Patent Description:
Many people suffer from urinary problems that can make it difficult to pass urine. Intermittent catheter assemblies can provide a convenient and portable solution to this problem as a user is able to self-catheterise to relieve themselves as required. This reduces the effect of their urinary condition on their life and allows thm to enjoy a relatively normal lifestyle.

Intermittent catheters are typically single-use devices that are carried by the user then unpackaged and used as required. When using an intermittent catheter in a public place, it is also advantageous to be able to re-package the catheter until a convenient time to dispose of the catheter. However, this can be difficult, especially for Male intermittent catheters which are generally several centimetres longer than female catheters, typically at least <NUM> long, with ISO <NUM>:<NUM> setting a minimal effective length of <NUM>. This can make them difficult to re-package in a discreet manner.

To reduce the risk of damage to the urinary tract and improve comfort while using the catheter, it is also important they are lubricated before use. However, once lubricated and used a catheter can be slippery and difficult to handle. This can make re-packaging of the catheter after use difficult and unhygienic, as the used catheter may inadvertently contact the user's hands, clothing or personal items.

Existing intermittent catheters such as the Coloplast SpeediCath Flex (RTM) and the Hollister VaPro (RTM) catheters disclose continuous handling sleeves that cover the entire length of the catheter. While these provide some assistance to handling, the sleeve must be bunched up against one end of the catheter during use which can be difficult and unhygienic as dirt may get onto the catheter prior to use during bunching of the sleeve. Examples of packaged catheters can be found in <CIT>, <CIT> or <CIT>.

It is an object of embodiments of the present invention to at least partially overcome or alleviate the above problems.

Advantageously, the present invention provides for a handling sleeve that provides at least two handling sleeve elements which allow for more convenient and simpler handling of the catheter before, during, and after use. This can reduce the need to adjust the sleeve prior to use of the catheter, reducing the chance of dirt contacting the catheter and associated infection. Furthermore, the handling sleeve elements provide greater flexibility in terms of handling the catheter than a single long sleeve, this makes the catheter easier to re-package into the pouch after use.

According to a first aspect, the catheter comprises one handling sleeve configured to provide at least two handling sleeve elements. Accordingly, in one example the catheter comprises one handling sleeve configured to provide two handling sleeve elements. Alternatively, the catheter may comprise two or more handling sleeves. Where there are two or more handling sleeves, each handling sleeve may be configured to provide at least one handling sleeve element. Thus, the handling sleeves and handling sleeve elements can be flexibly configured to allow for easier handling of the catheter as they can be optimised for the specific packaging requirements of a given catheter/pouch. They can also therefore be configured to suit users with different levels of mobility and dexterity.

The two handling sleeve elements are preferably separate. At least one handling sleeve is configured to separate into at least two handling sleeve elements. Thus, two or more handling sleeve elements may be retained in a convenient position prior to use as they form part of the same handling sleeve, this makes the catheter easier to use and the handling sleeve elements easier to access. The provision of a separable handling sleeve can also make manufacture of the packaged assembly simpler whilst still providing the benefits of at least two handling sleeve elements.

At least one handling sleeve may comprise one or more points of weakness to facilitate separation of the sleeve into at least two handling sleeve elements. The or each point of weakness may be one or more perforations. The one or more perforations may be provided about a circumference of the sleeve. The perforations may extend circumferentially around the circumference of the sleeve. In one example, the catheter may comprise one handling sleeve and the handling sleeve may be separable at the perforations to provide two handling sleeve elements. Thus, the handling sleeve may be easily separated by tearing the handling sleeve along the perforations. This facilitates easy separation without additional tools and the separation process does not create unnecessary loose parts that can be difficult and inconvenient to repackage back into the pouch after use.

The perforations may comprise a row of holes extending around the circumference of the handling sleeve. The holes may be separated by a distance that is no more than the size of each hole in a direction parallel to the circumference of the respective handling sleeve. The holes may each have a width and a length perpendicular to a width and a length of the handling sleeve (as defined below) respectively. The holes may be elongate. The aspect ratio (length:width) of each hole may be at least <NUM>:<NUM>, <NUM>:<NUM>, <NUM>:<NUM>, <NUM>:<NUM>. The holes may be separated by a distance that is no more than <NUM>%, <NUM>%, <NUM>%, <NUM>%, <NUM>%, <NUM>%, <NUM>%, <NUM>%, <NUM>% or <NUM>% the length of each hole. The separation of adjacent holes may depend on the length of the holes, alternatively the separation of adjacent holes may be constant irrespective of the length of the holes. The holes may be separated by a distance that is less than <NUM>, <NUM> or <NUM>. The holes may be separated by a distance that is at least <NUM>, <NUM>, or <NUM>. The length of each hole may be at least <NUM>, <NUM>, or <NUM>. The length of each hole may be less than <NUM>, <NUM>, <NUM>, or <NUM>. Preferably, the length is <NUM>, and the holes are separated by a distance of <NUM>. As such, the perforations provide for a point of weakness in the handling sleeve that is sufficient to allow easy separation of the handling sleeve into handling sleeve elements.

Each hole forming the perforations may be a slit. Where each hole is a slit, it may be formed by a one dimensional cut in the handling sleeve. Where each hole is a slit it may have an aspect ratio (length:width) that is effectively <NUM>:<NUM>. Each cut may be made over a distance corresponding to the desired length of each hole. Alternatively, the slitted perforations may be formed in any other suitable way. In some embodiments, each slit may be formed by attaching two or more handling sleeve elements end-to-end, and sealing adjacent handling sleeve elements at locations that do not correspond to the locations of the slits. Advantageously, where the holes are slits, the catheter is less likely to be exposed through the handling sleeve than if the hole was not a slit. This helps prevent inadvertent contamination of the catheter while handling.

The point of weakness may be provided by a tear-off strip. The point of weakness may be provided by a peel-off adhesive. The point of weakness may be provided by sealed hook-and-hook or hook-and-loop elements. Thus, the point of weakness may be configured in a variety of different ways.

At least one handling sleeve may form a sheath around at least part of the catheter. At least one handling sleeve may be tubular, for example cylindrical. At least one handling sleeve may be configured to be separable at a point along its axis. At least one handling sleeve element may form a sheath around only part of the catheter. At least two handling sleeve elements may each form a sheath around only part of the catheter. At least one handling sleeve element may be tubular, for example cylindrical. At least two handling sleeve elements may each be tubular, for example cylindrical. Thus, the handling sleeve provides a sheath around the catheter and may be separated into handling sleeve elements that also provide a sheath around parts of the catheter facilitating easy handling of the catheter without the user having to touch the catheter directly.

At least one handling sleeve may be formed of one or more strips of material joined together along their edges. The join may be provided by any suitable means such as a weld; mechanical seal; heat seal; pressure seal; adhesive; solvent bond; ultraviolet bond; ultrasonic weld; laser weld; impulse weld; or friction weld. The strips of material may be elongate. Where the strips of material are elongate, they may be joined along their elongate edges. The strips of material may be trapeziums. Thus, the handling sleeve can be easily manufactured in a production line by welding the elongate sides of each strip of material together. This can remove the need for the catheter to be fed through the sleeve during manufacture which is a complex process.

A point of weakness in a handling sleeve may be formed after formation of the handling sleeve. In such embodiments, this may be convenient where the handling sleeve or each handling sleeve element is formed from a single/the same type of material. In embodiments where the point of weakness is perforations, the perforations may be cut into the handling sleeve. Alternatively, a point of weakness may be formed during formation of the handling sleeve. In some embodiments, the handling sleeve may be formed from two or more handling sleeve elements joined end-to-end. This may be convenient where the handling sleeve or each handling sleeve element is formed from different strips of material. In one example, the point of weakness may form the end-to-end join between adjacent handling sleeve elements. For example, the ends of the respective handling sleeve elements may be intermittently welded together to form perforations at the join. In other examples, any suitable joining means may be used such as mechanical seal; heat seal; pressure seal; adhesive; solvent bond; ultraviolet bond; ultrasonic weld; laser weld; impulse weld; or friction weld. Thus, the points of weakness can be conveniently formed in the or each handling sleeve.

Each handling sleeve may have a length measured parallel to the axis of the catheter, and a width measured perpendicular to the axis of the catheter. The width of each handling sleeve may be constant along at least part of its length. The width of the handling sleeve may vary along at least part of its length. The length of the handling sleeve may be less than: <NUM>; <NUM>; <NUM>; <NUM>; <NUM>; or <NUM>. The length of a handling sleeve may be at least: <NUM>; <NUM>; <NUM>; <NUM>; <NUM>; or <NUM>. Preferably, the length of a handling sleeve may be between <NUM>-<NUM>, more preferably <NUM>. The width of a handling sleeve may be less than: <NUM>; <NUM>; <NUM>; <NUM>; <NUM>; or <NUM>. The width of a handling sleeve may be at least: <NUM>; <NUM>; <NUM>; <NUM>; <NUM>; or <NUM>. Preferably, the width of a handling sleeve is between <NUM>-<NUM>. Thus, each handling sleeve, and each corresponding handling sleeve element, can be manufactured to ensure it has the correct width to ensure it is both easy to use and also closely fits the catheter.

Where the width of a handling sleeve is constant along at least part of its length, it may be formed from two rectangular strips of material. In one example, the rectangular strips of material are <NUM> in length and <NUM> wide. At least part of a handling sleeve may be a conical. The width of a conical part may increase or decrease along the length of the conical part of the handling sleeve. A conical part of a handling sleeve may be formed from strips of material that are isosceles trapeziums. Where the strips of material are isosceles trapeziums they may be joined together along their legs. In one example, the strips may have a length (i.e. height of an isosceles trapezium) of <NUM>, and a width that varies from <NUM> at one end to <NUM> at the other. Thus, the handling sleeves and handling sleeve elements can be conveniently manufactured with strips of material into a variety of different sizes to ensure good fit to the catheter and easy use. Where part of a handling sleeve is conical this has the added benefit that it, and any corresponding handling sleeve elements, are less likely to be inadvertently removed from the catheter due to the narrower width at one end. Furthermore, the wider end of the conical part can more easily fit over the ends of the catheter to allow for easy manipulation of them without the user having to touch them directly and without the handling sleeve coming off the catheter.

Each handling sleeve element may form part of a corresponding handling sleeve. Each handling sleeve element may be at least <NUM>%, <NUM>%, <NUM>%, <NUM>%, <NUM>% or <NUM>% the length of its corresponding handling sleeve. The length of a handling sleeve element may be at least <NUM>, <NUM>, <NUM>, <NUM>, or <NUM>, and preferably <NUM>. Where a handling sleeve comprises two or more handling sleeve elements, each handling sleeve element is preferably the same length. Alternatively, where a handling sleeve comprises two or more handling sleeve elements, one or more of the handling sleeve elements may be different lengths. Where a handling sleeve comprises two handling sleeve elements, the ratio of the length of the elements may be between <NUM>:<NUM> and <NUM>:<NUM>, or more preferably between <NUM>:<NUM> and <NUM>:<NUM>. Thus, the handling sleeve elements are sized to ensure the user has adequate space to hold each handling sleeve element before, during, and after use of the catheter.

The catheter may be a urinary catheter. The catheter may be a male urinary catheter. The catheter may be an intermittent catheter. In one embodiment, the catheter is an intermittent male urinary catheter. Thus, the features of the present invention allow intermittent male urinary catheters to be provided in a compact packaging that also facilitates convenient and easy withdrawal, use and re-packaging of the catheter.

The catheter may comprise a proximal end for insertion into the body and a distal end. The catheter may comprise a funnel at its distal end. The funnel may facilitate easier handling of the catheter. Where the catheter is a urinary catheter, the funnel may allow the user to better direct urine as it leaves the catheter during use. At least one handling sleeve and/or handling sleeve element may be configured to overly the funnel. At least one handling sleeve and/or handling sleeve element may be arranged at the distal end, for example around or next to the funnel prior to withdrawal of the catheter from the pouch. The distal end and/or funnel may be withdrawn from the pouch before the proximal end. Thus, the handling sleeve(s)/handling sleeve elements can be arranged such that they can be used to withdraw the catheter from the pouch, this helps ensure the catheter remains clean and sterile prior to use and reduces the risk of infection. Furthermore, as the handling sleeve elements can overly the funnel, they can reduce the likelihood of touching the end of the funnel during re-packaging the catheter after use. This makes using the re-packaging the catheter more hygienic for the user.

The handling sleeve(s) and/or one or more handling sleeve elements may be movable along the length of the catheter. Each handling sleeve element may be independently movable along the length of the catheter. One or more handling sleeves and/or handling sleeve elements may not be joined to the catheter. Preferably the or each handling sleeve, and each handling sleeve element may not be joined to the catheter. Thus, the catheter can be more conveniently handled by moving the handling sleeve elements along the catheter to suit the circumstances of the use and requirements of the user. Alternatively, one handling sleeve element may be moveable along the length of the catheter and one handling sleeve element may be joined to the catheter. In particular one handling sleeve element closest to the distal end of the catheter may be joined to the catheter and one handling sleeve element closest to the proximal end of the catheter may be moveable along the length of the catheter.

One or more of the handling sleeve elements may be configured to enable arrangement of the catheter within the pouch after use. The handling sleeve elements may comprise a proximal handling sleeve element and/or a distal handling sleeve element. The proximal handling sleeve element may be arrangeable at the proximal end of the catheter after use. The distal handling sleeve element may be arrangeable at the distal end of the catheter. The handling sleeve elements may comprise one or more handling sleeve elements arrangeable at a midpoint of the catheter, or closer to a midpoint than the ends of the catheter. The proximal handling sleeve element and/or the distal handling sleeve element may be arrangeable at a midpoint of the catheter, or closer to a midpoint than the ends of the catheter. In a preferred embodiment the handling sleeve elements comprise a distal handling sleeve element and a proximal handling sleeve element. Thus, the handling sleeve elements can be configured to be arrangeable in convenient locations along the catheter.

At least one of the two or more handling sleeve elements may be configured to receive and/or retain at least two sections of the catheter simultaneously. The two or more handling sleeve elements may be configured to retain the catheter in a looped or coiled configuration. Where a handling sleeve element receives at least a first and second section of the catheter, the catheter may be looped between the first and second sections. One or more handling sleeve elements may be configured to receive and/or retain an end of the catheter. Preferably, one or more handling sleeve elements may be configured to receive and/or retain a proximal end of the catheter. The distal handling sleeve element may be configured to receive and retain the proximal end of the catheter. Thus, the size/shape of the catheter can be restricted by the handling sleeves and ensuring the catheter can be easily repackaged back into the pouch. The use of two or more handling sleeve elements further allows for a more restricted shape of the catheter than would be possible with a single handling sleeve element.

At least part of the catheter may be configured to be wetted during withdrawal of the catheter from the pouch. At least part of any one or more of the at least one handling sleeves may be configured not to be wetted during withdrawal of the catheter from the pouch. At least part of each handling sleeve element may be configured not to be wetted during withdrawal of the catheter from the pouch. Less than <NUM>%, <NUM>%, <NUM>%, <NUM>%, or <NUM>% of the length of a handling sleeve may be configured to be wetted during withdrawal of the catheter from the pouch. At least one handling sleeve element may be configured not to be wetted during withdrawal of the catheter from the pouch. Thus, the catheter may be adequately lubricated for use without significantly affecting the handling sleeve(s) or handling sleeve elements.

