CROSS REFERENCE TO RELATED APPLICATIONS

[0001] This application claims the benefit of U.S. Provisional Application No. 62/610,125 filed December 22, 2017, and GB 1721954.4, filed December 27, 2017, each of which is incorporated by reference herein in its entirety.

[0002] This application also incorporates in its entirety PCT application CV0662-PCT titled “Catheter Wetting Devices”, filed concurrently with the present application on December 21, 2018.

BACKGROUND OF THE DISCLOSURE

[0003] The present disclosure relates to urinary catheter devices such as intermittent urinary catheter devices, and cases or packages therefor. In particular, the present disclosure relates to urinary catheter devices for men that allow discreet, safe and controlled handling of the catheter device during extraction from its case, and a case that provides for easy and hygienic insertion of the catheter as well as convenient repackaging thereof for disposal.

[0004] An intermittent urinary catheter is a single use device. This device is inserted into a patient's bladder via the urethra to allow for the evacuation of urine from the bladder. The insertion process is referred to as catheterization.

[0005] There are indwelling catheters that are permanent or semi -permanent. Such indwelling catheters are typically used after surgical procedures. There are also intermittent catheters that are removed from the urethra/bladder after each drainage of the bladder. The use of intermittent catheters for catheterization can be performed by a clinician, such as a medical professional. However, intermittent catheters are more typically used for self-catheterization so that the patient or user has enhanced flexibility for use around their daily routines.

[0006] It is important for the health and safety of the patient that an intermittent catheter be used only once. Re-use of such a catheter could result in colonization of bacteria and other microbes in patient tissue that, in turn, could lead to serious infection and/or other medical complications.

SUMMARY OF THE DISCLOSURE

[0007] Disclosed herein, in some aspects, are urinary catheter assemblies comprising: a urinary catheter having a distal end, a proximal end and a length therebetween, wherein the distal end is configured to be inserted into a urethra to evacuate a bladder; and a catheter case comprising: a top and a bottom joined together to provide the catheter case with a length and a width; an opening through the top for removal and/or re-insertion of the urinary catheter from and into the catheter case, respectively; and a guiding element disposed in at least one of the top and the bottom, wherein the guiding element is configured to maintain at least a portion of the urinary catheter in a curved configuration until use and wherein the guiding element is configured to control the path of the urinary catheter during removal and re-insertion of the urinary catheter from and into the catheter case, respectively. In some instances, at least a portion of the curved configuration has an“S” shape. In some instances, at least a portion of the curved configuration has an“8” shape. In some instances, the curved configuration does not comprise more than two turns. In some instances, a region of the urinary catheter most proximal to the distal end of the urinary catheter is straight. In some instances, the region is about 5 cm to about 15 cm in length. In some instances, the guiding element is a bearing in a configuration that is the same as at least a portion of the curved configuration. In some instances, the urinary catheter assemblies comprise a lid configured to allow the lid to open to provide access to the opening. In some instances, the lid is configured to close the opening to provide a fluid tight seal to the catheter case. In some instances, the lid is connected to the top by a hinge. In some instances, the hinge is offset clockwise or counter-clockwise relative to a centre line of the assembly. For example the hinge offset may be at least 15 degrees, by at least 30 degrees, by at least 45 degrees, by at least 60 degrees, by at least 75 degrees or by at least 90 degrees. In some instances, the urinary catheter assembly comprises a hollow funnel connected to the proximal end, wherein the hollow funnel is configured to be held while the distal end is inserted into the urethra. In some instances, the hollow funnel has a substantially circular configuration at the proximal end and tapers to a flattened, substantially oval configuration at an opposite end that forms a spout. In some instances, the hollow funnel has a substantially circular configuration at the proximal end and a substantially circular configuration at an opposite end that forms a spout. For example, the spout end of the hollow funnel has semi-major and semi-minor axes that are substantially equal. In some instances, the urinary catheter assembly comprises an expandable sleeve disposed around the catheter and having a first sleeve end connected to the funnel and a second sleeve end disposed away from the funnel, wherein the expandable sleeve is compressed in an unexpanded state prior to use of the urinary catheter. In some instances, the urinary catheter assembly comprises a slidable gripper disposed around the catheter and having a first gripper end connected to the second sleeve end and a free second gripper end. In some instances, the urinary catheter assembly comprises a wetting device comprising: a front and a back, the front and the back form a volume therebetween, the front and the back each has an opening disposed and configured to allow the catheter to pass therethrough. In some instances, the urinary catheter assembly comprises a wetting applicator having a liquid absorbed therein disposed in the volume, wherein the wetting applicator has an opening therethrough configured to supply the liquid to a surface of the urinary catheter as the urinary catheter passes through the openings in the front and the back. In some instances, the wetting device is disposed adjacent the free gripper end to maintain the expandable sleeve compressed in an unexpanded state prior to use.

In some instances, the opening in the wetting applicator is smaller than the openings in the front and the back of the wetting device. In some instances, prior to use, the hollow funnel passes through the opening in the wetting applicator and passes through the openings in the front and the back to provide a fluid tight seal to the wetting device. In some instances, the urinary catheter assembly comprises an O-ring, wherein the O-ring is located between the top and bottom outer edges to provide a seal that maintains sterility of the catheter tube until use. In some instances, the urinary catheter assembly comprises an O-ring, wherein the O-ring is located between the top and bottom inner edges of a handle in the catheter case.

[0008] In some embodiments, to maintain sterility of the catheter assemblies disclosed herein, the top and bottom outer edges of the assembly are alternatively sealed using laser welding.

Once welded the resultant seal maintains sterility of the catheter tube until use. Alternatively, once welded the resultant seal maintains a sterile barrier after sterilization of the urinary catheter assembly. In such embodiments, the materials used in conjunction with laser welding are chosen to allow a laser to pass through the assembly region in the vicinity of where the laser weld is required.

[0009] The laser frequency may be a diode laser and may run at a frequency of for instance 850 tol 100 nm wavelength, or 900 to 1050 nm wavelength, or 960 to 1010 nm wavelength, or in one example 980nm wavelength .

[0010] In one instance, if the catheter assembly is sealed using laser welding, the top of the catheter case is laser absorbing, and the bottom of the case is laser translucent. In one instance, if the catheter assemble is sealed using laser welding, the bottom of the catheter case is laser absorbing, and the top of the case is laser translucent.

[0011] Materials that are capable of allowing a laser to pass through in order to establish a laser weld and resultant sterility in the device are known in the art, and include but are not limited to laser transparent or laser translucent plastic or resin, for example a polypropylene (PP) containing an organic pigment, or a polyphenylene ether (PPE) containing an organic pigment, or a polycarbonate (PC) containing an organic pigment, or an acrylonitrile butadiene styrene (ABS) containing an organic pigment. In one embodiment, the laser passes through a laser translucent plastic.

[0012] In some embodiments, the material that allows a laser to pass through may also comprise reduced amounts of (or zero) black or laser absorbing pigment (often considered inorganic), e.g ., iron oxide or carbon black. The removal of black or laser absorbing pigment reduces the amount of laser energy absorbed by the material, thereby allowing increased energy to pass through the assembly region being laser welded.

[0013] For a laser absorbing catheter case, the top and/or bottom may comprise plastic or resin, which may for example include a polypropylene (PP) containing an inorganic pigment (e.g., iron oxide) or carbon black, or a polyphenylene ether (PPE) containing an inorganic pigment or carbon black, or a polycarbonate (PC) containing an organic pigment or carbon black, or an acrylonitrile butadiene styrene (ABS) containing the organic pigment or carbon black.

[0014] Typically the urinary catheter assembly may be sterilised after manufacture by exposure to e-beam or gamma radiation, or ETO known in the art. Sterilization may typically occur when the urinary catheter assembly is in a packaged or boxed ready for shipment.

[0015] In some embodiments, the urinary catheter comprises or is integrated with a polymer, such as a hydrophilic polymer. In some embodiments, the urinary catheter is coated with a polymer, such as a hydrophilic polymer. In some embodiments, the urinary catheter comprises or is integrated with a polymer mixture of a thermoplastic or thermo-curing polymer base material and an amphiphilic block copolymer, e.g., as disclosed in WO 2011/051439 filed October 29, 2010, the entirety of which is incorporated by reference herein. In some

embodiments, the urinary catheter is coated with the polymer mixture of a thermoplastic or thermos-curing polymer base material and amphiphilic block copolymer, e.g, as disclosed in WO 2011/051439.

[0016] Further disclosed herein, in some aspects, are catheter cases for storing and dispensing a urinary catheter and wetting device, the catheter case comprising: a top and a bottom joined together to provide the catheter case with a length and a width; an opening through the top for removal and/or re-insertion of the urinary catheter from and into the catheter case, respectively; and a guiding element disposed in at least one of the top and the bottom, wherein the guiding element is configured to maintain at least a portion of the urinary catheter in a curved configuration until use and wherein the guiding element is configured to control the path of the urinary catheter during removal and re-insertion of the urinary catheter from and into the catheter case, respectively. In some instances, catheter cases disclosed herein comprise a lid configured to allow the lid to open to provide access to an opening for removal and/or re- insertion of the urinary catheter from and into the catheter case, respectively. In some instances, the lid is connected to the top by a hinge. In some instances, the hinge is offset clockwise or counterclockwise relative to a centre line of the catheter case (for example by at least 15 degrees, by at least 30 degrees, by at least 45 degrees, by at least 60 degrees, by at least 75 degrees or by at least 90 degrees). In some instances, the lid is configured to close the opening to provide a fluid tight seal to the catheter case. In some instances, the lid comprises a tab connected to the lid by a joint. In some instances, the tab is configured to be bent away from the catheter case and create a grip to open the lid. In some instances, bending of the tab creates a fatigue mark in the joint that provides a visible tamper-evident indication. In some instances, the lid comprises a first engaging member that interacts with a second engaging member of the top of the catheter case. The first and/or second engaging members may comprise a bump, clip, notch, or any protrusion or depression configured to interact with the other engaging member to close the catheter lid. In an exemplary embodiment, after re-insertion of the urinary catheter into the catheter case, the lid is closed by pressing the first engaging member of the lid against the top of the catheter case to enclose the urinary catheter within the catheter case. In some instances, minimal or no liquid from the catheter is released from the catheter case when the lid is closed. In some instances, the tab is connected to the catheter case using an ultrasonic weld, and wherein moving the tab away from the catheter case irreversibly and noticeably damages the ultrasonic weld to provide a visible tamper-evident indication. In some instances, catheter cases disclosed herein comprise a seal that covers the opening, and a connecting tab disposed on an upper surface of the seal and adhered to an underside of lid so that the seal is peeled open as the lid is opened to provide a visible tamper-evident indication. In some instances, catheter cases disclosed herein comprise a seal that covers the opening, and a connecting tab is not present, and a user manually has to open the seal separate from the lid. The seal continues to provide a visible tamper-evident indication. In some instances, the lid and the top further comprise mating elements comprised of a clip feature on the lid and a notch feature on the top that provide a labyrinthine pathway to prevent egress of liquid droplets from a re-closed catheter case. In some instances, the lid is sealed using an exterior paper-type seal that is placed on either the exterior top or bottom face of the assembly. In some options, the lid is sealed using an overlapping top and bottom face of the assembly, which clicks into place to lock the top and bottom faces of the assembly together. In some instances, the labyrinthine pathway prevents egress of liquid droplets from the closed catheter case. In some instances, catheter cases disclosed herein comprise a labyrinthine pathway to prevent egress of liquid droplets from a re-closed catheter case after use of the urinary catheter, wherein the labyrinthine pathway is formed by a plurality of protrusions projecting from the lid toward the opening. In some instances, one of the plurality of protrusions contacts the seal and another of the plurality of protrusions projects into a channel adjacent the opening. In some instances, at least a portion of the guiding element forms a generally "S"-shaped curved configuration. In some instances, the guiding element crosses itself not more than once and reverses direction not more than twice. In some instances, top and the bottom each have a generally oval shape, and wherein the opening has a generally circular shape. In some instances, the guiding element is comprised of a first plurality of ribs. In some instances, the first plurality of ribs is disposed in each of the top and the bottom. In some instances, the first plurality of ribs in each of the top and the bottom match each other. In some instances, catheter cases comprise a wetting device that comprises a front and a back, the front and the back forming a volume therebetween, the front and the back each has an opening disposed and configured to allow the catheter to pass therethrough. In some instances, catheter cases comprise a retaining element disposed in at least one of the top and the bottom, wherein the retaining element is configured to retain the wetting device. In some instances, the retaining element is comprised of a second plurality of ribs. In some instances, the second plurality of ribs is disposed in each of the top and the bottom. In some instances, the second plurality of ribs in each of the top and the bottom match each other.

