Urinary catheter assembly

Abstract

A urinary catheter assembly comprises a urinary catheter and a package forming at least one compartment to enclose the urinary catheter. The package comprises an inner layer and an outer layer, wherein one or more welds between at least two sheets of the inner layer form the at least one compartment, the outer layer being arranged connected to and overlying the sheets of the inner layer. Further, the package comprises an extraction opening formed by peelable sections of the welds, and a part of the outer layer being arranged overlying the peelable sections is arranged to be torn open upon peel opening of the peelable sections.

Description

[0001] Urinary catheter assembly

[0002] TECHNICAL FIELD OF THE INVENTION

[0003] The present invention relates to a urinary catheter assembly comprising a urinary catheter arranged in a package. The catheter is preferably a hydrophilic catheter, and a wetting fluid may be accommodated in the package for activation of the hydrophilic surface.

[0004] BACKGROUND OF THE INVENTION

[0005] Urinary catheters are widely used for intermittent catheterization. In intermittent catheterization, the urinary catheter is inserted into the bladder, urine is discharged, and the catheter is then immediately removed. The whole procedure takes only a few minutes, and normally has to be repeated a number of times per day. In order to reduce the risk of damage to the urethral wall, the catheters are typically coated with a hydrophilic coating imparting an extremely low friction on the surface of the catheters. This coating is normally activated by applying a fluid medium (for example tap water or sterilized water) to the coating. The coating may be maintained activated during storage, providing a ready to use assembly, or be activated immediately prior to use, e.g. by release of a fluid from a separate compartment inside the package.

[0006] Individuals who suffer from urinary incontinence will normally self-catheterize several times a day. Self-catheterization involves removing the catheter assembly from its package and inserting and advancing the catheter tube through the user's urethra. However, preparation and manipulation of known catheter assemblies is often complicated and tedious. Further, often users of intermittent urinary catheters have limited or diminished dexterity, e.g. as a result of spinal cord injuries. Also, users of intermittent catheters are often required to self-catheterize outside the privacy of the home, such as in public restrooms. Thus, for these and other reasons, it is desirable that the intermittent catheters are provided in discrete packaging that is easy to open and manipulate, which are compact and portable, and wherein the catheter can be deployed and used in a way that alleviates concerns about inadvertent urine leakage or spillage and avoids pain or discomfort to the user. Thus, there is a desire to have a catheter assembly which is small and convenient to use and to carry around. The catheter assembly should preferably also be easy to handle in a convenient, discreet and safe way, e.g. without spillage and without contamination of the catheter prior to insertion into the urethra.

[0007] In particular, male catheters are relatively long, making the catheter assemblies large and difficult to handle.

[0008] It is also quite common that users of catheters experience Urinary Tract Infections (UTI). To reduce risk of infection, the urinary catheter as well as the fluid medium may be sterilized. Furthermore, the surface of the urinary catheter should preferably remain uncontaminated prior to use.

[0009] Many attempts have been made over the years to fulfill this need. For example US 11779727, by the same applicant, discloses a urinary catheter assembly which addresses this need. Here, the catheter is arranged in a curled, compact state in the package. A telescopic insertion aid is attached to the distal end of the catheter and may be expanded during extraction to protect the catheter.

[0010] However, such and other known urinary catheter assemblies are relatively complicated and costly to produce, and may also be cumbersome and difficult to use, in particular for users having poor dexterity and impaired hand movement. There is therefore still a need for improved protective measures that could provide the same or improved protection against contamination, which can be produced easier and more cost-efficiently, and / or which are easier and more intuitive to use, and with less need for hand movement control. The assembly should also preferably be rather small, so that it can easily be carried around by the user in his / her daily life. Further, the product should preferably enable performing of the catheterization without contamination of at least the insertable parts of the product. Thus, there is a general need for a more simplified catheterization procedure, and for a urinary catheter assembly enabling this.

[0011] SUMMARY OF THE INVENTION

[0012] It is therefore an object of the present invention to address the above-discussed needs, and to overcome or alleviate all, or at least some, of the above-discussed problems. Specifically, it is an object of the present invention to provide an improved urinary catheter assembly that could provide the same or improved protection against contamination, which can be produced easier and more cost-efficiently, and / or which can be easier and more intuitive to use, and with less need for hand movement control. This object is obtained by urinary catheter assemblies as defined in the appended claims.

[0013] According to a first aspect of the invention there is provided a urinary catheter assembly comprising: a urinary catheter having a proximal part with an insertion tip, a distal part and a tubular shaft extending there between, wherein the distal part, on at least a part thereof, has a greater cross-sectional dimension than the tubular shaft and the proximal part; and a package forming at least one compartment to enclose the urinary catheter, wherein said package comprises an inner layer and an outer layer, wherein one or more welds between at least two sheets of the inner layer form the at least one compartment, the outer layer being arranged connected to and overlying the sheets of the inner layer to cover at least part of the at least one compartment; wherein the package comprises an extraction opening, the extraction opening being formed by one or more peelable sections of said one or more welds, and a part of the outer layer being arranged overlying the peelable sections being arranged to be torn open upon peel opening of the peelable sections, the outer layer preferably comprising tear lines in said outer layer being arranged essentially overlying said peelable sections.

[0014] This package is cost-efficient to manufacture and provides many advantages. The inner layer of the package may provide a barrier to maintain the wetting fluid inside the package. The inner layer may e.g. be gas and / or liquid impermeable. The outer layer may be used to provide other properties to the product, such as being colored to make the assembly more discreet. The outer layer may also provide a textured surface or the like, thereby increasing friction, which simplifies handling of the assembly. The outer layer may also in a cost-efficient way be printed to contain useful information about the assembly, such as instructions for use. Further, the outer layer can make the package quieter and less noisy to handle.

[0015] The peel opening of the inner layer is an efficient way of maintaining adequate barrier properties for the package and is also simple and intuitive to use. The package may e.g. contain one or more tabs extending out from the package in the vicinity of the extraction opening, enabling opening by simply pulling the tab(s) away from another tab or from the package. The peelable sections may have an extension sufficient to ensure that the distal part of the catheter is exposed and easy to grip, thereby facilitating subsequent extraction of the catheter from the package. By arrangement of a tear line in the outer layer arranged overlying, or at least essentially overlying, the peelable sections, it is ensured that tearing of the outer layer can occur simultaneously with the peel opening of the inner layer. This facilitates handling even further. Thus, both the inner package, formed by the inner layer, and the outer package, formed by the outer layer, may be opened simultaneously, by a single grip and action.

[0016] Since sterility and moisture barrier properties are provided primarily or solely by the inner layer, the outer layer need not provide such properties, and the provision of tear lines in the outer layer does not affect such properties in the package.

[0017] The outer layer may be attached to the inner layer in various ways. In an embodiment, the inner and outer layers are manufactured separately and subsequently connected together by welding, adhesion, e.g. by gluing, or the like. The outer layer may also be mechanically connected to the inner layer, such as by friction and geometrical shape.

[0018] The outer layer may have dimensions similar to the dimensions of the inner layer. In an embodiment, the outer layer is arranged to cover at least a greater part of the inner layer, and preferably essentially the entire inner layer, except possibly opening tabs and the like protruding out from the internal cavity of the package.

[0019] The inner layer preferably has greater barrier properties than the outer layer. The inner layer preferably forms a moisture barrier. The inner layer may e.g. be of a gas and / or liquid impermeable material. The inner layer is preferably made of a plastic material, such as polypropylene (PP) , polyethylene (PE) and / or polystyrene (PS). The material of the inner layer may be relatively thick and rigid and may e.g. be thermoformed into a desired shape.

[0020] In an embodiment, the package is thermoformed into a package that is relatively rigid, particularly the inner layer, the packaging preferably being more rigid than the tubular shaft.

[0021] The outer layer may be formed of a nonwoven or paper material. Such materials are sustainable and available at a low cost. Such materials may also easily be printed and / or colored and may also be provided with a surface texture providing adequate tactile properties, such as a relatively high friction, which facilitates handling.

[0022] The inner layer may be transparent, which facilitates production and quality control before the outer layer is added. The outer layer may be colored and may be opaque or semiopaque, making the product more discreet.

[0023] The tear lines are preferably lines of reduced thickness or strength, such as lines of perforations. However, the tear lines may also be obtained by melted channels with reduced thickness, etc. For materials being easy to tear, such as thin paper etc, the material may have inherent tear lines along, or otherwise be easily torn, so that a tear will propagate together with the peel opening upon opening of the peel opening, without any need for weakening of the material. In particular, if the outer layer is attached to the inner layer on both sides of the peel opening the outer layer a tear will propagate in a controlled manner upon opening of the peel opening, without any need for weakening of the material.

[0024] In an embodiment, the tear lines are formed by the outer layer being attached to the inner layer on both sides of each of the peelable sections.

[0025] In an embodiment, for materials being easy to tear, the tear can be forced to propagate in a controlled manner upon opening of the peel opening, by attaching the outer layer to the inner layer on both sides of the peel opening.

[0026] The catheter is preferably a hydrophilic urinary catheter with a hydrophilic surface, provided e.g. by a hydrophilic surface coating or by a catheter substrate made by a hydrophilic material. The hydrophilic surface provides low friction properties to the catheter when wetted. The assembly may further comprise a wetting fluid accommodated by the package. The wetting fluid may be arranged in direct contact with the hydrophilic urinary catheter, thereby maintaining the catheter in a constantly wetted, ready -to-use state. However, alternatively, the wetting fluid may be arranged in a separate compartment within the package, such as a sachet. The wetting fluid may hereby be released from the compartment, e.g. immediately prior to use, to activate the hydrophilic urinary catheter.

[0027] The urinary catheter assembly may further comprise a protective sleeve arrangement having a proximal holder part, a distal holder part and a compactable sleeve connected to the proximal holder part and the distal holder part, the compactable sleeve having a compacted storage configuration and being extendable into an expanded configuration, wherein the distal holder part is connected to the catheter at or near the distal part, and the proximal holder part and the distal holder part are releasably connected to each other.

[0028] The package may have at least a first compartment and a second compartment with a transition opening therebetween. The first compartment may be arranged to enclose the proximal part and at least a part of the tubular shaft of the catheter therein. The part of the urinary catheter being arranged in the first compartment may be arranged in a curved or curled state during storage, thereby making the assembly more compact.

[0029] A curved or curled state here means that the catheter is arranged in a non-straight disposition, such as being bent, folded, or otherwise curved or curled. Preferably, the curved or curled state in total forms at least a 180 degrees curvature. When the catheter inside the first compartment of the package is arranged in a curved or curled state, the length of the first compartment, and also the entire package, can be much shorter than the length of the catheter. In particular for male catheters, which conventionally has a length of about 40 cm, this is of great advantage, since the assembly of the present invention can have a length of less than 25 cm, and preferably less than 20 cm, less than 15 cm, or even shorter. This makes it easy to carry the urinary catheter assembly in a discreet way, e.g. in a small bag, a pocket, or the like. Thus, the present urinary catheter assembly can be made very compact.

[0030] The second compartment may be arranged to enclose at least the distal part of the catheter, wherein the tubular shaft extends through the transition opening. Hereby, the compartments are separated by the transition opening, which, prior to use, is at least partly closed by the tubular shaft of the catheter. However, the transition opening and the tubular shaft do preferably not provide a seal between the compartments, and fluid communication may still occur between the compartments through the transition opening.

[0031] In addition, a by-pass opening is preferably provided between the first compartment and the second compartment at a distance from the transition opening.

