WO2023180709A1

WO2023180709A1 - A catheter assembly

Info

Publication number: WO2023180709A1
Application number: PCT/GB2023/050678
Authority: WO
Inventors: Lukasz Natkaniec; Phillip EMRICH
Original assignee: Convatec Limited
Priority date: 2022-03-21
Filing date: 2023-03-20
Publication date: 2023-09-28
Also published as: GB202203897D0

Abstract

A packaged catheter assembly comprises 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. The first and second walls are opaque whereas the third wall is transparent or translucent. The peripheral seal allows 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. An external face of the pouch may comprise a wetting marker corresponding to the position of a fluid reservoir within the pouch. The pouch may have a textured or printed appearance. The bag may extend beyond the edge of the opened pouch. The fluid collection bag may comprise two sections and a fold line at an edge of 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.

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.

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.

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, 20 and 30 cm, or most preferably 28 cm. The bag may be configured to hold at least 500, 700, or 1000 ml of fluid, Most preferably 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 stowed configuration in which it is parallel to an edge of the fluid collection bag. In such embodiments, the fold line may be at an angle (i.e. not parallel) to the width of the passageway. The fold line may be at an angle to the edge of the fluid collection bag which the passageway is parallel to in the stowed configuration, for example an angle of 50-80 degrees, 60-70 degrees or most preferably 63 degrees. Thus, the passageway can be simply and conveniently stowed against the edge of the fluid collection bag.

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 comprise one or more pursing strips, preferably two or more pursing strips. The one or more pursing strips may be configured to open the passageway in response to user input. The one or more pursing strips may be configured to urge the passageway closed in the absence of user input. The one or more pursing strips may be configured to allow the user to more easily separate the respective sides of the passageway. The one or more pursing strips may be pinched to open the passageway. The one or more pursing strips may comprise a more rigid material than the passageway, for example high density polyethylene (HDPE). The or each pursing strip may be provided centrally with respect to the width and/or length of the passageway. The or each pursing strip may have a length parallel to the width of the passageway. The or each pursing strip may have a length approximately equal to width of the passageway (e.g. approximately equal to the distance between the inside edges of a peripheral weld defining the passageway). The or each pursing strip may have a maximum thickness no more than 50%, 40%, 30%, 20% or 10% the length of the passageway. The or each pursing strip may have a maximum thickness of at least 5%, 10%, 20%, 30%, or 40% the length of the passageway. The passageway may have a central region along its length that is a constant thickness. The central region may be a region of maximum thickness. Each end of the or each pursing strip may be approximately half the maximum thickness of the or each pursing strip. Each end of the or each pursing strip may be tapered. Each end of the or each pursing strip may have a convex shape, for example a convex quarter circle shape. Thus, the passageway may be more easily opened to allow fluid flow therethrough.

The one or more pursing strips may be provided in pairs. Each pursing strip in a pair of pursing strips may be positioned on opposite sides of the passageway. Each pursing strip in a pair of pursing strips may be substantially the same shape and/or size. Each pursing strip in a pair of pursing strips may be positioned at the same point along the length and/or width of the passageway. A pair of pursing strips may be configured to separate when compressed in a direction parallel to the width of the passageway. Thus, pairs of pursing strips may be provided to open and separate the layers of material that make up the passageway. When not compressed in a direction parallel to the width of the passageway, a pair of pursing strips may be configured to urge the passageway closed.

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.

The drain may comprise a pair of pursing strips, preferably arranged midway along the length of the drain.

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 fluid collection bag may comprise two or more sections, and preferably three sections. The fluid collection bag may comprise one or more fold lines dividing the fluid collection bag into the two or more sections. Any one or more of the two or more sections may correspond to a wall (e.g. a first/front or a second/rear wall) of the pouch. The fluid collection bag may comprise three or more sections. At least one of the three or more sections may correspond to the first and/or second walls. At least one of the three or more sections may not correspond to the first and/or second walls. Preferably, of the three or more sections, a first section corresponds to the first wall, a second section corresponds to the second wall and a third section does not correspond to the first or second wall. Thus, the bag can be divided into sections (by fold lines) to help control the movement of the contents of the bag within it.

Accordingly in one embodiment, 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, wherein the fluid collection bag comprises three or more sections and at least one of the three or more sections corresponds to the first and/or second walls.

