Catheter

Abstract

The present invention provides a reusable urethral catheter kit comprising a container comprising: a urethral catheter; and a medium comprising at least one chlorine-containing substance, wherein the container is resealable.

Description

Technical Field

[0001] The present invention relates to reusable urinary catheters and to the sterilization / lubrication of reusable urinary catheters using a chlorine-containing substance in a resealable package. Background Art

[0002] Urinary catheterization is a procedure that involves inserting a catheter through an individual's urethra into their bladder, where it is left in order to empty the bladder of urine. There are two main types of urinary catheterization—intermittent catheterization and long-term catheterization. Intermittent catheterization involves leaving the catheter in the bladder only for the time needed to empty it, after which the catheter is removed. This procedure differs from long-term catheterization, which utilizes an indwelling catheter or Foley catheter that is inserted into the bladder for extended periods of time (several days to several months) to continuously drain residual urine from the bladder throughout the day.

[0003] Catheterization is often used by patients with urinary tract abnormalities that result in urinary incontinence and / or inability to control voluntary urination. These individuals typically use an intermittent catheter several times a day.

[0004] Catheters are useful devices that provide users with the independence and freedom to insert their own catheters when needed, without having to rely on the presence of trained personnel. However, this increases the demand for user-friendly catheters: specifically, catheters that are easy to insert and remove with minimal discomfort, safe to use, and have features that minimize the risk of infection. Users often report experiencing pain and discomfort during catheter insertion and / or removal. For example, users report experiencing bladder spasms, burning sensations, and bleeding.

[0005] Catheters can also easily become contaminated, and bacteria can easily travel along the urethra into the urethra. Consequently, urinary tract infections (UTIs) are common in individuals who perform self-catheterization.

[0006] Based on the above, urinary catheters, especially intermittent urinary catheters, are typically disposable. Users will remove the catheter from its packaging, use it once, and then discard the catheter and packaging. This can be undesirable because it generates unnecessary waste. Therefore, reusable urinary catheters can be advantageous in reducing the amount of waste generated. However, there are various challenges associated with the use of reusable urinary catheters, such as issues surrounding storage, sterilization, and lubrication of the catheter. These challenges need to be overcome before reusable catheters can be widely accepted and used.

[0007] Sterilization and lubrication of reusable catheters are two particularly important factors, yet effective sterilization and lubrication of reusable catheters are notoriously difficult to achieve in practice and in most cases very inconvenient for catheter users.

[0008] There is a particular need for new solutions to the above challenges that allow for safe, effective, and simple reuse of catheters.

[0009] It is an object of embodiments of the present invention to solve one or more of the above problems by providing a setup for reusable catheterization that provides one or more of the following advantages:

[0010] Allows for simple and effective catheter sterilization.

[0011] Allows for easy and effective catheter lubrication.

[0012] Allows combined sterilization and lubrication.

[0013] Allows for sterilization / lubrication of the catheter without adversely affecting the catheter, and preferably without adversely affecting the catheter surface properties.

[0014] Allows safe long-term reuse of the catheter.

[0015] Frequent resterilization and / or re-lubrication is not required.

[0016] Allows for reduced infection potential, see prior art reusable setup.

[0017] Allows the high lubricity and non-stick properties of the catheter surface to be maintained even after repeated use. Allows the ease of insertion and removal of the catheter to be maintained even after repeated use.

[0018] Allows the catheter surface to remain inert and sterile even after reuse.

[0019] Allows the catheter's performance to be maintained even after reuse.

[0020] The setup is not overly complicated and is simple / cost-effective to implement.

[0021] It is another object of embodiments of the present invention to overcome or mitigate at least one problem of the prior art, whether explicitly described herein or not. Summary of the Invention

[0022] According to a first aspect of the present invention, there is provided a reusable urinary catheter kit comprising a container containing: a urinary catheter; and a medium containing at least one chlorine-containing substance, wherein the container is resealable.

[0023] The medium containing the chlorine-containing substance allows for effective sterilization and / or lubrication of the catheter, which can be achieved by simply contacting the catheter with the medium in the container. Thus, this arrangement allows the catheter to be removed from the resealable container for use and then sterilized after use by simply reinserting the catheter into the container and contacting the catheter with the medium in the container. The catheter can then be simply removed from the container for the next use without requiring any additional sterilization / lubrication steps.

[0024] The inventors have also shown that this reuse / sterilization cycle can be repeated multiple times with a single catheter without changing the media between uses, and the catheter can still be used safely and maintain its performance.

[0025] Furthermore, the use of such a medium minimizes changes in the relevant surface chemistry of the catheter upon contact, thereby allowing the catheter to be used multiple times without adversely affecting the lubricity of the catheter. The medium also provides long-term sterilization and / or lubrication, allowing the catheter to be safely reused for relatively long periods of time without the need for overly frequent resterilization and / or re-lubrication.

[0026] In some embodiments, the catheter comprises a hollow tubular body, preferably a hollow polymeric tubular body.The hollow polymeric tubular body may comprise a base polymer.

[0027] In some embodiments, the catheter further comprises at least one additive, preferably at least one lubricating additive.Preferably, the hollow tubular body comprises at least one additive.

[0028] Additives allow for improved lubricity and ease of insertion and removal of catheters. However, the use of additives on catheters, particularly on their surfaces, presents the catheter with a complex surface chemistry that makes sterilization and re-lubrication of the catheter challenging. For example, such catheters are known to swell when wetted during the sterilization process. Such catheters are also known to dry out, which can lead to considerable changes in the catheter surface morphology. As a result, the catheter can become rough and sticky, and is more susceptible to additive delamination. These negative effects are typically significantly amplified with repeated use of the catheter. However, the medium containing a chlorine-containing substance of the present invention allows for effective sterilization and / or lubrication of the catheter, which allows for a long-lasting effect of the additive. Consequently, such a medium allows for safe and simple use of catheters, with excellent performance in reducing pain and discomfort.

[0029] In some embodiments, at least one additive is a hydrophilic additive.

[0030] At least one hydrophilic additive can be independently selected from the group consisting of polyalkylene glycol, hyaluronic acid, chondroitin sulfate, chitosan, glycosaminoglycan, dextran, dextrin, dextran sulfate, cellulose acetate, carboxymethyl cellulose, hydroxyethyl cellulose, cellulose, polypeptides, poly(2-hydroxyethyl methacrylate), polyacrylamide, polyacrylimide, poly(vinylamine), poly(allylamine), poly(vinylpyrrolidone) (PVP), polyvinyl alcohol, poly(acrylic acid), poly(methacrylic acid), acrylic acid copolymers, methacrylic acid copolymers, polyvinyl alkyl ethers, nonionic tetrafunctional block copolymer surfactants, gelatin, collagen, albumin, chitin, heparin, elastin, fibrin, and combinations thereof.

[0031] At least one hydrophilic additive can be independently selected from the group consisting of polyalkylene glycol, hyaluronic acid, chondroitin sulfate, chitosan, glycosaminoglycan, dextran, dextrin, dextran sulfate, cellulose acetate, carboxymethyl cellulose, hydroxyethyl cellulose, cellulose, polypeptides, poly(2-hydroxyethyl methacrylate), polyacrylamide, polyacrylimide, poly(vinylamine), poly(allylamine), poly(vinylpyrrolidone) (PVP), polyvinyl alcohol, poly(acrylic acid), poly(methacrylic acid), acrylic acid copolymers, methacrylic acid copolymers, polyvinyl alkyl ethers, nonionic tetrafunctional block copolymer surfactants, gelatin, collagen, albumin, chitin, heparin, elastin, fibrin, and combinations thereof.

[0032] In some embodiments, the at least one hydrophilic additive is independently selected from the group consisting of: poly(ethylene glycol), poly(ethylene oxide), poly(propylene glycol), poly(ethylene oxide-co-propylene oxide), poly(trimethylene glycol), poly(tetramethylene glycol), and combinations thereof.

[0033] In some embodiments, the at least one hydrophilic additive is independently selected from the group consisting of poly(ethylene glycol), poly(ethylene oxide), poly(propylene glycol), poly(ethylene oxide-co-propylene oxide), poly(trimethylene glycol), poly(tetramethylene glycol), and combinations thereof.

[0034] The at least one hydrophilic additive may comprise PVP or a derivative thereof.

[0035] At least one of the additives can be an amphiphilic additive. The amphiphilic additive comprises a hydrophobic portion and a hydrophilic portion. When the base polymer is hydrophobic or substantially hydrophobic, such as a polyolefin, the amphiphilic additive will diffuse toward the outer surface of the catheter body due to the incompatibility of the hydrophilic portion of the amphiphilic additive with the hydrophobic base polymer.

[0036] Amphiphilic additives, particularly those described below, further allow for the formation of a hydration layer with water molecules and chlorine-containing species through temporary hydrogen bonding on the catheter surface. Consequently, the catheter remains sterile and lubricated for extended periods of time, with minimal to no surface morphological changes during sterilization / lubrication and catheter drying.

[0037] In some embodiments, the catheter comprises a hollow polymeric tubular body comprising a base polymer and an amphiphilic lubricating additive.

[0038] In some embodiments, at least one additive is a polymer or oligomer.

[0039] At least one additive may be an AB block copolymer comprising a hydrophobic hydrocarbon A block and a hydrophilic B block. In some embodiments, one or both of the hydrophobic hydrocarbon A block and the hydrophilic B block may be branched. The hydrophobic A block may include hydrophobic hydrocarbon chains branching therefrom. The hydrophobic hydrocarbon chains may be shorter in length than the hydrophobic hydrocarbon A block. The hydrophilic B block may include additional hydrophilic B blocks branching therefrom.

[0040] In some embodiments, the additive is a BAB triblock copolymer comprising hydrophobic hydrocarbon A blocks and hydrophilic B blocks.

[0041] In various other embodiments, the additive is a graft copolymer. The graft copolymer may comprise a hydrophobic hydrocarbon A block having a hydrophilic B block branching therefrom. Alternatively, the graft copolymer may comprise a hydrophilic portion having a hydrophobic portion branching therefrom.

[0042] In various other embodiments, the additive is a brush copolymer. The additive may comprise a single hydrophilic B block having more than one hydrophobic A block branching from one end. Alternatively, the additive may comprise a single hydrophobic A block having more than one hydrophilic B block branching from one end. In corresponding embodiments, the B-block or A-block may comprise 2, 3, 4, 5, 6, 7, 8, 9, 10, or more hydrophobic A-blocks or hydrophilic B-blocks branching from its end.

[0043] In various additional embodiments, the additive is a radial block copolymer or a multi-block copolymer comprising hydrophilic and hydrophobic monomer units.

[0044] In preferred embodiments, the additive is an AB block copolymer comprising a hydrophobic A block and a hydrophilic B block.

[0045] The following statements of the invention with respect to the additive or a portion thereof apply mutatis mutandis to each of the above-mentioned copolymer forms.

[0046] In some embodiments, the B block is a hydrophilic oligomer comprising at least 1, at least 2, at least 3, at least 4, or at least 5 monomeric units. In some embodiments, the B block comprises no more than 20, no more than 19, no more than 18, no more than 17, no more than 16, no more than 15, no more than 14, no more than 13, no more than 12, no more than 11, no more than 10, no more than 9, no more than 8, no more than 7, or no more than 6 monomeric units. In some embodiments, the B block comprises 2 to 15 monomeric units, preferably 2 to 10 monomeric units. At least one monomeric unit may be selected from: alkylene oxide, alkylene glycol, epihalohydrin, unsaturated carboxylic acid, alkylene imine, lactone, vinyl alcohol, and vinyl alkanoate. At least one monomeric unit may be selected from: alkylene oxide, alkylene glycol, epihalohydrin, unsaturated carboxylic acid, alkylene imine, lactone, vinyl alcohol, and vinyl alkanoate. At least one monomer unit may preferably be selected from the group consisting of ethylene oxide, propylene oxide, ethylene glycol, propylene glycol, epichlorohydrin, acrylic acid, methacrylic acid, ethylene imine, caprolactone, vinyl alcohol, and vinyl acetate. At least one monomer unit may preferably be selected from the group consisting of ethylene oxide, propylene oxide, ethylene glycol, propylene glycol, epichlorohydrin, acrylic acid, methacrylic acid, ethylene imine, caprolactone, vinyl alcohol, and vinyl acetate. In some embodiments, at least one monomer unit comprises an alkylene oxide group independently selected from ethylene oxide and propylene oxide, and in various preferred embodiments, all monomer units are ethylene oxide or all monomer units are propylene oxide.

[0047] The hydrophobic A-block may comprise a carbon chain having at least 5 carbon atoms, or at least 10 carbon atoms, at least 15 carbon atoms, at least 20 carbon atoms, at least 25 carbon atoms, at least 30 carbon atoms, at least 35 carbon atoms, or at least 40 carbon atoms. The hydrophobic portion may preferably comprise a carbon chain having 20-52 carbon atoms.

[0048] In some embodiments, the A block comprises the formula CH3CH2(CH2CH2) a The value of "a" may be in the range of 5-25; for example, "a" may be 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24 or 25, or a half integer of any of the above values. The value of "a" may preferably be in the range of 9-25; for example, "a" may be 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24 or 25, or a half integer of any of the above values.

[0049] In some embodiments, the additive is uniformly distributed with the polymer.The additive can be uniformly distributed in the base polymer of the catheter body.

[0050] At least some of the additive may be at or on the exterior surface of the body. "At the exterior surface" means that at least a portion of the additive is formed as part of or protrudes from the surface. In some embodiments, a portion of the additive is retained or anchored in the body, while a portion of the additive is formed as part of or protrudes from the exterior surface of the body. At least a portion of the hydrophilic portion of the additive may protrude from or form part of the exterior surface of the body, while at least a portion of the hydrophobic portion may be retained or anchored within the body.

[0051] The outer surface can comprise at least one member of the group consisting of the outward-facing surface of the body, the outward-facing surface of the lumen of the body, and the outward-facing surface of any eyelets present on the body. In preferred embodiments, the outer surface is the outward-facing surface of the body and / or lumen. In some embodiments, the outer surface can comprise the outward-facing surfaces of the catheter body, lumen, and eyelets.

[0052] The additive can be concentrated at or on the outer surface of the body. For example, at least 25%, at least 30%, at least 35%, at least 40%, at least 45%, at least 50%, at least 55%, at least 60%, at least 65%, at least 70%, at least 75%, at least 80%, at least 85%, at least 90%, or at least 95% of the number of additive molecules can be at or on the outer surface of the body.

[0053] In some embodiments, at least 25%, at least 30%, at least 35%, at least 40%, at least 45%, at least 50%, at least 55%, at least 60%, at least 65%, at least 70%, at least 75%, at least 80%, at least 85%, at least 90%, or at least 95% by number of the additive molecules may have a hydrophilic portion located at or on the outer surface of the body.

[0054] In some embodiments, the additive is located at and / or on at least 50%, at least 55%, at least 60%, at least 65%, at least 70%, at least 75%, at least 80%, at least 85%, at least 90%, at least 95%, at least 96%, at least 97%, at least 98% or at least 99% of the outer surface area of the polymeric tubular body, preferably, the additive is located at or on at least 75% or at least 90% of the outer surface area or between 75% and 100% of the outer surface area of the polymeric tubular body.

[0055] In some embodiments, the additive is present at a concentration of at least 0.1 weight percent (wt.%), at least 0.2 wt.%, at least 0.3 wt.%, at least 0.4 wt.%, at least 0.5 wt.%, at least 0.75 wt.%, at least 1 wt.%, at least 2 wt.%, at least 3 wt.%, at least 4 wt.%, at least 5 wt.%, at least 10 wt.%, at least 15, or at least 20 wt.% of the base polymer and additive combination. The additive may be present at a concentration of 0.1-20 wt.%, more preferably 0.5-15 wt.% or 0.5-5 wt.% of the base polymer and additive combination.

[0056] In some embodiments, the additive comprises a layer on or comprising a surface of the body, preferably an exterior surface.

[0057] The layer comprising the additive can be on the surface of the body. In some embodiments, the layer comprising the additive is substantially separate from the body, and the layer can be bound / bonded to the body. The layer can be bound to the body via covalent bonds, ionic bonds, hydrogen bonds, or van der Waals forces. The additive can be bound to the body via one or more surface attachment groups, which can be present on the additive, the catheter body, or both.

[0058] In some embodiments, the layer comprising the additive may comprise a surface of the body. In such embodiments, the layer may be formed as a surface of the body. The layer may comprise a coextruded layer that is fused or physically entangled with the body, and this may be formed as a monolithic layer. The additive layer may be formed integrally with the body.

[0059] In some embodiments, polymer diffusion occurs between the layer comprising the additive and the catheter body. The layer and body can be held together by polymer chains extending across the interface between the layer and the body. In some embodiments, the additive penetrates into the catheter body.

