Catheter

Abstract

The present invention relates to a catheter 10. The catheter 10 includes a catheter tube 12 having a tip 13 and a distal end 14, the distal end 14 being connected to or forming at least a portion of a funnel 16 for evacuating fluid from within the catheter tube 12. A sleeve 18 is disposed around the catheter tube 12 and is connected to the funnel 16 at the end of the catheter tube 12 and extends toward the tip 13 of the catheter tube 12. The catheter 10 further includes a wetting mechanism 20 integrally formed with the funnel 16, the wetting mechanism 20 including a retention chamber 22 and a fluid outlet 26 operable to release fluid 24 from within the retention chamber 22 into the sleeve 18 to wet the exterior surface of the catheter tube 12.

Description

Technical Field

[0001] The present invention relates to a catheter (for example, a urethral catheter) having an integral wetting mechanism for wetting the catheter tube during use.

Background Art

[0002] A catheter is a medical device composed of a hollow catheter tube designed to be inserted into a conduit, blood vessel, passage, or body cavity in order to enable injection, drainage, or removal of fluids or substances, or to ensure that conduits, blood vessels, passages, etc. are in communication. A urethral catheter is inserted from the urethra into the user's bladder and used for bladder excretion.

[0003] To maximize comfort and minimize the risk of trauma and / or infection, the outer surface of the catheter tube is usually lubricated with a wetting fluid before insertion by the user. As a further development, the catheter tube itself has, is integrated with, or is coated with a hydrophilic component (for example, a hydrophilic polymer) that serves to further reduce friction when the wetting fluid is applied.

[0004] Some catheters may be pre-lubricated and supplied in the package, for example, when the catheter is at least partially immersed in the wetting fluid in the package. However, in such an arrangement, there is a problem that components of the catheter other than the catheter tube, such as gripper elements and funnels, also become wet. Therefore, it may be difficult for the user to hold the catheter tube by hand and direct it in the required direction, which may have an adverse effect on the user's feeling of use. This is particularly problematic when the user performs self-catheterization. Furthermore, when the catheter is immersed, the components of the catheter are exposed to moisture over a long period of time, which may substantially shorten the storage period of the catheter.

[0005] Therefore, it is considered advantageous to provide a catheter that can be lubricated during use or immediately before use.

[0006] As an attempt to solve this, some catheters are provided in a package that includes a breakable container or sachet inside the package, which the user can break to release a wetting fluid. Generally, it involves the user pressing on the package to damage the container / sachet. However, in such an arrangement, the same problems as described above occur, such as the wetting fluid coming into contact with other components of the catheter.

[0007] As an extension of such a solution, some prior art catheters have replaced the container with a wetting device that is initially coupled to the distal end of the catheter tube. The wetting device is slidable along the catheter tube by the user and releases the fluid contained within the device to wet the catheter tube. However, such a solution has the same drawback in that the wetting fluid may generally be released inside the package. Furthermore, such a solution relies on a relatively complex series of operations performed by the user to sufficiently wet the catheter tube, and if not performed correctly, it may cause injury and / or infections. Also, due to the large number of moving parts, the manufacture of these solutions may be relatively complex.

[0008] Therefore, it is advantageous to provide a catheter that includes means for supplying the wetting fluid only to the catheter tube in order to improve the user experience. It is also advantageous to provide a catheter that includes means for supplying the wetting fluid that is simpler in terms of use and / or manufacture compared to prior art devices.

[0009] 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

[0010] According to one aspect of the present invention, a catheter is provided, the catheter comprising a catheter tube having a distal end that is coupled to or forms at least a portion of a funnel for discharge fluid from within the catheter tube, a sleeve provided around the catheter tube and coupled to the funnel at an end of the catheter tube, and a wetting mechanism integrally formed with the funnel, the wetting mechanism having a holding chamber that houses a volume of fluid therein and a fluid outlet operable to discharge fluid from within the holding chamber into the sleeve to wet an outer surface of the catheter tube.

[0011] According to a further aspect of the present invention, a catheter is provided, the catheter comprising a catheter tube having a tip and a distal end, the distal end being coupled to or forming at least a portion of a funnel for discharge fluid from within the catheter tube, a sleeve provided around the catheter tube and coupled to the funnel at an end of the catheter tube and extending towards the tip of the catheter tube, and a wetting mechanism integrally formed with the funnel, the wetting mechanism having a holding chamber that houses a volume of fluid therein and a fluid outlet operable to discharge fluid from within the holding chamber into the sleeve to wet an outer surface of the catheter tube.

