Packaged Catheter Assembly

Abstract

A packaged catheter assembly includes a pouch and a catheter. The pouch includes two walls and a peripheral seal between the two walls. The catheter includes a proximal end and a distal end for insertion into the body. The catheter is positioned within the pouch in a curved configuration, with a junction between the two walls, and the junction and an interior base of the peripheral seal define a channel that is filled with fluid prior to withdrawing the catheter from the pouch. The pouch and catheter are positioned such that, during withdrawal of the catheter from the pouch, the distal end of the catheter is withdrawn from the pouch before the proximal end, and the proximal end of the catheter passes through the channel. The assembly may also include a fluid reservoir that releases fluid into the pouch to form a pool of fluid in the channel.

Description

[Technical Field]

[0001] The present invention relates to a packaged catheter assembly, particularly to a packaged urinary catheter assembly, and more particularly to a packaged intermittent male urinary catheter assembly. [Background technology]

[0002] Many people suffer from urinary problems that make it difficult to pass urine. Intermittent catheters offer a convenient and portable solution to these problems, allowing people to enjoy a relatively normal lifestyle while reducing the impact of urinary disease on their lives.

[0003] Intermittent catheters are typically single-use devices that are carried by the user and unpackaged for use as needed. It is important to lubricate catheters before use to reduce the risk of urethral injury and improve comfort during catheter use. However, lubricating catheters in public places, such as public restrooms, can be difficult and inconvenient. Consequently, catheters are often not properly lubricated before use, increasing the risk of discomfort and injury.

[0004] Male intermittent catheters are typically several centimeters longer than female catheters, typically 20 cm or more, and ISO 20696:2018 specifies a minimum effective length of 275 mm. This can make them difficult to carry discreetly. The additional length can also make them more difficult to adequately lubricate and use.

[0005] It is an aim of embodiments of the present invention to at least partially overcome or mitigate the above mentioned problems. Summary of the Invention

[0006] Broadly speaking, the present invention relates to a packaged catheter assembly having one or more of: (a) a channel through which fluid can be introduced and through which the catheter is retracted when withdrawn from the packaged assembly; and (b) a means for visualizing when the fluid is released from the reservoir and / or ensuring that the fluid reservoir is visible but the catheter within the packaged assembly is hidden.

[0007] According to a first broad aspect of the present invention, there is provided a packaged catheter assembly comprising a pouch and a catheter, the catheter being positioned within the pouch in a curved configuration, with a join between the walls of the pouch defining a channel through which fluid can be introduced prior to withdrawal of the catheter from the pouch, and through which the catheter passes during withdrawal of the pouch, i.e., by withdrawing it by the distal end, with the distal end of the catheter withdrawn from the pouch before the proximal end.

[0008] According to a second aspect of the present invention, there is provided a packaged catheter assembly comprising a pouch and a catheter, wherein the pouch comprises two walls and a peripheral seal between the two walls, the catheter comprises a proximal end and a distal end for insertion into the body, the catheter is positioned within the pouch in a curved configuration and a junction is provided between the two walls, the junction and an interior base of the peripheral seal define a channel that is filled with fluid before the catheter is withdrawn from the pouch, and the pouch and catheter are arranged such that, upon withdrawal of the catheter from the pouch, the distal end of the catheter withdraws from the pouch before the proximal end, with the proximal end of the catheter passing through the channel.

[0009] According to a third aspect of the present invention, there is provided a method of forming a packaged catheter assembly, the method comprising providing a pouch, placing a catheter in the pouch in a curved configuration, sealing the catheter in the pouch, and forming a junction between the walls of the pouch to define a channel through which fluid can be introduced before the catheter is withdrawn from the pouch, and during withdrawal of the pouch (with the distal end withdrawn into the pouch before the proximal end, i.e., by the distal end being withdrawn), the proximal end of the catheter passes through the channel.

[0010] According to a fourth aspect of the present invention, there is provided a method of forming a packaged catheter assembly, the method comprising: providing two walls defining a pouch; placing a catheter in the pouch in a curved configuration; forming a peripheral seal between the walls to seal the catheter within the pouch; and forming a junction between the walls, the junction of the peripheral seal and the interior base defining a channel that is filled with fluid prior to withdrawing the catheter from the pouch, the catheter having a proximal end for insertion into a body and a distal end, the pouch and catheter being arranged such that, upon withdrawal of the catheter from the pouch, the distal end of the catheter withdraws from the pouch before the proximal end, and the proximal end of the catheter passes through the channel.

[0011] Advantageously, the present invention provides a packaged catheter that can be easily removed from the package and simultaneously lubricated for use. This joint offers the advantage that, when the catheter is removed, a fluid is drawn through the channel. The fluid is typically an activating liquid, such as water, that activates the hydrophilic coating, making it slippery, or it can be a lubricant. In either case, drawing the catheter through the channel (preferably provided) ensures that the catheter is properly lubricated. The fluid channel retains the fluid in a pool through which the catheter is forced, rather than potentially being drawn from the package without adequately wetting it, thereby increasing the coating of fluid on the catheter surface. Furthermore, the distal end of the catheter that can be drawn does not pass through a pool of fluid, making handling easier.

[0012] Furthermore, intentionally forming a pool at the bottom means that the fluid is always retained within the package, making the device more convenient to use and reducing the possibility of spillage, which can occur, for example, when opening a fluid reservoir into the pouch and attempting to dispense the fluid by shaking the pouch. The pouch can also be made smaller because the catheter is curved within the pouch. The use of a channel-forming junction also facilitates the use of less fluid, as the fluid is applied to the portion of the catheter that needs to be wetted, rather than being distributed throughout the catheter. Another advantage of this invention is that the proximal end is the last part of the catheter to be wetted, so it is least likely to dry out before being introduced into the urethra. Because the channel volume is controlled by the location of the junction, flexible, soft pouch walls can be used, making the pouch more convenient to carry and use.

[0013] The following optional or preferred features apply to the present invention in general terms, including both the (first and second) apparatus aspects and the (third and fourth) method aspects outlined above, and also to further aspects set out below.

[0014] The packaged catheter assembly may include a fluid reservoir. The method may include providing a fluid reservoir. The fluid reservoir may be configured to release fluid into the pouch and form a pool of fluid in the channel. Accordingly, embodiments of the present invention may provide a packaged catheter assembly including a pouch, a catheter, and a fluid reservoir, wherein the pouch includes two walls and a peripheral seal between the two walls, the catheter includes a proximal end for insertion into the body and a distal end, the catheter is disposed within the pouch in a curved configuration, and a junction is provided between the two walls, the junction and an interior base of the peripheral seal define a channel that is filled with fluid before withdrawing the catheter from the pouch, the fluid reservoir is configured to release fluid into the pouch to form a pool of fluid in the channel, and the pouch and catheter are positioned 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. The volume of the fluid reservoir is preferably sufficient to completely fill the channel, i.e., when the pouch is held at its lowest point, the fluid may extend at least to the level of the bottom of the junction, such that the fill level of the channel is 100% or more, for example at least 150%, at least 200%, or 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% of the volume of the channel.Thus, embodiments of the present invention may provide a packaged catheter assembly including a pouch, a catheter, and a fluid reservoir, wherein the pouch includes two walls and a peripheral seal between the two walls, the catheter includes a proximal end for insertion into the body and a distal end, the catheter is positioned within the pouch in a curved configuration, a junction between the two walls, the junction and an inner base of the peripheral seal defining a channel that is filled with fluid before the catheter is withdrawn from the pouch, the fluid reservoir is configured to release fluid into the pouch to form a pool of fluid within the channel, and the pouch and catheter are arranged such that during withdrawal of the catheter from the pouch, the distal end of the catheter withdraws from the pouch before the proximal end, the proximal end of the catheter passes through the channel, and the pool of fluid corresponds to a channel fill level of at least 90% of the channel's volume. Thus, the present invention provides an assembly having a reservoir capable of supplying fluid into the channel. The size of the reservoir is selected to ensure that sufficient fluid is delivered and that the catheter can be sufficiently lubricated upon removal.

[0015] The fluid reservoir can be disposed within a (sealed) pouch. The fluid reservoir can be provided as a separate device or can be incorporated into the pouch material. The method can include disposing the fluid reservoir within the pouch and sealing the fluid reservoir within the pouch with a catheter. The fluid reservoir can include a deformable, collapsible, or rupturable sachet. In this manner, the fluid reservoir is conveniently disposed within the pouch, allowing fluid to be released directly into a channel formed by the joint and the bottom of the peripheral seal. A deformable, collapsible, or rupturable reservoir can easily release fluid before opening the pouch without additional tools, increasing user convenience and thus reducing the likelihood of the user accidentally getting wet. Sachets, in particular, can be easily handled on an assembly line and can be introduced more easily than handling fluids in packages during manufacturing.