[0060] In some embodiments, the layer comprising the additive comprises the inner surface of the body, the outer surface of the body, or both, or is located on the inner surface of the body, the outer surface of the body, or both. The inner surface of the body may include the lumen of the catheter. In preferred embodiments, the layer comprising the additive comprises at least the outer surface of the body or is located at least on the outer surface of the body.

[0061] In some embodiments, the layer comprising the additive is located on the or each surface area of the body or comprises at least 50%, at least 55%, at least 60%, at least 65%, at least 70%, at least 75%, at least 80%, at least 85%, at least 90%, at least 95%, at least 96%, at least 97%, at least 98%, or at least 99% of the or each surface area of the body, preferably at least 75% or at least 90% of the or each surface area or from 75% to 100% of the or each surface area. In embodiments in which the layer comprising the additive comprises both the inner and outer surfaces of the body or is located on both the inner and outer surfaces of the body, the additive may comprise at least 50%, at least 55%, at least 60%, at least 65%, at least 70%, at least 75%, at least 80%, at least 85%, at least 90%, at least 95%, at least 96%, at least 97%, at least 98%, or at least 99% of each surface area of the body, preferably at least 75% or at least 90%, or from 75% to 100% of each surface area of both surfaces.

[0062] In some embodiments, at least 75% of a layer comprising an additive, or at least 76%, at least 77%, at least 78%, at least 79%, at least 80%, at least 81%, at least 82%, at least 83%, at least 84%, at least 85%, at least 86%, at least 87%, at least 88%, at least 89%, at least 90%, at least 91%, at least 92%, at least 93%, at least 94%, at least 95%, at least 96%, at least 97%, at least 98%, at least 99%, or 100% of the layer is an additive.

[0063] In some embodiments, the additive concentration of the layer containing the additive is at least 0.1 wt.%, at least 0.2 wt.%, at least 0.3 wt.%, at least 0.4 wt.%, at least 0.5 wt.%, at least 0.75 wt.%, at least 1 wt.%, at least 2 wt.%, at least 3 wt.%, at least 4 wt.%, at least 5 wt.%, at least 10 wt.%, at least 15 wt.%, or at least 20 wt.% of the combination of the base polymer and the additive.

[0064] In some embodiments, the additive concentration of the additive-containing layer is no greater than 70 wt.%, no greater than 65 wt.%, no greater than 60 wt.%, no greater than 65 wt.%, no greater than 60 wt.%, no greater than 55 wt.%, or no greater than 50 wt.% of the combination of the base polymer and the additive.

[0065] The layer comprising additives may have an additive concentration greater than 5 wt.% of the base polymer and additives combined.The additive concentration of this layer may be 6-50 wt.% of the base polymer and additives combined.

[0066] The layer comprising additives may have an additive concentration of 10-50 wt.% of the base polymer and additive combination, or 15-50 wt.%, 20-50 wt.%, 25-50 wt.%, 30-50 wt.%, 35-50 wt.%, 40-50 wt.%, or 45-50 wt.% of the base polymer and additive combination.

[0067] The additive concentration of the additive-containing layer can be 6-45 wt.% of the base polymer and additive combination, or 6-40 wt.%, 6-35 wt.%, 6-30 wt.%, 6-25 wt.%, 6-20 wt.%, 6-15 wt.%, or 6-10 wt.% of the base polymer and additive combination.

[0068] The additive concentration of the layer containing additives can be 10-45 wt.% of the combination of the base polymer and the additive, or 15-45 wt.%, 20-45 wt.%, 25-45 wt.%, 30-45 wt.%, 35-45 wt.%, 40-45 wt.%, 10-40 wt.%, 15-40 wt.%, 20-40 wt.%, 25-40 wt.%, 30-40 wt.%, 35-40 wt.%, 10-35 wt.%, 15-35 wt.%, 20-35 wt.%, 25-35 wt.%, 30-35 wt.%, 10-30 wt.%, 15-30 wt.%, 20-30 wt.%, 25-30 wt.%, 10-25 wt.%, 15-25 wt.%, 20-25 wt.%, 10-20 wt.%, 15-20 wt.%, or 10-15 wt.% of the combination of the base polymer and the additive.

[0069] In some embodiments, the thickness of the layer comprising the additive is at least 1 μm, or at least 2 μm, at least 3 μm, at least 4 μm, at least 5 μm, at least 6 μm, at least 7 μm, at least 8 μm, at least 9 μm, at least 10 μm, at least 15 μm, at least 20 μm, at least 25 μm, at least 30 μm, at least 35 μm, at least 40 μm, at least 45 μm, or at least 50 μm.

[0070] In some embodiments, the thickness of the layer comprising the additive is no more than 10,000 μm, or no more than 9,000 μm, no more than 8,000 μm, no more than 7,000 μm, no more than 6,000 μm, no more than 5,000 μm, no more than 4,000 μm, no more than 3,000 μm, no more than 2,000 μm, no more than 1,000 μm, no more than 900 μm, no more than 800 μm, no more than 700 μm, no more than 600 μm, no more than 500 μm, no more than 400 μm, or no more than 300 μm.

[0071] In some embodiments, the thickness of the layer comprising the additive is 50-300 μm.

[0072] The layer containing the additive may have a thickness of 60-300 μm, or 80-300 μm, 100-300 μm, 120-300 μm, 140-300 μm, 160-300 μm, 180-300 μm, 200-300 μm, 220-300 μm, 240-300 μm, 260-300 μm, or 280-300 μm.

[0073] The layer comprising the additive may have a thickness of 50-280 μm, or 50-260 μm, 50-240 μm, 50-220 μm, 50-200 μm, 50-180 μm, 50-160 μm, 50-140 μm, 50-120 μm, 50-100 μm, 50-80 μm, or 50-60 μm.

[0074] The thickness of the layer containing the additive may be 60-280 μm, or 80-280 μm, 100-280 μm, 120-280 μm, 140-280 μm, 160-280 μm, 180-280 μm, 200-280 μm, 220-280 μm, 240-280 μm, 260-280 μm, 60-260 μm, 80-260 μm, 100-260 μm, 120-26 ... 0-260μm, 160-260μm, 180-260μm, 200-260μm, 220-260μm, 240-260μm, 60-240μm, 80-240μm, 100-24 0μm, 120-240μm, 140-240μm, 160-240μm, 180-240μm, 200-240μm, 220-240μm, 60-220μm, 80-220μm, 100-220μm, 120-220μm, 140-220μm, 160-220μm, 180-220μm, 200-220μm, 60-200μm, 80-200μm, 100 -200μm, 120-200μm, 140-200μm, 160-200μm, 180-200μm, 60-180μm, 80-180μm, 100-180μm, 120-180 μm, 140-180μm, 160-180μm, 60-160μm, 80-160μm, 100-160μm, 120-160μm, 140-160μm, 60-140μm, 80 -140μm, 100-140μm, 120-140μm, 60-120μm, 80-120μm, 100-120μm, 60-100μm, 80-100μm, or 60-80μm.

[0075] In various preferred embodiments, the catheter base polymer is hydrophobic or partially hydrophobic. The hydrophobic base polymer helps to increase the hydrophobic-hydrophobic interactions between the hydrophobic portion of the additive and the base polymer. This further reduces the energy advantage for the hydrophobic portion to leave the base polymer and migrate to the more hydrophilic external environment.

[0076] In some embodiments, the base polymer comprises a polymer selected from the group consisting of polyvinyl chloride, polytetrafluoroethylene, polyolefins, latex, silicones, synthetic rubbers, polyurethanes, polyesters, polyacrylates, polyamides, thermoplastic elastomeric materials, styrenic block copolymers, polyether block amides, thermoplastic vulcanizates, thermoplastic copolyesters, thermoplastic polyamides, styrene-butadiene copolymers (SBC), styrene-ethylene-butylene-styrene copolymers (SEBS), and water-disintegrable or enzyme-hydrolyzable materials, or any combination, blend, or copolymer of the foregoing.

[0077] In some embodiments, the base polymer comprises a polymer selected from the group consisting of polyvinyl chloride, polytetrafluoroethylene, polyolefins, latex, silicone, synthetic rubber, polyurethane, polyester, polyacrylate, polyamide, thermoplastic elastomeric materials, styrenic block copolymers, polyether block amides, thermoplastic vulcanizates, thermoplastic copolyesters, thermoplastic polyamides, styrene-butadiene copolymers (SBC), styrene-ethylene-butylene-styrene copolymers (SEBS), and water-disintegrable or enzyme-hydrolyzable materials, or any combination, blend, or copolymer of the foregoing.

[0078] In various preferred embodiments, the base polymer comprises a polymer selected from the group consisting of polyolefins, polyesters, polyacrylates, polyamides, thermoplastic elastomers, polyether block amides, thermoplastic vulcanizates, thermoplastic copolyesters, thermoplastic polyamides, fluororubbers, and water-disintegrable or enzyme-hydrolyzable materials, or any combination, blend, or copolymer of the foregoing.

[0079] In preferred embodiments, the base polymer comprises a polymer selected from the group consisting of polyolefins, polyesters, polyacrylates, polyamides, thermoplastic elastomeric materials, polyether block amides, thermoplastic vulcanizates, thermoplastic copolyesters, thermoplastic polyamides, fluororubbers, and water-disintegrable or enzyme-hydrolyzable materials, or any combination, blend, or copolymer of the foregoing.

[0080] In some embodiments, the water-disintegrable or enzymatically hydrolyzable material comprises a material selected from the group consisting of polyvinyl alcohol, extrudable polyvinyl alcohol, polyacrylic acid, polylactic acid, polyesters, polyglycolide, polyglycolic acid, poly(lactic-co-glycolic acid), polylactide, amines, polyacrylamide, poly(N-(2-hydroxypropyl)methacrylamide), starch, modified starch or derivatives, pullulan, pectin, xanthan gum, scleroglucan, dextrin, chitosan, chitin, agar, alginate, carrageenan, laminarin, carbohydrates, polysaccharides, sucrose, polyethylene oxide, polypropylene oxide, acrylic resins, polyacrylic acid blends, poly(methacrylic acid), polystyrene sulfonate, polyethylene sulfonates, lignin sulfonates, polymethacrylamides, copolymers of aminoalkyl acrylamide and methacrylamide, melamine-formaldehyde copolymers, vinyl alcohol copolymers, cellulose ethers, polyethers, polyethylene oxide, polyethylene-polyethylene glycol blends, carboxymethyl cellulose, guar gum, locust bean gum, hydroxypropyl cellulose, vinyl pyrrolidone polymers and copolymers, polyvinyl pyrrolidone-ethylene-vinyl acetate, polyvinyl pyrrolidone-carboxymethyl cellulose, carboxymethyl cellulose shellac, copolymers of vinyl pyrrolidone and vinyl acetate, hydroxyethyl cellulose, gelatin, polycaprolactone, poly(p-dioxanone), or any combination, blend or copolymer of the foregoing.

[0081] In some embodiments, the water-disintegrable or enzyme-hydrolyzable material comprises a material selected from the group consisting of polyvinyl alcohol, extrudable polyvinyl alcohol, polyacrylic acid, polylactic acid, polyesters, polyglycolide, polyglycolic acid, poly(lactic-co-glycolic acid), polylactide, amines, polyacrylamide, poly(N-(2-hydroxypropyl)methacrylamide), starch, modified starch or derivatives, pullulan, pectin, xanthan gum, scleroglucan, dextrin, chitosan, chitin, agar, alginate, carrageenan, laminarin, carbohydrates, polysaccharides, sucrose, polyethylene oxide, polypropylene oxide, acrylic resins, polyacrylic acid blends, poly(methacrylic acid), polystyrene sulfonate, poly Ethylene sulfonate, lignin sulfonate, polymethacrylamide, copolymers of aminoalkylacrylamide and methacrylamide, melamine-formaldehyde copolymers, vinyl alcohol copolymers, cellulose ethers, polyethers, polyethylene oxide, polyethylene-polyethylene glycol blends, carboxymethyl cellulose, guar gum, locust bean gum, hydroxypropyl cellulose, vinyl pyrrolidone polymers and copolymers, polyvinyl pyrrolidone-ethylene-vinyl acetate, polyvinyl pyrrolidone-carboxymethyl cellulose, carboxymethyl cellulose shellac, copolymers of vinyl pyrrolidone and vinyl acetate, hydroxyethyl cellulose, gelatin, polycaprolactone, poly(p-dioxanone), or any combination, blend or copolymer of the foregoing.

[0082] In various other preferred embodiments, the base polymer comprises a polymer selected from the group consisting of polyolefins, polyvinyl chloride, polyurethane, styrene-butadiene copolymers (SBC), styrene-ethylene-butylene-styrene copolymers (SEBS), and thermoplastic elastomeric materials, or any combination, blend or copolymer of the foregoing.

[0083] In various other preferred embodiments, the base polymer comprises a polymer selected from the group consisting of polyolefins, polyvinyl chloride, polyurethane, styrene-butadiene copolymers (SBC), styrene-ethylene-butylene-styrene copolymers (SEBS), and thermoplastic elastomeric materials, or any combination, blend or copolymer of the foregoing.

[0084] In some preferred embodiments, the base polymer comprises a polyolefin, particularly polyethylene and / or polypropylene.

[0085] In some preferred embodiments, the base polymer comprises a thermoplastic elastomeric material.The base polymer may comprise a thermoplastic polyolefin.

[0086] The thermoplastic base polymer may include a hydrophobic polymer selected from the group consisting of: Accurel TM 、Styroflex TM 、Styrolux TM 、MelifleX TM and Mediprene TM , and any combination thereof.

[0087] The thermoplastic base polymer may include a hydrophobic polymer selected from the group consisting of: Accurel TM 、Styroflex TM 、Styrolux TM 、MelifleX TM and Mediprene TM , and any combination thereof.

[0088] Thermoplastic base polymers may include Estane TM 58315, which is both hydrophobic and hydrophilic.

[0089] In preferred embodiments, the catheter is an intermittent urinary catheter. Such catheters are typically inserted into the body for a short period of time, such as less than a day. Alternatively, the catheter can be an indwelling (Foley) catheter. Such catheters are typically inserted and maintained in the body for an extended period of time, such as several days to several months.

[0090] In some embodiments, the medium comprises at least one chlorine-containing species independently selected from the group consisting of hypochlorous acid, at least one hypochlorite salt, chlorine dioxide, molecular chlorine, dichloroisocyanurate salts, chloramidazole, dichlorodimethylhydantoin, chloroxylenol, chlorhexidine, and combinations thereof.

[0091] In some embodiments, a reusable urinary catheter kit is provided, comprising a container comprising: a urinary catheter; and a medium comprising at least one chlorine-containing substance, the at least one chlorine-containing substance independently selected from the group consisting of: hypochlorous acid, at least one hypochlorite, chlorine dioxide, molecular chlorine, dichloroisocyanurate, chloramizolidine, dichlorodimethylhydantoin, chloroxylenol, chlorhexidine, and combinations thereof, and wherein the container is resealable. In some embodiments, the medium comprises at least one chlorine-containing substance, the at least one chlorine-containing substance independently selected from the group consisting of: hypochlorous acid, at least one hypochlorite, chlorine dioxide, molecular chlorine, dichloroisocyanurate, chloramizolidine, dichlorodimethylhydantoin, chloroxylenol, chlorhexidine, and combinations thereof.

[0092] In various preferred embodiments, the medium comprises at least one chlorine-containing species independently selected from the group consisting of hypochlorous acid, at least one hypochlorite salt, chlorine dioxide, and combinations thereof.

[0093] In some preferred embodiments, a reusable urinary catheter kit is provided, comprising a container comprising: a urinary catheter; and a medium comprising at least one chlorine-containing substance, the at least one chlorine-containing substance independently selected from the group consisting of: hypochlorous acid, at least one hypochlorite, chlorine dioxide, and combinations thereof, and wherein the container is resealable.

[0094] In preferred embodiments, the medium comprises at least one chlorine-containing species independently selected from the group consisting of hypochlorous acid, at least one hypochlorite salt, chlorine dioxide, and combinations thereof.

[0095] In some preferred embodiments, the medium comprises at least one chlorine-containing species independently selected from the group consisting of hypochlorous acid, chlorine dioxide, and combinations thereof.

[0096] In some preferred embodiments, a reusable urinary catheter kit is provided, comprising a container comprising: a urinary catheter; and a medium comprising at least one chlorine-containing substance, the at least one chlorine-containing substance being independently selected from the group consisting of: hypochlorous acid, chlorine dioxide, and combinations thereof, and wherein the container is resealable.

[0097] In some embodiments, the medium comprises chlorine dioxide.

[0098] In some embodiments, the medium comprises hypochlorous acid.In some preferred embodiments, the medium comprises hypochlorous acid and at least one additional chlorine-containing substance.

