Catheter wetting mechanism

Abstract

The present invention relates to a wetting mechanism 20 for wetting the tube 12 of a catheter 10. The wetting mechanism 20 includes a housing 16 disposed at or proximal to the tip 13 of the catheter tube 12, the housing 16 including a holding chamber 22 and a wetting chamber 23. The wetting mechanism 20 includes a fluid release control component 26 for controlling the release of fluid in the holding chamber 22 into the wetting chamber 23. At least a portion of the catheter tube 12 is introduceable into and passable through the wetting chamber 23, wetting the catheter tube 12 during use.

Description

Technical Field

[0001] The present invention relates to a wetting mechanism for a catheter (e.g., a urethral catheter) for wetting a catheter tube during use. The present invention extends to a catheter having such a wetting mechanism and a method for wetting a catheter tube.

Background Art

[0002] A catheter is a medical device that includes a hollow catheter tube designed to be inserted into a duct, blood vessel, passageway, or body cavity to enable the injection, drainage, or extraction of liquids or substances, or to keep a duct, blood vessel, or passageway open. A urethral catheter is designed for use in inserting through the urethra into the user's bladder to drain urine from the bladder.

[0003] To maximize comfort and minimize the risk of trauma and / or infection, the outer surface of the catheter tube is usually wetted with a wetting fluid before insertion by the user. In further developments, the catheter tube itself is composed of hydrophilic components (e.g., hydrophilic polymers) that play a role in further reducing friction when applying the wetting fluid, or is integrated with hydrophilic components, or is coated with hydrophilic components.

[0004] For example, some catheters are supplied pre-wetted in a package such that they are at least partially immersed in a wetting fluid within the package. However, such an arrangement has the problem that components of the catheter other than the catheter tube, such as gripping elements and funnels, may also get wet. This has an adverse effect on the user's experience and makes it difficult to hold and orient the catheter tube as required. This is particularly problematic when the user is performing self-catheterization. Furthermore, when the catheter is immersed, the components of the catheter are exposed to moisture over a long period, which may effectively shorten the storage life of the catheter.

[0005] Therefore, it is considered advantageous to provide a catheter that can be moistened at the time of use or immediately before use.

[0006] As an attempt to address this, some catheters are supplied in a package that includes a ruptureable containment or pouch within the package, which the user can rupture to release the wet fluid. Generally, in this case, the user compresses the package to rupture the containment / pouch. However, in such a configuration, similar problems to those described above arise when it is acceptable for the wet fluid to come into contact with other components of the catheter.

[0007] Therefore, it is advantageous to provide a catheter that includes means for supplying a wet fluid only to the catheter tube in order to improve the user experience.

[0008] An object of embodiments of the present invention is to overcome, or at least partially mitigate, one or more problems of the prior art. [Overview of the Initiative]

[0009] According to one aspect of the present invention, a wetting mechanism for wetting a catheter tube is provided, the wetting mechanism comprising a housing having a holding chamber for containing a predetermined volume of fluid and a wetting chamber into which at least a portion of the catheter tube can be introduced and moved, the wetting mechanism comprising a fluid discharge control component for controlling the discharge of fluid from the holding chamber to the wetting chamber.

[0010] According to one aspect of the present invention, a wetting mechanism for wetting a catheter tube is provided, the wetting mechanism comprising a housing configured to be initially positioned at or near the tip of the catheter tube, the housing comprising a holding chamber for containing a predetermined volume of fluid, and a wetting chamber into which at least a portion of the catheter tube can be introduced and moved during use, allowing at least a portion of the catheter tube to pass through, the wetting mechanism comprising a fluid release control component for controlling the release of fluid from the holding chamber to the wetting chamber.

[0011] Advantageously, by controlling the release of fluid from the retaining chamber and keeping the fluid away from contact with other components of the catheter system, this overcomes the problems of prior art, particularly the unfavorable immersion of the catheter in the moist fluid before use. Furthermore, it improves the catheter's shelf life by reducing the exposure of most of the catheter's components to moisture until the time of use (or as far as possible). Additionally, by controlling the release of the moist fluid into the moist chamber, to which the catheter tube can move, better control is achieved over the application of the moist fluid to the outer surface of the catheter tube. This ensures sufficient humidification of the entire surface of the catheter tube before use by the user.

[0012] Any of the following features can be appropriately applied to any aspect of the present invention.

[0013] The fluid discharge control component may include a first configuration that prevents the discharge of fluid from the retaining chamber to the wet chamber. The fluid discharge control component may include a second configuration that allows the discharge of fluid from the retaining chamber to the wet chamber. The fluid discharge control component may be movable between the first and second configurations. For example, in some embodiments, the fluid discharge control component may be linearly movable between the first and second configurations. In other embodiments, the fluid discharge control component may be operable to rotate between the first and second configurations to control the flow of fluid from the retaining chamber to the wet chamber.

[0014] In some embodiments, the fluid discharge control component includes a plug. The plug may be linearly movable within the wetting mechanism between a first position and a second position. The plug may be rotatable between a first angular position and a second angular position. For example, the plug may be screw-type and may be provided within the wetting mechanism via interaction with complementary screw surfaces of the wetting mechanism. The first and second positions (or angular positions) of the plug may correspond to the first and second configurations of the fluid discharge control component.

[0015] A particularly preferred embodiment provides a wetting mechanism for wetting a catheter tube, the wetting mechanism comprising a housing configured to be initially positioned at or near the tip of the catheter tube, the housing comprising a retaining chamber for containing a predetermined volume of fluid, and a wetting chamber into which, during use, at least a portion of the catheter tube can be introduced and moved through to pass at least a portion of the catheter tube, the wetting mechanism comprising a fluid discharge control component for controlling the discharge of fluid from the retaining chamber to the wetting chamber, the fluid discharge control component comprising a first configuration for preventing the discharge of fluid from the retaining chamber to the wetting chamber, and a second configuration for enabling the discharge of fluid from the retaining chamber to the wetting chamber, the fluid discharge control component comprising a plug that is linearly movable within the wetting mechanism between a first position and a second position corresponding to the first and second configurations of the fluid discharge control component.

