WO2023180721A1

WO2023180721A1 - A catheter assembly

Info

Publication number: WO2023180721A1
Application number: PCT/GB2023/050691
Authority: WO
Inventors: Oliver PFLEGER
Original assignee: Convatec Limited
Priority date: 2022-03-21
Filing date: 2023-03-20
Publication date: 2023-09-28

Abstract

A packaged catheter assembly comprising a packaged catheter assembly comprising a catheter and a pouch having two walls and a peripheral seal between the two walls, wherein the pouch is configured to contain the catheter within it, each wall comprises a tab extending from an edge of the pouch, and the tabs are configured to be separated in use to create an opening in the peripheral seal. The catheter may be a male urinar catheter. The tabs may have a length less than the length of the edge of the pouch. The pouch may be resealable. Each tab may comprise a crease-line. Each tab may comprise a gripping hole. A gripping hole may be in overlap with an edge of the other tab. A method of manufacture and unpackaging is also provided. The method may involve folding or unfolding the tabs against the pouch.

Description

A catheter assembly

Technical Field of the Invention

The present invention relates to catheter assemblies. In particular the invention concerns packaged urinary catheter assemblies, and most particularly, but not exclusively packaged intermittent male urinary catheter assemblies, especially “closed” catheter assemblies.

Background to the Invention

Many people suffer from urinary problems that can make it difficult to pass urine. Intermittent catheter assemblies can provide a convenient and portable solution to this problem as a user is able to self-catheterise to relieve themselves as required. This reduces the effect of their urinary condition on their life and allows thm to enjoy a relatively normal lifestyle.

It is desirable for catheter assemblies to be compact so that they are easily portable. However, this can cause problems during use of the catheter as the components of the assembly are made smaller or are concealed within the assembly in a way that is difficult to access. This can make use of the catheter in a safe and controlled manner difficult.

When using a packaged catheter assembly, often multiple different actions are required to prepare the catheter for use. These actions may also require the manipulation of different parts of the packaged catheter assembly and as such at any one time one or more parts of the packaged catheter assembly may not be required. This can make the catheter difficult to use as the user must carefully hold and manipulate the different parts of the assembly while ensuring the entire assembly remains clean and free from dirt to minimise the risk of infection.

To reduce the risk of damage to the urinary tract and improve comfort while using the catheter, it is also important they are activated before use for example through wetting of the catheter by a wetting fluid. However, once wetted and/or used a catheter can be slippery and difficult to handle. This can make handling and re -packaging of the catheter after use difficult and unhygienic, as the catheter may inadvertently contact the user’s hands, clothing or personal items. Existing intermittent catheters disclose continuous handling sleeves that cover the entire length of the catheter. While these provide some assistance to handling, the sleeve can make the catheter more difficult to wet as wetting fluid may not be able to easily reach all parts of the catheter.

To provide discrete and portable catheter assemblies, packaging may be provided to contain the catheter and any other equipment such as wetting reservoirs or sachets and fluid collection bags before and/or after use. However, these items may become wet which makes handling and re-packaging of them difficult. In addition, where liquid is contained within a sachet, reservoir or bag within the packaging, any release (intentional or otherwise) of this may cause liquid to accidentally leak out of the packaging causing problems for the user.

It is further also desirable that catheter assemblies are discreet such that a layperson may not identify them as a packaged catheter assembly at all. This can make a user feel more comfortable carrying and using them. However, along with being compact, the packaged catheter assembly must remain usable such as by providing visual feedback of the drain of fluid from the body. This can make providing a discreet packaged catheter assembly that is also easy to use difficult and so a user may decide to place the packaged catheter assembly in a dedicated bag to hide it. However, this can cause hygiene issues if the bag is not cleaned/replaced regularly and also increase the weight and bulk of the packaged catheter assembly when carried around.

Users can also have problems in opening packaging and accessing its contents. This can happen because the packaging must be robust enough to ensure its contents is not inadvertently released and so opening of the packaging may require careful manipulation as well as a large force. This can mean the user either cannot use the catheter as they cannot access it or that the package is not opened in a controlled manner. This can cause embarrassment for the user but also inconvenience as the catheter may be rendered useless if it is allowed to fall on the floor or otherwise comes into contact with dirt.

To allow self-catheterisation as required, closed catheter assemblies collect and retain urine using a fluid collection bag, which removes the need for urine to pass directly into a toilet. However, once used, a fluid collection bag is heavy and bulky as it is filled with liquid. To allow the bag to be carried and disposed of more discretely and easily, existing bags may be provided with a drain to allow them to be emptied into a toilet. However, existing drains can either leak or are difficult to open which potentially results in inadvertent or uncontrolled release of liquid from the bag. In addition, after use the bag may be stored before cleaning or disposal, however, the drain can make storage of the bag difficult and unhygienic.

It is an object of embodiments of th present invention to at least partially overcome or alleviate the above problems and/or to provide an improved packaged catheter assembly.

Summary of the Invention

In broad terms, the present invention concerns a catheter assembly comprising a catheter. In addition, the present invention also concerns a packaged catheter assembly comprising a pouch and the catheter assembly, wherein the pouch is configured to contain the catheter assembly within it. The pouch may be configured to contain within it any one or more of: a catheter; a fluid reservoir; a fluid collection bag; and a sleeve, any of which may be as defined in the statements of invention below.

According to one broad aspect of the present invention there is provided a catheter assembly comprising a fluid collection bag; a catheter; and a passageway extending from the fluid collection bag. Preferably the passageway has an extended configuration and a stowed configuration. Preferably in the extended configuration the passageway permits fluid to pass therethrough and in/out of the bag, and preferably in the stowed configuration the passageway is folded or rolled to inhibit flow of fluid therethrough.

In the extended configuration, the passageway may extend beyond an edge of the bag.

As such, according to a first aspect of the present invention there is provided a catheter assembly comprising a fluid collection bag; a catheter having a proximal end for insertion into the body and a distal end; and a passageway extending from the fluid collection bag; the passageway having an extended configuration and a stowed configuration, wherein in the extended configuration the passageway extends beyond an edge of the bag and permits fluid to pass therethrough and in/out of the bag, and in the stowed configuration the passageway is folded or rolled to inhibit flow of fluid therethrough.

Thus, the stowed and extended configurations of the passageway ensure that fluid access during use of the catheter assembly can be easily and conveniently controlled while also enabling the catheter assembly to be compact. This provides a better user experience. In particular, where the passageway extends beyond an edge of the bag, this separates the passageway from the bag which makes fluid flow into and out of the bag via the passageway more controllable and also reduces the likelihood of spillage of fluid onto the exterior of the bag or user - improving hygiene whilst using the assembly. In addition, it allows the provision of hybrid open/closed catheter assemblies that the user can use in either an open mode where fluid passes straight through and out of the catheter assembly or a closed mode where fluid is collected/retained by the catheter assembly in use.

The stowed configuration of the passageway may be interchangeably referred to as a closed configuration. The extended configuration of the passageway may be interchangeably referred to as an open configuration.

Of course, the catheter assembly may comprise more than one passageway, in which case aspects of the passageway outlined below may apply either to one of the passageways, or to more than one, for example to each passageway.

The catheter may be a urinary catheter. The catheter may be a male urinary catheter. The catheter may be a female urinary catheter. The catheter may be an intermittent catheter. In one embodiment, the catheter is an intermittent male urinary catheter. Thus, the features of the present invention allow intermittent male urinary catheters to be used more easily and effectively.

The fluid collection bag may be any suitable shape or size, for example rectangular, circular, elliptical, cuboid, spherical, etc. The fluid collection bag may comprise a front panel and a rear panel. The fluid collection bag may comprise a peripheral bond joining the periphery of the front panel and rear panel to form the fluid collection bag. The peripheral bond may define a base, two lateral edges and an upper edge of the fluid collection bag. The two lateral edges may comprise a right lateral edge and a left lateral edge. The right lateral edge and left lateral edge may be defined as the right and left sides of the bag when viewing the bag with the rear panel behind the front panel, the base at the bottom of the bag and the upper edge at the top of the bag. The bag may have a width between the left lateral edge and right lateral edge of at least 10, 12, 15 or 20 cm. The bag may have a width no more than 25, 20, or 15 cm. Preferably, the width is between 10 and 20 cm, most preferably between 12 and 15 cm. The base may define a bottom of the bag. The upper edge may define a top of the bag. The length/height of the bag from the base to the upper edge may be at least 15, 20, 25, 30, 35 or 40 cm. The height of the bag may be no more than 45, 40, 35 ,30, 25, or 20 cm. The height may be between 20 and 40 cm, 25 and 40, 20 and 30 cm, 30 and 35cm or most preferably between 33 and 35cm, or 28 cm. The bag may be configured to hold at least 500, 700, or 1000 ml of fluid, and may hold no more than 1000 ml. For example, it may hold at least 700 ml of fluid.

The fluid collection bag may comprise a flexible plastics material. For example, polypropylene (PP), polyethylene terephthalate (PET), low density polyethylene (LDPE), metalized polyester (MET PET) orientated polypropylene (OPP) or polyvinyl chloride (PVC). At least part of the fluid collection bag may be transparent or translucent. The front panel of the fluid collection bag may be transparent or translucent. Thus, the fluid collection bag can conform to the shape of the catheter assembly, is convenient to carry and also provides a visual reference to the contents of the bag before, during and after use which makes it easier to use.

The peripheral bond may comprise any one or more of: a weld; mechanical seal; heat seal; pressure seal; adhesive; solvent bond; ultraviolet bond; ultrasonic weld; laser weld; impulse weld; or friction weld. The peripheral bond is generally permanent but in some embodiments may be re- sealable, for example through a resealable adhesive, an additional adhesive that is activated prior or during resealing, or a hook and loop/hook and hook fastener. The peripheral bond may provide a water-tight, and preferably sterile, seal. Thus the peripheral bong can be easily constructed to suit the specific needs of the catheter assembly and ensure the contents remains sterile if necessary. The passageway may extend from the peripheral bond. The passageway may be formed integral with the fluid collection bag. The peripheral bond may extend along either side of the passageway. Thus, the passageway can be easily and conveniently constructed at the same time as the fluid collection bag.

The passageway may extend adjacent to, or preferably from a corner of the fluid collection bag. In the extended configuration the passageway may extend beyond two edges of the bag, for example two adjacent perpendicular edges of the bag. The passageway may extend at an angle from the fluid collection bag. The passageway may extend at an angle from the fluid collection bag that is not parallel to any one edge of the fluid collection bag. The passageway may extend at an angle that is generally aligned with a central region of the fluid collection bag, for example, the central 80%, 70%, or 60% of the volume of the bag. The passageway may extend at an angle of at least 10, 20, 30, 40, 50, 60, 70, or 80 degrees from an edge of the peripheral bond adjacent to the passageway. The passageway may extend at an angle of less than 80, 70, 60, 50, 40, 30, 20, or 10 degrees from an edge of the peripheral bond adjacent to the passageway. Preferably, the passageway may extend at an angle of between 10 to 40, 15 to 35, or 20 to 30 degrees from an edge of the peripheral bond adjacent to the passageway, and most preferably 23 degrees. The passageway may extend at an angle from the left or right lateral edge of the peripheral bond. Thus, fluid flow through the passageway is enhanced through the alignment of the passageway to create direct access to the central regions of the bag via the passageway and furthermore as the passageway extends away from the centre of the bag and optionally beyond two edges of the bag, it is more easily accessible and any spillage of fluid at the end of the passageway is less likely to contact the fluid collection bag/user.

The fluid collection bag may be configured to funnel liquid towards the passageway. The shape of the fluid collection bag may funnel liquid towards the passageway. The base of the peripheral bond may be sloped at an angle of less than 85, 80, 70, 60, 50, or 45 degrees to the left or right lateral edges of the peripheral bond. The base of the peripheral bond may be sloped at an angle of at least 45, 50, 60, 70, 80, or 85 degrees to the left or right lateral edges of the peripheral bond. Preferably, the base of the peripheral bond may be sloped at an angle of 80 to 70 degrees with respect to the left or right edges of the peripheral bond and most preferably 74 degrees. One or more edges of the fluid collection bag/peripheral bond may be sloped towards the passageway. Thus, fluid flow through the passageway is enhanced through the orientation of the edges of the peripheral bond.

The passageway may be elongate. The passageway may be tubular. The passageway may be open-ended. The passageway may have a length in a direction parallel to the direction of fluid flow through the passageway in the extended configuration. The passageway may have a width perpendicular to its length. The passageway may have a length that is no more than 50%, 40%, 30%, 20% or 10% of the length of the fluid collection bag. Thus, the passageway may be efficiently folded against the fluid collection bag with a single fold even where the fluid collection bag may be subsequently folded as described below.

The passageway may be configured to be folded along a fold-line. The fold line may be configured to allow the passageway to be folded into the stowed configuration. The fold line may be parallel (i.e substantially parallel) to the width of the passageway. Thus, the fold-line may be at a right angle to the angle at which the passageway extends from the fluid collection bag as described above. The passageway may be configured to be folded (at its base) where it meets the fluid collection bag/peripheral bond of the fluid collection bag. The fold-line of the passageway may therefore truncate a comer of the fluid collection bag. In the stowed configuration, the passageway may extend into a central region of the fluid collection bag. In the stowed configuration, the passageway may not extend beyond an edge of the peripheral bond of the fluid collection bag. Thus, the passageway in the stowed configuration is folded and compact.

The passageway may comprise a distal end, which is the end of the passageway distal from the fluid collection bag. The passageway may be an open passageway in that the distal end of the passageway may be open-ended. Alternatively, the passageway may have a sealed/closed distal end. The passageway may be sealed by any suitable means, for example the peripheral bond may extend around the end of the passageway in order to seal it. Alternatively, a dedicated seal/bond may be provided to close the end of the passageway. Thus, the passageway may be provided open or closed to ensure that it either allows or inhibits fluid flow through the passageway.

The passageway may be configured to allow the user to form an opening in the passageway, and most preferably to form an opening in the end of the passageway distal from the bag. The passageway may comprise a point of weakness. The point of weakness may be disposed on one lateral side of the passageway. The point of weakness may be disposed adjacent an end of the passageway. The point of weakness may be arranged at the start or end of the opening. The point of weakness may be a notch, or thinned section, in the passageway. The passageway may comprise one or more points of weakness as described above. The passageway may comprise a tear line. The tear line may comprise a weakened region of the passageway. An end of the tear line may comprise a point of weakness. Where the passageway comprises two or more points of weakness, a point of weakness may be positioned at either end of the tear line. The tear line may be configured to preferentially tear. The tear line may be formed by any suitable means, such as laser scoring. Thus, the provision of one or more points of weakness assist controlled tearing of the passageway by providing points which preferentially break to form parts of the opening such as the start and/or end.

The passageway may comprise a plug configured to seal an end of the passageway distal from the bag. The plug may be configured to inhibit unintentional passage of fluid and/or the catheter through the passageway and into/out of the bag. A water-tight, and preferably sterile, seal may be provided between the plug and the passageway. Thus, fluid does not leak out between the plug and passageway, this ensures wetting fluid released into the fluid collection bag is most effectively used to wet the catheter and also does not cause discomfort/inconvenience for the user. In addition, the sterility of the catheter is maintained when it is within the passageway/fluid collection bag which reduces the risk of infection to the user. Thus, the plug can provide additional sealing which allows the catheter assembly to be more flexibly designed for the needs of the user.

The plug may seal the passageway by any suitable means, for example, push- fit, screw-fit or bayonet-fit. The plug may be re-sealable within the passageway. The plug may be any suitable shape, such as domed/spherical or cuboid. In a preferred embodiment, the plug is domed. The plug may comprise a pull-ring. The pull-ring may be integral with the plug. The pull-ring may be configured to be grasped by a user to remove the plug from the passageway and/or seal the passageway with the plug. Thus, the plug is easy to use and can re-seal the passageway as needed.

The passageway may be configured to allow the catheter to pass into and/or out of the fluid collection bag. The passageway may be configured to allow the proximal end of the catheter to pass out of the fluid collection bag (and passageway). Thus, the catheter may be exposed for use by passing it out through the passageway. This helps to ensure the catheter remains clean prior to use.

The passageway may be configured to retain at least part of the catheter (within the passageway). Thus, the catheter can be easily presented to the user at the end of the passageway. The passageway may be configured to retain the proximal end of the catheter within the passageway. The passageway may be configured to inhibit the distal end of the catheter from leaving the bag. Thus, the catheter may be conveniently retained within the bag and the proximal end of the catheter is retained in the clean passageway ready to be removed from the bag for use.

The passageway may comprise a guide tube at an end distal from the fluid collection bag (that is at a distal end of the passageway). The guide tube may extend within the passageway. The guide tube may extend towards the fluid collection bag. The guide tube may be configured to retain at least part of the catheter, and preferably the proximal end of the catheter. The guide tube may comprise an aperture therethrough sized to allow the catheter to pass through the guide tube. Alternatively, the end of the passageway may be sealed and the aperture provided in the sealed end of the passageway. In such embodiments the aperture may provide the functions of the guide tube described above. The guide tube/aperture may be configured to remove excessive fluid from the surface of catheter. Thus, the guide tube effectively prepares the catheter for use and form an effective seal between the catheter and the bag, to minimise the risk of leakage.

The passageway may be configured to prevent the distal end of the catheter from being removed from the fluid collection bag. The distal end of the catheter may be provided with a funnel or a cuff. The funnel or cuff may be too large to pass through the passageway. The cuff may comprise a protrusion extending parallel to the diameter of the catheter. The guide tube/aperture may be configured to engage with the distal end of the catheter. The guide tube/aperture may be configured to prevent the distal end of the catheter from passing therethrough (e.g. it may be narrower than the funnel or cuff). Engagement between the guide tube/aperture and the distal end of the catheter may form a liquid-tight seal (e.g. the guide tube/aperture may be sized to seal against the funnel/cuff with a resistance or interference fit). Thus, the passageway can also prevent inadvertent removal of the catheter from the fluid collection bag

The end of the passageway (distal the bag) may be configured to allow the user to locate the tip of the catheter. The end of the passageway may be an inserter locater tip. Thus, the user can more easily insert the catheter into the body.

The fluid collection bag may comprise an opening marker. The opening marker may be visible (only) when the passageway is in the stowed configuration. The opening marker may be configured to provide a visual/tactile guide to the user to open the passageway into the extended configuration. The opening marker may comprise an arrow provided on the fluid collection bag indicating a direction in which the passageway should be opened. The opening marker may be provided on the passageway. The opening marker may be provided on the rear panel of the fluid collection bag. Thus, the opening marker makes it easier for the user to open the passageway into the extended configuration.

The fluid collection bag may comprise a closure configured to seal/retain the passageway in its stowed configuration. The closure may be provided on a front or rear panel of the fluid collection bag. The closure may be provided on the passageway. The closure may be configured to retain the fluid passageway against the front or rear panel of the fluid collection bag. The closure may be temporarily sealed to either the fluid collection bag, the passageway, or both the fluid collection bag and the passageway. The closure may be permanently sealed to the fluid collection bag on a first side. The closure may be temporarily sealable to the passageway on a second side. The closure may be sealed through any suitable means such as adhesive, hook and hook or hook and loop fasteners, buttons, or the like. The closure may have any suitable size or shape, for example circular, elliptical, rectangular, or irregularly shaped. In one embodiment, the closure is stadium shaped. The closure may have a length equal to no more than a whole, 3/4, 1/2, 1/3 or 1/4 of the width of the passageway. The closure may have a length equal to at least a 1/4, 1/3, 1/2 or 3/4 of the width of the passageway. Preferably, the length of the closure is 1/3 the width of the passageway. The closure may have an aspect ratio (length: width) of at least 1:1, 2:1, 3:1, 4:1 or 5:1. The closure may have an aspect ratio (length: width) of no more than 5:1, 4:1, 3:1, or 2:1. Preferably the aspect ratio of the closure is 3 : 1. The length of the closure may be arranged parallel to the width of the passageway. Thus, the closure is small and convenient to use while providing sufficient area to ensure it seals the passageway effectively.