The handling sleeve(s) and/or handling sleeve elements may be formed of any suitable film materials. The handling sleeve(s) and/or handling sleeve elements may be impermeable to fluids. The handling sleeve(s) and/or handling sleeve elements may be made of a plastics material. The handling sleeve(s) and/or handling sleeve elements may be made from any one or more of: polypropylene (PP), low density polyethylene (LDPE), high density polyethylene (HDPE) or biaxially orientated polypropylene (BOPP), for example. The catheter and/or pouch may be made from the same or different materials as the handling sleeve(s) and/or handling sleeve elements. In a preferred embodiments, the catheter is a hydrophilic thermoplastic elastomer (TPE), and the handling sleeve(s) and/or handling sleeve elements are LDPE. Where the catheter comprises a funnel, the funnel may be polyvinyl chloride (PVC). Thus, the handling sleeve(s) and/or handling sleeve elements, and well as the catheter and funnel can be made from suitable materials.

The pouch may comprise two walls and a peripheral seal between the two walls. The catheter may be arranged within the pouch in a curved configuration. A join may be provided between the two walls of the pouch. The join and an internal base of the peripheral seal may define a channel to be filled with fluid prior to withdrawal of the catheter from the pouch. The pouch and catheter may be 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. One or more handling sleeves may be arranged not to pass through the channel during withdrawal of the catheter from the pouch. Thus, the catheter may be removed and simultaneously lubricated without the one or more handling sleeves passing through the channel and becoming lubricated. Furthermore, any risk of the handling sleeve becoming damaged or inadvertently separating into one or more handling sleeve elements during withdrawal of the catheter is reduced as the handling sleeve does not pass through the channel.

The one or more handling sleeves may be arranged around a section of the catheter that is not intended for insertion into the body. The one or more handling sleeves may not be arranged around sections of the catheter intended for insertion into the body. Sections of the catheter not intended for insertion into the body may not be arranged to pass through the channel during withdrawal of the catheter from the pouch. Sections of the catheter intended for insertion into the body may be arranged to pass through the channel during withdrawal of the catheter from the pouch. Thus, the one or more handling sleeves do not inhibit the lubrication of the catheter whilst it passes through the channel during withdrawal of the pouch.

The packaged catheter assembly may comprise a fluid reservoir. The fluid reservoir may be configured to release fluid into the pouch to form a pool of fluid in the channel. The volume of the fluid reservoir is preferably sufficient to completely fill the channel, i.e. with the pouch held with its base lowermost, the fluid may extend to at least the level of the bottom of the join, so that the fill level of the channel is <NUM>% or more, for example at least <NUM>%, at least <NUM>% or even at least <NUM>%. Alternatively, the fill level of the channel may be: at least <NUM>%, at least <NUM>%, at least <NUM>%; or at least <NUM>% the volume of the channel. At least one handling sleeve element may be arranged above the fill level of the channel prior to withdrawal of the catheter from the pouch. Thus, the present invention provides for an assembly with a reservoir that is able to deliver fluid into the channel. The size of the reservoir is selected to ensure sufficient fluid is delivered and the catheter can be adequately lubricated on removal, in addition, at least one handling sleeve element remains above the fill level and remains in a dry state enabling more convenient handling of the catheter.

The pouch may be sealed. The fluid reservoir may be arranged within the (sealed) pouch. The fluid reservoir may be provided as a separate device, or incorporated into the pouch material. The fluid reservoir may comprise a deformable, frangible or burstable sachet. Thus the fluid reservoir is conveniently located within the pouch where it may directly release fluid into the channel formed by the join and the base of the peripheral seal. A deformable, frangible or burstable reservoir enhances the convenience for a user as fluid can be easily released without additional tools and before the pouch is unsealed, thus reducing the chances of accidental wetting of the user. A sachet in particular can be easily handled on an assembly line and introduced more simply than attempting to handle fluid, so as to it into the package during manufacture.

The catheter may be arranged between the join and the internal base of the peripheral seal. The join may be separate from the base of the peripheral seal. The channel may be an open-ended channel. Thus, the catheter is held within the pouch in the open-ended channel formed by the join and the internal base of the peripheral seal. As such, when withdrawn, the catheter is drawn through the channel and is adequately lubricated.

The join and the peripheral seal may be independent. The join may be provided in a spot. The join is preferably provided by a weld, e.g. a spot weld. Such a weld may be provided after the catheter (and optionally the sachet) have been arranged between the walls, and can be achieved from outside of the pouch. Alternatively, the join may be provided by any of a: mechanical seal; heat seal; pressure seal; adhesive; solvent bond; ultraviolet bond; ultrasonic weld; laser weld; impulse weld; or friction weld. Similarly, the peripheral seal be provided by any one or more of a weld; mechanical seal; heat seal; pressure seal; adhesive; solvent bond; ultraviolet bond; ultrasonic weld; laser weld; impulse weld; or friction weld. At least part of the peripheral seal may be formed by a fold. In such embodiments, a single sheet may be folded, for example at the base or one of two sides, to form two opposing walls of the pouch. The join can be provided in a single location allowing the peripheral seal and join to be formed separately. Alternatively, the weld forming the join may be provided at the same time as the peripheral seal. In some embodiments, the join and peripheral seal are a single continuous seal. The manufacturing process of the join can thus be very convenient and avoid major modification of a typical packaged catheter assembly production line.

The catheter may comprise a surface which is activated by the fluid in the channel. For example, the catheter may comprise a hydrophilic surface, formed for example by a hydrophilic coating. Where a hydrophilic surface is provided, the fluid may be polar or water-based. The catheter may comprise a hydrophobic surface, which is activated by the fluid in the channel. For example the catheter may comprise a hydrophobic coating. Where a hydrophobic coating is used, the fluid may be nonpolar. Thus the catheter is easily lubricated by fluid in the channel and is easy and comfortable to use.

The handling sleeve may comprise a surface which is not activated by the fluid. A surface of the handling sleeve may be hydrophobic. An inner surface of the handling sleeve may be hydrophobic. The handling sleeve may be embossed with a pattern. An inner surface of the handling sleeve may be embossed with a pattern. The pattern may be a linen pattern. Preferably an inner surface of the handling sleeve adjacent to the catheter in use is hydrophobic and embossed with a pattern. Advantageously, this reduces friction between the handling sleeve and the catheter in use. In some embodiments, the surface properties of parts of the handling sleeve, or individual handling sleeve elements may vary depending on their functionality. For example, where a part of the handling sleeve, or a handling sleeve element, is intended not to move along the length of the catheter, its surface properties may be selected to increase friction between the handling sleeve and the catheter. Thus, the surface properties of the handling sleeve can be selected to ensure the handling sleeve and catheter are easy to use.

The pouch may comprise an interaction region defining a first point of contact for a user of the packaged catheter assembly. The interaction region may facilitate user access to the contents of the pouch. Actuation of the interaction region may create an opening in or near an upper edge of the peripheral seal. The catheter may be withdrawn through the opening. Thus, access to the pouch is provided at or near an upper edge of the pouch and as such, the fluid in the channel (at the bottom of the pouch) is retained in the pouch while the catheter is withdrawn reducing the risk of spilling fluid outside the pouch.

The interaction region may comprise a breakable region of the peripheral seal. The method may comprise forming a breakable region in the peripheral seal. The breakable region may comprise a tear-away region which may comprise a tear line defining a line along which the pouch may be torn to at least partially separate the tear-away region from the remainder of the pouch, thereby creating an opening in the peripheral seal. The tear-away region may comprise a tear start. The tear start may be provided at a first end of the tear away region. The tear start may comprise a notch, or area of weakness, in one or both of the walls of the pouch. The tear start may define the first part of the pouch to be torn. The tear-away region may comprise a tear stop. The tear stop may be provided at a second end of the tear-away region. The tear stop may act to prevent or reduce the likelihood of the tear-away region being completely separated from the remainder of the packaging. The tear-away region may be substantially triangular in shape having a sloped upper edge. Thus the breakable region provides a convenient and easy means to open the pouch with minimal effort and no additional equipment/tools.

The interaction region may comprise a sealing arrangement. The sealing arrangement may comprise one or more sealing members operable to provide a user-sealable seal between the two walls of the pouch, so as to close the pouch. In one embodiment, first and second sealing members are provided on an interior surface of the two walls of the pouch. The sealing arrangement may provide a watertight and/or fluid impermeable seal when closed. Thus the pouch can be resealed to ensure the fluid in the channel is not subsequently released from the pouch after use. This also allows the catheter to be repackaged back into the pouch after use and retained within it.

The sealing arrangement may come pre-sealed. In such embodiments, user access to the contents of the pouch may be provided by opening the sealing arrangement. The sealing arrangement may be resealable. The sealing arrangement may be any of: a zip-lock seal; hook and loop seal; hook and hook seal; or adhesive layer. Therefore, the sealing arrangement can be used to ensure the contents of the pouch remain inside until the sealing arrangement is opened, and the pouch can still be resealed after use. This can help if the breakable region requires force to be applied to the pouch to be opened, as the pouch may move or jerk in position while being opened causing fluid or the catheter to exit the pouch.

The interaction region may comprise a breakable region and a sealing arrangement. In certain embodiments, the interaction region comprises a tear-away region corresponding to the upper edge of the peripheral seal, and a resealable arrangement below the tear-away region.

The peripheral seal may have an upper edge. The peripheral seal may be substantially rectangular in shape with two lateral edges between the base and upper edge. The peripheral seal may have a height from the base to the upper edge of at least <NUM>, <NUM>, or <NUM>; and/or a height of no more than <NUM>, <NUM>, <NUM> or <NUM>, such as between <NUM> and <NUM>. The peripheral seal may have a width between the lateral edges of at least <NUM>, <NUM>; or <NUM>; and/or a width of no more than <NUM> or <NUM>, or <NUM> such as between <NUM> and <NUM>. The catheter may have a length of at least: <NUM>; <NUM>; <NUM>; <NUM>; <NUM>; <NUM>; or <NUM>, for example between <NUM> and <NUM>. In one embodiment, the peripheral seal has a height <NUM>-<NUM> and a width of <NUM>-<NUM>, and the catheter has a length of at least <NUM>. Thus, the peripheral seal defines a "pocket-sized" pouch that can store a catheter within in a curved configuration to reduce the apparent size of the catheter and enable convenient and discreet storage.

The at least one of the one or more handling sleeves may be arranged at or next to the distal end of the catheter. The distal end of the catheter may be arranged closer to an upper edge of the peripheral seal than the base of the peripheral seal. The distal end of the catheter may be arranged in the upper half of the pouch, or the upper quarter of the pouch. The distal end of the catheter may be arranged above the join. The distal end of the catheter may be arranged above the fill level of the fluid. Thus, the distal end of the catheter is easy to access and presents a handling sleeve to the user so that the catheter may be withdrawn conveniently using the handling sleeve. The handling sleeve is also positioned so as not to be pulled through the fluid, so will not be wetted and will remain easy to handle.

The distal end of the catheter may be provided with at least one handling sleeve, which may be arranged closer to an upper edge of the peripheral seal than the base of the peripheral seal. At least part of a handling sleeve may be arranged in the upper half of the pouch or the upper quarter of the pouch. At least part of a handling sleeve may be arranged above the join. At least part of a handling sleeve may be arranged above the fill level of the fluid. Thus, the handling sleeve is easy to access so that it may be withdrawn before the proximal end of the catheter as required by the invention. It is also positioned so as not to be pulled through the fluid, so at least part of it will not be wetted and will remain easy to handle, providing a dry surface that can be gripped and used to manoeuvre the catheter.

The join may be provided at a point equidistant from each lateral edge. Alternatively it may be offset. The method may comprise providing the join at a point equidistant from each lateral edge. Alternatively it may comprise proving the join in an offset lateral position. For example it may be arranged anywhere between <NUM>% and <NUM>% of the width of the pouch. The distance between the left and right lateral edges of the peripheral seal may be the width of the pouch. The distal end of the catheter may be provided at a distance from one left edge that is no more than <NUM>%, <NUM>%, <NUM>% or <NUM>% of the width of the pouch. Thus the join and distal end are provided in locations that make the catheter easy to withdraw and lubricate without spilling lubricant. The provision of a join that is equidistant between the edges ensures the channel volume is restricted and that the fluid level within it is optimised for lubricating the catheter.

The distal end of the catheter may be arranged closer to one (e.g. a left) lateral edge of the peripheral seal than another (e.g. a right) lateral edge of the peripheral seal. In embodiments comprising an interaction region, actuation of the interaction region may preferentially first create an opening in a first (e.g. left) lateral edge of the peripheral seal. In such embodiments, the distal end of the catheter may be arranged closer to the first (e.g. left) lateral edge. In embodiments comprising a tear-away region and a tear start, the location of the tear start may correspond to a lateral edge of the peripheral seal. In such embodiments, the distal end of the catheter may be arranged closer to the lateral edge of the peripheral seal corresponding to the location of the tear start. One or more handling sleeves and/or handling sleeve elements may be arranged at the distal end of the catheter. Thus, the distal end, and corresponding handling sleeves/handling sleeve elements are located next to the first part of the pouch to be opened and is easier to withdraw.

The join may be provided closer to the base of the peripheral seal than an upper edge of the peripheral seal. The distance between the base and the upper edge of the peripheral seal may define the height of the pouch. The distance between the join and base may be at least: <NUM>%; <NUM>%; <NUM>%; <NUM>%; <NUM>%; <NUM>%; <NUM>% or <NUM>% of the height of the pouch. The distance between the join and base may be less than: <NUM>%; <NUM>%; <NUM>%; <NUM>%; <NUM>%; <NUM>%; <NUM>%; or <NUM>% of the height of the pouch. In particular, the join can be arranged at between <NUM>% and <NUM>% of the height of the pouch. The join may be circular. The join may have a radius equivalent less than <NUM>%; <NUM>%; <NUM>%; or <NUM>% the height of the pouch. In a preferred embodiment, the join has a radius of <NUM>% the height of the pouch. Thus, the join can be arranged to ensure the catheter is adequately lubricated and that it defines a channel of suitable size to allow easy withdrawal of the catheter without excessive bending of the catheter or excessive force to be applied.

In one embodiment, the join is provided at a point equidistant from each lateral edge of the pouch and at a distance from the base that is <NUM>-<NUM>% of the height of the pouch.

The distal end of the catheter may be provided with a funnel arranged so as not to pass through the channel during withdrawal of the catheter from the pouch. The one or more handling sleeves may also be arranged so as not to pass through the channel during withdrawal of the catheter. The one or more handling sleeves may be no more than: <NUM>%; <NUM>%; <NUM>%; <NUM>%; or <NUM>% of the length of the catheter, but could be longer. Embodiments of the present invention provide a funnel and at least one handling sleeve to allow easy handling of the catheter. These elements, or at least part of them, do not pass through the channel and so are not coated in fluid during withdrawal. This makes the catheter more convenient to use as the fluid is only applied to the necessary parts of the catheter. It also facilitates using less fluid as it is applied in a targeted manner to the catheter.

