Patent Description:
A catheter is a medical device comprising a hollow catheter tube designed for insertion into canals, vessels, passageways or body cavities to permit injection, drainage or withdrawal of fluids or substances therefrom, or to ensure said canals, vessels, passageways etc. remain open. Urinary catheters are designed for use for insertion into a user's bladder via the urethra to drain the bladder.

To maximise comfort and minimise the risk of trauma and/or infection, an outer surface of the catheter tube is typically wetted using a wetting fluid prior to insertion by the user. In further developments, the catheter tube itself comprises, is integrated with or is coated with a hydrophilic component (e.g. a hydrophilic polymer) which serves to reduce friction further upon application of the wetting fluid.

Some catheters may be supplied pre-wetted in a packaging, for instance, where the catheter is at least partially submerged within wetting fluid within the packaging. Whilst this may ensure the catheter tube is adequately wetted prior to use, such arrangements suffer in that components of the catheter other than the catheter tube such as a gripper element or funnel can also become wetted. This has a detrimental effect of the experience of the user where it may become difficult to hold and direct the catheter tube as required. This is particularly problematic where the user is performing self-catheterisation. Further, having the catheter submerged may effectively reduce the shelf-life of the catheter due to long-term exposure of components of the catheter to moisture.

It is therefore seen advantageous to provide a catheter which may be wetted at or immediately prior to the point of use.

In an attempt to address this, some catheters are provided in packaging which includes a rupturable container or sachet within the packaging which a user may burst to release the wetting fluid. Typically, this involves the user squeezing the packaging to cause the container/sachet to break. However, such arrangements experience similar problems to those discussed above where the wetting fluid is allowed to come into contact with other components of the catheter. Such arrangements also result in the possibility of the catheter tube not being fully wetted, or indeed wetted at all, prior to use. This can be harmful for the user.

It is therefore advantageous to provide a catheter which includes a means of supplying a wetting fluid solely to the catheter tube to improve user experience.

In further prior art solutions, the catheter may be packaged within a packaging which includes a wetting device. In use, the catheter tube may be moved through the wetting device as the catheter is removed from the packaging and in doing so wetting the catheter tube. Examples of such catheters are shown in PCT application No. <CIT> in the name of Convatec Limited.

However, due to packaging constraints the amount of wetting fluid able to be contained in such wetting devices is low, and there therefore remains a possibility of the catheter tube not being fully wetted in such solutions, especially where the catheter is a male urinary catheter which might be up to and possibly in excess of <NUM> in length.

For mechanisms which wet the catheter tube from the distal end, an insufficient volume of wetting fluid may result in the tip end not being wetted at all which is undesirable since the tip end will be introduced into the urethra first and is hence most likely to cause injury if inadequately wetted before use. Further, if using an arrangement wherein the catheter tube is wetted by pulling the tube from its distal end through a wetting device, thereby exposing the length of the catheter tube, a male user may then find it extremely difficult if not impossible to correctly manoeuvre and position a long, flexible catheter tube without touching the tube itself, thereby risking contamination.

If using an arrangement wherein the catheter tube is pushed out of a packaging and thereby through a wetting device (e.g. using the plunger arrangement shown in figures <NUM>-<NUM> of PCT/IB2018/<NUM>) the length and flexibility of the male catheter tube would make this action difficult if not impossible for the user as the tube may simply bend along its length rather than being pushed through the wetting device. Further, the packaging itself would have to be of considerable size e.g. potentially twice the <NUM>-<NUM> length of a typical male catheter tube to accommodate both the male catheter tube and a plunger, which would need to be of a length broadly equal to the catheter tube. Accordingly, mechanisms of this type are generally only suited for use with female catheters where the length of the catheter tube is much shorter and which are, accordingly, stiffer and easier to manoeuvre and insert whilst holding only the distal end (opposite the tip of the catheter).

It would therefore be advantageous to provide a system which mitigates the possibility of a male catheter tube being used prior to or without adequate lubrication.

<CIT> discloses a catheter assembly comprising a catheter having a catheter shaft and proximal insertion end portion, and a collapsible sleeve. The sleeve defines a compartment containing a liquid, and comprises an introducer located at the proximal end portion of the sleeve. The introducer includes an anti-leak element.

<CIT> discloses a non-invasive device for lubricating and facilitating insertion and removal of an endoscope into a body cavity. The device consists of an annular outer tube and a foam annular tube positioned within the annular outer tube. The foam tube may be saturated with lubricant.

<CIT> discloses a medical tube holder. The holder comprises a holder body having a through hole therein and through which the medical tube passes. Protruding members of elastically deformable material protrude from the inner surface of the through hole and a lubricant is stored between the protruding members.

<CIT> discloses a catheter assembly including a catheter partially positioned within a sleeve. A protective tip is connected to the sleeve and has two seals which define a fluid reservoir containing an activating fluid for the catheter.

<CIT> discloses a urinary catheter wetting apparatus which as a chamber defined by a forward section opposite to a rearward section, each having an axially aligned aperture. A catheter tube is connected to a connector which spans the chamber and initially seals the apertures. A wetting applicator holding wetting agent is disposed in the chamber, and upon use, the connector passes through the chamber applying pressure to the wetting applicator to release the wetting agent onto the catheter tube.

It is an aim of an embodiment or embodiments of the invention to overcome or at least partially mitigate one or more problems with the prior art.

According to an aspect of the invention there is provided a male urinary catheter according to claim <NUM>.

Advantageously, the wetting mechanism of the present invention provides a wetting applicator at or proximal to the tip end of the catheter tube. This ensures the catheter tube is wetted from the tip end (i.e. the end that will be introduced into the urethra first, in use) and thereby reduces the likelihood of injury for the user due to inadequate wetting of the catheter tube. Furthermore, the wetting applicator is advantageously used to control the amount of fluid applied across the catheter tube surface, with the aim of obtaining a substantially even coating of wetting fluid. Having the wetting mechanism at or proximal to the tip end, and requiring the catheter tube to moved therethrough prior to use may advantageously wet the catheter tube irrespective of the orientation of the catheter and wetting mechanism. In this way, the user can be confident that the tube will be adequately wetted at any angle.

