Packaged catheter assembly

Abstract

A packaged catheter assembly (100) comprising a pouch (30) and a catheter (20). The pouch comprises two walls (31a, 31b) and a peripheral seal (32, 33, 34, 35) between the two walls, and the catheter comprises a distal end (22) and a proximal end (21) for insertion into the body. The catheter is arranged in a curved configuration within the pouch, and a junction (36) is provided between the two walls, wherein: the junction and a base (32) of the peripheral seal define a passageway to be filled with fluid prior to withdrawal of the catheter from the pouch; the pouch and catheter are arranged such that during withdrawal of the catheter from the pouch, the distal end of the catheter is withdrawn from the pouch prior to the proximal end and the proximal end passes through the passageway. The assembly can comprise a fluid reservoir for releasing fluid into the pouch to form a pool of fluid in the passageway.

Description

TECHNICAL FIELD

[0001] The present invention relates to packaged catheter assemblies, in particular to packaged urinary catheter assemblies, most particularly to packaged male intermittent urinary catheter assemblies. BACKGROUND

[0002] Many people suffer from urinary problems which can result in difficulties in urinating. Intermittent catheter assemblies can provide a convenient and portable solution to this problem as the user is able to self-catheterise as required to void. This reduces the impact of urinary disease on their lives, allowing them to enjoy a relatively normal lifestyle.

[0003] Intermittent catheters are typically disposable devices which are carried by the user and then unpacked / opened and used as required. In order to reduce the risk of damage to the catheter and to improve comfort when using the catheter, it is important that they are lubricated prior to use. However, lubricating the catheter in a public place, such as a public bathroom, can be difficult and inconvenient. This increases the risk that the catheter will not be properly lubricated prior to use, resulting in discomfort and injury.

[0004] Male intermittent catheters are typically a few centimetres longer than female catheters, typically at least 20cm long, with a minimum effective length of 275mm set by ISO 20696:2018. This makes them difficult to carry in a discreet manner. The additional length also makes them more difficult to fully lubricate and use.

[0005] It is an aim of embodiments of the present invention to at least partially overcome or alleviate the above problems. SUMMARY

[0006] In general terms, the present invention relates to a packaged catheter assembly having one or more of: (a) a channel into which fluid can be introduced and through which the catheter can be pulled as it is withdrawn from the packaged assembly; and (b) a means for viewing when fluid has been released from the reservoir and / or viewing the fluid reservoir, but which means ensures that the catheter within the packaged assembly is hidden / concealed.

[0007] According to a first broad aspect of the present invention, there is provided a packaged catheter assembly comprising a bladder and a catheter, wherein the catheter is arranged in a curved configuration within the bladder; and a junction is provided between the walls of the bladder so as to define a channel into which fluid can be introduced prior to withdrawal of the catheter from the bladder, such that the proximal end of the catheter passes through the channel during withdrawal of the catheter from the bladder (the distal end being withdrawn from the bladder first, for example by pulling out by the distal end).

[0008] According to a second aspect of the application, there is provided a packaged catheter assembly comprising a bladder and a catheter, wherein: the bladder comprises two walls and a peripheral seal between the two walls; the catheter comprises a distal end and a proximal end for insertion into the body; the catheter is arranged in a curved configuration within the bladder; and a junction is provided between the two walls, wherein: the junction, together with an inner base of the peripheral seal, defines a channel into which fluid is to be filled prior to withdrawal of the catheter from the bladder; and the bladder and catheter are arranged such that, during withdrawal of the catheter from the bladder, the distal end of the catheter is withdrawn from the bladder before the proximal end, and the proximal end of the catheter passes through the channel.

[0009] According to a third aspect of the application, there is provided a method of forming a packaged catheter assembly, the method comprising: providing a bladder; arranging a catheter in a curved configuration within the bladder; sealing the catheter within the bladder; and forming a junction between walls of the bladder to define a channel into which fluid is to be introduced prior to withdrawal of the catheter from the bladder, such that, during withdrawal (the distal end of the catheter is withdrawn from the bladder before the proximal end, for example by pulling out from the distal end), the proximal end of the catheter passes through the channel.

[0010] According to a fourth aspect of the application, there is provided a method of forming a packaged catheter assembly, the method comprising: providing two walls to define a bladder; arranging a catheter in a curved configuration within the bladder; forming a peripheral seal between the two walls to seal the catheter within the bladder; and forming a junction between the two walls, wherein: the junction, together with an inner base of the peripheral seal, defines a channel into which fluid is to be filled prior to withdrawal of the catheter from the bladder; the catheter comprises a distal end and a proximal end for insertion into the body; and the bladder and catheter are arranged such that, during withdrawal of the catheter from the bladder, the distal end of the catheter is withdrawn from the bladder before the proximal end, and the proximal end of the catheter passes through the channel.

[0011] Advantageously, the application provides a packaged catheter which can be easily removed from its packaging and simultaneously lubricated ready for use. The junction provides the advantage that, as the catheter is removed, it is pulled through a channel in which fluid is provided. The fluid is typically an activating liquid, such as water, which activates a hydrophilic coating to make it slippery, or can be a lubricant. Either way, pulling the catheter through the channel (in which the catheter is preferably disposed) ensures that the catheter is properly lubricated. The fluid channel increases the fluid coating of the catheter surface, as the fluid is held in a pool through which the catheter is forced to travel, rather than potentially being pulled out of the packaging without sufficiently wetting it. Furthermore, the distal end with which the catheter can be pulled should not pass through the fluid pool, making it easy to handle.

[0012] Furthermore, the deliberate formation of a pool at the bottom means that fluid can be held within the package at all times, which makes the device easier to use and reduces the likelihood of spillage, such as can occur if the fluid reservoir is intended to be directed at the pouch and the pouch is then shaken to dispense the fluid. The size of the pouch can also be reduced as the conduit is curved when inside the pouch. The use of a junction to form the channel also helps to use less fluid as the fluid is applied in a targeted manner to the part of the conduit that needs to be wetted rather than being distributed over the whole conduit. The invention also provides the advantage that the proximal end is the last part of the conduit to be wetted and so is least likely to dry out before being introduced into the urethra. The volume of the channel is controlled by the position of the junction, allowing the use of flexible and soft pouch walls which are more user friendly when carrying / using the pouch.

[0013] The following optional / preferred features are generally applicable to the invention, including both the two (first and second) device aspects and the two (third and fourth) method aspects outlined above, as well as the further aspects set out below.

[0014] The packaged catheter assembly can comprise a fluid reservoir. The method can comprise providing a fluid reservoir. The fluid reservoir can be configured to release fluid into the bladder to form a fluid pool in the channel. Thus, one embodiment of the present invention can provide a packaged catheter assembly comprising a bladder, a catheter, and a fluid reservoir, wherein: the bladder comprises two walls and a peripheral seal between the two walls; the catheter comprises a distal end and a proximal end for insertion into the body; the catheter is arranged in a curved configuration within the bladder; and a junction is provided between the two walls, wherein: the junction together with an inner base of the peripheral seal defines a channel to be filled with fluid prior to withdrawal of the catheter from the bladder; the fluid reservoir is configured to release fluid into the bladder to form a fluid pool in the channel; and the bladder and the catheter are arranged such that during withdrawal of the catheter from the bladder, the distal end of the catheter is withdrawn from the bladder prior to the proximal end and the proximal end of the catheter passes through the channel. The volume of the fluid reservoir is preferably sufficient to completely fill the channel, i.e. the fluid can extend to at least the level of the bottom of the junction with the bladder holding its base lowest, such that the filling level of the channel is 100% or more, e.g. at least 150%, at least 200%, or even at least 300%. Alternatively, the filling level of the channel can be: at least 70%, at least 80%, at least 90%, or at least 95% of the volume of the channel. Thus, one embodiment of the present invention can provide a packaged catheter assembly comprising a bladder and a catheter, and a fluid reservoir, wherein: the bladder comprises two walls and a peripheral seal between the two walls; the catheter comprises a distal end and a proximal end for insertion into the body; the catheter is arranged in a curved configuration within the bladder; and a junction is provided between the two walls, wherein: the junction together with an inner base of the peripheral seal defines a channel to be filled with fluid prior to withdrawal of the catheter from the bladder; the fluid reservoir is configured to release fluid into the bladder to form a fluid pool in the channel; and the bladder and the catheter are arranged such that during withdrawal of the catheter from the bladder, the distal end of the catheter is withdrawn from the bladder prior to the proximal end and the proximal end of the catheter passes through the channel, wherein the fluid pool corresponds to a channel filling level of at least 90% of the volume of the channel. Thus, the present invention provides an assembly with a reservoir capable of delivering fluid into the channel. The size of the reservoir is chosen to ensure that sufficient fluid is delivered and that the catheter can be sufficiently lubricated upon withdrawal.