Part of the closure may be permanently sealed to the fluid collection bag or the passageway. A minority of the closure may be permanently sealed to the fluid collection bag or the passageway. Less than 50%, 40%, 30%, 25%, or 20% of closure may be permanently sealed to the fluid collection bag or the passageway. A majority of the closure may be configured to temporarily seal to the passageway or the fluid collection bag. At least 50%, 60%, 70% or 80% of the closure may be configured to temporarily seal to the passageway or the fluid collection bag. In one embodiment, 25% of the closure is configured to be permanently sealed to the fluid collection bag and 75% of the closure is configured to be temporarily sealed to the passageway. The closure may be configured to overlap or overlie the passageway when the passageway is in the stowed configuration. At least 25%, 33%, 50%, 66% or 75% of the closure may be configured to overlap or overlie the passageway when the passageway is in the stowed configuration. In a preferred embodiment, 66% of the closure may overlap the passageway in the stowed configuration. Where a closure seals the passageway, the passageway may be configured to automatically unroll or unfold into the extended configuration when it is not sealed by the closure, for example through the force exerted on it by the weight of fluid in the fluid collection bag. Thus, the closure ensures the passageway remains in the stowed configuration when sealed by the closure and the passage of fluid through the passageway is inhibited effectively. The closure may be a closure flap. The flap may be any suitable shape such as square, rectangular, circular, ellipsoidal, or irregularly shaped. The closure flap may have any suitable aspect ratio (width: length), such as 1:1, 1:2, or 1:3. The flap may comprise a finger-hole. The finger-hole may be sized to fit within a half of the flap. The finger-hole may correspond to the part of the flap that is temporarily sealed to the fluid collection bag or passageway. The finger-hole may be configured to allow a user to better grip the flap. The finger-hole may be movable to release the closure flap from the passageway to allow it to be moved from its stowed configuration to its extended configuration. The finger-hole may be replaced with any suitable alternative such as ridges or another easily gripped surface to facilitate removal of the flap. Thus, the user can easily remove the closure by peeling it back to enable the passageway to be moved.

The passageway may be a neck of the fluid collection bag. The neck may extend from the upper edge of peripheral bond of the fluid collection bag. The neck may comprise the plug. The plug may comprise any one or more of the features of the plug as described above. The neck may retain the proximal end of the catheter. The neck may comprise the guide tube or aperture as described above. The neck may have a length equal to a third of the length of the fluid collection bag. The neck may be initially provided in its stowed configuration. The neck may be moved from its stowed configuration to its extended configuration before use of the catheter. Thus, the neck can conveniently protect and store the proximal end of the catheter prior to use.

In a different example, the neck may be open ended. The neck may be configured to be folded into the stowed configuration, in which it is parallel to an edge of the fluid collection bag., preferably the upper edge. The neck may comprise an aperture. The distal end of the catheter may comprise a cuff. The aperture may be engageable with the distal end of the catheter, and preferably the cuff.

The passageway may be a drain of the fluid collection bag. The drain may be configured to allow fluid to drain from the fluid collection bag. The drain may extend from the base of the peripheral bond of the fluid collection bag. The base may be sloped in a direction towards the drain. The drain may be shorter than the neck, or preferably half the length of the neck. The fluid collection bag may comprise a closure (as described above) to retain the drain in its stowed configuration. The drain may be open- ended. The drain may be sealed. The drain may be configured to allow the user to form an opening in the drain, for example through the provision of points of weakness in the passageway as described above. The drain may be initially provided in its stowed configuration. The drain may be moved from its stowed configuration to its extended configuration after use of the catheter. Thus, the drain provides a convenient way to empty fluid from the fluid collection bag in a controlled and hygienic manner.

Of course, the neck and/or drain may comprise any one or more features of the passageway in general as described above.

In one example, there is provided a catheter assembly wherein the catheter is arranged within the fluid collection bag and the or each passageway is in the stowed configuration prior to use. In this example the passageway may be the neck and/or drain; preferably the catheter assembly comprises both a neck and a drain, both stored in their stowed configuration. Thus, the catheter is safely stored prior to use.

The catheter assembly may be configured such that in use, the neck may be opened to the extended configuration and at least part of the catheter may remain arranged within the passageway. The fluid collection bag may further comprise a drain, which may be configured to remain in the stowed configuration during catheterisation. Thus, the catheter is easily accessible for the user and fluid passing through the catheter may be collected in the fluid collection bag.

The catheter assembly may be configured such that in use, after fluid has been passed into the fluid collection bag, the passageway may be extended to the extended configuration and to allow fluid to drain from the fluid collection bag. In this example, the passageway may be the drain. Thus, fluid may pass out of, or through, the fluid collection bag where it is convenient for the user to dispose of the fluid.

The fluid collection bag may comprise two or more passageways as described above, each featuring any one or more of the optional features described above. Each passageway may extend from a different comer of the fluid collection bag. Where there are two passageways, one may extend from a corner opposite to the other passageway. In a preferred embodiment, the fluid collection bag comprises a neck and a drain as described above; most preferably with the neck and the drain extending from opposite comers. Thus, the neck and drain provide a convenient and efficient means to both store and prepare the catheter for use as well as collecting and releasing of fluid that passes into the bag during use of the catheter.

The catheter assembly may comprise a fluid reservoir. The fluid reservoir may be configured to retain a wetting fluid within it. The fluid reservoir may be configured to release wetting fluid to activate the catheter. The wetting fluid may activate the surface of the catheter and render it lubricious. The wetting fluid may be water, such as where the catheter has a hydrophilic surface. Any suitable wetting fluid may be used, for example polar (e.g. water-based) or non-polar (e.g. oil-based) wetting fluids depending on the surface properties of the catheter. The fluid reservoir may be configured to retain at least 5, 10, 15, 25, or 50 ml of wetting fluid.

The fluid reservoir may be contained within the fluid collection bag. The fluid reservoir may be a sachet. The fluid reservoir may be any suitable shape or size, such as square, rectangular, circular, ellipsoidal or irregularly shaped. The fluid reservoir may be stadium shaped, that is a rectangle with semi-circular ends. The fluid reservoir may have a length approximately three quarters the width of the fluid collection bag. The fluid reservoir may have a length approximately equal to the width of the fluid collection bag minus the width of the passageway. The fluid reservoir may have any suitable aspect ratio (width: length) such as 1:1, 1:2, 1:3, 1:4 or 1:5. Thus, the fluid reservoir may be flexibly shaped and sized to conveniently fit within the fluid collection bag. In addition, the fluid reservoir is shaped to fit within the bag next to the passageway and without blocking the passageway.

The fluid reservoir may be configured to release wetting fluid when activated by a user. The fluid reservoir may be activated by a user by any suitable means, for example twisting the fluid reservoir, or applying a compressive force to the fluid reservoir. The fluid reservoir may be flexible. The fluid reservoir may comprise a flexible plastics material such as a hard moulded thermoplastic, for example HDPE. Under application of a compressive force, the fluid reservoir may configured to break when a threshold compressive force is exceeded. The fluid reservoir may comprise an activation marker. The activation marker may be on a surface of the fluid reservoir. The activation marker may comprise a region of the fluid reservoir that is identifiable to the user, for example through visual and/or tactile feedback. Preferably, the activation marker may be at least visually recognisable, for example a different colour, or pattern, to the fluid reservoir. The fluid reservoir may be configured to break at a point adjacent to the aperture of the sleeve through which the catheter exits the sleeve. Thus, the fluid reservoir does not prematurely release the wetting fluid and the user can easily control the release of wetting fluid by pinching the fluid reservoir between their fingers to break the fluid reservoir and release wetting fluid into the sleeve.

The fluid reservoir may comprise two or more activation markers. The fluid reservoir may comprise an activation marker at one or more ends of the fluid reservoir. Where the fluid reservoir is stadium shaped, the fluid reservoir may comprise two activation markers. Thus, more than one activation marker can be provided to ensure easy activation of the fluid reservoir.

The fluid reservoir may be configured to release wetting fluid into the passageway. The fluid reservoir may be positioned adjacent a corner of the fluid collection bag. The fluid reservoir may be positioned at a corner adjacent to the passageway. Where the passageway is the neck, the fluid reservoir may be positioned adjacent to the neck. As such, the fluid reservoir is ideally placed to deliver wetting fluid directly to the proximal end of the catheter ensuring it is adequately wetted prior to use and minimising the risk of injury and discomfort for the user.

The fluid reservoir may be retained in position by a join between the front and rear panels of the fluid collection bag. The join may be at a position corresponding to an edge of the fluid reservoir distal from the peripheral bond, for example distal from the upper edge or base of the peripheral bond. The join may be configured to prevent the fluid reservoir moving away from the upper edge or base of the peripheral bond/bag. The join may be independent from the peripheral bond. Thus, the join is positioned to retain the fluid reservoir and prevent movement of it with respect to the fluid collection bag.

The join may be separated from an edge of the peripheral bond by a distance equivalent to (i.e. approximately equivalent to) the width of the fluid reservoir. The join may be positioned closer to one lateral edge of the peripheral bond than the other. The join may be positioned closer to a lateral edge that comprises the passageway than the other. The join may be positioned at a point at least 20%, 30%, or 40% of the way across the width of the fluid collection bag. The join may be positioned at a point no more than 40%, 30%, or 20% of the way across the width of the fluid collection bag. Preferably, the join is positioned 33% of the way across the width of the fluid collection bag.

The fluid reservoir may be retained in position by a protrusion in the peripheral bond of the fluid collection bag. The protrusion may extend from an edge of the fluid collection bag, preferably a lateral edge. The protrusion may be positioned along a lateral edge of the fluid collection bag a distance equivalent to the width of the fluid reservoir. The protrusion may extend from a lateral edge opposite to the passageway. The protrusion may be integral with the peripheral bond. Thus, the protrusion provides a catch that prevents the fluid reservoir from moving with respect to the fluid collection bag.

The join and/or protrusion may any suitable shape such as circular, square, ellipsoidal or rectangular. The join and/or protrusion may have a length parallel to the length of the fluid reservoir in the fluid collection bag. The join and/or protrusion may have an aspect ratio (width: length) such as 1:1, 1:2, 1:3, 1:4. In a preferred embodiment, the join is generally ellipsoidal with an aspect ratio of 1:3. The join and protrusion may be the same width. Thus, the join and protrusion take up minimal space within the bag and facilitate free movement of fluid within the bag while performing their function of retaining the fluid reservoir in position.

The catheter may be arranged within the fluid collection bag. The catheter may be arranged within the fluid collection bag in a curved configuration. The proximal end of the catheter may be arranged within a passageway of the fluid collection bag, preferably a neck as described above. The catheter may be arranged between a fold line of the fluid collection bag and an upper edge of the peripheral bond of the fluid collection bag. The distal end of the catheter may be arranged close to a passageway of the fluid collection bag, for example a drain as described above. Thus, the catheter is efficiently stored within the bag where it can remain sterile prior to use, and can be arranged in a curved configuration to reduce the likelihood of damage to the catheter during storage, for example through kinking of the catheter. The funnel or cuff may be configured to remain within the fluid collection bag. The funnel may be configured to direct the flow of liquid out of the catheter and into the fluid collection bag. Thus, the provision of the funnel or cuff makes the catheter easier to use.

The pouch may be configured to contain within it any one or more of (and preferably all of): the catheter; the fluid reservoir; and the fluid collection bag. The pouch may comprise two walls and a peripheral seal between the two walls. An edge of the pouch may comprise a fold between the two walls. The peripheral seal may be configured to be broken to allow the fold to be opened to a flat position.

In another broad aspect of the present invention there is provided a packaged catheter assembly comprising a catheter and a pouch; the pouch having two walls and a peripheral seal between the two walls, wherein one edge of the pouch comprises a permanent join between the two walls, and the remaining edges are sealed by the peripheral seal, which is configured to be broken to allow the pouch to be opened to a flat position, (by unfolding it about the permanent join). The permanent join is preferably a fold. Alternatively, it could be a bond formed, for example, by a weld or adhesive. A fold is preferred as by using a fold in a naturally flat sheet of material the pouch may be naturally biased towards the unfolded configuration.

According to a second aspect of the present invention there is provided a packaged catheter assembly comprising a catheter and a pouch; the pouch having two walls and a peripheral seal between the two walls, wherein an edge of the pouch comprises a fold between the two walls, and the peripheral seal is configured to be broken to allow the fold to be opened to a flat position.

The packaged catheter assembly may therefore be a sealed packaged catheter assembly. Advantageously, the inside of the pouch is clean and can be opened to present a flat surface which the user can take advantage of when using the catheter assembly, for example by resting items of the assembly on the surface during use.

The flat position may be defined as when the angle between the first wall and the second wall is less than 30, 20, 10, 5, or 1 degrees. The flat position may be defined as when the angle between the first wall and second wall is zero. The angle between the first wall and second wall may be taken between lines extending from the point (that is on the pouch fold-line, see below) at which the walls meet to respective points at the centre (of mass) of each wall. The angle between the first wall and second wall may be taken between lines extending from the point (that is on the pouch fold-line) at which the walls meet to respective points at the edge of each wall distal the point at which the walls meet. The flat position may be defined as when a vector normal to the plane of the first wall is substantially parallel to a vector normal to the plane of the second wall, that is within 45, 30, 20, 10 or 5 degrees of parallel to each other. The vector normal to the plane of the first/second wall may be a vector normal to a centre of the first/second wall. Thus, the two walls are aligned with each other in the flat position and therefore provide a flat surface for the user.

The pouch may comprise a flexible plastics material, such as a flexible plastic sheet or film. For example, polypropylene (PP), polyethylene terephthalate (PET), low density polyethylene (LDPE), metalized polyester (MET PET), polyvinyle chloride (PVC) or orientated polypropylene (OPP).

The fold between the two walls may define a pouch fold-line. The two walls may be formed from a single sheet of material. The pouch fold-line may correspond to a line of symmetry of the sheet of material. The pouch fold-line may correspond to the middle of the sheet of material. The pouch fold-line may be at a midpoint along a length of the sheet of material. The pouch fold-line may span a width of the sheet of material. Thus, the pouch is efficiently formed from a single fold of the sheet of material which maximises the volume contained within the pouch and while minimising the size of the pouch in any one dimension.

The fold may be configured to remain in the flat position. The fold may remain in the flat position if at least a threshold force is applied to separate the first and second walls. The threshold force may be less than 5 N, 1 N, 0.5 N, or 0.1 N. The fold may be configured to remain in a folded position. The fold may undergo plastic deformation when opened to the flat position and/or when closed to the folded position. Thus, the fold does not move from the flat position to the folded position and vice versa unless the user specifically moves it between the two positions making it more convenient to use. The fold may be configured to open into the flat position from the folded position. Once the peripheral seal is broken, the fold may be configured to open into the flat position. The fold may be biased to the flat position. The fold may be elastically deformable. Thus, the fold may preferentially open flat once the peripheral seal is broken. This can make the pouch easier to use for users with reduced mobility who may struggle to open the peripheral seal and also open the fold to the flat position.

The pouch may be configured to be closed by folding the pouch. The pouch may be configured to be closed by bringing the two walls together. The pouch may be configured to preferentially fold along the pouch fold-line. The pouch may be configured to be re-folded along the pouch fold-line. The peripheral seal may be re- sealable. Thus, the pouch may be folded back to its original closed configuration and the used parts of the catheter re-packaged within it to allow hygienic storage, transport and disposal of the packaged catheter assembly.

Consequently, the pouch may have a closed configuration in which it is folded, and preferably sealed closed by the peripheral seal. The pouch may have an open configuration in which it is unfolded. The pouch may be initially provided in its closed configuration. The packaged catheter assembly may be a sealed packaged catheter assembly.

The peripheral seal may comprise any one or more of: a weld; mechanical seal; heat seal; pressure seal; adhesive; solvent bond; ultraviolet bond; ultrasonic weld; laser weld; impulse weld; or friction weld. The peripheral seal may be re-sealable, for example through a resealable adhesive, an additional adhesive that is activated prior or during resealing, or a hook and loop/hook and hook fastener. As outlined above, the peripheral seal may provide a sterile seal. Both the fluid collection bag and peripheral seal of the pouch may provide a sterile seal. Thus the peripheral seal can be easily constructed to suit the specific needs of the pouch and ensure the contents remains sterile within the pouch. Advantageously, additional protection is provided to ensure the catheter remains sterile allowing the pouch to be opened to provide a sterile surface which, if used and made dirty, does not affect the sterility of the catheter.

Alternatively, the peripheral seal may not provide a sterile seal. In one example the peripheral bond of the fluid collection bag may provide a sterile seal and the peripheral seal of the pouch may not. This may be beneficial where a sterile seal is provided/maintained by another feature/component of the packaged catheter assembly such as the fluid collection bag/peripheral bond as it may allow the peripheral seal to be more cheaply /efficiently constructed as well as being easier to break when opening the pouch and/or allow the peripheral seal to be more easily opened/an opening formed in the peripheral seal and re- sealed as described below.

The peripheral seal may form one or more edges of the pouch. A folded edge may comprise the fold between the two walls (the first wall and the second wall). All edges other than the folded edge may be formed by the peripheral seal The two walls may comprise a front wall and a rear wall. The first wall may be the front wall. The second wall may be the rear wall. The folded edge may comprise a base of the pouch. The peripheral seal may comprise a left lateral edge, right lateral edge and an upper edge. The left and right lateral edges may be defined as the left and right edges when viewing the pouch in the closed (folded) configuration with the front wall in front of the rear wall, the base at the bottom and the upper edge at the top. Consequently, when the pouch is in the open (unfolded) configuration, the parts of the upper edge on the rear and front walls may form the top and bottom of the pouch respectively.

The pouch may have a width defined as the distance between the left lateral edge and right lateral edge of the pouch of at least 100, 120, 140, 160 or 180 mm. The pouch may have a width of no more than 200, 180, 160, 140 or 120 mm. Preferably, the width is between 130-170 mm, and most preferably about 150 mm. The pouch may have a height defined as the distance between the upper edge and base (i.e. the height when in the closed/folded configuration) of at least 60, 70, 80, 90 or 100 mm. The pouch may have a height of no more than 110, 100, 90, 80 or 70 mm. Preferably, the height is between 80-100 mm, and most preferably it is about 90 mm. The height of the pouch in the open/unfolded configuration may be double the height of the pouch in the closed/folded configuration. Thus, the pouch is a compact shape when folded so that it is convenient and discreet for the user to carry, for example it is easier to fit in a bag or pocket.

The folded edge may be configured to resist being broken. A frangible portion of the peripheral seal may form one or more edges of the pouch that do not comprise the folded edge, in particular, all the edges other than the folded edge may form the frangible portion. The frangible portion may be configured to break before the folded edge. The pouch may comprise only one folded edge. Thus, the peripheral seal aids the opening of the pouch into a flat position by ensuring that the fold between the first wall and second wall is not broken during breaking of the peripheral seal.

The pouch may contain any one or more of the fluid collection bag, catheter and fluid reservoir, each of which may be as defined above in relation to the first aspect of the invention. The fluid collection bag may be attached to the pouch. The fluid collection bag may overlie the pouch, and optionally a majority of the pouch. The fluid collection bag may overlie the pouch when the pouch is in the open (unfolded) configuration or flat configuration. The peripheral bond of the fluid collection bag may lie within the left lateral edge, right lateral edge and upper edges of the peripheral seal of the pouch in its open configuration. The right lateral edges of the peripheral bond and peripheral seal may be adjacent to one another. The left lateral edges of the peripheral bond and peripheral seal may be adjacent to one another. The upper edge of the peripheral seal on the rear wall may be adjacent to the upper edge of the peripheral bond. The upper edge of the peripheral seal on the front wall may be adjacent the base of the peripheral bond. The peripheral bond and peripheral seal may be independent and/or independently formed. The peripheral bond and peripheral seal may be integral with one another and/or integrally formed. Thus, both the peripheral seal and peripheral bond can be conveniently manufactured together and in similar or the same steps.

The fluid collection bag may be attached to the front and/or rear wall of the pouch, preferably the fluid collection bag is attached to both the front and rear walls. The fluid collection bag may be attached to the pouch via any suitable means such as any one or more of: a weld; mechanical seal; heat seal; pressure seal; adhesive; solvent bond; ultraviolet bond; ultrasonic weld; laser weld; impulse weld; or friction weld. The fluid collection bag may be attached to the pouch via the peripheral seal and/or peripheral bond. Thus, the fluid collection bag and pouch can be securely and conveniently attached to one another during manufacturing.