The housing may advantageously form a separate and moveable (e.g. with respect to the catheter tube and/or other components of the catheter - e.g. a funnel) component of the catheter which acts as a gripping element in both handling the catheter whilst wetting the catheter tube, and handing the catheter whilst positioning and subsequently inserting the catheter tube into the urethra, in use. Having the wetting mechanism configured as part of a gripping element for the catheter improves the usability of the catheter in terms of both the wetting action and ultimately the use of the catheter. For instance, the gripping element may be moved relative to the catheter tube - i.e. along the tube to move the tube through the wetting chamber (thereby wetting the tube and exposing the tip end of the catheter tube), rather than in the prior art solutions where the catheter tube may need to be pushed or pulled through a wetting device, thereby mitigating problems caused by the length of the catheter tube of a male catheter. Furthermore, the gripping element can be used to hold the catheter tube close to the urethra to help a user guide the catheter tube without having to touch the tube itself, thereby mitigating potential contamination issues.

Optional features set out below may apply to any aspect of the invention as appropriate.

The housing may comprise a holding chamber. The holding chamber may contain a volume of wetting fluid therein. The wetting chamber may be fluidly connected or connectable to the holding chamber. Having the wetting chamber fluidly connected (or at least connectable) to a holding chamber containing the wetting fluid ensures the wetting applicator can be automatically/readily "topped up" with fluid from the holding chamber, for example, as the fluid held within the wetting applicator is released onto the catheter tube, in use. This may ensure there is sufficient fluid to coat the entire length of the catheter tube, which may up to and possibly greater than <NUM> where the catheter is a male urinary catheter.

The wetting applicator may comprise a flexible, compressible and/or resilient material. The wetting applicator may be deformable under the application of a force thereto, for example, upon movement of the catheter tube through the wetting chamber. Deformation of the wetting applicator may cause release of fluid held therein. Accordingly, movement of the catheter tube through the wetting chamber, e.g. in contact with and deforming the wetting applicator may automatically release fluid from the wetting applicator onto a surface of the catheter tube, in use.

The wetting applicator may comprise an absorbent material. For example, in some embodiments the wetting applicator comprises a sponge or foam material, operable to absorb the fluid, in use. In embodiments wherein the housing comprises a holding chamber, the absorbent material may be provided between the holding chamber and the wetting chamber, or may at least partly define the wetting chamber, for example, and be operable to absorb fluid from the holding chamber for subsequent application to the catheter tube as the catheter tube is moved through the wetting chamber, in use.

The wetting applicator may comprise a plastics material, such as polyethylene or polyurethane, for example. The foam or sponge material may comprise an open cell material, which may comprise an open cell hydrophilic foam material, for example. The foam or sponge material may be non-swelling, or at least substantially non-swelling, when exposed to the fluid. Advantageously, the dimensions of a non-swelling material may remain roughly constant during use, which may be particularly advantageous for use within a housing of the wetting mechanism of the invention.

The wetting applicator may comprise a wicking material. The wicking material may be operable in use to draw the fluid therethrough for application to the catheter tube. In embodiments wherein the housing comprises a holding chamber, the wicking material may be provided between the holding chamber and the wetting chamber, or may at least partly define the wetting chamber, for example, and be operable to draw fluid from the holding chamber for application to the catheter tube as the catheter tube is moved through the wetting chamber, in use. The wicking material may comprise polyester or nylon, for example.

The wetting applicator comprises a baffle arrangement. The baffle arrangement may define a plurality of subregions of the wetting applicator each configured to hold a portion of the fluid held within the wetting applicator. For example, the baffle arrangement may define a plurality of subregions within the housing, e.g. within the wetting chamber of the housing in which the fluid may reside and or be released into. The baffle arrangement may at least partially define a holding chamber of the housing.

One particularly preferred embodiment provides a catheter according to claim <NUM> wherein the baffle arrangement defines a plurality of subregions of the wetting applicator each configured to hold a portion of the fluid held within the wetting applicator.

Another particularly preferred embodiment provides a catheter according to claim <NUM> wherein the baffle arrangement defines a plurality of subregions within the wetting chamber in which the fluid may reside and/or be released into.

The wetting applicator may comprise a volume of aggregate material through which the wetting fluid may flow before wetting the catheter tube. The aggregate material may advantageously control the flow of the wetting fluid, e.g. between a holding chamber and a wetting chamber of the housing. The aggregate material may comprise a particulate material, for example. The aggregate material is non-soluble.

The wetting applicator may define a channel within the wetting chamber. The wetting applicator may at least partially define the wetting chamber of the wetting mechanism. The wetting applicator may define a channel within the wetting chamber through which the catheter tube is able to be moved through, in use. The wetting mechanism may be configured such that the catheter tube is moved in contact with the wetting applicator as it is moved through the wetting chamber (e.g. along the channel defined by the wetting applicator). In embodiments, the wetting applicator may be configured such that fluid held within the wetting applicator is able to be released, and preferably is automatically released, therefrom upon movement of the catheter tube through the wetting chamber.

The tip end of the catheter tube may, at least initially, be disposed outside the wetting chamber. The tip end of the catheter tube may, at least initially, be held within an inlet of the wetting chamber.

The wetting mechanism may comprise a fluid release control component.

The fluid release control component may be operable, in use, to control release of the fluid from the wetting applicator. For example, the fluid release control component may, in a first configuration, act to prevent the catheter tube from being brought into proximity and/or contact with the wetting applicator. The fluid release control component may act as a barrier between the wetting applicator and a channel through the wetting chamber through which the catheter tube may be moved, in use.

Additionally or alternatively, the fluid release control component may be operable, in use, to control release of the fluid from the holding chamber into the wetting chamber. The fluid release control component may be operable to control release of the fluid from the holding chamber onto and/or into the wetting applicator. In other words, the wetting mechanism may comprise a fluid release control component operable to fluidly connect the holding chamber and the wetting chamber, in use.