[0017] It should be noted that the terms“first”,“second”,“third”,“upper”,“low er”,“top” and “bottom” and the like have been used herein to modify various elements. However, these modifiers do not imply a spatial, sequential, or hierarchical order to the modified elements unless specifically stated.

BRIEF DESCRIPTION OF THE DRAWINGS

[0018] Figure l is a perspective view of a catheter case or package according to the present disclosure, shown in a closed or unused position.

[0019] Figures 2A-2C are a series of top front perspective views showing the progression of opening the catheter case of Figure 1 and first and second tamper-evident seals. Figure 2A is a front perspective view of the catheter case of Figure 1 shown in a closed position. Figure 2B is a front perspective view of the catheter case of Figure 1 with a tab bent away from the case, creating a fatigue mark. Figure 2C is a front perspective view of the catheter case of Figure 1 with the tab moved further away from the case to open the lid.

[0020] Figure 2D shows a cross-sectional view of a closure fitting of a catheter case of Figure 1

[0021] Figure 3 A is a top perspective view of the catheter case of Figure 1 with the case lid open to show a third tamper-evident seal for the catheter case and catheter assembly of the present disclosure; and Figure 3B is a top perspective view of the catheter case of Figure 1 with the case lid open to show a partial view of a catheter assembly of the present disclosure disposed therein.

[0022] Figure 4 is an exploded view of a catheter case and a catheter assembly therein according to the present disclosure.

[0023] Figure 5 is a cutaway top view of a catheter case and a catheter assembly therein in stored pre-use position according to the present disclosure.

[0024] Figure 6A is an exploded view of the embodiment of the catheter assembly of Figure 5. [0025] Figure 6B is a partial side cross-sectional view of an alternate embodiment of a catheter assembly according to the present disclosure.

[0026] Figure 7A is an exploded view of an embodiment of a wetting device sub-assembly according to the present disclosure.

[0027] Figure 7B is a cross-sectional view of the alternate embodiment of a catheter assembly shown in Figure 6B and a wetting device subassembly.

[0028] Figure 8 is an enlarged view of the catheter assembly of Figure 4.

[0029] Figure 9 is an exploded view of the lid, second tamper evident seal and top portion of the top sub-assembly of the catheter case of Figure 1.

[0030] Figure 10 is an exploded view of seals and the bottom portion of the catheter case of Figure 1.

[0031] Figure 11 is a perspective view of the interior of the catheter case of Figure 1, showing integrated ribs that guide the path of the catheter assembly of Figure 6A.

[0032] Figure 12 is a perspective view of an inner bearing of the catheter case and the catheter assembly of Figure 4.

[0033] Figure 13 is a schematic view of the removal travel path of the catheter assembly of Figure 6A from the catheter case of Figure 1.

[0034] Figure 14 is an exploded view of the catheter case of Figure 1 showing both inner and outer bearings.

[0035] Figure 15 shows exemplary configurations of catheter tubes in cases and catheter assemblies of the present disclosure. The white rectangle represents the funnel end.

[0036] Figure 16 shows exemplary designs of cases disclosed herein.

[0037] Figure 17 shows exemplary catheter assemblies.

[0038] Figure 18 shows an exemplary S-shaped catheter assembly and case. A top view of a closed case is shown at the left. A side view of a closed case is shown in the middle. A longitudinal cross section of an open case is shown at the right.

[0039] Figure 19 shows an exemplary oval shaped catheter assembly and case. A top view of a closed case is shown at the left. A side view of a closed case is shown in the middle. A longitudinal cross section of an open case is shown at the right.

[0040] Figure 20 shows a top view of an exemplary urinary catheter case.

[0041] Figure 21 shows a side view of a cross-section of Figure 20 through points A of an exemplary urinary catheter case at the end with a lid. The catheter assembly includes a catheter tube and periphery and internal O-rings for an O-ring compression seal to create sterility in the catheter assembly package. [0042] Figure 22 shows a side view of a cross-section of Figure 20 through points B, exposing a catheter tube and a periphery O-ring for an O-ring compression seal to create sterility in the catheter assembly package.

[0043] Figure 23 shows a side view of the exemplary urinary catheter case of Figure 20 with top case 150, bottom case 160, and split line 170.

[0044] Figure 24 shows an exemplary top view of a cross-section of an exemplary urinary catheter case and catheter assembly with ultrasonic welding ribs and a snap fit closure.

[0045] Figure 25A is a front perspective view of a catheter case shown in a closed position.

[0046] Figure 25B is a front perspective view of the catheter case of Figure 25 A shown in an open position.

[0047] Figure 26 is a top perspective view of the catheter case of Figure 25 A with the lid open to show a tamper-evident seal.

[0048] Figure 27A is a top view of the catheter case of Figure 25 A shown with the lid closed.

[0049] Figure 27B is a top view of a catheter case with the hinge offset relative to a centre line of the catheter case by about 30 degrees.

[0050] Figure 28A is a top view of a catheter case shown in a closed position. Figure 28B is a top view of the catheter case of Figure 28 A with the lid open to show a partial view of a catheter assembly disposed within the catheter case. Figure 28C is a top view of the catheter case of Figure 28A with the lid open to show a tamper-evident seal.

[0051] Figure 29A is a front perspective view of a catheter case shown in an open position to reveal a tamper-evident seal.

[0052] Figure 29A is a front perspective view of the catheter case of Figure 29A showing a substantially circular hollow funnel of a catheter assembly disclosed herein housed within the catheter case.

[0053] Figure 30 is a detailed front view of a closed catheter case described herein showing a lid having first engaging members contacting second engaging members of the top of the assembly to prevent egress of liquid from the closed catheter case.

[0054] The accompanying drawings illustrate presently preferred embodiments of the disclosure, and together with the general description given above and the detailed description given below, explain the principles of the disclosure. As shown throughout the drawings, like reference numerals designate like or corresponding parts.

DETAILED DESCRIPTION OF THE DISCLOSURE

[0055] With urinary catheters designed for use by a man, the problems are, perhaps, enhanced due to the length of the urinary catheter needed. For example, some existing or known catheters such as intermittent catheters are coiled tightly and retain a substantial degree of“coil” after removal from its package and prior to use. This renders insertion of the urinary catheter uncomfortable at best and painful at worst.

[0056] Other known male catheters are not coiled or not coiled tightly. Such catheters require a long package to accommodate the inherent length of the catheter. Therefore, the package of the catheter is difficult, if not impossible, to carry, conceal or dispose of discreetly.

[0057] With regard to intermittent catheters, the catheter should be designed for travel, so that it can be used wherever and whenever it is needed. Thus, it is desirable to a user of an intermittent catheter that it is provided in a package or case that is as small as possible.

[0058] There may also be a negative social stigma associated with the need for and use of intermittent catheters. Thus, it may be very important to the user that the carrying, use, and disposal of the catheter be discreet.

[0059] It is also important that the user has confidence that the catheter has not been tampered with. Such confidence may be provided with visual or tactical assurances on the catheter or package of the catheter.

[0060] Accordingly, there is a need for a catheter and package therefore that overcome the above problems, as well as other problems associated with catheter use.

[0061] The present disclosure provides catheters that are packaged in a compact manner, thereby making the catheter convenient for travel and easily concealable. While they are compact, a portion of the catheter that is inserted into the subject is not coiled in its package or case. Thus, the user is provided a highly desirable catheter package and a catheter that is not painful to insert.

[0062] Generally, catheters disclosed herein can be used without the patient directly touching the catheter to ensure that there is no contamination in use, and that the catheter can be disposed of without the patient directly touching the catheter to ensure sanitary disposal. Catheters and cases disclosed herein are configured for safe and controlled handling for insertion into the urethra and disposal thereafter.

[0063] The present disclosure also provides for systems comprising a combination of a catheter assembly disclosed herein and a case for storing and dispensing the catheter assembly. In some instances, catheter assemblies disclosed herein comprise: a catheter having a distal end; a proximal end and a length therebetween; wherein the distal end is configured to be inserted into a subject. In some instances, a hollow funnel is connected to the proximal end. In some instances, the hollow funnel is configured to be held while the distal end is inserted into the subject.

[0064] In some instances, catheter assemblies disclosed herein comprise a sleeve that is configured to slide over the catheter. In some instances, the sleeve has a first sleeve end connected to the proximal end or a funnel and the proximal end, and a second sleeve end disposed away from the proximal end. In some instances, the sleeve is an expandable sleeve, being compressed or folded before use and extended during use to be disposed around the catheter. In some instances, the sleeve is compacted in an“accordion” type configuration. In some instances, the catheter assemblies disclosed herein comprise a slidable gripper having a first gripper end connected to the second sleeve end and a free second gripper end. In some instances, the slidable gripper is disposed circumferentially around the catheter tube. The slidable gripper may be positioned and configured such that a user can pull the free second gripper end and extend the sleeve over the tube, thereby providing a means to handle the catheter tube by its sleeve versus the catheter tube itself. In this way, the slidable gripper may prevent contamination of the catheter tube and an infection in the subject.

[0065] In some instances, catheter assemblies disclosed herein comprise a wetting device comprising a front and a back, wherein the front and the back form a volume therebetween, wherein the front and the back each has an opening disposed and configured to allow the catheter to pass therethrough; and a wetting applicator disposed in the volume, wherein the wetting applicator has an opening therethrough configured to supply the wetting agent to at least a portion of a surface of the catheter as the catheter passes through the openings in the front and the back of the wetting device. In some instances, the wetting applicator has a wetting agent absorbed therein or disposed thereon. In some instances, the wetting device is disposed adjacent the free gripper end to maintain the expandable sleeve compressed in an unexpanded state prior to use.

[0066] The present disclosure also provides cases or packages for catheters disclosed herein that overcome, alleviate, and/or mitigate problems of tight coiling catheters and lengthy catheter packages. Cases disclosed herein generally give a patient confidence that the catheter has not been tampered with or has not already been used. In some instances, assemblies and devices disclosed herein comprise a case for storing and dispensing a catheter. In some instances, cases disclosed herein can also be described as a package.