[0016] The catheter may be a urethral catheter. The catheter may be a male urethral catheter. The catheter may be an intermittent catheter. In one embodiment, the catheter is an intermittent male urethral catheter. Thus, the constructional features of the present invention allow for the provision of an intermittent male urethral catheter in a compact package, and also facilitate convenient and easy catheter withdrawal while allowing for the catheter to be lubricated prior to use.

[0017] The catheter may be positioned between the junction and the internal base of the peripheral seal. The method may include positioning the catheter between the junction and the internal base of the peripheral seal. The junction may be separate from the base of the peripheral seal. The channel may be an open-ended channel. Thus, embodiments of the present invention may provide a packaged catheter assembly including a pouch and a catheter, wherein the pouch has two walls and a peripheral seal between the two walls, the catheter has a proximal end for insertion into the body and a distal end, the catheter is positioned within the pouch in a curved configuration, and the junction is provided between the two walls, the junction and the internal base of the peripheral seal define an open-ended channel that is filled with fluid before the catheter is withdrawn from the pouch, and the pouch and catheter are positioned such that, upon withdrawal of the catheter from the pouch, the distal end of the catheter withdraws from the pouch before the proximal end, and the proximal end of the catheter passes through the channel. Thus, the catheter is retained within the pouch within the open-ended channel formed by the junction and the internal base of the peripheral seal. In this way, when withdrawn, the catheter is withdrawn through the channel and is well lubricated.

[0018] The joint and the peripheral seal may be independent. Thus, embodiments of the present invention may provide a packaged catheter assembly including a pouch and a catheter, the pouch having two walls and a peripheral seal between the two walls, the catheter having a proximal end and a distal end for insertion into a body, the catheter disposed in a curved configuration within the pouch, and a joint between the two walls, the joint and the peripheral seal being independent, and an inner base of the joint and the peripheral seal defining a channel that is filled with fluid before the catheter is withdrawn from the pouch, the pouch and catheter being arranged such that, upon withdrawal of the catheter from the pouch, the distal end of the catheter withdraws from the pouch before the proximal end, and the proximal end of the catheter passes through the channel. The joint may be provided at a spot. The joint is preferably provided by welding, e.g., spot welding. Such welding may be provided after the catheter (and optionally the pouch) is disposed between the walls and can be accomplished from the outside of the pouch. Alternatively, the perimeter seal can be formed by mechanical sealing, heat sealing, pressure sealing, adhesives, solvent bonding, ultraviolet bonding, ultrasonic welding, laser welding, impulse welding, or friction welding. Similarly, the perimeter seal can be formed by one or more of welding, mechanical sealing, heat sealing, pressure sealing, adhesives, solvent bonding, ultraviolet bonding, ultrasonic welding, laser welding, impulse welding, or friction welding. At least a portion of the perimeter seal can be formed by a fold. 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 pouch. The perimeter seal and the perimeter seal can be formed separately. Alternatively, the welds forming the perimeter seal can be formed simultaneously with the perimeter seal. In some embodiments, the perimeter seal and the perimeter seal are a single, continuous seal. In this manner, the manufacturing process for the perimeter seal is highly convenient and avoids significant modifications to a typical packaged catheter assembly manufacturing line.

[0019] The catheter may include a surface that is activated by the fluid in the channel. For example, the catheter may include a hydrophilic surface formed, for example, by a hydrophilic coating. If a hydrophilic surface is provided, the fluid may be polar or aqueous. The catheter may also include a hydrophobic surface that is activated by the fluid in the channel. For example, the catheter may include a hydrophobic coating. If a hydrophobic coating is used, the fluid may be non-polar. In this way, the catheter is easily lubricated by the fluid in the channel, making it easy and comfortable to use.

[0020] The pouch can include an interaction area that defines a first contact point for a user of the packaged catheter assembly. The interaction area can facilitate user access to the contents of the pouch. Activation of the interaction area can form an opening at or near the top edge of the perimeter seal. The catheter can be withdrawn through this opening. In this manner, access to the pouch is provided at or near the top edge of the pouch, such that fluid in the channel (bottom of the pouch) is retained in the pouch while the catheter is withdrawn, reducing the risk of fluid spilling out of the pouch.

[0021] The interaction region can constitute a breakable region of the perimeter seal. The method can include forming the breakable region in the perimeter seal. The breakable region can include a tear line that at least partially separates the breakable region from the remainder of the pouch, thereby defining a line along which the pouch can be torn to form an opening in the perimeter seal. The tear region can include a tear start. The tear start can be located at a first end of the tear region. The tear start can include a notch or a weak area located in one or both walls of the pouch. The tear start can define the initial portion of the pouch that is torn. The tear region can include a tear stop. The tear stop can be located at a second end of the tear region. The tear stop can act to prevent or reduce the likelihood of the tear region being completely separated from the remainder of the package. A tear line may be defined between the tear start and tear stop. The tear line may be configured to tear preferentially. The tear line may comprise a weakened area of ​​the pouch. The tear line may be formed by any suitable means, such as laser scoring. The tearable area may be substantially triangular in shape with a beveled upper edge. In this manner, the breakable area provides a convenient and easy means of opening the pouch with minimal effort and without the use of additional devices / tools.

[0022] The interaction region may include a sealing arrangement. The sealing arrangement may include one or more sealing members operable to provide a user-sealable seal between the two walls of the pouch to close the pouch. In one embodiment, the first and second sealing members are provided on the inner surfaces of the two walls of the pouch. The sealing arrangement may provide a watertight and / or fluid-impermeable seal when closed. Thus, the pouch can be resealed after use to prevent fluid in the channel from subsequently being released from the pouch. Also, the catheter can be returned to the pouch and retained therein after use.

[0023] The sealing arrangement may be pre-sealed. In such embodiments, user access to the contents of the pouch may be provided by opening the sealing arrangement. The sealing arrangement may be resealable. The sealing arrangement may be either a Ziploc® seal, a hook-and-loop seal, a hook-and-hook seal, or an adhesive layer. Thus, the sealing arrangement may be used such that the contents of the pouch remain inside until the sealing arrangement is opened, and the pouch can still be resealed after use. This is useful because if the frangible region required the application of force to the pouch to open it, the pouch could shift or become misaligned during opening, potentially allowing fluids or the catheter to escape the pouch.

[0024] The interaction area may include a breakable area and a seal arrangement. In certain embodiments, the interaction area includes a breakable area corresponding to the top edge of the perimeter seal and a resealable arrangement below the breakable area.

[0025] The perimeter seal may have an upper edge. The perimeter seal may be substantially rectangular in shape with two side edges between the base and upper edge. The perimeter seal may have a height from base to upper edge of at least 10 cm, 15 cm, or 20 cm, and / or a height of 10 cm, 15 cm, 20 cm, or 25 cm or less, for example, between 15 cm and 20 cm. The perimeter seal may have a width between side edges of at least 5 cm, 10 cm, or 15 cm, and / or a width of 10 cm, 15 cm, or 20 cm or less, for example, between 5 cm and 15 cm. The catheter may have a length of at least 20 cm, 25 cm, 30 cm, 35 cm, 40 cm, 45 cm, or 50 cm, for example, between 35 cm and 45 cm. In one embodiment, the perimeter 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. The peripheral seal thus defines a "pocket-sized" pouch within which the catheter can be housed in a curved configuration to reduce the apparent size of the catheter and allow for convenient and discreet storage.

[0026] The distal end of the catheter may be positioned closer to the top edge of the perimeter seal than the base end of the perimeter seal. The method may include positioning the distal end of the catheter closer to the top edge of the perimeter seal than the base of the perimeter seal. The distal end of the catheter may be positioned in the top half of the pouch or the top quarter of the pouch. The distal end of the catheter may be positioned above the junction. The distal end of the catheter may be positioned above the fluid fill level. In this way, the distal end of the catheter is easily accessible so that it can be withdrawn before the proximal end of the catheter, as required by the present invention. Furthermore, because it is positioned so as not to be pulled through the fluid, it does not get wet and remains easy to handle.

