JP2023551959A - packaged catheter assembly - Google Patents

Abstract

Packaged catheter assembly including pouch and catheter. The pouch includes two walls and a peripheral seal between the two walls, and the catheter includes a proximal end of the catheter for insertion into the body, and a distal end. The catheter is placed within the pouch in a curved configuration, and a junction is provided between the two walls, the interior base of the junction and the peripheral seal defining a channel that is filled with fluid prior to withdrawing the catheter from the pouch. , the pouch and the catheter are arranged such that the distal end of the catheter is withdrawn from the pouch before the proximal end so that the proximal end of the catheter passes through the channel while the catheter is withdrawn from the pouch. The assembly may include a fluid reservoir that releases fluid into the pouch to form a pool of fluid within the channel.

Description

The present invention relates to packaged catheter assemblies. More particularly, the present invention relates to packaged urinary catheter assemblies, and in particular to packaged intermittent male urinary catheter assemblies.

Many people suffer from urinary problems, making it difficult to urinate. Intermittent catheters are a convenient and portable solution to these problems. This reduces the impact of urinary diseases on your life and allows you to enjoy a relatively normal lifestyle.

Intermittent catheters are typically single-use devices that are carried by the user and unpacked and used as needed. It is important to apply lubricant before use to reduce the risk of damage to the urethra and improve comfort during catheter use. However, lubricating catheters in public places, such as public restrooms, can be difficult and inconvenient. As a result, the catheter is not properly lubricated before use, increasing the risk of discomfort and injury.

Intermittent catheters for men are generally several centimeters longer than catheters for women, typically 20 cm or more, with ISO 20696:2018 specifying a minimum effective length of 275 mm. Therefore, it may be difficult to carry it inconspicuously. Also, the additional length can make it more difficult to adequately lubricate and use.

It is an objective of embodiments of the invention to at least partially overcome or alleviate the above-mentioned problems.

Broadly stated, the present invention provides (a) a channel through which fluid can be introduced and into which the catheter is drawn when withdrawn from the packaged assembly; and/or ensuring that the fluid reservoir is visible but concealed within the packaged assembly.

According to a first broad aspect of the present invention, a packaged catheter assembly is provided that includes a pouch and a catheter, the catheter being disposed within the pouch in a curved configuration and having a joint between the walls of the pouch. is provided and defines a channel through which fluid can be introduced prior to withdrawal of the catheter from the pouch (with the distal end of the catheter being withdrawn from the pouch before the proximal end, during withdrawal of the pouch, i.e., The catheter is passed through the channel (by withdrawing it by the distal end).

According to a second aspect of the invention, a packaged catheter assembly is provided that includes a pouch and a catheter, where the pouch includes two walls and a peripheral seal between the two walls, and the catheter is The catheter is disposed within the pouch in a curved configuration, and a junction is provided between the two walls, with an interior of the junction and a surrounding seal. The base defines a channel that is filled with fluid before the catheter is withdrawn from the pouch, and the pouch and catheter are arranged such that the distal end of the catheter is withdrawn from the pouch before the proximal end when the catheter is withdrawn from the pouch. The proximal end of the catheter is positioned to pass through the channel.

According to a third aspect of the invention, a method of forming a packaged catheter assembly is provided, the method comprising: providing a pouch; placing a catheter in the pouch in a curved configuration; sealing the catheter into the pouch and forming a joint 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 to define a channel through which fluid can be introduced during withdrawal of the pouch (the distal end The proximal end of the catheter passes through the channel while being withdrawn into the pouch before the proximal end (eg, the distal end is withdrawn).

According to a fourth aspect of the invention, a method of forming a packaged catheter assembly is provided, the method comprising: providing two walls defining a pouch; and placing the catheter in a curved configuration within the pouch. forming a circumferential seal between the walls to seal the catheter within the pouch; and forming a junction between the walls, the junction of the circumferential seal and the interior base forming a circumferential seal within the pouch. The catheter has a proximal end for insertion into the body, and a distal end, defining a channel that is filled with fluid before being withdrawn from the pouch. The pouch and catheter are positioned such that the end is withdrawn from the pouch before the proximal end and the proximal end of the catheter passes through the channel.

Advantageously, the present invention provides a packaged catheter that can be easily removed from the package while being lubricated in preparation for use. This junction provides the advantage that when the catheter is removed, fluid is drawn through the channel in which it is supplied. The fluid is typically an activating liquid, such as water, which activates the hydrophilic coating to make it slippery, and may also be a lubricant. In any case, pulling the catheter through the channel (preferably provided with a channel) ensures that the catheter is properly lubricated. Fluid channels increase fluid coating on the surface of the catheter, as the fluid is held in a pool where the catheter is forced to move, rather than potentially being pulled out of the package without fully wetting the catheter. do. Additionally, the distal end from which the catheter can be withdrawn can facilitate handling by avoiding passing through pools of fluid.

Furthermore, the deliberate formation of a pool at the bottom means that the fluid is always retained within the package, allowing the device to be used more conveniently, for example by opening the reservoir of fluid into the pouch and removing it from the pouch. It is possible to reduce the possibility of spills that can occur when attempting to dispense fluid by shaking. Furthermore, since the catheter is curved within the pouch, the size of the pouch can be reduced. The use of joints that form channels also facilitates the use of less fluid, since the fluid is applied targeted to the portion of the catheter that needs to be wetted, rather than being distributed throughout the catheter. The present invention also has the advantage that the proximal end is the last part of the catheter to get wet and is therefore least likely to dry out before being introduced into the urethra. Since the volume of the channel is controlled by the location of the joint, flexible and soft pouch walls can be used, making the pouch more convenient to carry and use.

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

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 within the channel. Accordingly, embodiments of the present invention may provide a packaged catheter assembly that includes a pouch, a catheter, and a fluid reservoir, where 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 interior base of the junction and peripheral seal defines a channel that is filled with fluid prior to withdrawing the catheter from the pouch, and 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 positioned such that the distal end of the catheter is withdrawn from the pouch before the proximal end so that the proximal end of the catheter passes through the channel while the catheter is withdrawn from the pouch. The volume of the fluid reservoir is preferably sufficient to completely fill the channel, i.e. with the pouch held at its lowest point, the fluid extends at least to the level of the bottom of the joint. Preferably, the filling level of the channel is greater than or equal to 100%, such as at least 150%, at least 200%, or at least 300%. Alternatively, the filling 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. Accordingly, embodiments of the invention may provide a packaged catheter assembly that includes a pouch, a catheter, and a fluid reservoir, the pouch including 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 being disposed within the pouch in a curved configuration and having a junction between the two walls. The inner base of the portion and the peripheral seal define a channel that is filled with fluid prior to withdrawing the catheter from the pouch, and the fluid reservoir is configured to release fluid into the pouch to form a pool of fluid within the channel. , 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, the proximal end of the catheter passes through the channel, and the pool of fluid fills the volume of the channel. is arranged to correspond to a channel filling level of at least 90% of the channel filling level. Accordingly, the present invention provides an assembly having a reservoir in which fluid can be supplied into the channel. The size of the reservoir is selected to ensure that sufficient fluid is delivered and the catheter can be adequately lubricated upon removal.