[0032] According to a second aspect of the invention, there is provided a urinary catheter assembly comprising: a urinary catheter having a proximal part with an insertion tip, a distal part and a tubular shaft extending there between, wherein the distal part, on at least a part thereof, has a greater cross-sectional dimension than the tubular shaft and the proximal part; and a package having at least a first compartment and a second compartment with a transition opening therebetween, said first compartment being arranged to enclose the proximal part and at least a part of the tubular shaft therein, and said second compartment being arranged to enclose at least the distal part, wherein the tubular shaft extends through said transition opening; wherein a by-pass opening is provided between the first compartment and the second compartment at a distance from said transition opening.

[0033] The features of this second aspect of the invention may be used in combination with the above-discussed features of the first aspect of the invention. Alternatively, the first and second aspects may be used independently of each other. The part of the urinary catheter being arranged in the first compartment is preferably arranged in a curved or curled state during storage. This is particularly of relevance for male catheters and provides a relatively small and compact assembly.

[0034] In embodiments, the distance between the transition opening and the by-pass opening may be very small, such as only a few millimeters, but may also be longer. Preferably the distance is at least a centimeter, such as in the range of 1-3 cm. The by-pass opening may be arranged closer to the transition opening than to an oppositely arranged extraction opening, but may alternatively be arranged closer to the extraction opening than to the transition opening.

[0035] The by-pass opening provide an additional path for fluid communication between the compartments. This is useful to ensure that any wetting fluid present in the second compartment may be transferred back to the first compartment, e.g. to ensure that the wetting fluid may serve its desired purpose of wetting a hydrophilic surface of the catheter. Hereby, the distal part of the catheter may be kept relatively dry, thereby making handling of the catheter simpler and more convenient.

[0036] The by-pass opening is also very useful in facilitating reinsertion of the catheter into the package after use. In many situations there may be no appropriate place to discard the catheter after use, and for reasons of discretion, the user may also not want to discard the catheter in such a way that it can be seen by others, such as in a public restroom. When the catheter is reinserted into the package there is a risk that pressure increases in the first compartment, which may make the reinsertion procedure more difficult, and which may also lead to an inadvertent splash of wetting fluid out from the first compartment, either through the lumen of the catheter or between an exterior surface of the catheter and an interior surface of the transition opening. This is efficiently avoided by the provision of the by-pass opening, allowing air to be released from the first compartment into the second compartment, and out to the ambient atmosphere through the extraction opening, as pressure increases in the first compartment.

[0037] As discussed in the foregoing, arrangement of the part of the urinary catheter being arranged in the first compartment in a curved or curled state during storage makes the assembly more compact.

[0038] Preferably, a cross-sectional area of the by-pass opening is smaller than a cross- sectional area of the transition opening. Further, an inner diameter of the by-pass opening is preferably smaller than an outer diameter of the tubular shaft. The small dimensions of the by- pass opening e.g. ensures that there is no risk of inadvertently inserting the catheter into the by-pass opening instead of through the transition opening during reinsertion of the catheter into the package after use.

[0039] The second compartment preferably has an extraction opening arranged opposite to the transition opening. The by-pass opening preferably extends away from the second compartment at least partly in a direction away from the extraction opening. In an embodiment, the second compartment is elongated in a first length direction, wherein the bypass opening extends along a second length direction, the first and second length directions being non-perpendicular, and preferably in the range 45-89 degrees, and more preferably in the range 70-85 degrees. The slanted disposition of the by-pass opening ensures that when the assembly is held in an upright position, such as when the package is about to be opened for use, any wetting fluid present in the second compartment will due to gravity drain into the first compartment.

[0040] In an embodiment, the second compartment forms an elongate compartment arranged along a sidewall of the first compartment. The sidewall of the first compartment is preferably a common sidewall also for the second compartment, the sidewall forming a separation between the first and second compartments, and may e.g. be formed by a weld separating the compartments. In such an embodiment, the by-pass opening may be arranged to extend through the common sidewall.

[0041] In an embodiment, a wall of the second compartment in the vicinity of an entrance of the by-pass opening, in a plane parallel to a length direction of the second compartment, forms outwardly slanted surfaces, thereby forming a drop towards the entrance of the by-pass opening.

[0042] According to a third aspect of the invention, there is provided a urinary catheter assembly comprising: a urinary catheter having a proximal part with an insertion tip, a distal part and a tubular shaft extending there between, wherein the distal part, on at least a part thereof, has a greater cross-sectional dimension than the tubular shaft and the proximal part; and a package forming at least one compartment to enclose the urinary catheter, wherein said package comprises at least two sheets connected together by one or more welds, thereby forming the at least one compartment; wherein the package comprises an extraction opening, the extraction opening being formed by one or more peelable sections of said one or more welds, the sheets in the vicinity of said peelable sections forming overlying tabs extending away from the compartment, a first of said tabs forming an opening and a second of said tabs forming a waist, thereby enabling a locking engagement between the tabs when the second tab is inserted into the opening of the first tab.

[0043] The features of this third aspect of the invention may be used in combination with the above-discussed features of the first and / or second aspect of the invention. Alternatively, the third aspect may be used independently of the other aspects.

[0044] The locking arrangement formed by the tabs in this way is a very efficient way of enabling closing of the package after use. This is of particular relevance for situations where the catheter is reinserted into the package after use.

[0045] In many situations, as discussed in the foregoing, there may be no appropriate place to discard the catheter after use, and for reasons of discretion, the user may also not want to discard the catheter in such a way that it can be seen by others, such as in a public restroom. When the catheter is reinserted into the package it is of great advantage that the package can be closed in such a way that the catheter or other components will not fall out.

[0046] The locking arrangement provided by the tabs forms a very efficient mechanical locking of the package, which is yet very simple to handle even for users with reduced dexterity. The locking arrangement is also very cost-efficient, imparting no, or only very limited, additional cost to the product.

[0047] In an embodiment, the waist is preferably formed by at least one pair of laterally extending protrusions arranged in the vicinity of a free end of the second tab.

[0048] Additionally, or alternatively, the waist may be formed by at least one pair of laterally extending indentations arranged as a distance from a free end of the second tab.

[0049] In an embodiment, the opening in the first tab has a width which is equal to or greater than the extension of the waist in the width direction. This is a simple, yet efficient, way of forming the mechanical locking arrangement.

[0050] The tabs preferably extend away from the compartment in the peel direction.

[0051] Additionally, or alternatively, it is preferred that a part of the second tab arranged in the vicinity of the free end of the second tab, and arranged on the other side of the waist than the compartment, has an extension in the width direction which is greater than the width of the opening in the first tab.

[0052] According to a fourth aspect of the invention, there is provided a urinary catheter assembly comprising: a urinary catheter having a proximal part with an insertion tip, a distal part and a tubular shaft extending there between, wherein the distal part, on at least a part thereof, has a greater cross-sectional dimension than the tubular shaft and the proximal part; and a package forming at least one compartment to enclose the urinary catheter, wherein said package comprises at least two sheets connected together by one or more welds, thereby forming the at least one compartment; wherein the package comprises an extraction opening, the extraction opening being formed by at least three peelable sections of said one or more welds, at least one, and preferably both, of the sheets in the vicinity of said peelable sections forming a tab extending away from the compartment, wherein a first peelable section extends transversely to the tab and a second and third peelable section, on opposite sides of the compartment, extend away from the tab, wherein a ridge is formed in at least one of the sheets, the ridge extending at least partly between the second peelable section to the third peelable section at a distance from said first peelable section.

[0053] The features of this fourth aspect of the invention may be used in combination with one or more, and preferably all, of the above-discussed features of the first, second and third aspects of the invention. Alternatively, the fourth aspect may be used independently of the other aspects.

[0054] The ridge arranged between the second and third peelable sections facilitates opening of the package. The ridge may also ensure that a part of the package peeled open remains open until it is again closed. The ridge may here provide a bistability to the opening, providing stable resting positions in an opened state and a closed state, respectively, but prohibiting that the opening remains in intermediate positions. This facilitates gripping and extraction of the catheter and is particularly useful for users having reduced dexterity. For example, this enables the package to be opened with only one hand, and subsequently gripping and extraction of the catheter can be made with the same hand, since the package remains open with the catheter exposed.

[0055] The opening that stays in an open state is also of great advantage for situations where the catheter is to be reinserted into the package after use, as discussed in the foregoing in relation to other aspects. Since the opening is already opened, the user needs only to concentrate on inserting the catheter tip into the package and then move the catheter further into the package. This can also be made with only one hand, with the package e.g. lying on a sink, in the lap of the user, arranged hanging in a loop formed in the tab, attached to a sink by an adhesive label, or the like.

[0056] The ridge is preferably a protruding ridge, extending in a direction into the compartment, i.e. an indentation extending inwardly as seen from the interior of the compartment.

[0057] The ridge preferably extends over a majority of the length between the second and third peelable section, and preferably over at least 60% of said length, and more preferably over at least 70 %, and most preferably over at least 80%.

[0058] The ridge preferably extends in a direction essentially perpendicular to the second and / or third peelable sections. However, alternatively, the ridge may occur in a slanted direction, forming a non-perpendicular angle to the second and / or third peelable sections. The ridge may extend as a straight line, but may also extend along a curved path, e.g. forming an arc.

[0059] The ridge is preferably arranged overlying the distal part of the catheter. This ensures that the distal part of the catheter becomes exposed upon opening, thereby facilitating extraction of the catheter.

[0060] The ridge may additionally, or alternatively, extend in a direction essentially perpendicular to the axial direction of the distal part of the catheter.

[0061] The sheet of the package in which the ridge is arranged preferably has a curved shape between the second and third peelable sections, at least in a part including the ridge. This enhances the functionality of the opening being maintained in an opened state once opened. The sheet of the package in which the ridge is arranged may further be reinforced in a wall section accommodating the ridge or in a wall section beneath the ridge. The reinforcement may e.g. be provided a corrugation or a wave-formed structure in the wall section. Such a reinforcement further facilitates opening of the assembly and assures that the package is folded at the ridge during opening.

[0062] In an embodiment, the sheet in which the ridge is arranged comprises a reinforcement at least in a part including the ridge, the reinforcement preferably comprising at least one of a corrugation in the sheet and a curved shape between the second and third peelable sections.

[0063] In an embodiment, a pivotable part of the sheet is defined by the first, second and third peelable sections and the ridge, wherein the ridge is arranged to function as a hinge between the pivotable part and the rest of the package. In an embodiment, the ridge is arranged to maintain the pivotable part in a pivoted position.

[0064] According to a fifth aspect of the invention, there is provided a urinary catheter assembly comprising: a urinary catheter having a proximal part with an insertion tip, a distal part and a tubular shaft extending there between, wherein the distal part, on at least a part thereof, has a greater cross-sectional dimension than the tubular shaft and the proximal part; a package having at least a first compartment and a second compartment with a transition opening therebetween, said first compartment being arranged to enclose the proximal part and at least a part of the tubular shaft therein and said second compartment being arranged to enclose at least the distal part, wherein the tubular shaft extends through said transition opening; and a protective sleeve arrangement having a proximal holder part, a distal holder part and a compactable sleeve connected to the proximal holder part and the distal holder part, the compactable sleeve having a compacted storage configuration and being extendable into an expanded configuration, wherein the distal holder part is connected to the catheter at or near the distal part, and the proximal holder part and the distal holder part are releasably connected to each other, wherein the package, at or in the vicinity of the transition opening, comprises inward protrusions and at least one channel between the inward protrusions, the inward protrusions arranged to releasably engage the proximal holder part and / or the compactable sleeve.

[0065] The features of this fifth aspect of the invention may be used in combination with one or more, and preferably all, of the above-discussed features of the first, second, third and fourth aspects of the invention. Alternatively, the fifth aspect may be used independently of the other aspects.

