Intermittent urinary catheter assembly with protective sleeve device

Abstract

The intermittent urinary catheter assembly includes a catheter (1) having a proximal insertion end (12) and a distal end opposite the proximal insertion end. The catheter has a lumen extending from a drainage opening (14) at or near the proximal insertion end to a drainage opening at or near the distal end. A protective sleeve device (2) is also provided, including a proximal retention portion (22), a distal retention portion (21), and a compressible sleeve (23) connected to the proximal and distal retention portions. The compressible sleeve has a compressed storage configuration and is expandable to an expanded configuration. The distal retention portion is connected to the catheter at or near the distal end, and the proximal and distal retention portions are releasably connected to each other.

Description

[Technical Field]

[0001] The present invention relates to an intermittent urinary catheter assembly including a protective sleeve device, the protective sleeve being compressible and deployable in a compressed storage configuration and expandable to an expanded configuration. [Background technology]

[0002] Urinary catheters are widely used for intermittent catheterization. In intermittent catheterization, a urinary catheter is inserted into the bladder, urine is drained, and the catheter is then immediately removed. The entire procedure takes only a few minutes and must usually be repeated many times a day. To reduce the risk of damage to the urethral wall, catheters are typically coated with a hydrophilic coating that imparts very low friction to the surface of the catheter. This coating is usually activated by applying a fluid medium (e.g., tap water or sterile water) to the coating. The coating can be maintained in an activated state during storage, providing a ready-to-use assembly, or it can be activated immediately before use, for example, by release of fluid from a separate compartment inside the package.

[0003] It is quite common for catheter users to experience urinary tract infections (UTIs). To reduce the risk of infection, urinary catheters as well as fluid media may be sterilized. Furthermore, the surface of the urinary catheter should preferably be kept uncontaminated prior to use.

[0004] To avoid contamination, it is known to provide insertion aids, protective sleeves, etc., which allow catheters to be handled and manipulated during preparation and insertion without the need to directly touch the insertable portion of the catheter. For example, commonly assigned US Pat. No. 9,884,167 discloses a tubular insertion aid placed over the connector portion of a catheter during storage. During use, the insertion aid can be released and moved up and down the catheter shaft for manipulation of the catheter in a no-touch manner. Another example is disclosed in WO 2010 / 006620, in which a sleeve is connected to and placed over the connector portion of a catheter. During storage, the sleeve is placed in a compressed state, but as soon as the package is opened and the catheter is removed, the sleeve expands to an expanded state, thereby covering all or most of the catheter shaft. Both of these known arrangements allow the user to hold the urinary catheter without the coating causing it to slip and without contaminating sterile surfaces.

[0005] However, known devices having protective sleeves and insertion aids are relatively complex and expensive to manufacture and can be cumbersome and difficult to use, especially for users with poor dexterity and impaired hand movement. Thus, there remains a need for improved protective measures that can provide the same or improved protection against contamination, which can be more easily and cost-effectively manufactured, and / or are easier and more intuitive to use and require less controlled hand movement. Summary of the Invention

[0006] It is therefore an object of the present invention to address the above-mentioned needs and to overcome or mitigate all or at least some of the above-mentioned problems. Specifically, it is an object of the present invention to provide an improved intermittent urinary catheter assembly that may be easier and more cost-effective to manufacture and / or that may be easier and more intuitive to use, require less manual control, and provide the same or improved protection against contamination.

[0007] This object is achieved by an intermittent urinary catheter assembly as defined in the appended claims.

[0008] According to one aspect of the present invention, there is provided an intermittent urinary catheter assembly comprising: a catheter having a proximal insertion end and a distal end opposite the proximal insertion end, wherein the catheter has a lumen extending from a drainage opening at or near the proximal insertion end to a drainage opening at or near the distal end; a protective sleeve device having a proximal retainer, a distal retainer, and a compressible sleeve connected to the proximal retainer and the distal retainer, wherein the compressible sleeve has a compressed storage configuration and is expandable to an expanded configuration; the distal retainer is connected to the catheter at or near its distal end, and the proximal and distal retainers are releasably connected to one another.

[0009] Because the distal and proximal retainers are releasably connected to one another, the sleeve will remain in its compressed storage position during storage and use of the catheter unless the distal and proximal retainers are actively separated. This is highly advantageous for a number of reasons. First, it ensures that the catheter shaft is accessible when placed in the packaging, for example, to wet the hydrophilic surface on the catheter shaft. Furthermore, the sleeve will not expand to the expanded configuration until the user desires expansion to occur and actively takes steps to separate the distal and proximal retainers. For example, a user may wish to activate the hydrophilic surface after removing the catheter from the packaging, such as to visually inspect the catheter shaft before insertion, and for that reason may wish to fully or partially remove the catheter from the packaging before expanding the sleeve. Some users may also prefer to handle the catheter without the sleeve, and for such users, the sleeve may be maintained in the compressed storage configuration during the entire catheterization procedure.