[0027] The distal end of the catheter may include a handling sleeve, which may be positioned closer to the upper edge of the peripheral seal than the base of the peripheral seal. The method may include positioning a handling sleeve at least partially on the distal end of the catheter, closer to the upper edge of the peripheral seal than the base of the peripheral seal. At least a portion of the handling sleeve may be positioned in the upper half of the pouch or the upper quarter of the pouch. At least a portion of the handling sleeve may be positioned above the junction. In some cases, the entire handling sleeve may be above the junction. In some cases, the handling sleeve may be further from the junction than the bottom of the pouch. At least a portion of the handling sleeve may be positioned above the fluid fill level. In some cases, the entire handling sleeve may be positioned above the fluid fill level. In this way, the handling sleeve is easily accessible so that it can be withdrawn in front of the proximal end of the catheter as required by the present invention. Furthermore, because it is positioned so as not to be pulled through the fluid, at least a portion of it will not get wet, remaining easy to handle and providing a dry surface that can be used to grasp and manipulate the catheter.

[0028] Any one or more of the distal end of the catheter, the funnel, and the handling sleeve may be centrally positioned relative to the opening formed in the pouch. The term "centrally positioned" may correspond to a position closer to the center of the opening than the edges of the opening. The term "centrally positioned" may correspond to a position in the central portion of the opening. The central portion may be the central 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 may be centrally positioned within the pouch. Any one or more of the distal end of the catheter, the funnel, and the handling sleeve may be located closer to the center of the pouch than the left and / or right edges. In this way, when the pouch is opened, the distal end / funnel / handling sleeve is more easily accessible because it is central and located at the point across the width of the pouch where it opens most widely.

[0029] The distal end of the catheter may be above the remainder of the catheter within the pouch. The handling sleeve and / or funnel may extend across an opening formed in the pouch. The handling sleeve and / or funnel may extend from the distal end to a point adjacent the left or right edge. The funnel may not be aligned parallel to the left and / or right edge. At least a portion of the handling sleeve may not be aligned parallel to the left and / or right edge. The end of the fluid reservoir may correspond to the location of the distal end of the catheter. The fluid reservoir may be adjacent to the right or left edge. If the handling sleeve extends adjacent to one side edge (e.g., the left or right edge), the fluid reservoir may be adjacent to the other side edge (e.g., the right or left edge). The distal end may be located adjacent to one side edge (e.g., the left or right edge), and the handling sleeve and / or funnel may extend to a point adjacent to the other side edge (e.g., the right or left edge). In this manner, the location of the distal end, funnel, handling sleeve, and fluid reservoir protects the remainder of the catheter from inadvertent direct contact by the user when removing the catheter from the pouch. This reduces the risk of infection during use by making it less likely for the catheter to become contaminated before use.

[0030] The distal end of the catheter may be positioned closer to one (e.g., left) side edge of the peripheral seal than to another (e.g., right) side edge of the peripheral seal. The method may include positioning the distal end of the catheter closer to one (e.g., left) side edge of the peripheral seal than to another (e.g., right) side edge of the peripheral seal.

[0031] The joints can be located at points equidistant from both lateral edges. Alternatively, they can be offset. This method can include providing joints at equidistant positions from each lateral edge. Alternatively, the joints can be located at offset lateral positions. For example, they can be located anywhere between 25% and 75% of the pouch width. The distance between the left and right edges of the perimeter seal can be the width of the pouch. The distal end of the catheter can be provided at a distance from one left edge that is 20%, 10%, 5%, or 1% or less of the pouch width. In this way, the joints and distal end are located in positions that facilitate catheter withdrawal and lubrication without spilling the lubricant. By providing joints equidistant between the edges, the volume of the channel is limited, optimizing the fluid level therein for catheter lubrication.

[0032] In embodiments including an interaction region, actuation of the interaction region can preferentially form an opening first at a first (e.g., left) side edge of the perimeter seal. In such embodiments, the distal end of the catheter can be positioned near the first (e.g., left) side edge. In embodiments including a tear region and a tear start, the location of the tear start can correspond to a side edge of the perimeter seal. In such embodiments, the distal end of the catheter can be positioned near the side edge of the perimeter seal corresponding to the location of the tear start. Thus, the distal end is positioned adjacent to the first portion of the pouch to be opened, facilitating withdrawal.

[0033] The seam may be located closer to the base of the perimeter seal than the upper edge of the perimeter seal. The distance between the base and the upper edge of the perimeter seal may define the height of the pouch. The distance between the seam and the base may be at least 10%, 15%, 20%, 25%, 30%, 35%, 40%, or 45% of the height of the pouch. The distance between the seam and the base may be less than 50%, 45%, 40%, 35%, 30%, 25%, 20%, or 15% of the height of the pouch. In particular, the seam may be located between 20% and 30% of the height of the pouch. The seam may be circular. The seam may have a radius corresponding to less than 15%, less than 10%, less than 5%, or less than 1% of the height of the pouch. In a preferred embodiment, the seam has a radius of 5% of the height of the pouch. Thus, the joint can be positioned to define a channel of suitable size to allow for adequate lubrication of the catheter and for easy withdrawal of the catheter without excessive bending or application of undue force.

[0034] In one embodiment, the joints are equidistant from each side edge of the pouch and are located 20-30% of the height of the pouch from the base.

[0035] The distal end of the catheter can include a funnel positioned to prevent the catheter from passing through the channel during withdrawal. A handling sleeve can also be positioned to prevent the catheter from passing through the channel during withdrawal. The sleeve can be no longer than 25%, 20%, 15%, 10%, or 5% of the length of the catheter, but can be as long as the entire length of the catheter. Embodiments of the present invention provide a funnel and sleeve to facilitate easy handling of the catheter. Because these elements, or at least some of them, do not pass through the channel, they are not covered with fluid during withdrawal. The sleeve may not extend below the level of the junction within the pouch. The sleeve may be further from the junction than the bottom of the pouch. This reduces the likelihood of the sleeve becoming wet when releasing fluid from the fluid reservoir into the channel. In this way, the catheter is more convenient to use because fluid is applied only to the necessary portion of the catheter. Furthermore, the targeted application of fluid to the catheter facilitates the use of less fluid.

[0036] The angle traversed by the end of the catheter when curved within the pouch may be at least 180 degrees, 210 degrees, 240 degrees, 270 degrees, 300 degrees, 330 degrees, or 360 degrees, or may be at least 420 degrees, 480 degrees, or even 540 degrees. It may be less than 720 degrees, 630 degrees, or 540 degrees. The catheter may be positioned within the pouch in a curled or coiled configuration. Thus, embodiments of the present invention can provide a packaged catheter assembly including a pouch and a catheter, the pouch including two walls and a peripheral seal between the two walls, the catheter including a proximal end for insertion into the body and a distal end, the catheter disposed within the pouch in a coiled configuration, and a junction between the two walls, wherein the junction and an interior base of the peripheral seal define a channel that is filled with fluid prior to withdrawal of the catheter from the pouch, and the pouch and catheter are positioned such that, upon 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. The junction may be located within an area defined by the curl or coil of the catheter. The peripheral seal can restrict the catheter to its curved configuration. Thus, the curved, curled, or coiled catheter can reduce the size of the pouch, allowing long catheters to be conveniently and discreetly stored ready for use.

[0037] The catheter can be positioned so that at least 30%, 40%, 50%, 60%, 70%, or 80% of its length passes through the channel during withdrawal. Accordingly, embodiments of the present invention may provide a packaged catheter assembly including a pouch and a catheter, wherein the pouch includes two walls and a peripheral seal between the two walls, the catheter includes a proximal end and a distal end for insertion into the body, and a junction between the two walls, the inner bottom of the junction and the peripheral seal defining a channel that is filled with fluid before the catheter is withdrawn from the pouch, and the pouch and catheter are positioned such that, during withdrawal of the catheter from the pouch, the distal end of the catheter withdraws from the pouch before the proximal end, and at least 50% of the catheter's length, including the proximal end of the catheter, passes through the channel. In one embodiment, 70-80% of the catheter's length passes through the channel during withdrawal. Advantageously, only the portion of the catheter intended for entry into the body is lubricated, thereby avoiding fluid waste and making the catheter easier to use.

[0038] The walls can be formed of any suitable material, such as a film material. The walls can be impermeable to fluids. The walls can be made of a plastic material. For example, the walls can be made of one or more of polypropylene (PP), polyethylene terephthalate (PET), low-density polyethylene (LDPE), polyethylene terephthalate polyester (MET PET), or oriented polypropylene (OPP). The walls can include a laminate of two or more layers. Each wall can include an inner layer and an outer layer. Each wall can include an inner layer and an outer layer of polypropylene. Each wall can include an inner layer of oriented polypropylene and an outer layer of polypropylene. Each wall can include, for example, an inner layer of polypropylene and an outer layer of 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 smaller thickness than the outer layer. In embodiments, the inner layer may have a thickness of between 5 and 20 microns, or between 10 and 10 microns, or between 10 and 15 microns, and the outer layer may have a thickness of between 10 and 50 microns, or between 20 and 40 microns, or between 35 and 45 microns. In one example, the inner layer may have a thickness of about 12 microns and the outer layer may have a thickness of about 40 microns.

[0039] According to a fifth aspect of the present invention, there is provided a method of unpacking a packaged catheter assembly, the packaged catheter assembly comprising a pouch, a catheter contained within the pouch, and a fluid reservoir, the method comprising the steps of releasing fluid from the reservoir to form a pool in a channel between a base and a joint of the pouch, opening the pouch, and withdrawing the catheter by a distal end of the catheter, wherein as the distal end is withdrawn, a proximal end of the catheter for insertion into a body is guided through the channel so as to be wetted by the pool of fluid.

[0040] The packaged catheter assembly may be a packaged catheter assembly defined in general terms, or one manufactured according to either the first or second aspect above, or by the method of the third or fourth aspect above, and optionally includes any of the features defined above. Indeed, it may include any of the features defined in the first through fourth aspects above, without necessarily including all of the features.

[0041] The step of expelling the fluid may include forming a pool of at least 60%, 70%, 80% of the volume of the channel, and particularly at least 90%, or at least 100%, or even at least 150%, 200%, or 300% of the volume of the channel. Thus, the method provides for creating a pool of fluid sufficient to lubricate the catheter without using 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 between the base of the pouch and the junction, opening the pouch, withdrawing the catheter by its distal end, whereby as the distal end is withdrawn, a proximal end of the catheter for insertion into the body is guided through the channel and becomes wetted by the pool of fluid, and then introducing the catheter by its proximal end into a urethra, which may be that of a human, particularly a male human, urethra.

[0043] The method may further include expelling urine through a funnel at the distal end of the catheter. The method may further include removing the catheter. The method may further include rolling or folding the catheter and reinserting it into the pouch for disposal. The method may further include sealing the used catheter in the pouch prior to disposal.

[0044] Again, the step of expelling the fluid may include forming a pool in the channel that is at least 60%, 70%, 80%, particularly at least 90%, or 100% of the volume of the channel, and even up to at least 150%, 200%, or 300% of the volume of the channel. Thus, this method provides for creating a pool of fluid sufficient to lubricate the catheter without using excess lubricant.

[0045] Of course, in the method of using a catheter, again, the packaged catheter assembly may be a packaged catheter assembly as defined in general terms, or one manufactured by the method of either the first or second aspects defined above, or the third or fourth aspects defined above, and optionally including any of the features defined above. Indeed, it may include any of the features defined in the four aspects above, without necessarily including all of the features.

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

[0047] According to an eighth aspect of the present invention, there is provided a packaged catheter assembly comprising a catheter, a fluid reservoir, and an opaque pouch containing the fluid reservoir and the catheter, the pouch being configured to include a transparent or translucent window (preferably corresponding to the location of the fluid reservoir in the pouch and / or a wetted area intended for flow from within the fluid reservoir).

[0048] According to a ninth broad aspect of the present invention, there is provided a method of forming a packaged catheter assembly, the method comprising providing a pouch, providing a fluid reservoir within the pouch, positioning the catheter within the pouch so as to be hidden from view, and configuring the pouch so that a user can view the fluid reservoir and / or view fluid being released from the reservoir.

[0049] According to a tenth aspect of the present invention, there is provided a method of forming a packaged catheter assembly, the method comprising: providing two opaque walls to define a pouch; providing a fluid reservoir within the pouch; placing 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 in the pouch and / or corresponding to a wetted area intended for flow from the fluid reservoir.

[0050] Thus, the present invention provides a packaged catheter assembly that is discreet because the contents of the assembly are hidden. The window provides a visual guide for the user to easily identify the fluid reservoir during catheter use and / or to easily identify successful fluid release from the reservoir into the wetted area of ​​the pouch for lubricating the catheter before use. While providing a transparent / translucent window is a preferred approach for allowing the user to see whether fluid has been successfully released from the reservoir, it is believed that other approaches are viable. For example, rather than providing a transparent / translucent window in the opaque wall of the pouch, it is believed that functionality can be achieved by providing a transparent / translucent pouch wall with an intervening opaque wall within the pouch that is located between the transparent / translucent pouch wall and the catheter (and optionally the reservoir). The intervening wall can include a window, or fluid released from the reservoir can flow between the outer transparent / translucent wall and the intervening wall, indicating successful release.

[0051] The following optional / preferred aspects apply equally to both the seventh and eighth aspects of the assembly having the fluid discharge visualization configuration set out above, and to both the ninth and tenth aspects of the method having the fluid discharge visualization configuration set out above. They apply equally to the invention as defined in general terms above, or to any other aspect of the invention described above, and similarly, any feature described in relation to the first to sixth aspects may apply equally to other aspects without themselves including the feature of those aspects (e.g., the catheter of the seventh to tenth aspects may of course be, for example, a male intermittent urinary catheter, as defined in relation to the first to sixth aspects). Thus, an embodiment of the present invention provides a packaged catheter assembly including a catheter, a fluid reservoir, and an opaque pouch containing the fluid reservoir and the catheter, the pouch including a transparent or translucent window, two walls, and a peripheral seal between the two walls, the catheter including a proximal end for insertion into the body and a distal end, the catheter being positioned within the pouch in a curved configuration with a junction between the two walls, the junction and the interior base of the peripheral seal defining a channel that is filled with fluid before the catheter is withdrawn from the pouch, and the pouch and catheter being positioned such that, upon withdrawal of the catheter from the pouch, the distal end of the catheter withdraws from the pouch before the proximal end, with the proximal end of the catheter passing through the channel.

[0052] The pouch may include two opaque walls. A window may be provided in one of the opaque walls. The window may be spaced from at least one edge of the pouch or the wall in which it is provided. The window may be spaced from all edges of the pouch. The window may be less than 25%, 20%, 15%, 10%, or 5% of the total area of ​​the pouch and / or the wall in which it is provided. The window may correspond to the size and / or shape of the fluid reservoir. The window may be smaller in size than the fluid reservoir. In one embodiment, the window has the same shape but is smaller in size than the fluid reservoir. Thus, in embodiments of the present invention, the window advantageously corresponds to the size, shape, and location of the fluid reservoir and is provided in only a portion of the pouch wall, spaced from the edge of the pouch.

[0053] The window can correspond to the location of the fluid reservoir. Accordingly, embodiments of the present invention provide a packaged catheter assembly including a catheter, a fluid reservoir, and an opaque pouch containing the fluid reservoir and the catheter, the pouch including a transparent or translucent window, the window corresponding to the location of the fluid reservoir. The window can correspond to the location of an indicator area on the pouch. The indicator area can correspond to a wetting area, which can extend from the bottom of the pouch to a level where sufficient fluid has flowed out of the pouch to wet the catheter. The indicator area can be configured to indicate successful release of fluid from the reservoir. Accordingly, embodiments of the present invention provide a packaged catheter assembly including a catheter, a fluid reservoir, and an opaque pouch containing the fluid reservoir and the catheter, the pouch including a transparent or translucent window, the window corresponding to the location of the indicator area on the pouch, the indicator area configured to indicate successful release of fluid from the reservoir. The indicator area can constitute a fill level marker indicating sufficient fluid is in the wetting area. Thus, the window also provides a visual guide to confirm that fluid released from the reservoir has been delivered to a particular area (e.g., a channel) of the pouch or has successfully lubricated the catheter.

[0054] The pouch may be substantially rectangular in shape, having two side edges, a base, and a top edge. The height of the pouch can be defined as the distance between the base and top edge. The width of the pouch may be defined as the distance between the side edges of the pouch. The window may 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 between 15-20% of the width of the pouch. Thus, the fluid reservoir is easily visible because the window is aligned with it, but at the same time, the area of ​​the window is minimized to ensure that the contents of the pouch remain generally obscured due to the fact that the pouch would be opaque without the window.

