WO2023180710A1

WO2023180710A1 - A catheter assembly

Info

Publication number: WO2023180710A1
Application number: PCT/GB2023/050679
Authority: WO
Inventors: Oliver PFLEGER; Daniel Allen; Jan UHL'AR; Lukasz Natkaniec; Phillip EMRICH
Original assignee: Convatec Limited
Priority date: 2022-03-21
Filing date: 2023-03-20
Publication date: 2023-09-28
Also published as: GB202211844D0; GB202203882D0; GB202211843D0

Abstract

A packaged catheter assembly comprises a catheter, a pouch, and a fluid collection bag configured to receive fluid from the catheter in use. The catheter and fluid collection bag are arranged within the pouch. The pouch comprises an interaction region to form an opening in the pouch and allow the fluid collection bag and catheter to be removed from the pouch, and the fluid collection bag is arranged adjacent to the opening. The catheter may be a male urinary catheter. The catheter and fluid collection bag may not overlap inside the pouch. The fluid collection bag may comprise an inlet to allow fluid to enter the bag from the distal end of the catheter. The fluid collection bag may be completely within an upper region of the pouch. The upper region may be defined between the inlet and the opening.

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.

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

When using a catheter, it is important that the catheter remains clean but when packaged this can be challenging as the catheter must be removed from the packaging. This can lead to the user touching a part of the catheter that is intended to be introduced into the body, such as the tube, by accident while they attempt to remove the catheter from the packaging which can lead to a risk of infection during use. It is therefore important to provide packaging which is convenient and easy for the user to open and which presents the catheter to the user such that it can be removed from the packaging for use without accidentally touching a part of the catheter that should remain clean directly. Many existing catheters attempt to maintain the sterility and cleanliness of the catheter prior to use by introducing a sleeve around the catheter. However, the sleeve itself can hinder the activation of the catheter surface prior to use, for example by blocking wetting fluid from coming into contact with the catheter. This can mean that the catheter is not activated prior to use which can lead to discomfort and injury during use.

It is also possible that the packaging containing the catheter and catheter are arranged such that if the user does not take care during removal of the catheter from the packaging, the entire catheter surface may not be activated by wetting fluid. This can also lead to discomfort and injury during use.

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

In packaged catheter assemblies, fluid collection bags must be designed to collect a sufficient amount of liquid such that during use the bag does not overflow. This must also be balanced against the need of providing compact and discrete catheter assemblies that are suitable for intermittent use. Users can have issues when fluid collection bags are packaged inefficiently or interfere with other parts of the catheter assembly, such as the catheter or wetting fluid/wetting fluid reservoir during use.

Many existing catheter assemblies require the catheter to be strapped to a user’s body, typically the user’s leg to support the fluid collection bag when in use. This is conventional when the catheter is a permanent catheter, such as a Foley catheter. For intermittent catheters, that is, catheters which are used intermittently throughout a day for short term catheter-based management of th bladder, it is not practical or comfortable for the user to have a catheter strapped to their body for the entire day when the catheter is intended to be inserted into the user only long enough to drain the bladder, then removed. As such, when a user intends to use an intermittent catheter, they must either hold the fluid collection bag during use or find a suitable place to rest the bag. In each instance, this is cumbersome and creates problems for the user, in particular for users with limited dexterity. It must be appreciated that holding a fluid collection bag by the bag itself during urination is increasingly difficult when the bag is being filled with liquid. This is because the user may grip the bag too tightly, which can disrupt the filling of the bag, cause the distal end of the catheter to detach from the bag, or cause the bag to overflow with liquid. In each case, what should be a private and discrete moment for the user, can become problematic and embarrassing.

In some existing catheter assemblies, the fluid collection bag is provided with an outlet valve for releasing the contents of the bag after use. This is particularly common in permanent catheter assemblies, such as a Foley catheter. Permanent catheters are attached, for example by a strap, to the body of a user, typically the user’s leg. As such, movement of the fluid collection bag is prevented when the user operates the outlet valve. Moreover, permanent catheters comprise a ‘north-south’ outlet valve, meaning that the valve must be actuated in an upward and downward motion to open and close the valve. Thus, the valve is arranged parallel to the user’s leg, so the user does not accidentally open the valve when crossing their legs, as lateral movement will not open the valve. Moreover, the ‘north-south’ outlet valve on a catheter of this type is typically operable by a user who is fully dextrous (having the Foley catheter as a temporary measure) or by a healthcare professional on the user’s behalf, where the user is bedridden. However, if the user has limited dexterity or the catheter assembly was not attached to the user’s body, for example where the catheter is an intermittent catheter, then ‘north-south’ outlet valves would be cumbersome to operate as they require the fluid collection bag to be held whilst operating the valve. This can be problematic for the user making the outlet valves difficult to operate.

In closed catheter assemblies, fluid collection bags are designed to collect a sufficient amount of liquid such that during use the bag does not overflow. Users can have issues when liquid does not efficiently flow within the bag, for example because the bag has been folded and compacted for a long period of time prior to use, therefore leading to an uncontrolled flow of liquid into the bag. If the liquid entering the bag does not efficiently flow within the bag, the liquid can fail to fill the total available volume of the bag. In such cases, the volume of liquid in the bag is considerably less than the bag is capable of holding, therefore leading to the bag overflowing with liquid during use which can be embarrassing for the user. Moreover, when partially filled, fluid can slosh around inside existing fluid collection bags, making them somewhat difficult to handle.

Many existing packaged closed catheter assemblies contain a fluid reservoir or sachet together with a fluid collection bag and catheter. 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 catheter assembly.

Summary of the Invention

In broad terms, the present invention concerns a catheter assembly. It also concerns a packaged catheter assembly comprising a pouch and a catheter, wherein the pouch is configured to contain the catheter within it.

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

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

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

The packaged catheter assembly may comprise a fluid collection bag configured to receive fluid from the catheter in use and as described in more detail below. Consequently, the packaged catheter assembly may be a closed catheter assembly. The absorbent material may be configured to absorb at least 10%, 20%, 30%, 40%, 50%, 60%, 70%, 80%, or 90% of the liquid capacity of the fluid collection bag. In one embodiment, the absorbent material is configured to absorb 100% of the liquid capacity of the fluid collection bag. Thus, the absorbent material ensures that it can absorb (all) liquid within the fluid collection bag if required to reduce sloshing of liquid within the pouch/fluid collection bag.

The packaged catheter assembly may comprise a fluid reservoir. The fluid reservoir may be configured to retain wetting fluid within it and as described in more detail below. The absorbent material may be configured to absorb at least 10%, 20%, 30%, 40%, 50%, 60%, 70%, 80%, or 90% of the liquid capacity of the fluid reservoir. In one embodiment, the absorbent material is configured to absorb 100% of the liquid capacity of the fluid reservoir. Thus, the absorbent material ensures that it can absorb liquid released from the fluid reservoir if required to dry components of the catheter assembly that must be handled by the user and to avoid liquid from leaking out of the pouch.

In another preferred embodiment the absorbent material may comprise an absorbent strip. The absorbent strip may be elongate. The absorbent strip may have a length and a width wherein the length is at least 2, 3, 4, 5, or 6 times larger than the width. The absorbent strip may be located adjacent to a mouth of the pouch. The absorbent strip may span the majority of the mouth of the pouch. The absorbent strip may span at least 50%, 60%, 70%, 80% or 90% of the width of the mouth. The absorbent strip may span no more than 90%, 80%, 70%, or 60% of the width of the pouch. The mouth may correspond to a part of the pouch which forms an opening to allow access to the contents of the pouch. The absorbent strip may line the mouth of the pouch. Two or more absorbent strips may be provided. For example, two opposing absorbent strips may be provided. One absorbent strip may be provided on each of two sides of the mouth of the pouch. Thus, absorbent strips may be used to help prevent fluid from leaking out of the pouch through the mouth of the pouch.

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

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 two walls (a front wall and a rear wall) and a peripheral seal between the two walls. The peripheral seal may provide a sterile seal. Thus, the pouch may maintain the sterility of its contents.

The peripheral seal may form one or more edges of the pouch. The peripheral seal may comprise a left lateral edge, right lateral edge, an upper edge and a base of the pouch. The left and right lateral edges may be defined as the left and right edges when viewing the pouch 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 be any suitable shape such as circular, elliptical, triangular, tubular, prismatic or polygon, preferably the pouch is rectangular. The pouch may have a width defined as the distance between the left lateral edge and right lateral edge of the pouch. The width may be at least 60, 70, 80, 90 or 100 mm. The pouch may have a width of no more than 110, 100, 90, 80, or 70 mm. Preferably, the width is between 90 and 110 mm, and most preferably about 100 mm. The pouch may have a height defined as the distance between the upper edge and base. The height may be at least 100, 125, 150, 175, 200 or 225 mm. The pouch may have a height of no more than 250, 225, 200, 175, 150, or 125 mm. Preferably, the height is between 120 and 140 mm, and most preferably it is about 130 mm. 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. Thus the peripheral seal can be easily constructed to suit the specific needs of the pouch.

One edge of the pouch may comprise a folded edge. A folded edge may comprise a fold between the two walls. All edges other than the folded edge may be formed by the peripheral seal. The pouch may be formed by folding the two walls to form the folded edge. Thus, the pouch can be flexibly constructed from folding material if required.

The packaged catheter assembly may comprise a fluid reservoir. The fluid reservoir may be configured to retain wetting fluid within it. The fluid reservoir may be configured to release fluid into the pouch. The pouch may comprise a wetting region in which fluid released by the fluid reservoir preferentially collects. The wetting region may comprise a lower section of the pouch. The wetting region may comprise the bottom 50%, 40%, 30%, 20%, or 10% of the pouch, preferably 20%. Preferably the wetting region is adjacent to the base of the pouch. The pouch may be configured to form a pool of released fluid in the wetting region. Thus, the catheter may be more efficiently wetted by being passed through the pool of wetting fluid formed in the pouch.

The fluid reservoir may be arranged within the (sealed) pouch. The fluid reservoir may be provided as a separate device, or incorporated into the pouch material. The fluid reservoir may comprise a deformable, frangible or burstable sachet. Thus the fluid reservoir is conveniently located within the pouch where it may directly release fluid into pouch to wet the catheter. A deformable, frangible or burstable reservoir enhances the convenience for a user as fluid can be easily released without additional tools and before the pouch is unsealed, thus reducing the chances of accidental wetting of the user. A sachet in particular can be easily handled on an assembly line and introduced more simply than attempting to handle fluid, so as to it into the package during manufacture.

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 a sachet. The fluid reservoir may be any suitable shape or size, such as square, rectangular, circular, ellipsoidal or irregularly shaped. Preferably, the fluid reservoir is elongate and rectangular. The fluid reservoir may have a length of at least 60%, 70% or 80% the height of the pouch. The fluid reservoir may have a length no more than 90%, 80% or 70% the height of the pouch. Preferably the fluid reservoir has a length of 80% the height of the pouch. The fluid reservoir may have a width of at least 5%, 10%, 15% or 20% the width of the pouch. The fluid reservoir may have a width of no more than 25%, 20%, 15% or 10% the width of the pouch. Preferably, the fluid reservoir has a width of 15% the width of the pouch. Thus, the fluid reservoir may be flexibly shaped and sized to conveniently fit within the pouch.

The fluid reservoir may be arranged within the pouch. The fluid reservoir may be arranged with its length parallel to one edge of the pouch. Preferably, the length of the fluid reservoir is parallel to the left and/or right lateral edge of the pouch. The fluid reservoir may be arranged adjacent to one edge of the pouch. Preferably, the fluid reservoir is arranged adjacent to the same edge of the pouch that the fluid reservoir’s length is parallel to. Thus, the fluid reservoir is conveniently located against an edge of the pouch where it does not take up too much space.

The pouch may be formed from an opaque material. The pouch may have a textured or printed fabric-like appearance and/or feel. Where the pouch is opaque, the pouch may comprise a wetting marker to assist the user in locating the fluid reservoir within the pouch. Thus, the pouch is more comfortable and discreet for the user to carry in day-to-day life and the user can easily find and activate the fluid reservoir.

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 or near an upper edge of the peripheral seal. The catheter may be withdrawn through the opening. The catheter may be withdrawn through the opening. Thus, access to the pouch is provided at or near an upper edge of the pouch and as such, the fluid in the pool adjacent the base of the pouch is retained in the pouch while the catheter is withdrawn reducing the risk of spilling fluid outside the pouch.

The interaction region may comprise a breakable region of the peripheral seal. The method may comprise forming a breakable region in the peripheral seal. The breakable region may comprise a tear-away region which may comprise a tear line defining a line along which the pouch may be tom to at least partially separate the tearaway region from the remainder of the pouch, thereby creating an opening in the peripheral seal. The fluid collection bag may be arranged adjacent to the tear line. The tear-away region may comprise a tear start. The tear start may be provided at a first end of the tear-away region. The tear start may comprise a notch, or area of weakness, in one or both of the walls of the pouch. The tear start may define the first part of the pouch to be torn. The tear-away region may comprise a tear stop. The tear stop may be provided at a second end of the tear-away region. The tear stop may act to prevent or reduce the likelihood of the tear-away region being completely separated from the remainder of the packaging. A tear line may be defined between the tear start and the tear stop. The tear line may be configured to preferentially tear. The tear line may comprise a weakened region of the pouch. The tear line may be formed by any suitable means, such as laser scoring. Thus the breakable region provides a convenient and easy means to open the pouch with minimal effort and no additional equipment/tools.

The tear-away region may be substantially triangular in shape having a sloped upper edge. The tear-away region may be tapered. The tear-away region may extend upwards more on one side than the other, preferably the tear-away region extends upwards more on the side corresponding to the tear start. The tear-away region may extend upwards no more than 200%, 100%, 75%, or 50% more on one side than the other. The tear-away region may extend upwards at least 25%, 50%, 75%, 100%, or 150% more on one side than the other. Preferably, the tear-away region extends upwards 50% more on one side than the other. Thus, the tear-away region is conveniently shaped to guide the user to grasp it on one side to open the pouch and also provides sufficient material for the user to securely grasp it on that side.

The absorbent strip may be positioned adjacent the tear line. The absorbent strip may be positioned below the tear line. The absorbent strip may span a majority of the tear line, for example at least 50%, 60%, 70%, 80% or 90% of the length of the tear line. Thus, the opening formed along the tear line is next to the absorbent strip and the absorbent strip may then absorb fluid within the pouch before it leaves through the opening.

The interaction region may comprise an aperture. The aperture may be sized to allow a finger to pass through and grip the interaction region. Preferably, the aperture is located in the tear-away region. The aperture may be located on the same side of the pouch as the tear start. The aperture may be located adjacent to the tear start. The aperture may be any suitable shape, for example, circular, elliptical, square or irregularly shaped. Preferably, the aperture is circular. Thus, the user can more easily grasp the tear-away region and open the pouch.

The catheter may be a male catheter (i.e. a catheter for catheterisation of men). The catheter may be a female catheter (i.e. a catheter for catheterisation of women). The catheter may comprise a proximal end for insertion into the body and a distal end. The catheter assembly may comprise a sleeve. The sleeve may comprise a proximal end and a distal end. The distal end of the sleeve may be secured or attached either directly or indirectly to the distal end of the catheter. The sleeve may be configured to enclose a majority of the length of the catheter. The sleeve may comprise a flexible plastics material. The sleeve may be liquid impermeable. Alternatively the sleeve may be liquid permeable. Where the sleeve is liquid permeable, it may be provided in a configuration in which it covers a majority of the length of the catheter. The sleeve may comprise a handling element. The handling element may be disposed at the proximal end of the sleeve. The handling element may be configured to control movement of the sleeve with respect to the catheter. The handling element may be annular. The handling element may be more rigid than the sleeve. The sleeve may comprise a thermoplastic polyurethane (TPU) or low-density polyethylene (LDPE). Thus, the sleeve is cheap and easy to produce and can be easily manipulated by the user during use.

The handling element may be arranged adjacent to the opening. Accordingly, in one embodiment, there is provided a packaged catheter assembly comprising a catheter having a proximal end for insertion into the body and a distal end, a sleeve enclosing the catheter from the proximal end to the distal end, a pouch, and a fluid collection bag configured to receive fluid from the catheter in use, wherein: the catheter, sleeve and fluid collection bag are arranged within the pouch; the pouch comprises an interaction region to form an opening in the pouch and allow the fluid collection bag and catheter to be removed from the pouch; and the fluid collection bag is arranged adjacent to the opening, wherein the pouch comprises two walls and a peripheral seal between the two walls, the peripheral seal comprises a left lateral edge, right lateral edge, an upper edge and a base of the pouch, the pouch has a width defined between the left lateral edge and right lateral edges and a height defined between the upper edge and base, wherein the fluid collection bag is provided in a stowed configuration while inside the pouch, wherein the fluid collection bag spans across a majority of the width and a minority of the height of the pouch when in the stowed configuration, wherein the sleeve comprises a handling element arranged at a proximal end of the sleeve corresponding to the proximal end of the catheter, and the handling element is arranged adjacent the opening. The pouch may comprise a gripping element. The gripping element may be configured to engage the sleeve. The gripping element may be configured to unfurl the sleeve along the length of the catheter. The gripping element may be configured to detach from the sleeve.

Thus, according to a broad aspect of the present invention, there is provided a packaged catheter assembly comprising a catheter having a proximal end for insertion into the body and a distal end, a sleeve enclosing the catheter, a pouch comprising a gripping element configured to engage the sleeve, and a fluid reservoir configured to release wetting fluid into the pouch so as to wet the catheter, wherein: the catheter and fluid reservoir are arranged within the pouch; and the gripping element is configured to unfurl the sleeve along the length of the catheter, and detach from the sleeve.

The gripping element may be configured to remain in the pouch.

Thus, according to a second aspect of the present invention, there is provided a packaged catheter assembly comprising a catheter having a proximal end for insertion into the body and a distal end, a sleeve enclosing the catheter, a pouch comprising a gripping element configured to engage the sleeve, and a fluid reservoir configured to release wetting fluid into the pouch so as to wet the catheter, wherein: the catheter and fluid reservoir are arranged within the pouch; and the gripping element is configured to unfurl the sleeve along the length of the catheter, detach from the sleeve, and remain in the pouch.

Consequently, the sleeve may be provided in a furled configuration. The gripping element may retain the sleeve in the furled configuration when within the pouch. Thus, the catheter is exposed within the pouch and may be directly wetted by the wetting fluid released into the pouch. Once wetted, the sleeve may be unfurled along the length of the catheter to protect the now wetted catheter from dirt and allow the user to handle the catheter via the sleeve and without coming into contact with the wetting fluid or catheter itself. In addition, as the gripping element detaches from the sleeve and remains in the pouch, it does not become an inconvenient loose object that the user must try to keep track of and dispose of. In the furled configuration, the sleeve may cover a minority of the length of the catheter. In the furled configuration, the sleeve may cover parts of the catheter which are not required to pass into the body during use. In the furled configuration, the sleeve may cover no more than 40%, 30%, 20%, 10% or 5% of the length of the catheter. In the furled configuration, the sleeve may cover at least 5%, 10%, 20%, or 30% of the length of the catheter. Thus, the furled sleeve leaves the majority of the catheter uncovered and ready to be wetted within the pouch.

The gripping element may be positioned in an upper half of the pouch. The gripping element may be positioned at least 50%, 60%, 70% or 80% of the way up the height of the pouch, preferably about 60% to 70% of the way up the height of the pouch. The sleeve may be positioned above the gripping element in the pouch. This means that wetting fluid released into the pouch is not likely to wet the sleeve.

Once unfurled, the sleeve may be in an unfurled configuration. In the unfurled configuration, the sleeve may cover a majority of the length of the catheter. In the unfurled configuration, the sleeve may cover at least 50%, 60%, 70%, 80%, 90% or 95% of the length of the catheter. Thus, the unfurled sleeve provides good protection to the catheter from contact with the user or other objects which may render it dirty and unusable.

The gripping element may be configured to unfurl the sleeve as the catheter is withdrawn from the pouch. The gripping element may unfurl the sleeve by preventing movement of a part of the sleeve, and preferably one end of the sleeve. The gripping element may engage the sleeve adjacent to, or at, an end of the sleeve corresponding to an end of the catheter which is the last part of the catheter to be withdrawn from the pouch. Where the catheter is withdrawn from the pouch by its distal end, the gripping element may engage the proximal end of the sleeve. Where the catheter is withdrawn from the pouch by its proximal end, the gripping element may engage the distal end of the sleeve. Thus, the gripping element can ensure the sleeve is completely unfurled and conveniently unfurls the sleeve as the catheter is withdrawn from the pouch.

The gripping element may be positioned adjacent or along an edge of the pouch. The gripping element may extend into the pouch. The gripping element may be attached to the peripheral seal of the pouch. The gripping element may be positioned on a lateral edge of the peripheral seal. The gripping element may be at a position corresponding to an end of an opening formed in the pouch. The gripping element may be positioned on the same side of the pouch as the tear start. Thus, the gripping element is positioned such that it does not hinder removal of the catheter/sleeve from the pouch as it is located in a position that is directly accessible through an opening formed adjacent to the upper edge of the pouch. The position of the gripping element on a lateral edge of the pouch is also beneficial when the gripping element engages the catheter as described below as it can help to ensure the catheter passes through the wetting region when the wetting region is adjacent the base of the pouch.

The gripping element may detach from the sleeve when a threshold tension is applied on the sleeve in a direction away from the gripping element. The threshold tension may be at least 5 N, 10 N, 15 N, 20 N or 30 N. The threshold tension may be no more than 40 N, 30 N, 20 N, 15 N or 10 N. Preferably, the threshold tension is 20 N. Thus, the sleeve/catheter is not accidentally detached from the gripping element and requires deliberate, but not excessive, force applied by the user.

The gripping element may engage the sleeve in any suitable way, for example through an interference fit or breakable seal. The gripping element may comprise a temporary attachment between the sleeve and the pouch, for example a spot weld. The gripping element may comprise a narrow channel in the pouch which restricts movement of the sleeve through it by friction. The pouch may comprise a join between the two walls of the pouch which together with a lateral edge of the pouch defines the narrow channel. The gripping element may comprise an aperture, for example the gripping element may be an O-ring. The gripping element may be configured to engage the handling element. The aperture may have a diameter that is smaller than an outer diameter of the handling element. The catheter may pass through the aperture. The sleeve may not pass through the aperture. The sleeve may be push-fit into the aperture. Thus, the sleeve can be unfurled and then detached from the sleeve in a simple manner.

The gripping element may be configured to engage the catheter. The gripping element may be configured to direct the catheter through the wetting region during withdrawal of the catheter from the pouch. Consequently, according to a third aspect of the present invention there is provided a packaged catheter assembly comprising a catheter having a proximal end for insertion into the body and a distal end, a pouch comprising a gripping element configured to engage the catheter, and a fluid reservoir configured to release wetting fluid into the pouch so as to wet the catheter, wherein: the catheter and fluid reservoir are arranged within the pouch; the pouch is configured to provide an opening through which the catheter may be withdrawn; the pouch comprises a wetting region in which wetting fluid preferentially collects; the wetting region is distal the opening; and the gripping element is configured to direct the catheter through the wetting region during withdrawal of the catheter from the pouch.

Thus, the gripping element guides the catheter through the wetting region during withdrawal of the catheter from the pouch to ensure the catheter is adequately wetted and ready for use.

The catheter may be configured to be drawn through the gripping element during withdrawal of the catheter from the pouch. The gripping element may restrict the direction of an axis of the catheter. The axis of the catheter may be restricted to within 30, 20, 10 or 5 degrees of an axis of the gripping element. The axis of the catheter may be restricted by the handling element. The axis of the gripping element may be directed towards the wetting region. The gripping element may comprise an aperture through which the catheter may pass, for example the gripping element may be an O-ring attached to the pouch, or may be a section of the sleeve attached to the pouch, or may be a narrow channel formed in the pouch as described above. Thus, the gripping element, or more particularly its aperture may ensure the catheter is angled towards the wetting region as it passes through the aperture, this can help to ensure the catheter passes through the wetting region.

The gripping element may engage the sleeve and/or the catheter. Thus, the catheter can be guided through the wetting region either indirectly via the sleeve or directly, for example in situations where the catheter assembly does not comprise a sleeve.

The gripping element may be located at a position outside the wetting region.

The catheter may be configured such that during withdrawal of the catheter from the pouch it passes through the wetting region before it reaches the gripping element. The catheter may be configured to be withdrawn from the pouch in a direction parallel to the axis of the gripping element, or more particularly its aperture. Thus, the gripping element can be positioned such that it does not hinder withdrawal of the catheter or block wetting fluid from reaching the catheter in the wetting region.

The catheter may be resiliently biased into a straight configuration. The catheter may have a threshold rigidity to ensure that it passes through the wetting region. The threshold rigidity may ensure that the tangent of the catheter resists changing by more than 10, 20, 30, 40, 50, 60, 70 or 80 degrees over a length equivalent to the distance between the gripping element and wetting region. Thus, the catheter is urged into the wetting region by the rigidity of the catheter and the action of the gripping element.

The wetting region may be configured to collect a pool of wetting fluid, for example as described in relation to the first aspect above.

The packaged catheter assembly may comprise a fluid collection bag. The fluid collection bag may be arranged within the pouch. The pouch may comprise an interaction region (as described above) to form an opening in the pouch and allow the catheter and fluid collection bag to be removed from the pouch. The fluid collection bag may be arranged adjacent to the opening.

Thus, according to a fourth aspect of the present invention there is provided a packaged catheter assembly comprising a catheter, a pouch, and a fluid collection bag configured to receive fluid from the catheter in use, wherein: the catheter and fluid collection bag are arranged within the pouch; the pouch comprises an interaction region to form an opening in the pouch and allow the fluid collection bag and catheter to be removed from the pouch; and the fluid collection bag is arranged adjacent to the opening.

With this arrangement, the fluid collection bag protects the catheter from coming into contact with dirt as the pouch is opened and also helps prevent the user from accidentally touching the catheter during opening of the pouch. This helps to reduce risk of infection during use of the pouch as the catheter is less likely to be dirty. In addition, where the pouch must be shaken to distribute wetting fluid within it, advantageously the fluid collection bag also reduces the amount of fluid which reaches the top of the bag and does not otherwise act to wet the surface of the catheter.

As outlined above, the fluid collection bag may be provided in a stowed configuration, preferably while inside the pouch. The fluid collection bag may be configured to remain in the stowed configuration. In the stowed configuration, the fluid collection bag may be folded or rolled to reduce its size in any one dimension. The stowed configuration may be a folded or rolled configuration. In the stowed configuration, the fluid collection bag may be cylindrical in shape. 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 stowed configuration of the fluid collection bag further inhibits fluid flow onto the exterior surface of the fluid collection bag as it must penetrate between folds.

The catheter may not overlap the fluid collection bag inside the pouch. Accordingly in one embodiment there is provided a packaged catheter assembly comprising a catheter, a pouch, and a fluid collection bag configured to receive fluid from the catheter in use, wherein: the catheter and fluid collection bag are arranged within the pouch; the pouch comprises an interaction region to form an opening in the pouch and allow the fluid collection bag and catheter to be removed from the pouch; and the fluid collection bag is arranged adjacent to the opening, wherein catheter does not overlap the fluid collection bag inside the pouch. This helps to ensure the fluid collection bag blocks the catheter and prevents dirt etc from getting to it when opening the pouch.

Alternatively, the catheter may overlap the fluid collection bag. Where the catheter is enclosed by a sleeve and the sleeve comprises a handling element at its proximal end, the handling element may overlap the fluid collection bag.

An axis parallel to the longest dimension of the stowed fluid collection bag may be arranged parallel to the tear line of the pouch (where the pouch has an interaction region as defined above comprising a tear line) and/or the opening formed in the pouch. This helps to protect the contents of the pouch from dirt when opening the pouch as the fluid collection bag provides an additional fluid impermeable barrier. A first end of the stowed fluid collection bag (for example the inlet) may be arranged adjacent to one lateral edge of the pouch, or a first end of the opening. Thus, the inlet may be provided at one end of the width of the stowed fluid collection bag. The stowed fluid collection bag may comprise a rolled or folded portion. The inlet may extend from the rolled or folded portion, preferably in a direction perpendicular to the width of the stowed fluid collection bag. A second end of the stowed fluid collection bag (distal the first end) may be arranged adjacent a second end of the opening. The opening may therefore be parallel to the width of the fluid collection bag. In one example, the first end of the stowed fluid collection bag may be arranged adjacent to the tear start. The inlet may be arranged no more than 40%, 30%, 20% or 10% of the way from the first end to the second end of the opening. Thus, the fluid collection bag is positioned to ensure the distal end of the catheter is arranged along the same side of the pouch as the tear start. Therefore, the opening may be configured to be formed starting from the first end. This helps the catheter to be withdrawn in a smooth and straight pulling action parallel to the lateral edge of the bag which reduces the force required to remove the catheter from the pouch. In addition, by providing the inlet at one side of the bag means that the catheter can be more efficiently stored in the pouch without excessive curvature.

Accordingly, in one embodiment there is provided a packaged catheter assembly comprising a catheter, a pouch, and a fluid collection bag configured to receive fluid from the catheter in use, wherein: the catheter and fluid collection bag are arranged within the pouch; the pouch comprises an interaction region to form an opening in the pouch and allow the fluid collection bag and catheter to be removed from the pouch; and the fluid collection bag is arranged adjacent to the opening, wherein the fluid collection bag comprises an inlet to allow fluid to enter the bag from the distal end of the catheter and the inlet is arranged adjacent a first end of the opening, wherein the opening is configured to be formed starting from the first end.

Preferably, the first and second ends of the stowed fluid collection bag are arranged adjacent to the first and second ends of the opening respectively as mentioned above. This advantageously ensures the fluid collection bag blocks and obscures substantially all of the opening to restrict access to enhance the advantages provided by the fourth aspect as mentioned above.

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

The peripheral bond may provide a water-tight seal. Preferably, the peripheral bond provides a sterile seal. The peripheral bond may comprise any one or more of: a weld; mechanical seal; heat seal; pressure seal; adhesive; solvent bond; ultraviolet bond; ultrasonic weld; laser weld; impulse weld; or friction weld. This ensures that the catheter is maintained within a sterile environment prior to use and also that once the catheter has been used any fluid contained within the bag does not leak out unintentionally. The fluid collection bag may comprise an inlet to allow fluid to enter the bag from the distal end of the catheter and optionally via the sleeve. The inlet may be connected to one end of the sleeve which corresponds to the distal end of the catheter. The inlet may comprise a one-way valve which prevents fluid flow through the inlet from the fluid collection bag to the sleeve and/or catheter. Thus, the inlet allows liquid to pass into the fluid collection bag but optionally may prevent fluid flow out of the bag and into the sleeve. This can reduce the likelihood of leaking.

The fluid collection bag may be configured to be withdrawn through the opening before the catheter. The fluid collection bag may be configured to withdraw the catheter from the pouch. Thus, the fluid collection bag facilitates removal of the catheter from the pouch without the user having to touch the catheter.

The fluid collection bag may be arranged to span across a majority of the width of the pouch, preferably when in the stowed configuration. Thus, the fluid collection bag may span a majority of the opening, preferably when in the stowed configuration. The fluid collection bag may span at least 50%, 60%, 70%, 80%, or 90% of the width of the pouch, preferably when in the stowed configuration. Thus, the fluid collection bag forms a barrier across the opening in the pouch and protects the contents of the pouch.

The fluid collection bag may be arranged to span across a minority of the height of the pouch, preferably when in the stowed configuration. The fluid collection bag may span no more than 50%, 40%, 30%, 20%, or 10% of the height of the pouch, preferably when in the stowed configuration. Thus, the fluid collection bag provides space in the pouch for the other components.