Cases

[0067] Cases disclosed herein may comprise: a top sub-assembly and a bottom sub-assembly joined together to provide the case with a length and a width. The top sub-assembly and bottom sub-assembly may also be simply referred to herein as the“top” and“bottom,” respectively. In some instances, the top sub-assembly and bottom sub-assembly are joined together to create a sterility seal. In some instances, the top sub-assembly and bottom sub-assembly are welded together. In some instances, the weld is an ultrasonic weld. In some instances, the weld is a high- frequency weld. In some instances, the weld is an induction weld, a laser weld, a solvent weld, or other suitable welding technique that joins a top sub-assembly and bottom sub-assembly together. In some instances, the laser weld is performed as disclosed in U.S. Patent No.

6,528,755, which is hereby incorporated by reference for this disclosure.

[0068] In some instances, the top sub-assembly and bottom sub-assembly welded together comprise materials capable of being welded together. In some instances, such materials include but are not limited to materials that are laser transparent or laser translucent, including for example, laser transparent or laser translucent plastics or resin, or the like. For example, in some instances the top sub-assembly and/or bottom sub-assembly comprise laser translucent plastic such that a laser source passes through the laser translucent plastic in the vicinity of the assembly region in order to laser weld the top sub-assembly and bottom sub-assembly parts together, creating a sterility seal. In some instances, the laser transparent or laser translucent material of the top sub-assembly and/or bottom sub-assembly may also comprise reduced amounts of black or laser-absorbing pigment, e.g ., iron oxide pigment. In such instances, the removal of black or laser-absorbing pigment reduces the amount of laser absorbed by the material thereby allowing an increased amount of energy passing through the assembly region being laser welded.

[0069] In some instances, case comprises a seal that seals the top sub-assembly and the bottom sub-assembly together to create a sterility seal. By way of non-limiting example, the seal may be an adhesive or glue. The seal may be a rubber. The rubber may be a silicone rubber. The rubber may be a nitrile rubber. In some instances, the seal is a compression seal. In some instances, the seal is an O-ring compression seal. The compression seal may comprise an O-ring. By way of non-limiting example, the O-ring may be silicone O-ring or other suitable elastomer that allows sufficient flexibility and minimizes clearance to maintain a continuous sterility seal. An O-ring compression seal may provide a continuous seal that may be unobtainable with a weld or an adhesive. A continuous seal may be due to the O-ring’ s flexibility, rotational symmetry, material properties (e.g, durometer hardness), dimensions or a combination thereof. In some instances, the O-ring compression seal works to create a near-zero or zero clearance within the case’s mating surface, blocking the flow of liquids or gases through the seal. In some instances, an O- ring compression seal is preferred over welding, adhesives, potting, alternative seals, and gaskets.

[0070] The O-ring is typically positioned in a trough between an outer wall and an inner wall of the edge of the bottom of the case. The top of the case may comprise at least one blade. In some instances, the bottom of the case may comprise at least one blade. A first side of at least one blade, from either the top of the case, the bottom of the case or both, may be configured to press against the outer wall of the case when the top of the case and the bottom of the case come into contact. The blade may deflect inwards when the top and bottom cases are brought together.

This deflection of the blade compresses the O-ring against the inner wall of the case and creates a seal. It is important that the blade achieve sufficient compression of the O-ring. Typically, the O-ring should compress between the inner and outer walls to about or at least 90% of its resting cross-sectional diameter, e.g ., 10% compression. A second, opposing, side of the blade from the O-ring may be forced into contact with the outer wall of the bottom case, thus creating an additional barrier.

[0071] The O-ring sealed case may comprise a long contorted path (labyrinth) which impedes ingress. An ingress pathway may begin at a split line between the top and bottom case before angling downwards to squeeze between the outer wall and the blade. The pathway may then take a U- turn around the blade before meeting the O-ring. Should the O-ring be navigated, the pathway then continues up the inner wall to the weld area where the inner wall contacts the top case, and where another turn may be required to enter the case cavity. Each contact point between the top case, bottom case and O-ring and turn/bend in the ingress pathway makes the ingress more and more difficult for contaminants to enter the case.

[0072] Generally O-rings are used as face seals (as in the manner of gaskets) or piston

(cylinder) grooves that are pseudo-radial in nature. Face seals may not be ideal for cases disclosed herein because thin polymer walls of face seals may not achieve or maintain flatness or across face tolerances. Piston or cylinder grooves may not be ideal because a gap is formed across two large radial, diametral or distance dimensions, and thus the tolerances across these, for each component, are too large for the O-ring. In contrast, O-ring compression seals disclosed herein have a stiff and small gap formed in the O-ring, so the tolerances are small and the gap is maintained. The O-ring is then compressed by a blade, creating a compression seal and maintaining sterility of the case. Thickness of the O-ring is small and can be controlled closely and yet it is also flexible so as to deform into the correct position for assembly. The thickness of the O-ring may be between 0.5 mm and 3 mm. The thickness of the O-ring may be less than 2 mm. The thickness of the O-ring may be less than 1 mm.

[0073] Cases disclosed herein may take on a variety of shape and forms, but generally are designed to be small and compact so as to provide the user with a discreet and convenient device. Examples of cases disclosed herein are depicted in Figures 16 and 17. Figure 16 shows a front view of a variety of cases. Figure 17 shows how catheter tubes may be configured inside of the cases shown in Figure. 16. In some instances, cases are substantially rectangular (see, e.g.,

A, B and F of Figures 16 and 17). In some instances, cases are oval-shaped (see, e.g., E of Figures 16 and 17). In some instances, cases are dumbbell-shaped (see, e.g., C and D of Figures 16 and 17). In some instances, cases comprise a hole (see, e.g., B-F of Figures 16 and 17). The hole may serve as a handle. The perimeter of the hole may serve as an inner bearing for the catheter tube within the case. The hole may reduce the weight of the case. In some instances, cases comprise at least one curved end (see, e.g., B-F of Figures 16 and 17). The at least one curved end may serve as an outer bearing for the catheter tube within the case.

[0074] Cases disclosed herein are generally designed to be small and compact, so as to be convenient and discreet for a user thereof. Cases disclosed herein may be described as having a length, a width and a thickness. In some instances, the length is about 10 cm to about 25 cm. In some instances, the length is about 10 cm to about 20 cm. In some instances, the length is about 10 cm to about 18 cm. In some instances, the length is about 10 cm to about 15 cm. In some instances, the length is not more than about 20 cm. In some instances, the length is not more than about 18 cm. In some instances, the length is not more than about 16 cm. In some instances, the length is not more than about 14 cm. In some instances, the length is not more than about 12 cm. In some instances, the length is not more than about 10 cm. In some instances, the length is at least 8 cm. In some instances, the length is at least about 10 cm. The width may be about 6 cm to about 12 cm. The width may be about 6 cm to about 10 cm. The width may be about 6 cm to about 8 cm. In some instances, the width is not more than about 12 cm. In some instances, the width is not more than about 10 cm. In some instances, the width at least about 6 cm. In some instances, the width is at least about 8 cm. In some instances, the thickness is about 1 cm to about 5 cm. In some instances, the thickness is about 2 cm to about 4 cm. In some instances, the thickness not greater than about 4 cm. In some instances, the thickness not greater than about 3 cm. In some instances, the thickness not greater than about 2 cm. In some instances, the thickness is at least about 1 cm.

[0075] In some instances, cases disclosed herein comprise an opening through at least one of the top sub-assembly and the bottom sub-assembly, wherein the opening is proximal a first end of the length of the case. In some instances, the case comprises a lid. In some instances, the lid is located on the top sub-assembly. In some instances, the lid is located only on the top sub- assembly (see, e.g., Figure 3 A). In some instances, the lid is located at an end of the case (see, e.g, Figures 16 and 17). The lid may cover the opening until use. The lid may seal the opening until use. In some instances, the lid is connected to the case by a hinge. In some instances, the hinge is configured to allow the lid to open to provide access to an opening for removal and/or re-insertion of the catheter from and into the case, respectively. In some instances, the hinge is configured to allow the lid to close the opening. In some instances, the hinge is configured to allow the lid to close and provide a fluid tight seal to the case. In some instances, the hinge is positioned 15, 30, 45, 60, 75 or 90 degrees, either clockwise or counter-clockwise, relative to the centre line of the assembly. [0076] In some instances, cases disclosed herein comprise an opening and a lid, wherein the opening is closed by the lid until use. In some instances, cases disclosed herein comprise an opening and a lid, wherein the opening is sealed by the lid until use. In some instances, cases disclosed herein comprise a closure that maintains the lid in a closed position until use. In some instances, the closure maintains the lid in a closed position after use. In some instances, the opening comprises the closure. In some instances, the lid comprises the closure. In some instances, the opening and the lid together comprise the closure. In some instances, the closure is not a part of the opening. In some instances, the closure is not a part of the lid. In some instances, the closure is not a part of the opening or the lid. The closure may be located around the opening. The closure may be located on the lid. The closure may be located around the perimeter of the lid. The closure may be located on the perimeter of the lid. By way of non limiting example, the closure may comprise at least one of an adhesive, a lip, a ridge, an edge, a recessed edge, a clip, an notch, and a hook. The closure may engage the perimeter of the opening. The closure may engage the lid. At least one of the closure, opening and lid may comprise a seal. The seal may make the case fluid tight when the opening is closed. The seal may be a rubber. The rubber may be a silicone rubber. The rubber may be a nitrile rubber.

[0077] In some instances, cases disclosed herein comprise at least one tamper-evident indicator. In some instances, cases disclosed herein comprise a lid, wherein the lid comprises at least one tamper-evident indicator. In some instances, cases disclosed herein comprise a closure, wherein the closure comprises at least one tamper-evident indicator. The tamper-evident indicator may be easily damaged or broken ( e.g ., with a user’s fingers alone). The tamper- evident indicator may be tom. The tamper-evident indicator may be peeled. The tamper-evident indicator may be separated from the case by the user without a tool. The tamper-evident indicator may be frangible. Non-limiting examples of tamper evident indicators include a tab, wax, metal foil, plastic film, waxed/coated paper, adhesive, paper, Tyvek®, and other similar materials known to those of skill in the art. In some instances, the tamper evident indicator is perforated.

[0078] In some instances, cases disclosed herein comprise at least one tamper-evident indicator that provides at least one tamper-evident indication. In some instances, cases disclosed herein comprise a closure that is capable of providing at least one tamper-evident indication. In some instances, cases disclosed herein comprise a lid that is capable of providing at least one tamper- evident indication. In some instances, cases disclosed herein comprise an opening that is capable of providing at least one tamper-evident indication. The tamper-evident indication may be a break in a tab. The tamper-evident indication may be a bend in a tab. A bend in the tab may create a fatigue mark, such as a line or discoloration. Also, by way of non-limiting example, the tamper-evident indication may be broken plastic, broken wax, tom paper, or separated adhesive.

[0079] In some instances, cases disclosed herein comprise an opening and a lid, wherein the lid is secured to the opening. In some instances, cases disclosed herein comprise a lid and a closure, wherein the lid is secured to the closure. In some instances, cases disclosed herein comprise an opening and a closure, wherein the closure is secured to the opening. In some instances, the security is provided by ultrasonic welding. The ultrasonic weld may create a joint between at least one of the opening, closure and lid. In some instances, a tab is connected to at least one of the opening, closure and lid by a joint. A joint may provide a tamper-evident indication that at least one of the opening, closure and lid has been disturbed. In some instances, the joint may be bent, broken, or noticeably damaged, thereby serving as a tamper-evident indicator.