[0055] Those skilled in the art will understand that when a pouch is described as being opaque but including a transparent or translucent window, it may be mostly opaque except for the window, e.g., completely opaque except for the window, and that there may be more than one window, e.g., a window in each of two opposing walls that are primarily opaque or completely opaque, or indeed two windows in one or more separate opaque walls.

[0056] This is in contrast to known catheter packages formed of two opposing walls, i.e., an opaque paper wall and a clear plastic film wall (only), which are not considered opaque despite the presence of a window because the clear film wall constitutes the entire second wall of the package, and which are not considered opaque despite the presence of a window because the clear film wall constitutes the entire second wall of the package.

[0057] The catheter within the pouch is preferably concealed. Thus, one embodiment of the present invention provides a packaged catheter assembly including a catheter, a fluid reservoir, and an opaque pouch containing the fluid reservoir and the catheter, the pouch having a transparent or translucent window, and the catheter being concealed within the pouch. The catheter may be concealed by the opaque walls of the pouch. The catheter may be concealed by the fluid reservoir. Since the catheter will likely appear to an observer as some kind of medical device even if they are unaware of its exact nature, it may be concealed by being positioned out of sight of the window or by being hidden behind another object, such as a liquid reservoir (optionally a dedicated sheet material, etc.).

[0058] Of note, the fluid reservoir (or other concealing object) may be opaque and may have a color that corresponds to or contrasts with the color of the pouch wall. Accordingly, embodiments of the present invention provide a packaged catheter assembly that includes a catheter, a fluid reservoir, and an opaque pouch that houses the fluid reservoir and catheter, the pouch including a transparent or translucent window to indicate that the fluid reservoir is opaque. For example, the reservoir (or other concealing object) may be the same color, a different shade than the pouch, or, if the opaque pouch has multiple colors, a shade of one of those colors. Gray or silver is considered particularly preferable for the reservoir (or other concealing object) from the standpoint of understatement.

[0059] The window may be patterned; that is, at least a portion of the window may have a pattern thereon, e.g., a pattern formed by opaque areas such as spots, stripes, etc. The pattern may provide a graduated appearance to the window. The pattern may provide a graduated appearance to one or more edges of the window. The pattern may allow the window to blend into the surrounding packaging of the pouch. Thus, the window is less noticeable to the untrained eye, and the packaged catheter assembly may therefore be more discreet for the user to carry.

[0060] A retention seal may be provided between the two walls to restrict movement of the fluid reservoir (which may, of course, be a pouch as defined above) within the pouch. Accordingly, an embodiment of the present invention provides a packaged catheter assembly including a catheter, a fluid reservoir, and an opaque pouch containing the fluid reservoir and the catheter, the pouch including a transparent or translucent window and a retention seal configured to restrict movement of the fluid reservoir within the pouch. The method may include forming a retention seal between the two walls to restrict movement of the fluid reservoir within the pouch. The retention seal may be provided outside the curvature of the catheter. The retention seal may be located closer to the top edge of the pouch's peripheral seal than the base of the pouch. The retention seal may extend from the top edge of the pouch's peripheral seal.

[0061] According to an eleventh aspect of the present invention, there is provided a method for wetting a catheter of a packaged catheter assembly, the method comprising the steps of releasing fluid from a reservoir in a pouch, inspecting the interior of the pouch (e.g., through a (transparent or translucent) window in an opaque wall of the pouch) to identify the reservoir releasing the fluid and / or to confirm that the reservoir has released the fluid into the pouch, and optionally opening the pouch after confirming release of the fluid and optionally withdrawing the catheter by the distal end of the catheter to remove the catheter from the pouch.

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

[0063] According to a twelfth aspect of the present invention, there is provided a method for wetting a catheter of a packaged catheter assembly, the method comprising the steps of: releasing fluid from a reservoir in a pouch; inspecting the interior of the pouch (e.g., through a (transparent or semi-transparent) window in an opaque wall of the pouch) to identify the reservoir releasing fluid and / or to confirm that the reservoir has released fluid into the pouch; removing the catheter from the pouch (optionally opening the pouch after confirming release of fluid, optionally withdrawing the catheter by its distal end, and optionally confirming sufficient wetting of the catheter through the window); and introducing the catheter from the proximal end into the urethra, which may be that of a human, particularly a male human.

[0064] The method may further include expelling urine through a funnel at the distal end of the catheter. The method may further include removing the catheter. The method may further include rolling or folding the catheter and reinserting it into the pouch for disposal. The method may further include sealing the used catheter in the pouch prior to disposal.

[0065] Again, in the method of using a catheter, the packaged catheter assembly may of course be a packaged catheter assembly defined in general terms, or one according to either the seventh or eighth aspects above, or one manufactured by the method of the ninth or tenth aspects above, optionally including any of the features set out above. Indeed, it may include any of the features set out in any one of the seventh to tenth aspects, without necessarily including all of the features set out in any one of the seventh to tenth aspects.

[0066] As noted above, in general terms, the present invention may include both (a) a channel through which fluid can be introduced and through which the catheter is retracted as it is withdrawn from the pouch, and (b) means for viewing the fluid reservoir and / or means for ensuring the catheter within the packaged assembly is visible but concealed when fluid is released from the reservoir. Indeed, this is preferred. As such, the following preferred features apply to pouches having both features (a) and (b), and particularly to devices including features of any of (i) both the first and seventh embodiments, (ii) both the first and eighth embodiments, (iii) both the second and seventh embodiments, and (iv) both the second and eighth embodiments, and particularly to methods including features of any of (v) both the third and ninth embodiments, (vi) both the third and tenth embodiments, (vii) both the fourth and ninth embodiments, and (viii) both the fourth and tenth embodiments. Furthermore, the following features apply in particular to a method of wetting a catheter that includes features of both the fifth and eleventh aspects, and to a method of using a catheter that includes features of both the sixth and twelfth aspects.

[0067] A portion of the window may correspond to a location below the junction of the pouch, so that if the channel defined by the junction is used for catheter lubrication, the fluid level within the channel can be visually confirmed using the window.

[0068] The interface can function as a retention seal to limit movement of the fluid reservoir. In such embodiments, the fluid reservoir can be located between the interface and a side edge of the perimeter seal. In some embodiments, the fluid reservoir can be located adjacent to a first side edge of the perimeter seal, and the interface can be located closer to the first side edge than the other (second) side edge of the perimeter seal. In this way, the retention seal ensures that the fluid reservoir does not move within the pouch and remains visible through the window (and in preferred embodiments, always hiding the catheter). [Brief explanation of the drawings]

[0069] In order that the present invention may be more clearly understood, one or more embodiments thereof will now be described, by way of example only, with reference to the accompanying drawings.

[0070] [Figure 1] FIG. 1 is an exploded view of a first embodiment of a packaged catheter assembly. [Figure 2] FIG. 2 is a front view of the sealed assembly of FIG. 1 prior to use. [Figure 3] FIG. 3 is a front view of the packaged catheter assembly of FIGS. 1 and 2 with fluid released into the pouch. [Figure 4] FIG. 4 is a front view of the packaged catheter assembly of FIGS. 1-3 with the package opened. [Figure 5] FIG. 5 is a front view of the packaged catheter assembly of FIGS. 1-4 with the catheter partially withdrawn from the pouch. [Figure 6] FIG. 6 is a front view of the packaged catheter assembly of FIGS. 1-5 with the catheter substantially fully withdrawn from the pouch. [Figure 7] FIG. 7 is a front view of the packaged catheter assembly of FIGS. 1-6 after use. [Figure 8] FIG. 8 is a front view of a second embodiment of a packaged catheter assembly. [Figure 9] FIG. 9 is a cutaway front view of a third embodiment of a packaged catheter assembly.

[0071] In the figures, dashed lines conventionally indicate hidden features. DETAILED DESCRIPTION OF THE INVENTION

[0072] 1-7, a first embodiment of a packaged catheter assembly 100 is shown.

[0073] Assembly 100 includes fluid reservoir 10, male intermittent single-use urinary catheter 20, and pouch 30. Pouch 30 includes front opaque wall 31a, rear opaque wall 31b, and a perimeter seal that joins walls 31a, 31b together around the perimeter to form the pouch. Perimeter seal comprises base 32, right edge 33, left edge 34, and top edge 35. Left edge 34 and right edge 33 are defined as the left and right sides of pouch 30 when viewed with rear wall 31b behind front wall 31a, with base 32 at the bottom of pouch 30 and top edge 35 at the top of pouch 30. The peripheral seal therefore defines a pouch 30 that is generally rectangular, suitably having a width between side edges of between 60-110 mm, for example about 100 mm, e.g., 95 mm, and a height from base 32 to top edge 35 of between 100-250 mm, for example about 200 mm, e.g., 197 mm. The base 32 defines the bottom of the pouch in use, and the top edge 35 defines the top. However, in other embodiments, alternative shapes and sizes may be envisaged, such as oval or circular pouches.