[0099] In some preferred embodiments, a reusable urinary catheter kit is provided, comprising a container containing: a urinary catheter; and a medium containing hypochlorous acid and at least one additional chlorine-containing substance, and wherein the container is resealable.

[0100] In some embodiments, the medium comprises at least one hypochlorite. The at least one hypochlorite may preferably comprise a counter cation. The counter cation may comprise an inorganic counter cation. The counter cation may comprise a metal counter cation. In some embodiments, the at least one counter cation is independently selected from the group consisting of alkali metal cations, alkaline earth metal cations, Group III metal cations, transition metal cations, ammonium cations, aromatic nitrogen-based cations, and combinations thereof. In some embodiments, the at least one counter cation is independently selected from the group consisting of alkali metal cations, alkaline earth metal cations, Group III metal cations, transition metal cations, ammonium cations, aromatic nitrogen-based cations, and combinations thereof. The at least one counter cation may be independently selected from the group consisting of ammonium, calcium, iron, magnesium, potassium, pyridinium, quaternary ammonium, sodium, copper, aluminum, lithium, beryllium, strontium, and zinc. The at least one counter cation may preferably be an alkali metal cation or an alkaline earth metal cation. The at least one counter cation can preferably be independently selected from the group consisting of calcium, lithium, and sodium. In preferred embodiments, the at least one hypochlorite is sodium hypochlorite. The at least one counter cation can preferably be independently selected from the group consisting of calcium, lithium, and sodium. In preferred embodiments, the at least one hypochlorite is sodium hypochlorite.

[0101] In some embodiments, the medium comprises hypochlorous acid and at least one hypochlorite. The at least one hypochlorite may preferably be as described above in the present invention. The medium may preferably comprise hypochlorous acid and at least one alkali metal hypochlorite. In some embodiments, the medium comprises hypochlorous acid and sodium hypochlorite.

[0102] In some preferred embodiments, a reusable urinary catheter kit is provided, comprising a container comprising: a urinary catheter; and a medium comprising hypochlorous acid and at least one hypochlorite, and wherein the container is resealable.

[0103] In embodiments where the medium comprises hypochlorous acid and at least one hypochlorite, the pH of the medium may preferably be in the range of 6-9.

[0104] In some embodiments, the medium comprises chlorine dioxide and at least one of: hypochlorous acid and at least one hypochlorite. In some embodiments, the medium comprises chlorine dioxide, hypochlorous acid, and at least one hypochlorite. In such embodiments, the at least one hypochlorite may preferably be as described above in the present invention. The at least one hypochlorite may preferably be an alkali metal hypochlorite, which may include sodium hypochlorite.

[0105] In some embodiments, the medium is in liquid, gel, or solid form.

[0106] In some embodiments, the medium is present as a solution of the chlorine-containing substance in a solvent. The solution can be an aqueous solution. Aqueous solutions are particularly effective because water allows for optimal lubricity of the catheter surface. Thus, the solvent can be water or an aqueous medium.

[0107] In some embodiments, the medium contains chlorine-containing species, and its total concentration in the medium is 0.005-1.5 wt.%, or 0.005-1 wt.%, or 0.005-0.6 wt.%, or 0.01-0.5 wt.%, 0.015-0.4 wt.%, 0.02-0.3 wt.%, or 0.025-0.2 wt.% or preferably 0.025-0.1 wt.%.

[0108] In some embodiments, the medium comprises a total concentration of at least 1 ppm, or at least 2 ppm, at least 3 ppm, at least 4 ppm, at least 5 ppm, at least 6 ppm, at least 7 ppm, at least 8 ppm, at least 9 ppm or at least 10 ppm of chlorine-containing species. In some embodiments, the medium comprises a total concentration of not more than 100 ppm, or not more than 90 ppm, not more than 80 ppm, not more than 70 ppm, not more than 60 ppm or not more than 50 ppm of chlorine-containing species. In some embodiments, the medium comprises a total concentration of 1-100 ppm or 5-100 ppm, 10-100 ppm, 10-90 ppm, 10-80 ppm, 10-70 ppm, 10-60 ppm or 10-50 ppm of chlorine-containing species.

[0109] In some preferred embodiments, a reusable urinary catheter kit is provided, comprising a container comprising: a urinary catheter; and a medium comprising at least one chlorine-containing substance, wherein the container is resealable, and wherein the at least one chlorine-containing substance is present in the medium at a total concentration of 1-100 ppm.

[0110] In some embodiments, the medium comprises chlorine dioxide at a total concentration of at least 0.0001 wt.%, or at least 0.0002 wt.%, at least 0.0003 wt.%, at least 0.0004 wt.%, at least 0.0005 wt.%, at least 0.0006 wt.%, at least 0.0007 wt.%, at least 0.0008 wt.%, at least 0.0009 wt.%, at least 0.001 wt.%, at least 0.002 wt.%, at least 0.003 wt.%, at least 0.004 wt.%, or at least 0.005 wt.%, or at least 0.006 wt.%, at least 0.007 wt.%, at least 0.008 wt.%, at least 0.009 wt.%, at least 0.01 wt.%, at least 0.015 wt.%, at least 0.02 wt.% of the medium. %, at least 0.025 wt.%, at least 0.03 wt.%, at least 0.035 wt.%, at least 0.04 wt.%, at least 0.045 wt.%, at least 0.05 wt.%, at least 0.055 wt.%, at least 0.06 wt.%, at least 0.065 wt.%, at least 0.07 wt.%, at least 0.075 wt.%, at least 0.08 wt.%, at least 0.085 wt.%, at least 0.09 wt.%, at least 0.095 wt.%, at least 0.1 wt.%, at least 0.11 wt.%, at least 0.12 wt.%, at least 0.13 wt.%, at least 0.14 wt.%, at least 0.15 wt.%, at least 0.16 wt.%, at least 0.17 wt.%, at least 0.18 wt.%, at least 0.19 wt.%, or at least 0.2 wt.%.

[0111] In some embodiments, the medium comprises chlorine dioxide at a total combined concentration in the medium of no greater than 5 wt.%, or no greater than 4.5 wt.%, no greater than 4 wt.%, no greater than 3.5 wt.%, no greater than 3 wt.%, no greater than 2.5 wt.%, no greater than 2 wt.%, no greater than 1.5 wt.%, no greater than 1 wt.%, no greater than 0.9 wt.%, no greater than 0.8 wt.%, no greater than 0.7 wt.%, no greater than 0.6 wt.%, no greater than 0.5 wt.%, no greater than 0.4 wt.%, no greater than 0.3 Or not more than 0.2wt.%, or not more than 0.1wt.%, not more than 0.05wt.%, not more than 0.04wt.%, not more than 0.03wt.%, not more than 0.02wt.%, not more than 0.01wt.%, not more than 0.009wt.%, not more than 0.008wt.%, not more than 0.007wt.%, not more than 0.006wt.%, not more than 0.005wt.%, not more than 0.004wt.%, not more than 0.003wt.%, not more than 0.002wt.% or not more than 0.001wt.%.

[0112] In some embodiments, the medium comprises chlorine dioxide at a total combined concentration in the medium of 0.005-1.5 wt.%, or 0.005-1 wt.%, or 0.005-0.6 wt.%, or 0.01-0.5 wt.%, 0.015-0.4 wt.%, 0.02-0.3 wt.%, or 0.025-0.2 wt.%, or preferably 0.025-0.1 wt.%.

[0113] In some embodiments, the medium comprises a total concentration of chlorine dioxide of at least 1 ppm, or at least 2 ppm, at least 3 ppm, at least 4 ppm, at least 5 ppm, at least 6 ppm, at least 7 ppm, at least 8 ppm, at least 9 ppm, or at least 10 ppm. In some embodiments, the medium comprises a total concentration of chlorine dioxide of no greater than 100 ppm, or no greater than 90 ppm, no greater than 80 ppm, no greater than 70 ppm, no greater than 60 ppm, or no greater than 50 ppm. In some embodiments, the medium comprises a total concentration of chlorine dioxide of 1-100 ppm, or 5-100 ppm, 10-100 ppm, 10-90 ppm, 10-80 ppm, 10-70 ppm, 10-60 ppm, or 10-50 ppm.

[0114] In some preferred embodiments, a reusable urinary catheter kit is provided, comprising a container comprising: a urinary catheter; and a medium comprising at least one chlorine-containing substance, the chlorine-containing substance comprising chlorine dioxide, wherein the container is resealable, and wherein the medium comprises chlorine dioxide at a total concentration in the range of 1-100 ppm.

[0115] In some embodiments, the medium comprises one or more of chlorine dioxide, hypochlorous acid, and at least one hypochlorite, wherein the total combined concentration in the medium is at least 0.0001 wt.%, or at least 0.0002 wt.%, at least 0.0003 wt.%, at least 0.0004 wt.%, at least 0.0005 wt.%, at least 0.0006 wt.%, at least 0.0007 wt.%, at least 0.0008 wt.%, at least 0.0009 wt.%, at least 0.001 wt.%, at least 0.002 wt.%, at least 0.003 wt.%, at least 0.004 wt.%, or at least 0.005 wt.%, or at least 0.006 wt.%, at least 0.007 wt.%, at least 0.008 wt.%, at least 0.009 wt.%, at least 0.01 wt.%, at least 0.015 wt.%, at least 0.016 wt.%, at least 0.017 wt.%, at least 0.018 wt.%, at least 0.020 wt.%, at least 0.021 wt.%, at least 0.023 wt.%, at least 0.024 wt.%, at least 0.025 wt.%, at least 0.026 wt.%, at least 0.027 wt.%, at least 0.028 wt.%, at least 0.029 wt.%, at least 0.030 wt.%, at least 0.031 wt.%, at least 0.032 wt.%, at least 0.034 wt.%, or at least 0.035 wt.%, or at least 0.036 wt.%, at least 0 %, at least 0.02 wt.%, at least 0.025 wt.%, at least 0.03 wt.%, at least 0.035 wt.%, at least 0.04 wt.%, at least 0.045 wt.%, at least 0.05 wt.%, at least 0.055 wt.%, at least 0.06 wt.%, at least 0.065 wt.%, at least 0.07 wt.%, at least 0.075 wt.%, at least 0.08 wt.%, at least 0.085 wt.%, at least 0.09 wt.%, at least 0.095 wt.%, at least 0.1 wt.%, at least 0.11 wt.%, at least 0.12 wt.%, at least 0.13 wt.%, at least 0.14 wt.%, at least 0.15 wt.%, at least 0.16 wt.%, at least 0.17 wt.%, at least 0.18 wt.%, at least 0.19 wt.%, or at least 0.2 wt.%.

[0116] In some embodiments, the medium comprises one or more of: chlorine dioxide, hypochlorous acid, and at least one hypochlorite, the total combined concentration of which in the medium is no greater than 5 wt.%, or no greater than 4.5 wt.%, no greater than 4 wt.%, no greater than 3.5 wt.%, no greater than 3 wt.%, no greater than 2.5 wt.%, no greater than 2 wt.%, no greater than 1.5 wt.%, no greater than 1 wt.%, no greater than 0.9 wt.%, no greater than 0.8 wt.%, no greater than 0.7 wt.%, no greater than 0.6 wt.%, no greater than 0.5 wt.%, no greater than 0.4 wt.%, no greater than % is not greater than 0.3wt.%, or not greater than 0.2wt.%, or not greater than 0.1wt.%, not greater than 0.05wt.%, not greater than 0.04wt.%, not greater than 0.03wt.%, not greater than 0.02wt.%, not greater than 0.01wt.%, not greater than 0.009wt.%, not greater than 0.008wt.%, not greater than 0.007wt.%, not greater than 0.006wt.%, not greater than 0.005wt.%, not greater than 0.004wt.%, not greater than 0.003wt.%, not greater than 0.002wt.%, or not greater than 0.001wt.%.

[0117] In some embodiments, the medium comprises one or more of: chlorine dioxide, hypochlorous acid, and at least one hypochlorite, with a total combined concentration in the medium of 0.005-1.5 wt.%, or 0.005-1 wt.%, or 0.005-0.6 wt.%, or 0.01-0.5 wt.%, 0.015-0.4 wt.%, 0.02-0.3 wt.%, or 0.025-0.2 wt.%, or preferably 0.025-0.1 wt.%.

[0118] In some embodiments, the medium comprises one or more of chlorine dioxide, hypochlorous acid, and at least one hypochlorite, the total combined concentration of which in the medium is at least 1 ppm, or at least 2 ppm, at least 3 ppm, at least 4 ppm, at least 5 ppm, at least 6 ppm, at least 7 ppm, at least 8 ppm, at least 9 ppm, or at least 10 ppm. In some embodiments, the medium comprises one or more of chlorine dioxide, hypochlorous acid, and at least one hypochlorite, the total combined concentration of which in the medium is no greater than 100 ppm, or no greater than 90 ppm, no greater than 80 ppm, no greater than 70 ppm, no greater than 60 ppm, or no greater than 50 ppm. In some embodiments, the medium comprises one or more of chlorine dioxide, hypochlorous acid, and at least one hypochlorite, the total combined concentration of which in the medium is 1-100 ppm, or 5-100 ppm, 10-100 ppm, 10-90 ppm, 10-80 ppm, 10-70 ppm, 10-60 ppm, or 10-50 ppm.

[0119] In some preferred embodiments, a reusable urinary catheter kit is provided, comprising a container comprising: a urinary catheter; and a medium comprising at least one chlorine-containing substance, wherein the container is resealable, and wherein the medium comprises one or more of the following in a total combined concentration in the range of 1-100 ppm: chlorine dioxide, hypochlorous acid, and at least one hypochlorite.

[0120] In some embodiments, the medium comprises hypochlorous acid and / or at least one hypochlorite salt at a total combined concentration in the medium of at least 0.0001 wt.%, or at least 0.0002 wt.%, at least 0.0003 wt.%, at least 0.0004 wt.%, at least 0.0005 wt.%, at least 0.0006 wt.%, at least 0.0007 wt.%, at least 0.0008 wt.%, at least 0.0009 wt.%, at least 0.001 wt.%, at least 0.002 wt.%, at least 0.003 wt.%, at least 0.004 wt.%, or at least 0.005 wt.%, or at least 0.006 wt.%, at least 0.007 wt.%, at least 0.008 wt.%, at least 0.009 wt.%, at least 0.01 wt.%, at least 0.015 wt.%, at least 0.02 wt.%, at least 0.025 wt.%, at least 0.03 wt.%, at least 0.035 wt.%, at least 0.04 wt.%, at least 0.045 wt.%, at least 0.05 wt.%, at least 0.055 wt.%, at least 0.06 wt.%, at least 0.065 wt.%, at least 0.07 wt.%, at least 0.075 wt.%, at least 0.08 wt.%, at least 0.085 wt.%, at least 0.09 wt.%, at least 0.095 wt.%, at least 0.1 wt.%, at least 0.11 wt.%, at least 0.12 wt.%, at least 0.13 wt.%, at least 0.14 wt.%, at least 0.15 wt.%, at least 0.16 wt.%, at least 0.17 wt.%, at least 0.18 wt.%, at least 0.19 wt.%, or at least 0.2 wt.%.

[0121] In some embodiments, the medium comprises hypochlorous acid and / or at least one hypochlorite at a total combined concentration in the medium of no greater than 5 wt.%, or no greater than 4.5 wt.%, no greater than 4 wt.%, no greater than 3.5 wt.%, no greater than 3 wt.%, no greater than 2.5 wt.%, no greater than 2 wt.%, no greater than 1.5 wt.%, no greater than 1 wt.%, no greater than 0.9 wt.%, no greater than 0.8 wt.%, no greater than 0.7 wt.%, no greater than 0.6 wt.%, no greater than 0.5 wt.%, no greater than 0.4 wt.%, no greater than 0.3 wt. .%, or not more than 0.2wt.%, or not more than 0.1wt.%, not more than 0.05wt.%, not more than 0.04wt.%, not more than 0.03wt.%, not more than 0.02wt.%, not more than 0.01wt.%, not more than 0.009wt.%, not more than 0.008wt.%, not more than 0.007wt.%, not more than 0.006wt.%, not more than 0.005wt.%, not more than 0.004wt.%, not more than 0.003wt.%, not more than 0.002wt.%, or not more than 0.001wt.%.

[0122] In some embodiments, the medium comprises hypochlorous acid and / or at least one hypochlorite in a total combined concentration in the medium of 0.005-1.5 wt.%, or 0.005-1 wt.%, or 0.005-0.6 wt.%, or 0.01-0.5 wt.%, 0.015-0.4 wt.%, 0.02-0.3 wt.%, or 0.025-0.2 wt.%, or preferably 0.025-0.1 wt.%.

