WO2023180726A1

WO2023180726A1 - A catheter assembly

Info

Publication number: WO2023180726A1
Application number: PCT/GB2023/050696
Authority: WO
Inventors: Oliver PFLEGER
Original assignee: Convatec Limited
Priority date: 2022-03-21
Filing date: 2023-03-20
Publication date: 2023-09-28

Abstract

A catheter assembly comprises a catheter having a proximal end for insertion into the body and a distal end, and a sleeve configured to enclose only part of the length of the catheter. The sleeve comprises a handling element projecting away from the catheter in a plane parallel to the axis of the catheter. The handling element may extend from only one side of the catheter. The catheter may be a male urinary catheter. The sleeve may comprise two or more independently moveable handling elements. The two or more handling elements may be provided joined together and may be separatable. The catheter assembly may comprise a fluid collection bag. The handling element may engage an inlet of the fluid collection bag. There is also provided a packaged catheter assembly comprising a pouch containing the catheter assembly. Methods of manufacture and of handling a catheter assembly are provided.

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.

Before the catheter has been used, it is important that it can be easily handled and manipulated while remaining sterile. Existing catheter’s can feature a sleeve which encloses the catheter and allows it to be handled indirectly via the sleeve. However, the sleeve may itself be difficult to handle and could become slippery due to contact with wetting fluid intended to activate the surface of the catheter prior to use. This can make it difficult for the user to use the catheter, especially if they have reduced dexterity.

Once used, a fluid collection bag is heavy and bulky as it is filled with liquid. To allow the bag to be carried and disposed of more discretely and easily, existing bags may be provided with a drain to allow them to be emptied into a toilet. However, existing drains can either leak or are difficult to open which potentially results in inadvertent or uncontrolled release of liquid from the bag. In addition, after use the bag may be stored before cleaning or disposal, however, the drain can make storage of the bag difficult and unhygienic.

After use, the catheter can also cause problems for the user as it is dirty having just been inside the body and an inconvenient shape to be packaged/stowed discreetly as it is long and thin and resiliently biased into a straight configuration. This can mean that the user must carry additional bags or other equipment to store the catheter after use if it is not possible for them to dispose of it immediately. Where the catheter is attached to a fluid collection bag, any storage bags must also be able to contain the fluid collection bag which may also be full of liquid. This further increases the challenges of storing a used catheter assembly until disposal is possible.

Many existing packaged closed catheter assemblies contain a fluid reservoir or sachet together with a fluid collection bag and catheter all contained within a pouch. Prior to use, the fluid reservoir or sachet is burst to release wetting fluid to activate the catheter surface and render it lubricious. In releasing the wetting fluid, the fluid collection bag may also become wet, which makes handling and re-packaging of the bag difficult, in particular for users with limited dexterity. In addition, if a significant portion of wetting fluid contacts, and gets stuck to the fluid collection bag, there may not be sufficient wetting fluid to activate the whole catheter surface. As such, the lack of sufficient lubrication of the catheter surface can lead to discomfort and injury during use.

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

Summary of the Invention

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

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

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

The 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 catheter may be formed of a material of the group comprising: polyvinyl chloride, polytetrafluoroethylene, polyolefins, latex, silicones, synthetic rubbers, polyurethanes, polyesters, polyacrylates, polyamides, thermoplastic elastomeric materials, styrene block copolymers, poly ether block amide, thermoplastic vulcanizates, thermoplastic copolyesters, thermoplastic polyamides, and water disintegrable or enzymatically hydrolysable material, or combinations, blends or copolymers of any of the above materials.

The water disintegrable or enzymatically hydrolysable material may comprise a material of the group comprising: polyvinyl alcohol, extrudable polyvinyl alcohol, polyacrylic acids, polylactic acid, polyesters, polyglycolide, polyglycolic acid, poly lactic-co-glycolic acid, polylactide, amines, polyacrylamides, poly(N-(2- Hydroxypropyl) methacrylamide), starch, modified starches or derivatives, amylopectin, pectin, xanthan, scleroglucan, dextrin, chitosans, chitins, agar, alginate, carrageenans, laminarin, saccharides, polysaccharides, sucrose, polyethylene oxide, polypropylene oxide, acrylics, polyacrylic acid blends, poly(methacrylic acid), polystyrene sulfonate, polyethylene sulfonate, lignin sulfonate, polymethacrylamides, copolymers of aminoalkyl-acrylamides and methacrylamides, melamine-formaldehyde copolymers, vinyl alcohol copolymers, cellulose ethers, poly-ethers, polyethylene oxide, blends of polyethylene- polypropylene glycol, carboxymethyl cellulose, guar gum, locust bean gum, hydroxypropyl cellulose, vinylpyrrolidone polymers and copolymers, polyvinyl pyrrolidone-ethylene-vinyl acetate, polyvinyl pyrrolidone- carboxymethyl cellulose, carboxymethyl cellulose shellac, copolymers of vinylpyrrolidone with vinyl acetate, hydroxyethyl cellulose, gelatin, poly-caprolactone, poly(p-dioxanone), or combinations, blends or co-polymers of any of the above materials.

Preferably, the intermittent catheter is formed of a polyolefin material, in particular polyethylene and/or polypropylene.

Preferably, the intermittent catheter is formed of a thermoplastic elastomeric material.

The catheter may comprise a proximal end for insertion into the body and a distal end. The distal end of the catheter may comprise a funnel. The funnel may be formed of a relatively rigid material compared to the rest of the catheter and/or fluid collection bag, for example high density poly-ethylene (HDPE). The funnel may have a truncated conical shape. The funnel may be joined to the distal end of the catheter at the narrow end of the funnel.

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

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

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

The fluid collection bag may comprise a fill level indicator. The fill level indicator may comprise fill markers. The fill markers may allow the user to measure the volume of fluid contained within the fluid collection bag. The fill markers may be regularly spaced or irregularly spaced. The fill markers may correspond to an absolute volume of liquid contained within the bag. The fill markers may correspond to a proportion of the volume of the bag which is filled with fluid. The fill markers may indicate when a safe fill level of the bag has been reached. The fill level indicator may be positioned in a transparent or translucent region of the bag. Thus, the fill level indicator ensures the bag is not overfilled.

The fluid collection bag may comprise an inlet. The inlet may be configured to receive the catheter into the fluid collection bag. The inlet may be configured to prevent the catheter from being (completely) removed from the fluid collection bag, for example separation of the catheter from the fluid collection bag. The inlet may engage with a part of the catheter, preferably the distal end and/or funnel. Thus, fluid can be securely and easily transferred from the catheter into the fluid collection bag and the risk of leaks associated with the separation of the catheter from the fluid collection bag is minimised (through engagement of the inlet and catheter).

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

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

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

The fluid collection bag may comprise more than one finger hole, for example at least two, three or more finger holes. One, two, three or more, or each finger hole may have any one or more of the features of the finger hole described above. Thus, easy handling of the bag is facilitated through positioning of finger holes or equivalent features which also does not restrict or affect the volume of liquid that can be contained by the bag.

The one or more finger holes may be configured to allow the bag to be rotated to a horizontal position wherein the base of the bag is aligned vertically. In a preferred embodiment, the fluid collection bag comprises a finger hole at either end of the right lateral edge, and/or a finger hole at either end of the left lateral edge, and/or a finger hole along the upper edge and a finger hole along the base. Advantageously, this allows the bag to be rotated in a controlled manner which aids with handling and using the bag.

The outlet may be positioned distal from a finger hole of the bag. Where the outlet is positioned at or adjacent to an edge of the bag, that edge may be free from finger holes. Where the outlet is position at or adjacent an edge of the bag, a different edge of the bag (that is the right/left lateral edge) may comprise one or more finger holes. For example, the outlet may be provided at one corner of the bag and a finger hole may be provided at an opposite comer of the bag. Thus, the finger holes are positioned on edges of the bag that generally do not correspond to the position of the outlet, this makes handling/emptying of the bag easier as the bag can be rotated and held using the finger holes to allow fluid to leave the bag due to gravity.

The outlet may project beyond an upper edge of the bag. The outlet may comprise a spout that projects from the upper edge of the bag. The pull-ring may be attached to the spout. The spout may be any suitable shape, for example rectangular, square, triangular or irregularly shaped, preferably it is rectangular or square. Advantageously, the outlet/spout projects from the edge of the bag and as such is easier to tear off the bag without damaging the rest of the bag and risking uncontrolled release of fluid from the bag.

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

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

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

The fluid collection bag may comprise a retaining element. The retaining element may be configured to receive at least part of the catheter to stow the catheter after use.

According to a second aspect of the invention, there is provided a catheter assembly comprising a fluid collection bag and a catheter, the fluid collection bag comprising a retaining element configured to receive at least part of the catheter to stow the catheter after use.

Advantageously, the retaining element ensures the catheter is stowed which makes the catheter assembly more hygienic to store and dispose of after use without having to carry a separate item, such as a bag, to stow/store the catheter in.

The catheter may be configured to be coiled when stowed. Thus, the catheter’s size is minimised to ensure it is stowed efficiently.