The angle subtended by the ends of the catheter when curved in the pouch may be at least: <NUM>; <NUM>; <NUM>; <NUM>; <NUM>; <NUM>; or <NUM> degrees; it may even be at least <NUM>; <NUM> or <NUM> degrees. It may be less than <NUM>; <NUM> or <NUM> degrees. The catheter may be arranged within the pouch in a curled or coiled configuration either before use, after use, or both before and after use. Prior to use, the catheter may be arranged such that the join is within an area defined by the curl or coil of the catheter. After use, the catheter may be arranged such that the join is not be provided within an area defined by the curl or coil of the catheter. The peripheral seal may confine the catheter in its curved configuration. As such, the catheter is curved, curved or coiled to reduce the size of the pouch and ensure that long catheters can be conveniently and discreetly stored ready for use.

The catheter may be arranged such that during withdrawal at least: <NUM>%; <NUM>%; <NUM>%; <NUM>%; <NUM>% or <NUM>% of the length of the catheter passes through the channel. In one embodiment, <NUM>-<NUM>% of the length of the catheter passes through the channel during withdrawal. Advantageously, only the part of the catheter intended to enter the body is lubricated and therefore fluid is not wasted and the catheter is easier to use.

The walls may be formed of any suitable material, such as film materials. The walls may be impermeable to fluids. The walls may be made of a plastics material. The walls may be made from any one or more of: polypropylene (PP), polyethylene terephthalate (PET), low density polyethylene (LDPE), metalized polyester (MET PET)or orientated polypropylene (OPP), for example. The walls may comprise a laminate of two or more layers. Each wall may comprise an inner layer and an outer layer. Each wall may comprise inner and outer layers of polypropylene. Each wall may comprise an inner layer of orientated polypropylene and an outer layer of polypropylene. Each wall may comprise an inner layer of polypropylene and an outer layer of polyethylene, for example. The inner layer and outer layer may have the same thickness. In other embodiments, the inner layer and outer layer may have different thicknesses. The inner layer may have a smaller thickness than the outer layer. In embodiments, the inner layer may have a thickness of between <NUM>-<NUM> microns, or between <NUM>-<NUM> microns, or between <NUM>-<NUM> microns, and the outer layer may have a thickness of between <NUM>-<NUM> microns, or between <NUM>-<NUM> microns, or between <NUM>-<NUM> microns. In one example, the inner layer may have a thickness of approximately <NUM> microns and the outer layer may have a thickness of approximately <NUM> microns.

The pouch may be an opaque pouch. The pouch may comprise a transparent or translucent window (preferably corresponding to the position of the fluid reservoir in the pouch and/or a wetting region into which fluid is intended to flow from the fluid reservoir). The catheter and/or one or more handling sleeves may be arranged within the pouch so as to be hidden from view. A fluid reservoir may be provided within the pouch, and the pouch may be configured so as to allow a user to view the fluid reservoir and/or view fluid released from the fluid reservoir.

Thus, the present invention provides for a packaged catheter assembly that is discreet as the contents of the assembly are hidden. The window provides a visual guide so that during use of the catheter, the user can easily identify the fluid reservoir, and/or easily identify that fluid has been successfully released from the reservoir into a wetting region of the pouch to lubricate the catheter prior to use. Whilst the provision of a transparent/translucent window is the preferred approach for allowing a user to view whether fluid has been successfully released from the reservoir, alternative approaches are considered feasible. For example, rather than providing a transparent/translucent window in an opaque wall of the pouch, it is conceived that the functionality could be achieved by providing a transparent/translucent pouch wall, but including an intervening opaque wall, within the pouch provided between the transparent/translucent pouch wall and the catheter (and optionally the reservoir). The intervening wall could include a window, or fluid released from the reservoir could flow between the outer transparent/translucent wall and the intervening wall, providing an indication of successful release.

The pouch may comprise two opaque walls. The window may be provided in one of the opaque walls. The window may be spaced from at least one edge of the pouch or the wall it is provided in. The window may be spaced from all edges of the pouch. The window may be less than: <NUM>%; <NUM>%; <NUM>%; <NUM>% or <NUM>% the total area of the pouch and/or the wall it is provided in. The window may correspond to the size and/or shape of the fluid reservoir. The window may be a smaller size than the fluid reservoir. In one embodiment, the window is the same shape but a smaller size than the fluid reservoir. Thus, in embodiments of the invention, the window advantageously corresponds to the size, shape and position of the fluid reservoir and is provided in a discrete manner, separated from the edges of the pouch and only provided in a section of the pouch's wall.

The window may correspond to the position of an indicator region of the pouch. the indicator region may correspond to a wetting region, which may extend from the base of the pouch to a level at which sufficient fluid has escaped from the pouch to wet the catheter. The indicator region may be configured to indicate successful release of fluid from the reservoir. The indicator region may comprise a fill-level marker indicating sufficient fluid is in the wetting region. Thus the window also provides a visual guide to ensure fluid released from the reservoir has been delivered to a specific area of the pouch (e.g. a channel) or that it has successfully lubricated the catheter.

The pouch may be substantially rectangular in shape with two lateral edges, a base, and an upper edge. The height of the pouch may be defined as the distance between the base and upper edge. The width of the pouch may be defined as the distance between the lateral edges of the pouch. The window may span at least: <NUM>%, <NUM>%; <NUM>%; <NUM>%; <NUM>%; <NUM>%; <NUM>% or <NUM>% the height of the pouch. In one embodiment, the window spans at least <NUM>-<NUM>% of the height of the pouch and the window is between <NUM>-<NUM>% of the width of the pouch. Thus, the fluid reservoir is easily visible as the window is aligned with it, but simultaneously, the area of the window is minimised to ensure the contents of the pouch remain generally not visible, on account of the fact that but for the window, the pouch is opaque.

The catheter in the pouch is preferably hidden. The catheter may be hidden by the opaque walls of the pouch. The catheter may be hidden by the fluid reservoir. The one or more handling sleeves in the pouch is preferably hidden. The one or more handling sleeves may be hidden by the opaque walls of the pouch. The one or more handling sleeves may be hidden by the fluid reservoir. This is particularly advantageous from the point of view of discretion -the catheter and handling sleeve(s) are likely to appear to observers as some kind of medical device, even if they are not aware of its precise nature; hiding it, either by ensuring that it is arranged out of register with the window, or by hiding it behind another object, for example the fluid reservoir (but optionally a dedicated sheet material, for example) obscures this.

Notably, the fluid reservoir (or other obscuring object) may be opaque, and may have a colour that corresponds to, or contrasts with that of the walls of the pouch. For example, the reservoir (or other obscuring object) may be in the same colour, but a different shade to that of the pouch, or where the opaque pouch has multiple colours, may be a shade of one of those colours. A grey or silver is considered particularly preferable for the reservoir (or other obscuring object) from the point of view of discretion.

One or more handling sleeve, and/or one or more handling sleeve elements, may be opaque and have a colour that corresponds to, or contrasts with, that of the walls of the pouch and/or the catheter. Thus, the handling sleeve can be constructed to be similar to the colour of the pouch and/or catheter and thereby provide a more discrete catheter.

The window may be patterned; i.e. at least part of the window may be provided with a pattern thereon, such as a pattern formed by opaque regions, such as spots, stripes or the like. The pattern may provide a graduated appearance to the window. The pattern may provide a graduated appearance to one or more of the edges the window. The pattern may blend the window into the surrounding packaging of the pouch. Thus, the window is less obvious to the untrained eye and is therefore the packaged catheter assembly (both before and after use) is more discreet for the user to carry with them.