[0012] Advantageously, the catheter of the present invention provides means for directly wetting the outer surface of the catheter tube at the point of use, i.e., an integrated wetting mechanism. First, since the wetting fluid and the catheter tube can be stored separately until use, there is an advantage in terms of the product's storage stability. Further, by discharging the wetting fluid into the sleeve, lubrication of the catheter tube is achieved without exposing further components of the catheter (e.g., the funnel itself, grippers or the outer surface of the sleeve) to the wetting fluid. In this regard, it also overcomes the user experience problems associated with catheters that are submerged for lubrication of the catheter tube and catheters where liquid can generally be released within the package. Having a wetting mechanism integrally formed with the funnel can further provide advantages in terms of manufacturing cost and complexity, and in some cases, can reduce the number of separate components of the catheter and the packaging, and realize advantages in terms of disposal of the catheter after use.

[0013] The wetting mechanism and the funnel may be integrally formed as one part. For example, the wetting mechanism and the funnel may be formed as one molded part. Alternatively, the wetting mechanism and the funnel may be separate parts, but permanently fixed or adhered to each other to form one integrally formed part of the catheter.

[0014] The funnel may be composed of one or more walls. The one or more walls may have an inner wall and / or an outer wall. The one or more walls of the funnel may at least partially define a holding chamber. For example, the holding chamber may be at least partially defined by one or more inner walls of the funnel. In a preferred embodiment, the holding chamber is at least partially defined by the inner wall and the outer wall of the funnel.

[0015] In one embodiment, one or more walls of the funnel may at least partially define an outlet for fluid within the catheter tube. For example, one or more walls of the funnel, particularly one or more inner walls, may define a bore through the funnel through which fluid within the catheter tube can be discharged during use. The funnel may be configured such that the distal end of the catheter tube is at least partially positioned within or through the bore so as to hold the catheter tube within the funnel. The distal end of the catheter tube may be fixed to the bore of the funnel. For example, the distal end of the catheter tube may be joined, otherwise fixed, or molded as part of the bore through the funnel.

[0016] The funnel may have an inner wall that separates the holding chamber from the outlet of the catheter tube.

[0017] In an embodiment, the funnel may be formed at least partially of a rigid material. For example, one or more inner walls of the funnel may be formed of a rigid material. In a preferred embodiment, the funnel may be formed at least partially of a flexible material. The funnel may be formed at least partially of a compressible material.

[0018] In an embodiment, the funnel has a wall, preferably an outer wall, that includes a flexible and / or compressible portion. The flexible and / or compressible portion may be formed of an elastic material and may be configured to deform from a first configuration by a force load applied by a user (e.g., the user compressing the funnel). The flexible and / or compressible portion may define an interaction region of the funnel. The interaction region may be configured to be compressed, bent, and / or flexed by a force load applied by a user (e.g., the user compressing the funnel). The interaction region may be configured such that compression, bending, and / or flexing of the interaction region in use results in the release of fluid from the holding chamber through the fluid outlet.

[0019] The catheter tube may have a length up to 35 cm (or more in some cases). The length of the catheter tube may be, for example, up to 20 cm, or 20 cm or more and up to 25 cm, or 25 cm or more and up to 30 cm, or 30 cm or more and up to 35 cm, or 35 cm or more, or 40 cm or more. In an embodiment, the length of the catheter tube may exceed 40 cm. In a preferred embodiment, the length of the catheter tube is from 25 to 35 cm.

[0020] In an embodiment, the fluid outlet has a valve arrangement. The valve arrangement may be provided as part of a funnel, for example, forming a closable opening within the wall of the funnel. The valve arrangement may be configured to open such that fluid flows through the valve arrangement in response to compression, bending and / or flexing of the funnel. The valve arrangement may have one or more valves.

[0021] In one embodiment, the fluid outlet may have a frangible portion within the funnel, for example, within the wall of the funnel. The frangible portion may be configured to open in response to compression, bending and / or flexing of the funnel, for example, in response to a user applying a force to one or more walls of the funnel. Opening the frangible portion may involve rupturing, splitting or otherwise breaking the frangible portion to form an opening that defines the fluid outlet into the holding chamber.

