PACKAGED CATHETER ASSEMBLY

Abstract

A packaged catheter assembly comprising a pouch and a catheter, wherein: the catheter is arranged within the pouch. The catheter comprises at least one handling sleeve configured to provide at least two handling sleeve elements after withdrawal of the catheter from the pouch. The catheter may comprise one handling sleeve configured to provide at least two handling sleeve elements. The handling sleeve may comprise a point of weakness comprising one or more perforations provided about a circumference of the respective handling sleeve. A method of packaging a catheter, the catheter comprising at least one handling sleeve, the method comprising: providing at least two handling sleeve elements; and arranging the catheter within a pouch using the handling sleeve elements. The method may comprise: separating at least one handling sleeve into at least two handling sleeve elements; coiling or looping the catheter; and forming a knot in the catheter.

Claims

1. A packaged catheter assembly comprising: a pouch; and a catheter; wherein the catheter is arranged within the pouch and the catheter comprises at least one handling sleeve formed of a film material and configured to provide at least two handling sleeve elements after withdrawal of the catheter from the pouch.

2. A catheter assembly as claimed in claim 1, wherein the catheter comprises one handling sleeve configured to provide at least two handling sleeve elements.

3. (canceled)

4. A catheter assembly of claim 1, wherein at least one of the at least two handling sleeve elements is configured to receive two or more sections of the catheter simultaneously.

5. A catheter assembly of claim 1, wherein one of the at least two handling sleeve elements may be is arrangeable to retain the catheter in a looped or coiled configuration.

6. A catheter assembly of claim 1, wherein at least one handling sleeve comprises a point of weakness comprising one or more perforations provided about a circumference of the respective handling sleeve.

7. (canceled)

8. A catheter assembly as claimed in claim 6, wherein the catheter comprises one handling sleeve and the handling sleeve is separable at the perforations to provide two handling sleeve elements.

9. (canceled)

10. A catheter assembly of claim 1, wherein the inner surface of the handling sleeve comprises an embossed pattern.

11. A catheter assembly of claim 1, wherein at least one handling sleeve forms a sheath around at least part of the catheter, and at least one of the at least two handling sleeve element forms a sheath around only part of the catheter.

12. A catheter assembly of claim 1, wherein at least one of the at least two handling sleeve elements are independently movable along the length of the catheter.

13. A catheter assembly of claim 1, wherein the catheter comprises a proximal end for insertion into the body and a distal end, a funnel at the distal end of the catheter, and at least one handling sleeve is arranged adjacent to the funnel prior to use.

14. A catheter assembly of claim 1, wherein the catheter comprises a proximal end for insertion into the body and a distal end, and the at least two handling sleeve elements comprise a proximal element arrangeable at or close to the proximal end and a distal element arrangeable at or close to the distal end.

15. A catheter assembly as claimed in claim 14 wherein the distal element is further arrangeable between a midpoint and the distal end of the catheter and is configured to receive the proximal end of the catheter.

16. (canceled)

17. (canceled)

18. A catheter assembly as claimed in claim 1, wherein the at least one handling sleeve is conical.

19. A catheter assembly of claim 1, wherein the at least one handling sleeve is formed of one or more strips of material joined together along their edges.

20. (canceled)

21. A method of packaging a catheter, the catheter comprising at least one handling sleeve, the method comprising: providing at least two handling sleeve elements; and arranging the catheter within a pouch using the handling sleeve elements.

22. (canceled)

23. The method of claim 21, comprising the step of separating at least one handling sleeve into at least two handling sleeve elements.

24. The method of claim 21, comprising the step of moving one or more of the at least two handling sleeve elements along at least part of the length of the catheter.

25. The method of claim 21, comprising the step of coiling or looping the catheter.

26. The method of claim 21, comprising forming a knot in the catheter.

27. The method of claim 21, comprising forming a loop in the catheter and subsequently forming a knot in the catheter.

Description

DETAILED DESCRIPTION OF THE INVENTION

[0077] 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:

[0078] FIG. 1 is an exploded view of a first embodiment of a packaged catheter assembly;

[0079] FIG. 2 is a front view of the sealed assembly of FIG. 1;

[0080] FIG. 3 is a front view of the packaged catheter assembly of FIGS. 1 and 2 where fluid has been released into the pouch;

[0081] FIG. 4 is a front view of the packaged catheter assembly of FIGS. 1-3 where the package has been opened;

[0082] 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;

[0083] 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;

[0084] FIG. 7 is a handling sleeve configured to be separable into two handling sleeve elements;

[0085] FIG. 8 is the handling sleeve of FIG. 7 separated into two handling sleeve elements

[0086] FIG. 9 is the catheter of the packaged catheter assembly of FIGS. 1-6 where the handling sleeve has been separated into two handling sleeve elements;

[0087] FIG. 10 is the catheter of FIG. 9 coiled using the two handling sleeve elements prior to re-packaging;

[0088] FIG. 11 is a front view of a used and re-packaged catheter assembly of FIGS. 1-6;

[0089] FIG. 12 is a front view of a second embodiment of a packaged catheter assembly; and

[0090] FIG. 13 is a schematic magnified view of a part of the inner surface of the handling sleeve of FIG. 7.

[0091] In the figures, as is conventional, broken lines show hidden features.

[0092] The present disclosure concerns a catheter and in particular a handling sleeve for the catheter. It is described in the context of a packaged catheter assembly. The packaged catheter assembly comprises a pouch and the catheter. The catheter is arranged within the pouch. The catheter comprises at least one handling sleeve configured to provide at least two handling sleeve elements after withdrawal of the catheter from the pouch. The two handling sleeve elements can thus be used separately to better manipulate the catheter without touching its surface. In the described embodiment the two handling sleeve elements are initially provided as two halves of a single handling sleeve, the handling sleeve being frangible, to separate into the two handling sleeve elements. Of course it will be immediately understood that in another embodiment the catheter is provided initially with two separate handling sleeves each providing an independent handling sleeve element.

[0093] Referring to FIGS. 1-11, a first embodiment of a packaged catheter assembly 100 is shown.

[0094] The assembly 100 comprises a fluid reservoir 10, a male intermittent single-use urinary catheter 20, and a pouch 30. 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, and it is provided adjacent to the distal end 22. The handling sleeve 25 comprises a point of weakness, which in this embodiment is a line of perforations 26 that extends around a circumference of the handling sleeve 25. The perforations 26 are breakable and as such the handling sleeve 25 is separable into two handling sleeve elements, a proximal element 25a and a distal element 25b, as described below.

[0095] In this embodiment, the catheter tube 23 is a hydrophilic thermoplastic elastomer (TPE), and the handling sleeve 25 and handling sleeve elements 25a, 25b are formed from a film of low-density polyethylene (LDPE). The funnel 24 is made from polyvinyl chloride (PVC).

[0096] In this embodiment, 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.

[0097] 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.

[0098] 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.

[0099] 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.

[0100] 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.

[0101] 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.

[0102] 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.

[0103] 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.

[0104] In this embodiment, the catheter 20 has a length of between 30-50 cm, for example 40 cm, and the handling sleeve 25 is between 10 and 30% the length of the catheter 20, for example 20-25%, e.g. 11 cm. In this embodiment, the perforations 26 are located at a mid-point along the length of the handling sleeve 25. The distal element 25b therefore constitutes the half of handling sleeve 25 closest to the distal end 22 of the catheter 20, and the proximal element 25a the half of the handling sleeve 25 closest to the proximal end 21 of the catheter 20.

[0105] Referring to FIG. 7, in this embodiment the handling sleeve 25 is formed from two elongate strips of material (for example, a first strip 51, and a second strip (not shown)) joined along their respective left and right elongate edges, for example by welding, to form the left edge 52 and right edge 54 of the handling sleeve 25. The handling sleeve 25 is a truncated cone with a width at an open proximal end 53 corresponding to the proximal element 25a of 17 mm, and a width at the opposite open distal end 55 corresponding to the distal element 25b of 23 mm. Advantageously, this allows the wider distal end 55 of the handling sleeve 25 to overly the funnel 24 if required, while the thinner proximal end 53 of the handling sleeve 25 prevents the handling sleeve from being removed from the catheter 20. The width of the handling sleeve 25 changes linearly along its length, and as such, its width at the perforations 26 is 20 mm. The elongate strips forming the handling sleeve 25 each have a length of 110 mm and are therefore isosceles trapeziums with a base of 23 mm, a top of 17 mm, and a height of 110 mm. Accordingly, the strips are joined along their legs to form the handling sleeve 25.

[0106] In this embodiment, the handling sleeve 25 is perforated across its width, half way along its length, to form the perforations 26 prior to joining the elongate edges 52, 54, so as to provide the two separable handling sleeve elements 25a, 25b. In this embodiment, the perforations 26 comprise a row of elongate holes extending around the circumference of the handling sleeve 25. The holes have a width and length perpendicular to the width and length of the handling sleeve 25 respectively. In this embodiment, the holes are slits and as such they are one dimensional and have an aspect ratio (length:width) that is much greater than 2:1 and effectively 1:0.

[0107] In this embodiment, the holes are separated by a distance that is no more than the length of each hole, and in this example the holes are separated by 1 mm. In this embodiment, the length of each hole is 2 mm. As such, the perforations 26 provide for a point of weakness in the handling sleeve 25 that is sufficient to allow easy separation of the handling sleeve 25 into two handling sleeve elements 25a, 25b. Furthermore, as they are slits, they reduce the likelihood of inadvertent contact with the catheter 20 through the holes when handling the catheter 20. This helps to ensure the catheter 20 remains clean and sterile prior to use.

[0108] 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. Referring to FIG. 13, in this embodiment the inner surface 56 of the handling sleeve 25 is hydrophobic and comprises an embossed pattern 57. This reduces friction between the catheter 20 and the handling sleeve 25 allowing easier arrangement of the sleeve along the catheter 20 during use. In this example, the embossed pattern 57 is a linen pattern.

[0109] The catheter 20 is arranged within the pouch 30 in a curved and coiled configuration, with the distal end 22 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, and as such, the perforations 26 are arranged above the join 36. As the catheter 20 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.

[0110] 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.

[0111] 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

[0112] In this embodiment, the fluid reservoir 10 is also placed within the pouch 30 at a position corresponding to the window 37. 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.

[0113] 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 30. 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.

[0114] 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.

[0115] 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.

[0116] 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 20 and water reservoir 10 introduced from the bottom before the base seal 32 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 interaction 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.

[0117] Referring to FIGS. 2-9, this first embodiment of a packaged catheter assembly 100 may be unpackaged as described below.

[0118] 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 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.

[0119] Referring to FIGS. 3-6, 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%, or may fill the pouch above the level of the join 36.

[0120] 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.

[0121] 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.

[0122] 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 22 is provided adjacent the upper edge 35 of the pouch 30. As such, the distal end 22 is above the fill line of the fluid released into the pouch 30 and is not wetted by the fluid. The distal end 22 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. 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. In particular, the distal handling sleeve element 25b is entirely above the fill line and is therefore dry.

[0123] In this embodiment, the distal end 22 is pulled upwards through the opening in the upper edge 35 of the pouch 30. As the distal end 22 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.

[0124] 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.

[0125] Referring to FIGS. 7-11, the catheter 20 may be placed back inside the pouch 30 in a coiled configuration after use. The handling sleeve 25 including proximal element 25a and distal element 25b, 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 catheter 20 may be repackaged back into the pouch 30 as described below.

[0126] Referring to FIGS. 7-9, the handling sleeve 25 may be separated into the proximal element 25a and distal element 25b. This may be done before or after use of the catheter 20 as required by the user. In this embodiment, to separate the handling sleeve 25, the perforations 26 may be broken about the circumference of the handling sleeve 25. The proximal element 25a and distal element 25b are thereby provided on the catheter 20. In this embodiment, each handling sleeve element, the proximal element 25a and distal element 25b, may be independently moved along the length of the catheter 20 to aid ease of use.

[0127] In this embodiment, the catheter 20 is then looped and knotted to restrict its size/shape and allow for easy repackaging. Firstly, the proximal element 25a is arranged at a first section of the catheter close to, or at, the proximal end of the catheter 20, and the distal element 25b is arranged at a second section of the catheter 20 between a midpoint and the distal end of the catheter 20. Secondly, the proximal element 25a may be used to create a loop in the catheter 20 between the first and second sections.

[0128] The proximal element 25a may then be used to insert the proximal end of the catheter 20 into the distal element 25b. The proximal end of the catheter 20 may thereby be received by, and retained within, the distal element 25b, next to the second section of the catheter 20. Thus, the handing sleeve elements 25a, 25b are used to tightly loop the catheter 20. In other embodiments, multiple loops may be achieved to further restrict the size/shape of the catheter 20 as required.

[0129] To further restrict the size/shape of the catheter 20, in this embodiment, the catheter 20 is then knotted. A knot is formed in the catheter 20 by passing the distal end of the catheter 20 through the loop. In this embodiment, this is done by holding the distal element 25b to retain the looped shape of the catheter 20, and then passing the funnel 24 through the loop using the funnel 24 itself (which of course is not inserted into the urethra in use, and is therefore clean and not provided with a hydrophilic surface and therefore not slippery, and as such is easy to grasp). Thus, the size/shape of the catheter may be further restricted by knotting the looped catheter.

[0130] Following looping and knotting, the catheter 20 may be held in this form using a single hand grasping the distal element 25b. The pouch 30 may then be held in the user's other hand, and the catheter 20 placed within the pouch 30. Advantageously, the loop and knot prevent the ends of the catheter 20 from getting caught on the sides of the pouch 30 and allow the catheter to easily pass through the opening in the upper edge 35 of the pouch 30.

[0131] 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.

[0132] 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.

[0133] 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.

[0134] 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.

[0135] 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.

[0136] 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.