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. 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 can be bulky which makes the catheter assembly less discreet and increases difficulty in handling the catheter assembly. 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 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.

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 comprising a catheter. The catheter assembly may comprise a fluid reservoir. The catheter may be arranged in a package. In one example the package may be a fluid collection bag. In an alternative, the package could be a pouch which may be sterile, i.e. a carrying pouch, in which the catheter is sold, and which is used by the user to transport the catheter. A channel may be provided surrounding the catheter. The fluid reservoir may be configured to release wetting fluid into the channel to wet the catheter. The package (e.g. the fluid collection bag) may have two panels. A peripheral bond may be provided between the two panels. At least one of the panels may comprise a flexible material. The fluid reservoir and catheter may be arranged within the package (e.g. within the fluid collection bag). The two panels may form the channel in the fluid collection bag; the channel may surround the catheter; and the fluid reservoir may be configured to release wetting fluid into the channel to wet the catheter.

According to a first aspect of the present invention there is provided a catheter assembly comprising a catheter, a fluid reservoir, and a fluid collection bag having two panels and a peripheral bond between the two panels, wherein: at least one of the panels comprises a flexible material; the fluid reservoir and catheter are arranged within the fluid collection bag; the two panels form a channel in the fluid collection bag, the channel surrounding the catheter; and the fluid reservoir is configured to release wetting fluid into the channel to wet the catheter.

Advantageously, the present invention provides for a catheter assembly which benefits from the introduction of wetting fluid into a channel formed around the catheter which efficiently directs the wetting fluid onto the catheter to ensure it is adequately wetted prior to use. This allows the fluid reservoir to hold a lower volume of wetting fluid which reduces the size and weight of the catheter assembly and reduces the cost and environmental impact of manufacturing the catheter assembly. In addition, as the fluid reservoir and catheter are contained within the fluid collection bag, the wetting fluid is unlikely to leak outside of the bag and into contact with the user and further can be collected inside the bag once the catheter has been wetted.

A further advantage is provided due to channel provided by the panels which reduces the available volume within the fluid collection bag resulting in more efficient wetting of the catheter by released wetting fluid. This allows the fluid reservoir to hold a lower volume of wetting fluid which reduces the size and weight of the catheter assembly and reduces the cost and environmental impact of manufacturing the catheter assembly.

The catheter may comprise a proximal end for insertion into the body and a distal end. The distal end of the catheter may comprise a funnel. The catheter may be a urinary catheter. The catheter may be a male urinary catheter. The catheter may be a female urinary catheter. The catheter may be an intermittent catheter. In one embodiment, the catheter is an intermittent male urinary catheter. Thus, the features of the present invention allow intermittent male urinary catheters to be adequately wetted prior to use which can be more difficult than for other types of catheter which are generally shorter.

The channel may surround the fluid reservoir. Preferably, the channel surrounds the fluid reservoir and the catheter. As such, wetting fluid may flow down the channel from the fluid reservoir onto the catheter.

The panels may be configured to adhere to one another to form the channel.

The panels may be separated at locations corresponding to the channel. The panels may be configured to temporarily adhere to one another to form the channel. In particular, the panels may adhere by suction. For example, the panels may be vacuum sealed to adhere to one another. The fluid collection bag may be configured to urge the panels together, for example due to a negative pressure difference between the inside and outside of the bag. The fluid collection bag may therefore have an internal pressure that is less than atmospheric pressure. Thus, the channel is efficiently formed by adherence of the panels together which removes the need for any additional seals, glues or physical barriers to be present within the fluid collection bag. In addition, as the panels are adhered to each other at locations that do not correspond to the channel, the available volume within the fluid collection bag is minimised resulting in more efficient wetting of the catheter by released wetting fluid.

Accordingly in one embodiment, there is provided a catheter assembly comprising a catheter, a fluid reservoir, and a fluid collection bag having two panels and a peripheral bond between the two panels, wherein: at least one of the panels comprises a flexible material; the fluid reservoir and catheter are arranged within the fluid collection bag; the two panels form a channel in the fluid collection bag, the channel surrounding the catheter; and the fluid reservoir is configured to release wetting fluid into the channel to wet the catheter, wherein the panels are configured to temporarily adhere to one another to form the channel.

Accordingly in one embodiment, there is provided a catheter assembly comprising a catheter, a fluid reservoir, and a fluid collection bag having two panels and a peripheral bond between the two panels, wherein: at least one of the panels comprises a flexible material; the fluid reservoir and catheter are arranged within the fluid collection bag; the two panels form a channel in the fluid collection bag, the channel surrounding the catheter; and the fluid reservoir is configured to release wetting fluid into the channel to wet the catheter, wherein the fluid collection bag is configured to urge the panels together due to a negative pressure difference between the inside and outside of the fluid collection bag.

The catheter may be configured to resist or prevent the panels from adhering to one another at locations corresponding to the catheter. The fluid reservoir may be configured to resist or prevent the panels from adhering to one another at locations corresponding to the fluid reservoir. Thus, the channel is automatically formed around the catheter and fluid reservoir irrespective of their respective locations within the bag. Where the panels are vacuum sealed to one another, the arrangement of the catheter and fluid reservoir between the panels can prevent the panels adhering to one another in that region. Moreover, by selecting an appropriate vacuum, the regions immediately around the catheter and fluid reservoir may also be prevented from adhering to one another, thus forming a channel that traces the shape of the catheter and fluid reservoir.

The fluid reservoir may be placed adjacent to the catheter within the fluid collection bag. Preferably, the fluid reservoir is placed adjacent to the proximal end of the catheter within the fluid collection bag. Thus, a continuous channel is automatically formed that connects the fluid reservoir and catheter. Further, the placement of the fluid reservoir adjacent to the proximal end of the catheter ensures it is adequately wetted which reduces risk of injury/discomfort during use as the first part of the catheter to enter the body.

Accordingly in one embodiment, there is provided a catheter assembly comprising a catheter, a fluid reservoir, and a fluid collection bag having two panels and a peripheral bond between the two panels, wherein: at least one of the panels comprises a flexible material; the fluid reservoir and catheter are arranged within the fluid collection bag; the two panels form a channel in the fluid collection bag, the channel surrounding the catheter; and the fluid reservoir is configured to release wetting fluid into the channel to wet the catheter, wherein the fluid reservoir is placed adjacent to the catheter within the fluid collection bag.