[0016] In some embodiments, the plug may be configured to be at least partially withdrawn from the wetting mechanism. The plug may be located within the wetting chamber of the wetting mechanism, at least in its initial state. In such embodiments, the plug may be configured to be at least partially withdrawn from the wetting chamber to cause fluid to be released from the retaining chamber into the wetting chamber. The plug may be configured to be only partially withdrawn from the wetting mechanism, i.e., not to be fully withdrawn from the wetting mechanism. The plug may remain attached to the housing or otherwise coupled, whether in a first or second position. In other embodiments, the plug may be configured to be fully withdrawn from the wetting mechanism. For example, in some embodiments, the plug may be located within the wetting chamber in its initial state and may be fully withdrawn from the wetting chamber during use to cause fluid to be released from the retaining chamber into the wetting chamber.

[0017] Another particularly preferred embodiment provides a wetting mechanism for wetting a catheter tube, the wetting mechanism comprising a housing configured to be initially positioned at or near the tip of the catheter tube, the housing comprising a retaining chamber for containing a predetermined volume of fluid, and a wetting chamber into which, during use, at least a portion of the catheter tube can be introduced and moved through to pass at least a portion of the catheter tube, the wetting mechanism comprising a fluid discharge control component for controlling the discharge of fluid from the retaining chamber to the wetting chamber, the fluid discharge control component comprising a first configuration for preventing the discharge of fluid from the retaining chamber to the wetting chamber, and a second configuration for enabling the discharge of fluid from the retaining chamber to the wetting chamber, the fluid discharge control component comprising a plug that is linearly movable within the wetting mechanism between a first and second position corresponding to its first and second configurations, the plug configured to be pulled out at least a portion from the wetting mechanism to cause the discharge of fluid from the retaining chamber to the wetting chamber.

[0018] Another particularly preferred embodiment provides a wetting mechanism for wetting a catheter tube, the wetting mechanism comprising a housing configured to be initially positioned at or near the tip of the catheter tube, the housing comprising a retaining chamber for containing a predetermined volume of fluid, and a wetting chamber into which, during use, at least a portion of the catheter tube can be introduced and moved through to pass at least a portion of the catheter tube, the wetting mechanism comprising a fluid discharge control component for controlling the discharge of fluid from the retaining chamber to the wetting chamber, the fluid discharge control component comprising a first configuration for preventing the discharge of fluid from the retaining chamber to the wetting chamber, and a second configuration for enabling the discharge of fluid from the retaining chamber to the wetting chamber, the fluid discharge control component comprising a plug that is linearly movable within the wetting mechanism between a first and second position corresponding to its first and second configurations, the plug being positioned in the wetting chamber of the wetting mechanism at least initially and configured to be at least partially withdrawn from the wetting chamber to cause the discharge of fluid from the retaining chamber to the wetting chamber.

[0019] Another particularly preferred embodiment provides a wetting mechanism for wetting a catheter tube, the wetting mechanism comprising a housing configured to be initially positioned at or near the tip of the catheter tube, the housing comprising a retaining chamber for containing a predetermined volume of fluid, and a wetting chamber into which, during use, at least a portion of the catheter tube can be introduced and moved through to pass at least a portion of the catheter tube, the wetting mechanism comprising a fluid discharge control component for controlling the discharge of fluid from the retaining chamber to the wetting chamber, the fluid discharge control component comprising a first configuration for preventing the discharge of fluid from the retaining chamber to the wetting chamber, and a second configuration for enabling the discharge of fluid from the retaining chamber to the wetting chamber, the fluid discharge control component comprising a plug that is linearly movable within the wetting mechanism between a first and second position corresponding to its first and second configurations, the plug being positioned within the wetting chamber of the wetting mechanism at least initially and configured to be at least partially withdrawn from the wetting chamber to cause the discharge of fluid from the retaining chamber to the wetting chamber, and configured not to be fully withdrawn from the wetting mechanism.

[0020] The wetting mechanism may be configured such that when the plug is at least partially withdrawn from the wetting mechanism during use, one or more fluid outlets in the retaining chamber open. The one or more fluid outlets may provide fluid communication between the retaining chamber and the wetting chamber, and when the one or more fluid outlets are opened during use, it may be possible to release fluid from the retaining chamber to the wetting chamber.

[0021] The wetting mechanism may be configured to hold the plug in a first position and / or a second position.

[0022] For example, in some embodiments, the wetting mechanism may be configured to hold the plug in a first position unless actively acted upon by the user, thereby preventing the release of fluid from the holding chamber. Advantageously, this prevents or at least reduces the possibility of premature fluid release from the holding chamber and / or exposure of the catheter tube. This ensures that the catheter tube is wetting at or as close to use as possible, thereby ensuring that the surface of the catheter tube is completely wetted. In such embodiments, the plug may be biased to the first position, and the user may be required to act against the bias to move the plug to a second position. At least a portion of the plug may contact other components of the wetting mechanism, such as a lip or projection on the surface of the housing, to prevent the plug from moving from the first position unless acted upon by the user. Such contact points may be provided between fragile parts on the plug and / or housing that are configured to break when force is applied by the user. For example, the contact point between the plug and other components may be configured such that the application of force (e.g., the user pulling the plug out of the housing) is sufficient to overcome the contact point and move the plug to the second position. The plug may "snap" or "click" as it passes the contact point, providing tactile and / or auditory feedback to the user.

[0023] In some embodiments, the wetting mechanism may be configured to hold the plug in a second position that prevents the plug from returning to a first position. Advantageously, once activated, the wetting mechanism may be configured to remain in a “used” configuration, thereby preventing the catheter and wetting mechanism from being returned to a configuration that appears unused, i.e., a configuration that appears (which may not be) that the wetting mechanism is still capable of wetting the catheter tube. This prevents, or at least reduces, the possibility of a user (accidentally or intentionally) reusing the catheter. In such embodiments, the wetting mechanism may be configured such that, in the second configuration, at least a portion of the plug is in contact with other components of the wetting mechanism (e.g., the housing) to prevent further movement of the plug.

[0024] In some embodiments, the fluid discharge control component may include a containment. The containment may be located within a holding chamber. The containment may contain a fluid. The containment may include, for example, a pouch, a blister pack, or a capsule.

[0025] A first configuration of the fluid discharge control component may correspond to a configuration in which the containment is intact and contains fluid. A second configuration of the fluid discharge control component may correspond to a configuration in which the containment is ruptured or otherwise opened to discharge fluid from the containment.

[0026] The wetting mechanism may be configured such that, during use, the housing can be ruptured or opened by the user's action on the housing itself. For example, in some embodiments, the housing is formed from a flexible, compressible, and / or elastic material, at least partially. In such embodiments, the wetting mechanism may be configured such that the housing is ruptured or otherwise opened by the user compressing, bending, and / or flexing the housing.

[0027] In other embodiments, the wetting mechanism may include a fluid release control component in the form of a plug in combination with the receiving portion. In such embodiments, the wetting mechanism may be configured such that, during use, the movement of the plug causes the receiving portion to rupture or open. For example, the wetting mechanism may be configured such that the receiving portion is compressed when the plug is (at least partially) withdrawn or when the plug rotates.

[0028] The tip of the catheter tube may be disposed outside the wetting chamber, at least in the initial state. In such embodiments, the wetting mechanism may be configured such that, during use, the tip of the catheter tube can be introduced into and move through the wetting chamber. For example, the wetting chamber may include an inlet through which the catheter tube can be introduced into the wetting chamber. In some embodiments, the wetting chamber may include an outlet through which the catheter tube can be withdrawn from the wetting chamber.

[0029] In some embodiments, the wetting mechanism may be configured such that the fluid released from the holding chamber into the wetting chamber is retained therein and wets the catheter tube as the catheter tube passes therethrough during use. For example, in some embodiments, the wetting mechanism may include a valve device. The valve device may be provided at the inlet and / or outlet of the wetting chamber to retain the fluid contained therein. The valve device may be configured such that the catheter can pass therethrough during use.

[0030] In some embodiments, the wetting mechanism is configured to be coupled to the sleeve. The wetting mechanism may be configured to be coupled to the sleeve, and in turn the sleeve can couple the wetting mechanism to the funnel, for example, the funnel is provided at the end of the catheter tube or is integrally formed with the catheter tube. The wetting mechanism may be configured such that the fluid released into the wetting chamber can flow into the sleeve and along the sleeve to wet the catheter tube. For example, the wetting chamber may include therein an opening that allows the fluid in the wetting chamber to flow into the coupled sleeve and along the sleeve. The opening may be an inlet to the catheter tube.

[0031] In some embodiments, the fluid release control component may be configured to prevent the insertion of the catheter tube into and / or through the wetting chamber. For example, in some embodiments, the fluid release control component, in a first configuration, i.e., before the fluid is released from the holding chamber into the wetting chamber, may be configured to prevent the insertion of the catheter tube into and / or through the wetting chamber. Advantageously, by preventing premature insertion of the catheter tube and / or movement through the wetting chamber, it can be ensured that the catheter tube cannot be used without the application of the wetting fluid. To achieve this, the fluid release control component may be configured to at least partially block the inlet for the catheter tube when in the first configuration. For example, in some embodiments, a part of the fluid release control component may be at least partially received within the inlet for the catheter tube to prevent the insertion of the catheter tube into the wetting chamber. A part of the fluid release control component may include a flexible, compressible, and / or elastic material, which may be compressed within the inlet for the catheter tube in the state of the fluid release control component in the first configuration.

[0032] The fluid discharge control component may be configured such that, when the fluid discharge control component is switched to a second configuration (e.g., moved), insertion of the catheter tube into and / or through the moist chamber is possible in the second configuration. In other words, switching / moving the fluid discharge control component to a second configuration may perform both the action of discharging fluid from within the retaining chamber and the action of removing an obstacle to the insertion and / or movement of the catheter tube through the moist chamber.

[0033] In some embodiments, the wetting mechanism includes a wetting application section. The wetting application section may be located within the wetting chamber. The wetting application section may be configured to hold the fluid released from the holding chamber into the wetting chamber. The wetting application section may be configured to control the application of fluid to the catheter tube as it passes through the wetting chamber during use.

[0034] A particularly preferred embodiment provides a wetting mechanism for wetting a catheter tube, the wetting mechanism comprising a housing configured to be initially positioned at or near the tip of the catheter tube, the housing comprising a retaining chamber for containing a predetermined volume of fluid, and a wetting chamber into which, during use, at least a portion of the catheter tube can be introduced and moved through to pass at least a portion of the catheter tube, the wetting mechanism comprising a fluid release control component for controlling the release of fluid from the retaining chamber to the wetting chamber, and the wetting mechanism comprising a wetting application section positioned within the wetting chamber and configured to hold the fluid released from the retaining chamber into the wetting chamber.

[0035] Another particularly preferred embodiment provides a wetting mechanism for wetting a catheter tube, the wetting mechanism comprising a housing configured to be initially positioned at or near the tip of the catheter tube, the housing comprising a retaining chamber for containing a predetermined volume of fluid, and a wetting chamber into which, in use, at least a portion of the catheter tube can be introduced and moved through to pass at least a portion of the catheter tube, the wetting mechanism comprising a fluid discharge control component for controlling the discharge of fluid from the retaining chamber to the wetting chamber, and the wetting mechanism comprising a wetting application unit disposed within the wetting chamber configured to hold the fluid discharged from the retaining chamber to the wetting chamber, the wetting application unit configured to control the application of fluid to the catheter tube as the catheter tube passes through the wetting chamber in use.

[0036] The wet application section may include an absorbent material. For example, in some embodiments, the wet application section includes a sponge, foam, or wicking material that is capable of absorbing the wet fluid during use. In other embodiments, the wet application section may include a baffling device. The baffling device may define a plurality of sub-regions of the wet application section, each configured to hold a portion of the fluid held within the wet application section.

[0037] The wetting application section may define a channel within the wetting chamber. The wetting application section may define a channel within the wetting chamber through which a catheter tube can pass during use. The wetting mechanism may be configured to move in contact with the wetting application section as the catheter tube moves within the wetting chamber (for example, as it moves along the channel defined by the wetting application section). In embodiments, the wetting application section may preferably be configured to automatically release fluid so that any fluid held within the wetting application section can be released from it as the catheter tube moves through the wetting chamber.

[0038] Another particularly preferred embodiment provides a wetting mechanism for wetting a catheter tube, the wetting mechanism comprising a housing configured to be initially positioned at or near the tip of the catheter tube, the housing comprising a retaining chamber for containing a predetermined volume of fluid, and a wetting chamber into which, in use, at least a portion of the catheter tube can be introduced and moved through to pass at least a portion of the catheter tube, the wetting mechanism comprising a fluid release control component for controlling the release of fluid from the retaining chamber to the wetting chamber, the wetting mechanism comprising a wetting application section configured to be located within the wetting chamber and to hold the fluid released from the retaining chamber to the wetting chamber, the wetting application section configured to control the application of fluid to the catheter tube as the catheter tube passes through the wetting chamber in use, the wetting application section defining a channel through which the catheter tube can pass through the wetting chamber in use, and the wetting application section configured such that the fluid held within the wetting application section can be released from there as the catheter tube moves through the channel.

[0039] 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, or up to 7.5 ml, or up to 10 ml of wet fluid.

[0040] In embodiments, the housing may form a gripping element for the catheter. During use, the gripping element may be used by the user to control the application of the catheter. For example, the gripping element can be used to hold the catheter tube close to the urethra to help guide the catheter tube without the user touching the tube itself. In embodiments, the housing may have a conical shape. A conical shape may be advantageous if the housing therein forms a gripping element for the catheter.

[0041] In embodiments where the fluid discharge control component includes a plug, the plug may have a conical shape. The plug may have a hollow or substantially hollow interior. When combined with a conical shape, such a plug may form a cup-shaped element that helps locate the catheter tube during use. This cup can be used, for example, to position the housing at the tip of the penis so that the catheter tube can be easily inserted into the urethra immediately after wetting.

[0042] In some embodiments, both the housing and the plug form a conical shape. In such embodiments, the wetting mechanism may be configured such that the housing and plug together form a substantially hourglass shape. The hourglass shape may be particularly advantageous in that it allows the user to move the wetting mechanism, i.e., remove (or at least partially remove) the plug from the housing with only one hand.

[0043] According to one aspect of the present invention, a catheter is provided comprising a catheter tube having a tip and a terminal, and a wetting mechanism of any of the aforementioned aspects operably coupled to the tip or proximal to the catheter tube for wetting the catheter tube during use.

[0044] The catheter may include a funnel. The funnel may be located at or near the end of the catheter tube. The funnel may include a fluid outlet for draining fluid from inside the catheter tube.

[0045] In embodiments, the catheter includes a sleeve. The sleeve may be positioned around the catheter tube. In embodiments, the sleeve may define an internal volume around at least a portion of the catheter tube. The sleeve may include a flexible material. The sleeve may be thin and easily crumpled. For example, the sleeve may be formed from a film of a plastic material, such as low-density polyethylene.

[0046] The sleeve may be coupled to a wetting mechanism. For example, the sleeve may be coupled to a wetting mechanism at a first end. In such an embodiment, the sleeve may be coupled at a second opposite end to a funnel located at or near the end of the catheter tube. In this way, the sleeve may define the internal volume around the catheter tube between the wetting mechanism located at or near the tip of the catheter tube and the funnel located at or near the end of the catheter tube.

[0047] The catheter may be configured such that the fluid released into the wetting chamber of the wetting mechanism flows into the sleeve during use and along the sleeve to wet the catheter tube. For example, in some embodiments, the housing of the wetting mechanism includes a hole or opening within it that allows the fluid in the wetting chamber to flow into the sleeve.

[0048] The catheter may be a urethral catheter. The catheter may be a female urethral catheter, but is preferably a male urethral catheter. The catheter may be a single-use catheter. The catheter may be an intermittent urethral catheter.

[0049] The catheter tube may have a maximum length of 35 cm (or more in some cases). The catheter tube may also have lengths of, for example, a maximum or minimum of 20 cm, a maximum or minimum of 25 cm, a maximum or minimum of 30 cm, a maximum or minimum of 35 cm, or a maximum or minimum of 40 cm. In embodiments, the catheter tube may be 40 cm or longer. In preferred embodiments, the catheter tube is between 25 and 35 cm in length. Male catheters typically have catheter tubes of such lengths, and since the fluid may not adequately cover the entire length of the tube, a mechanism for wetting the catheter tube from the end (opposite to the tip, as in the present invention) would not be very suitable. As a result, the tip may be the last to get wet (or not wet at all if there is insufficient fluid), which is undesirable because the tip is the first to be introduced into the urethra and is likely to cause injury if not adequately wet before use. Therefore, the present invention is particularly suitable for male catheters.

[0050] The catheter tube may include hydrophilic components, be integrated with hydrophilic components, or be coated with hydrophilic components. The hydrophilic components may be configured to provide a low-friction surface (e.g., the outer surface) of the catheter tube when a wet fluid is applied. The hydrophilic components may include, for example, a hydrophilic polymer.

[0051] According to one aspect of the present invention, a sealed packaged catheter of the present invention is provided, wherein a wetting mechanism is operably coupled to the tip or proximal to the catheter tube within the sealed package.

[0052] According to one aspect of the present invention, a method is provided for wetting a catheter tube using any of the wetting mechanisms described herein, the method comprising the steps of: operating a fluid discharge control component to cause a fluid discharge from a holding chamber to a wetting chamber; and introducing the tip of a catheter tube into the wetting chamber and moving it therein to wetting at least a portion of the outer surface of the catheter tube.

[0053] Operating the fluid discharge control component may include moving the fluid discharge control component from a first configuration that prevents the discharge of fluid from the retaining chamber to the wet chamber, to a second configuration that allows the discharge of fluid from the retaining chamber to the wet chamber.

[0054] In some embodiments, the fluid discharge control component includes a plug, and the method may include at least partially withdrawing the plug from the wetting mechanism to operate the fluid discharge control component. The method may include at least partially withdrawing the plug from the wetting chamber to cause the fluid to be discharged from the retaining chamber to the wetting chamber. The method may also include completely withdrawing the plug from the wetting mechanism to allow the fluid to be discharged from the retaining chamber to the wetting chamber.

[0055] The fluid release control component may include a housing such as a pouch, blister pack, or capsule, and the method may include rupturing or opening the housing to release the fluid therefrom. This method may include compressing, bending, and / or flexing the housing to rupture the housing or opening it in any other way.

[0056] In other embodiments, the wetting mechanism may include a fluid release control component in combination with the containment that takes the form of a plug, and the method may include at least partially withdrawing the plug from the wetting mechanism to rupture or open the containment. For example, this method may include compressing the containment within a retaining chamber when at least partially withdrawing the plug from the wetting mechanism. [Brief explanation of the drawing]

[0057] [Figure 1] A schematic diagram of the first embodiment of the present invention. [Figure 2] A schematic side cross-sectional view of section A in Figure 1. [Figure 3A] A series of schematic cross-sectional views illustrating the operation of the embodiment shown in the previous figure. [Figure 3B] A series of schematic cross-sectional views illustrating the operation of the embodiment shown in the previous figure. [Figure 3C] A series of schematic cross-sectional views illustrating the operation of the embodiment shown in the previous figure. [Figure 4A] A series of other schematic cross-sectional views illustrating other usage operations of the embodiment shown in the previous figure. [Figure 4B] A series of other schematic cross-sectional views illustrating other usage operations of the embodiment shown in the previous figure. [Figure 4C] A series of other schematic cross-sectional views illustrating other usage operations of the embodiment shown in the previous figure. [Figure 5A] A series of schematic cross-sectional views illustrating the operation of a second embodiment of the present invention. [Figure 5B] A series of schematic cross-sectional views illustrating the operation of a second embodiment of the present invention. [Figure 5C] A series of schematic cross-sectional views illustrating the operation of a second embodiment of the present invention. [Figure 6A] A series of schematic cross-sectional diagrams illustrating the operation of the third embodiment of the present invention. [Figure 6B] A series of schematic cross-sectional diagrams illustrating the operation of the third embodiment of the present invention. [Figure 6C] A series of schematic cross-sectional diagrams illustrating the operation of the third embodiment of the present invention. [Figure 7A] A series of schematic cross-sectional diagrams illustrating the operation of the fourth embodiment of the present invention. [Figure 7B] A series of schematic cross-sectional diagrams illustrating the operation of the fourth embodiment of the present invention. [Figure 7C] A series of schematic cross-sectional diagrams illustrating the operation of the fourth embodiment of the present invention. [Figure 8A] A series of schematic cross-sectional diagrams illustrating the operation of the fifth embodiment of the present invention. [Figure 8B] A series of schematic cross-sectional diagrams illustrating the operation of the fifth embodiment of the present invention. [Figure 8C] A series of schematic cross-sectional diagrams illustrating the operation of the fifth embodiment of the present invention. [Figure 9] A perspective view showing a sixth embodiment of the present invention. [Figure 10A] A pair of side views illustrating the operation of the embodiment shown in Figure 9. [Figure 10B] A pair of side views illustrating the operation of the embodiment shown in Figure 9. [Modes for carrying out the invention]

[0058] Next, to better understand the present invention, one or more embodiments will be described simply as examples with reference to the accompanying drawings.

[0059] In general, the present invention relates to catheters 10, 310, and more specifically to wetting mechanisms 20, 20', 120, 220, 220', 320 configured for wetting the tubes 12, 312 of catheters 10, 310 during use.

[0060] The drawings illustrate a series of embodiments of the present invention. Where equivalent components exist between embodiments, the same reference numerals are used.

[0061] Figures 1-4C show a first embodiment of a wetting mechanism 20 used to wet the tube 12 of the catheter 10.

[0062] The catheter 10 includes a catheter tube 12, the tip (proximal end) 13 of the catheter tube 12 is provided with a wetting mechanism 20, and the end 14 of the catheter tube 12 is provided with a funnel 30. Between the wetting mechanism 20 and the funnel 30, a sleeve 18 is provided so as to surround the catheter tube 12. The sleeve 18 is made of a flexible material and is coupled at a first end to the housing 16 of the wetting mechanism 20 and at a second end to the funnel 30. In this way, the sleeve 18 defines an internal volume around the catheter tube 12 into which fluid can be introduced to wet the outer surface of the catheter tube 12.

[0063] As described above, the catheter tube 12 has a tip 13 and a terminal 14. The tip 13 includes a tip portion for inserting the catheter tube 12 into a conduit, blood vessel, passage, or body cavity, etc., and removing fluid from there. Here, the catheter 10 is a male urethral catheter 10 configured so that its tip is inserted into the bladder of a male patient. The tip 13 of the catheter tube contains a hole 34 for introducing fluid into the inside of the catheter tube 12. The terminal 14 of the catheter tube 12 is located within a funnel 30. Specifically, the terminal 14 of the catheter tube 12 is located within the funnel 30 and opens into the funnel 30, and the funnel 30 defines a fluid outlet 32 ​​that functions as an outlet for draining fluid from inside the catheter tube 12. The catheter tube 12 itself includes a hydrophilic coating, which acts to provide a low-friction outer surface of the catheter tube 12 when wet fluid is applied.

[0064] The wetting mechanism 20 includes a tubular housing 16 positioned at the tip 13 of the catheter tube 12 (at least in the initial state). This housing 16 includes a retaining chamber 22, which contains a predetermined volume of fluid 24 for wetting the catheter tube 12. During use, as described herein, the fluid 24 may be released from the retaining chamber 22 through an opening 27 in the housing 16 into the wetting chamber 23 of the housing. The wetting chamber 23 defines a separate tubular portion of the housing 16 into which at least a portion of the catheter tube 12 can be introduced and moved. Thus, the outer surface of the catheter tube 12 can be wetted by the fluid 24 by releasing the fluid 24 into the wetting chamber 23 and then moving the catheter tube 12 through the wetting chamber 23.

[0065] The wetting mechanism 20 includes a fluid discharge control component in the form of a plug 26. As described herein, the plug 26 is configured to control the discharge of fluid 24 from the retaining chamber 22 to the wetting chamber 23. In the illustrated embodiment, the plug 26 is substantially cylindrical and defines an outlet 28 of the housing 16 into which the catheter tube 12 can be moved during use, but other shapes are equally applicable. As shown in Figures 1-3A, the plug 26 is initially positioned in the wetting chamber 23 such that a portion of it blocks the opening 27. This is referred here as the first position or first configuration of the plug 26 and corresponds to a position that prevents the discharge of fluid 24 from the wetting chamber 23. A lip 29 is provided at the end of the plug 26 that defines a point of action for the user, specifically to provide a leverage for the user to grasp the lip 29 and move the plug 26.

[0066] Figures 3A and 3B illustrate the operation of the wetting mechanism 20 in the horizontal direction. As described above, in the initial state, the wetting mechanism 20 is provided in a first configuration in which the plug 26 is in a first position that blocks the opening 27 (Figure 3A). To operate the wetting mechanism 20, the plug 26 is partially displaced from the wetting chamber 23 to a second position (i.e., pulled out) (Figure 3B). In doing so, the plug 26 moves to a position where the opening 27 is no longer blocked, allowing the fluid 24 to be released from the holding chamber 22 into the wetting chamber 23. Fluid outflow (or at least significant outflow) from the outlet 28 of the housing 16 is prevented because the supplied wetting fluid 24 is relatively small (about 2.5 ml) and due to the surface tension of the fluid 24 itself. The outer circumferential surface of the plug 26 is provided with notches 36 to define the range in which the plug 26 can be removed from the wetting chamber 23. Specifically, the notch 36 provides a contact point between the plug 26 and the flange 38 extending circumferentially inward at the end of the housing 16.

[0067] The catheter tube 12 then passes through the moist chamber 23, and the catheter tube 12 comes into contact with the moist fluid 24. Thus, the outer surface of the catheter tube 12 can be moistened. When the tip 13 of the catheter tube 12 moves over the lip 29 of the plug 26 and exits through the outlet 28 of the housing 16, the tip 13 becomes exposed for insertion by the user. The housing 16 then functions as a gripping element for the user to orient the catheter tube 12 during use. The user can then easily orient the exposed tip 13 of the catheter tube 12 using the housing 16 without directly touching the tube 12.

[0068] Figures 4A-4C illustrate other operating procedures for the wetting mechanism 20 shown in the previous figure. Specifically, referring first to Figure 4A, the housing 16 is held vertically with the plug 26 in a first position that prevents the release of the wetting fluid 24 from the retaining chamber 22. Next, the plug 26 is pulled out of the wetting chamber 23 in the same manner as described above, releasing the blockage of the opening 27 and thereby releasing the wetting fluid 24 (Figure 4B). With the housing 16 held in this direction, the wetting fluid 24 is released into the wetting chamber 23 and then into the sleeve 18 and around the outer surface of the catheter tube 12. In this way, the wetting fluid 24 flows along the sleeve 18, thereby wetting the catheter tube 12. The catheter tube 12 then moves within the wetting chamber 23, over the lip 29 of the plug 26, exposing its tip 13 for insertion by the user. Even in this case, the housing 16 functions as a gripping element for the user to direct the catheter tube 12 when it is led out through the housing 16 and introduced into the urethra during use.

[0069] Figures 5A–5C show modified examples of the wetting mechanism 20. Specifically, these figures show a wetting mechanism 20' configured substantially similarly to the wetting mechanism 20 shown in the previous figure. The wetting mechanism 20' differs in that it further includes a wetting application section in the form of a foam conduit 40' located within the wetting chamber 23'. As will be described in detail here, the foam conduit is configured to hold the fluid released from the holding chamber 22' into the wetting chamber 23' and, during use, to control the application of the fluid to the catheter tube 12 as it passes through the wetting chamber 23'.

[0070] The wetting mechanism 20' functions essentially the same as the wetting mechanism 20 and has a fluid release control component provided in the form of a plug 26' that is movable between two positions to control the release of the wetting fluid 24' from the retaining chamber 22'. Here, when the plug 26' moves to the second position, thereby releasing the opening 27', the fluid 24' contained in the retaining chamber 22' is released into the foam conduit 40'. The foam conduit 40' holds the fluid 24' released therein for subsequent application to the catheter tube 12. Specifically, the foam conduit 40' defines a channel within the wetting chamber 23' through which the catheter tube 12 can move and come into contact with the foam conduit 40'. The foam conduit 40' is configured such that the fluid held therein is released as the catheter tube 12 moves through the defined channel by contacting the foam conduit 40' and applying pressure to it. This type of wetting application section is advantageous in that it ensures that the wetting fluid 24' is applied uniformly to the entire outer surface of the catheter tube 12, thereby reducing the possibility of spillage.

[0071] Figures 6A to 6C show other embodiments of the wetting mechanism 120 according to the present invention for wetting the outer surface of the catheter tube 12.

[0072] Similar to the wetting mechanism 20, the wetting mechanism 120 includes a housing 116 positioned at the tip 13 of the catheter tube 12 (at least in the initial state). The housing 116 also includes a holding chamber 122 containing a predetermined volume of fluid 124 for wetting the catheter tube 12, and a wetting chamber 123 from which the fluid 124 can be released (specifically through an opening 127 in the housing 116). In this case as well, the wetting chamber 123 defines a separate portion of the housing 116, through which at least a portion of the catheter tube 12 can be introduced and passed.

[0073] The wetting mechanism 120 differs in that the fluid release control component in this embodiment is provided in the form of a plug 126 that must be completely removed from the chamber 123 in order to release the fluid 124 and allow the catheter tube 12 to pass through the chamber 123. In particular, the plug 126 is initially positioned as shown in Figure 6A and is almost completely contained within the wetting chamber 123 of the housing 116. In this position, the opening 127 of the housing 116 is closed, preventing the release of the fluid 123 from the retaining chamber 122. This is referred to here as the first position or first configuration of the plug 126. When in use, the plug 126 is removed from the wetting chamber 123 and the fluid 124 is released into the wetting chamber 123. This is done by the user grasping the working portion 129 of the plug 126 and pulling the plug 126 out of the wetting chamber 123 (see Figure 6B). When the plug 126 is removed, the outlet 128 of the housing 116 opens, which allows the catheter tube 12 to be exposed when in use. Similar to the wetting mechanism 20, the catheter tube 12 is passed through the wetting chamber 123 via the outlet 128, wetting the outer surface of the catheter tube 12 and exposing the tip 13 for user insertion. In this case as well, the housing 116 functions as a gripping element for the user to orient the catheter tube 12 during use.

[0074] Figures 7A to 7C show other embodiments of the wetting mechanism 220 according to the present invention for wetting the outer surface of the catheter tube 12.

[0075] Similar to the wetting mechanisms 20 and 120, the wetting mechanism 220 includes a housing 216 positioned at the tip 13 of the catheter tube 12 (at least in the initial state). The housing 216 also includes a retaining chamber 222 containing a predetermined volume of fluid 224 for wetting the catheter tube 12, and a wetting chamber 223 from which the fluid 124 can be released (specifically through an opening 227 in the housing 216). The wetting chamber 223 also defines a separate portion of the housing 216, through which at least a portion of the catheter tube 12 can be introduced and passed.