A retaining seal may be provided between the two walls to restrict the movement of the fluid reservoir (which may of course be a sachet as defined above) in the pouch. The retaining seal may be provided outside the curvature of the catheter. The retaining seal may be closer to an upper edge of a peripheral seal of the pouch than a base of the pouch. The retaining seal may extend from an upper edge of a peripheral seal of the pouch.

According to a second aspect of the present invention a method is provided as described in claim <NUM>.

The method may comprise first opening a packaged catheter assembly to provide the catheter and the pouch. The packaged catheter assembly is a packaged catheter assembly according to claim <NUM>, optionally including any of the optional features set out above. Indeed, it may comprise any of the optional features without necessarily including all the features set out in the first aspect above.

The method comprises separating at least one handling sleeve into at least two handling sleeve elements. Thus, the at least one handling sleeve may be separated to provide handling sleeve elements that enable convenient and easy packaging of the catheter.

The method may comprise moving one or more handling sleeve elements along the length of the catheter. Thus, the handling sleeve elements may be easily arranged to assist handling different parts of the catheter.

The catheter may comprise a proximal end for insertion into the body and a distal end. The method may comprise arranging one handling sleeve element, a distal handling sleeve element, at or near to the distal end of the catheter. The method may comprise arranging one handling sleeve element, a proximal handling sleeve element, at or near to the proximal end of the catheter. Thus, the ends of the catheter can be conveniently packaged without touching the used catheter surface itself.

The method may comprise coiling or looping the catheter. The method may comprise receiving at least first and second sections of the catheter within at least one handling sleeve elements, preferably at one handling sleeve element. The method may comprise looping the catheter between the first and second sections of the catheter. The first section may be an end of the catheter, preferably the proximal end. The second section may not be an end of the catheter. The method may comprise arranging a first handling sleeve element along the catheter at a point corresponding to the second section. The method may comprise inserting an end of the catheter into the first handling sleeve element. A second handling sleeve element may be used to insert an end of the catheter into the first handling sleeve element. Preferably, the first handling sleeve element is the distal handling sleeve element. Thus, the catheter can be looped tightly to restrict its size/shape using two or more handling sleeve elements.

The method may comprise forming a knot in the catheter. The method may comprise forming a loop in the catheter using the two or more handling sleeve elements. The method may comprise passing an end of the catheter through the loop so as to form a knot. Preferably, the distal end may be passed through the loop. Thus, the size/shape of the catheter may be further restricted by knotting the looped catheter. In addition, both ends of the catheter are retained in position ensuring the catheter is easily repackaged in the pouch.

The method may comprise arranging the distal end next to, or in contact with, the proximal end. The method may comprise fixing the distal end to the proximal end. The method may comprise arranging the catheter in a circular or looping shape. The catheter may comprise a funnel arranged at its distal end. The method may comprise inserting the proximal end into the distal end, or vice versa. The method may comprise inserting the proximal end into the funnel. The method may comprise compressing the funnel to retain the proximal end within it. Thus, the catheter's ends are connected together to form a circular shape which makes the catheter easier to handle and package.

The method may comprise restricting the shape of the catheter using two or more handling sleeve elements. The method may comprise gripping two or more of the two or more handling sleeve elements with one hand. The method may comprise inserting the catheter into the pouch using the two or more gripped handling sleeve elements. Thus, the catheter can be held in a restricted shape using just one hand allowing the other hand to hold the pouch open so as to receive the catheter.

According to a third aspect (not claimed) there is provided a method of using a catheter, wherein the catheter comprises at least one handling sleeve configured to provide at least two handling sleeve elements, the method comprising: introducing the catheter to the body; withdrawing the catheter from the body using at least one handling sleeve of the catheter; and arranging the catheter within a pouch using the at least two handling sleeve elements.

The method may comprise providing a packaged catheter assembly comprising the catheter retained within the pouch. The method may comprise opening the pouch and withdrawing the catheter from the pouch.

Where the catheter is a male urinary catheter, the method may further comprise introducing the catheter by its proximal end into the urethra. The method may comprise releasing urine through a funnel at the distal end of the catheter. The method may further comprise removing the catheter.

In the method of using the catheter, the packaged catheter assembly may be a packaged catheter assembly as defined in general terms, or according the first aspect set out above, optionally including any of the optional features set out above. Indeed, it may comprise any of the optional features without necessarily including all the features set out in the first aspect above.

The method of using the catheter may also optionally include any one of the features as set out in the method of packaging a catheter according to the second aspect above. It may comprise any of the optional features without necessarily including all the features set out in the second aspect above.

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

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.

Referring to <FIG>, a first embodiment of a packaged catheter assembly <NUM> is shown.

The assembly <NUM> comprises a fluid reservoir <NUM>, a male intermittent single-use urinary catheter <NUM>, and a pouch <NUM>. The catheter <NUM> comprises a proximal end <NUM> for insertion into the body, a distal end <NUM>, and a flexible tube <NUM> connecting the two ends <NUM>, <NUM>. The distal end <NUM> comprises a funnel <NUM> to guide urine from the bladder out of the tube <NUM> in use. A handling sleeve <NUM> is also provided around the tube <NUM>, and it is provided adjacent to the distal end <NUM>. The handling sleeve <NUM> comprises a point of weakness, which in this embodiment is a line of perforations <NUM> that extends around a circumference of the handling sleeve <NUM>. The perforations <NUM> are breakable and as such the handling sleeve <NUM> is separable into two handling sleeve elements, a proximal element 25a and a distal element 25b, as described below.

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

In this embodiment, the pouch <NUM> 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 <NUM>, a right lateral edge <NUM>, a left lateral edge <NUM>, and an upper edge <NUM>. The left lateral edge <NUM> and right lateral edge <NUM> being defined as the left and right sides of the pouch when viewing the pouch <NUM> with the rear wall 31b behind the front wall 31a, the base <NUM> at the bottom of the pouch <NUM> and the upper edge <NUM> at the top of the pouch <NUM>. The peripheral seal thus defines a pouch <NUM> that is generally rectangular and suitably has a width between the lateral edges of between <NUM>-<NUM>, for example about <NUM>, e.g. <NUM>, and a height from the base <NUM> to the upper edge <NUM> of between <NUM> to <NUM>, for example about <NUM>, e.g. <NUM>. The base <NUM> defines the bottom of the pouch in use, and the upper edge <NUM> the top. However, in other embodiments alternative shapes and sizes could be conceived, such as an elliptical or circular pouch.

The pouch also comprises a join <NUM> between the two walls 31a, 31b. The join <NUM> is a circular weld provided at point equidistant between the lateral edges <NUM>, <NUM> of the peripherals seal and at a distance above the base <NUM> extending from <NUM> to <NUM>. The join <NUM> may have a radius between <NUM>% and <NUM>% the height of the pouch, for example <NUM>%. 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.

The pouch also comprises a window <NUM> in one of the walls, which allows a user to see inside the pouch. In this particular embodiment, the window <NUM> is transparent elongate and generally rectangular with a length between <NUM>-<NUM>% the height of the pouch <NUM>, for example <NUM>%, and width between <NUM>-<NUM>% the width of the pouch <NUM>, for example <NUM>%. In this example, the window <NUM> has semi-circular ends, but in other embodiments they may be any suitable shape, such as flat ends or irregularly shaped ends. The window <NUM> is arranged parallel to the right lateral edge <NUM>, and a gap is provided between the edge of the window <NUM> and right lateral edge <NUM> equivalent to between <NUM>- <NUM>% the width of the pouch, for example <NUM>%. The bottom of the window <NUM> is separated from the base of the peripheral seal <NUM> by a distance equal to between <NUM>-<NUM>% the height of the pouch, for example <NUM>%. 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 <NUM> degrees with respect to the edges.