[0080] In some instances, cases disclosed herein comprise a closure that is attached to the catheter case. In some instances, the closure is attached to an edge of an opening in the case. In some instances, the closure is attached to a lid of the case. In some instances, cases disclosed herein comprise a closure that is directly attached to the catheter case. In some instances, the closure is directly attached to an edge of an opening in the case. In some instances, the closure is directly attached to a lid of the case. In some instances, the closure is directly attached to a recessed edge around an opening of the case. In some instances, the closure is directly attached to the recessed edge by an adhesive. In some instances, the closure is directly attached to the recessed edge by welding.

[0081] As described in greater detail herein, cases described herein may comprise a

labyrinthine pathway. In some instances, the labyrinthine pathway prevents egress of liquid from a re-closed catheter case. In some instances, at least one of a lid and a closure provides or maintains the labyrinthine pathway, thereby preventing egress of liquid from a re-closed catheter case. Alternatively, or additionally, the labyrinthine pathway may be provided or maintained by at least one of two protrusions that project from the lid toward the opening. The protrusions may contact the closure and the protrusion may project into a channel.

[0082] In some instances, egress of liquid from the re-closed catheter case can be prevented for up to 24 hours. In some instances, egress of liquid from the re-closed catheter case can be prevented for at least 24 hours. In some instances, cases disclosed herein comprise a guiding element. In some instances, the guiding element is disposed in at least one of the top and the bottom, wherein the guiding element is configured to control the path of the catheter during removal and/or re-insertion of the catheter from and into the catheter case, respectively.

[0083] Catheter assemblies disclosed herein may comprise at least one bearing within a case in order to maintain a configuration or guide movement of a catheter tube. Catheter assemblies disclosed herein may comprise at least one inner bearing. Catheter assemblies disclosed herein may comprise at least one outer bearing. In some instances, catheter assemblies disclosed comprise an inner bearing and an outer bearing. In some instances, catheter assemblies disclosed comprise at least two inner bearings and at least one outer bearing. In some instances, at least one bearing comprises a material that is dissimilar to at least one of the catheter case, catheter tube, and lid. The use of dissimilar materials may improve the lowering of the friction coefficient between the surfaces of two materials so that the two surfaces can move relative to one another more easily such as when catheter tube is removed from or re-inserted into a catheter case. By way of non-limiting example, the case may be made of polypropylene, and the bearing may be made of high-density polyethylene (HDPE), a nylon or a polyacetal, polyethylene (PE) or a polytetrafluoroethylene (PTFE) such as Teflon®. In some instances, the bearing is an inner bearing made of high-density polyethylene (HDPE), a nylon or a polyacetal. In some instances, the bearing is an outer bearing made of a polyethylene (PE) or a

polytetrafluoroethylene (PTFE) such as Teflon®. In addition to materials being dissimilar for the purposes of reducing the friction coefficient, the outer bearing is preferably a flexible material that does not exhibit set. This is beneficial so that the outer bearing conforms to the outer wall of the case during removal of the catheter from the pack. If the material sets then additional resistance will result when curved sections of the bearing travel along straight sections of the case and vice versa. Conversely, the inner bearings benefit from being constructed of a rigid material.

[0084] In addition to having bearings, catheter assemblies disclosed herein may comprise a feature such as a rib, flange, or undulation located in an interior surface of a case disclosed herein. In some instances, the interior surface is located on the bottom assembly. In some instances, the interior surface is located on the top assembly. The feature may serve to retain a component of the assembly in a position within the case. Alternatively or additionally, the feature may serve to guide movement of a component of the assembly that moves within the case. For instance, a bottom sub-assembly of the case may comprise a first raised flange and a second raised flange. First raised flange and second raised flange may have outer perimeter dimensions that are sized and arranged to accept inner perimeter dimensions first inner bearing and of second inner bearing for placement thereon in a close contacting fit, yet allowing for rotational movement of first inner bearing and second inner bearing around first raised flange and second raised flange, respectively, as the catheter tube is removed from or re-inserted into catheter case. This close contact fit may allow rotational movement of first inner bearing and second inner bearing. This rotational movement may allow for removal and replacement of catheter sub-assembly out of catheter case for use and back into catheter case after use. [0085] In some instances, there may be bearings, ribs, flanges or other elements sized and disposed on the inner surface of a top sub-assembly of the case to cooperate with any of those on the bottom assembly to maintain/guide catheter placement during assembly or during use. In some instances, the top sub-assembly may be placed over all previously assembled components. The top sub-assembly and bottom sub-assembly may be affixed, e.g., by laser weld, or liquid tight snap-fit features, or a combination thereof, or other methods that will be apparent to those of skill in the art. A seal may be included between the top sub-assembly and bottom sub- assembly.

Catheter Tubes & Related Components

[0086] Catheter tubes disclosed herein may be made of a flexible material such as a

thermoplastic elastomer. Thermoplastic elastomers (TPE), sometimes referred to as

thermoplastic rubbers, are a class of copolymers or a physical mix of polymers (usually a plastic and a rubber) which consist of materials with both thermoplastic and elastomeric properties. Thermoplastic elastomers show advantages typical of both rubbery materials and plastic materials. The benefit of using thermoplastic elastomers is the ability to stretch to moderate elongations and return to its near original shape creating a longer life and better physical range than other materials. Alternative materials for catheter tubes disclosed herein include polyvinyl chlorides (PVC) or rubber. Other alternative materials include those described in U.S. Patent 9,186,438, which is incorporated by reference in its entirety herein. This patent describes polymer mixtures comprising a first and a second polymer, with the first polymer being a thermoplastic or thermo-curing polymer and the second.

[0087] In some embodiments, a catheter tube disclosed herein comprises and/or is coated with a polymer. An exemplary polymer is a hydrophilic polymer. In some cases, a catheter tube comprises and/or is coated with any material disclosed in WO 2011/051439 filed October 29, 2019, the entirety of which is incorporated by reference herein. In some cases, a tube disclosed in WO 2011/051439 is a catheter tube utilized in any assembly disclosed herein.

[0088] In some instances, catheter cases disclosed herein comprises a polymeric material. In some instances, at least a component of the catheter case (e.g., a lid) comprises a polymeric material. In some instances, the catheter case is constructed of at least one polymeric material. In some instances, the catheter case is molded of at least one polymeric material. In some instances, the polymeric material is polypropylene (PP). In some instances, the polymeric material is polycarbonate (PC). In some instances, the polymeric material is acrylonitrile butadiene styrene (ABS). In some instances, the polymeric material is high-impact polystyrene (HIPS). Those of skill in the art will be able to easily select an appropriate polymeric material depending on the properties sought. [0089] In some instances, a catheter tube has a surface comprising a first material and a case, or feature thereof ( e.g ., bearing, rib, flange) comprises a second material, wherein the first material is different from the second material. In some instances, the difference in materials reduces the friction coefficient between the catheter tube and bearing thereby providing a smoother actuation of the device.

[0090] Catheter tubes disclosed herein may comprise a rounded distal end that is inserted into the urethra of a user. Catheter tubes disclosed herein also comprise a proximal end with at least one aperture or opening providing for release of urine into when in use. In some instances, the catheter tube comprises a plurality of apertures or openings. In some instances, the catheter tube comprises a funnel. The funnel may comprise an elongated, substantially circular neck portion and a shoulder portion that tapers from a substantially circular configuration similar to the neck portion to a flattened, substantially oval spout. In some instances, the hollow funnel has a substantially circular configuration at the proximal end and a substantially circular configuration at an opposite end that forms a spout. For example, the spout end of the hollow funnel has semi major and semi-minor axes that are substantially equal. In some instances, the neck portion is elongated so that it passes completely through a wetting device sub-assembly as described herein. The neck portion of the funnel may have an opening that has a diameter slightly larger than the outside diameter of the catheter. The spout may be configured so that it maintains a low profile. The low profile may be accommodated in an opening of the catheter case.

[0091] In some instances, catheter assemblies disclosed herein comprise a funnel, wherein at least a portion of the funnel is dumbbell-shaped. In some instances, funnels have a dumbbell shaped neck portion that includes an enlarged diameter distal end, i.e., the end disposed toward the catheter, gradually tapering to a relatively reduced diameter at the proximal end, i.e., the end disposed away from the catheter. The distal end of the funnel may have an enlarged internal diameter sized and configured to accommodate the outer diameter of the catheter. The catheter and distal end can be connected at the junction of internal diameter and outer diameter by, e.g., an adhesive or by welding. A non-limiting example of a suitable adhesive is a UV-curable adhesive. The inside diameter of the remainder of the dumbbell-shaped neck portion may be substantially the same as the inside diameter of the catheter. The funnel may have a distal terminal end having an internal size that is configured to matingly engage with a gradually tapering proximal end. The funnel may have a substantially circular central portion that is connected to a shoulder portion that tapers from a substantially circular configuration to a flattened, substantially oval spout. The central portion also may have an internal diameter (not shown) that is substantially the same as at least one internal diameter. The funnel may have a substantially oval spout that is configured so that it maintains a low profile accommodating a low-profile catheter case. In some instances, the cross-sectional area of the substantially oval spout is the same as or greater than the cross-sectional area of internal diameters for the same reason. These relative diameters may allow for a smoother flow, and reduced possibility of “back-up”, of urine through the catheter or funnel. In some instances, the spout does not taper to a flattened, substantially oval configuration, e.g ., the spout has a substantially circular configuration.

[0092] In some instances, the dumbbell-shaped portion comprises a relatively hard material having a low MVTR for reasons that will be appreciated by those of skill in the art. In some instances, the dumbbell-shaped portion comprises HDPE. In some instances, the dumbbell- shaped portion comprises PP. In some instances, the dumbbell-shaped portion comprises PET. The spout may comprise a material that is softer than the dumbbell shaped portion and has a better“feel” to the touch of a user since the spout is more likely to be handled by a user. In some instances, the spout comprises a thermoplastic polyurethane (TPU). In some instances, the spout comprises TPE. In some instances, the spout comprises rubber.

[0093] Because of the different material property characteristics desired for each of the spout and dumbbell-shaped neck portion, the funnel may be a two-part construction. In some instances, the spout and dumbbell-shaped neck portion are interlocked. In some instances, the interlocking can be enhanced by an adhesive.

[0094] In some instances, the spout comprises a slot. The slot may be located in a surface of a substantially circular central portion of the spout. The slot may end at the shoulder portion of the spout. As a gripper is slid along a catheter tube as the catheter is removed from the case, an expandable sleeve may progress along the length of catheter. The vent may allow air to enter an increased volume of the expandable sleeve so that there is no“vacuum” -like effect. As the catheter is inserted into a user’s urethra, the vent may allow air from collapsing the expandable sleeve so that the possibility of a rupture of the expandable sleeve is reduced.

[0095] In some instances, cases disclosed herein comprise a retaining element. In some instances, the retaining element is disposed in the interior of the case. In some instances, the retaining element is proximal to an opening of the case. In some instances, the retaining element is distal to an opening of the case. In some instances, the retaining element is configured to retain a placement or configuration of a catheter tube. In some instances the retaining element is configured to retain a wetting device.

