Hydrophilic urinary catheter having a wetting receptacle to apply lubrication for fitting

SWEDEN (12) PATENT (13) C2 (11) 522 331 (19) SE (si)

International class ⁷

A61M 25/01, A61F 5/44

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PATENT AND REGISTRATION (45) (41) (22) (24) (62) (86) (86) (83)

Patent filed Application widely available The patent application was submitted on expiration date

Tribal application number

2004-02-03

1998-09-14

1998-07-07

1997-01-22 (21) Patent Application Number θ8024359

Application received as:

International filing date 1997-01-22 Filing date for European patent application Deposit of microorganism Swedish patent application completed international patent application with number PCT / SE97 / 00096 converted European patent application with number (30) Priority information

1996-01-25 SE 9600276-1 (73) (72) (74) (54) (56) (57)

PATENTHOLDER Astra AB, 151 85 Södertälje INVENTOR Anette Israelsson, Gothenburg

SEE

SE, Agneta Pettersson, Gothenburg

SE, Jan Utas, Kungsbacka SEE OMBUD AWAPATENT AB

NAME Hydrophilic urinary catheter with one

CALLED PUBLICATIONS: - SUMMARY:

water-containing sachet

Wetting apparatus (110) for wetting a hydrophilic urinary catheter (103), comprising a wetting vessel (101), defining a wetting fluid receiving region (102) for receiving the hydrophilic urinary catheter, and a hydrophilic urinary catheter wetting fluid container (106) having a discharge ), which is movable from a closed position to an open position by applying a predetermined state thereto to effect the discharge of the wetting fluid from the wetting fluid container. The wetting fluid container can be positioned in the wetting vessel in an operating position, in which at least the discharge outlet of the wetting fluid container is located within the boundaries of the wetting vessel, which wetting vessel is so designed, of the wetting fluid container, when in the operating position, provides discharge of the wetting fluid into the wetting fluid receiving region for wetting the hydrophilic urinary catheter.

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The numbers in brackets indicate international identification code, INID code. Letters in clamps indicate International Document Code.

522 331

SUMMARY

Wetting apparatus (110) for wetting a hydrophilic urinary catheter (103), comprising a wetting vessel (101), defining a wetting fluid receiving region (102) for receiving the hydrophilic urinary catheter, and a hydrophilic urinary catheter wetting fluid container (106) having a discharge 126), which is movable from a closed position to an open position by applying a predetermined state thereto to effect emptying of the wetting fluid from the wetting fluid container. The wetting fluid container can be positioned in the wetting vessel in an operating position, in which at least the discharge outlet of the wetting fluid container is located within the boundaries of the wetting vessel, which wetting vessel is so designed, of the wetting fluid container, when in the operating position, provides discharge of the wetting fluid into the wetting fluid receiving region for wetting the hydrophilic urinary catheter.

522 331

The present invention relates to a wetting apparatus for wetting hydrophilic urinary catheters, comprising a wetting vessel defining a wetting fluid receiving region adapted for receiving a hydrophilic urinary catheter, and a hydrophilic urinary catheter wetting fluid container. having a discharge outlet that is movable from a closed position to an open position by applying a predetermined condition for effecting the discharge of the wetting fluid from the wetting fluid container to the wetting fluid receiving region for wetting the hydrophilic urinary catheter. The present invention further relates to a liquid container of a type which can be used in such an apparatus.

Periodic self-catheterisation is widely used by both patients suffering from, for example, strictures or trauma in the urinary system, which paralyze patients to induce patients to live an almost normal home life. Urine catheters arranged for periodic self-catheterization generally require a lubricant applied to its outer surfaces to facilitate insertion into the urethra. For example, hydrophilic urinary catheters have a hydrophilic outer coating which, for lubrication purposes, is to be wetted by a fluid, such as water or saline, for a certain period of time before being inserted into the urethra of a patient.

Various methods for lubricating urinary catheters have been proposed previously, examples of which are given below. A self-lubricating urinary catheter and a method of self-catheterization are known from the prior art US30 patent 5,209,726. The catheter has an annular lubricant magazine that surrounds an inner tube with perforations.

When the catheter is inserted into a patient's urethra, lubricant is forced from the magazine to the inner tube and into the urethra through a discharge outlet into the catheter. Therefore, lubrication of the outer surface of the catheter occurs only when

522 The 331 catheter is inserted into the patient's urethra, resulting in at least some initial discomfort to the patient upon insertion of the catheter.

From the prior art US Patent 3,967,728, a catheter package is known which includes a urine catheter and a rupturable, lubricant-containing bag. An edge of the bag is located inside the package adjacent to the tip of the catheter and the seal at that edge is designed to break when the bag is pinched to lubricate the tip of the catheter. Since only the tip of the catheter is lubricated, the patient will still experience discomfort when inserting the catheter into the urethra.

The prior art UK patent application 2 284 764 discloses a catheter and urine collection bag assembly which comprises (i) a catheter having a shank with a rounded tip, a drainage opening in the tip and a flanged portion behind the shaft, and (ii) a urine collection bag within which the catheter is provided and which is formed at an anterior end with an opening, which is large enough to pierce the tip and shaft of the catheter but small enough that the flanged portion of the catheter can intervene therewith to form a mechanical seal against urinary leakage. Once the catheter has been passed through the opening, it is ready for insertion into the urethra of a patient. Urine is transported backwards through the catheter from the bladder of the patient for collection into the urine collection bag. It is disclosed that a separate, defective container containing a lubricating substance may be contained within the urine collection bag for catheter lubrication. However, no details are given of the construction of the container, nor of the arrangement of the container relative to the catheter.

Applicant's previously known international patent application No. WO86 / 06284 discloses a wetting and storage device for a hydrophilic urinary catheter. A wetting pocket is provided which is closed at one end so that it can be filled with a wetting fluid, and a hydrophilic urinary catheter

522 331 is then inserted into the pocket for wetting thereof. However, no liquid container is provided in the wetting fluid discharge device in the pocket immediately prior to use of the catheter. Therefore, wetting fluid for the pocket must be supplied separately by the patient. This is troublesome as a sterile layer of wetting fluid is not necessarily always available to the patient and there is a considerable risk of wasting the wetting fluid.

The hitherto proposed urine catheter lubrication devices discussed above have the disadvantage that they do not or do not adequately provide for lubrication of hydrophilic urinary catheters. As an example, the lubrication arrangements known from US Patent 3,967,728 and UK Patent Application 2,284,764 are intended for non-hydrophilic catheters, so the lubricant is a gel which is unsuitable for lubricating a hydrophilic catheter. Therefore, the prior art lubricators fail to provide an integrated layer of hydrophilic urinary catheter wetting fluid and even less an integrated layer of hydrophilic urinary catheter wetting fluid, which layer upon emptying results in wetting the insertable length or substantially the entire insertable length of a hydrophilic catheter prior to in the urethra of a patient.

Accordingly, patients using hydrophilic urinary catheters need improved means for lubricating the catheters. The present invention is therefore intended to satisfy this need.

According to a first aspect of the invention, a wetting apparatus for wetting a hydrophilic urinary catheter is provided, said wetting apparatus comprising a wetting vessel defining a wetting fluid receiving region for receiving a hydrophilic urinary catheter, and a hydrophilic urinary catheter wetting fluid container, which is movable from a closed position to an open position by applying a predetermined state thereto for effecting the discharge of wetting fluid 521 from the wetting fluid container, which wetting fluid container is integrated with the wetting vessel in an operating position, in which at least emptying the wetting fluid can be removed from the wetting vessel. vätningskärlet, which wetting vessel is so formed and which wetting fluid container is so positioned relative to the wetting vessel, when in the operating position, that application of the predetermined state to the discharge outlet of the wetting fluid container, when in the operating position, provides for wetting fluid wetting in the wetting fluid area the hydrophilic urinary catheter, and which wetting fluid receiving region is so adapted that the insertable length or substantially all of the insertable length of the hydrophilic urinary catheter is wetted by the wetting fluid discharged into the wetting fluid receiving region.

By integrated is meant that the wetting fluid container and the wetting vessel are integrally formed, i.e. the wetting fluid container is supported on or by the wetting vessel.

A clear, tapped layer of lubricant for the hydrophilic urinary catheter is thus available to the patient and the problem of possible spillage of the wetting fluid is reduced. Furthermore, increased comfort is achieved when inserting the catheter into the urethra since the insertable length or substantially the entire insertable length of the catheter is lubricated prior to insertion.

According to a second aspect of the invention, a wetting apparatus for wetting a hydrophilic urinary catheter is provided, said wetting apparatus comprising a wetting vessel defining a wetting fluid receiving region for receiving a hydrophilic urinary catheter, and a hydrophilic urinary catheter wetting fluid container having a which is movable from a closed position to an open position by applying a predetermined condition thereto to effect the discharge of the wetting fluid from the wetting fluid container, which wetting fluid container is integral with the wetting vessel of an operating welding container, in the operating environment, at least emptying the wetting vessel, the wetting vessel being so formed and the wetting fluid container so located relative to the wetting vessel; when in the operating position, applying the predetermined state to the discharge outlet of the wetting fluid container, when in the operating position, discharges the wetting fluid into the wetting fluid 10 receiving chemistry for wetting the hydrophilic urinary catheter. The problem of possible spillage of the wetting fluid is also reduced in this case and the manufacture, packaging and transport of the apparatus is simplified.

According to a preferred embodiment of the invention, the wetting fluid is water or a saline solution.

According to an embodiment of the invention described hereinafter, the wetting fluid receiving region is an elongated pocket of sufficient length to receive at least the insertable length of the hydrophilic urinary catheter and the wetting fluid container is arranged to contain sufficient wetting fluid to provide a level of wetting fluid for filling. insertable length of the hydrophilic urinary catheter.

According to a preferred embodiment of the invention described hereinafter, the wetting vessel is a urine collection bag, the elongated pocket forming the front portion of the urine collection bag and having an open, trailing end and a weakened, closed front end which is releasable upon application of a pre-bias thereby enabling ejection of a portion of the hydrophilic urinary catheter, which portion comprises at least the insertable length of the catheter; through the front end of the pocket after wetting thereof for insertion into the urethra of a patient, and the urine collection bag further comprises a collection chamber behind the elongated pocket, which urine collection chamber has a front end which is in fluid communication with the urethra.

522 331 open the rear end of the pocket and is adapted for use in collecting urine which is transported backward through the hydrophilic urinary catheter after insertion into the patient's urethra.

A typical sterilizing agent which could be used to sterilize the wetting apparatus of the invention is ethylene oxide. In addition, the liquid in the liquid container should normally be sterile. For these reasons, the wetting fluid container is preferably made of a material which is impermeable or substantially impermeable to both ethylene oxide and the liquid contained therein. Non-limiting examples of materials that meet this condition when the liquid is water or saline are aluminum foil, poly (vinylidene chloride) or a metallized film such as metallized poly (ethylene terephthalate).

According to an embodiment of the invention described hereinafter, the wetting fluid container is completely housed within the boundaries of the wetting vessel and can be permanently fixed to the inner surface of the wetting vessel.

According to one embodiment of the invention, the wetting fluid container is an integrated trained compartment of the wetting vessel.

According to an embodiment of the invention hereinafter described, the wetting vessel is formed of a flexible material and the discharge outlet is brought to the open position by applying a predetermined force to the wetting fluid container through the material of the wetting vessel.