[0066] Since the distal holder part and the proximal holder part are releasably connected to each other, the sleeve will be maintained in its compacted storage position during storage and then be unfolded and expanded prior to use. This is of great advantage as it ensures that the catheter shaft is accessible for example for wetting of a hydrophilic surface thereon when arranged in the package. The protective sleeve arrangement is used to cover the surface of the catheter prior to use so that a user can use this for holding the catheter. Thereby, handling of the catheter is facilitated, and contamination of the surface is prevented. This also reduces the risk of UTIs.

[0067] Still further, the releasably connected proximal and distal holder parts may also be reconnected to each other if the user would want to bring the sleeve back to its compacted storage position at a later stage. The proximal and distal holder parts may be reconnectable by the same connection arrangement as used initially, or through a different connection arrangement. However, non-reconnectable proximal and distal holder parts may also be provided.

[0068] At the same time, expansion of the sleeve is very simple and intuitive, and follows automatically when the catheter is expelled from the package.

[0069] Thus, handling of the catheter and the protective sleeve arrangement is simple and intuitive, also for users having poor dexterity, limited hand movement control, etc.

[0070] The protective sleeve arrangement can also be produced as a separate part, with the proximal and distal parts being connected together and the sleeve arranged in the compacted storage configuration. This can then easily and cost-efficiently be assembled on the catheter. For example, the connection can be obtained by a snap lock arrangement, such as a snap-fit, whereby the connection is obtained automatically when the protective sleeve arrangement is pushed into place during assembling.

[0071] Since the protective sleeve arrangement can be produced separately, it also allows the catheter to be produced in a conventional way, making the production cost-efficient and simple, and without any risk of e.g. damaging a hydrophilic coating or the like provided on the catheter shaft. It also makes it possible to produce the catheter and the protective sleeve arrangement at one location, or at different locations, and to have the assembling optionally taking place at another location.

[0072] The inward protrusions arranged at, or in the vicinity of, the transition opening ensures that the catheter is held in place in the package. The inward protrusions may also form a friction connection between the package and the proximal holder part and / or the compactable sleeve strong enough to ensure that the proximal holder part is initially maintained in the package during extraction of the catheter, thereby expanding the protective sleeve arrangement to its expanded configuration, before release of the proximal holder part upon further extraction of the catheter. Specifically, the inward protrusions may form a friction connection between the package and the compactable sleeve, when in a compacted state. In the compacted configuration, the compactable sleeve may have a diameter greater than the diameter of the proximal holder part. During expelling of the catheter, the compacted sleeve will be gradually extended, moving from the compacted configuration to the extended configuration, and in this process the diameter of the compactable sleeve will diminish and the friction connection to the package will become gradually weaker. Hereby, a very low additional extraction force, or even no additional extraction force at all, will be needed to expel the sleeve insertion aid together with the catheter from the package when the sleeve insertion aid has reached the expanded configuration.

[0073] The one or more channel(s) formed between the inward protrusions forms a fluid path between an exterior surface of the proximal holder part and / or the compactable sleeve and an interior surface of the transition opening, thereby ensuring fluid communication between the first and second compartments.

[0074] The package preferably comprises a plurality of the inward protrusions arranged distributed both in a longitudinal and width direction. The inward protrusions may hereby form a pattern on a part of the interior wall, such as a leopard pattern.

[0075] The inward protrusions are preferably separated from each other, thereby forming channels between all the inward protrusions. However, alternatively, clusters of two or more inward protrusions may also be provided.

[0076] The inward protrusions are preferably distributed over essentially the entire part of the package housing the proximal holder part and / or the compactable sleeve. The inward protrusions may be evenly distributed.

[0077] The distal holder part is preferably arranged with a continuous wall extending around the circumference of the catheter, and can e.g. be realized as a short tube. The inner diameter of the distal holder part is preferably corresponding to an outer diameter of a proximal end of a funnel or connector part of the catheter.

[0078] The proximal holder part is preferably also arranged with a continuous wall extending around the circumference of the catheter, and can e.g. also be realized as a short tube. The inner diameter of the proximal holder part is preferably similar to, or slightly greater than, the outer diameter of the catheter shaft.

[0079] The distal holder part and the proximal holder part are both preferably made of a more rigid material than the sleeve. Additionally, or alternatively, the proximal holder part and the distal holder part may both have a greater wall thickness than the sleeve. The compactable sleeve is preferably made of a flexible, collapsible material. The relatively thicker and / or more rigid proximal holder part provides stability to the protective sleeve arrangement also in the expanded configuration.

[0080] The distal part of the catheter preferably comprises a funnel connected to or integrated with the distal end of a catheter shaft, the funnel defining the discharge opening, wherein the distal holder part is connected to the funnel. The funnel may also be referred to as a connector.

[0081] The compactable sleeve is extendable towards the proximal insertion tip, and wherein the compactable sleeve, in its expanded configuration, is preferably arranged to cover a substantial part of the catheter, and preferably more than 50% of the length of catheter, and more preferably at least 70% of the length of the catheter, and most preferably at least 90% of the length of the catheter. Generally, the larger the part of the surface that is covered by the protective sleeve, the lesser the risk of contamination of the surface if the catheter accidentally comes into contact with an object, for example a sink or a towel in the near vicinity of the user. The protective sleeve arrangement may, in the compacted storage configuration, have an axial length in the range of a few centimeters. Preferably, the axial length of the protective sleeve arrangement when in the compacted configuration is sufficiently low so that it does not extend over a coated part of the urinary catheter. More preferably, the axial length of the protective sleeve arrangement when in the compacted configuration is less than an uncoated part of the urinary catheter. Hereby, wetting of the entire coated part of the catheter shaft is facilitated.

[0082] The compactable sleeve is preferably folded in the compacted storage configuration, and preferably with concertina or accordion folds, to form an accordion or concertina pleated configuration. Hereby, the sleeve may be folded in the storage configuration, and in the expanded use configuration, the folds are straightened. However, other ways of compacting the compactable sleeve are also feasible, such as rolling the sleeve material, or just lumping the material together.

[0083] The distal holder part is preferably connected to the catheter by a snap lock attachment. This greatly facilitates the assembling process, since a snap fit or snap joint may hereby be obtained automatically as soon as the protective sleeve arrangement is brought into position on the catheter. The connection may be releasable or fixed. The distal holder part and the proximal holder part are preferably connected to each other by a snap lock and / or press lock arrangement. This makes manufacturing simple and cost-efficient. Further, it also allows the distal holder part and proximal holder part to be reassembled and reconnected after having been separated in the expanded configuration.

[0084] The compactable sleeve may, in the compacted storage configuration, be arranged outside the proximal and distal holder parts. Optionally, an outer tubular member may be provided to enclose and cover the compactable sleeve when in the compacted configuration.

[0085] The proximal holder part may be arranged to be inserted into the distal holder part. Thus, the releasable connection between the proximal and distal holder parts may hereby be provided between an outer surface of the proximal holder part and an inner surface of the distal holder part. The releasable connection may e.g. be formed as a snap joint or a friction joint. However, other types of joints are also feasible. Further, other embodiments, such as the distal holder part being arranged to be inserted into the proximal holder part, are also feasible.

[0086] In the present application, the term “proximal” is used to indicate the end or portion of a catheter that is inserted into the body of the user, i.e. the end or portion of the catheter shaft that during use is closer in proximity to the user’s body and / or initially enters the user’s body upon insertion. The term “distal” is used to refer to an end or portion of the catheter that is opposite the proximal end or portion and is typically further away from the user’s body. For the sake of consistency, when the terms "distal" and "proximal" are used in the context of other components, such as protective sleeve arrangement and its parts, which are not intended for introduction into the user's body, these terms are used in an analogous way. 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 an end or portion located opposite to such proximal end or portion.

[0087] For all the above-discussed aspects and embodiments, the catheter shaft of the catheter may be provided with a hydrophilic outer surface. The hydrophilic surface may be arranged as a hydrophilic coating arranged on a substrate of the catheter, as is per se well known in the art. However, the hydrophilic surface may alternatively be arranged as an integrated part of the catheter, such as an integrated layer, or alternatively, the entire catheter, or part(s) of the catheter, may be made of a hydrophilic material. The hydrophilic surface is preferably arranged to provide low friction when wetted. The hydrophilic surface may be a surface provided with a hydrophilic coating, for example made in accordance with EP 0 093 093 and EP 0 217 771. The package may also comprise a supply of wetting fluid, for wetting of the hydrophilic surface of the catheter. In an embodiment, the wetting fluid may be arranged in direct contact with the catheter, thereby maintaining the catheter in an activated, ready to use, state. Alternatively, the wetting fluid may be arranged in a separate compartment of the package, such as in a separate sachet arranged within the package. Hereby, the wetting fluid may be released at a suitable time prior to use, such as immediately before the intended use. Opening of the wetting fluid compartment for release of the wetting fluid can be made by e.g. applying a pressure on the wetting fluid compartment, such as by squeezing or pinching the sachet. However, other ways of opening the compartment are also feasible, as is per se well known in the art, such as by twisting, pulling, pushing, etc. According to yet another embodiment, the wetting fluid may be arranged in a separate compartment arranged in such a way that the catheter shaft can be moved through the compartment to be wetted. Such a compartment may e.g. be arranged so that the catheter shaft is pulled through the compartment upon extraction from a package.

[0088] The wetting fluid can e.g. be sterile water or saline. However, other fluids, such as vapor, may also be used.

[0089] The urinary catheter is preferably maintained sterile when arranged in the package. Hereby, the catheter is completely sterile when it exits the package, thereby reducing the risk of getting infected when used.

[0090] Intermittent urinary catheters are per se well-known in the art. An example of a urinary catheter is a catheter provided as a tube that is made of polyurethane (PU), polyolefin, or other polymer(s), and which is provided with a funnel / connector in the distal end. In the opposite proximal end (the tip end), the catheter is provided with one or more eyelets that let urine enter into the tube. For a male catheter the insertable length may be 250-350 mm and for a female catheter the insertable length may be between 60-130 mm. The insertable length corresponds to the length of the tubular element except for a few centimeters that are closest to the connector.

[0091] These and other aspects of the invention will be apparent from and elucidated with reference to the embodiments described hereinafter. BRIEF DESCRIPTION OF THE DRAWINGS

[0092] The present invention will be described in more detail with reference to the appended drawings, showing currently preferred embodiments of the invention.

[0093] Fig. l is a cross-sectional view of a urinary catheter assembly in accordance with one embodiment;

[0094] Fig. 2 is a cross-sectional view of a part of the package in Fig. 1;

[0095] Fig. 3 is a front view of the urinary catheter assembly of Fig 1;

[0096] Figs. 4a and 4b are a more detailed views of a part of the urinary catheter assembly of Fig. 1 in accordance with two different embodiments;

[0097] Figs. 5a-5c are illustrations of an intermittent urinary catheter assembly in accordance with an embodiment, with the sleeve in a compacted state, where Figs. 5a and 5b are perspective views, with the compactable sleeve being removed for visibility, and Fig. 5c is a cross-sectional view;

[0098] Figs. 6a-6d are schematic illustrations of alternative locking arrangements useable in e.g. the urinary catheter assembly of Fig. 1;

[0099] Fig. 7 is a cross-sectional view of a urinary catheter assembly in accordance with another embodiment;

[0100] Figs. 8a and 8b are schematic illustrations of alternative closure arrangements useable in urinary catheter assemblies in accordance with different embodiments; and

[0101] Figs. 9a and 9b are a sideview and a cross-sectional view, respectively, of a urinary catheter assembly in accordance with yet another embodiment.