In another embodiment, there is provided a packaged catheter assembly comprising a catheter, a pouch, and a fluid collection bag configured to receive fluid from the catheter in use, wherein: the catheter and fluid collection bag are arranged within the pouch; the pouch comprises an interaction region to form an opening in the pouch and allow the fluid collection bag and catheter to be removed from the pouch; and the fluid collection bag is arranged adjacent to the opening, wherein the pouch comprises two walls and a peripheral seal between the two walls, the peripheral seal comprises a left lateral edge, right lateral edge, an upper edge and a base of the pouch, the pouch has a width defined between the left lateral edge and right lateral edges and a height defined between the upper edge and base, wherein the fluid collection bag is provided in a stowed configuration while inside the pouch, wherein the fluid collection bag spans across a majority of the width and a minority of the height of the pouch when in the stowed configuration, wherein the fluid collection bag comprises an inlet provided at one end of the width of the stowed fluid collection bag to allow fluid to enter the bag from the distal end of the catheter.

The fluid collection bag may be arranged closer to the upper edge of the pouch than the base. The fluid collection bag may be arranged at least 1/2, 2/3, 3/4 or 4/5 of the way from the base to the upper edge of the pouch. Thus, the fluid collection bag is arranged in the upper region of the pouch and close to the opening. The catheter may not be arranged in the upper region occupied by the fluid collection bag, preferably the catheter is arranged completely outside the upper region. The upper region may be defined substantially between the inlet and the opening. The fluid collection bag may be completely within the upper region. This ensures the bag adequately protects the catheter.

Accordingly, in one embodiment, there is provided a packaged catheter assembly comprising a catheter, a pouch, and a fluid collection bag configured to receive fluid from the catheter in use, wherein: the catheter and fluid collection bag are arranged within the pouch; the pouch comprises an interaction region to form an opening in the pouch and allow the fluid collection bag and catheter to be removed from the pouch; and the fluid collection bag is arranged adjacent to the opening, wherein the fluid collection bag comprises an inlet to allow fluid to enter the bag from the distal end of the catheter, wherein the fluid collection bag is arranged completely within an upper region of the pouch and the upper region is defined between the inlet and the opening.

The fluid collection bag may obscure the catheter from the opening. The fluid collection bag may be arranged to span across a majority of the opening. The fluid collection bag may span at least 50%, 60%, 70%, 80%, or 90% of the opening. The fluid collection bag may obscure the rest of the contents of the bag from the opening. Thus, the user is less likely to see and then immediately grasp or touch the catheter itself. Accordingly in one embodiment, there is provided a packaged catheter assembly comprising a catheter, a pouch, and a fluid collection bag configured to receive fluid from the catheter in use, wherein: the catheter and fluid collection bag are arranged within the pouch; the pouch comprises an interaction region to form an opening in the pouch and allow the fluid collection bag and catheter to be removed from the pouch; and the fluid collection bag is arranged adjacent to the opening, wherein the fluid collection bag obscures the catheter from the opening.

The fluid collection bag may be configured to separate the two walls of the pouch. The fluid collection bag may be configured to separate the two walls of the pouch at the opening of the pouch. Thus, once the opening is formed in the pouch, the fluid collection bag removes the need for the user to separate the walls of the pouch which can be inconvenient or difficult, especially for users with reduced mobility.

The inlet of the fluid collection bag may be arranged adjacent to one lateral edge of the pouch. Where the packaged catheter assembly comprises a gripping element and/or a tear start, the inlet of the fluid collection bag may be arranged on the same side of the pouch as the gripping element and/or tear start. Thus, the inlet is positioned to ensure the distal end of the catheter is arranged along the same side of the pouch as the gripping element and/or tear start. This helps the catheter to be withdrawn in a smooth and straight pulling action parallel to the lateral edge of the bag which reduces the force required to remove the catheter from the pouch.

The catheter may be arranged within the pouch in a curved and/or coiled configuration. The distal end of the catheter may be adjacent to the inner (left or right) lateral edge near the upper edge of the pouch. The catheter may extend down the inside of the pouch. Consequently, the catheter may extend from the distal end substantially parallel to a lateral edge of the pouch. The catheter may extend substantially parallel to a lateral edge of the pouch over at least 10%, 20%, 30%, 40% or 50% of the height of the pouch from the distal end. The catheter may extend down through the aperture in the gripping element. The catheter may have a broadly elliptical anti-clockwise (or clockwise) coil as viewed with left lateral edge on the left, and upper edge at the top. The coil may have a single turn around the inner perimeter of the left lateral edge (or right lateral edge), base, and right lateral edge (or left lateral edge) of the pouch. The proximal end of the catheter may rest on the outside of the catheter’ s coil. The proximal end of the catheter may rest adjacent to the left lateral edge (or right lateral edge and base of the pouch. Thus, the catheter is safely stored within the pouch in a curved configuration which minimises risk of damage to the catheter - for example through kinking of the catheter - and also facilitates easy withdrawal of the catheter by pulling it by its distal end.

Consequently, in one embodiment there is provided a packaged catheter assembly comprising a catheter, a pouch, and a fluid collection bag configured to receive fluid from the catheter in use, wherein: the catheter and fluid collection bag are arranged within the pouch; the pouch comprises an interaction region to form an opening in the pouch and allow the fluid collection bag and catheter to be removed from the pouch; and the fluid collection bag is arranged adjacent to the opening, wherein the pouch comprises two walls and a peripheral seal between the two walls, the peripheral seal comprises a left lateral edge, right lateral edge, an upper edge and a base of the pouch and the opening is formed in or near the upper edge of the pouch, the pouch has a width defined between the left lateral edge and right lateral edges and a height defined between the upper edge and base, wherein the fluid collection bag is provided in a stowed configuration while inside the pouch, wherein the fluid collection bag spans across a majority of the width and a minority of the height of the pouch when in the stowed configuration, and the catheter extends from the distal end of the catheter parallel to a lateral edge of the pouch.

Alternatively, the catheter may be arranged within the pouch in a shape having two opposing turns of at least 180 degrees along the catheter’s length. This S-shape is outlined further below in relation to a nineth aspect of the invention.

The inlet of the fluid collection bag may be positioned at a comer of the peripheral bond. The fluid collection bag may comprise a neck adjacent to the inlet. The neck may comprise one or more projections extending into the fluid collection bag. The one or more projections may comprise regions of the peripheral bond that extend into the bag. The one or more projections may restrict fluid flow through a region of the bag adjacent to the inlet. The projections may be configured to provide gripping points adjacent to the inlet. Thus, the fluid collection bag resists the flow of fluid back towards the inlet and also is more easily handled by the user.

Any one or more of the one or more projections may have any one or more of the features of a projection as described below.

A projection may have any suitable size or shape. A projection may be triangular, square, rectangular, circular, ellipsoidal or irregularly shaped, preferably, a projection is triangular. A point on the projection furthest from an edge of the bag may be a (right-angled) comer in the projection. The projection may be a right-angled triangle. The hypotenuse of the projection may be aligned parallel to an edge of the bag. Thus, the projections can be suitably shaped to minimise loss of volume in the bag due to the projections. In addition, its shape can help to direct fluid flow within the bag, for example assisting flow into the bag and reducing flow out of the bag.

A projection may extend along no more than 90%, 80%, 70%, 60%, 50%, 40%, 30%, 20% or 10% of the length of an edge of the bag. A projection may extend by at least 10%, 20%, 30%, 40%, 50%, 60%, 70%, 80%, or 90% of the length of an edge of the bag. A projection may comprise a comer of the bag. A projection may not comprise from a corner of the bag. Thus, the projections can be flexibly sized and positioned to be most effective.

A projection may be a lateral projection extending from a left (or right) lateral edge of the bag. The lateral projection may be provided on the same side of the bag as the inlet. The lateral projection may extend along 10-40% of the length of the lateral edge of the bag, preferably 25%. The lateral projection may extend across 5-20% of the width of the bag, preferably 10%. The lateral projection may be a right-angled triangle. The right-angled vertex of the lateral projection may project into the bag. The right-angled vertex may be positioned below the inlet inside the bag. The right-angled vertex may be positioned 10% of the way from the upper edge to the base of the bag. The non-right-angled vertices of the lateral projection may be provided on the lateral edge of the bag from which the lateral projection extends. Thus, the lateral projection can assist in directing the flow of fluid into the bag and also helps prevent fluid flowing directly from the bag back up into the sleeve/catheter. A projection may be an end projection extending from the upper edge or base of the bag. Preferably, the end projection extends from the upper edge. The end projection may be provided adjacent to the inlet. The end projection may extend along 40-95% of the width of the bag, preferably 90%. The end projection may extend from a corner of the bag. The end projection may extend down 5-20% of the length of the bag, preferably 10%. The end projection may be a right-angled triangle. The right- angled vertex of the end projection may project into the bag. The right-angled vertex may be positioned adjacent the inlet inside the bag. The right-angled vertex may be positioned 20% of the way across the width of the bag. The non-right- angled vertices of the lateral projection may be provided on the edge of the bag from which the end projection extends. Thus, the end projection can assist in directing the flow of fluid into the bag and also helps prevent fluid flowing directly from the bag back up into the sleeve/catheter.

In a preferred embodiment, the fluid collection bag comprises both a lateral projection and an end projection extending from the upper edge of the bag as described above. Thus, the two projections work together to assist the user in handling the bag and also to manage fluid flow into/out of the bag.

A projection may comprise a rib. The rib may resist bending or deformation in a given direction. The rib may facilitate folding of the fluid collection bag. The rib may assist the user in grasping or gripping the bag. The strengthening element may comprise a region of the projection that is thicker or thinner than the rest of the projection. The rib may be any suitable shape or size, such as a line which could be straight or curved. The rib may extend across the projection. The rib may extend from an edge of the bag. The rib may extend from a midpoint of the projection along the edge of the bag. The rib may extend to a point on the projection furthest from the edge of the bag, for example a right-angled vertex of a right-angled projection. The rib may be at an angle (i.e. not parallel or perpendicular to) an edge of the bag. Preferably, the lateral projection may comprise a rib. Thus, the mechanical properties of the projection can be controlled through use of a rib to the benefit of the user.

A projection may be a join that is independent from the peripheral bond of the fluid collection bag. A join may have any one or more of the features of a projection as described herein. A join can be beneficial to reduce the total area of the panels of the fluid collection bag that are sealed together.

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 finger hole may be provided in a projection of the fluid collection bag. Preferably, the end projection as described above comprises a finger hole. The finger hole may be positioned adjacent to the right-angled vertex of the end projection.

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 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 pouch may comprise a sheath arranged around the fluid collection bag. The sheath may be configured to inhibit wetting fluid from the fluid reservoir from wetting the exterior of the fluid collection bag.

According to a fifth aspect of the present invention there is provided a packaged catheter assembly comprising a pouch, a catheter, a fluid reservoir, and a fluid collection bag configured to receive fluid from the catheter, wherein: the catheter, fluid reservoir and fluid collection bag are arranged within the pouch; the fluid reservoir is configured to release wetting fluid into the pouch to wet the catheter; and the pouch comprises a sheath arranged around the fluid collection bag to inhibit wetting fluid from the fluid reservoir wetting the exterior of the fluid collection bag.

Thus, the sheath makes the fluid collection bag easier to use and more comfortable for the user to handle as it the sheath prevents the exterior of the fluid collection bag from becoming wet. When the exterior is wet, the bag may be slippery which can make handling more difficult, in addition, it can be more likely to stick to itself due to surface tension forces between two wet surfaces.

The fluid collection bag may be provided in a stowed configuration preferably while inside the pouch. The fluid collection bag may be configured to remain in the stowed configuration. The sheath may retain the fluid collection bag in the stowed configuration. In the stowed configuration, the fluid collection bag may be folded or rolled to reduce its size in any one dimension. The stowed configuration may be a folded or rolled configuration. In the stowed configuration the fluid collection bag may be cylindrical in shape. 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 stowed configuration of the fluid collection bag further inhibits fluid flow onto the exterior surface of the fluid collection bag as it must penetrate between folds.

The sheath may be any suitable shape or size. The sheath is preferably tubular. The sheath may have one closed end. The sheath may enclose the majority of the (stowed) fluid collection bag. The sheath may enclose at least 50%, 60%, 70%, 80% or 90% of the outer surface of the (stowed) fluid collection bag, preferably at least 66%. Thus, the sheath is easy to manufacture and effectively inhibits wetting of the majority of the exterior of the fluid collection bag.

The sheath may comprise a fluid (or liquid) impermeable material. For example, the sheath may be formed of a thermoplastic polyurethane (TPU) or low- density polyethylene (LDPE).

The pouch may comprise an interaction region allowing the user to create an opening in the pouch. The axis of the sheath may be arranged parallel to the tear line of the pouch and/or the opening formed in the pouch. This helps to protect the contents of the pouch from dirt when opening the pouch as the sheath provides an additional fluid impermeable barrier.

A first end (for example the closed end) of the sheath may be arranged adjacent to one lateral edge of the pouch, or a first end of the opening. A second end (for example an open end opposite the closed end) of the sheath may be arranged adjacent a second end of the opening. For example, a first end, such as the closed end may be on the opposite side of the pouch as the inlet of the fluid collection bag/gripping element and/or tear start. Thus, the sheath and fluid collection bag are positioned to ensure the distal end of the catheter is arranged along the same side of the pouch as the gripping element and/or tear start. This helps the catheter to be withdrawn in a smooth and straight pulling action parallel to the lateral edge of the bag which reduces the force required to remove the catheter from the pouch. The sheath may be configured to be removed from the fluid collection bag. The sheath may be configured to be removed from the fluid collection bag after withdrawal of the fluid collection bag from the pouch. Thus, the sheath ensures the fluid collection bag is protected while in the pouch but easily useable when required.

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

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

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

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

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

The sleeve may comprise a reservoir adapter. An end of the sleeve may comprise a reservoir adapter. The reservoir adapter may be configured to engage the fluid reservoir. The reservoir adapter may be configured to receive wetting fluid from the fluid reservoir. The reservoir adapter may be configured to detach from the fluid reservoir. The reservoir adapter may be configured to permit the catheter to pass through the reservoir adapter.

According to a broad aspect of the present invention, there is provided catheter assembly comprising a fluid reservoir, a catheter which comprises a proximal end for insertion into the body and a distal end, and a sleeve extending from the proximal end to the distal end, wherein an end of the sleeve comprises a reservoir adapter configured to: engage the fluid reservoir; receive a wetting fluid from the fluid reservoir into the sleeve to wet the catheter; and detach from the fluid reservoir to permit the catheter to pass through the reservoir adapter.

The catheter assembly may be a packaged catheter assembly comprising a pouch containing the fluid reservoir and catheter.

According to a seventh aspect of the present invention, there is provided a packaged catheter assembly comprising a fluid reservoir, a catheter, and a pouch containing the fluid reservoir and catheter, wherein the catheter comprises a proximal end for insertion into the body, a distal end, and a sleeve extending from the proximal end to the distal end, wherein an end of the sleeve comprises a reservoir adapter configured to: engage the fluid reservoir; receive a wetting fluid from the fluid reservoir into the sleeve to wet the catheter; and detach from the fluid reservoir to permit the catheter to pass through the reservoir adapter.

Thus, wetting fluid is efficiently and easily introduced to wet the catheter as the reservoir adapter retains the fluid reservoir at one end of the sleeve. This ensures that wetting fluid is not wasted and also that wetting fluid is less likely to leak out and wet the external surface of the sleeve or pouch which may cause discomfort for the user.

The sleeve may comprise a proximal end and a distal end corresponding to the proximal end and distal end of the catheter respectively. The proximal end of the sleeve may comprise the reservoir adapter. The reservoir adapter may be positioned at or adjacent to the proximal end of the catheter. Thus, the reservoir is adapted to deliver wetting fluid to the proximal end of the catheter first, this ensures that the part of the catheter first introduced into the body is most likely to be adequately wetted. This reduces the risk of injury or discomfort during use of the catheter.

The reservoir adapter may tubular. The reservoir adapter may comprise a bore therethrough. The bore may be sized to allow the catheter to pass through the reservoir adapter. The bore may be sized to allow the catheter and wetting fluid to pass through the reservoir adapter. The reservoir adapter may be configured to inhibit passage of the catheter through the reservoir adapter/bore while the fluid reservoir is engaged by the reservoir adapter. The fluid reservoir may be configured to block the catheter from passing through the reservoir adapter/bore. The fluid reservoir may be configured to block the catheter from passing through the reservoir adapter/bore if the fluid reservoir is engaged by the reservoir adapter. Thus, the catheter may be withdrawn from the sleeve through the reservoir adapter and bore, but only once the fluid reservoir is removed from the reservoir adapter. This helps to protect the catheter from dirt and damage prior to use.

The reservoir adapter may comprise a distal end corresponding to an end of the reservoir adapter attached to the sleeve. The distal end may be circular or cylindrical. The distal end may have an annular cross-section. The distal end may comprise an internal diameter sized to allow the catheter and wetting fluid to pass therethrough. The distal end may have an outer structure that is any shape and optionally does not correspond to the shape of the inner structure. Thus, the sleeve and catheter are attached to the reservoir adapter and the catheter may pass through it.

The reservoir adapter may be configured to engage the fluid reservoir by any suitable means, such as push-fit, bayonet fit, or screw-fit engagement. The reservoir adapter may have an internal size and shape that matches the fluid reservoir. Thus, the fluid reservoir may be easily push-fit into the reservoir adapter.

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. Preferably, the fluid reservoir is elongate and optionally rectangular. The reservoir adapter may be configured to engage a first end of the fluid reservoir. The fluid reservoir may comprise a second end distal the first end. The fluid reservoir may have a length defined as the distance between the first end and the second end. The length of the fluid reservoir may be at least 50mm, at least 60mm, at least 70mm, at least 80mm, at least 90mm, at least 100mm, at least 120mm or at least 140mm. the length of the fluid reservoir may be no more than 160, 150, 140, 120, 100, 90 or 80mm. The length of the fluid reservoir may be between 120 and 150mm, e.g. 140mm, which is typical for fluid reservoirs used for male intermittent catheters. Alternatively the length of the fluid catheter may be between 70 and 90mm, e.g. 80mm. This length is typical for female intermittent catheters, but, because of the provision fo the reservoir adaptor, which ensrues that wetting fluid is not wasted, may be suitable even for male catheters (which are much longer than female catheters).

The reservoir adapter may be configured to extend around the first end of the fluid reservoir. The reservoir adapter may be configured to extend along the fluid reservoir. The reservoir adapter may be configured to extend along at least 10%, 20%, 30%, 40% or 50% of the length of the fluid reservoir. The reservoir adapter may be configured to extend along no more than 60%, 50%, 40%, 30% or 20% of the length of the fluid reservoir. Preferably, the reservoir adapter is configured to extend along a third of the length of the fluid reservoir. Thus the reservoir adapter ensures that the fluid reservoir is securely engaged and that wetting fluid is delivered efficiently from the fluid reservoir into the sleeve.

The reservoir adapter may comprise a proximal end distal from the sleeve. The proximal end may be configured to receive and/or retain the fluid reservoir. The proximal end may extend around and along the fluid reservoir as described above. Where the fluid reservoir is a rectangular sachet, the proximal end may comprise an elliptical annular cross-section. Thus, the fluid reservoir is engaged in a push- fit/interference fit with the reservoir adapter.

The reservoir adapter may comprise a midsection between the proximal end and distal end. The proximal end may be tapered, for example where the proximal end and distal end are different shapes/sizes. The proximal end may have a larger diameter than the distal end. The midsection may be configured to funnel wetting fluid towards the proximal end of the reservoir adapter. The midsection may comprise a convex surface. Thus, the midsection aids handling of the reservoir adapter by the user and also helps ensure wetting fluid passes through the reservoir adapter onto the catheter. The reservoir adapter may comprise a handling element. The handling element may be configured to allow the user to move at least part of the sleeve along the catheter, preferably the proximal end of the sleeve. The reservoir adapter/handling element may have a higher rigidity than the sleeve and/or catheter. The reservoir adapter/handling element may comprise high density polyethylene (HDPE). Thus, the reservoir adapter may act as a handling element for the catheter and provide the user with a convenient point to control the use of the catheter and the movement of the sleeve up and down the catheter.

The reservoir adapter may comprise an inserter tip. The inserter tip may disposed at the proximal end of the reservoir adapter distal from the sleeve. The inserter tip may be configured to guide the passage of the catheter into the body. Thus, the reservoir adapter can be used by the user to ensure comfortable, safe and efficient use of the catheter.

The fluid reservoir may comprise an activation marker. The fluid reservoir may be configure to release wetting fluid upon activation of the activation marker. The activation marker may be on a surface of the fluid reservoir. The activation marker may comprise a region of the fluid reservoir that is identifiable to the user, for example through visual and/or tactile feedback. The activation marker may be located at a position on the fluid reservoir that is not enclosed by the reservoir adapter when the fluid reservoir is engaged by the reservoir adapter. Preferably, the activation marker may be at least visually recognisable, for example a different colour, or pattern, to the fluid reservoir. Thus, the activation marker is easily recognisable while the fluid reservoir is engaged by the reservoir adapter.

The fluid reservoir may be configured to break to release wetting fluid, for example by creating a tear in the fluid reservoir. The fluid reservoir may be configured to break at a point enclosed by the reservoir adapter when the fluid reservoir is engaged by the reservoir adapter. The reservoir adapter and/or fluid reservoir may comprise a sealing element. The sealing element may be configured to prevent wetting fluid from passing out of the proximal end of the reservoir adapter. The sealing element may be configured to provide resistance to movement of the reservoir adapter with respect to the fluid reservoir. The sealing element may comprise an O-ring provided on an internal surface of the reservoir adapter and/or an O-ring provided on an external surface of the fluid reservoir. Thus, wetting fluid is released into the reservoir adapter and does not leak out of the distal end of the reservoir adapter where it could cause discomfort/inconvenience for the user.

The fluid reservoir may be secured to the pouch, e.g. secured by adhesive, by a weld, or by other means. As such, the fluid reservoir may be retained in the pouch after wetting, preventing misuse, e.g. by users taking the fluid reservoir out, pulling back the sleeve and seeking to wet the catheter manually.

The catheter assembly may comprise a jacket surrounding the fluid reservoir. The jacket may be configured to receive a wetting fluid from the reservoir. The jacket may be configured to direct wetting fluid into the sleeve to wet the catheter. Consequently, in a broad aspect of the invention there is provided a catheter assembly comprising a fluid reservoir and a catheter, the catheter having a proximal end for insertion into the body, a distal end, and a sleeve extending from the proximal end to the distal end; the assembly further comprising a jacket surrounding the fluid reservoir, the jacket being configured to receive a wetting fluid from the reservoir and direct the wetting fluid into the sleeve to wet the catheter.

The wetting fluid may be directed to the proximal end of the catheter before the distal end of the catheter. The wetting fluid may be directed into the proximal end of the sleeve.

Thus, according to an eighth aspect of the invention, there is provided a catheter assembly comprising a fluid reservoir and a catheter, the catheter having a proximal end for insertion into the body, a distal end, and a sleeve extending from the proximal end to the distal end; the assembly further comprising a jacket surrounding the fluid reservoir, the jacket being configured to receive a wetting fluid from the fluid reservoir and direct the wetting fluid into the sleeve at the proximal end to wet the catheter.

Thus, the provision of a jacket around the fluid reservoir ensures that the wetting fluid released by the reservoir is directed efficiently onto the catheter to wet the catheter. This prevents loss/leaks of wetting fluid which can lead to insufficient wetting of the catheter rendering it unsuitable for use and/or causing discomfort/injury to the user during use.

The jacket also allows more design freedom in relation to the fluid reservoir and catheter assembly as a whole as the jacket controls the delivery of fluid to the sleeve/catheter. This allows the fluid reservoir/catheter assembly to be more user friendly.

The reservoir adapter may be configured to engage the jacket. The reservoir adapter may engage the fluid reservoir via the jacket. The reservoir adapter may be configured to receive wetting fluid from the fluid reservoir via the jacket. The jacket may be configured to block the catheter from passing through the reservoir adapter (until the jacket is detached from the reservoir adapter). The reservoir adapter may be configured to detach from the jacket (to allow the catheter to pass through the reservoir adapter). Thus, the jacket can provide a more flexible engagement between the reservoir adapter and fluid reservoir, for example, where the fluid reservoir is an inappropriate size to directly engage with the reservoir adapter. The jacket may comprise a wetting aperture. The wetting aperture may be arranged at a position corresponding to a part of the fluid reservoir that is enclosed by the reservoir adapter. The wetting aperture may be arranged at an end of the fluid reservoir, preferably the first end referred to above. The wetting aperture may be configured to direct wetting fluid into the sleeve and/or onto the catheter. Thus, the wetting aperture helps ensure that wetting fluid released by the fluid reservoir is directed into the sleeve.

The fluid reservoir may be configured to rupture before the jacket. The jacket may be configured not to rupture under compression. The wetting aperture may be configured to allow fluids to exit and enter the jacket. Thus, the jacket remains intact when the user pinches the fluid reservoir to rupture it as any pressure build up is relieved through the wetting aperture.

The jacket may be impermeable to fluids, for example impermeable to liquid, in particular impermeable to water. The jacket may be formed of a material that is impermeable to fluids. The jacket may be formed from a flexible plastics material, for example a thermoplastic polyurethane (TPU) or low-density polyethylene (LDPE). Thus, the jacket can ensure that wetting fluid is directed into the sleeve and doesn’t escape/leak out.

The jacket may be formed of a transparent or translucent material. The jacket may be formed of an opaque material. The jacket may comprise a window of transparent or translucent material at a position corresponding to the activation marker of the fluid reservoir. The jacket may comprise an activation marker. The activation marker may be on a surface of the jacket. The activation marker may comprise a region of the jacket that is identifiable to the user, for example through visual and/or tactile feedback. The activation marker may be located at a position on the jacket corresponding to a position of the fluid reservoir which when pressed will cause the reservoir to rupture. The activation marker may be in a position corresponding to the activation marker positioned on the fluid reservoir. Thus, the user can see the activation marker of the fluid reservoir through the jacket (through a window in the jacket if necessary), or alternatively can activate the fluid reservoir through an activation marker disposed on the jacket.

The jacket may be formed from two strips of material joined about their edges. Each strip of material may have a shape corresponding to the shape of the fluid reservoir. The wetting aperture may comprise a section around the edge of the jacket where the two strips of material are not joined together. The wetting aperture may comprise a section of the jacket which has been cut or punched to form the wetting aperture. Thus, the jacket and wetting aperture can be easily formed around the fluid reservoir if required.

The jacket may be secured to the pouch, e.g. secured by adhesive, by a weld, or by other means. As such, the jacket and the fluid reservoir within may be retained in the pouch after wetting, preventing misuse, e.g. by users taking the fluid reservoir out, pulling back the sleeve and seeking to wet the catheter manually.

According to a broad aspect of the present invention, there is provided a packaged catheter assembly comprising a pouch and a catheter arranged within the pouch, wherein the catheter is arranged within the pouch in a shape having two opposing turns of at least 180 degrees along the catheter’s length. The pouch may comprise two walls and a peripheral seal between the two walls (as described above).

Accordingly, in a nineth aspect of the present invention there is provided a packaged catheter assembly comprising a pouch having two walls and a peripheral seal between the two walls and a catheter arranged within the pouch, wherein the catheter is arranged within the pouch in a shape having two opposing turns of at least 180 degrees along the catheter’s length.

Thus, the catheter is arranged in an “S-shape” which helps to retain the catheter (and anything connected to it) in a specific orientation while sealed within the pouch. This ensures the catheter is easy to remove from the pouch and use. In addition, it helps to protect the catheter from damage for example by reducing the likelihood of kinks forming along the catheter.

This is especially useful where the packaged catheter assembly is a packaged catheter assembly according to the seventh aspect of the invention as the catheter can easily be withdrawn to a straight (i.e. substantially straight) configuration by pulling the distal end of the catheter straight out of the opening of the bag, whilst leaving the proximal end of the catheter in its position. Then, the catheter assembly can be simply inverted and wetting fluid can flow straight down the sleeve. Obviously this approach could be trickier if the catheter were curled up inside the pouch.

Three advantages associated with this arrangement of the catheter are that it will be easier to pull out of the primary packaging (pouch); less coiled and therefore, easier to straighten out; and users do not have to uncoil it as it uncoils itself.

The two opposing turns may comprise a first turn and a second turn.

The distal end of the catheter may be adjacent to the inner (left or right) lateral edge near the upper edge of the pouch. The catheter may extend down the inside of the pouch. The two opposing turns may comprise a first turn arranged at an end of the pouch distal from an opening formed in the pouch. The first turn may be adjacent the base of the pouch. The catheter may then extend back up the pouch. The catheter may extend back up through a central region of the pouch, i.e. in a central half, third or quarter of the width of the pouch. The catheter may extend in a direction towards the distal end of the catheter. The two opposing turns may comprise a second turn arranged at an end of the pouch adjacent to an opening formed in the pouch. The second turn may be positioned adjacent the fluid collection bag. The second turn may be at a height in the pouch corresponding to the position of the distal end of the catheter. The catheter may then extend down the inside of the pouch. The catheter may extend adjacent to the inner edge opposite the edge adjacent to the distal end of the catheter (i.e. the right or left lateral edge). The proximal end of the catheter may be positioned approximately half the way down the height of the pouch. Thus, the catheter is safely stored within the pouch in a curved configuration which minimises risk of damage to the catheter - for example through kinking of the catheter - and also facilitates easy withdrawal of the catheter by pulling it by its distal end.

The catheter may be configured to be withdrawn from the pouch by the distal end of the catheter. The catheter may be configured such that during withdrawal of the catheter from the pouch the radius of curvature of a, or each, turn in the catheter is constant or increases. The two opposing turns may be configured to unravel simultaneously (during withdrawal of the catheter from the pouch). The two opposing turns may be configured to unravel after withdrawal of the catheter from the pouch. Thus, by pulling the catheter out of the pouch by its distal end, the catheter unravels without any one part of the catheter curving excessively, which could cause damage to the catheter.

The fluid reservoir may have a length of at least 20%, 30% or 40% the height of the pouch. The fluid reservoir may have a length no more than 50%, 40% or 30% the height of the pouch. Preferably the fluid reservoir has a length of 30% the height of the pouch. The fluid reservoir may have a width of at least 5%, 10%, 15% or 20% the width of the pouch. The fluid reservoir may have a width of no more than 25%, 20%, 15% or 10% the width of the pouch. Preferably, the fluid reservoir has a width of 15% the width of the pouch. The fluid reservoir (and reservoir adapter) may extend from the proximal end of the catheter to the base of the pouch. Thus, the fluid reservoir may be flexibly shaped and sized to conveniently fit within the pouch while allowing the catheter to remain in its S-shape. A, or each, turn may comprise a turn of at least 180, 190, 200, 210 or 220 degrees. A, or each, turn may comprise a turn of no more than 230, 220, 210, 200 or 190 degrees. Preferably, a, or each, turn is between 180-220 degrees and most preferably a, or each, turn is 200 degrees. This ensures that the shape of the catheter makes best use of the pouch and that the catheter is protected.

A, or each, turn may comprise a constant curvature. Alternatively, a, or each, turn may comprise a variable curvature.

A, or each, turn may comprise a radius of curvature of at least 1/5, 1/4 or 1/3 the width of the pouch. A, or each, turn may comprise a radius of curvature of no more than 1/2, 1/3, or 1/4 the width of the pouch. Preferably, the radius of curvature of a, or each, turn is 1/3 the width of the pouch. A, or each, turn may span at least 1/4, 1/3, 1/2, or 2/3 the width of the pouch. A, or each, turn may span no more than 3/4, 2/3, 1/2, or 1/3 the width of the pouch. Preferably, a, or each, turn spans 2/3 the width of the pouch. Thus, the size of the turns and their respective radii of curvature are maximised to protect the catheter while providing space in the pouch for the other components of the catheter assembly as required.

According to a broad aspect of the present invention, there is provided a fluid collection bag for a catheter assembly, wherein the fluid collection bag comprises a hand strap.

‘Hand strap’ as used herein means a strap sized to be easily gripped by hand.

The fluid collection bag may be provided in a packaged catheter assembly, the packaged catheter assembly may comprise a pouch, a catheter, and the fluid collection bag. The packaged catheter assembly may comprise a fluid reservoir. The fluid collection bag may be configured to receive fluid from the catheter. The catheter, fluid reservoir and fluid collection bag may be arranged within the pouch. The fluid collection bag may comprise a front panel and a rear panel. A bond between the two panels may define a (internal) cavity.

