PACKAGED CATHETER ASSEMBLY

Abstract

A packaged catheter assembly having a pouch and a catheter. The pouch has two walls and a peripheral seal between the two walls and the catheter comprises a proximal end for insertion into the body and a distal end. The catheter is arranged within the pouch in a curved configuration and a join is provided between the two walls, wherein: the join and an internal base of the peripheral seal define a channel to be filled with fluid before withdrawal of the catheter from the pouch; and the pouch and catheter are arranged such that during withdrawal of the catheter from the pouch, the distal end of the catheter is withdrawn from the pouch before the proximal end and the proximal end passes through the channel. The assembly may comprise a fluid reservoir to release fluid into the pouch to form a pool of fluid in the channel.

Claims

1. A packaged catheter assembly comprising a pouch and a catheter, wherein: the pouch comprises two walls and a peripheral seal between the two walls; the catheter comprises a proximal end for insertion into the body and a distal end; the catheter is arranged within the pouch in a curved configuration; and a join is provided between the two walls, wherein: the join and an internal base of the peripheral seal define a channel to be filled with fluid before withdrawal of the catheter from the pouch; and the pouch and catheter are arranged such that during withdrawal of the catheter from the pouch, the distal end of the catheter is withdrawn from the pouch before the proximal end and the proximal end of the catheter passes through the channel.

2. The assembly as claimed in claim 1 wherein the catheter is a male urinary catheter.

3. The assembly as claimed in claim 1 wherein the catheter is an intermittent catheter.

4. The assembly as claimed in claim 1 wherein the catheter is arranged between the join and the internal base of the peripheral seal.

5. The assembly as claimed in claim 1 further comprising a fluid reservoir configured to release fluid into the pouch to form a pool of fluid in the channel.

6. The assembly as claimed in claim 5 wherein the catheter comprises a surface configured to be activated by the fluid held in the fluid reservoir.

7. The assembly as claimed in claim 5 wherein the pool of fluid corresponds to a channel fill level of at least 90% the volume of the channel.

8. The assembly as claimed in claim 1 wherein the distal end of the catheter is arranged closer to an upper edge of the peripheral seal than the base of the peripheral seal.

9. The assembly as claimed in claim 1 wherein the distal end of the catheter is provided with a handling sleeve, wherein the handling sleeve is at least partially closer to an upper edge of the peripheral seal than the base of the peripheral seal.

10. The assembly as claimed in claim 1 wherein the pouch comprises an interaction region configured to create an opening in or near an upper edge of the peripheral seal.

11. The assembly as claimed in claim 10 wherein the distal end of the catheter is arranged centrally with respect to the opening.

12. The assembly as claimed in claim 10 wherein the opening is created from a first lateral edge of the peripheral seal, and the distal end of the catheter is arranged closer to the first lateral edge of the peripheral seal than a second lateral edge of the peripheral seal.

13. The assembly as claimed in claim 1 wherein the join and the peripheral seal are independent.

14. The assembly as claimed in claim 1 wherein the channel is open-ended.

15. The assembly as claimed in claim 1 wherein the peripheral seal is substantially rectangular in shape with two lateral edges between the base and an upper edge of the peripheral seal, wherein the join is provided at a point equidistant from the two lateral edges.

16. The assembly as claimed in claim 1 wherein the join is provided at a distance from the base that is 20-30% of the height of the pouch, wherein the height of the pouch is defined as the distance from the base of the peripheral seal to an upper edge of the peripheral seal.

17. The assembly as claimed in claim 1 wherein the catheter is arranged in the pouch in a coiled configuration.

18. The assembly as claimed in claim 1 wherein the catheter is arranged such that during withdrawal at least 50% of the length of the catheter passes through the channel.

19. A method of forming a packaged catheter assembly, the method comprising: providing two walls to define a pouch; arranging the catheter inside the pouch in a curved configuration; forming a peripheral seal between the walls to seal the catheter within the pouch; and forming a join between the walls, wherein: the join and an internal base of the peripheral seal define a channel to be filled with fluid before withdrawal of the catheter from the pouch; the catheter comprises a proximal end for insertion into the body and a distal end; and the pouch and catheter are arranged such that during withdrawal of the catheter from the pouch, the distal end of the catheter is withdrawn from the pouch before the proximal end and the proximal end of the catheter passes through the channel.