The retaining element may be permanently attached to the fluid collection bag. Thus, the retaining element is unlikely to be lost or become separated from the fluid collection bag, this makes it more convenient and easier to use.

The retaining element may comprise a pocket on the outside of the fluid collection bag. The pocket may be configured to receive a majority of the length of the catheter after use. The pocket may comprise a flexible sheet material, for example any one of the materials that were described in relation to the fluid collection bag above. Preferably, the pocket comprises a liquid impermeable material. Thus the pocket prevents liquid passing from the used catheter to the outside of the pocket where it could cause a hygiene risk if it comes into contact with the user or another object.

The pocket may have any suitable shape and size to stow the catheter, for example, the pocket may span the entire width (or length) of the fluid collection bag. In other embodiments, the pocket may not span the entire width (or length) of the fluid collection bag. Preferably, the pocket spans the entire width of the fluid collection bag. Preferably, the pocket spans a majority of the height of the fluid collection bag. The pocket may span 50-80% of the height of the fluid collection bag, for example at least 50%, 60%, or 70% of the height of the fluid collection bag and most preferably 60%. Thus, the pocket can be used to safely store the catheter and prevent inadvertent contact with it by the use.

The pocket may be attached to the fluid collection bag by the peripheral bond. The pocket may be joined to a base of the fluid collection bag. The pocket may be joined to left and/or right lateral edges of the fluid collection bag. Thus, the pocket can be easily attached to the bag in a single step when forming the peripheral bond.

The retaining element may comprise a strap. The strap may be configured to seal the catheter against the fluid collection bag after use. The strap may comprise a strip of material. The strap may be configured to seal to the fluid collection bag. The strap may be configured to seal to the catheter. The strap may be configured to seal to itself. The strap may seal to the fluid collection bag/catheter/itself via any suitable adhesive, for example an epoxy resin or alternatively a silicone-based adhesive. The strap 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. Thus, the strap can be configured to seal to a variety of different surfaces to ensure the catheter can be easily stowed.

A part of the strap may be permanently attached to the fluid collection bag. For example, a part of the strap may be permanently attached to the fluid collection bag by 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. Thus, as part of the strap is attached to the bag it is easier to retain the catheter against the bag. Preferably, one end of the strap (a first end) is attached to the bag. Thus, the rest of the strap can be used most efficiently to stow the catheter.

A part of the strap may be configured to temporarily attach to the fluid collection bag. A part of the strap may be re-sealable. Preferably, one end of the strap is re- sealable. A second end of the strap may be the re- sealable end. Thus, the catheter can be arranged in the stowed configuration and then the strap used to retain it in place by attaching the second end of the strap to the bag. This makes the strap more convenient to use as, for example, the user doesn’t need to feed the catheter through a gap between the strap and bag.

The retaining element may be configured to restrict the size of the fluid collection bag. Thus, the fluid collection bag can be more convenient and discreet for the user to transport, store, use and dispose of. The fluid collection bag may comprise one or more stowed configurations, for example a rolled configuration and/or a folded configuration. The strap may be configured to retain the fluid collection bag in a stowed configuration. A part of the strap (the first end) may be configured to seal to one panel of the fluid collection bag (e.g. the front panel). A different part of the strap (the second end) may be configured to seal to another panel of the fluid collection (e.g. the rear panel). Thus, the strap may retain the fluid collection bag in a folded configuration, which can help control and reduce leaks of liquid out of the bag.

In the folded configuration, the fluid collection bag may comprise a fold (in an upper region of the fluid collection bag, for example adjacent to the upper edge and/or neck). Thus, the passage of liquid towards the inlet from inside the bag is reduced by the fold helping to prevent leaks. The strap may be configured to extend around the fold. Thus, the strap ensures the fold is maintained.

The fluid collection bag may comprise a rolled configuration. The fluid collection bag may be arranged in the rolled configuration prior to use. For example, the fluid collection bag may be provided in the rolled configuration in a sterile sealed pouch. The strap may extend (all the way) around the fluid collection bag in the rolled configuration. The strap may seal to itself when retaining the fluid collection bag in the rolled configuration. Preferably, one end (e.g. the second end) may be configured to seal to another part of the strap. Thus, the fluid collection bag’s size is minimised making it more convenient and discreet to store prior to use.

As mentioned above, the catheter assembly may comprise a pouch and may a packaged catheter assembly. The retaining element may be configured to restrict movement of the fluid collection bag within the pouch, for example, the retaining element may retain the fluid collection bag in a particular part of the pouch. Thus, the fluid collection bag can be more easily accessible to the user when opening the pouch. The retaining element may be configured to (temporarily) attach the fluid collection bag to a part of the pouch, for example a wall of the pouch. The retaining element may be configured to retain the fluid collection bag adjacent to an opening formed in the pouch. Thus, the fluid collection bag is attached to the pouch wall next to the opening which makes it easier to identify and access.

The retaining element may comprise a release mechanism. The release mechanism may be configured to release the retaining element such that the fluid collection bag can be released from the pouch and/or unrolled/unfolded prior to use. The release mechanism may comprise a gripping hole or other tactile element to make it easier to use. Thus, the retaining element can be easily deactivated and the fluid collection bag used.

The release mechanism may comprise a pull-tab. The pull-tab may comprise a tab configured to be pulled by the user to release the retaining element. One end (the second end) of the strap may be the pull-tab. Thus, a tab is easy for the user to grasp and intuitive to use.

The release mechanism may comprise a release marker. The release marker may comprise a logo, marking, a different colour/shade of colour, or different texture/tactile feel than the rest of the fluid collection bag/release mechanism/retaining element. The release marker may be recognisable visually. The release marker may be recognisable through touch. The release marker may be configured to instruct the user how to activate the release mechanism. The release maker may comprise a pullmarker. The pull-marker may be configured to instruct the user to pull the release mechanism/pull-tab in a particular direction, for example, the pull-marker may comprise a directional arrow or point in that direction.

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

The peripheral seal may form one or more edges of the pouch. A folded edge may comprise the fold between the two walls (the first wall and the second wall). All edges other than the folded edge may be formed by the peripheral seal. Preferably, the peripheral seal comprises all edges of the pouch. The peripheral seal may comprise a base, 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 configuration with the front wall in front of the rear wall, the base at the bottom and the upper edge at the top.

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 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 closed 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 pouch may comprise one or more side walls, for example two side walls. The side walls may be configured to allow the front and rear walls to separate. Each side wall may comprise a lateral side of the pouch. The side walls may be elongate in a direction parallel to the length of the pouch. The side walls may be triangular, i.e. substantially triangular. The side walls may extend between the front and rear walls of the pouch. The side walls may extend along the left and/or right lateral edge of the pouch. The side walls may not extend along one or more edges of the pouch, for example the base and/or upper edge of the pouch. Thus, the side walls can be used to increase the internal volume of the pouch while minimising the size of the front and rear walls.

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.

The pouch may contain any one or more of the fluid collection bag and catheter. The fluid collection bag may be provided in a stowed configuration while inside the pouch. Thus, the size of the fluid collection bag is minimised inside the pouch and this assists the user in removing the bag and other elements of the packaged catheter assembly from the pouch.

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 pouch may comprise an interaction region defining a first point of contact for a user of the packaged catheter assembly. The interaction region may facilitate user access to the contents of the pouch. Actuation of the interaction region may create an opening in the pouch. The interaction region may be a break-away region such as a peel-away or tear-away region configured to be at least partially separated from the pouch. The catheter may be withdrawn through the opening. The catheter may be withdrawn through the opening. Before withdrawal of the catheter from the pouch, the opening may comprise a sterile seal. The sterile seal may be broken by actuation of the interaction region, for example by peeling a peel-away region from the pouch.

The break-away region may form a part of the walls of the pouch, for example, the break-away region may form a part of the front wall. Preferably, the break-away region forms a majority of the front wall. The break-away region may be any suitable shape or size, for example, rectangular, circular, ellipsoidal or irregularly shaped. Preferably, the break-away region is the same shape as the pouch, for example rectangular. The break-away region may comprise a base, left lateral edge, right lateral edge and upper edge that form the edges of the interaction region. The edges of the interaction region may correspond to the respective edges of the pouch. The breakaway region may comprise a width between its left lateral edge and right lateral edge. The width of the break-away region may be at least 50%, 60%, 70%, 80% or 90% of the width of the pouch, for example, between 50-100%, 70-90% or 80-90% of the width of the pouch, most preferably the break-away region has a width of 85% of the width of the pouch. The break-away region may comprise a height between its base and upper edge. The height of the break-away region may be at least 50%, 60%, 70%, 80% or 90% the height of the pouch, for example between 50-100%, 60-90% or 70-80% of the height of the pouch, most preferably 75% of the height of the pouch. The break-away region may be positioned centrally with respect to the width and/or height of the pouch. Alternatively, the break-away region may have a different shape to the pouch and may not be positioned centrally with respect to the width and/or height of the pouch. Thus, the break-away region can be configured in many different ways to provide easy access to the contents of the pouch.

The break-away region may comprise rounded edges. Thus, the break-away region has a smoother and less jagged appearance.

