WO2023237877A1

WO2023237877A1 - A catheter assembly

Info

Publication number: WO2023237877A1
Application number: PCT/GB2023/051482
Authority: WO
Inventors: Oliver PFLEGER; Sally Leyland
Original assignee: Convatec Limited
Priority date: 2022-06-08
Filing date: 2023-06-07
Publication date: 2023-12-14

Abstract

A packaged catheter assembly comprises a catheter (3) arranged within a sterile sealed pouch (2). The pouch has an openable edge and a resealing arrangement proximal the openable edge for resealing the pouch after use. The resealing arrangement comprises a pair of pursing strips (21,22) and a fastener (23). The edge can be sealed after opening by folding or rolling a sealable portion of the pouch about the pursing strips to form a folded or rolled section and fastening the folded or rolled section using the fastener.

Description

A catheter assembly

Technical Field of the Invention

The present invention relates at its broadest to medical devices in general, but primarily to catheter assemblies. In particular the invention concerns packaged urinary catheter assemblies, and most particularly, but not exclusively packaged intermittent male urinary catheter assemblies.

Background to the Invention

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.

To reduce the risk of damage to the urinary tract and improve comfort while using the catheter, it is important that catheters are activated before use for example through wetting of the catheter by a wetting fluid. It is important, of course that the catheter is adequately wetted, along its length and particularly at the proximal end, which will enter the urethra first. However, it is desirable to avoid providing too much wetting fluid, as excess fluid can leak out of the package in which it is provided, and of course, simply to reduce material cost. Various approaches exist to avoiding excess free-fluid in the package for a catheter, such as providing the catheter in a vapour rather than having a separate container of liquid that is opened to wet the catheter. However, it would be desirable to improve on the assurance of adequate wetting whilst using the simple approach of wetting the catheter by opening a container of fluid into a pouch which houses the catheter, then drawing the catheter through the pool of fluid to wet it.

In tandem with this aim, it is desirable to encourage opening of the container of wetting fluid, prior to opening the pouch housing the catheter and the container of wetting fluid. In particular, where a catheter is packaged with a container of wetting fluid, the user may be tempted to open the pouch that houses the catheter and the wetting fluid, then reach into the pouch to burst the container of wetting fluid. This risks contaminating, or dirtying the catheter and wetting the user’s hand unnecessarily. The correct approach is to open (e.g. burst) the container from the outside, by squeezing it through the material of the pouch, ideally prior to opening the pouch. It would be beneficial to promote this approach.

Where a catheter is packaged in a pouch, it has been proposed, for example in WO2021/214478A1 to provide a resealing arrangement, which can seal the pouch after use. It is noted that configuring the packaging such that it is sealable following opening may be beneficial in situations wherein liquid might be present (e.g. urine or wetting fluid for catheter), and/or where a user wishes to keep the contents of the packaging discreet, e.g. on exit from a toilet cubicle before disposal. As such, the pouch of WO2021/214478A1 is openable by tearing off a tear-away region at the top of the pouch, but has a strip of hook fasteners which is secured (e.g. adhesively) to the interior surface of the respective side of the packaging, so as to form a double hook fastener arrangement for resealing the open upper end of the packaging, in use. There is a downside to this arrangement in that the double hook fasteners can tend to close before use, such that the user has to first tear off the tear away region, then pull open the double-hook fasteners to access the contents of the pouch. This can be troublesome, especially for those with low manual dexterity - a fairly common trait amongst intermittent catheter users. As such an alternative resealing arrangement is desirable.

It is an object of embodiments of th present invention to at least partially overcome or alleviate the above problems and/or to provide an improved catheter assembly.

Summary of the Invention

In broad terms, aspects of the invention concern a medical device. The medical device may be a packaged medical device. The medical device may be a catheter assembly. The packaged medical device may be a packaged catheter assembly comprising a catheter arranged within a pouch. The medical device, e.g. catheter, may be arranged within a sterile sealed pouch. The pouch may have an openable edge. The openable edge may be an openable top (i.e. in use the openable end edge be held uppermost to remove the catheter upwards from it). The pouch may comprise a resealing arrangement for resealing the pouch after use. The resealing arrangement may be proximal the openable edge. The resealing arrangement may comprise a pair of pursing strips. The resealing element may comprise a fastener. The edge may be able to be sealed after opening by folding or rolling a sealable portion of the pouch about the pursing strips to form a folded or rolled section. The folded or rolled section may be fastened using the fastener. The packaged catheter assembly may comprise a container of wetting fluid. The container of wetting fluid may be arranged within the sterile sealed pouch. The pouch may comprising a guide. The guide may define a wetting region. The wetting region may be a region in which wetting fluid will pool. The guide may be configured to guide at least a portion of the catheter through the wetting region. The packaged catheter assembly may further comprise a wetting indicator. The wetting indicator may be arranged in the wetting region. The wetting indicator may change colour in response to contact with wetting fluid.

One broad aspect of the invention provides a packaged catheter assembly comprising a catheter arranged within a sterile sealed pouch; the pouch having an openable edge and a resealing arrangement for resealing the pouch after use; wherein the resealing arrangement comprises a pair of pursing strips and a fastener.

A first aspect of the invention provides a packaged catheter assembly comprising a catheter arranged within a sterile sealed pouch; the pouch having an openable edge and a resealing arrangement proximal the openable edge for resealing the pouch after use; wherein the resealing arrangement comprises a pair of pursing strips and a fastener, whereby the edge can be sealed after opening by folding or rolling a sealable portion of the pouch about the pursing strips to form a folded or rolled section and fastening the folded or rolled section using the fastener.

Use of pursing strips is advantageous compared to resealing elements such as hook-and-loop fasteners as previously proposed, because not only do pursing strips act, in their natural state, to close the opened edge, but pursing strips, when squeezed, act to open the edge, allowing easier access to the contents, especially for those with low manual dexterity.

Of course, the closure by the natural behaviour of the pursing strips alone to hold two sides of the pouch flat against one another cannot be expected to create a water-tight seal. However, the provision of a fastener allows the sealable portion of the pouch to be folded or rolled about the pursing strips, then fastened closed, with the folds/rolls creating an improved, preferably water-tight seal.

A first pursing strip and a second pursing strip may be arranged on the sealable portion of the pouch. The first and/or second pursing strips may be arranged on the inside of the sealable portion of the pouch.

Accordingly, in one embodiment there is provided a packaged catheter assembly comprising a catheter arranged within a sterile sealed pouch; the pouch having an openable edge and a resealing arrangement proximal the openable edge for resealing the pouch after use; wherein the resealing arrangement comprises a pair of pursing strips and a fastener, whereby the edge can be sealed after opening by folding or rolling a sealable portion of the pouch about the pursing strips to form a folded or rolled section and fastening the folded or rolled section using the fastener; wherein the first and/or second pursing strips are arranged on the inside of the sealable portion of the pouch.

Alternatively, the first and/or second pursing strips may be arranged on the outside of the sealable portion of the pouch.

Each pursing strip may comprise a strip of flexible and/or resilient material having higher rigidity that the material forming the pouch. Each pursing strip may comprise a strip of flexible and/or resilient material having higher rigidity that the other material forming the sealable portion of the pouch. Each pursing strip may be resiliently flexible, i.e. it may flex away from its natural (flat) configuration under external influence (e.g. squeezing by a user) and resile to its natural (flat) configuration when that external influence is removed.

Accordingly, in one embodiment there is provided a packaged catheter assembly comprising a catheter arranged within a sterile sealed pouch; the pouch having an openable edge and a resealing arrangement proximal the openable edge for resealing the pouch after use; wherein the resealing arrangement comprises a pair of pursing strips and a fastener, whereby the edge can be sealed after opening by folding or rolling a sealable portion of the pouch about the pursing strips to form a folded or rolled section and fastening the folded or rolled section using the fastener; wherein each pursing strip comprises a strip of flexible and resilient material having higher rigidity that the material forming the pouch.

