Urethral catheter products with increased lubricity

The urethral catheter with rounded edges and a hydration medium in the lumen addresses the challenge of maintaining lubricity, ensuring smooth insertion and removal by continuously hydrating the hydrophilic coating.

JP2026522812APending Publication Date: 2026-07-09HOLLISTER INCORPORAED
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Patent Information

Application Number
JP2025564611
Authority / Receiving Office
JP · JP
Patent Type
Applications
Current Assignee / Owner
Priority Date
2023-05-09
Filing Date
2024-05-01
Publication Date
2026-07-09

AI Technical Summary

Technical Problem

Existing urethral catheters with hydrophilic coatings face challenges in maintaining lubricity during packaging and use, leading to potential dry-out and increased discomfort during insertion.

Method used

A urethral catheter design with rounded hole edges and a hydrophilic coating, combined with a hydration medium in the lumen, ensures continuous hydration of the coating, enhancing lubricity and reducing discomfort.

Benefits of technology

The design maintains lubricity by continuously hydrating the hydrophilic coating, facilitating easy insertion and removal with minimal resistance and discomfort.

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Abstract

A catheter product comprising a catheter (10) having a small hole (20a, 20b, 22a, 22b) with at least one rounded edge and a hydrophilic coating (24) on the outer surface (18) of the catheter lumen and the rounded edge of at least one small hole, a package (150), and a hydration medium (130).
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Description

Technical Field

[0001] Cross - reference to Related Applications This application claims the benefit of U.S. Provisional Patent Application No. 63 / 465,019, filed on May 9, 2023, the disclosure of which is incorporated herein by reference in its entirety.

[0002] The present disclosure relates to a urinary catheter product comprising a urinary catheter having a small hole with a rounded edge at a proximal insertion end portion of a catheter tube. More specifically, the present disclosure relates to a urinary catheter product comprising a urinary catheter including a hydrophilic coating on an outer surface and a rounded edge of a small hole of the catheter tube, and even more specifically, to a catheter product having a residual moisture replenishment medium on an inner surface of the catheter tube that provides moisture to the hydrophilic coating of the rounded small hole.

Background Art

[0003] An intermittent urinary catheter includes a catheter shaft or tube having a proximal insertion end portion that is inserted into the bladder through the urethra. When in the bladder, urine enters the catheter through one or more openings or small holes. The urine enters the openings and is discharged through a drainage lumen of the catheter tube from a distal drainage opening at a distal end portion of the catheter shaft.

[0004] The surface of the catheter can be coated with a moisture replenishment medium, such as water, a hydrophilic coating that becomes slippery when in contact with water, to facilitate insertion of the catheter into the urethra. The slippery nature of such materials allows insertion (and subsequent removal) of the catheter to be achieved with minimal resistance, thereby reducing discomfort and the potential for injury.

[0005] Urethral catheters with a smooth, hydrophilic coating are typically packaged with a hydration or wetting medium, such as water or an aqueous solution. These urethral catheters may be packaged so that the hydration medium is free within the package and in free contact with the catheter, or so that the fluid comes into contact with the catheter only immediately before insertion into the body cavity.

[0006] While the use of smooth, hydrophilic coatings on catheters with packaged hydration media is becoming more common, preparing a smooth coating that remains smooth and does not dry out within the package remains challenging. [Overview of the Initiative] [Problems that the invention aims to solve]

[0007] Therefore, a urethral catheter is needed that has increased lubricity during use, is packaged, and has a hydrophilic coating and a hydration medium. [Means for solving the problem]

[0008] In a first embodiment, the urethral catheter product includes a package comprising an intermittent urethral catheter and a hydration medium. The intermittent urethral catheter comprises a catheter tube having an inner surface defining a lumen for draining urine, and a catheter tube having a proximal insertion end portion for advancing through the urethra into the bladder. The intermittent urethral catheter further comprises at least one hole located at the proximal insertion end portion of the catheter tube and communicating with the lumen. The at least one hole has a defined transition between the outer surface of the catheter tube and the surface of the catheter tube wall defining the at least one hole. The outer surface of the catheter tube and the transition of the at least one hole are hydrophilic coatings. The hydration medium is in the catheter lumen of the proximal insertion end portion of the catheter tube, forms a residual coating on the inner surface of the catheter tube, and is in contact with the hydrophilic coating of the transition of the at least one hole. [Brief explanation of the drawing]