[0096] In some instances, catheter assemblies disclosed herein comprise a wetting device. The wetting device may be configured to allow a catheter tube to pass therethrough. The wetting device may coat an exterior length of the catheter tube with a suitable wetting agent. The catheter tube may be coated with a suitable material that can be“activated” upon contact with an appropriate fluid from the wetting device to provide lubricity to the exterior surface of catheter. As known to those of skill in the art, wetting the exterior surface of the length of the catheter tube facilitates insertion of the catheter tube into the urethra of the user and reduces discomfort thereof. Such suitable liquids include, but are not limited to, deionized water, a light viscosity silicone fluid, a lubricating gel, and a mild saline solution.

[0097] In some instances, catheter assemblies disclosed herein comprise an expandable sleeve. The expandable sleeve may be connected to a shoulder portion of a funnel and also to a gripper. The connection to shoulder portion may be one formed by a laser or ultrasonic weld. The expandable sleeve may be connected to the gripper by a face-to-face surface bond. The expandable sleeve may be connected to the gripper by an overlap bond where inner diameter of expandable sleeve fits over outer diameter of gripper. The expandable sleeve may be connected to the gripper by an overlap bond where inner diameter of gripper fits over outer diameter of expandable sleeve. When expanded, expandable sleeves disclosed herein may cover from 25%- 95% the length of catheter. In some instances, the expandable sleeve covers at least about 25% of the length of the catheter. In some instances, the expandable sleeve covers at least about 50% of the length of the catheter. In some instances, the expandable sleeve covers at least about 75% of the length of the catheter.

[0098] In some instances, catheter assemblies disclosed herein comprise a funnel, a gripper, an expandable sleeve and a wetting device, wherein the wetting device is present around at least a portion of the funnel. The gripper and expandable sleeve may each have an inside diameter that is greater than the outside diameter of the catheter tube. The expandable sleeve and gripper may freely move laterally along the length of the catheter tube. When a user withdraws the catheter tube from the catheter case, the gripper may be retained in the bottom sub-assembly and the expandable sleeve freely travels the length of catheter, thereby protecting it from contact with a user’s hands or other potentially unsanitary surface. At the same time, the length of the catheter tube is drawn through the wetting device so that the exterior surface of the catheter tube is wetted by a suitable liquid absorbed into or onto a wetting applicator. In some instances, the gripper and expandable sleeve are connected to each other. In some instances, the gripper and expandable sleeve are bonded to each other. In some instances, the expandable sleeve is bonded to the shoulder portion of the gripper.

Catheter Assembly & Configuration

[0099] Catheter assemblies disclosed herein may comprise a catheter tube stored in a catheter case in various configurations. In some instances, the catheter tube is stored in a curved configuration that does not have sharp bends or turns. Catheter assemblies disclosed herein may comprise a catheter tube stored in a catheter case in a“serpentine” configuration.” The serpentine configuration may comprise a configuration in the form of letter“S.” The serpentine configuration may comprise a configuration in the form of figure“8.” In some instances, the catheter tube crosses over itself. In some instances, the catheter tube does not cross over itself. In some instances, the configuration does not comprise more than two turns. In some instances, the catheter tube reverses direction only once. In some instances, the catheter tube reverses direction only twice. In some instances, the configuration provides for a generally“straight” form in a region along the catheter tube from the distal end. In some instances, the region is about 5 cm to about 15 cm. In some instances, the region is about 5 cm to about 8 cm. In some instances, the catheter tube crosses over itself not more than once. In some instances, the catheter tube crosses over itself not more than twice. These configurations may allow a catheter assembly to occupy a small amount of lateral space when stored and compacted, but also allow for the full length of catheter tube to extend when the catheter tube is withdrawn from the catheter case.

[0100] In most instances, a catheter tube disclosed herein has a gentle, generally "uncoiled" shape, upon removal from a catheter case. In some instances, the catheter tube does not comprise more than one turn upon removal from the catheter case. In some instances, the catheter tube does not comprise more than two turns upon removal from the catheter case. In some instances, catheter assemblies disclosed herein are configured such that the catheter tube forms an“O” shape when it is placed back into catheter case.

[0101] Catheter assemblies disclosed herein may be configured such that as a catheter tube of the catheter assembly is removed from or re-inserted into a catheter case of the assembly, the movement of the catheter tube relative to the case comprises a combination of movement of the catheter tube and a bearing of the assembly, relative to the catheter case. In some instances, the catheter assembly is configured to allow for movement of the catheter tube and an inner bearing. In some instances, the catheter assembly is configured to allow for movement of the catheter tube and an outer bearing. In some instances, the movement of catheter tube relative to the catheter case is attributable only to movement of a first inner bearing, a second inner bearing and outer bearing relative to catheter case. When removing the catheter from the case, there is initially a high contact area between the case and the catheter tube and, as a result, a large pull force on the catheter is required to overcome the frictional forces between the catheter tube and the case. The inner bearings specifically reduce the frictional forces and allow the catheter to be removed from the case with significantly less force. Likewise, the outer bearing reduces the frictional forces when the catheter is re-inserted into the case. Due to the flexibility of the catheter tube there is a limit to the push force that can be applied before the tubing will flex and kink so it is doubly important that the frictional forces between the catheter tube and the case are minimized. [0102] Catheter assemblies disclosed herein can be assembled in various orders of steps.

Provided herein are catheter assemblies as well as methods of assembling them. By way of an example, an outer bearing may be placed inside and against a rib of a bottom sub-assembly of a case. Next, a first inner bearing and second inner bearing may be placed over and against an outer perimeter of a first raised flange and second raised flange.

[0103] The catheter tube may be placed in a case in a number of different configurations. Non limiting examples of these configurations are shown in Figure 15. In general, a region proximal the distal end of the catheter tube is maintained in a straight form. In some instances, a region proximal the distal end of the catheter tube is maintained in a straight form and the configuration comprises has not more than one curve (see, e.g., E, F, H and I of Figure 15). In some instances, a region proximal the distal end of the catheter tube is maintained in a straight form and the configuration has not more than two curves (see, e.g, G, J, K, and L of Figure 15). In some instances, a region proximal the distal end of the catheter tube is maintained in a straight form and the configuration has not more than three curves (see, e.g, B, C, and D of Figure 15). In some instances, the configuration is circular (see, e.g, A of Figure 15). In some instances, the configuration resembles an oval (see, e.g, G, J and K of Figure 15). In some instances, the configuration resembles an oval wherein the tips of that catheter tube are located on a side of the oval (see, e.g, G and J of Figure 15). In some instances, the configuration resembles an oval wherein the tips of that catheter tube are located on a side of the oval, but regions proximal to the tips overlap (see, e.g, J of Figure 15), which may allow for more compact packaging than when they do not overlap (see, e.g, G of Figure 15). In some instances, the configuration resembles an oval wherein the tips of that catheter tube are located on different sides of the oval (see, e.g, K of Figure 15). In some instances, the configuration is such that the proximal end and distal end of the catheter tube are proximal to the center point of the catheter tube (see, e.g, C and D of Figure 15). In some instances, the configuration resembles a“U”-shape (see, e.g, E and F of Figure 15). In some instances, the arms of the“U”-shape are parallel (see, e.g, E of Figure 15). In some instances, the arms of the“U”-shape are not parallel and are closer together near the proximal and distal tips of the catheter tube than at the curved region of the catheter tube (see, e.g, F of Figure 15). In some instances, the configuration resembles a hairpin (see, e.g, H and I of Figure 15). However, the ends of the hairpin need not be located at the same distance across the length of the assembly or case (see, e.g, I of Figure 15). In some instances, the configuration resembles an“S”-shape (see, e.g, B and L of Figure 15). In some instances, the middle of the“S”-shape is curved (see, e.g, B of Figure 15). In some instances, the middle of the“S”-shape is straight (see, e.g, L of Figure 15). By way of non-limiting example, the catheter tube may be placed as an "S"-shape configuration in a bottom sub-assembly inside an outer bearing and outside a first inner bearing and second inner bearing.

[0104] With reference to Figure 15, in some instances, configuration A is less preferred because of the configuration’s large diameter which presents a poor use of space. However, configuration A presents very little curve to the catheter which may lend to easier and more comfortable insertion. Configuration B may present a more efficient use of space. However, configuration B has two 270-degree bends. More bends result in more friction on removal and re-insertion of the catheter. In some instances, configuration L is preferable to configuration B as the bends of configuration L are reduced (-200 degrees instead of 270) and use of space is comparable. In some instances, removal of a catheter from the case would be easier when the catheter is in configuration B or L, then when it is in configuration C, D or G. In some instances, configurations B and L are packaged in a smaller case than, e.g., cases containing catheter tubes in configurations E and F, which contain only one bend.

[0105] In some instances, there is a limit to the radius of the bends that can be employed. With too small a radius, the catheter tubing may kink in the pack creating a weak point in the catheter which is then more likely to kink again during use which can then prevent drainage of the bladder. To avoid this, the diameter of each bend may be greater than the kink distance of the catheter tubing. Therefore, configuration F may provide a slightly narrower pack at one end. Similarly, configuration H and configuration I may create a narrower pack with a rounded end to provide an adequate radius for the tubing to prevent kinking. Configuration I may provide better access to the catheter funnel for easier removal from the pack but also results in a longer pack than configurations H, J, K and L. In some instances, configurations H, J, K and L are preferred as they have a balance of compactness and ease of access to the catheter funnel.

Configuration K may be preferred over configuration J as this allows a longer straight section at the proximal end of the catheter. Configuration L may be further preferred in some instances because the bends are in opposing directions. If the catheter tubing exhibits a degree of set or shape memory, then configurations J and K would form a U shape when removed from the pack. This may not be desirable as the catheter funnel may point upwards, towards the face of the user during insertion as opposed to downwards towards the toilet basin or other drainage receptacle.

[0106] The catheter assemblies, systems and catheter cases having the advantages and features described herein will be appreciated and understood by those skilled in the art from the following description of the drawings, and appended claims. Examples

[0107] Referring to the Figures and in particular to Figure 1, there is shown a catheter case or package for a catheter generally represented by reference numeral 100. Figure 1 shows catheter case 100 in the closed position. Catheter case 100 may be used to contain a urinary catheter such as an intermittent urinary catheter.

[0108] Catheter case 100 may include a generally circular opening 110 at first end and a lid 120 at an opposite second end. Lid 120 may be connected to catheter case 100 with a hinge 130. Catheter case 100 may also have a top sub-assembly 150 and a bottom sub-assembly 160 that are joined together, preferably by an ultrasonic weld, or a laser weld, along a split line 170 of catheter case 100. Hinge 130 may be on one side of lid 120 and may be connected to catheter case 100 at a location 140. In some instances, hinge 130 is positioned 15, 30, 45, 60, 75 or 90 degrees, either clockwise or counter-clockwise, relative to the centre line of the assembly.

Figure 27A shows a catheter case having a lid 120 and a hinge location 140 positioned along the centre line of the assembly. Figure 27B shows a catheter case having a lid 120 and a hinge positioned about 30 degrees clockwise relative to the centre line of the assembly. Catheter case 100, or a component thereof, may be molded of a polymeric plastic material having suitable physical properties of strength and hardness. In some instances, the catheter case comprises a lid 120 that is molded of a polymeric plastic material.