[0022] As used herein and throughout the specification, the terms "opening" or "open" when referring to the fluid outlet may be interpreted to mean moving to a configuration where fluid contained within the holding chamber can flow from the holding chamber through the outlet.

[0023] In one embodiment, the fluid may be contained in a container within the holding chamber. The container may have, for example, a sachet, blister pack, or capsule disposed within the holding chamber and holding the fluid therein. The wetting mechanism may be configured such that, for example, when compressing, bending, and / or flexing the funnel, the container ruptures, divides, or is otherwise damaged. In use, rupturing, dividing, or otherwise damaging the container may result in the release of the fluid contained therein, for example, resulting in the released fluid passing through the fluid outlet and flowing into the catheter sleeve.

[0024] In embodiments where the fluid is contained within a container within the holding chamber, the fluid outlet may include an opening within the holding chamber that allows the fluid to freely flow through the holding chamber upon release from the container, for example, by the methods described herein.

[0025] One particularly preferred embodiment provides a catheter, the catheter being a catheter tube having a tip and a distal end, the distal end being coupled to or forming at least part of a funnel for the discharged fluid from within the catheter tube, a sleeve provided around the catheter tube, coupled to the funnel at the end of the catheter tube, and extending towards the tip of the catheter tube, and a wetting mechanism integrally formed with the funnel, the wetting mechanism having a holding chamber for containing a volume of fluid within a container within the holding chamber and a fluid outlet operable to discharge fluid from within the holding chamber into the sleeve for wetting the outer surface of the catheter tube, the fluid outlet having an opening within the holding chamber that allows the fluid to freely flow through the holding chamber upon release from the container.

[0026] The sleeve may preferably have a flexible sleeve. In an embodiment, the sleeve may be formed of a film of plastic material.

[0027] In an embodiment, the funnel may have a circular profile. The holding chamber may be arranged (e.g., circumferentially) around the outlet of the catheter tube. In certain embodiments, the funnel may have a polygonal profile. The funnel may have a substantially triangular profile. In such an embodiment, the outlet of the catheter tube may be located at a first vertex, and the holding chamber may at least partially extend between the other vertices. Advantageously, the holding chamber extending between the other vertices provides a surface (i.e., the outer surface of the funnel adjacent to the holding chamber) that extends between two vertices that a user can act on to effect the release of the wetting fluid through the fluid outlet.

[0028] Another particularly preferred embodiment provides a catheter comprising a catheter tube having a tip and a distal end, the distal end being coupled to or forming at least part of a funnel for discharge fluid from within the catheter tube, a sleeve provided around the catheter tube, coupled to the funnel at an end of the catheter tube, and extending towards the tip of the catheter tube, and a wetting mechanism integrally formed with the funnel, the wetting mechanism having a holding chamber for containing a volume of fluid therein and a fluid outlet operable to release fluid from within the holding chamber into the sleeve for wetting the outer surface of the catheter tube, and the funnel having a substantially triangular profile.

[0029] Another particularly preferred embodiment is provided with a catheter, the catheter being a catheter tube having a tip and a distal end, the distal end being coupled to or forming at least a part of a funnel for discharging fluid from within the catheter tube, a sleeve provided around the catheter tube, coupled to the funnel at the end of the catheter tube, and extending towards the tip of the catheter tube, and a wetting mechanism integrally formed with the funnel, the wetting mechanism having a holding chamber for accommodating a volume of fluid therein and a fluid outlet operable to discharge fluid from within the holding chamber into the sleeve for wetting the outer surface of the catheter tube, the funnel having a generally triangular profile, the outlet of the catheter tube being located at a first vertex, and the holding chamber extending at least partially between the other vertices.

[0030] The holding chamber may be configured to hold, for example, up to 0.25 ml, or up to 0.5 ml, or up to 0.75 ml, or up to 1.0 ml, or up to 1.5 ml, or up to 2.0 ml, or up to 2.5 ml, or up to 3.0 ml, or up to 4.0 ml, or up to 5.0 ml of wetting fluid.

[0031] In an embodiment, the wetting mechanism may have a fluid release control component for controlling the release of fluid from the holding chamber. The fluid release control component may be movable between a first position and a second position. The fluid release control component may be movable between the first position and the second position to control the release of fluid from within the holding chamber. For example, the first position may correspond to a position where the fluid release control component prevents the release of fluid from within the holding chamber. In such an embodiment, the second position may correspond to a position where the fluid release control component allows the release of fluid from within the holding chamber. For example, the movement from the first position to the second position may form the fluid outlet of the wetting mechanism.

[0032] The fluid release control component may be linearly movable. The fluid release control component may be rotatable.

[0033] In one embodiment, the fluid release control component has a plug. The plug may be configured to be at least partially withdrawn from the wetting mechanism so as to effect the release of fluid from the holding chamber. The plug may be configured to be at least partially withdrawn from a first position to a second position. For example, in such an embodiment, the plug may be at least partially received within or at least partially coupled to the remaining portion of the wetting mechanism at the second position. In one embodiment, the plug may be configured such that the plug must be completely withdrawn from the wetting mechanism in order to effect the release of fluid from the holding chamber. In such an embodiment, the second position of the plug may correspond to a position where the plug is completely removed and separated from the remaining wetting mechanism.

[0034] The catheter may have a gripper element. The gripper element may be coupled to the sleeve of the catheter. In a preferred embodiment, the funnel is coupled to the sleeve at the first end of the sleeve, and the gripper element is coupled at the opposite end of the sleeve. The gripper element may be disposed at least initially at or proximal to the tip of the catheter. The catheter may be configured such that the catheter tube can move through the gripper element so as to expose the catheter tube (e.g., for use).

[0035] In an embodiment, the gripper element may have a fluid control component that controls the flow of fluid (e.g., wetting fluid) through the gripper element. In one embodiment, the fluid control component may be configured to prevent or substantially reduce the flow of fluid through the gripper element. Advantageously, the fluid control component can prevent excess wetting fluid from being discharged from the catheter, specifically from within the sleeve around the catheter tube, thereby preventing the excess fluid from contacting other components of the catheter (e.g., the outer surface of the funnel or the gripper element). This can provide an advantage in terms of the ease of use of the catheter for the end user.

[0036] The fluid control component may have an absorbent material such as a foam, sponge, or wicking material that can absorb a wetting fluid during use.

[0037] The fluid control component may be configured to function as a wetting applicator that can release the fluid contained therein when the catheter tube moves relative to the fluid control component during use, for example, when the catheter tube moves through the gripper element. Advantageously, the fluid control component may provide two distinct functions, both by preventing leakage of the wetting fluid from the sleeve and by controlling the distribution of the wetting fluid outside the catheter tube.

[0038] The catheter may have a urinary catheter. The catheter may have a male urinary catheter or a female urinary catheter. The catheter may have a disposable catheter. The catheter may have an intermittent urinary catheter.

[0039] According to one aspect of the present invention, there is provided a sealed packaged catheter according to the foregoing aspects of the present invention.

[0040] According to one aspect of the present invention, there is provided a method for wetting the tube of a catheter according to any aspect described herein, the method including operating a wetting mechanism to release fluid from a holding chamber into the sleeve so as to wet an outer surface of the catheter tube.

[0041] This method may include compressing, bending, and / or flexing the funnel so as to operate the wetting mechanism. This method may include compressing, bending, and / or flexing the funnel so as to form an opening in a brittle portion of the wall of the funnel so as to form an opening in the holding chamber that defines the fluid outlet (e.g., by rupture, splitting, or other means of damage).

[0042] In an embodiment, the fluid may be contained within a container (e.g., a sachet, blister pack, or capsule) within the holding chamber, and the method may include, for example, compressing, bending, and / or flexing a funnel so as to effect release of the contained fluid from the container, such that, for example, the released fluid flows through a fluid outlet and into a catheter sleeve.

[0043] The method may include operating a fluid release control component of the catheter so as to effect release of the fluid. Operating the fluid release control component may include moving the fluid release control component from a first configuration that prevents release of fluid from the holding chamber to a second configuration that enables release of fluid from the holding chamber.

[0044] For a clearer understanding of the present invention, one or more embodiments of the present invention are described, by way of example only, with reference to the accompanying drawings.

Brief Description of the Drawings

[0045]

Figure 1

Figure 2

Figure 3A

Figure 3B

Figure 4A

Figure 4B

Figure 5A

Figure 5B

Best Mode for Carrying Out the Invention

[0046] Generally, the present invention relates to catheters 10, 10' including wetting mechanisms 20, 20' for wetting the outer surfaces of catheter tubes 12, 12'.