The channel may extend along substantially the entire length of the catheter. The channel may extend along the entire length of the catheter. The channel may extend around the proximal end of the catheter. The channel may extend around the distal end of the catheter. Preferably, the channel extends around the proximal and distal ends of the catheter. The channel may comprise a catheter section that corresponds to the section of the channel surrounding the catheter. The catheter section may be defined by the separation of the panels from one another. That is to say, where the panels are adhered to one another there is no channel, and the region where they are separated from one another forms the channel. Preferably the panels are adhered to one another by suction along the edge of the catheter section. The channel may have a width defined in a direction perpendicular to the axis of the catheter. A width of the channel along the catheter section may be no more than 3 cm, 2 cm, 1.5 cm, 1 cm or 0.5 cm. A width of the channel along the catheter section may be no more than one and a half times, twice, or three times wider than a width/diameter of the catheter. Thus, the channel tightly surrounds the catheter to ensure it is adequately wetted.

The panels may be configured to separate along an edge of the catheter section of the channel. The panels may be configured to separate after wetting of the catheter. The catheter section of the channel may be configured to widen after wetting of the catheter. The catheter section of the channel may become substantially as wide as the fluid collection bag after wetting of the catheter, e.g. as wide as the width between opposing lateral edges as defined below. Thus, after wetting the panels separate and the channel widens until it is the same size as the fluid collection bag and effectively no longer distinguishable from it. This increases the available volume within the fluid collection bag for collection of liquids and allows the catheter to be more easily withdrawn from the bag.

Accordingly in one embodiment, there is provided a catheter assembly comprising a catheter, a fluid reservoir, and a fluid collection bag having two panels and a peripheral bond between the two panels, wherein: at least one of the panels comprises a flexible material; the fluid reservoir and catheter are arranged within the fluid collection bag; the two panels form a channel in the fluid collection bag, the channel surrounding the catheter; and the fluid reservoir is configured to release wetting fluid into the channel to wet the catheter, wherein the channel comprises a catheter section that corresponds to the section of the channel surrounding the catheter and the part of the two panels along the catheter section are configured to separate after wetting of the catheter.

Accordingly in one embodiment, there is provided a catheter assembly comprising a catheter, a fluid reservoir, and a fluid collection bag having two panels and a peripheral bond between the two panels, wherein: at least one of the panels comprises a flexible material; the fluid reservoir and catheter are arranged within the fluid collection bag; the two panels form a channel in the fluid collection bag, the channel surrounding the catheter; and the fluid reservoir is configured to release wetting fluid into the channel to wet the catheter, wherein the channel comprises a catheter section that corresponds to the section of the channel surrounding the catheter, and the catheter section of the channel is configured to widen after wetting of the catheter.

The fluid collection bag may be configured to receive fluid (preferably liquid) from the distal end of the catheter. Advantageously, the reduction in air within the fluid collection bag caused by the panels forming the channel around the catheter means that liquid can more easily pass into the bag as it does not need to displace any air within the bag. In addition, it reduces the likelihood that pockets of air become trapped inside the bag reducing the available volume for liquid and increasing the size of the fluid collection bag unnecessarily.

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 defined between the (left and right) lateral edges. The width may be at least 5, 10, 15 or 20 cm. The bag may have a width no more than 25, 20, 15, or 10 cm. Preferably, the width is between 5 and 15 cm, most preferably between 7 and 11 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 may be defined from the base to the upper edge. The height may be at least 15, 20, 25 or 30 cm. The height of the bag may be no more than 35, 30, 25 or 20 cm. The height may be between 15 and 35 cm, 20 and 30 cm, or most preferably 23 and 28 cm. The bag may be configured to hold at least 500, 700, or 1000 ml of fluid, and may hold no more than 1000 ml, for example, it may hold at least 700 ml of fluid. The fluid collection bag may comprise a flexible plastics material. For example, polypropylene (PP), polyethylene terephthalate (PET), low density polyethylene (LDPE), metalized polyester (MET PET), orientated polypropylene (OPP), polyvinylpyrrolidone (PVP), or polyvinyl chloride (PVC). At least one of the panels may be configured to deform to form the channel. The panels may be configured to reduce the internal volume of the fluid collection bag to form the channel, preferably under the action of a pressure difference between the inside and outside of the fluid collection bag. Thus, the panels may easily form the channel through deformation of them during vacuum sealing of the bag as described further below.

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 width of the channel along the catheter section may may be no more than 50%, 40%, 30%, 20% or 10% of the width of the fluid collection bag. Preferably, the channel is between 50-10% of the width of the fluid collection bag, for example 40- 20% and most preferably 25-35%. Thus, the channel ensures the catheter is tightly packed within it and wetting fluid is used efficiently. In addition, the panels extend a long way outside of the channel to the edges of the fluid collection bag and thus can separate to form a large internal volume for collection of liquids during use.

The fluid collection bag may comprise an inlet to allow fluid to enter the fluid collection bag from (the distal end of) the catheter. The inlet may be configured to allow the proximal end of the catheter to be withdrawn from the fluid collection bag. The inlet may comprise a bore therethrough sized to allow the proximal end of the catheter to pass through the inlet. The inlet may be positioned adjacent to the location of the proximal end of the catheter in the fluid collection bag. Thus, the catheter may be easily passed through the inlet and out of the bag for use. The inlet may be configured to prevent the distal end of the catheter from being withdrawn from the fluid collection bag. The distal end of the catheter may engage the inlet. The distal end of the catheter may comprise a funnel, or other equivalent feature such as a cuff, which is too large to fit through the bore of the inlet. Thus, inadvertent separation of the catheter from the fluid collection bag is avoided which reduces the likelihood of leaks. It also ensures the catheter assembly remains as a single object rather than multiple separate objects which makes it easier to handle/dispose of.

The inlet may be configured to provide a handling element. The inlet may be more rigid than the catheter and/or fluid collection bag. The inlet may be formed of high density poly-ethylene (HDPE). Thus, the inlet can be used by the user to manipulate the catheter without touching the catheter surface directly which risks compromising the sterility of the catheter which could cause infection.

The inlet may comprise a bridging tube. The bridging tube may be cylindrical. The bridging tube may extend from the inside of the fluid collection bag to an outside edge of the fluid collection bag. The bridging tube may span a section of the peripheral join. The bridging tube may comprise a stepped external diameter. The bridging tube may comprise a narrow portion and a wide portion. The wide portion may span a section of the peripheral join. The narrow portion may extend within the fluid collection bag.

The narrow portion may have a diameter that is 10-50% greater than the diameter of the catheter, for example 20%. Thus, the bore through the inlet can be more easily located and the catheter inserted into it.

The wide portion may have a diameter that is at least 1.5 times, 2 times, 2.5 times or 3 times the diameter of the narrow portion. The wide portion may have a diameter that is no more than 4 times, 3.5 times, 3 times or 2.5 times or 2 times the diameter of the narrow portion. Thus, the wide portion is easy to interact with and hold.