[0009] [Figure 1] This is a perspective view of a prior art urethral catheter. [Figure 2] This is a magnified cross-sectional view of the proximal insertion end of a urethral catheter according to an exemplary embodiment of the present disclosure. [Figure 3] Figure 2 is an enlarged cross-sectional view of a portion of the catheter wall of a urethral catheter. [Figure 4] This is a front view of a urethral catheter product of an exemplary embodiment of the present disclosure. [Figure 5] This is a perspective view of a urethral catheter product according to an exemplary embodiment of the present disclosure. [Figure 6] This is a front view of a urethral catheter product of an exemplary embodiment of the present disclosure. [Figure 7] This is a cross-sectional view of the proximal insertion end of a urethral catheter according to an exemplary embodiment of the present disclosure. [Figure 8] This is a cross-sectional view of the proximal insertion end of a urethral catheter according to an exemplary embodiment of the present disclosure. [Figure 9] This graph shows viscosity data for competing hydration media. [Modes for carrying out the invention]

[0010] While the subject matter of this disclosure is susceptible to various forms of embodiment, preferred embodiments of the invention are described below with the understanding that this disclosure is illustrative and not intended to limit the disclosure to any particular embodiment illustrated. The words "a" or "an" are to be interpreted as including both singular and plural. Conversely, references to plural items include the singular, where appropriate.

[0011] Methods to increase lubrication may include altering the shape of the holes, such as rounding the edges of the holes or coating the edges of the holes with a hydrophilic coating. Additionally, methods of supplying moisture to a hydration medium and / or a hydrophilic coated catheter may increase lubrication during insertion.

[0012] This disclosure relates to a urethral catheter product comprising an intermittent urethral catheter containing a hole having a rounded edge. The urethral catheter includes a smooth hydrophilic coating disposed on the outer surface of the catheter tube or shaft and the rounded edge of the hole. The urethral catheter product further includes a package comprising the urethral catheter and a hydration medium that contacts the hydrophilic coating to enhance the lubrication of the urethral catheter in order to facilitate insertion of the catheter into the urethra and reduce discomfort during insertion and removal of the catheter.

[0013] As a first component of a urethral catheter product, a urethral catheter includes a catheter tube or shaft having an insertable portion which is inserted through the urethra into the bladder and from which urine is drained. The catheter tube includes a proximal end portion which is inserted through the urethra and enters the bladder through the urethra. The proximal end portion may have a small hole or drainage hole that allows urine to be drained from the bladder and pass through into the catheter tube. The catheter tube also includes a distal end portion which may have an associated drainage element, such as a funnel, for draining urine into a collection container, such as a toilet or waste collection bag.

[0014] Figure 1 shows an example of prior art for an intermittent urethral catheter. The catheter C comprises a long catheter shaft or tube S having a proximal insertion end portion P and a distal end portion D. The proximal insertion end portion P includes a closed proximal terminal 100 suitable for insertion into the urethra. The proximal insertion end portion includes small holes or discharge holes E1 and E2 through which urine is received into the internal conduit or lumen of the catheter shaft S. The distal end portion D may include a distal opening that is in fluid communication with a discharge member F, such as a funnel, for fluid connection of the catheter C to a collection container, such as a collection bag, or for directing urine to a waste receptacle, such as a toilet.

[0015] The catheter includes a longitudinal axis A. The catheter is an elongated cylinder and has several surfaces that can be defined in relation to the arrangement of catheter holes. As shown in FIG. 1, there is a top surface 3 which is the surface of the first hole E1. There is also a second surface, or bottom surface 5, which is the surface of the second hole E2.