[0102] DETAILED DESCRIPTION OF CURRENTLY PREFERRED EMBODIMENTS

[0103] In the following detailed description, preferred embodiments of the invention embodiments are exchangeable between the embodiments and may be combined in different ways, unless anything else is specifically indicated. It may also be noted that, for the sake of clarity, the dimensions of certain components illustrated in the drawings may differ from the corresponding dimensions in real-life implementations of the invention, e.g. the length of the medical device, etc.

[0104] A urinary catheter assembly as illustrated in Figs. 1-4 comprises a catheter 1 having an insertable section 11, comprising an insertable, proximal part, with an insertion tip and a catheter shaft, and a non-insertable section 12 at a distal part, forming a funnel or connector part. The non-insertable section 12 has a larger diameter than the insertable section 11 at least on a part thereof. The rear end of the non-insertable section may be flared or funnel-shaped, and may be arranged to be connected to a tapered connection part of a urine collection bag or the like. However, the non-insertable section may alternatively have a relatively uniform cross-sectional area.

[0105] The package comprises a first compartment 2a and a second compartment 2b with a transition opening 2c therebetween. The first compartment 2a is arranged to enclose the proximal part and at least a part of the tubular shaft of the catheter, and preferably at least the insertable section 11. The part of the urinary catheter being arranged in the first compartment is in the illustrative embodiment arranged in a curved or curled state during storage. The second compartment 2b is arranged to enclose at least the distal part 12 of the catheter, wherein the tubular shaft extends through the transition opening.

[0106] At least a part of the insertable section 11 forms an insertable length to be inserted through a urethra of the user. The insertable section comprises a tubular shaft and an insertion tip, which may be a closed, rounded end. Further the insertable section may comprise inlet openings (not shown), arranged in the vicinity of the insertion tip, so called catheter eyes or eyelets, leading into a lumen extending through the catheter, and into a discharge outlet or drainage opening arranged at the rearward, distal end of the non-insertable section 12.

[0107] The insertable section may be 80-140 mm for a female user and 200-350 mm for a male user. The urinary catheter assembly is in particular suitable for male catheters.

[0108] The insertable section 11 may comprise a hydrophilic surface, and form a hydrophilic catheter, as is per se well known in the art. The hydrophilic surface may be in the form of a hydrophilic surface coating, for example polyvinyl-pyrrolidone (PVP), which provides a low- friction surface when wetted with a wetting fluid. Even though PVP is the preferred hydrophilic material, other hydrophilic materials may be used, such as polyethylene oxide, polyvinyl alcohol, and the like. However, instead of a hydrophilic surface coating, the entire insertable section of the catheter may be formed of a hydrophilic material.

[0109] In case a hydrophilic catheter is used, the urinary catheter assembly may also comprise a wetting fluid. However, the wetting fluid for activation of the catheter need not be provided within the package / first compartment. Instead, a wetting fluid may be poured into the package / first compartment after opening of the package / first compartment, for wetting of the catheter while it still remains in the package / first compartment. In some occasions, the catheter may even be removed from the package / first compartment and wetted e.g. in a different container, even though this is normally not preferred.

[0110] However, preferably the wetting fluid is arranged within the assembly, and preferably within the package / first compartment, so that the hydrophilic surface of the catheter can be activated even before opening of the package / first compartment.

[0111] In a preferred embodiment, the wetting fluid is arranged directly in the first compartment of the package accommodating the catheter, so that the hydrophilic surface of the catheter is in direct contact with the wetting fluid during storage, and thereby is maintained in an activated, ready-to-use state.

[0112] However, in an alternative embodiment, the wetting fluid may be arranged separated from the catheter, in a wetting fluid container (not shown), such as a pouch or a sachet, or in a separate wetting fluid compartment of the package. The wetting fluid container or compartment can be openable by means of e.g. exerting a pressure to the container or compartment, whereby the wetting fluid is released into the package / first compartment, thereby wetting the hydrophilic surface of the catheter. The wetting fluid container or compartment may also be arranged to open automatically when the catheter assembly is opened, or when extraction of the catheter from the package / first compartment is initiated. The wetting fluid may alternatively be arranged in a wetting fluid compartment encircling a part of the catheter shaft, and preferably a distal part, not provided with the hydrophilic coating, so that wetting of the hydrophilic coating is obtained while the catheter shaft is pulled out through the wetting fluid compartment.

[0113] The wetting fluid is preferably a liquid, and most preferably an aqueous liquid, such as water or saline. However, the wetting fluid may also be a gas, providing a moist atmosphere in the package / first compartment sufficient for activation of the hydrophilic surface. Thus, the wetting fluid may be any fluid, gas or liquid, that wets / activates a hydrophilic surface of the catheter.

[0114] However, alternatively the catheter may be non-hydrophilic, and may e.g. be lubricated with gel prior to insertion.

[0115] In case a non-hydrophilic catheter is used, the urinary catheter assembly may comprise a supply of lubricant, such as a compartment arranged overlying the catheter shaft, so that the shaft is lubricated while being pulled out from the tubular case.

[0116] The second compartment 2b is provided with an extraction opening 21, preferably arranged at an opposite end of the second compartment than the transition opening 2c. The first compartment is arranged to enclose the proximal part, and at least a part of the tubular shaft therein, and preferably at least the entire insertable section 11. However, at least the distal, non-insertable part 12 of the urinary catheter forms an extending part extending out from the first compartment through the transition opening and into the second compartment 2b.

[0117] The package is preferably relatively rigid, and can e.g. be thermoformed into a desired shape. The package may e.g. comprise two thermoformed halves, being connected together around the peripheral edges by a weld 22.

[0118] However, alternatively the package can be more flexible. For example, the package can be made of sheet material, such as foils, connected together around the periphery, e.g. by welding.

[0119] The package is preferably capable of maintaining the interior in a sterile state. Further, in particular for embodiments where the hydrophilic catheter is maintained wetted and ready- to-use in the package, the package is preferably liquid impermeable, and most preferably made of a gas impermeable material. For example, the material may be a laminate, comprising a layer of a gas and / or liquid barrier material, such as SiOx, Al Ox or a metal layer, i.e. a metallized laminate. However, other impermeable materials may also be used. In other embodiments, the package may also be at least to some extent permeable to liquid and / or gas.

[0120] In an embodiment, the package is made of an inner layer 23a and an outer layer 23b, as illustrated schematically in Fig. 2.

[0121] The inner layer 23a may e.g. be made a plastic material, such as polypropylene (PP), polyethylene (PE) and / or polystyrene (PS), and is preferably relatively rigid. The inner layer of the package may provide a barrier to maintain a wetting fluid inside the package. The inner layer may e.g. be gas and / or liquid impermeable. The inner layer preferably has greater barrier properties than the outer layer. The material of the inner layer may be relatively thick and rigid and may e.g. be thermoformed into a desired shape.

[0122] The outer layer 23b may be used to provide other properties to the product, such as being colored to make the assembly more discreet. The outer layer may also provide a textured surface or the like, thereby increasing friction, which simplifies handling of the assembly. The outer layer may also in a cost-efficient way be printed to contain useful information about the assembly, such as instructions for use. The outer layer may be formed of a nonwoven or paper material. Such materials are available to a low cost. Such materials may also easily be printed and / or colored and may also be provided with a surface texture providing adequate tactile properties, such as a relatively high friction, which facilitates handling. The outer layer need not be impermeable to gas or liquid.

[0123] The outer layer 23b may be attached to the inner layer 23a in various ways. In an embodiment, the inner and outer layers are manufactured separately and subsequently connected together by welding, adhesion, or the like. The outer layer may also be mechanically connected to the inner layer, such as by friction and geometrical shape. The outer layer may have dimensions similar to the dimensions of the inner layer. In an embodiment, the outer layer is arranged to cover at least a greater part of the inner layer, and preferably essentially the entire inner layer.

[0124] In the package of the illustrative example, the peripheral weld 22, together with one or more welds 22’ between at least two sheets of the inner layer, form the two compartments. The outer layer is arranged connected to and overlying the sheets of the inner layer to cover at least part of at least the second compartment 2b, and preferably over both compartments.

[0125] The opening 21 is here formed by one or more peelable sections of the one or more welds connecting the inner layers together, and tear line(s) 22” in the outer layer(s) being arranged essentially overlying the peelable sections. The tear lines are preferably lines of reduced thickness or strength, such as lines of perforations. However, materials having inherent tear lines properties, such as thin paper, may also be used, or tear lines formed by easily torn material, such as paper, arranged connected to the inner layer in the vicinity of the peelable section.

[0126] The package comprises one or more tabs 24 extending out from the package in the vicinity of the extraction opening, enabling opening by simply pulling the tab(s) away from another tab or from the package. The peelable sections may have an extension sufficient to ensure that the distal part of the catheter is exposed and easy to grip, thereby facilitating subsequent extraction of the catheter from the package. By arrangement of tear line(s) in the outer layer arranged overlying, or at least essentially overlying, the peelable sections, it is ensured that tearing of the outer layer occurs simultaneously with the peel opening of the inner layer.

[0127] In the illustrative example, the package comprises two compartments, i.e. the first and second compartments as discussed in the foregoing. However, the principle of using a combination of peelable sections in welds between inner layers and corresponding and essentially overlying tear lines in outer layers, may be used also in other types of packages, such as in packages having only a single compartment, or in packages having more than two compartments.

[0128] The extraction opening 21 is preferably formed by at least three peelable sections of the one or more welds 22, 22’. A first peelable section 22a extends transversely to the peeling direction and the tabs 24 and a second and third peelable section 22b, 22’b extend away from the tabs 24 and the first peelable section 22a, in the peeling direction. The second and third peelable sections 22b, 22’b preferably extend in the same direction, and are preferably essentially parallel to each other.

[0129] The first peelable section 22a may have a central area pointing away from the second and third peelable section, and slanted portions connecting the central area to the second and third peelable sections, as best seen in Fig. 4. This facilitates initiation of a peel operation.

[0130] Further, a ridge 25 may be formed in at least one of the sheets, the ridge extending at least partly from the second peelable section 22b to the third peelable section 22’b, at a distance from the first peelable section 22a. The ridge facilitates opening of the package. The ridge may also ensure that a part of the package, and in particular a pivotable part formed between the ridge 25 and the first, second and third peelable sections 22a, 22b and 22’b, remains open until it is again closed. The ridge 25 is preferably an inwardly protruding, indented ridge, extending into the compartment, i.e. extending inwardly as seen from the interior of the compartment. The ridge preferably extends over a majority of the length between the second and third peelable section, and preferably over at least 60% of said length, and more preferably over at least 70 %, and most preferably over at least 80%. Further, the ridge preferably extends in a direction essentially perpendicular to the second and / or third peelable sections, i.e. in a direction essentially perpendicular to the axial direction of the underlying, distal part of the catheter. However, alternatively, the ridge may occur in a slanted direction, forming a non-perpendicular angle to the second and / or third peelable sections. The ridge 25 is preferably arranged overlying the distal part 12 of the catheter. This ensures that the distal part of the catheter becomes exposed upon opening, thereby facilitating extraction of the catheter.

[0131] The sheet of the package in which the ridge is arranged preferably has a curved shape between the second and third peelable sections, at least in a part including the ridge. The curved shape can e.g. be obtained by thermoforming. This enhances the functionality of the opening being maintained in an opened state once opened. A by-pass opening 26 may be provided between the first compartment 2a and the second compartment 2b, at a distance from the transition opening 2c. The by-pass opening provide an additional path for fluid communication between the compartments. This is useful to ensure that any wetting fluid present in the second compartment 2b may be transferred back to the first compartment 2a, e.g. to ensure that the wetting fluid may serve its desired purpose of wetting a hydrophilic surface of the catheter. Hereby, the distal part 12 of the catheter may be kept relatively dry, thereby making handling of the catheter simpler and more convenient.

