WO2023180702A1 - Ensemble cathéter - Google Patents

Ensemble cathéter Download PDF

Info

Publication number
WO2023180702A1
WO2023180702A1 PCT/GB2023/050671 GB2023050671W WO2023180702A1 WO 2023180702 A1 WO2023180702 A1 WO 2023180702A1 GB 2023050671 W GB2023050671 W GB 2023050671W WO 2023180702 A1 WO2023180702 A1 WO 2023180702A1
Authority
WO
WIPO (PCT)
Prior art keywords
catheter
pouch
fluid
reservoir
sleeve
Prior art date
Application number
PCT/GB2023/050671
Other languages
English (en)
Inventor
Oliver PFLEGER
Daniel Allen
Jan UHL'AR
Original Assignee
Convatec Limited
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Convatec Limited filed Critical Convatec Limited
Publication of WO2023180702A1 publication Critical patent/WO2023180702A1/fr

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/0017—Catheters; Hollow probes specially adapted for long-term hygiene care, e.g. urethral or indwelling catheters to prevent infections
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/002—Packages specially adapted therefor ; catheter kit packages

Definitions

  • the present invention relates to catheter assemblies.
  • the invention concerns packaged urinary catheter assemblies, and most particularly, but not exclusively packaged intermittent male urinary catheter assemblies, especially “closed” catheter assemblies.
  • Intermittent catheter assemblies can provide a convenient and portable solution to this problem as a user is able to self-catheterise to relieve themselves as required. This reduces the effect of their urinary condition on their life and allows thm to enjoy a relatively normal lifestyle.
  • a catheter can be slippery and difficult to handle. This can make handling and repackaging of the catheter after use difficult and unhygienic, as the catheter may inadvertently contact the user’s hands, clothing or personal items.
  • Existing intermittent catheters disclose continuous handling sleeves that cover the entire length of the catheter. While these provide some assistance to handling, the sleeve can make the catheter more difficult to wet as wetting fluid may not be able to easily reach all parts of the catheter.
  • packaging may be provided to contain the catheter and any other equipment such as wetting reservoirs or sachets and fluid collection bags before and/or after use.
  • these items may become wet which makes handling and re-packaging of them difficult.
  • any release (intentional or otherwise) of this may cause liquid to accidentally leak out onto parts of the catheter assembly that the user has to touch - such as a handling element, or onto the packaging causing problems for the user.
  • the present invention concerns a catheter assembly comprising a catheter.
  • a catheter assembly comprising a catheter having a proximal end for insertion into the body and a distal end, a fluid collection bag arranged to receive fluid from the distal end of the catheter, a sleeve enclosing the catheter along the length of the catheter from the proximal end to the distal end, and a fluid reservoir arranged at the proximal end, wherein the fluid reservoir is configured to release wetting fluid into the sleeve to wet the catheter and wherein the sleeve is in fluid communication with the fluid collection bag. Consequently, excess wetting fluid may flow from the sleeve into the fluid collection bag.
  • the present invention provides for a catheter assembly which benefits from the introduction of wetting fluid at the proximal end of the catheter which reduces the risk of discomfort and injury while using the catheter as the proximal end, which enters the body first, is adequately wetted prior to use.
  • the wetting fluid is contained within the sleeve and flows from the proximal end to the distal end, the fluid is used efficiently to wet the whole length of the catheter by prioritising the parts of the catheter that enter the body first. Due to the sleeve being in fluid communication with the fluid collection bag, wetting fluid cannot escape outside the sleeve and as such the user’s hands or clothing does not inadvertently contact the wetting fluid which could make handling the catheter difficult. This ensures that the catheter is easy and convenient to use, as well as being discrete and hygienic to dispose of as the wetting fluid is contained within the sleeve/bag.
  • the catheter may be a urinary catheter.
  • the catheter may be a male urinary catheter.
  • the catheter may be a female urinary catheter.
  • the catheter may be an intermittent catheter.
  • the catheter is an intermittent male urinary catheter.
  • the sleeve may comprise a flexible plastics material.
  • the sleeve may be liquid impermeable.
  • the sleeve may comprise a thermoplastic polyurethane (TPU) or low-density polyethylene (LDPE).
  • TPU thermoplastic polyurethane
  • LDPE low-density polyethylene
  • the catheter may comprise a proximal end for insertion into the body and a distal end.
  • the sleeve may comprise a proximal end and a distal end.
  • the distal end of the sleeve may be secured or attached either directly or indirectly to the distal end of the catheter.
  • the sleeve may be configured to enclose a majority of the length of the catheter.
  • the sleeve may be liquid permeable. Where the sleeve is liquid permeable, it may be provided in a configuration in which it covers a majority of the length of the catheter.
  • the fluid reservoir may be configured to retain wetting fluid within it.
  • the fluid reservoir may comprise a deformable, frangible or burstable sachet.
  • a deformable, frangible or burstable reservoir enhances the convenience for a user as fluid can be easily released without additional tools.
  • a sachet in particular can be more easily handled on an assembly line compared to handling fluid itself.
  • the wetting fluid may activate the surface of the catheter and render it lubricious.
  • the wetting fluid may be water, such as where the catheter has a hydrophilic surface. Any suitable wetting fluid may be used, for example polar (e.g. water-based) or non-polar (e.g. oil-based) wetting fluids depending on the surface properties of the catheter.
  • the fluid reservoir may be configured to retain at least 5, 10, 15, 25, or 50 ml of wetting fluid.
  • the fluid collection bag may be any suitable shape or size, for example rectangular, circular, elliptical, cuboid, spherical, etc.
  • the fluid collection bag may comprise a front panel and a rear panel.
  • the fluid collection bag may comprise a peripheral bond joining the periphery of the front panel and rear panel to form the fluid collection bag.
  • the peripheral bond may define a base, two lateral edges and an upper edge of the fluid collection bag.
  • the two lateral edges may comprise a right lateral edge and a left lateral edge.
  • the right lateral edge and left lateral edge may be defined as the right and left sides of the bag when viewing the bag with the rear panel behind the front panel, the base at the bottom of the bag and the upper edge at the top of the bag.
  • the bag may have a width between the left lateral edge and right lateral edge of at least 10, 12, 15 or 20 cm.
  • the bag may have a width no more than 25, 20, or 15 cm. Preferably, the width is between 10 and 20 cm, most preferably between 12 and 15 cm.
  • the base may define a bottom of the bag.
  • the upper edge may define a top of the bag.
  • the height of the bag from the base to the upper edge may be at least 25, 30, 35 or 40 cm.
  • the height of the bag may be no more than 45, 40, 35 or 30 cm.
  • the height may be between 25 and 40 cm, 30 and 35 cm, or most preferably 33 and 35 cm.
  • the bag may be configured to hold at least 500, 700, or 1000 ml of fluid, and may hold no more than 1000 ml, for example, it may hold at least 700 ml of fluid.
  • the fluid collection bag may comprise a flexible plastics material.
  • a flexible plastics material for example, polypropylene (PP), polyethylene terephthalate (PET), low density polyethylene (LDPE), metalized polyester (MET PET), orientated polypropylene (OPP), polyvinylpyrrolidone (PVP), or polyvinyl chloride (PVC).
  • PP polypropylene
  • PET polyethylene terephthalate
  • LDPE low density polyethylene
  • MET PET metalized polyester
  • OPP orientated polypropylene
  • PVP polyvinylpyrrolidone
  • PVC polyvinyl chloride
  • the peripheral bond may provide a water-tight seal.
  • the peripheral bond provides a sterile seal.
  • the peripheral bond may comprise any one or more of: a weld; mechanical seal; heat seal; pressure seal; adhesive; solvent bond; ultraviolet bond; ultrasonic weld; laser weld; impulse weld; or friction weld. This ensures that the catheter is maintained within a sterile environment prior to use and also that once the catheter has been used any fluid contained within the bag does not leak out unintentionally.
  • the fluid collection bag may comprise an inlet to allow fluid to enter the bag from the distal end of the catheter and optionally via the sleeve.
  • the inlet may be connected to one end of the sleeve which corresponds to the distal end of the catheter.
  • the inlet may comprise a one-way valve which prevents fluid flow through the inlet from the fluid collection bag to the sleeve and/or catheter.
  • the inlet allows liquid to pass into the fluid collection bag but optionally may prevent fluid flow out of the bag and into the sleeve. This can reduce the likelihood of leaking.
  • the catheter assembly may be configured to allow fluid to pass directly from the sleeve to the inlet and/or directly from the catheter to the inlet.
  • One lateral side (e.g. a right lateral side) of the catheter may be attached to one side (e.g. a right side) of the inlet.
  • the distal end of the catheter may be within the inlet.
  • the sleeve may be sealed around a periphery of the inlet. As such, fluid travelling within the sleeve is directed into the inlet directly via the gap.
  • fluid travelling within the catheter passes out the distal end and into the inlet.
  • the catheter may be positioned differently and may be attached, for example, to the left side of the inlet.
  • the catheter assembly may be configured to allow fluid to pass from the catheter into the sleeve.
  • One lateral side (e.g. a right lateral side) of the catheter may be attached to a side (e.g. right side) of the sleeve.
  • a distal end of the catheter may be within the sleeve.
  • a distal end of the catheter may not be within the inlet.
  • the sleeve may be sealed around a periphery of the inlet. As such, fluid travelling within the sleeve is directed into the inlet directly and fluid travelling within the catheter passes out the distal end into the sleeve and then from there into the inlet.
  • the catheter may be positioned differently and may be attached to a left side of the sleeve (or indeed a front side or rear side). Furthermore, the distal end of the catheter may be blocked and an outlet may be provided in a lateral side of the catheter to allow fluid to pass out into the sleeve.
  • the catheter assembly may be configured to allow fluid to pass from the sleeve into the catheter.
  • One lateral side (e.g. a right lateral side) of the catheter may be attached to one side (e.g. a right side) of the inlet.
  • the inlet may be sealed around the catheter on all sides. Consequently, there may be no gap between the inlet and the catheter. As such, fluid may only pass from the sleeve/catheter into the inlet if it is within the catheter.
  • a side, e.g. a lateral side of the catheter may comprise a sleeve intake opening.
  • the sleeve intake opening may be any suitable shape such as oval or circular.
  • the sleeve intake opening may be adjacent to the inlet.
  • the sleeve intake opening may permit the passage of fluid from the sleeve into the catheter.
  • fluid may enter the catheter from the sleeve to join fluid travelling within the catheter. From here, the fluid may pass out the distal end of the catheter and into the inlet.
  • the sleeve may be attached to the outer sides of the catheter itself.
  • the inlet of the fluid collection bag may be positioned at a comer of the peripheral bond.
  • the fluid collection bag may comprise a neck adjacent to the inlet.
  • the neck may comprise one or more projections extending into the fluid collection bag.
  • the one or more projections may comprise regions of the peripheral bond that extend into the bag.
  • the one or more projections may restrict fluid flow through a region of the bag adjacent to the inlet.
  • the projections may be configured to provide gripping points adjacent to the inlet.
  • any one or more of the one or more projections may have any one or more of the features of a projection as described below.
  • a projection may have any suitable size or shape.
  • a projection may be triangular, square, rectangular, circular, ellipsoidal or irregularly shaped, preferably, a projection is triangular.
  • a point on the projection furthest from an edge of the bag may be a (right-angled) comer in the projection.
  • the projection may be a right- angled triangle.
  • the hypotenuse of the projection may be aligned parallel to an edge of the bag.
  • the projections can be suitably shaped to minimise loss of volume in the bag due to the projections.
  • its shape can help to direct fluid flow within the bag, for example assisting flow into the bag and reducing flow out of the bag.
  • a projection may extend along no more than 90%, 80%, 70%, 60%, 50%, 40%, 30%, 20% or 10% of the length of an edge of the bag.
  • a projection may extend by at least 10%, 20%, 30%, 40%, 50%, 60%, 70%, 80%, or 90% of the length of an edge of the bag.
  • a projection may comprise a corner of the bag.
  • a projection may not comprise from a comer of the bag. Thus, the projections can be flexibly sized and positioned to be most effective.
  • a projection may be a lateral projection extending from a left (or right) lateral edge of the bag.
  • the lateral projection may be provided on the same side of the bag as the inlet.
  • the lateral projection may extend along 10-40% of the length of the lateral edge of the bag, preferably 25%.
  • the lateral projection may extend across 5- 20% of the width of the bag, preferably 10%.
  • the lateral projection may be a right- angled triangle.
  • the right-angled vertex of the lateral projection may project into the bag.
  • the right-angled vertex may be positioned below the inlet inside the bag.
  • the right-angled vertex may be positioned 10% of the way from the upper edge to the base of the bag.
  • the non-right- angled vertices of the lateral projection may be provided on the lateral edge of the bag from which the lateral projection extends.
  • the lateral projection can assist in directing the flow of fluid into the bag and also helps prevent fluid flowing directly from the bag back up into the sleeve/catheter.
  • a projection may be an end projection extending from the upper edge or base of the bag. Preferably, the end projection extends from the upper edge. The end projection may be provided adjacent to the inlet. The end projection may extend along 40-95% of the width of the bag, preferably 90%. The end projection may extend from a comer of the bag. The end projection may extend down 5-20% of the length of the bag, preferably 10%. The end projection may be a right-angled triangle. The right-angled vertex of the end projection may project into the bag. The right- angled vertex may be positioned adjacent the inlet inside the bag. The right-angled vertex may be positioned 20% of the way across the width of the bag.
  • the non-right- angled vertices of the lateral projection may be provided on the edge of the bag from which the end projection extends.
  • the end projection can assist in directing the flow of fluid into the bag and also helps prevent fluid flowing directly from the bag back up into the sleeve/catheter.
  • the fluid collection bag comprises both a lateral projection and an end projection extending from the upper edge of the bag as described above.
  • the two projections work together to assist the user in handling the bag and also to manage fluid flow into/out of the bag.
  • a projection may comprise a rib.
  • the rib may resist bending or deformation in a given direction.
  • the rib may facilitate folding of the fluid collection bag.
  • the rib may assist the user in grasping or gripping the bag.
  • the strengthening element may comprise a region of the projection that is thicker or thinner than the rest of the projection.
  • the rib may be any suitable shape or size, such as a line which could be straight or curved.
  • the rib may extend across the projection.
  • the rib may extend from an edge of the bag.
  • the rib may extend from a midpoint of the projection along the edge of the bag.
  • the rib may extend to a point on the projection furthest from the edge of the bag, for example a right-angled vertex of a right-angled projection.
  • the rib may be at an angle (i.e. not parallel or perpendicular to) an edge of the bag.
  • the lateral projection may comprise a rib.
  • the mechanical properties of the projection can be controlled through use of a rib to the benefit of the user.
  • a projection may be a join that is independent from the peripheral bond of the fluid collection bag.
  • a join may have any one or more of the features of a projection as described herein.
  • a join can be beneficial to reduce the total area of the panels of the fluid collection bag that are sealed together.
  • the fluid collection bag may comprise a finger hole.
  • the finger hole may be sized to allow a user to put their finger through the finger hole and handle the bag. Thus the finger hole allows the bag to be handled more easily by a user.
  • the finger hole may be provided at an edge of the bag.
  • the finger hole may be provided in the peripheral bond of the bag.
  • the finger hole may be provided at a corner of the bag.
  • the finger hole may be provided at any of the following comers: where the left lateral edge meets the base; where the base meets the right lateral edge; where the right lateral edge meets the upper edge; or where the upper edge meets the left lateral edge.
  • the peripheral bond may be shaped to accommodate the finger hole.
  • the peripheral bond may truncate a corner of the bag to accommodate the finger hole.
  • the peripheral bond may project into the bag to accommodate the finger hole.
  • the fluid collection bag may comprise a series of ridges or otherwise easily gripped surface or feature in the place of the finger hole to allow the bag to be easily handled.
  • the fluid collection bag may comprise more than one finger hole, for example at least two, three or more finger holes.
  • One, two, three or more, or each finger hole may have any one or more of the features of the finger hole described above.
  • the finger hole may be provided in a projection of the fluid collection bag.
  • the end projection as described above comprises a finger hole.
  • the finger hole may be positioned adjacent to the right-angled vertex of the end projection.
  • the one or more finger holes may be configured to allow the bag to be rotated to a horizontal position wherein the base of the bag is aligned vertically.
  • the fluid collection bag comprises a finger hole at either end of the right lateral edge, and/or a finger hole at either end of the left lateral edge, and/or a finger hole along the upper edge and a finger hole along the base.
  • this allows the bag to be rotated in a controlled manner which aids with handling and using the bag.
  • the fluid collection bag may comprise a fill level indicator.
  • the fill level indicator may comprise fill markers.
  • the fill markers may allow the user to measure the volume of fluid contained within the fluid collection bag.
  • the fill markers may be regularly spaced or irregularly spaced.
  • the fill markers may correspond to an absolute volume of liquid contained within the bag.
  • the fill markers may correspond to a proportion of the volume of the bag which is filled with fluid.
  • the fill markers may indicate when a safe fill level of the bag has been reached.
  • the fill level indicator may be positioned in a transparent or translucent region of the bag. Thus, the fill level indicator ensures the bag is not overfilled.
  • the sleeve may comprise a reservoir adapter.
  • An end of the sleeve may comprise a reservoir adapter.
  • the reservoir adapter may be configured to engage the fluid reservoir.
  • the reservoir adapter may be configured to receive wetting fluid from the fluid reservoir.
  • the reservoir adapter may be configured to detach from the fluid reservoir.
  • the reservoir adapter may be configured
  • catheter assembly comprising a fluid reservoir, a catheter which comprises a proximal end for insertion into the body and a distal end, and a sleeve extending from the proximal end to the distal end, wherein an end of the sleeve comprises a reservoir adapter configured to: engage the fluid reservoir; receive a wetting fluid from the fluid reservoir into the sleeve to wet the catheter; and detach from the fluid reservoir to permit the catheter to pass through the reservoir adapter.
  • the catheter assembly may be a packaged catheter assembly comprising a pouch containing the fluid reservoir and catheter.
  • a packaged catheter assembly comprising a fluid reservoir, a catheter, and a pouch containing the fluid reservoir and catheter, wherein the catheter comprises a proximal end for insertion into the body, a distal end, and a sleeve extending from the proximal end to the distal end, wherein an end of the sleeve comprises a reservoir adapter configured to: engage the fluid reservoir; receive a wetting fluid from the fluid reservoir into the sleeve to wet the catheter; and detach from the fluid reservoir to permit the catheter to pass through the reservoir adapter.
  • wetting fluid is efficiently and easily introduced to wet the catheter as the reservoir adapter retains the fluid reservoir at one end of the sleeve. This ensures that wetting fluid is not wasted and also that wetting fluid is less likely to leak out and wet the external surface of the sleeve or pouch which may cause discomfort for the user.
  • the sleeve may comprise a proximal end and a distal end corresponding to the proximal end and distal end of the catheter respectively.
  • the proximal end of the sleeve may comprise the reservoir adapter.
  • the reservoir adapter may be positioned at or adjacent to the proximal end of the catheter.
  • the reservoir adapter may tubular.
  • the reservoir adapter may comprise a bore therethrough.
  • the bore may be sized to allow the catheter to pass through the reservoir adapter.
  • the bore may be sized to allow the catheter and wetting fluid to pass through the reservoir adapter.
  • the reservoir adapter may be configured to inhibit passage of the catheter through the reservoir adapter/bore while the fluid reservoir is engaged by the reservoir adapter.
  • the fluid reservoir may be configured to block the catheter from passing through the reservoir adapter/bore.
  • the fluid reservoir may be configured to block the catheter from passing through the reservoir adapter/bore if the fluid reservoir is engaged by the reservoir adapter.
  • the reservoir adapter may comprise a distal end corresponding to an end of the reservoir adapter attached to the sleeve.
  • the distal end may be circular or cylindrical.
  • the distal end may have an annular cross-section.
  • the distal end may comprise an internal diameter sized to allow the catheter and wetting fluid to pass therethrough.
  • the distal end may have an outer structure that is any shape and optionally does not correspond to the shape of the inner structure.
  • the reservoir adapter may be configured to engage the fluid reservoir by any suitable means, such as push-fit, bayonet fit, or screw-fit engagement.
  • the reservoir adapter may have an internal size and shape that matches the fluid reservoir. Thus, the fluid reservoir may be easily push-fit into the reservoir adapter.
  • the fluid reservoir may be a sachet.
  • the fluid reservoir may be any suitable shape or size, such as square, rectangular, circular, ellipsoidal or irregularly shaped.
  • the fluid reservoir is elongate and optionally rectangular.
  • the reservoir adapter may be configured to engage a first end of the fluid reservoir.
  • the fluid reservoir may comprise a second end distal the first end.
  • the fluid reservoir may have a length defined as the distance between the first end and the second end.
  • the length of the fluid reservoir may be at least 50mm, at least 60mm, at least 70mm, at least 80mm, at least 90mm, at least 100mm, at least 120mm or at least 140mm.
  • the length of the fluid reservoir may be no more than 160, 150, 140, 120, 100, 90 or 80mm.
  • the length of the fluid reservoir may be between 120 and 150mm, e.g. 140mm, which is typical for fluid reservoirs used for male intermittent catheters.
  • the length of the fluid catheter may be between 70 and 90mm, e.g. 80mm. This length is typical for female intermittent catheters, but, because of the provision fo the reservoir adaptor, which ensrues that wetting fluid is not wasted, may be suitable even for male catheters (which are much longer than female catheters).
  • the reservoir adapter may be configured to extend around the first end of the fluid reservoir.
  • the reservoir adapter may be configured to extend along the fluid reservoir.
  • the reservoir adapter may be configured to extend along at least 10%, 20%, 30%, 40% or 50% of the length of the fluid reservoir.
  • the reservoir adapter may be configured to extend along no more than 60%, 50%, 40%, 30% or 20% of the length of the fluid reservoir.
  • the reservoir adapter is configured to extend along a third of the length of the fluid reservoir.
  • the reservoir adapter may comprise a proximal end distal from the sleeve.
  • the proximal end may be configured to receive and/or retain the fluid reservoir.
  • the proximal end may extend around and along the fluid reservoir as described above. Where the fluid reservoir is a rectangular sachet, the proximal end may comprise an elliptical annular cross-section.
  • the fluid reservoir is engaged in a push- fit/interference fit with the reservoir adapter.
  • the reservoir adapter may comprise a midsection between the proximal end and distal end.
  • the proximal end may be tapered, for example where the proximal end and distal end are different shapes/sizes.
  • the proximal end may have a larger diameter than the distal end.
  • the midsection may be configured to funnel wetting fluid towards the proximal end of the reservoir adapter.
  • the midsection may comprise a convex surface. Thus, the midsection aids handling of the reservoir adapter by the user and also helps ensure wetting fluid passes through the reservoir adapter onto the catheter.
  • the reservoir adapter may comprise a handling element.
  • the handling element may be configured to allow the user to move at least part of the sleeve along the catheter, preferably the proximal end of the sleeve.
  • the reservoir adapter/handling element may have a higher rigidity than the sleeve and/or catheter.
  • the reservoir adapter/handling element may comprise high density polyethylene (HDPE).
  • HDPE high density polyethylene
  • the reservoir adapter may comprise an inserter tip.
  • the inserter tip may disposed at the proximal end of the reservoir adapter distal from the sleeve.
  • the inserter tip may be configured to guide the passage of the catheter into the body.
  • the reservoir adapter can be used by the user to ensure comfortable, safe and efficient use of the catheter.
  • the fluid reservoir may comprise an activation marker.
  • the fluid reservoir may be configure to release wetting fluid upon activation of the activation marker.
  • the activation marker may be on a surface of the fluid reservoir.
  • the activation marker may comprise a region of the fluid reservoir that is identifiable to the user, for example through visual and/or tactile feedback.
  • the activation marker may be located at a position on the fluid reservoir that is not enclosed by the reservoir adapter when the fluid reservoir is engaged by the reservoir adapter.
  • the activation marker may be at least visually recognisable, for example a different colour, or pattern, to the fluid reservoir.
  • the activation marker is easily recognisable while the fluid reservoir is engaged by the reservoir adapter.
  • the fluid reservoir may be configured to break to release wetting fluid, for example by creating a tear in the fluid reservoir.
  • the fluid reservoir may be configured to break at a point enclosed by the reservoir adapter when the fluid reservoir is engaged by the reservoir adapter.
  • the reservoir adapter and/or fluid reservoir may comprise a sealing element.
  • the sealing element may be configured to prevent wetting fluid from passing out of the proximal end of the reservoir adapter.
  • the sealing element may be configured to provide resistance to movement of the reservoir adapter with respect to the fluid reservoir.
  • the sealing element may comprise an O-ring provided on an internal surface of the reservoir adapter and/or an O-ring provided on an external surface of the fluid reservoir.
  • the fluid reservoir may be secured to the pouch, e.g. secured by adhesive, by a weld, or by other means. As such, the fluid reservoir may be retained in the pouch after wetting, preventing misuse, e.g. by users taking the fluid reservoir out, pulling back the sleeve and seeking to wet the catheter manually.
  • the catheter assembly may comprise a jacket surrounding the fluid reservoir.
  • the jacket may be configured to receive a wetting fluid from the reservoir.
  • the jacket may be configured to direct wetting fluid into the sleeve to wet the catheter.
  • a catheter assembly comprising a fluid reservoir and a catheter, the catheter having a proximal end for insertion into the body, a distal end, and a sleeve extending from the proximal end to the distal end; the assembly further comprising a jacket surrounding the fluid reservoir, the jacket being configured to receive a wetting fluid from the fluid reservoir and direct the wetting fluid into the sleeve at the proximal end to wet the catheter.
  • the provision of a jacket around the fluid reservoir ensures that the wetting fluid released by the reservoir is directed efficiently onto the catheter to wet the catheter. This prevents loss/leaks of wetting fluid which can lead to insufficient wetting of the catheter rendering it unsuitable for use and/or causing discomfort/injury to the user during use.
  • the jacket also allows more design freedom in relation to the fluid reservoir and catheter assembly as a whole as the jacket controls the delivery of fluid to the sleeve/catheter. This allows the fluid reservoir/catheter assembly to be more user friendly.
  • the reservoir adapter may be configured to engage the jacket.
  • the reservoir adapter may engage the fluid reservoir via the jacket.
  • the reservoir adapter may be configured to receive wetting fluid from the fluid reservoir via the jacket.
  • the jacket may be configured to block the catheter from passing through the reservoir adapter (until the jacket is detached from the reservoir adapter).
  • the reservoir adapter may be configured to detach from the jacket (to allow the catheter to pass through the reservoir adapter).
  • the jacket can provide a more flexible engagement between the reservoir adapter and fluid reservoir, for example, where the fluid reservoir is an inappropriate size to directly engage with the reservoir adapter.
  • the jacket may comprise a wetting aperture.
  • the wetting aperture may be arranged at a position corresponding to a part of the fluid reservoir that is enclosed by the reservoir adapter.
  • the wetting aperture may be arranged at an end of the fluid reservoir, preferably the first end referred to above.
  • the wetting aperture may be configured to direct wetting fluid into the sleeve and/or onto the catheter.
  • the wetting aperture helps ensure that wetting fluid released by the fluid reservoir is directed into the sleeve.
  • the fluid reservoir may be configured to rupture before the jacket.
  • the jacket may be configured not to rupture under compression.
  • the wetting aperture may be configured to allow fluids to exit and enter the jacket. Thus, the jacket remains intact when the user pinches the fluid reservoir to rupture it as any pressure build up is relieved through the wetting aperture.
  • the jacket may be impermeable to fluids, for example impermeable to liquid, in particular impermeable to water.
  • the jacket may be formed of a material that is impermeable to fluids.
  • the jacket may be formed from a flexible plastics material, for example a thermoplastic polyurethane (TPU) or low-density polyethylene (LDPE).
  • TPU thermoplastic polyurethane
  • LDPE low-density polyethylene
  • the jacket may be formed of a transparent or translucent material.
  • the jacket may be formed of an opaque material.
  • the jacket may comprise a window of transparent or translucent material at a position corresponding to the activation marker of the fluid reservoir.
  • the jacket may comprise an activation marker.
  • the activation marker may be on a surface of the jacket.
  • the activation marker may comprise a region of the jacket that is identifiable to the user, for example through visual and/or tactile feedback.
  • the activation marker may be located at a position on the jacket corresponding to a position of the fluid reservoir which when pressed will cause the reservoir to rupture.
  • the activation marker may be in a position corresponding to the activation marker positioned on the fluid reservoir.
  • the jacket may be formed from two strips of material joined about their edges. Each strip of material may have a shape corresponding to the shape of the fluid reservoir.
  • the wetting aperture may comprise a section around the edge of the jacket where the two strips of material are not joined together.
  • the wetting aperture may comprise a section of the jacket which has been cut or punched to form the wetting aperture.
  • the jacket may be secured to the pouch, e.g. secured by adhesive, by a weld, or by other means. As such, the jacket and the fluid reservoir within may be retained in the pouch after wetting, preventing misuse, e.g. by users taking the fluid reservoir out, pulling back the sleeve and seeking to wet the catheter manually.
  • the invention also concerns a packaged catheter assembly comprising a pouch and the catheter assembly, wherein the pouch is configured to contain the catheter assembly within it.
  • the fluid collection bag may be arranged within the pouch.
  • the pouch may comprise an interaction region to form an opening in the pouch and allow the catheter and fluid collection bag to be removed from the pouch.
  • the fluid collection bag may be arranged adjacent to the opening.
  • a packaged catheter assembly comprising a catheter, a pouch, and a fluid collection bag configured to receive fluid from the catheter in use, wherein: the catheter and fluid collection bag are arranged within the pouch; the pouch comprises an interaction region to form an opening in the pouch and allow the fluid collection bag and catheter to be removed from the pouch; and the fluid collection bag is arranged adjacent to the opening.
  • the fluid collection bag protects the catheter from coming into contact with dirt as the pouch is opened and also helps prevent the user from accidentally touching the catheter during opening of the pouch. This helps to reduce risk of infection during use of the pouch as the catheter is less likely to be dirty.
  • the fluid collection bag may be provided in a stowed configuration, preferably while inside the pouch.
  • the fluid collection bag may be configured to remain in the stowed configuration.
  • the fluid collection bag In the stowed configuration, the fluid collection bag may be folded or rolled to reduce its size in any one dimension.
  • the stowed configuration may be a folded or rolled configuration.
  • the fluid collection bag In the stowed configuration, the fluid collection bag may be cylindrical in shape.
  • the stowed configuration of the fluid collection bag further inhibits fluid flow onto the exterior surface of the fluid collection bag as it must penetrate between folds.
  • the pouch may comprise a flexible plastics material.
  • the pouch is formed of a flexible plastic film or sheet.
  • PP polypropylene
  • PET polyethylene terephthalate
  • LDPE low density polyethylene
  • MET PET metalized polyester
  • OPP orientated polypropylene
  • the pouch may comprise two walls (a front wall and a rear wall) and a peripheral seal between the two walls.
  • the walls may be formed of a flexible plastic film or sheet.
  • the peripheral seal may provide a sterile seal.
  • the pouch may maintain the sterility of its contents.
  • the peripheral seal may form one or more edges of the pouch.
  • the peripheral seal may comprise a left lateral edge, right lateral edge, an upper edge and a base of the pouch.
  • the left and right lateral edges may be defined as the left and right edges when viewing the pouch with the front wall in front of the rear wall, the base at the bottom and the upper edge at the top.
  • the pouch may be any suitable shape such as circular, elliptical, triangular, tubular, prismatic or polygon, preferably the pouch is rectangular.
  • the pouch may have a width defined as the distance between the left lateral edge and right lateral edge of the pouch, the width preferably being at least 60, 70, 80, 90 or 100 mm.
  • the pouch may have a width of no more than 110, 100, 90, 80, or 70 mm.
  • the width is between 90 and 110 mm, and most preferably about 100 mm.
  • the pouch may have a height defined as the distance between the upper edge and base, the height preferably being at least 100, 125, 150, 175, 200 or 225 mm.
  • the pouch may have a height of no more than 250, 225, 200, 175, 150, or 125 mm.
  • the height is between 120 and 140 mm, and most preferably it is about 130 mm.
  • the peripheral seal may comprise any one or more of: a weld; mechanical seal; heat seal; pressure seal; adhesive; solvent bond; ultraviolet bond; ultrasonic weld; laser weld; impulse weld; or friction weld.
  • the peripheral seal may be re- sealable, for example through a resealable adhesive, an additional adhesive that is activated prior or during resealing, or a hook and loop/hook and hook fastener.
  • the peripheral seal can be easily constructed to suit the specific needs of the pouch.
  • One edge of the pouch may comprise a folded edge.
  • a folded edge may comprise a fold between the two walls. All edges other than the folded edge may be formed by the peripheral seal.
  • the pouch may be formed by folding the two walls to form the folded edge.
  • the pouch can be flexibly constructed from folding material if required.
  • the pouch may comprise an interaction region defining a first point of contact for a user of the packaged catheter assembly.
  • the interaction region may facilitate user access to the contents of the pouch. Actuation of the interaction region may create an opening in or near an upper edge of the peripheral seal. The catheter may be withdrawn through the opening.
  • access to the pouch is provided at or near an upper edge of the pouch and as such, the fluid in the pool adjacent the base of the pouch is retained in the pouch while the catheter is withdrawn reducing the risk of spilling fluid outside the pouch.
  • the interaction region may comprise a breakable region of the peripheral seal.
  • the breakable region may comprise a tear-away region which may comprise a tear line defining a line along which the pouch may be tom to at least partially separate the tear-away region from the remainder of the pouch, thereby creating an opening in the peripheral seal.
  • the fluid collection bag may be arranged adjacent to the tear line.
  • the tear-away region may comprise a tear start.
  • the tear start may be provided at a first end of the tear-away region.
  • the tear start may comprise a notch, or area of weakness, in one or both of the walls of the pouch.
  • the tear start may define the first part of the pouch to be tom.
  • the tear-away region may comprise a tear stop.
  • the tear stop may be provided at a second end of the tear-away region.
  • the tear stop may act to prevent or reduce the likelihood of the tear-away region being completely separated from the remainder of the packaging.
  • a tear line may be defined between the tear start and the tear stop.
  • the tear line may be configured to preferentially tear.
  • the tear line may comprise a weakened region of the pouch.
  • the tear line may be formed by any suitable means, such as laser scoring. Thus the breakable region provides a convenient and easy means to open the pouch with minimal effort and no additional equipment/tools.
  • the tear-away region may be substantially triangular in shape having a sloped upper edge.
  • the tear-away region may be tapered.
  • the tear-away region may extend upwards more on one side than the other, preferably the tear-away region extends upwards more on the side corresponding to the tear start.
  • the tear-away region may extend upwards no more than 200%, 100%, 75%, or 50% more on one side than the other.
  • the tear-away region may extend upwards at least 25%, 50%, 75%, 100%, or 150% more on one side than the other.
  • the tear-away region extends upwards 50% more on one side than the other.
  • the tear-away region is conveniently shaped to guide the user to grasp it on one side to open the pouch and also provides sufficient material for the user to securely grasp it on that side.
  • the interaction region may comprise an aperture.
  • the aperture may be sized to allow a finger to pass through and grip the interaction region.
  • the aperture is located in the tear-away region.
  • the aperture may be located on the same side of the pouch as the tear start.
  • the aperture may be located adjacent to the tear start.
  • the aperture may be any suitable shape, for example, circular, elliptical, square or irregularly shaped.
  • the aperture is circular.
  • the pouch may be formed from an opaque material.
  • the pouch may have a textured or printed fabric-like appearance and/or feel. Where the pouch is opaque, the pouch may comprise a wetting marker to assist the user in locating the fluid reservoir within the pouch.
  • the pouch is more comfortable and discreet for the user to carry in day-to-day life and the user can easily find and activate the fluid reservoir.
  • An axis parallel to the longest dimension of the stowed fluid collection bag may be arranged parallel to the tear line of the pouch and/or the opening formed in the pouch. This helps to protect the contents of the pouch from dirt when opening the pouch as the fluid collection bag provides an additional fluid impermeable barrier.
  • a first end of the stowed fluid collection bag (for example the inlet) may be arranged adjacent to one lateral edge of the pouch, or a first end of the opening.
  • a second end of the stowed fluid collection bag (distal the first end) may be arranged adjacent a second end of the opening.
  • the first end of the stowed fluid collection bag may be arranged adjacent to the tear start.
  • the fluid collection bag is positioned to ensure the distal end of the catheter is arranged along the same side of the pouch as the tear start. This helps the catheter to be withdrawn in a smooth and straight pulling action parallel to the lateral edge of the bag which reduces the force required to remove the catheter from the pouch.
  • the fluid collection bag may be configured to be withdrawn through the opening before the catheter.
  • the fluid collection bag may be configured to withdraw the catheter from the pouch.
  • the fluid collection bag facilitates removal of the catheter from the pouch without the user having to touch the catheter.
  • the fluid collection bag may be arranged to span across a majority of the width of the pouch.
  • the fluid collection bag may span at least 50%, 60%, 70%, 80%, or 90% of the width of the pouch.
  • the fluid collection bag forms a barrier across the opening in the pouch and protects the contents of the pouch.
  • the fluid collection bag may be arranged closer to the upper edge of the pouch than the base.
  • the fluid collection bag may be arranged at least 1/2, 2/3, 3/4 or 4/5 of the way from the base to the upper edge of the pouch.
  • the fluid collection bag is arranged in the upper region of the pouch and close to the opening.
  • the fluid collection bag may obscure the catheter from the opening.
  • the fluid collection bag may be arranged to span across a majority of the opening.
  • the fluid collection bag may span at least 50%, 60%, 70%, 80%, or 90% of the opening.
  • the fluid collection bag may obscure the rest of the contents of the bag from the opening. Thus, the user is less likely to see and then immediately grasp or touch the catheter itself.
  • the fluid collection bag may be configured to separate the two walls of the pouch.
  • the fluid collection bag may be configured to separate the two walls of the pouch at the opening of the pouch.
  • the inlet of the fluid collection bag may be arranged adjacent to one lateral edge of the pouch and/or the opening.
  • the inlet of the fluid collection bag may be arranged on the same side of the pouch as the tear start.
  • the inlet is positioned to ensure the distal end of the catheter is arranged along the same side of the pouch as the tear start. This helps the catheter to be withdrawn in a smooth and straight pulling action parallel to the lateral edge of the bag which reduces the force required to remove the catheter from the pouch.
  • the fluid reservoir may be arranged within the pouch.
  • the fluid reservoir may be arranged with its length parallel to one edge of the pouch. Preferably, the length of the fluid reservoir is parallel to the left and/or right lateral edge of the pouch.
  • the fluid reservoir may be arranged adjacent to one edge of the pouch.
  • the fluid reservoir is arranged adjacent to the same edge of the pouch that the fluid reservoir’s length is parallel to.
  • the fluid reservoir is conveniently located against an edge of the pouch where it does not take up too much space.
  • the catheter may be arranged within the pouch in a shape having two opposing turns of at least 180 degrees along the catheter’s length
  • a packaged catheter assembly comprising a pouch and a catheter arranged within the pouch, wherein the catheter is arranged within the pouch in a shape having two opposing turns of at least 180 degrees along the catheter’s length.
  • the pouch may comprise two walls and a peripheral seal between the two walls (as described above). Accordingly, in a fifth aspect of the present invention there is provided a packaged catheter assembly comprising a pouch having two walls and a peripheral seal between the two walls and a catheter arranged within the pouch, wherein the catheter is arranged within the pouch in a shape having two opposing turns of at least 180 degrees along the catheter’s length.
  • the catheter is arranged in an “S-shape” which helps to retain the catheter (and anything connected to it) in a specific orientation while sealed within the pouch. This ensures the catheter is easy to remove from the pouch and use. In addition, it helps to protect the catheter from damage for example by reducing the likelihood of kinks forming along the catheter.
  • the packaged catheter assembly is a packaged catheter assembly according to the second aspect of the invention as the catheter can easily be withdrawn to a straight (i.e. substantially straight) configuration by pulling the distal end of the catheter straight out of the opening of the bag, whilst leaving the proximal end of the catheter in its position. Then, the catheter assembly can be simply inverted and wetting fluid can flow straight down the sleeve. Obviously this approach could be trickier if the catheter were curled up inside the pouch.
  • a packaged catheter assembly comprising a pouch having two walls and a peripheral seal between the two walls and a catheter arranged within the pouch, wherein the catheter is arranged within the pouch in a shape having two opposing turns each of at least 180 degrees along the catheter’s length, wherein the catheter comprises a proximal end for insertion into the body and a distal end, the catheter assembly further comprising a fluid collection bag arranged to receive fluid from the distal end of the catheter, a sleeve enclosing the catheter along the length of the catheter from the proximal end to the distal end, and a fluid reservoir arranged at the proximal end, wherein the fluid reservoir is configured to release wetting fluid into the sleeve to wet the catheter and wherein the sleeve is in fluid communication with the fluid collection bag.
  • the two opposing turns may comprise a first turn and a second turn.
  • the distal end of the catheter may be adjacent to the inner (left or right) lateral edge near the upper edge of the pouch.
  • the catheter may extend down the inside of the pouch.
  • the two opposing turns may comprise a first turn arranged at an end of the pouch distal from an opening formed in the pouch. The first turn may be adjacent the base of the pouch.
  • the catheter may then extend back up the pouch.
  • the catheter may extend back up through a central region of the pouch, i.e. in a central half, third or quarter of the width of the pouch.
  • the catheter may extend in a direction towards the distal end of the catheter.
  • the two opposing turns may comprise a second turn arranged at an end of the pouch adjacent to an opening formed in the pouch. The second turn may be positioned adjacent the fluid collection bag.
  • the second turn may be at a height in the pouch corresponding to the position of the distal end of the catheter.
  • the catheter may then extend down the inside of the pouch.
  • the catheter may extend adjacent to the inner edge opposite the edge adjacent to the distal end of the catheter (i.e. the right or left lateral edge).
  • the proximal end of the catheter may be positioned approximately half the way down the height of the pouch.
  • the catheter may be configured to be withdrawn from the pouch by the distal end of the catheter.
  • the catheter may be configured such that during withdrawal of the catheter from the pouch the radius of curvature of a, or each, turn in the catheter is constant or increases.
  • the two opposing turns may be configured to unravel simultaneously (during withdrawal of the catheter from the pouch).
  • the two opposing turns may be configured to unravel after withdrawal of the catheter from the pouch.
  • a packaged catheter assembly comprising a pouch having two walls and a peripheral seal between the two walls and a catheter arranged within the pouch, wherein the catheter is arranged within the pouch in a shape having two opposing turns each of at least 180 degrees along the catheter’s length wherein the two opposing turns are configured to unravel after withdrawal of the catheter from the pouch.
  • each opposing turn may change during withdrawal of the catheter from the pouch.
  • the first turn may move towards the opening during withdrawal of the catheter from the pouch.
  • the fluid reservoir may have a length of at least 20%, 30% or 40% the height of the pouch.
  • the fluid reservoir may have a length no more than 50%, 40% or 30% the height of the pouch.
  • the fluid reservoir has a length of 30% the height of the pouch.
  • the fluid reservoir may have a width of at least 5%, 10%, 15% or 20% the width of the pouch.
  • the fluid reservoir may have a width of no more than 25%, 20%, 15% or 10% the width of the pouch.
  • the fluid reservoir has a width of 15% the width of the pouch.
  • the fluid reservoir (and reservoir adapter) may extend from the proximal end of the catheter to the base of the pouch.
  • the fluid reservoir may be flexibly shaped and sized to conveniently fit within the pouch while allowing the catheter to remain in its S-shape.
  • A, or each, turn may comprise a turn of at least 180, 190, 200, 210 or 220 degrees.
  • A, or each, turn may comprise a turn of no more than 230, 220, 210, 200 or 190 degrees.
  • a, or each, turn is between 180-220 degrees and most preferably a, or each, turn is 200 degrees. This ensures that the shape of the catheter makes best use of the pouch and that the catheter is protected.
  • A, or each, turn may comprise a constant curvature.
  • a, or each, turn may comprise a variable curvature.
  • A, or each, turn may comprise a radius of curvature of at least 1/5, 1/4 or 1/3 the width of the pouch.
  • A, or each, turn may comprise a radius of curvature of no more than 1/2, 1/3, or 1/4 the width of the pouch.
  • the radius of curvature of a, or each, turn is 1/3 the width of the pouch.
  • A, or each, turn may span at least 1/4, 1/3, 1/2, or 2/3 the width of the pouch.
  • A, or each, turn may span no more than 3/4, 2/3, 1/2, or 1/3 the width of the pouch.
  • a, or each, turn spans 2/3 the width of the pouch.
  • a packaged catheter assembly comprising a pouch having two walls and a peripheral seal between the two walls and a catheter arranged within the pouch, wherein the catheter is arranged within the pouch in a shape having two opposing turns each of at least 180 degrees along the catheter’s length wherein each turn comprises a radius of curvature of at least 1/3 the width of the pouch and no more than 1/2 the width of the pouch.
  • a packaged catheter assembly comprising a pouch having two walls and a peripheral seal between the two walls and a catheter arranged within the pouch, wherein the catheter is arranged within the pouch in a shape having two opposing turns each of at least 180 degrees along the catheter’s length wherein the area enclosed by one, or both, of the two opposing turns is free from obstructions.
  • the catheter assemblies/packaged catheter assemblies of the first to fifth aspects may include any one or more features of a catheter assembly/packaged catheter assembly as defined in broad terms, or according to any other of the first to fifth aspects set out above.
  • the catheter assemblies/packaged catheter assemblies of the first to fifth aspects may comprise any of the optional features of the others of the first to fifth aspects without necessarily including all the features required of them.
  • the disclosure provides for the packaged catheter assembly of the fifth aspect comprising a pouch having two walls and a peripheral seal between the two walls and a catheter arranged within the pouch, wherein the catheter is arranged within the pouch in a shape having two opposing turns of at least 180 degrees along the catheter’s length, further comprising a fluid collection bag comprising an inlet and one or more projections as described in relation to the first aspect.
  • a method of forming a catheter assembly comprising the steps of providing a catheter having a proximal end for insertion into the body and a distal end, arranging a fluid collection bag to receive fluid from the distal end of the catheter, enclosing the catheter along the length of the catheter from the proximal end to the distal end with a sleeve, and arranging a fluid reservoir at the proximal end of the catheter, wherein the fluid reservoir is configured to release wetting fluid into the sleeve to wet the catheter and wherein the sleeve is in fluid communication with the fluid collection bag.
  • the method of the sixth aspect of the invention may be a method of forming the catheter assembly of the first aspect of the invention, which, of course, may include any optional feature outlined above.
  • a seventh aspect of the present invention there is provided a method of forming a packaged catheter assembly comprising the steps of providing a fluid reservoir, a catheter, and a pouch, and arranging the fluid reservoir and catheter within the pouch; wherein the catheter comprises a proximal end for insertion into the body, a distal end, and a sleeve extending from the proximal end to the distal end, wherein an end of the sleeve comprises a reservoir adapter configured to: engage the fluid reservoir; receive a wetting fluid from the fluid reservoir into the sleeve to wet the catheter; and detach from the fluid reservoir to permit the catheter to pass through the reservoir adapter.
  • the method of the seventh aspect of the invention may be a method of forming the packaged catheter assembly of the second aspect of the invention, which, of course, may include any optional feature outlined above.
  • the method may comprise arranging the reservoir adapter at the end of the sleeve.
  • the method may comprise inserting the fluid reservoir into the reservoir adapter so as to block/inhibit the passage of the catheter therethrough.
  • the catheter is protected by the fluid reservoir/reservoir adapter.
  • a method of forming a catheter assembly comprising providing a fluid reservoir surrounded by a jacket and a catheter; wherein the catheter comprises a proximal end for insertion into the body, a distal end, and a sleeve extending from the proximal end to the distal end; wherein the jacket is configured to receive a wetting fluid from the reservoir and direct the wetting fluid into the sleeve at the proximal end to wet the catheter.
  • the method of the eighth aspect of the invention may be a method of forming the catheter assembly of the third aspect of the invention, which, of course, may include any optional feature outlined above.
  • the method may comprise forming the jacket around the fluid reservoir.
  • the method may comprise arranging two strips of material, one on either side of the fluid reservoir.
  • the method may comprise joining the strips of material around their edge to form the jacket with the fluid reservoir within it.
  • the jacket is conveniently formed around the fluid reservoir.
  • the method may comprise forming a wetting aperture in the jacket.
  • the method may comprise providing a reservoir adapter at an end of the sleeve and inserting the jacket (containing the fluid reservoir) into the reservoir adapter.
  • a method of manufacturing a packaged catheter assembly comprising the steps of providing a catheter, a pouch, and a fluid collection bag configured to receive fluid from the catheter in use, arranging the catheter and fluid collection bag within the pouch wherein the pouch comprises an interaction region to form an opening in the pouch and allow the fluid collection bag and catheter to be removed from the pouch, and the fluid collection bag is arranged adjacent to the opening.
  • the method of the ninth aspect of the invention may be a method of manufacturing the packaged catheter assembly of the fourth aspect of the invention, which, of course, may include any optional feature outlined above.
  • the method may comprise arranging the catheter in the pouch and then arranging the fluid collection bag in the pouch. This can ensure the fluid collection bag remains adjacent to the opening.
  • the method may comprise attaching the catheter to an inlet of the fluid collection bag.
  • the method may comprise arranging the inlet on one side of the fluid collection bag.
  • a method manufacturing a packaged catheter assembly comprising providing a pouch having two walls and a peripheral seal between the two walls and a catheter, arranging the catheter within the pouch, and forming two opposing turns of at least 180 degrees along the catheter’s length.
  • the method of the tenth aspect of the invention may be a method of manufacturing the packaged catheter assembly of the fifth aspect of the invention, which, of course, may include any optional feature outlined above.
  • the method may comprise forming a turn in the catheter during the step of arranging the catheter within the pouch.
  • the method may comprise forming two opposing turns in the catheter before arranging the catheter in the pouch.
  • a method of wetting a catheter having a proximal end for insertion into the body and a distal end, the method comprising the steps of releasing wetting fluid from a fluid reservoir at the proximal end of the catheter, into a sleeve that encloses the catheter, allowing the wetting fluid to flow through the sleeve from the proximal end to the distal end, and collecting excess wetting fluid in a fluid collection bag configured to receive fluid from a distal end of the catheter and the sleeve.
  • the method of the eleventh aspect of the invention may be a method of wetting the catheter of the catheter assembly of the first aspect of the invention, which, of course, may include any optional feature outlined above and may be manufactured according to the sixth aspect of the invention.
  • the method may comprise introducing the catheter by its proximal end into the urethra.
  • the method may comprise allowing fluid to pass from the body and into the fluid collection bag via the catheter and/or the sleeve. Consequently, the method may be a method of using a catheter assembly.
  • a method of unpacking a packaged catheter assembly comprising a fluid reservoir, a catheter, and a pouch containing the fluid reservoir and catheter, wherein the catheter comprises a proximal end for insertion into the body, a distal end, and a sleeve extending from the proximal end to the distal end, wherein an end of the sleeve comprises a reservoir adapter configured to engage the fluid reservoir, the method comprising the steps of releasing wetting fluid from the fluid reservoir into the sleeve, and detaching the fluid reservoir to permit the catheter to pass through the reservoir adapter.
  • the method of the twelfth aspect of the invention may be a method of wetting a catheter from the packaged catheter assembly of the second aspect of the invention, which, of course, may include any optional feature outlined above and may be manufactured according to the seventh aspect of the invention.
  • the method may comprise forming an opening in the pouch.
  • the step of releasing wetting fluid may comprise rupturing the fluid reservoir, for example by pressing the activation or wetting marker.
  • the method may comprise allowing fluid to flow through the reservoir adapter.
  • the fluid reservoir may be easily activated to release wetting fluid into the sleeve.
  • the fluid reservoir may be detached from the reservoir adapter after the release of wetting fluid from the fluid reservoir.
  • the catheter is adequately wetted before the fluid reservoir is removed.
  • the method may comprise withdrawing the catheter from the sleeve. Only part of the catheter, preferably including the proximal end of the catheter, may be withdrawn from the sleeve.
  • the method may comprise passing the catheter through the reservoir adapter.
  • the method may comprise bunching the sleeve.
  • the catheter may be withdrawn from the sleeve after it has been wetted.
  • the catheter may be withdrawn from the sleeve after the fluid reservoir has been removed from the sleeve.
  • the fluid reservoir protects the catheter before use, and the catheter is easily withdrawn through the reservoir adapter.
  • the method may comprise introducing the catheter by its proximal end into the urethra.
  • the method may comprise allowing fluid to pass from the body and into the fluid collection bag via the catheter and/or the sleeve. Consequently, the method may be a method of using a catheter assembly.
  • an thirteenth aspect of the present invention there is provided a method of wetting a catheter of a catheter assembly, the catheter assembly comprising the catheter having a proximal end for insertion into the body, a distal end and a sleeve extending from the proximal end to the distal end, and a jacket surrounding a fluid reservoir, the method comprising releasing wetting fluid from the fluid reservoir into the jacket and directing wetting fluid from the jacket into the sleeve at the proximal end of the catheter.
  • the method of the thirteenth aspect of the invention may be a method of unpackaging a packaged catheter assembly of the third aspect of the invention, which, of course, may include any optional feature outlined above and may be manufactured according to the eighth aspect of the invention.
  • the method may comprise activating the fluid reservoir to release wetting fluid via an interaction with the jacket.
  • the method may comprise removing the jacket and fluid reservoir from the sleeve.
  • the method may comprise introducing the catheter by its proximal end into the urethra.
  • the method may comprise allowing fluid to pass out of the body via the catheter. Consequently, the method may be a method of using a packaged catheter assembly.
  • a fourteenth aspect of the present invention there is provided a method of unpackaging a packaged catheter assembly, the packaged catheter assembly comprising a catheter, a fluid collection bag configured to receive fluid from the catheter in use, and a pouch containing the catheter and fluid collection bag, the method comprising using an interaction region to form an opening in the pouch to allow the catheter and fluid collection bag to be removed from the pouch, wherein the fluid collection bag is arranged adjacent to the opening.
  • the method of the fourteenth aspect of the invention may be a method of unpackaging a packaged catheter assembly according to the fourth aspect of the invention and may, of course, include any optional feature outlined above and the packaged catheter assembly may be manufactured according to the ninth aspect of the invention.
  • the method may comprise withdrawing the fluid collection bag from the pouch before the catheter.
  • the method may comprise withdrawing the catheter from the pouch using the fluid collection bag.
  • the method may comprise unfolding the fluid collection bag.
  • the method may comprise handling the fluid collection bag via one or more projections and/or one or more finger holes disposed on the fluid collection bag.
  • the method may comprise measuring the fluid contained in the fluid collection bag via a fill level indicator disposed on the fluid collection bag.