The two or more sections may be defined between two opposite sides of the fluid collection bag, for example between the upper edge and base of the fluid collection bag. The one or more fold lines may each span between two opposite sides of the fluid collection bag, for example between the left and right lateral edges. Each of the two or more sections may be the same size and/or volume. The two or more sections may be configured to be folded against one another in a closed/stowed configuration. The two or more sections may be configured to be unfolded into an open configuration. Thus, the fluid collection bag’s size can be minimised through the use of sections. The fluid reservoir may be positioned centrally within a section of the fluid collection bag. The fluid reservoir may be positioned in a section of the fluid collection bag adjacent to the upper edge of the fluid collection bag. Thus, fluid released is retained close to the fluid reservoir by the action of gravity and also through folding at the fold line where applicable.

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 catheter may be arranged around the fluid reservoir. The catheter may be arranged in a curved/coiled configuration around the fluid reservoir. The catheter may be arranged in the same section of the fluid collection bag as the fluid reservoir. The catheter may spiral around the fluid reservoir. The proximal end of the catheter may be within a passageway. The catheter may extend through the passageway. The catheter may (then) exit the passageway. The catheter may (then) pass adjacent a (right or left) lateral edge of the fluid collection bag. The catheter may (then) pass between the fluid reservoir and a fold line in the fluid collection bag. The catheter may (then) pass adjacent to the (left or right) lateral edge of the fluid collection bag. The catheter may (then) pass between the fluid reservoir and the base or upper edge of the fluid collection bag. The distal end of the catheter may be positioned between the fluid reservoir and the catheter (tube). Thus, the catheter is present close to the fluid reservoir and in the same section, where it is retained by the fold line and its spiralling shape and as such wetting fluid efficiently activates the catheter ready for use.

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 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 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. For example, polypropylene (PP), polyethylene terephthalate (PET), low density polyethylene (LDPE), metalized polyester (MET PET) 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. 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 by another component of the packaged catheter assembly such as the fluid collection bag/peripheral bond as it may allow the peripheral seal to be more efficiently constructed as well as being easier to break when opening the pouch. The peripheral seal may form one or more edges of the pouch. A folded edge may comprise the fold between the two walls. 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. 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 fold- line 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 fluid collection bag may be configured to extend beyond the edge of the opened (flat) pouch. The fluid collection bag may be configurable into a stowed configuration in which it can be contained within the pouch. The stowed configuration of the fluid collection bag may be a rolled or folded configuration. The pouch fold-line may correspond to a (first) fold-line of the fluid collection bag. A (second) fold line of the fluid collection bag may correspond to an edge of the pouch. The fluid collection bag may comprise two or more sections as described above. One or more of the two or more sections may not be attached to the pouch, for example one section. At least one of the sections may be attached to the pouch. In a preferred embodiment, the fluid collection bag comprises three sections, two of which are attached to the pouch. Most preferably, only two of the three sections are attached to the pouch. Thus the size of the pouch can be minimised while retaining a fluid collection bag with high fluid capacity to be more user-friendly and convenient.

Accordingly in one embodiment 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, wherein the fluid collection bag comprises a stowed configuration in which it can be contained within the pouch and the fluid collection bag is configured to extend beyond an edge of the pouch.

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. Accordingly in one embodiment 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, a fourth wall 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, wherein the first wall is a front or rear wall of the pouch, the second wall is a corresponding rear or front wall of the pouch, and the fluid collection bag comprises a front panel formed from the third wall and a rear panel formed from the fourth wall. 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). Accordingly in one embodiment 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, wherein an external face of the pouch comprises a wetting marker corresponding to the position of a fluid reservoir within the pouch. 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. Accordingly in one embodiment 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, wherein the pouch has a textured or printed appearance. 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 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. 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.

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 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.

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.

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. The tab may be arranged to a left or right side of the pouch. 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 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.

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 hold of one tab may be in overlap with 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.

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.

The catheter assemblies/packaged catheter assemblies of the first to fifth aspects may include any one or more features of a catheter assembly/packaged catheter assembly as defined in broad terms, or according to any other of the first to fifth aspects set out above. The catheter assemblies/packaged catheter assemblies of the first to fifth aspects may comprise any of the optional features of the others of the first to fifth 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 a fifth 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 fifth 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 sixth 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 sixth 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. Where the fluid collection bag extends beyond the pouch, the method may comprise attaching only part of the fluid collection bag to 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 seventh 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 seventh 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 eighth 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 eighth 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.

According to a ninth 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 ninth 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 fifth 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 releasing fluid from the fluid reservoir into one section of the fluid collection bag, and preferably the section containing 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 opening the passageway using a pair of pursing strips provided on the passageway. 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 tenth 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 tenth 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 sixth 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 eleventh 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 eleventh 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 seventh 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.