[0132] The by-pass opening is also very useful in facilitating reinsertion of the catheter into the package after use, since it allows air to be released from the first compartment into the second compartment, and out to the ambient atmosphere through the extraction opening, as pressure increases in the first compartment.

[0133] Preferably, a cross-sectional area of the by-pass opening 26 is smaller than a cross- sectional area of the transition opening 2c. Further, an inner diameter of the by-pass opening 26 is preferably smaller than an outer diameter of the tubular shaft 11.

[0134] The by-pass opening 26 preferably extends away from the second compartment 2b at least partly in a direction away from the extraction opening 21, as best seen in Figs. 4a and 4b. In the illustrative embodiment, the second compartment 2b is elongated in a first length direction, wherein the by-pass opening 26 extends along a second length direction, the first and second length directions being non-perpendicular, and preferably in the range 45-89 degrees, and more preferably in the range 70-85 degrees. The slanted disposition of the bypass opening ensures that when the assembly is held in an upright position, such as when the package is about to be opened for use, any wetting fluid present in the second compartment will, due to gravity, drain into the first compartment.

[0135] In the illustrative embodiment, the weld 22’ separates the first and second compartments, forming a common sidewall for the two compartments. The by-pass opening is preferably arranged through this weld / sidewall.

[0136] In an embodiment, as best seen in Figs. 4a and 4b, a wall of the second compartment 2b in the vicinity of an entrance of the by-pass opening 26, in a plane parallel to a length direction of the second compartment, forms outwardly slanted surfaces, thereby forming a drop towards the entrance of the by-pass opening. In particular, this may be provided by providing the two weld sections 22’ c and 22’ d on each side of the by-pass opening in a slanted disposition, slanted towards the first compartment 2a. The package is preferably re-closable after use, which is of particular advantage in situations where the catheter is reinserted into the package after use. To this end, the package may be provided with a locking arrangement, e.g. formed by the tabs 24.

[0137] The tabs 24 formed in the sheets in the vicinity of the extraction opening 21 are preferably overlying each other, and extend away from the second compartment 2b. The tabs are preferably not entirely overlapping, thereby providing at least one area on one of the tabs which is not overlapping with the other tab. Such non-overlapping areas facilitates separation of the tabs, thereby facilitating handling of the catheter assembly.

[0138] Further, as best seen in Figs. 4a and 4b, at least one of the tabs, and preferably both, comprises an opening 241. The opening is formed by a closed loop encircling the periphery of the tab. At least one of the tabs 24 further comprises a waist 242. For locking, a tab with the waist 242 may be inserted into the opening 241 of the other tab, thereby forming a mechanical locking.

[0139] The waist 242 is preferably formed by at least one pair of laterally extending protrusions arranged in the vicinity of a free end of the second tab. This forms an enlargement, in the width direction, thereby forming the waist below the enlargement. Additionally, or alternatively, the waist may be formed by at least one pair of laterally extending indentations arranged as a distance from a free end of the second tab.

[0140] In an embodiment, the opening in the first tab has a width which is equal to or greater than the extension of the waist in the width direction. Additionally, or alternatively, it is preferred that a part of the second tab arranged in the vicinity of the free end of the second tab, and arranged on the other side of the waist than the compartment, has an extension in the width direction which is greater than the width of the opening in the first tab.

[0141] In an embodiment, as illustrated in Figs. 4a and 4b, a first pair of inwardly directed indentations 242 may be formed in a first tab. The indentations 242 are hereby directed towards each other from opposite sides of the tab. A second pair of outwardly directed indentations 242’ may be formed in a second tab. The indentations 242’ are hereby arranged in the closed opening 241, and directed away from each other, from opposite sides of the internal periphery of the internal opening 241. When arranged to be locked, the indentations 242 and 242’ will interact, thereby forming a relatively strong mechanical lock.

[0142] In the embodiment of Figs. 4a and 4b, the indentations 242 and 242’ are formed as relatively symmetric V-shapes, or triangular shapes, formed by upper and lower border sides arranged slanted towards each other. However, many other shapes are also feasible. For example, as illustrated in Figs. 6a and 6b, the indentations 242 and 242’ may have an essentially rectangular shape, with two border sides extending essentially perpendicularly to the length direction of the tabs and package. The border sides extending essentially perpendicular to the length direction of the tabs / package are particularly useful in forming a strong locking. In another example, as illustrated in Figs. 6c and 6d, only one of the border sides extends essentially perpendicular to the length direction, whereas another border side is slanted.

[0143] With continued reference to Figs. 1-4, the first compartment 2a is preferably arranged to maintain the urinary catheter, when arranged in the package / first compartment, in a curled state during storage. To this end, the container may have curved inner boundaries, forming a border which the catheter can follow, and thereby be maintained in the curled / curved state. In the illustrative embodiment, the catheter is curled into about 1.5 turns, i.e. with a full and a half convolution. This generally reduces the length of the catheter to a third of its original length, allowing the catheter assembly to be correspondingly compacted.

[0144] In the illustrative embodiment, the cavity holding the catheter is closed in the center, e.g. by a weld arranged in the center, thereby making the assembly more stable and rigid, and providing better protection for the catheter. However, additional boundaries, e.g. formed by welds, may also be formed in the interior of the cavity. Such additional boundaries may e.g. be used to define channels extending along the intended curved / curled path of the catheter. For example, in the illustrated example, the free area inside the curled catheter may comprise an additional inner boundary, e.g. defining a circle or ellipse, thereby reducing the space of the cavity. A totally open cavity is also feasible.

[0145] The catheter may also be arranged to be more or less curved / curled. For example, the catheter may be arranged in less than a full convolution, such as generally forming the shape of a C or U. Alternatively, the catheter may be arranged in more than 1 or 1.5 convolutions, such as in about 2 or about three convolutions.

[0146] For embodiment where the catheter extends over more than 1.5 convolutions, the same container / first compartment as shown in Fig. 1 may still be used. Hereby, the catheter will at places overlap itself, and at least parts of the convolutions will be in touch with each other. However, for such embodiments having more convolutions, the boundaries may be used to define also the additional convolutions.

[0147] The above shown curved or curled shape of the catheter are merely exemplary, and many other ways of forming a compact shaped catheter are feasible, and may be defined by T1 different types of boundaries within the container / first compartment. However, it is generally preferred to have curves with a relatively large radius of curvature, thereby avoiding kinking of the catheter shaft, and also to reduce the permanent deformation of the catheter due to the memory effect of the catheter shaft material. The catheter is preferably also arranged so that no part of the catheter shaft is in direct contact with any other part of the catheter shaft, thereby avoiding wear and deterioration of the hydrophilic coating on the catheter shaft.

[0148] The catheter preferably has a proximal section closest to the insertion tip which is relatively straight, which facilitates handling of the catheter and in particular facilitates insertion of the catheter into the urethra.

[0149] In embodiments, the package may also be configured to accommodate the catheter in a relatively straight state. In particular, such embodiments are well suited for female catheters, but may also be used for male catheters. Such an embodiment is illustrated in Fig. 7. Here, the first compartment 2a is positioned essentially directly below the second compartment 2b. A bypass opening 26 extends laterally, in a slanted disposition, out from the second compartment 2b, and then essentially in the length direction of the package into the first compartment. However, by-pass openings having other shapes are also feasible.

[0150] In the so far discussed embodiments, the extraction opening 21 is formed as a peel opening, comprising tabs 24 for facilitating peel opening by pulling the tabs apart. However, in embodiments, other types of openings are also feasible. For example, the extraction opening may be formed as an opening closed by a removable cap 21’, as illustrated schematically in Fig. 8a. The cap may be connected to the package by a snap lock mechanism, and the distal part 12 of the catheter may be arranged to extend out from the opening once the cap has been removed. The cap may further be recloseable after use. In an alternative embodiment, as illustrated schematically in Fig. 8b, the cap 21” may be provided with inwardly directed threads, and the package be provided with corresponding outwardly directed threads, thereby forming a screw connection between the cap and the package.

[0151] The opening may also be a peel opening formed by a sheet arranged overlying a perforation line extending along a closed or non-closed loop in a sheet material forming the package. The perforation line hereby defines a flap opening. The third sheet material covers, preferably with a margin, the entire flap opening. The adhesive is hereby adapted to maintain a sterile closure of the package before use, and to be resealable after use. Further, the third sheet material forms a tab not provided with adhesive, the tab providing a grip portion for peel opening of the package. Such opening arrangements are per se known from e.g. US 9649471 and US 10384033, by the same applicant, said documents hereby being incorporated in their entirety by reference.

[0152] In such embodiments, the upper or lower sheet forming the package may be essentially flat, whereas the other is thermoformed into a deep drawn shape. Such an embodiment is illustrated in Figs. 9a and 9b. Hereby, the peel opening may be formed in the essentially flat sheet. However, such peel openings may also be provided in sheets having curved, thermoformed shapes.

[0153] The urinary catheter assembly further comprises a protective sleeve arrangement 3 arranged around the non-insertable part of the urinary catheter, i.e. the distal part 12. The protective sleeve arrangement functions as an insertion aid, facilitating manipulation of the catheter for insertion into the urethra. In addition, the protective sleeve arrangement provides protection for the catheter shaft against contamination and enables manipulation of the catheter without touching it.

[0154] The protective sleeve arrangement 3 is connected to the distal part 12 of the catheter, and preferably connected to the connector or funnel. In the compacted configuration, as illustrated in Figs. 1 and 7, the protective sleeve arrangement 3 only extends over a very limited distal part of the catheter. In the expanded configuration a compactable sleeve of the protective sleeve arrangement 3 has been expanded, so that the protective sleeve arrangement extends over and covers a significant part of the catheter shaft. The protective sleeve arrangement 3 could have a length such that it essentially covers the entire catheter shaft. However, a longer protective sleeve arrangement could also be used, having a length exceeding the catheter shaft. Alternatively, the protective sleeve arrangement may have a shorter length, so that it does not cover the full length of the catheter shaft, thereby leaving a part of the catheter shaft in the vicinity of the proximal end uncovered and exposed also when the protective sleeve arrangement is in its expanded configuration.

[0155] Different embodiments of the protective sleeve arrangement will now be discussed in more detail, with reference to Figs. 5a-5c. In addition, the protective sleeve arrangement may also be realized in accordance with any of the embodiments disclosed in European patent application No. 22206363.8 by the same applicant, said document hereby being incorporated in its entirety by reference.

[0156] In one embodiment, as illustrated in Figs. 5a-5c, the protective sleeve arrangement comprises a distal holder part 31, a proximal holder part 32 and a compactable sleeve 33. The distal holder part 31 is connected to the catheter, and here to the proximal part of the funnel 12. The distal holder part in this embodiment comprises a tubular intermediate section 311, forming a continuous wall surrounding the catheter. At the distal end of the tubular intermediate section 311, one or more snap lock arms 313 may be provided. In the illustrative example, two such snap lock arms 313 are provided, arranged on opposite circumferential sides of the tubular intermediate section 311. The snap lock arms 313 may have small protrusions at the free ends, extending inwardly, towards the funnel 12. The funnel may be provided with one or more corresponding indentations, such as a waist formed in the vicinity of the proximal end of the funnel. Hereby, the snap lock arms 313 may form a snap joint or snap fit with the funnel when the distal holder part 31 is pushed up over the funnel 12.