The width of the peripheral bond may be between 0.2 and 3 cm. The width of the peripheral bond may be at least 0.2 cm, 0.5 cm, 0.75 cm, 1 cm, 1.5 cm, 2 cm, or 2.5 cm. The width of the peripheral bond may be no more than 3 cm, 2.5 cm, 2 cm, 1.5 cm, 1 cm, 0.75 cm, or 0.5 cm. At the inlet, the peripheral bond may have a width of at least 1 cm. Thus, the peripheral bond is wide enough to ensure that it is unlikely to fail during use.

The inlet may comprise a flange. The flange may be configured to brace the inlet against the peripheral bond. The flange may be positioned on the outside of the fluid collection bag. The flange may be attached to the bridging tube, and preferably the wide portion of the bridging tube. The flange may have an external diameter that is at least 1.5 times, 2 times, 2.5 times or 3 times the external diameter of the wide portion. The flange may have an external diameter that is no more than 3.5 times, 3 times, 2.5 time or 2 times the external diameter of the wide portion. Preferably, the flange has an external diameter that is twice the external diameter of the wide portion. Thus, the flange protects the peripheral bond of the fluid collection bag and prevents it from failing and causing leaks or allowing the inlet to pass completely into the fluid collection bag.

The inlet may comprise an external tube. The external tube may be attached to the flange on a distal side from the bridging tube. The external tube may have a larger external diameter than the bridging tube, for example 10-30% larger and preferably 20% larger. The external tube may have an external diameter that is less than the external diameter of the flange. The external tube may have a length that is approximately equal to the length of the wide portion of the bridging tube. The external tube may have a length that is approximately equal to its external diameter. The external tube may have a hemispherical end. Thus, the external tube is easy for the user to grasp, especially in view of the flange which provides additional features that can be gripped by the user.

The inlet may be open in that the bore is not blocked. The inlet may be closed in that the bore is blocked. The inlet may comprise a plug configured to seal the inlet. The plug may be removeable from the inlet. The inlet may comprise a frangible or deformable end configured to prevent access through the bore until activated. The inlet may be configured to be blocked/sealed by a portion of the catheter. Thus, the inlet may be blocked to ensure that dirt does not contaminate the catheter and reduce the likelihood of leakage of fluid out of the bag through the inlet. The inlet may comprise an inserter tip. The inserter tip may disposed on the external tube. The inserter tip may be configured to guide the passage of the catheter into the body. Thus, the inlet can be used by the user to ensure comfortable, safe and efficient use of the catheter.

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

The fluid reservoir may be configured to retain wetting fluid within it. The fluid reservoir may comprise a deformable, frangible or burstable sachet. The fluid reservoir may comprise a flexible plastics material, for example, a thermoplastic polyurethane (TPU) or low-density polyethylene (LDPE). A deformable, frangible or burstable reservoir enhances the convenience for a user as fluid can be easily released without additional tools. A sachet in particular can be more easily handled on an assembly line compared to handling fluid itself.

The fluid reservoir may be any suitable shape or size, such as square, rectangular, circular, ellipsoidal or irregularly shaped. The fluid reservoir may be stadium shaped, that is a rectangle with semi-circular ends. The fluid reservoir may have a length approximately three quarters the width of the fluid collection bag. The fluid reservoir may have a length approximately equal to the width of the fluid collection bag minus the width of the catheter. The fluid reservoir may have any suitable aspect ratio (width: length) such as 1 :1, 1:2, 1:3, 1:4 or 1:5. Thus, the fluid reservoir may be flexibly shaped and sized to conveniently fit within the fluid collection bag.

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 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. 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 and the fluid reservoir is intuitive to use.

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

The join may be separated from an edge of the peripheral bond by a distance equivalent to (i.e. approximately equivalent to) the width of the fluid reservoir. The join may be positioned closer to one lateral edge of the peripheral bond than the other. The join may span a majority of the length of the fluid reservoir, preferably at least 60%, 70%, 80% or 90% of the length of the fluid reservoir. Thus, the join ensures the fluid reservoir stays in position inside the bag.

The channel may comprise a reservoir section corresponding to the section of the channel surrounding the fluid reservoir. The reservoir section may be defined by the join. The reservoir section may be defined by the peripheral bond. The reservoir section may be arranged between the join and the peripheral bond. The reservoir section may be joined to the catheter section at a position corresponding to the proximal end of the catheter. The reservoir section may configured to retain the fluid reservoir within the reservoir section after wetting of the catheter. The part of the panels along the reservoir section may be configured to maintain a constant maximum separation distance. Thus, the reservoir section may be formed from physical welds between the panels and is therefore able to withstand the forces imposed on it during bursting of the fluid reservoir. This ensures wetting fluid remains in the channel and is directed onto the catheter and that the fluid reservoir remains in the same position and doesn’t complicate use of the catheter assembly.

Accordingly in one embodiment, there is provided a catheter assembly comprising a catheter, a fluid reservoir, and a fluid collection bag having two panels and a peripheral bond between the two panels, wherein: at least one of the panels comprises a flexible material; the fluid reservoir and catheter are arranged within the fluid collection bag; the two panels form a channel in the fluid collection bag, the channel surrounding the catheter; and the fluid reservoir is configured to release wetting fluid into the channel to wet the catheter, wherein the channel surrounds the fluid reservoir and the channel comprises a reservoir section corresponding to the section of the channel surrounding the fluid reservoir and the reservoir section is configured to retain the fluid reservoir within the reservoir section after wetting of the catheter.

The catheter section of the channel may be in fluid communication with the reservoir section of the channel. This is preferred, but it is possible that the catheter section of the channel could be separated from the reservoir section of the channel, and, upon bursting the fluid reservoir, the sections join.

The inlet of the fluid collection bag may be positioned at, or adjacent to, a comer of the peripheral bond. The fluid reservoir may be positioned adjacent to the inlet. Thus, the fluid reservoir is positioned close to the inlet and the proximal end of the catheter in order to ensure the catheter is adequately wetted. The catheter section and reservoir section may meet at a point adjacent to the inlet. In addition, the fluid reservoir is conveniently placed next to the inlet which, as mentioned above, acts as a handling element, therefore the user can activate the fluid reservoir and hold the inlet with one hand. The fluid collection bag may be provided in a stowed configuration, preferably while inside the pouch as described below. The fluid collection bag may be configured to remain in the stowed configuration. The fluid collection bag may configured to be moved into an unstowed configuration during use. 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 folded about a fold line. The fold line may span the width of the fluid collection bag. The fold line may be positioned at a midpoint along the height of the fluid collection bag. The fluid collection bag may have a width in the stowed configuration that is substantially equal to the width of the fluid collection bag in the unstowed configuration. The fluid collection bag may have a height in the stowed configuration that is less than the height of the fluid collection bag in the unstowed configuration. For example, he fluid collection bag may have a height in the stowed configuration that is half the height of the fluid collection bag in the unstowed configuration. Thus, the size of the fluid collection bag is minimised when inside the pouch and this assists the user in removing the bag from the pouch and reduces the size of the packaged catheter assembly making it more discreet.