The break-away region may formed of the same material as the walls of the pouch. This may ensure that the pouch has a consistent feel to the user and also that one area of the pouch is not weaker than the rest. Of course, in some embodiments, the break-away region may be formed of a different material to the rest of the pouch, for example where certain mechanical properties/tactile feel of the break-away region are desired.

The break-away region may be the same colour, a different shade of colour or a different colour to the rest of the pouch. Preferably, the break-away region is a different shade of colour, or different colour, to the rest of the pouch. This makes it more visually recognisable.

The pouch may comprise an access aperture. The access aperture may be positioned in one wall of the pouch, for example, the front wall. The break-away region may be configured to cover and/or seal the access aperture. The break-away region may be attached to the pouch by any suitable bonding/sealing method, for example chemical adhesives, chemical bonding, ultrasonic bonding, or mechanical bonding. This arrangement is preferred where the break-away region is a peel-away region, as the sealing/bonding method can be selected to allow the peel-away region to be peeled away. The break-away region may be formed from the same piece of material as a wall of the pouch. A line of weakness or tear-line in the pouch may define the break-away region. This arrangement is preferred where the break-away region is a tear-away region, as the tear-away region can be torn away along the line of weakness/tear line. Thus the user to form an opening in the pouch/reveal the access aperture by separating the break-away region from the pouch.

An edge of the break-away region may be both part of the break-away region and part of a wall (e.g. front wall) of the pouch. Thus, a fold-line may be defined at the edge of the break-away region. The break-away region may pivot to allow access to the pouch. The break-away region may be configured to remain connected to the pouch. This reduces the number of items that the user must worry about during use of the catheter assembly which makes it more convenient and easier to use.

The fold-line may correspond to the upper edge of the break-away region, thus the break-away region swings upwards away from the base of the pouch. The fold-line may correspond to the base of the break-away region, thus the break-away region swings down away from the upper edge of the pouch. In some embodiments, the foldline may correspond to a lateral edge of the break-away region allowing the break-away region to provide a door into the pouch. Thus, the break-away region can be flexibly configured to provide access to the pouch in many different ways.

The fluid collection bag may be attached to the break-away region, for example by the retaining element as described above. The break-away region may be configured to remove the fluid collection bag from the pouch during opening of the pouch. This makes it easier to access the fluid collection bag.

The pouch may comprise a tab. The tab may extend from an edge of the pouch/break-away region. The tab may be configured to create an opening in the peripheral seal of the pouch, for example through (partial) separation of the break-away region and pouch. 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 preferably front) wall of the pouch. The tab may be configured to seal to a (rear or preferably 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.

Preferably, one wall comprises the break-away region. A tab may be provided on the break-away region. A tab may extend from an edge of the pouch. The tab may be configured to be separate from the pouch to create an opening in the peripheral seal of the pouch. Advantageously, the tab extends from the pouch and so is easy to grasp by the user. This makes opening the pouch easy even for users with reduced mobility.

The tab may comprise a front opening tab. The front opening tab may be attached to the break-away region. The front opening tab may overlie the pouch and preferably the front opening tab overlies an edge of the pouch. The front opening tab may be smaller an edge of the pouch. Thus, the tab can be easily identified and separated to open the pouch.

The tab may comprise an opening marker. The opening marker may be configured to provide a visual/tactile guide to the user to prompt them to open the pouch. The opening marker may comprise an arrow, or a pointed shape such as a triangle. The opening 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. Preferably, an opening marker is provided on the tab connected to the break-away region. Thus, the pouch is more user friendly.

The tab may extend from an edge of the pouch that corresponds to a frangible portion of the peripheral seal. Thus, the tab is suitably located to ensure the frangible portion breaks when the tab and pouch are separated. The tab may be configured to provide a handling point for the pouch. Thus, the tab can be used to conveniently handle and move the pouch as may be required.

The tab may be configured to allow to the pouch to be closed. This feature may preferably be used in combination with a peripheral seal that is re-sealable. Thus, the tab provides 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 tab may be any suitable size or shape, such as rectangular, square, circular, elliptical, or irregular in shape. Various shapes and sizes of a tab are discussed below but of course each tab may be the same or different shapes.

The tab may extend from the break-away region, preferably the tab may extend from the centre of an edge of the break-away region. The tab may extend from the base or upper edge of the break-away region. The edge of the break-away region may be slanted towards the tab. The tab may span at least 30%, 40%, 50%, 60%, or 70% of the width of the break-away region. The tab may span no more than 80%, 70%, 60%, 50% or 40% of the width of the break-away region. The tab may have a length that is similar to its width. The tab may have any suitable shape, such as rectangular, triangular or semi-circular. Thus, the tab is easily identifiable at the end of the break-away region.

A tab may be curved. Preferably the tab is curved in a direction away from the plane of the pouch. Thus, the tab may naturally bend away from the pouch which makes it easier to grasp and separate the tab from the pouch. A wall of the pouch may curve away from the tab. Thus the pouch bends away from the tab which also makes it easier to grasp and separate the tab from the pouch.

The tab may comprise a gripping element, for example a gripping hole. The gripping hole may provide a grippy surface or feature. The gripping hole may comprise an aperture through the tab. The gripping hole may be any suitable size or shape, for example, rectangular, square, circular, elliptical. In one embodiment, the gripping hole is in the shape of a stadium, that is a rectangle with semicircles replacing two opposite sides. The parallel sides of the gripping hole may be parallel to the base and top of the 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.

An edge (e.g. base or upper edge) of the pouch may comprise a gripping hole, for example a gripping hole. The gripping hole of the pouch may have any one or more of the features of the gripping hold of the tab described above. Preferably, the gripping hole of the pouch has the same size/shape as the gripping hole of the tab. The gripping hole of the tab may be in overlap with the gripping hole of the pouch. Thus, the user can more easily separate the pouch and the tab.

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 pouch. 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 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, for example, a thermoplastic polyurethane (TPU) or low- density polyethylene (LDPE). Under application of a compressive force, the fluid reservoir may configured to break when a threshold compressive force is exceeded. The pouch may comprise a wetting marker. The wetting marker may be on a surface of the pouch. The wetting marker may comprise a region of the pouch that is identifiable to the user, for example through visual and/or tactile feedback. Preferably, the wetting marker may be at least visually recognisable, for example a different colour, or pattern, to the pouch. The wetting marker may be the opening marker of the tab as discussed above. 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 pouch may be divided into first and second compartments. The fluid reservoir and at least a portion of the catheter may be arranged in the first compartment. The fluid collection bag may be connected to the catheter and arranged in the second compartment. The fluid reservoir may be configured to release the wetting fluid into the first compartment to wet the catheter. The pouch may comprise an interaction region operable by a user to form an opening in the pouch allowing access to at least the second compartment

According to a third aspect of the invention, there is provided a packaged catheter assembly comprising a catheter, a fluid reservoir comprising wetting fluid, and a pouch, wherein: the pouch is divided into first and second compartments; the fluid reservoir and at least a portion of the catheter are arranged in the first compartment; and a fluid collection bag is connected to the catheter and is arranged in the second compartment; and the fluid reservoir is configured to release the wetting fluid into the first compartment to wet the catheter; and the pouch comprises an interaction region operable by a user to form an opening in the pouch allowing access to at least the second compartment.

With this arrangement, a substantial amount, if not all, of the wetting fluid remains in the first compartment upon release of the wetting fluid from the fluid reservoir. Advantageously, this means that the fluid collection bag remains dry and free from wetting fluid prior to use. Beneficially, for the user, in particular for users with limited dexterity, this means handling and re-packaging of the bag during and after use is considerably easier than if the bag is wetted with wetting fluid.

Further advantageously, the wetting fluid is retained in the first compartment comprising at least a portion of the catheter and is not distributed amongst the components in the second compartment of the pouch. This may be the case even where the pouch is vigorously shaken to distribute the wetting fluid within it. This means that all of the wetting fluid, or at least a substantial amount of the wetting fluid, is available to wet the catheter prior to use, as is intended. Beneficially, this arrangement ensures that there is sufficient wetting fluid to activate the whole catheter surface, therefore, preventing discomfort and injury during use.

The opening may be provided in the pouch by separating the break-away region from the pouch to reveal the access aperture as described above.

The opening may allow access to the first compartment. Access to the first compartment may be via the second compartment. Beneficially, this means that the fluid collection bag is withdrawn from the pouch through the opening before the catheter. Thus, the user does not need to touch the wetted catheter before touching the fluid collection bag, therefore, preventing accidental wetting of the fluid collection bag during withdrawal of the components from the pouch.

The pouch may comprise an internal wall. The internal wall may define the first and second compartments. The first compartment may comprise the rear wall and internal wall. The second compartment may comprise the front wall and internal wall. The internal wall may be the same material as the front wall and or rear wall of the pouch. The internal wall may be fluid impermeable. Thus, the compartments can be simply defined by including an additional wall within the pouch and further the wall prevents or at least inhibits liquid from passing between the compartments.