[0157] Similar snap lock arms 312 may be arranged on the proximal side of the tubular intermediate section 311.

[0158] The proximal holder part 32 may comprise a generally cylindrical tubular section 321. At or in the vicinity of the proximal end of the proximal holder part 32, an outward protrusion, here in the form of an outwardly protruding flange 322, may be arranged. The outward protrusion 322 facilitates holding of the proximal holder part, e.g. through the walls of a package, and may also reduce the risk of the fingers slipping and sliding past the proximal end of the proximal holder part 32 during use. The flange may e.g. have an oval shape, as illustrated in Fig. 5a, or a circular shape, as illustrated in Fig. 5b. However, other shapes are also feasible.

[0159] The distal holder part and the proximal holder part may be connected by a snap joint or snap fit. This snap lock should be releasable. Preferably, the connection formed between the proximal and distal holder parts is much looser, and much easier to release, than the connection formed between the distal holder part and the catheter. This latter connection may even be a fixed, non-releasable joint.

[0160] The compactable sleeve 33 is connected with a distal end or part to the distal holder part 31, and with a proximal end or part to the proximal holder part 32. The connection can be provided by welding, shrink fit, adhesive, or the like.

[0161] The sleeve 33 is preferably made of a thin, flexible plastic material. The distal and proximal holder parts 31, 32 are preferably made of a thicker, more rigid material, and may e.g. be formed by injection molding.

[0162] In the embodiment discussed in relation to Figs. 5a-c the proximal holder part 32 is long enough to accommodate most of the compactable sleeve 33, when in the compacted configuration. In particular, most of the compactable sleeve 33 is arranged overlying the cylindrical tubular section 321 of the proximal holder part 32.

[0163] However, alternatively, the proximal holder part may be shorter, and the distal holder part be longer. Hereby, the compactable sleeve may primarily be arranged overlying the proximal section of the distal holder part instead.

[0164] In the illustrative embodiment, the distal end of the proximal holder part 32 has an inner diameter so that it can be inserted into the proximal end of the distal holder part 31, to form the releasable connection. However, the opposite arrangement is also feasible.

[0165] In the so far discussed embodiment, the sleeve is arranged outside the proximal and distal holder parts. However, it is also possible to provide a cover over the sleeve, for protective or esthetic reasons.

[0166] With reference again to Figs. 1 and 7, the package may, at or in the vicinity of the transition opening, comprise an engagement structure 27 for engaging the proximal holder part and / or the compactable sleeve, in a compacted state. The engagement structure engages the proximal holder part and / or the compactable sleeve, in a compacted state, in a more or less loose engagement. In embodiments, the engagement structure may hold the proximal holder part and / or the compactable sleeve so loosely that the protective sleeve arrangement will not be expanded when the catheter is expelled from the package. However, preferably, the engagement structure engages the proximal holder part and / or the compactable sleeve, in a compacted state, in a way stronger than the connection between the distal and proximal holder part. Hereby, the proximal holder part will be released from the distal holder part as the catheter is expelled, thereby automatically bringing the protective sleeve arrangement to its expanded state as the catheter is expelled. However, in embodiments where the engagement structure engages the proximal holder part, the connection between the proximal holder part and the engagement structure is still preferably loose enough to be easily releasable, so that the proximal holder part will easily be released from the package when fully extended. However, in embodiments where the engagement structure engages the compactable sleeve, a stronger connection may be provided, since the connection will in such embodiment be gradually weaker as the compactable sleeve is expanded.

[0167] The releasable connection between the engagement structure 27 and the proximal holder part 32 and / or compactable sleeve 33 is preferably also such that fluid may pass between an outer surface of the proximal holder part / compactable sleeve and an inner surface of the transition opening and engagement structure 27. This provides fluid communication between the first and second compartments also when the proximal holder part / compactable sleeve is in an engaged position.

[0168] As best seen in Figs. 4a and 4b, the engagement structure 27 preferably comprises inward protrusions 271 and at least one channel between the inward protrusions. The engagements structure preferably comprises a plurality of the inward protrusions 271 arranged distributed both in a longitudinal and width or circumferential direction. The inward protrusions 271 may hereby form a pattern on a part of the interior wall, such as a leopard pattern.

[0169] All the inward protrusions 271 are preferably separated from each other, thereby forming channels between all the inward protrusions. However, alternatively, clusters of two or more inward protrusions may also be provided. The inward protrusions are preferably distributed over essentially the entire part of the package housing the proximal holder part. The inward protrusions may be evenly distributed.

[0170] The inward protrusions may be circular or oval in shape, thereby forming inwardly protruding bumps. In the illustrative embodiment of Fig. 4a, the inward protrusions 271 have an oval shape and extend primarily in the width direction, whereas in the illustrative embodiment of Fig. 4b, the oval shaped protrusions 271 extend primarily in the length direction.

[0171] In an embodiment, as illustrated in Fig. 4a, the inward protrusions 271 may form a friction connection between the package and the compactable sleeve 33, when in a compacted state. In the compacted configuration, the compactable sleeve 33 may have a diameter greater than the diameter of the proximal holder part 32. During expelling of the catheter, the compacted sleeve will be gradually extended, moving from the compacted configuration to the extended configuration, and in this process the diameter of the compactable sleeve 33 will diminish and the friction connection to the package will become gradually weaker. Hereby, a very low additional extraction force, or even no additional extraction force at all, will be needed to expel the sleeve insertion aid together with the catheter from the package when the sleeve insertion aid has reached the expanded configuration.

[0172] In another embodiment, as illustrated in Fig. 4b, the inward protrusions 271 may instead form a friction connection between the package and the proximal holder part 32. In such an embodiment, the proximal holder part preferably has a greater diameter than the compactable sleeve 33. Alternatively, the proximal holder part and the compactable sleeve may have essentially the same diameter, and the inward protrusions 271 may form a friction connection between the package and both the proximal holder part and the compactable sleeve.

[0173] Specific embodiments of the invention have now been described. However, several alternatives are possible, as would be apparent for someone skilled in the art. For example, the various aspects of the invention may be used separately or in various combinations. In a preferred embodiment, all the aspects are used in combination. Further, the urinary catheter assembly preferably comprises a wetting liquid arranged in direct contact with a hydrophilic surface of the catheter. However, alternatively the wetting liquid may be arranged separated from the catheter, in a wetting fluid container. The catheter assembly may also be used for non-hydrophilic catheters, and without any wetting fluid. Still further, the arrangement of the catheter in a curved or curled state may be realized in many different ways, and it is also feasible to accommodate the catheter in a relatively straight disposition.

[0174] Such and other obvious modifications must be considered to be within the scope of the present invention, as it is defined by the appended claims. It should be noted that the above- mentioned embodiments illustrate rather than limit the 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 between parentheses shall not be construed as limiting to the claim. The word "comprising" does not exclude the presence of other elements or steps than those listed in the claim. The word "a" or "an" preceding an element does not exclude the presence of a plurality of such elements. Further, a single unit may perform the functions of several means recited in the claims.

Claims

CLAIMS1. A urinary catheter assembly comprising: a urinary catheter having a proximal part with an insertion tip, a distal part and a tubular shaft extending there between, wherein the distal part, on at least a part thereof, has a greater cross-sectional dimension than the tubular shaft and the proximal part; and a package forming at least one compartment to enclose the urinary catheter, wherein said package comprises an inner layer and an outer layer, wherein one or more welds between at least two sheets of the inner layer form the at least one compartment, the outer layer being arranged connected to and overlying the sheets of the inner layer to cover at least part of the at least one compartment; wherein the package comprises an extraction opening, the extraction opening being formed by one or more peelable sections of said one or more welds, and a part of the outer layer being arranged overlying the peelable sections being arranged to be tom open upon peel opening of the peelable sections, the outer layer preferably comprising tear lines in said outer layer being arranged essentially overlying said peelable sections.

2. The urinary catheter assembly of claim 1, wherein the inner layer has greater barrier properties than the outer layer.

3. The urinary catheter assembly of claim 1 or 2, wherein the inner layer forms a moisture barrier.

4. The urinary catheter assembly of any one of the claims 1-3, wherein the outer layer is formed of a nonwoven or paper material.

5. The urinary catheter assembly of any one of the claims 1-4, wherein the inner layer is formed of a plastic material.

6. The urinary catheter assembly of any one of the claims 1-5, wherein the tear lines are lines of reduced thickness or strength, such as lines of perforations.

7. The urinary catheter assembly of any one of the claims 1-5, wherein the tear lines are formed by the outer layer being attached to the inner layer on both sides of each of the peelable sections.

8. The urinary catheter assembly of any one of the claims 1-7, wherein the package has at least a first compartment and a second compartment with a transition opening therebetween, said first compartment being arranged to enclose the proximal part and at least a part of the tubular shaft therein, and said second compartment being arranged to enclose at least the distal part, wherein the tubular shaft extends through said transition opening; and wherein a by-pass opening is provided between the first compartment and the second compartment at a distance from said transition opening.

9. The urinary catheter assembly of claim 8, wherein a cross-sectional area of the by-pass opening is smaller than a cross-sectional area of the transition opening.

10. The urinary catheter assembly of claim 8 or 9, wherein an inner diameter of the by-pass opening is smaller than an outer diameter of the tubular shaft.

11. The urinary catheter assembly of any one of the claims 8-10, wherein the second compartment further has an extraction opening arranged opposite to the transition opening.

12. The urinary catheter assembly of claim 11, wherein the by-pass opening extends away from the second compartment at least partly in a direction away from the extraction opening.

13. The urinary catheter assembly of any one of the claims 8-12, wherein the second compartment is elongated in a first length direction, wherein the by-pass opening extends along a second length direction, the first and second length directions being nonperpendicular, and preferably in the range 45-89 degrees, and more preferably in the range 70-85 degrees.

14. The urinary catheter of any one of the claims of the claims 8-13, wherein the part of the urinary catheter being arranged in the first compartment is arranged in a curved orcurled state during storage.

15. The urinary catheter assembly of any one of the claims 8-14, wherein the second compartment forms an elongate compartment arranged along a sidewall of the first compartment.

16. The urinary catheter assembly of claim 15, wherein the sidewall of the first compartment is a common sidewall also for the second compartment, the sidewall forming a separation between the first and second compartments.

17. The urinary catheter assembly of claim 16, wherein the by-pass opening extends through the common sidewall.

18. The urinary catheter assembly of any one of the claims 8-17, wherein a wall of the second compartment in the vicinity of an entrance of the by-pass opening, in a plane parallel to a length direction of the second compartment, form outwardly slanted surfaces, thereby forming a drop towards the entrance of the by-pass opening.

19. The urinary catheter assembly of any one of the preceding claims, wherein said package comprises at least two sheets connected together by one or more welds, thereby forming the at least one compartment; and wherein the package comprises an extraction opening, the extraction opening being formed by one or more peelable sections of said one or more welds, the sheets in the vicinity of said peelable sections forming at least partly overlying tabs extending away from the compartment, a first of said tabs forming an opening and a second of said tabs forming a waist, thereby enabling a locking engagement between the tabs when the second tab is inserted into the opening of the first tab.

20. The urinary catheter of claim 19, wherein the waist is formed by at least one pair of laterally extending protrusions arranged in the vicinity of a free end of the second tab.

21. The urinary catheter of claim 19 or 20, wherein the waist is formed by at least one pair of laterally extending indentations arranged as a distance from a free end of thesecond tab.

22. The urinary catheter assembly of any one of the claims 19-21, wherein the tabs extend away from the compartment in the peel direction.