[0123] In some embodiments, the medium comprises hypochlorous acid and / or at least one hypochlorite at a total combined concentration of at least 1 ppm, or at least 2 ppm, at least 3 ppm, at least 4 ppm, at least 5 ppm, at least 6 ppm, at least 7 ppm, at least 8 ppm, at least 9 ppm, or at least 10 ppm. In some embodiments, the medium comprises hypochlorous acid and / or at least one hypochlorite at a total combined concentration of no greater than 100 ppm, or no greater than 90 ppm, no greater than 80 ppm, no greater than 70 ppm, no greater than 60 ppm, or no greater than 50 ppm. In some embodiments, the medium comprises hypochlorous acid and / or at least one hypochlorite at a total combined concentration of 1-100 ppm, or 5-100 ppm, 10-100 ppm, 10-90 ppm, 10-80 ppm, 10-70 ppm, 10-60 ppm, or 10-50 ppm.

[0124] In some preferred embodiments, a reusable urinary catheter kit is provided, comprising a container comprising: a urinary catheter; and a medium comprising at least one chlorine-containing substance, the chlorine-containing substance comprising hypochlorous acid and / or at least one hypochlorite, wherein the container is resealable, and wherein the total combined concentration of hypochlorous acid and / or at least one hypochlorite in the medium is 1-100 ppm.

[0125] In some embodiments, the medium comprises hypochlorous acid at a total concentration in the medium of at least 0.0001 wt.%, or at least 0.0002 wt.%, or at least 0.0003 wt.%, at least 0.0004 wt.%, at least 0.0005 wt.%, at least 0.0006 wt.%, at least 0.0007 wt.%, at least 0.0008 wt.%, at least 0.0009 wt.%, at least 0.001 wt.%, at least 0.002 wt.%, at least 0.003 wt.%, at least 0.004 wt.%, or at least 0.005 wt.%, or at least 0.006 wt.%, or at least 0.007 wt.%, at least 0.008 wt.%, at least 0.009 wt.%, at least 0.01 wt.%, at least 0.015 wt.%, at least 0.02 wt.%, at least % ., at least 0.025 wt.%, at least 0.03 wt.%, at least 0.035 wt.%, at least 0.04 wt.%, at least 0.045 wt.%, at least 0.05 wt.%, at least 0.055 wt.%, at least 0.06 wt.%, or preferably at least 0.065 wt.%, at least 0.07 wt.%, at least 0.075 wt.%, at least 0.08 wt.%, at least 0.085 wt.%, at least 0.09 wt.%, at least 0.095 wt.%, at least 0.1 wt.%, at least 0.11 wt.%, at least 0.12 wt.%, at least 0.13 wt.%, at least 0.14 wt.%, at least 0.15 wt.%, at least 0.16 wt.%, at least 0.17 wt.%, at least 0.18 wt.%, at least 0.19 wt.%, or at least 0.2 wt.%.

[0126] In some embodiments, the medium comprises hypochlorous acid at a total concentration in the medium of no greater than 5 wt.%, or no greater than 4.5 wt.%, no greater than 4 wt.%, no greater than 3.5 wt.%, no greater than 3 wt.%, no greater than 2.5 wt.%, no greater than 2 wt.%, no greater than 1.5 wt.%, no greater than 1 wt.%, no greater than 0.9 wt.%, no greater than 0.8 wt.%, no greater than 0.7 wt.%, no greater than 0.6 wt.%, no greater than 0.5 wt.%, no greater than 0.4 wt.%, no greater than 0.3 wt.%, or no greater than 0. 0.2wt.%, or not more than 0.1wt.%, not more than 0.05wt.%, not more than 0.04wt.%, not more than 0.03wt.%, not more than 0.02wt.%, not more than 0.01wt.%, not more than 0.009wt.%, not more than 0.008wt.%, not more than 0.007wt.%, not more than 0.006wt.%, not more than 0.005wt.%, not more than 0.004wt.%, not more than 0.003wt.%, not more than 0.002wt.%, or not more than 0.001wt.%.

[0127] In some embodiments, the medium comprises hypochlorous acid at a total concentration in the medium of 0.005-1.5 wt.%, or 0.005-1 wt.%, or 0.005-0.6 wt.%, or 0.01-0.5 wt.%, 0.015-0.4 wt.%, 0.02-0.3 wt.%, or 0.025-0.2 wt.%, or 0.025-0.1 wt.%.

[0128] In some embodiments, the medium comprises a total concentration of at least 1 ppm, or at least 2 ppm, at least 3 ppm, at least 4 ppm, at least 5 ppm, at least 6 ppm, at least 7 ppm, at least 8 ppm, at least 9 ppm, or at least 10 ppm of hypochlorous acid. In some embodiments, the medium comprises a total concentration of no greater than 100 ppm, or no greater than 90 ppm, no greater than 80 ppm, no greater than 70 ppm, no greater than 60 ppm, or no greater than 50 ppm of hypochlorous acid. In some embodiments, the medium comprises a total concentration of 1-100 ppm, or 5-100 ppm, 10-100 ppm, 10-90 ppm, 10-80 ppm, 10-70 ppm, 10-60 ppm, or 10-50 ppm of hypochlorous acid.

[0129] In some preferred embodiments, a reusable urinary catheter kit is provided, comprising a container comprising: a urinary catheter; and a medium comprising at least one chlorine-containing substance, the chlorine-containing substance comprising hypochlorous acid, wherein the container is resealable, and wherein the medium comprises hypochlorous acid at a total concentration in the range of 1-100 ppm.

[0130] The medium may comprise hypochlorite in a total concentration in the medium of at least 0.0001 wt.%, or at least 0.0002 wt.%, at least 0.0003 wt.%, at least 0.0004 wt.%, at least 0.0005 wt.%, at least 0.0006 wt.%, at least 0.0007 wt.%, at least 0.0008 wt.%, at least 0.0009 wt.%, at least 0.001 wt.%, at least 0.002 wt.%, at least 0.003 wt.%, at least 0.004 wt.%, or at least 0.005 wt.%, or at least 0.006 wt.%, at least 0.007 wt.%, at least 0.008 wt.%, at least 0.009 wt.%, at least 0.01 wt.%, at least 0.015 wt.%, at least 0.02 wt.%, at least 0.0 %. %, at least 0.25 wt.%, at least 0.03 wt.%, at least 0.035 wt.%, at least 0.04 wt.%, at least 0.045 wt.%, at least 0.05 wt.%, at least 0.055 wt.%, at least 0.06 wt.%, at least 0.065 wt.%, at least 0.07 wt.%, at least 0.075 wt.%, at least 0.08 wt.%, at least 0.085 wt.%, at least 0.09 wt.%, at least 0.095 wt.%, at least 0.1 wt.%, at least 0.11 wt.%, at least 0.12 wt.%, at least 0.13 wt.%, at least 0.14 wt.%, at least 0.15 wt.%, at least 0.16 wt.%, at least 0.17 wt.%, at least 0.18 wt.%, at least 0.19 wt.%, or at least 0.2 wt.%.

[0131] In some embodiments, the medium may include hypochlorite at a total concentration in the medium of no greater than 5 wt.%, or no greater than 4.5 wt.%, no greater than 4 wt.%, no greater than 3.5 wt.%, no greater than 3 wt.%, no greater than 2.5 wt.%, no greater than 2 wt.%, no greater than 1.5 wt.%, no greater than 1 wt.%, no greater than 0.9 wt.%, no greater than 0.8 wt.%, no greater than 0.7 wt.%, no greater than 0.6 wt.%, no greater than 0.5 wt.%, no greater than 0.4 wt.%, no greater than 0.3 wt.%, or no greater than 0. Greater than 0.2wt.%, or not greater than 0.1wt.%, not greater than 0.05wt.%, not greater than 0.04wt.%, not greater than 0.03wt.%, not greater than 0.02wt.%, not greater than 0.01wt.%, not greater than 0.009wt.%, not greater than 0.008wt.%, not greater than 0.007wt.%, not greater than 0.006wt.%, not greater than 0.005wt.%, not greater than 0.004wt.%, not greater than 0.003wt.%, not greater than 0.002wt.%, or not greater than 0.001wt.%.

[0132] In some embodiments, the medium may contain hypochlorite at a total concentration in the medium of 0.005-1.5 wt.%, or 0.005-1 wt.%, or 0.005-0.6 wt.%, or 0.01-0.5 wt.%, 0.015-0.4 wt.%, 0.02-0.3 wt.%, or 0.025-0.2 wt.%, or 0.025-0.1 wt.%.

[0133] In some embodiments, the medium comprises at least one hypochlorite at a total concentration of at least 1 ppm, or at least 2 ppm, at least 3 ppm, at least 4 ppm, at least 5 ppm, at least 6 ppm, at least 7 ppm, at least 8 ppm, at least 9 ppm, or at least 10 ppm. In some embodiments, the medium comprises at least one hypochlorite at a total concentration of no greater than 100 ppm, or no greater than 90 ppm, no greater than 80 ppm, no greater than 70 ppm, no greater than 60 ppm, or no greater than 50 ppm. In some embodiments, the medium comprises at least one hypochlorite at a total concentration of 1-100 ppm, or 5-100 ppm, 10-100 ppm, 10-90 ppm, 10-80 ppm, 10-70 ppm, 10-60 ppm, or 10-50 ppm.

[0134] In some preferred embodiments, a reusable urinary catheter kit is provided, comprising a container comprising: a urinary catheter; and a medium comprising at least one chlorine-containing substance, the chlorine-containing substance comprising at least one hypochlorite, wherein the container is resealable, and wherein the medium comprises the at least one hypochlorite at a total concentration in the range of 1-100 ppm.

[0135] In some embodiments, the total amount of medium present in the combination of the conduit and the medium is at least 0.05 wt.%, or at least 0.1 wt.%, at least 0.15 wt.%, at least 0.2 wt.%, at least 0.25 wt.%, at least 0.35 wt.%, at least 0.4 wt.%, at least 0.45 wt.%, at least 0.5 wt.%, at least 0.55 wt.%, at least 0.6 wt.%, at least 0.65 wt.%, at least 0.7 wt.%, at least 0.75 wt.%, at least 0.8 wt.%, at least 0.85 wt.%, at least 0.9 wt.%, at least 0.95 wt.%, at least 1 wt.%, at least 2 wt.%, at least 3 wt.%, at least 4 wt.%, at least 5 wt.%, at least 6 wt.%, at least 7 wt.%, at least 8 wt.%, at least 9 wt.%, at least 10 wt.%, at least 15 wt.%, or at least 20 wt.%.

[0136] The total amount of medium present in the combination of the conduit and the medium may be no greater than 40 wt.%, or no greater than 35 wt.%, no greater than 30 wt.%, no greater than 25 wt.%, no greater than 20 wt.%, no greater than 15 wt.%, no greater than 10 wt.%, or no greater than 5 wt.%.

[0137] The total amount of medium present in the combination of the conduit and the medium may be 0.1-20 wt.%, or 0.5-15 wt.%, or 0.5-5 wt.%.

[0138] In some embodiments, the medium is present as a liquid having a viscosity greater than 0.5 centipoise (cP), or greater than 1 cP, greater than 1.5 cP, greater than 2 cP, greater than 3 cP, greater than 4 cP, greater than 5 cP, greater than 10 cP, greater than 20 cP, greater than 30 cP, greater than 40 cP, greater than 50 cP, greater than 75 cP, greater than 100 cP, greater than 150 cP, greater than 200 cP, greater than 300 cP, greater than 400 cP, greater than 500 cP, greater than 600 cP, greater than 700 cP, greater than 800 cP, greater than 900 cP, or greater than 1000 cP. The viscosity of the medium may be no greater than 100,000 cP, or no greater than 90,000 cP, no greater than 80,000 cP, no greater than 70,000 cP, no greater than 60,000 cP, no greater than 50,000 cP, no greater than 40,000 cP, no greater than 30,000 cP, no greater than 20,000 cP, no greater than 10,000 cP, no greater than 5,000 cP, no greater than 4,000 cP, no greater than 3,000 cP, no greater than 2,000 cP, no greater than 1,000 cP, no greater than 500 cP, no greater than 400 cP, no greater than 300 cP, no greater than 200 cP, no greater than 100 cP, no greater than 50 cP, no greater than 25 cP, no greater than 10 cP, no greater than 5 cP, no greater than 4 cP, no greater than 3 cP, no greater than 2 cP, or no greater than 1 cP. The viscosity of the medium may be 0.5-5000 cP, or 0.5-2500 cP, 0.5-1000 cP, 1-1000 cP, 10-1000 cP, 50-1000 cP, 100-1000 cP, 500-1000 cP, 0.5-500 cP, 1-500 cP, 10-500 cP, 50-500 cP, 100-500 cP, 250-500 cP, 0.5-250 cP, 1-250 cP, 10-250 cP, 50-250 cP, or 100-250 cP.

[0139] The medium may be a catheter wetting agent, which can promote the hydrophilic portion of the lubricating additive in the catheter to migrate to the outer surface of the catheter, further enhancing the lubricating effect of the additive.

[0140] In some embodiments, the pH of the medium is at least 2, at least 2.5, at least 3, at least 3.5, at least 4, at least 4.5, at least 5, at least 5.5, at least 6, at least 6.5, at least 7, at least 7.5, at least 8, at least 8.5, or no greater than 9. In some embodiments, the pH of the medium may be no greater than 14, or no greater than 13.5, no greater than 13, no greater than 12.5, no greater than 12, no greater than 11.5, no greater than 11, no greater than 10.5, or no greater than 10.

[0141] In some embodiments, the pH of the medium is in the range of 2-14, in the range of 3-13, or in the range of 4-12.

[0142] In some embodiments, the medium comprises at least one additional substance independently selected from the group consisting of: a peroxide substance, a base, an acid, a photosensitizer, a permanganate substance, an alcohol, a phenol, an aldehyde, ionic silver, molecular iodine or iodophor, an imine-containing substance, a salt, and combinations thereof.

[0143] In some embodiments, the medium comprises at least one additional substance independently selected from the group consisting of: a peroxide substance, a base, an acid, a photosensitizer, a permanganate substance, an alcohol, a phenol, an aldehyde, ionic silver, molecular iodine or an iodine carrier, an imine-containing substance, a salt, and combinations thereof.

[0144] In preferred embodiments, the medium comprises molecular chlorine. The medium may comprise molecular chlorine and at least one substance independently selected from the group consisting of hypochlorous acid, at least one hypochlorite, chlorine dioxide, and combinations thereof. The medium may comprise molecular chlorine and at least one of the following: hypochlorous acid and a hypochlorite. In some embodiments, the medium comprises at least one hypochlorite and molecular chlorine. In preferred embodiments, the medium comprises hypochlorous acid and molecular chlorine. In some embodiments, the medium comprises hypochlorous acid, molecular chlorine, and at least one hypochlorite.

[0145] In some preferred embodiments, a reusable urinary catheter kit is provided, comprising a container comprising: a urinary catheter; and a medium comprising at least one chlorine-containing substance, wherein the container is resealable, and wherein the at least one chlorine-containing substance comprises molecular chlorine and further comprises at least one substance independently selected from the group consisting of hypochlorous acid, at least one hypochlorite salt, chlorine dioxide, and combinations thereof.

[0146] In some preferred embodiments, a reusable urinary catheter kit is provided, comprising a container containing: a urinary catheter; and a medium containing at least one chlorine-containing substance, wherein the container is resealable, and wherein the at least one chlorine-containing substance contains molecular chlorine and further contains hypochlorous acid.

[0147] In some embodiments, the medium has a pH of less than 4, and the amount of molecular chlorine in the medium is greater than the total combined amount of hypochlorous acid and hypochlorite.

[0148] In some embodiments, the medium has a pH in the range of 4-7, and the amount of hypochlorous acid in the medium is greater than the total combined amount of molecular chlorine and hypochlorite.

[0149] In some embodiments, the medium has a pH greater than 8, and the amount of hypochlorite in the medium is greater than the total combined amount of molecular chlorine and hypochlorous acid.

[0150] The medium may comprise at least one additional salt (in addition to any hypochlorite present). The at least one salt may comprise a cation independently selected from the group consisting of ammonium, calcium, iron, magnesium, potassium, pyridinium, , quaternary ammonium, sodium, copper, aluminum, lithium, beryllium, strontium and zinc. At least one salt may comprise a cation independently selected from the group consisting of ammonium, calcium, iron, magnesium, potassium, pyridinium , quaternary ammonium, sodium, copper, aluminum, lithium, beryllium, strontium and zinc. At least one salt may preferably contain an alkali metal cation. At least one salt may contain anions independently selected from the group consisting of acetate, carbonate, bicarbonate, chloride, citrate, glutamate, fluoride, bromide, iodide, nitrate, nitrite, oxide, phosphate, ferrocyanide, silicate, gluconate and sulfate. At least one salt may contain anions independently selected from the group consisting of acetate, carbonate, bicarbonate, chloride, citrate, glutamate, fluoride, bromide, iodide, nitrate, nitrite, oxide, phosphate, ferrocyanide, silicate, gluconate and sulfate. At least one salt may preferably contain a halogen anion.