[0047] Figures 1 through 4B show a first embodiment of the catheter 10 of the present invention. The catheter 10 has a catheter tube 12, a funnel 16, and a gripper element 32. A sleeve 18 is provided between the funnel 16 and the gripper element 32 to surround the catheter tube 12 therebetween. In the illustrated embodiment, the sleeve is formed of a flexible material film and is coupled to the funnel 16 at a first end and to the gripper element 32 at a second end. In this way, the sleeve 18 defines an internal volume around the catheter tube 12, and a fluid may be introduced into the internal volume to wet the outer surface of the catheter tube 12.

[0048] As will be appreciated, the catheter tube 12 may be moved through the gripper element 32 during use to expose the catheter tube 12 for use by the user. Further, in Figure 1, while the catheter 10 is shown with the tip of the catheter tube 12 exposed, it is recognized that at least initially, the catheter tube 12 may be provided within the volume defined by the sleeve 18 or at least within the gripper element 32, and the tip of the catheter tube 12 is wetted using the wetting mechanism 20 and then it is possible to push the catheter tube 12 through the gripper element 32 to expose it for use.

[0049] The catheter tube 12 has a tip 13 and a distal end 14. The tip 13 includes a tip portion for inserting the catheter tube 12 into a conduit, blood vessel, passage, body cavity, etc. and removing fluid therefrom. Here, the catheter 10 has a urinary catheter 10 configured such that the tip portion can be inserted into the patient's bladder. The tip 13 of the catheter tube includes an opening (not shown) for introducing fluid into the interior of the catheter tube 12 therein. The distal end 14 of the catheter tube 12 is integrally formed within the funnel 16. Specifically, the distal end 14 of the catheter tube 12 is fixed within the funnel 16 (e.g., by suitable coupling, adhesive, or being molded together, etc.) and includes an outlet 28 that functions as an outlet for the discharged fluid from within the catheter tube 12.

[0050] A wetting mechanism 20 integrally formed with the funnel 16 is provided. The wetting mechanism 20 is provided for supplying a wetting fluid 24 onto the outer surface of the catheter tube 12. In the illustrated embodiment, the wetting mechanism 20 has a holding chamber 22 that contains the volume of the fluid 24 accommodated therein. Specifically, the fluid is accommodated within a container in the form of a sachet 25. As will be described in detail herein, the fluid 24 may be released from the sachet 25 to wet the outer surface of the catheter tube 12 during use. To enable this, the wetting mechanism 20 includes a fluid outlet 26 that is operable to release the fluid from within the holding chamber 22 into the sleeve 18.

[0051] As shown in the figure, the wetting mechanism 20 and the outlet 28 are provided in a side-by-side arrangement within the funnel 16. Specifically, the funnel has a series of walls including an outer wall 30 and an inner wall 31 that define a holding chamber 22 of the wetting mechanism 20 on the first surface side of the inner wall 31. The holding chamber 22 is surrounded by the outer wall 30 and the inner wall 31 on three sides, and an opening provided on the fourth side (the lower side in the orientation shown in the drawing, opposite to the outlet 28 for the discharged fluid from the catheter tube 12, and the outlet 28 is on the upper side in the orientation shown in the drawing) functions as the fluid outlet 26 of the wetting mechanism 20. The catheter tube 12 is disposed on the inner wall 31 opposite to the holding chamber 20 within a bore passing through the funnel 16 defined by the outer wall 30 and the inner wall 31.

[0052] As shown in the figure, the funnel 16 has a substantially triangular profile, the outlet 28 of the catheter tube 12 is located at the first vertex, and the holding chamber 22 extends between the other vertices of the funnel (see FIGS. 4A and 4B). In this way, the walls 30, 31 of the funnel 16 define the holding chamber 22 with the outer surface of the funnel 16 adjacent to the holding chamber 22. Here, the outer surface defines an interaction region 32 that can act to cause the release of the wetting fluid 24 through the fluid outlet 26 described herein by the user. The interaction region 32 is formed of a flexible material and may be depressed by a force load applied by the user, i.e., when the user compresses the funnel 16. The remaining walls of the funnel 16 are formed of a rigid material that structurally supports the funnel 16 together with the catheter tube 12, ensuring that the funnel 16 does not collapse as a whole even when compressed by the user.