[0010] The protective sleeve device is used to cover the surface of the catheter before use so that the user can use it to hold the catheter, making it easier to handle and preventing surface contamination, which also reduces the risk of UTIs.

[0011] Furthermore, the releasably connected proximal and distal retainers can also be reconnected to one another if the user wishes to return the sleeve to its compressed storage position at a later stage. The proximal and distal retainers can be reconnectable by the same connection arrangement as originally used or through a different connection arrangement. However, non-reconnectable proximal and distal retainers can also be provided.

[0012] At the same time, expanding the sleeve is very simple and intuitive. For example, when the catheter is to be removed from the package, the user simply holds the proximal retainer, e.g., through the package in which the catheter is located. The user can remove the catheter, for example, by grasping and pulling the connector end of the catheter. By holding the proximal retainer at the same time, this will also automatically release the proximal retainer from the distal retainer, thereby expanding the sleeve.

[0013] Thus, handling of the catheter and protective sleeve device is simple and intuitive, even for users with poor dexterity or limited hand control.

[0014] The protective sleeve device can also be manufactured as a separate piece, with the proximal and distal portions connected together and the sleeve arranged in a compressed storage configuration, which can then be easily and cost-effectively assembled onto the catheter. For example, the connection can be achieved by a snap-lock arrangement, such as a snap fit, whereby the connection is achieved automatically when the protective sleeve device is pressed into place during assembly.

[0015] Because the protective sleeve device can be manufactured separately, it also allows the catheter to be manufactured in a conventional manner, making manufacturing cost-effective and simple, and without any risk of damaging, for example, hydrophilic coatings or the like provided on the catheter shaft. It also allows the catheter and protective sleeve device to be manufactured in one location or different locations, with optional assembly taking place at another location.

[0016] In this application, the term "proximal" is used to refer to the end or portion of a catheter that is inserted into the user's body, i.e., the end or portion of the catheter shaft that is closer to the user's body during use and / or that enters the user's body first during insertion. The term "distal" is used to refer to the end or portion of a catheter that is opposite the proximal end or portion and that is typically further from the user's body. For consistency, the terms "distal" and "proximal" are also used in the context of other components, such as protective sleeve devices and parts thereof, that are not intended for introduction into the user's body. For such other components, "proximal" refers to the end or portion that is closer to the proximal end of the catheter within the assembly, while "distal" refers to the end or portion that is opposite such proximal end or portion.

[0017] The distal retainer is preferably arranged with a continuous wall extending around the circumference of the catheter and may be realized, for example, as a short tube, the inner diameter of which preferably corresponds to the outer diameter of the proximal end of the funnel or connector portion of the catheter.

[0018] The proximal retainer is also preferably arranged with a continuous wall extending around the circumference of the catheter and may, for example, also be realized as a short tube. The inner diameter of the proximal retainer is preferably similar to or slightly larger than the outer diameter of the catheter shaft.

[0019] The distal and proximal retainers are both preferably made of a stiffer material than the sleeve. Additionally or alternatively, the proximal and distal retainers may both have a greater wall thickness than the sleeve. The compressible sleeve is preferably made of a flexible, foldable material. The relatively thicker and / or stiffer proximal retainer also provides stability to the protective sleeve device, even in the expanded configuration.

[0020] In one embodiment, the proximal retainer may be relatively stiff and rigid, making it difficult or impossible to squeeze to grasp the catheter shaft. In such an embodiment, grasping of the catheter shaft may be achieved through the more flexible sleeve. However, in other embodiments, the proximal retainer may also be somewhat flexible, but still be at least somewhat stiffer than the sleeve, thereby allowing the user to grasp the catheter shaft even through the proximal retainer. The user may squeeze the proximal retainer, for example, by using the thumb and one or both of the index and middle fingers. By applying moderate finger pressure, the catheter shaft may thereby be grasped and manipulated.

[0021] The catheter preferably includes a funnel connected to or integral with the distal end of the catheter shaft, the funnel defining the discharge opening, and the distal retainer connected to the funnel. The funnel may also be referred to as a connector.

[0022] The compressible sleeve is preferably extendable toward the proximal insertion end, and the compressible sleeve is positioned such that in its expanded configuration it covers a substantial portion of the catheter, and preferably more than 50% of the length of the catheter shaft, and more preferably at least 70% of the length of the catheter shaft, and most preferably at least 90% of the length of the catheter shaft.

[0023] The compressible sleeve may be folded into a compressed storage configuration, preferably with concertina or accordion-like folds to form an accordion or concertina-like pleated configuration, whereby the sleeve is folded in the storage configuration and the folds are straightened out in the extended use configuration. However, other methods of compressing the compressible sleeve are also feasible, such as rolling the sleeve material or simply lumping the material.

[0024] The compressible sleeve may have a length in its extended configuration similar to the length of the catheter shaft. In embodiments, the compressible sleeve may have a length that allows it to completely cover the catheter shaft in the extended configuration. However, alternatively, the compressible sleeve may have a length that is shorter than the catheter shaft, thereby leaving a preferably short portion of the catheter shaft toward the insertable proximal end exposed and uncovered by the protective sleeve device even when in the extended configuration.