Another embodiment of the invention provides a packaged catheter assembly comprising a catheter arranged within a sterile sealed pouch; the pouch having an openable edge and a resealing arrangement proximal the openable edge for resealing the pouch after use; wherein the resealing arrangement comprises a pair of pursing strips and a fastener, whereby the edge can be sealed after opening by folding or rolling a sealable portion of the pouch about the pursing strips to form a folded or rolled section and fastening the folded or rolled section using the fastener; wherein each pursing strip is resiliently flexible.

Each strip may be arranged to extend parallel to the openable edge of the pouch. For example, where the openable edge of the pouch is the top of the pouch, each strip may extend laterally across the width of the pouch.

The pouch may be provided with a one or more pursing strip locators. A, the, or each pursing strip locator may show a user as to where to squeeze the pouch to operate the pursing strips to open the openable edge of the pouch.

A, the, or each pursing strip locator may comprise a marker and/or an indentation receive a user’s finger s/thumb. An indentation and/or marker may be arranged at each of two opposing ends of the strips.

Accordingly, in one embodiment there is provided a packaged catheter assembly comprising a catheter arranged within a sterile sealed pouch; the pouch having an openable edge and a resealing arrangement proximal the openable edge for resealing the pouch after use; wherein the resealing arrangement comprises a pair of pursing strips and a fastener, whereby the edge can be sealed after opening by folding or rolling a sealable portion of the pouch about the pursing strips to form a folded or rolled section and fastening the folded or rolled section using the fastener; wherein the pouch is provided with one or more pursing strip locators to show a user as to where to squeeze the pouch to operate the pursing strips to open the openable edge of the pouch..

In another embodiment there is provided a packaged catheter assembly comprising a catheter arranged within a sterile sealed pouch; the pouch having an openable edge and a resealing arrangement proximal the openable edge for resealing the pouch after use; wherein the resealing arrangement comprises a pair of pursing strips and a fastener, whereby the edge can be sealed after opening by folding or rolling a sealable portion of the pouch about the pursing strips to form a folded or rolled section and fastening the folded or rolled section using the fastener; wherein the pouch is provided with one or more pursing strip locators; each pursing strip locator comprising a marker and an indentation receive a user’s fingers/thumb; an indentation and a marker being arranged at each of two opposing ends of the strips.

Each lateral edge of the sealable portion of the pouch, at the end of each pursing strip, may be provided with a pursing strip locator. The pursing strip locator may be provided in the peripheral seal of the pouch.

The pouch may be formed from two opposing walls and the first pursing strip may be arranged on one wall, and the second pursing strip arranged on the other wall. The first pursing strip and the second pursing strip may be positioned at the same distance along the walls such that they are arranged opposite each other.

Alternatively the pair of pursing strips may be arranged adjacent to each other and spaced apart to define folding points of the walls of the pouch between the pursing strips such that the pouch is foldable in increments defined by the height of the pursing strips.

Each of the pursing strips may have the same height and may each extend the same distance along a length, e.g. the height, of the pouch.

The pouch may comprise only the pair of pursing strips, i.e. only two pursing strips. Alternatively the pouch may comprise additional pursing strips, for example three or more pursing strips (three being a pair and one further pursing strip).

The fastener may comprise an adhesive to adhere to the folded or rolled section of the pouch.

Accordingly in one embodiment there is provided a packaged catheter assembly comprising a catheter arranged within a sterile sealed pouch; the pouch having an openable edge and a resealing arrangement proximal the openable edge for resealing the pouch after use; wherein the resealing arrangement comprises a pair of pursing strips and a fastener, the fastener comprising an adhesive to adhere to the folded or rolled section of the pouch; whereby the edge can be sealed after opening by folding or rolling a sealable portion of the pouch about the pursing strips to form a folded or rolled section and fastening the folded or rolled section using the fastener.

For example, the fastener may be a sticker comprising an adhesive to adhere to the folded or rolled section of the pouch.

The adhesive may be covered by a release layer, for example a release paper, which may be removed to reveal the adhesive.

The sticker may be bonded to the pouch (e.g. welded or adhered to the pouch). The sticker may be removeably or irremoveably bonded to the pouch. Each has its own advantages.

The fastener may be provided on the outside of the pouch. The fastener may be arranged on a rear wall of the pouch.

Accordingly in one embodiment there is provided a packaged catheter assembly comprising a catheter arranged within a sterile sealed pouch; the pouch having an openable edge and a resealing arrangement proximal the openable edge for resealing the pouch after use; wherein the resealing arrangement comprises a pair of pursing strips and a fastener arranged on the outside of a rear wall of the pouch, whereby the edge can be sealed after opening by folding or rolling a sealable portion of the pouch about the pursing strips to form a folded or rolled section and fastening the folded or rolled section using the fastener.

The sticker may comprise a peelable adhesive. The sticker may thus be removeable from the pouch by peeling it off the pouch and the sticker may then be stuck back on to hold the folded or rolled section against the remainder of the pouch.

Alternatively, the sticker may be irremovably bonded to the pouch, such that it cannot be removed without breaking it. In that case, it may be configured such that the adhesive to adhere to the folded or rolled section of the pouch is arranged to overlie the folded or rolled section of the pouch, when folded/rolled As an alternative to an adhesive, the fastener may for example comprise a pair of opposing resealing elements, one resealing element attached to the sealable portion of the pouch and the other resealing element attached to the remainder of the pouch.

Accordingly in one embodiment there is provided a packaged catheter assembly comprising a catheter arranged within a sterile sealed pouch; the pouch having an openable edge and a resealing arrangement proximal the openable edge for resealing the pouch after use; wherein the resealing arrangement comprises a pair of pursing strips and a fastener, whereby the edge can be sealed after opening by folding or rolling a sealable portion of the pouch about the pursing strips to form a folded or rolled section and fastening the folded or rolled section using the fastener; the fastener comprising a pair of opposing resealing elements, one resealing element attached to the sealable portion of the pouch and the other resealing element attached to the remainder of the pouch.

The opposing resealing elements may comprise complementary attachment features on their opposing surfaces which interlock to reseal.

Accordingly in one embodiment there is provided a packaged catheter assembly comprising a catheter arranged within a sterile sealed pouch; the pouch having an openable edge and a resealing arrangement proximal the openable edge for resealing the pouch after use; wherein the resealing arrangement comprises a pair of pursing strips and a fastener, whereby the edge can be sealed after opening by folding or rolling a sealable portion of the pouch about the pursing strips to form a folded or rolled section and fastening the folded or rolled section using the fastener; the fastener comprising a pair of opposing resealing elements, one resealing element attached to the sealable portion of the pouch and the other resealing element attached to the remainder of the pouch, wherein the opposing resealing elements comprise complementary attachment features on their opposing surfaces which interlock to reseal.

For example, the opposing resealing elements may be strips of hook and loop (as commonly known by the Velcro™ brand), hook and hook, or “mushroom” fastening elements. Alternatively, the opposing resealing elements may take the form of a button and button-hole arrangement, poppers, or any of various alternative fasteners which may likewise be arranged with one section attached to the sealable portion of the pouch and the other section attached to the remainder of the pouch. A sticker is preferred primarily for reasons of cost, size and ease of manufacture.

The fastener may be configured so as to overlie the folded or rolled section of the pouch when folded at least once about the edge of the pursing strips, more preferably when folded at least twice about the edges of the pursing strips. The fastener may be configured so as to overlie the folded or rolled section of the pouch when folded no more than three times about the edge of the pursing strips, more preferably when folded no more than twice about the edges of the pursing strips. More folds lead to a better seal, but a more fiddly or time consuming folding process. Two folds is considered optimum.

The pouch may have a pair of lateral edges, a top and an opposing base.

The pouch may be formed of two walls of flexible sheet material. The two walls may be joined at their periphery. For example, they may be joined by a weld, or adhesive. The peripheral seal may comprise 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. They may also be joined by a fold, that is to say, one sheet of flexible material may be folded to provide two opposing walls, which may then be joined to define the remainder of the periphery of the pouch.

The pouch may have a break-away region. The break-away region may be at the openable edge of the pouch. The break-away region may open the openable edge and thereby break the sterile seal.