The internal wall may be arranged to inhibit wetting fluid from the fluid reservoir wetting the second compartment and the fluid collection bag arranged therein. Advantageously, this means that the fluid collection bag remains dry prior to use. Beneficially, for the user, in particular for users with limited dexterity, this means handling and re-packaging of the bag during and after use is considerably easier than if the bag is wetted with wetting fluid.

Moreover, this arrangement allows a user to vigorously shake the pouch after wetting fluid is released from the fluid reservoir, therefore, ensuring distribution of wetting fluid to the catheter without the risk of wetting the fluid collection bag. Beneficially, this ensures that there is sufficient wetting fluid to activate the whole catheter surface, therefore, preventing, or at least significantly reducing, discomfort and injury during use. The internal wall may be attached to the pouch by the peripheral seal. The internal wall may span the entire width of the pouch. The internal wall may span a majority of the height of the pouch, for example at least 50%, 60%, 70%, 80%, or 90% of the height of the pouch, most preferably the internal wall spans 80% of the height of the pouch. The internal wall may extend from the base of the pouch. Each compartment may be planar. The first and second compartment may be arranged parallel to one another. Thus, the internal wall ensures that both the first and second compartments are adequately sized and further the pouch may be sealed with the internal wall within by forming the peripheral seal in a single step.

The internal wall may comprise a separating edge. The separating edge may not form part of the peripheral seal. Access between the first and second compartments may be provided at or adjacent to the separating edge. The separating edge may be a free edge in that it is not sealed to either the front or rear walls of the pouch. In such embodiments, access may be provided between the first and second compartments at all points along the separating edge.

The separating edge may comprise a cut-away region. The cut-away region may be cut into the internal wall/separating edge. The cut-away region may be centrally located across the width of the pouch. The cut-away region may have a size which is substantially equal to, or greater than, the diameter of the catheter. The catheter may be arranged such that before withdrawal of the catheter from the pouch, a portion of the catheter (preferably a portion at or adjacent the distal end) is positioned within the cutaway region. Preferably, the cut-away region may have a size which is substantially equal to, or greater than, the diameter of the catheter tube, and that before withdrawal of the catheter from the pouch, the catheter tube is positioned within the cut-away region. The cut-away region may span at least 10%, 20%, 30%, 40%, 50%, or 60% of the width of the pouch and/or break-away region. The cut-away region may have any suitable shape or size, for example, semi-circular, triangular, rectangular, or irregularly shaped. In one example, the cut away region is trapezoid. The cut-away region may be an inverted (isosceles) trapezoid. The cut-away region may have an aspect ratio (length: width) of 1:2. Advantageously, this arrangement provides for a connection between the fluid collection bag and the catheter which does not impact the ability of the pouch to retain the wetting fluid in the first compartment. Thus, the fluid collection bag remains dry prior to use. Moreover, typically, a catheter is of sufficient length such that the distal end of the catheter is not required to be inserted into the body during use. Thus, in embodiments where a portion of the distal end of the catheter tube is positioned in the cut-away region, it is not essential for this portion of the catheter to be wetted by the wetting fluid. As such, the catheter tube can be positioned within the cut-away region without having a detrimental effect on the use of the catheter.

The separating edge may be sealed along part of its length to the front or rear wall (preferably rear wall). Thus, access is only provided along a part of the separating edge. Access between the first and second compartments may be provided (solely) by the cut-away region. This can help to control and restrict access between the compartments.

The opening/access aperture may be provided in a wall of the pouch that defines the second compartment, e.g. the front wall. The break-away region may form part of the second compartment. Thus, when the break-away region is separated from the pouch, access to the second compartment is provided.

The catheter may be arranged in the first compartment in any suitable configuration. The catheter may be arranged in a curved/coiled configuration. Thus, the catheter is less likely to suffer damage from kinking etc.

The catheter may comprise a sleeve configured to enclose part of the catheter. Preferably, the sleeve is configured to enclose only part of the length of the catheter. The sleeve may be tubular. The sleeve may comprise a flexible plastics material. The sleeve may comprise perforations about its circumference. The sleeve may comprise a line of weakness (provided by the perforations). The sleeve may be configured to separate into two tubular handling elements. Thus, the sleeve is cheap and easy to produce and can be easily manipulated by the user during use.

The tubular sleeve may be provided in the cut-away region of the internal wall. Thus, the sleeve provides a plug which prevents liquid from inadvertently passing along the outside of the catheter and through the cut-away region into the second compartment during wetting.

The sleeve may comprise a handling element. The handling element may project away from the catheter in a plane parallel to the axis of the catheter.

Thus, according to a fourth aspect of the present invention there is provided a catheter assembly comprising a catheter having a proximal end for insertion into the body and a distal end, and a sleeve configured to enclose only part of the length of the catheter, wherein the sleeve comprises a handling element projecting away from the catheter in a plane parallel to the axis of the catheter.

Advantageously, the provision of a handling element that projects away in a plane parallel to the axis of the catheter is more easy for the user to handle, especially where they have reduced dexterity. The projection of the handling element provides more space on the handling element for assistive features that help the user in manipulating the catheter without touching it. Also, as the handling element needs to only project in one plane, it can be packaged into a 2D packaging without substantially increasing the size of the package.

Accordingly, in one embodiment, there is provided a packaged catheter assembly comprising a pouch and the catheter assembly of the fourth aspect, wherein the pouch is configured to contain the catheter assembly within it.

Accordingly, in one embodiment, there is provided a packaged catheter assembly comprising a pouch and a catheter assembly comprising a catheter having a proximal end for insertion into the body and a distal end, and a sleeve configured to enclose only part of the length of the catheter, wherein the sleeve comprises a handling element projecting away from the catheter in a plane parallel to the axis of the catheter, wherein the pouch is configured to contain the catheter assembly within it.

The handling element may extend in a plane which contains the axis of the catheter. Thus, the handling element extends in a 2D plane from the side of the catheter which means it can be more space efficient while providing direct and intuitive handling of the catheter itself. The handling element may extend from one side of the catheter. The handling element may extend from only one side of the catheter. Thus, the handling element can allow the user to visualise the position of the catheter more easily as they are only holding it from one side and so the other side is visible.

Accordingly in one embodiment there is provided a catheter assembly comprising a catheter having a proximal end for insertion into the body and a distal end, and a sleeve configured to enclose only part of the length of the catheter, wherein the sleeve comprises a handling element projecting away from the catheter in a plane parallel to the axis of the catheter, wherein the handling element extends from only one side of the catheter.

The handling element may have a thickness measured in a direction perpendicular to the plane in which the handling element extends from the catheter. The thickness of the handling element may be no more than three times, two times or one and a half times the diameter of the catheter. Thus, the handling element does substantially increase the thickness of any packaging required to package the catheter/catheter assembly.

The handling element may have a length in a direction parallel to the axis of the catheter. The length of the handling element may be no more than 8 cm, 7 cm, 6 cm, 5 cm or 4 cm. The length of the handling element may be at least 3 cm, 4 cm, 5 cm, 6 cm or 7 cm. The handling element spans a minority of the length of the catheter. The handling element may be more rigid than the catheter. This helps to ensure that the catheter can be adequately wetted by wetting fluid prior to use and also allows the handling element to be relatively rigid compared to the catheter (which makes for easier handling of the catheter) without excessively restricting the curvature of the catheter. This is beneficial as restriction of the curvature of the catheter can lead to damage due to excessive curvature and kinks in other parts of the catheter.

The handling element may have a width in a direction perpendicular to its thickness and length. The width of the handling element may be at least 1/4, 1/3, or 1/2 the length of the handling element. Consequently, the handling element is planar. The handling element may comprise a bore through which the catheter extends. A internal diameter of the bore may be at least lx, 1.5x or 2x the diameter of the catheter. The bore may allow the handling element to be moved along the length of the catheter. The bore may be sized to fit over an inlet of the fluid collection bag. Thus, the handling element can be used to manipulate the catheter along its entire length.

The handling element may comprise a projection that is the part of the handling element that extends away from the catheter. The projection may be any suitable shape, for example rectangular, triangular, semi-circular or irregularly shaped. Preferably, the projection is rectangular. The projection may have rounded edges. Thus, the handling element is more comfortable for the user to grasp.

The handling element may comprise a gripping element configured to allow the user to grasp the handling element. The gripping element may comprise a gripping hole as described below, or an otherwise easily gripped feature such as a series of ridges or high friction surface. The gripping hole may be any suitable shape, for example, rectangular, square, triangular, circular or elliptical. The gripping hole may be stadium shaped, with its length parallel to the length of the handling element. The gripping hole may be centrally positioned on the projection. The gripping hole may correspond to a majority of the surface of the projection. The projection may define the edges of the gripping hole. Thus, the gripping hole provides the user with a convenient way to handle the catheter via the handling element.

The handling element may be configured to be retained close or at the fluid collection bag/distal end of the catheter. The handling element may engage the inlet of the fluid collection bag and/or distal end of the catheter. The bore may engage the inlet of the fluid collection bag and/or distal end of the catheter. Thus, the handling element can be retained in a position that is easy for the user to grasp and also that ensures the proximal end of the catheter is free from the handling element and is able to be wetted by wetting fluid.