The pouch and fluid collection bag may be integrally formed. The front and/or rear walls of the pouch may form part of the fluid collection bag. The front and/or rear walls of the pouch may form at least part of the rear panel of the fluid collection bag. Thus, the weight and bulk of the pouch may be reduced by integrally forming the pouch and fluid collection bag, such that the cavity of the fluid collection bag, into which fluid (e.g. urine) flows is formed in part (but only in part) by the pouch.

The pouch and fluid collection bag may be folded at the same or corresponding fold-lines. The catheter may be arranged within the pouch/fluid collection bag such that it is curved at a point corresponding to a fold-line of the pouch and/or fluid collection bag. The catheter may be arranged with a tangent of the catheter at a foldline of the pouch/fluid collection bag parallel to the fold-line. The catheter may be arranged with a tangent of the catheter at a fold-line of a passageway of the fluid collection bag parallel to the fold-line. Thus, the catheter curves around the folds in the pouch, fluid collection bag and passageways to ensure that the catheter is at a reduced risk of kinking.

The pouch may be formed from an opaque material. The fluid collection bag may be formed from a transparent or translucent material.

Consequently, according to a broad aspect of the present invention, there is provided a packaged catheter assembly comprising a pouch having first and second walls, a peripheral seal between the first and second walls, a third wall arranged between the first and second walls, and a catheter, wherein: the first and second walls are formed from opaque material; the third wall is formed from a transparent or translucent material.

The peripheral seal may be configured to allow the first and second walls to separate, exposing the third wall. The third wall may be sealed to the first and/or second wall to form a fluid collection bag to receive fluid from the catheter.

Thus, according to a third aspect of the present invention there is provided a packaged catheter assembly comprising a pouch having first and second walls, a peripheral seal between the first and second walls, a third wall arranged between the first and second walls, and a catheter, wherein: the first and second walls are formed from opaque material; the third wall is formed from a transparent or translucent material; the peripheral seal is configured to allow the first and second walls to separate, exposing the third wall; and the third wall is sealed to the first and/or second wall to form a fluid collection bag to receive fluid from the catheter.

Thus, the fluid collection bag is integrally formed with the pouch in a manner that allows visual reference to the contents of the bag before, during and after use. In addition, the contents of the pouch remain discrete for the user to carry with them while the benefits of a transparent or translucent wall are realised once the pouch is opened ready for use as it can retain either the components of the pouch in a clean and sealed environment where they can be viewed before use, be used to collect fluids and provide a visual indication of the fill-level of the bag that may be formed by the transparent/translucent wall, or both.

The first wall may be the front or rear wall of the pouch. The second wall may be the corresponding rear or front wall of the pouch. The third wall may form the front panel of the fluid collection bag. The first and second walls may form the rear panel of the fluid collection bag, or alternatively, a fourth wall may form the rear panel of the fluid collection bag. Thus, the packaged catheter assembly effectively forms a pouch which is discreet and contains an integral fluid collection bag.

The pouch may comprise a wetting marker. The wetting marker may be disposed on an external face of the pouch. The wetting marker may be disposed on the front or rear walls of the pouch, or both the front and rear walls of the pouch. The wetting marker may correspond to the position of the/a fluid reservoir within the pouch (when the pouch is in the closed configuration). The wetting marker may provide tactile and/or visual guidance to allow the user to activate the fluid reservoir within the pouch. The wetting marker may comprise a region of the pouch that is a different colour, pattern, texture, or shape than the rest of the pouch. Thus, the fluid reservoir can be easily activated from the outside of the pouch and activated to wet the catheter prior to the pouch being opened. This can reduce the likelihood of leaks during the wetting process.

The pouch may have a textured or printed appearance, such as matte, and/or feel. The pouch may be a different colour/contrast to the other components of the packaged catheter assembly, such as any one or more of: the fluid reservoir; the sleeve; the catheter; the fluid collection bag. Thus, the pouch is more comfortable to carry and handle and when opened, the contents of the pouch are easily identifiable against it.

The pouch may comprise a tab. The tab may extend from the edge of the pouch. The tab may therefore be formed from the same material as the pouch. The tab may be formed of a flexible plastic sheet or film material. The tab may be configured to create an opening in the peripheral seal of the pouch. The tab may comprise any one or more of the features of the opening tabs described below. Thus, the pouch can be more easily opened.

The tab may extend from one (i.e. the front or rear) wall of the pouch. The tab may be configured to fold down to overlie a (rear or front) wall of the pouch. Thus, the tab may comprise a crease-line. The crease-line may be along a base of the tab. Therefore, folding of the tab is easier. The tab may be configured to seal to a (rear or front) wall of the pouch. Thus, the folded tab does not extend out and increase the bulk of the pouch.

Accordingly, in one embodiment there is provided a packaged catheter assembly comprising a catheter and a pouch having two walls and a peripheral seal between the two walls, wherein the pouch is configured to contain the catheter within it, each wall comprises a tab extending from an edge of the pouch, and the tabs are configured to be separated in use to create an opening in the peripheral seal, wherein the tabs are moveable to a position where they do not project beyond an edge of the pouch, each tab is foldable against a wall of the pouch and each tab comprises a crease- line.

The tab may span the majority of the width of the pouch, for example the entire width of the pouch. The tab may be triangular. A tip of the tab may extend down about half the height of the pouch. The tab may give the closed pouch the appearance of a closed envelope. Thus, the pouch has a familiar appearance that the user will recognise and be able to open easily.

The tab may comprise a tab marker. The tab marker may be configured to provide a visual/tactile guide to the user to prompt them to open the pouch. The tab marker may comprise an arrow. The tab marker may prompt the user to pull or move the tab to open the pouch. The arrow may point in the direction the tab should be opened. Thus, the pouch is more user friendly.

Each wall of the pouch may comprise a tab. Each tab may extend from an edge of the pouch. The tabs may be configured to be separated to create an opening in the peripheral seal of the pouch.

Accordingly a fourth aspect of the present invention provides a packaged catheter assembly comprising a catheter and a pouch having two walls and a peripheral seal between the two walls, wherein the pouch is configured to contain the catheter within it, each wall comprises a tab extending from an edge of the pouch, and the tabs are configured to be separated in use to create an opening in the peripheral seal.

Advantageously, the tabs extend from the pouch and so are easy to grasp by the user. This makes opening the pouch easy even for users with reduced mobility.

The tabs may extend from the same edge of the pouch. The tabs may be overlapping. The tabs may extend from an upper edge of the pouch. The tabs may extend from the same point on an edge of the pouch. The tabs may be completely overlapping. Thus, the tabs may be at the same position which reduces the overall size of the pouch, this makes it more discrete and convenient to carry before use.

The tabs may individually comprise any one or more of the features of the tab described above, for example each or either of the tabs may comprise a tab marker as described above.

The tabs extend from different points on an edge of the pouch. The tabs may extend from adjacent points on edge of the pouch. The tabs may extend from different edges of the pouch. Thus, the tabs are not positioned in the same place and each is therefore more easily identifiable and accessible to the user. This can be advantageous for users with reduced mobility or eyesight.

The tabs may extend from different, but overlapping points, on an edge of the pouch. Thus, the tabs are only partially overlapping and do not completely overlap. Thus, the tabs can be easily separately identified, accessed and grasped on account of extending from different points, but the pouch can be more easily opened, on account of being pulled apart from an overlapping point on the edge of the pouch. Accordingly in one embodiment there is provided a packaged catheter assembly comprising a catheter and a pouch having two walls and a peripheral seal between the two walls, wherein the pouch is configured to contain the catheter within it, each wall comprises a tab extending from an edge of the pouch, and the tabs are configured to be separated in use to create an opening in the peripheral seal, wherein the tabs extend from different points on the same edge of the pouch, wherein the tabs are partially overlapping and are formed of a flexible plastic sheet material.

Each of the tabs may extend from an edge of the pouch that corresponds to a frangible portion of the peripheral seal. For example, the frangible portion as described above in relation to the second/third aspect. Thus, the tabs are suitably located to ensure the frangible portion breaks when the tabs are separated.

The pouch may be configured to be opened to a flat position, for example as described in the second aspect above. After opening of the pouch, the tabs may be disposed at opposite ends of the opened pouch.

Each tab may be configured to provide a handling point for the pouch. Thus, the tabs can be used to conveniently handle and move the pouch as may be required.

The tabs may be configured to allow to the pouch to be closed. The tabs may be configured to be brought towards each other to close the pouch. This feature may preferably be used in combination with a peripheral seal that is re-sealable as described in relation to the second aspect. Thus, the tabs provide a handling point for the user to close the pouch, this can be particularly useful after using the catheter as the rest of the pouch may be dirty or soiled and so is undesirable to touch.

Accordingly in one embodiment, there is provided a packaged catheter assembly comprising a catheter and a pouch having two walls and a peripheral seal between the two walls, wherein the pouch is configured to contain the catheter within it, each wall comprises a tab extending from an edge of the pouch, and the tabs are configured to be separated in use to create an opening in the peripheral seal, wherein the tabs are configured to allow the pouch to be closed after use of the catheter by bringing the tabs towards each other and wherein the peripheral seal is re-sealable. The tabs may be movable to a position where they do not project beyond an edge of the pouch. Each tab may be movable by deformation, folding or rolling of the tab. Each tab may be folded along a line corresponding to the edge of the pouch. Each tab may be folded against the a wall of the pouch (e.g. the front wall or the rear wall). Both tabs may be moved in the same direction. Both tabs may be folded against the same wall of the pouch. Thus, the tabs may be moved to a position where they do not project beyond an edge of the pouch, this beneficially reduces the size of the pouch. In addition, it reduces the likelihood of the pouch being inadvertently opened, for example by The tabs becoming caught on another object.

Each of the tabs may be any suitable size or shape, such as rectangular, square, circular, elliptical, or irregular in shape. In one example, the tabs are trapezoid in shape with two sides, a base and a top, and a height. The length of the base may be greater than the length of the top. The length of the base may be at least twice as great as the height. The tab may be arranged with its respective base parallel to an edge of the pouch.

Each tab may have a length that is parallel to the length of the edge of the pouch from which the tab extends. The length of each tab may be less than the length of the edge of the pouch from which the tab extends. The length of each tab may be at least half of the length of the edge of the pouch from which the tab extends. The tab may be arranged to a left or right side of the pouch. One tab may be arranged on the left side and the other tab may be arranged on the right side. The tab may comprise an extension of the left or right lateral edge of the pouch beyond the upper edge or base of the pouch. The left and right lateral edges may correspond to the left and right sides of the pouch respectively. The tab may extend from the left or right lateral edge of the pouch across the width of the pouch. The tab may extend to a midpoint across the width of the pouch. The tab may comprise a slanted edge. The slanted edge may extend past the midpoint across the width of the pouch. Of course, references to “the tab” above describe optional features that may be combined in either one, or both, of the tabs may have as required or desired. Advantageously, the shape of each tab as described above may make it less likely to snag on other objects which could cause accidental opening of the pouch. Accordingly, in one embodiment there is provided a packaged catheter assembly comprising a catheter and a pouch having two walls and a peripheral seal between the two walls, wherein the pouch is configured to contain the catheter within it, each wall comprises a tab extending from an edge of the pouch, and the tabs are configured to be separated in use to create an opening in the peripheral seal, wherein each tab has a length that is parallel to and less than the length of the edge of the pouch from which the tab extends and each tab is formed of a flexible plastic sheet material.

Accordingly in one embodiment, there is provided a packaged catheter assembly comprising a catheter and a pouch having two walls and a peripheral seal between the two walls, wherein the pouch is configured to contain the catheter within it, each wall comprises a tab extending from an edge of the pouch, and the tabs are configured to be separated in use to create an opening in the peripheral seal, wherein the peripheral seal comprises a left lateral edge, right lateral edge and an upper edge of the pouch, one tab is arranged on a left side of the pouch and the other tab is arranged on a right side of the pouch.

Each tab may comprise a gripping hole. Each gripping hole may provide a grippy surface or feature. Each gripping hole may comprise an aperture through the tab. Each gripping hole may be any suitable size or shape, for example, rectangular, square, circular, elliptical. In one embodiment, each gripping hole is in the shape of a stadium, that is a rectangle with semicircles replacing two opposite sides. The parallel sides of each gripping hole may be parallel to the base and top of each respective tab. The gripping hole of one tab may be in overlap with the other tab. The gripping hole of one tab may be in overlap with an edge of the other tab. Thus, the addition of a gripping hole to a tab allows the user to easily grasp it, of course a hole itself may not be necessary and instead any feature that allows the user to easily grasp the tab could be used.

Accordingly, in one embodiment there is provided a packaged catheter assembly comprising a catheter and a pouch having two walls and a peripheral seal between the two walls, wherein the pouch is configured to contain the catheter within it, each wall comprises a tab extending from an edge of the pouch, and the tabs are configured to be separated in use to create an opening in the peripheral seal, wherein one, or both, of the tabs comprises a gripping hole comprising an aperture through each tab, wherein a gripping hole of one tab is in overlap with an edge of the other tab.

One tab may extend from a right lateral edge of the pouch. One tab may extend from a left lateral edge of the pouch. One tab may comprise a slanted edge. The slanted edge of one tab may extend in overlap with the other tab. One (the other) tab may comprise a gripping hole. The slanted edge of one tab may extend in overlap with a gripping hole of the other tab. Both tabs may comprise a slanted edge. Both tabs may comprise a gripping hole. Preferably, the slanted edge of each tab overlaps the gripping hole of the other respective tab. Thus, the tabs may be easily separated using the slanted edges and by pushing one tab away from the other through the gripping hole.

According to a fifth aspect of the present invention there is provided a catheter assembly comprising a catheter having a proximal end for insertion into the body and a distal end, a fluid collection bag arranged to receive fluid from the distal end of the catheter, a sleeve enclosing the catheter along the length of the catheter from the proximal end to the distal end, and a fluid reservoir arranged at the proximal end, wherein the fluid reservoir is configured to release wetting fluid into the sleeve to wet the catheter and wherein the sleeve is in fluid communication with the fluid collection bag. Consequently, excess wetting fluid may flow from the sleeve into the fluid collection bag.

Advantageously, the present invention provides for a catheter assembly which benefits from the introduction of wetting fluid at the proximal end of the catheter which reduces the risk of discomfort and injury while using the catheter as the proximal end, which enters the body first, is adequately wetted prior to use. In addition, as the wetting fluid is contained within the sleeve and flows from the proximal end to the distal end, the fluid is used efficiently to wet the whole length of the catheter by prioritising the parts of the catheter that enter the body first. Due to the sleeve being in fluid communication with the fluid collection bag, wetting fluid cannot escape outside the sleeve and as such the user’s hands or clothing does not inadvertently contact the wetting fluid which could make handling the catheter difficult. This ensures that the catheter is easy and convenient to use, as well as being discrete and hygienic to dispose of as the wetting fluid is contained within the sleeve/bag. Thus, the features of the present invention allow intermittent male urinary catheters in particular to be adequately wetted prior to use which can be more difficult than for other types of catheter which are generally shorter.

The sleeve may comprise a flexible plastics material. The sleeve may be liquid impermeable. The sleeve may comprise a thermoplastic polyurethane (TPU) or low- density polyethylene (LDPE). Thus the sleeve is cheap and easy to produce and can be easily manipulated by the user during use.

The sleeve may comprise a handling element at one end corresponding to the proximal end of the catheter. The handling element may be cylindrical, or alternatively may be cuboid or any other suitable shape. The handling element may have a length in a direction parallel to the axis of the catheter and a width in a plane perpendicular to its length. The handling element may have a diameter or width at least twice a diameter of the catheter. The handling element may have a length no longer than half the diameter or width of the handling element. Thus, the handling element provides an end of the sleeve that projects outwardly so as to be easy to identify and manipulate. This enables the proximal end of the catheter to be easily positioned for use without actually touching the catheter directly.

The sleeve may comprise a tube extending from the handling element. The tube may define an aperture which permits the catheter to exit the sleeve. The tube may have any suitable cross-section but preferably it is the same shape as the catheter, that is preferably circular. The tube may have a diameter or width greater than the diameter of the catheter. The tube may have a diameter or width less than a diameter or width of the handling element. The tube may have a length no longer than 4x, 3x, 2x or lx its diameter or width, preferably lx its diameter or width. Thus, the tube creates a space between the handling element and the aperture through which the catheter exits the sleeve. This reduces the likelihood that the users hand blocks a view of the catheter leaving the sleeve and shields the catheter from direct contact with the user’s hand or fingers which are holding the handling element as the catheter leaves the sleeve.

The fluid reservoir may be disposed on the handling element. The handling element may engage the fluid reservoir. The handling element may releasably engage the fluid reservoir. As such, the handling element may serve as a reservoir adapter. The aperture and/or tube may engage the fluid reservoir. The aperture and/or tube may releasably engage the fluid reservoir. The aperture and/or tube may be configured to engage the fluid reservoir through any suitable means such as a push-fit, bayonet, or screw fitting. The fluid reservoir may be moveable to a position in which it cannot be removed from the sleeve. The fluid reservoir may be moveable to a position in which it can be removed from the sleeve. When fastened/engaged to the sleeve/handling element, the fluid reservoir may be moveable axially with respect to the sleeve. The fluid reservoir may configured to be removed from the sleeve through an axial movement and then a rotational movement. In one embodiment, the fluid reservoir is moveable axially with respect to a (screw) fitting of the sleeve (between a position in which the fluid reservoir does not engage the fitting and a position in which the fluid reservoir does engage the fitting). The aperture and/or tube may be in fluid communication with the fluid reservoir. Thus, the fluid reservoir is conveniently retained on the end of the sleeve prior to use such that it may deliver wetting fluid directly into the sleeve and can also be removed to allow the catheter to exit the sleeve. Further, the fluid reservoir is less likely to be unintentionally removed from the sleeve as it requires two different movements to be removed. The fluid reservoir may prevent the catheter from being withdrawn from the sleeve. The fluid reservoir may prevent the catheter from being withdrawn from the sleeve until after the fluid reservoir has released wetting fluid into the sleeve. A water-tight, and preferably sterile, seal may be provided between the handling element/sleeve and fluid reservoir. Thus, the catheter is always wetted prior to removal of the fluid reservoir and fluid released from the fluid reservoir does not leak out between the fluid reservoir and sleeve, this ensures it is most effectively used to wet the catheter. In addition, the sterility of the catheter is maintained prior to use which reduces the risk of infection to the user.

The fluid reservoir may be configured to retain the wetting fluid within it. The fluid reservoir may be configured to retain at least 5, 10, 15, 25, or 50 ml of wetting fluid, most preferably at least 12 ml of fluid. The fluid reservoir may be configured to release wetting fluid into the sleeve; in particular the fluid reservoir may be configured to release wetting fluid between an internal surface of the sleeve and an external surface of the catheter. The fluid reservoir may be configured to retain and/or release excess wetting fluid. Excess wetting fluid is defined herein as more than is normally required to activate/wet the catheter, for example 10%, 20%, 50% or more, in excess of that which would normally be provided to wet the catheter (having regard for example to the length of the catheter and the composition of the wetting fluid). The sleeve may be configured to allow excess wetting fluid to flow into the fluid collection bag. Thus, the reservoir may release an excess of wetting fluid to ensure that the catheter is well wetted and excess fluid can flow into the fluid collection bag ensuring it does not negatively affect subsequent use of the catheter.

The fluid reservoir may be configured to release wetting fluid when activated by a user. The fluid reservoir may be activated by a user by any suitable means, for example twisting the fluid reservoir, or applying a compressive force to the fluid reservoir. The fluid reservoir may be configured to break at a point adjacent to the aperture of the sleeve through which the catheter exits the sleeve. The fluid reservoir may be configured to release wetting fluid by pressing it against/towards the handling element. In one embodiment, the fluid reservoir is configured to be pierced. The fluid reservoir may be pierced when it is pressed against/into the sleeve, for example against the handling element. The fluid reservoir may be pierced by a spike on the handling element. Preferably, the fluid reservoir may be pierced by pressing it against the handling element. The fluid reservoir may then be detached from the handling element, for example by unscrewing the fluid reservoir from the handling element. Thus, the fluid reservoir may ensure timely and easy release of wetting fluid to wet the catheter.