The break-away region may be a peel-away or more preferably a tear-away region. The break-away region may be defined proximal to an upper edge of the pouch. The break-away (e.g. tear away) region may comprise a break line (e.g. tear line) between a first end and a second end of the break away (e.g. tear-away) region defining a line along which the pouch may be opened (e.g. tom to at least partially separate the tear-away region from the remainder of the pouch) to form an open end of the pouch, in use. The break away (e.g. tear-away) region may comprise an interaction region defining a point of contact for a user to grasp the break away (e.g. tear away) region. The interaction region may comprise one or more visual and/or tactile indicators, preferably whereby in use a user may grasp the interaction region with one hand and grasp the remainder of the pouch with another hand to break (e.g. tear) open the pouch.

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 tom. 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. A tear line may be defined between the tear start and the tear stop. The tear line may be configured to preferentially tear. The tear line may comprise a weakened region of the pouch. The tear line may be formed by any suitable means, such as laser scoring. 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 visual or tactile indicator of the interaction region may be a gripping hole, e.g. a finger-hole. A gripping hole is especially useful for the interaction region as in addition to indicating where to grasp the tear away region, it can help improve the user’ s grasp on that region. The gripping hole may provide a grippy surface or feature. The gripping hole may be any suitable size or shape, for example, rectangular, square, circular, elliptical. In one embodiment, the gripping hole is circular.

The pair of pursing strips may be arranged adjacent to the break away region. For example, the pair of pursing strips may be arranged on the remainder of the pouch adjacent to the tear away region. The pursing strips may be adjacent to and aligned with the tear line.

The packaged catheter assembly may comprise a container of wetting fluid arranged within the sterile sealed pouch. The packaged catheter assembly may comprise a wetting indicator wherein the wetting indicator changes colour in response to contact with wetting fluid. The wetting indicator may be arranged in a wetting region. Accordingly, in one embodiment there is provided a packaged catheter assembly comprising a catheter arranged within a sterile sealed pouch; the pouch having an openable edge and a resealing arrangement proximal the openable edge for resealing the pouch after use; wherein the resealing arrangement comprises a pair of pursing strips and a fastener, whereby the edge can be sealed after opening by folding or rolling a sealable portion of the pouch about the pursing strips to form a folded or rolled section and fastening the folded or rolled section using the fastener; wherein the packaged catheter assembly further comprises a container of wetting fluid arranged within the sterile sealed pouch and a wetting indicator, wherein the wetting indicator changes colour in response to contact with wetting fluid and the wetting indicator is arranged in a wetting region.

The wetting region may for example be a region near the base of the pouch, in which fluid will pool in use. More preferably, the wetting region may be a region defined by a channel through which at least the proximal end of the catheter will pass when it is pulled out of the pouch.

Another broad aspect of the invention provides a packaged catheter assembly comprising a catheter and a container of wetting fluid arranged within a sterile sealed pouch; the pouch comprising a wetting indicator; wherein the wetting indicator changes colour in response to contact with wetting fluid, wherein the wetting indicator is arranged in a wetting region.

A second aspect of the invention provides a packaged catheter assembly comprising a catheter and a container of wetting fluid arranged within a sterile sealed pouch; the pouch comprising a guide, the guide defining a wetting region in which wetting fluid will pool and the guide configured to guide at least a portion of the catheter through the wetting region; the packaged catheter assembly further comprising a wetting indicator; wherein the wetting indicator is arranged in the wetting region and changes colour in response to contact with wetting fluid.

The combination of a packaged catheter assembly including a wetting region defined by a guide which ensures that at least a portion of the catheter passes through the wetting region, along with a wetting indicator which indicates (by changing colour) that there is fluid in the wetting region ensures that the catheter is adequately wetted. Colour changing indicators are not new: CN214731005U discloses an indicator arranged near the top the top of the pouch/catheter carrier to indicate the catheter is ready to use after the sachet has been burst and the pouch/carrier shaken. However, the fact the pouch is shaken does not necessarily mean the catheter is fully lubricated and there may be some dry spots on the coating that would result in pain if the catheter is used. In addition W02020086302A proposes a catheter which itself changes colour to indicate that it is wetted.

In contrast, this aspect of the invention does not rely on the pouch being shaken, but rather (a) defines a wetting region though which at least a portion of the catheter must pass and (b) shows when the wetting region has fluid in. As such there is a synergy to the combination, because, of course, whilst the wetting region defined by a guide is advantageous, in the event that the fluid is not successfully released from the container, a catheter can still emerge dry and cause pain. Thus, in this context, showing that the fluid has reached the wetting region is especially useful as it provides the user with confidence that the catheter is submerged in fluid as the catheter tube passes through wetting region.

The wetting region may be defined between the guide and an edge of the pouch. For example, the wetting region may be defined between the guide and a base edge of the pouch.

The wetting region may comprise a channel defined between the guide and an edge, such as a base edge, of the pouch.

The channel may be open ended, such that a portion of the catheter can pass through the channel from one end to the other.

The wetting indicator may be arranged in the channel.

The wetting indicator may be visible from a front wall of the pouch. The pouch may be at least partially transparent or translucent. In particular the pouch may be transparent or translucent in the region of the wetting indicator. This will allow the colour change to be seen whilst the pouch is sealed closed, which is when the container of wetting fluid should be opened. The pouch may be at least partially opaque, preferably mainly opaque, most preferably opaque except in the region of the wetting indicator - as such, the package can be discreet, not obviously containing a medical device.

The wetting indicator may comprise a liquid activated ink. The liquid activated ink may comprise a liquid activated dye and/or hydrochromic compound. The liquid activated ink may further comprise an opacifier and/or a solvent. Preferably the liquid activated ink comprises a liquid activated dye; a hydrochromic ionic compound; an opacifier; and a solvent.

Some representative examples of liquid activated dyes that can be used in the practice of this invention include: Malachite green, brilliant green, crystal violet, erythrosine B, methyl green, methyl violet 2D, picric acid, naphthol yellow S, quinaldine red, eosine Y, metanil yellow, m-cresol purple, thymol blue, xylenol blue, basis fuchsin, eosin B, 4-p- aminophenol(azo)benzenesulphonic acid-sodium salt, cresol red, martins yellow, phloxine B, methyl yellow, bromophenol blue, congo red, methyl orange, bromochlorophenol blue WS, ethyl orange, flourocene WS, bromocresol green, chrysoidine, methyl red sodium salt, alizarine red S- H20, cochineal, chlorophenol red, bromocresol purple, 4-naphtha, alizarin, nitrazine yellow, bromothymol blue, brilliant yellow, neutral red, rosalic acid, phenol red, 3-nitro phenol, orange II, phenolphthalein, o-cresolphthalein, nile blue A, thymolphthalein, aniline blue WS, alizarine yellow GG, mordant orange, tropaolin O, orange G, acid fuchsin, thiazol yellow G, and indigo carmine.

The hydrochromic ionic compound is typically a reactive ionic compound, such as an ionizing salt. Some representative examples of hydrochromic ionic compounds that can be employed in the practice of this invention include: lithium hydrogen sulfate, lithium hydrogen carbonate, potassium hydrogen sulfate, potassium hydrogen carbonate, rubidium hydrogen sulfate, rubidium hydrogen carbonate, cesium hydrogen sulfate, cesium hydrogen carbonate, sodium hydrogen sulfate, sodium hydrogen carbonate, cesium hydroxide, lithium hydroxide, potassium hydroxide, calcium hydroxide, magnesium hydroxide, sodium thiosulfate penta hydrate, sodium hydroxide, rubidium hydroxide, cobalt chloride, cobalt nitrate, copper sulpate copper nitrate, iron (II) sulfate, iron (III) sulfate, iron (II) chloride, and iron (III) chloride. The opacifiers that can be utilized in the liquid activated ink formulations of this invention can be porosigens or antiporosigens and are typically white powders when they are in the form of dry solids (before being incorporated into the ink formulation). Some representative examples of opacifiers that can be utilized include titanium dioxide, calcium carbonate, calcium hydroxide, sodium silicate, potassium silicate, silica, starch, ethocell, methocell, barium carbonate, barium silicate, calcium silicate, aluminum silicate, aluminum hydroxide, and aluminum oxide.

The solvent utilized in the liquid activated ink formulation is typically a polar solvent, such as an aqueous solvent. The solvent will normally be water or an aqueous solution of one or more water soluble agents in water. For example, a glycol or an alcohol, such as methanol, ethanol, or isopropyl alcohol, or agents which facilitate or accelerate film formation can be included in the solvent.