Accordingly, in one embodiment, there is provided a catheter assembly comprising a catheter having a proximal end for insertion into the body and a distal end, a fluid collection bag coupled to the catheter such that it is configured to collect and retain fluid released from the body through the catheter and a sleeve configured to enclose only part of the length of the catheter, wherein the sleeve comprises a handling element projecting away from the catheter in a plane parallel to the axis of the catheter and the fluid collection bag comprises an inlet, wherein the handling element engages the inlet of the fluid collection bag to retain the handling element close to the fluid collection bag.

The sleeve may comprise two or more handling elements. Each handling element may comprise the any one or more of the features of the handling element described above. Each handling element may be identical. Each handling element may be different. Preferably, the sleeve comprises two handling elements. Thus, the user has two different handling elements and can therefore do more complex manipulation of the catheter without risking touching the catheter surface directly.

The two or more handling sleeve elements may be joined together. The two or more handling sleeve elements may be temporarily sealed together, for example through a tack weld, temporary adhesive or mechanical fastener such as hook and hook or hook and loop type fasteners. The two or more handling sleeve elements may be configured to be separated. This can provide more control on the position of the handling elements with respect to each other prior to use and make is easier for the user to locate them both.

The two or more handling sleeve elements may be provided separately (and not connected/joined together). Thus, the user does not need to separate them to use them independently, this can be more suitable for users with reduced dexterity or strength.

The, or each, handling element may be moveable along the length of the catheter. The two or more handling elements may be moveable along the length of the catheter, preferably independently of one another. Thus, the user can more accurately move the catheter during use through two independently moveable handling elements.

Accordingly, in one embodiment, there is provided a catheter assembly comprising a catheter having a proximal end for insertion into the body and a distal end, and a sleeve configured to enclose only part of the length of the catheter, wherein the sleeve comprises two or more handling elements each projecting away from the catheter in a plane parallel to the axis of the catheter, wherein the two or more handling elements are each independently movable along the length of the catheter.

The handling elements/sleeve may be liquid impermeable. The sleeve may comprise a thermoplastic polyurethane (TPU) or low-density polyethylene (LDPE).

The sleeve/handling element may be provided in the second compartment of the pouch. Thus, the sleeve/handling sleeve element is not likely to be wetted during wetting of the catheter in the first compartment and so is easier and more pleasant for the user to handle.

The catheter assemblies/packaged catheter assemblies of the first to fourth aspects may include any one or more features of a catheter assembly /packaged catheter assembly as defined in general/broad terms, or according to any other of the first to fourth aspects set out above. The catheter assemblies/packaged catheter assemblies of the first to fourth aspects may comprise any of the optional features of the others of the first to fourth 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 a packaged catheter assembly according to the third aspect comprising a packaged catheter assembly comprising a catheter, a fluid reservoir comprising wetting fluid, and a pouch, wherein: the pouch is divided into first and second compartments; the fluid reservoir and at least a portion of the catheter are arranged in the first compartment; and a fluid collection bag is connected to the catheter and is arranged in the second compartment; and the fluid reservoir is configured to release the wetting fluid into the first compartment to wet the catheter; and the pouch comprises an interaction region operable by a user to form an opening in the pouch allowing access to at least the second compartment, further comprising a fluid collection bag comprising a finger hole as described in relation to the first aspect.

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

The method of the fifth aspect of the invention may be a method of manufacturing the fluid collection bag of the first aspect of the invention, which, of course, may include any optional feature outlined above.

The method may comprise forming a finger hole in the bag. The finger hole may be formed at a point distal from the outlet, for example on a different edge of the bag from the outlet. Thus, the finger hole can be more easily use to handle the bag and direct fluid flow out of the outlet.

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

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

According to an sixth aspect of the present invention there is provided a method of manufacturing a catheter assembly the method comprising providing a catheter and a fluid collection bag comprising a retaining element, wherein the retaining element is configured to receive at least part of the catheter to stow the catheter after use.

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

According to a seventh aspect of the present invention there is provided a method of manufacturing a packaged catheter assembly comprising the steps of providing a catheter, a fluid reservoir comprising wetting fluid, a fluid collection bag and a pouch divided into first and second compartments; arranging the fluid reservoir and at least a portion of the catheter in the first compartment; connecting the fluid collection bag to the catheter; and arranging the fluid connection bag in the second compartment; wherein the pouch is configured to provide an opening allowing access to at least the second compartment, and through which the catheter may be withdrawn.

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

The method may comprise providing an internal wall in the pouch. The internal wall may divide the pouch into the first and second compartments. The method may comprise sealing a separating edge of the internal wall to a wall (e.g. front or rear) of the pouch. The method may comprise providing a cut-away region in the separating edge. The method may comprise arranging the catheter in the cut-away region.

According to an eighth aspect of the present invention, there is provided a method of manufacturing a catheter assembly, the method comprising providing a catheter having a proximal end for insertion into the body and a distal end, and a sleeve configured to enclose only part of the length of the catheter, wherein the sleeve comprises a handling element projecting away from the catheter in a plane parallel to the axis of the catheter.

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

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

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

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

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

The method may comprise rotating the bag by grasping one or more finger holes (disposed at the edges of the bag). The method may comprise grasping a finger hole disposed on an edge of the bag distal from the outlet. Thus, the bag can be rotated in a controlled manner using the finger holes and while reducing the risk of spillages from the outlet.

The method may comprise providing a catheter and introducing the catheter by its proximal end into the urethra. The method may comprise allowing fluid to pass from the body and into the fluid collection bag via the inlet and catheter. Fluid may pass from the catheter into the bag before an opening is formed in the bag with the outlet. Consequently, the method may be a method of using a catheter assembly.

According to a tenth aspect of the present invention there is provided a method of stowing a catheter assembly after use, the catheter assembly comprising a catheter and a fluid collection bag comprising a retaining element, the method comprising using the retaining element to receive at least part of the catheter and stow the catheter after use.

The method of the tenth aspect of the invention may be a method of stowing a 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 coiling the catheter in order to stow it. The method may comprise arranging the catheter against the fluid collection bag. The method may comprise retaining the catheter against the fluid collection bag and using the retaining element.

The method may comprise folding an upper region of the fluid collection bag. The method may comprise retaining the fluid collection bag in a folded configuration using the retaining element.

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 catheter assembly.

According to a eleventh aspect of the present invention there is provided a method of unpackaging a packaged catheter assembly, the packaged catheter assembly comprising a catheter, a fluid reservoir comprising wetting fluid, and a pouch, wherein: the pouch is divided into first and second compartments; the fluid reservoir and at least a portion of the catheter are arranged in the first compartment; and a fluid collection bag is connected to the catheter and arranged in the second compartment; the method comprising releasing the wetting fluid into the first compartment so as to wet the catheter arranged therein; forming an opening in the pouch allowing access to at least the second compartment and removing the catheter from the pouch, optionally via the second compartment.

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 method may comprise removing the fluid collection bag from the pouch before removing the catheter.

The method may comprise rupturing/bursting/opening the fluid reservoir within the pouch.

The method may comprise locating the fluid reservoir within the pouch via a window in the pouch and/or a wetting marker disposed on 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.

According to a twelfth aspect of the present invention, there is provided a method of handling a catheter assembly, the catheter assembly comprising a catheter having a proximal end for insertion into the body and a distal end, and a sleeve configured to enclose only part of the length of the catheter, wherein the sleeve comprises a handling element projecting away from the catheter in a plane parallel to the axis of the catheter, the method comprising grasping the handling element.

The method of the twelfth aspect of the invention may be a method of handling the 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 grasping a gripping hole of the handling element.

The method may comprise separating two or more handling elements. The method may comprise moving the two or more handling elements independently of one another.

Accordingly, in one embodiment there is provided a method of handling a catheter assembly, the catheter assembly comprising a catheter having a proximal end for insertion into the body and a distal end, and a sleeve configured to enclose only part of the length of the catheter, wherein the sleeve comprises two or more handling elements each projecting away from the catheter in a plane parallel to the axis of the catheter, the method comprising grasping each handling element, separating the two or more handling elements and moving the two or more handling elements independently of one another along the length of the catheter.

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 through the catheter. Consequently, the method may be a method of using a catheter assembly. 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, a 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 an embodiment of a packaged catheter assembly where the pouch is in the closed configuration;

Figure 2 is a cross-sectional view of the packaged catheter assembly of Figure 1;

Figure 3 is a front view of the packaged catheter assembly of Figure 1 where the pouch is in the open configuration and the fluid collection bag has been removed from the pouch;

Figure 4 is a front view of the fluid collection bag of the packaged catheter assembly of Figure 1;

Figure 5 is a front view of fluid collection bag of the packaged catheter assembly of Figure 1 where the neck has been folded;

Figure 6 is a front view fluid collection bag of the packaged catheter assembly of Figure 1 where the outlet has been partially opened; and

Figure 7 is a front view of fluid collection bag of the packaged catheter assembly of Figure 1 where the outlet has been completely opened. Referring to Figures 1-7, an embodiment of a packaged catheter assembly 1000 is shown.