[0025] The compressible sleeve may be extendable to a length of L-5 to L+5 cm, where L is the length of the catheter shaft. For female catheters, the length may be approximately 50 mm to 100 mm, and for male catheters, the length may be approximately 300 mm to 430 mm. The length of the compressible sleeve in its extended state should preferably be long enough to minimize the risk of contamination of any portion of the outer surface when touched. Generally, the greater the portion of the surface covered by the protective sleeve, the less risk of contamination if the surface accidentally comes into contact with an object, such as a sink or towel in the user's immediate vicinity.

[0026] The protective sleeve device may have an axial length in the compressed storage configuration in the range of 10 to 60 mm, preferably 15 to 50 mm, and more preferably 20 to 40 mm, such as approximately 20, 30, or 40 mm. Preferably, the axial length of the protective sleeve device when in the compressed configuration is small enough so that it does not extend over the coated portion of the urinary catheter. More preferably, the axial length of the protective sleeve device when in the compressed configuration is less than the uncoated portion of the urinary catheter. This facilitates wetting of the entire coated portion of the catheter shaft.

[0027] The maximum width of the compressible sleeve is preferably 1 to 15 mm larger than the diameter of the urinary catheter. The lower limit leaves enough room to surround the swollen coating of the catheter so that the coating is not obstructed by the protective sleeve. However, the catheter including the protective sleeve should not occupy too much space. Therefore, the protective sleeve should not be made larger than necessary relative to the catheter. Furthermore, a urinary catheter may be difficult to hold if the protective sleeve is too large, especially if the catheter is slippery due to the coating.

[0028] The compressible sleeve material can be a plastic foil, such as polyethylene (PE) or polypropylene (PP), or coated or uncoated paper. However, other materials are also feasible. The protective sleeve is primarily used to cover the surface of the intermittent urinary catheter immediately before use. As a result, the protective sleeve does not need to be impermeable for a long period of time. However, since moisture and contamination from the hands should be prevented from penetrating the protective sleeve, the protective sleeve preferably should not be too permeable. However, complete impermeability is not necessary, since it is only used while the urinary catheter is inserted, which usually takes only a few minutes. This means that many types of materials are suitable for this purpose, since the only requirement is that the material be foldable or otherwise compressible into a compressed state from which it can be relatively easily stretched.

[0029] The distal retainer is preferably connected to the catheter by a snap-lock attachment, which greatly facilitates the assembly process, as a snap fit or snap joint is automatically obtained as soon as the protective sleeve device is brought into position on the retaining catheter. The connection may be releasable or fixed.

[0030] The distal and proximal retaining portions are preferably connected to one another by a snap-lock and / or press-lock arrangement, which makes manufacturing simple and cost-effective, and also allows the distal and proximal retaining portions to be reassembled and reconnected after being separated in the expanded configuration.

[0031] The proximal retainer may include a protruding portion, preferably a flange, extending radially outward and preferably at the proximal end of the proximal retainer. This protruding portion facilitates manipulation of the protective sleeve device. For example, it facilitates grasping the proximal retainer through the packaging material enclosing the catheter, should a user wish to release the proximal retainer from the distal retainer upon catheter removal for automatic sleeve expansion. The protruding portion also forms a stop to prevent the user's fingers from accidentally slipping or sliding onto the exposed catheter shaft during handling.

[0032] The proximal retainer can be arranged to be inserted into the distal retainer. A releasable connection between the proximal retainer and the distal retainer can thereby be provided between the outer surface of the proximal retainer and the inner surface of the distal retainer. The releasable connection can be formed, for example, as a snap joint or a friction joint. However, other types of joints are also possible. Furthermore, other embodiments are also possible, such as one in which the distal retainer is arranged to be inserted into the proximal retainer.

[0033] The compressible sleeve can be connected to the proximal and distal retainers in a variety of ways: The sleeve can be attached to one or both of the retainers by welding, gluing, by a friction fit, or by attaching heat shrink foil around the sleeve, for example.

[0034] The compressible sleeve may be disposed primarily over the proximal retainer in the compressed storage configuration. Additionally or alternatively, the proximal retainer may have a greater axial length than the distal retainer. This is advantageous, particularly if the proximal retainer is also to be used for indirect gripping of the catheter. It also provides stability to the protective sleeve device in the expanded configuration.

[0035] However, in other embodiments, the compressible sleeve may instead be disposed primarily over the distal retainer in compressed storage, and in such embodiments, the distal retainer may have a greater axial length than the proximal retainer.

[0036] The compressible sleeve can be disposed outside the proximal and distal retainers in the compressed storage configuration. Optionally, an outer tubular member can be provided to surround and cover the compressible sleeve when in the compressed configuration.