  • the method may comprise introducing the catheter by its proximal end into the urethra.
  • the method may comprise allowing fluid to pass out of the body via the catheter. Consequently, the method may be a method of using a packaged catheter assembly.
  • a method of unpackaging a packaged catheter assembly comprising a pouch and a catheter arranged within the pouch, wherein the catheter is arranged within the pouch in a shape having two opposing turns of at least 180 degrees along the catheter’s length, the method comprising forming an opening in the pouch and withdrawing the catheter from the pouch through the opening.
  • the method of the fifteenth aspect of the invention may be a method of unpackaging a packaged catheter assembly according to the fifth aspect of the invention and may, of course, include any optional feature outlined above and the packaged catheter assembly may be manufactured according to the tenth aspect of the invention.
  • the method may comprise withdrawing the catheter from the pouch by holding it at one end.
  • the method may comprise withdrawing the catheter from the pouch by holding it at a position corresponding to one of the turns.
  • the method may comprise withdrawing the catheter from the pouch by holding it in two places: at one end and at a position corresponding to the second turn, optionally wherein the end and second turn are separated by the other (first) turn. This allows the catheter to be withdrawn in one motion without causing the catheter to be pulled out by one end alone which may damage the catheter by causing the radius of curvature at one of the turns to become so small that the catheter kinks.
  • the method may comprise unravelling the two opposing turns.
  • the method may comprise straightening the catheter.
  • the method may comprise wetting the catheter, for example as described in relation to the eleventh aspect of the invention.
  • the two opposing turns may be unravelled/the catheter straightened before the catheter is wetted.
  • the combination of these aspects is particularly advantageous as the orientation/curvature of the catheter is optimised to ensure wetting fluid can easily flow through the sleeve and wet the full length of the catheter prior to use.
  • the method may comprise introducing the catheter by its proximal end into the urethra.
  • the method may comprise allowing fluid to pass out of the body via the catheter. Consequently, the method may be a method of using a packaged catheter assembly.
  • the methods of the sixth to fifteenth aspects of the present invention may of course individually include any one or more of the features, optional or otherwise, of one another and further may include any one or more of the features, optional or otherwise, of the first to fifth aspects of the present invention.
  • the catheter is preferably a urinary catheter; and/or is an intermittent catheter.
  • the features of aspects of the present invention allow intermittent male urinary catheters to be adequately wetted prior to use which can be more difficult than for other types of catheter which are generally shorter.
  • Figure 1 is a cut-away front view of a first embodiment of a packaged catheter assembly
  • Figure 2 is a cut-away front view of the packaged catheter assembly of Figure 1 where wetting fluid from the fluid reservoir has been released into the sleeve;
  • Figure 3 is a cut-away front view of the packaged catheter assembly of Figure 1 during forming an opening in the pouch;
  • Figure 4 is a cut-away front view of the catheter assembly of Figure 1 where the closed catheter assembly has been removed from the pouch; and Figure 5 is a cut-away view of a first example of the inlet of the closed catheter assembly of Figure 1;
  • Figure 6 is a cut-away view of a second example of the inlet of the closed catheter assembly of Figure 1;
  • Figure 7 is a cut-away view of a third example of the inlet of the closed catheter assembly of Figure 1.
  • Figure 8 is a front view of the reservoir adapter of a second embodiment of a packaged catheter assembly.
  • FIG. 1-4 an embodiment of a packaged catheter assembly 100 is shown.
  • the packaged catheter assembly 100 comprises a pouch 170 containing a fluid collection bag 110, a catheter tube, or “catheter” 120, a sleeve 130, and a fluid reservoir 140 comprising wetting fluid.
  • the catheter 120 has a proximal end 121 for insertion into the body and a distal end 122, and the fluid collection bag 110 is attached to the distal end 122 of the catheter 120 and is arranged to receive fluid from the distal end 122 of the catheter 120, thereby forming a so-called “closed catheter assembly”.
  • the sleeve 130 and fluid reservoir 140 are also attached to the catheter 120 and so are also considered part of the “closed catheter assembly”.
  • the catheter 120 is a male urinary catheter made from a hydrophilic thermoplastic elastomer (TPE).
  • TPE thermoplastic elastomer
  • the sleeve 130 of this embodiment is a thermoplastic polyurethane (TPU) or low-density polyethylene (LDPE). Obviously those skilled in the art will be able to select suitable alternative materials.
  • the sleeve 130 of this embodiment is sized to enclose the catheter 120 along the majority of the length of the catheter 120, and preferably the entire length of the catheter 120.
  • the sleeve 130 comprises a proximal end 131 corresponding to the proximal end 121 of the catheter 120 and a distal end 132 corresponding to the distal end 122 of the catheter 120.
  • the distal end 132 of the sleeve 130 is attached to an inlet 150 of the fluid collection bag 110.
  • the proximal end 131 of the sleeve comprises a reservoir adapter 133.
  • the reservoir adapter 133 is generally tubular with a constant wall thickness and comprises a bore through its entire length.
  • the wall thickness may vary allowing the size/shape of the reservoir adapter to be varied as desired.
  • the reservoir adapter 133 comprises a distal end 133a with annular cross-section where it is attached to the proximal end 131 of the sleeve 130.
  • the distal end 133a comprises an internal diameter sized to allow the catheter 120 and wetting fluid to pass through the reservoir adapter 133 as described further below.
  • the reservoir adapter 133 is configured to releasably engage the fluid reservoir 140, and as such, a proximal end 133c of the reservoir adapter 133 distal from the sleeve 130 is configured to receive and retain the fluid reservoir 140.
  • the reservoir adapter 133 has an internal size and shape that matches the fluid reservoir 140 to allow the fluid reservoir to be push-fit into the reservoir adapter 133. This also allows the fluid reservoir 140 to be easily detached from the reservoir adapter 133 by pulling them apart.
  • the fluid reservoir 140 may be received in a different way, such as through a bayonet or screw type fit, or through use of a temporary adhesive.
  • the fluid reservoir 140 is an elongate rectangular burstable sachet of water.
  • the fluid reservoir 140 is arranged with a first end engaged into the reservoir adapter 133.
  • the reservoir adapter 133 extends around the first end of the fluid reservoir 140 and along the fluid reservoir 140 between 60-20% of the length of the fluid reservoir 140, for example 33%. Consequently, the proximal end 133b of the reservoir adapter 133 comprises a generally elliptical annular cross section to allow an interference fit between the fluid reservoir 140 and reservoir adapter 133.
  • the reservoir adapter 133 also comprises a midsection 133b between the annular distal end 133a and larger elliptical proximal end 133c enclosing the fluid reservoir 140.
  • the midsection 133b is tapered and has a convex shape to assist the user in gripping the reservoir adapter and using it as a handling element for the catheter 120 and/or sleeve 130.
  • the midsection 133b also acts as a funnel to deliver wetting fluid from the fluid reservoir 140 to the catheter 120/sleeve 130.
  • the fluid reservoir 140 is be configured to retain 5 to 50 ml of wetting fluid, for example 12 ml.
  • the fluid reservoir 140 has a height equal to between 20-50% the height of the pouch 170, for example 30%, and a width between 5-25% the width of the pouch 170, for example 15%.
  • the height and width of the pouch 170 are defined as the distance between a base 172a and an upper edge 172d of the pouch, and a left lateral edge 172b and right lateral edge 172c of the pouch 170 respectively and as described in more detail below.
  • the fluid reservoir 140 also comprises a wetting marker 144 configured to allow the user to identify where to activate the fluid reservoir 140 to release wetting fluid.
  • the wetting marker 144 comprises a logo/region of different colour or contrast from the rest of the fluid reservoir 140.
  • the wetting marker 144 is positioned in a region of the fluid reservoir 140 that is not enclosed by the reservoir adapter 133, this allows the user to easily identify the wetting marker 144 and activate the fluid reservoir 140.
  • the wetting marker 144 may provide any suitable visual or tactile indication to assist the user in identifying and activating the fluid reservoir 140 to release wetting fluid.
  • the fluid reservoir 140 is configured to release wetting fluid by rupturing upon depression/compression of the fluid reservoir 140, especially at a position corresponding to the wetting marker 144.
  • the fluid reservoir 140 is configured to rupture and create a tear 141 in the fluid reservoir 140 through which wetting fluid is released.
  • the fluid reservoir 140 is configured to create a tear 141 in locations that are enclosed by the reservoir adapter 133.
  • the reservoir adapter 133 is therefore configured to receive wetting fluid from the fluid reservoir 140 into the sleeve 130 to wet the catheter 120.
  • the reservoir adapter 133 and/or fluid reservoir 140 may comprise a sealing element to prevent wetting fluid from escaping into the pouch 170, for example an O-ring provided around the end of the reservoir adapter 133 that engages the fluid reservoir 140. Such an O-ring may also facilitate the push-fit engagement of the fluid reservoir 140 and reservoir adapter 133.
  • the wetting fluid is water and interacts with the hydrophilic surface of the catheter 120 to render it lubricious.
  • other wetting fluids may be used and they may be polar (e.g. waterbased) or non-polar (e.g. oil-based) depending on the catheter’s surface properties.
  • the fluid reservoir 140 comprises a thermoplastic polyurethane (TPU) or low-density polyethylene (LDPE).
  • the reservoir adapter 133 comprises a relatively rigid material compared to the sleeve 130, fluid reservoir 140 and catheter 120, for example high-density polyethylene (HDPE), and thus provides a handling element to facilitate movement of the proximal end 131 of the sleeve 130 up and down the catheter 120.
  • HDPE high-density polyethylene
  • the pouch 170 is formed from a front wall (not shown - cut away) and rear wall 171 of identical shape and size, and a peripheral seal joining the periphery of the walls to form the pouch 170 and containing its contents (i.e. the closed catheter assembly).
  • the peripheral seal defines a base 172a, a left lateral edge 172b, a right lateral edge 172c and an upper edge 172d of the pouch 170.
  • the left lateral edge 172b and right lateral edge 172c being defined as the left and right sides of the pouch 170 when viewing the pouch 170 with the rear wall 171 behind the front wall, the base 172a at the bottom of the pouch 170 and the upper edge 172d at the top of the pouch 170.
  • the peripheral seal thus defines a pouch 170 that is generally rectangular and suitably has a width between the lateral edges of between 60-110 mm, preferably 90-110 mm, for example about 100mm, and a height from the base 172a to the upper edge 172d of between 100 to 250 mm, preferably 120 to 140 mm, for example about 130 mm.
  • the base 172a defines the bottom of the pouch 170 in use, and the upper edge 172d the top.
  • alternative shapes and sizes could be conceived, such as elliptical or circular walls forming correspondingly shaped pouches, or even a tubular pouch or pouch with more than two walls, e.g. a prism or other polygon.
  • the peripheral seal may be formed from any suitable bonding/sealing methods such as chemical adhesives, chemical bonding, ultrasonic bonding, or mechanical bonding.
  • the pouch 170 may be formed from a single piece of material. The pouch 170 may then be formed by folding this single piece of material along a pouch fold line to form the walls.
  • any number of folds may be used to form the pouch 170. For example, none of the edges may comprise a fold, one edge may comprise a fold (as in the illustrated example), or two or more of the edges may comprise a fold.