Advantageously, controlling the release of the fluid from a holding chamber where it is held out of contact with other components of the catheter system overcomes issues with some prior art devices, particularly where catheters may be disadvantageously submerged in wetting fluid prior to use. It may also improve the shelf life of the catheter by reducing the exposure of most of the components of the catheter to moisture until (or as close as possible to) the point of use.

The fluid release control component may comprise a moveable plug. The plug may be moveable between first and second positions. In the position, the fluid release control component may prevent release of the fluid from the holding chamber to the wetting chamber and/or the wetting applicator. In the second position, the fluid release control component may allow release of the fluid from the holding chamber to the wetting chamber and/or the wetting applicator. The plug may be linearly moveable between first and second positions. For example, in use, the plug may be pushed or pulled by a user to move the plug between the first and second positions. Alternatively, the plug may be may be rotatable between first and second angular positions. The first and second angular positions may correspond to the first and second positions of the plug. The plug may be threaded, and may be provided within the wetting mechanism through interaction with a complementary threaded surface of the wetting mechanism, for example a complementary threaded surface provided on or within the wetting chamber of the housing.

The plug may be configured to be at least partly withdrawn from the wetting mechanism. The plug may be configured to be at least partly withdrawn from the wetting chamber of the wetting mechanism. Partial withdrawal of the plug may correspond to movement of the plug from the first position to the second position. The plug may be configured to be only partly withdrawn from the wetting mechanism - i.e. it cannot be fully withdrawn from the wetting mechanism. It may remain attached or otherwise coupled to the housing whether in the first or second position. In embodiments, the plug may be configured to be fully withdrawn from the wetting mechanism (optionally from the wetting chamber of the wetting mechanism).

Movement of the plug between first and second positions may expose or otherwise unblock one or more openings within the housing between the holding chamber and the wetting chamber. Accordingly, fluid at least initially contained within the holding chamber may be released from said holding chamber (and into the wetting chamber / onto or into the wetting applicator) upon movement of the plug between first and second positions.

The fluid release control component may comprise a container, such as a sachet, blister pack or capsule, for example. The container may be positioned within the holding chamber, or may at least partially define the holding chamber of the wetting mechanism, and may have the fluid contained therein. The container may be rupturable or otherwise openable to release fluid contained therein.

The wetting mechanism may be configured such that the container may be ruptured or otherwise opened, in use, through user action on the housing itself. For example, in some embodiments the housing is formed at least partly from a flexible, compressible and/or resilient material. In such embodiments, the wetting mechanism may be configured such that the container may be ruptured or otherwise opened upon a user compressing, bending and/or flexing the housing.

In further embodiments, the wetting mechanism may comprise a fluid release control component in the form of a plug, in combination with the container. In such embodiments, the wetting mechanism may be configured such that the container may be ruptured or otherwise opened, in use, through movement of the plug. For example, the wetting mechanism may be configured such that the container is compressed upon (at least partial) withdrawal of the plug, or upon rotation of the plug.

The wetting chamber may comprise an inlet through which the catheter tube is able to be introduced into the wetting chamber. The wetting mechanism may comprise a moveable or removeable stopper configured to block, or at least partially block the inlet. In some embodiments the wetting mechanism may be configured such that movement of the stopper (e.g. movement of the stopper from a first position to a second position, or indeed removal of the stopper) unblocks the inlet, thereby allowing for the catheter tube to be introduced into the wetting chamber (and be moved therethrough). In embodiments, the stopper may comprise or be combined with the fluid release control component, e.g. the plug. For example, in such embodiments, at least part withdrawal of the plug may cause both release of the wetting fluid and unblocking of the inlet of the wetting chamber.

The wetting chamber may have an outlet through which the catheter tube may be moved to expose the catheter tube for subsequent insertion by the user.

The inlet and/or outlet may be sealed. For example, the inlet and/or outlet may comprise a valve. The or each valve may provide a seal to retain the wetting fluid within the housing. The valve(s) may advantageously prevent the wetting fluid from being expelled unintentionally from the housing and, for example, onto a user.

The valve(s) may be configured to allow the catheter tube to be moved therethrough. For example, where the housing comprises a valve at the inlet, the inlet valve may be configured to allow the catheter tube to be moved therethrough to introduce the catheter tube into the wetting chamber of the housing. Where the housing comprises a valve at the outlet, the outlet valve may be configured to allow the catheter tube to be moved therethrough to expose the catheter tube, e.g. for subsequent use/insertion by the user.

The housing - e.g. the wetting chamber and/or the holding chamber - may be configured to hold up to <NUM>, or up to <NUM>, or up to <NUM>, or up to <NUM>, or up to <NUM>, or up to <NUM>, or up to <NUM>, or up to <NUM>, or up to <NUM>, or up to <NUM>, or up to <NUM>, or up to <NUM> of wetting fluid, for example.

The housing forms a gripping element of the catheter. As described herein, in use, a gripping element may be used by a user to control application of the catheter. For example, the gripping element can be used to hold the catheter tube close to the urethra to help a user guide the catheter tube without having to touch the tube itself. In embodiments, the housing may comprise a conical profile, which may assist with the user gripping and acting on the housing, in use.

In embodiments wherein the wetting mechanism comprises a fluid release control component in the form of a plug, the plug may comprise a conical profile. The plug may comprise a hollow or substantially hollow interior. Where combined with a conical profile, such a plug may form a cup shape element which may assist a user with locating the catheter tube, in use. The cup can, for example, be used to locate the housing over the tip of a penis such that the catheter tube can be easily inserted into the urethra immediately after wetting.

In some embodiments, the housing and the plug both comprise a conical profile. In such embodiments, the wetting mechanism may be configured such that, together, the housing and the plug form a substantially hourglass-shaped profile. An hourglass-shaped profile may be particularly advantageous in that it may allow the user to operate the wetting mechanism - i.e. to remove (or at least partially remove) the plug from the housing using only one hand.