The fluid collection bag of the broad aspect of the invention may comprise any of the features, including any optional features, as described in relation to the first to nineth aspects, or any other aspect, of the invention below. According to a tenth aspect of the present invention, there is provided an intermittent catheter assembly comprising: a catheter having a proximal end for insertion into the body and a distal end; and a fluid collection bag arranged to receive fluid from the distal end of the catheter, wherein the fluid collection bag comprises a hand strap.

Advantageously, if the user is to hold the fluid collection bag when in use, the hand strap provides for a convenient and easy way of holding the fluid collection bag, where the hand strap can be temporarily worn around the user’s wrist or be easily held. As such, the provision of a hand strap overcomes the problems of prior art intermittent catheters and ensures that the catheter is easy and convenient to use, in addition to being discrete and hygienic.

Further, the hand strap allows the fluid collection bag to be easily manipulated by the user during use. This means that the bag can be easily handled and manoeuvred by the user as is necessary. It also means that the user is no longer relying on their surroundings to use the catheter. For example, catheters described in the prior art are difficult to hold during use and so may need to be placed on the floor or leaning against an object to support the fluid collection bag during use. As stated above, this is associated with its own disadvantages. The present invention provides an assembly which can be easily and reliably held by the user.

Moreover, the provision of a hand strap means that the fluid collection bag can be hung from any suitable article, such as a wheelchair handle or bed post, when the catheter assembly is in use, i.e., during urination. Beneficially for the user, this means that the user does not need to transfer to a toilet cubicle or place the bag on the floor, which is plainly unhygienic, in order to urinate.

The fluid collection bag may receive fluid via an inlet arranged at an edge of the fluid collection bag. The hand strap may be arranged on the same edge as the inlet.

Advantageously, this means that when the fluid collection bag is held via the hand strap, for example by a user or by an article such as a wheelchair handle, the fluid entering the fluid collection bag flows away from the inlet, preventing back flow of the fluid toward the inlet and then the catheter, which can prevent the bag from being filled. Further advantageously, this provides for easier manipulation of the bag relative to the inlet. In use, it may be that the user will have to adjust the catheter and this will likely affect the position of the catheter relative to the fluid collection bag. As such, it is beneficial that the present invention provides for a fluid collection bag which can be easily manoeuvred and adjusted in use.

The fluid collection bag may comprise a front panel and a rear panel, and a bond between the two panels defining an internal cavity. The bond may be a peripheral bond. 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 8, 10, 12, 15 or 20 cm. The bag may have a width no more than 25, 20, 15, 10 or 8 cm. Preferably, the width is between 8and 20 cm, more preferably between 10 and 15 cm, and most preferably about 12 cm. The base may define a bottom of the bag. The upper edge may define a top of the bag. The height of the bag from the base to the upper edge may be at least 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 35 cm, or most preferably between 28 and 32 cm, for example 30 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 inlet may be arranged at the upper edge, left lateral edge, right lateral edge, or base of the fluid collection bag. Preferably, the inlet is arranged at the upper edge of the fluid collection bag. The hand strap may be arranged at the upper edge, left lateral edge, right lateral edge, or base of the fluid collection bag. Preferably, the hand strap is arranged at the upper edge of the fluid collection bag.

The hand strap may be arranged on a corner of the fluid collection bag where the upper edge and left lateral edge meet, a corner where the upper edge and right lateral edge meet, a corner where the left lateral edge and base meet, or a comer where the right lateral edge and base meet. The fluid collection bag may comprise an outlet provided to allow fluid to pass out of the fluid collection bag after use. The hand strap may be arranged at an opposite end of the fluid collection bag to the outlet. Advantageously, this means that, in use, the bag is arranged such that the fluid entering the bag flows toward the outlet, preferably at or toward the base of the bag, irrespective of the position of the inlet. This facilitates draining of the bag during and/or after use. Moreover, when the user wishes to drain the bag, the bag can be held via the hand strap and the fluid discharged from the bag via the outlet, therefore, the user is not required to upend the bag to pour away the contents, which can be cumbersome.

The outlet may be arranged at the upper edge, left lateral edge, right lateral edge, or base of the fluid collection bag. The outlet may be arranged on the front panel or rear panel of the fluid collection bag, toward the upper edge, left lateral edge, right lateral edge or base. Preferably, the outlet is arranged on the front panel toward the base of the fluid collection bag.

The outlet may be arranged off-centre when the fluid collection bag is viewed with the rear panel behind the front panel. The outlet may be arranged off-centre, toward the left lateral edge or toward the right lateral edge.

The outlet may be arranged off-centre toward the side of the fluid collection bag on which the hand strap is arranged. For example, the hand strap may be arranged on the corner where the upper edge and right lateral edge meet, and the outlet may be arranged proximal to the base, off-centre toward the right lateral edge.

The hand strap may be joined 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. In a preferred embodiment, the hand strap is joined to the bag by a weld. Advantageously, the hand strap may be joined to the bag easily and added to the fluid collection bag construction as part of conventional techniques for the manufacture of fluid collection bags.

The length of the hand strap may be between about 4 and about 30 cm, between about 5 and about 28 cm, between about 6 and about 26 cm, between about 7 and about 24 cm, between about 8 and about 22 cm, between about 9 and about 20 cm, between about 10 and about 19 cm, between about 11 and about 18 cm, between about 12 and about 17 cm, between about 13 and about 16 cm, between about 14 and about 16 cm, or about 15 cm. Advantageously, this provides a hand strap which can be arranged around many articles which a user may wish to hang the hand strap upon, such as a wheelchair handle or bed frame.

The length of the hand strap may be at least about 4 cm, about 5 cm, about 6 cm, about 7 cm, about 8 cm, about 9 cm, about 10 cm, about 11 cm, about 12 cm, about 13 cm, about 14 cm, about 15 cm, about 16 cm, about 17 cm, about 18 cm, about 19 cm, about 20 cm, about 22 cm, about 24 cm, about 26 cm, about 28 cm or at least about 30 cm.

The length of the hand strap may be no more than about 4 cm, about 5 cm, about 6 cm, about 7 cm, about 8 cm, about 9 cm, about 10 cm, about 11 cm, about 12 cm, about 13 cm, about 14 cm, about 15 cm, about 16 cm, about 17 cm, about 18 cm, about 19 cm, about 20 cm, about 22 cm, about 24 cm, about 26 cm, about 28 cm or no more than about 30 cm.

The hand strap may have a length equal to between about 20 and 100 %, between about 30 and about 90 %, between about 35 and about 80 %, between about 35 and about 70 %, between about 40 and about 60 %, between about 45 and about 55 %, or about 50% of the length of the fluid collection bag.

The hand strap may have a length equal to at least about 20%, about 30%, about 40%, about 50%, about 60%, about 70%, about 80%, about 90%, or at least about 100% of the length of the fluid collection bag.

The hand strap may have a length equal to no more than about 20%, about 30%, about 40%, about 50%, about 60%, about 70%, about 80%, about 90%, or no more than about 100% of the length of the fluid collection bag.

The size of the hand strap may be fixed, i.e., the size of the hand strap may not be adjustable. This means that the length of the hand strap cannot be decreased or increased. This may provide a more secure hand strap because means for shortening or lengthening the strap can create areas of weakness in the hand strap, which can cause the strap to break after repeated use or increased tension. Alternatively, the size of the hand strap may be adjustable such that the length of the hand strap can be decreased or increased.

The hand strap may have a width of between about 0.5 and about 4 cm, between about 0.6 and about 3.6 cm, between about 0.6 and about 3.2 cm, between about 0.7 and about 2.8 cm, between about 0.75 and about 2.4 cm, between about 0.8 and about 2 cm, between about 0.85 and about 1.6 cm, between about 0.9 and about 1.2 cm, between about 0.95 and about 1.1 cm, or about 1 cm.

The hand strap may have a width of at least about 0.5 cm, about 0.6 cm, about 0.7 cm, about 0.8 cm, about 0.9 cm, about 1 cm, about 1.5 cm, about 2 cm, about 2.5 cm, about 3 cm, about 3.5 cm, about 4 cm, about 4.5 cm, or at least about 5 cm.

The hand strap may have a width of no more than about 0.5 cm, about 0.6 cm, about 0.7 cm, about 0.8 cm, about 0.9 cm, about 1 cm, about 1.5 cm, about 2 cm, about 2.5 cm, about 3 cm, about 3.5 cm, about 4 cm, about 4.5 cm, or no more than about 5 cm.

The width of the hand strap may be constant along its entire length.

The hand strap may be a loop of material or a strip of material. The hand strap may be a single, continuous loop of material.

Where the hand strap is a strip of material it may be attached at only one end to the fluid collection bag. Where the hand strap is a loop of material, it may be attached at two ends to the fluid collection bag. Where the hand strap is a loop of material, it may be joined to the fluid collection bag at two positions on the fluid collection bag. Each of the two positions may be substantially the same.

The hand strap may be joined to the fluid collection bag at a first position and at a second position. Preferably, the first position and the second position are substantially the same. The first position and the second position may each be on the upper edge, left lateral edge, base, right lateral edge, front panel, or rear panel of the fluid collection bag. The first position may be on a different edge or panel to the second position. For example, the first position may be on the front panel and the second position may be on the rear panel. As a further example, the first position may be on the upper edge and the second position may be on the rear panel. The hand strap may be joined to the fluid collection bag via an aperture on the surface of the bag, and the hand strap is threaded through the aperture. The aperture may be provided on an edge of the fluid collection bag, preferably on the upper edge of the bag.

The hand strap may be formed of polyethylene terephthalate (PET), polypropylene or low-density polyethylene (LDPE).

The catheter may have a length of at least about 10 cm, about 15 cm, about 20 cm, about 25 cm, about 30 cm, about 35 cm, about 40 cm, about 45 cm, or about 50 cm.

The catheter may have a length of no more than about 70, 60, 50, 45, 40 or 35cm.

The catheter may have a width of no more than about 10 cm, about 15 cm, about 20 cm, about 25 cm, about 30 cm, about 35 cm, about 40 cm, about 45 cm, about 50 cm, about 55 cm, about 60 cm, about 65 cm, about 70 cm, about 80 cm, about 90 cm, or no more than about 100 cm.

The intermittent 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, polyether 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 intermittent catheter may be formed of a material of the group comprising: polyolefins, polyesters, polyacrylates, polyamides, thermoplastic elastomeric material, polyether block amide, thermoplastic vulcanizates, thermoplastic copolyesters, thermoplastic polyamides, fluororubber, and water disintegrable or enzymatically hydrolysable material or combinations, blends or co-polymers 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.

At least a portion of the fluid collection bag may be formed from an opaque material or be coated to present the appearance of being opaque. At least 10%, 20%, 30%, 40%, 50%, 60%, 70% or at least 80% of the fluid collection bag may be formed from an opaque material or be coated to present the appearance of being opaque. No more than 10%, 20%, 30%, 40%, 50%, 60%, 70% no more than 80% of the fluid collection bag may be formed from an opaque material or be coated to present the appearance of being opaque. The fluid collection bag may be opaque at the inlet and/or outlet. Advantageously, this makes the contents of the pouch during and after use at least partially hidden and, therefore, more discrete for the user.

The inlet may be located at the end of a spout. The spout may extend from the upper edge, left lateral edge, base or right lateral edge of the fluid collection bag, but preferably from the upper edge. The diameter of the spout may remain constant for its entire length. The spout may comprise an end, distal to the fluid collection bag, which comprises the inlet. The spout may have a length, i.e., the distance from where the spout joins an edge of the fluid collection bag to the inlet, of between 2 and 14 cm, between 4 and 12 cm, between 6 and 10 cm, between 7 and 9 cm, or about 8 cm.

Advantageously, the spout makes it easier for the user to locate the inlet and provides a more secure connection between the catheter and the fluid collection bag.

The fluid collection bag may comprise an outlet valve configured to control release of fluid out of the fluid collection bag in use. The outlet valve may comprise: a valve base attached to a panel of the fluid collection bag, the valve base comprising a base opening for receiving a liquid output from the fluid collection bag; and an outlet element configured to be laterally rotatable relative to the valve base from a closed configuration to an open configuration.

The outlet element may comprise a handle operable to rotate the outlet element between the closed configuration and the open configuration. The handle may be planar.

The plane of handle may be aligned with, i.e., parallel with, the plane of the panel of the fluid collection bag to which the valve base is attached, when in the closed configuration.

According to an eleventh aspect of the invention, there is provided an intermittent catheter assembly comprising a catheter having a proximal end for insertion into the body and a distal end, a fluid collection bag arranged to receive fluid from the distal end of the catheter, wherein the fluid collection bag comprises an outlet valve configured to control release of fluid out of the fluid collection bag in use, the outlet valve comprising: a valve base attached to a panel of the fluid collection bag, the valve base comprising a base opening for receiving a liquid output from the fluid collection bag; and an outlet element configured to be laterally rotatable relative to the valve base from a closed configuration to an open configuration.

Advantageously, the provision of the outlet element configured to be laterally rotatable relative to the valve base from a closed configuration to an open configuration means that the outlet valve is easily operable by a user. Of course the downsides of a laterally rotatable outlet element associated with Foley catheters is irrelevant to intermittent catheters as the fluid collection bag is not attached to the user. The lateral rotation of the outlet element does not require movement of the fluid collection bag to be restricted, for example by holding the bag, to operate the valve. Thus, the outlet valve can be operated by a user with limited dexterity and by users to whom the fluid collection bag is not attached to their body, such as where the catheter is an intermittent catheter.

The outlet element may be rotatable such that the outlet element moves through an arc of rotation and wherein at a first end of the arc of rotation, the outlet element may be in the closed configuration, and at a second end of the arc of rotation, the outlet element may be in the open configuration.

The fluid collection bag may comprise a base and an upper edge and first and second lateral edges. 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 outlet valve may be arranged on the front panel, rear panel, upper edge, left lateral edge, right lateral edge, or base of the fluid collection bag. The outlet valve may be arranged on the front panel or rear panel of the fluid collection bag, toward the upper edge, left lateral edge, right lateral edge, or base. The means that the outlet valve may be arranged proximal to the upper edge, left lateral edge, right lateral edge, or base. Preferably, the outlet valve is arranged on the front panel toward the base of the fluid collection bag. It will be understood that the left and right edges need not be sharp edges and whilst a preferred embodiment comprises front and rear walls joined at their periphery to define the upper edge, left lateral edge, right lateral edge and base, alternatives could be envisaged, such as a cylindrical fluid collection bag, with circular upper and lower edges and left and right edges formed by the curved left and right sides of the cylinder.

In the closed configuration, the outlet element may substantially overlie a cavity of the fluid collection bag. The outlet element may comprise a handle.

The handle may be rotatable from a position closer to the first lateral side to a position closer to the second lateral side.

The handle may be planar. Advantageously, this means that the handle is discreet and compact, and does not protrude away from the fluid collection bag. Thus, the handle is less likely to become caught on an object or be accidentally operated by the user, which may otherwise lead to unintentional opening of the outlet element when the fluid collection bag contains fluid.

The handle may comprise a finger-hole. The handle may be sized to allow at least one finger to pass through it. The handle may be sized to allow a user to grip it between at least their thumb and index finger. The handle may be any suitable shape, for example, circular, elliptical, square or irregularly shaped. Preferably, the aperture is elliptical. Thus, the user, in particular users with limited dexterity, can more easily grasp the outlet element, to operate the outlet valve.

The handle may be operable to rotate the outlet element between the closed configuration and the open configuration. Thus, the user, in particular users with limited dexterity, can more easily grasp the outlet element to operate the outlet valve.

The plane of the handle may be aligned with, i.e., parallel with, the plane of the panel of the fluid collection bag to which the valve base is attached, when in the closed configuration. The plane of the handle may be aligned with the plane of the panel of the fluid collection bag to which the valve base is attached, when in the open configuration. Advantageously, this means that the handle provides tactile feedback to the user to confirm when the handle, and therefore the outlet element, is in the open configuration or the closed configuration as the handle will be aligned with the valve base in each configuration. The user therefore has certainty that the outlet element is either open or closed, as desired.

Moreover, there is a reduced risk of the handle being caught on an object or be accidentally operated by the user, which may otherwise lead to unintentional opening of the outlet element when the fluid collection bag contains fluid. The handle may rotate by at least about 90, about 120, about 150 or about 180 degrees between the closed configuration and the open configuration. Advantageously, this means that a rotation of significant magnitude is required to operate the outlet valve whilst till providing a rotation easily manageable by those with limited dexterity. This reduces the possibility of accidentally opening the outlet valve which may occur should the required rotation be smaller.

The handle may rotate by no more than about 90, about 120, about 150 or about 180 degrees between the closed configuration and the open configuration.

The handle may be inhibited from rotating more than 180 degrees clockwise or anti-clockwise due to obstruction by the valve base.

The handle may extend above the outlet element. The handle may extend above the valve base. When in the closed or open configuration, the handle may extend laterally further than the valve base. Advantageously, this means that the handle is sufficiently sized to be easily grasped by a user, in particular by a user with limited dexterity.

The valve base may be any suitable shape, for example, circular, elliptical, square, trapezoidal or irregularly shaped. Preferably, the valve base is trapezoidal.

The valve base may be attached to a panel of the fluid collection bag 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. In a preferred embodiment, the valve base is attached to a panel of the fluid collection by a weld. Advantageously, the valve base may be joined to the bag easily and added to the fluid collection bag construction as part of conventional techniques for the manufacture of fluid collection bags.

The valve base may comprise a housing which houses a portion of the outlet element and in which the outlet element rotates. Thus, the housing may protect the outlet element from knocks against other objects, or similar. This prevents the outlet element becoming damaged and potentially inoperable or faulty.

The housing may define a cylindrical bore. The handle may be connected to the outlet element.

The handle may be integrally formed with the outlet element. The handle and the outlet element may be formed as a single moulding.

The outlet element may have a generally tubular form.

The housing may have a generally tubular form.

The outlet element have a connector portion which may be may be configured for use with a connector having a connector diameter, the housing having a diameter marginally smaller than the connector diameter such that, on insertion of the connector onto a distal end of the housing in use, the connector portion can accommodate the connector.

The connector portion may comprise a flange distal to the outlet element. The flange may be arranged to inhibit a connector being extended toward the outlet element whilst still allowing the connector portion to accommodate the connector. The flange may be annular. The flange may be tapered inwardly as it extends away from the outlet element.

The valve base may be formed of a material which is more rigid than the relatively flexible material from which the fluid collection bag is formed. This assists the user in rotating the outlet element.

The valve base, housing and/or outlet element may be formed, for example, from polypropylene or High-density polyethylene (HDPE), acrylonitrile butadiene styrene (ABS) or polycarbonate. The materials of the valve base, housing and the outlet element may be chosen to have different shrinkage rates to allow for hot assembly of these two components to produce a good seal therefore preventing leakage. The use of different materials may also be different to avoid sticking between the two components over time.

The outlet element may be rotatable about a vertical axis of rotation when in use.

The outlet element may be rotatable about an axis parallel to the longest dimension of the fluid collection bag. The longest dimension of the fluid collection bag may be along the left lateral edge and along the right lateral edge, i.e., between the upper edge and the base.

The outlet element may be rotatable about an axis parallel to the plane of the panel of the fluid collection bag to which the valve base is attached, when in the closed configuration or the open configuration.

The valve base may be arranged on the front panel of the fluid collection bag. The outlet element may be rotatable about an axis parallel to the plane of a front panel of the fluid collection bag. The valve base may be arranged on the rear panel of the fluid collection bag. The outlet element may be rotatable about an axis parallel to the plane of a rear panel of the fluid collection bag.

The outlet valve may be arranged on the front panel or on the rear panel of the fluid collection bag.

The outlet element may protrude from an outer face of the valve base. The outlet element may protrude from an outer face of the valve base no more than 1cm, 1.5cm, 2cm, 2.5cm, 3cm, 3.5cm, 4cm, 4.5cm, or no more than 5cm. The outlet element may protrude from an outer face of the valve base by at least 1cm, 1.5cm, 2cm, 2.5cm, 3cm, 3.5cm, 4cm, 4.5cm, or at least 5cm.

When in the open configuration or in the closed configuration, the outlet valve may extend from the surface of the fluid collection bag no more than 1cm, 1.5cm, 2cm, 2.5cm, 3cm, 3.5cm, 4cm, 4.5cm, or no more than 5cm.

When in the open configuration or in the closed configuration, the outlet valve may extend from the surface of the fluid collection bag by at least 0.5cm, 1cm, 1.5cm, 2cm, 2.5cm, 3cm, 3.5cm, 4cm, 4.5cm, or at least 5cm.

Advantageously, this provides a discreet and compact outlet valve which is not prone to accidental operating of the valve.

The catheter may have a length of at least about 10 cm, about 15 cm, about 20 cm, about 25 cm, about 30 cm, about 35 cm, about 40 cm, about 45 cm, about 50 cm, about 55 cm, about 60 cm, about 65 cm, about 70 cm, about 80 cm, about 90 cm, or at least about 100 cm. The catheter may have a width of no more than about 10 cm, about 15 cm, about 20 cm, about 25 cm, about 30 cm, about 35 cm, about 40 cm, about 45 cm, about 50 cm, about 55 cm, about 60 cm, about 65 cm, about 70 cm, about 80 cm, about 90 cm, or no more than about 100 cm.

The outlet valve may be formed of opaque materials.

The outlet valve may be arranged off-centre when the fluid collection bag is viewed with the rear panel behind the front panel. The outlet valve may be arranged off-centre, toward the left lateral edge or toward the right lateral edge.

The outlet valve may be arranged off-centre toward the side of the fluid collection bag on which the hand strap is arranged. For example, the hand strap may be arranged on the corner where the upper edge and right lateral edge meet, and the outlet valve may be arranged proximal to the base, off-centre toward the right lateral edge.

The fluid collection bag may comprise a cavity. The cavity may be provided with a plurality of internal baffles. Consequently, according to a broad aspect of the present invention, there is provided a fluid collection bag for a catheter assembly, wherein the fluid collection bag comprises a cavity and the cavity is provided with a plurality of internal baffles. A bond between the two panels may define the (internal) cavity, for example, the bond may be the peripheral bond referred to above.

According to a twelfth aspect of the present invention there is provided a packaged catheter assembly comprising a pouch, a catheter, a fluid reservoir, and a fluid collection bag configured to receive fluid from the catheter, wherein: the catheter, fluid reservoir and fluid collection bag are arranged within the pouch; and the fluid collection bag comprises a front panel and a rear panel, and a bond between the two panels defining an internal cavity; wherein the cavity is provided with a plurality of internal baffles.

Advantageously the provision of internal baffles in the cavity means that when the cavity is partially full, the contents are restricted from sloshing around within the cavity. Notably, it is normal for the cavity to be only filled partially, as fluid collection bags are typically over-engineered to be sure to retain the contents of a full, large, bladder, but are used by individuals with all sorts of sizes of bladders and frequently used before the bladder is full.

Moreover, the baffles may provide for a controlled flow of liquid in the fluid collection bag, which can improve the flow of liquid through the internal cavity of the bag. The flow of liquid is directed to the bottom of the fluid collection bag which facilitates the ingress of liquid into and within the bag. As such, the liquid fills all of the available space in the internal cavity of the bag, therefore, reducing the risk of the bag overflowing with liquid during use. Thus, the risk of embarrassment to the user is alleviated.

The fluid collection bag may be tightly folded to enable it to fit inside the pouch to provide a compact and discrete assembly, for example it may be in a stowed configuration as described in relation to other aspects above. Disadvantageously, in the prior art, the resultant fold lines may not allow the required flow of liquid within the bag despite the bag being unfolded by the user prior to use. In this situation, the provision of a fluid collection bag comprising an internal cavity provided with a plurality of internal baffles is advantageous. The internal baffles prevent the fold lines becoming too compacted before use, while still allowing the fluid collection bag to be folded to enable it to fit inside the pouch, therefore, facilitating the infill of liquid.

It will be understood that the packaged catheter assembly may be a closed catheter assembly, as the fluid collection bag is configured to receive fluid from the catheter. The fluid collection bag may be coupled to the catheter. The fluid collection bag may be coupled with a water-tight coupling, for example it may be bonded, e.g. adhered or welded to the catheter.

One or more, or each baffle may be provided by a join joining the front panel of the fluid collection bag to the rear panel of the fluid collection bag. Each join 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. In a preferred embodiment, the join is a weld. Advantageously, the baffle can be easily formed and added to the fluid collection bag construction as part of conventional techniques for the manufacture of fluid collection bags. Alternatively, one or more, or each baffle may comprise a further panel, joined between the front panel and the rear panel. The joins joining the further panel may be any of the joins outlined above, i.e. 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

Each baffle may create a fluid tight seal between the front panel and the rear panel.

The internal cavity may be provided with at least 2 baffles, at least 3 baffles, at least 4 baffles, at least 5 baffles, at least 6 baffles, at least 7 baffles, at least 8 baffles, at least 9 baffles, or at least 10 baffles.

The internal cavity may be provided with no more than 2 baffles, no more than 3 baffles, no more than 4 baffles, no more than 5 baffles, no more than 6 baffles, no more than 7 baffles, no more than 8 baffles, no more than 9 baffles, or no more than 10 baffles.

The internal cavity may be provided with 2, 3, 4, 5, 6, 7, 8, 9 or 10 baffles. For example, the internal cavity may be provided with between 3 and 5 baffles, such as 4 baffles.

One or more, or each baffle may have a length equal to between about 5 % and about 80 %, between about 10 % and about 75 %, between about 15 % and about 70 %, between about 20 % and about 65 %, between about 25 % and about 60 %, between about 27.5 % and about 55 %, between about 30 % and about 50 %, between about 32.5 % and about 47.5 %, between about 35 % and about 45 %, between about 37.5 % and about 42.5 %, or equal to about 40 %, of the width of the fluid collection bag.

One or more, or each baffle may have a length equal to, or greater than, about 5% of the width of the fluid collection bag. Each baffle may have a length equal to, or greater than, about 5%, about 10%, about 15%, about 20%, about 25%, about 30%, about 35%, about 40%, about 45%, about 50%, about 60%, about 65%, about 70%, about 75%, or equal to, or greater than, about 80%, of the width of the fluid collection bag.

One or more, or each baffle may have a length equal to no more than about 5%, about 10%, about 15%, about 20%, about 25%, about 30%, about 35%, about 40%, about 45%, about 50%, about 60%, about 65%, about 70%, about 75%, or no more than about 80%, of the width of the fluid collection bag.

One or more, or each baffle may have a length of between about 1 and about 15 cm, between about 2 and about 13 cm, between about 3 and about 11 cm, between about 4 and about 10 cm, between about 4.5 and about 9 cm, between about 5 and about 8 cm, between about 5.5 and about 7 cm, or about 6 cm.

One or more, or each baffle may have a length of at least about 1 cm, about 1.5 cm, about 2 cm, about 2.5 cm, about 3 cm, about 3.5 cm, about 4 cm, about 4.5 cm, about 5 cm, about 5.5 cm, about 6 cm, about 6.5 cm, or at least about 7 cm.

One or more, or each baffle may have a length of no more than about 1 cm, about 1.5 cm, about 2 cm, about 2.5 cm, about 3 cm, about 3.5 cm, about 4 cm, about 4.5 cm, about 5 cm, about 5.5 cm, about 6 cm, about 6.5 cm, or no more than about 7 cm.

The internal cavity may comprise a plurality of baffles each having a different length. Alternatively, the internal cavity may comprise a plurality of baffles each having the same length.

At least two of the plurality of internal baffles may be arranged as a diametrically opposed pair of baffles; a plurality of pairs of baffles may be arranged as diametrically opposed pairs of baffles. Each baffle may be arranged in a diametrically opposed pair of baffles. Each baffle of the diametrically opposed pairs of baffles may extend inwardly toward the opposing baffle in the pair to form a channel therebetween. Advantageously, the channel directs the flow of liquid entering the fluid collection bag at a flow rate in line with draining of a bladder, therefore, providing an improved flow of liquid through the internal cavity, thus facilitating filling of the bag through controlled liquid flow. On the other hand, the channel provided by the baffles restricts fast flow of the larger quantities of liquid that are provided in a partially filled fluid collection bag, preventing “sloshing” of the liquid within.

At the or each channel, the front panel is not joined to the rear panel, therefore, liquid is able to pass through the channel.

The diametrically opposed pairs of baffles may be arranged such that each pair is separated from an adjacent pair by a distance of between about 1 and about 20 cm, between about 2 and about 18 cm, between about 3 and about 16 cm, between about 4 and about 14 cm, between about 5 and about 12 cm, between about 6 and about 11 cm, between about 7 and about 10 cm, between about 7 and about 9 cm, or about 8 cm. Advantageously, the spacing between adjacent pairs of diametrically opposed baffles provides for an arrangement which does not unduly restrict the volume of the internal cavity of the bag whilst providing an improved flow of liquid into the internal cavity, therefore, reducing the risk of the bag overflowing with liquid during use.

The diametrically opposed pairs of baffles may be arranged such that each pair is separated from an adjacent pair by a distance of at least about 1 cm, about 2 cm, about 3 cm, about 4 cm, about 5 cm, about 6 cm, about 7 cm, about 8 cm, about 9 cm, or at least about 10 cm.

The diametrically opposed pairs of baffles may be arranged such that each pair is separated from an adjacent pair by a distance of no more than about 1 cm, about 2 cm, about 3 cm, about 4 cm, about 5 cm, about 6 cm, about 7 cm, about 8 cm, about 9 cm, or no more than about 10 cm.

The internal cavity may be provided with 1, 2, 3, 4, 5, 6, 7, 8, 9 or 10 diametrically opposed pairs of baffles.

The internal cavity may be provided with at least 1, 2, 3, 4, 5, 6, 7, 8, 9 or at least 10 diametrically opposed pairs of baffles. The internal cavity may be provided with no more than 1, 2, 3, 4, 5, 6, 7, 8, 9 or no more than 10 diametrically opposed pairs of baffles.

The diameter of one or more or the or each channel (which where the channel is formed by a pair of opposing baffles may be defined as the shortest distance between the tips of the opposing baffles) may be equal to between about 5 % and about 80 %, between about 5 % and about 75 %, between about 5 % and about 70 %, between about 5 % and about 65 %, between about 5 % and about 60 %, between about 5 % and about 55 %, between about 5 % and about 50 %, between about 5 % and about 45 %, between about 5 % and about 40 %, between about 10 % and about 40 %, between about 10 % and about 35 %, between about 10 % and about 30 %, between about 10 % and about 25 %, between about 12.5 % and about 25 %, between about 15 % and about 25 %, between about 17.5% and about 25 %, between about 17.5 % and about 22.5 %, or equal to about 20%, of the width of the fluid collection bag. Advantageously, where the diameter of the channel is selected appropriately, the flow of liquid into the bag is improved by the liquid being directed to the bottom of the bag, and sloshing is impeded.

The diameter of one or more or the or each channel may be equal to no more than about 5 %, about 7.5 %, about 10 %, about 12.5 %, about 15 %, about 17.5 %, about 20 %, about 22.5 %, about 25 %, about 27.5 %, about 30 %, about 35 %, about 40 %, about 45 %, about 50 %, about 55 %, about 60 %, about 65 %, about 70 %, about 75 %, about 80 %, about 85 %, or no more than about 90 % of the width of the fluid collection bag.

The diameter of one or more or the or each channel may be equal to at least about 5 %, about 7.5 %, about 10 %, about 12.5 %, about 15 %, about 17.5 %, about 20 %, about 22.5 %, about 25 %, about 27.5 %, about 30 %, about 35 %, about 40 %, about 45 %, about 50 %, about 55 %, about 60 %, about 65 %, about 70 %, about 75 %, about 80 %, about 85 %, or at least about 90 % of the width of the fluid collection bag.

The diameter of one or more or the or each channel may be between about 0.5 and about 5 cm, between about 0.75 and about 4.5 cm, between about 1 and about 4 cm, between about 1.25 and about 3.5 cm, between about 1.5 and about 3 cm, between about 1.5 and about 2.5 cm, between about 1.75 and about 2.25 cm, or about 2 cm. The diameter of one or more or the or each channel may be at least about 0.25 cm, about 0.5 cm, about 0.75 cm, about 1 cm, about 1.25 cm, about 1.5 cm, about 1.75 cm, about 2 cm, about 2.25 cm, about 2.5 cm, about 2.75 cm, about 3 cm, about 3.25 cm, about 3.5 cm, about 3.75 cm, about 4 cm, about 4.25 cm, about 4.5 cm, about 4.75 cm, or at least about 5 cm.

