail, these specific embodiments are not intended to limit the scope of the concepts provided herein. Additional adaptations or modifications will be apparent to the ordinary person skilled in the art and, in a broader sense, these adaptations or modifications are also encompassed. Accordingly, changes may be made to the specific embodiments disclosed herein without departing from the scope of the concepts provided herein.

Claims

1. An intermittent catheter system, comprising: A rigid catheter housing, the rigid catheter housing comprising: An inner sleeve; An outer sleeve, slidably mounted over the inner sleeve; and An end cap, configured to be located within the end of the outer sleeve opposite the closed end of the inner sleeve, the end cap contributing to both a first chamber for a first containment and a second chamber for a second containment; and An intermittent catheter, comprising a catheter fitting and a funnel over a proximal portion of the catheter fitting, the intermittent catheter system having: A storage state, comprising the catheter housing in its maximum extended state, the intermittent catheter sealed within the first chamber; and An open state, comprising the outer sleeve of the catheter housing sliding over the inner sleeve of the catheter housing such that the catheter housing is in its maximum collapsed state, the end cap popping out of the outer sleeve, and the funnel of the intermittent catheter being exposed to remove the intermittent catheter from the catheter housing.

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

3. The intermittent catheter system according to claim 1 or 2, wherein an end cap gasket around the end cap and an inner sleeve gasket around the inner sleeve define longitudinal boundaries of the second chamber between the inner surface of the outer sleeve and the outer surfaces of the end cap and the inner sleeve.

4. The intermittent catheter system according to any one of claims 1 to 3, wherein the first chamber and the second chamber respectively provide the first containment and the second containment for any residual urine in or around the intermittent catheter, thereby preventing urine from leaking from the catheter housing in the storage state of the intermittent catheter system after use of the intermittent catheter.

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

6. The intermittent catheter system according to any one of claims 3 to 5, wherein towards the end of the outer sleeve opposite the end including the end cap, the inner circumference of the outer sleeve cavity of the outer sleeve gradually decreases in magnitude of an outer sleeve step, and the inner sleeve includes an outer ridge configured to abut the outer sleeve step in the opposite end of the outer sleeve, thereby defining the maximum extended state of the catheter housing.

7. The intermittent catheter system according to claim 6, wherein towards the closed end of the inner sleeve, the outer perimeter of the inner sleeve gradually increases in magnitude of the inner sleeve step, and the taper of the inner perimeter of the outer sleeve cavity of the outer sleeve is configured to restrain the movement of the inner sleeve through the end of the outer sleeve including the end cap, thereby defining the maximum collapsed state of the catheter housing.

8. The intermittent catheter system according to claim 7, wherein when transitioning between the storage state and the open state of the catheter housing, the inner sleeve step in the outer perimeter of the inner sleeve causes the inner sleeve to be centered within the outer sleeve.

9. The intermittent catheter system according to any one of claims 1 to 8, further comprising a lubricating coating on the catheter fitting of the intermittent catheter sealed within the first chamber in the storage state of the intermittent catheter system or a lubricant around the catheter fitting.

10. The intermittent catheter system according to claim 9, wherein the first chamber and the second chamber respectively provide the first accommodation and the second accommodation for the lubricant around the catheter fitting of the intermittent catheter, thereby preventing leakage of the lubricant from the catheter housing in the storage state of the intermittent catheter system before use of the intermittent catheter.

11. The intermittent catheter system according to any one of claims 1 to 10, wherein the catheter housing is configured to collapse when the closed end of the inner sleeve remains against a surface and the outer sleeve slides towards the surface over the inner sleeve, thereby exposing the funnel of the intermittent catheter for removal of the intermittent catheter from the catheter housing.

12. The intermittent catheter system according to any one of claims 1 to 11, wherein the funnel includes a plurality of ridges integrated into the outer surface of the funnel, the ridges being configured to be grasped as a handle when removing the intermittent catheter from the catheter housing or draining urine.

13. The intermittent catheter system according to any one of claims 1 to 12, wherein the catheter fitting includes a plurality of eyelets near the catheter tip, the eyelets being in fluid communication with the funnel opening.

14. The intermittent catheter system according to any one of claims 1 to 13, wherein the intermittent catheter is configured for use by a female.

15. A method of an intermittent catheter system, comprising: obtaining the intermittent catheter system in its storage state, the intermittent catheter system including: a rigid catheter housing, the rigid catheter housing including: an inner sleeve; an outer sleeve slidably mounted over the inner sleeve; and an end cap configured to be located within the end of the outer sleeve opposite the closed end of the inner sleeve, the end cap contributing to both a first chamber for a first accommodation and a second chamber for a second accommodation; and An intermittent catheter, comprising a catheter fitting and a funnel over a proximal portion of the catheter fitting, in the storage state of the intermittent catheter system, the catheter housing is in its maximum extended state, and the intermittent catheter is sealed within the first chamber; Converting the intermittent catheter system to its open state, converting the intermittent catheter system to the open state includes: Gripping an outer sleeve of the catheter housing; Holding a closed end of an inner sleeve of the catheter housing against a surface through the outer sleeve of the catheter housing; and Sliding the outer sleeve of the catheter housing over the inner sleeve of the catheter housing towards the surface to expose the funnel of the intermittent catheter; and Removing the intermittent catheter from the catheter housing through the funnel of the intermittent catheter.

16. The method according to claim 15, wherein when sliding the outer sleeve over the inner sleeve of the catheter housing, the funnel of the intermittent catheter causes the end cap to pop out from the outer sleeve of the catheter housing.

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

18. The method according to 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 longitudinal boundaries of the second chamber between an inner surface of the outer sleeve and outer surfaces of the end cap and the inner sleeve.

19. The method according to any one of claims 15 to 18, wherein the first chamber and the second chamber respectively provide the first accommodation and the second accommodation for any lubricant around the catheter fitting of the intermittent catheter, thereby preventing leakage of the lubricant from the catheter housing in the storage state of the intermittent catheter system before use of the intermittent catheter.

20. The method according to any one of claims 15 to 19, further comprising: Inserting a distal portion of the catheter fitting into the urethra; Discharging urine from the bladder through the intermittent catheter; Replacing the intermittent catheter back into the inner sleeve of the catheter housing; And Replacing the end cap back into the end of the outer sleeve, thereby reforming the first chamber for the first accommodation of any residual urine in or around the intermittent catheter and the second chamber for the second accommodation of any urine leaking from the first chamber, while preventing leakage of urine from the catheter housing in the storage state of the intermittent catheter system after use of the intermittent catheter.

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