[0074] The pouch also includes a joint 36 between the two walls 31 a, 31 b. The joint 36 is a circular weld located equidistant between the side edges 33, 34 of the perimeter seal, at a distance ranging from 45 to 55 mm above the base 32. The joint 36 can have a radius between 1% and 10% of the height of the pouch, for example, 5%. In other embodiments, the joint can be a different shape and size, located in a different position, or potentially integrated with the perimeter seal as a continuous seal.

[0075] The pouch also includes a window 37 in one of its walls, allowing the user to view the interior of the pouch. In this particular embodiment, the window 37 is transparent, elongated, and generally rectangular, with a length between 20% and 50%, e.g., 33%, of the height of the pouch 30 and a width between 5% and 25%, e.g., 12.5%, of the width of the pouch 30. In this example, the window 37 has semicircular edges, but in other embodiments, they may have any suitable shape, such as flat edges or irregularly shaped edges. The window 37 is positioned parallel to the right edge 33, with a gap between the edge of the window 37 and the right edge 33 that is between 5% and 20%, e.g., 10%, of the width of the pouch. The bottom of the window 37 is spaced from the bottom of the perimeter seal 32 by a distance that is between 5% and 20%, e.g., 10%, of the height of the pouch. In other embodiments, a translucent window may be used, and further, alternative shapes, sizes, and positions or angles of the window are contemplated (eg, up to a 20 degree angle relative to the edge).

[0076] In this particular embodiment, each wall 31a, 31b is made of multiple layers of foil, in one particular embodiment a 97 micron two-ply foil of 12 micron PET and 60 micron LLDPE. In other embodiments, walls 31a, 31b may comprise only a single layer, and different plastic materials may be used interchangeably.

[0077] As noted above, 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. Window 37 in front wall 31a may be formed by laminating an opaque layer of material onto a transparent wall, with the opaque layer having an opening corresponding to window 37. Alternatively, the transparent wall can be printed to block light from passing through, making it opaque everywhere except where window 37 is located. Further alternatives are contemplated and achieved, such as creating an opening in the opaque wall corresponding to window 37 and then adhering a transparent layer over the opening to achieve a continuous front wall 31a with window 37, or starting with a multilayer foil having opaque and transparent layers and then removing portions of the opaque layer of the foil to form the transparent window.

[0078] In this particular embodiment, the pouch also includes an interaction area. The interaction area forms the top of the pouch 30 and spans between the right edge 33 and the left edge 34. The interaction area is used to access the pouch by passing near the top edge 35. In this embodiment, the interaction area includes a tapered tear area 38 and a seal arrangement 39. The tear area 38 includes a tear start 40 at the left edge approximately 2 cm below where the top edge 35 and the left edge 34 meet, and a tear stop 41 at a point within the pouch 30 approximately 1 cm below where the top edge 35 and the right edge 33 meet. The distance between the tear stop 41 and the right edge 33 is between 1 and 10% of the width of the pouch, for example, 5%. Tear start 40 includes a notch in walls 31 a, 31 b to provide a weakened area, allowing tear zone 38 to be separated from pouch 30 by tearing the walls from tear start 40 to tear stop 41. Thus, a tear is created below the level of top edge 35, allowing pouch 30 to be opened to access its contents. Tear stop 41 provides a small opening in walls 31 a, 31 b to prevent further tearing of pouch 30 and separation of tear zone 38 from pouch 30. To provide a tapered shape, tear zone 38 extends upwardly approximately 50% more on the left side than on the right side. A circular opening 42 is formed on the left side of tear zone 38, large enough to allow a finger to pass through and grasp tear zone 38. To ensure that the pouch is completely sealed, the front wall 31 a and rear wall 31 b are sealed to one another around the periphery of the tear stop 41 and circular opening 42. In other embodiments, other seals, such as a Ziplock® arrangement, can be used to provide access to the pouch, and of course the sizes and shapes defined above are exemplary.

[0079] In this embodiment, the sealing arrangement 39 extends between the left and right edges 34, 33 of the perimeter seal just below the tear area 38. The sealing arrangement 39 includes first and second sealing members (not shown) disposed on the interior surfaces of the walls 31 a, 31 b of the pouch 30. In this embodiment, the sealing members include corresponding sealing grooves and ridges so that the sealing members can be press-fit to form a watertight seal and then pulled apart again as needed. In other embodiments, a single adhesive sealing member may be used, or the sealing members may be disposed on the exterior of the pouch so that the pouch can be folded or rolled to seal in place, and of course alternative sealing mechanisms such as hook-and-loop, hook-and-hook seals, Ziploc®, etc. may also be used.

[0080] In this embodiment, fluid reservoir 10 is an elongated, rectangular, rupturable pouch of water, although any suitable reservoir can be used in other embodiments. Fluid reservoir 10 has a height equal to between 60-90%, e.g., 80%, of the height of pouch 30 and a width equal to between 5-25%, e.g., 15%, of the width of pouch 30. In this embodiment, the fluid contained within reservoir 10 is water. In other embodiments, reservoirs of different shapes and sizes, or many other types of reservoirs, including non-rupturable reservoirs and other external fluid sources, would be suitable. Additionally, other fluids, such as lubricants, gels, oils, etc., could be used.

[0081] In this embodiment, catheter 20 includes a proximal end 21 for insertion into the body, a distal end 22, and a flexible tube 23 connecting ends 21 and 22. Distal end 22 includes a funnel 24 for directing urine from the bladder out of tube 23 during use. A handling sleeve 25 is also provided around tube 23 adjacent distal end 22. In this embodiment, the catheter has a length of 30-50 cm, e.g., 40 cm, and the handling sleeve is 10-30%, e.g., 20-25%, e.g., 11 cm, of the catheter length. In this embodiment, catheter 20 includes a hydrophilic coating that activates upon contact with fluid held in reservoir 10. In other embodiments, any suitable catheter length or type can be used.

[0082] Catheter 20 is positioned within pouch 30 in a curved, coiled state, with distal end 21 adjacent inner left edge 33 of pouch 30 near top edge 35, just below seal arrangement 39. Catheter 20 extends in a broadly oval, counterclockwise coil (looking at left edge 34 to the left and top edge 35 upward) inside pouch 30. This coil wraps around the inside of left edge 34, base 23, and right edge 33 of the pouch, with proximal end 21 of catheter 20 resting inside the catheter coil, adjacent left edge 34 and base 32 of the pouch. Notably, while the majority of the handling sleeve 25 is positioned above the junction 36, as the catheter extends in a curve from left to right, the catheter tubing 23 runs below the junction, through a channel defined by the junction and the interior base of the perimeter seal, then upward to the side of the junction, then back over the junction, and finally downward so that the proximal end 21 is below and to the left of the junction 36. In essence, the catheter 20 is coiled (or curled) around the junction 36 (although not tightly wound). In other embodiments, the position of the catheter 20 may be different; in particular, the catheter 20 may simply be curved within the pouch 30 rather than coiled or curled. On the other hand, embodiments of the present invention may have a catheter 20 with a multi-turn coil.

[0083] 2, pouch 30 is formed by first providing two walls 31 a, 31 b that will define pouch 30 itself, and front wall 31 a that includes transparent window 37 as described above and is manufactured by one of the techniques described above. In this embodiment, walls 31 a, 31 b are sized to correspond to the final shape of pouch 30, although in other embodiments the walls may extend outside pouch 30 if desired.

[0084] In this embodiment, the base 32, right edge 33, and left edge 34 are first formed by welding the two walls 31a, 31b together, leaving the pouch 30 open at the top edge 35. The catheter 20 is then placed within the pouch 30 in a curved, coiled state, as set forth above.

[0085] In this embodiment, fluid reservoir 10 is also positioned within pouch 30 at a location corresponding to window 37. Thus, reservoir 10 is positioned above catheter 20 so that it is visible through window 37, and catheter 20 is hidden within pouch 30 because reservoir 10 obstructs any view of catheter 20 through window 37. In other embodiments, reservoir 10 may not need to be positioned above catheter 20, as the location of catheter 20 within pouch 30 may not correspond to window 37.

