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. However, 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.

<CIT> discloses a catheter that is movable between un-expanded configuration and an expanded configuration by use of an advancing mechanism. The advancing mechanism facilitates safe and non-contaminated use of the catheter.

<CIT> discloses a catheter disinfection device, the device comprises a liquid chamber holding disinfectant and a cone chamber for delivering the disinfectant to the tip end of a catheter. A push button is used to drive disinfectant from the liquid chamber onto the catheter.

<CIT> discloses a ready to use catheter assembly comprising a tubular body filled with a therapeutic liquid and a urinary catheter having a piston slidably installed in the tubular body. This ensures catheterisation is accompanied by automatic injection of the therapeutic liquid into the body.

<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.

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

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.

The invention provides a wetting mechanism for a catheter according to claim <NUM>.

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 the prior art, 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. Further, controlling the release of the wetting fluid into a wetting chamber through which the catheter tube may be moved through provides greater control over the application of the wetting fluid to the external surface of the catheter tube. This may ensure the whole surface of the catheter tube is adequately wetted prior to use by the user.

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

The fluid release control component comprises a first configuration wherein it prevents release of the fluid from the holding chamber to the wetting chamber. The fluid release control component comprises a second configuration wherein it allows release of the fluid from the holding chamber to the wetting chamber. The fluid release control component may be moveable between the first and second configurations. For example, in some embodiments the fluid release control component may be linearly moveable between the first and second configurations. In other embodiments the fluid release control component may be operable to rotate between first and second configurations for controlling the flow of fluid from the holding chamber to the wetting chamber.

In some embodiments the fluid release control component comprises a plug. The plug may be linearly moveable within the wetting mechanism between first and second positions. The plug may be rotatable between first and second angular positions. For example, the plug may be threaded, and may be provided within the wetting mechanism through interaction with a complementary threaded surface of the wetting mechanism. The first and second (optionally angular) positions of the plug may correspond to first and second configurations of the fluid release control component.

One particularly preferred embodiment provides a wetting mechanism according to claim <NUM> wherein the fluid release control component comprises a plug which is linearly moveable within the wetting mechanism between first and second positions corresponding to first and second configurations of the fluid release control component.

In embodiments, the plug may be configured to be at least partly withdrawn from the wetting mechanism. The plug may, at least initially be positioned within the wetting chamber of the wetting mechanism. In such embodiments, the plug may be configured to be at least partly withdrawn from the wetting chamber to cause release of the fluid from the holding chamber into the wetting chamber. 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 further embodiments, the plug may be configured such that it can be fully withdrawn from the wetting mechanism. For example, in some embodiments the plug may initially be positioned within the wetting chamber and may be fully withdrawn from the wetting chamber, in use, to cause release of the fluid from the holding chamber to the wetting chamber.

Another particularly preferred embodiment provides a wetting mechanism according to claim <NUM> wherein the fluid release control component comprises a plug which is linearly moveable within the wetting mechanism between first and second positions corresponding to first and second configurations of the fluid release control component; wherein the plug is configured to be at least partly withdrawn from the wetting mechanism to cause release of fluid from the holding chamber into the wetting chamber.

Another particularly preferred embodiment provides a wetting mechanism according to claim <NUM> wherein the fluid release control component comprises a plug which is linearly moveable within the wetting mechanism between first and second positions corresponding to first and second configurations of the fluid release control component; wherein the plug is, at least initially, positioned within the wetting chamber of the wetting mechanism and is configured to be at least partly withdrawn from the wetting chamber to cause release of the fluid from the holding chamber into the wetting chamber.

Another particularly preferred embodiment provides a wetting mechanism according to claim <NUM> wherein the fluid release control component comprises a plug which is linearly moveable within the wetting mechanism between first and second positions corresponding to first and second configurations of the fluid release control component; wherein the plug is, at least initially, positioned within the wetting chamber of the wetting mechanism and is configured to be at least partly withdrawn from the wetting chamber to cause release of the fluid from the holding chamber into the wetting chamber; and wherein the plug is configured such that it cannot be fully withdrawn from the wetting mechanism.

The wetting mechanism may be configured such that, in use, at least partly withdrawing the plug from the wetting mechanism causes the opening of one or more fluid outlets in the holding chamber. The one or more fluid outlets may provide a fluid communication between the holding chamber and the wetting chamber such that, in use, opening of said fluid outlet(s) may allow fluid to be released from within the holding chamber into the wetting chamber.

The wetting mechanism may be configured to retain the plug in the first and/or second position.

For example, in some embodiments the wetting mechanism may be configured to retain the plug in the first position, preventing release of the fluid from the holding chamber, unless positively acted on by a user. Advantageously, this may prevent or at least reduce the likelihood of fluid being release from the holding chamber and/or the catheter tube being exposed prematurely. This may ensure that the catheter tube is wetted at or as close as possible to the point of use to ensure the surface of the catheter tube is fully wetted. In such embodiments, the plug may be biased to the first position, and the user may be required to act against said bias to move the plug to the second position. At least a portion of the plug may abut a further component of the wetting mechanism, e.g. a lip, projection or the like from a surface of the housing preventing movement of the plug from the first position unless acted on by a user. The abutment may be provided between a frangible portion on the plug and/or on the housing configured to break upon application of a force by the user. For example, the abutment between the plug and the further component may be configured such that application of a force (e.g. the user pulling the plug away from the housing), may be sufficient to overcome said abutment, allowing the plug to be moved to the second position. The plug may "snap" or "click" in overcoming said abutment to provide tactile and/or audible feedback for the user.

In embodiments, the wetting mechanism may be configured to retain the plug in the second position, preventing the plug being returned to the first position. Advantageously, once activated, the wetting mechanism may be configured to be retained in a "used" configuration, ensuring that the catheter and wetting mechanism cannot be returned to a configuration which appears as though it has not been used - i.e. a configuration which suggests that the wetting mechanism may still be operable to wet the catheter tube (which may not be the case). This may prevent or at least reduce the likelihood of the user re-using the catheter (either mistakenly or intentionally). In such embodiments, the wetting mechanism may be configured such that, in the second configuration at least a portion of the plug is provided in an abutting relationship with a further component of the wetting mechanism (e.g. the housing) preventing further movement of the plug.

The fluid release control component comprises a container. The container is positioned within the holding chamber. The container houses the fluid. The container may comprise one of a sachet, blister pack, or capsule, for example.

The first configuration of the fluid release control component corresponds to a configuration wherein the container is intact, having the fluid contained therein. The second configuration of the fluid release control component corresponds to a configuration wherein the container has ruptured or has otherwise been opened to release fluid therefrom.

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 tip end of the catheter tube may, at least initially, be disposed outside the wetting chamber. In such embodiments, the wetting mechanism may be configured such that the tip end of the catheter tube is able to be introduced into the wetting chamber and moved therethrough, in-use. For example, the wetting chamber may comprise an inlet through which the catheter tube is able to be introduced into the wetting chamber. In some embodiments the wetting chamber may comprise an outlet through which the catheter tube is able to exit the wetting chamber.

In some embodiments the wetting mechanism may be configured such that fluid released into the wetting chamber from the holding chamber is retained therein for wetting the catheter tube as it is moved therethrough, in use. For example, in some embodiments the wetting mechanism may comprise a valve arrangement. The valve arrangement may be provided at the inlet and/or outlet of the wetting chamber in order to retain fluid contained therein. The valve arrangement may be configured such that the catheter may be moved therethrough, in use.

In some embodiments the wetting mechanism is configured to be coupled to a sleeve. The wetting mechanism may be configured to be coupled to a sleeve which in turn is able to couple the wetting mechanism to a funnel, e.g. a funnel provided at or integrally formed with the distal end of the catheter tube. The wetting mechanism may be configured such that fluid released into the wetting chamber is able to flow into and along the sleeve to wet the catheter tube. For example, the wetting chamber may include an opening therein allowing fluid within the wetting chamber to flow into and along a coupled sleeve. The opening may be the inlet for the catheter tube.

In some embodiments the fluid release control component may be configured to prevent insertion of the catheter tube into and/or through the wetting chamber. For example, in some embodiments the fluid release control component may be configured to prevent insertion of the catheter tube into and/or through the wetting chamber in the first configuration - i.e. before the fluid is released from the holding chamber to the wetting chamber. Advantageously, preventing the catheter tube from being prematurely inserted and/or moved through the wetting chamber may ensure that the catheter tube is unable to be used without application of the wetting fluid. To achieve this, the fluid release control component may be configured to at least partially block an inlet for the catheter tube when in the first configuration. For example, in some embodiments a portion of the fluid release control component may be at least partially received within the inlet for the catheter tube, preventing insertion of the catheter tube into the wetting chamber. The portion of the fluid release control component may comprise a flexible, compressible and/or resilient material which may be compressed within the inlet for the catheter tube with the fluid release control component in the first configuration.

The fluid release control component may be configured such that switching (e.g. moving) the fluid release control component to a second configuration may allow insertion of the catheter tube into and/or through the wetting chamber in the second configuration. In other words, switching/moving the fluid release control component to the second configuration may both act to release fluid from within the holding chamber and remove any block on the catheter tube being inserted and/or moved through the wetting chamber.

In some embodiments the wetting mechanism comprises a wetting applicator. The wetting applicator may be positioned within the wetting chamber. The wetting applicator may be configured to hold fluid released into the wetting chamber from the holding chamber. The wetting applicator may be configured to control application of the fluid to the catheter tube, in use, as the catheter tube is moved through the wetting chamber.

One particularly preferred embodiment provides a wetting mechanism according to claim <NUM> and comprising a wetting applicator positioned within the wetting chamber configured to hold fluid released into the wetting chamber from the holding chamber.

Another particularly preferred embodiment provides a wetting mechanism according to claim <NUM> and comprising a wetting applicator positioned within the wetting chamber configured to hold fluid released into the wetting chamber from the holding chamber, wherein the wetting applicator is configured to control application of the fluid to the catheter tube, in use, as the catheter tube is moved through the wetting chamber.

The wetting applicator may comprise an absorbent material. For example, in some embodiments the wetting applicator comprises a sponge, foam or wicking material, operable to absorb the wetting fluid, in use. In further embodiments, the wetting applicator may comprise 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.

The wetting applicator may define a channel within the wetting chamber. 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.

Another particularly preferred embodiment provides a wetting mechanism according to claim <NUM> and comprising a wetting applicator positioned within the wetting chamber configured to hold fluid released into the wetting chamber from the holding chamber, wherein the wetting applicator is configured to control application of the fluid to the catheter tube, in use, as the catheter tube is moved through the wetting chamber; wherein the wetting applicator defines a channel within the wetting chamber through which the catheter tube is able to be moved through, in use, and the wetting applicator is configured such that fluid held within the wetting applicator is able to be released therefrom upon movement of the catheter tube through said channel.

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.

In embodiments, the housing may form a gripping element of the catheter. In use, the 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. A conical profile may be advantageous where there housing forms a gripping element of the catheter.

In embodiments wherein the fluid release control component comprises 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.

According to an aspect of the invention there is provided a catheter, comprising: a catheter tube having a tip end and a distal end; and the wetting mechanism of claim <NUM> operably coupled at or proximal to the tip end of the catheter tube for wetting the catheter tube, in use.

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.

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 at a second, opposing end 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.

The catheter may be configured such that fluid released 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 urinary catheter. The catheter may comprise a female urinary catheter, but is preferably a male urinary catheter. 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 would be 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. Accordingly, the invention is particularly suited to male catheters.

The catheter tube may comprise, may be integrated with, or may be coated with a hydrophilic component. The hydrophilic component may be 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 the preceding aspect of the invention, 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 of the invention there is provided a method for wetting a tube of a catheter using the wetting mechanism of any aspect described herein, the method comprising: operating the fluid release control component to cause the release of fluid from the holding chamber into the wetting chamber; and introducing the tip end of the catheter tube into the wetting chamber and moving it therethrough, thereby wetting the at least a portion of an outer surface of the catheter tube.

Operating the fluid release control component may comprise moving the fluid release control component from a first configuration wherein it prevents release of the fluid from the holding chamber to the wetting chamber to a second configuration wherein it allows release of the fluid from the holding chamber to the wetting chamber.

In some embodiments the fluid release control component comprises a plug and method may comprise at least partly withdrawing the plug from the wetting mechanism to operate the fluid release control component. The method may comprise at least partly withdrawing the plug from the wetting chamber to cause release of the fluid from the holding chamber into the wetting chamber. The method may comprise fully withdrawing the plug from the wetting mechanism to cause release of the fluid from the holding chamber to the wetting chamber.

The fluid release control component comprises a container, such as a sachet, blister pack or capsule, for example, and the method comprises rupturing or opening the container to release fluid therefrom. The method may comprise compressing, bending and/or flexing the housing to rupture or otherwise open the container.

In further embodiments, the wetting mechanism may comprise a fluid release control component in the form of a plug, in combination with the container, and the method may comprise at least partly withdrawing the plug from the wetting mechanism to rupture or otherwise open the container. For example, the method may comprise compressing the container within the holding chamber upon at least partial withdrawal of the plug from the wetting mechanism.

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 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> which serves 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.

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 a holding chamber <NUM> which contains a volume of fluid <NUM> therein for wetting the catheter tube <NUM>. In use, and as is described herein, the fluid <NUM> may be released from said holding chamber <NUM> into a wetting chamber <NUM> of the housing through an opening <NUM> within the housing <NUM>. The wetting chamber <NUM> defines a separate tubular portion of the housing <NUM> through which at least a portion of the catheter tube <NUM> is able to be introduced and be moved therethrough. Accordingly, by releasing the fluid <NUM> into the wetting chamber <NUM>, and subsequently moving the catheter tube <NUM> through the wetting chamber <NUM>, an outer surface of the catheter tube <NUM> may be wetted using the fluid <NUM>.

The wetting mechanism <NUM> 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>. In the illustrated embodiment, the plug <NUM> is substantially cylindrical and defines an outlet <NUM> of the housing <NUM> through which, in use, the catheter tube <NUM> can be moved, although other profiles are equally applicable. As shown in <FIG>, the plug <NUM> is initially located within the wetting chamber <NUM> with a portion of the plug <NUM> blocking opening <NUM>. This is herein referred to as a first position or first configuration of the plug <NUM>, corresponding to a position wherein the fluid <NUM> is prevented from being released from the wetting chamber <NUM>. A lip <NUM> is provided at an end of the plug <NUM> which defines an interaction point for the user, specifically for the user to grip the lip <NUM> to provide leverage for moving the plug <NUM>.

<FIG> illustrate the operational use of the wetting mechanism <NUM> in a horizontal orientation. As set out above, initially the wetting mechanism <NUM> is provided in the first configuration 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>. Spillage (or at least major spillage) of fluid through the outlet <NUM> of the housing <NUM> is prevented due to the relatively small volume of wetting fluid <NUM> provided (approximatley <NUM>), and the surface tension of the fluid <NUM> itself. 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 through the wetting chamber <NUM>, bringing the catheter tube <NUM> into contact with the wetting fluid <NUM> and hence 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.

<FIG> illustrate a further operational use of the wetting mechanism <NUM> shown in the preceding figures. Specifically, starting at <FIG>, the housing <NUM> is held in a vertical orientation with the plug <NUM> in a first position preventing release of the wetting fluid <NUM> from the holding chamber <NUM>. The plug <NUM> is then pulled out from the wetting chamber <NUM> in the same manner as discussed above to unblock opening <NUM> and thereby release the wetting fluid <NUM> (<FIG>). With the housing <NUM> held in this orientation, the wetting fluid <NUM> is released into the wetting chamber <NUM> and subsequently into the sleeve <NUM> and about the exterior surface of the catheter tube <NUM>. In this way, the wetting fluid <NUM> is allowed to run along the sleeve <NUM>, thereby wetting the catheter tube <NUM>. The catheter tube <NUM> may then be moved through the wetting chamber <NUM> and past the lip <NUM> in the plug <NUM> to 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, as it is expelled through the housing <NUM> and introduced into the urethra.

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 the preceding Figures. Wetting mechanism <NUM>' differs in that it additionally includes a wetting applicator in the form of a foam conduit <NUM>'positioned within the wetting chamber <NUM>'. As is discussed in detail herein, the foam conduit is configured to hold fluid released into the wetting chamber <NUM>' 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 wetting chamber <NUM>'.

Wetting mechanism <NUM>' functions in essentially the same way as wetting mechanism <NUM>, with a fluid release control component provided in the form of a plug <NUM>' movable between two positions to control release of the wetting fluid <NUM>' from the holding chamber <NUM>'. Here, upon movement of the plug <NUM>' to the second position, thereby unlocking the opening <NUM>', the fluid <NUM>'contained within the holding chamber <NUM>' is released onto the foam conduit <NUM>'. The foam conduit <NUM>' stores the fluid <NUM>' released onto it for subsequent application to the catheter tube <NUM>. Specifically, the foam conduit <NUM>' defines a channel within the wetting chamber <NUM>' through which the catheter tube <NUM> is able to move through and be brought into contact with the foam conduit <NUM>'. The foam conduit <NUM>' is configured such that fluid held therein is released upon movement of the catheter tube <NUM> through the defined channel by virtue of the catheter tube <NUM> coming into contact with the foam conduit <NUM>' and applying a pressure thereto. A wetting applicator of this type may advantageously ensure that the wetting fluid <NUM>' is applied evenly across the outer surface of the catheter tube <NUM>, and reduce the prospect of any spillage.

<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 mechanism <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> 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 the fluid release control component in this embodiment is provided in the form of a plug <NUM> which must be fully removed from the chamber <NUM> in order to release the fluid <NUM> and allow the catheter tube <NUM> to be moved through the housing <NUM>. Specifically, the plug <NUM> is initially provided in the position shown in <FIG>, with the plug <NUM> provided almost entirely within the wetting chamber <NUM> of the housing <NUM>. In this position, the opening <NUM> in the housing <NUM> is blocked preventing the release of the fluid <NUM> from the holding chamber <NUM>. This is referred to herein as a first position or first configuration of the plug <NUM>. In use, the plug <NUM> is removed from the wetting chamber <NUM> to release the fluid <NUM> into the wetting chamber <NUM>. This is performed by a user gripping and interaction region <NUM> on the plug <NUM> and pulling the plug <NUM> from the wetting chamber <NUM> (as shown in <FIG>). Removal of the plug <NUM> opens an outlet <NUM> in the housing <NUM> through which the catheter tube <NUM> may be exposed, in use. As with wetting mechanism <NUM>, catheter tube <NUM> may then be moved through the wetting chamber <NUM> through the outlet <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.

As with wetting mechanisms <NUM> and <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 openings <NUM> within the housing <NUM>. The wetting chamber <NUM> again defines a separate portion of the housing <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 the fluid release control component in this embodiment is provided in the form of a plug 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>. Specifically, 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> through openings <NUM> provided within the housing <NUM>. As with wetting mechanisms <NUM>, <NUM>, the catheter tube <NUM> may then be moved through the wetting chamber <NUM> through an outlet <NUM> at a distal end of the housing <NUM> to both wet the outer surface of the catheter tube <NUM> 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.

A variant of wetting mechanism <NUM> is shown in <FIG>. Wetting mechanism <NUM>' differs in that it additionally includes a wetting applicator in the form of a foam conduit <NUM>'. As with foam conduit <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>'. Wetting mechanism <NUM>' functions in essentially the same way as wetting mechanism <NUM>, with a fluid release control component provided in the form of a rupturable sachet <NUM>' controlling the release of the wetting fluid <NUM>'. In use, rupturing the sachet <NUM>' causes the fluid <NUM>' contained therein to be released onto the foam conduit <NUM>' which stores the fluid <NUM>' for subsequent application to the catheter tube <NUM>. Here, the sachet <NUM>' defines the holding chamber <NUM>' with the foam conduit <NUM>' defining the wetting chamber <NUM>' through which the catheter tube <NUM> may be moved, in use.

<FIG> illustrate further embodiments 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, any of the embodiments of <FIG> or <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 the other embodiments described herein, by releasing the fluid into the wetting chamber, and subsequently moving the catheter tube <NUM> through the wetting chamber, 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.

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.

In a variant, the fluid release control component (e.g. the plug <NUM>, <NUM>, <NUM>) may alternatively be rotatable between first and second positions/configurations to control the release of the wetting fluid. For example, rotation of the plug <NUM>, <NUM>, <NUM> (rather than linear movement) may align an opening in the plug to unblock an opening <NUM>, <NUM> or valve in the housing <NUM>, <NUM>, <NUM> allowing for the release of the wetting fluid.

In a variant, the wetting mechanism (e.g. mechanism <NUM>) may be configured to retain the plug <NUM> in the first and/or second position. For example, the wetting mechanism <NUM> may be configured to retain the plug <NUM> in the first position, preventing release of the fluid from the holding chamber <NUM> unless positively acted on by a user. This may be provided, for example, in the form of an abutment between a frangible portion on the plug <NUM> and/or on the housing <NUM> configured to break upon application of a force by the user. In this way, the plug <NUM> may "snap" or "click" in overcoming said abutment to provide tactile and/or audible feedback for the user. The wetting mechanism <NUM> may be configured such that, in the second position at least a portion of the plug <NUM> is provided in an abutting relationship with a further component of the wetting mechanism (e.g. the housing <NUM>) preventing further movement of the plug <NUM> and thereby preventing the plug <NUM> being returned to the first position.

In a variant, the wetting mechanism <NUM>, <NUM>', <NUM>, <NUM>, <NUM> of the invention may include both a plug (e.g. plug <NUM>) and rupturable container (e.g. sachet <NUM>). Here, the wetting mechanism may be configured such that the container may be ruptured through compression on the container upon (at least partial) withdrawal of the plug, or upon rotation of the plug.

In a variant, the housing (e.g. housing <NUM>) may include a valve arrangement or the like preventing the wetting fluid from being released from the housing. For example, the housing can include a valve arrangement at an inlet and/or an outlet. The valve arrangement may be configured to allow the catheter tube <NUM>, <NUM> to be moved therethrough.

In a variant, the fluid release control component (e.g. the plug <NUM>, <NUM>, <NUM> can be configured to prevent insertion of the catheter tube into and/or through the wetting chamber when in the first position - i.e. before the fluid is released from the holding chamber to the wetting chamber. This may, for example, involve the fluid release control component at least partially blocking an inlet for the catheter tube <NUM>, <NUM>.

In a variant, the wetting applicator can comprise a sponge or wicking material, operable to absorb the wetting fluid, in use, or may comprise a baffle arrangement.

Claim 1:
A wetting mechanism (<NUM>, <NUM>', <NUM>, <NUM>, <NUM>', <NUM>) for wetting a tube (<NUM>, <NUM>) of a catheter (<NUM>, <NUM>), the wetting mechanism comprising:
a housing (<NUM>, <NUM>', <NUM>, <NUM>, <NUM>', <NUM>) configured to be positioned initially at or proximal to the tip end (<NUM>, <NUM>) of the catheter tube, and wherein the housing comprises:
a holding chamber (<NUM>, <NUM>', <NUM>, <NUM>, <NUM>') for containing a volume of fluid (<NUM>, <NUM>', <NUM>, <NUM>, <NUM>') therein; and
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 fluid release control component for controlling release of the fluid from the holding chamber to the wetting chamber,
wherein the fluid release control component comprises a container of fluid positioned within the holding chamber,
wherein the fluid release control component comprises a first configuration wherein it prevents release of the fluid from the holding chamber to the wetting chamber and the container is intact, having the fluid contained therein,
wherein the fluid release control component comprises a second configuration wherein it allows release of the fluid from the holding chamber to the wetting chamber and the container has ruptured or has otherwise been opened to release fluid therefrom.