[0037] Thus, in one embodiment, the intermittent urinary catheter assembly may further comprise an outer sleeve disposed outside the compressible sleeve in the compressed storage configuration.

[0038] However, alternatively, the sleeve may be disposed inside the proximal and / or distal retainer when in the compressed storage configuration.

[0039] The catheter shaft of the catheter may be provided with a hydrophilic outer surface and preferably a hydrophilic coating.

[0040] The intermittent catheter assembly may further comprise a package arranged to house at least the insertable portion of the catheter, hi embodiments, the package may enclose and house the entire catheter and protective sleeve device.

[0041] The package may also include a supply of wetting fluid for wetting the hydrophilic surface of the catheter. In one embodiment, the wetting fluid is placed in direct contact with the catheter, thereby maintaining the catheter in an activated, ready-to-use state. Alternatively, the wetting fluid may be placed in a separate compartment of the package, such as in a separate sachet placed in the package. This allows the wetting fluid to be released at a suitable time before use, for example, immediately before intended use. Opening the wetting fluid compartment for release of the wetting fluid may be performed by applying pressure to the wetting fluid compartment, for example, by squeezing or pinching the sachet. However, other methods of opening the compartment are also feasible, for example, by twisting, pulling, pushing, etc., as are known per se in the art. According to yet another embodiment, the wetting fluid may be placed in a separate compartment, which is arranged so that the catheter shaft can be moved through it and wetted. For example, such a compartment may be arranged so that the catheter shaft is pulled through it upon removal from the package.

[0042] The wetting fluid may be, for example, sterile water or saline, however, other fluids such as steam may also be used.

[0043] The wetting fluid compartment may be provided as a separate component from the package and either loosely located within the package or connected to the package, or alternatively, the wetting fluid compartment may form an integral part of the package.

[0044] During use, the user releases the wetting fluid to wet the catheter immediately before use, or moves the catheter shaft through the wetting fluid. Alternatively, the catheter may already be wetted during storage, thereby eliminating the need for wetting. The user then opens the package. The package may be provided with an opening at or near the distal end of the package, i.e., near where the distal end of the catheter will be located when placed in the package. The user can grasp the catheter's connector at the distal end and pull it out of the package. When the user wishes to use the protective sleeve device to handle the catheter, they can simultaneously hold the proximal holder through the package, thereby pulling the sleeve over the catheter to its extended configuration, where the sleeve covers all or part of the surface of the urinary catheter during catheter removal.

[0045] The package may be made of foil welded along the sides. For this purpose, materials such as polyethylene terephthalate (PETP), low-density polyethylene (LDPE), high-density polyethylene (HDPE), polypropylene (PP), polyamide (PA), amorphous polyester (PET), and surface-treated paper may be used. However, other materials may also be used, as are known per se in the art.

[0046] The urinary catheter is preferably maintained in a sterile state while placed in the package so that the catheter is completely sterile when it leaves the package, thereby reducing the risk of infection during use.

[0047] Intermittent urinary catheters are well known in the art. One example of a urinary catheter is a catheter provided as a tube made of polyurethane (PU), polyolefin, or other polymer(s), which is provided with a funnel / connector at its distal end. At the opposite proximal end (tip), the catheter is provided with one or more eyelets that allow urine to enter the tube. For male catheters, the insertable length may be 250-350 mm, and for female catheters, the insertable length may be 60-130 mm. The insertable length corresponds to the length of the tubular element, excluding the few centimeters closest to the connector. This portion of the catheter is not coated, as the catheter is coated by immersion. Furthermore, the uncoated portion allows for welding or gluing a connector or funnel to the catheter.

[0048] The present invention will now be described in more detail with reference to the accompanying drawings, which show presently preferred embodiments of the invention. [Brief explanation of the drawings]