As mentioned above, the fluid reservoir may be movable between a position where it can be removed from the sleeve and a position where it cannot be removed from the sleeve. The fluid reservoir may be configured to release wetting fluid when it is in a position where it can be removed from the sleeve. The fluid reservoir may be configured to release wetting fluid before it is removed from the sleeve. Thus, the fluid reservoir may not be removed from the sleeve without it first being pierced and releasing wetting fluid into the sleeve to wet the catheter for use.

The fluid reservoir may be flexible. The fluid reservoir may comprise a flexible plastics material such as a hard moulded thermoplastic, for example HDPE. In some embodiments, under application of a compressive force, the fluid reservoir may configured to break when a threshold compressive force is exceeded. Thus, the fluid reservoir does not prematurely release the wetting fluid and the user can easily control the release of wetting fluid by pinching the fluid reservoir between their fingers to break the fluid reservoir and release wetting fluid into the sleeve.

The peripheral bond may provide a water-tight seal. Preferably, the peripheral bond may provide a sterile seal. The peripheral bond may comprise any one or more of: a weld; mechanical seal; heat seal; pressure seal; adhesive; solvent bond; ultraviolet bond; ultrasonic weld; laser weld; impulse weld; or friction weld. This ensures that the catheter is maintained within a sterile environment prior to use and also that once the catheter has been used any fluid contained within the bag does not leak out unintentionally.

The fluid collection bag may comprise a finger hole. The finger hole may be sized to allow a user to put their finger through the finger hole and handle the bag. Thus the finger hole allows the bag to be handled more easily by a user. The finger hole may be provided at an edge of the bag. The finger hole may be provided in the peripheral bond of the bag. The finger hole may be provided at a comer of the bag. The finger hole may be provided at any of the following comers: where the left lateral edge meets the base; where the base meets the right lateral edge; where the right lateral edge meets the upper edge; or where the upper edge meets the left lateral edge. Where the finger hole is provided in the bag, the peripheral bond may be shaped to accommodate the finger hole. The peripheral bond may truncate a comer of the bag to accommodate the finger hole. The peripheral bond may project into the bag to accommodate the finger hole. As an alternative to the finger hole, the fluid collection bag may comprise a series of ridges or otherwise easily gripped surface or feature in the place of the finger hole to allow the bag to be easily handled.

The fluid collection bag may comprise more than one finger hole, for example at least two, three or more finger holes. One, two, three or more, or each finger hole may have any one or more of the features of the finger hole described above. Thus, easy handling of the bag is facilitated through positioning of finger holes or equivalent features which also does not restrict or affect the volume of liquid that can be contained by the bag. The one or more finger holes may be configured to allow the bag to be rotated to a horizontal position wherein the base of the bag is aligned vertically. In a preferred embodiment, the fluid collection bag comprises a finger hole at either end of the right lateral edge and/or a finger hole at either end of the left lateral edge. Advantageously, this allows the bag to be rotated in a controlled manner which aids with handling and using the bag.

The fluid collection bag may comprise an inlet to allow fluid to enter the bag from the distal end of the catheter and optionally via the sleeve. The inlet may be connected to one end of the sleeve which corresponds to the distal end of the catheter. The inlet may comprise a one-way valve which prevents fluid flow through the inlet from the fluid collection bag to the sleeve and/or catheter. Thus, the inlet allows liquid to pass into the fluid collection bag but optionally may prevent fluid flow out of the bag and into the sleeve. This can reduce the likelihood of leaking.

The catheter assembly may be configured to allow fluid to pass directly from the sleeve to the inlet and/or directly from the catheter to the inlet. One lateral side (e.g. a right lateral side) of the catheter may be attached to one side (e.g. a right side) of the inlet. There may be a gap between a different lateral side (e.g. a left lateral side) of the catheter and a respective different side (e.g. a left side) of the inlet. The distal end of the catheter may be within the inlet. The sleeve may be sealed around a periphery of the inlet. As such, fluid travelling within the sleeve is directed into the inlet directly via the gap. In addition, fluid travelling within the catheter passes out the distal end and into the inlet . In other examples, the catheter may be positioned differently and may be attached, for example, to the left side of the inlet.

The catheter assembly may be configured to allow fluid to pass from the catheter into the sleeve. One lateral side (e.g. a right lateral side) of the catheter may be attached to a side (e.g. right side) of the sleeve. A distal end of the catheter may be within the sleeve. A distal end of the catheter may not be within the inlet. The sleeve may be sealed around a periphery of the inlet. As such, fluid travelling within the sleeve is directed into the inlet directly and fluid travelling within the catheter passes out the distal end into the sleeve and then from there into the inlet. In other examples, the catheter may be positioned differently and may be attached to a left side of the sleeve (or indeed a front side or rear side). Furthermore, the distal end of the catheter may be blocked and an outlet may be provided in a lateral side of the catheter to allow fluid to pass out into the sleeve.

The catheter assembly may be configured to allow fluid to pass from the sleeve into the catheter. One lateral side (e.g. a right lateral side) of the catheter may be attached to one side (e.g. a right side) of the inlet. The inlet may be sealed around the catheter on all sides. Consequently, there may be no gap between the inlet and the catheter. As such, fluid may only pass from the sleeve/catheter into the inlet if it is within the catheter. A side, e.g. a lateral side of the catheter may comprise a sleeve intake opening. The sleeve intake opening may be any suitable shape such as oval or circular. The sleeve intake opening may be adjacent to the inlet. The sleeve intake opening may permit the passage of fluid from the sleeve 3 into the catheter. Thus fluid may enter the catheter from the sleeve to join fluid travelling within the catheter. From here, the fluid may pass out the distal end of the catheter and into the inlet. Many other configurations may be possible to achieve the same effect, for example, the sleeve may be attached to the outer sides of the catheter itself.

The upper edge of the peripheral bond may comprise a neck. The inlet may be located on the neck. The neck may project out in the plane of the fluid collection bag. The neck may project away from the fluid collection bag. The neck may span at least 10%, 20%, 30%, 40%, 50%, 60%, or 70% of the length of the upper edge. The neck may be positioned at any point on the upper edge, but preferably in the middle of the upper edge. The neck may be any suitable shape, but preferably it is triangular. The neck may comprise a left sloped edge and/or a right sloped edge. The left sloped edge and right sloped edge may project from the upper edge and converge at the inlet. Thus, the neck spaces the inlet from the rest of the bag which makes it easier for the user to locate. The provision of a neck can also help liquid entering the bag to be dispersed evenly within the bag.

The fluid collection bag may comprise an outlet to allow fluid to be drained from the bag. The inlet and the outlet may be positioned next to one another. The outlet may be sealed to allow fluid to fill the bag. The outlet may comprise a pull ring configured to be pulled and thereby form an opening in the bag. The pull ring may be configured to be moved in a direction away from the inlet to form the opening. The inlet may be configured to be folded along a neck fold-line. Once folded, the neck foldline may form an edge of the bag. The pull ring may project beyond the edge of the bag defined by the neck fold-line.

Accordingly, a sixth aspect of the present invention provides a fluid collection bag for use with a catheter having a proximal end for insertion into the body and a distal end, the fluid collection bag comprising an inlet to allow fluid to enter the bag from the distal end of the catheter, and an outlet to allow fluid to be drained from the bag, wherein the inlet and the outlet are positioned next to one another, the outlet is sealed to allow fluid to fill the bag, the outlet comprises a pull ring configured to be moved in a direction away from the inlet to form an opening in the bag, and the inlet is configured to be folded so as to form an edge of the bag with the pull ring projecting beyond the edge.

Advantageously, the outlet is sealed so there is a low risk of leakage of fluid during filling the bag. In addition, the folding of the inlet reinforces the bag and inlet to ensure the opening is easily and reliably formed with clean edges that allow controlled emptying of the bag.

The inlet and outlet may be positioned on the same edge of the bag. The inlet may positioned centrally on an edge of the bag. The outlet may be position between the neck and a lateral edge of the bag. The outlet may be positioned at a comer of the bag. Thus, tearing/shear forces on the bag are minimised as they are concentrated on the comer of the bag this reduces the likelihood of the bag breaking and spilling liquid.

The outlet may be positioned distal from a finger hole of the bag, for example the finger hole described above in relation to the fifth aspect of the present invention. Where the outlet is positioned at or adjacent to an edge of the bag, that edge may be free from finger holes. Where the outlet is position at or adjacent an edge of the bag, a different edge of the bag (that is the right/left lateral edge) may comprise one or more finger holes. Thus, the finger holes are positioned on edges of the bag that generally do not correspond to the position of the outlet, this makes handling/emptying of the bag easier as the bag can be rotated and held using the finger holes to allow fluid to leave the bag due to gravity. The outlet may project beyond an upper edge of the bag. The outlet may comprise a spout that projects from the upper edge of the bag. The pull-ring may be attached to the spout. The spout may be any suitable shape, for example rectangular, square, triangular or irregularly shaped, preferably it is rectangular or square. Advantageously, the outlet/spout projects from the edge of the bag and as such is easier to tear off the bag without damaging the rest of the bag and risking uncontrolled release of fluid from the bag.

The pull-ring may be disposed between the spout and inlet. The pull-ring may have any suitable shape, for example circular, elliptical, rectangular, square, triangular, or irregularly shaped. Thus, as the pull-ring is disposed between the spout and the inlet, when it is moved away from the inlet, shearing force from the movement is concentrated at the point the outlet meets the rest of the bag. This facilitates controlled tearing of the bag to create the opening.

The inlet may extend away from the bag, for example where the bag comprises a neck as described in relation to the first aspect of the invention. The outlet and the inlet may extend/project the same distance beyond an edge of the bag. The outlet and inlet/neck may have corresponding shapes. The outlet and inlet/neck may be shaped to fit into, around or next to one another. The pull-ring may be shaped to fit into, around or next to the inlet/neck. As such, there may be little or no gaps between the outlet/pull- ring and inlet/neck. Where the neck is triangular as described above in relation to the first aspect of the invention, the pull-ring may also be triangular in shape. The pullring may have the shape of a right-angled triangle with two perpendicular sides and a hypotenuse. The hypotenuse may be parallel and/or adjacent to one of the left sloped edge or right sloped edge of the neck. One of the perpendicular sides may form a side of the spout. As the inlet and outlet project the same distance beyond the edge of the pouch and have corresponding shapes, they protect one another from damage due to being caught on other objects.

The outlet may comprise a point of weakness. The point of weakness may be disposed in the peripheral bond at a point the outlet meets the peripheral bond. The point of weakness may be disposed at a point the outlet meets a lateral edge of the peripheral bond. The point of weakness may be arranged at the start or end of the opening. The point of weakness may be a notch, or thinned section, in the peripheral bond. The outlet may comprise one or more points of weakness as described above. The outlet may comprise a tear line. The tear line may comprise a weakened region of the outlet. An end of the tear line may comprise a point of weakness. Where the outlet comprises two or more points of weakness, a point of weakness may be positioned at either end of the tear line. The tear line may be configured to preferentially tear. The tear line may be formed by any suitable means, such as laser scoring. Thus, the provision of one or more points of weakness further assist controlled tearing of the bag by providing points in the outlet which preferentially break to form parts of the opening such as the start and/or end.

The pouch may comprise an absorbent material.

Accordingly, a seventh aspect of the present invention provides a packaged catheter assembly comprising a pouch and a catheter, wherein the pouch is configured to contain the catheter within it and wherein the pouch comprises an absorbent material.

Advantageously the provision of absorbent material allows any fluid in the pouch to be absorbed. This reduces leakage from the pouch making it more convenient and comfortable for a user to use and carry. A leak could occur prior to use (e.g. if someone inadvertently bursts a fluid reservoir); during use (e.g. when using the pouch as a surface on which to set up, or pack away the catheter assembly); or after use. In each of these situations, the provision of an absorbent material will be advantageous. Furthermore, as fluid in the pouch is absorbed by the absorbent material, then there is less fluid pooling within the bag and less fluid moving around within the pouch. This reduces noise associated with fluid sloshing within the bag and also makes the bag easier to carry as the weight distribution within it is more stable.

The absorbent material may be any suitable shape or size. The absorbent material may be any one of: an absorbent sachet; an absorbent layer; an absorbent strip. Preferably, the absorbent material is an absorbent layer. The absorbent layer may line at least part of an inside surface of the pouch. The absorbent layer may line at least 50%, 60%, 70%, 80%, or 90% of the inside surface of the pouch. The absorbent layer may line the whole inside surface of the pouch. Where the pouch comprises a front and/or rear wall, the absorbent layer may line at least part of the front and/or rear walls. The absorbent layer may line both the front and rear walls. The absorbent layer may comprise a single sheet of absorbent material folded to line both the front and rear walls of the pouch. Advantageously, the absorbent layer can be easily formed and added to the pouch construction as it can line the inside of the pouch and be folded inside.

The absorbent material may be configured to absorb at least 10%, 20%, 30%, 40%, 50%, 60%, 70%, 80%, or 90% of the liquid capacity of the fluid collection bag. In one embodiment, the absorbent material is configured to absorb 100% of the liquid capacity of the fluid collection bag. Thus, the absorbent material ensures that it can absorb (all) liquid within the fluid collection bag if required to reduce sloshing of liquid within the pouch/fluid collection bag.

The absorbent material may comprise an absorbent strip. The absorbent strip may be elongate. The absorbent strip may have a length and a width wherein the length is at least 2, 3, 4, 5, or 6 times larger than the width. The absorbent strip may be placed adjacent to a mouth of the pouch. The mouth may correspond to a part of the pouch which forms an opening to allow access to the contents of the pouch. The absorbent strip may line the mouth of the pouch. Two or more absorbent strips may be provided. Thus, absorbent strips may be used to help prevent fluid from leaking out of the pouch through the mouth of the pouch.

The absorbent material may comprise an absorbent polymer, a super absorbent, for example polyacrylic acid.

The catheter assemblies/packaged catheter assemblies of the first to seventh aspects may include any one or more features of a catheter assembly /packaged catheter assembly as defined in general/broad terms, or according to any other of the first to seventh aspects set out above. The catheter assemblies/packaged catheter assemblies of the first to seventh aspects may comprise any of the optional features of the others of the first to seventh aspects without necessarily including all the features required of them. That is to say, an optional feature which happens to be set out following one particular aspect does not necessarily apply only to that aspect, so, for example, the disclosure provides for the packaged catheter assembly of the second aspect comprising a catheter and a pouch; the pouch having two walls and a peripheral seal between the two walls, wherein an edge of the pouch comprises a fold between the two walls, and the peripheral seal is configured to be broken to allow the fold to be opened to a flat position wherein the catheter assembly comprises a fluid collection bag (but not necessarily comprising a passageway) and fluid reservoir retained in position within fluid collection bag by a join and protrusion as described in relation to the first aspect of the invention, and the pouch comprises a wetting marker corresponding to the position of the fluid reservoir in the pouch as described in relation to the third aspect of the invention.

According to an eighth aspect of the present invention there is provided a method of forming a catheter assembly comprising the steps of providing a catheter having a proximal end for insertion into the body and a distal end and a fluid collection bag, the fluid collection bag comprising a passageway extending from the fluid collection bag; the passageway having an extended configuration and a stowed configuration, wherein in the extended configuration the passageway permits fluid to pass therethrough and in/out of the bag, and in the stowed configuration the passageway is folded or rolled to inhibit flow of fluid therethrough.

The passageway may extend beyond an edge of the fluid collection bag. Accordingly there is provided a method of forming a catheter assembly comprising the steps of providing a catheter and a fluid collection bag, the fluid collection bag comprising a passageway extending from the fluid collection bag; the passageway having an extended configuration and a stowed configuration, wherein in the extended configuration the passageway extends beyond an edge of the bag permits fluid to pass therethrough and in/out of the bag, and in the stowed configuration the passageway is folded or rolled to inhibit flow of fluid therethrough.

The method of the eighth aspect of the invention may be a method of forming the catheter assembly of the first aspect of the invention, which, of course, may include any optional feature outlined above.

The method may comprise forming the passageway in its extended configuration. The method may comprise rolling or folding the passageway to the stowed position. Thus, the passageway is more easy to manufacture in the extended position and can then be rolled/folded into the stowed position ready for use. The method may comprise providing a front and a rear panel of the fluid collection bag. The method may comprise sealing the front panel to the rear panel to form the peripheral bond. The passageway may be provided integrally with the front and rear panels of the fluid collection bag. The method may comprise forming the passageway at the same time as the peripheral bond. The method may comprise rolling or folding the passageway to the stowed position after forming the peripheral bond. Thus, the fluid collection bag and passageway can be formed in a single-step process that reduces the complexity of manufacture.

The method may comprise forming the passageway separately from the peripheral bond of the fluid collection bag. The method may comprise rolling or folding passageway to the stowed position before sealing with peripheral bond.

The method may comprise placing the catheter within the fluid collection bag. The method may comprise arranging the catheter on the rear panel, preferably in a curved/coiled configuration as described in relation to the first aspect of the invention above. The method may comprise placing the front panel over the rear panel and catheter. The method may comprise forming the peripheral bond (and join where applicable) between the front and rear panels and around the catheter. Of course, the method may equally apply where the front and rear panels are interchanged, such as the catheter is arranged on the front panel and the rear panel is placed over it and then the peripheral bond formed. Thus, the fluid collection bag is efficiently manufactured with the catheter inside and in a curved configuration to reduce the risk of kinks to the catheter.

The method may comprise providing a guide tube/aperture in the passageway (preferably in the neck). The method may comprise inserting a proximal end of the catheter into the guide tube so as to retain the catheter in the guide tube. The method may comprise arranging the catheter (at least partly) inside the passageway. The method may comprise arranging the guide tube outside the passageway and/or fluid collection bag. Preferably, the catheter may be inserted into the guide tube prior to arranging the catheter on the rear panel of fluid collection bag. The catheter may be arranged with its distal end on the rear panel, and its proximal end retained in the guide tube outside the rear panel. A portion of the catheter may be arranged in a position corresponding to the passageway on the rear panel. The front panel may then be placed over the catheter (including its distal end) and the peripheral bond formed between the front and rear panels to create the fluid collection bag and passageway with the catheter passing through the passageway. The method may (then) comprise inserting the (entire) catheter and guide tube into the passageway. Thus, the guide tube and catheter can be easily manufactured and arranged to provide easy access to the catheter during use.

The method may comprise providing a plug to seal the passageway. The method may comprise inserting the plug into the passageway to seal the passageway. The plug may be inserted into the passageway after the guide tube. The method may then comprise the step of rolling or folding the passageway into the stowed configuration. The method may comprise installing the plug, catheter and guide tube into a neck of the fluid collection bag. Thus, the plug, catheter and guide tube are installed into the passageway in an efficient manner.

The method may comprise providing a closure. The method may comprise permanently attaching the closure to the fluid collection bag. The closure may be attached to the fluid collection bag before or after the peripheral bond is formed. The method may comprise sealing the passageway with the closure. The step of sealing the passageway may be done after rolling/folding the passageway into the stowed configuration. The method may comprise sealing a drain of the fluid collection bag with the closure. The closure may be a closure flap. Thus, closure is easily added to the bag and used to seal the drain prior to use.

The method may comprise arranging a fluid reservoir on the rear panel. The method may comprise arranging the front panel over the rear panel and fluid reservoir. The method may comprise coiling the catheter around the fluid reservoir, or placing the fluid reservoir within a coil of the catheter. The method may comprise placing the catheter and fluid reservoir in the same section of the fluid collection bag. The method may comprise forming the peripheral bond including protrusion and join to seal the fluid reservoir within the fluid collection bag. Thus, the fluid reservoir is efficiently arranged within the fluid collection bag.

According to a ninth aspect of the present invention, there is provided a method of forming a packaged catheter assembly comprising the steps of providing a catheter and a sheet of material, folding the sheet to form two walls, and sealing the two walls with a peripheral seal to form the pouch, wherein the peripheral seal is configured to be broken to allow the fold to be opened to a flat position.

The method of the ninth aspect of the invention may be a method of forming the packaged catheter assembly of the second aspect of the invention, which, of course, may include any optional feature outlined above.

The method may comprise arranging the contents of the pouch on the inside of one of the walls (e.g. a first wall). The method may then comprise folding the other (second) wall over the first wall and sealing the two walls with the peripheral seal. Thus, the packaged catheter assembly can be conveniently and quickly manufactured.