[0086] In this embodiment, first and second sealing elements (not shown) are then attached to the inside of walls 31 a, 31 b immediately above coiled catheter 20, and walls 31 a, 31 b are welded along upper edge 35 to form the upper edge 35, thereby sealing catheter 20 and reservoir 10 within the pouch. In other embodiments, sealing elements can be provided on the walls prior to further assembly of pouch 30 or sealing of the peripheral seal.

[0087] In this embodiment, walls 31 a, 31 b are then welded together to form joint 36. Because catheter 20 is coiled around the inner circumference of pouch 30, joint 36 is located within the coil of catheter 20. Thus, a portion of catheter tubing 23 passes between joint 36 and base 32 of the pouch. In other embodiments, joint 36 can be provided before the perimeter seal or at any point during the assembly process.

[0088] Finally, in this embodiment, the tear start 40, tear stop 41, and opening 42 can be formed by cutting out appropriate portions of the pouch 30. The use of a hot punch can simultaneously bond the peripheral walls 31 a, 31 b of the cut-out area to ensure that the pouch 30 remains completely sealed.

[0089] It will be understood that the above is an example, and that in other embodiments, pouch 30 may be formed in a different manner, with steps performed in a different order. For example, the bottom may be open, and the catheter and water reservoir introduced through the bottom before the base seal is provided. Alternatively, for example, in an industrially applied process, two webs of wall material may have half of a seal arrangement applied to each (on their inner surfaces), and catheter 20 and reservoir 10 may be placed between the opposing inner surfaces of the webs of wall material. Then, potentially in a single operation, a hot die may join and form walls 31 a, 31 b by forming perimeter seals 32, 33, 34, and 35, simultaneously forming tear start 40, forming bond 36, and punching and sealing opening 42 and tear stop 41 in tear region 38. Furthermore, while perimeter seal and bond 36 have been described as being formed by welding, any suitable means of joining the walls may be used, such as an adhesive.

[0090] Referring to FIGS. 2 to 7, the packaged catheter assembly 100 of this first embodiment can be opened as described below.

[0091] First, the fluid reservoir 10 is placed within the pouch 30 with the aid of a window 37 through which the reservoir 10 can be viewed. Next, the fluid is released from the reservoir 10 into the pouch 30. In this embodiment, the reservoir 10 is a rupturable pouch from which fluid can be released by manually applying pressure to the reservoir 10. The window 37 provides a visual indication of when the reservoir 10 has successfully ruptured and released fluid into the pouch 30. In particular, it can be seen that enough fluid has been released to fill the channel defined by the weld 36 and the interior base 32 of the perimeter seal. In other embodiments, the fluid may be released by other means.

[0092] 3-7, fluid released from reservoir 10 pools at the bottom of pouch 30, as indicated by the hatching. In this embodiment, fluid fills pouch 30 to a fill level corresponding to junction 36. Thus, in this embodiment, junction 36 and base 32 define a channel that is completely filled with fluid. However, in other embodiments, fluid may only partially fill the channel, for example, filling the channel between 60-95%, preferably at least 90%, or filling the pouch to a level above junction 36.

[0093] The bottom of window 37 corresponds to a position on pouch 30 slightly lower than seam 36, so that dispensed fluid is also visible through window 37. In other embodiments, the window may comprise an indicator area that indicates the presence of fluid in the pouch, such as a fluid-sensitive color-changing strip, so that direct visualization of the fluid is not required. A fill level marker could also be provided to indicate when sufficient fluid has been dispensed.

[0094] In this embodiment, the contents of pouch 30 are then accessed by tearing the top of pouch 30 using tear region 38. Opening 42 is grasped with one hand, the remainder of pouch 30 is grasped with the other, and tear region 38 is torn from tear start 40 to tear stop 41. In this manner, the pouch is torn between left edge 34 and right edge 33 below top edge 35, thus forming an opening in pouch 30 that can be used to access its contents. Advantageously, tear region 38 is not completely separated from pouch 30, thereby reducing the number of separate parts and making pouch 30 easier to handle. Other embodiments may feature other methods of accessing the pouch, such as a Ziploc® seal.

[0095] 4-6, the catheter 20 can then be withdrawn from the pouch 30. As described above, in this embodiment, the catheter 20 is coiled within the pouch 30, with the distal end 21 located adjacent to the upper edge 35 of the pouch 30. As such, the distal end 21 is above the fill line of the fluid released into the pouch 30 and is not wetted by the fluid. Thus, the distal end 21 provides a dry, easily accessible point that can be used to withdraw the catheter 20 from the pouch 30. In this embodiment, a majority of the handling sleeve 25, i.e., at least 50%, preferably between 60 and 100%, e.g., as much as 70%, is above the fill line and is not wetted. Thus, the sleeve 25 also provides a convenient, dry surface for handling the catheter 20.

[0096] In this embodiment, the distal end 21 is withdrawn upward through an opening in the upper edge 35 of the pouch 30. As the distal end 21 is withdrawn from the pouch 30, the catheter tube 23 uncoils and is withdrawn upward toward the upper edge 35 of the pouch 30. However, because the junction 36 is disposed within the coil of the catheter 20, the tube 23 is prevented from moving directly upward by the junction 36. Thus, the junction 36 causes the tube 23 to be withdrawn from the pouch 30 along a path that includes passing through a channel defined by the junction 36 and the base 32. In this manner, the entire remainder of the tube 23, up to the proximal tip 21, passes through a pool of fluid within the channel, and the hydrophilic coating of the catheter 20 is activated by the fluid. Furthermore, the proximal end 21 of the catheter 20 is the final portion of the catheter 20 to pass through the channel and be withdrawn from the pouch 30. In this manner, catheter 20 is fluid-activated as it is withdrawn, making withdrawal convenient and easy because only a dry portion of catheter 20 needs to be touched during withdrawal. As catheter 20 passes through a pool of fluid, it will be more thoroughly wetted than would be the case with fluid held in another medium, such as a sponge. In other embodiments, catheter 20 need not be withdrawn directly upward, but can be withdrawn sideways from the pouch, for example, through an opening in the side of the pouch, but of course, above the weld to reduce the possibility of spillage. Furthermore, catheter 20 may not directly contact junction 36, but instead may be prevented from moving upward by the convergence of walls 31 a, 31 b as it approaches junction 36.

[0097] Once the catheter is fully withdrawn, it can be used by inserting the proximal end 21 into the urethra until urine begins to flow through the catheter 20. A (nearly dry) handling sleeve 25 aids insertion. Urine can then be directed out of the catheter 20 by the funnel 24.

[0098] Referring to FIG. 7 , in this embodiment, the catheter 20 can be placed back into the pouch 30 in a coiled configuration after use. The handling sleeve 25 and funnel 24 provide a dry surface that can be used to recoil the catheter 20 and place it into the pouch 30. The sealing arrangement 39 can then be used to reseal the pouch 30 between the left edge 34 and the right edge 33 by pressing two corresponding sealing elements (not shown) together. This provides for more convenient disposal of the catheter 20 after use and ensures that fluids released into the pouch 30 do not subsequently leak out of the pouch 30. In other embodiments, alternative sealing arrangements can be used, such as an external flap with adhesive that allows the top of the pouch 30 to be rolled or folded to seal. Alternatively, the sealing arrangement can be omitted if the pouch 30 is intended to be disposed of immediately after use.

[0099] 8, there is shown a second embodiment of a packaged catheter assembly 200. The second embodiment shares many of the features of the first embodiment described above, and therefore only the differences in features will be described below, with like numerals used to denote like features.

[0100] In this embodiment, the joint 236 is offset from the midpoint between the right edge 233 and the left edge 234. Specifically, the joint is positioned 20-45%, e.g., 35%, of the width of the pouch 230 from the right edge 234. The joint 236 serves a second function as a retention seal that restricts movement of the reservoir 210 within the pouch 230, sandwiching the reservoir 210 between the joint 236 and the right edge 234. The joint 236 thus ensures that the window 237 corresponds to the position of the reservoir 210 regardless of the movement of the pouch 230 when carried by a user, ensuring both that the catheter 223 remains hidden and that the reservoir 210 can be easily identified and its fluid released. In other embodiments, the retention seal function may be provided by a separate seal between the walls 231a, 231b. For example, a separate seal extending downward from the seal arrangement 239 or a separate seal extending upward from the base 232 .