[0151] The at least one additional salt can be independently selected from the group consisting of sodium chloride, potassium chloride, calcium chloride, magnesium chloride, calcium chloride, sodium nitrite, magnesium nitrate, calcium nitrate, potassium carbonate, sodium carbonate, sodium bicarbonate, potassium iodide, copper iodide, sodium ferrocyanide, monosodium glutamate, calcium silicate, sodium citrate, potassium citrate, sodium phosphate, potassium phosphate, sodium sulfate, calcium sulfate, sodium gluconate, calcium gluconate, potassium gluconate, sodium acetate, and potassium acetate.

[0152] At least one additional salt can be independently selected from the group consisting of sodium chloride, potassium chloride, calcium chloride, magnesium chloride, calcium chloride, sodium nitrite, magnesium nitrate, calcium nitrate, potassium carbonate, sodium carbonate, sodium bicarbonate, potassium iodide, copper iodide, sodium ferrocyanide, monosodium glutamate, calcium silicate, sodium citrate, potassium citrate, sodium phosphate, potassium phosphate, sodium sulfate, calcium sulfate, sodium gluconate, calcium gluconate, potassium gluconate, sodium acetate, and potassium acetate.

[0153] The at least one additional salt may preferably be an alkali metal halide. The at least one salt may be independently selected from the group consisting of: alkali metal chlorides, alkali metal bromides, alkali metal iodides, and combinations thereof. The at least one salt may be independently selected from the group consisting of: alkali metal chlorides, alkali metal bromides, alkali metal iodides, and combinations thereof.

[0154] Preferably, the medium may comprise an alkali metal salt and a hypochlorite. The medium may comprise a halide salt and a hypochlorite. The medium may comprise an alkali metal halide and a hypochlorite.

[0155] In a particularly preferred embodiment, the medium comprises sodium chloride. The medium may comprise sodium and at least one of: hypochlorous acid and a hypochlorite. The medium may preferably comprise a hypochlorite and sodium chloride, preferably an alkali metal hypochlorite and sodium chloride, more preferably sodium hypochlorite and sodium chloride.

[0156] In some embodiments, the total concentration of the additional salts in the medium is in the range of 5-30 wt.%, or in the range of 10-25 wt.%, or in the range of 10-20 wt.%.

[0157] In some embodiments, the medium comprises hypochlorite in a total concentration in the medium in the range of 0.25-2 wt. %, or in the range of 0.5-1.5 wt. % or an additional salt in a total concentration in the medium in the range of 5-30 wt. %, in the range of 10-25 wt. %, or in the range of 10-20 wt. %.

[0158] In some embodiments, the ratio of the total concentration of additional salt to hypochlorite in the medium is at least 5, or at least 10, or at least 15. The ratio of the total concentration of additional salt to hypochlorite in the medium may be in the range of 5-30, or in the range of 10-25, or preferably in the range of 10-20.

[0159] In some preferred embodiments, a reusable urinary catheter kit is provided, comprising a container comprising: a urinary catheter; and a medium comprising at least one chlorine-containing substance, the chlorine-containing substance comprising at least one hypochlorite, wherein the container is resealable, and wherein the medium further comprises at least one alkali metal halide salt, preferably sodium chloride, wherein the ratio of the total concentration of the at least one alkali metal halide salt to the at least one hypochlorite in the medium is 10-20.

[0160] In some embodiments, the medium further comprises at least one base. The medium may comprise a base and at least one chlorine-containing substance selected from the group consisting of hypochlorous acid, at least one hypochlorite, chlorine dioxide, and combinations thereof. The medium may comprise a base and at least one of the following: hypochlorous acid and a hypochlorite. In preferred embodiments, the medium may comprise a base and a hypochlorite.

[0161] At least one base may comprise an inorganic base. The at least one inorganic base may be independently selected from the group consisting of hydroxide bases, carbonate bases, bicarbonate bases, and combinations thereof. The at least one inorganic base may be independently selected from the group consisting of hydroxide bases, carbonate bases, bicarbonate bases, and combinations thereof. In some preferred embodiments, the at least one base is a hydroxide base. The at least one hydroxide base may be independently selected from the group consisting of alkali metal hydroxides, alkaline earth metal hydroxides, Group III metal hydroxides, transition metal hydroxides, and combinations thereof. The at least one hydroxide base may be independently selected from the group consisting of alkali metal hydroxides, alkaline earth metal hydroxides, Group III metal hydroxides, transition metal hydroxides, and combinations thereof. The at least one hydroxide base may preferably comprise an alkali metal hydroxide and / or an alkaline earth metal hydroxide. In some embodiments, the at least one base comprises an alkali metal hydroxide independently selected from the group consisting of lithium hydroxide, sodium hydroxide, potassium hydroxide, and combinations thereof. In some embodiments, the at least one base comprises an alkali metal hydroxide independently selected from the group consisting of lithium hydroxide, sodium hydroxide, potassium hydroxide, and combinations thereof.

[0162] In some preferred embodiments, a reusable urinary catheter kit is provided, comprising a container comprising: a urinary catheter; and a medium comprising at least one chlorine-containing substance, the at least one chlorine-containing substance independently selected from the group consisting of: hypochlorous acid, at least one hypochlorite, chlorine dioxide, and combinations thereof, wherein the container is resealable, and wherein the medium further comprises at least one base, preferably at least one alkali metal hydroxide base, preferably comprising sodium hydroxide.

[0163] Preferably, the medium may comprise an alkali metal base and a hypochlorite. The medium may comprise a hydroxide base and a hypochlorite. The medium may comprise an alkali metal hydroxide and a hypochlorite.

[0164] In a particularly preferred embodiment, the base comprises sodium hydroxide. The medium may comprise sodium hydroxide and at least one of: hypochlorous acid and a hypochlorite. The medium may preferably comprise a hypochlorite and sodium hydroxide, preferably an alkali metal hypochlorite and sodium hydroxide, more preferably sodium hypochlorite and sodium hydroxide.

[0165] In some preferred embodiments, a reusable urinary catheter kit is provided, comprising a container comprising: a urinary catheter; and a medium comprising at least one chlorine-containing substance, the chlorine-containing substance comprising at least one hypochlorite, wherein the container is resealable, and wherein the medium further comprises at least one base, preferably at least one alkali metal hydroxide base, preferably comprising sodium hydroxide.

[0166] In some embodiments, the medium comprises at least one acid that is a carboxylic acid. In some embodiments, the medium comprises at least one acid independently selected from the group consisting of acetic acid, citric acid, peracetic acid, diperoxydodecanoic acid, and combinations thereof. In some embodiments, the medium comprises at least one acid independently selected from the group consisting of acetic acid, citric acid, peracetic acid, diperoxydodecanoic acid, and combinations thereof.

[0167] In some embodiments, the medium comprises at least one C1-C10 alcohol, or at least one C1-C5 alcohol, or at least one C1-C3 alcohol. In some embodiments, the medium comprises at least one alcohol independently selected from the group consisting of ethanol, isopropanol, and combinations thereof. In some embodiments, the medium comprises at least one alcohol independently selected from the group consisting of ethanol, isopropanol, and combinations thereof.

[0168] In some embodiments, the medium comprises at least one phenol independently selected from the group consisting of: phenol, thymol, chloroxylenol, and combinations thereof.

[0169] In some embodiments, the medium comprises at least one phenol independently selected from the group consisting of phenol, thymol, chloroxylenol, and combinations thereof.

[0170] In some embodiments, the medium comprises at least one aldehyde independently selected from the group consisting of glutaraldehyde, noxytiolin, and combinations thereof.

[0171] In some embodiments, the medium comprises at least one aldehyde independently selected from the group consisting of glutaraldehyde, northiocarbamide, and combinations thereof.

[0172] In some embodiments, the medium comprises at least one imine-containing substance independently selected from the group consisting of: polyhexanide, octenidine, and combinations thereof.

[0173] The container preferably includes a resealable opening. The resealable opening can be configured such that a catheter can be removed and inserted through the resealable opening. The resealable opening can be opened and closed using a resealable opening mechanism independently selected from the group consisting of a zipper closure, a press-to-seal closure, a resealable lid, a peel-to-seal closure, a slide closure, and a Velcro closure. The resealable opening can be opened and closed using a resealable opening mechanism independently selected from the group consisting of a zipper closure, a press-to-seal closure, a resealable lid, a peel-to-seal closure, a slide closure, and a Velcro closure.

[0174] The container may preferably define a cavity configured to accommodate the catheter and preferably include a resealable opening. The catheter may preferably be configured to be repeatedly inserted into and removed from the container, preferably through the resealable opening of the container.

[0175] In some embodiments, the container is rigid. In a number of other embodiments, the container is flexible. In some embodiments, the container comprises a rigid region and a flexible region. The container may comprise a tubular member. The tubular member may have a flexible central portion and two rigid side portions adjacent to the flexible central portion. The tubular member may be resealable at its side portions.

[0176] In some embodiments, the container is a bag comprising a resealable opening.The catheter may preferably be configured to be repeatedly inserted into and removed from the bag, preferably through the resealable opening of the bag.

[0177] The catheter may preferably be configured to be repeatedly inserted into and removed from the container, preferably through a resealable opening of the container.

[0178] In some embodiments, the medium is in direct contact with the catheter. The medium may be in direct contact with at least one surface of the catheter. The at least one surface may include the outer surface of the catheter. The medium may cover at least a portion of the outer surface of the catheter.

[0179] The at least one surface may include an interior surface of the conduit, and the medium may cover at least a portion of the interior surface.

[0180] In some embodiments, the medium is in direct contact with the inner and outer surfaces of the conduit.

[0181] In some embodiments, the conduit is in direct contact with the medium along at least 30% of the conduit length, or at least 40%, at least 50%, at least 60%, at least 70%, at least 80%, at least 90%, or at least 95% of the conduit length. In some embodiments, the conduit is in direct contact with the medium along the entire length of the conduit.

[0182] In some embodiments, at least the outer surface of the conduit, preferably both the inner and outer surfaces of the conduit, are in direct contact with the medium along at least 30% of the conduit length, or at least 40%, at least 50%, at least 60%, at least 70%, at least 80%, at least 90%, or at least 95% of the conduit length. In some embodiments, at least the outer surface of the conduit, preferably both the inner and outer surfaces of the conduit, are in direct contact with the medium along the entire length of the conduit.

[0183] In some embodiments, the catheter is immersed in a medium. Immersing the catheter in a medium has been shown to impart optimal catheter lubricity.

[0184] The conduit can be completely immersed in the medium. In such embodiments, the medium can comprise at least 30% of the interior volume of the container, or at least 40%, at least 50%, at least 60%, at least 70%, at least 80%, at least 90%, or at least 95% of the interior volume of the container.

[0185] In some embodiments, the conduit is not completely immersed in the medium. In such embodiments, the medium can comprise no more than 30% of the internal volume of the container, or no more than 25%, no more than 20%, no more than 15%, no more than 10%, no more than 5%, no more than 4%, no more than 3%, no more than 2%, or no more than 1% of the internal volume of the container. In such embodiments, the medium can be in direct contact with at least a portion of the conduit, preferably in direct contact with at least one surface thereof. In some embodiments, the medium can move freely within the container. In such embodiments, the medium can be configured to sway around within the container, for example, when the container is shaken and / or due to the natural movement of the container by the user.

[0186] In some embodiments, the catheter comprises a medium layer on or comprising at least a portion of the catheter surface, preferably at least a portion of the catheter outer surface. In such embodiments, the medium can be a liquid or a gel.

[0187] The dielectric layer may preferably be on a surface of the catheter, preferably on a surface of the catheter body.

[0188] In some embodiments, the layer is located on the inner surface of the catheter, the outer surface of the catheter, or both. The inner surface of the catheter may include the lumen of the catheter. In preferred embodiments, the layer is on at least the outer surface of the catheter.

[0189] In some embodiments, the layer is on at least 50%, at least 55%, at least 60%, at least 65%, at least 70%, at least 75%, at least 80%, at least 85%, at least 90%, at least 95%, at least 96%, at least 97%, at least 98%, or at least 99% of the or each surface area of the conduit, preferably on at least 75% or at least 90% of the or each surface area, or on from 75% to 100% of the or each surface area. In embodiments where the layer is on both the inner and outer surfaces of the conduit, the additive may be on at least 50%, at least 55%, at least 60%, at least 65%, at least 70%, at least 75%, at least 80%, at least 85%, at least 90%, at least 95%, at least 96%, at least 97%, at least 98%, or at least 99% of each surface area of the conduit, preferably on at least 75% or at least 90% of each surface area or on from 75% to 100% of each surface area of both surfaces, or comprise such surface area.

[0190] In some embodiments, at least 75% of the layer, or at least 76%, at least 77%, at least 78%, at least 79%, at least 80%, at least 81%, at least 82%, at least 83%, at least 84%, at least 85%, at least 86%, at least 87%, at least 88%, at least 89%, at least 90%, at least 91%, at least 92%, at least 93%, at least 94%, at least 95%, at least 96%, at least 97%, at least 98%, at least 99%, or 100% of the layer is medium.

[0191] In some embodiments, the layer has a thickness of at least 1 μm, or a thickness of at least 2 μm, at least 3 μm, at least 4 μm, at least 5 μm, at least 6 μm, at least 7 μm, at least 8 μm, at least 9 μm, at least 10 μm, at least 15 μm, at least 20 μm, at least 25 μm, at least 30 μm, at least 35 μm, at least 40 μm, at least 45 μm, or at least 50 μm.

[0192] In some embodiments, the thickness of the layer is no greater than 10,000 μm, or no greater than 9,000 μm, no greater than 8,000 μm, no greater than 7,000 μm, no greater than 6,000 μm, no greater than 5,000 μm, no greater than 4,000 μm, no greater than 3,000 μm, no greater than 2,000 μm, no greater than 1,000 μm, no greater than 900 μm, no greater than 800 μm, no greater than 700 μm, no greater than 600 μm, no greater than 500 μm, no greater than 400 μm, or no greater than 300 μm.

[0193] In some embodiments, the thickness of this layer is in the range of 50-300 μm.

[0194] The thickness of the layer may be 60-300 μm, or 80-300 μm, 100-300 μm, 120-300 μm, 140-300 μm, 160-300 μm, 180-300 μm, 200-300 μm, 220-300 μm, 240-300 μm, 260-300 μm, or 280-300 μm.

[0195] The thickness of the layer may be 50-280 μm, or 50-260 μm, 50-240 μm, 50-220 μm, 50-200 μm, 50-180 μm, 50-160 μm, 50-140 μm, 50-120 μm, 50-100 μm, 50-80 μm, or 50-60 μm.

[0196] The layer thickness can be 60-280μm、or 80-280μm、100-280μm、120-280μm、140-280μm、160-280μm、180-280μm、200- 280μm、220-280μm、240-280μm、260-280μm、60-260μm、80-260μm、100-260μm、120-260μm、140-260 μm, 160-260μm, 180-260μm, 200-260μm, 220-260μm, 240-260μm, 60-240μm, 80-240μm, 100-240μm, 120-240μm, 140-240μm, 160-240μm, 180-240μm, 200-240μm, 220-240μm, 60-220μm, 80-220μm, 100 -220μm, 120-220μm, 140-220μm, 160-220μm, 180-220μm, 200-220μm, 60-200μm, 80-200μm, 100-200μm, 120-200μm, 140-200μm, 160-200μm, 180-200μm, 60-180μm, 80-180μm, 100-180μm, 120-180μm , 140-180μm, 160-180μm, 60-160μm, 80-160μm, 100-160μm, 120-160μm, 140-160μm, 60-140μm, 80-140μm, 100-140μm, 120-140μm, 60-120μm, 80-120μm, 100-120μm, 60-100μm, 80-100μm, or 60-80μm.

[0197] The viscosity of the dielectric layer may be at least 200 cP, or 400 cP, at least 600 cP, at least 800 cP, or at least 1000 cP, or at least 1200 cP, at least 1400 cP, at least 1600 cP, at least 1800 cP, at least 2000 cP, at least 2200 cP, at least 2400 cP, at least 2600 cP, at least 2800 cP, at least 3000 cP, at least 3200 cP, at least 3400 cP, at least 3600 cP, at least 3800 cP, at least 4000 cP, at least 4200 cP, at least 4400 cP, at least 4600 cP, at least 4800 cP, at least 5000 cP cP, at least 5200 cP, at least 5400 cP, at least 5600 cP, at least 5800 cP, at least 6000 cP, at least 6200 cP, at least 6400 cP, at least 6600 cP, at least 6800 cP, at least 7000 cP, at least 7200 cP, at least 7400 cP, at least 7600 cP, at least 7800 cP, at least 8000 cP, at least 8200 cP, at least 8400 cP, at least 8600 cP, at least 8800 cP, at least 9000 cP, at least 9200 cP, at least 9400 cP, at least 9600 cP, at least 9800 cP, or at least 10000 cP.