The diameter of one or more or the or each channel may be no more than about 0.25 cm, about 0.5 cm, about 0.75 cm, about 1 cm, about 1.25 cm, about 1.5 cm, about

1.75 cm, about 2 cm, about 2.25 cm, about 2.5 cm, about 2.75 cm, about 3 cm, about 3.25 cm, about 3.5 cm, about 3.75 cm, about 4 cm, about 4.25 cm, about 4.5 cm, about

4.75 cm, or no more than about 5 cm.

Each baffle of a diametrically opposed pair of baffles may be the same length. Alternatively, each baffle of a diametrically opposed pair of baffles may be a different length.

Each diametrically opposed pair of baffles may comprise baffles the same length. Alternatively the baffles in one diametrically opposed pair of baffles may be a different length to that of another diametrically opposed pair of baffles.

In one embodiment, the plurality of baffles are arranged as two pairs of diametrically opposed pairs of baffles, wherein each baffle extends inwardly toward the corresponding baffle in its pair to form a channel therebetween. In this example, the diameter of the channel is equal to about 20% of the width of the fluid collection bag, and each baffle of each diametrically opposed pair of baffles has a length equal to about 40 % of the width of the fluid collection bag.

In an example embodiment, the fluid collection bag may comprise a number of baffles extending from the left lateral edge and a number of baffles extending from the right lateral edge. The example embodiment is particularly advantageous where the fluid collection bag comprises an inlet configured to receive fluid from the catheter arranged at an upper edge of the fluid collection bag. For example, the bag may comprise two baffles extending from the left lateral edge and two baffles extending from the right lateral edge. The four baffles may be arranged as diametrically opposed pairs of baffles, such that a first baffle extending from the left lateral edge and a first baffle extending from the right lateral edge are a first diametrically opposed pair, and a second baffle extending from the left lateral edge and a second baffle extending from the right lateral edge are a second diametrically opposed pair. The first diametrically opposed pair of baffles may form a channel therebetween, and the second diametrically opposed pair of baffles may form a channel therebetween.

The internal cavity may comprise at least one baffle arranged to form a channel between one end, or both ends, of the baffle and the bond. For example, the internal cavity may comprise at least one baffle having an end arranged proximal to the upper edge, left lateral edge, base or right lateral edge of the peripheral bond and forming a channel between the end of the baffle and an aforementioned part of the bond. This channel may comprise any of the dimensions described above.

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.

At least one, preferably each, of the baffles may extend inwardly from the bond, i.e. at least one baffle originates at the bond and extends inwardly therefrom.

Each baffle may extend inwardly from any part of the bond. Preferably, each of the baffles extend inwardly from the left lateral edge or the right lateral edge.

At least one of the baffles may extend inwardly from the left lateral edge or right lateral edge at a distance equal to about 5%, about 10%, about 15%, about 20%, about 25%, about 30%, about 35%, about 40%, about 45%, about 50%, about 55%, about 60%, about 65%, about 70%, about 75%, about 80%, about 85%, about 90% or about 95% of the distance from the base to the upper edge.

At least one of the baffles may extend inwardly from the left lateral edge or right lateral edge at a distance equal to at least about 5%, about 10%, about 15%, about 20%, about 25%, about 30%, about 35%, about 40%, about 45%, about 50%, about 55%, about 60%, about 65%, about 70%, about 75%, about 80%, about 85%, about 90% or at least about 95% of the distance from the base to the upper edge. At least one of the baffles may extend inwardly from the left lateral edge or right lateral edge at a distance equal to no more than about 5%, about 10%, about 15%, about 20%, about 25%, about 30%, about 35%, about 40%, about 45%, about 50%, about 55%, about 60%, about 65%, about 70%, about 75%, about 80%, about 85%, about 90% or no more than about 95% of the distance from the base to the upper edge.

At least one of the baffles may extend inwardly from the base or upper edge at a distance equal to about 5%, about 10%, about 15%, about 20%, about 25%, about 30%, about 35%, about 40%, about 45%, about 50%, about 55%, about 60%, about 65%, about 70%, about 75%, about 80%, about 85%, about 90% or about 95% of the distance from the left lateral edge to the right lateral edge.

At least one of the baffles may extend inwardly from the base or upper edge at a distance equal to at least about 5%, about 10%, about 15%, about 20%, about 25%, about 30%, about 35%, about 40%, about 45%, about 50%, about 55%, about 60%, about 65%, about 70%, about 75%, about 80%, about 85%, about 90% or at least about 95% of the distance from the left lateral edge to the right lateral edge.

At least one of the baffles may extend inwardly from the base or upper edge at a distance equal to no more than about 5%, about 10%, about 15%, about 20%, about 25%, about 30%, about 35%, about 40%, about 45%, about 50%, about 55%, about 60%, about 65%, about 70%, about 75%, about 80%, about 85%, about 90% or no more than about 95% of the distance from the left lateral edge to the right lateral edge.

At least one of the baffles may extend inwardly from the left lateral edge a distance equal to about 5%, about 10%, about 15%, about 20%, about 25%, about 30%, about 35%, about 40%, about 45%, about 50%, about 55%, about 60%, about 65%, about 70%, about 75%, about 80%, about 85%, about 90% or about 95% of the distance between the left lateral edge and the right lateral edge.

At least one of the baffles may extend inwardly from the right lateral edge a distance equal to about 5%, about 10%, about 15%, about 20%, about 25%, about 30%, about 35%, about 40%, about 45%, about 50%, about 55%, about 60%, about 65%, about 70%, about 75%, about 80%, about 85%, about 90% or about 95% of the distance between the right lateral edge and the left lateral edge. At least one of the baffles may extend inwardly from the left lateral edge a distance equal to at least about 5%, about 10%, about 15%, about 20%, about 25%, about 30%, about 35%, about 40%, about 45%, about 50%, about 55%, about 60%, about 65%, about 70%, about 75%, about 80%, about 85%, about 90% or at least about 95% of the distance between the left lateral edge and the right lateral edge.

At least one of the baffles may extend inwardly from the right lateral edge a distance equal to at least about 5%, about 10%, about 15%, about 20%, about 25%, about 30%, about 35%, about 40%, about 45%, about 50%, about 55%, about 60%, about 65%, about 70%, about 75%, about 80%, about 85%, about 90% or at least about 95% of the distance between the right lateral edge and the left lateral edge.

At least one of the baffles may extend inwardly from the left lateral edge a distance equal to no more than about 5%, about 10%, about 15%, about 20%, about 25%, about 30%, about 35%, about 40%, about 45%, about 50%, about 55%, about 60%, about 65%, about 70%, about 75%, about 80%, about 85%, about 90% or no more than about 95% of the distance between the left lateral edge and the right lateral edge.

At least one of the baffles may extend inwardly from the right lateral edge a distance equal to no more than about 5%, about 10%, about 15%, about 20%, about 25%, about 30%, about 35%, about 40%, about 45%, about 50%, about 55%, about 60%, about 65%, about 70%, about 75%, about 80%, about 85%, about 90% or no more than about 95% of the distance between the right lateral edge and the left lateral edge.

At least one of the baffles may extend inwardly from the base a distance equal to about 5%, about 10%, about 15%, about 20%, about 25%, about 30%, about 35%, about 40%, about 45%, about 50%, about 55%, about 60%, about 65%, about 70%, about 75%, about 80%, about 85%, about 90% or about 95% of the distance between the base and the upper edge.

At least one of the baffles may extend inwardly from the upper edge a distance equal to about 5%, about 10%, about 15%, about 20%, about 25%, about 30%, about 35%, about 40%, about 45%, about 50%, about 55%, about 60%, about 65%, about 70%, about 75%, about 80%, about 85%, about 90% or about 95% of the distance between the upper edge and the base. At least one of the baffles may extend inwardly from the base a distance equal to at least about 5%, about 10%, about 15%, about 20%, about 25%, about 30%, about 35%, about 40%, about 45%, about 50%, about 55%, about 60%, about 65%, about 70%, about 75%, about 80%, about 85%, about 90% or at least about 95% of the distance between the base and the upper edge.

At least one of the baffles may extend inwardly from the upper edge a distance equal to at least about 5%, about 10%, about 15%, about 20%, about 25%, about 30%, about 35%, about 40%, about 45%, about 50%, about 55%, about 60%, about 65%, about 70%, about 75%, about 80%, about 85%, about 90% or at least about 95% of the distance between the upper edge and the base.

At least one of the baffles may extend inwardly from the base a distance equal to no more than about 5%, about 10%, about 15%, about 20%, about 25%, about 30%, about 35%, about 40%, about 45%, about 50%, about 55%, about 60%, about 65%, about 70%, about 75%, about 80%, about 85%, about 90% or no more than about 95% of the distance between the base and the upper edge.

At least one of the baffles may extend inwardly from the upper edge a distance equal to no more than about 5%, about 10%, about 15%, about 20%, about 25%, about 30%, about 35%, about 40%, about 45%, about 50%, about 55%, about 60%, about 65%, about 70%, about 75%, about 80%, about 85%, about 90% or no more than about 95% of the distance between the upper edge and the base.

At least one, preferably each, baffle may extend inwardly from the bond at an angle perpendicular, i.e., substantially perpendicular, at about 90° to the bond. Advantageously, this arrangement provides an improved flow of liquid through the internal cavity, thus facilitating filling of the bag.

At least one, preferably each, baffle may extend inwardly from the bond at an angle of between about 5° and about 175°, between about 10° and about 170°, between about 15° and about 165°, between about 20° and about 160°, between about 25° and about 155°, between about 30° and about 150°, between about 35° and about 145°, between about 40° and about 140°, between about 45° and about 135°, between about 50° and about 130°, between about 55° and about 125°, between about 60° and about 120°, between about 65° and about 115°, between about 70° and about 110°, between about 75° and about 105°, between about 80° and about 100°, between about 85° and about 95°, or about 90°, relative to the bond.

At least one, preferably each, baffle may extend inwardly from the bond at an angle of at least about 5°, about 10°, about 15°, about 20°, about 25°, about 30°, about 35°, about 40°, about 45°, about 50°, about 60°, about 65°, about 70°, about 75°, about 80°, about 85°, or at least about 90°, relative to the bond.

At least one, preferably each baffle may extend inwardly from the bond at an angle of no more than about 5°, about 10°, about 15°, about 20°, about 25°, about 30°, about 35°, about 40°, about 45°, about 50°, about 60°, about 65°, about 70°, about 75°, about 80°, about 85°, or no more than about 90°, relative to the bond.

The plurality of baffles may be arranged in a regular arrangement. For example, each baffle in a plurality of pairs of baffles may extend by the same distance from the peripheral bond so as to define a plurality of channels each in alignment along the centreline of the fluid collection bag. Alternatively, the plurality of internal baffles may be arranged in a random, or scattered arrangement. By this, we mean that the internal cavity does not comprise an identifiable channel formed between adjacent baffles. Such an arrangement provides for separation of the panels of the fluid collection bag, therefore, facilitating the infill of liquid.

The fluid collection bag may be any suitable shape or size, for example rectangular, circular, elliptical, cuboid, spherical, etc, preferably rectangular.

The fluid collection bag may comprise an interaction region as described below in relation to the thirteenth aspect of the invention. The interaction region of the fluid collection bag may be used to facilitate pouring away or discarding of the contents of the bag, or for allowing access to the contents of the bag.

The fluid collection bag may comprise an inlet to allow fluid to enter the bag from the distal end of the catheter. The inlet may comprise a one-way valve which prevents fluid flow through the inlet from the fluid collection bag to the catheter. Thus, the inlet allows liquid to pass into the fluid collection bag but prevents fluid flow out of the bag and into the catheter. This can reduce the likelihood of leaking. Preferably, the inlet is located at an upper edge of the fluid collection bag (the upper edge of the fluid collection bag may be defined as the end where the inlet is located). The inlet may be located at the end of a spout. The spout may extend from the upper edge, left lateral edge, base or right lateral edge of the bag, but preferably from the upper edge. The spout may taper inwardly as it extends away from the fluid collection bag. The spout may comprise an end, distal to the fluid collection bag, which comprises the inlet. The spout may have a length, i.e., the distance from where the spout joins an edge of the fluid collection bag to the inlet, of between 2 and 14 cm, between 4 and 12 cm, between 6 and 10 cm, between 7 and 9 cm, or about 8 cm.

Advantageously, the spout makes it easier for the user to locate the inlet and provides a more secure connection between the catheter and the fluid collection bag. The spout may also facilitate draining of the contents of the fluid collection bag after use.

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 thirteenth 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 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 a front wall and a rear wall, a peripheral seal between the two walls, and an internal join, joining the walls to divide the pouch into the first and second compartments. Advantageously, this arrangement requires only minor modifications to existing packaged catheter assembly manufacturing techniques as the internal join can be formed simultaneously with the peripheral seal. Further, the first and second compartments are formed without the need for additional components to be contained within the pouch, which otherwise may act to obstruct withdrawal of the fluid collection bag and catheter from the pouch, and may inhibit wetting of the catheter.

The internal join 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. Preferably, the internal join comprises a weld. Thus, advantageously, existing manufacturing techniques may be adapted to form the internal join. The peripheral seal may provide a water-tight seal.

The internal join may provide a water-resistant or water tight seal. Advantageously, a water resistant seal inhibits the passage of wetting fluid from the first compartment through the internal join to the second compartment, whilst a watertight seal prevents the passage of wetting fluid from the first compartment, through the internal join, into the second compartment. Thus, the fluid collection bag which is arranged in the second compartment remains dry.

The internal join 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.

A catheter assembly may comprise a catheter tube and a fluid collection bag. The internal join may define a channel having a diameter which is substantially equal to, or greater than, the diameter of the catheter at the channel. The catheter may be arranged such that before withdrawal of the catheter from the pouch, a portion of the catheter is positioned within the channel. Preferably, the internal join may define a channel having a diameter 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 channel. Preferably, a portion of the distal end of the catheter tube is positioned within the channel. Alternatively, the catheter assembly may comprise a connector arranged to connect the distal end of the catheter to the fluid collection bag. In this case, if the connector is arranged in the channel then the diameter of the channel may be substantially equal to, or greater than, the diameter of the connector or gripping element.

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 channel, 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 channel without having a detrimental effect on the use of the catheter.

The interaction region may define 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. The opening may be in or near an upper edge of a peripheral seal of the pouch. The opening may allow access to the second compartment. The opening may allow access to the first compartment via the second compartment. The catheter may be withdrawn through the opening, for example via the second compartment. Thus, access to the pouch may be provided adjacent to the second compartment and as such, the wetting fluid in the first compartment is retained in the pouch while the catheter is withdrawn via the second compartment, therefore reducing the risk of spilling wetting fluid outside the pouch or contacting the fluid collection bag with wetting fluid.

The interaction region may comprise an aperture or pull tab. The aperture may be sized to allow a finger to pass through and grip the interaction region. The pull tab may be sized to allow a user to grip it between their thumb and index finger. Preferably, the aperture or pull tab is located in the tear-away region. The aperture or pull tab may be located on the same side of the pouch as the tear start. The aperture or pull tab may be located adjacent to the tear start. The aperture may be any suitable shape, for example, circular, elliptical, square or irregularly shaped. Preferably, the aperture is circular. Thus, the user can more easily grasp the tear-away region and open the pouch.

The interaction region may be arranged at one edge of the pouch. The channel may be arranged adjacent to the interaction region. Advantageously, where the catheter is positioned within the channel, this means that it is easier for a user to withdraw the catheter from the pouch as the catheter is adjacent to the interaction region which forms the opening in the pouch. In particular, this arrangement facilitates removal of the catheter by withdrawing the fluid collection bag, therefore, removing the need for the user to touch the catheter. This prevents the catheter becoming dirty and also means the healthcare professional or user avoids touching the wetting fluid on the catheter which could be transferred to the fluid collection bag, therefore, making handling of the fluid collection bag difficult.

The internal join may be linear. The internal join may be elongated. The internal join may comprise a first end and a second end. The internal join may be curved, for example an ‘S’-shape or a ‘U’-shape.

The internal join may extend from the peripheral seal to the channel. Preferably, the internal join extends from the peripheral seal to the channel on an edge other than that where the interaction region is provided and most preferably opposite the interaction region. This arrangement facilitates withdrawal of the catheter and fluid collection bag from the pouch.

The internal join may extend toward the interaction region from its first end at the peripheral seal, for example from the left lateral edge, upper edge, right lateral edge base, at a corner where the upper edge and the left lateral edge meet, at a comer where the left lateral edge and base meet, at a comer where the base and the right lateral edge meet, or at a comer where the right lateral edge and the upper edge meet. The internal join may terminate at its second end. The second end may be positioned anywhere within the pouch, for example joined to any part of the peripheral seal or proximal to the upper edge, left lateral edge, base or right lateral edge. Preferably, the second end of the internal join is positioned proximal to the interaction region. Preferably, the second end is positioned approximately mid-way between the base and upper edge of the peripheral seal proximal to the right lateral edge of the pouch.

When viewing the pouch with the front wall in front of the rear wall, the second compartment may be any shape, for example triangular, rectangular, square, trapezoidal or irregularly shaped. The second compartment may be bordered by any of the edges of the fluid collection bag and the internal join. The second compartment may be triangular and may be bordered by the, or a portion of the, upper edge, left lateral edge, base, right lateral edge or internal join. For example, the second compartment may be triangular and bordered by the upper edge, internal join and part of, e.g. approximately half of the length of a lateral edge, e.g. the right lateral edge. This is particularly preferred where the interaction region is arranged at the same lateral edge that forms the triangular compartment.

When viewing the pouch with the front wall in front of the rear wall, the first compartment may be any shape, for example triangular, rectangular, square, trapezoidal or irregularly shaped. The first compartment may be bordered by any of the edges of the fluid collection bag and the internal join. The first compartment may be bordered by the, or a portion of the, upper edge, left lateral edge, base, right lateral edge or internal join. For example, the first compartment may be bordered by the left lateral edge, base, internal join and approximately half of the length of the right lateral edge.

The internal join may have a length substantially equal to the width of the pouch and/or may span approximately the entire width of the pouch.

The internal join may have a length of between about 2 and about 28 cm, between about 4 and about 26 cm, between about 6 and about 24 cm, between about 8 and about 22 cm, between about 10 and about 20 cm, between about 11 and about 18 cm, between about 12 and about 16 cm, between about 13 and about 15 cm, or about 14 cm.

The internal join may have a length of at least about 1 cm, about 2 cm, about 3 cm, about 4 cm, about 5 cm, about 6 cm, about 7 cm, about 8 cm, about 9 cm, about 10 cm, about 11 cm, about 12 cm, about 13 cm, about 14 cm, about 15 cm, about 16 cm, about 17 cm, about 18 cm, about 19 cm, about 20 cm, about 21 cm, about 22 cm, about 23 cm, about 24 cm, about 25 cm, about 26 cm, about 27 cm, or at least about 28 cm.

The internal join may have a length of no more than about 1 cm, about 2 cm, about 3 cm, about 4 cm, about 5 cm, about 6 cm, about 7 cm, about 8 cm, about 9 cm, about 10 cm, about 11 cm, about 12 cm, about 13 cm, about 14 cm, about 15 cm, about 16 cm, about 17 cm, about 18 cm, about 19 cm, about 20 cm, about 21 cm, about 22 cm, about 23 cm, about 24 cm, about 25 cm, about 26 cm, about 27 cm, or no more than about 28 cm.

The internal join may have a width of between about 0.2 and about 2 cm, between about 0.3 and about 1.8 cm, between about 0.4 and about 1.6 cm, between about 0.5 and about 1.4 cm, between about 0.6 and about 1.2 cm, between about 0.7 and about 1.0 cm, between about 0.75 and about 0.95 cm, between about 0.75 and about 0.90 cm, between about 0.75 and about 0.85 cm, or about 0.80 cm.

The internal join may have a width of at least about 0.10 cm, about 0.15 cm, about 0.20 cm, about 0.25 cm, about 0.30 cm, about 0.35 cm, about 0.40 cm, about 0.45 cm, about 0.50 cm, about 0.55 cm, about 0.60 cm, about 0.65 cm, about 0.70 cm, about 0.75 cm, about 0.80 cm, about 0.85 cm, about 0.90 cm, about 0.95 cm, or at least about 1.00 cm.

The internal join may have a width of no more than about 0.10 cm, about 0.15 cm, about 0.20 cm, about 0.25 cm, about 0.30 cm, about 0.35 cm, about 0.40 cm, about 0.45 cm, about 0.50 cm, about 0.55 cm, about 0.60 cm, about 0.65 cm, about 0.70 cm, about 0.75 cm, about 0.80 cm, about 0.85 cm, about 0.90 cm, about 0.95 cm, or no more than about 1.00 cm.

The channel may have a diameter defined by the distance between the second end of the internal join and an inner perimeter of the peripheral seal adjacent to the second end. Preferably, the channel has a diameter defined by the distance between the second end of the internal join and the inner perimeter of the right lateral edge.

The catheter may have a diameter of between CH8 and CH 18, for example CH14 as defined by the French Scale system.

The channel may have a diameter of between about 0.1 and about 1 cm, between about 0.2 and about 0.9 cm, between about 0.25 and about 0.8 cm, between about 0.3 and about 0.75 cm, between about 0.35 and about 0.7 cm, between about 0.4 and about 0.65 cm, between about 0.42 and about 0.6 cm, between about 0.44 and about 0.55 cm, between about 0.46 and about 0.52, between about 0.48 and about 0.51 cm, or about 0.5 cm. 3

The channel may have a diameter of at least about 0.10 cm, about 0.15 cm, about 0.20 cm, about 0.25 cm, about 0.30 cm, about 0.35 cm, about 0.40 cm, about 0.45 cm, about 0.50 cm, about 0.55 cm, about 0.60 cm, about 0.65 cm, about 0.70 cm, about 0.75 cm, about 0.80 cm, about 0.85 cm, about 0.90 cm, about 0.95 cm, or at least about 1.00 cm.

The channel may have a diameter of no more than about 0.10 cm, about 0.15 cm, about 0.20 cm, about 0.25 cm, about 0.30 cm, about 0.35 cm, about 0.40 cm, about 0.45 cm, about 0.50 cm, about 0.55 cm, about 0.60 cm, about 0.65 cm, about 0.70 cm, about 0.75 cm, about 0.80 cm, about 0.85 cm, about 0.90 cm, about 0.95 cm, or no more than about 1.00 cm.

Because of the dimensions of the internal join and channel, in embodiments where the catheter is positioned within the channel, the catheter may be held within the channel on one side by the internal join and on the other side by the peripheral seal. Advantageously, this means that ingress of wetting fluid through the channel into the second compartment is significantly inhibited as the channel is obstructed by the catheter. Thus, the fluid collection bag remains dry prior to use.

The channel may be tapered. The channel may extend upwards more on one side than the other. The channel may extend upwards more on the side corresponding to the terminus of the internal join. The channel may extend upwards no more than 200%, 100%, 75%, or 50% more on one side than the other. The channel may extend upwards at least 25%, 50%, 75%, 100%, or 150% more on one side than the other.

The pouch may be divided into more than two compartments, for example three compartments, four compartments, or more compartments, and each compartment may be separated from its adjacent compartment(s) by an internal join. Each compartment may comprise a different component of the catheter assembly.

The pouch may be configured such that after release of the wetting fluid into the first compartment, the wetting fluid is retained in the first compartment and the second compartment remains free, or at least substantially free, from wetting fluid. ‘Substantially free’ may be defined as having less than 5% of the wetting fluid reaching the second compartment after rupturing the fluid reservoir and vigorously shaking the pouch for five seconds.

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 discomfort and injury during use.

The interaction region may be configured such that before withdrawal of the catheter from the pouch, the opening comprises a sterile seal. Beneficially, this ensures that the catheter is maintained within a sterile environment prior to use.

The sterile seal may be broken by tearing off a removable tear strip. Advantageously, this provides an easy way of opening the pouch and provides no obstacle or restriction to opening the pouch to a user with limited dexterity.

The fluid collection bag may obscure the catheter from the opening. The fluid collection bag may obscure the rest of the contents of the bag from the opening. Thus, the user is less likely to see and then immediately grasp or touch the catheter itself.

The front panel, rear panel and bond between the two panels may define an internal cavity. The internal cavity may be provided with a plurality of internal baffles, as described in relation to the twelfth aspect. The catheter assembly may comprise a handling element. The handling element may be configured to engage the catheter tube. The handling element may comprise a handling portion mounted to a sleeve. The handling element may be annular. The handling element may be arranged surrounding a portion of the catheter tube. The handling element may be movable along the catheter tube. The handling element may permit gripping of the catheter tube when the handling element is gripped by a user. The handling portion may be arranged around the sleeve. The sleeve extends beyond the handling portion. The sleeve may extend to the side of the handling portion toward the proximal end of the catheter. The sleeve may extend to the side of the handling portion toward the distal end of the catheter.

The handling element may be more rigid than the sleeve. The handling element may be formed of silicon. The handling element may comprise at least one rib to assist gripping by the user. The sleeve may comprise a thermoplastic polyurethane (TPU) or low-density polyethylene (LDPE). Thus, the sleeve is cheap and easy to produce and can be easily manipulated by the user during use.

The sleeve may have a width of at least about 10 mm, about 155 mm, about 20 mm, about 25 mm, about 30 mm, about 35 mm, about 40 mm, about 45 mm, or at least about 50 mm. The sleeve may have a width of no more than about 10 mm, about 155 mm, about 20 mm, about 25 mm, about 30 mm, about 35 mm, about 40 mm, about 45 mm, or no more than about 50 mm.

The sleeve may have a length of at least about 10 mm, about 15 mm, about 20 mm, about 25 mm, about 30 mm, about 35 mm, about 40 mm, about 45 mm, or at least about 50 mm. Each sleeve may have a length of no more than about 10 mm, about 155 mm, about 20 mm, about 25 mm, about 30 mm, about 35 mm, about 40 mm, about 45 mm, or no more than about 50 mm.

The handling portion may have a width of at least about 10 mm, about 15 mm, about 20 mm, about 25 mm, about 30 mm, about 35 mm, about 40 mm, about 45 mm, about 50 mm, about 55 mm, about 60 mm, about 65 mm, about 70 mm, about 75 mm, or at least about 80 mm. The handling portion may have a width of no more than about 10 mm, about 155 mm, about 20 mm, about 25 mm, about 30 mm, about 35 mm, about 40 mm, about 45 mm, about 50 mm, about 55 mm, about 60 mm, about 65 mm, about

70 mm, about 75 mm, or no more than about 80 mm.

The handling portion may have a length of at least about 10 mm, about 15 mm, about 20 mm, about 25 mm, about 30 mm, about 35 mm, about 40 mm, about 45 mm, about 50 mm, about 55 mm, about 60 mm, about 65 mm, about 70 mm, about 75 mm, or at least about 80 mm. The handling portion may have a length of no more than about 10 mm, about 155 mm, about 20 mm, about 25 mm, about 30 mm, about 35 mm, about 40 mm, about 45 mm, about 50 mm, about 55 mm, about 60 mm, about 65 mm, about 70 mm, about 75 mm, or no more than about 80 mm.

Advantageously, the handling element may be used to progressively introduce the proximal end of the catheter into the urethra until fluid flows through the catheter from the bladder.

The fluid collection bag may be arranged to occupy between about 5 and about 50 %, between about 10 and about 45 %, between about 12 and about 40 %, between about 14 and about 35 %, between about 16 and about 30 %, between about 18 and about 25 %, or about 20 % of the internal volume of the pouch.

The fluid collection bag may be arranged to occupy at least about 5%, about 10%, about 15%, about 20%, about 25%, about 30%, about 35%, about 40%, about 45%, about 50%, about 55%, about 60%, about 65%, or at least about 70% of the internal volume of the pouch.

The fluid collection bag may be arranged to occupy no more than about 5%, about 10%, about 15%, about 20%, about 25%, about 30%, about 35%, about 40%, about 45%, about 50%, about 55%, about 60%, about 65%, or no more than about 70% of the internal volume of the pouch.

The catheter assemblies / packaged catheter assemblies of the first to thirteenth aspects may include any one or more features of a (packaged) catheter assembly as defined in broad terms, or according to any other of the first to thirteenth aspects set out above. The (packaged) catheter assemblies of the first to thirteenth aspects may comprise any of the optional features of the others of the first to thirteenth aspects without necessarily including all the features required of them. So, as one specific example, any optional features following any of the first, second, third, fifth, sixth, seventh, eighth and nineth aspects can each individually and in combination be incorporated in a packaged catheter assembly according to the fourth aspect, as well as those features which happen to be set out after the fourth example. That is to say, even more specifically, an optional feature which happens to be set out following one particular aspect does not necessarily apply only to that aspect, so, for example, the disclosure provides for the packaged catheter assembly of the fifth aspect comprising a pouch, a catheter, a fluid reservoir, and a fluid collection bag configured to receive fluid from the catheter, wherein: the catheter, fluid reservoir and fluid collection bag are arranged within the pouch; the fluid reservoir is configured to release wetting fluid into the pouch to wet the catheter; and the pouch comprises a sheath arranged around the fluid collection bag to inhibit wetting fluid from the fluid reservoir wetting the exterior of the fluid collection bag, wherein the fluid collection bag further comprises an inlet and one or more projections as described in relation to the fourth aspect.

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

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

The method may comprise positioning the absorbent material adjacent to a mouth, opening or tear line of the pouch.

According to a fifteenth aspect of the present invention, there is provided a method manufacturing a packaged catheter assembly comprising the steps of providing a catheter having a proximal end for insertion into the body and a distal end, a sleeve enclosing the catheter, a pouch comprising a gripping element configured to engage the sleeve, and a fluid reservoir configured to release wetting fluid into the pouch so as to wet the catheter, and arranging the catheter and fluid reservoir within the pouch; wherein the gripping element is configured to unfurl the sleeve along the length of the catheter and detach from the sleeve. The method of the fifteenth aspect of the invention may be a method of forming the packaged catheter assembly of the second aspect of the invention, which, of course, may include any optional feature outlined above.

The method may comprise providing the sleeve in a furled configuration. The method may comprise attaching the sleeve to the gripping element.

The method may comprise providing two walls and sealing them around their periphery to form a peripheral seal defining the pouch. The gripping element may be attached to the pouch by the peripheral seal. The gripping element may be attached to the pouch during formation of the peripheral seal. The gripping element may be formed during formation of the peripheral seal. The method may comprise sealing the sleeve to the pouch to form the gripping element. The method may comprise joining the two walls of the pouch together (at a location independent of the peripheral seal) to form the gripping element. Thus, the gripping element is easily and securely integrated into the pouch.

According to an sixteenth aspect of the present invention there is provided a method of forming a packaged catheter assembly comprising the steps of providing a catheter having a proximal end for insertion into the body and a distal end, a pouch comprising a gripping element configured to engage the catheter, and a fluid reservoir configured to release wetting fluid into the pouch so as to wet the catheter, and arranging the catheter and fluid reservoir within the pouch, wherein the pouch is configured to provide an opening through which the catheter may be withdrawn, the pouch comprises a wetting region in which wetting fluid preferentially collects, the wetting region is distal the opening, and the gripping element is configured to direct the catheter through the wetting region during withdrawal of the catheter from the pouch.

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

According to a seventeenth aspect of the present invention there is provided a method of manufacturing a packaged catheter assembly, the method comprising the steps of providing a catheter, a pouch, and a fluid collection bag configured to receive 9 fluid from the catheter in use, arranging the catheter and fluid collection bag within the pouch wherein the pouch comprises an interaction region to form an opening in the pouch and allow the fluid collection bag and catheter to be removed from the pouch, and the fluid collection bag is arranged adjacent to the opening.

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

The method may comprise arranging the catheter in the pouch and then arranging the fluid collection bag in the pouch. This can ensure the fluid collection bag remains adjacent to the opening.

The method may comprise attaching the catheter to an inlet of the fluid collection bag. The method may comprise arranging the inlet on one side of the fluid collection bag.