The method may comprise attaching the fluid collection bag to the front and/or rear walls of the pouch. Where the front/rear walls of the pouch form a rear panel of the fluid collection bag, the method may comprise forming a peripheral bond between the front panel of the fluid collection bag and the respective front/rear walls of the pouch. The rear panel of the fluid collection bag may be arranged over the front and rear walls of the pouch. The front panel of the fluid collection bag may be arranged over the rear panel of the fluid collection bag. The front panel, rear panel, and front and rear walls may be all sealed together in a single step. The method may then comprise folding the pouch and forming the peripheral seal between the front and rear walls. Thus, the fluid collection bag and pouch can be easily and efficiently manufactured together and with the fluid collection bag sealed within the pouch.

According to a tenth aspect of the present invention there is provided a method manufacturing a packaged catheter assembly comprising the steps of providing a pouch comprising first and second walls formed of an opaque material and a third wall that is transparent or translucent, and a catheter, arranging the third wall between the first and second walls, and providing a peripheral seal between the first and second walls.

The peripheral seal may be configured to allow the first and second walls to separate. The first and second walls may be separated to expose the third wall. The method may comprise sealing the third wall to the first and/or second wall to form a fluid collection bag to receive fluid from the catheter. Thus, there is provided a method manufacturing a packaged catheter assembly comprising the steps of providing a pouch comprising first and second walls formed of an opaque material and a third wall that is transparent or translucent, and a catheter, arranging the third wall between the first and second walls, sealing the third wall to the first and/or second wall to form a fluid collection bag to receive fluid from the catheter, then providing a peripheral seal between the first and second walls; wherein the peripheral seal is configured to allow the first and second walls to separate to expose the third wall.

The method of the tenth aspect of the invention may be a method of forming the packaged catheter assembly of the third aspect of the invention, which, of course, may include any optional feature outlined above.

The method may comprise providing a wetting marker on an external face of the pouch. The method may comprise providing a wetting marker at a position corresponding to the fluid reservoir within the pouch. The method may comprise printing the wetting marker to the pouch. Thus, the wetting marker is added to help the user identify the fluid reservoir.

According to an eleventh aspect of the present invention there is provided a method of manufacturing a packaged catheter assembly comprising providing two walls to form a pouch, arranging a catheter within the pouch, and forming a peripheral seal between the two walls to seal the pouch, wherein each wall comprises a tab extending from an edge of the pouch and the tabs are configured to be separated in use to create an opening in the peripheral seal.

The method of the eleventh aspect of the invention may be a method of forming the packaged catheter assembly of the fourth aspect of the invention, which, of course, may include any optional feature outlined above.

The method may comprise providing a gripping hole in each tab. The method may comprise cutting or punching a gripping hole in each tab. Thus, the gripping hole can be conveniently created in the tab to make it easier to grasp.

The method may comprise folding the tabs against the pouch. The method may comprise folding the tabs against the same side of the pouch, for example the front wall of the pouch. The method may include forming a crease-line in each tab and folding each tab about the crease-line. Thus, the form factor of the pouch is reduced and the tabs are less likely to be damaged by being caught on other objects.

Accordingly in one embodiment, there is provided a method of manufacturing a packaged catheter assembly comprising providing two walls to form a pouch, arranging a catheter within the pouch, and forming a peripheral seal between the two walls to seal the pouch, wherein each wall comprises a tab extending from an edge of the pouch and the tabs are configured to be separated in use to create an opening in the peripheral seal, the method comprising folding the tabs against the pouch.

According to a twelfth aspect of the present invention there is provided a method of forming a catheter assembly comprising the steps of providing a catheter having a proximal end for insertion into the body and a distal end, arranging a fluid collection bag to receive fluid from the distal end of the catheter, enclosing the catheter along the length of the catheter from the proximal end to the distal end with a sleeve, and arranging a fluid reservoir at the proximal end of the catheter, wherein the fluid reservoir is configured to release wetting fluid into the sleeve to wet the catheter and wherein the sleeve is in fluid communication with the fluid collection bag.

The method of the twelfth aspect of the invention may be a method of forming the catheter assembly of the fifth aspect of the invention, which, of course, may include any optional feature outlined above.

According to a thirteenth aspect of the present invention, there is provided a method of forming a fluid collection bag, the method comprising providing a bag, forming an inlet in the bag to allow fluid to enter the bag, and forming a sealed outlet in the bag next to the inlet, wherein the outlet comprises a pull ring configured to be moved in a direction away from the inlet to form an opening in the bag, and the inlet is configured to be folded so as to form an edge of the bag with the pull ring projecting beyond the edge.

The method of the thirteenth aspect of the invention may be a method of forming a fluid collection bag of the sixth aspect of the invention, which, of course, may include any optional feature outlined above. The method may comprise forming a finger hole in the bag. The finger hole may be formed at a point distal from the outlet, for example on a different edge of the bag from the outlet. Thus, the finger hole can be more easily use to handle the bag and direct fluid flow out of the outlet.

The method may comprise providing front and rear panels of the fluid collection bag as described in relation to the first aspect of the invention above. The outlet and/or inlet may be provided integrally with the front and rear panels. The outlet and/or inlet may be formed by sealing the front and rear panels together and creating the peripheral bond. Thus, the inlet and/or outlet and fluid collection bag may be formed in a single step which simplifies manufacture.

The method may comprise forming a point of weakness in the outlet. The method may comprise forming a point of weakness at either side of the outlet. The method may comprise forming a tear line extending from at least one point of weakness in the outlet. The tear line may be formed by laser scoring as described in the second aspect of the invention above.

According to a fourteenth aspect of the present invention there is provided a method manufacturing a packaged catheter assembly comprising the steps of providing a pouch comprising an absorbent material, and arranging a catheter within the pouch.

The method of the fourteenth aspect of the invention may be a method of manufacturing the catheter assembly of the seventh aspect of the invention, which, of course, may include any optional feature outlined above.

According to a fifteenth aspect of the present invention there is provided a method of providing fluid access to a fluid collection bag of a catheter assembly, the catheter assembly comprising the fluid collection bag and a catheter, the fluid collection bag comprising a passageway extending from the fluid collection bag; the passageway having an extended configuration and a stowed configuration, wherein in the extended configuration the passageway permits fluid to pass therethrough and in/out of the bag, and in the stowed configuration the passageway is folded or rolled to inhibit flow of fluid therethrough, wherein the passageway is provided in the stowed configuration and the method comprises moving the passageway to the extended configuration by unfolding or unrolling the passageway.

The passageway may extend beyond an edge of the fluid collection bag. Accordingly there is provided a method of providing fluid access to a fluid collection bag of a catheter assembly, the catheter assembly comprising the fluid collection bag and a catheter having a proximal end for insertion into the body and a distal end, the fluid collection bag comprising a passageway extending from the fluid collection bag; the passageway having an extended configuration and a stowed configuration, wherein in the extended configuration the passageway extends beyond an edge of the bag and permits fluid to pass therethrough and in/out of the bag, and in the stowed configuration the passageway is folded or rolled to inhibit flow of fluid therethrough, wherein the passageway is provided in the stowed configuration and the method comprises moving the passageway to the extended configuration through unfolding or unrolling the passageway.

The method of fifteenth aspect of the present invention may be a method of providing fluid access to a fluid collection bag of the catheter assembly of the first aspect of the invention, which, of course, may include any optional feature outlined above and may be manufactured according to the eighth aspect of the invention.

The method may comprise removing a plug from the passageway, optionally after the passageway has been unfolded/unrolled into the extended configuration. The method may comprise withdrawing the catheter from the fluid collection bag. The method may comprise withdrawing the catheter through the passageway after removal of the plug. The passageway may be the neck. Thus, the catheter can be easily and safely accessed.

The method may comprise releasing fluid from a fluid reservoir (into the fluid collection bag) to wet the catheter. The method may comprise wetting the catheter prior to withdrawal of the catheter from the bag. The method may comprise wetting the catheter when the passageway is in the stowed or extended configuration. The method may comprise rotating the bag to direct wetting fluid into the passageway containing the catheter, preferably into the neck. Thus, the catheter adequately wetted prior to use. The method may comprise introducing the catheter by its proximal end into the urethra. The method may comprise allowing fluid to pass from the body and into the fluid collection bag via the catheter. Consequently, the method may be a method of using a catheter assembly.

The method may comprise draining fluid from the fluid collection bag. The method may comprise holding the fluid collection bag with the passageway at the bottom of the bag. The method may comprise releasing the closure from the passageway. The method may comprise unfolding/unrolling the passageway into the extended configuration. The method may comprise allowing the passageway to unfold/unroll into the extended configuration under the weight of fluid within the fluid collection bag. The passageway may be the drain. Thus, the fluid collection bag can be easily drained and the closure ensures that the risk of getting fluid from the bag onto the users hands is minimised as it facilitates automatic opening of the drain.

According to a sixteenth aspect of the present invention there is provided a method of unpackaging a packaged catheter assembly, the packaged catheter assembly comprising a pouch and a catheter, the method comprising the steps of breaking a peripheral seal of the pouch, and unfolding the pouch to a flat position. Preferably the step of unfolding the pouch involves unfolding the pouch about a fold-line which joins a first and second wall of the pouch.

The method of the sixteenth aspect of the invention may be a method of unpackaging a packaged catheter assembly of the second aspect of the invention, which, of course, may include any optional feature outlined above and may be manufactured according to the ninth aspect of the invention.

The method may comprise applying a threshold force to separate the first and second walls. This may allow them to be separated in a controlled manner, and the walls may then remain separated and flat as described above in relation to the second aspect of the invention.

The method may comprise removing the catheter from the pouch after opening the fold in the pouch. The method may comprise introducing the catheter by its proximal end into the urethra. The method may comprise allowing fluid to pass out of the body via the catheter. Consequently, the method may be a method of using a packaged catheter assembly.

The method may comprise bringing the walls of the pouch together to close the pouch. The method may comprise re-sealing the peripheral seal of the pouch. The method may comprise closing/re-sealing the pouch with the catheter within it. The steps of closing/re-sealing the pouch may be performed after use of the catheter. Thus, the pouch can be used to cleanly store the catheter after use and prior to disposal.

According to an seventeenth aspect of the present invention there is provided a method unpackaging a packaged catheter assembly, the packaged catheter assembly comprising a pouch having first and second walls, a peripheral seal between the first and second walls, a third wall arranged between the first and second walls, and a catheter, wherein: the first and second walls are formed from opaque material; the third wall is formed from a transparent or translucent material, the method comprising separating the first and second walls to expose the third wall.

The method of the seventeenth aspect of the invention may be a method of unpackaging a packaged catheter assembly of the third aspect of the invention, which, of course, may include any optional feature outlined above and may be manufactured according to the tenth aspect of the invention.

The third wall may be sealed to the first and/or second wall to form a fluid collection bag to receive fluid from the catheter. Accordingly, the invention provides a method unpackaging a packaged catheter assembly, the packaged catheter assembly comprising a pouch having first and second walls, a peripheral seal between the first and second walls, a third wall arranged between the first and second walls, and a catheter, wherein the first and second walls are formed from opaque material, the third wall is formed from a transparent or translucent material, and the third wall is sealed to the first and/or second wall to form a fluid collection bag to receive fluid from the catheter, the method comprising separating the first and second walls to expose the third wall and fluid collection bag.

The method may comprise releasing wetting fluid from a fluid reservoir within the pouch and/or fluid collection bag. The method may comprise locating a wetting marker disposed on the exterior of the pouch. The method may comprise pressing the wetting marker to release fluid from the fluid reservoir. The method may comprise pinching the pouch at a location corresponding to the wetting marker. The step of releasing wetting fluid from the fluid reservoir may be done prior to opening the pouch, or alternatively, after opening the pouch. Thus, the fluid reservoir can be easily activated even though the pouch is opaque and obscures the location of the fluid reservoir.

The method may comprise removing the catheter from the pouch after opening the pouch. The method may comprise introducing the catheter by its proximal end into the urethra. The method may comprise allowing fluid to pass out of the body via the catheter. Consequently, the method may be a method of using a packaged catheter assembly.

The method may comprise identifying when the fluid collection bag of the pouch is full by watching fluid fill the bag through the third wall. Thus, the transparent/translucent wall allows for the fluid collection bag to be efficiently used and ensures it is not overfilled.

The method may comprise draining the fluid collection bag. The method may comprise verifying the fluid collection bag is empty by inspecting it through the third wall. Thus, the fluid collection bag can be efficiently emptied and the user can ensure the bag is empty.

According to a eighteenth aspect of the present invention there is provided a method of unpackaging a packaged catheter assembly, the packaged catheter assembly comprising a catheter and a pouch having two walls and a peripheral seal between the two walls, wherein the pouch is configured to contain the catheter within it, each wall comprises a tab extending from an edge of the pouch, and the tabs are configured to be separated in use to create an opening in the peripheral seal, the method comprising separating the tabs to form an opening in the peripheral seal.

The method of the eighteenth aspect of the invention may be a method of unpackaging a packaged catheter assembly of the fourth aspect of the invention, which, of course, may include any optional feature outlined above and may be manufactured according to the eleventh aspect of the invention.

The tabs may be folded against the pouch. The method may comprise unfolding the tabs. Unfolding may be done prior to separation of the tabs.

Accordingly, in one embodiment, there is provided a method of unpackaging a packaged catheter assembly, the packaged catheter assembly comprising a catheter and a pouch having two walls and a peripheral seal between the two walls, wherein the pouch is configured to contain the catheter within it, each wall comprises a tab extending from an edge of the pouch and folded against the pouch, and the tabs are configured to be separated in use to create an opening in the peripheral seal, the method comprising unfolding the tabs and then separating the tabs to form an opening in the peripheral seal.

The method may comprise separating the tabs at the point they overlap. The method may comprise separating the tabs by pushing one tab away from the other via an aperture (such as the gripping hole) in one of the tabs. Thus, the tabs can be easily separated to open the pouch.

The method may comprise handling the pouch by grasping either one, or both, of the tabs. The pouch may be handled by grasping a, or each, tab either before, after, or before and after use of the catheter. Thus, the pouch can be handled/moved by the user as required without needing to touch the inside of the pouch which they may wish to keep clean or avoid as it is dirty.

The method may comprise closing/re-sealing the pouch as described above. The step of closing/re-sealing the pouch may comprise grasping each tab and bringing them together. Thus, the tabs can be used to avoid contact with the walls of the pouch which may have become dirty during use of the catheter. According to a nineteenth aspect of the present invention there is provided a method of wetting a catheter having a proximal end for insertion into the body and a distal end, the method comprising the steps of releasing wetting fluid from a fluid reservoir at the proximal end of the catheter, into a sleeve that encloses the catheter, allowing the wetting fluid to flow through the sleeve from the proximal end to the distal end, and collecting excess wetting fluid in a fluid collection bag configured to receive fluid from a distal end of the catheter and the sleeve.

The method of the nineteenth aspect of the invention may be a method of wetting the catheter of the catheter assembly of the fifth aspect of the invention, which, of course, may include any optional feature outlined above and may be manufactured according to the twelfth aspect of the invention.

The method may comprise pressing the fluid reservoir against or towards the sleeve to release wetting fluid from the fluid reservoir. The method may comprise grasping a handling element of the sleeve and pressing the fluid reservoir against/towards the handling element to allow fluid to be released from the fluid reservoir. The method may comprise allowing fluid to flow from the fluid reservoir, through the handling element and into the sleeve. The step of releasing wetting fluid may comprise piercing the fluid reservoir. Thus, the fluid reservoir may be easily activated to release wetting fluid into the sleeve.

The method may comprise removing the fluid reservoir from the sleeve. The fluid reservoir may be removed from the sleeve after the release of wetting fluid from the fluid reservoir. Thus, the catheter is adequately wetted before the fluid reservoir is removed.

The method may comprise withdrawing the catheter from the sleeve. Only part of the catheter, preferably including the proximal end of the catheter, may be withdrawn from the sleeve. The method may comprise passing the catheter through the handling element. The method may comprise bunching the sleeve. The catheter may be withdrawn from the sleeve after it has been wetted. The catheter may be withdrawn from the sleeve after the fluid reservoir has been removed from the sleeve. Thus, the fluid reservoir protects the catheter before use, and the catheter is easily withdrawn through the handling element. The method may comprise introducing the catheter by its proximal end into the urethra. The method may comprise allowing fluid to pass from the body and into the fluid collection bag via the catheter and/or the sleeve. Consequently, the method may be a method of using a catheter assembly.

According to a twentieth aspect of the present invention, there is provided a method of draining a fluid collection bag, the fluid collection bag comprising an inlet and a sealed outlet next to one another, the outlet comprising a pull ring, the method comprising folding the inlet to form an edge of the bag with the pull ring projecting beyond the edge, moving the pull ring in a direction away from the inlet to form an opening in the bag, and emptying the contents of the bag out through the opening.

The method of the twentieth aspect of the invention may be a method of draining the fluid collection bag of the sixth aspect of the invention, which, of course, may include any optional feature outlined above and may be manufactured according to the thirteenth aspect of the invention.

The method may comprise forming an opening extending from at least one point of weakness disposed on the outlet. The method may comprise forming an opening along a weakened region of the outlet. Thus, the opening is easily formed in a controlled manner.

The method may comprise rotating the bag such that the outlet is at a point above the rest of the bag, and then forming an opening in the bag. Thus, fluid in the bag is not near the outlet as it is opened which reduces the likelihood of spillage.

The method may comprise rotating the bag such that the outlet is at a point below the rest of the bag after forming an opening in the bag. Thus, fluid may flow out of the bag and the bag may be efficiently drained.

The method may comprise rotating the bag by grasping one or more finger holes disposed at the edges of the bag. The method may comprise grasping a finger hole disposed on an edge of the bag distal from the outlet. Thus, the bag can be rotated in a controlled manner using the finger holes and while reducing the risk of spillages from the outlet. The method may comprise providing a catheter and introducing the catheter by its proximal end into the urethra. The method may comprise allowing fluid to pass from the body and into the fluid collection bag via the inlet and catheter. Fluid may pass from the catheter into the bag before an opening is formed in the bag with the outlet. Consequently, the method may be a method of using a catheter assembly.

According to a twenty-first aspect of the present invention there is provided a method of unpackaging a packaged catheter assembly, the packaged catheter assembly comprising a pouch and a catheter, wherein the pouch is configured to contain the catheter within it and wherein the pouch comprises an absorbent material, the method comprising removing the catheter from the pouch.

The method of the twenty-first aspect of the invention may be a method of unpackaging a catheter assembly according to the seventh aspect of the invention and may, of course, include any optional feature outlined above and the catheter assembly may be manufactured according to the fourteenth aspect of the invention.

The method may comprise wetting the catheter and absorbing any excess wetting fluid with the absorbent material.

The method may comprise introducing the catheter by its proximal end into the urethra. The method may comprise allowing fluid to pass out of the body via the catheter. Consequently, the method may be a method of using a packaged catheter assembly.

The method may comprise absorbing liquid that has passed through the catheter. Thus, the volume of free liquid is reduced by the absorbent material and this can make transportation and disposal of the liquid easier and more convenient for the user.

The method comprising absorbing liquid present on the outside of the catheter. This may preferably be done after use of the catheter. The method may comprise placing the catheter within the pouch. The method may comprise closing the pouch. Thus, any excess liquids are absorbed by the absorbent material and retained within the pouch after use of the catheter.

The methods of the eighth to twenty-first aspects of the present invention may of course individually include any one or more of the features, optional or otherwise, of one another and further may include any one or more of the features, optional or otherwise, of the first to seventh aspects of the present invention.

In any aspect, the catheter assembly is preferably a closed catheter assembly, that is that the catheter assembly comprises a catheter coupled to a fluid collection bag, such that it is configured to collect and retain fluid released from the body through the catheter. The fluid collected/catheter assembly may then be disposed of by the user when is convenient. Of course, embodiments of the invention may also be open catheter assemblies in that fluid is not collected or retained by the catheter assembly.