[0198] The viscosity of the medium layer may be no greater than 2,000,000 cP, or no greater than 1,750,000 cP, no greater than 1,500,000 cP, no greater than 1,250,000 cP, or no greater than 1,000,000 cP.

[0199] The viscosity of the dielectric layer may be 100-2,000,000 cP, or 500-1,000,000 cP, or 1,000-500,000 cP.

[0200] In some embodiments, the medium is contained in a medium container, and the catheter is contained in a separate catheter container. The medium container can be a bag or a sealed bag. The medium container can be located within the catheter container. In some embodiments, the medium is contained in a medium container located within the catheter container, and the medium does not come into direct contact with the catheter. In some embodiments, during use, the medium container is rupturable or puncturable to release the contained medium from the medium container and into direct contact with the catheter in the catheter container, preferably without opening the catheter container.

[0201] Before opening the catheter container and / or before removing the catheter, the user may release the medium from the medium container so that the medium is in direct contact with the catheter in the catheter container, preferably with the outer surface of the catheter.

[0202] In some embodiments, the media container is configured such that when the catheter container is opened, the contained media is released from the separate media container and into direct contact with the catheter. The media container may be configured to rupture or break to release the contained media from the separate media container and into direct contact with the catheter when the catheter container is opened.

[0203] In some embodiments, the catheter is immersed in a liquid and / or solution that does not contain a chlorine-containing substance, which may be contained in a separate medium container. The separate medium container may be as described in the above statement of the invention.

[0204] The chlorine-containing substance can be present in a separate medium container in solid, liquid or gel form. The liquid can include a solution containing the chlorine-containing substance. In embodiments where the chlorine-containing substance exists in solid form, the solid can include a powder or at least one tablet.

[0205] In such an embodiment, the chlorine-containing substance can be released from a separate medium container during use. The chlorine-containing substance of the present invention can be used to treat the catheter after being released from the medium container. In embodiments where the chlorine-containing substance is present in solid form, the solid can be dissolved in a liquid to provide a solution containing the chlorine-containing substance, which solution can be used to treat the catheter. The liquid can be a liquid in which the catheter is immersed.

[0206] In some embodiments, the reusable catheter can be configured to be reused at least 1 time, or at least 2 times, at least 3 times, at least 4 times, at least 5 times, at least 6 times, at least 7 times, at least 8 times, at least 9 times, at least 10 times, at least 11 times, at least 12 times, at least 13 times, at least 14 times, at least 15 times, at least 16 times, at least 17 times, at least 18 times, at least 19 times, or at least 20 times. The reusable catheter can be configured to be reused up to 5 times, or up to 10 times, up to 15 times, up to 20 times, up to 25 times, up to 30 times, up to 35 times, up to 40 times, up to 45 times, or up to 50 times.

[0207] In some embodiments, the reusable catheter can be configured to be reused for up to 10 hours, or up to 15 hours, or up to 20 hours, preferably up to 1 day, or up to 2 days, 3 days, 4 days, 5 days, or up to 6 days, or up to 1 week, or up to 8 days, or up to 9 days, 10 days, 11 days, 12 days, or up to 13 days, or up to 2 weeks, or up to 3 weeks, or up to 1 month, or up to 2 months. The reusable catheter can be configured to be reused for up to 1 day to 2 months, or up to 1 week to 1.5 months, or up to 2 weeks to 1 month.

[0208] In some embodiments, the reusable catheter is configured to be reused without the need to replenish and / or replace the medium. In some embodiments, the reusable catheter is configured to be reused for up to 5 hours without the need to replenish and / or replace the medium, or up to 10 hours, or up to 15 hours, or up to 20 hours, or up to 24 hours without the need to replenish and / or replace the medium.

[0209] According to a second aspect of the present invention, there is provided a method for sterilizing and / or lubricating a reusable urinary catheter, the method comprising the following steps:

[0210] (a) providing a resealable container in its sealed configuration, the container comprising a urinary catheter, and further providing a medium comprising at least one chloride-containing substance;

[0211] (b) removing the seal from the container;

[0212] (c) removing the catheter from the unsealed container;

[0213] (d) catheterization with a catheter;

[0214] (e) reinserting the conduit into the container and contacting the conduit with the medium containing at least one chlorine-containing substance in the container; and

[0215] (f) resealing the container.

[0216] The catheter of the second aspect of the present invention is preferably the catheter of the first aspect of the present invention. The medium of the second aspect of the present invention is preferably the medium of the first aspect of the present invention. The container of the second aspect of the present invention is preferably the container of the first aspect of the present invention.

[0217] The above statements regarding the first aspect of the invention also apply mutatis mutandis to the second aspect of the invention.

[0218] In some embodiments, a method of sterilizing and / or lubricating a reusable urinary catheter is provided, the method comprising the steps of:

[0219] (a) providing a resealable container in its sealed configuration, the container containing a urinary catheter, and further providing a medium containing at least one chlorine-containing substance, the at least one chlorine-containing substance independently selected from the group consisting of hypochlorous acid, at least one hypochlorite, chlorine dioxide, molecular chlorine, dichloroisocyanurate, chlorazolidinone, dichlorodimethylhydantoin, chloroxylenol, chlorhexidine, and combinations thereof;

[0220] (b) removing the seal from the container;

[0221] (c) removing the catheter from the unsealed container;

[0222] (d) catheterization with a catheter;

[0223] (e) reinserting the conduit into the container and contacting the conduit with the medium in the container; and

[0224] (f) Reseal the container.

[0225] In some preferred embodiments, a method for sterilizing and / or lubricating a reusable urinary catheter is provided, the method comprising the steps of:

[0226] (a) providing a resealable container in its sealed configuration, the container comprising a urinary catheter, and further providing a medium comprising at least one chlorine-containing substance, the at least one chlorine-containing substance independently selected from the group consisting of hypochlorous acid, at least one hypochlorite salt, chlorine dioxide, and combinations thereof;

[0227] (b) removing the seal from the container;

[0228] (c) removing the catheter from the unsealed container;

[0229] (d) catheterization with a catheter;

[0230] (e) reinserting the conduit into the container and contacting the conduit with the medium in the container; and

[0231] (f) Reseal the container.

[0232] In some preferred embodiments, a method for sterilizing and / or lubricating a reusable urinary catheter is provided, the method comprising the steps of:

[0233] (a) providing a resealable container in its sealed configuration, the container comprising a urinary catheter, and further providing a medium comprising at least one chlorine-containing substance, the at least one chlorine-containing substance independently selected from the group consisting of hypochlorous acid, chlorine dioxide, and combinations thereof;

[0234] (b) removing the seal from the container;

[0235] (c) removing the catheter from the unsealed container;

[0236] (d) catheterization with a catheter;

[0237] (e) reinserting the conduit into the container and contacting the conduit with the medium in the container; and

[0238] (f) Reseal the container.

[0239] In some preferred embodiments, a method for sterilizing and / or lubricating a reusable urinary catheter is provided, the method comprising the steps of:

[0240] (a) providing a resealable container in its sealed configuration, the container comprising a urinary catheter, and further providing a medium comprising hypochlorous acid and at least one additional chlorine-containing substance;

[0241] (b) removing the seal from the container;

[0242] (c) removing the catheter from the unsealed container;

[0243] (d) catheterization with a catheter;

[0244] (e) reinserting the conduit into the container and contacting the conduit with the medium in the container; and

[0245] (f) Reseal the container.

[0246] In some preferred embodiments, a method for sterilizing and / or lubricating a reusable urinary catheter is provided, the method comprising the steps of:

[0247] (a) providing a resealable container in its sealed configuration, the container comprising a urinary catheter, and further providing a medium comprising hypochlorous acid and at least one hypochlorite;

[0248] (b) removing the seal from the container;

[0249] (c) removing the catheter from the unsealed container;

[0250] (d) catheterization with a catheter;

[0251] (e) reinserting the conduit into the container and contacting the conduit with the medium in the container; and

[0252] (f) Reseal the container.

[0253] In some preferred embodiments, a method for sterilizing and / or lubricating a reusable urinary catheter is provided, the method comprising the steps of:

[0254] (a) providing a resealable container in its sealed configuration, the container comprising a urinary catheter, and further providing a medium comprising at least one chlorine-containing species, wherein the at least one chlorine-containing species is present in the medium at a total concentration of 1 to 100 ppm;

[0255] (b) removing the seal from the container;

[0256] (c) removing the catheter from the unsealed container;

[0257] (d) catheterization with a catheter;

[0258] (e) reinserting the conduit into the container and contacting the conduit with the medium containing at least one chlorine-containing substance in the container; and

[0259] (f) Reseal the container.

[0260] In some preferred embodiments, a method for sterilizing and / or lubricating a reusable urinary catheter is provided, the method comprising the steps of:

[0261] (a) providing a resealable container in its sealed configuration, the container comprising a urinary catheter, and further providing a medium comprising at least one chlorine-containing substance, the at least one chlorine-containing substance comprising chlorine dioxide, wherein the medium comprises a total concentration of chlorine dioxide in the range of 1-100 ppm;

[0262] (b) removing the seal from the container;

[0263] (c) removing the catheter from the unsealed container;

[0264] (d) catheterization with a catheter;

[0265] (e) reinserting the conduit into the container and contacting the conduit with the medium in the container; and

[0266] (f) Reseal the container.

[0267] In some preferred embodiments, a method for sterilizing and / or lubricating a reusable urinary catheter is provided, the method comprising the steps of:

[0268] (a) providing a resealable container in its sealed configuration, the container comprising a urinary catheter, and further providing a medium comprising a total combined concentration in the range of 1-100 ppm of at least one of: chlorine dioxide, hypochlorous acid, and at least one hypochlorite;

[0269] (b) removing the seal from the container;

[0270] (c) removing the catheter from the unsealed container;

[0271] (d) catheterization with a catheter;

[0272] (e) reinserting the conduit into the container and contacting the conduit with the medium; and

[0273] (f) Reseal the container.

[0274] In some preferred embodiments, a method for sterilizing and / or lubricating a reusable urinary catheter is provided, the method comprising the steps of:

[0275] (a) providing a resealable container in its sealed configuration, the container comprising a urinary catheter, and further providing a medium comprising at least one chlorine-containing substance, the at least one chlorine-containing substance comprising hypochlorous acid and / or at least one hypochlorite, wherein the hypochlorous acid and / or at least one hypochlorite are present in the medium at a total combined concentration of 1-100 ppm;

[0276] (b) removing the seal from the container;

[0277] (c) removing the catheter from the unsealed container;

[0278] (d) catheterization with a catheter;

[0279] (e) reinserting the conduit into the container and contacting the conduit with the medium in the container; and

[0280] (f) Reseal the container.

[0281] In some preferred embodiments, a method for sterilizing and / or lubricating a reusable urinary catheter is provided, the method comprising the steps of:

[0282] (a) providing a resealable container in its sealed configuration, the container comprising a urinary catheter, and further providing a medium comprising at least one chlorine-containing substance, the at least one chlorine-containing substance comprising hypochlorous acid, wherein the medium comprises hypochlorous acid at a total concentration in the range of 1-100 ppm;

[0283] (b) removing the seal from the container;

[0284] (c) removing the catheter from the unsealed container;

[0285] (d) catheterization with a catheter;

[0286] (e) reinserting the conduit into the container and contacting the conduit with the medium in the container; and

[0287] (f) Reseal the container.

[0288] In some preferred embodiments, a method for sterilizing and / or lubricating a reusable urinary catheter is provided, the method comprising the steps of:

[0289] (a) providing a resealable container in its sealed configuration, the container comprising a urinary catheter, and further providing a medium comprising at least one chlorine-containing substance, the at least one chlorine-containing substance including at least one hypochlorite, wherein the medium comprises the at least one hypochlorite at a total concentration in the range of 1-100 ppm;

[0290] (b) removing the seal from the container;

[0291] (c) removing the catheter from the unsealed container;

[0292] (d) catheterization with a catheter;

[0293] (e) reinserting the conduit into the container and contacting the conduit with the medium in the container; and

[0294] (f) Reseal the container.

[0295] In some preferred embodiments, a method for sterilizing and / or lubricating a reusable urinary catheter is provided, the method comprising the steps of:

[0296] (a) providing a resealable container in its sealed configuration, the container containing a urinary catheter, and further providing a medium containing at least one chlorine-containing substance, the at least one chlorine-containing substance comprising molecular chlorine and further comprising at least one substance independently selected from the group consisting of hypochlorous acid, at least one hypochlorite salt, chlorine dioxide, and combinations thereof;

[0297] (b) removing the seal from the container;

[0298] (c) removing the catheter from the unsealed container;

[0299] (d) catheterization with a catheter;

[0300] (e) reinserting the conduit into the container and contacting the conduit with the medium in the container; and

[0301] (f) Reseal the container.

[0302] In some preferred embodiments, a method for sterilizing and / or lubricating a reusable urinary catheter is provided, the method comprising the steps of:

[0303] (a) providing a resealable container in its sealed configuration, the container comprising a urinary catheter, and further providing a medium comprising at least one chlorine-containing substance, the at least one chlorine-containing substance comprising molecular chlorine and further comprising hypochlorous acid;

[0304] (b) removing the seal from the container;

[0305] (c) removing the catheter from the unsealed container;

[0306] (d) catheterization with a catheter;

[0307] (e) reinserting the conduit into the container and contacting the conduit with the medium in the container; and

[0308] (f) Reseal the container.

[0309] In some preferred embodiments, a method for sterilizing and / or lubricating a reusable urinary catheter is provided, the method comprising the steps of:

[0310] (a) providing a resealable container in its sealed configuration, the container comprising a urinary catheter, and further providing a medium comprising at least one chlorine-containing substance, the at least one chlorine-containing substance comprising at least one hypochlorite, wherein the medium further comprises at least one alkali metal halide salt, preferably sodium chloride, wherein the ratio of the total concentration of the at least one alkali metal halide salt to the at least one hypochlorite in the medium is in the range of 10-20;

[0311] (b) removing the seal from the container;

[0312] (c) removing the catheter from the unsealed container;

[0313] (d) catheterization with a catheter;

[0314] (e) reinserting the conduit into the container and contacting the conduit with the medium in the container; and

[0315] (f) Reseal the container.

[0316] In some preferred embodiments, a method for sterilizing and / or lubricating a reusable urinary catheter is provided, the method comprising the steps of:

[0317] (a) providing a resealable container in its sealed configuration, the container comprising a urinary catheter, and further providing a medium comprising at least one chlorine-containing substance, the at least one chlorine-containing substance being independently selected from the group consisting of hypochlorous acid, at least one hypochlorite, chlorine dioxide, and combinations thereof, and wherein the medium further comprises at least one base, preferably at least one alkali metal hydroxide base, preferably comprising sodium hydroxide;

[0318] (b) removing the seal from the container;

[0319] (c) removing the catheter from the unsealed container;

[0320] (d) catheterization with a catheter;

[0321] (e) reinserting the conduit into the container and contacting the conduit with the medium in the container; and

[0322] (f) Reseal the container.

[0323] In some preferred embodiments, a method for sterilizing and / or lubricating a reusable urinary catheter is provided, the method comprising the steps of:

[0324] (a) providing a resealable container in its sealed configuration, said container comprising a urinary catheter, and further providing a medium comprising at least one chlorine-containing substance, said at least one chlorine-containing substance comprising at least one hypochlorite, and wherein said medium further comprises at least one base, preferably at least one alkali metal hydroxide base, preferably comprising sodium hydroxide;

[0325] (b) removing the seal from the container;

[0326] (c) removing the catheter from the unsealed container;

[0327] (d) catheterization with a catheter;

[0328] (e) reinserting the conduit into the container and contacting the conduit with the medium in the container; and

[0329] (f) Reseal the container.

[0330] In some embodiments, in step (a) of the method, the medium is contained in a container. In step (a), the conduit may be in direct contact with the medium in the container, preferably as described above in the statement of the invention regarding the first aspect of the present invention. In step (a), at least one surface of the conduit may be in direct contact with the medium in the container. In step (a), the conduit may be immersed in the medium.

[0331] In some embodiments, the medium is contained in a separate medium container located in the catheter container in step (a), and the medium is not in direct contact with the catheter. The separate medium container may preferably be as described above in the invention statement of the first aspect of the present invention. The method may also include the step of releasing the contained medium from the separate medium container and bringing it into direct contact with the catheter. The step of releasing the contained medium may be performed between steps (a) and (b) of the method. The step of releasing the contained medium may include piercing the medium container to release the contained medium from the medium container and bringing it into direct contact with the catheter in the catheter container.

[0332] In some embodiments, unsealing the catheter container in step (b) causes the contained medium to be released from the separate medium container and into direct contact with the catheter in the catheter container. In some embodiments, unsealing the catheter container in step (b) causes the medium container to rupture or break to release the contained medium from the separate medium container and into direct contact with the catheter in the catheter container.

[0333] In some embodiments, in step (a) of the method, the medium is not contained in the container, and the method includes the further step of adding the medium to the container. The step of adding the medium to the container may include filling the container with the medium.

[0334] In some embodiments, the method further comprises the step of adding a medium to the container after step (b).The method may comprise the step of adding a medium to the container after step (b) and before reinserting the catheter into the container in step (e).

[0335] In some embodiments, the method further comprises the step of adding a medium to the container after reinserting the catheter into the container in step (e).

[0336] In some embodiments, step (e) comprises contacting at least one surface of the conduit, preferably at least the outer surface of the conduit, with the medium.

[0337] In some embodiments, step (e) comprises contacting at least 20% of the outer surface area of the conduit with the medium, or contacting at least 25%, at least 30%, at least 35%, at least 40%, at least 45%, at least 50%, at least 55%, at least 60%, at least 65%, at least 70%, at least 75%, at least 80%, at least 85%, at least 90%, at least 95%, at least 96%, at least 97%, at least 98%, or at least 99% of the outer surface area of the conduit with the medium, preferably at least 75%, or at least 90% of the outer surface area, or between 75% and 100% of the outer surface area of the conduit with the medium.

[0338] In some embodiments, step (e) comprises immersing the catheter in the medium.

[0339] Immersing the catheter in the medium, particularly between uses, has been shown to achieve optimal catheter lubricity.

[0340] In some embodiments, step (e) comprises contacting the catheter with the medium in the container for at least 5 seconds, or at least 10 seconds, at least 20 seconds, at least 30 seconds, at least 40 seconds, or at least 50 seconds, or at least 1 minute, or at least 2 minutes, at least 3 minutes, at least 4 minutes, or at least 5 minutes, or at least 10 minutes, at least 20 minutes, at least 30 minutes, at least 40 minutes, or at least 50 minutes, or at least 1 hour, or a total time of at least 1.5 hours, at least 2 hours, at least 2.5 hours, at least 3 hours, at least 3.5 hours, or at least 4 hours. Step (e) may comprise contacting the catheter with the medium for no more than 1 week, or no more than 6 days, or no more than 5 days, no more than 4 days, no more than 3 days, no more than 2 days, or no more than 1 day, or a total time of no more than 20 hours, no more than 19 hours, no more than 18 hours, no more than 17 hours, no more than 16 hours, no more than 15 hours, no more than 14 hours, no more than 13 hours, no more than 12 hours, no more than 11 hours, no more than 10 hours, no more than 9 hours, no more than 8 hours, no more than 7 hours, no more than 6 hours, or no more than 5 hours.

[0341] In some embodiments, step (e) is performed at a temperature of at least 1° C., or at least 2° C., at least 3° C., at least 4° C., or at least 5° C. In some embodiments, step (e) is performed at a temperature of no greater than 60° C., or no greater than 55° C., no greater than 50° C., no greater than 45° C., no greater than 40° C., no greater than 35° C., no greater than 30° C., or no greater than 25° C. In some embodiments, step (e) is performed at a temperature of 1-60° C., or 5-50° C., or 10-40° C.

[0342] In some embodiments, the container in step (a) is provided before the first use of the catheter. In some embodiments, the container in step (a) is provided after the first use of the catheter. Steps (b) to (f) can be repeated. The method may include repeating steps (b) to (f) for each subsequent use of the catheter. In some embodiments, step (a) may include providing a container containing an unused catheter, followed by initial steps (b) to (f), followed by repeating steps (b) to (f) for the subsequent use of the catheter. This repetition of steps (b) to (f) can be completed multiple times. Steps (b) to (f) can be repeated at least 1 time, at least 2 times, at least 3 times, at least 4 times, at least 5 times, at least 6 times, or at least 7 times, preferably within 24 hours. Steps (b) to (f) can be repeated 1-10 times, or 1-7 times, preferably within 24 hours.

[0343] In some embodiments, the catheter is used for at least 5 hours after first use, or for at least 10 hours, at least 15 hours, at least 20 hours, or at least 24 hours after first use. In some embodiments, the catheter is used for up to 24 hours after first use.

[0344] The medium contained in the catheter container does not need to be replenished or replaced between uses of the catheter. In embodiments where steps (b) through (f) are repeated, the repeated step (e) may comprise reinserting the catheter into the container and contacting the catheter with the same medium in the container as in the previous step (e), without replenishing or replacing the medium between runs.

[0345] In some embodiments, the medium may not be replaced or replenished for at least 6 hours after the first catheter use, or for at least 12 hours, at least 18 hours, or at least 24 hours after the first catheter use.

[0346] In some embodiments, the medium can be replaced or replenished 18 hours or more after the first catheter use, or 20 hours or more, or 22 hours or more, or 24 hours or more after the first catheter use.

[0347] In some embodiments, the method further comprises the step of cleaning and / or rinsing the catheter before reinserting the catheter into the container in step (e). The method may include such a cleaning and / or rinsing step before each step (e) of the method. In some embodiments, the cleaning and / or rinsing step occurs directly before reinserting the catheter into the container in step (e). The cleaning and / or rinsing step may comprise the surface of the cleaning and / or rinsing catheter, preferably its outer surface. In some embodiments, the cleaning and / or rinsing step comprises cleaning and / or rinsing the catheter with water. In some embodiments, the cleaning and / or rinsing step comprises cleaning and / or rinsing the catheter with an aqueous solution. The cleaning and / or rinsing step may comprise cleaning and / or rinsing the catheter with a detergent and water or an aqueous solution. In some embodiments, the cleaning and / or rinsing step comprises applying a detergent to the catheter, preferably to its outer surface, and then rinsing the catheter with water or an aqueous solution.

[0348] In some embodiments, the method further comprises the step of lubricating the catheter with an additional lubricant. The additional lubrication step may preferably be performed after step (c). In some embodiments, the catheter may be dried after step (c) and before the additional lubrication step. The drying step may comprise air drying and / or wiping the catheter to dry the catheter. In some embodiments, the additional lubrication step is performed before the catheter is used, preferably just before the catheter is used. Preferably, the additional lubrication step is performed after step (c) and before the catheter is used.

[0349] The additional lubricant may be water or may comprise water.The additional lubricant may be an aqueous solution.

[0350] The further lubricating step may comprise treating the catheter, preferably treating at least a portion of the outer surface of the catheter, with a lubricant. The further lubricating step may comprise applying a lubricant to the catheter, preferably applying to at least a portion of the outer surface of the catheter.

[0351] In some embodiments, no additional lubrication step is performed. In such embodiments, the catheter can be used directly after step (c). Treating the catheter with a medium containing a chlorine-containing substance provides both catheter sterilization and lubrication, and allows for optimal catheter lubrication even without an additional lubrication step.

[0352] The following statements apply mutatis mutandis to all aspects of the invention.

[0353] Catheter assemblies or components thereof disclosed in one or more of the following applications, the entire contents of which are incorporated herein by reference, may be used in the kit of the first aspect of the invention and / or the method of the second aspect of the invention: WO2019 / 123004A1, WO2019 / 123003A1, WO2022 / 223986A1, WO2022 / 223987A1, WO2022 / 223985A1, WO2022 / 223984A1, WO2022 / 223983A1, WO2022 / 223982A1, WO2022 / 22398 1A1, WO2022 / 223980A1, WO2022 / 223979A1, WO2022 / 223978A1, PCT / GB2023 / 052464, PCT / GB2023 / 052467, PCT / GB2023 / 052469, PCT / GB2023 / 052470, PCT / GB2023 / 052693, GB2305009.9, GB2314379.5, GB2314382.9, GB2314381.1 and PCT / GB2023 / 052465. In particular, the chemistry of the present invention may be used with the catheter assemblies or components thereof disclosed in the examples and drawings of the above-mentioned applications, or with any other device / technology set forth in the statements, examples and / or claims of the above-mentioned applications.

[0354] Catheters, kits, and components thereof sold under the ConvaTec GentleCath (RTM) product line, including catheter kits sold under the GentleCath (RTM) Glide and GentleCath (RTM) Glide hydrophilic lines (including elongated packaging containing the catheter and a burstable bag containing a wetting agent), can be used in the kits of the first aspect of the invention and / or the methods of the second aspect of the invention. In particular, the chemistries of the present invention can be used with catheters, kits, and components thereof sold under the GentleCath (RTM) line. For example, the media of the present invention can be used as a wetting agent with catheter kits sold under the GentleCath (RTM) Glide and GentleCath (RTM) Glide hydrophilic lines.

[0355] The flip-top catheter packages or components thereof disclosed in European Patent Application 3445436 and U.S. Patents Nos. 10,561,817, 11,534,573, and 11,103,676 to Hollister, the entire contents of which are incorporated herein by reference, may be used in the kit of the first aspect of the present invention and / or the method of the second aspect of the present invention. In particular, the chemistry of the present invention may be used with the flip-top catheter packages or components thereof disclosed in the examples and figures of the aforementioned applications and patents, or with any other device / technique set forth in the statements, examples, and / or claims of the aforementioned applications and patents.

[0356] Catheters, kits, and components thereof sold by Coloplast Ltd. under the SpeediCath (RTM) product line (including catheter kits sold under the SpeediCath (RTM) standard line (including an elongated package containing a catheter and a burstable bag containing a wetting agent, or including a package containing a catheter in direct contact with a wetting agent)) can be used in the kit of the first aspect of the invention and / or the method of the second aspect of the invention. In particular, the chemical substances of the present invention can be used with catheters, kits, and components thereof sold under the SpeediCath (RTM) line. For example, the media of the present invention can be used as a wetting agent with catheter kits sold under the SpeediCath (RTM) standard line. BRIEF DESCRIPTION OF THE DRAWINGS

[0357] In order that the present invention may be more clearly understood, embodiments of the invention will now be described, by way of example only, with reference to the accompanying drawings, in which:

[0358] Figure 1 is a front view of one embodiment of a reusable urinary catheter kit of the present invention showing the resealable container in its sealed configuration.

[0359] Figure 2 yes Figure 1 Front view of a reusable urinary catheter kit showing the resealable container in an open configuration. DETAILED DESCRIPTION

[0360] Reusable urinary catheter kit

[0361] Figure 1 and 2One embodiment of a reusable urinary catheter kit of the present invention is shown. The kit includes a resealable container 1 in the form of a catheter bag 1. The bag 1 defines an internal cavity 2 that is configured to accommodate a urinary catheter 3. The urinary catheter 3 is an intermittent catheter 3 that includes a hollow polymer tubular body that includes a base polymer formed from a thermoplastic elastomer material and also includes an amphiphilic additive. The bag 1 is also filled with a medium 4 that includes at least one chlorine-containing substance—in this example, the medium 4 includes sodium hypochlorite and sodium chloride. The bag 1 also includes a resealable opening 5 formed at the edge of the bag 1 that allows the bag 1 to be opened and closed repeatedly. The resealable opening 5 includes a resealable opening mechanism in the form of a press-seal closure. Such resealable opening mechanisms are known to those skilled in the art, who will also understand that in various other embodiments, a range of alternative opening mechanisms may be employed.

[0362] like Figure 1 As shown, in the sealed configuration of the bag 1, the resealable opening 5 is in its sealed configuration. The conduit 3 is contained within the interior cavity 2 of the bag 1 and is completely immersed in the medium 4 within the bag 1. Both the outer surface and the inner surface (not shown) of the conduit 3 are in direct contact with the medium 4 along the entire length of the conduit 3. In various other embodiments, the medium 4 can be contained in a separate medium container, which can be configured to release the medium 4 into the interior cavity 2 of the bag before or when the bag is opened for the first time, so that the conduit 3 is in direct contact with the medium 4.

[0363] like Figure 2 As shown, during use, the user opens the bag 1 at the resealable opening 5 and removes the catheter 3 from the bag 1 through the resealable opening 5. The catheter 3 is then used in a conventional manner, without the need to rinse the catheter 3 after removal from the medium 4 and before use. After use, the catheter 3 is simply reinserted into the bag 1 through the resealable opening 5, thereby re-immersing the catheter 3 in the medium 4, and the bag 1 is resealed at the resealable opening 5. After use of the catheter 3, no rinsing / washing step is required, as reinserting the catheter 3 into the medium 4 effectively sterilizes the catheter 3. However, based on personal preference, the user may also rinse / wash the catheter 3 after use.

[0364] The catheter 3 is then reused simply by removing it from the resealable bag 1 as described above and reusing it. Again, no further flushing / washing steps are required.

[0365] The catheter 3 was reused in this manner for 24 hours without additional cleaning / flushing steps or replacement / replenishment of the medium 4 in the bag. Even after this extended period, and even without changing the medium, the lubricity of the catheter remained excellent. The medium also provided excellent antimicrobial properties and overall catheter sterility. These variables were evaluated using the following laboratory tests.

[0366] Example 1 - Lubrication of catheter using sodium hypochlorite and sodium chloride solutions (no solution replenishment)

[0367] Water is added to the empty catheter storage container at room temperature. Thereafter, the tablet containing sodium hypochlorite and sodium chloride is dissolved in the water to provide the medium of the present invention containing sodium hypochlorite and sodium chloride.

[0368] The catheters were immersed in an aqueous / water solution containing sodium hypochlorite and sodium chloride as described above in Example 1. The catheters were immersed in the solution for different times (2 hours, 4 hours, 6 hours, 8 hours and 24 hours) before being tested for their lubricity by measuring their coefficient of friction (COF).

[0369] One set of samples was tested immediately after removal from the aqueous solution. A second set of samples included a step of rinsing the catheters with water to remove any residual aqueous solution prior to COF testing. A control group was also included, in which the catheters were immersed in pure water instead of the aqueous solution.

[0370] The sample size for each group of samples was n = 10. Combined COF data for all time points were generated.

[0371] The COF values for catheters immersed in the sodium hypochlorite / sodium chloride solution were lower and well within the acceptable range for intermittent catheters with lubricious coatings. Furthermore, the results showed that storage in the sodium hypochlorite / sodium chloride solution after removal without a flushing step provided the best catheter lubricity.

[0372] Example 2 - Catheter Sterilization Using Sodium Hypochlorite and Sodium Chloride Solutions

[0373] To evaluate the sterilization potential of media containing chlorine-containing substances, a microbiological evaluation was conducted, including evaluation of kill rates against repeated inoculations of Escherichia coli and Enterococcus faecalis. These microorganisms were selected because they are commonly identified in catheter-associated urinary tract infections. The selection also included both Gram-positive and Gram-negative species to test the media's broad-spectrum antimicrobial properties.

[0374] The intermittent urinary catheter used in Example 1 was provided and immersed in an aqueous medium containing sodium hypochlorite and sodium chloride. The medium containing the catheter was inoculated with two microorganisms.

[0375] A direct inoculation method was used for each microorganism. The test bacteria / test organism was re-inoculated after 1, 2, 3, 4, 5, 6, and 24 hours. After each inoculation, samples were taken 5 seconds, 1 minute, 5 minutes, 10 minutes, and 15 minutes to assess the kill rate.

[0376] Rapid killing of E. coli and E. faecalis was observed within 3 hours and 2 hours, respectively. In the case of E. coli, considerable efficacy was also observed 15 minutes after inoculation for samples collected up to 6 hours after the catheter was initially immersed in the medium.

[0377] Overall, the results demonstrated the excellent antimicrobial activity and bactericidal potential of the medium. Furthermore, the results showed that the medium provided significant antimicrobial activity even up to several hours after the initial contact of the catheter with the medium.

[0378] Example 3 - Using Hypochlorous Acid to Lubricate a Catheter

[0379] A lubricity evaluation similar to that of Example 1 was performed, however, using an aqueous hypochlorous acid solution as the medium in which the catheter was immersed between COF tests.

[0380] Similar results were observed as in Example 1, with the COF values obtained being well within the acceptable range for intermittent catheters with lubricious coatings.

[0381] Overall, the performance in these tests demonstrates the lubricity-enhancing effect of the hypochlorous acid-containing media of the present invention, which is effective even after extended periods of time and without the need for replenishment of the media between runs.

[0382] Example 4 - Using Chlorine Dioxide to Lubricate Catheters

[0383] A lubricity evaluation similar to that of Example 3 was performed, however, using an aqueous chlorine dioxide solution as the medium in which the catheter was immersed between COF tests.