[0049] [Figure 1] FIG. 1 is a side view of an intermittent urinary catheter assembly according to one embodiment, with a protective sleeve device disposed in a compressed storage configuration. [Figure 2] FIG. 2 is a side view of an intermittent urinary catheter assembly according to one embodiment, with the protective sleeve device positioned in an expanded configuration. [Figure 3a-3c] 3a-3c illustrate an intermittent urinary catheter assembly according to one embodiment with the sleeve in a compressed state, where FIGS. 3a and 3b are perspective views with the compressible sleeve removed for visibility, and FIG. 3c is a cross-sectional view. [Figures 4a-4g]Figures 4a-4g illustrate an intermittent urinary catheter assembly according to another embodiment, where Figures 4a and 4b are cross-sectional views showing the protective sleeve device in a compressed configuration and a partially expanded configuration, respectively; Figure 4c is a perspective view of the distal retainer; Figure 4d is a perspective view of the proximal retainer; Figures 4e and 4f are detailed cross-sectional views of the connection between the distal and proximal retainers; and Figure 4g is a detailed cross-sectional view of the connection between the distal retainer and the funnel of the catheter. [Figures 5a-5d] 5a-5d illustrate an intermittent urinary catheter assembly according to another embodiment, where FIGS. 5a and 5b are cross-sectional views showing the protective sleeve device in a compressed configuration and a partially expanded configuration, respectively, FIG. 5c is a cross-sectional detailed view of the connection between the distal retainer and the funnel of the catheter, and FIG. 5d is a cross-sectional detailed view of the connection between the distal retainer and the proximal retainer. [Figures 6a-6d] Figures 6a-6d illustrate a protective sleeve device according to another embodiment, where Figure 6a is a side perspective view of the protective sleeve device in a compressed configuration, Figure 6b is a cross-sectional view of the same items as Figure 6a, Figure 6c is a side view of the same items as Figure 6a, and Figure 6d is a side perspective view of the protective sleeve device in an expanded configuration. [Figure 7] FIG. 7 is a cross-sectional view of an intermittent urinary catheter assembly according to another embodiment. [Figure 8] FIG. 8 is a cross-sectional view of an intermittent urinary catheter assembly according to yet another embodiment. [Figure 9] FIG. 9 is a cross-sectional view of an intermittent urinary catheter assembly according to yet another embodiment. [Figure 10] FIG. 10 is a side perspective view of an intermittent urinary catheter assembly according to one embodiment, with the catheter disposed within the package. [Figure 11] FIG. 11 is an exploded view of the intermittent urinary catheter assembly of FIG. DETAILED DESCRIPTION OF THE INVENTION

[0050] An intermittent urinary catheter assembly, as illustrated, for example, in Figures 1 and 2, includes a catheter 1 and a protective sleeve device 2. The protective sleeve device is shown in a compressed storage configuration in Figure 1 and in an expanded use configuration in Figure 2. Various embodiments of the protective sleeve device are described in more detail below.

[0051] The catheter comprises a catheter shaft 11 extending from a proximal end 12 to a connector or funnel 13, forming the non-insertable distal section of the catheter. An internal lumen extends from an inlet drainage opening, called an eyelet 14, located at or near the proximal end 12, through the catheter shaft, up the funnel 13 and terminating in a drainage opening located at the distal end 15.

[0052] As previously mentioned, a hydrophilic coating may be disposed on the catheter shaft over at least its insertable length. Alternatively, the catheter shaft may be formed of a hydrophilic material. The hydrophilic surface provides the catheter shaft with very low friction when wet.

[0053] The protective sleeve device 2 is connected to the distal portion of the catheter, preferably to a funnel 13. In the compressed configuration illustrated in FIG. 1, the protective sleeve device 2 extends over only a very limited distal portion of the catheter. In the expanded configuration illustrated in FIG. 2, the compressible sleeve of the protective sleeve device 2 is expanded, such that the protective sleeve device extends over and covers a substantial portion of the catheter shaft. In the illustrated embodiment, the protective sleeve device 2 has a length that essentially covers the entire catheter shaft. However, longer protective sleeve devices having lengths that extend beyond the catheter shaft can also be used. Alternatively, the protective sleeve device can have a shorter length such that the protective sleeve device does not cover the entire length of the catheter shaft, thereby leaving a portion of the catheter shaft near the proximal end 12 uncovered and exposed when the protective sleeve device is in its expanded configuration.

[0054] Next, different embodiments of the protective sleeve device will be described in more detail.

[0055] In one embodiment, as illustrated in FIGS. 3a-3c, the protective sleeve device comprises a distal retainer 21, a proximal retainer 22, and a compressible sleeve 23.

[0056] The distal retainer 21 is connected to the catheter, here, to the proximal portion of the funnel 13. The distal retainer in this embodiment includes a tubular middle section 211 that forms a continuous wall surrounding the catheter. One or more snap lock arms 213 may be provided at the distal end of the tubular middle section 211. In an illustrative example, two such snap lock arms 213 are provided, located on opposite circumferential sides of the tubular middle section 211. The snap lock arms 213 may have small protrusions at their free ends that extend inward toward the funnel 13. The funnel may be provided with one or more corresponding recesses, such as a waist formed near the proximal end of the funnel, so that the snap lock arms 213 can form a snap joint or snap fit with the funnel 13 when the distal retainer 21 is pushed up onto the funnel.

[0057] A similar snap lock arm 212 may be located proximally of the tubular mid-section 211 .

[0058] The proximal retainer 22 may include a generally cylindrical tubular section 221. An outward protrusion, here in the form of an outwardly protruding flange 222, may be disposed at or near the proximal end of the proximal retainer 22. The outward protrusion 222 may facilitate retention of the proximal retainer, for example, through a packaging wall, and may also reduce the risk of slipping or shifting over the proximal end of the proximal retainer 22 during use. The flange may have, for example, an oval shape as illustrated in FIG. 3a or a circular shape as illustrated in FIG. 3b. However, other shapes are also possible.