The fluid collection bag may be configured to be a handling sleeve for the catheter. The fluid collection bag may be configured to allow the user to manipulate the catheter inside the fluid collection bag. The fluid collection bag may be configured to be bunched, rolled, or folded during withdrawal of the catheter from the fluid collection bag. Thus, the fluid collection bag can act as a handling sleeve which removes the need for a separate handling sleeve, reducing cost and complexity of the catheter assembly. In addition, as wetting fluid wets the catheter within the fluid collection bag (sleeve), the problem of a handling sleeve blocking wetting of the catheter is overcome.

The proximal end of the catheter may be arranged adjacent to the fluid reservoir and/or inlet of the fluid collection bag. The proximal end of the catheter may be arranged next to the upper edge (or base) of the fluid collection bag. The distal end and/or funnel of the catheter may be arranged at a end of the fluid collection bag distal from the inlet. The distal end and/or funnel of the catheter may be arranged next to the base (or upper edge) of the fluid collection bag. The proximal end of the catheter may be arranged against a lateral side (e.g.left or right) of the fluid collection bag. The distal end of the catheter may be arranged against the other lateral side (e.g. right or left) of the fluid collection bag. The catheter may cross from one lateral side of the fluid collection bag to the other at a position corresponding to a fold line of the fluid collection bag. Where the catheter crosses a fold line of the fluid collection bag, the angle between the catheter and fold line may be less than 90 degrees, and most preferably less than 80 degrees, 70 degrees, 60 degrees or 50 degrees. Most preferably, the angle between the catheter and fold line may be 45 degrees (when the fluid collection bag is unstowed (unfolded). When the fluid collection bag is in the stowed configuration, the catheter may parallel to the fold line at the fold line. When the fluid collection bag is in the stowed configuration, the catheter may be in a U-shaped configuration. Thus, the curvature of the catheter is controlled as it crosses the fold line and ensures that the catheter is not damaged due to kinking.

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 preferably being 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 preferably being 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 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 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 tom. 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 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 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 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.

According to a second aspect of the present invention there is provided a method of manufacturing a catheter assembly comprising the steps of: providing a catheter, a fluid reservoir and a package (e.g a fluid collection bag) having two panels and a peripheral bond between the two panels wherein at least one of the panels comprises a flexible material, arranging the catheter and the fluid reservoir inside the package (e.g. fluid collection bag), and forming a channel surrounding the catheter using the two panels, wherein the fluid reservoir is configured to release wetting fluid into the channel to wet the catheter.

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

The method may comprise adhering the panels to one another to form the channel. The method may comprise evacuating the fluid collection bag. The method may comprise vacuum sealing the fluid collection bag. The method may comprise attaching a source of negative pressure to the inlet to evacuate the fluid collection bag.

Accordingly in one embodiment, there is provided a method of manufacturing a catheter assembly comprising the steps of: providing a catheter, a fluid reservoir and a fluid collection bag having two panels and a peripheral bond between the two panels wherein at least one of the panels comprises a flexible material, arranging the catheter and the fluid reservoir inside the fluid collection bag, and forming a channel surrounding the catheter using the two panels, wherein the fluid reservoir is configured to release wetting fluid into the channel to wet the catheter, wherein the method comprises vacuum sealing the fluid collection bag.

The method may comprise sealing the inlet. The method may comprise reducing the internal pressure of the fluid collection bag. The method may comprise sealing the fluid collection bag with an internal pressure that is lower than atmospheric pressure, for example lower than approximately 1 bar or 101 kPa. Preferably, the fluid collection bag is sealed with an internal pressure that is no more than 50, 40, 30, 20 or 10 kPa, preferably, the internal pressure of the bag is 20 kPa. The internal pressure of the bag may be lower than the atmospheric pressure outside the bag by at least 50, 60, 70, or 80 kPa. Thus, the channel is tightly formed around the catheter.

The method may comprise sealing the front panel to the rear panel to form the join.

The method may comprise providing a pouch. The method may comprise folding the fluid collection bag. The method may comprise arranging the fluid collection bag in the pouch.

According to third aspect of the present invention there is provided a method of wetting a catheter of a catheter assembly, the catheter assembly comprising a catheter and a fluid reservoir contained within a package (e.g. a fluid collection bag) having two panels and a peripheral bond between the two panels, the method comprising releasing wetting fluid into a channel to wet the catheter, wherein at least one panel is flexible, the channel is formed by the two panels and the channel surrounds the catheter.

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

The method may comprise handling the catheter via the fluid collection bag. The method may comprise withdrawing the catheter from the fluid collection bag.

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. The methods of the second and third 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 aspect of the present invention.

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 Description of the Invention

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

Figure 1 is a cut-away front view of an embodiment of a packaged catheter assembly;

Figure 2 is a cut-away front view of the packaged catheter assembly of Figure 1 during forming an opening in the pouch;

Figure 3 is a front view of the closed catheter assembly of the packaged catheter assembly of Figure 1 where the closed catheter assembly has been removed from the pouch;

Figure 4 is a front view of the closed catheter assembly of Figure 3 where wetting fluid has been released from the fluid reservoir into the fluid collection bag to wet the catheter; and

Figure 5 is a front view of the closed catheter assembly of Figure 3 where the catheter has been partially removed from the fluid collection bag.

Referring to Figures 1-5, an embodiment of a packaged catheter assembly 1400 is shown.

The packaged catheter assembly 1400 comprises a pouch 1470 containing a fluid collection bag 1410, a catheter tube, or “catheter” 1420, and a fluid reservoir 1440 comprising wetting fluid. The catheter 1420 has a proximal end 1421 for insertion into the body and a distal end 1422, and the fluid collection bag 1410 contains the catheter 1420 and is arranged to receive fluid from the distal end 1422 of the catheter 1420, thereby forming a so-called “closed catheter assembly”. In this embodiment, the fluid reservoir 1440 is also contained within the fluid collection bag 1410 and is also considered part of the “closed catheter assembly”.

In this embodiment, the catheter 1420 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 1420 comprises a funnel 1423 arranged at the distal end 1422 of the catheter 1420. The funnel 1423 is configured to prevent the catheter 1420 from being removed/separated from the fluid collection bag 1410 as described below in more detail.