[0016] FIGS. 2-3 show enlarged portions of the proximal insertion part of the catheter tube 12 of the urethral catheter 10, which is part of the catheter product of the present disclosure. The non-illustrated part of the urethral catheter 10 may include any of the components of the prior art catheter of FIG. 1, including the distal end part. The proximal insertion part includes holes E1 and E2 which are open and communicate with the lumen 14 of the catheter tube 12. The lumen 14 is defined by the inner surface 16 of the catheter tube 12. Two holes are shown in a particular embodiment, but there may be at least one hole or three or more holes.

[0017] The most proximal hole (E1 in FIG. 2) may be located from about 2 mm to about 50 mm, or preferably from about 5 mm to about 40 mm, from the proximal end 100 of the catheter.

[0018] The holes in the embodiments disclosed herein can be formed in any suitable manner including, but not limited to, mechanical punching, thermoforming, ultrasonic cutting, laser cutting, forming during a forming process, etc. The discharge holes and holes in the embodiments disclosed herein are optionally arranged to maximize discharge capacity and efficiency.

[0019] In the illustrated embodiment, the holes E1, E2 have a substantially elliptical shape. However, in other embodiments, the holes may have other shapes, such as oval, circular, irregular, or polygonal. The holes may have any of the above-mentioned sizes. In alternative embodiments, the holes may have various sizes and shapes relative to each other.

[0020] The small holes E1, E2 function to drain urine from the bladder into the internal lumen of the catheter. Each of the small holes disclosed herein is an aperture or passageway that extends through the surface of the catheter wall 25 and includes an aperture or passageway bounded or defined by the surface of the catheter wall 25.

[0021] As shown in FIGS. 2 and 3, the edges or transitions 20a, 20b, 22a, and 22b of the small holes E1 and E2 between the outer surface 18 of the catheter tube and the surface of the catheter wall 25 can be rounded transitions or edges. For example, the transition of the small hole may be rounded between the outer surface 18 and the catheter wall 25 that defines the small hole. That is, the transition between the outer surface 18 and the catheter wall 25 can have a smooth transition with no or virtually no angle. This can be done during or by a process after the formation of the catheter small holes. In other embodiments, the small hole transitions between the outer surface 18 of the catheter tube and the wall 25 may be angled or chamfered.

[0022] The catheter 10 with the tube 12 includes an inner surface 16 and an outer surface 18. The outer surface 18 can be coated with a hydrophilic coating 24. As shown in FIG. 3, the hydrophilic coating 24 can extend from the outer surface 18 to the transitions 20a and 20b of the small hole E1 and the transitions 22a and 22b of the small hole E2 and, optionally, extend to contact or cover the inner surface 16 that defines the catheter lumen 14. The hydrophilic coating 24 can extend continuously across the outer surface, the transitions, and the inner surface.

[0023] A hydrophilic coating may include a hydrophilic polymer that can provide hydrophilicity to the coating and provide smoothness when the coating is moistened. The polymer may be synthetic, bio-derived, a blend of both, or a copolymer. Suitable hydrophilic polymers include, but are not limited to, poly(lactams), e.g., polyvinylpyrrolidone (PVP), polyurethanes, homo- and copolymers of acrylics and methacrylic acids, polyvinyl alcohols, polyvinyl ethers, maleic anhydride copolymers, polyesters, vinylamines, polyethyleneimines, polyethylene oxides, poly(carboxylic acids), polyamides, polyanhydrides, polyphosphazenes, cellulosic materials, e.g., methylcellulose, carboxymethylcellulose, hydroxymethylcellulose, and hydroxypropylcellulose, heparin, dextran, polysaccharides, e.g., chitosan, hyaluronic acid, alginic acid, gelatin, and chitin, polyesters, e.g., polylactic acid, polyglycolide, and polycaprolactone, polypeptides, e.g., collagen and fibrin.