Advantageously, the wetting mechanism is configured such that the catheter tube is wetted from the tip end (i.e. the end that will be introduced into the urethra first, in use) and immediately prior to insertion by the user. This thereby reduces the likelihood of injury for the user due to inadequate wetting of the catheter tube, e.g. due to a lack of wetting fluid or drying of the catheter tube due to a delay between the wetting process and subsequent insertion by the user.

As mentioned above, the optional aspects of the invention described above may apply to any aspect of the invention - for avoidance of doubt, where compatible, that includes hhe aspects of the invention mentioned immediately above.

The wetting fluid is contained within the wetting chamber. The wetting fluid may be contained within a holding chamber within the housing. The holding chamber and wetting chamber may be fluidly connected, e.g. to allow for wetting fluid to enter the wetting chamber for wetting the catheter tube as it is moved therethrough. For example, the housing may comprise an opening or a port located between the holding chamber and the wetting chamber, and through which the wetting fluid may flow. The opening or port may be configured such that the rate at which the wetting fluid may flow therethrough is limited by the surface tension of the wetting fluid. In this way, the flow of wetting fluid into the wetting chamber may be advantageously controlled to control the application of wetting fluid onto the catheter tube, in use.

The housing may have an inlet and an outlet. The inlet and/or outlet may be sealed. For example, the inlet and/or outlet may comprise a valve. The or each valve may provide a seal to retain the wetting fluid within the housing. The valve(s) may advantageously prevent the wetting fluid from being expelled unintentionally from the housing and, for example, onto a user.

The catheter may comprise a funnel. The funnel may be provided at or proximal to the distal end of the catheter tube. The funnel may comprise a fluid outlet for the discharge of fluid from within the catheter tube. Preferably the catheter comprises the wetting mechanism at or proximal to the tip end of the catheter tube, with the funnel at or proximal to the distal end of the catheter tube, with the wetting mechanism and funnel being separate components coupled via the catheter tube.

In embodiments, the catheter comprises a sleeve. The sleeve may be positioned about the catheter tube. In embodiments, the sleeve may define an internal volume about at least a portion of the catheter tube. The sleeve may comprise a flexible material. The sleeve may be thin and readily crumpled. For example, the sleeve may be formed of a film of plastics material, which may be low-density polyethylene, for example.

The sleeve may be coupled to the wetting mechanism. For example, the sleeve may be coupled at a first end to the wetting mechanism. In such embodiments, the sleeve may be coupled to the catheter at a second, opposing end; for example, it may be coupled to a funnel at or proximal to a distal end of the catheter tube. In this way, the sleeve may define an internal volume about the catheter tube between the wetting mechanism at or proximal to the tip end of the catheter tube, and a funnel at or proximal to a distal end of the catheter tube.

One particularly preferred embodiment provides a male urinary catheter, according to claim <NUM>, the catheter further comprising a funnel provided at or proximal to the distal end of the catheter tube, with the wetting mechanism and funnel being separate components coupled via the catheter tube; and the catheter comprising a sleeve formed of a film of plastics material positioned about the catheter tube, defining an internal volume about at least a portion of the catheter tube; the sleeve being coupled at a first end to the wetting mechanism and at a second, opposing end to the funnel.

The sleeve may advantageously form an interaction point for a user of the catheter. For example, in use, the user may grip the catheter at both the housing of the wetting mechanism and at a point along the sleeve. The catheter may be configured such that the user may then, through indirect contact with the tube via the sleeve, act to urge the catheter tube in and through the wetting chamber of the wetting mechanism. In this way, the catheter of the invention may be used to assist in the wetting of the catheter tube (and exposure of the tip end of the tube for subsequent insertion into the urethra) without a user having to contact the catheter tube directly. Advantageously, this may reduce the risk of contamination.

The catheter may be configured such that at least a portion of the fluid within the wetting chamber of the wetting mechanism is able to flow into and along the sleeve to wet the catheter tube, in use. For example, in some embodiments the housing of the wetting mechanism comprises an aperture or opening therein allowing fluid within the wetting chamber to flow into the sleeve.

The catheter may comprise a single-use catheter. The catheter may comprise an intermittent urinary catheter.

The catheter tube may have a length of up to (and possibly upwards) of <NUM>. The catheter tube may be up to or at least <NUM>, up to or at least <NUM>, up to or at least <NUM>, up to or at least <NUM>, or up to or at least <NUM>, in length, for example. In embodiments, the catheter tube may be more than <NUM> in length. In preferred embodiments, the catheter tube is between <NUM>-<NUM>, in length. Male catheters typically have a catheter tube of such lengths and are therefore less suited to mechanisms which wet the catheter tube from the distal end (as opposed to the tip end as in the present invention), as the fluid may not adequately cover the entire length of the tube. This potentially results in the tip end being wetted last (or not at all if there is insufficient fluid), which is undesirable since the tip end will be introduced into the urethra first and is hence most likely to cause injury if inadequately wetted before use. Further, due to the length requirements of male catheters, wetting arrangements whereby the catheter tube is wetted by a wetting device integrated within the catheter packaging are generally also unsuitable.

The catheter tube comprises, is integrated with, or is coated with a hydrophilic component. The hydrophilic component is configured to provide a low friction surface (e.g. outer surface) of the catheter tube upon application of the wetting fluid. The hydrophilic component may comprise a hydrophilic polymer, for example.

According to an aspect of the invention there is provided a sealed packaged catheter according to claim <NUM>, wherein the wetting mechanism is operably coupled at or proximal to the tip end of the catheter tube within the sealed package.

According to an aspect which is not part of of the invention there is provided a method for wetting a tube of the catheter of claim <NUM> including using the wetting mechanism, the method comprising: introducing the tip end of the catheter tube into the wetting chamber and moving it therethrough, causing release of the fluid from the wetting applicator thereby wetting the at least a portion of an outer surface of the catheter tube.

The method may comprise operating a fluid release control component to control release of fluid from the holding chamber into the wetting chamber, and preferably from the holding chamber onto or into the wetting applicator positioned within (or at least partly defining) the wetting chamber.

In general, the present invention relates to a catheter <NUM>, <NUM>, and specifically to a wetting mechanism <NUM>, <NUM>', <NUM>, <NUM>, <NUM>, <NUM> configured for use to wet a tube <NUM>, <NUM> of the catheter <NUM>, <NUM>, in use.

The Figures illustrate a series of embodiments of the invention. Where equivalent components are present between embodiments, like reference numerals have been used.

<FIG> illustrate a first embodiment of a wetting mechanism <NUM> for use in wetting a tube <NUM> of a catheter <NUM>.

The catheter <NUM> includes the catheter tube <NUM>, with the wetting mechanism <NUM> provided at a tip end (proximal end) <NUM> of the catheter tube <NUM> and a funnel <NUM> at a distal end <NUM> of the catheter tube <NUM>. A sleeve <NUM> is provided between the wetting mechanism <NUM> and the funnel <NUM>, enclosing the catheter tube <NUM> therebetween. Here, the sleeve <NUM> is formed of a flexible material and is coupled at a first end to a housing <NUM> of the wetting mechanism <NUM> and at a second end to the funnel <NUM>. In this way, the sleeve <NUM> defines an internal volume about the catheter tube <NUM> into which, in some instances, fluid may be introduced to wet the outer surface of the catheter tube <NUM>.

As mentioned above, the catheter tube <NUM> has a tip end <NUM> and a distal end <NUM>. The tip end <NUM> includes a tip for insertion of the catheter tube <NUM> into a canal, vessel, passageway, body cavity, etc. for removal of fluid therefrom. Here, the catheter <NUM> comprises a male urinary catheter <NUM> with the tip configured for insertion into a male patient's bladder. The tip end <NUM> of the catheter tube includes an aperture <NUM> therein for allowing for fluid to enter the interior of the catheter tube <NUM>. The distal end <NUM> of the catheter tube <NUM> is provided within the funnel <NUM>. Specifically, the distal end <NUM> of the catheter tube <NUM> is located within the funnel <NUM> and opens into the funnel <NUM>, which defines a fluid outlet <NUM> serving as an outlet for discharging fluid from within the catheter tube <NUM>. The catheter tube <NUM> itself comprises a hydrophilic coating which acts to provide a low friction outer surface of the catheter tube <NUM> upon application of a wetting fluid <NUM>.

The wetting mechanism <NUM> includes a tubular housing <NUM> positioned (at least initially) at a tip end <NUM> of the catheter tube <NUM>. The housing includes an inlet <NUM> and outlet <NUM> through which the catheter tube <NUM> may be moved, in use. Specifically, the catheter tube <NUM> may be introduced into the housing <NUM> through the inlet <NUM>, and may be moved out of the housing <NUM> through the outlet <NUM> to expose the tip end <NUM> thereof, i.e. for subsequent insertion into the urethra.

A wetting applicator in the form of a foam conduit <NUM> is provided within the wetting chamber <NUM>, and is configured to hold wetting fluid <NUM> therein and to control application of the fluid to the catheter tube <NUM>, in use, as the catheter tube <NUM> is moved through the wetting chamber <NUM>. The wetting chamber <NUM>, and specifically the foam conduit <NUM> define a channel through the housing <NUM> through which at least a portion of the catheter tube <NUM> is able to be introduced and be moved therethrough. The channel is defined between the inlet <NUM> and outlet <NUM> of the housing <NUM> such that the catheter tube <NUM> is moved along the length of the foam conduit <NUM> in moving through the housing <NUM>. When moving through the channel, the catheter tube <NUM> is brought into contact with the foam conduit <NUM> resulting in a force being applied to the foam conduit <NUM> causing it to compress. The compression of the foam conduit <NUM> causes fluid stored therein to be released directly on to the outer surface of the catheter tube <NUM>, thereby providing a coating of fluid <NUM> on the catheter tube <NUM> as it is moved through the wetting chamber <NUM>.

Once the tip end <NUM> of the catheter tube <NUM> is moved out through the outlet <NUM> of the housing <NUM>, the tip end <NUM> then becomes exposed for insertion by the user. The housing <NUM> then acts as a gripping element for the user to direct the catheter tube <NUM>, in use, as the user may then use the housing <NUM> to easily direct the exposed tip end <NUM> of the catheter tube <NUM> without contacting the tube <NUM> directly.

A wetting applicator of this type may advantageously ensure that the wetting fluid <NUM> is applied substantially evenly across the outer surface of the catheter tube <NUM>, and reduce the prospect of any spillage. Further, having the wetting mechanism <NUM> provided as a gripping element for the catheter <NUM> improves the usability of the catheter <NUM> in terms of both the wetting action and ultimately the use of the catheter.

A variant of wetting mechanism <NUM> is shown in <FIG>. Specifically, these figures shown a wetting mechanism <NUM>' configured similarly to wetting mechanism <NUM>. Wetting mechanism <NUM>' differs in that it comprises a housing <NUM>' which further includes a holding chamber <NUM>' which contains a volume of fluid <NUM> therein for wetting the catheter tube <NUM>. In use, the fluid <NUM>' may be released from said holding chamber <NUM>' into the wetting chamber <NUM>', and specifically onto a wetting applicator in the form of a foam conduit <NUM>' positioned within the wetting chamber <NUM>'. The fluid <NUM>' is released from the holding chamber <NUM>' to the wetting chamber <NUM>' through an opening <NUM>' within the housing <NUM>'.

As with foam conduit <NUM>, the foam conduit <NUM>' is configured to hold fluid, but specifically here fluid <NUM>' released into the wetting chamber <NUM>' from the holding chamber <NUM>'. Again, foam conduit <NUM>' is configured to control application of the fluid to the catheter tube <NUM>, in use, as the catheter tube <NUM> is moved through the wetting chamber <NUM>'.

The catheter tube <NUM> may be moved into and through the wetting chamber <NUM>' via the inlet <NUM>' in the same manner as wetting mechanism <NUM> described above, bringing the catheter tube <NUM> into contact with (and apply pressure to) the foam conduit <NUM>'. This pressure causes release of the fluid <NUM>' from the foam conduit <NUM>', thereby wetting an outer surface of the catheter tube <NUM>. Once the tip end <NUM> of the catheter tube <NUM> is moved out through an outlet <NUM>' of the housing <NUM>', the tip end <NUM> then becomes exposed for insertion by the user. The housing <NUM>' then acts as a gripping element for the user to direct the catheter tube <NUM>, in use, as the user may then use the housing <NUM>' to easily direct the exposed tip end <NUM> of the catheter tube <NUM> without contacting the tube <NUM> directly.

A wetting applicator of this type may advantageously ensure that the foam conduit <NUM>' can be "topped up" with fluid <NUM>' from the holding chamber <NUM>' as the fluid held within the foam conduit <NUM>' is released onto the catheter tube <NUM>. This may ensure there is sufficient fluid to coat the entire length of the catheter tube <NUM>, which may up to and possibly greater than <NUM>.

A variant of wetting mechanism <NUM>' is shown in <FIG>. Specifically, these figures show a wetting mechanism <NUM> configured in substantially the same way as wetting mechanism <NUM>' shown in <FIG>. Wetting mechanism <NUM> differs in that it comprises a fluid release control component in the form of a plug <NUM>. As is described herein, the plug <NUM> is configured to control release of the fluid <NUM> from the holding chamber <NUM> to the wetting chamber <NUM>, and specifically from the holding chamber <NUM> onto a wetting applicator in the form of foam conduit <NUM>. The holding chamber <NUM> and wetting chamber <NUM> are fluidly connected to one another by an opening <NUM> in the housing <NUM>.

The fluid <NUM> is released from said holding chamber <NUM> into the wetting chamber <NUM>, and onto the foam conduit <NUM>, upon movement of the plug <NUM>. To assist with this, a lip <NUM> is provided at an end of the plug <NUM> defining an interaction point for the user, specifically for the user to grip the lip <NUM> to provide leverage.

Initially, the wetting mechanism <NUM> is provided in a first position with the plug <NUM> in a first position blocking the opening <NUM> (<FIG>). In order to activate the wetting mechanism <NUM>, the plug <NUM> is partially displaced from (i.e. pulled out from) the wetting chamber <NUM> to a second position (<FIG>). In doing so, the plug <NUM> is moved to a position where the opening <NUM> is no longer blocked, allowing the fluid <NUM> to be released from the holding chamber <NUM> into the wetting chamber <NUM>, and specifically onto the foam conduit <NUM>. A notch <NUM> is provided on an outer circumferential surface of the plug <NUM> to define the extent to which the plug <NUM> can be removed from the wetting chamber <NUM>. Specifically, the notch <NUM> provides a point of contact between the plug <NUM> and a circumferentially inwardly extending flange <NUM> at the end of the housing <NUM>.

Subsequently, the catheter tube <NUM> may be moved into and through the wetting chamber <NUM> via the inlet <NUM> in the same manner as wetting mechanisms <NUM>, <NUM>' described above, bringing the catheter tube <NUM> into contact with (and apply pressure to) the foam conduit <NUM>. This pressure causes release of the fluid <NUM> from the foam conduit <NUM>, thereby wetting an outer surface of the catheter tube <NUM>. Once the tip end <NUM> of the catheter tube <NUM> is moved beyond the lip <NUM> in the plug <NUM>, and out through an outlet <NUM> of the housing <NUM>, the tip end <NUM> then becomes exposed for insertion by the user. The housing <NUM> then acts as a gripping element for the user to direct the catheter tube <NUM>, in use, as the user may then use the housing <NUM> to easily direct the exposed tip end <NUM> of the catheter tube <NUM> without contacting the tube <NUM> directly.

Advantageously, having the fluid <NUM> stored in a separate holding chamber <NUM> until (or as close as possible to) the point of use of the catheter <NUM> reduces the contact time of most components of the catheter <NUM> with the fluid <NUM>, which may be advantageous in terms of shelf-life of the catheter <NUM>.

<FIG> illustrate a further embodiment of a wetting mechanism <NUM> according to the invention, for wetting an outer surface of the catheter tube <NUM>.

As with wetting mechanisms <NUM>, <NUM>', <NUM>, the wetting mechanism <NUM> comprises a housing <NUM> positioned (at least initially) at a tip end <NUM> of the catheter tube <NUM>. The housing <NUM> again includes a holding chamber <NUM> which contains a volume of fluid <NUM> therein for wetting the catheter tube <NUM>, and a wetting chamber <NUM> into which the fluid <NUM> may be released - specifically through an opening <NUM> within the housing <NUM>. The wetting chamber <NUM> again defines a separate portion of the housing <NUM> and includes a foam conduit <NUM> defining a channel through the wetting chamber <NUM> through which at least a portion of the catheter tube <NUM> is able to be introduced and be moved therethrough.

Wetting mechanism <NUM> differs in that it includes a plug <NUM> which is, at least initially, provided within the wetting chamber <NUM> and specifically within the channel defined by the foam conduit <NUM>. In this position (<FIG>), fluid <NUM> from the holding chamber <NUM> may be released through the opening <NUM> and on to the foam conduit <NUM>, however, the plug <NUM> acts to effectively seal the wetting chamber <NUM> such that none of the fluid within the foam conduit <NUM>, or indeed still within the holding chamber <NUM> can be released. In this position, the plug <NUM> also prevents the catheter tube <NUM> from being introduced into the wetting chamber <NUM>. Accordingly, the plug <NUM> may prevent or at least reduce the likelihood of inadvertent activation of the wetting mechanism <NUM>.