[0053] FIGS. 3A to 4B show how the catheter 10 may be used operationally, specifically how the wetting mechanism 20 may be used to wet the outer surface of the catheter tube 12.

[0054] Figures 3A and 4A show the catheter 10 before activation of the wetting mechanism 20, specifically, with the sheath 25 as it is and the wetting fluid 24 contained therein. To activate the wetting mechanism 20, the user needs to compress the funnel 16 to apply an external force to the interaction region 32. As a result, sequentially, the flexible interaction region 32 is depressed and contacts the sheath 25 within the holding chamber 22 (see Figures 3B and 4B). The sheath 25 is sequentially compressed and ruptured within the holding chamber 22, and the wetting fluid 24 flows out from the holding chamber 22 through the fluid outlet 26 and is discharged. As described herein, the fluid outlet 26 has an opening within the funnel 16, so that the fluid discharged from the sheath 25 can freely flow through the fluid outlet 26. As shown in the figure, the fluid 24 is discharged into the volume defined by the sleeve 18 around the outer surface of the catheter tube 12 and is contained therein to wet the catheter tube 12 for use.

[0055] Figures 5A and 5B are diagrams showing a second embodiment of the catheter 10' according to the present invention. Unless otherwise specifically described herein, the catheter 10' is configured substantially the same as the catheter 10 shown in the previous figures. Similar reference numerals are used to identify equivalent components of the catheters 10, 10'.

[0056] The catheter 10' differs in the configuration of the wetting mechanism 20'. Specifically, the wetting mechanism 20' has a wetting fluid 24' contained within the holding chamber 22' itself, rather than in a separate container. Further, the fluid outlet of the wetting mechanism 20' takes the form of a valve 26' that can be opened and closed during use to allow or restrict the flow of the wetting fluid 24' from the holding chamber 22'.

[0057] In use, the wetting mechanism 20’ is provided in the configuration shown in FIG. 5A, the valve 26’ is closed, and the wetting fluid 24’ is retained within the holding chamber 22’. To activate the wetting mechanism 20’, the user needs to compress the funnel 16’ to apply an external force to the interaction region 32’. As a result, sequentially, the flexible interaction region 32’ is depressed, and the volume of the holding chamber 22’ decreases (see FIG. 5B). This decrease in volume (and the accompanying pressure increase) causes the valve 26’ to open, allowing the wetting fluid 24’ to flow therethrough. Similar to the catheter 10, the fluid 24’ is discharged into the volume defined by the sleeve 18’ around the outer surface of the catheter tube 12’ and is received therein to wet the catheter tube 12’ for use. When the external force applied to the interaction region 32’ is removed, the flexible interaction region 32’ returns to the configuration shown in FIG. 5A, thereby increasing the volume of the holding chamber 22’ and this time closing the valve 26’.

[0058] In a variant of the catheter 10’, the valve 26’ may be replaced by a fragile portion of the funnel 16’ that can rupture when the pressure in the holding chamber 22’ rises (i.e., when the user compresses the funnel 16’). The rupture of the fragile portion forms a permanent opening in the holding chamber 22’, allowing the wetting fluid 24’ to freely flow into the sleeve 18’. Advantageously, in this case, the user does not need to maintain the force applied to release all of the wetting fluid 24’, but only needs to compress the funnel 16’ once to rupture the fragile portion.

[0059] Conditional expressions such as "can", "might", "may", "may do", etc., generally convey that a particular embodiment includes a particular function, element, and / or procedure, and other embodiments do not, unless otherwise specified or understood in the context in which they are used. Thus, such conditional expressions generally do not imply that a feature, element, and / or procedure is in any way required in one or more embodiments, or that one or more embodiments necessarily include logic for determining whether or not these features, elements, and / or steps are included in or performed in any particular embodiment, regardless of user input or prompting.

[0060] Each of the documents mentioned above is incorporated herein by reference. Unless otherwise indicated by way of example or explicitly shown, all numerical values indicating amounts of materials, dimensions of devices, etc. in this specification are to be understood as having been modified by the word "about".

[0061] Unless otherwise specified, each chemical substance or composition referred to in this specification is to be construed as a commercially available product that may include isomers, by-products, derivatives, and other such materials that are normally understood to be included in commercially available products.