[0024] In one embodiment, the hydrophilic polymer coating may include poly(lactam), such as polyvinylpyrrolidone (PVP), polyurethane, homo- and copolymers of acrylic and methacrylic acid, polyvinyl alcohol, polyvinyl ether, maleic anhydride copolymer, polyester, vinylamine, polyethyleneimine, or polyethylene oxide. Preferably, the hydrophilic polymer coating contains polyvinylpyrrolidone (PVP).

[0025] Hydrophilic coatings may also contain various additives, such as dispersants and stabilizers (surfactants or emulsifiers), antioxidants, photoinitiators and curing agents, such as UV curing agents.

[0026] Hydrophilic coatings can be applied by any preferred method. For example, hydrophilic coatings can be applied by dip coating, brushing, or spraying. After the coating is applied, it can be cured, for example, by UV curing.

[0027] The catheter product may also include a hydration medium or hydration fluid as shown in figures 30, 130, and 416 in the accompanying diagrams. The hydration medium may be a hydration liquid containing a liquid, such as water, in addition to various other components. For example, the hydration medium of this disclosure contains liquid water and optionally one or more of a surface tension reducer, a mucus, a deep eutectic liquid, an oil, and an osmotic pressure increaser. Optionally, the hydration medium may contain other additives and agents, such as polyols. Any of the hydration mediums disclosed herein may be used in a foamed or non-foamed state.

[0028] Optionally, the hydration medium may be foamed to produce a hydration foam or mousse that can be used to hydrate or moisten a device or product. The hydration foam may hydrate a hydrophilic material by direct contact with it. The hydration foam contains a certain mass of bubbles formed in or within the liquid. Additionally, the creation or formation of the hydration foam may occur at any of the various stages from manufacture to use, depending on the design and use of the medical device. Any of the hydration mediums disclosed herein may be foamed or formed to become foam, depending on the desired use, but the hydration mediums disclosed herein may also be used in a non-foamed state.

[0029] Optionally, the hydration medium may contain mucus. For example, the hydration medium may contain water and mucus, as well as other additives and agents. When a mucus containing a hydration medium is used, it can hydrate the hydrophilic material of a medical device and form a mucus layer on the hydrophilic material. For example, when the hydrophilic device is a hydrophilic coated urethral catheter, the hydration medium hydrates the hydrophilic coating and forms a mucus-containing layer on the hydrophilic coating. As disclosed in more detail below, the mucus layer may have thixotropic properties, being viscous under thick, stationary conditions, and then becoming less viscous and flowing when sheared or otherwise pressure is applied. That is, the hydration medium or layer formed therefrom may be semi-solid or gel-like, and may have more liquid states under stress. The mucus-containing hydration medium may be used in a foamed or non-foamed state.

[0030] Optionally, the hydration medium may contain a deep eutectic liquid. The deep eutectic liquid may be added to the hydration medium, and / or compounds added to the hydration medium interact to form a deep eutectic liquid. The hydration medium may contain water and a deep eutectic liquid, as well as other additives or agents. A deep eutectic liquid is a mixture or blend of two or more compounds, the melting point of which is substantially lower than the melting points of the individual compounds. The deep eutectic liquid is explained by intermolecular hydrogen bonding between compounds, resulting in a significant drop in melting point compared to that of the individual components, at a specific molar ratio. A deep eutectic liquid is typically liquid at room temperature (approximately 23°C). Hydration mediums containing a deep eutectic liquid can be used in a foaming or non-foaming state.

[0031] Optionally, the hydration medium may contain oil. For example, the hydration medium may contain water and oil, as well as other additives and activators. When an oil-containing hydration medium is used, it may hydrate the hydrophilic material of a medical device and form an oil-containing layer on the hydrophilic material. The oil-containing hydration medium may be used in a foamed or non-foamed state.