  • the pouch 170 is formed from an opaque material and as such provides a discrete package for its contents which can make the user more comfortable in carrying the packaged catheter assembly 100 in day-to-day life.
  • the exterior of the pouch 170 may have a textured or printed appearance, for example a matte appearance, and feel to reduce the impression that it is a medical device.
  • the front and/or rear wall of the pouch may comprise a wetting marker (not shown) which provides a visual/tactile guide to help the user locate the fluid reservoir 140 within the closed pouch and activate it to release wetting fluid.
  • the pouch 170 also comprises an interaction region.
  • the interaction region forms the top part of the pouch 170 and spans between the right lateral edge 172c and left lateral edge 172b.
  • the interaction region is used to provide access to the pouch through/near to the upper edge 172d.
  • the interaction region comprises a tapered tear-away region 175.
  • the tear-away region 175 comprises a tear start 176 at the point the left lateral edge 172b meets the tearaway region 175, a tear stop 177 at a corresponding point on the right lateral edge 172c, and a tear line 178 spanning between the tear start 176 and tear stop 177.
  • the tear line 178 comprises a line of weakness in the walls of the pouch 170, which may be formed by any suitable means but in this embodiment is laser etched.
  • the tear start 176 comprises a notch to provide an area of weakness in the peripheral seal. This allows the tear-away region 175 to be separated from the pouch 170 by tearing the walls apart from the tear start 176 to the tear stop 41 along the tear line 178. Thus the tear is provided beneath the location of the upper edge 172d and thus the pouch 170 may be opened provided access to its contents.
  • the tear stop 177 may comprise a small aperture in the walls to prevent further tearing of the pouch 170.
  • the tear-away region 175 extends upwards on the left side approximately 50% more than it does on the right side.
  • the left side of the tear-away region 175 comprises a circular aperture 179 sized to allow a finger to pass through and grip the tear-away region 175.
  • the front wall and rear wall 171 are sealed to one another over the entire tear-away region 175.
  • other seals such as a zip-lock arrangement, or hook and hook, hook and loop (VELCRO (RTM)) or the like may be used to provide access to the pouch (or to reseal the pouch after opening), and of course, the sizes and shapes set out above are exemplary.
  • the catheter 120 is arranged within the pouch 170 in a curved and S-shaped configuration with two opposing turns of at least 180 degrees along the length of the catheter 120.
  • the distal end 122 of the catheter 120 is arranged adjacent to the inner left lateral edge 172b near the upper edge 172d of the pouch 170.
  • the catheter 120 extends down the inside of the pouch 170 into a first turn adjacent the base 172a of the pouch and then extends back up the pouch 170 towards the distal end 122 of the catheter 120.
  • the catheter 120 then comprises a second turn adjacent the fluid collection bag 110 (as described below) and at a height in the pouch 170 corresponding to the position of the distal end 122 of the catheter 120.
  • the catheter 120 extends down the inner right lateral edge 172c of the pouch 170 with the proximal end 121 of the catheter 120 resting approximately half the way down the height of the pouch 170. As the pouch 170 is otherwise empty, the area enclosed by each turn is free from obstruction.
  • each of the first and second turns in the catheter 120 comprise turns of at least 180 degrees, and preferably 180-220 degrees, for example 200 degrees.
  • Each of the first and second turns has a radius of curvature approximately equal to one third the width of the pouch and as such, each turn spans two-thirds the width of the pouch.
  • the S-shape of the catheter 120 helps to maintain the contents of the pouch 170 in a stable position before use and also protects the catheter 120 from damage, for example kinking, due to mechanical stresses imposed on the pouch 170.
  • the catheter 120 straightens as it is pulled out of the pouch, as described below.
  • the fluid collection bag 110 is provided in a stowed configuration, which in this embodiment is a folded configuration, within the pouch 170 and is retained in the folded configuration by the walls of the pouch 170 which provide compressive pressure to the folded fluid collection bag 110.
  • the fluid collection bag 110 may be retained in the folded configuration by any other suitable means, such as an elastic band, paper band or closure.
  • the folded fluid collection bag 110 is generally cylindrical in shape and is arranged within the pouch 170 just below the tear line 178 and with an axis of the cylindrical folded fluid collection bag 110 approximately parallel to the tear line 178.
  • the inlet 150 of the bag 110 receives the distal end 122 of the catheter 120 adjacent to the left lateral edge 172b of the pouch 170, and the opposite end of the bag 110 is positioned adjacent to the right lateral edge 172c of the pouch 170.
  • the fluid collection bag 110 is therefore arranged adjacent to the opening formed in the pouch 170 by the tearaway region 175 as described further below and spans between the left lateral edge 172b and right lateral edge 172c.
  • the sleeve 130 is arranged around the catheter 120 and covering the majority of the length of the catheter 120.
  • the distal end 132 of the sleeve 130 is attached to the inlet 150 of the fluid collection bag 110, and as described above, the proximal end 131 of the sleeve 130 is attached to the reservoir adapter 133.
  • the reservoir adapter 133 is positioned at the proximal end 121 of the catheter 120 and adjacent the right lateral edge 172c of the pouch 170.
  • the fluid reservoir 140 is engaged by the reservoir adapter 133 and extends from the proximal end 121 of the catheter 120 down the inner right lateral edge 172c of the pouch 170 to the base 172a of the pouch 170.
  • the fluid reservoir of this embodiment is attached to a wall of the pouch, e.g. by adhesive, to prevent it being accidentally removed from the pouch.
  • the fluid reservoir 140 can therefore be activated by pressing the walls of the sealed closed pouch 170 together adjacent the base 172a and right lateral edge 172c.
  • the catheter 120, fluid collection bag, sleeve 130 with reservoir adapter 133 and fluid reservoir 140 may be arranged differently within the pouch 170.
  • the fluid collection bag 110 comprises a front panel 111, a rear panel of identical shape and size (not shown), and a peripheral bond joining the periphery of the panels to form the bag 110.
  • the front panel 111 and rear panel are both transparent or translucent in this embodiment.
  • the peripheral bond defines a base 112, a right lateral edge 113, a left lateral edge 114 and an upper edge 115.
  • the right lateral edge 113 and left lateral edge 114 being defined as the right and left sides of the bag 110 when viewing the bag 110 with the rear panel behind the front panel 111, the base 112 at the bottom of the bag 110 and the upper edge 115 at the top of the bag 110.
  • the peripheral bond thus defines a bag 110 that, when unfolded, is generally rectangular and suitably has a width between the lateral edges of at least 10, 12, 15 or 20 cm.
  • the bag may have a width no more than 25, 20, or 15 cm. Preferably, the width is between 10 and 20 cm, most preferably between 12 and 15 cm.
  • a height from the base 112 to the upper edge 115 may be at least 25, 30, 35 or 40 cm.
  • the height of the bag may be no more than 45, 40, 35 or 30 cm.
  • the height may be between 25 and 40 cm, 30 and 35 cm, or most preferably 33 and 35 cm.
  • the bag may be configured to hold at least 500, 700, or 1000 ml of fluid, and may hold no more than 1000 ml.
  • the base 112 defines the bottom of the bag 110 in use, and the upper edge 115 the top.
  • alternative shapes and sizes could be conceived, such as elliptical or circular panels forming correspondingly shaped bags, or even a tubular bag or bag with more than two panels, e.g. a prism or other polygon.
  • the panels comprise a flexible plastics material, for example polypropylene (PP), polyethylene terephthalate (PET), low density polyethylene (LDPE), metalized polyester (MET PET), orientated polypropylene (OPP) or polyvinyl chloride (PVC).
  • PP polypropylene
  • PET polyethylene terephthalate
  • LDPE low density polyethylene
  • MET PET metalized polyester
  • OPP orientated polypropylene
  • PVC polyvinyl chloride
  • the inlet 150 is positioned at the comer of the peripheral bond where the upper edge 115 and left lateral edge 114 meet.
  • a neck 151 is formed adjacent to the inlet 150 in the bag 110 by the peripheral bond which comprises two triangular projections 117a, 117b into the bag 110, a left edge projection 117a along the left lateral edge 114 and an upper edge projection 117b along the upper edge 115.
  • the left edge projection 117a is a right-angle triangle with its right-angled vertex projecting into the bag 110 and the other vertices along the left lateral edge 114.
  • the left edge projection 117a is approximately one quarter the length of the left lateral edge 114 and begins approximately 10% along the length of the left lateral edge 114 from the upper edge 115.
  • the left edge projection 117a extends from this point approximately 10% across the width of the bag 110 angled slightly below perpendicular to the left lateral edge 114 before turning 90 degrees at the right-angled vertex and returning to meet the left lateral edge 114.
  • the left edge projection 117a also comprises a rib 117c spanning from its right-angled vertex to a point on the left lateral edge 114 and approximately midway along the length of the left edge projection 117a.
  • the rib 117c comprises a region which preferentially folds to help with maintaining the shape of the bag 110 both when folded and unfolded and also makes it easier for a user to grasp/grip the bag 110.
  • the upper edge projection 117b is a right-angle triangle.
  • the right-angled vertex projecting into the bag 110 and the other vertices along the upper edge 115.
  • the upper edge projection 117b is approximately 90% the length of the upper edge 115 and begins approximately 10% along the length of the upper edge 115 from the left lateral edge 114 and ends at the right lateral edge 113.
  • the upper edge projection 117b extends from where it meets the upper edge 115 approximately 10% down the length of the bag 110 angled slightly right of perpendicular to the upper edge 115 before turning through 90 degrees towards the right lateral edge 113 at the right-angled vertex and then returning to meet the right lateral edge 113.
  • the right-angled vertices of the left edge projection 117a and upper edge projection 117b define the narrowest point of the neck 151.
  • the peripheral bond further comprises two finger holes
  • finger holes 116 to allow the bag 110 to be easily handled by a user.
  • One finger hold is positioned in the upper edge projection 117b adjacent to its right-angled vertex.
  • the other finger hole 116 is at the corner of the bag 110 where the right lateral edge 113 meets the base 112, and the peripheral bond truncates the corner of the bag 110 to accommodate this finger hole 116.
  • the finger holes 116 may comprise a series of ridges, or otherwise easily gripped surface or feature to allow the user to easily handle the bag 110.
  • there may be different numbers of finger holes 116 such as only one or more than two, and they may be placed in different locations on the bag 110.
  • the fluid collection bag 110 further comprises a fill level indicator 118 comprising fill markers which allow the user to measure the volume of fluid contained within the fluid collection bag 110. Due to the shape of the bag 110, the cross-sectional area of the bag 110 may vary along the length of the bag 110 from the base 112 to upper edge 115. As such, the fill level indicator may comprise irregularly spaced fill markers to account for this.
  • the fill markers may indicate, either the proportion of the volume of the bag which is filled with fluid, for example 10%, 25%, 50%, 75%, 100% of a safe fill level, or the absolute volume of fluid, for example 100ml, 200ml, 300ml, etc. as required or as is convenient for the user.
  • the packaged catheter assembly 100 is provided with the folded fluid collection bag 110, catheter 120, sleeve 130 and fluid reservoir 140 all contained with the pouch 170 as mentioned above.