[0059] At or adjacent the distal end, tubular section 221 may be provided with an outward protrusion 223, such as an outwardly protruding ring, as better seen in FIG. 4d. Outward protrusion 223 may interact with proximal snap lock arm 212 of the distal retainer to form a snap joint or snap fit between the proximal retainer and the distal retainer in the compressed configuration. This snap lock should be releasable. Preferably, the connection formed between the proximal retainer and the distal retainer is much looser and much easier to release than the connection formed between the distal retainer and the catheter. This latter connection may even be a fixed, non-releasable joint.

[0060] Compressible sleeve 23 is connected at its distal end or portion to distal retainer 21 and at its proximal end or portion to proximal retainer 22. This connection may be provided by welding, an interference fit, or the like.

[0061] The sleeve 23 is preferably made of a thin, flexible plastic material. The distal and proximal retainers 21, 22 are preferably made of a thicker, more rigid material and may be formed, for example, by injection molding.

[0062] A similar embodiment is illustrated in Figures 4a-4g, where Figure 4a illustrates the protective sleeve device in a compressed configuration, where the proximal and distal retainers 22, 21 are releasably connected to one another and the compressible sleeve 23 is in a compressed state, and Figure 4b illustrates the protective sleeve device in a partially expanded configuration, where the proximal and distal retainers 22, 21 are disengaged from one another and the compressible sleeve 23 is in a somewhat expanded state.

[0063] Figures 4e and 4f illustrate in more detail the releasable connection between the proximal and distal retainers. In the embodiment of Figure 4e, the outward protrusion(s) 223 at the distal end of the proximal retainer interact with the inward protrusion 214 located at the proximal end of the distal retainer in the same manner as described above. Alternatively, as illustrated in Figure 4f, one of the protrusions 214 and 223 is eliminated. In the illustrative example, the inward protrusion 214 is eliminated, thereby instead forming a straight cylindrical wall at the distal portion of the distal retainer. This results in a friction-fit connection instead of the snap joint of the embodiment of Figure 4e, thereby creating an even looser connection.

[0064] FIG. 4g illustrates in more detail the connection between the distal retainer and the funnel 13, illustrating how the inward protrusions 215 on the arms 213 interact with the constrictions 131 formed in the funnel 13, thereby forming a snap joint.

[0065] 3a-3c and 4a-4g, the proximal retainer 22 is long enough to accommodate a majority of the compressible sleeve 23 when in the compressed configuration. In particular, a majority of the compressible sleeve 23 is disposed overlying the cylindrical tubular section 221 of the proximal retainer 22.

[0066] However, alternatively, as illustrated in Figures 5a-5d, proximal retainer 22' can be shorter and distal retainer 21' can be longer, so that compressible sleeve 23 can instead be positioned primarily overlying the proximal portion of distal retainer 21'.

[0067] The connection between the distal retainer 21' and the funnel 13 may be provided in the same way as in the previous embodiment, as illustrated in Figure 5c.

[0068] In the foregoing embodiment, the distal end of proximal retainer 22 has an inner diameter such that it can be inserted into the proximal end of distal retainer 21 to form a releasable connection. However, as shown in the embodiment of Figures 5a-5d and illustrated in most detail in Figure 5d, the opposite arrangement is also feasible, where the proximal end of distal retainer 21' is insertable into the distal end of proximal retainer 22' to form a releasable friction-fit connection.

[0069] Another form of releasable connection between distal retainer 21″ and proximal retainer 22″ will now be described below with reference to FIGS. 6a-6c. Here, the connection is instead formed by an inwardly protruding pin or knob 213′ extending inward from the inner surface of distal retainer 21″. Proximal retainer 22″ is provided with a recess or notch 223′ extending generally axially from the distal end of proximal retainer 22″. Notch 223′ may be provided with an inward protrusion near the opening. Notch 223′ and inward protrusion 213′ form a snap-lock arrangement to form a releasable snap joint between distal retainer 21″ and proximal retainer 22″.

[0070] In the embodiments described so far, the sleeve is located outside the proximal and distal holders. However, for protective or aesthetic reasons, it is also possible to provide a cover over the sleeve. Such an embodiment will now be described with reference to Figures 7 to 9.

[0071] In the embodiment of Figure 7, the upper and lower retainers 21, 22 are generally of the same type as those described with respect to the embodiment of Figures 4a-4g, for example. However, in addition, an outer sleeve 24 is connected to the proximal retainer 22. Preferably, the proximal end or portion of the outer sleeve 24 is connected to the proximal end or portion of the proximal retainer 22. The outer sleeve 24 extends over the compressible sleeve 23 when in the compressed configuration.

[0072] The embodiment of FIG. 8 is similar to that described in connection with FIG. 7. However, here, the outer sleeve 24′ is provided with an inward protrusion 241, such as an inwardly protruding ring, that is positioned to interact with the outward protrusion 215 on the distal retainer 21′″ to form a snap joint between these portions. This connection between the distal and proximal retainers may be used in addition to the releasable connection described above. However, as an alternative, this snap joint may replace other joints and connections, such as in the illustrative example. In this embodiment, the proximal retainer 22′″ may be shorter and does not require any contact with the distal retainer 21′″. Instead, here, the outer sleeve 24′ forms an extension of the proximal retainer 22′″.