The assembly 1000 comprises a fluid collection bag 1010, a catheter 1020, a sleeve 1030, a fluid reservoir 1040 and a pouch 1070 containing the fluid collection bag 1010, catheter 1020, sleeve 1030 and fluid reservoir 1040. The catheter 1020 has a proximal end 1021 for insertion into the body and a distal end 1022, and the fluid collection bag 1010 is arranged to receive fluid from the distal end 1022 of the catheter 1020.

In this embodiment, the catheter 1020 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.

The pouch 1070 is formed from a front wall 1071a and rear wall 1071b of identical shape and size, and a peripheral seal joining the periphery of the walls to form the pouch 1070 and containing its contents (i.e. the closed catheter assembly and fluid reservoir 1040).

The peripheral seal defines a base 1072a, a left lateral edge 1072b, a right lateral edge 1072c and an upper edge 1072d of the pouch 1070. The left lateral edge 1072b and right lateral edge 1072c being defined as the left and right sides of the pouch 1700 when viewing the pouch 1070 with the rear wall 1071b behind the front wall 1071a, the base 1072a at the bottom of the pouch 1070 and the upper edge 1072d at the top of the pouch 1070. The peripheral seal thus defines a pouch 1070 that is generally rectangular and suitably has a width between the lateral edges of between 60-110 mm, preferably 90-110 mm, for example about 100mm, and a height from the base 1072a to the upper edge 1072d of between 100 to 250 mm, preferably 120 to 140 mm, for example about 130 mm. The base 1072a defines the bottom of the pouch 1070 in use, and the upper edge 1072d the top. However, in other embodiments alternative shapes and sizes could be conceived, such as elliptical or circular walls forming correspondingly shaped pouches, or even a tubular pouch or pouch with more than two walls, e.g. a prism or other polygon. The peripheral seal may be formed from any suitable bonding/sealing methods such as chemical adhesives, chemical bonding, ultrasonic bonding, or mechanical bonding. In alternative embodiments, the pouch 1070 may be formed from a single piece of material. The pouch may then be formed by folding this single piece of material along a pouch fold line to form the walls. In addition, in some embodiments any number of folds may be used to form the pouch 1070. For example, none of the edges may comprise a fold (as in the illustrated example), one edge may comprise a fold, or two or more of the edges may comprise a fold.

In this embodiment, the pouch 1070 is formed from an opaque material and as such provides a discrete package for its contents which can make the user more comfortable in carrying the packaged catheter assembly 1000 in day-to-day life. In addition, the exterior of the pouch 1070 may have a textured or printed appearance, for example a matte appearance, and feel to reduce the impression that it is a medical device.

In this embodiment, the pouch 1070 also comprises an interaction region which forms a majority of the front wall 1071a of the pouch 1070. The interaction region is used to provide access to the pouch through/near to the upper edge 1072d. In this embodiment, the interaction region comprises a rectangular break-away region, in the form of a peel-away region 1074. The peel-away region 1074 comprises a base 1074a, left lateral edge 1074b, right lateral edge 1074c and upper edge 1074d that correspond to the base 1072a, left lateral edge 1072b, right lateral edge 1072c and upper edge 1072d of the pouch 1070 respectively. Consequently, the peel-away region 1074 comprises a width between its left lateral edge 1074b and right lateral edge 1074c and a height between its base 1074a and upper edge 1074d. The width of the peel-away region 1074 is between 50-100%, 70-90% or most preferably 80-90% of the width of the pouch 1070, for example 85% of the width of the pouch 1070. The height of the peel-away region 1074 is between 50-100%, 60-90% or most preferably 70-80% of the height of the pouch 1070, for example 75% of the height of the pouch 1070. In this embodiment, the peel-away region 1074 is positioned centrally with respect to the width and height of the pouch 1070. In this embodiment, the comers of the peel-away region 1074 are rounded to provide a smoother and less jagged appearance to the peel-away region 1074. In other embodiments, the comers may not be rounded.

In other embodiments, the tear-away region may have a different shape or size as required by the shape/size of the pouch 1070 or the contents of the pouch 1070. It may also not be positioned centrally with respect to the width and/or height of the pouch 1070, for example it may be positioned closer to one edge of the pouch than another.

In this embodiment, the peel-away region 1074 is formed from the same material as the front wall 1071a of the pouch 1070 but is a different shade of colour to the front wall 1071a, this gives the pouch 1070 a more continuous feel but makes the peel-away region visually recognisable to the user. In other embodiments, the breakaway region may be formed of a different material.

In this embodiment, the front wall 1071a of the pouch 1070 comprises an access aperture 1078a in a position corresponding to the peel-away region 1074. Around a periphery 1078b of the aperture 1078a, the peel-away region 1074 is attached to the front wall 1071a of the pouch 1070 by a frangible adhesive. This allows the user to form an opening in the pouch 1070 by peeling the peel-away region 1074 away from the front wall 1071a and breaking the frangible adhesive positioned at the periphery 1078b of the aperture 1078a.

In other embodiments the break-away region may be attached to the front wall by any suitable bonding/sealing method, for example chemical adhesives, chemical bonding, ultrasonic bonding, or mechanical bonding, such as hook-and-hook or hook- and-loop fasteners. Alternatively, the break-away region may be formed from the same piece of material as the front wall 1071a. In such (tear-away) embodiments, a line of weakness or tear-line in the front wall may define the tear-away region and allow the user to form an opening in the pouch by separating the tear-away region from the front wall.

In this embodiment, the base 1074a of the peel-away region 1074 is configured not to separate from the front wall 1071a, this prevents the peel-away region 1074 from separating from the pouch 1070 and reduces the number of items that the user must worry about during use of the catheter assembly 1000. In other embodiments, the break-away region may be configured to fully separate from the pouch 1070 - for example to allow for easier access to the contents of the pouch 1070.

In this embodiment, the peel-away region 1074 comprises a front opening tab 1075. The front opening tab 1075 projects from the upper edge 1074d of the peel-away region 1074. The front opening tab 1075 is rectangular in shape with rounded corners and has a width that spans approximately 50% of the width of the upper edge 1074d. The front opening tab 1075 has a height that is approximately half its width

In this embodiment, the front opening tab 1075 is not adhered to the front wall 1071a of the pouch 1070. The front opening tab 1075 in this embodiment is curved away from the plane of the pouch 1070. This makes it easier for a user to grasp the front opening tab 1075 and consequently the peel-away region 1074.

In this embodiment, the tab 1075 overlaps the upper edge 1072d of the pouch 1070. The upper edge 1072d extends beyond the lateral edges of the front tab 1075 as upper edge 1072d extends across the full width of the pouch 1070 whereas the front tab 1075 does not. This helps the user to identify the tab 1075 and separate it from the pouch 1070.

The tab 1075 and upper edge 1072d of the pouch 1070 also each comprise a gripping element in the form of a gripping hole 1077. Each gripping hole 1077 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 1077 are parallel to the upper edge 1072d of the pouch 1070 and form apertures which allow the user to easily grasp the tab 1075 and pouch 1070. Of course alternative shapes of gripping hole can be readily imagined.

As described above, the tab 1075 allows the user to handle the catheter assembly 1000 more easily and provides a gripping point to allow the user to open the pouch 1070 by separating the peel-away region 1074 from the pouch 1070. The gripping holes 1077 can also be used to hang the catheter assembly 1000 for example when displayed in a shop for purchase. In this embodiment, the pouch 1070 comprises a first compartment 1081 and a second compartment 1082 separated by an internal wall 1083. The internal wall 1083 comprises a fluid impermeable material that is the same as the material of the front wall 1071a and rear wall 1071b. The internal wall 1083 spans the entire width of the pouch 1070 from the left lateral edge 1072b to the right lateral edge 1072c. The internal wall 1083 spans from the base 1072a of the pouch 1070 up approximately 70-90% of the height of the pouch 1070 and most preferably 80% of the height of the pouch 1070. Consequently, an upper (separating) edge 1084 of the internal wall 1083 is revealed when the peel-away region 1074 is at least partially removed from the pouch 1070. The internal wall 1083 is sealed to the pouch 1070 by the peripheral seal which, in this embodiment, seals together the front wall 1071a, internal wall 1083 and rear wall 1071b.

In this embodiment, the first compartment is defined by the rear wall 1071b and internal wall 1083, and the second compartment is defined by the internal wall 1083 and the front wall 1071a. Thus, the first and second compartments 1081, 1082 comprise two parallel and planar compartments with access provided between them adjacent to the upper edge 1072d of the pouch 1070.

In this embodiment, the internal wall 1083 comprises a cut-away region 1085 cut into the upper edge 1084 of the internal wall 1083. The cut-away region 1085 is centrally located across the width of the pouch 1070 and spans approximately 50% of the width of the peel-away region 1074. The cut-away region 1085 has an inverted isosceles trapezoid shape with a height approximately half its width and legs at either end angled at approximately 70 degrees with respect to the upper edge 1084 of the internal wall 1083. The cut-away region 1085 thereby allows for easier access between the first compartment 1081 and second compartment 1082 towards the centre of the upper edge 1084 of the internal wall 1083. Of course, in other embodiments the cutaway region 1085 may have any suitable shape, such as rectangular, triangular, circular, semi-circular, ellipsoidal or irregularly shaped.