Accordingly in one embodiment there is provided a method of 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 releasing wetting fluid from a fluid reservoir within the pouch and/or fluid collection bag and separating the first and second walls to expose the third wall.

Accordingly in one embodiment there is provided a method of 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 locating a wetting marker disposed on the exterior of the pouch, pressing the wetting marker to release fluid from the fluid reservoir and separating the first and second walls to expose the third wall.

In another embodiment there is provided a method of 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 releasing wetting fluid from a fluid reservoir within the pouch and/or fluid collection bag and then separating the first and second walls to expose the third wall.

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 twelfth 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 twelfth 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 eighth aspect of the invention.

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 in relation to the thirteenth aspect 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.

The methods of the fifth to twelfth 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 fourth 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 packaged catheter assembly where the pouch is in the closed configuration;

Figure 10 is a front view of the packaged catheter assembly of Figure 9 where the pouch is in the open configuration and the neck and drain are in the stowed/closed configuration;

Figure 11 is a front view of the packaged catheter assembly of Figure 9 where the pouch and neck are in the open configuration, and the drain is in the stowed/closed configuration;

Figure 12 is a front view of the packaged catheter assembly of Figure 9 where wetting fluid has been released into the fluid collection bag;

Figure 13 is a front view of the packaged catheter assembly of Figure 9 where the catheter has been withdrawn from the fluid collection bag; and

Figure 14 is a front view of the packaged catheter assembly of Figure 9 where the drain is in the open configuration and the fluid collection bag is in a different orientation.

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 10 and 20 cm, and most preferably between 12 and 15 cm 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 25 and 40 cm, 30 and 35 cm, or most preferably 33 and 35 cm.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, 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.

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 14, a second embodiment of a packaged catheter assembly 200 is shown. The second embodiment shares many of the features of the first embodiment described above, and so only differences in the features are described below, and like numerals are used to denote like features unless described differently below.

In this embodiment, the closed pouch 270 comprises a width between the left lateral edge 273b and right lateral edge 273c of 120-170 mm, preferably 140-150 mm, for example 146 mm. The closed pouch 270 comprises a height between the base edge 273a and upper edge 273d of 50-110 mm, preferably 80-90 mm, for example 86 mm. These sizes make the packaged catheter assembly 200 more discreet for the user and also easier to fit in a bag or pocket. Each of the front wall 271 and rear wall 272 of the pouch 270 have the same dimensions as the closed pouch. Consequently, when unfolded and opened, the pouch 270 has a width as described above and a height that is double the height of the folded configuration, i.e. 100-220 mm, or preferably 160- 180 mm and most preferably 172 mm. Clearly those skilled in the art will readily see that the features of the invention apply equally to embodiments of other sizes and shapes.

In this embodiment, the pouch 270 comprises a single opening tab 275 arranged on the front wall 271 of the pouch 270 (rather than the two opening tabs of the first embodiment). When the pouch 270 is folded and closed, the tab 275 folds down to overlie the rear wall 272 and seal against it. For example, the tab 275 and/or rear wall 272 may comprise any suitable bonding to seal the tab 275 to the rear wall 272 in a releasable manner such as Velcro (RTM), chemical adhesives, chemical bonding, ultrasonic bonding, or mechanical bonding.

In this embodiment, the opening tab 275 comprises a rectangular protrusion in the central quarter of the upper edge 273d on the front wall 271. The end of the opening tab 275 distal from the upper edge 273d is semi-circular. The length of the opening tab 275 from where it meets the front wall 271 to the tip of its semi-circular end is equal to its width, that is a quarter the width of the pouch 270. In other embodiments, the opening tab 275 could be any suitable size or shape, for example the size/shape of the tabs of the first embodiment. In another embodiment, shown in Figure 9, the opening tab 275 may comprise a triangular tab spanning the entire width of the pouch 270, thus the closed pouch 270 may have the appearance of a closed envelope. In this example, the tab 275 comprises an tab marker 277 comprising an arrow printed onto the tab 275. The tab marker 277 points in the direction which the user should open the tab 275 in order to open the pouch 270.