The fluid reservoir can be placed within a (sealed) pouch. The fluid reservoir may be provided as a separate device or may be incorporated into the material of the pouch. The method can include placing a fluid reservoir within the pouch and sealing the fluid reservoir within the pouch with a catheter. The fluid reservoir may include a deformable, collapsible, or rupturable sachet. In this way, the fluid reservoir is conveniently placed within a pouch that can release fluid directly into the channel formed by the joint and the bottom of the peripheral seal. Deformable, collapsible, or rupturable reservoirs increase convenience for the user, as the fluid can be easily released without additional tools and before unsealing the pouch, thus making it easier to use. Reduces the possibility of people accidentally getting wet. In particular, sachets can be easily handled on an assembly line and can be introduced more easily than handling fluids into packages during manufacturing.

The catheter may be a urinary catheter. The catheter may be a male urinary catheter. The catheter may be an intermittent catheter. In one embodiment, the catheter is an intermittent male urinary catheter. Accordingly, the constructional features of the present invention allow an intermittent male urinary catheter to be provided in a compact package, and also facilitate convenient and easy catheter withdrawal while also providing the ability to lubricate the catheter prior to use. I can do it.

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 joint may be separate from the base of the peripheral seal. The channel may be an open-ended channel. Accordingly, embodiments of the present invention may provide a packaged catheter assembly that includes a pouch and a catheter, the pouch having two walls and a peripheral seal between the two walls, and the catheter being able to connect to the body. a proximal end for insertion of a catheter, and a distal end, the catheter being disposed within the pouch in a curved configuration, with a junction between the two walls and a peripheral seal at the junction and a peripheral seal. The interior base of the pouch defines an open-ended channel that is filled with fluid before the catheter is withdrawn from the pouch, and the pouch and catheter are arranged such that the distal end of the catheter precedes the proximal end when the catheter is withdrawn from the pouch. The proximal end of the catheter is positioned to pass through the channel as it is withdrawn from the pouch. The catheter is thus retained within the pouch within the open-ended channel formed by the joint and the internal base of the peripheral seal. In this way, when withdrawn, the catheter is pulled through the channel and is well lubricated.

The joint and peripheral seal may be independent. Accordingly, embodiments of the present invention may provide a packaged catheter assembly that includes a pouch and a catheter, the pouch having two walls and a peripheral seal between the two walls, and the catheter being in the body. The catheter has a proximal end and a distal end for insertion, the catheter is disposed within the pouch in a curved configuration, and a junction is provided between the two walls, the junction and the circumferential seal being independent. The interior base of the junction and circumferential seal define a channel that is filled with fluid before the catheter is withdrawn from the pouch, and the pouch and catheter are connected so that the distal end of the catheter The proximal end of the catheter is positioned to pass through the channel, with the proximal end of the catheter being withdrawn from the pouch before the end. Joints may be provided in spots. The joint is preferably provided by welding, for example spot welding. Such welding may be provided after the catheter (and optionally the pouch) has been placed between the walls and can be accomplished from the outside of the pouch. Alternatively, joining can be 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 may be provided 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. Ru. At least a portion of the peripheral seal may be formed by a fold. In such embodiments, a single sheet may be folded, for example, at the base or one of the two sides to form two opposing walls of the pouch. The joint can be provided in one location, or the peripheral seal and the joint can be formed separately. Alternatively, the weld forming the joint can be provided at the same time as the peripheral seal. In some embodiments, the joint and perimeter seal are a single continuous seal. Thus, the joint manufacturing process is very convenient and avoids major changes in typical packaged catheter assembly manufacturing lines.

The catheter may include a surface that is activated by fluid within the channel. For example, the catheter may include a hydrophilic surface formed by, for example, 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 fluid within 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 within the channel and is easy and comfortable to use.

The pouch can include an interaction area that defines a first point of contact for a user of the packaged catheter assembly. The interaction area can facilitate user access to the contents of the pouch. Actuation of the interaction region may form an opening at or near the upper edge of the peripheral seal. The catheter may be withdrawn through this opening. In this way, access to the pouch is provided at or near the top edge of the pouch, so that while the catheter is withdrawn, fluid within the channel (bottom of the pouch) is retained in the pouch and fluid is directed out of the pouch. Reduce the risk of spillage.

The interaction region can constitute a breakable region of the peripheral seal. The method may include forming a breakable region in the peripheral seal. The breakable region may include a tear line defining a line at which the pouch can be torn to at least partially separate the breakable region from the remainder of the pouch, thereby forming an opening in the peripheral seal. It may also include a breakable region. The tear region can include a tear start. A tear start may be provided at the first end of the tear region. Tear starts may include notches or areas of weakness in one or both walls of the pouch. A tear start can define the first portion of the pouch that is torn. The tear region may include a tear stop. A tear stop may be provided at the second end of the tear region. The tear stop may act to prevent or reduce the likelihood that the tear region will become completely separated from the rest of the package. A tear line may be defined between a tear start and a tear stop. The tear line may be configured to be preferentially torn. The tear line may include a weakened area of the pouch. Tear lines can be formed by any suitable means, such as laser scoring. The tearable region may be substantially triangular in shape with a sloped upper edge. The breakable region thus provides a convenient and simple means of opening the pouch with minimal effort and without the use of additional equipment/tools.

The interaction area may include a sealing arrangement. The seal arrangement may include one or more sealing members operable to close the pouch and provide a user-sealable seal between the two walls of the pouch. In one embodiment, the first and second seal members are provided on the inner surfaces of two walls of the pouch. The seal arrangement may provide a water-tight and/or fluid-impermeable seal when closed. Thus, the pouch can be resealed after use so that fluid within the channel is not subsequently released from the pouch. The catheter can also be returned to the pouch and retained therein after use.

The seal arrangement may be pre-sealed. In such embodiments, user access to the contents of the pouch may be provided by opening the seal deployment. The seal arrangement may be resealable. The seal arrangement may be either a ziplock seal, a hook and loop seal, a hook and hook seal, or an adhesive layer. Thus, a seal deployment can be used such that the contents of the pouch remain inside until the seal deployment is opened, and the pouch can still be resealed after use. This is because if the breakable region requires force to be applied to the pouch to open it, the pouch may move or become misaligned during opening, allowing fluid or catheter to exit the pouch. This is useful because there is a possibility that the

The interaction region may include a breakable region and a seal arrangement. In certain embodiments, the interaction region includes a breakable region corresponding to the upper edge of the peripheral seal and a resealable configuration below the breakable region.

The peripheral seal may have a top edge. The peripheral seal may be substantially rectangular in shape with two side edges between the base and the top edge. The peripheral seal may have a height from the base to the top edge of at least 10 cm, 15 cm, or 20 cm, and/or a height of no more than 10 cm, 15 cm, 20 cm, or 25 cm, such as between 15 cm and 20 cm. The peripheral seal may have a width between side edges of at least 5 cm, 10 cm, or 15 cm, and/or a width of no more than 10 cm, 15 cm, or 20 cm, such as 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, such as between 35 cm and 45 cm. In one embodiment, the peripheral seal has a height of 10-25 cm, a width of 6-11 cm, and the catheter has a length of at least 30 cm. The circumferential 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.

The distal end of the catheter may be positioned closer to the upper edge of the circumferential seal than the proximal end of the circumferential seal. The method may include positioning the distal end of the catheter closer to an upper edge of the circumferential seal than to a base of the circumferential seal. The distal end of the catheter may be placed in the top half of the pouch or in 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 easier to access so that it can be withdrawn before the proximal end of the catheter, as required by the present invention. It is also positioned so that it cannot be pulled through fluids, so it does not get wet and remains easy to handle.