According to an embodiment of the invention hereinafter described, the wetting vessel is provided with an inlet which is in fluid communication with the wetting fluid receiving region, and the wetting fluid container is integral with the wetting vessel in the operating position by inserting at least one front part of the wetting fluid in the inlet portion thereof in the inlet portion. the discharge outlet.

522 331

According to an embodiment of the invention described hereinafter, the wetting fluid container is integral with the wetting vessel in the operating position by a frictional fit between the wetting fluid container and the inlet of the wetting vessel.

According to a third aspect of the invention, a liquid container is provided for use with a vessel having an inlet and a fluid receiving region in fluid communication with the inlet, said liquid container comprising a front portion adapted to be placed in the inlet of the vessel and comprising a discharge outlet movable by applying a predetermined state thereto from a closed position in which the liquid is retained in the liquid container to an open position; in which the liquid can be discharged forward from the front portion of the liquid container, the predetermined condition which can be applied to the discharge outlet when the front portion of the liquid container is located in the inlet, the liquid contained in the liquid container is capable of being discharged into the liquid container. in the vessel.

The liquid container therefore reduces the problem of spillage when emptying the contents into the liquid receiving area.

According to a further described embodiment of the invention of this third page, the liquid container is intended for use with a vessel whose fluid receiving region is adapted to receive a hydrophilic urinary catheter in use, and the liquid container contains a liquid which, upon discharge into the liquid receiving region, wets it. hydrophilic coating of the catheter.

According to an embodiment of the invention described hereinafter, the liquid container comprises means for applying a predetermined state, which means is intended for applying a predetermined state to the discharge outlet for bringing the discharge outlet to the open position.

According to an embodiment of the invention described hereinafter, the front portion of the liquid container is located in the inlet to the vessel when the liquid container is in the operating position, the liquid container comprises a rear portion which in the operating position of the liquid container protrudes from the inlet to the vessel part of the means for applying a predetermined condition.

According to an embodiment of the invention described hereinafter, the discharge outlet comprises a region of attenuation in the material of the front portion of the liquid container, which discharge outlet is applied to the open position by application of a predetermined force.

According to an embodiment of the invention hereinafter described, at least part of the means for applying a predetermined condition, which means is comprised of the rear part of the liquid container, is a flap which, when applying a predetermined pulling force, causes the predetermined force to be applied in the area of weakening in material of the front portion of the liquid container.

According to an embodiment of the invention described hereinafter, the area of ​​weakening in the material of the front part of the liquid container is a tear line, which is torn by applying the predetermined tensile force to the tab. The means for applying a predetermined condition further comprises holding means for retaining the liquid container in the operating position against the action of the predetermined traction applied to the tab.

According to an embodiment of the invention described hereinafter, the vessel is made of a flexible material and the holding means is arranged on the front part for gripping by a user through the material of the vessel when the liquid container is in the operating position.

According to an embodiment of the invention described hereinafter, the front portion of the liquid container has a front edge, the tear line extending backwards from the front edge, the tab being a first tab extending backwards from the front edge of the liquid container.

522 331, the front portion on a first side of the tear line and having such dimensions that when the liquid container is in the operating position, the first flap projects from the inlet to the vessel, the holding means for retaining the liquid container in the operating position against the action of the traction applied to the first flap; is a second tab extending forwardly from the leading edge of a second, opposite side of the demolition line, and applying an predetermined, backward pulling force on the first tab relative to the second tab causes tearing of the tear line and emptying of the liquid from the liquid container into the liquid receiving region of the vessel.

According to the embodiments hereinafter described, the liquid container takes the form of a sachet.

According to an embodiment of the invention described hereinafter in accordance with its third side, the liquid container is adapted for integration with the vessel through friction fitting in the inlet to the vessel for retaining the liquid container in the operating position. An integrated unit is thus obtained which has the advantages of the apparatus according to the first and second aspects of the invention.

According to an embodiment of the invention according to its third page, the liquid container contains water or saline solution and is made of aluminum foil, poly (vinylidene chloride) or a metallized film such as metallized poly (ethylene terephthalate).

The present invention has the advantage of providing a safe, compact, sterile and disposable wetting apparatus for a hydrophilic urinary catheter which is easy to operate. This is due to the provision of a container component part for wetting fluid, which container component part is adapted for such cooperation with a wetting vessel component part of the apparatus that it can empty its contents into the wetting vessel for wetting a hydrophilic urinary catheter, which is provided therein, any need for touching the catheter, fluid or inner surface of the wetting vessel;

522 331 ίο which avoids or reduces the risk of contamination.

Exemplary embodiments will now be described with reference to the accompanying drawings.

Fig. 1 shows a wetting apparatus in accordance with a first embodiment of the invention, which wetting apparatus comprises a urine collection bag and an integrated wetting fluid container.

Fig. 2 shows a wetting apparatus according to a second embodiment of the invention, which wetting apparatus comprises a urine collection bag and an integrated, unopened wetting fluid bag according to the invention, an operating position in the inlet of the urine collection bag.

Fig. 3 is an exploded view of the unopened sachet of the wetting apparatus shown in Fig. 2 in an operating position in the inlet of the urine collection bag.

Fig. 4 is a front view of the unopened sachet of the wetting apparatus shown in Fig. 2 in an extended position prior to insertion thereof into the inlet of the urine collection bag to the operating position.

Fig. 5 is a side view of the unopened sachet shown in Fig. 4.

Fig. 6 is a perspective view of the unopened sachet of the wetting apparatus shown in Fig. 2 in a retracted state ready for insertion into the inlet of the urine collection bag into the operating position.

Fig. 7 corresponds to Fig. 2, but with opened wetting fluid sachet.

Fig. 8 corresponds to Fig. 3, but with opened wetting fluid sachet.

In Fig. 1, to which reference is first made, a wetting apparatus 10 according to the invention is shown, which wetting apparatus 10 comprises a urine collection bag 1 of a transparent, flexible plastic material. The bag 1 has at the front end thereof an elongated pocket 2 having a depth sufficient to receive at least the insertable length of a hydrophilic urinary catheter 3. The urine collection bag 1 further defines behind the pocket 2 a urine collection chamber 12 which is in fluid communication with the pocket 2. Further backward is an inlet 14 to the urine collection bag 1, through which inlet 14 the hydrophilic urinary catheter 3 can be inserted into the bag 1.

As can be seen, the catheter 3 includes a flanged rear portion 16 and an elongate shaft 18, which extends forwardly from the rear portion 16 and terminates with a rounded tip 4 at the front end thereof. The catheter 3 is provided with a channel (not shown) extending from an open end in the rear portion 16 to a drainage opening 5 in the tip 4.

A container of the form of a sachet 6 is attached to the inner surface of the urinary bag 1. The sachet 6 contains sterile water or saline or other liquid suitable for wetting the hydrophilic urinary catheter 3 and is permeable or otherwise openable, e.g. applying a handshake, to drain substantially all of the water or saline solution contained therein, into the pocket 2 immediately prior to the use of the catheter 3.

Normally, the urine collection bag 1 comes with it integ2 dose bag 6 and the catheter 3, when packaged therewith, will be sterilized using ethylene oxide. Since the sachet 6 contains sterile water or saline, there is no need to sterilize the contents of the sachet 6. Accordingly, the material of the sachet 6 is preferably impermeable to ethylene oxide and water. Non-limiting examples of materials meeting these requirements are poly (vinylidene chloride) (PVDC), aluminum foil laminates and metallized films, for example metallized poly (ethylene terephthalate). Other sterilization processes could of course be used instead, for example by radiation, in which case the liquid in the sachet 6 could

522 331 is sterilized in place while the rest of the components of the apparatus 10.

The volume of the dose bag 6 is sufficient to discharge such an amount of water or saline into the pocket 2 to allow wetting of the insertable length of the catheter 3 immediately before use. By insertable length is meant at least the length of the elongated shaft 18, which length is coated with a hydrophilic material, for example PVP, and inserted into the patient's urethra. This is normally 80-140 mm for a female patient and 200-350 mm for a male patient.

The holding time of the catheter 3 in the pocket 2 may vary over a wide range, but usually amounts to at least 30 seconds.

The location of the dose bag 6 inside the bag 1 is not critical, as long as the dose bag 6 empties its contents into the pocket 2. However, it is preferred that the dose bag 6 is located as close to the open end of the bag 2 as possible. In this embodiment, the sachet 6 is permanently attached to the urine collection bag 1, for example, by glueing in the bag 1. However, it will be appreciated that the sachet 6 may in fact be freely movable in the bag 1. The important thing is that the dose bag 6 is within the boundaries of the bag 1 so that the two components form an integrated unit.

In use, the catheter 3 is inserted into the bag 1 through the inlet 14 and the elongated shaft 18 is actuated into the pocket 2 as shown. The inlet 14 is then sealed, for example, by tying a knot in the material forming the inlet 14, or by squeezing the inlet 14 by means of a clamp. The sachet 6 is then opened, for example, by applying a pressure thereto through the material of the bag 1, for discharging the wetting fluid into the pocket 2 and the catheter 3 being retained for permeation for a predetermined period of time in the wetting fluid for wetting the hydrophilic outer surface thereof.

Alternatively, the bag 1 may be provided with a closed end instead of the inlet and with the catheter 3 packaged inside the bag 1. However, an inlet 14 is preferred when ethylene oxide is used as a sterilizing agent since it provides a passage through which the ethylene oxide can enter or exit. from the interior of the bag 1.

After wetting the catheter 3 for a predetermined period of time, the bag 1 is turned upside down and the front portion of the pocket 2 is torn off. The elongated shaft 18 of the catheter 3 is then operated through the opening at the front end of the pocket 2 and into the patient's urethra until the flanged, posterior portion 16 forms a mechanical sealing connection with the opening. Therefore, there is no need to directly treat catheter 3 for insertion thereof into the urethra, which is an advantage as the outer surface of catheter 3 will become slippery, which is detrimental to the wetting procedure, and thus difficult to grasp, and furthermore because the risk of contamination of catheter 3 is avoided in this step.

Urine in the bladder of the patient is transported backward through the duct of catheter 3 and into the urine collection chamber 12. Catheter 3 is operated back within the boundaries of bag 1 and the open end of pocket 2 is closed, for example, by attaching a knot to the material forming the pocket 2 or by squeezing the pocket 2 by means of a clamp. An opening can then be made into the urine collection chamber 12 for pouring the collected urine, after which the bag 1 can be thrown.

Referring now to Figures 2 and 3, an alternative wetting apparatus 110 in accordance with the present invention is shown. The wetting apparatus 110 comprises a urine collection bag 101 of a flexible, transparent plastic material, which urine collection bag 101 corresponds to the urine collection bag 1 of the wetting apparatus 10 previously described with reference to Figure 1. Thus, the urine collection bag 101 has a downwardly extending, elongated pocket 102 at the front end, a urine collection chamber 112 behind, and in fluid communication with the

522 331 elongated pocket 102 and an inlet 114 to the bag 101 a further distance there.

Like the wetting apparatus 10 previously described with reference to Fig. 1, a hydrophilic urinary catheter can

103 having a flanged rear portion 116, an elongate shaft 118 extending forwardly from the rear portion 116, and an open channel at both ends (not shown) extending from the rear end of the rear portion 116 to a drainage opening 105 in the rounded tip 104 at the front end of the catheter 103, is inserted into the urine collection bag 101 through the inlet 114 so that preferably at least the insertable length of the catheter 103 is received in the pocket 102.

As can be seen in particular with reference to Fig. 3, a wetting fluid containing sachet 106 is inserted in the inlet 114 to an operating position in which it is held in place by a friction fit. The sachet 106 has a front portion 120 which extends forwardly into the inlet 114 in the operating position of the sachet 106, and a rear portion 122 which extends rearwardly from the inlet 114 in the operating position.

The sachet 106 is preferably made of aluminum foil, especially when ethylene oxide is the sterilizing agent for the apparatus 110 and the sachet contains sterile water or saline. When ethylene oxide is the sterilizing agent for the apparatus 110, the fit of the sachet 106 in the inlet 114 is not so tight that ethylene oxide is prevented from entering and exiting the interior of the bag 101 and sterilizing the inner surface of the bag 101 and the outer surfaces of the sachet. 106 and the catheter

103rd The wetting fluid is retained in the sachet 106 by a circumferential seal of the sachet 106, as shown.

In Figures 4 and 5, now referred to, the front portion 120 of the sachet 106 has a leading edge 124. A tear line 126 extends backward from the front edge 124. A first flap 128 extends forwardly from the front edge 124 of the sachet. 106 on one side of the demolition line 126. On the other side of the demolition line 126

522 331 is provided an elongated second tab 130, which is shown here in an extended state, in which the second tab 130 extends forwardly from the leading edge 124.

As shown in Fig. 6, the elongated, second flap 130 is self-movable about the leading edge 124 from the elongated position shown in Figs. 4 and 5 to a retracted position in which the second flap 130 extends backwardly from the front edge 124. When the second tab 130 is in the retracted position, the dose bag 106 is inserted into the inlet 114 to the operating position shown in Figures 2 and 3.

Figures 2 and 3, now referred to again, show that the dimensions of the second flap 130 are such that, when the sachet 106 is in the operating position, a pulling portion 132 of the second flap 130 projects rearwardly from the inlet 114 to the urine collection bag 101 and forms a portion of the rear portion 122 of the dose bag 106.

Figures 7 and 8 show the operation of the sachet 106 for emptying the contents of sachet 106 into the pocket 102 for wetting the hydrophilic outer coating of the catheter 103. The user grasps the first tab 128 through the flexible, transparent plastic material of the sachet 101. and then pulls backward in the pull member 132 of the second tab 130, which projects from the inlet 114, to tear the tear line 126 and cause the wetting fluid to drain into the pocket 102 for wetting the catheter 103. Preferably, the dose bag 106 contains sufficient wetting fluid to fill the pocket 102 to a level which results in wetting the insertable length of catheter 103.

After emptying the wetting fluid into the pocket 102, the dose bag 106 is removed from the bag 101 and discarded. The bag 101 and catheter 103 are then used in the manner described above for the wetting apparatus 10 shown in Fig. 1.

If required, the bag 101 may be a sealed bag with the sachet 106 and the catheter 103 packaged inside the bag 101. In this case, the design of the bag 101

522 331 such that the dose bag 106 can be opened in the aforementioned manner through the material of the bag 101.

The wetting apparatus 110 described above with reference to Figs. 2-8 has the advantage of, inter alia (i) being environmentally gentle in that the sachet 106, when made of aluminum foil, can be discarded separately from the bag 101, thereby facilitating recovery aluminum foil; and (ii) having a sachet 106 which can better withstand the cyclic pressures normally exerted on the wetting apparatus when packaged and subjected to a sterilization process, because the sachet 106 does not have to be opened by applying a direct pressure thereto by the material of bag 101, in which case a significantly weakened dose bag would be required because a high pressure could not be applied through bag 101 without damaging bag 101.

According to the exemplary embodiments described with reference to the figures of the drawings, the layer of wetting fluid for wetting the hydrophilic urinary catheter assumes the form of a separate sachet which is integrated within the wetting vessel. It will be appreciated by those skilled in the art that the bearing could also take the form of an integrally formed chamber in the material of the wetting vessel without departing from the scope of the invention.

522 331