  • the user may release the wetting fluid from the fluid reservoir 140 into the sleeve 130. This may be done by any suitable means, but preferably by applying pressure to the outside of the pouch 170 at a region corresponding to the position of the fluid reservoir 140.
  • the user may first remove the fluid collection bag 110, catheter 120, sleeve 130 and fluid reservoir 140 from the pouch 170 (as described below) and then activate the fluid reservoir 140 by pressing the activation marker 144.
  • the fluid reservoir 140 is configured to rupture under external pressure and create a tear 141 in the fluid reservoir 140 at a position that is enclosed by the reservoir adapter 133. As such, the wetting fluid is released into the reservoir adapter 133 where it is able to flow through the bore of the reservoir adapter 133 along the length of the catheter 120 between the catheter 120 and sleeve 130.
  • the user may then access the catheter 120 by creating an opening in the pouch 170 using the interaction region.
  • the aperture 179 is grasped in one hand, and the pouch 170 below the tear line 178 in another, and the tear-away region 175 is tom from the tear start 176 to the tear stop 177 along the tear line 178.
  • the pouch 170 is torn between the left lateral edge 172b and right lateral edge 172c at a location below the upper edge 172d, as such, an opening is formed in the pouch 170 that may be used to access its contents.
  • the tear-away region 175 is fully separated from the pouch 170 to improve access to the contents of the pouch 170.
  • the tearaway region 175 may not be fully separated from the pouch 170 to reduce the number of separate parts and make the pouch 170 easier to handle.
  • Other embodiments may also feature other ways to access the pouch for example a zip-lock seal.
  • the closed catheter assembly i.e. catheter 120 attached to the sleeve 130, reservoir adapter 133, fluid reservoir 140, and fluid collection bag 110
  • the turns may not unravel until after the catheter has been withdrawn from the pouch. This allows the user to more easily remove the catheter in one go, for example by holding the second turn and the fluid collection bag together then pulling the catheter assembly from the pouch.
  • the folded fluid collection bag 110 is easily accessible to the user as it is directly accessible via the opening in the pouch 170. To withdraw the closed catheter assembly from the pouch 170 the user inverts the pouch, so that the fluid collection bag 110 is towards the bottom of the pouch and pulls it downwards out of the pouch 170, at which point the fluid will flow down through the sleeve.
  • the fluid collection bag 110 may then be unfolded so that it is ready to accept fluid from the catheter 120.
  • the catheter 120 may be handled via the sleeve 130 and/or the reservoir adapter 133.
  • the fluid reservoir 140 must be removed from the reservoir adapter 133 to allow the proximal end of 121 of the catheter 120 to be withdrawn from the sleeve 130 and inserted into the body.
  • the fluid reservoir 140 is removed from the reservoir adapter 133 by simply pulling the reservoir adapter 133 out of the pouch and hence away from the fluid reservoir 140 which is retained within the pouch. Now that the fluid reservoir 140 is removed from the reservoir adapter 133, the catheter 120 is able to be passed through the reservoir adapter 133 for use.
  • the fluid reservoir 140 may be actively disengaged by twisting or otherwise activating the reservoir adapter 133 to release the sleeve 130 for example.
  • the steps of releasing wetting fluid into the sleeve 130, unfolding the fluid collection bag 110, and disengaging the fluid reservoir 140 as described above may be performed in any order depending on the construction of the packaged catheter assembly and the preference of the user.
  • the catheter 120 is now ready for use.
  • the sleeve 130 may be used to handle the catheter 120 and the reservoir adapter 133 may be used to progressively introduce the proximal end 121 of the catheter 120 into the urethra until fluid flows through the catheter 120 from the bladder. Fluid flowing through the catheter 120 is collected in the fluid collection bag 110 and the volume of fluid contained in the bag can be monitored using the fill level indicator.
  • the reservoir adapter 133 may be used to cover the length of the catheter 120 with the sleeve 130 and the packaged catheter assembly 100 may then be disposed of.
  • the catheter 120 and sleeve 130 are in fluid communication with the fluid collection bag 110 via the inlet 150.
  • the configuration of the catheter 120, sleeve 130, inlet 150 and bag 110 is relatively flexible and many different configurations could be employed in embodiments of the invention.
  • sleeve 130 and inlet 150 fluid passes directly from the sleeve 130 to the inlet 150 and directly from the catheter 120 to the inlet 150.
  • a right lateral side 123 of the catheter 120 is attached to a right side 155 of the inlet 150 and there is a gap between a left lateral side 124 of the catheter 120 and the respective left side 156 of the inlet 150.
  • the distal end 122 of the catheter 120 is within the inlet 150, and the sleeve 130 is sealed around a periphery of the inlet 150.
  • fluid travelling within the sleeve 2 is directed into the inlet 150 directly via the gap between the left lateral side 124 of the catheter 120 and the left side 156 of the inlet 150.
  • fluid travelling within the catheter 3 passes out the distal end 122 and into the inlet 150 directly.
  • the catheter 120 may be positioned differently and may be attached to the left side 156 of the inlet 150, or to a front or rear side.
  • fluid passes from the catheter 120 into the sleeve 130 and then into the inlet 150.
  • the right lateral side 123 of the catheter 120 is attached to a left side 134 of the sleeve 130 and a distal end 122 of the catheter 120 is not within the inlet 150.
  • the sleeve 130 is sealed around a periphery of the inlet 150. As such, fluid travelling within the sleeve 2 is directed into the inlet 150 directly and fluid travelling within the catheter 3 passes out the distal end 122 into the sleeve 130 and then from there into the inlet 150.
  • the catheter 120 may be positioned differently and may be attached to a left side 135 of the sleeve 130, or indeed to a front or rear side. Furthermore, the distal end 122 of the catheter 120 may be blocked and an outlet (not shown) may be provided in a lateral side of the catheter 120 to allow fluid to pass out into the sleeve 130.
  • fluid passes from the sleeve 130 into the catheter 120 and then into the inlet 150.
  • the configuration of this example is similar to the first example shown in Figure 12 and so only the differences are described.
  • the inlet 150 is sealed between the left side 156 and right side 155 such that the catheter 120 is sealed on all sides.
  • fluid may only pass from the sleeve 130/catheter 120 into the inlet 150 if it is within the catheter 120.
  • the left lateral side 124 of the catheter 120 comprises an oval sleeve intake opening 125 adjacent to the inlet 150 which permits the passage of fluid travelling within the sleeve 3 into the catheter to join fluid travelling within the catheter 2. From here, the fluid 2, 3 passes out the distal end 122 of the catheter 120 and into the inlet 150.
  • the sleeve 130 may be attached to the outer sides of the catheter 120 itself.
  • a second embodiment of a packaged catheter assembly shares many of the features of the first embodiment described above, in particular, the pouch 170, fluid collection bag 110, catheter 220, sleeve 230 and reservoir adapter 233 are identical and so only differences in the features are described below, and like numerals are used to denote like features.
  • the fluid reservoir 240 further comprises a reservoir jacket 242 configured to enclose the fluid reservoir 240.
  • the reservoir jacket 242 comprises an impermeable material, for example, a thermoplastic polyurethane (TPU) or low- density polyethylene (LDPE).
  • the reservoir jacket 242 further comprises a wetting aperture 243 arranged at a position corresponding to the first end of the fluid reservoir 240, that is, the end engaged by the reservoir adapter 233 and closest to the sleeve 230 and catheter 220.
  • the reservoir jacket 242 is therefore configured to direct wetting fluid released from the fluid reservoir 240 into the sleeve 230 and onto the catheter 220 via the wetting aperture 243. This helps ensure that wetting fluid released by the fluid reservoir 240 is directed into the sleeve 230, for example in the situation where the fluid reservoir 240 inadvertently ruptures at a position that is not enclosed by the reservoir adapter 233.
  • the reservoir jacket 242 comprises the wetting aperture 243
  • pressure applied to the fluid reservoir 240 to rupture it does not also rupture the reservoir jacket 242, as any increase in pressure within the reservoir jacket 242 is relieved through the wetting aperture 243.
  • the reservoir jacket 242 remains impermeable to wetting fluid and can direct it into the sleeve 130 irrespective of the location in which the fluid reservoir 140 ruptures.
  • the reservoir jacket 242 is transparent or translucent and allows the activation marker 244 to be visible through the reservoir jacket 242.
  • the reservoir jacket 242 may be opaque or may otherwise obscure the activation marker 244.
  • an activation marker may be placed on the reservoir jacket 244 itself. While the embodiments disclosed above is described as a closed catheter assembly in that fluid is collected in a fluid collection bag, other embodiments may not comprise a fluid collection bag and may be open catheter assemblies in that fluid is not collected during use. The one or more embodiments are described above by way of example only.

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Abstract

L'invention porte sur un ensemble cathéter emballé comprenant une poche ayant deux parois et un joint périphérique entre les deux parois et un cathéter disposé à l'intérieur de la poche. Le cathéter est disposé à l'intérieur de la poche sous une forme ayant deux spires opposées chacune d'au moins 180 degrés le long de la longueur du cathéter. Le cathéter peut être un cathéter urinaire masculin. La zone entourée par une ou chaque spire peut être exempte d'obstruction. Les deux spires opposées peuvent être configurées pour se dérouler uniquement après le retrait du cathéter de la poche. Les spires opposées peuvent avoir un rayon de courbure d'au moins 1/3 de la largeur de la poche et pas plus de 1/2 de la largeur de la poche. L'invention porte également sur un procédé de fabrication d'un ensemble cathéter emballé et de déballage d'un ensemble cathéter.
PCT/GB2023/050671 2022-03-21 2023-03-20 Ensemble cathéter WO2023180702A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
GB2203886.3 2022-03-21
GBGB2203886.3A GB202203886D0 (en) 2022-03-21 2022-03-21 A catheter assembly

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WO2023180702A1 true WO2023180702A1 (fr) 2023-09-28

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Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4230115A (en) * 1978-10-20 1980-10-28 Illinois Tool Works Inc. Catheterization unit
US4925448A (en) * 1988-03-30 1990-05-15 The Cleveland Clinic Foundation Catheter package
US5147341A (en) * 1991-03-05 1992-09-15 Starke Richard N Self contained urinary catheter assembly
US20060025753A1 (en) * 2004-08-02 2006-02-02 Kubalak Thomas P Urinary catheter assembly
US20180169377A1 (en) * 2015-06-26 2018-06-21 Coloplast A/S A Urinary Catheter Assembly
US20200391002A1 (en) * 2017-12-22 2020-12-17 Convatec Limited Catheter wetting devices

Patent Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4230115A (en) * 1978-10-20 1980-10-28 Illinois Tool Works Inc. Catheterization unit
US4925448A (en) * 1988-03-30 1990-05-15 The Cleveland Clinic Foundation Catheter package
US5147341A (en) * 1991-03-05 1992-09-15 Starke Richard N Self contained urinary catheter assembly
US20060025753A1 (en) * 2004-08-02 2006-02-02 Kubalak Thomas P Urinary catheter assembly
US20180169377A1 (en) * 2015-06-26 2018-06-21 Coloplast A/S A Urinary Catheter Assembly
US20200391002A1 (en) * 2017-12-22 2020-12-17 Convatec Limited Catheter wetting devices

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