[0015] The fluid reservoir can be arranged within the (sealed) pouch. The fluid reservoir can be provided as a separate device, or incorporated into the pouch material. The method can comprise arranging the fluid reservoir within the pouch and sealing the fluid reservoir within the pouch together with the catheter. The fluid reservoir can comprise a deformable, frangible or rupturable sachet. Thus, the fluid reservoir is conveniently located within the pouch, where it can release fluid directly into the channel formed by the base of the junction and the peripheral seal. The deformable, frangible or rupturable reservoir improves the convenience for the user, as the fluid can be released easily without additional tools and before the pouch is opened, thereby reducing the likelihood of the user being accidentally wetted. The sachet is particularly easy to manipulate on a production line and can be introduced more simply than trying to manipulate the fluid in order to place it into the packaging during manufacture.

[0016] The catheter can be a urinary catheter. The catheter can be a male urinary catheter. The catheter can be an intermittent catheter. In one embodiment, the catheter is a male intermittent urinary catheter. Thus, features of the present invention allow a male intermittent urinary catheter to be provided in a compact package, which also facilitates convenient and easy withdrawal of the catheter, while lubricating it prior to use.

[0017] The catheter can be arranged between the internal base of the junction and the peripheral seal. The method can comprise arranging the catheter between the internal base of the junction and the peripheral seal. The junction can be separate from the base of the peripheral seal. The channel can be an open channel. Thus, one embodiment of the present invention can provide a packaged catheter assembly comprising a pouch and a catheter, wherein: the pouch comprises two walls and a peripheral seal between the two walls; the catheter comprises a distal end and a proximal end for insertion into the body; the catheter is arranged in a curved configuration within the pouch; and a junction is provided between the two walls, wherein: the junction defines an open channel with the internal base of the peripheral seal to be filled with fluid prior to withdrawal of the catheter from the pouch; and the pouch and catheter are arranged such that during withdrawal of the catheter from the pouch, the distal end of the catheter is withdrawn from the pouch before the proximal end, and the proximal end of the catheter passes through the channel. Thus, the catheter is held within the open channel formed by the junction and the internal base of the peripheral seal within the pouch. Thus, when withdrawn, the catheter is pulled through the channel and becomes sufficiently lubricated.

[0018] The junction and the peripheral seal can be independent of each other. Thus, one embodiment of the present application can provide a packaged catheter assembly comprising a bladder and a catheter, wherein: the bladder comprises two walls and a peripheral seal between the two walls; the catheter comprises a distal end and a proximal end for insertion into the body; the catheter is arranged in a curved configuration within the bladder; and a junction is provided between the two walls, wherein: the junction is independent of the peripheral seal; the junction, together with an inner base of the peripheral seal, defines a passageway to be filled with fluid prior to withdrawal of the catheter from the bladder; and the bladder and catheter are arranged such that during withdrawal of the catheter from the bladder, the distal end of the catheter is withdrawn from the bladder prior to the proximal end, and the proximal end of the catheter passes through the passageway. The junction can be provided at a point. The junction is preferably provided by welding, for example spot welding. Such welding can be provided after the catheter (and optional pouch) has been arranged between the walls, and can be achieved from the outside of the bladder. Alternatively, the junction can be provided by any one of: a mechanical seal; a heat seal; a pressure seal; an adhesive; a solvent bond; an ultraviolet bond; an ultrasonic weld; a laser weld; a pulse weld; or a friction weld. Similarly, the peripheral seal is provided by one or more of: welding; a mechanical seal; a heat seal; a pressure seal; an adhesive; a solvent bond; an ultraviolet bond; an ultrasonic weld; a laser weld; a pulse weld; or a friction weld. At least part of the peripheral seal can be formed by folding. In such embodiments, a single sheet can be folded, for example at the base or one of the two sides, to form the two opposing walls of the bladder. The junction can be provided at a single location, thereby allowing the peripheral seal and the junction to be formed separately. Alternatively, the weld forming the junction can be provided simultaneously with the peripheral seal. In some embodiments, the junction and the peripheral seal are a single continuous seal. The manufacturing process for the junction can therefore be very convenient and avoid major modifications to a typical packaged catheter assembly production line.

[0019] The catheter can comprise a surface that is activatable by the fluid in the passageway. For example, the catheter can comprise a hydrophilic surface, for example formed by a hydrophilic coating. Where a hydrophilic surface is provided, the fluid can be polar or water-based. The catheter can comprise a hydrophobic surface that is activatable by the fluid in the passageway. For example, the catheter can comprise a hydrophobic coating. Where a hydrophobic coating is used, the fluid can be non-polar. The catheter is thus readily lubricated by the fluid in the passageway and can be used easily and comfortably.

[0020] The pouch can include an interaction region defining a first point of contact of the user with the packaged catheter assembly. The interaction region can facilitate the user to access the contents of the pouch. Actuation of the interaction region can form an opening in or adjacent to the upper edge of the peripheral seal. The catheter can be withdrawn through the opening. Thus, a passage into the pouch is provided at or adjacent to the upper edge of the pouch, whereby the fluid in the passage (at the bottom of the pouch) is retained in the pouch as the catheter is withdrawn, thereby reducing the risk of spillage of the fluid outside the pouch.

[0021] The interaction region can include a breakable region of the peripheral seal. The method can include forming the breakable region in the peripheral seal. The breakable region can include a tear-away region which can include a tear line defining a line along which the pouch can be torn to at least partially separate the tear-away region from the rest of the pouch, thereby forming an opening in the peripheral seal. The tear-away region can include a tear initiation portion. The tear initiation portion can be provided at a first end of the tear-away region. The tear initiation portion can include a notch or a weakened region in one or both walls of the pouch. The tear initiation portion can define a first portion of the pouch to be torn. The tear-away region can include a tear termination portion. The tear termination portion can be provided at a second end of the tear-away region. The tear termination portion can serve to prevent or reduce the likelihood of the tear-away region completely separating from the rest of the package. The tear line can be defined between the tear initiation portion and the tear termination portion. The tear line can be configured to tear preferentially. The tear line can comprise a weakened region of the pouch. The tear line can be formed by any suitable means, such as laser scoring. The tear-away region can be generally triangular in shape with a beveled upper edge. Thus, the breakable region provides a convenient and easy way to open the pouch which is least effort and does not require additional equipment / tools.

[0022] The interaction region can include a sealing device. The sealing device can include one or more sealing members operable to provide a seal between two walls of the pouch sealable by the user in order to close the pouch. In one embodiment, first and second sealing members are provided on the inner surfaces of the two walls of the pouch. The sealing device can provide a water and / or fluid tight seal when closed. Thus, the pouch can be resealed to ensure that the fluid in the passage is not subsequently released from the pouch after use. This also allows the catheter to be re-packaged back into the pouch and retained therein after use.

[0023] The sealing means can be pre-sealed. In such embodiments, the user can access the contents of the pouch by opening the sealing means. The sealing means can be re-sealable. The sealing means can be any of: a zip-lock seal; a hook-and-loop seal; a hook-and-hook seal; or an adhesive layer. Thus, the sealing means can be used to ensure that the contents of the pouch remain inside until the sealing means is opened, and the pouch can still be re-sealed after use. This can be helpful if the rupturable region requires force to be applied to the pouch to open it, as the pouch can move or jerk when it is opened, causing the fluid or catheter to exit the pouch.

[0024] The interaction region can comprise the rupturable region and the sealing means. In certain embodiments, the interaction region comprises a tear-away region corresponding to the upper edge of the peripheral seal, and a re-sealable means beneath the tear-away region.

[0025] The peripheral seal can have an upper edge. The peripheral seal can be generally rectangular in shape, with two lateral edges between the base and the upper edge. The height of the peripheral seal from the base to the upper edge can be at least 10 cm, 15 cm or 20 cm; and / or the height is no more than 10 cm, 15 cm, 20 cm or 25 cm, for example between 15 cm and 20 cm. The width of the peripheral seal between the lateral edges can be at least 5 cm, 10 cm; or 15 cm; and / or the width is no more than 10 cm or 15 cm, or 20 cm, for example between 5 cm and 15 cm. The length of the catheter can be at least: 20 cm; 25 cm; 30 cm; 35 cm; 40 cm; 45 cm; or 50 cm, for example between 35 and 45 cm. In one embodiment, the peripheral seal has a height of 10-25 cm and a width of 6-11 cm, and the catheter has a length of at least 30 cm. Thus, the peripheral seal defines a "pocket-sized" pouch which can store the catheter in a curved configuration, to reduce the apparent size of the catheter and enable convenient and unobtrusive storage.

[0026] The distal end of the catheter can be arranged closer to the upper edge of the peripheral seal than to the base of the peripheral seal. The method can comprise arranging the distal end of the catheter closer to the upper edge of the peripheral seal than to the base of the peripheral seal. The distal end of the catheter can be arranged in the upper half of the pouch, or in the upper quarter of the pouch. The distal end of the catheter can be arranged above the junction. The distal end of the catheter can be arranged above the fill level of the fluid. Thus, the distal end of the catheter is easily accessible, such that it can be withdrawn prior to the proximal end of the catheter, as required by the present application. The catheter is also positioned so as not to be pulled through the fluid, and thus is not wetted and is easy to handle.