The distal end of the catheter may include a handling sleeve that may be located closer to the upper edge of the circumferential seal than to the proximal end of the circumferential seal. The method may include positioning a handling sleeve at a distal end of the catheter at least partially closer to an upper edge of the peripheral seal than to a base of the peripheral seal. At least a portion of the handling sleeve may be located in the upper half or upper quarter of the pouch. At least a portion of the handling sleeve may be positioned above the joint. In some cases, the entire handling sleeve is above the joint. The handling sleeve may be further away from the joint than the bottom of the pouch. At least a portion of the handling sleeve may be positioned above the fluid fill level. The entire handling sleeve may be placed above the fluid fill level. In this way, the handling sleeve is easily accessible so that it can be withdrawn before the proximal end of the catheter as required by the present invention. Also, because it is positioned so that it is not pulled through the fluid, at least a portion of it does not become wet and remains easy to handle, providing a dry surface that can be grasped and used to manipulate the catheter.

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 located may correspond to a position closer to the center of the opening than to the edges of the opening. The term centrally located may correspond to the location of 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 located 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. This way, when the pouch is opened, the distal end/funnel/handling sleeve is central and located at the point across the width of the pouch that opens widest, making it more easily accessible. be.

The distal end of the catheter may be above the remainder of the catheter within the pouch. A 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 side edge. The funnel may not be aligned parallel to the left and/or right edges. At least a portion of the handling sleeve may not be aligned parallel to the left side edge and/or the right side 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 side edge or the left side edge. If the handling sleeve extends adjacent one side edge (eg, the left or right edge), the fluid reservoir may be adjacent the other side edge (eg, the right or left edge). The distal end may be positioned adjacent one side edge (e.g., the left or right side edge) and the handling sleeve and/or funnel may be positioned adjacent the other side edge (e.g., the right side or left side edge). It may extend to adjacent points. 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 makes it difficult for the catheter to become dirty before use, thereby reducing the risk of infection when using the catheter.

The distal end of the catheter may be positioned closer to one (eg, left) side edge of the circumferential seal than to another (eg, right) side edge of the circumferential seal. The method may include positioning the distal end of the catheter closer to one (eg, left) side edge of the circumferential seal than to another (eg, right) side edge of the circumferential seal.

The joints can be provided at points equidistant from both edges. Alternatively, it may be offset. The method may include providing a joint equidistant from each lateral edge. Alternatively, it may include providing the joints at offset lateral positions. For example, it can be placed anywhere between 25% and 75% of the width of the pouch. The distance between the left and right edges of the peripheral seal can be the width of the pouch. The distal end of the catheter may be provided at a distance from one left edge that is no more than 20%, 10%, 5% or 1% of the width of the pouch. In this manner, the junction and distal end are located in a location that facilitates withdrawal and lubrication of the catheter without spilling lubricant. Providing equidistant junctions between the edges limits the volume of the channel and optimizes the liquid level therein for catheter lubrication.

In embodiments that include an interaction region, actuation of the interaction region may preferentially first form an opening in a first (eg, left) side edge of the peripheral seal. In such embodiments, the distal end of the catheter may be positioned proximate the first (eg, left) side edge. In embodiments that include a tear region and a tear start, the location of the tear start may correspond to a side edge of the peripheral seal. In such embodiments, the distal end of the catheter may be positioned proximate the side edge of the circumferential seal corresponding to the tear start location. The distal end is thus positioned adjacent to the first portion of the pouch to be opened, facilitating withdrawal.

The joint may be located closer to the base of the peripheral seal than the top edge of the peripheral seal. The distance between the base and the top edge of the peripheral seal can define the height of the pouch. The distance between the joint 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 joint 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 joint can be located between 20% and 30% of the height of the pouch. The joint may be circular. The joint can have a radius that is less than 15%, less than 10%, less than 5%, or less than 1% of the height of the pouch. In a preferred embodiment, the joint has a radius of 5% of the pouch height. Therefore, the joint is suitable to ensure that the catheter is well lubricated and to allow easy withdrawal of the catheter without excessive bending or applying excessive force. The channels may be arranged to define a channel of size.

In one embodiment, the joint is located equidistant from each side edge of the pouch and at a distance from the base of 20-30% of the height of the pouch.

The distal end of the catheter can include a funnel positioned so as not to pass through the channel during withdrawal of the catheter. The handling sleeve can also be positioned so that it does not pass through the channel during withdrawal of the catheter. The sleeve may be no more than 25%, 20%, 15%, 10%, or 5% of the length of the catheter, but may be as long as the entire length of the catheter. Embodiments of the invention provide a funnel and sleeve to enable easy handling of the catheter. These elements, or at least some of them, do not pass through the channels and are therefore not coated with fluid during withdrawal. The sleeve may not extend below the level of the joint within the pouch. The sleeve may be further away from the joint than the bottom of the pouch. This reduces the possibility of wetting the sleeve when releasing fluid from the fluid reservoir into the channel. In this way, the catheter is more convenient to use because the fluid is applied only to the necessary parts of the catheter. It also facilitates the use of less fluid because the fluid is applied to the catheter in a targeted manner.

The angle drawn 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; 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 placed within the pouch in a curled or coiled configuration. Accordingly, embodiments of the present invention may provide a packaged catheter assembly that includes a pouch and a catheter, the pouch including two walls and a peripheral seal between the two walls, and the catheter being The catheter is coiled within the pouch and includes a proximal end for insertion into the pouch, and a distal end, and a junction is provided between the two walls, where the catheter is coiled within the pouch and a junction is provided between the two walls. The interior base of the junction and circumferential seal defines a channel that is filled with fluid before the catheter is withdrawn from the pouch, and the pouch and catheter are arranged such that the distal end of the catheter is in front of the proximal end when the catheter is withdrawn from the pouch. The catheter is then withdrawn from the pouch and the proximal end of the catheter is positioned to pass through the channel. The junction may be provided within the area defined by the curl or coil of the catheter. The circumferential seal can restrict the catheter to its curved configuration. Thus, the bending, curling or coiling of the catheter reduces the size of the pouch and allows long catheters to be conveniently and unobtrusively stored ready for use.

The catheter can be positioned such that at least 30%, 40%, 50%, 60%, 70% or 80% of the catheter's length passes through the channel upon withdrawal. Accordingly, embodiments of the invention may provide a packaged catheter assembly that includes a pouch and a catheter, the pouch including two walls and a peripheral seal between the two walls, and the catheter being inserted into the body. a proximal end and a distal end for insertion of the catheter, and a junction is provided between the two walls, the junction and the inner bottom of the peripheral seal having a channel that is filled with fluid before withdrawing the catheter from the pouch. and the pouch and catheter are such that when the catheter is withdrawn from the pouch, the distal end of the catheter is withdrawn from the pouch before the proximal end, and at least 50% of the length of the catheter including the proximal end of the catheter is is arranged so that it passes through the channel. In one embodiment, 70-80% of the length of the catheter passes through the channel during withdrawal. Advantageously, only the portion of the catheter intended to enter the body is lubricated, so no fluid is wasted and the catheter is easier to use.

The walls may be formed of any suitable material, such as film material. The wall may be impermeable to fluids. The walls may be made of plastic material. The walls can be made, for example, from one or more of polypropylene (PP), polyethylene terephthalate (PET), low density polyethylene (LDPE), polyethylene terephthalate polyester (MET PET) or oriented polypropylene (OPP). The wall may include a laminate of two or more layers. Each wall may include an inner layer and an outer layer. Each wall may include an inner layer and an outer layer of polypropylene. Each wall may include an inner layer of oriented polypropylene and an outer layer of polypropylene. Each wall may include, for example, an inner layer of polypropylene and an outer layer of polyethylene. The inner layer and outer layer may have the same thickness. In other embodiments, the inner and outer layers may have different thicknesses. The inner layer may have a smaller thickness than the outer layer. In embodiments, the inner layer may have a thickness 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 between 10 and 50 microns, or It may have a thickness of 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.