Referring to Figures 3-5, in this embodiment, the fluid collection bag 1410 comprises a front panel 1411a, a rear panel 1411b of identical shape and size, and a peripheral bond joining the periphery of the panels to form the bag 1410. The front panel 141 la is transparent or translucent but the rear panel 141 lb is opaque, of course in other embodiments, both may be transparent or translucent, or both may be opaque. Preferably, the front panel 1411a is transparent or translucent in positions corresponding to the catheter 1420 and fluid reservoir 1440 to allow the user to inspect the contents and handle the catheter 1420 and fluid reservoir 1440 when within the bag 1410. The peripheral bond defines a base 1412, a right lateral edge 1413, a left lateral edge 1414 and an upper edge 1415. The right lateral edge 1413 and left lateral edge 1414 being defined as the right and left sides of the bag 1410 when viewing the bag 1410 with the rear panel behind the front panel 1411, the base 1412 at the bottom of the bag 1410 and the upper edge 1415 at the top of the bag 1140. The peripheral bond thus defines a bag 1410 that is generally rectangular and suitably has a width between the lateral edges of at least 7, 10, 15 or 20 cm. The bag may have a width no more than 20, 15, or 10 cm. Preferably, the width is between 7 and 15 cm, most preferably 13 cm. A height from the base 1412 to the upper edge 1415 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, or 25 cm. The height may be between 20 and 35 cm, 20 and 30 cm, or most preferably 24 and 30 cm. In one embodiment, the height is preferably 40 cm. The bag 1410 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 1412 defines the bottom of the bag 1410 in use, and the upper edge 1415 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 1411a, 1411b 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 fluid collection bag 1410 comprises an inlet 1450 positioned in the upper edge 1415 of the peripheral bond adjacent to the comer of the peripheral bond where the upper edge 1415 and right lateral edge 1413 meet. The inlet 1450 comprises a bore (not shown) therethrough sized to allow the proximal end 1421 of the catheter 1420 and the tubular part of the catheter 1420 (catheter tube) to pass through the inlet 1450. The bore is sized such that the funnel 1423 cannot pass through the inlet 1450 and as such, the catheter 1420 cannot be separated/removed from the fluid collection bag 1410, as mentioned above. Preferably, the funnel is an interference fit into the bore, and thus prevents, or at least inhibits any fluid (e.g. wetting fluid or urine) escaping through the bore.

In this embodiment, the inlet 1450 comprises a material that is more rigid than the catheter 1420 and/or fluid collection bag 1410, this allows the inlet 1450 to act as a handling element to assist the user in handling the catheter 1420 and introducing it into the body for use. For example, the inlet may comprise high density poly-ethylene (HDPE).

In this embodiment, the inlet 1450 comprises a cylindrical bridging tube 1451 that extends from the inside of the bag 1410 to the outside edge of the upper edge 1415 of the peripheral bond. The bridging tube 1451 comprises a stepped external diameter with a narrow portion 1452 within the fluid collection bag 1410 and a wide portion 1453 spanning across the upper edge 1415 of the peripheral bond. The narrow portion 1452 within the fluid collection bag 1451 has an external diameter that is only slightly larger than the diameter of the catheter, e.g. 10-50% larger, for example 20%. Consequently, the narrow portion 1452 enables the user to more easily locate the bore through the inlet 1450 (as compared to the wide portion 1453) and insert the proximal end 1421 of the catheter 1420 into the bore in the event that it is not already located there. In this embodiment, the wide portion 1453 has an external diameter that is approximately twice the diameter of the catheter 1420.

In this embodiment, the upper edge 1415 of the peripheral bond spans approximately 0.5-2 cm of the height of the fluid collection bag 1410, for example 1 cm. The wide portion 1453 of the bridging tube 1451 has a length equal to the span of the upper edge 1415, for example 0.5-2 cm or preferable 1 cm. The narrow portion 1452 extends into the fluid collection bag 1410 a similar distance, for example 0.5-2 cm. Preferably, the narrow portion 1452 extends into the fluid collection bag 1410 0.5 cm to ensure it remains easy and convenient to locate the cateter 1420 into the bore of the inlet 1450.

In this embodiment, the inlet 1450 comprises a flange 1454 attached to the bridging tube 1451 and on the outside of the fluid collection bag 1410. The flange 1454 braces the intlet 1450 against the upper edge 1415 of the fluid collection bag 1410 and prevents the inlet 1450 from passing into the fluid collection bag 1410 as well as helping to ensure the peripheral bond does not break or the panels 1411a, 1411b separate around the inlet 1450. The flange 1454 has an external diameter of approximately twice that of the wide portion 1453. The flange 1454 has rounded edges. Of course, in other embodiments, the flange may have a different diameter and features as required/desired.

In this embodiment, the inlet 1450 comprises an external tube 1455 attached to the flange 1454 on the distal side from the bridging tube 1451. The external tube 1455 has a larger diameter than the bridging tube 1451, for example 10-30% larger, for example 20%. The external tube 1455 has a length that is approximately equal to the length of the wide portion 1453 of the bridging tube 1451. The end of the external tube 1455 is hemi -spherical, but in other embodiments it may be a different shape such as flat. In this embodiment, the external tube 1455/inlet 1450 is initially closed in that the bore is covered or blocked to prevent access to the inside of the fluid collection bag 1410. In this embodiment, the external tube 1455 comprises a plug (not shown) that seals the end of the bore to prevent access to the bag 1450. In other embodiments, the external tube may be closed in a different way, for example, the catheter 1420 itself may block the bore/inlet 1450, or the external tube may comprise a frangible or deformable end that prevents access until activated. In such embodiments, the external tube may comprise one or more lines of weakness or slits arranged in a star pattern that can be broken/deformed by the catheter being forced out of the inlet through the external tube. A closed external tube 1455 helps prevent inadvertent leaks of wetting fluid during wetting of the catheter 1420 and also helps maintain the channel 1417 around the catheter 1420 as described further below.

In this embodiment, the fluid reservoir 1440 is a rectangular sachet which contains wetting fluid. The fluid reservoir 1440 has a length equivalent to approximately three quarters the separation distance between the left and right lateral edges 1414, 1413 of the bag 1410 (i.e three quarters the width of the bag 1410) and a width approximately one quarter its length. The fluid reservoir 1440 is be configured to retain at least 5, 10, 15, 25, or 50 ml of wetting fluid, preferably it retains 12 ml of wetting fluid. In other embodiments, different sizes or shapes of fluid reservoir 1440 may be used as required.