Detailed Description of the Invention

In order that the invention may be more clearly understood one or more embodiments thereof will now be described, by way of example only, with reference to the accompanying drawings, of which:

Figure 1 is a front view of a first embodiment of a packaged catheter assembly where the pouch is in the closed configuration;

Figure 2 is a front view of the packaged catheter assembly of Figure 1 where the pouch is between the closed and open configurations;

Figure 3 is a front view of the packaged catheter assembly of Figure 1 where the pouch is in the open configuration and the neck and drain are in the stowed/closed configuration;

Figure 4 is a front view of the packaged catheter assembly of Figure 1 where the pouch and neck are in the open configuration, and the drain is in the stowed/closed configuration;

Figure 5 is a front view of the packaged catheter assembly of Figure 1 where wetting fluid has been released into the fluid collection bag;

Figure 6 is a front view of the packaged catheter assembly of Figure 1 where wetting fluid has been released into the fluid collection bag, but in a different orientation from that of Figure 5; Figure 7 is a front view a fluid collection bag of the packaged catheter assembly of Figure 1 where the pouch, neck and drain are in the open configuration;

Figure 8 is a front view a fluid collection bag of the packaged catheter assembly of Figure 1 where the catheter has been partially withdrawn from the pouch;

Figure 9 is a front view of a second embodiment of a catheter assembly;

Figure 10 is a front view of the catheter assembly of Figure 9 where wetting fluid from the fluid reservoir has wetted the catheter;

Figure 11 is a front view of the catheter assembly of Figure 9 where the fluid reservoir has been removed from the catheter;

Figure 12 is a front view of the catheter assembly of Figure 9 where the catheter the sleeve is only covering part of the length of the catheter;

Figure 13 is a front view a fluid collection bag of the catheter assembly of Figure 9 where the neck has been folded;

Figure 14 is a front view a fluid collection bag of the catheter assembly of Figure 9 where the outlet has been partially opened;

Figure 15 is a front view of the fluid collection bag of Figure 9 where the outlet has been fully opened;

Figure 16 is a front view of a pouch of the catheter assembly of Figure 9;

Figure 17 is a cut-away view of the interior of the pouch of the catheter assembly of Figure 16;

Figure 18 is a front view of the catheter assembly of Figure 16 where the pouch has been opened;

Figure 19 is a front view of the catheter assembly of Figure 16 where the pouch has been closed;

Figure 20 is a cut-away view of a first example of the inlet of the catheter assembly of Figure 9; Figure 21 is a cut-away view of a second example of the inlet of the catheter assembly of Figure 9; and

Figure 22 is a cut-away view of a third example of the inlet of the catheter assembly of Figure 9

In the figures, as is conventional, broken lines show hidden features.

Referring to Figures 1-8, a first embodiment of a packaged catheter assembly 100 is shown. Those skilled in the art will immediately recognise that it is a “closed” catheter assembly, including a fluid collection bag 110.

The assembly 100 comprises a pouch 170 with an integral fluid collection bag 110, a catheter 120, and a fluid reservoir 140. The catheter 120 has a proximal end 121 for insertion into the body and a distal end 122. In this embodiment, the catheter 120 is a male urinary catheter made from a hydrophilic thermoplastic elastomer (TPE). Obviously those skilled in the art will be able to select suitable alternative examples.

In this embodiment, the pouch 170 is formed from a single rectangular piece of material. The pouch is formed by folding this single piece of material along a pouch fold-line spanning the width of the pouch at a point midway along its length to form a front wall 171 and a rear wall 172 of the pouch 170. A peripheral seal exists between the front wall 171 and rear wall 172 around the edges of the front wall 171 and rear wall 172 to form the pouch 170 and contain the contents of the pouch 170.

In this embodiment, the pouch fold-line forms a base edge 173a of the pouch. In this embodiment, the peripheral seal forms a left lateral edge 173b, right lateral edge 173c and upper edge 173d. The left lateral edge 173b and right lateral edge 173c being defined as the right and left sides of the pouch 170 when viewing the pouch 170 with the rear wall 172 behind the front wall 171, the base edge 173a at the bottom of the pouch 170 and the upper edge 173d at the top of the pouch 170.

In this embodiment, the left lateral edge 173b, right lateral edge 173c and upper edge 173d are formed through heat sealing the front wall 171 to the second wall 172, but in other embodiments any suitable bonding may be used such as Velcro (RTM), chemical adhesives, chemical bonding, ultrasonic bonding, or mechanical bonding. In addition, in some embodiments one or more further folds may be included, in addition to the peripheral seal. It is also conceivable that no folds may be provided. For example, none of the edges may comprise a fold, one, and only one, edge may comprise a fold (as in the illustrated example), or two or more of the edges may comprise a fold.

In this embodiment, the peripheral seal is configured to break to allow the pouch 170 to be unfolded. Consequently, the pouch 170 has a closed configuration in which it is folded and preferably the peripheral seal is sealed, and an open configuration in which it is unfolded.

In this embodiment, the pouch 170 is formed from an opaque material and as such provides a discreet package for the packaged catheter assembly 100 which can make the user more comfortable in carrying the packaged catheter assembly 100 in day- to-day life. In addition, the exterior of the pouch 170 may have a textured or printed appearance and feel, such as a matte finish to reduce the impression that it is a medical device.

In this embodiment, the front wall 171 comprises a front opening tab 175 and the rear wall 172 comprises a rear opening tab 176. Both the front opening tab 175 and rear opening tab 176 project from the pouch 170 along an edge corresponding to the upper edge 173d of the peripheral seal. Each of the tabs 175, 176 of this particular embodiment are rectangular in shape with lateral edges 175b, 176c parallel to and continuing from a respective lateral edge of the pouch 170. The front opening tab 175 positioned on a left side of the pouch 170 and extends to a midpoint across the width of the pouch 170, and the rear opening tab 176 is positioned on a right side of the pouch 170 and also extends to a midpoint across the width of the pouch 170. Where each tab 175, 176 reaches the midpoint across the width of the pouch 170, each comprises a slanted edge 175d, 176d extending in overlap with the other respective tab 175, 176. As such, the tabs 175, 176 are arranged at either side of the pouch 170 but with a region of overlap at the middle quarter of the width of the pouch 170.

In this embodiment, the tabs 175, 176 are positioned at offset but corresponding positions on the edge of the pouch 170. This helps to make it easier to grasp and separate the tabs 175, 176. In other embodiments, the tabs 175, 176 may be positioned at overlapping positions with no offset to reduce the form factor of the pouch 170. Likewise, the overlap is a preferred feature they may be arranged in other embodiments so as not to overlap.

Each tab 175, 176 also comprises an optional gripping hole 177. Each gripping hole 177 of this particular example is in the shape of a stadium, that is a rectangle with semicircles replacing two opposite sides. The parallel sides of each gripping hole 177 are parallel to the upper edge 173d of the peripheral seal and form apertures which allow the user to easily grasp each tab 175, 176. Of course, alternative shapes of gripping hole can be readily imagined. Each gripping hole 177 is partially in overlap with the slanted edge 175d, 176d of the other respective tab 175, 176. This ensures the user can easily separate the tabs 175, 176 by pushing one tab 175, 176 away from the other through one of the respective gripping holes 177.

The pouch 170 is initially provided in the closed configuration in which it is folded and the fluid collection bag 110, catheter 120, and fluid reservoir 140 sealed within the pouch 170 by the peripheral seal. To access the contents, the user grasps each of the tabs 175, 176 using the gripping holes 177 and pulls the tabs 175, 176 away from one another. This in turn pulls the front wall 171 away from the rear wall 172 and breaks the peripheral seal namely breaking a frangible portion of the seal which comprises all of the edges 173b, 173c, 173d of the peripheral seal. The pouch fold-line, on the other hand is not frangible, and represents a permanent join between the front wall 171 and the rear wall 172. In this embodiment, the pouch 170 is therefore configured to be moved from the closed configuration to the open configuration in which it is flat and unfolded. In this embodiment, in the open configuration, at the foldline 173 a, the fold along the base 173 a of the pouch is no longer present and as such the front and rear walls 171, 172 of the pouch 170 are adjacent to one another and combine to form a single flat rectangular piece of material. Accordingly, when holding the pouch 170 in the open configuration, the locations on the front and rear walls 171, 172 where the left and right lateral edges 173b, 173c of the peripheral seal previously sealed the walls 171, 172 define the left and right lateral edges 173b, 173c of the open pouch 170 respectively. Similarly, the location in which the upper edge 173d previously sealed the rear wall 172 forms the top of the open pouch 170 and the location in which the upper edge 173d previously sealed the front wall 172 forms the bottom of the open pouch 170.

In this embodiment, the front wall 171 further comprises a wetting marker 178 disposed on an external face of the pouch 170 (i.e. on the front wall 171) is in the closed configuration and further at a position corresponding to the fluid reservoir 140 in the pouch 170. In other embodiments, the wetting marker 178 may be disposed on the rear wall 172 or on both the front and rear walls 171, 172. Thus, the wetting marker 178 is configured to provide a tactile and/or visual guide to allow the user to activate the fluid reservoir 140 to release wetting fluid into the fluid collection bag 110 as described below. For example, in this embodiment the wetting marker 178 comprises a region of the front wall 171 that is a different colour from the rest of the front wall 171. In other embodiments, the wetting marker 178 may be a pattern or logo, or may provide tactile feedback by comprising a raised area or different texture to the rest of the front wall 171. Of course, in other embodiments the wetting marker 178 may be positioned on the rear wall 172 or there may be two or more wetting markers 178 placed on the front and/or rear walls 171, 172.

In this embodiment, the fluid collection bag 110 is arranged to receive fluid from the distal end 122 of the catheter 120. The fluid collection bag 110 comprises a front panel 111, a rear panel (not shown) of identical shape and size to the front panel 111, and a peripheral bond joining the periphery of the panels to form the bag 110. In addition, in this embodiment, the front and rear panels are sized to fit within the area enclosed by the lateral edges 173b, 173c and upper edge 173d of the peripheral seal of the pouch 170 in its open configuration. In other embodiments, the front and rear panels may be sized differently according to the needs of the user, for example they may be sized to be larger than the front and/or rear walls 171, 172.

In this embodiment, the rear panel is bonded to the pouch 170 at points corresponding to the front and rear walls 171, 172 such that the fluid collection bag 110 is within the pouch 170 when the pouch 170 is in the closed configuration and fixed to the pouch 170 when the pouch 170 is in the open configuration. Of course, in other embodiments, the fluid collection bag 110 may only be bonded to the front wall 171 or rear wall 172, or may not be bonded to the pouch 170 at all. Alternatively, in some embodiments the front and rear walls 171, 172 of the pouch 170 may themselves form the rear panel.

In this embodiment, the peripheral bond defines a base 112, a right lateral edge 113, a left lateral edge 114 and an upper edge 115 of the bag 110. The base 112 of the bag 110 corresponding to the end of the bag 110 closest to the position of the upper edge 173d of the peripheral seal of the pouch 170 on its front wall 171. The right lateral edge 113 and left lateral edge 114 of the bag 110 corresponding to the left and right lateral edges 173c, 173d of the pouch 170. The upper edge 115 of the bag 110 corresponding to the end of the bag 110 closest to the position of the upper edge 173d of the peripheral seal of the pouch 170 on its rear wall 171. The peripheral bond thus defines a bag 110 that is generally rectangular and suitably has a width between the lateral edges of between 60-110 mm, for example about 100mm, e.g. 95 mm, and a height from the base 112 to the upper edge 115 of between 100 to 250 mm, for example about 200 mm, e.g. 197 mm. The bag is thus configured to hold at least 700 ml of fluid released from the user through the catheter safely. The base 112 defines the bottom of the bag 110 in use, and the upper edge 115 the top. However, in other embodiments alternative shapes and sizes could be conceived, such as elliptical or circular panels forming correspondingly shaped bags, or even a tubular bag or bag with more than two panels, e.g. a prism or other polygon.

In this embodiment, when the pouch 170 is opened it has the same dimensions as the fluid collection bag 110 as described above. When the pouch 170 is folded about the pouch fold-line, its height is necessarily halved whereas its width remains the same.

In this embodiment, the panels comprise a flexible plastics material, for example polypropylene (PP), polyethylene terephthalate (PET), low density polyethylene (LDPE), metalized polyester (MET PET), orientated polypropylene (OPP) or polyvinyl chloride (PVC). The panels are preferably transparent, but may be translucent. In other embodiments the panels may be opaque. In particular, the front panel 111 may be transparent/translucent, but the rear panel opaque.

In this embodiment, the fluid collection bag 110 as described above overlies a majority of the pouch 170 when the pouch 170 is in the open configuration. The pouch 170 may therefore be held in its open configuration with the front/rear walls 171, 172 forming a single bottom layer, then the rear panel of the fluid collection bag 110 and finally the front panel 111 of the fluid collection bag 110 forming a top layer.

In addition, in this embodiment when the pouch 170 is folded in the closed configuration, the fluid collection bag 110 is similarly folded along a fold-line corresponding to the pouch fold-line and base 173a of the pouch 170. In the closed configuration, the base 112 of peripheral bond of the fluid collection bag 110 and upper edge 115 of the peripheral bond of the fluid collection bag 110 are consequently adjacent to one another as well as the upper edge 173d of the peripheral seal of the pouch 170.

In this embodiment, the fluid collection bag 110 comprises two passageways: a neck 150 and a drain 160. Both the neck 150 and drain 160 are formed internally with the fluid collection bag and extend from the fluid collection bag 110. They are each movable between a stowed (closed) configuration and an extended (open) configuration as described below. Of course, in other embodiments, the fluid collection bag may only comprise one passageway or more than two passageways, and each passageway may have a function as required by the bag 110. In one example, a fluid collection bag may have only comprise one passageway that fulfils the role of the neck and drain described in the illustrated embodiment.

In this embodiment, the upper edge 115 of the bag 110 comprises the neck 150 which spans approximately 25% of the length of the upper edge 115 from the left lateral edge 114. In other embodiments, it may be located a different point on the upper edge 115 or peripheral bond, such as on the left or right lateral edges 114, 113, or base 112, and may have a different size in relation to the rest of the bag 110 or edge in which it is situated. The neck 150 is elongate and tubular having a length approximately equal to a third of the height of the pouch 170 in the open configuration. The height of the pouch 170 in the open configuration being defined as the distance between the upper edge 173d adjacent the front opening tab 175 and the upper edge 173d adjacent the rear opening tab 176 taken parallel to the left lateral edge 173b of the pouch 170.

In this embodiment, the neck 150 comprises a proximal end 151 distal from the bag 110 configured to allow the proximal end 121 of the catheter 120 to pass through it and out of the bag 110. The proximal end 151 of the neck 150 comprises a cylindrical plug 152 that is push-fit into a socket at the proximal end 151 of the neck 150 to prevent the catheter 120 leaving the bag 110 unintentionally. The plug 152 also seals the proximal end 151 of the neck 150 to prevent unintentional passage of fluids into/out of the bag 110. The plug 152 has a domed end and also comprises a pull-ring 153 integral with the dome of the plug 152. The plug 152 may therefore be easily removed from the neck 150 by pulling the pull-ring 153 away from the bag 110.

In this embodiment, the neck 150 also comprises a guide tube 154 extending from the proximal end 151 towards the fluid collection bag 110 and within the neck 150. The guide tube 154 is cylindrical with a smaller radius than the neck 150. The guide tube 154 comprises an aperture therethrough sized to allow the catheter 120 to pass through the tube 154 and proximal end 151 of the neck 150.

In this embodiment, the proximal end 151 of the neck 150 comprises an optional catheter locater tip configured to allow the proximal end 121 of the catheter 120 to be easily located by the user prior to use. This allows the user to more easily use the catheter 120 as the tip can be more easily located and inserted into the body through use of the neck 150.

In this embodiment, the neck 150 extends away from a central region of the bag 110 at an angle of 20 to 30 degrees from an angle parallel to the left lateral edge 114 of the bag 110, preferably at an angle of 23 degrees. As such, the neck 150 is angled towards the centre of the bag 110 to allow the catheter 120 and/or fluids more easy access to the bag 110 without sharp turns/folds of the bag 110 or neck 150 obstructing fluid flow.

In this embodiment the base 112 of the bag 110 comprises the drain 160 which spans 25% of the length of the base 112 of the bag 110 from the right lateral edge 113 of the bag 110. As with the neck 150, in other embodiments the drain 160 may be located a different point on the base 112 or peripheral bond, such as on the left or right lateral edges 114, 113, or upper edge 115, and may have a different size in relation to the rest of the bag 110 or edge in which it is situated.

In this embodiment, the drain 160 is a similar shape and size to the neck 150 and is elongate and tubular, however, it has a length approximately half that of the neck 150. The drain 160 also extends away from the bag 110 in a direction parallel to the angle the neck 150 extends but in the opposite direction and as such also extends away from a central region of the bag.

In this embodiment, the drain 160 comprises a distal end 161 distal from the bag 110. The distal end 161 is open-ended and as such can provide a conduit for fluids to pass out of the bag 110. In other embodiments the drain 160 may be closed, for example having a tear-off end to open it.

In this embodiment, the base 112 of the bag 110 is sloped between the left lateral edge 114 of the bag 110 and drain 160 such that fluid more easily flows from the bag 110 to the drain 160 if required. Preferably, the base 112 of the bag 110 is sloped at an angle of 70 to 80 degrees with respect to the left lateral edge 114 of the bag 110 and most preferably 74 degrees. Advantageously, this funnels liquid in the bag 110 towards the drain and balances the needs of allowing fluid to easily flow from the bag 110 whilst maintaining the internal volume of the bag 110.

Referring to Figures 1, 3, 4 and 7, in this embodiment the neck 150 and drain 160 are movable between respective extended (open) and stowed (closed) configurations. To facilitate this, the neck 150 is configured to be folded at the point it meets the bag 110 along a neck fold-line 155 that is perpendicular to the direction the neck 150 extends away from the bag 110. The neck fold-line 155 therefore truncates the corner of the bag 110 between the left lateral edge 114 and upper edge 115 of the bag 110. Similarly, the drain 160 is configured to be folded along a drain fold-line 162. The drain fold-line 162 is at the same angle as the neck fold-line 155 and truncates the comer of the bag 110 between the right lateral edge 114 and base 112.

In this embodiment, the neck 150 and drain 160 have open configurations in which they are unfolded and extend away from the bag 110 as described above. As they extend at an angle, the proximal end 151 of the neck 150 is positioned to the left of the left lateral edge 114 and above the upper edge 115 of the bag 110 in the open configuration. Similarly, the distal end 161 of the drain 160 is positioned to the right of the right lateral edge 113 and below the base 112 of the bag 110 in the open configuration. This helps to ensure that the ends of the neck/drain are more easily accessible and that any leakage of fluid from them is less likely to spill onto the pouch 170 or fluid collection bag 110. Of course, in other embodiments where the neck 150 and drain 160 may extend at different angles or from different edges of the bag 110, they may extend to be in different positions while still realising the benefits of the invention.

In this embodiment, in the closed configuration the neck 150 and drain 160 are folded about the neck fold-line 155 and drain fold-line 162 respectively such that they lie on the front panel 111 of the bag 110. In the closed configuration, the neck 150 and drain 160 extend into a central region of the bag 110 from their respective corners of the bag 160.

In this embodiment, the bag 110 further comprises a closure flap 116 disposed on, and attached to, the front panel 111. The closure flap 116 is rectangular with rounded comers and an aspect ratio (width: length) of approximately 1:2. The width of the closure 116 is aligned with and parallel to the drain fold-line 162 and the closure 116 spaced from the drain fold-line 162 in a direction perpendicular to the drain foldline 162 and by a distance approximately equal to a third of the length of the drain 160. As such, approximately two-thirds of the drain 160 in its folded configuration overlaps with the closure 116.

In this embodiment, one side of the closure flap 116 is adhesive. An upper quarter of the flap 116, that is the quarter furthest from the drain fold-line 162, is permanently adhered to the front panel 111. The remaining three quarters of the flap 116 comprises a re- sealable adhesive that is configured to seal to the drain 160 between the flap 116 and front panel 111 of the bag 110 and retain the drain 160 in its closed configuration. In this embodiment, permanent adherence of the flap 116 to the front panel 111 of the bag 110 is achieved through welding but in other embodiments any suitable sealing method may be used as described elsewhere in this disclosure. Similarly, any suitable re-sealable or temporary adhesive means may be used such as hook-and-hook or hook-and-loop, chemical adhesives, magnetism, etc. The closure flap 116 firmly holds the drain 160 in its initial stowed/closed position, maintaining a tight fold that is intended to prevent liquid entering the drain in its stowed/closed position. Moreover, the adhesive flap covers the entire open end of the drain, sticking it to the panel and closing it off, thus further inhibiting leakage in the unlikely event that fluid passes the fold into the drain 160.