23. The urinary catheter assembly of any one of the claims 19-22, wherein the first tab comprises inwardly directed indentations and the second tab comprises outwardly directed indentations, wherein the indentations are arranged to interact in a locking arrangement.

24. The urinary catheter assembly of any one of the claims 19-23, wherein the opening in the first tab has a width which is equal to or greater than the extension of the waist in the width direction; and / or wherein a part of the second tab arranged in the vicinity of the free end of the second tab, and arranged on the other side of the waist than the compartment, has an extension in the width direction which is greater than the width of the opening in the first tab.

25. The urinary catheter assembly of any one of the preceding claims, wherein said package comprises at least two sheets connected together by one or more welds, thereby forming the at least one compartment; wherein the package comprises an extraction opening, the extraction opening being formed by at least three peelable sections of said one or more welds, at least one of the sheets in the vicinity of said peelable sections forming a tab extending away from the compartment, wherein a first peelable section extends transversely to the tabs and a second and third peelable section extend away from the tabs; and wherein a protruding ridge is formed in at least one of the sheets, the protruding ridge extending at least partly between the second peelable section to the third peelable section at a distance from said first peelable section.

26. The urinary catheter assembly of claim 25, wherein the ridge is an inwardly protruding, indented ridge, extending into the compartment.

27. The urinary catheter assembly of claim 25 or 26, wherein the ridge extends over a majority of the length between the second and third peelable section, and preferably over at least 60% of said length, and more preferably over at least 70 %, and most preferably over atleast 80%.

28. The urinary catheter assembly of any one of the claims 25-27, wherein the ridge extends in a direction essentially perpendicular to the second and / or third peelable sections.

29. The urinary catheter assembly of any one of the claims 25-28, wherein the ridge is arranged overlying the distal part of the catheter.

30. The urinary catheter assembly of any one of the claims 25-29, wherein the ridge extends in a direction essentially perpendicular to the axial direction of the distal part of the catheter.

31. The urinary catheter assembly of any one of the claims 25-30, wherein the sheet in which the ridge is arranged comprises a reinforcement at least in a part including the ridge, the reinforcement preferably comprising at least one of a corrugation in the sheet and a curved shape between the second and third peelable sections.

32. The urinary catheter assembly of any one of the claims 25-31, wherein a pivotable part of the sheet is defined by the first, second and third peelable sections and the ridge, wherein the ridge is arranged to function as a hinge between the pivotable part and the rest of the package.

33. The urinary catheter assembly of claim 32, wherein the ridge is arranged to maintain the pivotable part in a pivoted position.

34. The urinary catheter assembly of any one of the preceding claims wherein the package has at least a first compartment and a second compartment with a transition opening therebetween, further comprising a protective sleeve arrangement having a proximal holder part, a distal holder part and a compactable sleeve connected to the proximal holder part and the distal holder part, the compactable sleeve having a compacted storage configuration and being extendable into an expanded configuration, wherein the distal holder part is connected to the catheter at or near the distal part, and the proximal holder part and the distal holder part are releasably connected to each other; wherein the package, at or in the vicinity of thetransition opening, comprises inward protrusions and at least one channel between the inward protrusions, the inward protrusions arranged to releasably engage the proximal holder part and / or the compactable sleeve.

35. The urinary catheter assembly of claim 34, wherein the package comprises a plurality of the inward protrusions arranged distributed both in a longitudinal and width direction.

36. The urinary catheter assembly of claim 34 or 35, wherein the inward protrusions are separated from each other, thereby forming channels between all the inward protrusions.

37. The urinary catheter assembly of any one of the claims 34-36, wherein the inward protrusions are distributed over essentially the entire part of the package housing the proximal holder part and / or the compactable sleeve.

38. The urinary catheter assembly of any one of the claims 34-37, wherein the distal holder part and the proximal holder part are both made of a more rigid material than the sleeve.

39. The urinary catheter assembly of any one of the claims 34-38, wherein the distal part of the catheter comprises a funnel connected to or integrated with the distal end of the tubular shaft, said funnel defining the discharge opening, wherein the distal holder part is connected to the funnel.

40. The urinary catheter assembly of any one of the claims 34-39, wherein the compactable sleeve is extendable towards the proximal insertion tip, and wherein the compactable sleeve, in its expanded configuration, is arranged to cover a substantial part of the catheter, and preferably more than 50% of the length of catheter, and more preferably at least 70% of the length of the catheter, and most preferably at least 90% of the length of the catheter.

41. The urinary catheter assembly of any one of the claims 34-40, wherein the compactable sleeve is folded in the compacted storage configuration, and preferably withconcertina or accordion folds, to form an accordion or concertina pleated configuration.

42. The urinary catheter assembly of any one of the claims 34-41, wherein the distal holder part is connected to the catheter by a snap lock attachment.

43. The urinary catheter assembly of any one of the claims 34-42, wherein the distal holder part and the proximal holder part are connected to each other by a snap lock and / or press lock arrangement.

44. The urinary catheter assembly of any one of the claims 34-43, wherein the compactable sleeve, in the compacted storage configuration, is arranged outside the proximal and distal holder parts.

45. A urinary catheter assembly comprising: a urinary catheter having a proximal part with an insertion tip, a distal part and a tubular shaft extending there between, wherein the distal part, on at least a part thereof, has a greater cross-sectional dimension than the tubular shaft and the proximal part; and a package forming at least one compartment to enclose the urinary catheter, wherein said package comprises at least two sheets connected together by one or more welds, thereby forming the at least one compartment; wherein the package comprises an extraction opening, the extraction opening being formed by one or more peelable sections of said one or more welds, the sheets in the vicinity of said peelable sections forming at least partly overlying tabs extending away from the compartment, a first of said tabs forming an opening and a second of said tabs forming a waist, thereby enabling a locking engagement between the tabs when the second tab is inserted into the opening of the first tab.

46. The urinary catheter of claim 45, wherein the waist is formed by at least one pair of laterally extending protrusions arranged in the vicinity of a free end of the second tab.

47. The urinary catheter assembly of claim 45 or 46, wherein the waist is formed by at least one pair of laterally extending indentations arranged as a distance from a free end ofthe second tab.

48. The urinary catheter assembly of any one of the claims 45-47, wherein the tabs extend away from the compartment in the peel direction.

49. The urinary catheter assembly of any one of the claims 45-48, wherein the first tab comprises inwardly directed indentations and the second tab comprises outwardly directed indentations, wherein the indentations are arranged to interact in a locking arrangement.

50. The urinary catheter assembly of any one of the claims 45-49, wherein the opening in the first tab has a width which is equal to or greater than the extension of the waist in the width direction; and / or wherein a part of the second tab arranged in the vicinity of the free end of the second tab, and arranged on the other side of the waist than the compartment, has an extension in the width direction which is greater than the width of the opening in the first tab.

51. The urinary catheter assembly of any one of the claims 45-50, wherein the package has at least a first compartment and a second compartment with a transition opening therebetween, said first compartment being arranged to enclose the proximal part and at least a part of the tubular shaft therein, and said second compartment being arranged to enclose at least the distal part, wherein the tubular shaft extends through said transition opening; and wherein a by-pass opening is provided between the first compartment and the second compartment at a distance from said transition opening.

52. The urinary catheter assembly of claim 51, wherein a cross-sectional area of the by-pass opening is smaller than a cross-sectional area of the transition opening.

53. The urinary catheter assembly of claim 51 or 52, wherein an inner diameter of the by-pass opening is smaller than an outer diameter of the tubular shaft.

54. The urinary catheter assembly of any one of the claims 51-53, wherein the second compartment further has an extraction opening arranged opposite to the transitionopening.

55. The urinary catheter assembly of claim 54, wherein the by-pass opening extends away from the second compartment at least partly in a direction away from the extraction opening.

56. The urinary catheter assembly of any one of the claims 51-55, wherein the second compartment is elongated in a first length direction, wherein the by-pass opening extends along a second length direction, the first and second length directions being nonperpendicular, and preferably in the range 45-89 degrees, and more preferably in the range 70-85 degrees.

57. The urinary catheter of any one of the claims 51-56, wherein the part of the urinary catheter being arranged in the first compartment is arranged in a curved or curled state during storage.

58. The urinary catheter assembly of any one of the claims 51-57, wherein the second compartment forms an elongate compartment arranged along a sidewall of the first compartment.

59. The urinary catheter assembly of claim 58, wherein the sidewall of the first compartment is a common sidewall also for the second compartment, the sidewall forming a separation between the first and second compartments.

60. The urinary catheter assembly of claim 59, wherein the by-pass opening extends through the common sidewall.

61. The urinary catheter assembly of any one of the claims 51-60, wherein a wall of the second compartment in the vicinity of an entrance of the by-pass opening, in a plane parallel to a length direction of the second compartment, form outwardly slanted surfaces, thereby forming a drop towards the entrance of the by-pass opening.

62. The urinary catheter assembly of any one of the claims 45-61, wherein said package comprises at least two sheets connected together by one or more welds, thereby forming the at least one compartment; wherein the package comprises an extraction opening, the extraction opening being formed by at least three peelable sections of said one or more welds, at least one of the sheets in the vicinity of said peelable sections forming a tab extending away from the compartment, wherein a first peelable section extends transversely to the tabs and a second and third peelable section extend away from the tabs; and wherein a protruding ridge is formed in at least one of the sheets, the protruding ridge extending at least partly between the second peelable section to the third peelable section at a distance from said first peelable section.

63. The urinary catheter assembly of claim 62, wherein the ridge is an inwardly protruding, indented ridge, extending into the compartment.

64. The urinary catheter assembly of claim 62 or 63, wherein the ridge extends over a majority of the length between the second and third peelable section, and preferably over at least 60% of said length, and more preferably over at least 70 %, and most preferably over at least 80%.

65. The urinary catheter assembly of any one of the claims 62-64, wherein the ridge extends in a direction essentially perpendicular to the second and / or third peelable sections.

66. The urinary catheter assembly of any one of the claims 62-65, wherein the ridge is arranged overlying the distal part of the catheter.

67. The urinary catheter assembly of any one of the claims 62-66, wherein the ridge extends in a direction essentially perpendicular to the axial direction of the distal part of the catheter.

68. The urinary catheter assembly of any one of the claims 62-67, wherein the sheet in which the ridge is arranged comprises a reinforcement at least in a part including the ridge, the reinforcement preferably comprising at least one of a corrugation in the sheet and acurved shape between the second and third peelable sections.

69. The urinary catheter assembly of any one of the claims 62-68, wherein a pivotable part of the sheet is defined by the first, second and third peelable sections and the ridge, wherein the ridge is arranged to function as a hinge between the pivotable part and the rest of the package.

70. The urinary catheter assembly of claim 69, wherein the ridge is arranged to maintain the pivotable part in a pivoted position.

71. The urinary catheter assembly of any one of the claims 45-70 wherein the package has at least a first compartment and a second compartment with a transition opening therebetween, further comprising a protective sleeve arrangement having a proximal holder part, a distal holder part and a compactable sleeve connected to the proximal holder part and the distal holder part, the compactable sleeve having a compacted storage configuration and being extendable into an expanded configuration, wherein the distal holder part is connected to the catheter at or near the distal part, and the proximal holder part and the distal holder part are releasably connected to each other; wherein the package, at or in the vicinity of the transition opening, comprises inward protrusions and at least one channel between the inward protrusions, the inward protrusions arranged to releasably engage the proximal holder part and / or the compactable sleeve.

72. The urinary catheter assembly of claim 71, wherein the package comprises a plurality of the inward protrusions arranged distributed both in a longitudinal and width direction.