[0062] It should be noted that one or more embodiments are described above merely by way of example. Many modifications are possible without departing from the scope of protection set forth in the appended claims.

Claims

1. A catheter tube having a proximal end and a distal end, the distal end being coupled to or forming at least a portion of a funnel for discharging fluid from within the catheter tube, A sleeve provided around the catheter tube, coupled to the funnel at an end of the catheter tube, and extending toward the proximal end of the catheter tube, A wetting mechanism integrally formed with the funnel, comprising, The wetting mechanism, A holding chamber for containing a volume of fluid, A fluid outlet operable to discharge fluid from within the holding chamber into the sleeve for wetting an outer surface of the catheter tube, having, The fluid outlet has a valve arrangement, catheter.

2. The catheter according to claim 1, wherein the funnel has one or more walls that at least partially define the holding chamber.

3. The catheter according to claim 1 or 2, wherein one or more walls of the funnel at least partially define an outlet for fluid within the catheter tube.

4. The catheter according to any one of claims 1 to 3, wherein the funnel is at least partially formed of a flexible material.

5. The catheter according to claim 4, wherein the funnel is at least partially formed of a compressible material.

6. The funnel has a wall including a flexible and / or compressible portion that defines an interaction region of the funnel, The interaction region is configured to be compressed, bent, and / or flexed by a force load applied by a user, the catheter according to claim 4 or 5.

7. The catheter according to claim 6, wherein the interaction region is configured such that, in use, compression, bending, and / or flexure of the interaction region results in the release of fluid from the holding chamber through the fluid outlet.

8. The catheter according to any one of claims 1 to 7, wherein the holding chamber is defined by an inner wall and an outer wall of the funnel. Claim 9 The catheter according to any one of claims 1 to 8, wherein the valve arrangement is provided as part of the funnel and forms a closable opening within the wall of the funnel. Claim 10 The catheter according to any one of claims 1 to 9, wherein the valve arrangement is configured to open such that fluid flows through the valve arrangement in response to compression, bending, and / or flexure of the funnel. Claim 11 The catheter according to any one of claims 1 to 10, wherein the fluid outlet has a frangible portion of the funnel. Claim 12 The catheter according to claim 11, wherein the frangible portion is configured to open in response to compression, bending, and / or flexure of the funnel in use. Claim 13 The catheter according to any one of claims 1 to 12, wherein the fluid is contained within a container in the holding chamber. Claim 14 The catheter according to claim 13, wherein the container is disposed within the holding chamber and has a sachet, blister pack, or capsule for holding the fluid. Claim 15 The catheter according to claim 13 or 14, wherein the wetting mechanism is configured such that the container ruptures, divides, or otherwise fails when the funnel is compressed, bent, and / or flexed. Claim 16 Rupturing, dividing, or otherwise damaging the container results in the release of the fluid contained within the container, causing the released fluid to pass through the fluid outlet and flow into the sleeve of the catheter, as claimed in claim 15.

17. The fluid outlet has an opening within the holding chamber that allows fluid to flow freely through the holding chamber upon release from the container, as claimed in any one of claims 13 to 16.

18. The funnel has a generally triangular profile, as claimed in any one of claims 1 to 17.

19. The outlet of the catheter tube is located at the first vertex of the triangular profile of the funnel, The holding chamber extends at least partially between the other vertices, as claimed in claim 18.

20. The wetting mechanism has fluid release control components for controlling the release of fluid from the holding chamber, as claimed in any one of claims 1 to 19.

21. The fluid release control components are movable between a first position where the fluid release control components prevent the release of fluid from within the holding chamber and a second position where the fluid release control components allow the release of fluid from within the holding chamber, as claimed in claim 20.

22. Further comprising a gripper element, The funnel is coupled to the sleeve at a first end of the sleeve, The gripper element is coupled at an end opposite the sleeve, as claimed in any one of claims 1 to 21.

23. Having an intermittent urethral catheter, as claimed in any one of claims 1 to 22. **Claim 24**: The catheter according to any one of claims 1 to 23, provided in a sealed package. **Claim 25** A method of wetting a catheter according to any one of claims 1 to 24, the method comprising operating the wetting mechanism to discharge fluid from the holding chamber into the sleeve so as to wet an outer surface of the catheter tube.

Images