The plug <NUM> is configured such that it can be fully removed from the wetting chamber <NUM>, specifically by pulling the plug <NUM> out through outlet <NUM> in the housing <NUM>. The plug <NUM> is provided with an enlarged rounded end portion <NUM> to assist with the user gripping the plug <NUM>. Withdrawal of the plug <NUM> from the wetting chamber <NUM> unblocks the inlet <NUM> (<FIG>). The catheter tube <NUM> may then be moved into and through the wetting chamber <NUM> via the inlet <NUM> in the same manner as wetting mechanisms <NUM>, <NUM> described above, bringing the catheter tube <NUM> into contact with (and apply pressure to) the foam conduit <NUM>. This pressure causes release of the fluid <NUM> from the foam conduit <NUM>, thereby wetting an outer surface of the catheter tube <NUM>. Once the tip end <NUM> of the catheter tube <NUM> is moved out through the outlet <NUM> of the housing <NUM>, the tip end <NUM> then becomes exposed for insertion by the user. Again, the housing <NUM> acts as a gripping element for the user to direct the catheter tube <NUM>, in use, as the user may then use the housing <NUM> to easily direct the exposed tip end <NUM> of the catheter tube <NUM> without contacting the tube <NUM> directly.

As with wetting mechanisms <NUM>, <NUM>', <NUM>, <NUM>, the wetting mechanism <NUM> comprises a housing <NUM> positioned (at least initially) at a tip end <NUM> of the catheter tube <NUM>. The housing <NUM> again includes a holding chamber <NUM> which contains a volume of fluid <NUM> therein for wetting the catheter tube <NUM>, and a wetting chamber <NUM> into which the fluid <NUM> may be released.

Wetting mechanism <NUM> differs in that it includes a fluid release control component in the form of a container of fluid, specifically a sachet <NUM> which must be ruptured in order to release the fluid <NUM> therefrom and into the wetting chamber <NUM> and onto a wetting applicator in the form of a foam conduit <NUM>. As with foam conduit <NUM>, <NUM>, <NUM>, the foam conduit <NUM> is configured to hold fluid released thereon from the holding chamber <NUM> and is configured to control application of the fluid to the catheter tube <NUM>, in use, as the catheter tube <NUM> is moved through the housing <NUM>. As shown, the sachet <NUM> effectively defines the holding chamber <NUM>. Similarly, the foam conduit <NUM> defines the wetting chamber <NUM> through which the catheter tube <NUM> may be moved, in use.

The sachet <NUM> is initially provided in the configuration shown in <FIG> - i.e. intact, with the fluid contained therein. In use, the sachet <NUM> is ruptured through a user applying an external force to the housing <NUM>, i.e. by squeezing the housing <NUM> (as shown figuratively in <FIG>), which may be formed of a deformable material, or with a deformable region that can be squeezed. Rupture of the sachet <NUM> causes the fluid contained therein to be released into the wetting chamber <NUM>, and specifically onto the foam conduit <NUM>. As with wetting mechanisms <NUM>, <NUM>', <NUM>, <NUM> the catheter tube <NUM> may then be moved through the wetting chamber <NUM> in contact with the foam conduit <NUM> and out through an outlet <NUM> at a distal end of the housing <NUM> to both wet the outer surface of the catheter tube <NUM> and expose the tip end <NUM> for insertion by the user. Again, the housing <NUM> acts as a gripping element for the user to direct the catheter tube <NUM>, in use.

<FIG> illustrate a further embodiment of a catheter <NUM> and wetting mechanism <NUM> operable to wet a tube <NUM> of the catheter <NUM>, in use.

As with catheter <NUM>, the catheter <NUM> includes the catheter tube <NUM>, with the wetting mechanism <NUM> provided at a tip end <NUM> of the catheter tube <NUM> and a funnel <NUM> at a distal end <NUM> of the catheter tube <NUM>. A sleeve <NUM> is provided between the wetting mechanism <NUM> and the funnel <NUM>, enclosing the catheter tube <NUM> therebetween.

The tip end <NUM> of the catheter <NUM> includes a tip for insertion of the catheter tube <NUM> into a canal, vessel, passageway, body cavity, etc. for removal of fluid therefrom. Here, the catheter <NUM> comprises a male urinary catheter <NUM> with the tip configured for insertion into a male patient's bladder. The distal end <NUM> of the catheter tube <NUM> is provided within the funnel <NUM>. Specifically, the distal end <NUM> of the catheter tube <NUM> is located within the funnel <NUM> and opens into the funnel <NUM> which defines a fluid outlet <NUM> which serves as an outlet for discharging fluid from within the catheter tube <NUM>. The funnel <NUM> is shaped to aid the user's control over the direction of discharge of the fluid from the catheter tube <NUM>. The catheter tube <NUM> itself comprises a hydrophilic coating which acts to provide a low friction outer surface of the catheter tube <NUM> upon application of a wetting fluid.

The wetting mechanism <NUM> is similar in configuration to wetting mechanism <NUM> described herein, and may be of the nature of, with the same features as the embodiment shown in <FIG>. It includes a housing <NUM> positioned (at least initially) at the tip end <NUM> of the catheter tube <NUM>. The housing <NUM> includes a holding chamber (not shown) which contains a volume of fluid therein for wetting the catheter tube <NUM>. In use, and as is described herein, the fluid may be released from said holding chamber into a wetting chamber (not shown) of the housing <NUM> under the operation of a plug <NUM>. As with wetting mechanism <NUM>, by releasing the fluid into the wetting chamber, and specifically onto a wetting applicator in the form of a foam conduit (not shown), and then subsequently moving the catheter tube <NUM> through the wetting chamber in contact with the foam conduit, an outer surface of the catheter tube <NUM> may be wetted using the fluid. The plug <NUM> is moveable from the position shown in <FIG> (a first position) to the position shown in <FIG> (a second position) to release the fluid from the holding chamber. Specifically, movement of the plug <NUM> between these positions may unblock an opening within the housing <NUM> or rupture a sachet, for example, to allow for the fluid to be released from the holding chamber into the wetting chamber and into / onto the foam conduit for subsequent application to the catheter tube <NUM>.