[0109] Referring to Figures 2A-2C, these Figures show catheter case 100 in three positions for opening. Catheter case 100 may have a closure 200. Closure 200 may include a tab 210 shown in Figures 2A and 2B that provides two tamper-evident indications. Closure 200 and tab 210 may be secured in place, preferably by ultrasonic welds or laser welds. Tab 210 may be connected to closure 200 by a joint 220. Joint 220 may provide a first tamper-evident indication that closure 200 and tab 210 have been disturbed, as explained in the following. To open catheter case 100, tab 210 may be bent away from catheter case 100, as shown in Figure 2B, to create a gripping area to open lid 120. The bending of tab 210 may create a fatigue mark 225 in joint 220 that is visibly observable. A fatigue mark 225 may serve as a tamper-evident indicator.

[0110] Referring to Figure 2C, as tab 210 is further moved away from catheter case 100, an ultrasonic weld location 230 may be broken and closure 200 and/or tab 210 may be irreversibly and noticeably damaged. This noticeable damage may serve as a tamper-evident indicator. In some instances, both the breaking ultrasonic weld location 230 and fatigue mark 225 provide visual and tactile evidence of tampering and, thus, provide tamper-evident security to catheter case 100 and the user thereof. [0111] Also shown in Figure 2C is a recessed edge 240. Recessed edge 240 may be disposed along the periphery of opening 250. Mating elements comprised of a clip feature (not shown) built into the underside of lid 120 may engage a notch feature (not shown) adjacent to weld location 230. In Figure 2C, clip feature (not shown) on lid 120 and notch feature (not shown) adjacent to weld location 230 may provide a labyrinthine pathway between the lid 120 and opening 250, that prevents the egress of liquid from re-closed catheter case 100. This may allow for carrying a re-closed catheter case 100 in a sanitary state, without leakage. Thus, the re-closed catheter case can be carried anywhere, such as in a user’s pocket, discretely without concerns of leakage. Figure 2C further shows an optional feature 255 within the opening 250 of catheter case 100.

[0112] In an alternative to the embodiment exemplified in Figures 2A-2C, a catheter case comprises a lid that is not sealed with a closure comprising a tab 210, joint 220, fatigue mark 225, and weld location 230. In some embodiments, the catheter case comprises a lid 120 without a tab 210. In some embodiments, the catheter case comprises a lid 120 and tab 210 without fatigue mark 225. In some embodiments, the lid is sealed with an exterior paper type seal that is placed on either the exterior top 150 or bottom 160 of the case 100. In some embodiments, the lid is sealed using an overlapping top 150 and bottom 160 of the case 100, which clicks into place to lock the top 150 and bottom 160 of the case 100 together. A catheter case comprising an exemplary lid closure is shown in Figures 25A and 25B. Case 5100 comprises a lid 120 that opens over portion 235 exposing opening 250. In this embodiment, opening 250 lacks the interior feature 255 shown in Figure 25C.

[0113] In an alternative embodiment to exemplified Figures 2A-2C, a catheter case comprises a lid that is not sealed with the closure comprising tab 210, joint 220, fatigue mark 225, and weld location 230. In one embodiment, the lid is sealed with clip on either side of the lid as is shown in Figure 30. In this embodiment, the lid 120 comprises first engaging members 215, represented as a clip, that engage with second engaging members 217 of the top sub-assembly 150 to close the catheter case after use. In an exemplary embodiment, after re-insertion of the urinary catheter into the catheter case, the lid 120 is closed by pressing the first engaging members 215 of the lid 120 against the top sub-assembly 150 of the catheter case to engage with second engaging members 217 and enclose the urinary catheter within the catheter case. In some instances, minimal or no liquid from the catheter is released from the catheter case when the lid 120 is closed.

[0114] Referring to Figure 2D, one embodiment of a labyrinthine pathway to prevent egress of liquid from re-closed catheter case 100 is shown. As shown, lid 120 and tamper-evident closure 300 shown in Figure 3A may provide or maintain the labyrinthine pathway, thereby preventing egress of liquid from re-closed catheter case 100. In some instances, egress of liquid from the re- closed catheter case can be prevented for up to 24 hours. In some instances, egress of liquid from the re-closed catheter case can be prevented for at least 24 hours. Alternatively, or additionally, the labyrinthine pathway in this embodiment may be provided or maintained by at least one of two protrusions 260 and 270 that project from lid 120 toward opening 250.

Protrusion 260 may contact tamper-evident closure 300, and protrusion 270 may project into a channel 280. Together, protrusions 260 and 270, tamper-evident closure 300 and channel 280 may provide one type of the described labyrinthine pathway.

[0115] Referring to Figure 3 A, a tamper-evident closure 300 on catheter case 100 is shown. Figure 26 shows another embodiment of a catheter case comprising a tamper-evident closure 300. Tamper-evident closure 300 may comprise a substrate or seal. Tamper-evident closure 300 may be made of any suitable material, such as metal foil, plastic film or waxed/coated paper and other similar materials known to those of skill in the art. In some instances, tamper-evident closure 300 comprises a material that provides a breathable membrane. In some embodiments, as shown in Figure 3 A, tamper-evident closure 300 is made of Tyvek®. Tamper-evident closure 300 may be connected to catheter case 100 and recessed edge 240 by a suitable attachment mechanism. In some instances, tamper-evident closure is directly attached to the catheter case.

In some instances, tamper-evident closure is directly attached to the recessed edge. In some instances, tamper-evident closure is directly attached to the recessed edge or tamper-evident closure by an adhesive. In some instances, tamper-evident closure is directly attached to the recessed edge or tamper-evident closure by welding. Tamper-evident closure 300 may completely cover opening 250 to provide direct access to catheter assembly 400 (see, e.g.,

Figure 4) disposed in catheter case 100. Optionally, a connecting tab 310 of any suitable size or shape can be disposed on the surface of tamper-evident closure 300 and adhered to the underside of lid 120 so that tamper-evident closure 300 is peeled open as lid 120 is opened. Figure 3B shows catheter case 100 of Figure 3 A with tamper-evident closure 300 removed, exposing catheter funnel 411 (see, Figure 4). Figures 28A-28C provide an exemplary catheter case, where Figure 28C shows tamper-evident closure 300 and Figure 28B shows tamper-evident closure 300 removed to expose catheter funnel 411. Figures 29A-29B provide another exemplary catheter case, where Figure 29 A shows tamper-evident closure 300 and Figure 29B shows the tamper-evident closure 300 removed to expose catheter funnel 411 having a substantially circular spout.

[0116] Referring to Figure 4, catheter case 100 is shown in an exploded view to better illustrate the placement of a catheter assembly 400 therein of the present disclosure. Catheter assembly 400 may include a urinary catheter sub-assembly 410 and a wetting device sub-assembly 420. Catheter assembly 400 may include at least one of a first inner bearing 430, a second inner bearing 440 and an outer bearing 450. First inner bearing 430, second inner bearing 440 and outer bearing 450 are may be made of a material that is dissimilar to at least one of the catheter case 100 and lid 120. The use of dissimilar materials may improve the lowering of the friction coefficient between the surfaces of two materials so that the two surfaces can move relative to one another more easily such as when catheter 414 is removed from or re-inserted into catheter case 100. For example, when catheter case 100 and lid 120 are made of polypropylene, first inner bearing 430 and second inner bearing 440 can be made of a high-density polyethylene (HDPE), a nylon or a polyacetal, and outer bearing 450 can be made of a polyethylene (PE) or a polytetrafluoroethylene (PTFE) such as Teflon®.

[0117] As shown in Figure 4, both top sub-assembly 150 and bottom sub-assembly 160 of catheter case 100 have a plurality of ribs 1150, 1160 (only shown in conjunction with bottom sub-assembly 160) that will be discussed in more detail in conjunction with Figure 11. Catheter sub-assembly 410 has a funnel 411, an expandable sleeve 412, a gripper 413 and a catheter 414.

[0118] Catheter 414 may be made of a flexible material such as a thermoplastic elastomer. While the friction coefficient between catheter case 100 and first inner bearing 430, second inner bearing 440 and outer bearing 450 may be improved by the use of dissimilar materials as noted above, the friction coefficient between catheter 414 and first inner bearing 430, second inner bearing 440 and outer bearing 450 is similarly improved. When catheter 414 is removed from or re-inserted into catheter case 100, the movement of catheter 414 relative to catheter case 100 may comprise any combination of movement of catheter 414 and first inner bearing 430, second inner bearing 440 and outer bearing 450 with respect to each other and with respect to catheter case 100. In some instances, the movement of catheter 414 relative to catheter case 100 is attributable only to movement of first inner bearing 430, second inner bearing 440 and outer bearing 450 relative to catheter case 100.

[0119] Catheter 414 may have a rounded distal end 415 that is inserted into the urethra of a user. Proximal rounded distal end 415, as is known in the art, may comprise at least one aperture or opening providing for release of urine from catheter 414 when in use. Preferably, there is a plurality of apertures or openings. Figure 4 shows expandable sleeve 412 may be included. When in place in catheter assembly 400 before and after use, the expandable sleeve may be compacted in an“accordion” type configuration. Also as shown in Figure 4, catheter sub-assembly 410 may be stored in catheter case 100 in a“serpentine” or figure“S” or figure “8” configuration, such that catheter sub-assembly 410 does not cross over itself more than once. This configuration may allow catheter assembly 400 to occupy a small amount of lateral space when stored and compacted, but can be extended to the full length of catheter 414 when catheter 414 is withdrawn from catheter case 100. Wetting device sub-assembly 420 has a wetting device front 421, a wetting device rear 422 and a wetting applicator 710, shown in Figures 7A and 7B in different embodiments, disposed inside wetting device sub-assembly 420 between wetting device front 421 and wetting device rear 422.

[0120] Wetting device front 421 and wetting device rear 422 may be made of a material that has a low moisture vapor transmission rate (MVTR) (also referred to as water vapor

transmission rate (WVTR)), that is a measure of the passage of water vapor through a substance. A low MVTR of wetting device front 421 and wetting device rear 422 may be desired so that moisture/wetting agent on/in wetting applicator 710 may be retained. In the preferred embodiments shown in the Figures, the wetting applicator may comprise a sponge, preferably a synthetic foam sponge. Having a low and controlled MVTR is helpful in achieving the required quality, safety, and shelf life of catheter assembly 400. In some instances, wetting device front 421 and wetting device rear 422 are made of PP or PET, or other material with similar low MVTR described herein. In some instances, low MVTR is less than 1.5 (g*mm)/(m ² *24hr).

[0121] In addition to having ribs 1150, 1160 bottom sub-assembly 160 may also include a first raised flange 470 and a second raised flange 480. First raised flange 470 and second raised flange 480 may have outer perimeter dimensions, e.g., line "A"-"A" that are sized and arranged to accept inner perimeter dimensions, e.g., line "B" of first inner bearing 430 and of second inner bearing 440 (dimension“B” of inner perimeter of second inner bearing 440 being omitted) for placement thereon in a close contacting fit, yet allowing for rotational movement of first inner bearing 430 and second inner bearing 440 around first raised flange 470 and second raised flange 480, respectively, as catheter 414 is removed from or re-inserted into catheter case 100, as described below in conjunction with Figure 11. This close contact fit, that allows rotational movement of first inner bearing 430 and second inner bearing 440, may be an important feature to allow for removal and replacement of catheter sub-assembly 410 out of catheter case 100 for use and back into catheter case 100 after use.