According to a fifth aspect of the invention, a method of unpacking a packaged catheter assembly is provided, the packaged catheter assembly comprising a pouch, a catheter contained within the pouch, and a fluid reservoir; discharging fluid from the reservoir to form a pool within a channel between the base and junction of the pouch; opening the pouch and withdrawing the catheter by the distal end of the catheter; When the end is withdrawn, the proximal end of the catheter for insertion into the body is guided through the channel so that it is wetted by a pool of fluid.

The packaged catheter assembly is a packaged catheter assembly as defined in general terms or manufactured according to any of the first or second aspects above or by the method of the third or fourth aspect above. optionally including any of the features defined above. Indeed, it may include any of the features without necessarily including all the features defined in the first to fourth aspects above.

The step of releasing the fluid is at least 60%, 70%, 80% of the volume of the channel, in particular at least 90%, or at least 100%, even up to at least 150%, 200% or 300% of the volume of the channel. may include pool formation. This method thus provides for creating a pool of fluid sufficient to lubricate the catheter without using excess lubricant.

A sixth aspect of the invention includes releasing fluid from the reservoir to form a pool in the channel between the base of the pouch and the junction, opening the pouch and withdrawing the catheter by the distal end of the catheter, thereby When the distal end is withdrawn, the proximal end of the catheter for insertion into the body is guided through the channel, making it wet by the pool of fluid, and then introducing the catheter by its proximal end into the urethra; A method of using a catheter is provided. The urethra may be that of a human, especially a human male.

The method can further include discharging urine through a funnel at the distal end of the catheter. The method can further include removing the catheter. The method may further include rolling or folding the catheter and reintroducing it into the pouch for disposal. The method can further include sealing the used catheter within a pouch prior to disposal.

Here too, the step of releasing the fluid may be at least 60%, 70%, 80%, especially 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. It may include forming a pool within a channel. This method thus provides for creating a pool of fluid sufficient to lubricate the catheter without using excess lubricant.

Of course, in the method of use of the catheter, a packaged catheter assembly again refers to a packaged catheter assembly as defined in general terms, or according to any of the first or second aspects defined above, or as defined above. and may optionally include any of the features defined above. In fact, it may include any of the features without necessarily including all the features defined in the four aspects above.

According to a seventh broad aspect of the invention, a packaged catheter assembly is provided that includes a catheter, a fluid reservoir, and a pouch containing the fluid reservoir and the catheter, the pouch concealing the catheter from view but allowing the user to The device is configured to be able to view the reservoir and/or view the fluid released from the reservoir.

According to an eighth aspect of the invention, there is provided 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 (preferably (corresponding to the location of the fluid reservoir of the pouch and/or to the wetting area intended for flow from within the fluid reservoir).

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; and removing the catheter from view. and configuring the pouch so that a user can view the fluid reservoir and/or view the fluid released from the reservoir.

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; and 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; providing a window (the window preferably corresponding to the location of the fluid reservoir of the pouch and/or corresponding to a wetted area intended for flow from the fluid reservoir);

Accordingly, the present invention provides a packaged catheter assembly that is discreet since the contents of the assembly are hidden. The window allows the user to easily identify the fluid reservoir during use of the catheter and/or allows fluid to be normally released from the reservoir into the wet area of the pouch to lubricate the catheter before use. Provide a visual guide for easy identification. Although providing a transparent/semi-transparent window is the preferred approach to allow the user to see whether fluid has been successfully released from the reservoir, we believe that other approaches are also viable. It will be done. For example, rather than having a transparent/semi-transparent window in the opaque wall of the pouch, an opaque wall may be interposed within the pouch between the transparent/translucent pouch wall and the catheter (and optionally the reservoir). It is contemplated that this functionality can be achieved by providing a transparent/semi-transparent pouch wall while allowing the pouch to remain transparent. The intervening wall may include a window or fluid ejected from the reservoir may flow between the outer transparent/translucent wall and the intervening wall to indicate successful ejection.

The following optional/preferred aspects include both the seventh and eighth aspects of the assembly having the fluid release visualization configuration set out above, and the ninth and tenth aspects having the fluid release visualization configuration set out above. It applies equally to both method aspects. They apply equally to the invention defined in the general terms above, or to other aspects of the invention as described above, and likewise any features described in relation to the first to sixth aspects. may equally apply to other aspects without themselves including the features of those aspects (e.g. catheters of aspects 7 to 10 are of course defined in relation to aspects 1 to 6). (for example, a male intermittent urinary catheter). Accordingly, embodiments of the present invention provide a packaged catheter assembly that includes 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 two a wall and a circumferential seal between the two walls, the catheter includes a proximal end for insertion into the body, and a distal end, the catheter is disposed in a curved configuration within the pouch and has two a junction between the walls, the interior base of the junction and the peripheral seal defining a channel that is filled with fluid before the catheter is withdrawn from the pouch; The catheter is positioned such that the distal end of the catheter is withdrawn from the pouch before the proximal end so that the proximal end of the catheter passes through the channel.

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 on which it is mounted. The window can 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 can 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 is of the same shape but smaller in size than the fluid reservoir. Accordingly, in an embodiment of the invention, the window is advantageously provided in only a portion of the wall of the pouch, corresponding to the size, shape and location of the fluid reservoir and spaced from the edge of the pouch.

The window can correspond to the location of the fluid reservoir. Accordingly, embodiments of the present invention provide a packaged catheter assembly that includes 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 the pouch including a transparent or translucent window; Corresponds to the location of the fluid reservoir. The window can correspond to the location of the indicator area of the pouch. The indicator region may correspond to a wetting region, which may extend from the bottom of the pouch to a level at which sufficient fluid has exited the pouch to wet the catheter. The indicator area may be configured to indicate successful release of fluid from the reservoir. Accordingly, embodiments of the present invention provide a packaged catheter assembly that includes a catheter, a fluid reservoir, and an opaque pouch containing the fluid reservoir and the catheter, the pouch having a transparent or translucent window; corresponds to the position of an indicator area of the pouch, the indicator area configured to indicate successful release of fluid from the reservoir. The indicator region can constitute a fill level marker that indicates that sufficient fluid is in the wetted region. Thus, the window also provides a visual guide to confirm that fluid released from the reservoir has been delivered to a particular area of the pouch (eg, a channel) or has successfully lubricated the catheter.

The pouch may be substantially rectangular in shape with two side edges, a base, and a top edge. The height of the pouch can be defined as the distance between the base and the top edge. The width of a pouch may be defined as the distance between the lateral 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 aligns with it, but at the same time, the area of the window allows the contents of the pouch to generally remain invisible due to the fact that without the window the pouch is opaque. Minimized to ensure that.

Those skilled in the art will understand that when a pouch is described as opaque but includes a transparent or translucent window, it is mostly opaque except for the window, e.g., completely opaque except for the window. can. It is also possible to have more than one window, for example a window in each of two opposing walls that are mainly or completely opaque, and in fact two windows can be one (or It will be appreciated that a plurality of separate opaque walls may also be provided.

This is in contrast to known catheter packages formed of (only) two opposing walls, an opaque paper wall and a transparent plastic film wall, where the transparent film wall forms the second wall of the package. Since they constitute a whole, they cannot be considered opaque even with windows. Since the transparent film wall makes up the entire second wall of the package, it cannot be considered opaque just because it has a window.

The catheter within the pouch is preferably hidden. Accordingly, one embodiment of the present invention provides a packaged catheter assembly that includes 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 having a hidden inside the pouch. The catheter may be hidden by the opaque walls of the pouch. The catheter may be hidden by a fluid reservoir. The catheter is likely to appear to an observer as some kind of medical device, even if they are not aware of its exact nature, so it should either be placed out of view through the window, or it should be surrounded by another object, such as a liquid reservoir (optionally). This can be hidden by hiding it behind a special sheet material (such as a special sheet material).

Of note, the fluid reservoir (or other concealing object) may be opaque and may have a color that corresponds to or contrasts the color of the pouch walls. Accordingly, embodiments of the present invention provide packaged catheter assemblies that include 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 fluid reservoir. The reservoir is shown to be opaque. For example, the reservoir (or other concealing object) may be the same color, a different shade than the pouch color, or, if the opaque pouch has multiple colors, a combination of those colors. It may be one of the shades. Gray or silver may be particularly preferred for the reservoir (or other concealment object) from a conservative point of view.

The window may be patterned; that is, at least part of the window may be provided with a pattern thereon, for example a pattern formed by opaque areas such as spots, stripes, etc. The pattern can provide a graduated look to the window. The pattern can provide a graduated appearance to one or more of the edges of the window. The pattern allows the window to blend into the packaging around the pouch. Therefore, the window is less noticeable to the untrained eye, and the packaged catheter assembly is therefore more unobtrusive for a user to carry.

A retaining seal may be provided between the two walls to limit movement of the fluid reservoir within the pouch (which may of course be a pouch as defined above). Accordingly, embodiments of the present invention provide packaged catheter assemblies that include 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 a fluid reservoir within the pouch. and a retaining seal configured to restrict movement of the fluid reservoir of the fluid reservoir. The method can include forming a retaining seal between the two walls to limit movement of the fluid reservoir within the pouch. A retaining seal may be provided on the outside of the curve of the catheter. The retaining seal may be located closer to the top edge of the peripheral seal of the pouch than to the base of the pouch. A retaining seal can extend from the top edge of the peripheral seal of the pouch.

According to an eleventh aspect of the invention, there is provided a method of wetting a catheter of a packaged catheter assembly, the method comprising: releasing fluid from a reservoir within a pouch; identifying the reservoir from which the fluid is to be released; Inspecting the interior of the pouch (e.g., through a (transparent or translucent) window in an opaque wall) of the pouch to confirm that the reservoir has released fluid into the pouch (or both) and optionally opening the pouch after confirming release and optionally withdrawing the catheter by the distal end of the catheter to remove the catheter from the pouch.

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

According to a twelfth aspect of the invention, there is provided a method of wetting a catheter of a packaged catheter assembly, the method comprising the steps of: releasing a fluid from a reservoir within a pouch; identifying the reservoir from which the fluid is to be released; Inspecting the interior of the pouch (e.g., through a window (transparent or translucent in an opaque wall) of the pouch) to confirm that the reservoir has released fluid into the pouch (or both); removing the catheter from the pouch, optionally opening the pouch after confirming the release of and introducing the catheter into the urethra from the proximal end. The urethra may be that of a human, especially a human male.

The method can further include discharging urine through a funnel at the distal end of the catheter. The method can further include removing the catheter. The method may further include rolling or folding the catheter and reintroducing it into the pouch for disposal. The method can further include sealing the used catheter within a pouch prior to disposal.

Again, in the method of use of the catheter, the packaged catheter assembly is defined in general terms as a packaged catheter assembly, or according to any of the seventh or eighth aspects above, or according to the ninth or tenth aspect above. Of course, it may be manufactured by the method of the embodiment and optionally include any of the features set out above. Indeed, it may include any of the features without necessarily including all the features defined in any one of the seventh to tenth aspects.

As mentioned above, in general terms, the present invention provides (a) a channel through which fluid can be introduced and into which the catheter is retracted when withdrawn from the pouch; and (b) a means for viewing the fluid reservoir and/or It may include means to ensure that the catheter is both visible but hidden within the packaged assembly when fluid is released from the reservoir. In fact, that's a good thing. The following preferred features therefore apply to a pouch having both features (a) and (b), in particular (i) both the first and seventh aspects, (ii) the first and eighth aspects. (iii) both the second and seventh aspects, and (iv) both the second and eighth aspects, in particular (v) the third and ninth aspects. (vi) both the third and tenth aspects, (vii) both the fourth and ninth aspects, and (viii) both the fourth and tenth aspects. This applies to methods that include the following characteristics. Furthermore, the following features apply in particular to a method of wetting a catheter comprising features of both the fifth and eleventh aspects, and to a method of using a catheter comprising features of both the sixth and twelfth aspects.

A portion of the window may correspond to a location lower than the joint of the pouch. Thus, when the channel defined by the joint is used for catheter lubrication, the liquid level within the channel can be visually verified using the window.

The joint can function as a retaining seal to limit movement of the fluid reservoir. In such embodiments, the fluid reservoir may be located between the joint and the side edge of the peripheral seal. In some embodiments, the fluid reservoir may be positioned adjacent a first side edge of the peripheral seal, and the joint is located closer to the first side edge than the other (second) side edge of the peripheral seal. It may be provided at a position close to the side edge. In this way, the retaining seal ensures that the fluid reservoir does not move within the pouch and is always visible through the window (in a preferred embodiment, always concealing the catheter).

For a clearer understanding of the invention, one or more embodiments thereof will be described by way of example with reference to the accompanying drawings, in which: FIG.

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

In the diagram, as is customary, dashed lines indicate hidden features.

Referring to FIGS. 1-7, a first embodiment of a packaged catheter assembly 100 is shown.

Assembly 100 includes a fluid reservoir 10, a male intermittent single use urinary catheter 20, and a pouch 30. Pouch 30 includes a front opaque wall 31a, a rear opaque wall 31b, and a perimeter seal that joins together the perimeter of walls 31a, 31b to form the pouch. The peripheral seal is comprised of a base 32, a right side edge 33, a left side edge 34, and a top edge 35. The left side edge 34 and the right side edge 33 are defined as the left and right sides of the pouch when looking at the pouch 30 with the back wall 31b behind the front wall 31a, with the base 32 at the bottom of the pouch 30 and the top edge 35 is at the top of the pouch 30. The peripheral seal is therefore generally rectangular, preferably with a width between the side edges of between 60 and 110 mm, such as about 100 mm, such as 95 mm, and a base 32 of between 100 and 250 mm, such as about 200 mm, such as 197 mm. A pouch 30 is defined having a height from to an upper edge 35. Base 32 defines the bottom of the pouch in use, and top edge 35 defines the top. However, in other embodiments, alternative shapes and sizes may be devised, such as oval or circular pouches.

The pouch also includes a joint 36 between the two walls 31a, 31b. The joint 36 is a circular weld located at a distance ranging from 45 to 55 mm above the base 32 at an equidistant point between the side edges 33, 34 of the peripheral seal. Joint 36 can have a radius of between 1% and 10% of the pouch height, for example 5%. In other embodiments, the joints can be provided in different shapes and sizes, in different locations, or potentially integrated as a continuous seal with the surrounding seal.