[0073] 9, but here the outer sleeve 24' is used to completely replace the proximal retainer described above, and instead forms the proximal retainer itself. In this case, the compressible sleeve 23 may be directly connected to the outer sleeve 24', for example, at or adjacent its proximal end.

[0074] The intermittent urinary catheter assembly described above, comprising a catheter and a protective sleeve device, may further comprise a package 4 enclosing the catheter set. Such a catheter assembly will now be disclosed with reference to Figures 10 and 11. This package may be structured and configured in the same manner as disclosed in US2015 / 141966, which is incorporated herein by reference in its entirety.

[0075] Package 4 encloses catheter 1 and assembled thereon protective sleeve device 2, as previously described. The package may further comprise a wetting fluid, preferably disposed in wetting fluid reservoir 5, for activating the hydrophilic surface coating of the catheter.

[0076] The wetting fluid may be disposed separately from the catheter in a wetting fluid container 5, such as a pouch or sachet. The wetting fluid container is hereby openable, for example, by applying pressure to the container, which releases the wetting fluid into the package, thereby wetting the hydrophilic surfaces of the catheter. However, alternatively, the wetting fluid may be disposed in direct contact with the catheter and hydrophilic surfaces during storage, thereby providing a ready-to-use catheter assembly, or may be arranged such that the catheter shaft is moved through the wetting fluid during removal.

[0077] The wetting fluid is preferably an aqueous liquid such as water or saline, etc. Such wetting fluid containers and wetting fluids are known per se in the art.

[0078] The package may be formed from sheet materials such as first and second sheet materials 41, 42 connected around their edges to form an internal cavity for containing the catheter and wetting fluid. The first and second sheet materials are preferably connected around their edges by welding to form a welded edge joint 6. Preferably, the first and second sheet materials comprise laminated sheets having a weldable inner layer and a protective outer layer. However, one or both of the sheets may alternatively be non-laminated and made, for example, of extruded or coextruded materials. The sheet materials are preferably of a flexible plastic material. For example, the sheets may be made of polymeric materials such as polyethylene, polypropylene, polyamide, and PET, or the receptacle may be made of a laminate of such polymeric materials and / or aluminum, aluminum oxide, or oriented polypropylene (OPP).

[0079] One of the sheets, such as sheet 41, may also be deep drawn into a trough shape.

[0080] Furthermore, the package can be manipulated to withdraw the catheter before intended use. For this purpose, the package can be provided with a tear opening, peel opening, or the like. For example, the sheets can be arranged so that they can be peeled from one another at one or several locations. Preferably, however, the opening is arranged as a resealable opening. Such a resealable opening can be formed, for example, by forming a full or partial cut non-closing loop 71 in one of the sheets, or alternatively, by forming a closed loop and adding an additional tear sheet 7 on top of this loop. Attachment of the sheet 7 can be performed, for example, by adhesive. The sheet 7 can be provided with a non-adhesive grip tab 72 to facilitate opening. Additionally, the grip tab can be provided with a finger hole to further facilitate opening. Tabs can also be arranged at positions other than those illustrated in the illustrative example.

[0081] Additionally, means may be provided for attaching the catheter package to a wall, sink, or the like. Such means may, for example, comprise an adhesive area located on one of the sheets, preferably the non-apertured sheet, and covered by a removable cover sheet 8.

[0082] A method for manufacturing a catheter assembly of this type includes the following steps: - Separately manufacturing the catheter and the protective sleeve device. - Assembling a protective sleeve device onto the catheter. - placing the catheter assembly and the wetting fluid container on one of the sheets, which is preferably deep-drawn into a trough shape; - connecting a second sheet onto the first sheet, thereby closing the package. - Optionally, attaching a tear sheet and a cover sheet to the package.

[0083] Of course, the order of these steps may be different, for example the package may be partially closed before the insertion of the catheter and / or wetting fluid container, and further the attachment of the tear sheet and / or cover sheet may occur before or after any of the other steps.

[0084] The packaged assembly can then be sterilized, for example, by radiation sterilization or other sterilization methods.

[0085] In use, the following steps may be performed: - If not already in a wetted activated state, wetting fluid is released to wet the hydrophilic surface of the catheter. - The package is opened. - The catheter is removed from the package. - the protective sleeve device is brought from its compressed configuration to its expanded configuration, thereby covering all or at least a substantial portion of the catheter shaft. The expansion of the protective sleeve device may occur simultaneously with the removal of the catheter from the package. To this end, the user may hold the proximal retention portion through the package as the catheter is withdrawn, thereby simultaneously releasing the proximal retention portion from the distal retention portion. Alternatively, the catheter may be removed from the package first, and then the protective sleeve device may be expanded. A protective sleeve device may be used to grasp and manipulate the catheter for insertion into the urethra. As the catheter is inserted deeper into the urethra, the protective sleeve device will again compress, and in this case will remain compressed outside the urethra during drainage of urine from the bladder. After the urine has been drained, the catheter may be removed from the urethra and discarded. In this step, the protective sleeve device may remain in the compressed configuration or may be re-expanded to the expanded configuration.