In this embodiment, the fluid reservoir 1040 is configured to retain a wetting fluid and release wetting fluid to activate the surface of the catheter 1020. In this embodiment, the wetting fluid is water and interacts with the hydrophilic surface of the catheter 1020 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. oil-based) depending on the catheter’s surface properties.

In this embodiment, the fluid reservoir 1040 comprises a burstable rectangular sachet positioned within the first compartment 1081 of the pouch 1070 adjacent to the base 1072a of the pouch 1070. The user can release wetting fluid held by the fluid reservoir 1040 by compressing the fluid reservoir 1040, for example by pinching it between their fingers. The user can advantageously do this while the fluid reservoir 1040 is contained within the pouch 1070 as described in more detail below. To facilitate the user in activating the fluid reservoir 1040, the pouch 1070 comprises a wetting marker 1042. The wetting marker 1042 comprises a region of the pouch 1070 that is a different colour or texture to the rest of the pouch 1070 to allow the user to easily identify the position of the fluid reservoir 1040 and where to press to activate it and release wetting fluid into the pouch 1070. In this embodiment, the wetting marker 1042 is disposed on the peel-away region 1074. In other embodiments, the fluid reservoir 1040 may be configured to release wetting fluid through a different means, for example by twisting or bursting the fluid reservoir in a different way.

In this embodiment, the fluid collection bag 1010 comprises a front panel 1011, a rear panel of identical shape and size (not shown), and a peripheral bond joining the periphery of the panels to form the bag 1010. The peripheral bond defines a base 1012, a right lateral edge 1013, a left lateral edge 1014 and an upper edge 1015. The right lateral edge 1013 and left lateral edge 1014 being defined as the right and left sides of the bag 1010 when viewing the bag 1010 with the rear panel behind the front panel 1011, the base 1012 at the bottom of the bag 1010 and the upper edge 1015 at the top of the bag 1010. The peripheral bond thus defines a bag 1010 that is generally rectangular and suitably has a width between the lateral edges of between 10 and 20 cm, and most preferably between 12 and 15 cm, and a height from the base 1012 to the upper edge 1015 of between 25 and 40 cm, 30 and 35 cm, or most preferably 33 and 35 cm. The bag 1010 is thus configured to hold at least 700 ml of fluid released from the user through the catheter safely. The base 1012 defines the bottom of the bag 1010 in use, and the upper edge 1015 the top. However, in other embodiments alternative shapes and sizes could be conceived, such as elliptical or circular panels forming correspondingly shaped bags, or even a tubular bag or bag with more than two panels, e.g. a prism or other polygon.

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

In this embodiment, the corners of the peripheral bond at either end of the left lateral edge 1014 each comprise finger holes 1016 to allow the bag 1010 to be easily handled by a user. Where the left lateral edge 1014 meets the base 1012, the peripheral bond truncates the corner of the bag 1010 to accommodate the finger hole 1016, and where the left lateral edge 1014 meets the upper edge 1015, the peripheral bond forms a square projecting into the interior of the bag 1010 with the finger hole 1016 at its centre. In other embodiments, the finger holes 1016 may comprise a series of ridges, or otherwise easily gripped surface or feature to allow the user to easily handle the bag 1010. In addition, there may be different numbers of finger holes 1016, such as only one or more than two, and they may be placed in different locations on the bag 1010.

In this embodiment, the upper edge 1015 of peripheral bond comprises a neck 1050 which spans the middle 50% of the length of the upper edge 1015. In other embodiments, it may be located a different point on the upper edge 1015 or peripheral bond, such as on the left or right lateral edges 1014, 1013, or base 1012, and may have a different size in relation to the rest of the bag 1000 or edge in which it is situated. The neck 1050 projects out from the plane of the bag 1010. The neck 1050 is triangular and comprises a left sloped edge 1051 and a right sloped edge 1052 which project from the upper edge 1015 and converge at an inlet 1053. The inlet 1053 is connected to the catheter 1020 and is configured to received fluid from the catheter 1020 as described below.

In this embodiment, the upper edge 1015 also comprises an outlet 1060 arranged between the neck 1050 and the right lateral edge 1013. The outlet 1060 comprises a rectangular spout 1061 that projects from the upper edge 1015 the same distance as the inlet 1053. The outlet 1060 also comprises a pull-ring 1062 attached to the spout 1061 and disposed between the spout 1061 and neck 1050. The pull-ring 1062 has the shape of a right-angled triangle, with two perpendicular sides and a hypotenuse 1063. The hypotenuse 1063 is parallel and adjacent to the right sloped edge 1052 of the neck 1050. In other embodiments, the pull-ring 1062 may be any suitable shape or size - such as circular, rectangular or square. This helps to protect the neck 1050, inlet 1053 and outlet 1060 as they project out from the fluid collection bag 1010 together without significant gaps between them.

The outlet 1060 also comprises a point of weakness, which in this embodiment is a notch 1064 in the peripheral bond at the point where the spout 1061 meets the right lateral edge 1013. This helps ensure that the opening 1016 is formed cleanly and does not propagate down the right lateral edge 1013 of the pouch. In other embodiments, the outlet may comprise a tear line which comprises a weakened region of the outlet 1016. The notch 1064 may be positioned at an end of the tear line and as such, the tear line further assists with forming the opening 1016. The tear line may be formed by any suitable means, such as laser scoring.

In this embodiment, the fluid collection bag 1010 also comprises a retaining element in the form of a pocket 1017. The pocket 1017 is configured to receive all or part of the length of the catheter 1020 in order to stow the catheter 1020 after use. The pocket 1017 comprises a flexible sheet material, for example, the same material as is used to construct the front/rear panels of the fluid collection bag 1010. The pocket 1017 spans the entire width of the fluid collection bag 1010 and extends from the base 1012 of the bag 1010 up approximately 50-80% of the height of the bag 1010, for example 60% of the height. Thus, the catheter 1020 (and optionally also the sleeve 1030) can be stowed in the pocket 1017 after use, for example using the sleeve 1030. Advantageously, this reduces the likelihood of the user touching the catheter 1020 directly which may be unhygienic and also makes the used catheter 1020 easier to dispose of.

In this embodiment, the distal end 1022 of the catheter 1020 is in fluid communication with the bag 1010 via the inlet 1053.

In this embodiment, the fluid collection bag 1010 is provided in a stowed folded configuration and in a different compartment as the fluid reservoir 1040, consequently, the fluid collection bag 1010 is provided in the second compartment 1082. The inlet 1053 is positioned closer to the cut-away region 1085 and upper edge 1084 of the internal wall 1083 than the rest of the stowed fluid collection bag 1010 and the catheter 1020 extends from the inlet 1053 between the upper edge 1084 of the internal wall 1083 and upper edge 1072d of the pouch 1070 into the first compartment 1081.

The position and configuration of the catheter 1020 in the first compartment 1081 is not particularly limited so long as it is not curved to the extent that damage to the catheter is likely, for example from kinking. In this embodiment, the catheter 1020 is arranged within the first compartment 1081 in a curved/coiled configuration, this helps ensure that the catheter 1020 is not excessively curved and minimises risk of damage.

In this embodiment, the sleeve 1030 comprises two identical handling elements 1031. Each handling element 1031 comprises a bore along its length through which the catheter 1020 extends and which allows the handling element 1031 to be moved along the length of the catheter 1020. Each handling element 1031 is approximately 2- 8 cm in length, preferably 3-7 cm, for example 5 cm in length. Consequently, each handling element 1031 and both handling elements 1031 together span a minority of the length of the catheter 1020. This leaves the majority of the catheter 1020 uncovered and as such easily wetted by wetting fluid released from the fluid reservoir 1040 as described below.

In this embodiment, each handling element 1031 projects away from the catheter 1020 in a plane parallel to the axis of the catheter 1020, and in a plane through which the catheter 1020 extends. In this embodiment, each handling element projects away in only one direction. Each handling element 1031 comprises a planar and rectangular projection 1032 with rounded edges distal from the catheter 1020. Each handling element 1031 comprises a width in a direction perpendicular to its length (and thickness, see below) and parallel to the direction in which it extends from the catheter 1020). The width of each handling element is about 1/2 the length of each handling element. This allows each handling element 1031 to be more easily grasped by the user and used to move and handle the catheter 1020 without touching the catheter 1020 directly. Of course, in other embodiments, each handling element 1031 may project away from the catheter 1020 in multiple directions and may have a different shape such as circular or ellipsoidal.

In this embodiment, each handling element 1031 has a thickness measured in a direction perpendicular to the direction in which each handling element 1031 extends from the catheter 1020. Each handling element has a thickness that is no more than 2x (twice) the diameter of the catheter 1020. This ensures the handline elements 1031 have a low profile and do not cause the packaging/pouch 1070 to be unnecessarily bulky.