The pouch also includes a window 37 in one of the walls, allowing the user to see inside the pouch. In this particular embodiment, the window 37 is transparent, elongated, generally rectangular, with a length between 20 and 50%, such as 33%, of the height of the pouch 30 and a width between 5 and 25% of the width of the pouch 30. For example, it is 12.5%. In this example, the windows 37 have semi-circular ends, but in other embodiments they may have any suitable shape, such as flat ends or irregularly shaped ends. The window 37 is arranged parallel to the right side edge 33, and a gap corresponding to between 5 and 20%, for example 10%, of the width of the pouch is provided between the end of the window 37 and the right side edge 33. The bottom of the window 37 is spaced from the bottom of the peripheral seal 32 by a distance corresponding to between 5 and 20%, for example 10%, of the height of the pouch. In other embodiments, translucent windows may be used, and alternative shapes, sizes, and positions or angles of windows are also contemplated (eg, up to a 20 degree angle to the edge).

In this particular embodiment, each wall 31a, 31b is comprised of multiple layers of foil, in one particular embodiment a 97 micron two layer foil of 12 micron PET and 60 micron LLDPE. In other embodiments, the walls 31a, 31b may include only a single layer and different plastic materials may be used interchangeably.

As mentioned above, walls 31a, 31b are opaque. This may be achieved by forming each wall 31a, 31b from one or more layers of opaque material, or by printing an opaque pattern on one of the layers. The windows 37 in the front wall 31a may be formed by laminating an opaque layer of material to a transparent wall, the opaque layer having an opening corresponding to the window 37. Alternatively, a transparent wall can be printed to block light passing through the wall, making it opaque everywhere except at the window 37 location. For example, an opening corresponding to the window 37 is provided in an opaque wall, and a transparent layer is glued to cover the opening to realize a continuous front wall 31a having a window 37, or a multilayer foil having an opaque layer and a transparent layer. Further alternatives are also contemplated and may be achieved, such as starting from , removing a portion of the opaque layer of the foil to form a transparent window.

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 side edge 33 and the left side edge 34. The interaction area is used to access the pouch through near the top edge 35. In this embodiment, the interaction region includes a tapered tear region 38 and a seal deployment 39. The tear area 38 is located at a tear start 40 located on the left side edge approximately 2 cm below the position where the top edge 35 and the left side edge 34 intersect, and at a point within the pouch 30 approximately 1 cm below the position where the top edge 35 and the right side edge 33 intersect. Includes a tear stop 41. The distance between the tear stop 41 and the right side edge 33 is between 1 and 10%, for example 5%, of the width of the pouch. Tear start 40 includes a cutout to provide a weak area in walls 31a, 31b, and tear region 38 can be separated from pouch 30 by tearing the wall from tear start 40 to tear stop 41. In this way, a tear is provided below the location of the upper edge 35 so that the pouch 30 can be opened to access its contents. Tear stop 41 provides a small opening in walls 31a, 31b to prevent further tearing of pouch 30 and separation of tear region 38 from pouch 30. To provide the tapered shape, tear region 38 extends upwardly about 50% more on the left side than on the right side. A circular opening 42 is formed on the left side of the tear region 38 and is sized to allow a finger to pass through and grasp the tear region 38 . The front wall 31a and the back wall 31b are sealed together around the tear stop 41 and the circular opening 42 so that the pouch is completely sealed. In other embodiments, other seals may be used to provide access to the pouch, such as a Ziploc® arrangement; of course, the sizes and shapes set forth above are exemplary. be.

In this embodiment, the seal deployment 39 extends between the left and right edges 34 and 33 of the peripheral seal immediately below the tear region 38. Seal arrangement 39 includes first and second seal members (not shown) provided on the inner surfaces of walls 31a, 31b of pouch 30. In this embodiment, the sealing member includes corresponding sealing grooves and ridges so that the sealing member can be press-fitted to form a watertight seal and pulled apart again as required. In other embodiments, a single adhesive sealing member may be used, or a sealing member may be provided on the outside of the pouch so that the pouch can be folded or rolled to seal accordingly, and of course, a hook Alternative sealing mechanisms such as and-loop, hook-and-hook seals, and ziplocks may also be used.

In this embodiment, fluid reservoir 10 is an elongated rectangular burstable pouch of water, although in other embodiments any suitable reservoir can be used. The fluid reservoir 10 has a height of between 60 and 90%, for example equal to 80%, of the height of the pouch 30 and a width of between 5 and 25%, for example 15%, of the width of the 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, may be suitable. Additionally, other fluids may be used, such as lubricants, gels, oils, etc.

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 ends 21, 22. Distal end 22 includes a funnel 24 for directing urine from the bladder out of tube 23 in use. A handling sleeve 25 is also provided around the tube 23 adjacent the distal end 22 . In this embodiment, the catheter has a length of 30-50 cm, such as 40 cm, and the handling sleeve is 10-30%, such as 20-25%, of the length of the catheter, such as 11 cm. In this embodiment, the catheter 20 is provided with a hydrophilic coating that becomes activated when it comes into contact with the fluid held in the reservoir 10. In other embodiments, any suitable catheter length or type can be used.

Catheter 20 is placed within pouch 30 in a curved and coiled configuration, with distal end 21 adjacent inner left side edge 33 near upper edge 35 of pouch 30 and just below seal deployment 39. be. The catheter 20 extends inside the pouch 30 in a wide oval counterclockwise coil (looking at the left edge 34 to the left and the upper edge 35 upward). The coil rotates around the inner circumference of the left side edge 34, base 23, and right side edge 33 of the pouch, and the proximal end 21 of the catheter 20 is placed adjacent the left side edge 34 and base 32 of the pouch, and the coil of the catheter It is placed inside the . Of note, although most of the handling sleeve 25 is positioned over the junction 36, as the catheter curves from left to right, the catheter tube 23 runs under the junction and meets the junction. runs in a channel defined by the internal base of the peripheral seal, then runs upward to the side of the junction, then back over the junction, and finally with proximal end 21 lower than and above junction 36. It extends downward as shown on the left. In short, catheter 20 is coiled (or curled) (although not tightly wound) around junction 36 . 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 being coiled or curled. On the other hand, embodiments of the present invention may have catheters 20 with multiple turns of coils.

Referring to FIG. 2, the pouch 30 initially includes two walls 31a, 31b which will define the pouch 30 itself and a transparent window 37 as described above, before being manufactured by one of the techniques described above. It is formed by providing a wall 31a. In this embodiment, the walls 31a, 31b are sized to correspond to the final shape of the pouch 30, although in other embodiments the walls may extend outside the pouch 30 as desired.

In this embodiment, the base 32, right side edge 33 and left side edge 34 are initially formed by welding the two walls 31a, 31b together, leaving the pouch 30 with an open top edge 35. Catheter 20 is then placed into pouch 30 in a curved and coiled state as set out above.

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

In this embodiment, first and second sealing elements (not shown) are then attached to the inside of the walls 31a, 31b just above the coiled catheter 20, and the walls 31a, 31b are attached to the upper edge 35. Its upper edge 35 is formed by welding along to complete the peripheral seal. This seals catheter 20 and reservoir 10 within the pouch. In other embodiments, the sealing element can be provided to the wall prior to other assembly of the pouch 30 or sealing of the perimeter seal.

In this embodiment, the joint 36 is then formed by welding the walls 31a and 31b. Catheter 20 is coiled around the inner circumference of pouch 30 so that junction 36 is located within the coil of catheter 20. A portion of the catheter tube 23 thus passes between the junction 36 and the base 32 of the pouch. In other embodiments, joint 36 may be provided prior to the perimeter seal or at any point during the assembly process.

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 glue the walls 31a, 31b at the periphery of the cut out area to ensure that the pouch 30 remains completely sealed.