Exemplary liquid activated inks are disclosed in EP2900281.

The wetting indicator may comprise a sheet or a strip of colour-changing material. The wetting indicator may be a moisture detection test paper. For example, it may be a moisture detection test paper produced by Wuxi Lierjie Biotechnology Co., Ltd., which is white when it is not in contact with moisture, and changes colour after contact with water. Alternatively the moisture detection paper may be a sheet or strip of paper printed with the ink disclosed above. This is particularly convenient when the wetting fluid is water, or is an aqueous solution. An alternative test paper may be provided for other wetting fluids, for example non-polar, oil based, fluids.

As an alternative to the wetting indicator comprising a sheet or strip of colourchanging material, the wetting indicator may comprise a colour-changing coating. The colour changing coating may be an ink as described above. The coating may be provided on an inside surface of the pouch, for example on the inside surface of the front wall of the pouch, opposite a transparent/translucent region of the pouch. The coating may be provided on an exterior surface of the container of wetting fluid. The container of wetting fluid may be arranged in the pouch such that the coating is visible through a transparent/translucent region of the pouch. The colour-changing ink may be printed onto a substrate (such as the inside surface of the front wall of the pouch, or the exterior surface of the container of wetting fluid, to provide the coating). The guide may be provided by a join between two walls of the pouch. 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.

The catheter may comprise a catheter tube having a proximal end for insertion into the body and a distal end. The portion of the catheter that is guided through the wetting region may comprise the proximal end.

The catheter may be arranged within the pouch in a curved configuration. At least a portion of the catheter may be arranged in the wetting region.

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 wetting region (e.g. through the channel).

It is advantageous that the proximal end is the last part of the catheter to be wetted and therefore is least likely to dry up before it is introduced into the urethra.

The guide and the peripheral seal may be independent. 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 be arranged between the join and the 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.

The pouch may comprise a flexible plastics material. For example, polypropylene (PP), polyethylene terephthalate (PET), low density polyethylene (LDPE), linear low density polyethylene (LLDPE), metalized polyester (MET PET) or orientated polypropylene (OPP). Each wall of the pouch may comprise a plurality of layers. In for example 2-layer foil of PET LLDPE may be used. In other embodiments, the walls may only comprise a single layer, and different plastics materials may be used interchangeably.

The pouch may be formed from a predominantly opaque material. The pouch may have a textured or printed appearance and/or feel, such as a matte finish. The pouch may be a different colour from the other components of the packaged catheter assembly, such as any one or more of: the container of wetting fluid and the catheter. Thus, these components are easily identifiable in the pouch and the catheter assembly is more discrete as the appearance and feel of the pouch means it is less likely to be identified as a medical device. The pouch may have a window, that is to say a transparent or translucent section, in register with the wetting indicator. The window may be in a front wall of the pouch. A rear wall may have no window.

The container of wetting fluid may be provided in the wetting region. The wetting indicator may be provided between the container of wetting fluid and the window. The wetting indicator may cover the window. As such, the contents of the pouch (other than the indicator) may be hidden by the opaque walls of the pouch and the wetting indicator. The wetting indicator may be provided on the outside of the container of wetting fluid.

The container of wetting fluid may be a rupturable sachet, for example a deformable, frangible or burstable sachet. 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 put it into the package during manufacture.

It is very convenient to provide a rupturable sachet as the container of wetting fluid. The wetting fluid may be water and the catheter may have a hydrophilic surface. Water interacts with the hydrophilic surface of the catheter to render it lubricious. In other embodiments, other wetting fluids may be used and they may be polar (e.g. waterbased) or non-polar (e.g. oil-based).

The container of wetting fluid may be configured to release the wetting fluid directly into the pouch. As such, the fluid may flow freely to the wetting region of the pouch. The container of wetting fluid may be configured to release wetting fluid when activated by a user. The fluid reservoir may be activated by a user by any suitable means, for example applying a compressive force to the fluid reservoir, in particular squeezing it through the pouch.

As outlined above, the top of the pouch may be openable. This is particularly preferred where fluid flows freely and accumulates in a wetting region at the base, because the top is furthest from the base, so leakage is less likely than if a side of the pouch is openable instead.

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 100% or more, for example at least 150%, at least 200% or even at least 300%. Alternatively, the fill level of the channel may be: at least 70%, at least 80%, at least 90%; or at least 95% the volume of the channel.

The container of wetting fluid may contain at least 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 20 25, or 50 ml of wetting fluid, most preferably at least 5 ml of fluid. The container of wetting fluid may contain no more than 50, 25, 15, 14, 13, 12, 11, 10, 9, 8, 7, 6 or 5ml of fluid, most preferably no more than 15ml; for example between 5 and 7ml, such as about 6ml, or between 10 and 15ml, such as about 12 ml.

The container of wetting fluid may have a polygonal outline. The container of wetting fluid may have a length, a width and a depth. The length (the longest dimension of the length, width and depth) may be aligned with an edge that defines the wetting region, for example the base. The length of the container of wetting fluid may extend across the pouch. The container of wetting fluid may have a rectangular outline.

The catheter may be provided with a sleeve, but is preferably sleeveless. A sleeveless catheter is more easily wetted than one with a sleeve surrounding the catheter tube. If a sleeve is provided, the packaged catheter assembly (in particular the packaged catheter assembly in a sterile sealed state) preferably contains the sleeve in a furled configuration, or the sleeve may be short, i.e. not covering the full length of the catheter tube, but rather exposing part of it. As such, the majority of the catheter tube may be exposed despite the provision of a sleeve. For example, at least 40%, 50%, 60%, 70%, 80%, 90% or 95% of the catheter tube may be exposed. In another alternative, the sleeve may be permeable.

The catheter may be a urinary catheter. The catheter may be a male urinary catheter (i.e. a urinary catheter for men). Alternatively it may be a female urinary catheter (i.e. a urinary catheter for women). 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 of the catheter whilst simultaneously ensuring sufficiently lubricating it prior to use. The catheter may for example be at least 20cm, at least 25cm, at least 30cm, or at least 35cm long. It may be no more than 50cm, no more than 45cm, or no more than 40cm long, for example between 35 and 40cm long, such as 37cm long.

The packaged catheter assembly may be an open catheter assembly (as opposed to a closed catheter assembly) i.e. one in which the catheter tube is not connected to a urine bag, but rather is used to direct urine directly to a lavatory or the like.

In this specification, the expression “catheter” when used alone as a noun, as opposed to as a descriptor (e.g. catheter tube or catheter assembly) is intended to be read broadly as encompassing both a catheter tube alone (that being the simplest form of catheter and the fundamental element of a catheter) and a catheter assembly, a catheter assembly comprising both a catheter tube and at least one other element, such as a funnel, gripping element, sleeve, and so forth. Of course, the packaged catheter assembly of the first aspect of the invention may comprise the features described in relation to the second aspect of the invention.

In addition, the packaged catheter assembly of the first aspect may include any of the optional features of the second aspect of the invention without necessarily including all the features required of the second aspect, and vice versa. That is to say, an optional feature which happens to be set out following one particular aspect does not necessarily apply only to that aspect, so, for example, although details of preferred features of the container of fluid (such as it being a rupturable sachet, and certain preferred sizes) are set out in relation to the second aspect of the invention, they are equally applicable to the first aspect of the invention.

According to a third aspect of the invention there is provided a method of forming a packaged catheter assembly comprising a catheter arranged with a sterile sealed pouch; the method comprising forming the pouch having an openable edge; providing a resealing arrangement proximal the openable edge for resealing the pouch after use; arranging the catheter in the pouch, sealing and sterilising the pouch to form a sealed sterile pouch; wherein the resealing arrangement comprises a pair of pursing strips and a fastener, whereby the edge can be sealed after opening by folding or rolling a sealable portion of the pouch about the pursing strips to form a folded or rolled section and fastening the folded or rolled section using the fastener.

The method of the third aspect of the invention may be a method of forming a packaged catheter assembly according to the first aspect of the invention and may of course include any optional feature outlined above.

According to a fourth aspect of the invention there is provided a method of forming a packaged catheter assembly comprising a catheter and a container of wetting fluid arranged within a sterile sealed pouch; method comprising forming a pouch and a guide, the guide defining a wetting region in which wetting fluid will pool and the guide configured to guide at least a portion of the catheter through the wetting region; providing a wetting indicator, which changes colour in response to contact with wetting fluid in the pouch, and arranging the wetting indicator in the wetting region; and sealing and sterilising the pouch. The method of the fourth aspect may be a method of forming a packaged catheter assembly according to the second aspect of the invention and may of course include any optional feature outlined above.

According to a fifth aspect of the invention, there is provided a method of resealing a packaged catheter assembly, the packaged catheter assembly comprising a pouch having an openable edge and a resealing arrangement proximal the openable edge for resealing the pouch after use; wherein the resealing arrangement comprises a pair of pursing strips and a fastener; the method comprising sealing the openable edge by folding or rolling a sealable portion of the pouch about the pursing strips to form a folded or rolled section and fastening the folded or rolled section using the fastener.

The method may comprise first opening an openable edge, then resealing the packaged catheter assembly according to the method of the fifth aspect of the invention.

The method may comprise removing the catheter from the open edge of the pouch.

The method may introducing the catheter (preferably by its proximal end into the urethra. The method may comprise allowing fluid to pass from the body via the catheter. Consequently, the method may be a method of using a catheter.

The method may comprise wetting the catheter, e.g. wetting the catheter prior to removing it from the pouch and/or prior to opening the pouch. The method may comprise resealing the pouch according to the method of the fifth aspect of the invention after wetting the catheter and removing it from the pouch, and optionally before reintroducing the catheter to the pouch. This can prevent fluid leaking out of the pouch when the user is using the catheter.

The method may comprise reintroducing the catheter (optionally after use) into the pouch, then resealing the pouch according to the method of the fifth aspect. The resealed pouch may then be disposed of, or kept without the user needing to be concerned that fluid (e.g. wetting fluid or urine) will leak out of the resealed pouch.

The method of the fifth aspect of the invention may be a method of resealing a packaged catheter assembly according to the first aspect of the invention and may of course include any optional feature outlined above. According to a sixth aspect of the invention there is provided a method of wetting a catheter in a packaged catheter assembly comprising the catheter and a container of wetting fluid arranged within a sterile sealed pouch; the method comprising releasing fluid from the container of wetting fluid into a wetting region defined by a guide that is configured to guide at least a portion of the catheter through the wetting region; the method further comprising inspecting a wetting indicator that is arranged in the wetting region and determining that the wetting fluid has been released into the wetting region by a change in colour of the wetting indicator.

The method may further comprise opening the pouch (preferably after determining that the wetting fluid has been released into the wetting region).

The method may comprise removing the catheter, preferably by pulling the catheter out by a distal end of the catheter, whereby as the distal end is pulled out, a proximal end of the catheter for insertion into the body is guided by the guide through the wetting region, so as to be wetted by the fluid.

The step of releasing fluid may comprise forming a pool in the channel that is at least 60%; 70%; 80% of the volume of the wetting region; in particular it may be at least 90%; or at least 100% the volume of the wetting region, even up to at least 150%, 200% or 300%. Thus the method provides for creation of a pool of fluid that is adequate to lubricate the catheter without excess lubricant being used.

The method of the sixth aspect of the invention may further comprise introducing the catheter by its proximal end into the urethra. The method may comprise allowing fluid to pass from the body via the catheter. Consequently, the method may be a method of using a catheter. The method may comprise re-introducing the catheter to the pouch after use, then sealing the pouch with the resealing arrangement. For example, the method may comprise bringing the walls of the pouch together to close the pouch. The method may comprise closing/re- sealing the pouch with the catheter within it. The steps of closing/re-sealing the pouch may be performed after use of the catheter. Thus, the pouch can be used to cleanly store the catheter after use and prior to disposal. Of course the packaged catheter assembly may be according to the second aspect of the invention and may include any optional feature outlined above.

In any of the methods of wetting the catheter the method may comprise handling the catheter using a handling element, which may comprise a handling tube arranged around part of the catheter tube.

Likewise in any method the method may comprise forming an opening in the pouch, for example opening the pouch along a line of weakness to provide an open mouth.

In any aspect, the catheter is preferably an open catheter, that is that the catheter tube is not coupled to a fluid collection bag, but rather simply directs fluid out of a distal opening (e.g. via a funnel) to a lavatory, urinal or other suitable destination. Of course, embodiments of the invention may also be closed catheter assemblies in which fluid is collected or retained in a fluid collection bag coupled to the catheter.

Obviously in all the methods, it is most preferred if the packaged catheter assembly is one according to both the first aspect and the second aspect.

Detailed Description of the Invention

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 thee accompanying drawings, of which:

Figure 1 is a front view of a first embodiment of a packaged catheter assembly;

Figure 2 is a front view of the packaged catheter assembly of Figure 1 with the front wall, and the wetting indicator and pursing strip attached thereto not shown;

Figure 3 is a rear view of the packaged catheter assembly of Figure 1;

Figure 4 is a lateral cross sectional view of the bottom section of the packaged catheter assembly of figure 1 in the region of the join and the wetting indicator;

Figure 5a is a front view the packaged catheter assembly of Figure 1 showing a user releasing wetting fluid; Figure 5b is a front view the packaged catheter assembly of Figure 1 after release of wetting fluid;

Figure 6 is a front view the packaged catheter assembly of Figure 1 where top has been fully opened;

Figure 7 is a top perspective view of the packaged catheter assembly of Figure 1 showing the pursing strips assisting in opening the pouch;

Figure 8 is a front view showing the catheter assembly being removed from the pouch of Figure 1 ;

Figure 9 is a front view of the catheter assembly of Figure 1 where the catheter is being re-introduced into the pouch;

Figure 10 is a front view of the catheter assembly of Figure 1 where the catheter has been re-introduced into the pouch and the pouch has been resealed;

Figure 11 is a is a lateral cross sectional view of the bottom section of the packaged catheter assembly of a second embodiment in the region of the join and the wetting indicator; and

Figure 12 is a lateral cross sectional view of the bottom section of the packaged catheter assembly of a third embodiment in the region of the join and the wetting indicator.

Referring to Figures 1-10, a first embodiment of a packaged catheter assembly 1 is shown.

The packaged catheter assembly 1 comprises a pouch 2, which houses a catheter assembly (also referred to as a catheter) 3, best seen in figure 2, and a container of wetting fluid 4, best seen in figures 2, and 4.

In this particular embodiment, the catheter 3 is a male intermittent urinary catheter assembly (i.e. sized for use by men and longer than a typical female catheter assembly, although the aspects of the invention are applicable to female catheter assemblies too and potentially has applicability not only for intermittent urinary catheters). Referring to figure 2, the catheter 3 of the embodiment comprises a catheter tube 5, with apertures (not shown) at the proximal end to allow fluid (e.g. urine) to pass from the bladder into the catheter tube 5. The catheter tube of this embodiment is 37cm long, but of course those skilled in the art will be able to conceive of alternative lengths.

At the distal end of the catheter tube, a funnel 6 is provided to aid the user in directing urine to a suitable location (e.g. a lavatory as the catheter assembly is “open”, not “closed”). Moreover, a gripping element 7 in the form of a handling tube extends around part of the catheter tube 5 and is moveable along the length of the catheter tube 5 to aid in sanitary handling of the catheter 3. Prior to use, the handling tube is arranged adjacent to the funnel 6. The handling tube is short compared to the length of the catheter tube, less than a fifth of its length, such that the large majority of the catheter tube is exposed and will therefore be easily wetted prior to use.

In this embodiment, the catheter tube 3 is made from a hydrophilic thermoplastic elastomer (TPE). The handling tube 7 of this example is formed of LDPE. Obviously those skilled in the art will be able to select suitable alternative examples.

In this embodiment, the wetting fluid is water and interacts with the hydrophilic surface of the catheter 3 to render it lubricious. In other embodiments, other wetting fluids may be used and they may be polar (e.g. water-based) or non-polar (e.g. oilbased) depending on the catheter’s surface properties.

The container of wetting fluid 4 is a sachet, namely an elongate, rectangular rupturable/burstable sachet. In this embodiment it has a length of 7.8cm, a width of 2cm and holds a volume of 5- 15ml of water. This is a relatively small amount of water for wetting a male catheter assembly, but is adequate because of the unique features of the pouch.

Turning now to the pouch 2 itself, the pouch 2 is formed from two opposing walls of flexible sheet material of identical shape and size, namely a front wall 19 and a rear wall 20 which are joined by a peripheral seal 12. The flexible sheet material may for example be polypropylene (PP), polyethylene terephthalate (PET), low density polyethylene (LDPE) Linear low-density polyethylene (LLDPE), metalized polyester (MET PET) or orientated polypropylene (OPP); the material may be predominantly opaque with a textured or printed appearance and/or feel, such as a matte finish. The pouch 2 may be a different colour from the other components of the packaged catheter assembly, such as any one or more of: the container of wetting fluid 4 and the catheter 3. For example it may be a dark colour and, these components may be a light colour and thus easily identifiable in the pouch.

The peripheral seal 12 is preferably a weld, but in alternative embodiments may be an adhesive join; mechanical seal; heat seal; pressure seal; solvent bond; ultraviolet bond; ultrasonic weld; laser weld; impulse weld; or friction weld. The front wall 19 and rear wall 20 wall may also be joined by a fold, that is to say, one sheet of flexible material may be folded to provide two opposing walls, which may then be joined to define the remainder of the periphery of the pouch 2.

The peripheral seal 12 extends around the entire periphery of the pouch and defines both the outer outline of the pouch (being the outermost outline of the weld) and the inner outline of the pouch (being the innermost outline of the weld). The peripheral seal 12 constitutes a sterile seal, thus maintains the sterility of the contents of the pouch 2 (which may of course be sterilised by any approach known in the art) until the seal is broken.

The peripheral seal 12 of the pouch 2 defines a pair of lateral, major edges, namely a left-hand edge 8 and a right hand edge 9. In this embodiment the lateral, major edges 8, 9 are parallel and straight, although that is not essential. The pouch 2 also has a top, 10 and an opposing base 11 defined by the peripheral seal 12. The base 11 is straight and perpendicular to the major edges 8 and 9, whereas the top edge of the closed pouch is slanted, being higher at the left hand side than the right hand side, but of course those skilled in the art will be able to conceive of alternatives.

In this embodiment, the peripheral seal is of uniform thickness around the lateral edges 8, 9 and the base 11 of the pouch 2. As such, the shapes of the interior and the exterior of the pouch correspond in these regions. By contrast, at the top of the pouch, the peripheral seal is of non-uniform thickness, being broadly trapezoidal, so as to define a sloped exterior upper edge, but a flat interior edge, at a right-angle to the lateral, major, edges 8, 9. The top edge of the pouch 2 is openable, in order to form an open mouth through which the catheter 3 can be removed. In this embodiment to open the top, the pouch has a tear away region proximal to an upper edge of the pouch 2. The tear away region, best seen in figures 1 and 6 comprises a tear line 13, which is a line of weakness, e.g. laser-etched, between a first end 14 and a second end 15 of the tear- aw ay region defining a line along which the pouch may be tom to at least partially separate the tearaway region from the remainder of the pouch. The tear line extends just beneath the peripheral seal at the top of the pouch 2, i.e. in a region where the walls of the pouch are not welded to one another. In consequence, tearing here opens the mouth of the pouch 2. The first end 14 is a tear-start, and in this embodiment the tear start takes the form of a triangular cutout extending from the periphery of the pouch into the peripheral weld, so as to preferentially tear through the remainder of the weld along the tear line 13. The second end 15 of the tear away region is a tear-stop, and in this embodiment that takes the form of a circular perforation in the peripheral weld at the opposite end of the tear line. The tear stop, as the name suggests, causes the tearing to stop, meaning that the tear-away region does not entirely tear off from the remainder of the pouch, having formed an open upper end of the pouch 2 in use (as shown in figures 6-9).

The tear-away region comprises an interaction region 16, which defines a point of contact for a user to grasp the tear away region. In this embodiment the first interaction region is a visual and tactile indicator, taking the form of an aperture through the generally trapezoidal upper weld towards the left hand side, which in this embodiment is the side where the weld is biggest and (more importantly) corresponds to the side where the tear-start is arranged. The aperture, or “gripping hole” in this embodiment is circular and sized to receive a finger and thumb, being about 1cm in diameter. Of course, however, the gripping hole may be any suitable size or shape, for example, rectangular, square, circular, elliptical.

The pouch 2 is also provided with a resealing arrangement 17. The resealing arrangement 17 comprises a pair of pursing strips 21, 22 best seen in figures 2 and 7 arranged proximal the openable top of the pouch 2, in particular, just beneath the tear line 13, and parallel thereto, at the mouth of the pouch 2, when opened. The resealing arrangement 17 further comprises a fastener in the form of a sticker 23 attached to the rear wall 20 of the pouch 2. The resealing arrangement 17 is intended for resealing the pouch 2 after use.

Each pursing strip, 21, 22 comprises a strip of resilient flexible material having higher rigidity that the material forming the pouch 2 (in particular the sealable portion of the pouch). For example, each pursing strip may be formed from a plastics material, and may have a thickness of 0.5mm compared to the lower thickness of 0.1 to 0.2mmtypical of the pouch, thereby providing localised rigidity to that region of the pouch.

As best seen in figures 2 and 7, the pair of pursing strips are made up of a first pursing strip 21 attached (e.g. adhered) to the inside of the front wall 19 adjacent the mouth of the pouch 2 when opened, and a second pursing strip 22 attached to the inside of the rear wall 20 adjacent to the mouth of the pouch 2 when opened, extending laterally across the width of the pouch, with the length of each pursing strip being approximately equal to the entire width of the pouch 2 between the peripheral seal 12. One or each pursing strip could alternatively be provided on the outside of the wall, 19, 20, or even integrated into a wall 19, 20 if the wall 19, 20 were formed of more than one layer.

Referring to figure 3, the section of the pouch defined by the distance from the bottom edge 21a, 22a of the pursing strips to the top of the open edge (defined by the tear line 13) and approximately equal to the height (h) of the pursing strips 21, 22 can be folded about the bottom edge 21a, 22a of the pursing strips and as such forms a first segment 24 of a sealable portion 25 of the pouch 2, which is folded about the pursing strips 21, 22 to form a folded or rolled section. In this embodiment, a second segment 26 of the sealable portion 25 of the pouch is provided by the section which is overlayed by the first segment 24 of the sealable portion 25; this second segment 26 can also be folded about the pursing strips 21, 22 after the first fold has taken place, as such, the second segment 26 is folded about the top edge 21b, 22b of the pursing strips 21, 22.

In use, in this embodiment, each fold of the sealable portion 25 is towards the sticker 23 on the rear wall 20 of the pouch, so that the sticker 23 can then fasten the folded section 25 in place (as shown in figure 10). Referring to figures 1 and 3, at each lateral edge of the first segment 24 of the sealable portion 25 of the pouch 2 (i.e. at the end of each pursing strip 21, 22), the pouch 2 is provided with a pursing strip locator 27. The pursing strip locator 27 takes the form of a coloured marker and finger/thumb sized indentation into the peripheral seal 12 in the left and right hand edges 8, 9 of the pouch, and shows a user as to where to squeeze the pouch 2 to operate the pursing strips 21, 22 to open the openable edge of the pouch 2.

The user / ostomate may, in use, use a thumb and forefinger, for example, at opposing pursing strip locators 27 to open the mouth of the pouch 2 by performing a pinching action.

The pursing strips 21, 22 provide localised rigidity to the pouch 2 and assist with the opening of the mouth of the pouch 2, in use. Specifically, the pursing strips 21, 22 may be squeezed laterally to arch the pursing strips 21, 22 (and hence the front and rear walls 19, 22 respectively) in opposing directions to open the mouth of the pouch 2, as shown in figure 7. This can be especially useful for those with low manual dexterity.