According to a eighteenth aspect of the present invention there is provided a method manufacturing a packaged catheter assembly comprising the steps of providing a pouch, a catheter, a fluid reservoir, and a fluid collection bag configured to receive fluid from the catheter, arranging the catheter, fluid reservoir and fluid collection bag within the pouch, and providing a sheath arranged around the fluid collection bag; wherein the fluid reservoir is configured to release wetting fluid into the pouch to wet the catheter, and the sheath is configured to inhibit wetting fluid from the fluid reservoir wetting the exterior of the fluid collection bag.

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

The method may comprise folding or rolling the fluid collection bag. The fluid collection bag may be folded or rolled before it is arranged inside the pouch. The method may comprise arranging the sheath around the folded or rolled fluid collection bag. The sheath may be arranged around the folded or rolled fluid collection bag before it is arranged in the pouch. The method may comprise attaching the catheter to the fluid collection bag. The catheter may be attached to the fluid collection bag before it is arranged in the pouch. The method may comprise arranging the sheath and/or catheter with the fluid collection bag in the pouch simultaneously.

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

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

According to a twentieth aspect of the present invention, there is provided a method of forming a packaged catheter assembly comprising the steps of providing a fluid reservoir, a catheter, and a pouch, and arranging the fluid reservoir and catheter within the pouch; wherein the catheter comprises a proximal end for insertion into the body, a distal end, and a sleeve extending from the proximal end to the distal end, wherein an end of the sleeve comprises a reservoir adapter configured to: engage the fluid reservoir; receive a wetting fluid from the fluid reservoir into the sleeve to wet the catheter; and detach from the fluid reservoir to permit the catheter to pass through the reservoir adapter.

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

The method may comprise arranging the reservoir adapter at the end of the sleeve. The method may comprise inserting the fluid reservoir into the reservoir adapter so as to block/inhibit the passage of the catheter therethrough. Thus, the catheter is protected by the fluid reservoir/reservoir adapter. According to an twenty-first aspect of the present invention there is provided a method of forming a catheter assembly, the method comprising providing a fluid reservoir surrounded by a jacket and a catheter; wherein the catheter comprises a proximal end for insertion into the body, a distal end, and a sleeve extending from the proximal end to the distal end; wherein the jacket is configured to receive a wetting fluid from the reservoir and direct the wetting fluid into the sleeve at the proximal end to wet the catheter.

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

The method may comprise forming the jacket around the fluid reservoir. The method may comprise arranging two strips of material, one on either side of the fluid reservoir. The method may comprise joining the strips of material around their edge to form the jacket with the fluid reservoir within it. Thus, the jacket is conveniently formed around the fluid reservoir.

The method may comprise forming a wetting aperture in the jacket. The method may comprise providing a reservoir adapter at an end of the sleeve and inserting the jacket (containing the fluid reservoir) into the reservoir adapter.

According to a twenty-second aspect of the present invention there is provided a method manufacturing a packaged catheter assembly, the method comprising providing a pouch having two walls and a peripheral seal between the two walls and a catheter, arranging the catheter within the pouch, and forming two opposing turns of at least 180 degrees along the catheter’s length.

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

The method may comprise forming a turn in the catheter during the step of arranging the catheter within the pouch. The method may comprise forming two opposing turns in the catheter before arranging the catheter in the pouch. According to a twenty-third aspect of the present invention, there is provided a method of manufacturing an intermittent catheter assembly comprising the steps of providing a catheter having a proximal end for insertion into the body and a distal end; and a fluid collection bag, arranging the fluid collection bag to receive fluid from the distal end of the catheter, wherein the fluid collection bag comprises a hand strap.

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

According to a twenty-fourth aspect of the present invention, there is provided a method of manufacturing a catheter assembly comprising the steps of providing a catheter having a proximal end for insertion into the body and a distal end, and a fluid collection bag, arranging the fluid collection bag to receive fluid from the distal end of the catheter, wherein the fluid collection bag comprises an outlet valve configured to control release of fluid out of the fluid collection bag in use, the outlet valve comprising: a valve base attached to a panel of the fluid collection bag, the valve base comprising a base opening for receiving a liquid output from the fluid collection bag; and an outlet element configured to be laterally rotatable relative to the valve base from a closed configuration to an open configuration.

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

According to a twenty-fifth aspect of the present invention, there is provided a method of manufacturing a packaged catheter assembly, the method comprising the steps of providing a pouch comprising a fluid reservoir and a fluid collection bag, and arranging a catheter within the pouch, wherein the fluid collection bag comprises a front panel and a rear panel, and a bond between the two panels defining an internal cavity; wherein the cavity is provided with a plurality of internal baffles.

The method of the twenty-fifth aspect of the invention may be a method of manufacturing the packaged catheter assembly of the twelfth aspect of the invention, which, of course, may include any optional feature outlined above. According to an twenty- sixth 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 twenty- sixth aspect of the invention may be a method of manufacturing the packaged catheter assembly of the thirteenth aspect of the invention, which, of course, may include any optional feature outlined above.

The method may comprise providing an internal join dividing the pouch into the first compartment and the second compartment.

The method may comprise providing a channel in the internal join and optionally arranging a portion of the catheter in the channel.

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

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

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

The method may comprise introducing the catheter by its proximal end into the urethra. The method may comprise allowing fluid to pass out of the body via the catheter. Consequently, the method may be a method of using a packaged catheter assembly. The method may comprise absorbing liquid that has passed through the catheter. Thus, the volume of free liquid is reduced by the absorbent material and this can make transportation and disposal of the liquid easier and more convenient for the user.

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

According to a twenty-eighth aspect of the present invention, there is provided a method of unpackaging a packaged catheter assembly, the packaged catheter assembly comprising a pouch comprising a gripping element, a catheter contained within the pouch and a sleeve enclosing the catheter, the method comprising the steps of releasing wetting fluid from the fluid reservoir into the pouch so as to wet the catheter, unfurling the sleeve along the length of the catheter using the gripping element which is configured to engage the sleeve, and detaching the sleeve from the gripping element.

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

The method may comprise forming an opening in the pouch. The method may comprise withdrawing the catheter through the opening. The method may comprise allowing the gripping element to remain in the pouch. The method may comprise unfurling the sleeve by withdrawing the catheter from the pouch. Thus, the sleeve is automatically unfurled as the catheter is withdrawn from the pouch.

The method may comprise rupturing/opening/bursting the fluid reservoir within the pouch. The method may comprise locating the fluid reservoir within the (closed/sealed) pouch. The method may comprise locating the fluid reservoir via a window in the pouch and/or a wetting marker disposed on the pouch. Thus, wetting fluid is easily released into the pouch. The step of forming an opening may comprise using an interaction region of the pouch to form the opening. The method may comprise grasping a tear-away region of the pouch. The method may comprise grasping an aperture in the interaction region/tear-away region. The method may comprise tearing the pouch from a tear start. The method may comprise tearing the pouch along a tear line. The method may comprise tearing the pouch until a tear stop. Thus, the pouch is easily opened by the user.

The method may comprise removing moisture or liquids from the exterior of the sleeve using an absorbent material disposed within the pouch. Thus, the method of the twelfth aspect may be combined with features of the eleventh aspect (or vice versa) to provide a sleeve with an exterior that is dry and easy to handle.

The method may comprise handling the catheter via the unfurled sleeve. 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 an twenty-nineth aspect of the present invention there is provided a method of unpackaging a packaged catheter assembly, the packaged catheter assembly comprising a catheter having a proximal end for insertion into the body and a distal end, a pouch comprising a gripping element configured to engage the catheter, and a fluid reservoir configured to release wetting fluid into the pouch so as to wet the catheter, wherein the catheter and fluid reservoir are arranged within the pouch, the method comprising the steps of releasing wetting fluid into the pouch so as to wet the catheter, allowing wetting fluid to collect in a wetting region of the pouch, and withdrawing the catheter from the pouch, wherein the gripping element is configured to direct the catheter through the wetting region during withdrawal of the catheter from the pouch.

The method of the twenty-nineth 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 sixteenth aspect of the invention. The method may comprise restricting the direction of an axis of the catheter. The method may comprise passing the catheter through the wetting region before it reaches the gripping 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 packaged catheter assembly.

According to a thirtieth 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 collection bag configured to receive fluid from the catheter in use, and a pouch containing the catheter and fluid collection bag, the method comprising using an interaction region to form an opening in the pouch to allow the catheter and fluid collection bag to be removed from the pouch, wherein the fluid collection bag is arranged adjacent to the opening.

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

The method may comprise withdrawing the fluid collection bag from the pouch before the catheter. The method may comprise withdrawing the catheter from the pouch using the fluid collection bag.

The method may comprise unfolding the fluid collection bag. The method may comprise handling the fluid collection bag via one or more projections and/or one or more finger holes disposed on the fluid collection bag.

The method may comprise measuring the fluid contained in the fluid collection bag via a fill level indicator disposed on the fluid collection bag.

According to a thirty-first 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, and a fluid collection bag configured to receive fluid from the catheter, and a pouch containing the catheter, fluid reservoir and fluid collection bag, the method comprising releasing wetting fluid into the pouch so as to wet the catheter, wherein the pouch comprises a sheath arranged around the fluid collection bag to inhibit wetting fluid from the fluid reservoir wetting the exterior of the fluid collection bag.

The method of the thirty-first aspect of the invention may be a method of unpackaging a packaged catheter assembly according to the fifth aspect of the invention and may, of course, include any optional feature outlined above and the packaged catheter assembly may be manufactured according to the eighteenth aspect of the invention.

The method may comprise withdrawing the fluid collection bag from the pouch using the sheath. The method may comprise removing the sheath from the fluid collection bag, which may optionally be done after withdrawal of the fluid collection bag from the pouch. The method may comprise unfolding the fluid collection bag, after removal of the sheath from the fluid collection bag.

According to an thirty- second aspect of the present invention there is provided a method of wetting a catheter having a proximal end for insertion into the body and a distal end, the method comprising the steps of releasing wetting fluid from a fluid reservoir at the proximal end of the catheter, into a sleeve that encloses the catheter, allowing the wetting fluid to flow through the sleeve from the proximal end to the distal end, and collecting excess wetting fluid in a fluid collection bag configured to receive fluid from a distal end of the catheter and the sleeve.

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

The method may comprise introducing the catheter by its proximal end into the urethra. The method may comprise allowing fluid to pass from the body and into the fluid collection bag via the catheter and/or the sleeve. Consequently, the method may be a method of using a catheter assembly.

According to a thirty-third aspect of the present invention , there is provided a method of unpacking a packaged catheter assembly, the packaged catheter assembly comprising a fluid reservoir, a catheter, and a pouch containing the fluid reservoir and catheter, wherein the catheter comprises a proximal end for insertion into the body, a distal end, and a sleeve extending from the proximal end to the distal end, wherein an end of the sleeve comprises a reservoir adapter configured to engage the fluid reservoir, the method comprising the steps of releasing wetting fluid from the fluid reservoir into the sleeve, and detaching the fluid reservoir to permit the catheter to pass through the reservoir adapter.

The method of the thirty-third aspect of the invention may be a method of wetting a catheter from the packaged catheter assembly of the seventh aspect of the invention, which, of course, may include any optional feature outlined above and may be manufactured according to the twentieth aspect of the invention.

The method may comprise forming an opening in the pouch. The step of releasing wetting fluid may comprise rupturing the fluid reservoir, for example by pressing the activation or wetting marker. The method may comprise pressing the fluid reservoir against or towards the sleeve to release wetting fluid from the fluid reservoir. The method may comprise grasping the reservoir adapter and pressing the fluid reservoir against/towards the reservoir adapter to allow fluid to be released from the fluid reservoir. The method may comprise allowing fluid to flow through the reservoir adapter. Thus, the fluid reservoir may be easily activated to release wetting fluid into the sleeve.

The fluid reservoir may be detached from the reservoir adapter after the release of wetting fluid from the fluid reservoir. Thus, the catheter is adequately wetted before the fluid reservoir is removed.

The method may comprise withdrawing the catheter from the sleeve. Only part of the catheter, preferably including the proximal end of the catheter, may be withdrawn from the sleeve. The method may comprise passing the catheter through the reservoir adapter. The method may comprise bunching the sleeve. The catheter may be withdrawn from the sleeve after it has been wetted. The catheter may be withdrawn from the sleeve after the fluid reservoir has been removed from the sleeve. Thus, the fluid reservoir protects the catheter before use, and the catheter is easily withdrawn through the reservoir adapter.

According to an thirty-fourth aspect of the present invention there is provided a method of wetting a catheter of a catheter assembly, the catheter assembly comprising the catheter having a proximal end for insertion into the body, a distal end and a sleeve extending from the proximal end to the distal end, and a jacket surrounding a fluid reservoir, the method comprising releasing wetting fluid from the fluid reservoir into the jacket and directing wetting fluid from the jacket into the sleeve at the proximal end of the catheter.

The method of the thirty-fourth aspect of the invention may be a method of unpackaging a packaged catheter assembly of the eighth aspect of the invention, which, of course, may include any optional feature outlined above and may be manufactured according to the twenty-first aspect of the invention. The method may comprise activating the fluid reservoir to release wetting fluid via an interaction with the jacket. The method may comprise removing the jacket and fluid reservoir from the sleeve.

According to a thirty-fifth aspect of the present invention there is provided a method of unpackaging a packaged catheter assembly, the packaged catheter assembly comprising a pouch and a catheter arranged within the pouch, wherein the catheter is arranged within the pouch in a shape having two opposing turns of at least 180 degrees along the catheter’s length, the method comprising forming an opening in the pouch and withdrawing the catheter from the pouch through the opening.

The method of the thirty-fifth aspect of the invention may be a method of unpackaging a packaged catheter assembly according to the nineth aspect of the invention and may, of course, include any optional feature outlined above and the packaged catheter assembly may be manufactured according to the twenty-second aspect of the invention.

The method may comprise withdrawing the catheter from the pouch by holding it at one end. The method may comprise withdrawing the catheter from the pouch by holding it at a position corresponding to one of the turns. The method may comprise withdrawing the catheter from the pouch by holding it in two places: at one end and at a position corresponding to the second turn, optionally wherein the end and second turn are separated by the other (first) turn. This allows the catheter to be withdrawn in one motion without causing the catheter to be pulled out by one end alone which may damage the catheter by causing the radius of curvature at one of the turns to become so small that the catheter kinks.

The method may comprise unravelling the two opposing turns. The method may comprise straightening the catheter. The method may comprise wetting the catheter, for example as described in relation to the nineteenth aspect of the invention. Preferably, the two opposing turns may be unravelled/the catheter straightened before the catheter is wetted. The combination of these aspects is particularly advantageous as the orientation/curvature of the catheter is optimised to ensure wetting fluid can easily flow through the sleeve and wet the full length of the catheter prior to use.

According to a thirty-sixth aspect of the present invention, there is provided a method of unpackaging a packaged intermittent catheter assembly, the packaged catheter assembly comprising a catheter having a proximal end for insertion into the body and a distal end; and a fluid collection bag arranged to receive fluid from the distal end of the catheter, wherein the fluid collection bag comprises a hand strap, further wherein the catheter and fluid collection bag are arranged within a pouch.

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

According to a thirty- seventh aspect of the present invention, there is provided a method of unpackaging a packaged catheter assembly, the packaged catheter assembly comprising a catheter assembly comprising the steps of providing a catheter having a proximal end for insertion into the body and a distal end, and a fluid collection bag, arranging the fluid collection bag to receive fluid from the distal end of the catheter, wherein the fluid collection bag comprises an outlet valve configured to control release of fluid out of the fluid collection bag in use, the outlet valve comprising: a valve base attached to a panel of the fluid collection bag, the valve base comprising a base opening for receiving a liquid output from the fluid collection bag; and an outlet element configured to be laterally rotatable relative to the valve base from a closed configuration to an open configuration, wherein the catheter and the fluid collection bag are arranged within a pouch. The method of the thirty-seventh aspect of the invention may be a method of unpackaging a packaged catheter assembly of the eleventh aspect of the invention, which, of course, may include any optional feature outlined above and may be manufactured according to the twenty-fourth aspect of the invention.

According to a thirty-eighth aspect of the present invention, there is provided a method of unpacking a packaged catheter assembly, the packaged catheter assembly comprising a pouch, a catheter, and a fluid collection bag configured to receive fluid from the catheter, wherein: the catheter, fluid reservoir and fluid collection bag are arranged within the pouch; and the fluid collection bag comprises a front panel and a rear panel, and a bond between the two panels defining an internal cavity; wherein the cavity is provided with a plurality of internal baffles, the method comprising removing the catheter and fluid collection bag from the pouch.

The method of the thirty-eighth aspect of the invention may be a method of unpackaging a packaged catheter assembly of the twelfth aspect of the invention, which, of course, may include any optional feature outlined above and may be manufactured according to the twenty-fifth aspect of the invention.

The method of the thirty-eighth aspect may further comprise, where the fluid collection bag is in a stowed configuration, unfolding the fluid collection bag.

According to an thirty-nineth 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 thirty-nineth aspect of the invention may be a method of unpackaging a packaged catheter assembly of the thirteenth aspect of the invention, which, of course, may include any optional feature outlined above and may be manufactured according to the twenty-sixty 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 methods of the fourteenth to thirty-nineth 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 thirteenth aspects of the present invention.

In any aspect, the catheter assembly is preferably a closed catheter assembly, that is that the catheter assembly comprises a catheter coupled to a fluid collection bag, such that it is configured to collect and retain fluid released from the body through the catheter. The fluid collected/catheter assembly may then be disposed of by the user when is convenient. Of course, embodiments of the invention may also be open catheter assemblies in that fluid is not collected or retained by the catheter assembly. Likewise in any aspect the catheter is preferably a urinary catheter; and/or is an intermittent catheter. Thus, the features of aspects of the present invention allow intermittent male urinary catheters to be adequately wetted prior to use which can be more difficult than for other types of catheter which are generally shorter. Detailed

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 cut-away front view of a first embodiment of a packaged catheter assembly;

Figure 2 is a cut-away front view of the packaged catheter assembly of Figure 1 where wetting fluid from the fluid reservoir has been released into the pouch;

Figure 3 is a cut-away front view of the packaged catheter assembly of Figure 1 during forming an opening in the pouch;

Figure 4 is a cut-away front view of the packaged catheter assembly of Figure 1 during withdrawal of the catheter assembly from the pouch;

Figure 5 is a cut-away front view of the packaged catheter assembly of Figure 1 during withdrawal of the catheter assembly from the pouch;

Figure 6 is a cut-away front view of the packaged catheter assembly of Figure 1 during withdrawal of the catheter assembly from the pouch;

Figure 7 is a cut-away front view of the catheter assembly of Figure 1 where the closed catheter assembly has been removed from the pouch;

Figure 8 is a cut-away front view of a second embodiment of a packaged catheter assembly;

Figure 9 is a cut-away front view of a third embodiment of a packaged catheter assembly;

Figure 10 is a cut-away front view of the packaged catheter assembly of Figure 9 where wetting fluid from the fluid reservoir has been released into the sleeve;

Figure 11 is a cut-away front view of the packaged catheter assembly of Figure 9 during forming an opening in the pouch; Figure 12 is a cut-away front view of the catheter assembly of Figure 9 where the closed catheter assembly has been removed from the pouch; and

Figure 13 is a cut-away view of a first example of the inlet of the closed catheter assembly of Figure 9;

Figure 14 is a cut-away view of a second example of the inlet of the closed catheter assembly of Figure 9;

Figure 15 is a cut-away view of a third example of the inlet of the closed catheter assembly of Figure 9;

Figure 16 is a front view of the reservoir adapter of a fourth embodiment of a packaged catheter assembly;

Figure 17 is a front view of a fifth embodiment of a packaged catheter assembly;

Figure 18 is a cut-away front view of the packaged catheter assembly of Figure 17 during forming an opening in the pouch;

Figure 19 is a cut-away front view of the packaged catheter assembly of Figure 17 during withdrawal of the catheter assembly from the pouch;

Figure 20 is a front view of the catheter assembly of Figure 17 where the catheter assembly has been removed from the pouch; and

Figure 21 is a front view view of a fluid collection bag catheter assembly of Figure 17;

Figure 22 is a partial front view of a fluid collection bag catheter assembly of Figure 17;

Figure 23 is a front view of an outlet valve of the fluid collection bag of Figure 17;

Figure 24 is a cut-away view of a first example of the inlet of the catheter assembly of Figure 17;

Figure 25 is a cut-away view of a second example of the inlet of the catheter assembly of Figure 17;

Figure 26 is a cut-away view of a third example of the inlet of the catheter assembly of Figure 17; Figure 27 is a front view of a sixth embodiment of a packaged catheter assembly;

Figure 28 is a cut-away front view of the packaged catheter assembly of Figure 27 ;

Figure 29 is a front view of the packaged catheter assembly of Figure 27 during withdrawal of the catheter assembly from the pouch;

Figure 30 is a cut-away front view of the fluid collection bag of the packaged catheter assembly of Figure 27 where the catheter assembly has been removed from the pouch and the fluid collection bag is in an open configuration; and

Figure 31 is a partial cut-away front view of the fluid collection bag of Figure 30 after use.

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

Referring to Figures 1-7, an embodiment of a packaged catheter assembly 100 is shown.

The packaged catheter assembly 100 comprises a pouch 170 containing a fluid collection bag 110, a catheter tube, or “catheter” 120, a sleeve 130, and a fluid reservoir 140 comprising wetting fluid. The catheter 120 has a proximal end 121 for insertion into the body and a distal end 122, and the fluid collection bag 110 is attached to the distal end 122 of the catheter 120 and is arranged to receive fluid from the distal end 122 of the catheter 120, thereby forming a so-called “closed catheter assembly”.

The sleeve 130 of this embodiment is sized to enclose the catheter 120 along the majority of the length of the catheter 120. The sleeve 130 comprises a proximal end 131 corresponding to the proximal end 121 of the catheter 120 and a distal end 132 corresponding to the distal end 122 of the catheter 120. The distal end 132 of the sleeve 130 is attached to an inlet 150 of the fluid collection bag 110. The proximal end 131 of the sleeve comprises an annular handling element 133. The handling element 133 comprises a relatively rigid material compared to the sleeve 130 and facilitates movement of the proximal end 131 of the sleeve 130 up and down the catheter 120.

In this embodiment, the catheter 120 is a male urinary catheter made from a hydrophilic thermoplastic elastomer (TPE). The sleeve 130 of this example is a thermoplastic polyurethane (TPU) or low-density polyethylene (LDPE). Obviously those skilled in the art will be able to select suitable alternative materials.

The pouch 170 is formed from a front wall (not shown - cut away) and rear wall 171 of identical shape and size, and a peripheral seal joining the periphery of the walls to form the pouch 170 and containing its contents (i.e. the closed catheter assembly and fluid reservoir 140).

The peripheral seal defines a base 172a, a left lateral edge 172b, a right lateral edge 172c and an upper edge 172d of the pouch 170. The left lateral edge 172b and right lateral edge 172c being defined as the left and right sides of the pouch 170 when viewing the pouch 170 with the rear wall 171 behind the front wall, the base 172a at the bottom of the pouch 170 and the upper edge 172d at the top of the pouch 170. The peripheral seal thus defines a pouch 170 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 172a to the upper edge 172d of between 100 to 250 mm, preferably 120 to 140 mm, for example about 130 mm. The base 172a defines the bottom of the pouch 170 in use, and the upper edge 172d 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 170 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 170. For example, none of the edges may comprise a fold, one edge may comprise a fold (as in the illustrated example), or two or more of the edges may comprise a fold.

In this embodiment, the pouch 170 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 100 in day-to-day life. In addition, the exterior of the pouch 170 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 170 also comprises an interaction region. The interaction region forms the top part of the pouch 170 and spans between the right lateral edge 172c and left lateral edge 172b. The interaction region is used to provide access to the pouch through/near to the upper edge 172d. In this embodiment, the interaction region comprises a tapered tear-away region 175. The tear-away region 175 comprises a tear start 176 at the point the left lateral edge 172b meets the tear-away region 175, a tear stop 177 at a corresponding point on the right lateral edge 172c, and a tear line 178 spanning between the tear start 176 and tear stop 177. The tear line 178 comprises a line of weakness in the walls of the pouch 170, which may be formed by any suitable means but in this embodiment is laser etched. The tear start 176 comprises a notch to provide an area of weakness in the peripheral seal. This allows the tearaway region 175 to be separated from the pouch 170 by tearing the walls apart from the tear start 176 to the tear stop 41 along the tear line 178. Thus the tear is provided beneath the location of the upper edge 172d and thus the pouch 170 may be opened provided access to its contents. In other embodiments, the tear stop 177 may comprise a small aperture in the walls to prevent further tearing of the pouch 170.

In order to provide the tapered shape, the tear-away region 175 extends upwards on the left side approximately 50% more than it does on the right side. The left side of the tear-away region 175 comprises a circular aperture 179 sized to allow a finger to pass through and grip the tear-away region 175. To ensure the pouch 170 is fully sealed, the front wall and rear wall 171 are sealed to one another over the entire tear-away region 175. In other embodiments, other seals such as a zip-lock arrangement, or hook and hook, hook and loop (VELCRO (RTM)) or the like may be used to provide access to the pouch (or to reseal the pouch after opening), and of course, the sizes and shapes set out above are exemplary.

In this embodiment, the pouch 170 also comprises an absorbent strip 174. The absorbent strip 174 is a thin piece of absorbent material that is arranged close to, and slightly below, the tear line 178. The absorbent strip is arranged on the inside of the rear wall 171 in this embodiment, but in other embodiments may be arranged on the front wall or both the front and rear walls 171. The absorbent strip 174 spans the majority of the tear line 178 and is configured to absorb any fluids that come into contact with it. In other embodiments, the absorbent strip 174 may be an absorbent layer and may line the front wall and/or rear wall 172, or may be replaced by an absorbent that is not shaped like a strip or layer, such as an absorbent sachet. The absorbent strip may be formed, for example, from a sponge material, an absorbent polymer, or a super absorbent for example polyacrylic acid (but those skilled in the art will easily identify alternatives, in light of this disclosure).

In this embodiment, the left lateral edge 172b of the pouch 170 comprises a gripping element 136 which projects into the inside of the pouch 170 at a point approximately mid-way between the base 172a and upper edge 172d of the peripheral seal. In this embodiment, the gripping element 136 is configured to engage the proximal end 131 of the sleeve 130 and to restrict the direction of the tangent to the catheter 120 at the gripping element 136. Consequently, the gripping element 136 can both control the position of the sleeve 130 on the catheter 120 and also control the position of the catheter 120 within the pouch 170.

In this embodiment, the gripping element 136 comprises an O-ring with aperture (not shown) through which the catheter 120 is arranged. The O-ring of the gripping element 136 has an inner diameter that is slightly smaller than the outer diameter of the handling element 133, thus, the handling element 133 may be push-fit within the gripping element 136. In other embodiments, the gripping element 136 instead comprise a temporary /frangible attachment between the pouch wall(s) and sleeve 130, for example a spot weld. In further alternative embodiments, the gripping element may comprise a narrow channel in the pouch, providing an aperture between the pouch walls that restricts movement of the sleeve 130 by friction. The narrow channel may be formed by forming a join between the walls and independent from the peripheral seal to define the narrow channel between the join and the left 172b (or right 172c) lateral edge of the peripheral seal.

In this embodiment, the aperture of the gripping element 136 comprises an axis extending perpendicular to the aperture and parallel to the left lateral edge 172c of the pouch 170. The gripping element 136 is configured to restrict the tangent of the catheter 120 to within a certain degree (e.g. about 20 degrees) of the axis of the aperture at the gripping element, as it is pulled out of the top of the pouch 170. In this embodiment, this is achieved through the handling element 133 which is push-fit inside the gripping element 133 and provides a tubular path through which the catheter 120 must pass. In this embodiment, the pouch 170 comprises a wetting region adjacent to the base 172a of the pouch 170, as described below. The axis of the aperture, and the path of the catheter 120 through the gripping element 136 defined by the handling element 133, is therefore pointing towards the wetting region and so is the catheter 120.

In this embodiment, the catheter 120 is resiliently biased into a straight configuration to the extent that over a distance equivalent to the distance between the gripping element 136 and base 172a/wetting region, the catheter 120 resists being bent by more than about 20 degrees. As such, due to the restriction of the tangent of the catheter 120 imposed by the gripping element 136 and the resilience of the catheter 120 itself, the catheter 120 extends away from the gripping element 136 substantially parallel to the left lateral edge 172c of the pouch 170 and extends down into the wetting region and adjacent to the base 172a of the pouch 170.

The catheter 120 is arranged within the pouch 170 in a curved and coiled configuration, with the distal end 122 adjacent to the inner left lateral edge 172b near the upper edge 172d of the pouch 170. The distal end 122 is connected to the inlet 150 and the inlet 150 defines an upper region of the pouch 170 with the upper edge 172d of the pouch 170 into which the catheter 120 does not extend while packaged in the pouch 170. The catheter 120 extends down the inside of the pouch 170, through the aperture in the gripping element 136 and into a broadly elliptical anti-clockwise coil (as viewed with left lateral edge 172b on the left, and upper edge 172d at the top). The coil has a single turn around the inner perimeter of the left lateral edge 172b, base 172a, and right lateral edge 172c of the pouch, with the proximal end 121 of the catheter 120 resting on the outside of the catheter’s coil, adjacent to the left lateral edge 172b and base 172a of the pouch 170. Of course, the catheter uncoils as it is pulled out of the pouch, as described below.

In this embodiment, the fluid collection bag 110 is provided in a stowed configuration, which in this embodiment is a folded configuration, within the pouch 170 and is retained in the folded configuration by a sheath 119 provided around the folded fluid collection bag 110. The sheath 119 encloses a folded portion of the fluid collection bag from which the inlet 150 extends perpendicular to the width/length of the stowed bag. The sheath 119 is tubular with one closed end and encloses the majority of the folded fluid collection bag 110, in this embodiment it encloses approximately two thirds of the length of the folded bag 110 but in other embodiments it may be more or less. The sheath 119 comprises a fluid impermeable material and as such, resists fluids from contacting the fluid collection bag 110.

In this embodiment, the sheath 119 and folded fluid collection bag 110 are arranged within the pouch 170 just below the absorbent strip 174 and with the axis of the tubular sheath 119 approximately parallel to the absorbent strip 174. The fluid collection bag 110 is arranged completely within the upper region mentioned above. The closed end of the sheath 119 is positioned adjacent to the right lateral edge 172c of the pouch 170 and the inlet 150 of the bag 110 receives the distal end 122 of the catheter 120 adjacent to the left lateral edge 172b of the pouch 170. The fluid collection bag 110 is therefore arranged adjacent to the opening formed in the pouch 170 by the tearaway region 175 as described further below and spans between the left lateral edge 172b and right lateral edge 172c.

In this embodiment, prior to use, the sleeve 130 is arranged around the catheter 120 in a furled configuration between the inlet 150 and gripping element 136. The distal end 132 of the sleeve 130 is attached to the inlet 150 and the proximal end 131 of the sleeve 130 is engaged by the gripping element 136. Consequently, the sleeve 130 in the furled configuration only covers a minority of the length of the catheter 120. In this embodiment, the sleeve 130 is engaged by the gripping element 136 through a push-fit engagement of the handling element 133 of the sleeve 130 within the aperture of the gripping element 136, as described above. The sleeve 130 is therefore configured to unfurl along the length of the catheter 120 as the catheter 120 is withdrawn from the pouch 170. Once the sleeve 130 is completely unfurled it is configured to disengage from the gripping element 136 once a threshold tension is present in the sleeve 130 as described below. In other embodiments any suitable engagement between the gripping element 136 and proximal end 131 of the sleeve 130 may be used. In this embodiment, the fluid reservoir 140 is an elongate rectangular burstable sachet of water. The fluid reservoir 140 is arranged within the pouch 170 adjacent the right lateral edge 172c. The fluid reservoir 140 has a height equal to between 60-90% the height of the pouch 170, for example 80%, and a width between 5-25% the width of the pouch 170, for example 15%. In other embodiments, many other types of reservoir would be suitable including different shapes and sizes of reservoir, or non- burstable reservoirs and other external sources of fluid. In this embodiment, the wetting fluid is water and interacts with the hydrophilic surface of the catheter 120 to render it lubricious. In other embodiments, other wetting fluids may be used and they may be polar (e.g. water-based) or non-polar (e.g. oil-based) depending on the catheter’s surface properties.