In this embodiment, the fluid reservoir 1440 comprises an activation marker 1444 on its surface. The activation marker 1444 comprises a region of the fluid reservoir 1440 that is identifiable to the user for example through visual and/or tactile feedback to allow the user to activate the fluid reservoir 1440 to release wetting fluid into the fluid collection bag 1410. For example, in this embodiment the activation marker 1444 comprises a logo/icon on the fluid reservoir 1440 that is a different colour/shade of colour from the rest of the fluid reservoir 1440. In other embodiments, the activation marker may be a pattern or simply a region that is different colour/shade of colour, or may provide tactile feedback by comprising a raised area or different texture to the rest of the fluid reservoir. In other embodiments, the activation marker may be located on the front panel (or rear panel) of the fluid collection bag instead of on the fluid reservoir itself, for example where the front panel (or rear panel) is (at least partially) opaque.

In this embodiment, the fluid reservoir 1440 is configured to release wetting fluid by rupturing upon depression/compression of the fluid reservoir 1440, especially at a position corresponding to the activation marker 1444. The fluid reservoir 1440 is configured to rupture and create a tear 1441 in the fluid reservoir 1440 through which wetting fluid is released. 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 1420 to render it lubricious. In other embodiments, other wetting fluids may be used and they may be polar (e.g. water-based) or non-polar (e.g. oilbased) depending on the catheter’s surface properties.

In this embodiment, the fluid reservoir 1440 comprises a thermoplastic polyurethane (TPU) or low-density polyethylene (LDPE).

In this embodiment, the fluid reservoir 1440 is positioned inside the fluid collection bag 1410 at the comer where the upper edge 1415 and left lateral edge 1414 meet. The length of the fluid reservoir 1440 is aligned parallel to the upper edge 1415 and as such, the inlet 1450 is at one end of the fluid reservoir 1440 and the left lateral edge 1414 at the other. In other embodiments, the fluid reservoir 1440 may be positioned at different points within the bag 1410. Preferably, the fluid reservoir 1440 is located adjacent to the proximal end 14 1 of the catheter 1420 such that wetting fluid preferentially wets the proximal end 1421 first. This reduces risk of injury/discomfort during use as the first part of the catheter 1420 to enter the body, the proximal end 1421, is more likely to be adequately wetted and is described in more detail below.

In this embodiment, the fluid reservoir 1440 is retained in this position by a join 1442 between the front 1441a and rear panels 1441b of the bag 1410. The join 1442 is separated from the upper edge 1415 of the bag 1410 by a distance approximately equal to the width of the fluid reservoir 1440. The join 1442 spans from the left lateral edge 1414 along the majority of the length of the fluid reservoir 1440. Consequently, the fluid reservoir 1440 is securely maintained in position.

In this embodiment, the join 1442 is formed by a weld between the front and rear panels 1411a, 1411b, but in other embodiments may be formed by any suitable means such as: a mechanical seal; heat seal; pressure seal; adhesive; solvent bond; ultraviolet bond; ultrasonic weld; laser weld; impulse weld; or friction weld.

In this embodiment, the fluid collection bag 1410 further comprises a fill level indicator 1418 comprising fill markers 1419 which allow the user to measure the volume of fluid contained within the fluid collection bag 1410. The fill markers 1419 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. In this embodiment, the fill level markers 1419 are evenly spaced along the front panel 1411a of the bag 1410 adjacent to the right lateral edge 1413 of the peripheral bond.

In this embodiment, the catheter 1420 is arranged within the fluid collection bag 1410 with the proximal end 1421 of the catheter 1420 adjacent to the inlet 1450 and fluid reservoir 1440 and thus adacent to the upper edge 1415 and right lateral edge 1413 of the fluid collection bag 1410. The catheter 1420 extends down the right lateral edge 1413 approximately two fifths down the height of the fluid collection bag 1410. In a portion corresponding to the middle fifth of the fluid collection bag 1410, the catheter 1420 crosses from the right lateral edge 1413 to the left lateral edge 1414. Consequently, at a midpoint along the height of the fluid collection bag 1410, the catheter 1420 is angled at approximately 30-60 degrees with respect to the direction of the width (and/or height) of the fluid collection bag 1410. Preferably, the catheter is angled at 40-50 degrees (most preferably 45 degrees) with respect to the direction of the width (and/or height) of the fluid collection bag 1410. In this embodiment, the midpoint corresponds to a fold line 1416 of the fluid collection bag 1410 as described below. In the lower two fifths of the fluid collection bag 1410, the catheter 1420 extends adjacent to the left lateral edge 1414. The distal end 1422 of the catheter 1420 and funnel 1423 are positioned adjacent to the left lateral edge 1414 and base 1412 of the fluid collection bag 1410. Of course, in other embodiments, the position of the catheter 1420 may vary but preferably the proximal end 1421 is always positioned adjacent to the to the inlet 1450 and fluid reservoir 1440. In addition, preferably, the catheter 1420 is always angled at 30-60 degrees or 40-50 degrees, or most preferably 45 degrees with respect to a fold line 1416 of the fluid collection bag 1410.

As mentioned above, in this embodiment the catheter 1420 exits the fluid collection bag 1410 through the inlet 1450 and the inlet 1450 may be used as a handling element to help manipulation of the catheter 1420. To further assist with using the catheter 1420, the fluid collection bag 1410 is configured to act as a handling sleeve for the catheter 1420 and may be bunched up to allow the catheter 1420 to be partially removed from the fluid collection bag 1410 (see Figure 5). This further reduces the risk of infection associated with handling the catheter 1420 directly.

In this embodiment, the fluid collection bag 1410 further comprises a channel 1417 surrounding the catheter 1420 and fluid reservoir 1440. The channel 1417 is formed in the fluid collection bag 1410 during manufacture of the catheter assembly which comprises arranging the fluid reservoir 1440 and catheter 1420 between the front 1411a and rear 1411b panels and vacuum sealing the two panels 1411a, 1411b together to form the channel 1417. For example, air may be evacuated from the fluid collection bag 1410 through the inlet 1450 to vacuum seal the two panels 1411a, 1411b together. In an alternative, air may be evacuated through a gap in the peripheral seal, which may then be sealed, whilst under vacuum. Indeed, the peripheral seal could be formed whilst the panels are under vacuum. Consequently, the bag 1410 is sealed with an internal pressure that is lower than atmospheric pressure and this (negative) pressure difference between the inside and outside of the bag 1410 urges the panels 1411a, 141 lb together. Once sealed, the pressure inside the bag 1410 may be at least 50, 60, 70, or 80 kPa lower than atmospheric pressure outside the bag 1410, preferably it is 80 kPa lower. The internal pressure of the bag 1410 may therefore be no more than 50, 40, 30, 20 or 10 kPa, preferably, the internal pressure of the bag 1410 is 20 kPa, this ensures that the channel 1417 is tightly formed around the catheter 1420.