20. A method of unpacking a packaged catheter assembly, the packaged catheter assembly comprising a pouch, a catheter contained within the pouch and a fluid reservoir, the method comprising: releasing fluid from a reservoir to form a pool in a channel between a base of the pouch and a join, opening the pouch and pulling the catheter out by a distal end of the catheter, whereby as the distal end is pulled out, a proximal end of the catheter for insertion into the body is guided through the channel, so as to be wetted by the pool of fluid.

Description

DETAILED DESCRIPTION OF THE INVENTION

[0070] In order that the invention may be more clearly understood one or more embodiments thereof will now be described, by way of example only, with reference to the accompanying drawings, of which:

[0071] FIG. 1 is an exploded view of a first embodiment of a packaged catheter assembly;

[0072] FIG. 2 is a front view of the sealed assembly of FIG. 1 prior to use;

[0073] FIG. 3 is a front view of the packaged catheter assembly of FIGS. 1 and 2 where fluid has been released into the pouch;

[0074] FIG. 4 is a front view of the packaged catheter assembly of FIGS. 1-3 where the package has been opened;

[0075] FIG. 5 is a front view of the packaged catheter assembly of FIGS. 1-4 where the catheter has been part withdrawn from the pouch;

[0076] FIG. 6 is a front view of the packaged catheter assembly of FIGS. 1-5 where the catheter has been almost fully withdrawn from the pouch;

[0077] FIG. 7 is a front view of a used packaged catheter assembly of FIGS. 1-6;

[0078] FIG. 8 is a front view of a second embodiment of a packaged catheter assembly;

[0079] and,

[0080] FIG. 9 is a cut-away front view of a third embodiment of a packaged catheter assembly.

[0081] In the figures, as is conventional, broken lines show hidden features.

[0082] Referring to FIGS. 1-7, a first embodiment of a packaged catheter assembly 100 is shown.

[0083] The assembly 100 comprises a fluid reservoir 10, a male intermittent single-use urinary catheter 20, and a pouch 30. The pouch 30 comprises a front opaque wall 31a, a rear opaque wall 31b opaque wall, and a peripheral seal joining the periphery of the walls 31a, 31b together to form the pouch. The peripheral seal comprises a base 32, a right lateral edge 33, a left lateral edge 34, and an upper edge 35. The left lateral edge 34 and right lateral edge 33 being defined as the left and right sides of the pouch when viewing the pouch 30 with the rear wall 31b behind the front wall 31a, the base 32 at the bottom of the pouch 30 and the upper edge 35 at the top of the pouch 30. The peripheral seal thus defines a pouch 30 that is generally rectangular and suitably has a width between the lateral edges of between 60-110 mm, for example about 100 mm, e.g. 95 mm, and a height from the base 32 to the upper edge 35 of between 100 to 250 mm, for example about 200 mm, e.g. 197 mm. The base 32 defines the bottom of the pouch in use, and the upper edge 35 the top. However, in other embodiments alternative shapes and sizes could be conceived, such as an elliptical or circular pouch.

[0084] The pouch also comprises a join 36 between the two walls 31a, 31b. The join 36 is a circular weld provided at point equidistant between the lateral edges 33, 34 of the peripherals seal and at a distance above the base 32 extending from 45 to 55 mm. The join 36 may have a radius between 1% and 10% the height of the pouch, for example 5%. In other embodiments the join may be provided in different shapes and sizes, at different locations, or could potentially even be integrated into a continuous seal with the peripheral seal.

[0085] The pouch also comprises a window 37 in one of the walls, which allows a user to see inside the pouch. In this particular embodiment, the window 37 is transparent elongate and generally rectangular with a length between 20-50% the height of the pouch 30, for example 33%, and width between 5-25% the width of the pouch 30, for example 12.5%. In this example, the window 37 has semi-circular ends, but in other embodiments they may be any suitable shape, such as flat ends or irregularly shaped ends. The window 37 is arranged parallel to the right lateral edge 33, and a gap is provided between the edge of the window 37 and right lateral edge 33 equivalent to between 5-20% the width of the pouch, for example 10%. The bottom of the window 37 is separated from the base of the peripheral seal 32 by a distance equal to between 5-20% the height of the pouch, for example 10%. In other embodiments, translucent windows may be used and additionally alternative shapes, sizes and positions or angles of the window are contemplated (for example say at an angle of up to 20 degrees with respect to the edges.

[0086] In this particular embodiment, each wall 31a, 31b comprises a plurality of layers of foil; in one specific embodiment a 97 micron 2-layer foil of 12 micron PET and 60 micron LLDPE. In other embodiments, the walls 31a, 31b may only comprise a single layer, and different plastics materials may be used interchangeably.

[0087] As mentioned above, the walls 31a, 31b are opaque. This may be achieved by forming each wall 31a, 31b from one or more opaque layers of material or printing an opaque pattern onto one of the layers. The window 37 in the front wall 31a, may be formed by laminating an opaque layer of material onto a transparent wall, wherein the opaque layer has an aperture corresponding to the window 37. Alternatively, a transparent wall may be printed on to block light from passing through the wall, rendering it opaque in all places except for the location of the window 37. Further alternatives may also be contemplated and achieved, for example, providing an aperture corresponding to the window 37 in an opaque wall, and bonding a transparent layer so as to cover the aperture and achieve a continuous front wall 31a with a window 37, or starting with a multi-layer foil with an opaque layer and a transparent layer and removing part of the opaque layer of foil to form the transparent window.

[0088] In this particular embodiment, the pouch also comprises an interaction region. The interaction region forms the top part of the pouch 30 and spans between the right lateral edge 33 and left lateral edge 34. The interaction region is used to provide access to the pouch through/near to the upper edge 35. In this embodiment, the interaction region comprises a tapered tear away region 38 and a sealing arrangement 39. The tear away region 38 comprises a tear start 40 on the left lateral edge, about 2 cm below at the point the upper edge 35 and left lateral edge 34 meet, and a tear stop 41 at a point in the pouch 30 about 1 cm below where the upper 35 and right lateral 33 edges meet. The distance from the tear stop 41 and the right lateral edge 33 being between 1-10% the width of the pouch, for example 5%. The tear start 40 comprises a notch to provide an area of weakness in the walls 31a, 31b allowing the tear away region 38 to be separated from the pouch 30 by tearing the walls apart from the tear start 40 to the tear stop 41. Thus the tear is provided beneath the location of the upper edge 35 and thus the pouch 30 is opened provided access to its contents. The tear stop 41 comprises a small aperture in the walls 31a, 31b to prevent further tearing of the pouch 30 and separation of the tear away region 38 from the pouch 30. In order to provide the tapered shape, the tear away region 38 extends upwards on the left side approximately 50% more than it does on the right side. The left side of the tear away region 38 comprises a circular aperture 42 sized to allow a finger to pass through and grip the tear away region 38. To ensure the pouch is fully sealed, the front wall 31a and rear wall 31b are sealed to one another around the periphery of the tear stop 41 and circular aperture 42. In other embodiments, other seals such as a zip-lock arrangement may be used to provide access to the pouch, and of course, the sizes and shapes set out above are exemplary.

[0089] In this embodiment, the sealing arrangement 39 extends between the left lateral edge 34 and right lateral edge 33 of the peripheral seal just below the tear away region 38. The sealing arrangement 39 comprises first and second sealing members (not shown) provided on an interior surface of the walls 31a, 31b of the pouch 30. In this embodiment, the sealing members comprise corresponding sealing grooves and ridges to allow the sealing members to be press-fit together to form a water-tight seal and pulled apart again if necessary. In other embodiments, a single adhesive sealing member may be used, or a sealing member may be provided on the outside of the pouch to allow the pouch to be folded or rolled and sealed accordingly and of course, alternative sealing mechanisms like a hook-and-loop or hook-and-hook seal or zip-lock could be used.