73. The urinary catheter assembly of claim 71 or 72, wherein the inward protrusions are separated from each other, thereby forming channels between all the inward protrusions.

74. The urinary catheter assembly of any one of the claims 71-73, wherein the inward protrusions are distributed over essentially the entire part of the package housing the proximal holder part.

75. The urinary catheter assembly of any one of the claims 71-74, wherein the distal holder part and the proximal holder part are both made of a more rigid material than the sleeve.

76. The urinary catheter assembly of any one of the claims 71-75, wherein the distal part of the catheter comprises a funnel connected to or integrated with the distal end of the tubular shaft, said funnel defining the discharge opening, wherein the distal holder part is connected to the funnel.

77. The urinary catheter assembly of any one of the claims 71-76, wherein the compactable sleeve is extendable towards the proximal insertion tip, and wherein the compactable sleeve, in its expanded configuration, is arranged to cover a substantial part of the catheter, and preferably more than 50% of the length of catheter, and more preferably at least 70% of the length of the catheter, and most preferably at least 90% of the length of the catheter.

78. The urinary catheter assembly of any one of the claims 71-77, wherein the compactable sleeve is folded in the compacted storage configuration, and preferably with concertina or accordion folds, to form an accordion or concertina pleated configuration.

79. The urinary catheter assembly of any one of the claims 71-78, wherein the distal holder part is connected to the catheter by a snap lock attachment.

80. The urinary catheter assembly of any one of the claims 71-79, wherein the distal holder part and the proximal holder part are connected to each other by a snap lock and / or press lock arrangement.

81. The urinary catheter assembly of any one of the claims 71-80, wherein the compactable sleeve, in the compacted storage configuration, is arranged outside the proximal and distal holder parts.

82. A urinary catheter assembly comprising: a urinary catheter having a proximal part with an insertion tip, a distal part and atubular shaft extending there between, wherein the distal part, on at least a part thereof, has a greater cross-sectional dimension than the tubular shaft and the proximal part; and a package forming at least one compartment to enclose the urinary catheter, wherein said package comprises at least two sheets connected together by one or more welds, thereby forming the at least one compartment; wherein the package comprises an extraction opening, the extraction opening being formed by at least three peelable sections of said one or more welds, at least one of the sheets in the vicinity of said peelable sections forming a tab extending away from the compartment, wherein a first peelable section extends transversely to the tab and a second and third peelable section extend away from the tab, wherein a ridge is formed in at least one of the sheets, the ridge extending at least partly between the second peelable section to the third peelable section at a distance from said first peelable section.

83. The urinary catheter assembly of claim 82, wherein the ridge is an inwardly protruding, indented ridge, extending into the compartment.

84. The urinary catheter assembly of claim 82 or 83, wherein the ridge extends over a majority of the length between the second and third peelable section, and preferably over at least 60% of said length, and more preferably over at least 70 %, and most preferably over at least 80%.

85. The urinary catheter assembly of any one of the claims 82-84, wherein the ridge extends in a direction essentially perpendicular to the second and / or third peelable sections.

86. The urinary catheter assembly of any one of the claims 82-85, wherein the ridge is arranged overlying the distal part of the catheter.

87. The urinary catheter assembly of any one of the claims 82-86, wherein the ridge extends in a direction essentially perpendicular to the axial direction of the distal part of the catheter.

88. The urinary catheter assembly of any one of the claims 82-87, wherein the sheet in which the ridge is arranged comprises a reinforcement at least in a part including the ridge,the reinforcement preferably comprising at least one of a corrugation in the sheet and a curved shape between the second and third peelable sections.

89. The urinary catheter assembly of any one of the claims 82-88, wherein a pivotable part of the sheet is defined by the first, second and third peelable sections and the ridge, wherein the ridge is arranged to function as a hinge between the pivotable part and the rest of the package.

90. The urinary catheter assembly of claim 89, wherein the ridge is arranged to maintain the pivotable part in a pivoted position.

91. The urinary catheter assembly of any one of the claims 82-90, wherein the package has at least a first compartment and a second compartment with a transition opening therebetween, said first compartment being arranged to enclose the proximal part and at least a part of the tubular shaft therein, and said second compartment being arranged to enclose at least the distal part, wherein the tubular shaft extends through said transition opening; and wherein a by-pass opening is provided between the first compartment and the second compartment at a distance from said transition opening.

92. The urinary catheter assembly of claim 91, wherein a cross-sectional area of the by-pass opening is smaller than a cross-sectional area of the transition opening.

93. The urinary catheter assembly of claim 91 or 92, wherein an inner diameter of the by-pass opening is smaller than an outer diameter of the tubular shaft.

94. The urinary catheter assembly of any one of the claims 91-93, wherein the second compartment further has an extraction opening arranged opposite to the transition opening.

95. The urinary catheter assembly of claim 94, wherein the by-pass opening extends away from the second compartment at least partly in a direction away from the extraction opening.

96. The urinary catheter assembly of any one of the claims 91-95, wherein the second compartment is elongated in a first length direction, wherein the by-pass opening extends along a second length direction, the first and second length directions being nonperpendicular, and preferably in the range 45-89 degrees, and more preferably in the range 70-85 degrees.

97. The urinary catheter of any one of the preceding claims, wherein the part of the urinary catheter being arranged in the first compartment is arranged in a curved or curled state during storage.

98. The urinary catheter assembly of any one of the claims 91-97, wherein the second compartment forms an elongate compartment arranged along a sidewall of the first compartment.

99. The urinary catheter assembly of claim 98, wherein the sidewall of the first compartment is a common sidewall also for the second compartment, the sidewall forming a separation between the first and second compartments.

100. The urinary catheter assembly of claim 99, wherein the by-pass opening extends through the common sidewall.

101. The urinary catheter assembly of any one of the claims 91-100, wherein a wall of the second compartment in the vicinity of an entrance of the by-pass opening, in a plane parallel to a length direction of the second compartment, form outwardly slanted surfaces, thereby forming a drop towards the entrance of the by-pass opening.

102. The urinary catheter assembly of any one of the claims 82-101 wherein the package has at least a first compartment and a second compartment with a transition opening therebetween, further comprising a protective sleeve arrangement having a proximal holder part, a distal holder part and a compactable sleeve connected to the proximal holder part and the distal holder part, the compactable sleeve having a compacted storage configuration and being extendable into an expanded configuration, wherein the distal holder part is connected to the catheter at or near the distal part, and the proximal holder part and the distal holder partare releasably connected to each other; wherein the package, at or in the vicinity of the transition opening, comprises inward protrusions and at least one channel between the inward protrusions, the inward protrusions arranged to releasably engage the proximal holder part and / or the compactable sleeve.

103. The urinary catheter assembly of claim 102, wherein the package comprises a plurality of the inward protrusions arranged distributed both in a longitudinal and width direction.

104. The urinary catheter assembly of claim 102 or 103, wherein the inward protrusions are separated from each other, thereby forming channels between all the inward protrusions.

105. The urinary catheter assembly of any one of the claims 102-104, wherein the inward protrusions are distributed over essentially the entire part of the package housing the proximal holder part and / or the compactable sleeve.

106. The urinary catheter assembly of any one of the claims 102-105, wherein the distal holder part and the proximal holder part are both made of a more rigid material than the sleeve.

107. The urinary catheter assembly of any one of the claims 102-106, wherein the distal part of the catheter comprises a funnel connected to or integrated with the distal end of the tubular shaft, said funnel defining the discharge opening, wherein the distal holder part is connected to the funnel.

108. The urinary catheter assembly of any one of the claims 102-107, wherein the compactable sleeve is extendable towards the proximal insertion tip, and wherein the compactable sleeve, in its expanded configuration, is arranged to cover a substantial part of the catheter, and preferably more than 50% of the length of catheter, and more preferably at least 70% of the length of the catheter, and most preferably at least 90% of the length of the catheter.

109. The urinary catheter assembly of any one of the claims 102-108, wherein the compactable sleeve is folded in the compacted storage configuration, and preferably with concertina or accordion folds, to form an accordion or concertina pleated configuration.

110. The urinary catheter assembly of any one of the claims 102-109, wherein the distal holder part is connected to the catheter by a snap lock attachment.

111. The urinary catheter assembly of any one of the claims 102-110, wherein the distal holder part and the proximal holder part are connected to each other by a snap lock and / or press lock arrangement.

112. The urinary catheter assembly of any one of the claims 102-111, wherein the compactable sleeve, in the compacted storage configuration, is arranged outside the proximal and distal holder parts.

113. A urinary catheter assembly comprising: a urinary catheter having a proximal part with an insertion tip, a distal part and a tubular shaft extending there between, wherein the distal part, on at least a part thereof, has a greater cross-sectional dimension than the tubular shaft and the proximal part; a package having at least a first compartment and a second compartment with a transition opening therebetween, said first compartment being arranged to enclose the proximal part and at least a part of the tubular shaft therein and said second compartment being arranged to enclose at least the distal part, wherein the tubular shaft extends through said transition opening; and a protective sleeve arrangement having a proximal holder part, a distal holder part and a compactable sleeve connected to the proximal holder part and the distal holder part, the compactable sleeve having a compacted storage configuration and being extendable into an expanded configuration, wherein the distal holder part is connected to the catheter at or near the distal part, and the proximal holder part and the distal holder part are releasably connected to each other, wherein the package, at or in the vicinity of the transition opening, comprises inward protrusions and at least one channel between the inward protrusions, the inward protrusionsarranged to releasably engage the proximal holder part and / or the compactable sleeve.

114. The urinary catheter assembly of claim 113, wherein the package comprises a plurality of the inward protrusions arranged distributed both in a longitudinal and width direction.

115. The urinary catheter assembly of claim 113 or 114, wherein the inward protrusions are separated from each other, thereby forming channels between all the inward protrusions.

116. The urinary catheter assembly of any one of the claims 113-115, wherein the inward protrusions are distributed over essentially the entire part of the package housing the proximal holder part and / or the compactable sleeve.

117. The urinary catheter assembly of any one of the claims 113-116, wherein the distal holder part and the proximal holder part are both made of a more rigid material than the sleeve.

118. The urinary catheter assembly of any one of the claims 113-117, wherein the distal part of the catheter comprises a funnel connected to or integrated with the distal end of the tubular shaft, said funnel defining the discharge opening, wherein the distal holder part is connected to the funnel.

119. The urinary catheter assembly of any one of the claims 113-118, wherein the compactable sleeve is extendable towards the proximal insertion tip, and wherein the compactable sleeve, in its expanded configuration, is arranged to cover a substantial part of the catheter, and preferably more than 50% of the length of catheter, and more preferably at least 70% of the length of the catheter, and most preferably at least 90% of the length of the catheter.

120. The urinary catheter assembly of any one of the claims 113-119, wherein the compactable sleeve is folded in the compacted storage configuration, and preferably withconcertina or accordion folds, to form an accordion or concertina pleated configuration.

121. The urinary catheter assembly of any one of the claims 113-120, wherein the distal holder part is connected to the catheter by a snap lock attachment.

122. The urinary catheter assembly of any one of the claims 113-121, wherein the distal holder part and the proximal holder part are connected to each other by a snap lock and / or press lock arrangement.

123. The urinary catheter assembly of any one of the claims 113-122, wherein the compactable sleeve, in the compacted storage configuration, is arranged outside the proximal and distal holder parts.

124. The urinary catheter assembly of any one of the preceding claims, wherein the package is thermoformed to a relatively rigid package, the package preferably being more rigid than the tubular shaft.

125. The urinary catheter assembly of any one of the preceding claims, wherein the tubular shaft of the catheter is provided with a hydrophilic outer surface, and preferably a hydrophilic coating.

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