In this embodiment, the plug <NUM> comprises a conical cross section, with a ridged exterior surface defining an interaction surface for the user. The housing <NUM> is also substantially conical in profile, and is positioned in such a way to define an hourglass-shaped configuration of the housing <NUM> and plug <NUM>. This arrangement is particularly beneficial as it may allow for operation of the plug <NUM> using only one hand, as shown in <FIG>. Specifically, and as shown in these Figures, the user may grip the housing <NUM> and plug <NUM> between their thumb and forefinger, before using their thumb to push or "pop" the plug <NUM> upwards (in the orientation shown in the Figures) to release the fluid. Moreover, the conical plug <NUM> has a cup like end, which eases location of the housing <NUM> over the tip of the penis to aid insertion of the catheter tube <NUM> into the urethra, in use.

<FIG> illustrate a further embodiment of a wetting mechanism <NUM> for use in wetting catheter tube <NUM> of catheter <NUM>.

The wetting mechanism <NUM> includes a tubular housing <NUM> positioned (at least initially) at a tip end <NUM> of the catheter tube <NUM>. The housing <NUM> includes an inlet <NUM> and outlet <NUM> through which the catheter tube <NUM> may be moved, in use. Specifically, the catheter tube <NUM> may be introduced into the housing <NUM> through the inlet <NUM>, and may be moved out of the housing <NUM> through the outlet <NUM> to expose the tip end <NUM> thereof, i.e. for subsequent insertion into the urethra.

Wetting mechanism <NUM> differs from the mechanisms described hereinabove in that it does not include a wetting applicator within the wetting chamber <NUM>. Rather, the wetting fluid <NUM> is contained within the wetting chamber <NUM> itself, and the wetting fluid <NUM> is applied to catheter tube <NUM>, in use, as the catheter tube <NUM> is moved through the wetting chamber <NUM>.

The wetting chamber <NUM> defines a channel through the housing <NUM> through which at least a portion of the catheter tube <NUM> is able to be introduced and be moved therethrough. The channel is defined between the inlet <NUM> and outlet <NUM> of the housing <NUM>. When moving through the channel, the catheter tube <NUM> is brought into contact with wetting fluid <NUM> held within the wetting chamber <NUM> thereby coating an exterior surface of the tube <NUM> with the wetting fluid <NUM> as it is moved through the wetting chamber <NUM>.

The wetting mechanism <NUM> includes an inlet valve <NUM> provided at the inlet <NUM> and an outlet valve <NUM> provided at the outlet <NUM>. The inlet and outlet valves <NUM>, <NUM> advantageously seal the inlet and outlet <NUM>, <NUM> preventing the wetting fluid <NUM> from leaking from the wetting chamber <NUM>. The valves <NUM>, <NUM> further allow for the passage of the catheter tube <NUM> through the wetting chamber <NUM>. Specifically, the inlet valve <NUM> is configured to allow the catheter tube <NUM> to be moved therethrough to introduce the catheter tube <NUM> into the wetting chamber <NUM> of the housing <NUM>. Similarly, the outlet valve <NUM> is configured to allow the catheter tube <NUM> to be moved therethrough to expose the catheter tube <NUM> for subsequent use/insertion by the user.

As with the other embodiments described hereinabove, once the tip end <NUM> of the catheter tube <NUM> is moved out through the outlet <NUM> of the housing <NUM>, the tip end <NUM> then becomes exposed for insertion by the user, and the housing <NUM> then acts as a gripping element for the user to direct the catheter tube <NUM>, in use. The user may then advantageously use the housing <NUM> to easily direct the exposed tip end <NUM> of the catheter tube <NUM> without contacting the tube <NUM> directly.

In a variant, the wetting applicator (where present) may comprise a wicking material. The wicking material may be configured to provide a wicking action between the holding chamber (e.g. holding chambers <NUM>, <NUM>, <NUM>, <NUM>) and the wetting chamber (e.g. wetting chambers <NUM>, <NUM>, <NUM>, <NUM>), enabling the transfer of the fluid from the holding chamber into the wetting chamber for subsequent application to the catheter tube. This is enabled in the illustrated embodiments, for example, by having the wetting fluid <NUM>, <NUM>, <NUM>, <NUM> in contact with the wetting applicator, or indeed by releasing the wetting fluid onto and in contact with the wetting applicator - e.g. through use of a fluid release control component.

In a further variant, the wetting applicator (where present) may comprise a baffle arrangement which defines a plurality of subregions of the wetting applicator each configured to hold a portion of the fluid held within the wetting applicator. For example, the baffle arrangement may define a plurality of subregions within the housing <NUM>, <NUM>, <NUM>, <NUM>, <NUM> e.g. within the wetting chamber <NUM>, <NUM>, <NUM>, <NUM> of the housing <NUM>, <NUM>, <NUM>, <NUM>, <NUM> in which the fluid may reside and or be released into, e.g. from the holding chamber <NUM>, <NUM>, <NUM>, <NUM>.

Claim 1:
A male urinary catheter (<NUM>, <NUM>), comprising:
a catheter tube (<NUM>, <NUM>) having a tip end (<NUM>, <NUM>, <NUM>) and a distal end (<NUM>, <NUM>); and
a wetting mechanism (<NUM>, <NUM>', <NUM>, <NUM>, <NUM>, <NUM>) operably coupled at or proximal to the tip end of the catheter tube for wetting the catheter tube, in use,
the wetting mechanism comprising:
a housing (<NUM>, <NUM>', <NUM>, <NUM>, <NUM>, <NUM>) forming a gripping element for the catheter, the housing being configured to be positioned initially at or proximal to the tip end of the catheter tube;
wherein the housing comprises a wetting chamber (<NUM>, <NUM>', <NUM>, <NUM>, <NUM>) into which at least a portion of the catheter tube is able to be introduced and be moved therethrough to move at least a portion of the catheter tube through the wetting chamber, in use; and
wherein the wetting mechanism comprises a wetting applicator positioned within the wetting chamber configured to hold fluid therein and release said fluid to wet the catheter tube upon movement of the tube through the wetting chamber,
wherein the wetting applicator comprises a baffle arrangement, and
wherein the catheter tube comprises, is integrated with, or is coated with a hydrophilic component.