[0090] In this embodiment, the fluid reservoir 10 is an elongate rectangular burstable sachet of water, but in other embodiments any suitable reservoir may be used. The fluid reservoir 10 has a height equal to between 60-90% the height of the pouch 30, for example 80%, and a width between 5-25% the width of the pouch 30, for example 15%. In this embodiment, the fluid contained within the reservoir 10 is water. In other embodiments, many other types of reservoir would be suitable including different shapes and sizes of reservoir, or non-burstable reservoirs and other external sources of fluid. In addition, other fluids could be used, for example lubricants, gels, oils or the like.

[0091] In this embodiment, the catheter 20 comprises a proximal end 21 for insertion into the body, a distal end 22, and a flexible tube 23 connecting the two ends 21, 22. The distal end 22 comprises a funnel 24 to guide urine from the bladder out of the tube 23 in use. A handling sleeve 25 is also provided around the tube 23 adjacent to the distal end 22. In this embodiment, the catheter has a length of between 30-50 cm, for example 40 cm, and the handling sleeve is between 10 and 30% the length of the catheter, for example 20-25%, e.g. 11 cm. In this embodiment, the catheter 20 is provided with a hydrophilic coating, this is activated when it contacts the fluid held in the reservoir 10. In other embodiments, any suitable catheter length or type may be used.

[0092] The catheter 20 is arranged within the pouch 30 in a curved and coiled configuration, with the distal end 21 adjacent to the inner left lateral edge 33 near the upper 35 edge of the pouch 30, just beneath the sealing arrangement 39. The catheter 20 extends down the inside of the pouch 30 into a broadly elliptical anti-clockwise coil (as viewed with left lateral edge 34 on the left, and upper edge 35 at the top). The coil having a single turn around the inner perimeter of the left lateral edge 34, base 23, and right lateral edge 33 of the pouch, with the proximal end 21 of the catheter 20 resting on the inside of the catheter's coil, adjacent to the left lateral edge 34 and base 32 of the pouch. Notably, the majority of the handling sleeve 25 is arranged above the join 36, but as the catheter curves and extends from left to right, the catheter tube 23 runs underneath the join, in a channel defined by the join and the internal base of the peripheral seal, then runs upwards to the side of the join, before returning over the top of the join and finally extending downwardly such that the proximal end 21 is lower than and on the left side of the join 36. In short, the catheter 20 is coiled (or curled) around the join 36 (albeit not tightly coiled). In other embodiments, the position of the catheter 20 may be different, in particular, the catheter 20 may not coil or curl but may simply curve within the pouch 30. On the other hand, embodiments of the invention may have a catheter 20 that has multiple turns of coil.

[0093] Referring to FIG. 2, the pouch 30 is formed by first providing the two walls 31a, 31b which are to define the pouch 30 itself, and the front wall 31a comprising the transparent window 37 as described above and produced by one of the techniques described above. In this embodiment, the walls 31a, 31b are sized to correspond to the final shape of the pouch 30, however in other embodiments, the walls may extend outside the pouch 30 as required.

[0094] In this embodiment, the base 32, right lateral edge 33 and left lateral edge 34 are the first to be formed by welding the two walls 31a, 31b together, leaving the pouch 30 with an open upper edge 35. The catheter 20 is then arranged within the pouch 30 in a curved and coiled configuration, as set out above

[0095] In this embodiment, the fluid reservoir 10 is also placed within the pouch 30 at a position corresponding to the window 37. The catheter 20 is therefore hidden in the pouch 30, as the reservoir 10 is placed over the catheter 20 so that the reservoir 10 is visible through the window 37 and the reservoir 10 obstructs any view of the catheter 20 through the window 37. In other embodiments, the reservoir 10 may not need to be placed over the catheter 20 as the position of the catheter 20 in the pouch 30 may not correspond to the window 37.

[0096] In this embodiment, the first and second sealing elements (not shown) are then attached to the inside of the walls 31a, 31b just above the coiled catheter 20, and the peripheral seal is completed by forming its upper edge 35 by welding the walls 31a, 31b together along the upper edge 35. This seals the catheter 20 and reservoir 10 within the pouch. In other embodiments, the sealing elements may be provided to the walls prior to any other assembly of the pouch 30, or sealing of the peripheral seal.

[0097] In this embodiment, the join 36 is then formed by welding the walls 31a, 31b together. Because the catheter 20 is coiled around the inner perimeter of the pouch 30, the join 36 is located within the coil of the catheter 20. Therefore, part of the catheter tube 23 passes between the join 36 and the base 32 of the pouch. In other embodiments, the join 36 may be provided before the peripheral seal, or at any point of the assembly process.

[0098] Finally, in this embodiment, the tear-start 40, tear-stop 41, and aperture 42 may be formed by cutting out the appropriate sections of the pouch 30. Use of a hot punch can simultaneously bond the walls 31a, 31b around the periphery of the cut-out regions to ensure the pouch 30 remains fully sealed.

[0099] As will be appreciated, the above is an example and in other embodiments the pouch 30 may be formed in different ways with the steps performed in different orders. For example, the bottom could be open and the catheter and water reservoir introduced from the bottom before the base seal is provided. Or, for example, in an industrially applied process, two webs of wall material may have one half of the sealing arrangement applied to (an interior surface of) each of them, the catheter 20 and reservoir 10 may be arranged between opposing interior surfaces of the webs of wall material, then potentially in a single action, a hot die may join and form the walls 31a, 31b by forming the peripheral seals 32, 33, 34, 35, simultaneously forming the tear start 40, forming the join 36 and punching out and sealing the aperture 42 and tear stop 41 in the tear away region 38. Furthermore, while the peripheral seal and join 36 have been described as formed by a weld, any suitable means of joining the walls could be used, for example, an adhesive may be used.

[0100] Referring to FIGS. 2-7, this first embodiment of a packaged catheter assembly 100 may be unpackaged as described below.

[0101] First, the fluid reservoir 10 is located within the pouch 30 with the assistance of the window 37, though which the reservoir 10 can be seen. Fluid is then released from the reservoir 10 into the pouch 30. In this embodiment, the reservoir 10 is a burstable sachet and fluid may be released from it by applying manual pressure to the reservoir 10. The window 37 provides a visual reference to show when the reservoir 10 has been successfully burst and fluid released into the pouch 30. In particular, it can be seen that sufficient fluid has been released to fill the channel defined by the weld 36 and the internal base 32 of the peripheral seal. In other embodiments, the fluid may be released from other means.

[0102] Referring to FIGS. 3-7, the fluid released from the reservoir 10 collects in a pool at the bottom of the pouch 30, as shown by the hashing. In this embodiment, the fluid fills the pouch 30 up to a fill level corresponding to the join 36. As such, in this embodiment, the join 36 and base 32 define a channel that is completely full of fluid. However, in other embodiments, the fluid may only partially fill the channel, for example filling the channel between 60-95%, preferably at least 90%, or may fill the pouch above the level of the join 36.

[0103] The released fluid is also visible through the window 37, as the base of the window 37 corresponds to a location on the pouch 30 that is slightly lower than the join 36. In other embodiments, the window may comprise an indicator region that shows the presence of fluid in the pouch. For example, a fluid-sensitive colour changing strip such that direct visualisation of the fluid is not required. A fill-level marker could also be provided to show that sufficient fluid has been released.

[0104] In this embodiment, the contents of the pouch 30 are then accessed by tearing the top of the pouch 30 using the tear away region 38. The aperture 42 is grasped in one hand, and the rest of the pouch 30 in another, and the tear away region 38 is torn from the tear start 40 to the tear stop 41. Thus, the pouch is torn between the left lateral edge 34 and right lateral edge 33 at a location below the upper edge 35, as such, an opening is formed in the pouch 30 that may be used to access its contents. Advantageously, the tear away region 38 is not fully separated from the pouch 30 which reduces the number of separate parts and makes the pouch 30 easier to handle. Other embodiments may feature other ways to access the pouch for example a zip-lock seal.

[0105] Referring to FIGS. 4-6, the catheter 20 may then be withdrawn from the pouch 30. As described above, in this embodiment the catheter 20 is coiled in the pouch 30, and the distal end 21 is provided adjacent the upper edge 35 of the pouch 30. As such, the distal end 21 is above the fill line of the fluid released into the pouch 30 and is not wetted by the fluid. The distal end 21 therefore provides a dry and easy to access point which may be used to withdraw the catheter 20 from the pouch 30. In this embodiment, the majority of the handling sleeve 25, i.e. at least 50% and preferably between 60-100%, for example 70% of the sleeve 25 is also above the fill line and is not wetted. Thus, the sleeve 25 also provides a convenient dry surface to handle the catheter 20.

[0106] In this embodiment, the distal end 21 is pulled upwards through the opening in the upper edge 35 of the pouch 30. As the distal end 21 is pulled out of the pouch 30, the catheter tube 23 is uncoiled and also pulled upwards towards the upper edge 35 of the pouch 30. However, as the join 36 is arranged within the coil of the catheter 20, the tube 23 is prevented from moving directly upwards by the join 36. The join 36 therefore causes the tube 23 to be withdrawn from the pouch 30 along a path that includes passing through the channel defined by the join 36 and base 32. As such, the entire remainder of the tube 23 to the proximal tip 21 passes though the pool of fluid in the channel and the hydrophilic coating of the catheter 20 is activated by the fluid. Furthermore, the proximal end 21 of the catheter 20 is the final part of the catheter 20 to pass through the channel and be withdrawn from the pouch 30. Thus, the catheter 20 is activated by the fluid as it is withdrawn and the withdrawal is convenient and easy as only a dry part of the catheter 20 needs to be touched during withdrawal. As the catheter 20 passes through a pool of fluid it is more completely wetted than would be the case for a fluid held within another medium such as a foam. In other embodiments, the catheter 20 need not be withdrawn directly upwards but may be pulled out to sideways from the pouch, for example from an opening provided at the side of the pouch, but, of course, above the weld, so as to reduce the prospect of spillage. Further the catheter 20 may not directly touch the join 36 and may instead be prevented from moving upwards by the convergence of the walls 31a, 31b as they approach the join 36.

[0107] Once the catheter is fully withdrawn, the catheter may be used by inserting the proximal end 21 into the urethra until urine begins to flow through the catheter 20. The (largely dry) handling sleeve 25 assists in the insertion. The urine may then be directed out of the catheter 20 by the funnel 24.

[0108] Referring to FIG. 7, in this embodiment, the catheter 20 may be placed back inside the pouch 30 in a coiled configuration after use. The handling sleeve 25 and funnel 24 provide for dry surfaces that can be used to re-coil the catheter 20 and place it into the pouch 30. The sealing arrangement 39 can then be used to reseal the pouch 30 between the left lateral edge 34 and right lateral edge 33 by pressing together the two corresponding sealing elements (not shown). This provides for a more convenient disposal of the catheter 20 after use and ensures the fluid released into the pouch 30 does not subsequently leak out of the pouch 30. In other embodiments, alternative sealing arrangements may be used, such as an external flap with adhesive that allows the top of the pouch 30 to be rolled or folded and sealed. Alternatively, no sealing arrangement may be used where the pouch 30 is intended to be disposed of immediately after use.

[0109] Referring to FIG. 8, a second embodiment of a packaged catheter assembly 200 is shown. The second embodiment shares many of the features of the first embodiment described above, and so only differences in the features are described below, and like numerals are used to denote like features.

[0110] In this embodiment, the join 236 is provided a location offset from the midpoint between the right lateral edge 233 and left lateral edge 234. In particular, the join is provided at a distance from the right lateral edge 234 that is 20-45% the width of the pouch 230, for example, 35%. The join 236 provides a second function as a retaining seal to restrict the movement of the reservoir 210 in the pouch 230, sandwiching the reservoir 210 between the join 236 and the right lateral edge 234. The join 236 therefore ensures the window 237 corresponds to the position of the reservoir 210 regardless of the movement of the pouch 230 as it is carried around by a user, ensuring both that the catheter 223 remains hidden and that the reservoir 210 can be identified easily to release its fluid. In other embodiments, the function of the retaining seal may be provided by a separate seal between the walls 231a, 231b. For example, a separate seal extending downwards from the sealing arrangement 239, or up from the base 232.