[0032] In one embodiment, the hydration medium optionally includes a thickener, such as a combination of a high molecular weight polysaccharide and a low molecular weight polyol. The high molecular weight polysaccharide may be xanthan gum. The low molecular weight polyol may be glycerol. In some alternative forms, the thickener includes a high molecular weight polysaccharide at a concentration of 0.1 to 0.5 wt.% of the hydration medium, combined with a low molecular weight polyol at a concentration of 1 to 5 wt.% of the hydration medium. The thickener may assist in the formation of mucus at the interface of the hydrated hydrophilic coating. In some alternative forms, the hydration medium optionally includes a dispersant. If a dispersant is included, it may be at a concentration of 0.01 wt.% to 2 wt.% of the hydration medium. The dispersant may be an anionic surfactant, such as sodium cocoyl methyl taurate.

[0033] The hydration medium may have a specific or desired viscosity. In one embodiment, the hydration medium has a viscosity of about 4 cP to about 7 cP at 25°C. In a preferred embodiment, the hydration medium has a viscosity of about 4.5 cP to about 6 cP at 25°C. The viscosity is determined using the cone-plate method at 25°C for 5 to 50 seconds. -1 It can be measured as a function of shear rate. The hydration medium has a pH of approximately 3.6 to approximately 8 and a concentration of approximately 40 to approximately 590 mOsm / dm 3 It has an osmotic pressure of approximately 3.8 to approximately 7.5 and approximately 300 to approximately 550 mOsm / dm 3 The osmotic pressure.

[0034] Urethral catheter products may also include packaging or wrapping. The packaging may be any suitable catheter packaging. The packaging may be single-layer or multi-layer and may consist of a single or multiple parts. In one embodiment, the packaging includes a sleeve.

[0035] Figures 4-5 show embodiments of a urethral catheter product comprising a catheter 110, for example, the illustrated catheter and a package 150 containing a hydration medium 130. The package may optionally also include a gripping aid, such as a tubular gripping portion positioned around the catheter shaft. Optionally, in any of the catheters disclosed herein, the distal end of the catheter may be connected to a collection bag. In such embodiments, the collection bag may be included in the package with the catheter.

[0036] The package 150 may be any suitable package for holding the device. For example, the package may be a tear-open package, such as one that is torn open from the side, or a peel-open package. In the illustrated embodiment, the package 150 includes a front sheet 114 and a rear sheet 115 (Figure 5). The front sheet 114 includes an inner surface 116 facing the rear sheet 115, an outer surface 117 facing the surrounding environment, a top edge 118, a bottom edge 119, and opposing first and second side edges 120 and 121. Referring to Figures 6 and 7, the rear sheet 115 includes an inner surface 122 facing the front sheet 114, an outer surface 128 facing the surrounding environment, a top edge 123, a bottom edge (not shown), and opposing first and second side edges 124 and 125.

[0037] The front sheet 114 and the rear sheet 115 may be made from a liquid and gas impermeable material. For example, the front and rear sheets 114 and 115 may be made from a polymer film and / or a metal film. In one embodiment, the material may be a polymer / metal laminate, for example, a polymer / aluminum laminate.

[0038] The front sheet 114 and the rear sheet 115 can be sealed to each other to define a cavity for holding the catheter 110. In one embodiment, the front sheet 114 and the rear sheet 115 can be sealed to each other to form an airtight cavity. In the illustrated embodiment, the front sheet 114 and the rear sheet 115 are sealed to each other by a peripheral seal 126. The peripheral seal 126 may be a heat seal, an adhesive seal, or any other preferred peelable seal that allows the front sheet 114 to be separated from the rear sheet 115 if the sheets are peeled off during use.

[0039] The catheter product 410 may also include a thin, flexible sleeve 442 (Figure 6) that covers at least a portion of the outer surface of the catheter 412. The sleeve 442 may be formed from any variety of thin, flexible polymer film materials, such as polyethylene, plasticized PVC, polypropylene, polyurethane, or hydrogel of an elastomer. The sleeve 442 may be permeable to liquids and / or vapors so as to allow liquids and / or vapors to pass through it to replenish the hydrophilic coating while the catheter is stored in the package. Alternatively, the sleeve 442 may contain a hydration medium 416 within the sleeve. In embodiments with the sleeve 442, the catheter product may also include a cap 444.