The pursing strips 21, 22 are largely rectangular but this is not essential. Other shapes and arrangement are known in other fields of endeavour, and could be incorporated into the pouch 2, such as those disclosed in relation to ostomy pouches in WO2021245394A1 (the contents of which are incorporated by reference) which have cut out regions at comers thereof, and also are arranged adjacent rather than opposing one another, with one pursing strip on one folding segment and another pursing strip on another folding segment.

Returning to the fastener of the resealing arrangement 17, which in this embodiment takes the form of a sticker 23. The sticker of this embodiment happens to be rectangular and has a first section 28 which is irremovably bonded (e.g. adhered) to the rear wall of the pouch 2, and a second section 29 which comprises a peelable adhesive underside covered by a release layer (not shown), for example a release paper, which may be removed to reveal the adhesive. The sticker 23 is arranged such that when the sealable portion 25 is folded (twice) about the lower, then upper edges of the pursing strips 21, 22, the second section 29 of the sticker 23 is juxtaposed with the second section 26 of the front wall 19 of the pouch 2. As such, the second section 29 of the sticker 23 can be lifted prior to folding the sealable portion, then, pressed back down once the sealable portion 25 is folded, overlying the folded portion, so as to hold the sealable portion 25 in its sealed state (i.e. resealing the pouch 2 after the sterile seal has been opened).

In an alternative embodiment (not shown) the sticker 2 may be removeable from the pouch 2 by peeling it off the pouch 2 and the sticker 23 may then be stuck back on to hold the folded or rolled section 25 against the remainder of the pouch 2.

Of course alternatives to a sticker could be used, such as strips of hook and loop (as commonly known by the Velcro™ brand), hook and hook, or “mushroom” fastening elements arranged between the sealing portion 25 and the remainder of the pouch 2.

As can be seen well in figure 2, the catheter is arranged in a somewhat S- shaped or figure-of-8 shaped arrangement, extending from the funnel at the top middle of the pouch, downwards and across towards the left hand side, then extending across the middle of the pouch to the right hand side, before extending down to the bottom of the pouch, back from right to left following the base 11 of the pouch, then up and across from the bottom left hand side to the top right hand side.

A guide 18 is provided, and in this embodiment takes the form of a secondary weld joining the walls of the pouch 2 near its base 11, defining, together with the base, an open ended channel through which the catheter tube 3 extends. The secondary weld 18 is a guide, which guides at least a portion of the catheter 3 through a wetting region 30. Specifically the guide 18 acts to ensure that as the catheter 3 is pulled out by the funnel, it unwinds and all areas of the catheter tube 3 between the secondary weld 18 and its proximal end are forced through the channel, near the base 11, where the wetting fluid will pool.

Specifically, the guide 18 is a circular weld provided at point equidistant between the lateral edges 8, 9 of the pouch and at a distance above the base 11 extending from 45 to 55mm. In other embodiments the guide 18 may be provided in different ways (not a weld, for example) different shapes and sizes, at different locations, or could potentially even be integrated into a continuous seal with the peripheral seal.

The guide 18, along with the base 11 of the pouch 2 defines a wetting region 30 in which wetting fluid from the container of wetting fluid 4 will pool.

In this embodiment, the container of wetting fluid 4 is arranged in the wetting region 30, extending laterally across the base 11 of the pouch 2 and held in place between the guide 18 and the base 11. Of course in other embodiments the container of wetting fluid could be arranged elsewhere, but this location is preferable as it inhibits a user inadvertently removing the container of wetting fluid 4 and ensures that the wetting fluid is released into the wetting region 30. Of course in light of this disclosure those skilled in the art could use trial and error to locate other suitable positions for the container of wetting fluid 4, as well as suitable sizes of container of wetting fluid 4 and alternatives to the sachet of the embodiment, provided they adequately fill the wetting region 30 to ensure that the catheter 3 is properly wetted.

Notably, the packaged catheter assembly 1 further comprises a wetting indicator 31, which is arranged in the wetting region 30 and changes colour in response to contact with wetting fluid.

The wetting indicator 31 indicates, by changing colour, that there is fluid in the wetting region 30 ensures that the catheter is adequately wetted.

As best seen in figure 4, the wetting indicator 31 includes a strip of colourchanging material 32 such as a moisture detection test paper produced by Wuxi Lierjie Biotechnology Co., Ltd., which is white when it is not in contact with moisture, and changes colour after contact with water, which is arranged in the channel between the base 11 and the guide 18. Specifically, the strip of colour changing material 32 is attached to the inside of the front wall 19 of the pouch 2, in front of the catheter 3, which in turn is arranged in front of the container of wetting fluid 4, which extends across the width of the pouch 2 in the wetting region 30.

The wetting indicator 31 is visible from a front wall 19 of the pouch. To achieve this, although the pouch is predominantly opaque, it is transparent or translucent in the region of the wetting indicator 31. This will allow the colour change to be seen whilst the pouch 2 is sealed closed, which is when the container of wetting fluid 4 should be opened.

The transparency/translucency is provided by a window 33 in the front wall 9 which allows a user to see inside the pouch 2. In this particular embodiment, the window 33 is generally circular and patterned, with a dotted pattern shown. The window 33, is of course arranged in juxtaposition with the strip of colour changing material 32, so only the strip of colour changing material 32 can be seen through the window 33, not the catheter 3. In this particular embodiment the patterned window has a diameter of approximately 1cm and is arranged centrally between the two lateral edges 8, 9 of the pouch and half way between the base 11 and the guide 18. In other embodiments, translucent windows may be used and additionally alternative shapes, sizes and positions of the window are contemplated.

In this particular embodiment, each wall 19, 20b 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 19, 20 may only comprise a single layer, and different plastics materials may be used interchangeably.

As mentioned above, the walls 19, 20 are predominantly opaque. This may be achieved by forming each wall 19, 20 from one or more opaque layers of material or printing an opaque pattern onto one of the layers. The window 33 in the front wall 19, 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 33. 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 33. Further alternatives may also be contemplated and achieved, for example, providing an aperture corresponding to the window 33 in an opaque wall, and bonding a transparent layer so as to cover the aperture and achieve a continuous front wall 19 with a window 33, 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 33.

Referring to figure 11, a second embodiment of a packaged catheter assembly 1 is shown. The second embodiment shares many features in common with the first embodiment, to the extent that figures 1-3 and 5a- 10 would be the same for the second embodiment. Like reference numerals are used for like features and this description focusses only on the differences.

The key difference between the packaged catheter assembly 1 of the second embodiment and that of the first embodiment is that in the second embodiment, the wetting indicator 31 is provided not by a strip of colour changing material, but instead by a coating of liquid activated ink 34.

The liquid activated ink may be that of example 1 of EP2900281 (i.e. prepared by adding 3.0 parts of bromochlorophenol blue WS, 20 parts of sodium hydrogen carbonate, and 35 parts of aluminium silicate into 42 parts of water and mixing by stirring until a homogeneous solution is attained).

The liquid activated ink 34 is printed on the inside surface of the front wall 19 opposite the window 33. The entire surface opposing the window 33 is coated with the liquid activated ink 34, so that it obscures the internal contents of the pouch from the window (being white when dry and turning blue when wet).

Referring to figure 12, a third embodiment of a packaged catheter assembly 1 is shown. The third embodiment shares many features in common with the first and second embodiment, to the extent that figures 1, 3 and 5a- 10 would be the same for the second embodiment. Like reference numerals are used for like features and this description focusses only on the differences.

One relatively minor difference between the packaged catheter assembly 1 of the third embodiment and that of the first and second embodiments is that the container of wetting fluid 4 is arranged adjacent to the window 33, rather than being separated therefrom by the catheter 3. As such, the catheter 3 is obscured by the container of wetting fluid 4 and cannot be seen through the window 33.

The key difference between the packaged catheter assembly 1 of the third embodiment and that of the first and second embodiments is that in the third embodiment, the wetting indicator 31 is provided a coating of liquid activated ink 35 printed onto the exterior surface of the container of wetting fluid 4.