[0076] The wetting mechanism 220 differs in that the fluid release control component in this embodiment is provided in the form of a fluid plug housing, specifically in the form of a pouch 226 that must be ruptured to release the fluid 224 into the wetting chamber 223. Specifically, the pouch 226 is provided intact in the configuration shown in Figure 7A in its initial state, i.e., with the fluid contained therein. During use, the user ruptures the pouch 226 by applying an external force to the housing 216, i.e., by squeezing the housing 216 (as metaphorically shown in Figure 7B). The pouch 226 may be formed of a deformable material or may have a deformable portion that can be squeezed. Upon rupture of the pouch 226, the fluid contained therein is released into the wetting chamber 223 through an opening 227 provided in the housing 216. Similar to the wetting mechanisms 20 and 120, the catheter tube 12 then passes through the wetting chamber 223 via the outlet 128 at the end of the housing 216, wetting the outer surface of the catheter tube 12 and exposing the tip 13 for user insertion. In this case as well, the housing 216 functions as a user gripping element for orienting the catheter tube 12 during use.

[0077] Figures 8A-8C show a modified version of the wetting mechanism 220. The wetting mechanism 220' differs in that it additionally includes a wetting application section in the form of a foam conduit 240'. Similar to the foam conduit 40', the foam conduit 240' is configured to hold the fluid released from the holding chamber 222' and to control the application of the fluid to the catheter tube 12 as the catheter tube 12 passes through the housing 216' during use. The wetting mechanism 220' functions essentially the same as the wetting mechanism 220 and has a fluid release control component provided in the form of a burstable pouch 226' that controls the release of the wetting fluid 224'. During use, when the pouch 226' is burst, the fluid 224' contained in the pouch 226' is released into the foam conduit 240' that holds the fluid 224' for subsequent application to the catheter tube 12. Here, the small bag 226' defines the retaining chamber 222', and the foamed conduit 240' defines the moist chamber 223' through which the catheter tube 12 can pass during use.

[0078] Figures 9-10B show other embodiments relating to the catheter 310 and a wetting mechanism 320 that can operate to wet the tube 312 of the catheter 310 during use.

[0079] Similar to catheter 10, catheter 310 includes a catheter tube 312, with a wetting mechanism 320 provided at the tip 313 of the catheter tube 312 and a funnel 330 provided at the end 314 of the catheter tube 312. Between the wetting mechanism 320 and the funnel 330, a sleeve 318 is provided so as to surround the catheter tube 12.

[0080] The tip 313 of the catheter 310 includes a tip for inserting the catheter tube 312 into a conduit, blood vessel, passage, or body cavity and removing fluid from there. Here, the catheter 310 is a male urinary catheter 310 whose tip is configured for insertion into the bladder of a male patient. The end 314 of the catheter tube 312 is located within a funnel 330. Specifically, the end 314 of the catheter tube 312 is located within the funnel 330 and opens into the funnel 330, defining a fluid outlet 332 that serves as an outlet for draining fluid from within the catheter tube 312. The funnel 330 is shaped to assist the user in controlling the direction of fluid drainage from the catheter tube 312. The catheter tube 312 itself includes a hydrophilic coating, which acts to provide a low-friction outer surface of the catheter tube 312 upon application of a wet fluid.

[0081] The wetting mechanism 320 has a similar configuration to the wetting mechanism 20 described herein and may have the same characteristics as the embodiment in Figures 1-5C or Figures 7A-8C. The wetting mechanism 320 includes a housing 316 positioned at the tip 313 of the catheter tube 312 (at least in the initial state). The housing 316 includes a retaining chamber (not shown) containing a predetermined volume of fluid for wetting the catheter tube 312. During use, as described herein, the fluid may be released from the retaining chamber of the housing 316 into the wetting chamber (not shown) under the operation of the plug 326. As in other embodiments described herein, the outer surface of the catheter tube 312 can be wetted with fluid by releasing the fluid into the wetting chamber and then moving the catheter tube 312 through the wetting chamber. The plug 326 is movable from the position shown in Figure 10A (first position) to the position shown in Figure 10B (second position) to release the fluid from the retaining chamber. Specifically, the movement of the plug 326 between these positions allows, for example, the blockage of the opening in the housing 316 to be released, or the sac to burst, thereby enabling the fluid to be released from the holding chamber.

[0082] In this embodiment, the plug 326 has a conical cross-section, with a raised outer surface defining the working surface for the user. The housing 316 also has a substantially conical shape and is positioned to define the hourglass configuration of the housing 316 and plug 326. This arrangement is particularly beneficial as it allows the plug 326 to be operated using only one hand, as shown in Figures 10A and 10B. Specifically, as shown in these figures, the user can grasp the housing 316 and plug 326 between their thumb and index finger, and then use their thumb to push or "pop" the plug 326 upward (in the direction shown in the figures) to release the fluid. Furthermore, the conical plug 326 has a cup-like end, which facilitates positioning the housing 316 on the tip of the penis to assist in the insertion of the catheter tube 312 into the urethra during use.

[0083] In a modified version, the fluid discharge control component (e.g., plugs 26, 126, 326) may be rotatable between a first position and a second position (between a first configuration and a second configuration) to control the discharge of the wet fluid. For example, rotation (not linear motion) of plugs 26, 126, 326 may align the openings within the plugs, releasing the blockage of the openings 27, 127 or valves within the housings 16, 116, 316, and allowing the discharge of the wet fluid.

[0084] In a modified version, the wetting mechanism (e.g., mechanism 20) may be configured to hold the plug 26 in a first and / or second position. For example, the wetting mechanism 20 may be configured to hold the plug 26 in the first position and prevent the release of fluid from the holding chamber 22 unless actively operated by the user. This may be provided, for example, in the form of a contact between a fragile portion of the plug 26 and / or housing 16 configured to break when force is applied by the user. In this way, the plug 26 may "snap" or "click" as it moves over the contact to provide the user with tactile and / or auditory feedback. In the second position, the wetting mechanism 20 may be configured such that at least a portion of the plug 26 is in contact with other parts of the wetting mechanism (e.g., housing 16) to prevent further movement of the plug 26 and thereby prevent the plug 26 from returning to the first position.

[0085] In a modified example, the wetting mechanism 20, 20', 120, 220, 320 of the present invention may include both a plug (e.g., plug 26) and a burstable containment (e.g., sack 226). Herein, the wetting mechanism may be configured to burst the containment through compression upon (at least partially) pulling out the plug or upon rotation of the plug.