[0040] The assembly of the catheter product involves inserting the urethral catheter into the package and adding a hydration medium. The hydration medium can be added in any number of conventional ways, resulting in a sealed product in which the urethral catheter and hydration medium are packaged. The hydration medium can be added to the package in any known way such that the hydration medium comes into contact with the hydrophilic coating in the package. If a sleeve is used, the medium may be added to the sleeve and the catheter, and the sleeve may then be inserted into the package. In other embodiments, the hydration medium is added directly to the package.

[0041] Figure 7 shows the proximal insertion portion of the catheter lumen after the hydration medium 30 has been added to the catheter product packaging. As shown in Figure 7, a certain amount of hydration medium 30 is held within the catheter lumen, specifically at the proximal end 100 of the catheter tube 12. For example, a section of the lumen 14 of the catheter tube 12 between at least one small hole defines a reservoir 15 containing the hydration medium 30. During storage and normal handling (packaging, transport, etc.), the catheter assembly will move and / or bump during storage and transport and before use. This movement causes the hydration medium 30 to move within the packaging, including within the lumen 14 of the catheter tube 12. When the hydration medium is at a selected viscosity, it adheres to the inner surface 16 defining the catheter lumen 14, forming a layer or residual coating 30a on part of the hydrophilic coating. Additionally, the hydration medium enters the reservoir 15. Due to the viscosity and flow characteristics of the hydration medium 30, a certain amount of the hydration medium remains in the storage container and does not leave the container regardless of the orientation of the catheter tube 12 or the catheter product packaging.

[0042] Figure 8 shows the proximal insertion end portion of the urethral catheter 10 as a result of the package transfer, where the hydration medium forms a residual coating 30a on the inner surface 16 defining the catheter lumen 14. Due to the viscosity and composition of the fluid, the coating adheres to and contacts the hydrophilic coating. The residual coating 30a maintains the hydration of the hydrophilic coating 24 at the transition sections 20a, 20b, 22a, and 22b. Optionally, contact between the residual coating 30a of the hydration medium 30 and the hydrophilic coating 24 results in continuous hydration of the hydrophilic coating or maintains the hydration of the hydrophilic coating. This continuous hydration may result from a capillary effect in which the hydrophilic coating 24 draws the hydration medium from the residual coating 30a. This results in increased lubricity of the urethral catheter, facilitating insertion during use. [Examples]

[0043] The results of the comparative viscosity test are shown in Figure 9. The moisture replenishment media are represented by A to H, as shown in Table 1 below. The moisture replenishment media were prepared by adding 2-4 wt.% glycerol, 0.1-0.2 wt.% xanthan gum, and 0.2 wt.% sodium cocoyl methyl taurate to deionized water. Specifically, xanthan gum was moistened with glycerol to form a paste. The paste was added to water in a water tank and stirred until a homogeneous solution was obtained. Then, sodium cocoyl methyl taurate was added to the homogeneous solution and gently stirred to form the moisture replenishment media identified as "A" in Table 1.

[0044] The viscosity of hydration media A to H (Table 1 below) was measured using a Kinexus Rheometer (Model KNX2100). Viscosity was measured using the cone-plate method at 25°C for 5 to 50 seconds. -1 It was measured as a function of shear rate.

[0045] [Table 1]

[0046] The viscosity of the hydration medium A, which may be included in embodiments of the catheter product of this disclosure, is numerically low but has a clearly higher viscosity at 25°C than other competing hydration mediums shown in the graph of Figure 9. The viscosity is compared with the shear rate over time. The viscosity of hydration medium A decreases as the shear rate increases, indicating pseudoplastic behavior, i.e., viscosity decreases as the shear rate increases.

[0047] It should be understood that any changes and modifications to the preferred embodiments of the invention described herein will be obvious to those skilled in the art. Such changes and modifications may be made without departing from the spirit and scope of the invention disclosed herein.