[0122] Catheter assembly 400 can be assembled as follows, although assembly can possibly be accomplished in any other order of steps. First, outer bearing 450 may be placed inside and against a continuous rib 1160 of bottom sub-assembly 160. Second, first inner bearing 430 and second inner bearing 440 may be placed over and against outer perimeter dimension“A” -“A” of first raised flange 470 and second raised flange 480. Third, the combination of the catheter sub- assembly 410 and wetting device sub-assembly 420 may be placed in position, in the "S"-shape configuration shown in Figure 4, in bottom sub-assembly 160 inside outer bearing 450 and outside first inner bearing 430 and second inner bearing 440. It should be noted that first inner bearing 430 and second inner bearing 440 cooperatively meet elements 1110 and 1120, respectively, shown in Figure 11, correctly sized and disposed on the inner surface 1130 of top sub-assembly 150. Next, top sub-assembly 150 may be placed over all previously assembled components, and top sub-assembly 150 and bottom sub-assembly 160 may be affixed by laser weld, or liquid tight snap-fit features, or a combination thereof, or other methods that will be apparent to those of skill in the art. Two seals, a perimeter seal 1010 and an opening seal 1020, may be placed as indicated in conjunction with the description of Figure 10. Assembly of catheter assembly 400 may then be complete.

[0123] Referring to Figure 5, ribs 510 and 520 may be part of the plurality of ribs 1150, 1160 as shown in Figures 4 and 11. However, ribs 510 and 520 may be configured and disposed on bottom sub-assembly 160 to accept and retain wetting device sub assembly 420 when catheter sub-assembly 410 is removed from and re-inserted into catheter case 100. The arrow 530 shown in Figure 5 indicates the direction of movement of catheter sub-assembly 410 when removed from catheter case 100. As shown in Figure 5, prior to removal of catheter sub-assembly 410 from catheter case 100, catheter sub-assembly 410 may form a curved configuration that does not have sharp bends or features in catheter 414. Preferably, this curved configuration may be a generally "S"-shaped. This generally“S”-shaped configuration may cross itself only once at point 540 and reverses direction only twice, i.e., around curves 550 and 560 formed by first inner bearing 430 and second inner bearing 440, respectively. This configuration may provide catheter sub-assembly 410 with a gentle generally "uncoiled" shape upon removal from catheter case 100. In particular, this“S”- shaped configuration may provide for a generally“straight” shape from rounded distal end 415 for several inches along the length of catheter 414 upon removal from catheter case 100. It should be noted that, upon replacement of catheter sub- assembly 410 into catheter case 100, catheter 414 may not follow the general "S"-shape. Rather, referring to the structure shown in Figure 5, upon replacement into catheter case 100, catheter 414 may proceed around first inner bearing 430, then in a straight line in the space occupied by rounded distal end 415, then around second inner bearing 440 and finally in a straight line in channel 570. As a result, when placed back into catheter case 100, catheter sub-assembly 410 may form a generally "0"-shape.

[0124] Referring to catheter sub-assembly 410 shown in Figure 6A, funnel 411 may have an elongated, substantially circular neck portion 610, and a shoulder portion 620 that tapers from a substantially circular configuration similar to the neck portion 610 to a spout 630 that is optionally flattened and substantially oval. In some instances, the spout does not taper to a flattened, substantially oval configuration, e.g ., the spout has a substantially circular

configuration. In the embodiment shown in Figure 6A, neck portion 610 is elongated so that it may pass completely through wetting device sub-assembly 420. Neck portion 610 of funnel 411 may have an opening 640 that has a diameter slightly larger than the outside diameter of catheter 414. Also, spout 630 may be configured so that it maintains a low profile that can be accommodated in opening 250 of the low-profile cross-section of catheter case 100. An exemplary embodiment of a catheter case comprising a catheter sub-assembly with a funnel 411 having a substantially circular spout is shown in Figures 29A-29B.

[0125] Catheter sub-assembly 410 shown in Figure 6A may be assembled as follows.

Expandable sleeve 412 may be connected to shoulder portion 620 and also to gripper 413.

Preferably, the connection to shoulder portion 620 may be by a laser or ultrasonic weld.

Expandable sleeve 412 can be connected to gripper 413 in any number of ways, such as a face- to-face surface bond, an overlap bond where inner diameter of expandable sleeve 412 fits over outer diameter of gripper 413, or an overlap bond where inner diameter of gripper 413 fits over outer diameter of expandable sleeve 413 at points indicated by line“A” in Figure 6A. Next, wetting device sub-assembly 420 may be slid onto neck portion 610 of funnel 411, and then flat proximal end 650 of catheter 414 may be inserted into opening 640 and connected, preferably by bonding, to inside of neck portion 610 as indicated by line“B” in Figure 6A. By this assembly, gripper 413 and expandable sleeve 412 each may have an inside diameter that is necessarily greater than the outside diameter of catheter 414. Also, expandable sleeve 412 and gripper 413, although connected or preferably bonded to each other (as well as expandable sleeve 412 being bonded to shoulder portion 620), can freely move laterally along the length of catheter 414. In this way, when a user holds funnel shoulder portion 620 as catheter sub-assembly 410 is withdrawn from catheter case 100, gripper 413 may be retained in bottom sub-assembly 160 by ribs 510 and 520 and expandable sleeve 412 may freely travel the length of catheter 414 and protects it from contact with a user’s hands or other potentially unsanitary surface. At the same time, the length of catheter 414 may be drawn through wetting device sub-assembly 420 so that the exterior surface of catheter 414 may be wetted by a suitable liquid absorbed into or onto wetting applicator/sponge 710 shown in different embodiments in Figures 7A and 7B.

Alternatively, the exterior length of catheter 414 can be coated with a suitable material that can be“activated” upon contact with an appropriate fluid to provide lubricity to the exterior surface of catheter 414. As known to those of skill in the art, wetting the exterior surface of the length of catheter 414 may facilitate insertion of catheter 414 into the urethra of the user and reducing discomfort thereof. In use, expandable sleeve 412 may expand to cover less that the entire length of catheter 414. All that is preferred is that expandable sleeve 412 sufficiently covers the length of catheter 414 to protect it from contact with an unsanitary surface, such as a user’s hands, as catheter 414 is removed from catheter case 100. [0126] Referring to Figure 6B, an embodiment of a funnel 600 is shown. Funnel 600 may have a substantially dumbbell-shaped neck portion 610 that includes an enlarged diameter distal end 611, i.e., the end disposed toward catheter 414, and a reduced diameter, gradually tapering proximal end 612, i.e., the end disposed away from catheter 414. Distal end 611 may have an enlarged internal diameter 613 sized and configured to accommodate outer diameter 614 of catheter 414. Catheter 414 and distal end 611 can be connected at the junction of internal diameter 613 and outer diameter 614 by, e.g., a suitable adhesive, such as a UV-curable adhesive, or can be laser-welded together, or connected by other mechanisms known to those of skill in the art. Of note, inside diameter 615 of the remainder of dumbbell-shaped neck portion 610 may be substantially the same as the inside diameter 616 of catheter 414. These

substantially same diameters 615, 616 may allow for smoother flow, and reduced possibility of “back-up”, of urine through catheter 414. Funnel 600 also may have a distal terminal end 622 that has an internal size 623 that is configured to matingly engage with gradually tapering proximal end 612, and a substantially circular central portion 621 that is connected to shoulder portion 620 that tapers from a substantially circular configuration to a spout 630 that is flattened and substantially oval. In some instances, the spout does not taper to a flattened, substantially oval configuration, e.g., the spout has a substantially circular configuration. Central portion 621 also may have an internal diameter (not shown) that is substantially the same as internal diameters 615, 616. As mentioned above in conjunction with Figure 6A, spout 630 may be configured so that it maintains a low profile that can be accommodated in opening 250 of the low-profile cross-section of catheter case 100. Also preferably, the cross-sectional area of spout 630 may be the same as or greater than the cross-sectional area of internal diameters 615, 616 for the same reason, i.e., to allow for smoother flow, and reduced possibility of“back-up”, of urine through catheter 414 and out of funnel 600.

[0127] As shown in Figures 7A and 7B, and mentioned previously in conjunction with Figure 4, wetting device sub-assembly 420 may have wetting device front 421, wetting device rear 422 and a wetting applicator/sponge 710 disposed inside wetting device sub-assembly 420 and between wetting device front 421 and wetting device rear 422. Feature 797 refers to deionized water held within the wetting applicator 710. Wetting device sub-assembly 420 may be a sub- assembly in catheter assembly 400.

[0128] In the embodiment shown in Figure 7 A, wetting device front 421 and wetting device rear 422 may each have an elongated portion 720 and 730, respectively, that have a substantially circular opening 740 and 750, respectively, of sufficient diameter to accommodate the outside diameter of neck portion 610 of funnel 411. Also, in the embodiment of wetting device sub- assembly 420 shown in Figure 7 A, each of wetting device front 421 and wetting device rear 422 may have a "chamber" 760 and 770, respectively, sized and configured to accept wetting applicator/sponge 710. Wetting device front 421 and wetting device rear 422 may be connected to each other at facial surfaces 780 and 790, respectively, by a facial surface attachment such as an ultrasonic weld or suitable adhesive. It will be appreciated that wetting applicator/sponge 710 may have an opening 795 that is smaller than openings 740 and 750 which, in turn, are similar to the diameter of catheter 414. By this size configuration, it may be ensured that the entire length of catheter 414 contacts the periphery of opening 795 and is wetted by fluid on wetting applicator/sponge 710 as catheter 414 is withdrawn from catheter case 100. In other words, wetting applicator/sponge 710, being a flexible material such as a suitable foam, may allow opening 795 to expand over neck portion 610 but then collapse again and make contact with the exterior surface of catheter 414 as catheter 414 is withdrawn from catheter case 100. Wetting applicator/sponge 710 can be any suitable material that retains the liquid absorbed thereon. As noted above, some preferred materials for the wetting applicators are foams, such as polyurethane or polyethylene foams.

[0129] Figure 7B shows a cross-sectional view of funnel 600 of Figure 6B disposed in a wetting device sub-assembly 420 as shown in Figure 4. Funnel 600 of Figure 7B is of a different design than wetting device sub-assembly 420 shown in Figure 7A. One difference is that wetting device sub-assembly 420 of Figure 7B does not have a very elongated portion 720, and another difference is that wetting device sub-assembly 420 of Figure 7B includes a wetting device fill port 796 (shown on the top edge of wetting device front 421 of Figure 4) that may be sealed after filling at an appropriate time during assembly. As shown in Figure 7B, dumbbell- shaped neck portion 610 may be designed and configured to contact wetting device front 421 at points 799 and wetting device rear 422 at points 798. These contact points may serve to“seal” wetting device front 421 and wetting device rear 422 from the outside environment and retain wetting fluid in wetting device sub-assembly 420. This helps to ensure that wetting device sub- assembly 420 maintains its proper function, i.e., wetting the length of catheter 414 as it is removed from catheter case 100 for use.