[0086] In a modified example, the housing (e.g., housing 16) may include a valve device to prevent the wet fluid from being released from the housing. For example, the housing may have a valve device at the inlet and / or outlet. The valve device may be configured to allow the catheter tubes 12,312 to pass through it.

[0087] In a modified example, the fluid discharge control component (e.g., plugs 26, 126, 326) may be configured to prevent the insertion of a catheter tube into and / or through the wet chamber when it is in a first position, i.e., before the fluid is discharged from the holding chamber to the wet chamber. This may include, for example, the fluid discharge control component at least partially blocking the inlets for the catheter tubes 12, 312.

[0088] In a modified version, the wet application section includes a sponge or wicking material capable of absorbing the wet fluid during use, or includes a baffling device.

[0089] Conditional language such as “can,” “may,” “may,” or “may,” unless otherwise specified or understood within the context in which they are used, is generally intended to convey that a particular embodiment includes certain features, elements, and / or steps, while other embodiments do not. Therefore, such conditional language is not generally intended to imply that features, elements, and / or steps are required in some way to one or more embodiments, or that one or more embodiments necessarily include logic for determining whether these features, elements, and / or steps are included in or performed in any particular embodiment, with or without user input or prompting.

[0090] One or more embodiments are described above only as examples. Many modifications are possible without departing from the scope of protection provided by the appended claims. [Explanation of Symbols]

[0091] 10 Catheters 12 Catheter tube (tube) 13 Tip 14 Terminal 16 Housing 18 sleeves 20,20' Wetting mechanism 22,22' Holding Chamber 23,23' Wet chamber 24,24' Wet fluid 26 Fluid discharge control components 26,26' plug 27,27' Opening 28 Exit 29 Lip 30 Funnel 32 Fluid outlet 34 holes 36 Notches 38 Flange 40' foam conduit 116 Housing 120 Wetting Mechanism 122 Holding Chamber 123 Wet Chamber 124 Fluid 126 plug 127 Opening 128 Exit 129 Acting part 216 housing, 216' housing 220,220' Wetting mechanism 222,222' Holding Chamber 223,223' Wet Chamber 224,224' fluid 226,226' sachet 227 Opening 240' foam conduit 310 Catheter 312 Catheter tube 313 Tip 314 Terminal 316 Housing 318 sleeves 320 Wetting Mechanism 326 Plug 330 Funnel 332 Fluid outlet

Claims

1. A wetting mechanism for wetting a catheter tube, The catheter tube comprises a housing configured to be initially positioned at or near the tip of the catheter tube, The aforementioned housing is A holding chamber for containing a predetermined volume of fluid, A moist chamber is provided in which, during use, at least a portion of the catheter tube can be introduced and moved through, allowing at least a portion of the catheter tube to pass through. Equipped with, The wetting mechanism includes a fluid discharge control component for controlling the discharge of fluid from the holding chamber to the wetting chamber, The fluid discharge control component includes a first configuration that prevents the discharge of fluid from the holding chamber to the wet chamber. The fluid discharge control component includes a second configuration that enables the discharge of fluid from the holding chamber to the wet chamber, The fluid discharge control component includes a plug that is linearly movable within the wetting mechanism between a first position and a second position corresponding to the first and second configurations of the fluid discharge control component. The plug is configured to be at least partially withdrawn from the wetting mechanism to cause the release of fluid from the retaining chamber to the wetting chamber, The plug is configured so that it cannot be completely withdrawn from the wetting mechanism. The plug is cylindrical and comprises a wetting mechanism that defines an outlet through which the catheter tube passes.

2. The wetting mechanism according to claim 1, wherein the plug is located in the wetting chamber of the wetting mechanism at least in an initial state and is configured to be at least partially drawn out of the wetting chamber to cause the release of fluid from the holding chamber to the wetting chamber.

3. The fluid discharge control component includes a fluid containment section located within the holding chamber. The wetting mechanism according to claim 1 or 2, wherein the first configuration of the fluid discharge control component corresponds to a configuration in which the containment portion contains the fluid as is, and the second configuration of the fluid discharge control component corresponds to a configuration in which the containment portion is ruptured or opened to discharge fluid from the containment portion.

4. The wetting mechanism according to claim 3, wherein the wetting mechanism is configured such that, during use, the housing can be opened by a user's action on the housing, either by rupturing or by other means.

5. The wetting mechanism according to claim 4, wherein the housing is at least partially formed from a flexible, compressible, and / or elastic material, and the wetting mechanism is configured such that the user can burst the housing or otherwise open it by compressing, bending, and / or flexing the housing.

6. The wetting mechanism according to any one of claims 1 to 5, wherein the tip of the catheter tube is positioned outside the wetting chamber at least in the initial state, and the wetting mechanism is configured so that the tip of the catheter tube is introduced into the wetting chamber and can move within it when in use.

7. The wetting mechanism according to any one of claims 1 to 6, wherein the wetting mechanism is configured such that, during use, a fluid released from the holding chamber into the wetting chamber to wet the catheter tube moving within the wetting chamber is retained within the holding chamber.

8. A wetting mechanism according to any one of claims 1 to 7, configured to be coupled to a sleeve, wherein a fluid released into the wetting chamber flows into the coupled sleeve during use to wet the catheter tube along the sleeve.

9. The wetting mechanism according to any one of claims 1 to 8, wherein the fluid discharge control component is configured in the first configuration to prevent the catheter tube from being inserted into and / or through the wetting chamber, and in the second configuration to allow the catheter tube to be inserted into and / or through the wetting chamber.

10. The wetting mechanism according to any one of claims 1 to 9, wherein the wetting mechanism is configured to hold the plug in the second position and to prevent the plug from returning to the first position.

11. It includes a wetting application unit configured to hold the fluid released from the holding chamber into the wetting chamber and disposed within the wetting chamber, The wetting mechanism according to any one of claims 1 to 10, wherein the wetting application section is configured to control the application of fluid to the catheter tube when the catheter tube passes through the wetting chamber during use.

12. A catheter tube having a tip and an end, A wetting mechanism according to any one of claims 1 to 11, which is operably coupled to the tip or proximal to the catheter tube for wetting the catheter tube during use, A catheter equipped with [a specific feature / equipment].

13. The catheter according to claim 12, which is a male urinary catheter.

14. A sealed packaged catheter, The catheter according to claim 12 or 13, wherein the wetting mechanism is operably coupled to the tip or proximal to the catheter tube within the sealed package.

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