In this embodiment, a lower half of the flap 116, that is the half closest to the drain fold-line 162, comprises a finger hole 117. The finger hole 117 is rectangular and is configured to allow the user to better grip the flap 116 to remove the flap 116 from the drain 160 allowing the drain 160 to be moved from its closed configuration to its open configuration. In other embodiments, the flap 116 may comprise an alternative to the finger hole 117 such as ridges or another easily gripped element to facilitate removal of the flap 116 from the drain 160.

In other embodiments, the flap 116 may be replaced with any suitable means for retaining the drain 160 in the closed configuration. For example, the drain 160 itself may adhere to the front panel 111 through a flap or other similar feature permanently attached to the drain 160. In other embodiments, the front panel 111 may comprise a retaining slot which the drain 160 can be fed within to retain it in the closed configuration.

In this embodiment, the fluid reservoir 140 is a rectangular sachet which contains wetting fluid. The fluid reservoir 140 has a length equivalent to approximately three quarters the separation distance between the left and right lateral edges 114, 113 of the bag 110 and a width approximately one third its length. In other embodiments, different sizes or shapes of fluid reservoir 140 may be used as required.

In this embodiment, the fluid reservoir 140 comprises an activation marker 144 on its surface. The activation marker 144 comprises a region of the fluid reservoir 140 that is identifiable to the user for example through visual and/or tactile feedback in an equivalent manner to the wetting marker 178 described above. Preferably, the activation marker 144 is at least visually recognisable and a different colour, or pattern, to the fluid reservoir 140.

In this embodiment, the fluid reservoir 140 is positioned inside the fluid collection bag 110 at the corner where the upper edge 115 and right lateral edge 113 meet. The length of the fluid reservoir 140 is aligned parallel to the upper edge 115 and as such, the neck 150 is at one end of the fluid reservoir 140 and the right lateral edge 113 at the other. In other embodiments, the fluid reservoir 140 may be positioned at different points within the bag 110 or pouch 170, or may be external from the bag 110 and/or pouch 170 as required.

In this embodiment, the fluid reservoir 140 is retained in this position by a join

142 between the front and rear panels of the bag 110. The join 142 is separated from the upper edge 115 of the bag 110 by a distance approximately equal to the width of the fluid reservoir. The join 142 is further positioned approximately one third of the way from the left lateral edge 114 to the right lateral edge 113 of the bag. The join 142 is generally elliptical in shape with a major axis aligned with the length of the fluid reservoir 140 and an aspect ratio (width: length) of 1:3. Of course, in other embodiments the join 142 may be different shapes for example circular or rectangular, and may be positioned in different places within the bag 110.

In this embodiment, the fluid reservoir 140 is further retained by a protrusion

143 in the peripheral bond of the bag 110. In this embodiment, the protrusion 143 extends from the right lateral edge 113 of the bag 110 at a point separated from the upper edge 115 of the bag 110 by a distance equal to the width of the fluid reservoir 140. The protrusion 143 is rectangular with a length and width in directions parallel to the length and width of the fluid reservoir 140. The protrusion 13 has a width approximately the same as the minor axis of the join 143, and an aspect ratio (width: length) of 1:2. Thus, the join 142 and protrusion 143 together retain the fluid reservoir 140 in position adjacent to the upper edge 115 and right lateral edge 113 of the bag 110. As with the join 142, in other embodiments the protrusion 143 may have a different size and shape to suit the configuration and features of the catheter assembly such as the size/shape of the fluid reservoir 140 or fluid collection bag 110.

In this embodiment, the wetting fluid is water and interacts with the hydrophilic surface of the catheter 120 to render it lubricious. In other embodiments, other wetting fluids may be used and they may be polar (e.g. water-based) or non-polar (e.g. oilbased) depending on the catheter’s surface properties.

In this embodiment, the catheter 120 is positioned in the bag 110 with the proximal end 121 of the catheter 120 retained within the guide tube 154 of the neck 150. The catheter 120 then extends along the neck 150 and adjacent to the upper edge 115 of the bag 110 before passing over the fluid reservoir 140 and between the join 142 and protrusion 143. The catheter 120 then curves towards the drain 160 and the distal end 122 of the catheter 120 is positioned adjacent the drain fold-line 162 and beneath the closure flap 116. The catheter 120 is therefore free to move within the fluid collection bag 110 except for the portion of the catheter 120 positioned between the join 142 and upper edge 115 of the bag 110 and the portion of the catheter 120 retained within the tube 154 of the neck 150. In other embodiments, the catheter 120 may be positioned differently, for example it may be partially or completely outside the bag 110 and even partially outside the pouch 170.

In this embodiment, the catheter 120 comprises a funnel 123 at its distal end

122, this allows fluid to pass out of the catheter 120 in a controlled manner and further is easily handled by the user to control the direction of fluid flow out of the catheter 120. In other embodiments, the catheter 120 may not comprise a funnel 123 and/or may comprise a different type of handling element at its distal end 122.

In this embodiment, the catheter 120 is configured to pass through the guide tube 154 and out of the distal end 151 of the neck 150. However, the funnel 123 is not configured to pass through the guide tube 154, but rather, when the catheter 120 is pulled out, the proximal end of the funnel is a tight fit in the guide tube and as such prevents separation of the catheter 120 from the bag 110 and ensures that fluid within the catheter 120 always passes into the bag 110 and does not escape through the guide tube 154. Of course in other embodiments, the catheter 120 may be completely removable from the bag 110, for example the catheter 120 may not comprise a funnel

123.

In this embodiment, as described above, the proximal end 121 of the catheter 120 is retained in the tube 154 which prevents the proximal end 121 from falling into the inside of the bag 110. This ensures the catheter 120 is easy to feed through the neck 150 and out of the bag 110 as the proximal end 121 of the catheter 120 need not be lined up with the guide tube 154 which may be difficult especially for a user with reduced mobility. In other embodiments, the proximal end 121 may not be retained in a guide tube 154 and may be removable from the guide tube 154 or positioned in a different point in the bag. Referring to Figure 1, in this embodiment the curvature and position of the catheter 120 as described above is engineered to reduce the risk of damage and kinks to the catheter 120 when stored within the pouch 170. When the pouch 170 is in the closed configuration, the neck 150 is folded against the front panel 111 of the bag 110 at the neck fold-line 155. The catheter 120 is curved so that the tangent angle of the catheter 120 at the neck fold-line 155 is parallel to the neck fold-line 155. Similarly, the curvature of the catheter 120 between the join 142 and drain 160 ensures that the tangent angle of the catheter 120 at a position in the bag 110 corresponding to the pouch fold-line/base 173a of the pouch is parallel to the pouch fold-line/base 173a. Thus, the degree of curvature of the catheter 120 is reduced as it passes out of the folded neck 150 and through the bag 110 when the neck 150 and/or pouch 170 are in the closed configuration.

The packaged catheter assembly 100 is initially provided with the pouch 170 in its closed configuration and the peripheral seal containing the fluid collection bag 110, catheter 120, and fluid reservoir 140 within the pouch 170. Advantageously, as the catheter 120 is itself contained within the fluid collection bag 110, the peripheral seal need not provide a sterile seal as the fluid collection bag 110 can provide a sterile environment for the catheter 120. This can make the packaged catheter assembly 100 cheaper and easier to manufacture especially where the peripheral seal is configured to be breakable. In alternative embodiments, the peripheral bond of the fluid collection bag 110 may not provide a sterile seal and the peripheral seal of the pouch 170 may provide a sterile seal. Alternatively, both the peripheral bond and peripheral seal may provide a sterile seal which can provide extra assurance that the catheter 120 remains sterile prior to use.

Referring to Figures 1-3 the catheter 120 may be withdrawn from the packaged catheter assembly 100 for use by first opening the pouch 170. As described above, in this embodiment, the user grasps the tabs 175, 176 and pulls them apart to separate the front and rear walls 171, 172 of the pouch 170 and create an opening in the peripheral seal. In this embodiment, the user continues to separate the tabs 175, 176 and front and rear walls 171, 172 until the pouch 170 is completely unfolded and the front panel 111 of the fluid collection bag 110 is exposed. In this embodiment, the base 173a of the peripheral seal is configured to deform plastically which ensures the pouch 170 remains in the flat and opened configuration.

In this embodiment, as the front panel 111 of the fluid collection bag 110 was previously contained within the sealed pouch 170, it can now present a flat and clean surface for the user. This makes use of the catheter 120 easier as parts of the assembly 100 may be placed on the opened pouch 170 as required without them being potentially contaminated with dirt.

Referring to Figures 3-4, in this embodiment the neck 150 is initially provided in its closed configuration and folded against the front panel 111 of the fluid collection bag 110. The user may therefore unfold the neck 150 and move it into its open configuration. This may allow the catheter 120, which is retained by the tube 154 of the neck 150 at the proximal end 121 of the catheter 120, to be more effectively wetted by the wetting fluid released by the fluid reservoir 140 as described below.

Referring to Figures 1-6, before use of the catheter 120, it is important that it is adequately wetted to ensure the risk of injury and discomfort is minimised. In this embodiment, the fluid reservoir 140 is configured to release the wetting fluid contained within it. The user can release the wetting fluid by applying pressure to the fluid reservoir 140, such as between the activation marker 144 and wetting marker 178, to create a tear 141 in the fluid reservoir 140 allowing the wetting fluid to pass out of the reservoir 140 and into the fluid collection bag 110. Of course in other embodiments, the wetting fluid may be released from the fluid reservoir 140 in a different way such as by activating an opening mechanism of the fluid reservoir 140.

In this embodiment, the wetting fluid passes out the tear 141 in the fluid reservoir 140 and into the fluid collection bag 110 where it comes into contact with the catheter 120 and activates the surface of the catheter 120. In this embodiment, the wetting fluid is contained within the fluid collection bag 110 as the plug 152 prevents it from leaving via the neck 150, and the drain 160 is in the closed configuration which prevents fluids from leaving the bag 110 therethrough.

Referring to Figures 5-6, in this embodiment the fluid reservoir 140 is located close to the neck 150 and proximal end 121 of the catheter 120 and as such, wetting fluid may preferentially wet the catheter adjacent to and at its proximal end before the rest of the catheter 120. This ensures that the part of the catheter 120 that enters the body first is adequately wetted which reduces the risk of injury and discomfort during use of the catheter 120. However, depending on the orientation of the packaged catheter assembly 100, the wetting fluid may flow towards the entrance of the drain 160 and collect in a pool of wetting fluid 1. If this occurs, it can be necessary to vary the orientation of the packaged catheter assembly 100, for example by rotating it such that the neck 150 is below the drain 160, such that the wetting fluid forms a pool 1 at the neck 150. Advantageously, the close fit between the catheter 120 and the tube 154 prevents inadvertent passage of fluid between the catheter 120 and tube 154 and out of the bag 110. This ensures that the proximal end 121 of the catheter 120 is adequately wetted prior to use.

The steps of opening the pouch 170 and releasing wetting fluid from the fluid reservoir 140 may of course be performed in any order as desired by the user. In this embodiment, the wetting marker 178 described above may be used to locate and activate the fluid reservoir 140 when the pouch 170 is in the closed configuration. Release of the wetting fluid into the fluid collection bag 110 prior to opening of the pouch 170 may be desirable as the fold in the pouch 170 can reduce the likelihood that the wetting fluid passes towards the drain 160 and distal end 122 of the catheter 120 before the proximal end 121 of the catheter 120 has been adequately wetted.

Referring to Figures 5-7, in this embodiment the drain 160 may be moved to its open configuration by using the finger hole 117 to peel the flap 116 off the drain 160. The drain 160 may then be unfolded into its open configuration and fluid may then exit the fluid collection bag 110 through the drain 160. This may be done after urine has been released into the pouch, or, in the event that it is desired to immediately pass urine into a lavatory or the like, it may be done prior to releasing urine.

In this embodiment, the catheter 120 may be withdrawn from the pouch 170 by user grasping the neck 150 of the pouch 170 in one hand and the plug 152/pull-ring 153 in the other and then pulling the plug 152 out of the end of the neck 151. The catheter 120 may then be passed out of the neck 150 by feeding it through the neck 150 and tube 154. Advantageously, the proximal end 121 of the catheter 120 is retained in the tube 154 through a push-fit fitting, this removes the need for the user to carefully align the proximal end 121 of the catheter 120 with the tube 154. It also ensures that excess wetting fluid does not pass out of the fluid collection bag 110 where it could cause discomfort and inconvenience for the user.

The user can then progressively pass more of the catheter 120 out of bag 110 and insert the proximal end 121 of the catheter 120 into the body. Once the catheter 120 has been sufficiently inserted into the body, fluid may pass out of the body through the catheter 120 and into the fluid collection bag 110 via the funnel 123.

As noted above, if the drain 160 is in its open configuration at this stage, the packaged catheter assembly 100 is configured as an open system in which fluid entering the fluid collection bag 110 from the body and catheter 120 passes straight out of the bag 110 via the drain 160. However, the packaged catheter assembly is a closed system and can be used as such, simply by omitting the step of opening the drain 160 mentioned above prior to inserting the catheter into the body. Fluid is then prevented from leaving the bag 110 via the drain 160 and collects within the fluid collection bag 110. This can be useful where immediate disposal of the fluid from the body is not possible. After use of the catheter 120, the user may wish to empty the contents of the fluid collection bag 110 to reduce the size and weight of the used bag 110 and/or to dispose of the bag 110. To allow the bag 110 to be emptied, in this embodiment the drain 160 may be opened to allow fluid to leave the bag 110 as described above. Advantageously, in this embodiment the packaged catheter assembly 100 may be used as either an open or closed system as required by the user.

In some embodiments, the catheter 120 and fluid collection bag 110 may be repackaged within the pouch 170. This may be possible in embodiments where the peripheral seal is configured to be re-sealable. The process for this is generally reverse of the opening procedure described above. The catheter 120 can be drawn back within the fluid collection bag 110 by manipulating the funnel 123 and without the need to touch the surface of the catheter 120 which may be unhygienic after use.

The neck 150 may be resealed by re-inserting the plug 152 into the proximal end 151 of the neck 150. The neck 150 can then be re-folded such that it no longer extends out from the pouch 170. 3

If the drain 160 has been opened, it can be re-folded and sealed using the flap 116 in embodiments where the flap 116 is configured to provide a re-sealable seal. Of course where the flap has been opened, handling and re-folding of it may not be considered hygienic and so this step may be avoided at user-discretion.

Finally, the pouch 170 may be closed by bringing, the tabs 175, 176 towards each other, resulting in folding of the pouch 170 about the pouch fold-line and base 173a and the bringing together of the front wall 171 and rear wall 172. The peripheral seal may then be re-sealed closed, for example by pressing the front wall 171 and rear wall 172 together. Thus, the pouch 170 may be closed without the user needing to touch the interior surfaces of the pouch 170 which may have become dirty or soiled during use of the catheter 120.

Referring to Figures 9 to 22, a second embodiment of a catheter assembly 300 is shown and like features are given like reference numerals

The assembly 300 comprises a fluid collection bag 310, a catheter 320, a sleeve 330, and a fluid reservoir 340. The catheter 320 has a proximal end 321 for insertion into the body and a distal end 322, and the fluid collection bag 310 is arranged to receive fluid from the distal end 322 of the catheter 320. The sleeve 330 encloses the catheter 320 along the length of the catheter 320 from the proximal end 321 to the distal end 322. The sleeve 330 is also in fluid communication with the fluid collection bag 310. The fluid reservoir 340 is arranged at the proximal end 321 of the catheter 320 and is configured to release wetting fluid into the sleeve 330 to wet the catheter 320.

In this embodiment, the catheter 320 is a male urinary catheter made from a hydrophilic thermoplastic elastomer (TPE). The sleeve 330 of this example is a low- density polyethylene (LDPE). Obviously those skilled in the art will be able to select suitable alternative examples.

In this embodiment, the wetting fluid is water and interacts with the hydrophilic surface of the catheter 320 to render it lubricious. In other embodiments, other wetting fluids may be used and they may be polar (e.g. water-based) or non-polar (e.g. oilbased) depending on the catheter’s surface properties. In this embodiment, the fluid collection bag 310 comprises a front panel 311, a rear panel of identical shape and size (not shown), and a peripheral bond joining the periphery of the panels to form the bag 310. The peripheral bond defines a base 312, a right lateral edge 313, a left lateral edge 314 and an upper edge 315. The right lateral edge 313 and left lateral edge 314 being defined as the right and left sides of the bag 310 when viewing the bag 310 with the rear panel behind the front panel 311, the base 312 at the bottom of the bag 310 and the upper edge 315 at the top of the bag 310. The peripheral bond thus defines a bag 310 that is generally rectangular and suitably has a width between the lateral edges of between 10 and 20 cm, and most preferably between 12 and 15 cm, and a height from the base 312 to the upper edge 315 of between 25 and 40 cm, 30 and 35 cm, or most preferably 33 and 35 cm. The bag is thus configured to hold at least 700 ml of fluid released from the user through the catheter safely. The base 312 defines the bottom of the bag 310 in use, and the upper edge 315 the top. However, in other embodiments alternative shapes and sizes could be conceived, such as elliptical or circular panels forming correspondingly shaped bags, or even a tubular bag or bag with more than two panels, e.g. a prism or other polygon.

In this embodiment, the panels comprise a flexible plastics material, for example polypropylene (PP), polyethylene terephthalate (PET), low density polyethylene (LDPE), metalized polyester (MET PET) orientated polypropylene (OPP) , polyvinylpyrrolidone (PVP), or polyvinyl chloride (PVC).

In this embodiment, the corners of the peripheral bond at either end of the left lateral edge 314 each comprise finger holes 316 to allow the bag 310 to be easily handled by a user. Where the left lateral edge 314 meets the base 312, the peripheral bond truncates the comer of the bag 310 to accommodate the finger hole 316, and where the left lateral edge 314 meets the upper edge 315, the peripheral bond forms a square projecting into the interior of the bag 310 with the finger hole 316 at its centre. In other embodiments, the finger holes 316 may comprise a series of ridges, or otherwise easily gripped surface or feature to allow the user to easily handle the bag 310. In addition, there may be different numbers of finger holes 316, such as only one or more than two, and they may be placed in different locations on the bag 310. In this embodiment, the upper edge 315 of peripheral bond comprises a neck 350 which spans the middle 50% of the length of the upper edge 315. In other embodiments, it may be located a different point on the upper edge 315 or peripheral bond, such as on the left or right lateral edges 314, 313, or base 312, and may have a different size in relation to the rest of the bag 300 or edge in which it is situated. The neck 350 projects out from the plane of the bag 310. The neck 350 is triangular and comprises a left sloped edge 351 and a right sloped edge 352 which project from the upper edge 315 and converge at an inlet 353. The inlet 353 is connected to the catheter 320 and sleeve 330 and is configured to received fluid from the catheter 320 and sleeve 330 as described below.

In this embodiment, the upper edge 315 also comprises an outlet 360 arranged between the neck 350 and the right lateral edge 313. The outlet 360 comprises a rectangular spout 361 that projects from the upper edge 315 the same distance as the inlet 353. The outlet 360 also comprises a pull-ring 362 attached to the spout 361 and disposed between the spout 361 and neck 350. The pull-ring 362 has the shape of a right-angled triangle, with two perpendicular sides and a hypotenuse 363. The hypotenuse 363 is parallel and adjacent to the right sloped edge 352 of the neck 350. In other embodiments, the pull-ring 362 may be any suitable shape or size - such as circular, rectangular or square. This helps to protect the neck 350, inlet 353 and outlet 360 as they project out from the fluid collection bag 310 together without significant gaps between them.

The outlet 360 also comprises a point of weakness, which in this embodiment is a notch 364 in the peripheral bond at the point where the spout 361 meets the right lateral edge 313. This helps ensure that the opening 316 is formed cleanly and does not propagate down the right lateral edge 313 of the pouch. In other embodiments, the outlet may comprise a tear line which comprises a weakened region of the outlet 316. The notch 364 may be positioned at an end of the tear line and as such, the tear line further assists with forming the opening 316. The tear line may be formed by any suitable means, such as laser scoring.