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

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 <NUM> 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 <NUM>. 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 <NUM>. Further alternatives may also be contemplated and achieved, for example, providing an aperture corresponding to the window <NUM> 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 <NUM>, 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.

In this particular embodiment, the pouch also comprises an interaction region. The interaction region forms the top part of the pouch <NUM> and spans between the right lateral edge <NUM> and left lateral edge <NUM>. The interaction region is used to provide access to the pouch through/near to the upper edge <NUM>. In this embodiment, the interaction region comprises a tapered tear away region <NUM> and a sealing arrangement <NUM>. The tear-away region <NUM> comprises a tear start <NUM> on the left lateral edge, about <NUM> below at the point the upper edge <NUM> and left lateral edge <NUM> meet, and a tear stop <NUM> at a point in the pouch <NUM> about <NUM> below where the upper <NUM> and right lateral <NUM> edges meet. The distance from the tear stop <NUM> and the right lateral edge <NUM> being between <NUM>-<NUM>% the width of the pouch, for example <NUM>%. The tear start <NUM> comprises a notch to provide an area of weakness in the walls 31a, 31b allowing the tear away region <NUM> to be separated from the pouch <NUM> by tearing the walls apart from the tear start <NUM> to the tear stop <NUM>. Thus the tear is provided beneath the location of the upper edge <NUM> and thus the pouch <NUM> is opened provided access to its contents. The tear stop <NUM> comprises a small aperture in the walls 31a, 31b to prevent further tearing of the pouch <NUM> and separation of the tear away region <NUM> from the pouch <NUM>. In order to provide the tapered shape, the tear away region <NUM> extends upwards on the left side approximately <NUM>% more than it does on the right side. The left side of the tear away region <NUM> comprises a circular aperture <NUM> sized to allow a finger to pass through and grip the tear away region <NUM>. 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 <NUM> and circular aperture <NUM>. 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.

In this embodiment, the sealing arrangement <NUM> extends between the left lateral edge <NUM> and right lateral edge <NUM> of the peripheral seal just below the tear away region <NUM>. The sealing arrangement <NUM> comprises first and second sealing members (not shown) provided on an interior surface of the walls 31a, 31b of the pouch <NUM>. 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.

In this embodiment, the fluid reservoir <NUM> is an elongate rectangular burstable sachet of water, but in other embodiments any suitable reservoir may be used. The fluid reservoir <NUM> has a height equal to between <NUM>-<NUM>% the height of the pouch <NUM>, for example <NUM>%, and a width between <NUM>-<NUM>% the width of the pouch <NUM>, for example <NUM>%. In this embodiment, the fluid contained within the reservoir <NUM> 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.

In this embodiment, the catheter <NUM> has a length of between <NUM>-<NUM>, for example <NUM>, and the handling sleeve <NUM> is between <NUM> and <NUM>% the length of the catheter <NUM>, for example <NUM>-<NUM>%, e.g. <NUM>. In this embodiment, the perforations <NUM> are located at a mid-point along the length of the handling sleeve <NUM>. The distal element 25b therefore constitutes the half of handling sleeve <NUM> closest to the distal end <NUM> of the catheter <NUM>, and the proximal element 25a the half of the handling sleeve <NUM> closest to the proximal end <NUM> of the catheter <NUM>.

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

In this embodiment, the handling sleeve <NUM> is perforated across its width, half way along its length, to form the perforations <NUM> prior to joining the elongate edges <NUM>, <NUM>, so as to provide the two separable handling sleeve elements 25a, 25b. In this embodiment, the perforations <NUM> comprise a row of elongate holes extending around the circumference of the handling sleeve <NUM>. The holes have a width and length perpendicular to the width and length of the handling sleeve <NUM> 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 <NUM>:<NUM> and effectively <NUM>:<NUM>.

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 <NUM>. In this embodiment, the length of each hole is <NUM>. As such, the perforations <NUM> provide for a point of weakness in the handling sleeve <NUM> that is sufficient to allow easy separation of the handling sleeve <NUM> into two handling sleeve elements 25a, 25b. Furthermore, as they are slits, they reduce the likelihood of inadvertent contact with the catheter <NUM> through the holes when handling the catheter <NUM>. This helps to ensure the catheter <NUM> remains clean and sterile prior to use.

In this embodiment, the catheter <NUM> is provided with a hydrophilic coating, this is activated when it contacts the fluid held in the reservoir <NUM>. In other embodiments, any suitable catheter length or type may be used. Referring to <FIG>, in this embodiment the inner surface <NUM> of the handling sleeve <NUM> is hydrophobic and comprises an embossed pattern <NUM>. This reduces friction between the catheter <NUM> and the handling sleeve <NUM> allowing easier arrangement of the sleeve along the catheter <NUM> during use. In this example, the embossed pattern <NUM> is a linen pattern.

The catheter <NUM> is arranged within the pouch <NUM> in a curved and coiled configuration, with the distal end <NUM> adjacent to the inner left lateral edge <NUM> near the upper <NUM> edge of the pouch <NUM>, just beneath the sealing arrangement <NUM>. The catheter <NUM> extends down the inside of the pouch <NUM> into a broadly elliptical anti-clockwise coil (as viewed with left lateral edge <NUM> on the left, and upper edge <NUM> at the top). The coil having a single turn around the inner perimeter of the left lateral edge <NUM>, base <NUM>, and right lateral edge <NUM> of the pouch, with the proximal end <NUM> of the catheter <NUM> resting on the inside of the catheter's coil, adjacent to the left lateral edge <NUM> and base <NUM> of the pouch. Notably, the majority of the handling sleeve <NUM> is arranged above the join <NUM>, and as such, the perforations <NUM> are arranged above the join <NUM>. As the catheter <NUM> curves and extends from left to right, the catheter tube <NUM> 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 <NUM> is lower than and on the left side of the join <NUM>. In short, the catheter <NUM> is coiled (or curled) around the join <NUM> (albeit not tightly coiled). In other embodiments, the position of the catheter <NUM> may be different, in particular, the catheter <NUM> may not coil or curl but may simply curve within the pouch <NUM>. On the other hand, embodiments of the invention may have a catheter <NUM> that has multiple turns of coil.

Referring to <FIG>, the pouch <NUM> is formed by first providing the two walls 31a, 31b which are to define the pouch <NUM> itself, and the front wall 31a comprising the transparent window <NUM> 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 <NUM>, however in other embodiments, the walls may extend outside the pouch <NUM> as required.

In this embodiment, the base <NUM>, right lateral edge <NUM> and left lateral edge <NUM> are the first to be formed by welding the two walls 31a, 31b together, leaving the pouch <NUM> with an open upper edge <NUM>. The catheter <NUM> is then arranged within the pouch <NUM> in a curved and coiled configuration, as set out above.

In this embodiment, the fluid reservoir <NUM> is also placed within the pouch <NUM> at a position corresponding to the window <NUM>. The reservoir <NUM> is placed over the catheter <NUM> so that the reservoir <NUM> is visible through the window <NUM> and the reservoir <NUM> obstructs any view of the catheter <NUM> through the window <NUM>. In other embodiments, the reservoir <NUM> may not need to be placed over the catheter <NUM> as the position of the catheter <NUM> in the pouch <NUM> may not correspond to the window <NUM>.