[0086] The present invention has been disclosed with reference to certain exemplary embodiments. However, those skilled in the art will recognize that certain modifications are possible. For example, the proximal and distal retainers may be of different shapes and configurations, and the releasable connection therebetween may be achieved in ways other than those described above. Furthermore, the connection between the distal retainer and the catheter may be achieved in other ways. For example, the connection may instead be achieved by welding, adhesive bonding, an interference fit, etc. Furthermore, the distal retainer may be connected to the funnel portion of the catheter, as described above. However, it is also possible to connect the distal retainer to the distal portion of the catheter shaft.

[0087] The above and other obvious modifications must be considered within the scope of the present invention as defined by the appended claims. It should be noted that the above-described embodiments illustrate rather than limit the present invention, and that those skilled in the art will be able to design many alternative embodiments without departing from the scope of the appended claims. In the claims, any reference signs placed in parentheses shall not be construed as limiting the claim. The word "comprising" does not exclude the presence of other elements or steps than those stated in a claim. The word "a" or "an" preceding an element does not exclude the presence of a plurality of such elements.

Claims

1. 1. An intermittent urinary catheter assembly comprising: a catheter having a proximal insertion end and a distal end opposite the proximal insertion end, wherein the catheter has a lumen extending from a drainage opening at or near the proximal insertion end to a discharge opening at or near the distal end; a protective sleeve device having a proximal retainer, a distal retainer, and a compressible sleeve connected to the proximal retainer and the distal retainer, wherein the compressible sleeve has a compressed storage configuration and is expandable to an expanded configuration; wherein the distal retention portion is connected to the catheter at or near the distal end, and the proximal retention portion and the distal retention portion are releasably connected to one another.

2. 2. The intermittent urinary catheter assembly of claim 1, wherein the distal retention portion and the proximal retention portion are both made of a material that is stiffer than the sleeve.

3. 3. The intermittent urinary catheter assembly of claim 1, wherein the compressible sleeve is made of a flexible, foldable material.

4. The intermittent urinary catheter assembly of any one of claims 1 to 3, wherein the proximal retention portion and the distal retention portion both have a wall thickness greater than that of the sleeve.

5. 5. The intermittent urinary catheter assembly of claim 1, wherein the catheter comprises a funnel connected to or integral with a distal end of the catheter shaft, the funnel defining the discharge opening, and the distal retention portion connected to the funnel.

6. 6. The intermittent urinary catheter assembly of claim 1, wherein the compressible sleeve is extendable toward the proximal insertion end, and wherein the compressible sleeve, in its expanded configuration, is arranged to cover a substantial portion of the catheter, and preferably more than 50% of the length of the catheter shaft, and more preferably at least 70% of the length of the catheter shaft, and most preferably at least 90% of the length of the catheter shaft.

7. 7. The intermittent urinary catheter assembly of claim 1, wherein the compressible sleeve is folded into the compressed storage configuration, preferably with concertina or accordion-like folds to form an accordion- or concertina-like pleated configuration.

8. 8. The intermittent urinary catheter assembly of claim 1, wherein the compressible sleeve is expandable to a length of L-5 to L+5 cm, where L is the length of the catheter shaft.

9. The intermittent urinary catheter assembly of any one of claims 1 to 8, wherein the distal retainer is connected to the catheter by a snap lock attachment.

10. 10. The intermittent urinary catheter assembly of claim 1, wherein the distal retention portion and the proximal retention portion are connected to each other by a snap lock and / or press lock arrangement.

11. 11. An intermittent urinary catheter assembly according to any one of claims 1 to 10, wherein the proximal retention portion comprises a protruding portion, and preferably a flange, extending radially outward and preferably at the proximal end of the proximal retention portion.

12. The intermittent urinary catheter assembly of any one of claims 1 to 11, wherein the proximal retainer is arranged to be inserted into the distal retainer.

13. The intermittent urinary catheter assembly of any one of claims 1 to 12, wherein the compressible sleeve is disposed primarily across the proximal retention portion in the compressed storage configuration.

14. The intermittent urinary catheter assembly of any one of claims 1 to 13, wherein the proximal retention portion has a greater axial length than the distal retention portion.

15. The intermittent urinary catheter assembly of any one of claims 1 to 14, wherein the compressible sleeve is disposed outside the proximal and distal retainers in the compressed storage configuration.

16. The intermittent urinary catheter assembly of any one of claims 1 to 15, further comprising an outer sleeve disposed outside the compressible sleeve in the compressed storage configuration.

17. An intermittent urinary catheter assembly according to any one of claims 1 to 16, wherein the catheter shaft of the catheter is provided with a hydrophilic outer surface, and preferably a hydrophilic coating.

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