In this embodiment, the fluid collection bag 210 is configured to be opened into an upside-down configuration wherein the neck 250 is arranged at a bottom of the fluid collection bag 210 - for example as shown in Figures 9-13. Consequently, numerals denoting the left and right lateral edges of the pouch 270 and fluid collection bag 210 are shown on the right and left sides respectively in Figures 9-13, and in these Figures the base 212 and upper edge 215 of the fluid collection bag 210 are shown at the top and bottom respectively. The opening of the fluid collection bag 210 in this way removes the need for the user to rotate the fluid collection bag 210 to ensure wetting fluid can access the neck 250, as required in the first embodiment above. The fluid collection bag 210 may then be rotated to a configuration in which the neck 250 is arranged at the top of the fluid collection bag 210 for use, as described below in more detail below.

In this embodiment, the fluid collection bag 210 has a width between the left lateral edge 213 and right lateral edge 214 of the fluid collection bag 210 that is approximately 3-10 mm smaller than the width of the pouch 270, for example between 100-170 mm, preferably 120-150 mm, for example 140 mm. The fluid collection bag 210 has a height between the base 212 and upper edge 215 of the fluid collection bag 210 of 150-350 mm, preferably 200-300 mm, for example 280 mm. The fluid collection bag 210 therefore has a height that is greater than the height of the unfolded pouch 270.

In this embodiment, to ensure the fluid collection bag 210 is securely and efficiently packaged within the pouch 270, the fluid collection bag 210 is split into three equally sized sections along its length. A first section is defined between the base 212 and a bag fold line 218. The bag fold line 218 spanning the width of the fluid collection bag 210 at a point approximately one third of the way from the base 212 to the upper edge 215 of the fluid collection bag 210. A second section is defined between the bag fold line 218 and the position of the pouch fold line which corresponds to the position of the base 273a of the closed pouch 270 when the pouch is unfolded and open. A third section is defined between the pouch fold line or base 273a of the pouch 270 and the upper edge 215 of the fluid collection bag 210. Of course, in other embodiments, the fluid collection bag 210 may be split into 4 or more sections, or 2 sections, as required. In addition, each of the sections may have different sizes as required by the circumstances.

In this embodiment, the second and third sections of the fluid collection bag 210 are attached to the front wall 271 and rear wall 272 of the pouch 270 respectively, for example as described above in relation to the first embodiment. The second and third sections therefore lie completely within the peripheral seal of the pouch 270.

In this embodiment, the first section of the fluid collection bag 210 is not attached to the pouch 270 and is therefore free to pivot about the bag fold line 218 between a stowed configuration in which the fluid collection bag 210 is folded at the bag fold line 218 and the first section overlies the second section, and an open or unfolded configuration in which the fluid collection bag 210 is not folded at the bag fold line 218. In the open configuration, the first section therefore extends beyond the edge of the pouch 270 and over the opening tab 275. Of course, in other embodiments, only one section may be joined to the pouch 270 and the other two (or more) may be free to pivot/fold as required. Alternatively, all sections of the fluid collection bag 210 may be attached to the pouch 270.

Compared to the first embodiment described above, the position of the neck 250 and drain 260 are the same as in the first embodiment and further, both the drain 260 and neck 250 extend away from the fluid collection bag 210 at the same angle as described in relation to the first embodiment. In contrast to the first embodiment, the neck 250 has a width of between 10-30% the width of the fluid collection bag 210, for example 20%. Whereas the drain 260 has a width of between 15-35% of the fluid collection bag 210, for example 25%. The neck 250 has a length of 30-60% of the height of the fluid collection bag 210, for example 45%, or most preferably a length equal to the width of the fluid collection bag 210. The drain 260 has a length of approximately half the neck 250, as with the first embodiment.

In this embodiment, the neck-fold line 255 is angled with respect to the base 212 of the fluid collection bag 210 by an angle of 50-80 degrees, preferably 60-70 degrees, for example 63 degrees. In addition, the neck 250 is angled with respect to the left lateral edge 214 such that when folded about the neck-fold line 255, the neck 250 lies parallel to the upper edge 215. Consequently, the neck 250 in the stowed configuration spans across the width of the fluid collection bag 250 along its upper edge 215.

Referring to Figure 13, in this embodiment, the neck 250 does not comprise the plug or guide tube of the first embodiment. The neck 250 comprises a distal end 151 which comprises a small aperture 254 which is configured to allow the catheter 220 to pass out of the fluid collection bag 210.