[0027] The distal end of the catheter can be provided with a handling sleeve which can be arranged closer to the upper edge of the peripheral seal than to the base of the peripheral seal. The method can comprise arranging the handling sleeve at the distal end of the catheter at least partly closer to the upper edge of the peripheral seal than to the base of the peripheral seal. At least a portion of the handling sleeve can be arranged in the upper half of the bladder or in the upper quarter of the bladder. At least a portion of the handling sleeve can be arranged above the junction. The entire handling sleeve can be above the junction. The handling sleeve can be further from the junction than the base of the bladder. At least a portion of the handling sleeve can be arranged above the fill level of the fluid. The entire handling sleeve can be arranged above the fill level of the fluid. Thus, the handling sleeve is easily accessible so that it can be withdrawn prior to the proximal end of the catheter as required by the present invention. It is also positioned so that it will not be pulled through the fluid so that at least a portion of it will not get wet and still be easily handled, providing a dry surface which can be gripped and used to steer the catheter.

[0028] Any one or more of the distal end of the catheter, the funnel and the handling sleeve can be centrally arranged in relation to the opening formed in the bladder. The term "centrally arranged" can correspond to a position closer to the middle of the opening than to the edges of the opening. The term "centrally arranged" can correspond to a position in the middle portion of the opening. The middle portion can be the middle 70%, 60%, 50%, 40% or 30% of the opening. Any one or more of the distal end of the catheter, the funnel and the handling sleeve can be centrally arranged within the bladder. Any one or more of the distal end of the catheter, the funnel and the handling sleeve can be closer to the middle of the bladder than to the left lateral edge and / or the right lateral edge. Thus, when the bladder is opened, the distal end / funnel / handling sleeve is more easily accessible as it is in the center and at the position where the opening is widest across the width of the bladder.

[0029] The distal end of the catheter can be within the pocket above the rest of the catheter. The steering sleeve and / or funnel can extend through an opening formed in the pocket. The steering sleeve and / or funnel can extend from the distal end to a point adjacent the left lateral edge or the right lateral edge. The funnel can be positioned non-parallel to the left lateral edge and / or the right lateral edge. At least a portion of the steering sleeve can be positioned non-parallel to the left lateral edge and / or the right lateral edge. One end of the fluid reservoir can correspond to the location of the distal end of the catheter. The fluid reservoir can be adjacent the right lateral edge or the left lateral edge. Where the steering sleeve extends adjacent one lateral edge (e.g. the left lateral edge or the right lateral edge), the fluid reservoir can be adjacent the other lateral edge (e.g. the right lateral edge or the left lateral edge). The distal end can be disposed adjacent one lateral edge (e.g. the left lateral edge or the right lateral edge), and the steering sleeve and / or funnel can extend to a point adjacent the other lateral edge (e.g. the right lateral edge or the left lateral edge). Thus, the location of the distal end, funnel, steering sleeve, and fluid reservoir protects the rest of the catheter from inadvertent direct contact with the user when the user removes the catheter from the pocket. This reduces the risk of infection when using the catheter, as it is less likely to become soiled prior to use.

[0030] The distal end of the catheter can be disposed closer to one (e.g. left) lateral edge of the perimeter seal than the other (e.g. right) lateral edge of the perimeter seal. The method can include disposing the distal end of the catheter closer to one (e.g. left) lateral edge of the perimeter seal than the other (e.g. right) lateral edge of the perimeter seal.

[0031] The junction can be disposed at a location equidistant from each lateral edge. Alternatively it can be offset. The method can include disposing the junction at a location equidistant from each lateral edge. Alternatively, it can include disposing the junction at an offset lateral location. For example, the junction can be disposed at any location between 25% and 75% of the width of the pocket. The distance between the left and right lateral edges of the perimeter seal can be the width of the pocket. The distal end of the catheter can be disposed at a location no more than 20%, 10%, 5%, or 1% of the width of the pocket from one of the left edges. Thus, the junction and the distal end are disposed at locations that make the catheter easy to withdraw and lubricate without spillage of the lubricant. Disposing the junction equidistant from each edge between the edges ensures that the channel volume is limited and the fluid level therein is optimized for lubricating the catheter.

[0032] In embodiments comprising an interaction region, actuation of the interaction region can preferably first form an opening in the first (e.g. left) lateral edge of the peripheral seal. In such embodiments, the distal end of the catheter can be arranged closer to the first (e.g. left) lateral edge. In embodiments comprising a tear-away region and a tear initiation portion, the position of the tear initiation portion can correspond to a lateral edge of the peripheral seal. In such embodiments, the distal end of the catheter can be arranged closer to the lateral edge of the peripheral seal corresponding to the position of the tear initiation portion. Thus, the distal end is close to the first portion of the bladder to be opened and is easier to pull out.

[0033] The junction can be arranged closer to the base of the peripheral seal than to the upper edge of the peripheral seal. The distance between the base and the upper edge of the peripheral seal can define the height of the bladder. The distance between the junction and the base can be at least: 10%; 15%; 20%; 25%; 30%; 35%; 40% or 45% of the height of the bladder. The distance between the junction and the base can be less than: 50%; 45%; 40%; 35%; 30%; 25%; 20%; or 15% of the height of the bladder. In particular, the junction can be arranged between 20% and 30% of the height of the bladder. The junction can be circular. The junction can have a radius less than or equal to 15%; 10%; 5%; or 1% of the height of the bladder. In a preferred embodiment, the radius of the junction is 5% of the height of the bladder. Thus, the junction can be arranged to ensure that the catheter is sufficiently lubricated and that it defines a channel of suitable dimensions to allow the catheter to be easily pulled out without over-bending the catheter or applying too much force.

[0034] In one embodiment, the junction is arranged equidistant from each lateral edge of the bladder and at a position 20-30% of the height of the bladder from the base.

[0035] The distal end of the catheter can be provided with a funnel arranged not to pass through the channel during catheter extraction. The steering sleeve can also be arranged not to pass through the channel during catheter extraction. The sleeve can not extend more than: 25%; 20%; 15%; 10%; or 5% of the length of the catheter, but can be longer, even up to the full length of the catheter. Embodiments of the invention provide a funnel and a sleeve to allow the catheter to be easily steered. These elements, or at least a portion of them, do not pass through the channel and are therefore not covered by fluid during extraction. The sleeve can not extend below the height of the junction within the bladder. The sleeve can be further from the junction than the base of the bladder. This reduces the likelihood of the sleeve being wetted during release of fluid from the fluid reservoir into the channel. Thus, the catheter is easier to use as fluid is applied only to the necessary portion of the catheter. It also helps to use less fluid as it is applied in a targeted manner to the catheter.

[0036] The included angle formed by the ends of the catheter when the catheter is bent in the pouch can be at least: 180 degrees; 210 degrees; 240 degrees; 270 degrees; 300 degrees; 330 degrees; or 360 degrees; it can even be at least 420 degrees; 480 degrees or 540 degrees. It can be less than 720 degrees; 630 degrees or 540 degrees. The catheter can be arranged in a coiled or wound configuration within the pouch. Thus, one embodiment of the present invention can provide a packaged catheter assembly comprising a pouch and a catheter, wherein: the pouch comprises two walls and a peripheral seal between the two walls; the catheter comprises a distal end and a proximal end for insertion into the body; the catheter is arranged in a wound configuration within the pouch; and a junction is provided between the two walls, wherein: the junction together with an inner base of the peripheral seal defines a passageway to be filled with fluid prior to withdrawal of the catheter from the pouch; the pouch and catheter are arranged such that during withdrawal of the catheter from the pouch, the distal end of the catheter is withdrawn from the pouch prior to the proximal end and the proximal end of the catheter passes through the passageway. The junction can be provided within an area defined by the coiled or wound portion of the catheter. The peripheral seal can constrain the catheter in its bent configuration. Thus, the catheter is bent, curved or wound to reduce the size of the pouch and to ensure that a long catheter can be conveniently and unobtrusively stored for use.

[0037] The catheter can be arranged such that at least: 30%; 40%; 50%; 60%; 70% or 80% of the length of the catheter passes through the passageway during withdrawal. Thus, one embodiment of the present invention can provide a packaged catheter assembly comprising a pouch and a catheter, wherein: the pouch comprises two walls and a peripheral seal between the two walls; the catheter comprises a distal end and a proximal end for insertion into the body; a junction is provided between the two walls, wherein: the junction together with an inner base of the peripheral seal defines a passageway to be filled with fluid prior to withdrawal of the catheter from the pouch; the pouch and catheter are arranged such that during withdrawal of the catheter from the pouch, the distal end of the catheter is withdrawn from the pouch prior to the proximal end and at least 50% of the length of the catheter (including the proximal end of the catheter) passes through the passageway. In one embodiment, 70-80% of the length of the catheter passes through the passageway during withdrawal. Advantageously, only the portion of the catheter intended to enter the body is lubricated and thus there is no wastage of fluid and the catheter is easier to use.