[0130] Dumbbell-shaped neck portion 610 may be preferably made of a relatively hard material having a low MVTR for reasons that will be appreciated by those of skill in the art. For example, a preferred material for dumbbell-shaped neck portion 610 may be HDPE. In addition, PP or PET, or any other material with similar low MVTR may be used. On the other hand, spout 630 may be made of a material that is softer and has a better“feel” to the touch of a user since spout 630 may be the portion that will be most handled by a user. A preferred material for spout 630 is a thermoplastic polyurethane (TPU) having the desired characteristics. Alternative materials that can be used are TPE, discussed above, and rubber. Because of the different material property characteristics desired for each of spout 630 and dumbbell-shaped neck portion 610, funnel 600 maybe a two-part construction, with spout 630 and dumbbell-shaped neck portion 610 interlocked by a“T”-shaped junction indicated at“A” shown in Figure 7B. Figure 6B shows the interlocking between spout 630 and dumbbell-shaped neck portion 610 by the mating engagement of the junction of tapered distal internal diameter 622 with tapering proximal end 612. The interlocking nature of either of the foregoing junctions can be enhanced by a suitable adhesive, such as a UV-cured adhesive. In the embodiment shown in Figure 7B, the connections between expandable sleeve 412 and gripper 413, and spout 630, are more clearly shown. Expandable sleeve 412 may be bonded to spout 630 near or adjacent to shoulder portion 620 and may be bonded to gripper 413 at/near the end of gripper 413 disposed away from dumbbell-shaped neck portion 610. Expandable sleeve 412 may be made of TREG, but can also be made of a film material having good tear strength, such as a PE film. Gripper 413 may be made of a material similar to that of the 630 ( e.g ., TREG, TPE and rubber).

[0131] Referring to Figure 8, catheter sub-assembly 410 and wetting device sub-assembly 420 shown in Figure 4 is shown in an enlarged view. Of note in Figure 8, a vent 810 is shown. Vent 810 is a slot in the surface of substantially circular central portion 621 and may end at shoulder portion 620. Vent 810 is optional and functions in the following manner. As gripper 413 is slid along catheter 414 as catheter is removed from case 100, expandable sleeve 413 likewise progresses along the length of catheter 414. Vent 810 may allow air to enter the increased volume of expandable sleeve 413 so that there is no“vacuum” -like effect. On the other hand, as catheter 414 is inserted into a user’s urethra, vent 810 may allow air from collapsing expandable sleeve 412 to exit so that the possibility of rupture of expandable sleeve 412 is reduced.

[0132] Referring to Figure 9, second tamper-evident closure 300 may be connected, and possibly affixed, to recessed edge 240 by a suitable attachment mechanism, such as weld or adhesive. The adhesive or other attachment mechanism may provide a strong and non- reversible attachment of second tamper-evident closure 300 so that, once removed, second tamper-evident closure 300 cannot be reattached. As shown in Figure 9, connecting tab 310 on second tamper evident closure 300 may be attached to inside of lid 120 (but in one embodiment 310 is present but not attached to the inside of lid 120), as described above. In the embodiment shown in Figure 9, hinge 130 of lid 120 may be ultrasonically welded at location 140. Lastly, the contact points of first tamper-evident closure 200 and tab 210 may also be ultrasonically welded. However, other ways to connect lid 120 to hinge 130 and to form the contact points of first tamper-evident closure 200 and tab 210 that are known in the art can be used to provide the necessary“hinge” and contact point features. [0133] The sealing mechanisms for bottom sub-assembly 160 are shown in Figure 10. Sealing mechanisms may be used to prevent leakage of fluids (either from wetting device sub-assembly 420 or from catheter sub-assembly 410 after use) from catheter case 100. In the embodiment shown in Figure 10, two different seals may be used. These two seals may be a perimeter seal 1010 and an opening seal 1020. Bottom sub-assembly 160 may have two channels, perimeter channel 1030 and opening channel 1040. Perimeter channel 1030 may be disposed around the entire perimeter of bottom sub-assembly 160, and opening channel 1040 may be disposed around the entire perimeter of opening 110. Perimeter seal 1010 may be sized and configured to fit into perimeter channel 1030, and opening seal 1020 may be sized and configured to fit into opening channel 1040. Perimeter seal 1010 and opening seal 1020 can be made of any suitable material known to those of skill in the art that provides a water tight seal between joined parts.

In this embodiment, both perimeter seal 1010 and opening seal 1020 may be silicone rubber O- rings. Perimeter seal 1010 and opening seal 1020 may, alternatively, be made of a nitrile rubber.

[0134] Referring to Figure 11, the inside surface 1130 of top sub-assembly 150 and the inside surface 1140 of bottom sub-assembly 160 are shown. As noted with respect to Figure 4, first inner bearing 430 and second inner bearing 440 may cooperatively meet elements 1110 and 1120, respectively, on inner surface 1130 of top sub-assembly 150. Additional elements shown on inner surface 1130 and the inner surface 1140 of bottom sub-assembly 160 may serve the following functions. As mentioned above with respect to the description of Figure 5, ribs 510 and 520 may be provided to accept and retain wetting device sub-assembly 420 when catheter sub-assembly 410 is removed from and reinserted into catheter case 100. A plurality of central ribs 1150 may be present. Central ribs 1150 may control small to large catheters 414 along the path of removal and reinsertion, thus reducing friction and the risk of jamming. Two or more perimeter ribs 1160 may also be present. In combination, central ribs 1150 and perimeter ribs 1160 may tightly control the path of catheter 414 both during removal of catheter 414 from catheter case 100 for use, and reinsertion of catheter 414 into catheter case 100 for storage after use. Further ribs 1170 on inside surface 1130 between the circular opening 110 and ribs 510 and 520 may form an interference fit with gripper 413 in the packaged state such that gripper 413 may be retained during withdrawal of catheter sub assembly 410 until expandable sleeve 412 has fully expanded. The ensuing tension in the expandable sleeve 412, created as catheter sub assembly 410 continues to be withdrawn, may pull the gripper 413 free from the interfering ribs 1170.

[0135] Figure 12 shows details of first and second inner bearings 430, 440 that are shown in Figure 5. First and second inner bearings 430, 440 each may have a surface 1210, shown in figure 12, sized and configured to surround and contact first raised flange 470 and second raised flange 480 of bottom sub-assembly 160. First and second inner bearings 430, 440 each also may have a flange 1220 that is disposed substantially perpendicular to surface 1210. Flange 1220 may be connected to surface 1210 at an angle of approximately 90°. Flange 1220 may be added to surface 1210 to add some strength and rigidity to first and second inner bearings 430, 440, which help transport catheter 414 around turns. First and second inner bearings 430, 440 may be made of a material dissimilar to that of catheter case 100. The use of dissimilar materials for inner bearings 430, 440 as compared to catheter case 100 may improve the frictional coefficient between inner bearings 430, 440 and catheter case 100. Alternatively or additionally, a wetting agent could be introduced to further reduce the frictional coefficient.

[0136] Referring to Figure 13, one removal path of catheter 414 from catheter case 100 is shown and the function of first inner bearing 430 and second inner bearing 440 therewith.

Catheter 414 removal path may be indicated by the dashed arrow 1310. Removal path 1310 may cause catheter 414 to slide around first inner bearing 430 and second inner bearing 440. Catheter case 100 may be also designed to provide a maximum clearance at the entrance of catheter case 100 as indicated at point A. Further, catheter case 100 may be designed to provide a maximum space for rounded distal end 415 of catheter 414 upon reinsertion of catheter 414 back into catheter case 100. As noted above with respect to Figure 5, upon reinsertion into catheter case 100, catheter 414 may follow an "0"-shaped path rather than the "S"-shaped configuration of prior to removal.

[0137] Figure 14 shows the spatial arrangement of outer bearing 450 in relation to top sub- assembly 150 and bottom sub-assembly 160 and first inner bearing 430 and second inner bearing 440. With respect to the materials, placement and function of outer bearing 450, it has been found that outer bearing 450 made of PTFE or acetate or PET was beneficial in providing a proper frictional coefficient for reinsertion of catheter 414 into catheter case 100, and in providing proper frictional coefficient for reinsertion of catheter 414 into catheter case 100 without any internal rib(s) controlling its position or freedom of movement.

[0138] Non-limiting examples of a catheter assembly and case are shown in Figures 18 and 19. A top view of the case 2100, 3100 is shown on the left panel with an opening 2110, 3110. A side view of the case 2100, 3100 is shown in the middle panel. The right panel shows a longitudinal cross-section of an open case 2100, 3100 showing the bottom of main body 2160, 3160, and catheter assembly 2410, 3410. The catheter assembly may comprise one or more components from one or a combination of catheter assemblies described elsewhere herein, e.g., the assemblies and components as shown in Figures 6A, 6B, 7A, 7B, and/or 8. The catheter assembly 2410 is shown having an“S” shape. The catheter assembly 3410 is shown having an oval shape. The catheter assembly 2410, 3410 comprises a catheter 2414, 3414, wetting chamber 2420, 3420, sleeve 2412, 3412, sleeve flange or gripper 2413, 3413, and a funnel 2411, 3411. Cap 2120, 3120 is connected to the main body 2160, 3160 at hinge 2130, 3130. The contact point between the cap and main body may be ultrasonically welded to provide a tamper-evident closure.

[0139] Figures 20-23 show an exemplary urinary catheter case 100. A top view of the catheter case 100 in a closed position is shown in Figure 20. Catheter case 100 may include an opening 110 at a first end and a lid 120 at an opposite second end. Lid 120 may be connected to catheter case 100 with a hinge 130. Catheter case 100 may also have a top sub -assembly 150 and a bottom sub-assembly 160 that are joined together, preferably by an ultrasonic weld, along a split line 170 of catheter case 100. Hinge 130 may be on one side of lid 120 and may be connected to catheter case 100 at a location 140. In some instances, hinge 130 is positioned 15, 30, 45, 60, 75 or 90 degrees, either clockwise or counter-clockwise, relative to the centre line of the assembly. A side view of a cross-section of Figure 20 through points A is shown in Figure 21. Figure 21 shows catheter 410, outer O-ring 1010, and inner O-ring 1020, which may be positioned within a catheter device as shown in Figure 10. A side view of a cross-section of Figure 20 through points B is shown in Figure 22. In this view the top sub-assembly 150 is connected to the bottom sub-assembly 160 by a weld along split line 170 in weld area 1012. The bottom sub-assembly 160 has an inner wall 1018, outer wall 1016, and blade 1014. Figure 23 is a side view of the urinary catheter case of Figure 20 in a closed configuration with top-subassembly 150 connected to the bottom sub-assembly by the weld along split line 170.

[0140] Figure 24 shows a top view of a cross-section of an exemplary urinary catheter case 4100 configured for holding a catheter assembly (not shown), e.g ., a catheter assembly as described elsewhere herein. The case 4100 comprises top and bottom sub-assemblies that are connected by a series of snap fits 1180. Ultrasonic welding ribs 1190 are shown around opening 110. A plurality of central ribs 1150 that may control a catheter along the path of removal and reinsertion are provided on the inside surface 1140 of the bottom sub-assembly.

[0141] While the present disclosure has been described with reference to one or more exemplary embodiments, it will be understood by those skilled in the art that various changes can be made and equivalents may be substituted for elements thereof without departing from the scope of the present disclosure. In addition, many modifications can be made to adapt a particular situation or material to the teachings of the disclosure without departing from the scope thereof. Therefore, it is intended that the present disclosure is not limited to the particular embodiment s) disclosed as the best mode contemplated, but that the present disclosure will include all embodiments falling within the scope of the appended claims.