Referring to Figure 7, in this embodiment, the fluid collection bag 110 comprises a front panel 111, a rear panel of identical shape and size (not shown), and a peripheral bond joining the periphery of the panels to form the bag 110. The front panel 111 and rear panel are both transparent or translucent in this embodiment. The peripheral bond defines a base 112, a right lateral edge 113, a left lateral edge 114 and an upper edge 115. The right lateral edge 113 and left lateral edge 114 being defined as the right and left sides of the bag 110 when viewing the bag 110 with the rear panel behind the front panel 111, the base 112 at the bottom of the bag 110 and the upper edge 115 at the top of the bag 110. The peripheral bond thus defines a bag 110 that, when unfolded, is generally rectangular and suitably has a width between the lateral edges 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. A height from the base 112 to the upper edge 115 may be at least 25, 30, 35 or 40 cm. The height of the bag may be no more than 45, 40, 35 or 30 cm. The height may be between 25 and 40 cm, 30 and 35 cm, or most preferably 33 and 35 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 base 112 defines the bottom of the bag 110 in use, and the upper edge 115 the top. However, in other embodiments alternative shapes and sizes could be conceived, such as elliptical or circular panels forming correspondingly shaped bags, or even a tubular bag or bag with more than two panels, e.g. a prism or other polygon. In this embodiment, the panels comprise a flexible plastics material, for example polypropylene (PP), polyethylene terephthalate (PET), low density polyethylene (LDPE), metalized polyester (MET PET), orientated polypropylene (OPP) or polyvinyl chloride (PVC).

In this embodiment, the inlet 150 is positioned at the comer of the peripheral bond where the upper edge 115 and left lateral edge 114 meet. A neck 151 is formed adjacent to the inlet 150 in the bag 110 by the peripheral bond which comprises two triangular projections 117a, 117b into the bag 110, a left edge projection 117a along the left lateral edge 114 and an upper edge projection 117b along the upper edge 115.

In this embodiment, the left edge projection 117a is a right-angle triangle with its right-angled vertex projecting into the bag 110 and the other vertices along the left lateral edge 114. The left edge projection 117a is approximately one quarter the length of the left lateral edge 114 and begins approximately 10% along the length of the left lateral edge 114 from the upper edge 115. The left edge projection 117a extends from this point approximately 10% across the width of the bag 110 angled slightly below perpendicular to the left lateral edge 114 before turning 90 degrees at the right-angled vertex and returning to meet the left lateral edge 114.

In this embodiment, the left edge projection 117a also comprises a rib 117c spanning from its right-angled vertex to a point on the left lateral edge 114 and approximately midway along the length of the left edge projection 117a. The rib 117c comprises a region which preferentially folds to help with maintaining the shape of the bag 110 both when folded and unfolded and also makes it easier for a user to grasp/grip the bag 110.

In this embodiment, the upper edge projection 117b is a right-angle triangle. The right-angled vertex projecting into the bag 110 and the other vertices along the upper edge 115. The upper edge projection 117b is approximately 90% the length of the upper edge 115 and begins approximately 10% along the length of the upper edge 115 from the left lateral edge 114 and ends at the right lateral edge 113. The upper edge projection 117b extends from where it meets the upper edge 115 approximately 10% down the length of the bag 110 angled slightly right of perpendicular to the upper edge 115 before turning through 90 degrees towards the right lateral edge 113 at the right- angled vertex and then returning to meet the right lateral edge 113.

Thus, as described above, in this embodiment the right-angled vertices of the left edge projection 117a and upper edge projection 117b define the narrowest point of the neck 151.

In this embodiment, the peripheral bond further comprises two finger holes 116 to allow the bag 110 to be easily handled by a user. One finger hold is positioned in the upper edge projection 117b adjacent to its right-angled vertex. The other finger hole 116 is at the comer of the bag 110 where the right lateral edge 113 meets the base 112, and the peripheral bond truncates the corner of the bag 110 to accommodate this finger hole 116. In other embodiments, the finger holes 116 may comprise a series of ridges, or otherwise easily gripped surface or feature to allow the user to easily handle the bag 110. In addition, there may be different numbers of finger holes 116, such as only one or more than two, and they may be placed in different locations on the bag 110.

In this embodiment, the fluid collection bag 110 further comprises a fill level indicator 118 comprising fill markers which allow the user to measure the volume of fluid contained within the fluid collection bag 110. Due to the shape of the bag 110, the cross-sectional area of the bag 110 may vary along the length of the bag 110 from the base 112 to upper edge 115. As such, the fill level indicator may comprise irregularly spaced fill markers to account for this. The fill markers may indicate, either the proportion of the volume of the bag which is filled with fluid, for example 10%, 25%, 50%, 75%, 100% of a safe fill level, or the absolute volume of fluid, for example 100ml, 200ml, 300ml, etc. as required or as is convenient for the user.

Referring to Figures 1 and 2, in this embodiment, the packaged catheter assembly 100 is provided with the sheath 119 containing the folded fluid collection bag 110, catheter 120, sleeve 130 and fluid reservoir 140 all contained with the pouch 170 as mentioned above. To wet the catheter 120 so that it is ready for use, the user may release the wetting fluid from the fluid reservoir 140 into the pouch 170. This may be done by any suitable means, but preferably by applying pressure to the outside of the pouch 170 at a region corresponding to the position of the fluid reservoir 140. In embodiments where the pouch is opaque or the fluid reservoir 140 is otherwise not visible, the pouch may comprise a wetting marker to assist the user in locating the fluid reservoir 140.

In this embodiment, the fluid reservoir 140 is configured to rupture under external pressure, creating a tear 141 in the fluid reservoir 140 which release wetting fluid into the pouch 170 where it collects in a wetting region of the pouch 170 to form a pool 1 in the bottom of the pouch 170.

Referring to Figures 3 and 4, in this embodiment, the user may then access the catheter 120 by creating an opening in the pouch 170 using the interaction region. The aperture 179 is grasped in one hand, and the pouch 170 below the tear line 178 in another, and the tear-away region 175 is tom from the tear start 176 to the tear stop 177 along the tear line 178. Thus, the pouch 170 is tom between the left lateral edge 172b and right lateral edge 172c at a location below the upper edge 172d, as such, an opening is formed in the pouch 170 that may be used to access its contents. In this embodiment, the tear-away region 175 is fully separated from the pouch 170 to improve access to the contents of the pouch 170. In other embodiments, the tear-away region 175 may not be fully separated from the pouch 170 to reduce the number of separate parts and make the pouch 170 easier to handle. Other embodiments may also feature other ways to access the pouch for example a zip-lock seal.

In this embodiment and referring to Figures 3 and 4, the closed catheter assembly (i.e. catheter 120 and fluid collection bag 110) may then be removed from the pouch 170. The sheath 117 and folded fluid collection bag 110 are easily accessible to the user as they are directly accessible via the opening in the pouch 170, the fluid collection bag 110 and catheter 120 may then be withdrawn from the pouch 170 by pulling the sheathed fluid collection bag 110 up and out of the pouch 170.

In this embodiment, prior to withdrawal, only parts of the catheter 120 that are close to the base 172a of the pouch 170 may have been wetted by the pool 1 of wetting fluid. To ensure the parts of the catheter 120 intended to enter the body are adequately wetted, during withdrawal the position of the catheter 120 within the pouch 170 is restricted such that parts of the catheter 120 intended to enter the body must pass through the wetting region and pool 1 of wetting fluid before withdrawal. As described above, in this embodiment this is achieved through a combination of the gripping element 136 restricting the direction of the catheter 120 such that the tangent of the catheter 120 at the gripping element 136 points towards the pool 1 and the resilience of the catheter 120 ensuring that it resists bending over a length equivalent to the distance between the gripping element 136 and pool 1 and thus uncoils as it is pulled out, such that parts of the catheter that are initially above the pool 1 pass through it as the catheter 120 is pulled out of the pouch. As shown in Figures 4-6, during withdrawal this leads to the catheter 120 passing through the pool 1, then past the gripping element 136 and finally being withdrawn from the pouch 170. In some embodiments, the aperture of the gripping element 136 may be further configured to ensure excess wetting fluid is removed from the catheter 120 prior to withdrawal.

In this embodiment, during withdrawal of the catheter 120, the sleeve 130 is unfurled, moving from the initial furled configuration of Figures 1-3, to an unfurled configuration as shown in Figure 7. As the fluid collection bag 110 and inlet 150 are moved up and away from the gripping element 136, the distal end 132 of the sleeve 130 also moves upwards. Because the gripping element 136 engages the handling element 133 and proximal end 131 of the sleeve 130, the sleeve 130 therefore unfurls along the catheter 120 as the catheter 120 is removed from the pouch 170. This ensures that the now wetted catheter 120 is protected by the sleeve 130 from dirt from contact with other objects external to the pouch 170 until use. In addition, as the sleeve 130 is located above the gripping element 136 and close to the upper edge 172d of the pouch 170, the outside of the sleeve 130 does not come into contact with the pool of wetting fluid 1. As such, the outside of the sleeve 130 is dry and convenient for the user to handle.

In this embodiment, the absorbent strip 174 advantageously removes moisture from the sheath 119, fluid collection bag 110 and sleeve 130 as it is withdrawn from the pouch 170 which makes these devices more comfortable for the user to handle. In addition, the absorbent strip 174 does not remove moisture from the now wetted catheter 120 as the sleeve 130 creates a barrier that prevents moisture from being absorbed by the strip 174 from the catheter 120.

Referring to Figures 4 to 7, in this embodiment, the sheath 119 may then be removed from the folded collection bag 110. Advantageously, the sheath 119 prevents any wetting fluid from contacting the outside of the fluid collection bag 110 or entering between the folds of the folded fluid collection bag 110. This makes the bag 110 easier to open and handle, because if the folds of the bag 110 are wet they can be more likely to stick together or be slippery to touch. The sheath 119 may be removed by sliding it off the folded fluid collection bag 110, or in other embodiments, the sheath 119 may be removed by other means such as tearing or opening the sheath 119 to disengage it from the fluid collection bag 110.

In this embodiment, the fluid collection bag 110 may then be unfolded so that it is ready to accept fluid from the catheter 120. The catheter 120 may be handled via the sleeve 130 and the gripping element 136 disengaged from the sleeve 130. In this embodiment, the gripping element 136 is disengaged by simply pulling the sleeve 130 and catheter 120 away from the pouch 170. In other embodiments, the gripping element 136 may be actively disengaged by twisting the sleeve 130 or otherwise activating the gripping element 136 to release the sleeve 130 for example.

The steps of unsheathing/unfolding the fluid collection bag 110 and disengaging the gripping element 136 as described above may be performed in any order depending on the preference of the user.

Referring to Figure 7, in this embodiment, the catheter 120 is now ready for use. The sleeve 130 may be used to handle the catheter 120 and the handling element 133 may be used to progressively introduce the proximal end 121 of the catheter 120 into the urethra until fluid flows through the catheter 120 from the bladder. Fluid flowing through the catheter 120 is collected in the fluid collection bag 110 and the volume of fluid contained in the bag can be monitored using the fill level indicator. After use, in this embodiment, as the catheter 120 is withdrawn from the body, the handling element 133 may be used to cover the length of the catheter 120 with the sleeve 130 and the packaged catheter assembly 100 may then be disposed of.

Referring to Figure 8, a second embodiment of a packaged catheter assembly 200 is shown. The second embodiment shares many of the features of the first embodiment described above, and so only differences in the features are described below, and like numerals are used to denote like features. In this embodiment, the sleeve 230 is not provided in a furled configuration and instead is provided in an unfurled configuration in which it covers the majority of the length of the catheter 220, preferably at least 90% of its length. Consequently, the pouch 270 does not comprise a gripping element.

In this embodiment, the sleeve 230 is configured to allow wetting fluid to penetrate the sleeve 230, for example, the sleeve 230 may comprise perforations or an otherwise permeable material that facilitates transport of the wetting fluid through the sleeve 230. This allows wetting fluid in the pouch 270 to activate the catheter 270 surface even though the sleeve 230 covers most of the length of the catheter 270.

In use, the user may first locate and burst the fluid reservoir 240 to release wetting fluid into the pouch 270. They may then apply the wetting fluid to the catheter 220 to activate its surface. In this embodiment, the user shakes the pouch 270 to distribute wetting fluid over the entire catheter 220. Advantageously, the sheath 219 protects the fluid collection bag 210 from getting wet and also reduces the amount of wetting fluid that reaches the top of the pouch 270 where it may be inconvenient for the user, this also helps to concentrate wetting fluid on the catheter 220. Any wetting fluid that does reach the top of the pouch 270 may be absorbed by the absorbent strip 274.

In this embodiment, the pouch 270 is then opened and the fluid collection bag 110 withdrawn along with the catheter 220 and used as described above in relation to the first embodiment.

In other embodiments, the catheter 220 may be wetted in a different way, for example it may be wetted during withdrawal by being guided through a pool of wetting fluid/wetting region, as described above in relation to the first embodiment.

Referring to Figures 9-12, a third embodiment of a packaged catheter assembly 400 is shown. Again this embodiment shares many features with that of the first embodiment and like numerals are used to denote like features.

The packaged catheter assembly 400 comprises a pouch 470 containing a fluid collection bag 410, a catheter tube, or “catheter” 420, a sleeve 430, and a fluid reservoir 440 comprising wetting fluid. The catheter 420 has a proximal end 421 for insertion into the body and a distal end 422, and the fluid collection bag 410 is attached to the distal end 422 of the catheter 420 and is arranged to receive fluid from the distal end 422 of the catheter 420, thereby forming a so-called “closed catheter assembly”. In this embodiment, the sleeve 430 and fluid reservoir 440 are also attached to the catheter 420 and so are also considered part of the “closed catheter assembly”.

Again, the catheter 420 is a male urinary catheter made from a hydrophilic thermoplastic elastomer (TPE). The sleeve 430 of this embodiment is a thermoplastic polyurethane (TPU) or low-density polyethylene (LDPE). Obviously those skilled in the art will be able to select suitable alternative materials.

The sleeve 430 of this embodiment is sized to enclose the catheter 420 along the majority of the length of the catheter 420, and preferably the entire length of the catheter 420. The sleeve 430 comprises a proximal end 431 corresponding to the proximal end 421 of the catheter 420 and a distal end 432 corresponding to the distal end 422 of the catheter 420. The distal end 432 of the sleeve 430 is attached to an inlet 450 of the fluid collection bag 410. The proximal end 431 of the sleeve comprises a reservoir adapter 433.

In this embodiment, the reservoir adapter 433 is generally tubular with a constant wall thickness and comprises a bore through its entire length. Of course, in other embodiments the wall thickness may vary allowing the size/shape of the reservoir adapter to be varied as desired. The reservoir adapter 433 comprises a distal end 433a with annular cross-section where it is attached to the proximal end 431 of the sleeve 430. The distal end 433a comprises an internal diameter sized to allow the catheter 420 and wetting fluid to pass through the reservoir adapter 433 as described further below.

The reservoir adapter 433 is configured to releasably engage the fluid reservoir 440, and as such, a proximal end 433c of the reservoir adapter 433 distal from the sleeve 430 is configured to receive and retain the fluid reservoir 440. In this embodiment, the reservoir adapter 433 has an internal size and shape that matches the fluid reservoir 440 to allow the fluid reservoir to be push-fit into the reservoir adapter 433. This also allows the fluid reservoir 440 to be easily detached from the reservoir adapter 433 by pulling them apart. Of course, in other embodiments the fluid reservoir 440 may be received in a different way, such as through a bayonet or screw type fit, or through use of a temporary adhesive. In this embodiment, the fluid reservoir 440 is an elongate rectangular burstable sachet of water. The fluid reservoir 440 is arranged with a first end engaged into the reservoir adapter 433. The reservoir adapter 433 extends around the first end of the fluid reservoir 440 and along the fluid reservoir 440 between 60-20% of the length of the fluid reservoir 440, for example 33%. Consequently, the proximal end 433b of the reservoir adapter 433 comprises a generally elliptical annular cross section to allow an interference fit between the fluid reservoir 440 and reservoir adapter 433.

In this embodiment, the reservoir adapter 433 also comprises a midsection 433b between the annular distal end 433a and larger elliptical proximal end 433c enclosing the fluid reservoir 440. The midsection 433b is tapered and has a convex shape to assist the user in gripping the reservoir adapter and using it as a handling element for the catheter 420 and/or sleeve 430. The midsection 433b also acts as a funnel to deliver wetting fluid from the fluid reservoir 440 to the catheter 420/sleeve 430.

In this embodiment, the fluid reservoir 440 is be configured to retain 5 to 50 ml of wetting fluid, for example 12 ml. The fluid reservoir 440 has a height equal to between 20-50% the height of the pouch 470, for example 30%, and a width between 5-25% the width of the pouch 470, for example 15%. The height and width of the pouch 470 are defined as the distance between a base 472a and an upper edge 472d of the pouch, and a left lateral edge 472b and right lateral edge 472c of the pouch 470 respectively and as described in more detail below.

The fluid reservoir 440 also comprises a wetting marker 444 configured to allow the user to identify where to activate the fluid reservoir 440 to release wetting fluid. In this embodiment, the wetting marker 444 comprises a logo/region of different colour or contrast from the rest of the fluid reservoir 440. In this embodiment, the wetting marker 444 is positioned in a region of the fluid reservoir 440 that is not enclosed by the reservoir adapter 433, this allows the user to easily identify the wetting marker 444 and activate the fluid reservoir 440. In other embodiments, the wetting marker 444 may provide any suitable visual or tactile indication to assist the user in identifying and activating the fluid reservoir 440 to release wetting fluid.

In this embodiment, the fluid reservoir 440 is configured to release wetting fluid by rupturing upon depression/compression of the fluid reservoir 440, especially at a I l l position corresponding to the wetting marker 444. The fluid reservoir 440 is configured to rupture and create a tear 441 in the fluid reservoir 440 through which wetting fluid is released. In this embodiment, the fluid reservoir 440 is configured to create a tear 441 in locations that are enclosed by the reservoir adapter 433. Thus, the reservoir adapter 433 is therefore configured to receive wetting fluid from the fluid reservoir 440 into the sleeve 430 to wet the catheter 420. To ensure that wetting fluid released from the fluid reservoir 440 is directed into the sleeve 430, the reservoir adapter 433 and/or fluid reservoir 440 may comprise a sealing element to prevent wetting fluid from escaping into the pouch 470, for example an O-ring provided around the end of the reservoir adapter 433 that engages the fluid reservoir 440. Such an O-ring may also facilitate the push-fit engagement of the fluid reservoir 440 and reservoir adapter 433.

In other embodiments, many other types of fluid reservoir would be suitable including different shapes and sizes of reservoir, or non-burstable reservoirs and other external sources of fluid. In this embodiment, the wetting fluid is water and interacts with the hydrophilic surface of the catheter 420 to render it lubricious. In other embodiments, other wetting fluids may be used and they may be polar (e.g. waterbased) or non-polar (e.g. oil-based) depending on the catheter’s surface properties.

In this embodiment, the fluid reservoir 440 comprises a thermoplastic polyurethane (TPU) or low-density polyethylene (LDPE). In this embodiment, the reservoir adapter 433 comprises a relatively rigid material compared to the sleeve 430, fluid reservoir 440 and catheter 420, for example high-density polyethylene (HDPE), and thus provides a handling element to facilitate movement of the proximal end 431 of the sleeve 430 up and down the catheter 420.

The pouch 470 is formed from a front wall (not shown - cut away) and rear wall 471 of identical shape and size, and a peripheral seal joining the periphery of the walls to form the pouch 470 and containing its contents in just the same way as the first embodiment. The front and/or rear wall of the pouch may comprise a wetting marker (not shown) which provides a visual/tactile guide to help the user locate the fluid reservoir 440 within the closed pouch and activate it to release wetting fluid.

The pouch 470 also comprises an interaction region, which is identical to that of the first embodiment. In this embodiment, the catheter 420 is arranged within the pouch 470 in a curved and S-shaped configuration with two opposing turns of at least 180 degrees along the length of the catheter 420. The distal end 422 of the catheter 420 is arranged adjacent to the inner left lateral edge 472b near the upper edge 472d of the pouch 470. The catheter 420 extends down the inside of the pouch 470 into a first turn adjacent the base 472a of the pouch and then extends back up the pouch 470 towards the distal end 422 of the catheter 420. The catheter 420 then comprises a second turn adjacent the fluid collection bag 410 (as described below) and at a height in the pouch 470 corresponding to the position of the distal end 422 of the catheter 420. Finally, the catheter 420 extends down the inner right lateral edge 472c of the pouch 470 with the proximal end 421 of the catheter 420 resting approximately half the way down the height of the pouch 470.

In this embodiment, each of the first and second turns in the catheter 420 comprise turns of at least 180 degrees, and preferably 180-220 degrees, for example 200 degrees. Each of the first and second turns has a radius of curvature approximately equal to one third the width of the pouch and as such, each turn spans two-thirds the width of the pouch. Thus, the S-shape of the catheter 420 helps to maintain the contents of the pouch 470 in a stable position before use and also protects the catheter 420 from damage, for example kinking, due to mechanical stresses imposed on the pouch 470. Of course, the catheter 420 straightens as it is pulled out of the pouch, as described below.

In this embodiment, the fluid collection bag 410 is provided in a stowed configuration, which in this embodiment is a folded configuration, within the pouch 470 and is retained in the folded configuration by the walls of the pouch 470 which provide compressive pressure to the folded fluid collection bag 410. In other embodiments, the fluid collection bag 410 may be retained in the folded configuration by any other suitable means, such as an elastic band, paper band or closure. The folded fluid collection bag 410 is generally cylindrical in shape and is arranged within the pouch 470 just below the tear line 478 and with an axis of the cylindrical folded fluid collection bag 410 approximately parallel to the tear line 478. The inlet 450 of the bag 410 receives the distal end 422 of the catheter 420 adjacent to the left lateral edge 472b of the pouch 470, and the opposite end of the bag 410 is positioned adjacent to the right lateral edge 472c of the pouch 470. The fluid collection bag 410 is therefore arranged adjacent to the opening formed in the pouch 470 by the tear-away region 475 as described further below and spans between the left lateral edge 472b and right lateral edge 472c.

In this embodiment, the sleeve 430 is arranged around the catheter 420 and covering the majority of the length of the catheter 420. The distal end 432 of the sleeve 430 is attached to the inlet 450 of the fluid collection bag 410, and as described above, the proximal end 431 of the sleeve 430 is attached to the reservoir adapter 433. The reservoir adapter 433 is positioned at the proximal end 421 of the catheter 420 and adjacent the right lateral edge 472c of the pouch 470. The fluid reservoir 440 is engaged by the reservoir adapter 433 and extends from the proximal end 421 of the catheter 420 down the inner right lateral edge 472c of the pouch 470 to the base 472a of the pouch 470. The fluid reservoir of this embodiment is attached to a wall of the pouch, e.g. by adhesive, to prevent it being accidentally removed from the pouch. The fluid reservoir 440 can therefore be activated by pressing the walls of the sealed closed pouch 470 together adjacent the base 472a and right lateral edge 472c. Of course, in other embodiments, the catheter 420, fluid collection bag, sleeve 430 with reservoir adapter 433 and fluid reservoir 440 may be arranged differently within the pouch 470.

The fluid collection bag 410 comprises a front panel 411, a rear panel of identical shape and size (not shown), and a peripheral bond joining the periphery of the panels to form the bag 410 and is identical to that of the first embodiment

Referring to Figures 9 and 10, in this embodiment, the packaged catheter assembly 400 is provided with the folded fluid collection bag 410, catheter 420, sleeve 430 and fluid reservoir 440 all contained with the pouch 470 as mentioned above. To wet the catheter 420 so that it is ready for use, the user may release the wetting fluid from the fluid reservoir 440 into the sleeve 430. This may be done by any suitable means, but preferably by applying pressure to the outside of the pouch 470 at a region corresponding to the position of the fluid reservoir 440. Alternatively, if the fluid reservoir is not attached to the pouch, the user may first remove the fluid collection bag 410, catheter 420, sleeve 430 and fluid reservoir 440 from the pouch 470 (as described below) and then activate the fluid reservoir 440 by pressing the activation marker 444.

As described above, in this embodiment, the fluid reservoir 440 is configured to rupture under external pressure and create a tear 441 in the fluid reservoir 440 at a position that is enclosed by the reservoir adapter 433. As such, the wetting fluid is released into the reservoir adapter 433 where it is able to flow through the bore of the reservoir adapter 433 along the length of the catheter 420 between the catheter 420 and sleeve 430.

Referring to Figures 11 and 12, the user may then access the catheter 420 by creating an opening in the pouch 470 using the interaction region, in just the same way as in the first embodiment.

In this embodiment, the closed catheter assembly (i.e. catheter 420 attached to the sleeve 430, reservoir adapter 433, fluid reservoir 440, and fluid collection bag 410) may then be removed from the pouch 470. The folded fluid collection bag 410 is easily accessible to the user as it is directly accessible via the opening in the pouch 470. To withdraw the closed catheter assembly from the pouch 470 the user inverts the pouch, so that the fluid collection bag 410 is towards the bottom of the pouch and pulls it downwards out of the pouch 470, at which point the fluid will flow down through the sleeve.

In this embodiment, the fluid collection bag 410 may then be unfolded so that it is ready to accept fluid from the catheter 420. The catheter 420 may be handled via the sleeve 430 and/or the reservoir adapter 433.

In this embodiment, the fluid reservoir 440 must be removed from the reservoir adapter 433 to allow the proximal end of 421 of the catheter 420 to be withdrawn from the sleeve 430 and inserted into the body. The fluid reservoir 440 is removed from the reservoir adapter 433 by simply pulling the reservoir adapter 433 out of the pouch and hence away from the fluid reservoir 440 which is retained within the pouch. Now that the fluid reservoir 440 is removed from the reservoir adapter 433, the catheter 420 is able to be passed through the reservoir adapter 433 for use. In other embodiments, the fluid reservoir 440 may be actively disengaged by twisting or otherwise activating the reservoir adapter 433 to release the sleeve 430 for example.

The steps of releasing wetting fluid into the sleeve 430, unfolding the fluid collection bag 410, and disengaging the fluid reservoir 440 as described above may be performed in any order depending on the construction of the packaged catheter assembly and the preference of the user.

Referring to Figure 12, in this embodiment, the catheter 420 is now ready for use and is used in much the same way as the first embodiment, in that the sleeve 430 may be used to handle the catheter 420 and the reservoir adapter 433 may be used to progressively introduce the proximal end 421 of the catheter 420 into the urethra until fluid flows through the catheter 420 from the bladder.

As mentioned above, in this embodiment the catheter 420 and sleeve 430 are in fluid communication with the fluid collection bag 410 via the inlet 450. The configuration of the catheter 420, sleeve 430, inlet 450 and bag 410 is relatively flexible and many different configurations could be employed in embodiments of the invention.

Referring to Figure 13, in a first example of the configuration for the catheter 420, sleeve 430 and inlet 450 fluid passes directly from the sleeve 430 to the inlet 450 and directly from the catheter 420 to the inlet 450. In this example, a right lateral side 423 of the catheter 420 is attached to a right side 455 of the inlet 450 and there is a gap between a left lateral side 424 of the catheter 420 and the respective left side 456 of the inlet 450. In addition, the distal end 422 of the catheter 420 is within the inlet 450, and the sleeve 430 is sealed around a periphery of the inlet 450. As such, fluid travelling within the sleeve 2 is directed into the inlet 450 directly via the gap between the left lateral side 424 of the catheter 420 and the left side 456 of the inlet 450. In addition, fluid travelling within the catheter 3 passes out the distal end 422 and into the inlet 450 directly. In other examples, the catheter 420 may be positioned differently and may be attached to the left side 456 of the inlet 450, or to a front or rear side.

Referring to Figure 14, in a second example fluid passes from the catheter 420 into the sleeve 430 and then into the inlet 450. In this example, the right lateral side 423 of the catheter 420 is attached to a left side 434 of the sleeve 430 and a distal end 422 of the catheter 420 is not within the inlet 450. As in the first example, the sleeve 430 is sealed around a periphery of the inlet 450. As such, fluid travelling within the sleeve 2 is directed into the inlet 450 directly and fluid travelling within the catheter 3 passes out the distal end 422 into the sleeve 430 and then from there into the inlet 450. In other examples, the catheter 420 may be positioned differently and may be attached to a left side 435 of the sleeve 430, or indeed to a front or rear side. Furthermore, the distal end 422 of the catheter 420 may be blocked and an outlet (not shown) may be provided in a lateral side of the catheter 420 to allow fluid to pass out into the sleeve 430.

Referring to Figure 15, in a third example fluid passes from the sleeve 430 into the catheter 420 and then into the inlet 450. The configuration of this example is similar to the first example shown in Figure 12 and so only the differences are described. In this example, the inlet 450 is sealed between the left side 456 and right side 455 such that the catheter 420 is sealed on all sides. As such, fluid may only pass from the sleeve 430/catheter 420 into the inlet 450 if it is within the catheter 420. The left lateral side 424 of the catheter 420 comprises an oval sleeve intake opening 425 adjacent to the inlet 450 which permits the passage of fluid travelling within the sleeve 3 into the catheter to join fluid travelling within the catheter 2. From here, the fluid 2, 3 passes out the distal end 422 of the catheter 420 and into the inlet 450. Many other configurations may be possible to achieve the same effect, for example, the sleeve 430 may be attached to the outer sides of the catheter 420 itself.

Referring to Figure 16, a fourth embodiment of a packaged catheter assembly shares many of the features of the third embodiment described above, in particular, the pouch 470, fluid collection bag 410, catheter 520, sleeve 530 and reservoir adapter 533 are identical and so only differences in the features are described below, and like numerals are used to denote like features.

In this embodiment, the fluid reservoir 540 further comprises a reservoir jacket 542 configured to enclose the fluid reservoir 540. The reservoir jacket 542 comprises an impermeable material, for example, a thermoplastic polyurethane (TPU) or low- density polyethylene (LDPE). The reservoir jacket 542 further comprises a wetting aperture 543 arranged at a position corresponding to the first end of the fluid reservoir 540, that is, the end engaged by the reservoir adapter 533 and closest to the sleeve 530 and catheter 520. The reservoir jacket 542 is therefore configured to direct wetting fluid released from the fluid reservoir 540 into the sleeve 530 and onto the catheter 520 via the wetting aperture 543. This helps ensure that wetting fluid released by the fluid reservoir 540 is directed into the sleeve 530, for example in the situation where the fluid reservoir 540 inadvertently ruptures at a position that is not enclosed by the reservoir adapter 533.

Furthermore, as the reservoir jacket 542 comprises the wetting aperture 543, pressure applied to the fluid reservoir 540 to rupture it does not also rupture the reservoir jacket 542, as any increase in pressure within the reservoir jacket 542 is relieved through the wetting aperture 543. Thus, the reservoir jacket 542 remains impermeable to wetting fluid and can direct it into the sleeve 430 irrespective of the location in which the fluid reservoir 440 ruptures.

In this embodiment, the reservoir jacket 542 is transparent or translucent and allows the activation marker 544 to be visible through the reservoir jacket 542. In other embodiments, the reservoir jacket 542 may be opaque or may otherwise obscure the activation marker 544. In such embodiments, an activation marker may be placed on the reservoir jacket 544 itself.

Referring to Figures 17-26, a fifth embodiment of a (packaged) catheter assembly 800 is shown. Again, like features are given like reference numerals.

The packaged catheter assembly 800 comprises a pouch 870 containing a fluid collection bag 810, a catheter tube, or “catheter” 820, a sleeve 830, and a fluid reservoir 840 comprising wetting fluid. The catheter 820 has a proximal end 821 for insertion into the body and a distal end 822, and the fluid collection bag 810 is attached to the distal end 822 of the catheter 820 and is arranged to receive fluid from the distal end 822 of the catheter 820, thereby forming a so-called “closed catheter assembly”. In this embodiment, the sleeve 830 and fluid reservoir 840 are also attached to the catheter 820 and so are also considered part of the “closed catheter assembly”.