[0038] The walls can be formed from any suitable material, for example a film material. The walls can be fluid impermeable. The walls can be made from a plastics material. The walls can be made from any one or more of the following materials: polypropylene (PP), polyethylene terephthalate (PET), low density polyethylene (LDPE), polyethylene terephthalate polyester (METPET) or oriented polypropylene (OPP). The walls can comprise a laminate made up of two or more layers. Each wall can comprise an inner layer and an outer layer. Each wall can comprise an inner layer and an outer layer formed from polypropylene. Each wall can comprise an inner layer formed from oriented polypropylene and an outer layer formed from polypropylene. For example, each wall can comprise an inner layer formed from polypropylene and an outer layer formed from polyethylene. The inner and outer layers can have the same thickness. In other embodiments, the inner and outer layers can have different thicknesses. The inner layer can have a thickness that is less than the thickness of the outer layer. In embodiments, the inner layer can have a thickness of between 5-20 microns, or 10-10 microns, or 10-15 microns, while the outer layer can have a thickness of between 10-50 microns, or 20-40 microns, or 35-45 microns. In one example, the inner layer can have a thickness of approximately 12 microns and the outer layer can have a thickness of approximately 40 microns.

[0039] According to a fifth aspect of the application, there is provided a method for opening / unpacking a packaged catheter assembly comprising a bladder, a catheter housed in the bladder and a fluid reservoir, the method comprising releasing fluid from the reservoir to form a pool in a channel located between a base of the bladder and a junction, opening the bladder and pulling the catheter through a distal end of the catheter, whereby as the distal end is pulled out, a proximal end of the catheter for insertion into the body is guided through the channel so as to be wetted by the pool of fluid.

[0040] The packaged catheter assembly can be a packaged catheter assembly as generally defined, or manufactured according to any one of the first or second aspects as set out above, or by the method of the third or fourth aspects as set out above, optionally including any of the optional features set out above. Indeed, it can include any of the optional features, without necessarily including all of the features set out above in the first to fourth aspects.

[0041] The step of releasing fluid can comprise forming a pool in the channel, the volume of the pool being at least 60%; 70%; 80% of the volume of the channel; in particular, it can be at least 90%; or at least 100%, even up to at least 150%, 200% or 300% of the volume of the channel. Thus, the method allows a pool of fluid to be formed sufficient to lubricate the catheter without the use of excess lubricant.

[0042] A sixth aspect of the invention provides a method of using a catheter, comprising releasing fluid from a reservoir to form a pool in a channel located between the base of a sac and a junction, opening the sac and pulling the catheter out through its distal end, thereby guiding the proximal end of the catheter for insertion into the body through the channel as the distal end is pulled out so as to wet it with the fluid pool; and then introducing the catheter into the urethra through its proximal end. The urethra can be the human urethra, particularly the male urethra.

[0043] The method may also include releasing urine through a funnel at the distal end of the catheter. The method may also include removing the catheter. The method may also include coiling or folding the catheter and placing it back into the pouch for disposal. The method may also include sealing the used catheter in the pouch prior to disposal.

[0044] Similarly, the fluid release step may include forming a pool in the channel that is at least 60%, 70%, 80%, particularly at least 90%, or 100% of the channel volume, or even up to at least 150%, 200%, or 300% of the channel volume. Thus, this method allows for the formation of a fluid pool sufficient to lubricate the conduit without using excessive lubricant.

[0045] Of course, in the method of using the catheter, the packaged catheter assembly may also be a packaged catheter assembly as generally defined or according to any of the first or second aspects stated above, or a packaged catheter assembly manufactured by the methods of the third or fourth aspects stated above, optionally including any of the optional features stated above. In fact, it may include any optional feature, and not necessarily all the features stated in the four aspects above.

[0046] According to a seventh broad aspect of the invention, a packaged catheter assembly is provided, comprising a catheter, a fluid reservoir, and a pouch containing the fluid reservoir and the catheter, wherein the pouch is configured to conceal the catheter from view but allow a user to view the fluid reservoir and / or view the fluid being released from the reservoir.

[0047] According to an eighth aspect of the invention, a packaged catheter assembly is provided, comprising a catheter, a fluid reservoir, and an opaque pouch containing the fluid reservoir and the catheter, wherein the pouch includes a transparent or translucent window (preferably corresponding to the location of the fluid reservoir in the pouch and / or a wetting area from which the fluid is intended to flow).

[0048] According to a ninth broad aspect of the invention, a method of forming a packaged catheter assembly is provided, the method comprising: providing a pouch; providing a fluid reservoir within the pouch; arranging a catheter within the pouch such that it is concealed and invisible; and configuring the pouch to allow a user to view the fluid reservoir and / or view fluid being released from the reservoir.

[0049] According to a tenth aspect of the invention, a method of forming a packaged catheter assembly is provided, the method comprising: providing two opaque walls to define a pouch; providing a fluid reservoir within the pouch; arranging a catheter within the pouch; forming a peripheral seal between the walls to seal the catheter and the fluid reservoir within the pouch; and providing a transparent or translucent window in at least one wall of the pouch (the window preferably corresponding to the location of the fluid reservoir within the pouch and / or a wetting area from which fluid is intended to flow).

[0050] Therefore, the present invention provides a packaged catheter assembly that does not draw attention to itself because the contents of the assembly are obscured. A window provides visual guidance, allowing the user to easily identify the fluid reservoir during catheter use and / or easily identify that fluid has been successfully released from the reservoir into the wetting area of ​​the pouch for lubrication of the catheter before use. While providing a transparent / semi-transparent window is the preferred method to allow the user to see whether fluid has been successfully released from the reservoir, alternative methods are considered feasible. For example, instead of providing a transparent / semi-transparent window in the opaque wall of the pouch, this functionality can be conceived to be achieved by providing a transparent / semi-transparent pouch wall, but including an opaque intermediate wall within the pouch between the transparent / semi-transparent pouch wall and the catheter (and optionally the reservoir). This intermediate wall may include a window, or fluid released from the reservoir may flow between the outer transparent / semi-transparent wall and the intermediate wall, thereby providing an indication of successful release.

[0051] The following optional / preferred aspects are equally applicable to the seventh and eighth aspects of the component with a fluid release visualization configuration stated above, as well as the ninth and tenth method aspects with a fluid release visualization configuration stated above. They are equally applicable to the invention as generally stated above or to other aspects of the invention described above, and similar optional features described with respect to the first through sixth aspects are also applicable to other aspects, without including features of these aspects themselves (e.g., the catheters of the seventh through tenth aspects can, of course, be as defined with respect to the first through sixth aspects, such as male intermittent urinary catheters). Therefore, one embodiment of the present invention provides a packaged catheter assembly including a catheter, a fluid reservoir, and an opaque pouch housing the fluid reservoir and the catheter, wherein the pouch includes a transparent or translucent window, two walls, and a peripheral seal between the two walls; the catheter includes a distal end and a proximal end for insertion into the body; the catheter is arranged in a curved configuration within the pouch; a joint is provided between the two walls, wherein: the joint, together with the inner base of the peripheral seal, defines a channel for filling with fluid before the catheter is withdrawn from the pouch; the pouch and the catheter are arranged such that during withdrawal of the catheter from the pouch, the distal end of the catheter is withdrawn from the pouch before the proximal end, and the proximal end of the catheter passes through the channel.

[0052] The pouch can comprise two opaque walls. A window can be provided in one of the opaque walls. The window can be spaced apart from at least one edge of the pouch or the wall in which the window is located. The window can be spaced apart from all edges of the pouch. The window can be less than 25%; 20%; 15%; 10% or 5% of the total area of the pouch and / or the wall in which the window is located. The window can correspond to the size and / or shape of the fluid reservoir. The size of the window can be less than the fluid reservoir. In one embodiment, the window has the same shape as the fluid reservoir but is smaller in size. Thus, in embodiments of the application, the window advantageously corresponds to the size, shape and location of the fluid reservoir and is provided in a discrete manner, separate from the edges of the pouch and only in a portion of the pouch wall.

[0053] The window can correspond to the location of the fluid reservoir. Thus, one embodiment of the application provides a packaged catheter assembly comprising a catheter, a fluid reservoir and an opaque pouch containing the fluid reservoir and the catheter, wherein the pouch comprises a transparent or translucent window and the window corresponds to the location of the fluid reservoir. The window can correspond to the location of an indicator area of the pouch. The indicator area can correspond to a wetting area which can extend from a base of the pouch to a fluid level / horizon at which there is sufficient fluid to escape from the pouch to wet the catheter. The indicator area can be configured to indicate successful release of fluid from the reservoir. Thus, one embodiment of the application provides a packaged catheter assembly comprising a catheter, a fluid reservoir and an opaque pouch containing the fluid reservoir and the catheter, wherein the pouch comprises a transparent or translucent window and the window corresponds to the location of an indicator area of the pouch, wherein the indicator area is configured to indicate successful release of fluid from the reservoir. The indicator area can comprise a fill level indicia indicating that there is sufficient fluid in the wetting area. Thus, the window also provides visual guidance to ensure that fluid released from the reservoir has been delivered to a particular area of the pouch (e.g. a channel) or that it has successfully lubricated the catheter.

[0054] The pouch can have a generally rectangular shape with two lateral edges, a base and an upper edge. The height of the pouch can be defined as the distance between the base and the upper edge. The width of the pouch can be defined as the distance between the lateral edges of the pouch. The window can span at least: 20%; 30%; 40%; 50%; 60%; 70%; 80% or 90% of the height of the pouch. In one embodiment, the window spans at least 30-40% of the height of the pouch and the window is 15-20% of the width of the pouch. Thus, as the window is aligned with the fluid reservoir, the fluid reservoir is easily visible, but at the same time, the area of the window is minimised to ensure that the contents of the pouch remain generally invisible as the pouch is opaque except for the window.

[0055] It will be appreciated by the skilled person that where a pouch is described as being opaque but including a transparent or translucent window, the pouch is predominantly opaque except for the window; for example, completely opaque except for the window. It will also be appreciated that more than one window can be provided, for example one on each of two otherwise predominantly or completely opaque opposing walls, or indeed two on an otherwise opaque wall(s).

[0056] This is in contrast to known catheter packages formed by (only) two opposing walls: one opaque paper wall and one transparent plastic film wall; these cannot be considered to be opaque except for the window because the transparent film wall constitutes the entire second wall of the package. They cannot be considered to have an opaque wall with a transparent or translucent window therein.

[0057] The catheter in the pouch is preferably obscured. Thus, one embodiment of the present application provides a packaged catheter assembly comprising a catheter, a fluid reservoir, and an opaque pouch containing the fluid reservoir and the catheter, wherein the pouch includes a transparent or translucent window and the catheter is hidden in the pouch. The catheter can be obscured by the opaque wall of the pouch. The catheter can be obscured by the fluid reservoir. This is particularly advantageous from the perspective of not drawing attention - the catheter is likely to appear to an observer to be some kind of medical device, even if they do not know its exact nature; it is hidden either by ensuring that it is arranged out of alignment with the window or by hiding it behind another object, for example the fluid reservoir (but optionally can be, for example, a dedicated panel).

[0058] Notably, the fluid reservoir (or other obscuring object) can be opaque and can have a colour which corresponds to or contrasts with the colour of the pouch wall. Thus, one embodiment of the present application provides a packaged catheter assembly comprising a catheter, a fluid reservoir, and an opaque pouch containing the fluid reservoir and the catheter, wherein the pouch includes a transparent or translucent window and the fluid reservoir is opaque. For example, the reservoir (or other obscuring object) can be the same colour as the pouch but a different shade, or the opaque pouch can be a plurality of colours, possibly a different shade of one of the colours. Grey or silver are considered particularly suitable for the reservoir (or other obscuring object) from the perspective of not drawing attention.

[0059] The window can have a pattern; that is, at least a portion of the window can have a pattern provided thereon, for example a pattern formed by opaque areas, for example spots, stripes, etc. The pattern can provide a gradient appearance to the window. The pattern can provide a gradient appearance to one or more edges of the window. The pattern can blend the window into the surrounding packaging of the pouch. Thus, the window is less apparent to the untrained eye and thus the packaged catheter assembly is more unobtrusive to carry for the user.

[0060] A positioning seal can be provided between two walls to limit movement of the fluid reservoir, which can of course be a pouch as defined above, in the pouch bag. Thus, one embodiment of the present application provides a packaged catheter assembly comprising a catheter, a fluid reservoir, and an opaque pouch bag containing the fluid reservoir and the catheter, wherein the pouch bag comprises a transparent or translucent window and a positioning seal configured to limit movement of the fluid reservoir within the pouch bag. The method can comprise the step of forming a positioning seal between two walls to limit movement of the fluid reservoir in the pouch bag. The positioning seal can be disposed outside the arc of the catheter. The positioning seal can be closer to the upper edge of the peripheral seal of the pouch bag than to the base of the pouch bag. The positioning seal can extend from the upper edge of the peripheral seal of the pouch bag.

[0061] According to an eleventh aspect of the present application, there is provided a method of wetting a catheter in a packaged catheter assembly, the method comprising releasing fluid from a reservoir in a pouch bag, and inspecting the interior of the pouch bag (e.g. through a (transparent or translucent) window in (an opaque wall of) the pouch bag) to identify whether the reservoir has released fluid or to confirm whether the reservoir has released fluid into the pouch bag (or both), and removing the catheter from the pouch bag, optionally opening the pouch bag after confirming fluid release and optionally pulling the catheter out through the distal end of the catheter.

[0062] The packaged catheter assembly can be a packaged catheter assembly as generally defined or according to any of the seventh or eighth aspects described above, or manufactured by the method of the ninth or tenth aspects described above, optionally comprising any of the optional features described above. Indeed, it can comprise any of the optional features, without necessarily comprising all of the features described above in the seventh to tenth aspects.

[0063] A twelfth aspect of the present application provides a method of using a catheter, the method comprising releasing fluid from a reservoir in a pouch bag, and inspecting the interior of the pouch bag (e.g. through a (transparent or translucent) window in (an opaque wall of) the pouch bag) to identify whether the reservoir has released fluid or to confirm whether the reservoir has released fluid into the pouch bag (or both), and removing the catheter from the pouch bag (optionally opening the pouch bag after confirming fluid release; optionally pulling the catheter out through the distal end of the catheter; and optionally confirming that the catheter is sufficiently wet via the window), and then introducing the catheter into the urethra via its proximal end. The urethra can be a human, especially a male, urethra.

[0064] The method can further comprise releasing urine via the funnel at the distal end of the catheter. The method can further comprise removing the catheter. The method can further comprise coiling or folding the catheter up and placing it back into the pouch bag for disposal. The method can further comprise sealing the used catheter in the pouch bag prior to disposal.

[0065] Of course, in the method of using a catheter, the packaged catheter assembly can also be a packaged catheter assembly as generally defined, or according to any of the seventh or eighth aspects stated above, or a packaged catheter assembly manufactured by the method of the ninth or tenth aspects stated above, optionally including any of the optional features stated above. Indeed, it can include any of the optional features, without necessarily including all of the features stated in any of the seventh to tenth aspects.

[0066] As stated above, in general, the application can include both: (a) a channel into which fluid can be introduced and through which a catheter can be pulled as it is withdrawn from the pouch; (b) a means for viewing the fluid reservoir and / or for viewing when fluid has been released from the reservoir, but which ensures that the catheter is hidden within the packaged assembly. Indeed, this is more preferred. Thus, the following preferred features apply to a pouch having both features (a) and (b), and in particular to an apparatus including any of the following: (i) the first and seventh aspects; (ii) the first and eighth aspects; (iii) the second and seventh aspects; and (iv) the second and eighth aspects; and in particular to a method including any of the following: (v) the third and ninth aspects; (vi) the third and tenth aspects; (vii) the fourth and ninth aspects; and (viii) the fourth and tenth aspects. Furthermore, the following features apply in particular to a method of wetting a catheter including the features of the fifth and eleventh aspects; and a method of using a catheter including the features of the sixth and twelfth aspects.

[0067] A portion of the window can correspond to a position below the junction in the pouch. Thus, in the case that the channel defined by the junction is used to lubricate the catheter, the level of fluid in the channel can be visually inspected using the window.

[0068] The junction can act as a positioning seal to limit movement of the fluid reservoir. In such embodiments, the fluid reservoir can be arranged between the junction and a lateral edge of the perimeter seal. In some embodiments, the fluid reservoir can be arranged adjacent a first lateral edge of the perimeter seal, and the junction can be provided closer to the first lateral edge than to the other (second) lateral edge of the perimeter seal. Thus, the positioning seal ensures that the fluid reservoir does not move within the pouch, and that the fluid reservoir is always visible through the window (and in preferred embodiments always obscures the catheter). BRIEF DESCRIPTION OF DRAWINGS

[0069] So that the application can be more clearly understood one or more embodiments thereof will now be described, by way of example only, with reference to the accompanying drawings in which:

[0070] Figure 1 is an exploded view of a first embodiment of a packaged catheter assembly;

[0071] Figure 2 before use Figure 1 front view of the sealed assembly of

[0072] Figure 3 before use Figure 1 and 2 front view of the packaged catheter assembly of

[0073] Figure 4 before use Figures 1-3 front view of the packaged catheter assembly of

[0074] Figure 5 before use Figures 1-4 front view of the packaged catheter assembly of

[0075] Figure 6 before use Figures 1-5 front view of the packaged catheter assembly of

[0076] Figure 7 after use Figures 1-6 front view of the packaged catheter assembly of

[0077] Figure 8 front view of a second embodiment of a packaged catheter assembly; and

[0078] Figure 9 front cross-sectional view of a third embodiment of a packaged catheter assembly.

[0079] In the drawings, dashed lines represent features that are obscured. DETAILED DESCRIPTION

[0080] Referring to Figures 1-7 , a first embodiment of a packaged catheter assembly 100 is shown.

[0081] The assembly 100 comprises a fluid reservoir 10, a male intermittent urinary catheter 20 and a pouch 30. The pouch 30 comprises an opaque front wall 31a, an opaque back wall 31b and a peripheral seal joining the periphery of the walls 31a, 31b together to form the perimeter of the pouch. The peripheral seal comprises a base 32, a right lateral edge 33, a left lateral edge 34 and an upper edge 35. The left lateral edge 34 and the right lateral edge 33 are defined as the left and right sides of the pouch as viewed when the pouch 30 is viewed with the back wall 31b behind the front wall 31a, the base 32 at the bottom of the pouch 30 and the upper edge 35 at the top of the pouch 30. Thus, the peripheral seal defines a pouch 30 which is generally rectangular and suitably has a width between the lateral edges of between 60-110mm, for example about 100mm, for example 95mm, a height from the base 32 to the upper edge 35 of between 100-250mm, for example about 200mm, for example 197mm. The base 32 defines the bottom of the pouch in use and the upper edge 35 defines the top. However, in other embodiments alternative shapes and dimensions can be envisaged, for example an oval or circular pouch.

[0082] The pouch further comprises a join 36 between the two walls 31a, 31b. The join 36 is a circular weld provided at an equidistant point between the lateral edges 33, 34 of the peripheral seal and extending a distance of 45mm to 55mm above the base 32. The radius of the join 36 can be between 1% and 10%, for example 5% of the height of the pouch. In other embodiments, the join can be provided in different shapes and dimensions, at different locations or even potentially integrated into a continuous seal with the peripheral seal.

[0083] The pouch further comprises a window 37 in one of the walls which allows a user to see inside the pouch. In this particular embodiment, the window 37 is transparent, elongate and generally rectangular with a length of between 20% and 50%, for example 33% of the height of the pouch 30 and a width of between 5% and 25%, for example 12.5% of the width of the pouch 30. In this example, the window 37 has semi-circular ends but in other embodiments the ends can have any suitable shape, for example flat ends or irregularly shaped ends. The window 37 is arranged parallel to the right lateral edge 33 and there is a gap between the edge of the window 37 and the right lateral edge 33 equivalent to between 5% and 20%, for example 10% of the width of the pouch. The base of the window 37 is spaced apart from the base of the peripheral seal 32 by a distance equivalent to between 5% and 20%, for example 10% of the height of the pouch. In other embodiments, a translucent window can be used and additionally alternative shapes, dimensions and positions or angles of the window (for example, at an angle of up to 20 degrees relative to the edge) can be envisaged.

[0084] In this particular embodiment, each wall 31a, 31b comprises a plurality of foil layers; in one specific embodiment, 97 micron 2-layer foil comprising 12 micron PET and 60 micron LLDPE. In other embodiments, the walls 31a, 31b can comprise only a single layer, and different plastic materials can be used interchangeably.

[0085] As mentioned above, the walls 31a, 31b are opaque. This can be achieved by forming each wall 31a, 31b from one or more layers of opaque material or by printing an opaque pattern onto one of the layers. The window 37 in the front wall 31a can be formed by laminating an opaque layer of material to a transparent wall, with the opaque layer having a hole corresponding to the window 37. Alternatively, printing can be carried out on the transparent wall to block light from passing through the wall, making it opaque everywhere except at the location of the window 37. Still more alternatives can be envisaged and implemented, for example, providing a hole in the opaque wall corresponding to the window 37 and gluing a transparent layer so as to cover the hole and obtain a continuous front wall 31a with the window 37, or starting from a multi-layer foil with an opaque layer and a transparent layer and removing a portion of the opaque foil layer to form the transparent window.

[0086] In this particular embodiment, the pouch further comprises an interaction region. The interaction region forms the top of the pouch 30 and spans between the right lateral edge 33 and the left lateral edge 34. The interaction region is used to provide access to the pouch through / near the upper edge 35. In this embodiment, the interaction region comprises a tear-away region 38 and a sealing arrangement 39. The tear-away region 38 comprises a tear initiation 40 on the left lateral edge, about 2 cm below the point where the upper edge 35 and the left lateral edge 34 intersect, and a tear termination 41 in the pouch 30 at a point about 1 cm below the intersection of the upper edge 35 and the right lateral edge 33. The tear termination 41 is between 1-10%, for example 5%, of the pouch width from the right lateral edge 33. The tear initiation 40 comprises a notch to provide a weakened region in the walls 31a, 31b to allow the tear-away region 38 to be separated from the pouch 30 by tearing the walls from the tear initiation 40 to the tear termination 41. Thus, the tear is provided below the location of the upper edge 35 so that the pouch 30 is opened to access its contents. The tear termination 41 comprises a small hole in the walls 31a, 31b to prevent further tearing of the pouch 30 and further separation of the tear-away region 38 from the pouch 30. To provide a tapered shape, the tear-away region 38 extends laterally further on the left than on the right by about 50%. The left side of the tear-away region 38 comprises a circular hole 42 sized to allow a finger to pass through and grip the tear-away region 38. To ensure that the pouch is fully sealed, the front wall 31a and the back wall 31b are sealed relative to each other around the periphery of the tear termination 41 and the circular hole 42. In other embodiments, other sealing arrangements such as zip-lock arrangements can be used to provide access to the pouch, of course the dimensions and shapes stated above are exemplary.

[0087] In this embodiment, the sealing arrangement 39 extends between the left lateral edge 34 and the right lateral edge 33 of the periphery seal directly below the tear-away region 38. The sealing arrangement 39 comprises first and second sealing members (not shown) provided on the inner surfaces of the walls 31a, 31b of the pouch 30. In this embodiment, the sealing members comprise respective sealing grooves and ridges to allow the sealing members to press-fit together to form a water-tight seal and to be pulled apart again if necessary. In other embodiments, a single adhesive sealing member can be used, or the sealing members can be provided on the outside of the pouch to allow the pouch to be folded or rolled up and sealed accordingly, of course alternative sealing mechanisms such as hook-and-loop or hook-and-hook seals or zip locks can be used.

[0088] In this embodiment, the fluid reservoir 10 is an elongated rectangular burstable water bag, although any suitable reservoir can be used in other embodiments. The fluid reservoir 10 has a height equal to 60-90%, e.g. 80%, of the height of the pouch 30, and a width equal to 5-25%, e.g. 15%, of the width of the pouch 30. In this embodiment, the fluid contained in the reservoir 10 is water. In other embodiments, many other types of reservoirs will be suitable, including reservoirs of different shapes and sizes, or non-burstable reservoirs and other external sources of fluid. In addition, other fluids can be used, such as lubricants, gels, oils, etc.

[0089] In this embodiment, the catheter 20 includes a proximal end 21 for insertion into the body, a distal end 22, and a flexible tube 23 connecting the two ends 21, 22. The distal end 22 includes a funnel 24 for directing urine out of the tube 23 from the bladder in use. A steering sleeve 25 is also provided around the tube 23 adjacent the distal end 22. In this embodiment, the length of the catheter is between 30-50 cm, e.g. 40 cm, and the length of the steering sleeve is 10-30%, e.g. 20-25%, e.g. 11 cm, of the length of the catheter. In this embodiment, the catheter 20 is provided with a hydrophilic coating which is activated when it contacts the fluid contained in the reservoir 10. In other embodiments, any suitable catheter length or type can be used.

[0090] The catheter 20 is arranged in a curved and coiled configuration within the pouch 30, with the distal end 22 adjacent the inner left lateral edge 33 near the upper edge 35 of the pouch 30 just below the sealing means 39. The catheter 20 extends down the interior of the pouch 30 into a wide oval anticlockwise coil (as seen with the left lateral edge 34 to the left and the upper edge 35 at the top). The coil spirals around the inner periphery of the left lateral edge 34, the base 32 and the right lateral edge 33 of the pouch, with the proximal end 21 of the catheter 20 resting on the inside of the catheter coil, adjacent the left lateral edge 34 and the base 32 of the pouch. Notably, the majority of the steering sleeve 25 is arranged above the junction 36, but as the catheter curves and extends from left to right, the catheter tube 23 extends below the junction in a channel defined by the interior base of the junction and the peripheral seal, then up the side of the junction, then back to the top of the junction and finally down so that the proximal end 21 is below and to the left of the junction 36. In short, the catheter 20 is coiled (or crimped) around the junction 36 (although not tightly coiled). In other embodiments, the catheter 20 can be positioned differently, in particular the catheter 20 can not be coiled or crimped, but can simply be curved within the pouch 30. On the other hand, embodiments of the invention can have a catheter 20 comprising a multi-turn coil.

[0091] Referring to Figure 2The pouch 30 is formed by first providing two walls 31a, 31b which will define the pouch 30 itself, and a front wall 31a which includes a transparent window 37 as described above and formed by one of the techniques described above. In this embodiment, the walls 31a, 31b are dimensioned to correspond to the final shape of the pouch 30, however, in other embodiments, the walls can extend beyond the pouch 30 as required.

[0092] In this embodiment, the base 32, right lateral edge 33 and left lateral edge 34 are first formed by welding the two walls 31a, 31b together, leaving the pouch 30 with an open upper edge 35. The conduit 20 is then arranged within the pouch 30 in the coiled and wound configuration as described above.

[0093] In this embodiment, the fluid reservoir 10 is also placed within the pouch 30 at a location corresponding to the window 37. The conduit 20 is thus concealed within the pouch 30 as the reservoir 10 is placed over the conduit 20 such that the reservoir 10 is visible through the window 37, and the reservoir 10 obstructs any view of the conduit 20 through the window 37. In other embodiments, the reservoir 10 can not need to be placed over the conduit 20 as the location of the conduit 20 within the pouch 30 can not correspond to the window 37.

[0094] In this embodiment, first and second sealing elements (not shown) are then attached to the inner sides of the walls 31a, 31b just above the coiled conduit 20, and the peripheral seal is completed by welding the walls 31a, 31b together along the upper edge 35 to form the upper edge 35 thereof. This seals the conduit 20 and the reservoir 10 within the pouch. In other embodiments, the sealing elements can be provided to the walls prior to any other assembly or peripheral sealing of the pouch 30.

[0095] In this embodiment, the junction 36 is then formed by welding the walls 31a, 31b together. As the conduit 20 is coiled around the inner periphery of the pouch 30, the junction 36 is located within the coiled portion of the conduit 20. Thus, a portion of the conduit 23 passes between the junction 36 and the base 32 of the pouch. In other embodiments, the junction 36 can be provided prior to the peripheral seal, or at any time during the assembly process.

[0096] Finally, in this embodiment, the tear initiation 40, tear termination 41 and aperture 42 can be formed by cutting away appropriate portions of the pouch 30. The walls 31a, 31b can be joined together around the periphery of the cut-away area using hot stamping to ensure that the pouch 30 remains completely sealed.

[0097] As should be appreciated, the above is an example and in other embodiments the pouch 30 can be formed in different ways with the steps performed in different orders. For example, the bottom can be open and the conduit and reservoir introduced from the bottom prior to providing the base seal. Or, for example, in an industrial application, the two web of wall material can have one half of the sealing means applied to each of their inner surfaces, the conduit 20 and reservoir 10 can be disposed between the opposing inner surfaces of the webs of wall material, then possibly in a single action, the heat die can bond and form the walls 31a, 31b by forming the perimeter seals 32, 33, 34, 35, simultaneously forming the tear initiation 40, forming the bond 36 and punching out the hole 42 in the tear region 38 and sealing it and punching out the tear termination 41. Further, while the perimeter seals and bond 36 have been described as being formed by welding, any suitable way of bonding the walls can be used, for example, an adhesive can be used.

[0098] Referring to Figures 2-7 This first embodiment of the packaged conduit assembly 100 can be unpackaged as follows.

[0099] First, the fluid reservoir 10 is positioned within the pouch 30 with the aid of the window 37 through which the reservoir 10 can be seen. Fluid is then released from the reservoir 10 into the pouch 30. In this embodiment, the reservoir 10 is a burstable sachet and the fluid can be released therefrom by applying manual pressure to the reservoir 10. The window 37 provides a visual reference to show when the reservoir 10 has successfully burst and the fluid has been released into the pouch 30. In particular, it can be seen that sufficient fluid has been released to fill the channel defined by the weld 36 and the inner base 32 of the perimeter seal. In other embodiments, the fluid can be released from other means.

[0100] Referring to Figures 3-7 The fluid released from the reservoir 10 collects in a pool at the bottom of the pouch 30 as indicated by the diagonal line. In this embodiment, the fluid fills the pouch 30 up to a fill level corresponding to the bond 36. Thus, in this embodiment, the bond 36 and the base 32 define a channel that is completely filled with fluid. However, in other embodiments, the channel can be only partially filled with fluid, for example 60-95%, preferably at least 90%, or the pouch can be filled above the height of the bond 36.

[0101] The released fluid can also be seen through the window 37 as the base of the window 37 corresponds to a position on the pouch 30 that is slightly below the bond 36. In other embodiments, the window can include an indicator area for showing the presence of fluid in the pouch. For example, a fluid sensitive color changing strip can be used so that direct visualization of the fluid is not required. A liquid level marker can also be provided to show that sufficient fluid has been released.

[0102] In this embodiment, the contents of the pouch 30 are then accessed by tearing the top of the pouch 30 using the tear-away region 38. With one hand grasping the aperture 42, and the other hand grasping the remainder of the pouch 30, the tear-away region 38 is then torn from the tear initiation 40 to the tear termination 41. As a result, the pouch is torn between the left lateral edge 34 and the right lateral edge 33 at a location below the upper edge 35, thereby forming an opening in the pouch 30 that can be used to access its contents. Advantageously, the tear-away region 38 does not completely separate from the pouch 30, which reduces the number of separate components and makes the pouch 30 easier to handle. Other embodiments can feature accessing the pouch in other ways, such as a zipper clasp seal.

[0103] Referring to Figures 4-6 The catheter 20 can then be withdrawn from the pouch 30. As described above, in this embodiment, the catheter 20 is coiled in the pouch 30, and the distal end 22 is disposed adjacent the upper edge 35 of the pouch 30. As a result, the distal end 22 is above the fill line of fluid released into the pouch 30 and is not wetted by the fluid. As a result, the distal end 22 provides a dry and easily accessible point that can be used to withdraw the catheter 20 from the pouch 30. In this embodiment, a substantial portion of the handling sleeve 25 (i.e., at least 50% of the sleeve 25, preferably between 60%-100%, such as 70%) is also above the fill line and is not wetted. As a result, the sleeve 25 also provides a convenient dry surface to handle the catheter 20.

[0104] In this embodiment, the distal end 22 is pulled upwards through the opening in the upper edge 35 of the pouch 30. As the distal end 22 is pulled out of the pouch 30, the conduit tube 23 uncoils and is also pulled upwards towards the upper edge 35 of the pouch 30. However, as the junction 36 is disposed within the coiled portion of the conduit 20, the tube 23 is prevented from moving directly upwards by the junction 36. The junction 36 thus causes the tube 23 to be withdrawn from the pouch 30 along a path that includes through the channel defined by the junction 36 and the base 32. Thus, the entire remaining portion of the tube 23 to the proximal end 21 passes through the fluid pool in this channel and the hydrophilic coating of the conduit 20 is activated by the fluid. Furthermore, the proximal end 21 of the conduit 20 is the portion of the conduit 20 that is last to pass through the channel and be withdrawn from the pouch 30. Thus, the conduit 20 is activated by the fluid upon withdrawal, the withdrawal is facilitated and easy as only the dry portion of the conduit 20 needs to be touched during the withdrawal process. As the conduit 20 passes through the fluid pool, it is more thoroughly wetted than if it were to remain in a fluid in another medium such as a foam. In other embodiments, the conduit 20 need not be pulled directly upwards, but can be pulled sideways out of the pouch, for example from an opening provided in the side of the pouch but of course above the weld, in order to reduce the likelihood of leakage. Furthermore, the conduit 20 can not directly contact the junction 36, but can be prevented from moving upwards by the convergence of the walls 31a, 31b as they approach the junction 36.

[0105] Once the conduit is fully withdrawn, the conduit can be used by inserting the proximal end 21 into the urethra until urine begins to flow through the conduit 20. The handling sleeve 25, which is (mostly) dry, facilitates insertion. Urine can then be directed out of the conduit 20 through the funnel 24.

[0106] Referring to Figure 7 In this embodiment, the conduit 20 can be placed back into the pouch 30 in a coiled configuration after use. The handling sleeve 25 and funnel 24 provide dry surfaces that can be used to re-coil the conduit 20 and place it into the pouch 30. The pouch 30 can then be re-sealed between the left lateral edge 34 and the right lateral edge 33 using the sealing means 39 by pressing the two corresponding sealing elements (not shown) together. This allows for more convenient handling of the conduit 20 after use and ensures that the fluid released into the pouch 30 does not subsequently leak out of the pouch 30. In other embodiments, alternative sealing means can be used, for example external flaps with adhesive, allowing the top of the pouch 30 to be rolled up or folded and sealed. Alternatively, no sealing means can be used in the case where the pouch 30 is intended to be immediately discarded after use.

[0107] Referring to Figure 8 A second embodiment of a packaged catheter assembly 200 is shown. The second embodiment shares many features of the first embodiment described above, so only the differences in features will be described below and like reference numerals are used to denote like features.

[0108] In this embodiment, the junction 236 is provided at a location that is offset from the midpoint between the right lateral edge 233 and the left lateral edge 234. In particular, the junction is provided at a distance from the right lateral edge 234 that is 20-45%, for example 35%, of the width of the pouch 230. The junction 236 provides a second function, as a locating seal to limit movement of the reservoir 210 in the pouch 230, thereby sandwiching the reservoir 210 between the junction 236 and the right lateral edge 234. The junction 236 thus ensures that the window 237 corresponds to the location of the reservoir 210 regardless of movement of the pouch 230 as it is carried by the user, thereby ensuring that the conduit 223 remains hidden / concealed and the reservoir 210 can be easily identified for release of its fluid. In other embodiments, the function of the locating seal can be provided by a separate seal between the walls 231a, 231b. For example, a separate seal extends downwardly from the seal arrangement 239, or upwardly from the base 232.

[0109] In this embodiment, the front wall 231a also includes a pattern 243 corresponding to the edge of the window 237. The pattern 243 is displayed only on a portion of the window, but of course could extend across the entire window and include a graduated appearance that softens the boundary between the transparent window 237 and the remainder of the opaque front wall 231a. In this embodiment, the pattern is a series of uniformly spaced opaque lines of graduated thickness that become thinner as they approach the centre of the window 237. The pattern 243 thus makes the window 237 less visually apparent, and hence makes the pouch 230 less attention- grabbing. In other embodiments, the pattern 243 can be any suitable pattern, for example opaque circles of graduated size, and can complement or combine with the surface pattern or colour applied to the reservoir 210.

[0110] Referring to Figure 9 A third embodiment of a packaged catheter assembly 300 is shown. The third embodiment shares many features of the first embodiment described above, so only differences in features are described below, and like reference numerals are used to denote like features. Figure 9 A cross-sectional elevation view of the assembly 300 is shown, so the front wall 331a and the window 337 are not shown. The diagonal lines show where the front wall 331a is joined to the rear wall 331b, for example at the left lateral edge 334, the base 322, the right lateral edge 333, the upper edge 335, the tear-away region 338 and the junction 336.

[0111] In this embodiment, the tear-away region 338 comprises a tear line 344 across between the tear initiation 340 and the tear termination 341. The tear line 344 is a line of weakness that preferentially tears to allow the tear-away region 338 to be torn. This makes it easier to remove the tear-away region 338 in a consistent manner. In this embodiment, the tear line 344 is formed by laser scoring to weaken the pouch 330, but in other embodiments other techniques can be used, such as thinning the material of the pouch 330 along the tear line 344.

[0112] In this embodiment, the sealing means 339 comprises a zip-lock seal to allow the user to reclose the pouch 330. The locations at which the front wall 331a and the rear wall 331b can be sealed together by the sealing means 339 are indicated by vertical slashes in Figure 9 . These correspond to the strips of the pouch 330 that are directly below the tear line 344.

[0113] In this embodiment, the catheter 320 is arranged within the pouch 330 in a similar manner to the first embodiment, being coiled within the pouch. However, in this embodiment, the distal end 322 and the funnel 324 of the catheter 320 are arranged centrally with respect to the opening formed by the tear-away region 338. The distal end 322 and the funnel 324 are approximately equidistant from the left lateral edge 334 and the right lateral edge 333, rather than being closer to either lateral edge 333, 334. Thus, when the pouch 330 is opened, the distal end 322, including the funnel 324 and the handling sleeve 325, is more easily accessible as it is centrally located and at the widest point of the opening across the width of the pouch 330. Additionally, when the catheter 320 is coiled, the handling sleeve 325 extends from the distal end 322 to a position adjacent to the left lateral edge 334. Thus, the distal end 322, the handling sleeve 325 and the fluid reservoir 310, together with the fluid reservoir 310 positioned adjacent to the right lateral edge 33, protect the remainder of the catheter 323 from being inadvertently directly contacted by the user as they withdraw the catheter 320 from the pouch 330. This reduces the risk of infection when using the catheter 320 as it is less likely to be contaminated before use.

[0114] In this embodiment, the sleeve 325 is configured such that it does not extend below the height of the junction 336 within the pouch 330, in particular, the sleeve 325 is further from the junction 336 than the base 332 of the pouch 330. This reduces the likelihood of the sleeve 325 becoming wet as fluid is released from the fluid reservoir 310 into the channel. Thus, the sleeve 325 is easier for the user to handle.

[0115] Conditional language, such as "can," "could," "might," or "may," unless specifically stated otherwise, or otherwise understood within the context as used, is generally intended to convey that certain embodiments include, while other embodiments do not include, certain features, elements, and / or steps. Thus, such conditional language is not generally intended to imply that one or more embodiments are required to include a feature, element and / or step in order to be deemed to be an embodiment. The use of conditional language, and related terms, is intended to convey that the feature, element and / or step is an optional element with the embodiment.

[0116] One or more embodiments have been described above with the intent of providing those skilled in the art with what is believed to be the most reliable and / or useful information available having the salient features of the application. Many variations, modifications, and / or alternatives can be possible within the scope of the attached claims.

Claims

1. A packaged catheter assembly comprising a pouch and a catheter, wherein: The pouch includes two walls and a peripheral seal between the two walls; the catheter includes a distal end and a proximal end for insertion into the body; the catheter is arranged in a curved configuration within the pouch; a joint is provided between the two walls, wherein: the joint, together with the inner base of the peripheral seal, defines a channel for being filled with fluid before the catheter is withdrawn from the pouch; the pouch and the catheter are arranged such that during withdrawal of the catheter from the pouch, the distal end of the catheter is withdrawn from the pouch before the proximal end, and the proximal end of the catheter passes through the channel; wherein the joint and the peripheral seal are independent of each other.

2. The component according to claim 1, wherein, The catheter is a male urinary catheter.

3. The component according to claim 1 or claim 2, wherein, The catheter is an intermittent catheter.

4. The component according to any one of the preceding claims, wherein, The conduit is disposed between the inner base of the joint and the peripheral seal.

5. The component according to any one of the preceding claims further includes a fluid reservoir configured to release fluid into the sac to form a fluid pool in the channel.

6. The component according to claim 5, wherein, The conduit includes a surface configured to be activated by fluid held in the fluid reservoir.

7. The component according to claim 5 or claim 6, wherein, The fluid pool corresponds to a channel filling level that is at least 90% of the channel's volume.

8. The component according to any one of the preceding claims, wherein, The distal end of the conduit is positioned closer to the upper edge of the peripheral seal than the base of the peripheral seal.

9. The component according to any one of the preceding claims, wherein, The distal end of the catheter is provided with a manipulator sleeve, wherein the manipulator sleeve is at least partially closer to the upper edge of the peripheral seal than the base of the peripheral seal.

10. The component according to any one of the preceding claims, wherein, The pouch includes an interaction region configured to form an opening in or near the upper edge of the peripheral seal.

11. The component of claim 10, wherein, The distal end of the catheter is centered relative to the opening.

12. The component of claim 10, wherein, The opening is formed from the first lateral edge of the peripheral seal, and the distal end of the conduit is arranged closer to the first lateral edge of the peripheral seal than to the second lateral edge of the peripheral seal.

13. The component according to any one of the preceding claims, wherein, The channel is open.

14. The component according to any one of the preceding claims, wherein, The peripheral sealing portion is generally rectangular in shape, and has two lateral edges between the base and the upper edge of the peripheral sealing portion.

15. The component of claim 14, wherein, The joint is located at a position equidistant from the two lateral edges.

16. The component according to any one of the preceding claims, wherein, The joint is located at a distance of 20%-30% of the height of the pouch from the base, wherein the height of the pouch is defined as the distance from the base of the peripheral seal to the upper edge of the peripheral seal.

17. The component according to any one of the preceding claims, wherein, The joint is circular, with a radius less than or equal to 15% of the height of the pouch, wherein the height of the pouch is defined as the distance from the base of the peripheral seal to the upper edge of the peripheral seal.

18. The component according to any one of the preceding claims, wherein, The catheter is arranged in a coiled configuration within the pouch.

19. The component according to any one of the preceding claims, wherein, The catheter is arranged such that at least 50% of the length of the catheter passes through the channel during extraction.

20. The component according to any one of the preceding claims, wherein, The component includes a fluid reservoir, the sac is opaque, and the sac contains the fluid reservoir, wherein the sac includes a transparent or translucent window.

21. A method of forming a packaged catheter assembly, the method comprising: Two walls are provided to define the pouch; The catheter is arranged in a curved configuration within the pouch; A peripheral seal is formed between the walls to seal the catheter within the pouch; And a joint is formed between the walls, wherein: the joint, together with the inner base of the peripheral seal, defines a channel for fluid to be filled before the catheter is withdrawn from the sac; The catheter includes a distal end and a proximal end for insertion into the body; the pouch and the catheter are arranged such that during withdrawal of the catheter from the pouch, the distal end of the catheter is withdrawn from the pouch before the proximal end, and the proximal end of the catheter passes through the channel; wherein the junction and the peripheral seal are independent of each other.

22. The method according to claim 21, wherein, The two walls are opaque, and the method includes the steps of: providing a fluid reservoir within the sac; and providing a transparent or translucent window in at least one wall of the sac, wherein the step of forming the peripheral seal includes sealing the fluid reservoir within the sac.

23. The method according to claim 21 or claim 22, wherein, The packaged catheter assembly is the packaged catheter assembly according to any one of claims 1 to 20.

24. A method of unpacking a packaged catheter assembly, the packaged catheter assembly including a pouch, a catheter housed within the pouch, and a fluid reservoir, the pouch including two walls and a peripheral seal between the two walls, the method comprising releasing fluid from the fluid reservoir to form a pool in a channel located between a base of the pouch and a junction disposed between the two walls, opening the pouch and pulling the catheter through a distal end, thereby guiding a proximal end of the catheter for insertion into the body through the channel as the distal end is pulled out, thereby being wetted by the fluid pool; wherein the junction and the peripheral seal are independent of each other.

25. The method of claim 24, further comprising the step of: The interior of the bladder can be inspected through a transparent or semi-transparent window in the opaque wall of the bladder to identify whether the fluid reservoir has released fluid or to confirm whether the fluid reservoir has released fluid into the bladder, or both the identification and the confirmation can be performed.

26. The method according to claim 24 or claim 25, wherein, The packaged catheter assembly is the assembly according to claims 1 to 20 and / or the packaged catheter assembly formed by the method according to claims 21 to 23.

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