As will be appreciated, the above is one example; in other embodiments, pouch 30 may be formed in different ways with the steps performed in a different order. For example, the bottom can be opened and a catheter and water reservoir can be introduced from the bottom before the base seal is provided. Alternatively, for example, in an industrially applied process, two webs of wall material are applied with one half of the seal deployment on each (inner surface of) the catheter 20 and reservoir 10 on opposite inner surfaces of the web of wall material. Then, potentially in a single action, a hot die simultaneously forms a tear start 40, forms a bond 36 and forms an opening 42 in the tear region 38, potentially in a single action. Tear stops 41 may be punched and sealed to join and form walls 31a, 31b. Additionally, although the perimeter seal and joint 36 have been described as being formed by welding, any suitable means of joining the walls may be used, such as adhesives.

Referring to FIGS. 2-7, this first embodiment packaged catheter assembly 100 can be unpackaged as described below.

First, the fluid reservoir 10 is placed in the pouch 30 with the help of a 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, reservoir 10 is a rupturable pouch from which fluid can be released by manually applying pressure to reservoir 10. Window 37 provides a visual indicator when reservoir 10 has successfully ruptured and fluid has been released into pouch 30. In particular, it can be seen that sufficient fluid has been released to fill the channel defined by the weld 36 and the internal base 32 of the peripheral seal. In other embodiments, fluid may be released from other means.

Referring to FIGS. 3 to 7, the fluid released from the reservoir 10 accumulates at the bottom of the pouch 30, as indicated by 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 completely fluid-filled channel. However, in other embodiments, the fluid only partially fills the channel, for example between 60-95%, preferably at least 90%, or fills the pouch to a level above junction 36. can be fulfilled.

The bottom of the window 37 corresponds to a position on the pouch 30 that is slightly lower than the joint 36, so that the expelled fluid will also be visible through the window 37. In other embodiments, the window may be configured with an indicator area that indicates the presence of fluid within the pouch. Examples include fluid-sensitive color-changing strips that do not require direct visualization of the fluid. A fill level marker may also be provided to indicate when sufficient fluid has been released.

In this embodiment, the contents of pouch 30 are then accessed by tearing off the top of pouch 30 using tear region 38. Grasping opening 42 with one hand and the remainder of pouch 30 with the other hand, tear region 38 from tear start 40 to tear stop 41. The pouch is thus torn between the left side edge 34 and the right side edge 33 at a location below the top edge 35, such that an opening is formed in the pouch 30 that can be used to access its contents. be done. Advantageously, tear region 38 is not completely separated from pouch 30, 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, for example, a Ziploc® seal.

Referring to FIGS. 4-6, catheter 20 can then be withdrawn from pouch 30. As mentioned above, in this embodiment, catheter 20 is wound within pouch 30 and distal end 21 is provided adjacent upper edge 35 of 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. Distal end 21 thus provides a dry, easily accessible point that can be used to withdraw catheter 20 from pouch 30. In this embodiment, a large part of the handling sleeve 25, ie at least 50%, preferably between 60 and 100%, for example 70%, is also above the filling line and is not wetted. Thus, sleeve 25 also provides a convenient dry surface for handling catheter 20.

In this embodiment, the distal end 21 is pulled upwardly through an opening in the upper edge 35 of the pouch 30. When the distal end 21 is withdrawn from the pouch 30, the catheter tube 23 is uncoiled and withdrawn upwardly toward the upper edge 35 of the pouch 30. However, because the junction 36 is located within the coil of the catheter 20, the tube 23 is prevented from moving upwardly by the junction 36. Joint 36 thus allows tube 23 to be pulled out of pouch 30 along a path that includes passing through the channel defined by joint 36 and base 32. In this way, the entire remainder of the tube 23 up to the proximal tip 21 passes through the pool of fluid within the channel and the hydrophilic coating of the catheter 20 is activated by the fluid. Additionally, proximal end 21 of catheter 20 is the final portion of catheter 20 that is passed through the channel and withdrawn from pouch 30. In this way, the catheter 20 is fluid-activated and is convenient and easy to withdraw because only the dry portion of the catheter 20 needs to be touched during withdrawal. When catheter 20 passes through the pool of fluid, it will become wetter more thoroughly than if the fluid was held within another medium, such as a sponge. In other embodiments, the catheter 20 need not be withdrawn directly upwards, but may be withdrawn laterally from the pouch, for example through an opening provided in the side of the pouch, of course to reduce the possibility of spillage. above the weld. Further, the catheter 20 may not directly touch the junction 36, but instead may be prevented from moving upwardly as it approaches the junction 36 by the convergence of walls 31a, 31b.

Once the catheter is fully withdrawn, the catheter 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 catheter 20 by funnel 24.

Referring to FIG. 7, in this embodiment, catheter 20 can be returned to pouch 30 in a coiled configuration after use. Handling sleeve 25 and funnel 24 provide a dry surface that can be used to recoil catheter 20 into pouch 30. Seal deployment 39 may then be used to reseal pouch 30 between left side edge 34 and right side edge 33 by pushing together two corresponding sealing elements (not shown). This provides more convenient disposal of catheter 20 after use and ensures that fluid released into pouch 30 does not subsequently leak out of pouch 30. In other embodiments, alternative seal arrangements may be used, such as an external flap with an adhesive that allows the top of the pouch 30 to be rolled or folded to form a seal. Alternatively, seal deployment may not be used if the pouch 30 is intended to be disposed of immediately after use.

Referring to FIG. 8, a second embodiment of a packaged catheter assembly 200 is shown. Since the second embodiment shares many of the features of the first embodiment described above, only the differences in features will be described below and similar numbers will be used to indicate similar features.

In this embodiment, the joint portion 236 is provided at a position offset from the midpoint between the right side edge 233 and the left side edge 234. In particular, the joint is provided such that the distance from the right side edge 234 is between 20 and 45%, such as 35%, of the width of the pouch 230. Joint 236 provides a second function as a retaining seal to limit movement of reservoir 210 within pouch 230, sandwiching reservoir 210 between joint 236 and right side edge 234. Joint 236 thus ensures that window 237 corresponds to the position of reservoir 210 regardless of movement of pouch 230 when carried by the user, ensuring that catheter 223 remains hidden and that the reservoir 210 to ensure both easy identification and the ability to release its fluids. In other embodiments, the retaining seal function may be provided by a separate seal between walls 231a, 231b. For example, a separate seal extending downwardly from seal arrangement 239 or a separate seal extending upwardly from base 232.

In this embodiment, front wall 231a also includes a pattern 243 that corresponds to the edge of window 237. Although the pattern 243 is shown in only a portion of the window, it may of course extend throughout it, creating a graduated pattern that softens the boundary between the transparent window 237 and the remainder of the opaque front wall 231a. Construct a unique appearance. In this embodiment, the pattern is a series of evenly spaced opaque lines of graduated thickness that taper toward the center of the window 237. In this way, pattern 243 visually obscures window 237 and therefore makes pouch 230 less obtrusive. In other embodiments, pattern 243 may be any suitable pattern, such as opaque circles of graduated size, complemented by or integrated with a surface pattern or color applied to reservoir 210. obtain.

Referring to FIG. 9, a third embodiment of a packaged catheter assembly 300 is shown. Since the third embodiment shares many of the features of the first embodiment described above, only the differences in features will be described below and similar numbers will be used to indicate similar features. . FIG. 9 shows a cutaway front view of assembly 300 so that front wall 331a and window 337 are not shown. Diagonal hatching indicates where front wall 331a is adhered to rear wall 331b, for example at left edge 334, base 322, right edge 333, top edge 335, tear area 338 and bond 336.