Referring to Figure 14, in this embodiment, the fluid collection bag 220 comprises a closure 216 that replaces the closure flap of the first embodiment. Like the closure flap of the first embodiment, the closure 216 is configured to retain the drain 260 in the stowed configuration. In this embodiment, the closure 216 is a layer of material permanently adhered to the fluid collection bag 210 on one side, the other side comprising a resealable adhesive, for example Velcro (RTM), that can be temporarily sealed to a corresponding closure (not shown) on the drain 260, for example positioned on a side of the drain 260 corresponding to the rear panel 211a of the fluid collection bag 210. The closure 216 is stadium shaped (rectangular with semi-circular ends), with a length equal to a third of the width of the drain 260 and aligned parallel to the width of the drain and an aspect ratio (length: width) of 3 : 1. Of course, in other embodiments, the closure 216 may have a different size or shape as required.

In this embodiment, the drain 260 further comprises a pair of pursing strips, one pursing strip 266 arranged on the front panel 21 lb of the fluid collection bag 210 and a second pursing strip (not shown) arranged in a corresponding position on the rear panel 211a of the fluid collection bag 210. Each pursing strip in the pair is identical and comprises a more rigid material than the drain 260, for example high density polyethylene (HDPE). The pursing strips are configured such that in the absence of user-input they are both flat and therefore urge the two opposing panels of the drain towards one another, keeping it closed, but also allow the user to more easily separate the respective sides of the drain 260 to ensure that fluid can flow more easily out of the fluid collection bag 210 through the drain 260.

Each pursing strip 266 is positioned half way down the length of the drain 260. Along a proximal edge of each pursing strip 266 proximal to the drain fold line 262, each pursing strip 266 spans the entire width of the drain 260 between the peripheral seal that defines the drain 260. The central half of the width of each pursing strip 266 is approximately double the thickness of its edges. Between its edges and the central half of the width, each pursing strip 266 comprises a tapered region with a convex quarter circle shape. Each pursing strip 266 spans 10 to 20% of the length of the drain 260. Consequently, by pinching the pursing strips the two pursing strips flex along their length and across the width of the drain 260 and separate the front and rear panels which make up the drain 260. Of course, in other embodiment, the pursing strips may have a different shape or size.

In this embodiment, the section of the drain 260 adjacent to the drain fold line 262 comprises an opening marker 267 on its surface corresponding to the rear panel 211a of the fluid collection bag 210. The opening marker 267 comprises an arrow pointing in a direction towards the drain fold line 262. Thus, the opening marker 267 is visible to the user when the drain 260 is in the stowed configuration and guides them in opening the drain 260. In other embodiments, the opening marker 267 may of course have a different shape or be positioned differently, for example on the front panel 211b of the fluid collection bag 210 adjacent to the stowed drain 260.

In this embodiment, the fluid reservoir 240 is similarly shaped and sized compared to the first embodiment, however, it comprises rounded ends and is thus stadium shaped. In contrast to the first embodiment, the fluid reservoir 240 comprises two circular activation markers 244: one positioned at each end of the fluid reservoir 240 and each comprising the word “PRESS” on it. As with the first embodiment, the fluid reservoir 240 is configured to rupture when activated and a tear 241 is created in the fluid reservoir 240 allowing wetting fluid to be released into the fluid collection bag 210. In this embodiment, the fluid reservoir 240 is configured to rupture when activated by either of the activation markers 244 individually or when both are pressed simultaneously. This provides greater flexibility to the user. In other embodiments, the fluid reservoir 240 may only rupture when both are activated, this could help prevent premature release of wetting fluid.

In this embodiment, the fluid reservoir 240 is positioned equidistant between the left lateral edge 214 and right lateral edge 213 of the fluid collection bag 210 and also equidistant between the base 212 of the fluid collection bag 210 and the pouch fold line/base 273a of the pouch 270. Thus, the fluid reservoir 240 is positioned centrally in the third section of the fluid collection bag 240 described above.

In this embodiment, the fluid collection bag 210 comprises fold line 242 between the front and rear panels 21 lb, 21 la of the fluid collection bag 210 configured to partially block fluid flow between the third and second sections of the fluid collection bag 210 when folded. The fold line 242 is positioned along the pouch fold line/base 273a of the pouch 270 and on the side of it closest to the upper edge 215 of the fluid collection bag 210.