[0384] Similar results as in Example 3 were observed.

[0385] Overall, the performance in these tests demonstrated the enhanced lubricity of the chlorine dioxide-containing media, which remained effective even after extended periods and without the need for replenishment of the media between runs.

[0386] Example 5 - Catheter Sterilization Using Hypochlorous Acid

[0387] Microbiological evaluation was performed using a medium according to the present invention containing hypochlorous acid in a manner similar to Example 2. However, for this test, samples were taken only 5 seconds after each inoculation to assess the kill rate. In addition, in addition to the previously tested microorganisms, another Gram-positive microorganism, Staphylococcus aureus, was also tested.

[0388] The results demonstrated excellent antimicrobial activity, with rapid killing observed in just 5 seconds after inoculation of Staphylococcus aureus and Enterococcus faecalis for 6 hours and Escherichia coli for 24 hours.

[0389] To further evaluate the antimicrobial activity, the test was repeated using the same inoculation frequency, but sampling was performed 5 minutes after the second inoculation at 24 hours. Even for the most challenging organism, Enterococcus faecalis, a reduction of more than 3 orders of magnitude in microbial colony forming unit (CFU) counts was observed 5 minutes after inoculation.

[0390] Overall, the results indicate that the hypochlorous acid medium possesses excellent antimicrobial activity and bactericidal potential.

[0391] Example 6 - Catheter Sterilization Using Chlorine Dioxide

[0392] In a manner similar to Example 5, microbiological evaluations were performed using a medium containing chlorine dioxide.

[0393] The results demonstrated excellent antimicrobial activity, with rapid killing again observed in just 5 seconds after inoculation of S. aureus and E. faecalis for up to 6 hours and E. coli for up to 24 hours.

[0394] To further evaluate antimicrobial activity, the test was repeated using the same inoculation frequency, but sampling was performed 5 minutes after the second inoculation at 24 hours. For the most challenging organism, Enterococcus faecalis, a 4-log reduction in microbial colony forming unit (CFU) counts was observed approximately 30 seconds after inoculation.

[0395] Overall, the results demonstrated the excellent antimicrobial activity and bactericidal potential of the chlorine dioxide medium.

[0396] Example 7 - Effect of Hypochlorous Acid Concentration on Sterilization Potential

[0397] The effect of the concentration of hypochlorous acid in the medium on the bactericidal potential was tested. Aqueous media were provided with hypochlorous acid concentrations of 250 ppm, 675 ppm, 1000 ppm and 2000 ppm.

[0398] Microbiological evaluation was performed using a medium containing hypochlorous acid in a manner similar to Example 2. However, for this test, samples were taken after 5 seconds, 30 seconds, 1 minute, 2 minutes, and 5 minutes after each inoculation to assess the kill rate.

[0399] After sampling for 5 minutes, effective killing was found for 24 hours for each hypochlorous acid concentration tested and for both challenge microorganisms, E. coli and Enterococcus faecalis.

[0400] For hypochlorous acid at a concentration of only 675 ppm, effective killing of both organisms was observed for up to 24 hours after sampling 30 seconds later.

[0401] For E. coli, when only the 250 ppm hypochlorous acid solution was used, efficient killing was observed at all time periods up to 5 hours after inoculation. For concentrations of 675 ppm and above, efficient killing was observed at all time periods up to 24 hours after inoculation.

[0402] For the more challenging organism, Enterococcus faecalis, when only 250ppm hypochlorous acid solution was used, efficient killing was observed for up to 4 hours in all time periods after inoculation. Using the 250ppm solution, efficient killing was observed for up to 5 hours just 30 seconds after inoculation. At 675ppm, efficient killing was observed for up to 6 hours in all time periods after inoculation, and efficient killing was observed for up to 24 hours starting from just 30 seconds after inoculation. At 1000ppm, efficient killing was observed for up to 24 hours in all time periods after inoculation.

[0403] Overall, the results indicate that, although the antimicrobial activity of the media showed dependence on the active ingredient concentration, it exhibited excellent performance even at very low concentrations and after prolonged periods of time.

[0404] Example 8 - Effect of Very Low Hypochlorous Acid Concentrations on Bactericidal Potential

[0405] The antimicrobial efficacy of hypochlorous acid was tested at even lower concentrations (10 ppm, 25 ppm, and 50 ppm) against the challenging organism Escherichia coli NCIMB 14067.

[0406] A representative colony of E. coli NCIMB 14067 was dispersed in maximum recovery diluent (MRD) to obtain a volume equivalent to approximately 1 × 10 6 Optical density (OD) of CFU / mL 540nm ). Perform a quantitative plate count on this suspension to determine the total number of viable organisms inoculated. Prepare a new suspension for each test concentration.

[0407] The 1000 ppm hypochlorous acid solution was diluted in sterile deionized water to provide 10 ppm, 25 ppm, and 50 ppm hypochlorous acid solutions, respectively.

[0408] Aliquot the hypochlorous acid sample into 9 mL volumes, add 1 mL of the challenge organism suspension and mix (the final number of bacteria present is now approximately 1 × 10 5 CFU / mL). After 5 seconds, 30 seconds, 1 minute, 2 minutes, and 5 minutes, a volume of 100 μL was sampled and transferred to 0.9 mL and 9.9 mL Dey-Engley Neutralising Broth (DENB) (to provide a dilution of 1:10 and 1:100, respectively), and a total viable count was performed to determine the amount present. The plates were air-dried before being inverted and incubated at 35±3°C for at least 48 hours. A negative control was also tested in which 1 mL of the challenge organism suspension was added to 9 mL of MRD and tested as described above. After the incubation period, the number of CFU was counted for the most appropriate dilution of each sample, i.e., 25-250 CFU / plate.

[0409] Results for each concentration of hypochlorous acid solution against E. coli NCIMB 14067 showed that 25 ppm and 50 ppm hypochlorous acid solutions resulted in undetectable numbers of bacteria after 30 seconds. The 10 ppm hypochlorous acid solution did show some minor bacterial recovery at 30 seconds (reaching slightly above 10 CFU / mL), but this decreased to undetectable levels by the 1 minute time point. Bacterial recovery in the negative control (MRD control) remained constant throughout the assay, with CFU / mL four orders of magnitude higher than that of the hypochlorous acid samples at all concentrations and time points tested.

[0410] Overall, all solutions demonstrated rapid antimicrobial activity against the challenging organism Escherichia coli NCIMB 14067, despite using very low concentrations of hypochlorous acid.

[0411] Example 9 - Antimicrobial Efficacy of Sulfonamides (Comparative Compound - Not of the Invention)

[0412] For comparison with the media of the present invention, the bactericidal potential of known antimicrobial agents was investigated.

[0413] The antimicrobial activity of sulfonamides in an intermittent urinary catheterization setting was evaluated using an in vitro direct inoculation assay against Gram-positive Escherichia coli NCIMB 14067 and Gram-negative Enterococcus faecalis NCTC 12201, two microorganisms associated with urinary tract infections. Sulfonamide concentrations of 0.1% and 0.01% were tested, and bacterial levels were monitored over a 5-minute period.

[0414] A representative colony of the challenge microorganism from the 18-24 h challenge plate was dispersed in MRD to obtain the equivalent of approximately 1 × 10 8 Optical density (OD) of CFU / mL 540nm ). Dilute it to obtain 1×106 The working concentration is CFU / mL. Perform quantitative counts to confirm the inoculum level.

[0415] The challenge bioparticles were prepared in MRD to approximately 1 × 10 6 The concentration of CFU / mL was calculated. A 1 mL volume of this suspension was added to 9 mL of sample (n=3 per sample, n=2 per control) in a sterile 30 mL universal container and pipetted up and down to mix. After each test period, 5 seconds, 30 seconds, 1 minute, 2 minutes, and 5 minutes, 100 μL of the test solution was transferred to 0.9 mL and 9.9 mL volumes of DENB (1:10 and 1:100 dilutions, respectively). The most appropriate dilution (100 μL) was inoculated onto duplicate pre-dried (tryptone soy agar) TSA plates and the inoculum was spread using a separate sterile L-shaped spreader (for 10 -1 and 10 -2 For each dilution, 0.5 mL was plated in duplicate. TSA plates were dried before inversion and incubated at 35 ± 3°C for at least 48 hours. Following the incubation period, bacterial colonies were counted at the most appropriate dilution for each dressing type (i.e., 25-250 CFU / plate).

[0416] The samples tested were: 0.1% sulfanilamide in sterile deionized water (SDW); 0.01% sulfanilamide in SDW; 100 ppm hypochlorous acid in SDW; and an SDW control.

[0417] When compared to the control at any time point tested, there was no reduction in the challenge organism counts of E. coli NCIMB 14067 or Enterococcus faecalis NCTC 12201 when sulfonamide was added (at both tested concentrations). In contrast, when tested, the 100 ppm hypochlorous acid solution resulted in undetectable counts of both challenge organisms within the shortest time point of 5 seconds, and these undetectable counts were then observed for the remainder of the test period.

[0418] in conclusion

[0419] In summary, the above experiments show that the arrangement of the present invention facilitates simple and safe catheter reuse.

[0420] The medium comprising a chloride-containing substance allows for efficient catheter lubrication and sterilization in a single step by simply contacting the catheter with the medium, such as by immersing the catheter in the medium. The medium also provides long-term sterilization and / or lubrication, allowing the catheter to be safely reused repeatedly for relatively long periods of time without requiring excessively frequent resterilization and / or relubrication, or requiring frequent changes of the medium.

[0421] Thus, this arrangement allows the catheter to be removed from the resealable container for use and then sterilized / lubricated after use by simply reinserting the catheter into the container and contacting the catheter with the medium containing the chlorine-containing substance in the container. The catheter can then be simply removed from the container again for the next use without requiring any additional sterilization / lubrication steps.

[0422] The inventors have shown that this reuse / sterilization cycle can be repeated multiple times with a single catheter. They have also shown that even if the medium in the container is not changed within 24 hours, the catheter can be effectively sterilized and made safe for use simply by contacting the catheter with the medium.

[0423] The above embodiments are described by way of example only. Many variations are possible without departing from the scope of the present invention as defined in the appended claims.

Claims

1. A reusable urinary catheter kit comprising a container containing: a urinary catheter; and a medium containing at least one chlorine-containing substance, wherein the container is resealable.

2. The reusable urinary catheter kit according to claim 1, wherein The urinary catheter is an intermittent urinary catheter.

3. A reusable urinary catheter kit according to any one of the preceding claims, wherein: The urinary catheter further comprises at least one additive, preferably at least one amphiphilic additive, wherein the amphiphilic additive is preferably a polymer or an oligomer.

4. The reusable urinary catheter kit according to claim 3, wherein: The amphiphilic additive is an amphiphilic AB block copolymer comprising a hydrophobic hydrocarbon A block and a hydrophilic B block.

5. The reusable urinary catheter kit according to claim 4, wherein: The amphiphilic additive is an AB block copolymer comprising an A block and a hydrophilic B block, wherein the A block comprises a structure of the formula CH3CH2(CH2CH2) a wherein "a" is 5-25, and preferably 9-25.

6. The reusable urinary catheter kit according to claim 4 or 5, wherein: The B-block is a hydrophilic oligomer comprising 2 to 10 monomer units, optionally derived from monomers selected from the group consisting of alkylene oxides, alkylene glycols, epihalohydrins, unsaturated carboxylic acids, alkyleneimines, lactones, vinyl alcohols, and vinyl alkanoates.

7. A reusable urinary catheter kit according to any one of the preceding claims, wherein The urinary catheter comprises a hollow polymeric tubular body comprising a base polymer independently selected from the group consisting of polyolefins, polyesters, polyacrylates, polyamides, thermoplastic elastomeric materials, polyether block amides, thermoplastic vulcanizates, thermoplastic copolyesters, thermoplastic polyamides, fluororubbers, water-disintegrable or enzyme-hydrolyzable materials, and combinations, blends or copolymers of any of the above materials, and wherein the base polymer preferably comprises a polymer independently selected from the group consisting of polyolefins, polyvinyl chloride, polyurethanes, styrene-butadiene copolymers (SBC), styrene-ethylene-butylene-styrene copolymers (SEBS), thermoplastic elastomeric materials, and combinations, blends or copolymers of any of the above materials.

8. A reusable urinary catheter kit according to any one of the preceding claims, wherein The medium comprises at least one chlorine-containing substance independently selected from the group consisting of hypochlorous acid, at least one hypochlorite, chlorine dioxide, molecular chlorine, dichloroisocyanurate, chlorazolidinone, dichlorodimethylhydantoin, chloroxylenol, chlorhexidine, and combinations thereof.

9. The reusable urinary catheter kit according to claim 8, wherein: The medium comprises at least one chlorine-containing species independently selected from the group consisting of hypochlorous acid, at least one hypochlorite salt, chlorine dioxide, and combinations thereof.

10. The reusable urinary catheter kit according to claim 9, wherein The medium comprises one or more of the following: chlorine dioxide, hypochlorous acid, and at least one hypochlorite salt at a total combined concentration in the range of 1-100 ppm.

11. The reusable urinary catheter kit according to claim 9 or 10, wherein: The medium contains at least one chlorine-containing substance comprising hypochlorous acid and at least one further chlorine-containing substance.

12. The reusable urinary catheter kit according to claim 11, wherein The medium comprises hypochlorous acid and at least one hypochlorite.

13. The reusable urinary catheter kit according to any one of claims 9 to 12, wherein: The medium contains at least one chlorine-containing substance including hypochlorous acid and / or chlorine dioxide.

14. The reusable urinary catheter kit according to any one of claims 9 to 13, wherein The medium comprises molecular chlorine and at least one of: hypochlorous acid and a hypochlorite.

15. A reusable urinary catheter kit according to any one of the preceding claims, wherein The medium contains at least one chlorine-containing species in a total concentration in the medium in the range of 0.005-0.6 wt.%.

16. A reusable urinary catheter kit according to any one of the preceding claims, wherein The medium comprises at least one alkali metal halide salt, preferably sodium chloride, and preferably sodium chloride and at least one of: hypochlorous acid and a hypochlorite.

17. The reusable urinary catheter kit according to claim 16, wherein: The medium comprises at least one hypochlorite and further comprises at least one alkali metal halide salt, preferably sodium chloride, wherein the ratio of the total concentration of the at least one alkali metal halide salt to the at least one hypochlorite in the medium is in the range of 10-20.

18. A reusable urinary catheter kit according to any one of the preceding claims, wherein The medium comprises a base, preferably sodium hydroxide, and the medium preferably comprises at least one base, preferably sodium hydroxide and at least one of: hypochlorous acid and a hypochlorite.

19. A reusable urinary catheter kit according to any one of the preceding claims, wherein The medium is present in the form of a solution, preferably an aqueous solution.

20. A reusable urinary catheter kit according to any one of the preceding claims, wherein The medium is in the form of a liquid having a viscosity in the range of 0.5-5000 cP.

21. A reusable urinary catheter kit according to any one of the preceding claims, wherein The pH value of the medium is in the range of 2 to 14.

22. A reusable urinary catheter kit according to any one of the preceding claims, wherein The medium is in direct contact with the urinary catheter, preferably with at least one surface of the urinary catheter, wherein preferably the urinary catheter is immersed in the medium.

23. A reusable urinary catheter kit according to any one of the preceding claims, wherein The medium is contained in a separate container located in the container and is not in direct contact with the urinary catheter, wherein preferably the separate container is rupturable or puncturable during use to release the contained medium from the separate container and allow the medium to be in direct contact with the urinary catheter.

24. A method for sterilizing and / or lubricating a reusable urinary catheter, the method comprising the steps of: a. providing a resealable container in its sealed configuration, said container comprising a urinary catheter, and further providing a medium comprising at least one chlorine-containing substance; b. Remove the seal of the container; c. removing the catheter from the unsealed container; d. performing catheterization using the catheter; e. reinserting the catheter into the container and contacting the catheter with the medium containing at least one chlorine-containing substance in the container; and f. Reseal the container.

25. The method according to claim 24, wherein In step (a) of the method, the medium is contained in the container.

26. The method according to claim 24, wherein The method further comprises the step of adding the medium to the container after step (b) and before reinserting the urinary catheter into the container in step (e).

27. The method according to claim 24, wherein The method further comprises the step of adding the medium to the container after reinserting the urinary catheter into the container in step (e).

28. The method according to any one of claims 24 to 27, wherein Step (e) comprises contacting at least one surface of the urinary catheter with the medium, preferably contacting at least the outer surface of the urinary catheter with the medium.

29. The method according to any one of claims 24 to 28, wherein The method further comprises repeating steps (b) to (f) for each subsequent use of the urinary catheter.

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