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 <NUM>, and the peripheral seal is completed by forming its upper edge <NUM> by welding the walls 31a, 31b together along the upper edge <NUM>. This seals the catheter <NUM> and reservoir <NUM> within the pouch <NUM>. In other embodiments, the sealing elements may be provided to the walls prior to any other assembly of the pouch <NUM>, or sealing of the peripheral seal.

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

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

As will be appreciated, the above is an example and in other embodiments the pouch <NUM> may be formed in different ways with the steps performed in different orders. For example, the bottom could be open and the catheter <NUM> and water reservoir <NUM> introduced from the bottom before the base seal <NUM> 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 <NUM> and reservoir <NUM> 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 <NUM>, <NUM>, <NUM>, <NUM>, simultaneously forming the tear start <NUM>, forming the join <NUM> and punching out and sealing the aperture <NUM> and tear stop <NUM> in the interaction region <NUM>. Furthermore, while the peripheral seal and join <NUM> 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.

Referring to <FIG>, this first embodiment of a packaged catheter assembly <NUM> may be unpackaged as described below.

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

Referring to <FIG>, the fluid released from the reservoir <NUM> collects in a pool at the bottom of the pouch <NUM>, as shown by the hashing. In this embodiment, the fluid fills the pouch <NUM> up to a fill level corresponding to the join <NUM>. As such, in this embodiment, the join <NUM> and base <NUM> 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 <NUM>-<NUM>%, or may fill the pouch above the level of the join <NUM>.

The released fluid is also visible through the window <NUM>, as the base of the window <NUM> corresponds to a location on the pouch <NUM> that is slightly lower than the join <NUM>. 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.

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

Referring to <FIG>, the catheter <NUM> may then be withdrawn from the pouch <NUM>. As described above, in this embodiment the catheter <NUM> is coiled in the pouch <NUM>, and the distal end <NUM> is provided adjacent the upper edge <NUM> of the pouch <NUM>. As such, the distal end <NUM> is above the fill line of the fluid released into the pouch <NUM> and is not wetted by the fluid. The distal end <NUM> therefore provides a dry and easy to access point which may be used to withdraw the catheter <NUM> from the pouch <NUM>. In this embodiment, the majority of the handling sleeve <NUM>, i.e. between <NUM>-<NUM>%, for example <NUM>% of the sleeve <NUM> is also above the fill line and is not wetted. Thus, the sleeve <NUM> also provides a convenient dry surface to handle the catheter <NUM>. In particular, the distal handling sleeve element 25b is entirely above the fill line and is therefore dry.

In this embodiment, the distal end <NUM> is pulled upwards through the opening in the upper edge <NUM> of the pouch <NUM>. As the distal end <NUM> is pulled out of the pouch <NUM>, the catheter tube <NUM> is uncoiled and also pulled upwards towards the upper edge <NUM> of the pouch <NUM>. However, as the join <NUM> is arranged within the coil of the catheter <NUM>, the tube <NUM> is prevented from moving directly upwards by the join <NUM>. The join <NUM> therefore causes the tube <NUM> to be withdrawn from the pouch <NUM> along a path that includes passing through the channel defined by the join <NUM> and base <NUM>. As such, the entire remainder of the tube <NUM> to the proximal tip <NUM> passes though the pool of fluid in the channel and the hydrophilic coating of the catheter <NUM> is activated by the fluid. Furthermore, the proximal end <NUM> of the catheter <NUM> is the final part of the catheter <NUM> to pass through the channel and be withdrawn from the pouch <NUM>. Thus, the catheter <NUM> is activated by the fluid as it is withdrawn and the withdrawal is convenient and easy as only a dry part of the catheter <NUM> needs to be touched during withdrawal. As the catheter <NUM> 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 <NUM> 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 <NUM> may not directly touch the join <NUM> and may instead be prevented from moving upwards by the convergence of the walls 31a, 31b as they approach the join <NUM>.

Once the catheter is fully withdrawn, the catheter may be used by inserting the proximal end <NUM> into the urethra until urine begins to flow through the catheter <NUM>. The (largely dry) handling sleeve <NUM> assists in the insertion. The urine may then be directed out of the catheter <NUM> by the funnel <NUM>.

Referring to <FIG>, the catheter <NUM> may be placed back inside the pouch <NUM> in a coiled configuration after use. The handling sleeve <NUM> including proximal element 25a and distal element 25b, and funnel <NUM> provide for dry surfaces that can be used to re-coil the catheter <NUM> and place it into the pouch <NUM>. The catheter <NUM> may be repackaged back into the pouch <NUM> as described below.

Referring to <FIG>, the handling sleeve <NUM> may be separated into the proximal element 25a and distal element 25b. This may be done before or after use of the catheter <NUM> as required by the user. In this embodiment, to separate the handling sleeve <NUM>, the perforations <NUM> may be broken about the circumference of the handling sleeve <NUM>. The proximal element 25a and distal element 25b are thereby provided on the catheter <NUM>. 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 <NUM> to aid ease of use.

In this embodiment, the catheter <NUM> 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 <NUM>, and the distal element 25b is arranged at a second section of the catheter <NUM> between a midpoint and the distal end of the catheter <NUM>. Secondly, the proximal element 25a may be used to create a loop in the catheter <NUM> between the first and second sections.

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

To further restrict the size/shape of the catheter <NUM>, in this embodiment, the catheter <NUM> is then knotted. A knot is formed in the catheter <NUM> by passing the distal end of the catheter <NUM> through the loop. In this embodiment, this is done by holding the distal element 25b to retain the looped shape of the catheter <NUM>, and then passing the funnel <NUM> through the loop using the funnel <NUM> 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.

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

The sealing arrangement <NUM> can then be used to reseal the pouch <NUM> between the left lateral edge <NUM> and right lateral edge <NUM> by pressing together the two corresponding sealing elements (not shown). This provides for a more convenient disposal of the catheter <NUM> after use and ensures the fluid released into the pouch <NUM> does not subsequently leak out of the pouch <NUM>. In other embodiments, alternative sealing arrangements may be used, such as an external flap with adhesive that allows the top of the pouch <NUM> to be rolled or folded and sealed. Alternatively, no sealing arrangement may be used where the pouch <NUM> is intended to be disposed of immediately after use.

Referring to <FIG>, a second embodiment of a packaged catheter assembly <NUM> 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.

In this embodiment, the join <NUM> is provided a location offset from the midpoint between the right lateral edge <NUM> and left lateral edge <NUM>. In particular, the join is provided at a distance from the right lateral edge <NUM> that is <NUM>-<NUM>% the width of the pouch <NUM>, for example, <NUM>%. The join <NUM> provides a second function as a retaining seal to restrict the movement of the reservoir <NUM> in the pouch <NUM>, sandwiching the reservoir <NUM> between the join <NUM> and the right lateral edge <NUM>. The join <NUM> therefore ensures the window <NUM> corresponds to the position of the reservoir <NUM> regardless of the movement of the pouch <NUM> as it is carried around by a user, ensuring both that the catheter <NUM> remains hidden and that the reservoir <NUM> 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 <NUM>, or up from the base <NUM>.

In this embodiment, the front wall 231a also comprises a pattern <NUM> that corresponds to the edge of the window <NUM>. The pattern <NUM> 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 <NUM> 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 <NUM>. As such, the pattern <NUM> makes the window <NUM> less visually obvious and therefore makes the pouch <NUM> more discreet. In other embodiments, the pattern <NUM> 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 <NUM>.

Claim 1:
A packaged catheter assembly comprising a pouch (<NUM>) and a catheter (<NUM>), wherein: the catheter is arranged within the pouch; and the catheter comprises at least one handling sleeve (<NUM>) formed of a film material and configured to separate into at least two handling sleeve elements (25a, 25b) after withdrawal of the catheter from the pouch.