The liquid activated ink 35 is printed on the exterior surface of the container of wetting fluid 4, such that in use it is arranged opposite the window 33. The entire surface of the container of wetting fluid 4 that in use is opposing the window 33 is coated with the liquid activated ink 35, so that the only thing visible through the window is the coated surface of the container of wetting fluid. Thus, prior to use, all that can be seen through the window is the white coating of liquid activated ink 35 and, when the container is burst, releasing the water within, the coating of ink 35 will turn blue in response to contact with the water, with this change to blue being visible through the window.

Use of the packaged catheter assembly 1 is the same, whether the assembly 1 is that of the first, second or third embodiment. In use, a user will hold the pouch generally upright, with its openable top above its base 11 and as shown in figure 5a and will squeeze it, rupturing the container of wetting fluid 4, such that the wetting fluid flows freely in the wetting region 30 between the guide 18 and the base 11, where it forms a pool. Successful release of the wetting fluid 4 will be indicated by a visible change in colour of the wetting indicator 31, as illustrated in figure 5b (e.g. from white to blue).

Having confidence that the wetting fluid 4 has been successfully released, the user then grasps the interaction region 16 and tears open the top, with the tear opening from the tear start at the first end 14 of the tear line 13 and ending at the tear stop 15, thereby opening the mouth of the pouch, but not tearing off the tear away region completely, as can be seen by figure 6.

Having opened the container of wetting fluid 4 and broken the sterile seal, opening the mouth of the pouch 2, the user then squeezes the pouch between thumb and forefinger at the pursing strip locators 27. As shown in figure 7, this causes the pursing strips 21, 22 to bend, arching away from each other to open the mouth widely, presenting the user with the funnel 6 of the catheter 3. Being arranged above the container of wetting fluid 4 and indeed above the lateral guide 18, the funnel 6 will be dry, as will the handling tube 7. The user will then draw out the catheter 3, as shown in figure 8, holding it by the funnel 6. As the catheter 3 is drawn out, the guide 18 will bear on the catheter tube, forcing the entirety of the tube that is between the guide 18 and its proximal tip to be drawn through the wetting fluid which is pooled in the wetting region, namely in the channel between the secondary join 18 and the base 11 of the pouch 2. Thus a portion of the catheter 3 will be wetted as it is pulled out, and importantly the proximal part of the catheter 3, which will travel furthest through the urethra, is well wetted.

The user can then insert the catheter 3 into the urethra and drain the bladder as usual, using the handling tube 7 to aid insertion into the urethra. Once the bladder has been adequately drained, the user can re-introduce the catheter to the pouch 2 to store it prior to disposal (as indicated by the arrow in figure 9). This step is made simpler than in the prior art because, once again, the user can pinch the pouch 2 at the ends of the pursing strips 21, 22 to open the mouth wide. Once the used catheter 3 is pushed down beneath the pursing strips 21, 22 of the resealing arrangement 17, the pursing strips 21, 22 will resile back to their natural flat configuration facing one another.

At this stage, optionally, the user can pull the top of the tear away region hard, breaking it away from the remainder of the pouch 2 and introducing it into the pouch 2 for disposal, rather than leaving it flapping around. Again, once introduced, the pursing strips 21, 22 will resile back to their natural flat configuration facing one another.

The user can then fold the sealable section 25 of the pouch, first folding the first segment 24 towards the rear about 180 degrees with the bottom edges 21a, 22a of the pursing strips 21, 22 as the pivot point, then lift the second section 29 of the sticker 23 make a second fold of the sealable section 25, this time folding the second segment towards the rear about 180 degrees with the top edges 21b, 22b of the pursing strips 21, 22 as the pivot point, before sticking down the second section 29 of the sticker 23 and fastening the folded section of the to the remainder of the pouch 2, as shown in figure 10. Of course, whilst folding has been described, a similar result would be achieved by rolling the sealable section up.

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.

Claims

CLAIMS A packaged catheter assembly comprising a catheter arranged within a sterile sealed pouch; the pouch having an openable edge and a resealing arrangement proximal the openable edge for resealing the pouch after use; wherein the resealing arrangement comprises a pair of pursing strips and a fastener, whereby the edge can be sealed after opening by folding or rolling a sealable portion of the pouch about the pursing strips to form a folded or rolled section and fastening the folded or rolled section using the fastener. A packaged catheter assembly according to claim 1 wherein a first pursing strip and a second pursing strip are arranged on the sealable portion of the pouch. A packaged catheter assembly according to claim 2 wherein the first and/or second pursing strips are arranged on the inside of the sealable portion of the pouch. A packaged catheter assembly according to any preceding claim wherein each pursing strip comprises a strip of flexible and resilient material having higher rigidity that the material forming the pouch. A packaged catheter assembly according to any preceding claim wherein each strip is arranged to extend parallel to the openable edge of the pouch. A packaged catheter assembly according to any preceding claim wherein the openable edge of the pouch is the top of the pouch and each strip extends laterally across the width of the pouch. A packaged catheter assembly according to any preceding claim further comprising one or more pursing strip locators which show a user as to where to squeeze the pouch to operate the pursing strips to open the openable edge of the pouch. A packaged catheter assembly according to claim 7 wherein the or each pursing strip locator comprises a markers and an indentation to receive a user’s finger s/thumb; the indentations and markers being arranged at each of two opposing ends of the strips. A packaged catheter assembly according to any preceding claim wherein the pouch is formed from two opposing walls, wherein the first pursing strip is arranged on one wall, and the second pursing strip arranged on the other wall; the first pursing strip and the second pursing strip being positioned at the same distance along the walls such that they are arranged opposite each other. A packaged catheter assembly according to any preceding claim wherein the fastener comprises an adhesive to adhere to the folded or rolled section of the pouch. A packaged catheter assembly according to claim 10 wherein the fastener is a sticker comprising an adhesive to adhere to the folded or rolled section of the pouch. A packaged catheter assembly according to claim 11 wherein the adhesive is covered by a release layer. A packaged catheter assembly according to claim 11 or 12 wherein the sticker is removably bonded to the pouch. A packaged catheter assembly according to claim 11 or 12 wherein the sticker is irremovably bonded to the pouch. A packaged catheter assembly according to any of claims 11 to 14 wherein the sticker comprises a peelable adhesive. A packaged catheter assembly according to claim 15 when dependent on claim 14 wherein the sticker is configured such that the adhesive to adhere to the folded or rolled section of the pouch is arranged to overlie the folded or rolled section of the pouch, when folded/rolled. A packaged catheter assembly according to any preceding claim wherein the fastener is provided on the outside of the pouch and arranged on a rear wall of the pouch. A packaged catheter assembly according to any of claims 1 to 9 or claim 17 when directly dependent on any of claims 1 to 9 wherein the fastener comprises a pair of opposing resealing elements, one resealing element attached to the sealable portion of the pouch and the other resealing element attached to the remainder of the pouch, wherein the opposing resealing elements comprise complementary attachment features on their opposing surfaces which interlock to reseal. A packaged catheter assembly according to any of the preceding claims wherein the fastener is configured so as to overlie the folded or rolled section of the pouch when folded at least at least twice and no more than twice about the edges of the pursing strips. A packaged catheter assembly according to any preceding claims wherein the pouch has a pair of lateral edges, a top and an opposing base and is formed of two walls of flexible sheet material, the two walls joined at their periphery, the pouch having break-away region which opens the openable edge and thereby breaks the sterile seal; the break-away region being a tear-away region defined proximal to an upper edge of the pouch and comprising a tear line between a first end and a second end of the tear-away region 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 to form an open end of the pouch, in use. A packaged catheter assembly according to claim 20 wherein the pair of pursing strips are arranged adjacent to the break away region on the remainder of the pouch adjacent to the tear away region, adjacent to and aligned with the tear line. A packaged catheter assembly according to any preceding claim further comprising a container of wetting fluid arranged within the sterile sealed pouch. A packaged catheter assembly according to claim 22 wherein the packaged catheter assembly comprises a wetting indicator, wherein the wetting indicator changes colour in response to contact with wetting fluid, the wetting indicator being arranged in a wetting region. A packaged catheter assembly according to claim 23 wherein the wetting region is a region near the base of the pouch, in which fluid will pool in use. A packaged catheter assembly according to claim 23 wherein the wetting region is a region defined by a channel through which at least the proximal end of the catheter will pass when it is pulled out of the pouch.