In this embodiment, the tear region 338 includes a tear line 343 that spans between a tear start 340 and a tear stop 341 . Tear line 344 is a line of weakness that is preferentially torn to permit tearing of region 338. This facilitates removing tear region 338 in a consistent manner. In this embodiment, the tear line 344 is formed by weakening the pouch 330 by laser scoring, but in other embodiments, other techniques such as thinning the material of the pouch 330 along the tear line 344 can be used. can be used.

In this embodiment, seal deployment 339 includes a Ziploc® seal to allow the user to reseal pouch 330 closed. The location where seal deployment 339 can be used to seal front wall 331a and rear wall 331b together is indicated by vertical hashing in FIG. This corresponds to the strip just below tear line 344 of pouch 330.

In this embodiment, catheter 320 is placed within pouch 330, similar to the first embodiment in that it is coiled. However, in this embodiment, the distal end 322 and funnel 324 of catheter 320 are centered relative to the opening formed by tear region 338. The distal end 322 and funnel 324 are approximately equidistant from the left and right edges 334, 333, rather than being closer to either side edge 333, 334. In this way, when pouch 330 is opened, distal end 322, including funnel 324 and handling sleeve 324, is more easily accessible because it is central and located at a point across the width of pouch 330 that opens the most. be. Further, when catheter 320 is rolled, handling sleeve 325 extends from distal end 322 to a position adjacent left side edge 334. Thus, along with fluid reservoir 310 located adjacent right side edge 33, distal end 322, handling sleeve 325 and fluid reservoir 310 are protected from inadvertent direct contact with a user when withdrawing catheter 320 from pouch 330. Protect the rest of the catheter. This makes it difficult for the catheter 320 to get dirty before use, so it is possible to reduce the risk of infection when using the catheter 320.

In this embodiment, the sleeve 325 is configured such that it does not extend below the level of the joint 336 within the pouch 330, and in particular, the sleeve 325 is farther from the joint 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. Therefore, the sleeve 325 is easier for the user to handle.

Conditional language, such as "could," "could," "might," or "could," generally refers to specific is intended to convey that embodiments of include certain features, elements, and/or steps that other embodiments do not. Thus, such conditional language states that a feature, element, and/or step is required in some way by one or more embodiments, or that one or more embodiments require that a feature, element, and/or step be required in some way by those features, elements, and/or steps. , and/or steps are included or performed in any particular embodiment, with or without user input or prompting. It has not been.

One or more embodiments are described above by way of example only. Many modifications are possible without departing from the scope of protection afforded by the appended claims.

Claims (27)

A packaged catheter assembly including a pouch and a catheter, the packaged catheter assembly comprising:
the pouch includes two walls and a peripheral seal between the two walls;
A catheter includes a proximal end for insertion into the body, and a distal end, the catheter being disposed within the pouch in a curved configuration, with a junction between the two walls, and a junction and a peripheral seal. The internal base defines a channel that is filled with fluid before the catheter is withdrawn from the pouch, and the pouch and catheter are such that the distal end of the catheter is withdrawn from the pouch before the proximal end when the catheter is withdrawn from the pouch. and the proximal end of the catheter is positioned to pass through the channel. The catheter is a male urinary catheter,
An assembly according to claim 1. the catheter is an intermittent catheter;
Assembly according to claim 1 or 2. a catheter is disposed between the junction and the internal base of the circumferential seal;
Assembly according to any one of claims 1 to 3. further comprising a fluid reservoir configured to release fluid into the pouch to form a pool of fluid within the channel;
Assembly according to any one of claims 1 to 4. the catheter includes a surface configured to be activated by fluid held within the fluid reservoir;
Assembly according to claim 5. the pool of fluid corresponds to a channel filling level of at least 90% of the channel volume;
Assembly according to claim 5 or 6. the distal end of the catheter is positioned closer to the upper edge of the circumferential seal than the base of the circumferential seal;
Assembly according to any one of claims 1 to 7. the distal end of the catheter includes a handling sleeve;
the handling sleeve is at least partially located closer to the upper edge of the peripheral seal than the base of the peripheral seal;
Assembly according to any one of claims 1 to 8. the pouch includes an interaction region configured to form an opening at or near the upper edge of the peripheral seal;
Assembly according to any one of claims 1 to 9. the distal end of the catheter is centered with respect to the opening;
Assembly according to claim 10. an opening is made from a first side edge of the circumferential seal, and the distal end of the catheter is disposed closer to the first side edge of the circumferential seal than a second side edge of the circumferential seal;
Assembly according to claim 10. The joint and the surrounding seal are independent,
Assembly according to any one of claims 1 to 12. the channel is an open-ended channel,
Assembly according to any one of claims 1 to 13. the peripheral seal is substantially rectangular and has two side edges between the base and the top edge of the peripheral seal;
Assembly according to any one of claims 1 to 14. a joint is provided at a point equidistant from the two side edges;
Assembly according to claim 15. The joint is located at a distance from the base that is 20-30% of the pouch height, where the pouch height is defined as the distance from the base of the peripheral seal to the top edge of the peripheral seal.
Assembly according to any one of claims 1 to 16. the joint has a radius less than a length corresponding to 15% of the height of the pouch;
Pouch height 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. a catheter is disposed within the pouch in a coiled configuration;
Assembly according to any one of claims 1 to 18. the catheter is positioned such that upon withdrawal, at least 50% of the catheter's length passes through the channel;
Assembly according to any one of claims 1 to 19. the assembly includes a fluid reservoir, the pouch is opaque, the pouch includes the fluid reservoir, and the pouch includes a transparent or translucent window;
Assembly according to any one of claims 1 to 20. A method of forming a packaged catheter assembly, the method comprising:
The method is
providing two walls to define the pouch;
placing the catheter within the pouch in a curved configuration;
forming a circumferential seal between the walls to seal the catheter within the pouch;
forming a joint between the walls;
The interior base of the junction and peripheral seal defines a channel that is filled with fluid prior to withdrawing the catheter from the pouch;
The catheter includes a proximal end for insertion into the body, and a distal end;
The pouch and catheter are arranged such that the distal end of the catheter is withdrawn from the pouch before the proximal end such that the proximal end of the catheter passes through the channel while the catheter is withdrawn from the pouch. two walls are opaque,
The method is
providing a fluid reservoir within the pouch;
providing a transparent or translucent window in at least one wall of the pouch;
forming a peripheral seal includes sealing a fluid reservoir within the pouch;
23. The method according to claim 22. The packaged catheter assembly is a packaged catheter assembly according to any one of claims 1 to 21.
24. A method according to claim 22 or 23. 1. A method of unpacking a packaged catheter assembly, the method comprising:
The packaged catheter assembly includes a pouch, a catheter contained within the pouch, and a fluid reservoir;
The method is
releasing fluid from the reservoir to form a pool within the channel between the base and the junction of the pouch;
opening the pouch and withdrawing the catheter by the distal end of the catheter;
A method in which the proximal end of the catheter for insertion into the body is guided through the channel such that when the distal end is withdrawn, the proximal end of the catheter is wetted by a pool of fluid. through a transparent or translucent window in the opaque wall of the pouch, either to identify the reservoir releasing fluid or to confirm that the reservoir has released fluid into the pouch, or both. , further comprising inspecting the interior of the pouch;
26. The method according to claim 25. The packaged catheter assembly is an assembly according to any one of claims 1 to 21 and/or the packaged catheter assembly is formed by a method according to any one of claims 22 to 24. ,
27. A method according to claim 25 or 26.

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