In this embodiment, the catheter 820 is a male urinary catheter made from a hydrophilic thermoplastic elastomer (TPE). The sleeve 830 of this embodiment is a thermoplastic polyurethane (TPU) or low-density polyethylene (LDPE). Obviously those skilled in the art will be able to select suitable alternative materials.

The sleeve 830 of this embodiment is sized to enclose the catheter 820 along the majority of the length of the catheter 820, and preferably the entire length of the catheter 820. The sleeve 830 comprises a proximal end 831 corresponding to the proximal end 821 of the catheter 820 and a distal end 832 corresponding to the distal end 822 of the catheter 820. The distal end 832 of the sleeve 830 is attached to an inlet 850 of the fluid collection bag 810. The proximal end 831 of the sleeve comprises a reservoir adapter 833.

In this embodiment, the reservoir adapter 833 is generally tubular with a constant wall thickness and comprises a bore through its entire length. Of course, in other embodiments the wall thickness may vary allowing the size/shape of the reservoir adapter to be varied as desired. The reservoir adapter 833 comprises a distal end (not shown) with annular cross-section where it is attached to the proximal end 831 of the sleeve 830. The distal end comprises an internal diameter sized to allow the catheter 820 and wetting fluid to pass through the reservoir adapter 833 as described further below.

The reservoir adapter 833 is configured to releasably engage the fluid reservoir 840, and as such, a proximal end (not shown) of the reservoir adapter 833 distal from the sleeve 830 is configured to receive and retain the fluid reservoir 840. In this embodiment, the reservoir adapter 833 has an internal size and shape that matches the fluid reservoir 840 to allow the fluid reservoir to be push-fit into the reservoir adapter 833. This also allows the fluid reservoir 840 to be easily detached from the reservoir adapter 833 by pulling them apart. Of course, in other embodiments the fluid reservoir 840 may be received in a different way, such as through a bayonet or screw type fit, or through use of a temporary adhesive.

In this embodiment, the fluid reservoir 840 is an elongate rectangular burstable sachet of water. The fluid reservoir 840 is arranged with a first end engaged into the reservoir adapter 833. The reservoir adapter 833 extends around the first end of the fluid reservoir 840 and along the fluid reservoir 840 between 60-20% of the length of the fluid reservoir 840, for example 33%. Consequently, the proximal end of the reservoir adapter 833 comprises a generally elliptical annular cross section to allow an interference fit between the fluid reservoir 840 and reservoir adapter 833.

In this embodiment, the reservoir adapter 833 also comprises a midsection (not shown) between the annular distal end and larger elliptical proximal end enclosing the fluid reservoir 840. The midsection is tapered and has a convex shape to assist the user in gripping the reservoir adapter and using it as a handling element for the catheter 820 and/or sleeve 830. The midsection also acts as a funnel to deliver wetting fluid from the fluid reservoir 840 to the catheter 820/sleeve 830.

In this embodiment, the fluid reservoir 840 is be configured to retain 5 to 50 ml of wetting fluid, for example 82 ml. The fluid reservoir 840 has a height equal to between 20-50% the height of the pouch 870, for example 30%, and a width between 5-25% the width of the pouch 870, for example 15%. The height and width of the pouch 870 are defined as the distance between a base 872a and an upper edge 872d of the pouch, and a left lateral edge 872b and right lateral edge 872c of the pouch 870 respectively and as described in more detail below.

The fluid reservoir 840 also comprises a wetting marker (not shown) configured to allow the user to identify where to activate the fluid reservoir 840 to release wetting fluid. In this embodiment, the wetting marker comprises a logo/region of different colour or contrast from the rest of the fluid reservoir 840. In this embodiment, the wetting marker is positioned in a region of the fluid reservoir 840 that is not enclosed by the reservoir adapter 833, this allows the user to easily identify the wetting marker and activate the fluid reservoir 840. In other embodiments, the wetting marker may provide any suitable visual or tactile indication to assist the user in identifying and activating the fluid reservoir 840 to release wetting fluid.

In this embodiment, the fluid reservoir 840 is configured to release wetting fluid by rupturing upon depression/compression of the fluid reservoir 840, especially at a position corresponding to the wetting marker 844. The fluid reservoir 840 is configured to rupture and create a tear in the fluid reservoir 840 through which wetting fluid is released. In this embodiment, the fluid reservoir 840 is configured to create a tear in locations that are enclosed by the reservoir adapter 833. Thus, the reservoir adapter 833 is therefore configured to receive wetting fluid from the fluid reservoir 840 into the sleeve 830 to wet the catheter 820. To ensure that wetting fluid released from the fluid reservoir 840 is directed into the sleeve 830, the reservoir adapter 833 and/or fluid reservoir 840 may comprise a sealing element to prevent wetting fluid from escaping into the pouch 870, for example an O-ring provided around the end of the reservoir adapter 833 that engages the fluid reservoir 840. Such an O-ring may also facilitate the push-fit engagement of the fluid reservoir 840 and reservoir adapter 833.

In other embodiments, many other types of fluid reservoir would be suitable including different shapes and sizes of reservoir, or non-burstable reservoirs and other external sources of fluid. In this embodiment, the wetting fluid is water and interacts with the hydrophilic surface of the catheter 820 to render it lubricious. In other embodiments, other wetting fluids may be used and they may be polar (e.g. waterbased) or non-polar (e.g. oil-based) depending on the catheter’s surface properties.

In this embodiment, the fluid reservoir 840 comprises a thermoplastic polyurethane (TPU) or low-density polyethylene (LDPE). In this embodiment, the reservoir adapter 833 comprises a relatively rigid material compared to the sleeve 830, fluid reservoir 840 and catheter 820, for example high-density polyethylene (HDPE), and thus provides a handling element to facilitate movement of the proximal end 831 of the sleeve 830 up and down the catheter 820.

The pouch 870 is formed from a front wall 873 and rear wall 871 of identical shape and size, and a peripheral seal joining the periphery of the walls to form the pouch 870 and containing its contents (i.e. the closed catheter assembly).

The peripheral seal defines a base 872a, a left lateral edge 872b, a right lateral edge 872c and an upper edge 872d of the pouch 870. The left lateral edge 872b and right lateral edge 872c being defined as the left and right sides of the pouch 870 when viewing the pouch 870 with the rear wall 871 behind the front wall, the base 872a at the bottom of the pouch 870 and the upper edge 872d at the top of the pouch 870. The upper edge 872d is linear and the base 872a is outwardly curved, away from the upper edge 872d, and forms a curved bottom of the pouch 870. The peripheral seal thus defines a pouch 870 that is generally rectangular with a curved bottom and suitably has a width between the lateral edges of between 80-160 mm, preferably 100-140 mm, for example about 120mm, and a height from the lowermost part of the base 872a to the upper edge 872d of between 100 to 250 mm, preferably 120 to 180 mm, more preferably 140 to 160 mm, for example about 150 mm. The base 872a defines the bottom of the pouch 870 in use, and the upper edge 872d the top. However, in other embodiments alternative shapes and sizes could be conceived, such as rectangular, 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 870 may be formed from a single piece of material. The pouch 870 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 870. For example, none of the edges may comprise a fold, one edge may comprise a fold, or two or more of the edges may comprise a fold.

In this embodiment, the pouch 870 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 800 in day-to-day life. In addition, the exterior of the pouch 870 may have a textured or printed appearance, for example a matte appearance, and feel to reduce the impression that it is a medical device. The front and/or rear wall of the pouch may comprise a wetting marker 882 which provides a visual/tactile guide to help the user locate the fluid reservoir 840 within the closed pouch and activate it to release wetting fluid. In this embodiment, the wetting marker 882 is located on the front wall 873 at the centre of the upper edge 872d of the pouch 870.

In this embodiment, the pouch 870 also comprises an interaction region. The interaction region forms the right side of the pouch 870 and spans between the upper edge 872d and base 872a. The interaction region is used to provide access to the pouch through/near to the right lateral edge 872c. In this embodiment, the interaction region comprises a tear-away region 875. The tear away region 875 is of equal width throughout its length. The tear-away region 875 comprises a tear start 876 at the point the upper edge 872d meets the tear-away region 875, a tear stop 877 at a corresponding point on the base 872a, and a tear line 878 spanning between the tear start 876 and tear stop 877. The tear line 878 comprises a line of weakness in the walls of the pouch 870, which may be formed by any suitable means but in this embodiment is laser etched. The tear start 876 comprises a notch to provide an area of weakness in the peripheral seal. This allows the tear-away region 875 to be separated from the pouch 870 by tearing the walls apart from the tear start 876 to the tear stop 877 along the tear line 878. Thus the tear is provided beneath the location of the right lateral edge 872c and thus the pouch 870 may be opened provided access to its contents. In other embodiments, the tear stop 877 may comprise a small aperture in the walls to prevent further tearing of the pouch 870.

The tear-away region 875 comprises a circular aperture 879 sized to allow a finger to pass through and grip the tear-away region 875. The circular aperture 879 is positioned in a corner where the upper edge 872d and right lateral edge 872c meet. To ensure the pouch 870 is fully sealed, the front wall 873 and rear wall 871 are sealed to one another over the entire tear-away region 875. In other embodiments, other seals such as a zip-lock arrangement, or hook and hook, hook and loop (VELCRO (RTM)) or the like may be used to provide access to the pouch (or to reseal the pouch after opening), and of course, the sizes and shapes set out above are exemplary.

In this embodiment, the catheter 820 is arranged within the pouch 870 in a curved, generally elliptical, curled/coiled configuration. The distal end 822 of the catheter 820 is arranged adjacent to the inner left lateral edge 872b near the basel72a of the pouch 870. The catheter 820 extends from a position where the proximal end 821 of the catheter 820 is adjacent the right lateral edge 872c down the inside of the pouch 870 into a first turn adjacent the base 872a of the pouch and then extends back up the pouch 870 adjacent to the left lateral edge 872b towards the upper edge 872d, into a second turn adjacent the upper edge 872d and then extends back down the pouch adjacent to the right lateral edge 872c towards the base 872a. The catheter 820 then comprises a third turn adjacent the base 872a where the distal end 822 of the catheter 820 connects to the fluid collection bag 810.

In this embodiment, the generally elliptical shape of the catheter 820 helps to maintain the contents of the pouch 870 in a stable position before use and also protects the catheter 820 from damage, for example kinking, due to mechanical stresses imposed on the pouch 870. Of course, the catheter 820 straightens as it is pulled out of the pouch, as described below.

In this embodiment, the fluid collection bag 810 is provided in a stowed configuration, which in this embodiment is a folded configuration, within the pouch 870 and is retained in the folded configuration by the walls of the pouch 870 which provide compressive pressure to the folded fluid collection bag 810. In other embodiments, the fluid collection bag 810 may be retained in the folded configuration by any other suitable means, such as an elastic band, paper band or closure. The folded fluid collection bag 810 is generally rectangular in shape and is arranged within the pouch 870 just below the upper edge 872d and with an axis of the rectangular folded fluid collection bag 810 approximately parallel to the upper edge 872d.

The fluid collection bag 810 comprises an inlet 850 to receive the distal end 822 of the catheter 820 adjacent to the left lateral edge 872b of the pouch 870, and the opposite end of the bag 810 is positioned adjacent to the right lateral edge 872c of the pouch 870. The fluid collection bag 810 is therefore arranged adjacent to the opening formed in the pouch 870 by the tear-away region 875 as described further below and spans between the left lateral edge 872b and right lateral edge 872c.

In this embodiment, the sleeve 830 is arranged around the catheter 820 and covering the majority of the length of the catheter 820. The distal end 832 of the sleeve 830 is attached to the inlet 850 of the fluid collection bag 810, and as described above, the proximal end 831 of the sleeve 830 is attached to the reservoir adapter 833. The reservoir adapter 833 is positioned at the proximal end 821 of the catheter 820 and adjacent the right lateral edge 872c of the pouch 870. The fluid reservoir 840 extends adjacent the inner upper edge 872d from the inner left lateral edge 872b to the inner right lateral edge 872c of the pouch 870. The fluid reservoir of this embodiment is attached to a wall of the pouch, e.g. by adhesive, to prevent it being accidentally removed from the pouch. The fluid reservoir 840 can therefore be activated by pressing the walls of the sealed closed pouch 870 together adjacent the upper edge 872d. Of course, in other embodiments, the catheter 820, fluid collection bag, sleeve 830 with reservoir adapter 833 and fluid reservoir 840 may be arranged differently within the pouch 870.

In this embodiment, the pouch 870 comprises a reservoir jacket 842 configured to enclose the fluid reservoir 840. The reservoir jacket 842 comprises an impermeable material, for example, silicon, a thermoplastic polyurethane (TPU) or low-density polyethylene (LDPE). The reservoir jacket 842 is rectangular and spans across the width of the pouch 870 adjacent to the upper edge of the pouch 870. The reservoir jacket 842 further comprises a wetting aperture 843 arranged at a position adjacent to the opening formed in the pouch 870 by actuation of the interaction region. The wetting aperture is configured to receive an inserter tip 839 of the reservoir adapter 833 and to direct wetting fluid from the reservoir jacket 842 and/or fluid reservoir 840 into the sleeve 830 and onto the catheter 820. In this embodiment, the wetting aperture is resiliently deformed by insertion of the inserter tip 839 therein. Consequently, the wetting aperture provides a fluid tight seal around the inserter tip 839. In other embodiments, the wetting aperture may fit to the reservoir adapter 833 through a different type of fitting, such as a screw or bayonet fitting. This ensures that wetting fluid released by the fluid reservoir 840 is directed into the sleeve 830. Of course, in other embodiments, the reservoir jacket 842 may have a different shape and size and the wetting aperture may be in a different position. Alternatively, the reservoir jacket 842 may couple to the reservoir adapter 833 via a different method, such as being inserted into the reservoir adapter 833.

Furthermore, as the reservoir jacket 842 comprises the wetting aperture, pressure applied to the fluid reservoir 840 to rupture it does not also rupture the reservoir jacket 842, as any increase in pressure within the reservoir jacket 842 is relieved through the wetting aperture 843. Thus, the reservoir jacket 842 remains impermeable to wetting fluid and can direct it into the sleeve 830 irrespective of the location in which the fluid reservoir 840 ruptures.

In this embodiment, the reservoir jacket 842 is attached to the inside of the pouch 870, for example by welding or gluing of the reservoir jacket 842 to the pouch 870. This ensures that the reservoir jacket 842 and fluid reservoir 840 are not removed from the pouch 870 unnecessarily or accidentally, which makes the packaged catheter assembly 800 more convenient to use.

Referring to Figures 21 to 23, the fluid collection bag 810 comprises a front panel 811, a rear panel of identical shape and size (not shown), and a peripheral bond joining the periphery of the panels to form the bag 810. The peripheral bond defines a base 812, a right lateral edge 813, a left lateral edge 814 and an upper edge 815. The right lateral edge 813 and left lateral edge 814 being defined as the right and left sides of the bag 810 when viewing the bag 810 with the rear panel behind the front panel 811, the base 812 at the bottom of the bag 810 and the upper edge 815 at the top of the bag 810. The peripheral bond thus defines a bag 810 that, when unfolded, is generally rectangular and suitably has a width between the lateral edges of at least 10, 12, 15 or 20 cm. The bag may have a width no more than 25, 20,15, 12 or 10 cm. Preferably, the width is between 10 and 20 cm, most preferably between 10 and 15 cm, for example 12 cm. A height from the base 812 to the upper edge 815 may be at least 25, 30, 35 or 40 cm. The height of the bag may be no more than 45, 40, 35 or 30 cm. The height may be between 25 and 40 cm, 28 and 34 cm, or most preferably 29 and 31 cm, for example 30 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 base 812 defines the bottom of the bag 810 in use, and the upper edge 815 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.

The front panel 811 and rear panel are both substantially formed from an opaque material. In this embodiment, 70% of the fluid collection bag 810 is formed from an opaque material. The remaining 30% of the fluid collection bag 810 is located proximal to the left lateral edge 814 and spans between the upper edge 815 and the base 812.

In this embodiment, the panels comprise a flexible plastics material, for example polypropylene (PP), polyethylene terephthalate (PET), low density polyethylene (LDPE), metalized polyester (MET PET), orientated polypropylene (OPP) or polyvinyl chloride (PVC). In this embodiment, the inlet 850 is positioned at the upper edge 815 the peripheral bond. The inlet 850 is located at the end of a spout 850a. The spout 850a extends from the upper edge 815 of the fluid collection bag 810 equidistant between the comer where the upper edge 815 and left latera ledge 814 meet and the corner where the upper edge 815 and right lateral edge 813 meet. The spout 850a has a length, i.e. the distance from where the spout 850a joins the upper edge 815 to the inlet 850, of about 8 cm.

In this embodiment, the fluid collection bag 810 comprises a hand strap 817. The hand strap 817 is arranged adjacent to the inlet 850 on a corner of the fluid collection bag 810 where the upper edge 815 and right lateral edge 813 meet. The hand strap 817 is joined to the fluid collection bag 810 by a weld. Thus, the hand strap 817 can be joined to the fluid collection bag 810 simultaneously with the formation of the peripheral bond.

The hand strap 817 provides for a convenient and easy way of holding the fluid collection bag 810, where the hand strap 817 can be temporarily worn around the user’s wrist or be easily held. Moreover, the hand strap 817 allows the fluid collection bag 810 to be easily manipulated by the user during use, meaning that the fluid collection bag 810 can be easily handled and manoeuvred by the user as is necessary. Further, the dimensions of the hand strap (as described below) means that the fluid collection bag 810 can be hanged hung from any suitable article, such as a wheelchair handle or bed post, when the catheter assembly is in use.

The hand strap 817 is arranged at the opposite end of the fluid collection bag 810 to an outlet valve 890a (described further below) configured to control release of fluid out of the fluid collection bag 810 in use. This facilitiates the flow of fluid within the fluid collection bag 810, including the draining of liquid, toward the outlet valve 890a and away from the inlet 850, when in use.

The hand strap 817 is formed of an opaque material, such as polyethylene terephthalate, polypropylene or low-density polyethylene.

The hand strap 817 has a length (measeured from the point at which it is joined to the bag 810 to its furthest point) of 15 cm and a width of 1 cm. The width of the hand strap 817 is constant along its entire length. In this embodiment, the length of the hand strap 817 is fixed, i.e. not adjustable.

The hand strap 817 is formed of a single, continuous loop of material which is joined at two ends to the fluid collection bag 810. The hand strap 817 is joined to the fluid collection bag 810 at two positions on the fluid collection bag 810. In the present embodiment, each of these positions are substantially the same and are each located on the corner where the upper edge 815 and right lateral edge 813 meet. (In this embodiment the distance from one end of the strap to the opposite end, is 30 cm, i.e. 2x15cm as both ends are attached to the same point.)

In this embodiment, the cathter tube has a length of 35 cm and a width defined as CH14 by the French System, i.e. about 0.5 cm. The catheter is formed of polyolefin material comprising polyethylene and polypropylene.

Referring to Figures 17 to 23, the fluid collection bag 810 comprises an outlet valve 890a. The outlet valve 890a is configured to control release of fluid out of the fluid collection bag 810 in use.

The outlet valve 890a is arranged on the front panel 811 of the fluid collection bag 810. The outlet valve 890a is arranged proximal to the base 812, off-centre toward the right lateral edge 813.

The outlet valve 890a comprises a valve base 891a attached to the front panel 811 of the fluid collection bag 810 by a weld. In the present embodiment, the valve base 891a is trapezoidal. The valve base has a height of 8cm and a width, at its widest part, of 10cm. The valve base 891a is formed of a material more rigid than the material from which the fluid collection bag 810 is formed. In the present embodiment, the valve base 891a is formed of polypropylene.

The valve base 891a comprises a base opening (not shown) for receiving a liquid output from the fluid collection bag 810. The base opening is an aperture of any suitable size and shape but is preferably a circular aperture having an diameter of at least 0.5 cm.

The outlet valve 890a further comprises an outlet element 893 configured to be laterally rotatable relative to the valve base 891a from a closed configuration to an open configuration. The outlet element 893 is rotatable about a vertical axis of rotation when in use. This means that the fluid collection bag 810, comprising an upper edge, left lateral edge, right lateral edge and base, comprises a vertical axis parallel to the left and right lateral edges, and it is about this axis which the outlet element 893 is rotatable.

The outlet element 893 is housed in a housing 898 (best seen in Figure 23) which is formed integrally with the valve base 891a and sized to receive the outlet element 893 within it, so as to be rotatable between the open and closed configurations.

The outlet element 893 is rotatable such that the outlet element 893 moves through an arc of rotation. At a first end of the arc of rotation, the outlet element 893 is in the closed configuration, and at a second end of the arc of rotation, the outlet element 893 is in the open configuration. Moreover, the outlet element 893 is rotatable about an axis parallel to the plane of the front panel 811 of the fluid collection bag 810 to which the valve base 891a is attached.

The outlet element 893 is has a hollow tubular form with an internal cavity /bore of approximately 1cm and comprises a circular aperture 897 having a diameter of 1cm. The aperture 897 opens into, and is hence in fluid communication with the internal cavity of the outlet element 893. The aperture 897 is positioned in an upper portion of the outlet element 893. When the outlet element 893 is in the closed configuration, the aperture 897 is positioned facing outwardly relative to the fluid collection bag 810, facing away from the valve base 891a. In this configuration, the aperture 897 is not aligned with the base opening. Moreover, in the closed configuration, the base opening is aligned with a solid portion of the outlet element 893, therefore, flow of liquid from the fluid collection bag 810 through the base opening is prevented.

When the outlet element 893 is in the open configuration, the aperture 897 is positioned facing inwardly relative to the fluid collection bag 810, facing toward the valve base 891a. In this configuration, the base opening and aperture 897 are in fluid communication. As shown in Figure 22, liquid 899 within the fluid collection bag 810 can therefore drain from the bag 810 via the base opening, aperture 897 and downwardly through the outlet element and through a connector portion 895b (further described below) and then into a receptacle or toilet or similar. The connector portion 895b is a hollow cylindrical bore extending from the outlet element such that fluid entering the outlet element 893 via the aperture 897 flows downwardly, through the outlet element 893 and into, through the connector portion 895b and out of a connector portion outlet 895a located at a distal end of the connector portion 895b. The connector portion outlet 895a has a diameter of 1cm. The connector portion 895b and outlet element 893 each have an inner diameter of 1cm.

The outlet element 893 comprises a handle 894 arranged between the housing 898 and the connector portion 895b. The handle 894 and connector portion 895b are integrally formed with the outlet element 893 and are formed as a single moulding. The handle 894 is arranged at approximately 90 degrees anti-clockwise relative to the positon of the aperture 897. This means that when the outlet element 893 is in the closed position, the handle 894 is arranged against the trapezoidal section of the valve base 891a. Lateral rotation of the outlet element 893 using the handle 894 by 880 degrees moves the handle 894 from a first position closer toward the right lateral edge 813 of the fluid collection bag 810 to a second position closer toward the left lateral edge 814 of the fluid collection bag 810, i.e. to the open position. Simultaneously, this rotates the outlet element 180 degrees such that the aperture is rotated from a position where the aperture 897 is facing away from the valve base 891a and the aperture 897 is not aligned with the base opening, to a position where the aperture is facing toward the valve base 891a and the aperture 897 is in fluid communication with the valve base 891a.

The handle 894 is inhibited from rotating more than 180 degrees clockwise or anti-clockwise due to obstruction by the valve base 891a.

The handle 894 is planar such that when the outlet element 893 is in the open or closed configuration, the handle 894 lies flat against the valve base 891a and only minimally protrudes away from the fluid collection bag 810.

The handle 894 is operable to rotate the outlet element 893 between the closed configuration and the open configuration. The handle 894 is rotatable from a position closer to the right lateral side 813 to a position closer to the left lateral side 814. Such rotation moves the outlet element 893 from the closed configuration to the open configuration. The handle 894 has a length of 8cm and a width of 4cm. The handle 894 is sized to allow a user to easily grip it between at least their thumb and index finger, in particular for users with limited dexterity. The handle 894 is elliptical in shape.

The handle 894 comprises a finge-hole 894a. The finger-hole 894a is sized to allow at least one of the user’s fingers to pass through it to facilitate rotation of the handle 894.

The handle 894 extends above the outlet element 893 and valve base 891a to facilitate gripping by the user. When in the closed or open configuration, the handle extends laterally further than the valve base 891a.

The connector portion 895b is configured for use with tubing (not shown) having a diameter marginally smaller than that of the connector portion 895b, such that, on insertion of the tubing onto a distal end of the connector portion 895b, over the connector outlet 895a, in use, the tubing attaches fluid-tight to the connector portion 895b. The annular flange 896 arranged proximal to the connector outlet 895a engages with the tubing.

The valve base 891a, including the housing 898, and outlet element 893, including the connector portion 895b are each formed of a material which is more rigid than the relatively flexible material from which the fluid collection bag is formed. In the present embodiment, the valve base 891a, and outlet element 893 are each formed of polypropylene.

The outlet element 893 protrudes away from the valve base 891a by 1.5 cm. The flange 896 protrudes away from the housing 898 by 0.3 cm.

Each component of the outlet valve 890a is formed of opaque materials.

Referring to Figures 17 to 20, in this embodiment, the packaged catheter assembly 800 is provided with the folded fluid collection bag 810, catheter 820, sleeve 830 and fluid reservoir 840 all contained with the pouch 870 as mentioned above. To wet the catheter 820 so that it is ready for use, the user may release the wetting fluid from the fluid reservoir 840 into the sleeve 830. This may be done by any suitable means, but preferably by applying pressure to the outside of the pouch 870 at a region corresponding to the position of the fluid reservoir 840 by pressing the wetting marker 882.

As described above, in this embodiment, the fluid reservoir 840 is configured to rupture under external pressure and create a tear in the fluid reservoir 840 at a position that is enclosed by the reservoir adapter 833. As such, the wetting fluid is released into the reservoir adapter 833 where it is able to flow through the bore of the reservoir adapter 833 along the length of the catheter 820 between the catheter 820 and sleeve 830.

Referring to Figures 18 and 19, in this embodiment, the user may then access the catheter 820 by creating an opening in the pouch 870 using the interaction region. The aperture 879 is grasped in one hand, and the pouch 870 below the tear line 878 in another, and the tear-away region 875 is tom from the tear start 876 to the tear stop 877 along the tear line 878 in a direction corresponding to arrow A in Fig. 18. Thus, the pouch 870 is torn between the upper edge 872d and base 872a at a location below the right lateral edge 872c, as such, an opening is formed in the pouch 870 that may be used to access its contents. In this embodiment, the tear-away region 875 is fully separated from the pouch 870 to improve access to the contents of the pouch 870. In other embodiments, the tear-away region 875 may not be fully separated from the pouch 870 to reduce the number of separate parts and make the pouch 870 easier to handle. Other embodiments may also feature other ways to access the pouch for example a zip-lock seal.

In this embodiment, the closed catheter assembly (i.e. catheter 820 attached to the sleeve 830, reservoir adapter 833, fluid reservoir 840, and fluid collection bag 810) may then be removed from the pouch 870. The folded fluid collection bag 810 is easily accessible to the user as it is directly accessible via the opening in the pouch 870. To withdraw the closed catheter assembly from the pouch 870 the user pulls the closed catheter assembly laterally out of the pouch 870 in the direction of arrow B in Fig. 19.

In this embodiment, the fluid collection bag 810 may then be unfolded so that it is ready to accept fluid from the catheter 820. The catheter 820 may be handled via the sleeve 830 and/or the reservoir adapter 833. In this embodiment, the fluid reservoir 840 must be removed from the reservoir adapter 833 to allow the proximal end of 821 of the catheter 820 to be withdrawn from the sleeve 830 and inserted into the body. The fluid reservoir 840 is removed from the reservoir adapter 833 by simply pulling the reservoir adapter 833 out of the pouch and hence away from the fluid reservoir 840 which is retained within the pouch. Now that the fluid reservoir 840 is removed from the reservoir adapter 833, the catheter 820 is able to be passed through the reservoir adapter 833 for use. In other embodiments, the fluid reservoir 840 may be actively disengaged by twisting or otherwise activating the reservoir adapter 833 to release the sleeve 830 for example.

The steps of releasing wetting fluid into the sleeve 830, unfolding the fluid collection bag 810, and disengaging the fluid reservoir 840 as described above may be performed in any order depending on the construction of the packaged catheter assembly and the preference of the user.

The catheter 820 is now ready for use. The sleeve 830 may be used to handle the catheter 820 and the reservoir adapter 833 may be used to progressively introduce the proximal end 821 of the catheter 820 into the urethra until fluid flows through the catheter 820 from the bladder. Fluid flowing through the catheter 820 is collected in the fluid collection bag 810. After use, in this embodiment, as the catheter 820 is withdrawn from the body, the reservoir adapter 833 may be used to cover the length of the catheter 820 with the sleeve 830 and the packaged catheter assembly 800 may then be disposed of.

As mentioned above, in this embodiment the catheter 820 and sleeve 830 are in fluid communication with the fluid collection bag 810 via the inlet 850. The configuration of the catheter 820, sleeve 830, inlet 850 and bag 810 is relatively flexible and many different configurations could be employed in embodiments of the invention.

Referring to Figure 24, in a first example of the configuration for the catheter 820, sleeve 830 and inlet 850 fluid passes directly from the sleeve 830 to the inlet 850 and directly from the catheter 820 to the inlet 850. In this example, a right lateral side 823 of the catheter 820 is attached to a right side 855 of the inlet 850 and there is a gap between a left lateral side 824 of the catheter 820 and the respective left side 856 of the inlet 850. In addition, the distal end 822 of the catheter 820 is within the inlet 850, and the sleeve 830 is sealed around a periphery of the inlet 850. As such, fluid travelling within the sleeve 2 is directed into the inlet 850 directly via the gap between the left lateral side 824 of the catheter 820 and the left side 856 of the inlet 850. In addition, fluid travelling within the catheter 3 passes out the distal end 822 and into the inlet 850 directly. In other examples, the catheter 820 may be positioned differently and may be attached to the left side 856 of the inlet 850, or to a front or rear side.

Referring to Figure 25, in a second example fluid passes from the catheter 820 into the sleeve 830 and then into the inlet 850. In this example, the right lateral side

823 of the catheter 820 is attached to a left side 834 of the sleeve 830 and a distal end 822 of the catheter 820 is not within the inlet 850. As in the first example, the sleeve 830 is sealed around a periphery of the inlet 850. As such, fluid travelling within the sleeve 2 is directed into the inlet 850 directly and fluid travelling within the catheter 3 passes out the distal end 822 into the sleeve 830 and then from there into the inlet 850. In other examples, the catheter 820 may be positioned differently and may be attached to a left side 835 of the sleeve 830, or indeed to a front or rear side. Furthermore, the distal end 822 of the catheter 820 may be blocked and an outlet (not shown) may be provided in a lateral side of the catheter 820 to allow fluid to pass out into the sleeve 830.

Referring to Figure 26, in a third example fluid passes from the sleeve 830 into the catheter 820 and then into the inlet 850. The configuration of this example is similar to the first example shown in Figure 24 and so only the differences are described. In this example, the inlet 850 is sealed between the left side 856 and right side 855 such that the catheter 820 is sealed on all sides. As such, fluid may only pass from the sleeve 830/catheter 820 into the inlet 850 if it is within the catheter 820. The left lateral side

824 of the catheter 820 comprises an oval sleeve intake opening 825 adjacent to the inlet 850 which permits the passage of fluid travelling within the sleeve 3 into the catheter to join fluid travelling within the catheter 2. From here, the fluid 2, 3 passes out the distal end 822 of the catheter 820 and into the inlet 850. Many other configurations may be possible to achieve the same effect, for example, the sleeve 830 may be attached to the outer sides of the catheter 820 itself. Before use, providing the user does not want the fluid collection bag 810 to drain from the outlet valve 890a during urination, the user must ensure that the outlet valve 890a is in a closed configuration. In this configuration, the handle 894 is arranged closer to the right lateral edge 813 of the fluid collection bag 810 and the aperture 897 therefore positioned facing away from the valve base 891a such that the base opening is adjacent to a solid portion of the outlet element 893. After urination, when the user wishes to drain the fluid collection bag 810, the user grips the handle 894, optionally using the finger-hole 894a, and rotates the handle 894 approximately 880 degrees toward the left lateral edge 814 of the fluid collection bag 810. Simultaneously, the outlet element 893 is rotated. This brings into alignment the aperture 897 and the base opening. As such, fluid from the fluid collection bag 810 can drain through the base opening in the vlave base 891a, through the aperture 897, into the outlet element 893 and downwardly through the connector portion 895b and out of the outlet 895a.