In this embodiment, the catheter 220 is arranged with its proximal end 221 inside the neck 250 at the distal end 251 of the neck 250. The catheter 220 extends through the neck 250 and then into a curved and coiled around the fluid reservoir 240. In this embodiment, the catheter 220 curves in an anti-clockwise direction (when viewed through the front panel 211b of the fluid collection bag 210), exiting the neck 250 and passing adjacent the left lateral edge 214 of the fluid collection bag 210. It then turns left and passes between the fluid reservoir 240 and the fold line 242 before turning left again and passing down adjacent to the right lateral edge 213 of the fluid collection bag 210. The catheter 220 then turns to pass between the fluid reservoir 240 and the upper edge 215 of the fluid collection bag 210 before finally turning left round the end of the fluid reservoir 240 again on the inside of itself. The distal end 222 of the catheter 220 resting at a position just right of centre across the width of the fluid collection bag 210 and between the fluid reservoir 240 and the catheter (tube) 220. Thus, the catheter 220 is positioned only within the third section of the fluid collection bag 210 and is prevented from moving out of this section by the fold line 242 (when the fluid collection bag is folded). In other embodiments, the catheter may of course coil in the other direction as required.

In this embodiment, the distal end 222 of the catheter 220 does not comprise a funnel and instead comprises a cuff 223. The cuff 223 is configured to prevent movement of the distal end 222 of the catheter 220 through the aperture 254 of the neck 250. As such, the cuff 223 comprises a protrusion extending parallel to the diameter of the catheter 220 and configured to contact the distal end 251 of the neck 250 preventing the catheter 220 from being completely withdrawn from the fluid collection bag 220.

In use, the packaged catheter assembly 200 of the second embodiment is used in a similar manner to the first embodiment. The main difference being that in this embodiment the neck 250, fluid reservoir 240 and catheter 220 are arranged below the drain 260 when the fluid collection bag 210 is opened. As such, once wetting fluid is released from the fluid reservoir 240 it preferentially collects around the catheter 220 and in the neck 250 without the user needing to rotate or change the orientation of the fluid collection bag 210. Of course, to ensure fluid flows into and is retaining in the fluid collection bag 210 in use, the fluid collection bag 210 must then be rotated through 180 degrees so that the neck 250 is positioned above the rest of the fluid collection bag 210 and the upper edge 215 and base 212 are at the corresponding top and bottom of the fluid collection bag 210. In addition, before using the catheter 220, all three sections of the fluid collection bag 210 of the second embodiment needs to be unfolded.

Drainage of the fluid collection bag 220 is achieved in this embodiment by unfolding the drain into the open extended configuration, for example by pulling the folded stowed drain up/away from the closure 216 as indicated by the opening marker 267. The pursing strips 266 are used to assist opening of the drain 260 by pinching them together as described above.

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 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. The catheter assembly of claim 1 wherein the catheter is a male urinary catheter. The catheter assembly of any preceding claim wherein the catheter is coupled to the fluid collection bag, 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 first wall is a front or rear wall of the pouch, the second wall is a corresponding rear or front wall of the pouch, and the third wall forms a front panel of the fluid collection bag. The catheter assembly of claim 4 wherein the first and second walls form a rear panel of the fluid collection bag. The catheter assembly of claim 4 wherein a fourth wall forms a rear panel of the fluid collection bag. The catheter assembly of any preceding claim wherein an external face of the pouch comprises a wetting marker corresponding to the position of a fluid reservoir within the pouch. The catheter assembly of any preceding claim wherein the pouch has a textured or printed appearance. The catheter assembly of any preceding claim wherein the fluid collection bag comprises a stowed configuration in which it can be contained within the pouch and the fluid collection bag is configured to extend beyond the edge of the opened pouch. The catheter assembly of claim 9 wherein the stowed configuration comprises a rolled or folded configuration. The catheter assembly of claims 9 or 10 wherein the fluid collection bag comprises two or more sections and a fold line corresponding to an edge of the pouch. The catheter assembly of claim 11 wherein the two or more sections are configured to be folded against one another in the stowed configuration. The catheter assembly of claims 11 or 12 wherein the fluid collection bag comprises three or more sections, wherein at least one of the three or more sections corresponds to the first and/or second walls of the pouch. The catheter assembly of any preceding claim wherein the fluid collection bag comprises two or more sections divided by one or more fold lines in the fluid collection bag. A method of 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. A method of 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.

17. The method of claim 16 wherein the method comprises releasing wetting fluid from a fluid reservoir within the pouch and/or fluid collection bag.

18. The method of claim 15 or 16 wherein the step of releasing wetting fluid precedes the step of separating the first and second walls. 19. The method of any of claims 15 to 17 wherein the method comprises identifying when the fluid collection bag of the pouch is full by watching fluid fill the bag through the third wall. 0. The method of any of claims 15 to 19 wherein the catheter assembly is the catheter assembly of any of claims 1 to 14.