Claims

1. A urethral catheter product including packaging, The package comprises a catheter tube having an inner surface defining a lumen for draining urine, and a catheter tube having a proximal insertion end portion for advancing through the urethra into the bladder, At least one small hole located in the proximal insertion end portion of the catheter tube and communicating with the lumen, the at least one small hole having a transition portion defined between the outer surface of the catheter tube and the surface of the wall of the catheter tube defining the at least one small hole, The hydrophilic coating on the outer surface of the catheter tube and the transition portion of the at least one small hole An intermittent urethral catheter including, A hydration medium in the lumen of the catheter, in the proximal insertion end portion tube of the catheter, wherein the hydration medium forms a residual coating on the inner surface of the catheter tube and contacts the hydrophilic coating of the transition portion of the at least one small hole. Products including urethral catheters.

2. The urethral catheter product according to claim 1, wherein the transition portion of the at least one small hole includes a rounded transition portion.

3. The urethral catheter product according to claim 1, wherein the transition portion of the at least one small hole includes an angle or a chamfered portion.

4. The urethral catheter product according to any one of claims 1 to 3, wherein the hydrophilic coating extends continuously from the outer surface of the catheter tube to the transition portion of the at least one small hole.

5. The urethral catheter product according to any one of claims 1 to 4, wherein the hydrophilic coating extends continuously from the outer surface of the catheter tube across the transition portion of the at least one small hole and onto the inner surface of the catheter tube.

6. The urethral catheter product according to any one of claims 1 to 5, wherein the moisture supply medium of the remaining coating comes into contact with the hydrophilic coating and provides continuous moisture supply to the hydrophilic coating.

7. The catheter tube includes a closed proximal end, The urethral catheter product according to any one of claims 1 to 5, wherein a portion of the lumen tube of the catheter between the at least one small hole and the closed proximal end defines a reservoir containing a certain amount of residual moisture replenishment medium.

8. The urethral catheter product according to claim 7, wherein a certain amount of residual moisture supply medium comes into contact with the hydrophilic coating.

9. The urethral catheter product according to any one of claims 1 to 8, wherein the hydration medium is a foam containing liquid and gas.

10. The aforementioned water supply medium has a viscosity of approximately 4 cP to approximately 7 cP and 5s at 25°C. -1 A urethral catheter product according to any one of claims 1 to 9, having a shear rate of [value missing].

11. The aforementioned water supply medium has a viscosity of approximately 4.5 cP to approximately 6 cP and 5s at 25°C. -1 A urethral catheter product according to any one of claims 1 to 10, having a shear rate of [value missing].

12. The urethral catheter product according to any one of claims 1 to 11, wherein the water supply medium is pseudoplastic.

13. The urethral catheter product according to any one of claims 1 to 12, wherein the at least one small hole comprises at least two small holes.

14. The urethral catheter product according to any one of claims 1 to 13, wherein the hydration medium comprises water and a polyol.

15. The urethral catheter product according to claim 14, wherein the polyol is glycerol.

16. The urethral catheter product according to any one of claims 1 to 15, wherein the aforementioned water supply medium contains polysaccharides.

17. The urethral catheter product according to claim 16, wherein the polysaccharide is xanthan gum.

18. The urethral catheter product according to any one of claims 1 to 17, wherein the aforementioned water supply medium includes a dispersant.

19. The urethral catheter product according to claim 18, wherein the dispersant is sodium cocoyl methyl taurate.

20. The urethral catheter product according to any one of claims 1 to 19, wherein the package includes a sleeve.

21. The urethral catheter product according to any one of claims 1 to 20, wherein the hydrophilic coating comprises polyvinylpyrrolidone.

22. The aforementioned water supply medium has a pH of approximately 3.6 to approximately 8 and a concentration of approximately 40 to approximately 590 mOsm / dm 3 A urethral catheter product according to any one of claims 1 to 21, having an osmotic pressure of the following:

23. The aforementioned water supply medium has a pH of approximately 3.8 to approximately 7.5 and a concentration of approximately 300 to approximately 550 mOsm / dm 3 A urethral catheter product according to any one of claims 1 to 22, having an osmotic pressure of the following: