Wetting mechanism for a catheter

Abstract

The present invention relates to a wetting mechanism 20 for wetting a tube body 12 of a catheter 10. The wetting mechanism 20 includes a housing 16 positioned at or near a distal end 13 of the catheter tube body 12. The housing 16 includes a wetting chamber 23 into which at least a portion of the catheter tube body 12 can be introduced and moved through in use to wet the catheter tube body 12. The wetting mechanism 20 includes a wetting applicator 40 located within the wetting chamber 23, the wetting applicator being configured to hold a fluid therein and release the fluid to wet the catheter tube body 12 as the tube body 12 moves through the wetting chamber 23.

Description

Technical Field

[0001] The present invention relates to a wetting mechanism for a catheter (such as a urinary catheter), which is used to wet the body of the catheter during use. The present invention extends to a catheter including the wetting mechanism and a method for wetting the body of the catheter. Background Art

[0002] A catheter is a medical device that includes a hollow tube designed to be inserted into a duct, blood vessel, passage, or body cavity to allow injection of a fluid or substance, drainage or extraction of a fluid or substance therefrom, or to ensure that the duct, blood vessel, passage, etc. remains open. A urinary catheter is designed to be inserted through the urethra into a user's bladder for drainage from the bladder.

[0003] To maximize comfort and minimize the risk of trauma and / or infection, the outer surface of the catheter is typically wetted with a wetting fluid before insertion by the user. In a further development, the body of the catheter itself includes, incorporates, or is coated with a hydrophilic component (such as a hydrophilic polymer) that is used to further reduce friction after the application of the wetting fluid.

[0004] Some catheters can be pre-wetted in the package, for example, where the catheter is at least partially immersed in the wetting fluid within the package. Although this ensures that the body of the catheter is adequately wetted before use, a disadvantage of this arrangement is that components of the catheter other than the body of the catheter, such as the gripping element or the funnel-shaped member, may also become wet. This has an adverse effect on the user experience, in which case it may become difficult to hold and guide the body of the catheter as required. This is particularly problematic when the user performs self-catheterization. In addition, immersing the catheter significantly reduces the shelf life of the catheter due to the long-term exposure of its components to moisture.

[0005] Therefore, it is advantageous to provide a catheter that can be wetted during or just prior to use.

[0006] In an attempt to solve this problem, some catheters are provided in a package that includes a breakable container or bag within the package that the user can rupture to release the wetting fluid. Typically, this involves the user squeezing the package to rupture the container / bag. However, this arrangement encounters similar problems to those discussed above, where the wetting fluid is allowed to contact other components of the catheter. This arrangement may also result in the body of the catheter not being adequately / fully wetted before use, or not being wetted at all in practice. This can be harmful to the user.

[0007] Therefore, it is advantageous to provide such a catheter that includes a mechanism for supplying the wetting fluid only to the body of the catheter to improve the user experience.

[0008] In a further prior art solution, the catheter can be packaged within a package that includes a wetting device. In use, when the catheter is removed from the package, the catheter can be moved through the wetting device and, in so doing, wets the catheter. An example of such a catheter is shown in PCT application PCT / IB2018 / 001539 of Convatec Limited.

[0009] However, due to the limitations of the package, the amount of wetting fluid that can be accommodated within such a wetting device is small, and thus there remains a possibility that the catheter cannot be fully wetted in such a solution, particularly where the catheter is a male urinary catheter that may be up to and possibly in excess of 35 cm in length.

[0010] For a mechanism that wets the catheter body from the distal end, an insufficient volume of wetting fluid may result in the tip not being wetted at all, which is undesirable since the tip will be introduced into the urethra first and thus is most likely to cause injury if inadequately wetted prior to use. Additionally, if a configuration is used in which the catheter body is wetted by pulling the catheter body through the wetting device from the distal end of the body and thereby exposing the length of the catheter body, a male user may find it very difficult, if not impossible, to correctly manipulate and position the long, flexible catheter body without touching the body itself, thereby presenting a risk of contamination.

[0011] If a configuration is used in which the catheter body is pushed out of the package and thus through the wetting device (e.g., using the plunger device shown in FIGS. 23 - 26 of PCT / IB2018 / 001539), then for the user, the length and flexibility of the male catheter body will make this action difficult, if not impossible, since the body may simply bend along its length rather than being pushed through the wetting device. Additionally, the package itself must be of a relatively large size, potentially twice the length of a typical male catheter body, e.g., 30 - 40 cm, in order to accommodate both the male catheter body and a plunger that will need to have a length approximately equal to that of the catheter body. Thus, this type of mechanism is generally only suitable for female catheters, where the catheter is much shorter in length and thus stiffer and easier to manipulate and insert while only holding the distal end (opposite the tip of the catheter).

[0012] Accordingly, it is advantageous to provide a system that reduces the likelihood of using a male catheter body before or without adequate lubrication.

[0013] An object of one or more embodiments of the present invention is to overcome or at least partially mitigate one or more problems of the prior art. Summary of the Invention

[0014] According to one aspect of the present invention, there is provided a wetting mechanism for wetting the body of a catheter. The wetting mechanism includes a housing configured to be initially positioned at or near the distal end of the catheter body. The housing includes a wetting chamber. In use, at least a portion of the catheter body can be introduced into the wetting chamber and move through the wetting chamber such that at least a portion of the catheter body moves through the wetting chamber. And the wetting mechanism includes a wetting applicator located within the wetting chamber. The wetting applicator is configured to control the release of fluid onto the catheter body to wet the catheter body in use.

[0015] According to one aspect of the present invention, there is provided a wetting mechanism for wetting the body of a male urinary catheter. The wetting mechanism includes: a housing forming a gripping element for the catheter, the housing being configured to be initially positioned at or near the distal end of the catheter body; the housing includes a wetting chamber. In use, at least a portion of the catheter body can be introduced into the wetting chamber and move through the wetting chamber such that at least a portion of the catheter body moves through the wetting chamber. And the wetting mechanism includes a wetting applicator located within the wetting chamber. The wetting applicator is configured to hold fluid therein and release the fluid to wet the catheter body as the body moves through the wetting chamber.

[0016] Advantageously, the wetting mechanism of the present invention has a wetting applicator provided at or near the distal end of the catheter body. This ensures that the catheter body is wetted from the distal end (i.e., the end that is first introduced into the urethra in use), thereby reducing the likelihood of harm to the user due to the catheter body not being sufficiently wetted. In addition, the wetting applicator is advantageously used to control the amount of fluid applied across the surface of the catheter body, with the aim of obtaining a substantially uniform coating of wetting fluid. Having the wetting mechanism at or near the distal end and requiring the catheter body to move through it prior to use can advantageously wet the catheter body regardless of the orientation of the catheter and the wetting mechanism. In this way, the user can be confident that the body will be sufficiently wetted at any angle.

[0017] The housing can advantageously form a separate and movable (e.g., relative to the catheter body and / or other components of the catheter - e.g., the funnel-shaped member) component of the catheter, which acts as a gripping element both during use while wetting the catheter body and during manipulating the catheter while positioning the catheter body and subsequently inserting the catheter body into the urethra. Configuring the wetting mechanism as part of the gripping element of the catheter improves the usability of the catheter in terms of wetting action and ultimate use. For example, the gripping element can move relative to the catheter body, i.e., along the body, to move the body through the wetting chamber (thereby wetting the body and exposing the tip of the catheter body), rather than as in prior art solutions where the catheter body may need to be pushed or pulled through the wetting device, thus alleviating problems caused by the length of the catheter body of a male catheter. In addition, the gripping element can be used to hold the catheter body near the urethra to assist the user in guiding the catheter body without having to contact the body itself, thus alleviating potential contamination problems.

[0018] The optional features set out below can be suitably applied to any aspect of the present invention.

[0019] The housing can include a reservoir chamber. A certain volume of wetting fluid can be contained in the reservoir chamber. The wetting chamber can be fluidly connected or can be fluidly connectable to the reservoir chamber. Fluidly connecting (or at least being connectable) the wetting chamber to the reservoir chamber containing the wetting fluid ensures that, in use, for example, as the fluid held within the wetting applicator is released onto the catheter body, it is automatically / easily "replenished" by the fluid from the reservoir chamber. This can ensure that there is sufficient fluid to coat the entire length of the catheter body, which, in the case of a male urinary catheter, can be up to 35 cm and may also be greater than 35 cm.

[0020] The wetting applicator can include a flexible, compressible, and / or elastic material. The wetting applicator can deform when a force is applied to it, e.g., when the catheter body moves through the wetting chamber. The deformation of the wetting applicator may cause the fluid held therein to be released. Thus, in use, the catheter body moving through the wetting chamber, for example, by contacting the wetting applicator and deforming the wetting applicator, can cause the fluid to be automatically released from the wetting applicator onto the surface of the catheter body. [[ID=X]]

[0021] The wetting applicator can include absorbent material. For example, in some embodiments, the wetting applicator includes a sponge or foam material that can operate to absorb fluid in use. In embodiments where the housing includes a reservoir chamber, the absorbent material can be disposed between the reservoir chamber and the wetting chamber, or can, for example, at least partially define the wetting chamber, and in use, operably absorb fluid from the reservoir chamber for subsequent application to the catheter body when the catheter body moves through the wetting chamber.

[0022] The wetting applicator may comprise a plastic material such as polyethylene or polyurethane. The foam or sponge material may comprise an open-cell material, which may comprise, for example, an open-cell hydrophilic foam material. When exposed to a fluid, the foam or sponge material may not expand, or at least substantially not expand. Advantageously, the size of the non-expanding material may remain substantially constant during use, which may be particularly advantageous for use within the housing of the wetting mechanism of the present invention.

[0023] The wetting applicator may comprise a wicking material. The wicking material may be operable in use to draw fluid therethrough for application to the catheter body. In embodiments where the housing comprises a reservoir chamber, the wicking material may be disposed between the reservoir chamber and the wetting chamber, or may, for example, at least partially define the wetting chamber, and in use, when the catheter body is moved through the wetting chamber, the wicking material is operable to draw fluid from the reservoir chamber for application to the catheter body. The wicking material may comprise, for example, polyester or nylon.

[0024] The wetting applicator may comprise baffle means. The baffle means may define a plurality of sub-regions of the wetting applicator, each sub-region being configured to hold a portion of the fluid held within the wetting applicator. For example, the baffle means may define a plurality of sub-regions within the housing, such as within the wetting chamber of the housing, where fluid may reside and / or be released into the wetting chamber. The baffle means may at least partially define the reservoir chamber of the housing.

[0025] A particularly preferred embodiment provides a wetting mechanism for wetting the body of a male urinary catheter, the wetting mechanism comprising: a housing forming a gripping element for the catheter, the housing being configured to be initially positioned at or near the distal end of the catheter body; wherein the housing comprises a wetting chamber, in use, at least a portion of the catheter body being capable of being introduced into and moved through the wetting chamber such that at least a portion of the catheter body is moved through the wetting chamber; and herein, the wetting mechanism comprises a wetting applicator located within the wetting chamber, the wetting applicator being configured to hold fluid therein and release the fluid to wet the catheter body as the body is moved through the wetting chamber; wherein the wetting applicator comprises baffle means.

[0026] Another particularly preferred embodiment provides a wetting mechanism for wetting the tube body of a male urinary catheter. The wetting mechanism includes: a housing forming a gripping element for the catheter, the housing being configured to be initially positioned at or near the distal end of the catheter tube body; wherein the housing includes a wetting chamber, and in use, at least a portion of the catheter tube body can be introduced into the wetting chamber and can move through the wetting chamber, so that at least a portion of the catheter tube body moves through the wetting chamber; and herein, the wetting mechanism includes a wetting applicator located within the wetting chamber, the wetting applicator being configured to hold a fluid therein and release the fluid to wet the catheter tube body when the tube body moves through the wetting chamber; wherein the wetting applicator includes baffle means that define a plurality of sub-regions of the wetting applicator, each sub-region being configured to hold a portion of the fluid held within the wetting applicator.

[0027] Another particularly preferred embodiment provides a wetting mechanism for wetting the tube body of a male urinary catheter. The wetting mechanism includes: a housing forming a gripping element for the catheter, the housing being configured to be initially positioned at or near the distal end of the catheter tube body; wherein the housing includes a wetting chamber, and in use, at least a portion of the catheter tube body can be introduced into the wetting chamber and can move through the wetting chamber, so that at least a portion of the catheter tube body moves through the wetting chamber; and herein, the wetting mechanism includes a wetting applicator located within the wetting chamber, the wetting applicator being configured to hold a fluid therein and release the fluid to wet the catheter tube body when the tube body moves through the wetting chamber; wherein the wetting applicator includes baffle means that define a plurality of sub-regions within the wetting chamber, and the fluid can reside in and / or be released into the plurality of sub-regions.

[0028] The wetting applicator may include a volume of aggregating material through which the wetting fluid can flow before wetting the catheter tube body. The aggregating material can advantageously control the flow of the wetting fluid, such as the flow between a storage chamber and a wetting chamber of the housing. For example, the aggregating material may include particulate material / microparticulate material. The aggregating material is insoluble.

[0029] The wetting applicator can define a passage within the wetting chamber. The wetting applicator can at least partially define the wetting chamber of the wetting mechanism. The wetting applicator can define a passage within the wetting chamber through which, in use, the catheter body can move through the wetting chamber. The wetting mechanism can be configured such that when the catheter body moves through the wetting chamber (e.g., moves through the wetting chamber along the passage defined by the wetting applicator), the catheter body moves in contact with the wetting applicator. In multiple embodiments, the wetting applicator can be configured such that the fluid held within the wetting applicator can be released from the wetting applicator when the catheter body moves through the wetting chamber, and preferably automatically released.

[0030] The distal end of the catheter body is at least initially positioned outside the wetting chamber. The distal end of the catheter body can at least initially be held within the inlet of the wetting chamber.

[0031] The wetting mechanism can include a fluid release control component.

[0032] In use, the fluid release control component can be operable to control the release of fluid from the wetting applicator. For example, in a first configuration, the fluid release control component can be used to prevent the catheter body from approaching and / or contacting the wetting applicator. In use, the fluid release control component can act as a barrier between the wetting applicator and the passage through the wetting chamber through which the catheter body can move.

[0033] Additionally or alternatively, in use, the fluid release control component can be operable to control the release of fluid from the storage chamber into the wetting chamber. The fluid release control component can be operable to control the release of fluid from the storage chamber onto and / or into the wetting applicator. In other words, the wetting mechanism can include a fluid release control component that is operable to fluidly connect the storage chamber and the wetting chamber in use.

[0034] Advantageously, controlling the release of fluid from the storage chamber (where the fluid stored in the storage chamber does not contact other components of the catheter system) overcomes the problems of the prior art, particularly where the catheter may be disadvantageously immersed in the wetting fluid prior to use. It can also increase the shelf life of the catheter by reducing the exposure of most of the components of the catheter to moisture prior to use (or keeping it as close as possible to the time of use).

[0035] The fluid release control component may include a movable plug. The plug may be movable between a first position and a second position. In the first position, the fluid release control component may prevent fluid from being released from the storage chamber to the wetting chamber and / or the wetting applicator. In the second position, the fluid release control component may allow fluid to be released from the storage chamber to the wetting chamber and / or the wetting applicator. The plug may move linearly between the first and second positions. For example, in use, the user may push or pull the plug to move the plug between the first and second positions. Alternatively, the plug may rotate between a first and a second angular position. 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 disposed within the wetting mechanism by interacting with a complementary threaded surface of the wetting mechanism (such as a complementary threaded surface disposed on or within the wetting chamber of the housing).

[0036] The plug may be configured to be at least partially withdrawn from the wetting mechanism. The plug may be configured to be at least partially withdrawn from the wetting chamber of the wetting mechanism. The partial withdrawal of the plug may correspond to the movement of the plug from the first position to the second position. The plug may be configured to be only partially withdrawn from the wetting mechanism, i.e., it cannot be completely withdrawn from the wetting mechanism. Whether in the first position or the second position, it may remain attached or otherwise coupled to the housing. In various embodiments, the plug may be configured such that it can be completely withdrawn from the wetting mechanism (optionally from the wetting chamber of the wetting mechanism).

[0037] The movement of the plug between the first and second positions may expose or otherwise open one or more openings within the housing that are located between the storage chamber and the wetting chamber. Thus, when the plug moves between the first and second positions, the fluid that was at least initially contained in the storage chamber can be released from the storage chamber (and released into the wetting chamber / onto or into the wetting applicator).

[0038] The fluid release control component may include a container, such as a bag, blister pack, or capsule. The container may be located within the storage chamber, or may at least partially define the storage chamber of the wetting mechanism, and may contain fluid therein. The container may be rupturable or may otherwise be opened to release the fluid contained therein.

[0039] The wetting mechanism may be configured such that the container can be ruptured or otherwise opened in use by the user's action on the housing itself. For example, in some embodiments, the housing is at least partially formed of a flexible, compressible, and / or elastic material. In such embodiments, the wetting mechanism may be configured such that the container can be ruptured or otherwise opened when the user acts to compress, bend, and / or flex / deform the housing.

[0040] In other embodiments, the wetting mechanism may include a fluid release control component in the form of a plug that is coupled to the container. In such an embodiment, the wetting mechanism may be configured such that the container can be ruptured or otherwise opened during use by movement of the plug. For example, the wetting mechanism may be configured such that the container is compressed when the plug is (at least partially) withdrawn or when the plug is rotated.

[0041] The wetting chamber may include an inlet through which the conduit body can be introduced into the wetting chamber. The wetting mechanism may include a movable or removable 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 in effect removal of the stopper) opens the inlet, thereby allowing the conduit body to be introduced into (and moved through) the wetting chamber. In multiple embodiments, the stopper may include a fluid release control component such as a plug, or may be coupled with a fluid release control component such as a plug. For example, in such an embodiment, at least partial withdrawal of the plug may result in release of the wetting fluid and opening of the inlet to the wetting chamber.

[0042] The wetting chamber may have an outlet through which the conduit body can be moved to expose the conduit body for subsequent insertion by a user.

[0043] The inlet and / or outlet may be sealed. For example, the inlet and / or outlet may include a valve. The valve or each valve may provide a seal to retain the wetting fluid within the housing. The valve can advantageously prevent accidental discharge of the wetting fluid from the housing, e.g., onto the user.

[0044] The valve may be configured to allow the conduit body to move therethrough. For example, in the case where the housing includes a valve at the inlet, the inlet valve may be configured to allow the conduit body to move therethrough to introduce the conduit body into the wetting chamber of the housing. In the case where the housing includes a valve at the outlet, the outlet valve may be configured to allow the conduit body to move therethrough to expose the conduit body, e.g., for subsequent use / insertion by a user.

[0045] The housing---such as the wetting chamber and / or the storage chamber---may be configured to accommodate up to 0.25 milliliters, or up to 0.5 milliliters, or up to 0.75 milliliters, or up to 1.0 milliliters, or up to 1.5 milliliters, or up to 2.0 milliliters, or up to 2.5 milliliters, or up to 3.0 milliliters, or up to 4.0 milliliters, or up to 5.0 milliliters, or up to 7.5 milliliters, or up to 10 milliliters of wetting fluid.

[0046] The housing forms a gripping element for the catheter. As described herein, in use, the gripping element can be used by a user to control the application of the catheter. For example, the gripping element can be used to hold the catheter body near the urethra to assist the user in guiding the catheter body without having to contact the body itself. In various embodiments, the housing can include a tapered / conical profile that can assist the user in gripping and acting on the housing during use.

[0047] In embodiments where the wetting mechanism includes a fluid release control component in the form of a plug, the plug can include a tapered / conical profile. The plug can include a hollow or substantially hollow interior. In combination with the tapered profile, such a plug can form a cup-shaped element that can assist the user in positioning the catheter body during use. For example, the cup-shaped element can be used to position the housing on the tip of the penis such that the catheter body can be easily inserted into the urethra immediately after wetting.

[0048] In some embodiments, both the housing and the plug include a tapered / conical profile. In such embodiments, the wetting mechanism can be configured such that the housing and the plug together form a generally hourglass-shaped profile. The hourglass-shaped profile can be particularly advantageous as it can allow the user to manipulate the wetting mechanism with only one hand, i.e., remove (or at least partially remove) the plug from the housing with only one hand.

[0049] According to one aspect of the invention, there is provided a wetting mechanism for wetting the body of a catheter, the wetting mechanism comprising: a housing forming a gripping element for the catheter, the housing being configured to be initially positioned at or near the distal end of the catheter body; wherein the housing includes a wetting chamber, and in use, at least a portion of the catheter body can be introduced into the wetting chamber and can move through the wetting chamber such that at least a portion of the catheter body moves through the wetting chamber; wherein the wetting mechanism is configured such that the catheter body can be wetted as the body moves through the wetting chamber.

[0050] According to one aspect of the invention, there is provided a wetting mechanism for wetting the body of a male urinary catheter, the wetting mechanism comprising: a housing forming a gripping element for the catheter, the housing being configured to be initially positioned at or near the distal end of the catheter body; wherein the housing includes a wetting chamber, and in use, at least a portion of the catheter body can be introduced into the wetting chamber and can move through the wetting chamber such that at least a portion of the catheter body moves through the wetting chamber; wherein the wetting mechanism is configured such that the catheter body can be wetted by a wetting fluid contained within the housing as the body moves through the wetting chamber.

[0051] Advantageously, the wetting mechanism is configured such that the catheter body can be wetted from the tip (i.e., the end that is first introduced into the urethra during use) immediately before insertion by the user. Thus, this reduces the likelihood of harm to the user due to insufficient wetting of the catheter body. For example, it reduces the likelihood of harm to the user caused by a lack of wetting fluid or drying of the catheter due to a delay between the wetting process and subsequent insertion by the user.

[0052] As described above, the optional aspects of the present invention described above can be applied to any aspect of the present invention - for the avoidance of doubt, including any aspect of the present invention immediately above, where compatible.

[0053] The wetting fluid can be contained within a wetting chamber. The wetting fluid can be contained within a storage chamber within the housing. The storage chamber and the wetting chamber can be fluidly connected so as to, for example, allow the wetting fluid to enter the wetting chamber for wetting the catheter body as it moves through. For example, the housing can include an opening or port located between the storage chamber and the wetting chamber through which the wetting fluid can flow. The opening or port can be configured such that the rate at which the wetting fluid can flow through it can be limited by the surface tension of the wetting fluid. In this way, during use, the flow rate of the wetting fluid entering the wetting chamber can be advantageously controlled to control the application of the wetting fluid onto the catheter body.

[0054] The housing can have an inlet and an outlet. The inlet and / or the outlet can be sealed. For example, the inlet and / or the outlet can include a valve. The valve or each valve can provide a seal to retain the wetting fluid within the housing. The valve can advantageously prevent the accidental discharge of the wetting fluid from the housing, for example, onto the user.

[0055] The valve can be configured to allow the catheter body to move through it. For example, in a case where the housing includes a valve at the inlet, the inlet valve can be configured to allow the catheter body to move through it so that the catheter body can be introduced into the wetting chamber of the housing. In a case where the housing includes a valve at the outlet, the outlet valve can be configured to allow the catheter body to move through it to expose the catheter body for subsequent use / insertion by the user, for example.

[0056] According to one aspect of the present invention, there is provided a wetting mechanism for wetting the body of a catheter, the wetting mechanism comprising: a housing forming a gripping element for the catheter, the housing being configured to be initially positioned at or near the distal end of the catheter body; wherein the housing includes: a storage chamber for containing a volume of fluid therein; and a wetting chamber, the wetting chamber being fluidly connected or capable of being fluidly connected to the storage chamber and being configured such that in use, at least a portion of the catheter body can be introduced into the wetting chamber and can move through the wetting chamber, so that at least a portion of the catheter body moves through the wetting chamber; wherein the wetting mechanism includes a wetting applicator located within the wetting chamber, the wetting applicator being configured to hold fluid therein and to release the fluid to wet the catheter body as the body moves through the wetting chamber.

[0057] According to one aspect of the present invention, there is provided a catheter comprising: a catheter body having a distal end and a proximal end; and a wetting mechanism as in any of the foregoing aspects, the wetting mechanism being operably coupled at or near the distal end of the catheter body for wetting the catheter body in use.

[0058] According to one aspect of the present invention, there is provided a male catheter comprising: a catheter body having a distal end and a proximal end; and a wetting mechanism as in any of the foregoing aspects, the wetting mechanism being operably coupled at or near the distal end of the catheter body for wetting the catheter body in use.

[0059] The catheter may include a funnel-shaped member. The funnel-shaped member may be provided at or near the distal end of the catheter body. The funnel-shaped member may include a fluid outlet for discharging fluid from within the catheter body. Preferably, the catheter includes a wetting mechanism at or near the distal end of the catheter body, wherein the funnel-shaped member is at or near the distal end of the catheter body, and wherein the wetting mechanism and the funnel-shaped member are separate components coupled by the catheter body.

[0060] In some embodiments, the catheter includes a sleeve. The sleeve may be positioned around the catheter body. In some embodiments, the sleeve may define an internal volume around at least a portion of the catheter body. The sleeve may include a flexible material. The sleeve may be thin and prone to wrinkling. For example, the sleeve may be formed from a plastic material film, such as low density polyethylene.

[0061] The sleeve can be coupled to the wetting mechanism. For example, the sleeve can be coupled to the wetting mechanism at a first end. In such an embodiment, the sleeve can be coupled to a conduit at an opposite second end; for example, the sleeve can be coupled to a funnel-shaped member at or near the distal end of the conduit body. In this way, the sleeve can define an internal volume around the conduit body between the wetting mechanism at or near the tip of the conduit body and the funnel-shaped member at or near the distal end of the conduit body.

[0062] A particularly preferred embodiment provides a male urinary catheter comprising: a conduit body having a tip end and a distal end; and a wetting mechanism operatively coupled at or near the tip end of the conduit body for wetting the conduit body in use; the wetting mechanism comprising: a housing forming a gripping element for the conduit, the housing being configured to be initially positioned at or near the tip end of the conduit body; wherein the housing includes a wetting chamber, and in use, at least a portion of the conduit body can be introduced into and moved through the wetting chamber such that at least a portion of the conduit body moves through the wetting chamber; wherein the wetting mechanism includes a wetting applicator located within the wetting chamber, the wetting applicator being configured to hold a fluid therein and to release the fluid to wet the conduit body as the conduit body moves through the wetting chamber; the conduit further includes a funnel-shaped member at or near the distal end of the conduit body, wherein the wetting mechanism and the funnel-shaped member are separate components coupled by the conduit body; and the conduit includes a sleeve formed of a plastic material film positioned around the conduit body, the sleeve defining an internal volume around at least a portion of the conduit body; the sleeve is coupled to the wetting mechanism at a first end and to the funnel-shaped member at an opposite second end.

[0063] The sleeve can advantageously form an interaction point for the conduit user. For example, in use, the user can grip the catheter at the housing of the wetting mechanism and at a point along the sleeve. The catheter can then be configured such that the user can urge the conduit body into and through the wetting chamber of the wetting mechanism by indirect contact with the body via the sleeve. In this way, the catheter of the present invention can be used to assist in wetting the conduit body (and exposing the tip of the body for subsequent insertion into the urethra) without the user having to directly contact the conduit body. Advantageously, this can reduce the risk of contamination.

[0064] The catheter can be configured such that at least a portion of the fluid within the wetting chamber of the wetting mechanism can flow into the sleeve and along the sleeve to wet the conduit body in use. For example, in some embodiments, the housing of the wetting mechanism includes a hole or opening therein to allow the fluid within the wetting chamber to flow into the sleeve.

[0065] The catheter may include a disposable catheter. The catheter may include an intermittent urinary catheter.

[0066] The catheter body may have a length of up to 35 cm (and potentially longer). For example, the length of the catheter body may be up to or at least 20 cm, up to or at least 25 cm, up to or at least 30 cm, up to or at least 35 cm, or up to or at least 40 cm. In various embodiments, the length of the catheter body may be greater than 40 cm. In various preferred embodiments, the length of the catheter body is in the range of 25 cm to 35 cm. Male catheters typically have a catheter body of such a length and are thus less suitable for mechanisms that wet the catheter body from the distal end (opposite the tip in the present invention), as the fluid may not be sufficient to cover the entire length of the body. This may result in the tip being wetted last (or not at all if there is insufficient fluid), which is undesirable as the tip will be introduced into the urethra first and thus is most likely to cause injury if not adequately wetted prior to use. Additionally, due to the length requirements of male catheters, wetting configurations that wet the catheter through a wetting device integrated within the catheter package are generally also not suitable.

[0067] The catheter body may include a hydrophilic component, or may be integrated with / formed integrally with a hydrophilic component, or may be coated with a hydrophilic component / hydrophilic composition. The hydrophilic component may be configured to provide a low-friction surface (e.g., the outer surface) of the catheter body when a wetting fluid is applied. For example, the hydrophilic component may include a hydrophilic polymer.

[0068] According to one aspect of the present invention, there is provided a sealed package of a catheter according to the foregoing aspects of the present invention, wherein the wetting mechanism is operatively coupled at or near the tip of the catheter body within the sealed package.

[0069] According to one aspect of the present invention, there is provided a method of wetting the body of a catheter using a wetting mechanism of any of the aspects described herein, the method comprising: introducing the tip of the catheter body into a wetting chamber and moving it through the wetting chamber, thereby causing fluid to be released from the wetting applicator and thereby wetting at least a portion of the outer surface of the catheter body.

[0070] The method may include manipulating a fluid release control component to control the release of fluid from the storage chamber into the wetting chamber, and preferably to control the release of fluid from the storage chamber onto or into a wetting applicator positioned within (or at least partially defining) the wetting chamber. BRIEF DESCRIPTION OF THE DRAWINGS

[0071] To more clearly understand the present invention, reference will now be made to the accompanying drawings, which describe one or more embodiments of the present invention by way of example only, wherein:

[0072] Figure 1A is a schematic diagram of the first embodiment of the present invention;

[0073] Figure 1B - 1C is Figure 1A a series of cross-sectional schematic diagrams of part A in

[0074] Figure 2A - 2C showing the operation and use of the device shown;

[0075] Figure 3A - 3C is a series of cross-sectional schematic diagrams showing the operation and use of the second embodiment of the present invention;

[0076] Figure 4A - 4D is a series of cross-sectional schematic diagrams showing the operation and use of the fourth embodiment of the present invention;

[0077] Figure 5A - 5C is a series of cross-sectional schematic diagrams showing the operation and use of the fifth embodiment of the present invention;

[0078] Figure 6 is a perspective view of the sixth embodiment of the present invention;

[0079] Figure 7A - 7B is showing Figure 6 a pair of side views showing the operation and use of the embodiment shown;

[0080] Figure 8A - 8B is a series of cross-sectional side views showing the operation and use of the seventh embodiment of the present invention. Detailed Description of the Invention

[0081] Generally speaking, the present invention relates to a catheter 10, 410, and more particularly, to a wetting mechanism 20, 20', 120, 220, 320, 420, which is configured to wet the tube bodies 12, 412 of the catheter 10, 410 during use.

[0082] The accompanying drawings illustrate a series of embodiments of the present invention. Where there are equivalent components between the embodiments, the same reference numerals are used.

[0083] Figure 1A - 1C shows a first embodiment of the wetting mechanism 20 for wetting the tube body 12 of the catheter 10.

[0084] The catheter 10 includes a catheter body 12, wherein a wetting mechanism 20 is disposed at the distal (proximal) end 13 of the catheter body 12, and a funnel-shaped member 30 is disposed at the distal end 14 of the catheter body 12. A sleeve 18 is disposed between the wetting mechanism 20 and the funnel-shaped member 30, thereby encapsulating the catheter body 12 therebetween. Here, the sleeve 18 is formed of a flexible material that is coupled to the housing 16 of the wetting mechanism 20 at a first end and to the funnel-shaped member 30 at a second end. Thus, the sleeve 18 defines an internal volume around the catheter body 12 into which, in some examples, fluid can be introduced to wet the outer surface of the catheter body 12.

[0085] As described above, the catheter body 12 has a distal end 13 and a proximal end 14. The distal end 13 includes a tip for inserting the catheter body 12 into a tube, vessel, passageway, body cavity, etc. for removing fluid therefrom. Here, the catheter 10 includes a male catheter 10 having a tip configured for insertion into the bladder of a male patient. The distal end 13 of the catheter body includes a hole 34 therein for allowing fluid to enter the interior of the catheter body 12. The distal end 14 of the catheter body 12 is disposed within the funnel-shaped member 30. Specifically, the distal end 14 of the catheter body 12 is located within the funnel-shaped member 30 and leads to the funnel-shaped member 30, which defines a fluid outlet 32 that serves as an outlet for discharging fluid from within the catheter body 12. The catheter body 12 itself includes a hydrophilic coating that provides a low-friction outer surface of the catheter body 12 when a wetting fluid 24 is applied.

[0086] The wetting mechanism 20 includes (at least initially) a tubular housing 16 located at the distal end 13 of the catheter body 12. The housing includes an inlet 43 and an outlet 28 through which, in use, the catheter body 12 can be moved. Specifically, the catheter body 12 can be introduced into the housing 16 through the inlet 43 and can be removed from the housing 16 through the outlet 28 to expose its distal end 13, i.e., for subsequent insertion into the urethra.

[0087] A wetting applicator in the form of a foam duct 40 is disposed within the wetting chamber 23 and is configured to hold a wetting fluid 24 therein, and in use, controls the application of the fluid to the catheter body 12 as the catheter body 12 is moved through the wetting chamber 23. The wetting chamber 23, particularly the foam duct 40, defines a passage through the housing 16 through which at least a portion of the catheter body 12 can be introduced and moved. The passage is defined between an inlet 43 and an outlet 28 of the housing 16 such that the catheter body 12 moves along the length of the foam duct 40 as it moves through the housing 16. As it moves through the passage, the catheter body 12 contacts the foam duct 40, causing a force to be applied to the foam duct 40, compressing it. Compression of the foam duct 40 causes the fluid stored therein to be released directly onto the outer surface of the catheter body 12, thereby providing a coating of the fluid 24 on the catheter body 12 as the catheter body 12 moves through the wetting chamber 23.

[0088] Once the tip 13 of the catheter body 12 has moved out through the outlet 28 of the housing 16, the tip 13 becomes exposed for insertion by the user. In use, the housing 16 then serves as a gripping element for the user to guide the catheter body 12, as the user can then easily guide the exposed tip 13 of the catheter body 12 using the housing 16 without directly contacting the body 12.

[0089] This type of wetting applicator can advantageously ensure that the wetting fluid 24 is applied substantially uniformly over the entire outer surface of the catheter body 12 and reduces the likelihood of any spillage. Additionally, providing the wetting mechanism 20 as a gripping element for the catheter 10 improves the usability of the catheter 10 in terms of the wetting action and the ultimate use of the catheter.

[0090] A variant of the wetting mechanism 20 is as Figure 2A - 2C shown. Specifically, these illustrate a wetting mechanism 20' having a similar construction to the wetting mechanism 20. The wetting mechanism 20' differs in that it includes a housing 16' which also includes a storage chamber 22' containing a volume of fluid 24 for wetting the catheter body 12. In use, the fluid 24' can be released from the storage chamber 22' into the wetting chamber 23' and specifically onto a wetting applicator in the form of a foam duct 40' located within the wetting chamber 23'. The fluid 24' is released from the storage chamber 22' into the wetting chamber 23' via an opening 27' within the housing 16'.

[0091] Like the foam conduit 40, the foam conduit 40' is configured to hold fluid, but specifically here, the fluid 24' is released from the storage chamber 22' into the wetting chamber 23'. Similarly, the foam conduit 40' is configured to control the application of fluid to the catheter body 12 during use as the catheter body 12 moves through the wetting chamber 23'.

[0092] The catheter body 12 can be moved into and through the wetting chamber 23' via the inlet 43' in the same manner as the wetting mechanism 20 described above, such that the catheter body 12 contacts (and applies pressure to) the foam conduit 40'. This pressure causes the fluid 24' to be released from the foam conduit 40', thereby wetting the outer surface of the catheter body 12. Once the tip 13 of the catheter body 12 exits through the outlet 28' of the housing 16', the tip 13 is exposed for insertion by the user. In use, the housing 16' then serves as a gripping element for the user to guide the catheter body 12, as the user can then use the housing 16' to easily guide the exposed tip 13 of the catheter body 12 without directly contacting the body 12.

[0093] This type of wetting applicator can advantageously ensure that the foam conduit 40' is "refilled" with the fluid 24' from the storage chamber 22' as the fluid held within the foam conduit 40' is released onto the catheter body 12. This can ensure that there is sufficient fluid to coat the entire length of the catheter body 12, which may be up to 35 cm and may also be greater than 35 cm.

[0094] A variant of the wetting mechanism 20' is shown in Figure 3A - 3C Specifically, these figures show a wetting mechanism 120 constructed in substantially the same manner as the wetting mechanism 20' shown in Figure 2A - 2C The wetting mechanism 120 differs in that it includes a fluid release control component in the form of a plug 126. As described herein, the plug 126 is configured to control the release of fluid 124 from the storage chamber 122 to the wetting chamber 123, and specifically to the wetting applicator in the form of a foam conduit 140. The storage chamber 122 and the wetting chamber 123 are in fluid communication with each other through an opening 127 in the housing 116.

[0095] When the plug 126 is moved, the fluid 124 is released from the storage chamber 122 into the wetting chamber 123 and onto the foam conduit 140. To facilitate this, a lip 129 is provided at one end of the plug 126, which defines an interaction point for the user, in particular the user can grip the lip 129 to provide leverage / lever force.

[0096] Initially, the wetting mechanism 120 is set in a first position, where the plug 126 in the first position blocks the opening 127( Figure 3A ). To enable the wetting mechanism 120, the plug 126 is partially displaced (i.e., pulled outwards from the wetting chamber 123) from the wetting chamber 123 to a second position( Figure 3B ). In this way, the plug 126 is moved to a position where the opening 127 is no longer blocked, allowing the fluid 124 to be released from the storage chamber 122 into the wetting chamber 123, in particular onto the foam conduit 140. The notch / protrusion 136 is provided on the outer circumferential surface of the plug 126 to define the extent to which the plug 126 can be removed from the wetting chamber 123. Specifically, the protrusion 136 provides a contact point between the plug 126 and the inwardly extending circumferential flange 138 at the end of the housing 116.

[0097] Subsequently, the catheter body 12 can be moved into and through the wetting chamber 123 via the inlet 143 in the same manner as the above-described wetting mechanisms 20, 20', bringing the catheter body 12 into contact with (and applying pressure to) the foam conduit 140. This pressure causes the fluid 124 to be released from the foam conduit 140, thereby wetting the outer surface of the catheter body 12. Once the tip 13 of the catheter body 12 moves past the lip 129 in the plug 126 and exits through the outlet 128 of the housing 116, the tip 13 becomes exposed for insertion by the user. In use, the housing 116 then serves as a gripping element for the user to guide the catheter body 12, as the user can then easily guide the exposed tip 13 of the catheter body 12 using the housing 116 without directly contacting the body 121.

[0098] Advantageously, storing the fluid 124 in a separate storage chamber 122 until (or as close as possible to) the point of use of the catheter 10 reduces the contact time of most components of the catheter 10 with the fluid 124, which may be advantageous in terms of the shelf life of the catheter 10.

[0099] Figure 4A - 4D Another embodiment of a wetting mechanism 220 for wetting the outer surface of a catheter body 12 in accordance with the present invention is shown.

[0100] Like the wetting mechanisms 20, 20', 120, the wetting mechanism 220 includes (at least initially) a housing 216 positioned at the distal end 13 of the catheter body 12. The housing 216 also includes a storage chamber 222 and a wetting chamber 223. A volume of fluid 224 for wetting the catheter body 12 is contained in the storage chamber 222, and the fluid 324 can be released into the wetting chamber 223 - specifically through an opening 227 within the housing 216. The wetting chamber 223 also defines a separate portion of the housing 216 and includes a foam conduit 240 that defines a passage through the wetting chamber 223 through which at least a portion of the catheter body 12 can be introduced and moved.

[0101] The wetting mechanism 220 differs in that it includes a plug 226 that is at least initially disposed within the wetting chamber 223, particularly within the passage defined by the foam conduit 240. In this position ( Figure 4A and 4B ), the fluid 224 from the storage chamber 222 can be released through the opening 227 and reach the foam conduit 240. However, the plug 226 serves to effectively seal the wetting chamber 223 such that the fluid within the foam conduit 240 or actually still within the storage chamber 222 is not released. In this position, the plug 226 also prevents the catheter body 12 from being introduced into the wetting chamber 223. Thus, the plug 226 can prevent or at least reduce the likelihood of the wetting mechanism 220 being inadvertently activated.

[0102] The plug 226 is configured such that it can be completely removed from the wetting chamber 223, particularly by pulling the plug 226 out through an outlet 228 in the housing 216. The plug 226 is provided with an enlarged and rounded end portion 229 to assist the user in gripping the plug 226. Withdrawing the plug 226 from the wetting chamber 223 opens the inlet 243 ( Figure 4C ). The catheter body 12 can then be moved into and through the wetting chamber 223 via the inlet 243 in the same manner as the above-described wetting mechanisms 20, 120, such that the catheter body 12 contacts (and applies pressure to) the foam conduit 240. This pressure causes the fluid 224 to be released from the foam conduit 140, thereby wetting the outer surface of the catheter body 12. Once the distal end 13 of the catheter body 12 exits through the outlet 228 of the housing 216, the distal end 13 becomes exposed for insertion by the user. Additionally, the housing 216 serves as a gripping element for the user to guide the catheter body 12 during use, as the user can then easily guide the exposed distal end 13 of the catheter body 12 using the housing 216 without directly contacting the body 12.

[0103] Figure 5A - 5CShows another embodiment of a wetting mechanism 320 for wetting the outer surface of the catheter body 12 according to the present invention.

[0104] Like the wetting mechanisms 20, 20', 120, 220, the wetting mechanism 320 includes (at least initially) a housing 316 positioned at the distal end 13 of the catheter body 12. The housing 316 also includes a storage chamber 322 and a wetting chamber 323, and a certain volume of fluid 324 for wetting the catheter body 12 is contained in the storage chamber 322, and the fluid 324 can be released into the wetting chamber 323.

[0105] The wetting mechanism 320 is different in that it includes a fluid release control member in the form of a container for the fluid, particularly a bag 326, which must be ruptured in order to release the fluid 324 therefrom into the wetting chamber 323 and onto a wetting applicator in the form of a foam conduit 340. Like the foam conduits 40, 140, 240, the foam conduit 340 is configured to hold the fluid released onto it from the storage chamber 322 and is configured to control the application of the fluid to the catheter body 12 when the catheter body 12 moves through the housing 316 during use. As shown, the bag 326 effectively defines the storage chamber 322. Similarly, the foam conduit 340 defines the wetting chamber 323, through which the catheter body 12 can move during use.

[0106] The bag 326 is initially provided in the Figure 5A configuration shown, i.e., intact and containing the fluid. During use, the bag 326 is ruptured by the user applying an external force to the housing 316, i.e., by squeezing the housing 316 (as Figure 5B symbolically shown), and the housing 316 can be made of a deformable material or have a deformable region that can be squeezed. The rupture of the bag 326 causes the fluid contained therein to be released into the wetting chamber 323 and specifically onto the foam conduit 340. Like the wetting mechanisms 20, 20', 120, 220, the catheter body 12 can then move through the wetting chamber 323 in contact with the foam conduit 340 and exit through an outlet 328 at the distal end of the housing 316 to wet the outer surface of the catheter body 12 and expose the distal end 13 for insertion by the user. Also, during use, the housing 316 acts as a gripping element for the user to guide the catheter body 12.

[0107] Figure 6 - 7B Shows another embodiment of a catheter 410 and a wetting mechanism 420, which is operable to wet the body 412 of the catheter 410 during use.

[0108] Like catheter 10, catheter 410 includes a catheter body 412, a wetting mechanism 420 disposed at the distal end 413 of the catheter body 412, and a funnel-shaped member 430 disposed at the distal end 414 of the catheter body 412. A sleeve 418 is disposed between the wetting mechanism 420 and the funnel-shaped member 430 to encapsulate the catheter body 12 therebetween.

[0109] The distal end 413 of catheter 410 includes a tip / aperture for inserting the catheter body 412 into a tube, vessel, passage, body cavity, etc. for removing fluid therefrom. Here, catheter 410 includes a male catheter 410 having a tip / aperture configured to be inserted into the bladder of a male patient. The distal end 414 of the catheter body 412 is disposed within the funnel-shaped member 430. Specifically, the distal end 414 of the catheter body 412 is located within and opens into the funnel-shaped member 430 which defines a fluid outlet 432 that serves as an outlet for discharging fluid from within the catheter body 412. The shape of the funnel-shaped member 430 aids the user in controlling the direction of fluid discharge from the catheter body 412. The catheter body 412 itself includes a hydrophilic coating that serves to provide a low-friction outer surface of the catheter body 412 when a wetting fluid is applied.

[0110] The wetting mechanism 420 is structurally similar to the wetting mechanism 120 described herein and may have the same features as the Figure 3A - 3C illustrated embodiment. It includes (at least initially) a housing 416 located at the distal end 413 of the catheter body 412. The housing 416 includes a storage chamber (not shown) that contains a volume of fluid for wetting the catheter body 412. In use, as described herein, upon manipulation of the plug 426, the fluid can be released from the storage chamber into a wetting chamber (not shown) of the housing 416. Similar to the wetting mechanism 120, 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 moving the catheter body 412 through the wetting chamber in contact with the foam conduit, the outer surface of the catheter body 412 can be wetted with the fluid. The plug 426 can be moved from the Figure 7A illustrated position (first position) to the Figure 7B illustrated position (second position) to release the fluid from the storage chamber. Specifically, for example, the movement of the plug 426 between these positions can open an aperture within the housing 416 or rupture a pouch to allow the fluid to be released from the storage chamber into the wetting chamber and onto the foam conduit for subsequent application to the catheter body 412.

[0111] In this embodiment, the plug 426 includes a conical cross-section and has a ridged outer surface that defines an interaction surface for use by the user. The profile of the housing 416 is also substantially conical and is positioned to define an hourglass configuration formed by the housing 416 and the plug 426. This arrangement is particularly advantageous because it allows the plug 426 to be manipulated with only one hand, as Figure 7A and 7B shown. Specifically, as shown in these figures, before the user pushes or "pops" the plug 426 upward (in the direction shown in the figures) to release the fluid, the user can grasp the housing 416 and the plug 426 with their thumb and index finger. Additionally, the conical plug 426 has a cup-shaped end, which facilitates the positioning of the housing 416 on the penile tip and thus helps to insert the catheter body 412 into the urethra during use.

[0112] Figure 8A - 8B Another embodiment of a wetting mechanism 520 for wetting the catheter body 12 of the catheter 10 is shown.

[0113] The wetting mechanism 520 includes a tubular housing 516 (at least initially) located at the tip 13 of the catheter body 12. The housing 516 includes an inlet 543 and an outlet 528, through which the catheter body 12 can be moved during use. Specifically, the catheter body 12 can be introduced into the housing 516 through the inlet 543 and removed from the housing 516 through the outlet 528 to expose its tip 513, which is then used to insert into the urethra.

[0114] The wetting mechanism 520 differs from the above-described mechanism in that it does not include a wetting applicator within the wetting chamber 523. Instead, the wetting fluid 524 is contained within the wetting chamber 523 itself, and during use, when the catheter body 12 moves through the wetting chamber 523, the wetting fluid 524 is applied to the catheter body 12.

[0115] The wetting chamber 523 defines a passage through the housing 516 through which at least a portion of the catheter body 12 can be introduced and moved. The passage is defined between the inlet 543 and the outlet 528 of the housing 516. As it moves through the passage, the catheter body 12 contacts the wetting fluid 524 held within the wetting chamber 523, such that the outer surface of the body 12 is coated with the wetting fluid 524 as it moves through the wetting chamber 523.

[0116] The wetting mechanism 520 includes an inlet valve 550 disposed at the inlet 543 and an outlet valve 552 disposed at the outlet 528. The inlet valve and the outlet valves 550, 552 advantageously seal the inlet and the outlet 542, 528, thereby preventing the wetting fluid 524 from leaking out of the wetting chamber 523. The valves 550, 552 also allow the catheter body 12 to pass through the wetting chamber 523. Specifically, the inlet valve 550 is configured to allow the catheter body 12 to move therethrough to introduce the catheter body 12 into the wetting chamber 523 of the housing 516. Similarly, the outlet valve 552 is configured to allow the catheter body 12 to move therethrough to expose the catheter body 12 for subsequent use / insertion by the user.

[0117] As with the other embodiments described above, once the tip 13 of the catheter body 12 exits through the outlet 528 of the housing 516, the tip 13 becomes exposed for insertion by the user, and the housing 516 serves as a gripping element for guiding the catheter body 12 by the user during use. The user can then advantageously use the housing 16 to easily guide the exposed tip 13 of the catheter body 12 without directly contacting the body 12.

[0118] In one variant, the wetting applicator (if present) may include a capillary material. The capillary material can be configured to provide wicking / capillary action between a storage chamber (e.g., storage chambers 22, 122, 222, 322) and a wetting chamber (e.g., wetting chambers 23, 123, 223, 323) such that fluid can be transferred from the storage chamber to the wetting chamber for subsequent application to the catheter body. This can be achieved in the illustrated embodiments, for example, by bringing the wetting fluid 24, 124, 224, 324 into contact with the wetting applicator, or in fact by releasing the wetting fluid onto and into contact with the wetting applicator, e.g., by using a fluid release control member.

[0119] In another variant, the wetting applicator (if present) may include a baffle device that defines a plurality of sub-regions of the wetting applicator, each sub-region being configured to hold a portion of the fluid held within the wetting applicator. For example, the baffle device can define a plurality of sub-regions within the housing 16, 116, 216, 316, 416, such as within the wetting chambers 23, 123, 223, 323 of the housing 16, 116, 216, 316, 416, in which the fluid can reside and / or into which the fluid can be released, for example, from the storage chambers 22, 122, 222, 322.

[0120] Unless otherwise specified or unless otherwise understood from the context in which it is used, conditional language such as "may," "can," "could," or "might" typically is intended to convey that certain embodiments include certain features, elements, and / or steps while other embodiments do not include certain features, elements, and / or steps. Thus, such conditional language generally is not intended to imply that one or more embodiments in any way require features, elements, and / or steps, or that one or more embodiments must include logic for deciding, with or without user input or prompting, whether such features, elements, and / or steps are included in any particular embodiment or will be performed in any particular embodiment.

[0121] The above has described one or more embodiments by way of example only. Many variations are possible without departing from the scope of protection provided by the appended claims.

Claims

1. A male urinary catheter, comprising: A catheter body having a tip end and a distal end, the catheter body comprising, integrating, or coating with a hydrophilic component; And A wetting mechanism for wetting the catheter body, the wetting mechanism comprising: A housing forming a gripping element for the male urinary catheter, the housing being configured to be initially positioned at or near the tip end of the catheter body; Wherein the housing includes a wetting chamber, and in use, at least a portion of the catheter body can be introduced into and move through the wetting chamber so that at least a portion of the catheter body moves through the wetting chamber; and Wherein the wetting mechanism includes a wetting applicator located within the wetting chamber, the wetting applicator being configured to hold a fluid therein and release the fluid to wet the catheter body as the catheter body moves through the wetting chamber, the wetting applicator including a baffle device.

2. The male urinary catheter according to claim 1, wherein, The wetting applicator includes a flexible, compressible, and / or elastic material.

3. The male urinary catheter according to claim 2, wherein, The wetting applicator is deformable upon application of a force thereto; wherein deformation of the wetting applicator causes the fluid held therein to be released.

4. The male urinary catheter according to any one of claims 1 to 3, wherein The wetting applicator includes a sponge or foam material, which in use can operate to absorb a fluid.

5. The male urinary catheter according to any one of claims 1 to 3, wherein, The wetting applicator includes a capillary material, which in use can operate to draw a fluid therethrough for application to the catheter body.

6. The male urinary catheter according to any one of claims 1 to 3, wherein, The wetting applicator defines a channel within the wetting chamber, or the wetting applicator at least partially defines the wetting chamber of the wetting mechanism.

7. The male urinary catheter according to any one of claims 1 to 3, wherein, The tip end of the catheter body is at least initially positioned outside the wetting chamber.

8. The male urinary catheter according to any one of claims 1 to 3, wherein, The tip end of the catheter body is at least initially held within the inlet of the wetting chamber.

9. The male urinary catheter according to any one of claims 1 to 3, wherein, The housing includes a storage chamber containing a volume of wetting fluid, wherein the wetting chamber is fluidly connected or can be fluidly connected to the storage chamber.

10. The male urinary catheter according to claim 9, wherein, The wetting mechanism further includes a fluid release control component, which in use can operate to control the release of fluid from the storage chamber into the wetting chamber.

11. The male urinary catheter according to claim 10, wherein, The fluid release control component can operate to control the release of fluid from the storage chamber onto and / or into the wetting applicator.

12. The male urinary catheter according to claim 10 or 11, wherein, The fluid release control component includes a container located within the storage chamber or at least partially defining the storage chamber, and the container contains a fluid therein, wherein the container is rupturable or can be opened in some other way to release the fluid contained therein.

13. The male urinary catheter according to claim 12, wherein, The wetting mechanism is configured such that, in use, the container can be ruptured or opened in some other way when the user causes the housing to compress, bend, and / or flex and deform.

14. The male urinary catheter according to claim 9, wherein, The wetting chamber includes an inlet through which the catheter body can be introduced into the wetting chamber; wherein the wetting mechanism includes a removable stopper configured to block or at least partially block the inlet.

15. The male urinary catheter according to claim 10 or 11, wherein, The fluid release control component includes a movable plug that is movable between a first position and a second position. In the first position, the fluid release control component can prevent fluid from being released from the storage chamber to the wetting chamber and / or the wetting applicator. In the second position, the fluid release control component allows fluid to be released from the storage chamber to the wetting chamber and / or the wetting applicator.

16. The male urinary catheter according to claim 15, wherein, The plug is linearly movable or rotatable between the first position and the second position.

17. The male urinary catheter according to claim 15, wherein, The movement of the plug between the first position and the second position exposes or otherwise opens one or more openings located within the housing between the storage chamber and the wetting chamber, thereby allowing fluid to be released from the storage chamber and reach the wetting chamber and / or reach or be applied to the wetting applicator.

18. The male urinary catheter according to claim 15, wherein, The plug is configured to be at least partially withdrawn from the wetting chamber of the wetting mechanism. The partial withdrawal of the plug corresponds to the movement of the plug from the first position to the second position, and the plug cannot be completely withdrawn from the wetting mechanism.

19. The male urinary catheter according to any one of claims 1 to 3, wherein The wetting fluid is contained within the wetting chamber.

20. The male urinary catheter according to claim 19, wherein, The wetting fluid is contained within a storage chamber within the housing, and the storage chamber is fluidly connected to the wetting chamber.

21. The male urinary catheter according to claim 20, wherein, The housing includes an opening or port located between the storage chamber and the wetting chamber, through which the wetting fluid can flow; wherein the opening or port is configured such that the rate at which the wetting fluid can flow through it is limited by the surface tension of the wetting fluid.

22. The male urinary catheter according to any one of claims 1 to 3, wherein, The housing includes an inlet and an outlet, wherein the inlet and / or the outlet includes a valve that provides a seal to retain the wetting fluid within the housing.

23. The male urinary catheter according to claim 22, wherein, The valve or each valve is configured to allow the catheter body to move through it.

24. The male urinary catheter according to claim 23, wherein, The housing includes an inlet valve that is configured to allow the catheter body to move through it so that the catheter body can be introduced into the wetting chamber of the housing; and / or wherein the housing includes an outlet valve that is configured to allow the catheter body to move through it to expose the catheter body for subsequent use / insertion by the user.

25. The male urinary catheter according to any one of claims 1 to 3, wherein, The baffle device defines a plurality of sub-regions of the wetting applicator, each sub-region being configured to hold a portion of the fluid held within the wetting applicator.

26. The male urinary catheter according to any one of claims 1 to 3, wherein, The baffle device defines a plurality of sub-regions within the wetting chamber, and fluid can reside within and / or be released into the plurality of sub-regions.

27. The male urinary catheter according to any one of claims 1 to 3, further comprising a funnel-shaped member disposed at or near the distal end of the catheter body, wherein the wetting mechanism and the funnel-shaped member are separate components coupled by the catheter body.

28. The male urinary catheter according to claim 27, wherein, The male urinary catheter includes a sleeve formed of a plastic material film positioned around the catheter body, the sleeve defining an internal volume around at least a portion of the catheter body; the sleeve is coupled to the wetting mechanism at a first end and to the funnel-shaped member at an opposite second end.

29. The male urinary catheter according to any one of claims 1 to 3, wherein, The male catheter is provided in a sealed package, and the wetting mechanism is operatively coupled at or near the distal end of the catheter body within the sealed package.

30. A method of wetting a catheter body using the wetting mechanism in a male catheter according to any one of claims 1 to 29, the method comprising: introducing the distal end of the catheter body into the wetting chamber and moving it through the wetting chamber such that fluid is released from the wetting applicator and thereby wets at least a portion of the outer surface of the catheter body.

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