In this embodiment, the distal end 322 of the catheter 320 and sleeve 330 are in fluid communication with the bag 310 via the inlet 353, as described in more detail with reference to Figures 20-22 below. At the other end of the sleeve 330, corresponding to the proximal end 321 of the catheter 320, the sleeve 330 comprises a reservoir adapter in the form of a handling element 331. In this embodiment, the handling element 331 is cylindrical and has a radius at least twice that of the catheter 320 and a length no longer than the radius of the handling element 331. In other embodiments, the handling element 331 may have different dimensions or different shapes entirely.

In this embodiment, the sleeve 330 further comprises a tube 332 extending from the handling element 331 and defining an aperture 333 which permits the catheter 320 to exit the sleeve 330 as described below. The tube 332 has a radius greater than that of the catheter by less than that of the handling element 331, as such, it protects the catheter 320 as it emerges from the aperture 333 and reduces the likelihood that it is inadvertently touched by the user’s hand which is grasping the handling element 331.

In this embodiment, the aperture 333 releasably engages with the fluid reservoir 340 through a screw fitting. Further, the fluid reservoir 340 is moveable axially with respect to the thread of the aperture 333 between positions where it engages the thread and does not engage the thread respectively. This ensures that the fluid reservoir 340 is less likely to be unintentionally removed from the sleeve 330 as it requires two different movements to be removed. In other embodiments, different types of engagement could be used such as bayonet or push-fit fittings.

In this embodiment, the fluid reservoir 340 is an elongate cylinder filled with a wetting fluid. The fluid reservoir also comprises two wings 341 which project from opposite sides of the cylindrical fluid reservoir 340 in a plane parallel to the axis of the fluid reservoir. The wings 341 of this particular embodiment are rectangular with rounded comers and extend along most of the length of the reservoir 340 with a width approximately equal to the diameter of the reservoir. The wings 341 provide gripping surfaces which allow a user to easily grasp and manipulate the fluid reservoir 340. In other embodiments, alternative gripping surfaces may be provided and/or the wings 341 may comprise other features that allow the fluid reservoir 340 to be handled easily, such as pull-rings or finger holes.

In this embodiment, the fluid reservoir 340 comprises a flexible plastics material, for example a hard moulded thermoplastic such as HDPE. In use, the fluid reservoir 340 retains the wetting fluid within it until the fluid reservoir 340 is burst which then allows wetting fluid to enter the sleeve the sleeve 330 adjacent to the proximal end 321 of the catheter 320, this ensures that the proximal end 321 is well wetted which improves comfort and reduces risk of injury when using the catheter 320 as the proximal end 321 is the first part to be introduced into the body. In this embodiment, the fluid reservoir 340 is burst by pressing the fluid reservoir 340 into the handling element 331 which causes the fluid reservoir 340 to be pierced by a spike (not shown) on the end of the sleeve 330/handling element 331. As mentioned above, the fluid reservoir 340 is movable axially with respect to the aperture 333, in this embodiment, the spike is configured to pierce the fluid reservoir 340 when it is in a position that the thread of the aperture 333 engages the thread of the fluid reservoir 340 allowing it to be unscrewed and removed. Thus, the fluid reservoir 340 may not be removed from the sleeve 330 without it first being pierced and releasing wetting fluid into the sleeve 330 to wet the catheter 320 for use.

Referring to Figures 9-12, the efficiency of the wetting fluid in wetting the catheter 320 varies depending on the orientation of the catheter 320 and sleeve 330 as well as how the user is gripping or holding the assembly 300. As such, to increase the likelihood that the catheter 320 is adequately wetted, in this embodiment the fluid reservoir 340 is configured to release excess wetting fluid into the sleeve 330 ensuring there is more than adequate wetting fluid to wet the catheter 320 irrespective of how the assembly is being held or its orientation. If this excess wetting fluid is not required for wetting the catheter 320, it may then flow through the sleeve 330 and into the fluid collection bag 310 via the inlet 353 to form a pool 3 in the bag 310. Advantageously, this ensures the excess wetting fluid does not get out of the assembly 300 and onto the user or surfaces of the assembly 300 that the user may need to hold/manipulate. This improves the ease of use of the assembly 300 and makes it more convenient to carry while ensuring the catheter 320 is adequately wetted.

Referring to Figure 11, after the wetting fluid has been released from the fluid reservoir 340 into the sleeve 330, in this embodiment the fluid reservoir 340 may be removed from the assembly 300. In this embodiment, the fluid reservoir 340 is simply pulled off the sleeve 330 by separating the handling element 331 from the fluid reservoir 340. In other embodiments, a different action may be required such as releasing a locking element or twisting/unscrewing the fluid reservoir 340.

Referring to Figures 11 and 12, in this embodiment after removal of the fluid reservoir 340, the aperture 333 is exposed which allows the proximal end 321 of the catheter 320 to pass out of the sleeve 330. The handling element 331 can then be used to guide the proximal end 321 into the body without the user having to touch the catheter 320, this reduces the risk of infection to the user. The user can then progressively pass more of the catheter 320 out of the sleeve 330 and into the body by bunching the sleeve 330. Once the catheter 320 has been sufficiently inserted into the body, fluid may pass through the catheter 320 out of the body, and into the fluid collection bag 310 via the inlet 353 as described in greater detail below with reference to Figures 20-22.

Referring to Figures 13-15, after use of the catheter 320, the user may wish to empty the contents of the fluid collection bag 310. This can be desirable in order to reduce the size and weight of the used bag 310 and/or to dispose of the bag 310. To allow the bag 310 to be emptied, in this embodiment the outlet 360 may be removed from the bag 310 to form an opening 316 in the peripheral bond between the neck 350 and notch 364 as described below.

To form the opening 316, in this embodiment the user first folds the neck 350 onto the front panel 311 of the bag 310 creating a neck fold-line 354 parallel to the base 312 of the peripheral bond and spanning between the end of the left sloped edge 351 and the end of the right sloped edge 352 distal the inlet 353. Advantageously, this helps to ensure fluid in the fluid collection bag 310 is less likely to pass back into the sleeve 330 via the inlet 353 and also ensures the opening 316 is correctly formed while the outlet 360 is being removed from the fluid collection bag 310. In other embodiments, the same effect may be achieved by different means such as deforming, rolling or folding the neck 350 in different ways.

In this embodiment, once the neck 350 is folded, the outlet 360 is exposed and projects beyond the edge of the bag 310 which is now defined by the neck fold-line 354. The pull-ring 362 may then be grasped by the user and pulled in a direction parallel to the neck fold-line 354 and away from the left lateral edge 314 to separate the outlet 360 from the fluid collection bag 310 forming the opening 316. Advantageously, the 9 peripheral bond preferentially tears from a point between the right sloped edge 352 of the neck 350 and outlet 360 due to the neck fold-line 354 which reinforces the peripheral bond around the neck 350 and reduces tearing forces on the right sloped edge 352. In addition, the shape of the pull-ring 362 means that when moved away from the inlet 353, shearing force is concentrated at the point the outlet 360 meets the upper edge 315. This ensures the opening 316 is created in a controlled manner.

In this embodiment, the notch 364 provides a second point on the peripheral bond which preferentially forms one end of the opening 316. Thus, the outlet 360 may be easily, conveniently, and reliably removed from the fluid collection bag 310 to form a clean opening 316 in the peripheral bond. This allows the user to easily empty the contents of the bag 310 and reduces the risk of spilling the contents of the bag 310 during emptying.

Referring to Figures 16-19, in this embodiment, the catheter assembly also comprises a pouch 370 which contains the fluid collection bag 310, catheter 320, sleeve 330 and fluid reservoir 340 within it. The pouch 370 is formed from a single rectangular piece of material. The pouch is formed by folding this single piece of material along a pouch fold-line 373a spanning its width at a point midway along its length to form a front wall 371 and a rear wall 372 of the pouch 370. A peripheral seal 373 exists between the front wall 371 and rear wall 372 around the edges of the front wall 371 and rear wall 372 (except the edge corresponding to the pouch fold-line 373a) to form the pouch 370 and contain the contents of the pouch 370. In this embodiment, the peripheral seal 373 comprises all edges of the pouch other than the pouch fold-line 373a and is formed through heat sealing the front wall 371 to the second wall 372, but in other embodiments any suitable bonding may be used such as Velcro (RTM), chemical adhesives, chemical bonding, ultrasonic bonding, or mechanical bonding. In addition, in some embodiments any number of folds may be used to form the pouch 370. For example, none of the edges may comprise a fold and instead one edge may be formed by a peripheral join which is not configured to be separated during opening of the pouch - such as through bonding the walls in a similar manner to the peripheral seal but in a way that is stronger than the peripheral seal. Alternatively, one edge may comprise a fold (as in the illustrated example), or two or more of the edges may comprise a fold. In this embodiment, the pouch 370 is formed from an opaque material and as such provides a discrete package for the catheter assembly 300 which can make the user more comfortable in carrying the catheter assembly 300 in day-to-day life. In addition, the exterior of the pouch 370 may have a textured or printed appearance and feel, such as a matte finish to reduce the impression that it is a medical device.

In this embodiment, the pouch 370 also comprises an absorbent layer 374. The absorbent layer 374 is a layer of absorbent material that lines the inside surfaces of both the front wall 371 and rear wall 372. As such, the absorbent layer 374 is a single sheet of absorbent material folded at the pouch fold-line 373a. In other embodiments, the absorbent layer 374 may only line one of the front wall 371 or rear wall 372, or may only be present at certain locations in the pouch 370. In other embodiments, the absorbent layer 374 may be replaced by an absorbent that is not shaped like a layer, such as an absorbent sachet or absorbent strip of material.

In this embodiment, the front wall 371 comprises a front opening tab 375 and the rear wall 372 comprises a rear opening tab 376. Both the front opening tab 375 and rear opening tab 376 project from an edge of the pouch 370 opposite the pouch foldline 373a. Each of the tabs 375, 376 of this particular embodiment are trapezoid in shape with two sides 378, a base 379 and a top 380, and a height between the base 379 and top 380, wherein the length of the base 379 is greater than the length of the top 380 and also at least twice as great as the height. The tabs 375, 376 are arranged with their respective bases 379 parallel to the pouch fold-line 373a and the base 379 of each tab 375, 376 forms an edge of the pouch 370.

In this embodiment, the tabs 375, 376 are positioned at corresponding positions on the edge of the pouch 370 and therefore overlap one another and without any offset or overhang. This helps to reduce the form factor of the pouch 370. In other embodiments, the tabs 375, 376 may be positioned at different positions to introduce an offset or overhang between the tabs 375, 376. This may be done to make it easier to grasp one of the tabs 375, 376 without the other.

In this embodiment, each tab 375, 376 is also configured to be folded about its base against either the front wall 371 or rear wall 372. The base of each tab may therefore be a crease-line to assist in folding. Both tabs 375, 376 may be folded against the front wall 371, or both against the rear wall 372. This allows the user to reduce the form factor of the pouch 370. Furthermore, where both tabs 375, 376 are folded against the same wall, the folding of the tabs 375, 376 in the same direction provides resistance to the inadvertent separation of the tabs 375, 376 and resultant opening of the pouch 370.

Each tab 375, 376 also comprises a gripping hole 377. Each gripping hole 377 of this particular example is in the shape of a stadium, that is a rectangle with semicircles replacing two opposite sides. The parallel sides of each gripping hole 377 are parallel to the base and top of the tabs 375, 376 and form apertures which allow the user to easily grasp each tab 375, 376. Of course alternative shapes of gripping hole can be readily imagined.

In use, the pouch 370 is initially provided sealed with the fluid collection bag 310, catheter 320, sleeve 330 and fluid reservoir 340 within it. To access the contents, the user grasps each of the tabs 375, 376 using the gripping holes 377 and pulls the tabs 375, 376 away from one another. This in turn pulls the front wall 371 away from the rear wall 372 and breaks a frangible portion of the peripheral seal 373 which comprises the edges of the pouch 370 that do not correspond to the pouch fold-line 373a.

Referring to Figure 18, as the pouch 370 is folded about the pouch fold-line 373a, the front wall 371 and rear wall 372 preferentially open out to a flat position. In this embodiment, a flat position is defined as when the angle between the front wall 371 and rear wall 372 is less than 1 degree. This opening of the pouch 370 exposes the absorbent layer 374 as well as the contents of the pouch 370 for use as described above in relation to the first embodiment. Advantageously, any leakage from the fluid reservoir 340 may be absorbed by the absorbent layer 374 preventing accidental wetting of items/surfaces which are to be handled by the user.

During preparation and use of the catheter 320, the opened pouch 370 may present a flat and clean surface for the user. This makes use of the catheter 320 as parts of the assembly 300 may be placed on the opened pouch 370 as required without them being potentially contaminated with dirt. After use of the catheter 320, the fluid collection bag 310 may be emptied as described above.

Referring to Figures 18 and 19, the catheter 320, fluid collection bag 310, sleeve 330 and reservoir 340, as well as the outlet 360 that is now separated from the bag 310 may be repackaged within the pouch 370. This may be possible in embodiments where the peripheral seal 373 is configured to be re-sealable. Advantageously, any fluid that has leaked from the bag 310 during use or emptying of the bag 310 can be absorbed by the absorbent layer 340 which ensures there are no leaks from the catheter assembly 300 and pouch 370.

To close the pouch 370, the tabs 375, 376 may be brought towards each other, resulting in folding of the pouch about the pouch fold-line 373a and the bringing together of the front wall 371 and rear wall 372. The peripheral seal 373 may then be re-sealed closed, for example by pressing the front wall 371 and rear wall 372 together. Thus, the pouch 370 may be closed without the user needing to touch the interior surfaces of the pouch 370 which may have become dirty or soiled during use of the catheter 320. In addition, both the tabs 375, 376 may be folded about their respective bases 380 against the front wall 371 of the pouch. This provides an additional mechanical resistance to the re-opening of the peripheral seal 373, reduces the form factor of the pouch 370 and also reduces the likelihood that the tabs 375, 376 are inadvertently separated by contact with another object.

As mentioned above, in this embodiment the catheter 320 and sleeve 330 are in fluid communication with the fluid collection bag 310 via the inlet 353. The configuration of the catheter 320, sleeve 330, inlet 353 and bag 310 is relatively flexible and many different configurations could be employed in embodiments of the invention.

Referring to Figure 20, in a first example of the configuration for the catheter 320, sleeve 330 and inlet 353 fluid passes directly from the sleeve 330 to the inlet 353 and directly from the catheter 320 to the inlet 353. In this example, a right lateral side 323 of the catheter 320 is attached to a right side 355 of the inlet 353 and there is a gap between a left lateral side 324 of the catheter 320 and the respective left side 356 of the inlet 353. In addition, the distal end 322 of the catheter 320 is within the inlet 353, and the sleeve 330 is sealed around a periphery of the inlet 353. As such, fluid travelling within the sleeve 2 is directed into the inlet 353 directly via the gap between the left lateral side 324 of the catheter 320 and the left side 356 of the inlet 353. In addition, fluid travelling within the catheter 3 passes out the distal end 322 and into the inlet 353 directly. In other examples, the catheter 320 may be positioned differently and may be attached to the left side 356 of the inlet 353, or to a front or rear side.

Referring to Figure 21, in a second example fluid passes from the catheter 320 into the sleeve 330 and then into the inlet 353. In this example, the right lateral side

323 of the catheter 320 is attached to a left side 334 of the sleeve 330 and a distal end 322 of the catheter 320 is not within the inlet 353. As in the first example, the sleeve 330 is sealed around a periphery of the inlet 353. As such, fluid travelling within the sleeve 302 is directed into the inlet 353 directly and fluid travelling within the catheter 303 passes out the distal end 322 into the sleeve 330 and then from there into the inlet 353. In other examples, the catheter 320 may be positioned differently and may be attached to a left side 335 of the sleeve 330, or indeed to a front or rear side. Furthermore, the distal end 322 of the catheter 320 may be blocked and an outlet (not shown) may be provided in a lateral side of the catheter 320 to allow fluid to pass out into the sleeve 330.

Referring to Figure 22, in a third example fluid passes from the sleeve 330 into the catheter 320 and then into the inlet 353. The configuration of this example is similar to the first example shown in Figure 20 and so only the differences are described. In this example, the inlet 353 is sealed between the left side 356 and right side 355 such that the catheter 320 is sealed on all sides. As such, fluid may only pass from the sleeve 330/catheter 320 into the inlet 353 if it is within the catheter 320. The left lateral side

324 of the catheter 320 comprises an oval sleeve intake opening 325 adjacent to the inlet 353 which permits the passage of fluid travelling within the sleeve 303 into the catheter to join fluid travelling within the catheter 302. From here, the fluid 302, 303 passes out the distal end 322 of the catheter 320 and into the inlet 353. Many other configurations may be possible to achieve the same effect, for example, the sleeve 330 may be attached to the outer sides of the catheter 320 itself.

While the embodiments disclosed above is described as a closed catheter assembly in that fluid is collected in a fluid collection bag, other embodiments may not comprise a fluid collection bag and may be open catheter assemblies in that fluid is not collected during use.

The one or more embodiments are described above by way of example only. Many variations are possible without departing from the scope of protection afforded by the appended claims.

Claims

CLAIMS A packaged catheter assembly comprising a catheter and a pouch having two walls and a peripheral seal between the two walls, wherein the pouch is configured to contain the catheter within it, each wall comprises a tab extending from an edge of the pouch, and the tabs are configured to be separated in use to create an opening in the peripheral seal. The catheter assembly of claim 1 wherein the catheter is a male urinary catheter. The catheter assembly of any preceding claim wherein the catheter assembly comprises a fluid collection bag coupled to the catheter, such that it is configured to collect and retain fluid released from the body through the catheter. The catheter assembly of any preceding claim wherein the tabs extend from the same edge of the pouch. The catheter assembly of claim 4 wherein the tabs are overlapping. The catheter assembly of claim 5 wherein the tabs extend from different points on an edge of the pouch, are partially overlapping and are formed of a flexible plastic sheet material. The catheter assembly of any preceding claim wherein each tab has a length that is parallel to and less than the length of the edge of the pouch from which the tab extends and each tab is formed of a flexible plastic sheet material. The catheter assembly of any preceding claim wherein the peripheral seal comprises a left lateral edge, right lateral edge and an upper edge of the pouch, one tab is arranged on a left side of the pouch and the other tab is arranged on a right side of the pouch. The catheter assembly of any preceding claim wherein the tabs are configured to allow the pouch to be closed after use of the catheter by bringing the tabs towards each other and wherein the peripheral seal is re-sealable. The catheter assembly of any preceding claim wherein each tab is foldable against a wall of the pouch to a position where it does not project beyond an edge of the pouch and each tab comprises a crease-line. The catheter assembly of claim 11 wherein both tabs is foldable against the same wall of the pouch. The catheter assembly of any preceding claim wherein one, or both, of the tabs comprises a gripping hole comprising an aperture through each tab wherein a gripping hole of one tab is in overlap with the other tab. The catheter assembly of any preceding claim wherein one, or both, of the tabs comprises a gripping hole comprising an aperture through each tab wherein a gripping hole of one tab is in overlap with an edge of the other tab. The catheter assembly of claim 13 wherein a gripping hole of one tab is in overlap with a slanted edge of the other tab. A method of manufacturing a packaged catheter assembly comprising providing two walls to form a pouch, arranging a catheter within the pouch, and forming a peripheral seal between the two walls to seal the pouch, wherein each wall comprises a tab extending from an edge of the pouch and the tabs are configured to be separated in use to create an opening in the peripheral seal. The method of claim 15 further comprising folding the tabs against the pouch. A method of unpackaging a packaged catheter assembly, the packaged catheter assembly comprising a catheter and a pouch having two walls and a peripheral seal between the two walls, wherein the pouch is configured to contain the catheter within it, each wall comprises a tab extending from an edge of the pouch, and the tabs are configured to be separated in use to create an opening in the peripheral seal, the method comprising separating the tabs to form an opening in the peripheral seal. The method of claim 17 wherein the tabs are provided folded against the pouch and the method comprising unfolding the tabs prior to separation of the tabs. The method of claim 17 or 18 comprising closing or re-sealing the pouch by bringing the tabs together.

20. The method of any of claims 15 to 19 wherein the catheter assembly is the catheter assembly of any of claims 1 to 14.