Referring to Figures 27-29, an embodiment of a packaged catheter assembly 600 is shown.

The packaged catheter assembly 600 comprises a pouch 670 containing a fluid collection bag 610, a catheter tube, or “catheter” 620, and a fluid reservoir 640 comprising wetting fluid. The catheter 620 has a proximal end 621 for insertion into the body and a distal end 622, and the fluid collection bag 610 is attached to the distal end 622 of the catheter 620 and is arranged to receive fluid from the distal end 622 of the catheter 620, thereby forming a so-called “closed catheter assembly”.

The distal end 622 of the catheter 620 is attached to an inlet 650 of the fluid collection bag 610 via a connector 622a.

In this embodiment, the catheter 620 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 materials.

In this embodiment, the catheter 620 comprises a handling element 690 comprising a handling portion 691 mounted to a sleeve 692, arranged around the sleeve, such that the sleeve 692, rather than the handling portion 691 is in contact with the surface of the catheter. The handling element 690 is arranged surrounding a portion of the catheter tube 620 and is movable along the catheter tube 620. Two ends 692a, 692b of the sleeve extend either side of the handling portion 691. The first end 692a is arranged on the side of the handling portion 691 toward the proximal end 621 of the catheter 620, and the second end 692b is arranged on the side of the handling portion 691 toward the distal end 622 of the catheter 620.

The first end 692a and the second end 692b of the sleeve each have a width of 28 mm and extend beyond the handling portion 691 by a length of 35 mm. The handling portion 691 has a width of 40mm and a length of 30 mm. Obviously those skilled in the art will appreciate that the handling element is optional, that alternative handling elements could be provided and that these dimensions are merely preferred.

The handling portion 691 is formed of silicon, but clearly those skilled in the art will be able to select suitable alternative materials. The handling element 691 comprises several ribs to assist gripping by the user. The handling element 690 facilitates handling of the catheter 620 by the user. In use, the handling portion 691 can be gripped by a user to exert pressure upon the catheter tube 620 such that the handling element 690 no longer moves along the catheter tube 620 but instead can be used to guide the catheter 620. In use, handling element 633 may be used to progressively introduce the proximal end 621 of the catheter 620 into the urethra until fluid flows through the catheter 620 from the bladder.

The pouch 670 is formed from a front wall 673 and rear wall 671 of identical shape and size, and a peripheral seal joining the periphery of the walls to form the pouch 670 and containing its contents (i.e. the closed catheter assembly and fluid reservoir 640). The peripheral seal defines a base 672a, a left lateral edge 672b, a right lateral edge 672c and an upper edge 672d of the pouch 670. The left lateral edge 672b and right lateral edge 672c being defined as the left and right sides of the pouch 670 when viewing the pouch 670 with the rear wall 671 behind the front wall, the base 672a at the bottom of the pouch 670 and the upper edge 672d at the top of the pouch 670. The peripheral seal thus defines a pouch 670 that is generally rectangular and suitably has a width between the lateral edges of between 100-150 mm, preferably 120-140 mm, for example about 136mm, and a height from the base 672a to the upper edge 672d of between 100 to 250 mm, preferably 150 to 200 mm, for example about 174 mm. The base 672a defines the bottom of the pouch 670 in use, and the upper edge 672d 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 670 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 670. For example, none of the edges may comprise a fold, one edge may comprise a fold, or two or more of the edges may comprise a fold.

In this embodiment, the pouch 670 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 600 in day-to-day life. In addition, the exterior of the pouch 670 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 670 also comprises an interaction region. The interaction region forms the right side of the pouch 670 and spans between the base 672a and upper edge 672d. The interaction region is used to provide access to the pouch through/near to the right lateral edge 672c. In this embodiment, the interaction region comprises a tear-away region 675. The tear-away region 675 comprises a tear start 676 at the point the upper edge 672d meets the tear-away region 675, a tear stop 677 at a corresponding point on the base 672a, and a tear line 678 spanning between the tear start 676 and tear stop 677. The tear line 678 comprises a line of weakness in the walls of the pouch 670, which may be formed by any suitable means but in this embodiment is laser etched. The tear start 676 comprises a notch to provide an area of weakness in the peripheral seal. This allows the tear-away region 675 to be separated from the pouch 670 by tearing the walls apart from the tear start 676 to the tear stop 677 along the tear line 678, therefore, providing access to the contents of the pouch 670. In other embodiments, the tear stop 677 may comprise a small aperture in the walls to prevent further tearing of the pouch 670.

The upper part of the tear-away region 675 comprises a circular aperture 679 sized to allow a finger to pass through and grip the tear-away region 675. To ensure the pouch 670 is fully sealed, the front wall and rear wall 671 are sealed to one another over the entire tear-away region 675. In other embodiments, other seals such as a ziplock arrangement, or hook and hook, hook and loop (VELCRO (RTM)) or the like may be used to provide access to the pouch (or to reseal the pouch after opening), and of course, the sizes and shapes set out above are exemplary.

In this embodiment, the pouch 670 is divided into a first compartment 680a and a second compartment 680b. The compartments 680a, 680b are separated by an internal join 685. The internal join 685 joins the front wall 673 to the rear wall 671 to form a fluid tight seal therebetween. The internal join 685 is a linear, elongated join comprising a first end 685a and a second end 685b. In other embodiments, the internal join 685 may be curved, for example an ‘S’-shape or a ‘U’-shape. The internal join 685 extends toward the interaction region from its first end 685a at the peripheral seal at a comer where the upper edge 672d and the left lateral edge 672b meet. The internal join 685 terminates, at its second end 685b, approximately mid-way between the base 672a and upper edge 672d of the peripheral seal proximal to the right lateral edge 672c of the pouch 670. The second end 685b is separated from the right lateral edge 672c by a channel 695. At the channel 695, the front wall 673 is not joined to the rear wall 671. Unless obstructed, as described below, fluid may pass from the first compartment 680a to the second compartment 680b, and vice versa, via the channel 695.

The internal join 685 has a length of approximately 14 cm and a width of approximately 0.8 cm, which is substantially equal to the width of the peripheral seal. The channel 695 has a diameter defined by the distance between the second end 685b of the internal join 685 and the inner perimeter of the right lateral edge 672c. In this embodiment, the channel 695 has a diameter of approximately 0.5 cm which is substantially equal to the diameter of the catheter tube 620 which, in this embodiment, has a diameter classified as CH14 by the French Scale system. The first end 685a of the internal join 685 is joined to the peripheral seal, therefore, forming a fluid tight seal between the first end 685a of the internal join 685 and the peripheral seal. In other embodiments, the internal join 685 may extend from any part of the peripheral seal, preferably from an edge other than that where the interaction region is provided, and most preferably from the edge opposite to the interaction region. In further embodiments, the first end 685a of the internal join 685 may not be joined to the peripheral seal so as to form a channel between the first end 685a of the internal join 685 and the peripheral seal.

As shown in Figure 28, which shows the embodiment before use, the catheter tube 620 is positioned with the distal end 622 of the catheter 620 in the channel 695, therefore providing a fluid-tight, or at least substantially fluid-tight, seal between the second end 685b of the internal join 685, the catheter 620 and the right lateral edge 672c. In other embodiments, the channel 695 may have a diameter substantially equal to the diameter of connector 622a, or other component, arranged on the catheter 620, and in this embodiment, the connector 622a, or other component, may be arranged in the channel 695.

The first compartment 680a is trapezoidal. The first compartment 680a is bordered by the left lateral edge 672b, base 672a, a portion of, in this embodiment, approximately half the length of, the right lateral edge 672c and the internal join 685. The first compartment 680a comprises the fluid reservoir 640, a significant portion of the catheter tube 620, including its proximal end 621, and the handling element 690.

The second compartment 680b is triangular. The second compartment 680b is bordered by the upper edge 672d, internal join 685, and a portion of, in this embodiment, approximately half the length of, the right lateral edge 672c. The second compartment 680b comprises the fluid collection bag 610, a portion of the distal end 622 of the catheter and the connector 622a, which is connected to the inlet 650 of the fluid collection bag 610.

The arrangement of this embodiment creates a ‘wet region’, upon release of the wetting fluid, as defined by the first compartment 680a, and a ‘dry region’ as defined by the second compartment 680b. As such, upon release of wetting fluid from the fluid reservoir 640, all of the wetting fluid, or at least a substantial amount, is retained in the first compartment 680a and does not, therefore, contact the fluid collection bag 610. Thus, the fluid collection bag 610 remains dry, therefore, facilitating handling and re-packaging of the bag 610 during and after use.

The internal join 685 may be formed in the same way as the peripheral seal, i.e., from any suitable bonding/sealing methods such as chemical adhesives, chemical bonding, ultrasonic bonding, or mechanical bonding. In the present embodiment, the internal join 685 is formed by plastic welding.

In this embodiment, the catheter 620 is resiliently biased into a straight configuration to the extent that over a distance equivalent to the distance between the channel 695 and base 672a, the catheter 620 resists being bent by more than about 20 degrees. As such, due to the restriction of the tangent of the catheter 620 imposed by the channel 695 and the resilience of the catheter 620 itself, the catheter 620 extends away from the channel 695 substantially parallel to the right lateral edge 672c of the pouch 670 and extends down into the first compartment 680a and adjacent to the base 672a of the pouch 670.

The catheter 620 is arranged within the pouch 670 in a curved and coiled configuration, with the distal end 622 adjacent to the right lateral edge 672c approximately mid-way between the upper edge 672d and the base 672a. The catheter 620 extends down through the first compartment 680a inside of the pouch 670 and into a broadly elliptical clockwise coil (as viewed with left lateral edge 672b on the left, and upper edge 672d at the top). The coil has a single turn around the inner perimeter of the right lateral edge 672c, base 672a, and left lateral edge 672b of the pouch 670, with the proximal end 621 of the catheter 620 resting on the fluid reservoir 640, adjacent to the right lateral edge 672c and base 672a of the pouch 670. Of course, the catheter uncoils as it is pulled out of the pouch, as described below.

In this embodiment, the fluid collection bag 610 is provided in a stowed configuration, which in this embodiment is a folded configuration, within the pouch 670. In this embodiment, the folded fluid collection bag 610 is arranged within the pouch 670 in the second compartment 680b. The inlet 650 of the bag 610 receives the distal end 622 of the catheter 620 adjacent to the right lateral edge 672c of the pouch 670. The fluid collection bag 610 is therefore arranged adjacent to the opening formed in the pouch 670 by the tear-away region 675 as described further below and spans between the upper edge 672d, internal join 685 and a portion of the right lateral edge 672c.

In this embodiment, prior to use, the handling element 690 is arranged around a portion of the catheter 620 between the inlet 650 and proximal end 621. The distal end 622 of the catheter 620 is positioned in the channel 695. Consequently, only a minority of the length of the catheter 620 is positioned in the channel 695.

In this embodiment, the fluid reservoir 640 is an elongate rectangular burstable sachet of water. The fluid reservoir 640 is arranged within the first compartment 680a of the pouch 670. The fluid reservoir 640 has a height equal to between 60-90% the height of the pouch 670, for example 80%, and a width between 5-25% the width of the pouch 670, for example 15%. In other embodiments, many other types of reservoir would be suitable including different shapes and sizes of reservoir, or non-burstable reservoirs and other external sources of fluid. In this embodiment, the wetting fluid is water and interacts with the hydrophilic surface of the catheter 620 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.

Referring to Figures 30 and 31, the fluid collection bag 610 comprises a front panel (not shown), a rear panel 610a of identical shape and size, and a peripheral bond joining the periphery of the panels to form the bag 610. The fluid collection bag 610 defines an internal cavity 655. The internal cavity 655 provides the volume of the fluid collection bag 610 which can be filled with liquid during use. The front panel and rear panel 610a are both transparent or translucent in this embodiment. The peripheral bond defines a base 612, a right lateral edge 613, an upper edge 615a, a right neck edge 613a, an uppermost edge 615, a left neck edge 614a and a left lateral edge 614. The right neck edge 613a, uppermost edge 615 and left neck edge 614a define a neck 651 which extends from the left lateral edge 614 and upper edge 615a.

The upper edge 615a extends linearly inwardly at an approximate right angle from the top of the right lateral edge 613. The upper edge 615a extends linearly inwardly approximately 50% of the width of the bag 610.

The right lateral edge 613 and left lateral edge 614 being defined as the right and left sides of the bag 610 when viewing the bag 610 with the rear panel 610a behind the front panel, the base 612 at the bottom of the bag 610 and the uppermost edge 615 at the top of the bag 610. The peripheral bond thus defines a bag 610 that, when unfolded (i.e., in an open configuration), is generally rectangular and suitably has a width between the lateral edges 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, more preferably between 14 and 19 cm, and most preferably about 17 cm. A height from the base 612 to the uppermost edge 615 may be at least 25, 30, 35 or 40 cm. The height of the bag may be no more than 45, 40, 35 or 30 cm. The height may be between 25 and 45 cm, between 30 and 40 cm, more preferably between 34 and 38 cm, or most preferably about 36 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 base 612 defines the bottom of the bag 610 in use, and the uppermost edge 615 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 formed of polypropylene (PP).

In this embodiment, the uppermost edge 615 comprises a spout 650a extending upwardly from the uppermost edge 615. At the end of the spout 650a, distal to the fluid collection bag, there is provided an inlet 650 for receiving a catheter tube 620. The spout 650a extends upwardly from the uppermost edge 615 at approximately mid-way between the corner where the left neck edge 614a and uppermost edge 615 meet and the corner where the right neck edge 613a and uppermost edge 615 meet. The spout 650a tapers inwardly as it extends away from the uppermost edge 615. The spout 650a has a length, i.e., the distance from where the spout joins the uppermost edge 615 to the inlet 650, of between 2 and 14 cm, between 4 and 12 cm, between 6 and 10 cm, between

7 and 9 cm, or about 8 cm.

At the base of the neck 651 is a left edge projection 617a and a right edge projection 617b which define the narrowest point of the neck 651. Left edge projection 617a is diametrically opposed to the right edge projection 617b, and each project inwardly at approximate right angles relative to the left lateral edge 614 and right neck edge 613a, respectively. The right edge projection 617b projects inwardly from the comer of where the right neck edge 613a and upper edge 615a meet. The left edge projection 617a projects inwardly from the top of the left lateral edge 614, which is approximately three quarters the height of the bag 610, and is just below the left neck edge 614a. The left edge projection 617a and right edge projection 617b each project inwardly approximately one quarter of the width of the neck 651. Thus the narrowest point of the neck 651 has a width equal to approximately 50% of the distance from the left lateral edge 614a to the right lateral edge 613a.

In this embodiment, the fluid collection bag 610 further comprises a finger hole 616 to allow the bag 610 to be easily handled by a user. The finger hole 616 is arranged to accommodate at least one of the user’s fingers. The finger hole 616 is positioned adjacent to the neck portion 651 and comprises a loop of material attached to the bag 610 at the corner where the uppermost edge 615 and right neck edge 613a meet, and separately at the comer where the right lateral edge 613 and upper edge 615a meet. The loop of material comprises two portions; a transverse part 616a and a lateral part 616b. The transverse part 616a extends, parallel to the upper edge 615a, from the outer perimeter of the corner where the uppermost edge 615 and the right neck edge 613a meet. Thus, the distance from the base 612 to the transverse part 616a is equal to the distance from the base 612 to the uppermost edge 615.

The lateral part 616b extends, parallel to the right neck edge 613a, from the outer perimeter of the corner where the right lateral edge 613 and the upper edge 615a meet. Thus, the distance from the left neck edge 614a to the lateral part 616b is equal to the distance from the left lateral edge 614 to the right lateral edge 613. In other embodiments, the finger holes 616 may comprise a series of ridges, or otherwise easily gripped surface or feature to allow the user to easily handle the bag 610. In addition, there may be different numbers of finger holes 616, such as two or more than two, and they may be placed in different locations on the bag 610.

The fluid collection bag 610 comprises four internal baffles; first baffle 619a, second baffle 619b, third baffle 619c and fourth baffle 619d.

Each internal baffle 619a, 619b, 619c, 619d is an elongated join joining the front panel (not shown) to the rear panel 610a. Each baffle 619a, 619b, 619c, 619d is provided as a weld. Each internal baffle 619a, 619b, 619c, 619d provides a fluid tight seal between the front panel (not shown) and the rear panel 610a.

First internal baffle 619a and second internal baffle 619b each extend linearly inwardly at substantially 90° from the left lateral edge 614. Third internal baffle 619c and fourth internal baffle 119d each extend linearly inwardly at substantially 90° from the right lateral edge 613.

First internal baffle 619a extends inwardly from the left lateral edge 614 at approximately 25% of the distance from the base 612 to the uppermost edge 615.

Second internal baffle 619b extends inwardly from the left lateral edge 614 at approximately 50% of the distance from the base 612 to the uppermost edge 615.

Third internal baffle 619c extends inwardly from the right lateral edge 613 at approximately 25% of the distance from the base 612 to the uppermost edge 615.

Fourth internal baffle 619d extends inwardly from the right lateral edge 613 at approximately 50% of the distance from the base 612 to the uppermost edge 615.

As such, first internal baffle 619a and third internal baffle 619c are arranged as a diametrically opposed pair of baffles, and the second internal baffle 619b and fourth internal baffle 619d are arranged as a diametrically opposed pair of baffles.

First internal baffle 619a and second internal baffle 619b each extend inwardly from the left lateral edge 614 a distance equal to approximately 40% of the distance between the left lateral edge 614 and the right lateral edge 613. Third internal baffle 619c and fourth internal baffle 619d each extend inwardly from the right lateral edge 613 a distance of approximately 40% of the distance between the right lateral edge 613 and the left lateral edge 614.

Thus, each baffle 619a, 619b, 619c, 619d has a length of about 40 % of the width of the fluid collection bag 610.

Diametrically opposed pair of baffles 619a and 619c, therefore, form a first channel 619e between the terminus of each of the first internal baffle 619a and the third internal baffle 619c.

Diametrically opposed pair of baffles 619b and 619d, therefore, form a second channel 619f between the terminus of each of the second internal baffle 619b and the fourth internal baffle 619d.

The diameter of each channel 619e, 619f is equal to about 20% of the width of the fluid collection bag 610. Each channel 619e, 619f is arranged centrally relative to the width of the fluid collection bag 610.

Because each baffle 619a, 619b, 619c, 619d provides a fluid tight seal between the front panel (not shown) and the rear panel 610a, the channels 619e, 619f direct the flow of liquid 625a entering the fluid collection bag 610 via inlet 650 then spout 650a through the internal cavity 655 toward the base of the bag 610. Thus, providing an improved flow of liquid 625a through the fluid collection bag 610, therefore, facilitating filling of the bag 610. The liquid 625a entering the fluid collection bag 610 therefore settles at the base of the bag, which advantageously means that the entire volume of the bag can be filled with liquid 625a, thus preventing, or at least significantly reducing, the possibility of the bag 610 overflowing with liquid 625a during use which can be embarrassing for the user. More importantly, when partially filled, the baffles prevent fluid from sloshing about in the bag, or at least reduce the quantity of fluid free to slosh and the space to slosh in - for example when, as shown in figure 31 the space beneath the first and third baffles 619a, 619c is full and the space between the first and third baffles 619a, 619c and the second and fourth baffles 619b, 619d is only partially full, the fluid in the bottom part beneath the first and third baffles 619a, 619c will not slosh around and the fluid above those baffles 619a, 619c will be constrained from sloshing too much by the second and fourth baffles 619b, 619d.

In this embodiment, the fluid collection bag 610 also comprises an interaction region. The interaction region forms the base of the neck 651 of the fluid collection bag 610 and spans between the left neck edge 614a and right neck edge 613a. The interaction region is used to provide access to the fluid collection bag and/or to dispose of its contents more easily near the uppermost edge 615. In this embodiment, the interaction region comprises a tear-away region 775. The tear-away region 775 comprises a tear start 776 at the point the left neck edge 614a meets the tear-away region 775, a tear stop 777 at a corresponding point on the right neck edge 613a, and a tear line (not shown) spanning between the tear start 776 and tear stop 777. The tear line comprises a line of weakness in the panels of the fluid collection bag 610, which may be formed by any suitable means but in this embodiment is laser scored. The tear start 776 comprises a notch to provide an area of weakness in the peripheral bond. This allows the tear-away region 775 and the neck 651 to be partially or fully separated from the fluid collection bag 610 by tearing the panels apart from the tear start 776 to the tear stop 777 along the tear line, therefore, providing access to the contents of the fluid collection bag 610, and/or allowing the contents of the bag 610 to be poured away with greater ease than if the contents were to be poured away through the considerably narrower inlet 650. In other embodiments, the tear stop 777 may comprise a small aperture in the panels to prevent further tearing of the fluid collection bag 610.

The tear-away region 775 comprises a gripping tab 779 sized to allow a finger and thumb to grip the tear-away region 775. After use, when a user requires access to the contents of the fluid collection bag 610, or wants to discard the contents, the gripping tab 779 can be gripped and pulled across the front panel of the fluid collection bag 610 in a direction substantially toward the tear stop 777. This action will separate the neck 651 from the rest of the fluid collection bag 610 and therefore create an opening in the fluid collection bag 610 through which the contents of the bag 610 can be accessed or easily discarded.

To ensure the fluid collection bag 610 is fully sealed, the front panel and rear panel 610a are sealed to one another over the entire tear-away region 775. In this embodiment, the packaged catheter assembly 600 is provided with the first compartment 680a containing the catheter 620, handling element 690 and fluid reservoir 640, and the second compartment 680b containing the fluid collection bag 610 and a portion of the catheter 620, all contained within the pouch 670 as mentioned above. To wet the catheter 620 so that it is ready for use, the user may release the wetting fluid from the fluid reservoir 640 into the pouch 670. This may be done by any suitable means, but preferably by applying pressure to the outside of the pouch 670 at a region corresponding to the position of the fluid reservoir 640. In this embodiment, the pouch comprises a wetting marker 682 to assist the user in locating the fluid reservoir 640.

In this embodiment, the fluid reservoir 640 is configured to rupture/burst under external pressure, creating a tear (not shown) in the fluid reservoir 640 which releases wetting fluid (not shown) into the first compartment 680a of the pouch 670 where it collects to form a pool in the first compartment 680a of the pouch 670. The pouch can then be shaken gently, ideally whilst held upright, to wet the catheter 620.

The user may then access the catheter 620 by creating an opening in the pouch 670 using the interaction region. The aperture 679 is grasped in one hand, and the pouch 670 below the tear line 678 in another, and the tear-away region 675 is torn from the tear start 676 toward the tear stop 677 along the tear line 678. Thus, the pouch 670 is torn between the upper edge 672d and base 672a, as such, an opening is formed in the pouch 670 that may be used to access its contents. Typically the pouch will be turned on its side, such that the side where the tera away region is formed is uppermost, before opening to avoid wetting fluid spilling out of the pouch. In this embodiment, as shown in Figure 29, the tear-away region 675 is fully separated from the pouch 670 to improve access to the contents of the pouch 670. In other embodiments, the tear-away region 675 may not be fully separated from the pouch 670 to reduce the number of separate parts and make the pouch 670 easier to handle. Moreover, in another embodiment, the tear-away region 675 may be separated to an approximate mid-point between the upper edge 672d and the base 672a, i.e., approximately half the length of the right lateral edge 672c, adjacent to the channel 695. Thus, closed catheter assembly (i.e. catheter 620 and fluid collection bag 610) are accessible to the user via the second compartment 680b but the opening does not extend to the first compartment, therefore, preventing spilling out of the wetting fluid in the first compartment. Other embodiments may also feature other ways to access the pouch for example a zip-lock seal.

In this embodiment, prior to withdrawal, only parts of the catheter 620 that are intended to enter the body should be wetted by the wetting fluid. To ensure that the fluid collection bag 610 is not wetted, the fluid collection bag 610 is arranged in a separate compartment to that of the catheter 620. As described above, in this embodiment this is achieved by the internal join 685 joining the front wall 673 to the rear wall 671 to form a fluid tight seal therebetween, and, therefore, forming a first compartment 680a comprising the catheter 620 and the fluid reservoir 640, and a second compartment 680b comprising the fluid collection bag 610, connector 622a and a portion of the catheter 620. Removal of the catheter assembly from the pouch 670, while keeping the fluid collection bag 610 dry, is facilitated by providing a channel 695 between the second end 685b of the internal join 685 and the right lateral edge 672c of the pouch 670, in which can be positioned the distal end 622 of the catheter 620 joined to the fluid collection bag 610, as described above.

Moreover, providing a channel 695 having a diameter which is substantially equal to the diameter of the catheter 620 inhibits ingress of wetting fluid into the second compartment 680b from the first compartment 680a after rupturing the fluid reservoir 640 and shaking the pouch 670 to distribute the wetting fluid to activate the surface of the catheter 620. Because the fluid collection bag 610 can be withdrawn from the pouch 670 before the wetted catheter 620, the user does not need to touch the wetted catheter 620 before touching the fluid collection bag 610. As such, the user can withdraw the fluid collection bag 610 from the second compartment 680b by partially separating the tear-away region 675 from the remainder of the pouch 670 to a point along the right lateral edge 672c approximately mid-way between the upper edge 672d and the base 672a, thereby creating an opening in the peripheral seal which provides the user with access to the components in the second compartment 680b, i.e. the fluid collection bag 610. By withdrawing the fluid collection bag 610, which is connected to the catheter 620, the catheter 620 is also withdrawn from the pouch 670. Thus, the fluid collection bag 610 remains dry, or at least substantially dry, before and during use. The fluid collection bag 610 may then be unfolded so that it is ready to accept fluid from the catheter 620.

The catheter 620 is now ready for use. The handling element 690 may be used to progressively introduce the proximal end 621 of the catheter 620 into the urethra until fluid flows through the catheter 620 from the bladder. Fluid flowing through the catheter 620 is collected in the fluid collection bag 610. After use, in this embodiment, the catheter 620 is withdrawn from the body and the contents of the fluid collection bag 610 may then be disposed of. The one or more embodiments are described above by way of example only.

Many variations are possible without departing from the scope of protection afforded by the appended claims.

Claims

CLAIMS A packaged catheter assembly comprising a catheter, a pouch, and a fluid collection bag configured to receive fluid from the catheter in use, wherein: the catheter and fluid collection bag are arranged within the pouch; the pouch comprises an interaction region to form an opening in the pouch and allow the fluid collection bag and catheter to be removed from the pouch; and the fluid collection bag is arranged adjacent to the opening. The catheter assembly of claim 1 wherein the catheter is a male urinary catheter. The catheter assembly of any preceding claim wherein the fluid collection bag comprises an inlet to allow fluid to enter the bag from the distal end of the catheter and the inlet is arranged adjacent to a first end of the opening, wherein the opening is configured to be formed starting from the first end. The catheter assembly of any preceding claim wherein the fluid collection bag comprises an inlet to allow fluid to enter the bag from the distal end of the catheter, wherein the fluid collection bag is arranged completely within an upper region of the pouch and the upper region is defined between the inlet and the opening. The catheter assembly of any preceding claim wherein the catheter does not overlap the fluid collection bag inside the pouch. The catheter assembly of any preceding claim wherein the pouch comprises two walls and a peripheral seal between the two walls, the peripheral seal comprises a left lateral edge, right lateral edge, an upper edge and a base of the pouch, the pouch has a width defined between the left lateral edge and right lateral edges and a height defined between the upper edge and base, wherein the fluid collection bag is provided in a stowed configuration while inside the pouch, wherein the fluid collection bag spans across a majority of the width and a minority of the height of the pouch when in the stowed configuration, wherein the fluid collection bag comprises an inlet provided at one end of the width of the stowed fluid collection bag to allow fluid to enter the bag from the distal end of the catheter. The catheter assembly of claim 7 wherein the stowed fluid collection bag comprises a rolled or folded portion and the inlet extends from the rolled or folded portion in a direction perpendicular to the width of the stowed fluid collection bag. The catheter assembly of any preceding claim wherein the pouch comprises two walls and a peripheral seal between the two walls, the peripheral seal comprises a left lateral edge, right lateral edge, an upper edge and a base of the pouch and the opening is formed in or near the upper edge of the pouch, the pouch has a width defined between the left lateral edge and right lateral edges and a height defined between the upper edge and base, wherein the fluid collection bag is provided in a stowed configuration while inside the pouch, wherein the fluid collection bag spans across a majority of the width and a minority of the height of the pouch when in the stowed configuration, and the catheter extends from the distal end of the catheter parallel to a lateral edge of the pouch. The catheter assembly of any preceding claim wherein the catheter comprises a proximal end for insertion into the body and a distal end and the catheter assembly further comprises a sleeve enclosing the catheter from the proximal end to the distal end, wherein pouch comprises two walls and a peripheral seal between the two walls, the peripheral seal comprises a left lateral edge, right lateral edge, an upper edge and a base of the pouch, the pouch has a width defined between the left lateral edge and right lateral edges and a height defined between the upper edge and base, wherein the fluid collection bag is provided in a stowed configuration while inside the pouch, wherein the fluid collection bag spans across a majority of the width and a minority of the height of the pouch when in the stowed configuration, wherein the sleeve comprises a handling element arranged at a proximal end of the sleeve corresponding to the proximal end of the catheter, and the handling element is arranged adjacent the opening. The catheter assembly of any preceding claim wherein the fluid collection bag obscures the catheter from the opening. The catheter assembly of claim 10 wherein a first end of the stowed fluid collection bag is arranged adjacent to a first end of the opening. The catheter assembly of claim 10 or 11 wherein a second end of the stowed fluid collection bag is arranged adjacent to a second end of the opening. The catheter assembly of any preceding claim wherein the pouch comprises two walls and a peripheral seal between the two walls, the peripheral seal comprising a left lateral edge, right lateral edge, an upper edge and a base of the pouch, wherein the pouch has a width defined as the distance between the left lateral edge and right lateral edge of the pouch and the actuation of the interaction region creates an opening in or near an upper edge of the peripheral seal. The catheter assembly of claim 13 wherein the fluid collection bag is arranged to span across a majority of the width of the pouch. The catheter assembly of claim 13 or 14 wherein the interaction region comprises a breakable region of the peripheral seal and the breakable region comprising a tear-away region which may comprise a tear line defining a line along which the pouch may be torn to at least partially separate the tear-away region from the remainder of the pouch, thereby creating an opening in the peripheral seal, wherein the fluid collection bag is arranged adjacent to the tear line. The catheter assembly of any preceding claim wherein the catheter comprises a proximal end for insertion into the body and a distal end, the fluid collection bag comprises an inlet to allow fluid to enter the fluid collection bag from the distal end of the catheter, and the inlet is arranged adjacent to the opening. A method of manufacturing a packaged catheter assembly, the method comprising the steps of providing a catheter, a pouch, and a fluid collection bag configured to receive fluid from the catheter in use, arranging the catheter and fluid collection bag within the pouch wherein the pouch comprises an interaction region to form an opening in the pouch and allow the fluid collection bag and catheter to be removed from the pouch, and the fluid collection bag is arranged adjacent to the opening.

18. The method of claim 17 wherein the catheter is arranged in the pouch before the fluid collection bag.

19. A method of unpackaging a packaged catheter assembly, the packaged catheter assembly comprising a catheter, a fluid collection bag configured to receive fluid from the catheter in use, and a pouch containing the catheter and fluid collection bag, the method comprising using an interaction region to form an opening in the pouch to allow the catheter and fluid collection bag to be removed from the pouch, wherein the fluid collection bag is arranged adjacent to the opening 20. The method of any of claims 17 to 19 wherein the catheter assembly is the catheter assembly of any of claims 1 to 16.