In this embodiment, the flexible nature of the panels 1411a, 1411b allows them to deform and seal together during vacuum sealing reducing the internal volume of the fluid collection bag 1410. However, the physical size of the fluid reservoir 1440 and catheter 1420 prevents the panels 1411a, 1411b from vacuum sealing together at locations corresponding to and surrounding the fluid reservoir 1440 and catheter 1420, thus forming the channel 1417 without the need for any additional joins or physical barriers to be present within the fluid collection bag 1410.

In this embodiment, the channel 1417 comprises a catheter section 1417a that corresponds to the section of the channel 1417 surrounding the catheter 1420 and a reservoir section 1417b that corresponds to the section of the channel 1417 surrounding the fluid reservoir 1440. The catheter section 1417a has a width that 20-30% of the width of the fluid collection bag. In other embodiments, preferably the channel has a width that is less than 50% of the width of the fluid collection bag. In this embodiment, the channel 1417 extends only a short distance away from the catheter 1420, for example 1 cm as the channel 1417 has a width only 2 cm wider than the catheter 1420. This ensures wetting fluid is efficiently used to wet the catheter.

In this embodiment, the catheter section 1417a is defined by temporary adherence of the panels 1411a, 141 lb together; i.e. the edge separating the region where the panels are adhered to one another from where they are separated defines the catheter section 1417a of the channel 1417. This ensures that after wetting the panels 1411a, 1411b may separate and allow the catheter 1420 to be manipulated within the bag 1410 and also for liquid to efficiently fill the available volume inside the bag 1410.

In this embodiment, the reservoir section 1417b of the channel 1417 is arranged between the join 1442 and the peripheral bond, this helps ensure that the wetting fluid is directed into the catheter section 1417a of the channel 1417 when the fluid reservoir 1440 is burst. In addition, it retains the fluid reservoir 1440 in place after wetting to ensure it does not interfere with use of the catheter assembly.

In this embodiment, the channel 1417 is configured to direct wetting fluid released by the fluid reservoir 1440 to wet the catheter 1420. Thus, the wetting fluid is more efficient in wetting the catheter 1420. Furthermore, as the fluid collection bag 1410 is evacuated, the available volume within the bag 1410 is minimised which further increases the prospects of successfully wetting the catheter 1420 prior to use. This also reduces the volume of liquid required to be carried in the fluid reservoir 1440 reducing the size and weight of the packaged catheter assembly 1400 as well as the cost (environmental and financial) of manufacturing it.

Referring to Figures 1-5, in this embodiment, the fluid collection bag 1410 is provided in a stowed configuration, which in this embodiment is a folded configuration. The fluid collection bag 1410 comprises a fold line 1416 which spans the width of the fluid collection bag 1410 at the midpoint of the height of the fluid collection bag 1410, as mentioned above. Consequently, the stowed fluid collection bag 1410 has a width equal to the unstowed (unfolded) bag 1410 and a height that is half the height of the unstowed (unfolded) bag 1410 described above. In this embodiment, the front panel 141 la is on the inside of the folded bag 1410 and consequently, the rear panel 1411b froms the outside surfaces of the folded bag 1410. In other embodiments, the bag 1410 may instead be rolled or folded more than once in the stowed configuration as required.

As described above, the catheter 1420 is arranged within the fluid collection bag 1410 such that it is angled (or not perpendicular) with respect to the fold line 1416, this reduces the likelihood that the catheter 1420 is damaged, for example due to kinking, as it passes through the fold. In addition, it means that when the fluid collection bag 1410 is folded, the catheter 1420 is generally U-shaped with the apex of the U positioned at the fold line 1416.

In this embodiment, the pouch 1470 is formed from a front wall (not shown - cut away) and rear wall 1471 of identical shape and size, and a peripheral seal joining the periphery of the walls to form the pouch 1470 and containing its contents (i.e. the closed catheter assembly).

The peripheral seal defines a base 1472a, a left lateral edge 1472b, aright lateral edge 1472c and an upper edge 1472d of the pouch 1470. The left lateral edge 1472b and right lateral edge 1472c being defined as the left and right sides of the pouch 1470 when viewing the pouch 1470 with the rear wall 1471 behind the front wall, the base 1472a at the bottom of the pouch 1470 and the upper edge 1472d at the top of the pouch 1470. The peripheral seal thus defines a pouch 1470 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 1472a to the upper edge 1472d of between 100 to 250 mm, preferably 120 to 140 mm, for example about 130 mm. The base 1472a defines the bottom of the pouch 1470 in use, and the upper edge 1472d 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 1470 may be formed from a single piece of material. The pouch 1470 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 1470. For example, none of the edges may comprise a fold (as in the illustrated example), one edge may comprise a fold, or two or more of the edges may comprise a fold.

In this embodiment, the pouch 1470 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 1400 in day-to-day life. In addition, the exterior of the pouch 1470 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 1470 also comprises an interaction region. The interaction region forms the top part of the pouch 1470 and spans between the right lateral edge 1472c and left lateral edge 1472b. The interaction region is used to provide access to the pouch through/near to the upper edge 1472d. In this embodiment, the interaction region comprises a tapered tear-away region 1475. The tear-away region 1475 comprises a tear start 1476 at the point the left lateral edge 1472b meets the tearaway region 1475, a tear stop 1477 at a corresponding point on the right lateral edge 1472c, and a tear line 1478 spanning between the tear start 1476 and tear stop 1477. The tear line 1478 comprises a line of weakness in the walls of the pouch 1470, which may be formed by any suitable means but in this embodiment is laser etched. The tear start 1476 comprises a notch to provide an area of weakness in the peripheral seal. This allows the tear-away region 1475 to be separated from the pouch 1470 by tearing the walls apart from the tear start 1476 to the tear stop 1477 along the tear line 1478. Thus the tear is provided beneath the location of the upper edge 1472d and thus the pouch 1470 may be opened provided access to its contents. In other embodiments, the tear stop 1477 may comprise a small aperture in the walls to prevent further tearing of the pouch 1470.

In order to provide the tapered shape, the tear-away region 1475 extends upwards on the left side approximately 50% more than it does on the right side. The left side of the tear-away region 1475 comprises a circular aperture 1479 sized to allow a finger to pass through and grip the tear-away region 1475. To ensure the pouch 1470 is fully sealed, the front wall and rear wall 1471 are sealed to one another over the entire tear-away region 1475. 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.

Referring to Figures 1 and 2, in this embodiment, the packaged catheter assembly 1400 is provided with the folded fluid collection bag 1410, catheter 1420, and fluid reservoir 1440 all contained with the pouch 1470. The catheter 1420 and fluid reservoir 1440 are within the fluid collection bag 1410 as described above and the fluid collection bag 1410 in its stowed (folded) configuration fills almost the entire area bounded by the peripheral seal of the pouch 1470.