In this embodiment, each handling element 1031 comprises a gripping element in the form of a gripping hole 1037 that is stadium shaped like the gripping hole 1077 provided in the opening tab 1075. Each gripping hole 1037 is positioned centrally within the projection 1032 of each handling element 1031 and corresponds to almost the entire surface area of the projection 1032 such that the projection 1032 is simply defining the edges of the gripping hole 1077. Of course, in other embodiments, the gripping hole 1077 may be replaced with any suitable feature that allows the handling element 1031 to be handled more easily, for example a series of ridges.

In this embodiment, each handling element 1031 is independent of the other and is not adhered or sealed to the other. This allows the handling elements 1031 to be easily moved along the catheter 1020 as required by the user. In other embodiments, the handling elements 1031 may be sealed together, this can allow them to more securely remain in a given position prior to use. The user may then separate the handling elements 1031 by breaking a temporary seal that is present between them, for example a tack weld.

While in this embodiment the sleeve 1030 comprises two handling elements 1031, in other embodiments, the sleeve 1030 may comprise a single handling element 1031 or more than two handling elements 1031 as required.

In this embodiment, the handling elements 1031 are arranged on the catheter 1020 adjacent to the fluid collection bag 1010. The bore through each handling element 1031 is sized such that the handling element 1031 can overlie a portion of the inlet 1053 and consequently the handling element 1031 closest to the fluid collection bag 1010 may be push-fit over the inlet 1053 to retain it in place close to the fluid collection bag 1010 before use.

In this embodiment, both handling elements 1031 are located in the second compartment 1082 along with the fluid collection bag 1010. As described above, the fluid reservoir 1040 is arranged in the first compartment 1081 and the catheter 1020 extends from the fluid collection bag 1010 into the first compartment 1081.

Prior to use, the pouch 1070 is provided sealed closed with the contents arranged within it as mentioned above. To ensure the catheter 1020 is wetted prior to use, the user must activate the fluid reservoir 1040 by locating it within the pouch 1070 and squeezing it to rupture the fluid reservoir 1040 and release wetting fluid into the first compartment 1081. This can be done with the aid of the wetting marker 1042 on the outside of the pouch 1070.

Advantageously, once wetting fluid is released into the first compartment 1081 it is prevented from reaching the fluid collection bag 1010 and sleeve 1030 by the internal wall 1083. This ensures that the wetting fluid is most efficiently used to wet the catheter 1020, the majority of which is in the first compartment including the proximal end 1021 of the catheter. In addition, it ensures that the fluid collection bag 1010 and sleeve 1030 remain dry and easier to handle.

Once the catheter 1020 has been wetted, the contents of the pouch 1070 can be accessed by opening the pouch 1070. The pouch 1070 is opened by separating the front opening tab 1075 from the pouch 1070 to break the adhesive present around the periphery 1078b of the access aperture 1078a present in the front wall 1071a of the pouch 1070. As the tab 1075 is separated from the pouch 1070, the peel-away region 1074 peels away from the front wall 1071a of the pouch 1070 revealing the contents of the second compartment 1082.

Once the pouch 1070 has been opened, which in some embodiments may involve completely removing the peel-away region 1074 from the pouch 1070, the fluid collection bag 1010, catheter 1020 and sleeve 1030 may be removed from the pouch 1070. Preferably, the user grasps the dry folded stowed fluid collection bag 1010 and/or one or both dry handling elements 1031 of the sleeve 1030 and uses them to pull the now wetted catheter out of the pouch 1070 via the second compartment 1082.

Before use, the fluid collection bag 1010 may be unfolded to ensure that the collection of liquid within it is not hindered by folds in the fluid collection bag 1010. The handling elements 1031 can be used to handle the catheter 1020 and progressively introduce it into the body until urine flows therethrough and into the fluid collection bag 1010.

Referring to Figures 5-7, after use of the catheter 1020, the user may wish to empty the contents of the fluid collection bag 1010. This can be desirable in order to reduce the size and weight of the used bag 1010 and/or to dispose of the bag 1010. To allow the bag 1010 to be emptied, in this embodiment the outlet 1060 may be removed from the bag 1010 to form an opening 1016 in the peripheral bond between the neck

1050 and notch 1064 as described below.

To form the opening 1016, in this embodiment the user first folds the neck 1050 onto the front panel 1011 of the bag 1010 creating a neck fold-line 1054 parallel to the base 1012 of the peripheral bond and spanning between the end of the left sloped edge

1051 and the end of the right sloped edge 1052 distal the inlet 1053. Advantageously, this helps to ensure fluid in the fluid collection bag 1010 is less likely to pass back into the sleeve 1030 via the inlet 1053 and also ensures the opening 1016 is correctly formed while the outlet 1060 is being removed from the fluid collection bag 1010. In other embodiments, the same effect may be achieved by different means such as deforming, rolling or folding the neck 1050 in different ways.

In this embodiment, the fold in the neck 1050 may be maintained by stowing the used catheter 1020 into the pocket 1017 in the fluid collection bag 1010. The user may do this using the sleeve 1030. Thus, the used and dirty catheter 1020 is retained within the pocket 1017 and is less likely to be accidentally touched during emptying of the fluid collection bag 1010.

In this embodiment, once the neck 1050 is folded, the outlet 1060 is exposed and projects beyond the edge of the bag 1010 which is now defined by the neck foldline 1054. The pull-ring 1062 may then be grasped by the user and pulled in a direction parallel to the neck fold-line 1054 and away from the left lateral edge 1014 to separate the outlet 1060 from the fluid collection bag 1010 forming the opening 1016. Advantageously, the peripheral bond preferentially tears from a point between the right sloped edge 1052 of the neck 1050 and outlet 1060 due to the neck fold-line 1054 which reinforces the peripheral bond around the neck 1050 and reduces tearing forces on the right sloped edge 1052. In addition, the shape of the pull-ring 1062 means that when moved away from the inlet 1053, shearing force is concentrated at the point the outlet 1060 meets the upper edge 1015. This ensures the opening 1016 is created in a controlled manner.

In this embodiment, the notch 1064 provides a second point on the peripheral bond which preferentially forms one end of the opening 1016. Thus, the outlet 1060 may be easily, conveniently, and reliably removed from the fluid collection bag 1010 to form a clean opening 1016 in the peripheral bond. This allows the user to easily empty the contents of the bag 1010 and reduces the risk of spilling the contents of the bag 1010 during emptying.

While the embodiment 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 catheter assembly comprising a catheter having a proximal end for insertion into the body and a distal end, and a sleeve configured to enclose only part of the length of the catheter, wherein the sleeve comprises a handling element projecting away from the catheter in a plane parallel to the axis of 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 handling element extends in a plane which contains the axis of the catheter. The catheter assembly of any preceding claim wherein the handling element extends from only one side of the catheter. The catheter assembly of any preceding claim wherein the handling element has a thickness measured in a direction perpendicular to the plane in which the handling element extends from the catheter, wherein the thickness is no more than two times the diameter of the catheter. The catheter assembly of any preceding claim wherein the handling element is more rigid than the catheter. The catheter assembly of any preceding claim wherein the handling element comprises a gripping hole configured to allow the user to grasp the handling element. The catheter assembly of any preceding claim wherein the sleeve comprises two or more handling elements. The catheter assembly of claim 8 wherein each handling element is identical. The catheter assembly of claim 8 or 9 wherein the two or more handling elements are each independently movable along the length of the catheter. The catheter assembly of claim 8 or 9 wherein the two or more handling elements are joined together. The catheter assembly of claim 11 wherein the two or more handling elements are configured to be separated and moved independently along the length of the catheter. The catheter assembly of any of claims 8 to 10 wherein the two or more handling elements are provided separately. The catheter assembly of any preceding claim further comprising a fluid collection bag coupled to the catheter such that it is configured to collect and retain fluid released from the body through the catheter, the fluid collection bag comprising an inlet wherein the handling element engages the inlet of the fluid collection bag to retain the handling element close to the fluid collection bag. A packaged catheter assembly comprising a pouch and the catheter assembly of any preceding claim, wherein the pouch is configured to contain the catheter assembly within it. A method of manufacturing a catheter assembly, the method comprising providing a catheter having a proximal end for insertion into the body and a distal end, and a sleeve configured to enclose only part of the length of the catheter, wherein the sleeve comprises a handling element projecting away from the catheter in a plane parallel to the axis of the catheter. A method of handling a catheter assembly, the catheter assembly comprising a catheter having a proximal end for insertion into the body and a distal end, and a sleeve configured to enclose only part of the length of the catheter, wherein the sleeve comprises a handling element projecting away from the catheter in a plane parallel to the axis of the catheter, the method comprising grasping the handling element. The method of claim 17 wherein the handling element comprises a gripping hole and the method further comprising grasping a gripping hole of the handling element. The method of claim 17 or claim 18 wherein the sleeve comprises two or more handling elements and the method further comprising separating the two or more handling elements and moving the two or more handling elements independently of one another along the length of the catheter.

20. The method of any of claims 16 to 19 wherein the catheter assembly is the catheter assembly of any of claims 1 to 15.