[0101] In this embodiment, front wall 231a also includes pattern 243 corresponding to the edge of window 237. While pattern 243 is shown only on a portion of the window, it could, of course, extend throughout, creating a graduated appearance that softens the boundary between transparent window 237 and the remainder of opaque front wall 231a. In this embodiment, the pattern is a series of evenly spaced opaque lines of graduated thickness that become thinner toward the center of window 237. In this manner, pattern 243 visually obscures window 237 and, therefore, makes pouch 230 less noticeable. In other embodiments, pattern 243 can be any suitable pattern, such as graduated-sized opaque circles, and can be complemented or integrated with a surface pattern or color applied to reservoir 210.

[0102] Referring to Figure 9, a third embodiment of a packaged catheter assembly 300 is shown. Because the third embodiment shares many of the features of the first embodiment described above, only the differences in features will be described below, with like numerals used to indicate like features. Figure 9 shows a cutaway front view of the assembly 300, so the front wall 331a and window 337 are not shown. Diagonal hatching indicates where the front wall 331a is bonded to the rear wall 331b, for example, at the left edge 334, base 322, right edge 333, top edge 335, tear zone 338, and seam 336.

[0103] In this embodiment, tear region 338 includes a tear line 343 spanning between tear start 340 and tear stop 341. Tear line 344 is a line of weakness that preferentially tears to allow tearing of region 338. This facilitates consistent removal of tear region 338. In this embodiment, tear line 344 is formed by weakening pouch 330 by laser scoring, although other techniques, such as thinning the material of pouch 330 along tear line 344, can be used in other embodiments.

[0104] In this embodiment, the sealing arrangement 339 comprises a Ziplock® seal to allow a user to close and reseal the pouch 330. The location where the sealing arrangement 339 can be used to seal the front wall 331 a and the rear wall 331 b together is indicated in Figure 9 by the vertical hashing, which corresponds to the strip immediately below the tear line 344 of the pouch 330.

[0105] In this embodiment, the catheter 320 is positioned within the pouch 330 similarly to the first embodiment in that it is coiled. However, in this embodiment, the distal end 322 and funnel 324 of the catheter 320 are centrally positioned relative to the opening formed by the tear region 338. The distal end 322 and funnel 324 are approximately equidistant from the left and right edges 334, 333, rather than being proximate either side edge 333. In this manner, when the pouch 330 is opened, the distal end 322, including the funnel 324 and handling sleeve 325, is more easily accessible because it is central and located at the point across the width of the pouch 330 where it opens most widely. Furthermore, when the catheter 320 is coiled, the handling sleeve 325 extends from the distal end 322 to a position adjacent the left edge 334. Thus, together with the fluid reservoir 310 located adjacent the right edge 33, the distal end 322, handling sleeve 325, and fluid reservoir 310 protect the remainder of the catheter 320 from inadvertent direct contact with the user as the catheter 320 is withdrawn from the pouch 330. This reduces the risk of infection when using the catheter 320, as the catheter 320 is less likely to become contaminated prior to use.

[0106] In this embodiment, the sleeve 325 is configured so that it does not extend below the level of the junction 336 within the pouch 330, and in particular, the sleeve 325 is further from the junction 336 than the base 332 of the pouch 330. This reduces the likelihood that the sleeve 325 will become wet during the release of fluid from the fluid reservoir 310 into the channel, making the sleeve 325 easier for the user to handle.

[0107] Conditional language, such as "can," "could," "might," or "could," unless otherwise specified or understood within the context in which it is used, is generally intended to convey that certain embodiments include certain features, elements, and / or steps and that other embodiments do not. Thus, such conditional language is generally not intended to imply that the features, elements, and / or steps are somehow required for one or more embodiments, or that one or more embodiments necessarily include logic for determining whether these features, elements, and / or steps are included in or performed in any particular embodiment, with or without user input or prompting.

[0108] One or more embodiments are described above by way of example only, and many variations are possible without departing from the scope of protection afforded by the appended claims.

Claims

1. A packaged catheter assembly comprising an opaque pouch and a catheter, The opaque pouch a transparent or translucent window, at least a portion of which includes a pattern to provide a graduated appearance to the window; The opaque pouch also two walls and a perimeter seal between the two walls; An assembly comprising a catheter including a proximal end for insertion into the body and a distal end, the catheter disposed in a curved configuration within the opaque pouch with a joint between two walls, the joint and an interior base of the peripheral seal defining a channel that is filled with fluid before the catheter is withdrawn from the opaque pouch, the opaque pouch and the catheter arranged such that, upon withdrawal of the catheter from the opaque pouch, the distal end of the catheter withdraws from the opaque pouch before the proximal end, and the proximal end of the catheter passes through the channel.

2. The catheter is a male urethral catheter, The assembly of claim 1 .

3. The catheter is an intermittent catheter, 3. An assembly according to claim 1 or 2.

4. The catheter is positioned between the joint and the inner base of the perimeter seal. Assembly according to any one of claims 1 to 3.

5. a fluid reservoir configured to release fluid into the opaque pouch to form a pool of fluid in the channel; Assembly according to any one of claims 1 to 4.

6. the catheter including a surface configured to be activated by a fluid held within the fluid reservoir; 6. The assembly of claim 5.

7. the pool of fluid corresponds to a channel fill level of at least 90% of the channel volume; 7. An assembly according to claim 5 or 6.

8. the distal end of the catheter is positioned closer to the top edge of the perimeter seal than to the base of the perimeter seal; 8. An assembly according to any one of claims 1 to 7.

9. the distal end of the catheter comprises a handling sleeve; the handling sleeve is at least partially positioned closer to the top edge of the perimeter seal than to the base of the perimeter seal; Assembly according to any one of claims 1 to 8.

10. The opaque pouch includes an interaction area configured to form an opening at or near an upper edge of the perimeter seal. Assembly according to any one of claims 1 to 9.

11. The distal end of the catheter is centrally positioned relative to the opening.

11. The assembly of claim 10.

12. an opening is formed from a first side edge of the perimeter seal, and the distal end of the catheter is positioned closer to the first side edge of the perimeter seal than to the second side edge of the perimeter seal; 11. The assembly of claim 10.

13. The joint and perimeter seal are independent, Assembly according to any one of claims 1 to 12.

14. the channel is an open-ended channel; Assembly according to any one of claims 1 to 13.

15. the perimeter seal is substantially rectangular and has two side edges between a base and a top edge of the perimeter seal; Assembly according to any one of claims 1 to 14.

16. The joint is provided at a point equidistant from the two side edges; 16. The assembly of claim 15.

17. The joint is located at a distance from the base that is 20-30% of the height of the opaque pouch, the height of the opaque pouch being defined as the distance from the base of the perimeter seal to the top edge of the perimeter seal; Assembly according to any one of claims 1 to 16.

18. the joint has a radius that is less than a length corresponding to 15% of the height of the opaque pouch; The height of the opaque pouch is defined as the distance from the base of the perimeter seal to the top edge of the perimeter seal; Assembly according to any one of claims 1 to 17.

19. The catheter is placed within the opaque pouch in a coiled configuration; Assembly according to any one of claims 1 to 18.

20. Upon withdrawal, the catheter is positioned so that at least 50% of its length passes through the channel. Assembly according to any one of claims 1 to 19.

21. the assembly includes a fluid reservoir, and the opaque pouch includes the fluid reservoir; Assembly according to any one of claims 1 to 20.

22. 1. A method of forming a packaged catheter assembly, comprising: The method is: providing two walls to define an opaque pouch; placing the catheter in a curved configuration within an opaque pouch; forming a peripheral seal between the walls to seal the catheter within the opaque pouch; forming a joint between the walls; The opaque pouch includes a transparent or translucent window, at least a portion of which includes a pattern that provides the window with a graduated appearance; the joint and the interior base of the peripheral seal define a channel that is filled with fluid prior to withdrawing the catheter from the opaque pouch; The catheter includes a proximal end for insertion into the body and a distal end; The opaque pouch and catheter are positioned such that, during withdrawal of the catheter from the opaque pouch, the distal end of the catheter is withdrawn from the opaque pouch before the proximal end, causing the proximal end of the catheter to pass through the channel.

23. Two walls are opaque, The method is: providing a fluid reservoir within an opaque pouch; providing a transparent or translucent window in at least one wall of the opaque pouch; forming a peripheral seal includes sealing the fluid reservoir within an opaque pouch; 23. The method of claim 22.

24. The packaged catheter assembly is a packaged catheter assembly according to any one of claims 1 to 21.

24. The method of claim 22 or 23.

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