In this embodiment, the user may access the closed catheter assembly (and catheter 1420) by creating an opening in the pouch 1470 using the interaction region. The aperture 1479 is grasped in one hand, and the pouch 1470 below the tear line 1478 in another, and the tear-away region 1475 is tom from the tear start 1476 to the tear stop 1477 along the tear line 1478. Thus, the pouch 1470 is tom between the left lateral edge 1472b and right lateral edge 1472c at a location below the upper edge 1472d, as such, an opening is formed in the pouch 1470 that may be used to access its contents. In this embodiment, the tear-away region 1475 is fully separated from the pouch 1470 to improve access to the contents of the pouch 1740. In other embodiments, the tearaway region 1475 may not be fully separated from the pouch 14470 to reduce the number of separate parts and make the pouch 1470 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. fluid collection bag 1410 containing the catheter 1240 and fluid reservoir 1440) may then be removed from the pouch 1470. The folded fluid collection bag 1410 is easily accessible to the user as it is directly accessible via the opening in the pouch 1470 and can be simply grapsed and pulled out through the opening in the pouch 1470.

Referring to Figures 3-5, in this embodiment, the user releases the wetting fluid from the fluid reservoir 1440 into the channel 1417 of the fluid collection bag 1410 before removing the catheter 1420 from the fluid collection bag 1410. This may be done by any suitable means, but preferably by applying pressure to the outside of the fluid collection bag 1410 at a region corresponding to the position of the fluid reservoir 1440, for example by locating the fluid reservoir 140 and pressing the activation marker 1444. Preferably, the fluid collection bag 1410 is unfolded prior to the release of wetting fluid to avoid the potential obstruction of the flow of wetting fluid through the channel 1417 that may be caused by the fold line 1416.

In this embodiment, the wetting fluid is directed out of the reservoir section 1417b and into the catheter section 1417a of the channel 1417 by the peripheral bond and join 1442. Wetting fluid then preferentially wets the proximal end 1421 of the catheter 1420 and then flows down the channel 1417 and along the catheter 1420 which helps to ensure the catheter 1420 is sufficiently prepared for use. The vacuum sealing of the fluid collection bag 1410 during manufacture inhibits the flow of wetting fluid away from the catheter 1420 and also reduces the available volume within the fluid collection bag 1410 further improving the efficiency of the wetting process.

In this embodiment, the proximal end of 1421 of the catheter 1420 may then be inserted into the inlet 1450 and progressively withdrawn from the fluid collection bag 1410 through the inlet 1450. Of course, where the inlet 1450 is provided closed, it must be opened to allow the catheter 1420 to pass through it, for example by removing a plug blocking the inlet 1450. Once the inlet 1450 is opened, air (and other fluids) may enter the fluid collection bag 1410, this may cause the panels 1411a, 1411b to separate and the channel 1417 to widen or be ineffective in constraining wetting fluid, as such this should only be done after wetting the catheter 1420.

In this embodiment, the fluid collection bag 1410 may act as a sleeve for the catheter 1420 and can be bunched to allow the user to more easily withdraw the catheter 1420 from the fluid collection bag 1410. In addition, the inlet 1450 may act as a handling element to allow the user to direct the catheter 1420 into the body. In some embodiments, the inlet 1450 may comprise an inserter tip configured to be inserted into the body to allow the catheter to pass straight into the body from the fluid collection bag.

The catheter 1420 may be inserted into the urethra until fluid flows through the catheter 1420 from the bladder. Fluid flowing through the catheter 1420 is collected in the fluid collection bag 1410 and the volume of fluid contained in the bag can be monitored using the fill level indicator. Of course, the fluid flowing into the fluid collection bag 1410 will overcome any attraction between the panels 1411a, 1411b caused by vacuum sealing of them together prior to use. As such a section of the panels 1411a, 1411b corresponding to the position of the channel 1417 are configured to separate after wetting of the catheter 1420 and as liquid enters the bag 1410. Consequently, the available volume within the fluid collection bag 1410 is increased.

In this embodiment, as the fluid collection bag 1410 was evacuated during manufacture, the bag 1410 is not filled with air and as such it can be easier for liquid from the bladder to fill the bag 1410 as air need not be displaced out of the inlet 1450 to make room for liquid flowing in.

After use, in this embodiment, as the catheter 1420 is withdrawn from the body and stowed inside the fluid collection bag 1410, for example, by pulling the catheter 1420 back through the inlet 1450 by grasping the funnel 1423 via the fluid collection bag 1410. The inlet 1450 may then be closed again to reduce the risk of urine spilling out of the bag 1410 after use.

In this embodiment, the packaged catheter assembly 1400 described above is manufactured by first arranging the catheter 1420 and fluid reservoir 1440 on the inside surface of the rear panel 141 lb. The inlet 1450 is arranged at the top edge of the rear panel 141 lb and the catheter 1420 is arranged in the curved configuration as described above.

In this embodiment, the front panel 141 la is then placed over the catheter 1420, fluid reservoir 1440 and intlet 1450 in register with the rear panel 1411b. The peripheral bond is then formed by welding the panels 1411a, 141 lb together about their periphery to seal the fluid reservoir 1440 and catheter 1420 within the fluid collection bag 1410 and retain the inlet 1450 in the upper edge 1415 of the peripheral bond.

In this embodiment, the join 1442 is then formed by welding the panels 1411a, 1411b together, of course, in other embodiments this could be done either before, or simultaneously with, the formation of the peripheral bond.

In this embodiment, a source of negative pressure is then applied to the inlet 1450 to evacuate the fluid collection bag 1410. This reduces the internal pressure within the bag 1410 such that a vacuum seal is created between the panels 141 la, 1411b at all locations inside the bag 1410 to form the channel 1417, for example, the internal pressure may be reduced to 20 kPa which is about 80 kPa lower than normal atmospheric pressure. Of course, in other embodiments, the channel 1417 may be formed by applying negative pressure through a dedicated hole/gap in either panel or the peripheral bond and then subsequently sealing the hole, or by forming the bag 1410 in an evacuated environment.

In this embodiment, the fluid collection bag 1410 is then folded about the foldline 1416. The pouch 1470 is provided with the two walls of the pouch sealed about three sides: the left lateral edge 1472b, base 1472a and right lateral edge 1472c. The fluid collection bag is inserted into the pouch 1470 and then the upper edge 1472d of the pouch 1470 sealed to close the pouch 1470. While the embodiments disclosed above is described as a closed catheter assembly in that fluid is collected in a fluid collection bag, other embodiments may not comprise a fluid collection bag and may be open catheter assemblies in that fluid is not collected during use - in that case, the pouch 1470 could be vacuum formed to provide the channel around the catheter. 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.