[0111] In this embodiment, the front wall 231a also comprises a pattern 243 that corresponds to the edge of the window 237. The pattern 243 is only shown on part of the window, but may of course extend over the entirety of it and comprises a graduated appearance that softens the boundary between the transparent window 237 and the rest of the opaque front wall 231a. In this embodiment, the pattern is a series of evenly spaced opaque lines with graduated thicknesses, getting thinner as they approach the centre of the window 237. As such, the pattern 243 makes the window 237 less visually obvious and therefore makes the pouch 230 more discreet. In other embodiments, the pattern 243 could be any suitable pattern, for example opaque circles of graduated size, and may be complemented by or integrate with surface patterns or colour applied to the reservoir 210.

[0112] Referring to FIG. 9, a third embodiment of a packaged catheter assembly 300 is shown. The third embodiment shares many of the features of the first embodiment described above, and so only differences in the features are described below, and like numerals are used to denote like features. FIG. 9 shows a cut-away front view of the assembly 300 and as such, front wall 331a and window 337 are not shown. Diagonal hashing shows the locations in which the front wall 331a is bonded to the rear wall 331b, for example at the left lateral edge 334, base 322, right lateral edge 333, upper edge 335, tear off region 338 and join 336.

[0113] In this embodiment, the tear away region 338 comprises a tear line 343 spanning between the tear start 340 and tear stop 341. The tear line 344 is a line of weakness that preferentially tears to allow the tear away region 338. This makes it easier to remove the tear away region 338 in a consistent manner. In this embodiment, the tear line 344 is formed by weakening of the pouch 330 by laser scoring but in other embodiments other techniques could be used such as thinning of the pouch 330 material along the tear line 344.

[0114] In this embodiment, the sealing arrangement 339 comprises a zip-lock seal to allow the user to reseal the pouch 330 closed. The location in which the sealing arrangement 339 can be used to seal the front wall 331a and rear wall 331b together is denoted in FIG. 9 by vertical hashing. This corresponds to a strip of the pouch 330 just below the tear line 344.

[0115] In this embodiment, the catheter 320 is arranged within the pouch 330 in a similar manner to the first embodiment in that it is coiled. However, in this embodiment, the distal end 322 of the catheter 320 and funnel 324 are arranged centrally with respect to the opening formed by the tear away region 338. The distal end 322 and funnel 324 are approximately equidistant from the left lateral edge 334 and right lateral edge 333 rather than closer to either lateral edge 333, 334. As such, when the pouch 330 is opened, the distal end 322 including funnel 324 and handling sleeve 324 are more easily accessible as it is central and located at a point across the width of the pouch 330 which opens widest. In addition, as the catheter 320 is coiled, the handling sleeve 325 extends from the distal end 322 to a positing adjacent the left lateral edge 334. Thus, together with the fluid reservoir 310 which is positioned adjacent to the right lateral edge 33, the distal end 322, handling sleeve 325 and fluid reservoir 310 protect the rest of the catheter 323 from inadvertent direct contact with the user as they withdraw the catheter 320 from the pouch 330. This reduces the risk of infection when using the catheter 320 as it is less likely to become dirty before use.

[0116] In this embodiment, the sleeve 325 is configured so that it does not extend below the height of the join 336 within the pouch 330, in particular, the sleeve 325 is further from the join 336 than the base 332 of the pouch 330. This reduces the likelihood that the sleeve 325 is wetted during release of fluid into the channel from the fluid reservoir 310. As such, the sleeve 325 is easier for the user to handle.

[0117] Conditional language, such as “can,” “could,” “might,” or “may,” unless specifically stated otherwise, or otherwise understood within the context as used, is generally intended to convey that certain embodiments include, while other embodiments do not include, certain features, elements, and/or steps. Thus, such conditional language is not generally intended to imply that features, elements, and/or steps are in any way required for one or more embodiments or that one or more embodiments necessarily include logic for deciding, with or without user input or prompting, whether these features, elements, and/or steps are included or are to be performed in any particular embodiment.

[0118] The one or more embodiments are described above by way of example only. Many variations are possible without departing from the scope of protection afforded by the appended claims.