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
  • A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
  • A61M25/0105—Steering means as part of the catheter or advancing means; Markers for positioning
  • A61M25/0111—Aseptic insertion devices
• • 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
• • 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
  • A61M2210/00—Anatomical parts of the body
  • A61M2210/10—Trunk
  • A61M2210/1078—Urinary tract
  • A61M2210/1085—Bladder
• • 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
  • A61M2210/00—Anatomical parts of the body
  • A61M2210/10—Trunk
  • A61M2210/1078—Urinary tract
  • A61M2210/1089—Urethra

Definitions

• This application concerns closing of the connection between the outlet from a compartment and the inlet to a package in connection with an assembly for wetting a medical device.
• the compartment contains the fluid medium and the package contains the medical device.
• the invention provides a blocking device to be used to close the connection between the outlet and the inlet.
• Urinary catheters are widely used for intermittent catherisation, particularly in connection with operative procedures, where the caregiver is performing the intermittent catherisation, and in connection with spinal cord injuries, where the user is left without control of the bladder.
• the catheters are typically coated with a coating imparting an extremely low friction on the surface of the catheters.
• This coating is normally activated by applying a fluid medium (for example tap water or sterilised water) to the coating - either in the production stage or prior to use. If the coating is activated prior to use, the fluid medium may be provided in a separate compartment with the medical device, thus forming an assembly comprising a package for the medical device and a compartment for the fluid medium.
• a fluid medium for example tap water or sterilised water
• Such assemblies are shown in for example WO2006/092150, which provides an assembly for preparing a medical device, in particular a urinary catheter, by releasing a fluid medium onto the device.
• the device is packed in a package, which contains the fluid medium confined in a compartment.
• DE10334372 provides a catheter system for urine withdrawal, comprising a tube for inserting into the human or animal body, which is provided with a coating that can be activated by means of liquid, and a compartment for containing the liquid, the compartment of which contains a disinfectant dissolved in the liquid.
• UTI Urinary Tract Infections
• the medical device as well as the fluid medium may be sterilised.
• the fluid medium this is particularly the case if the fluid medium is prepacked with the medical device in an assembly. It may be beneficiary to be able to sterilise the medical device and the fluid medium separately, and then attach the closed package containing the medical device and the closed compartment containing the fluid medium to each other after the sterilisation process.
• the fluid medium and the medical device may be sterilised during the assembling process.
• the inlet to the package and the outlet from the compartment may both be covered with a protective liner or barrier film prior to use. Such a barrier film may be removed by pulling at it, thereby reducing the risk of unintended activation of the assembly.
• the barrier film is the only cover of the outlet and the inlet, then, as soon as the barrier film is removed, the fluid medium contained in the compartment may be able to spill out of the compartment.
• the gap between the compartment and the package needs to be closed at least when the barrier film is removed.
• This invention relates to the provision of a gap-closing device (a blocking device) for closing at least the lower part of the gap between the compartment and the package when a cover covering the outlet and inlet is no longer present.
• the gap may be closed at all times or the blocking device may provide for a closure when the outlet is opened. This will prevent (or minimize) spillage of the fluid medium when the assembly is to be brought from a storage-position to a use-position.
• the barrier film may be provided in different ways according to which blocking device is to be used.
• the invention also provides for a method of wetting a medical device.
• the invention in a first aspect, relates to an assembly for wetting a medical device that comprises a compartment for a fluid medium and a package for containing the medical device,
• the package and the compartment are separate elements which are joined together; where an outlet from the compartment and an inlet to the package are covered by a barrier film in a storage-position, where the barrier film in a use-position is removed from the outlet and inlet thereby allowing fluid communication between the outlet and the inlet; where the assembly comprises a blocking device for closing a gap between the outlet and the inlet at least in a use-position.
• the assemblies make it possible to wet the medical device only at a part of the device. Thereby the top part of the device is left unwetted and less slippery and may be used for holding the device.
• the need for removing the barrier film prior to use will help prevent unintended activation of the assembly, because the user would need to apply a pulling force to the barrier film to open into the fluid medium and package.
• the fluid medium may be water or a saline-solution, for example physiological 0.9% saline-solution.
• the fluid medium may include an anti-microbial such as hydrogen peroxide. Using hydrogen peroxide provides an anti-microbial effect to the medical device, which helps prevent infections.
• the assembly comprises a package and a compartment, which are two separate parts but attached together.
• the fluid medium Prior to use, the fluid medium is stored in the compartment.
• the package comprises an inlet and the compartment comprises an outlet for the fluid medium.
• the outlet and the inlet may be adapted to be moved from a position from where they are out of contact with each other, to a position where the outlet and inlet are in contact with each other. In the first position, the assembly is in a storing-position and in the second connected position, the assembly is in a use-position.
• the package may be made of foil, which is welded along the sides.
• materials such as aluminium, Poly-Ethylene-Tere-Phtalate (PETP), Low-Density PoIy- Ethylene (LDPE), High-Density Poly-Ethylene (HDPE), Poly-Propylene (PP), Poly-Vinyl- Chloride (PVC), Poly-Amide (PA), Amorphous Polyester (PET) and surface treated paper are suitable.
• PETP Poly-Ethylene-Tere-Phtalate
• LDPE Low-Density PoIy- Ethylene
• HDPE High-Density Poly-Ethylene
• PP Poly-Propylene
• PVC Poly-Vinyl- Chloride
• PA Poly-Amide
• PET Amorphous Polyester
• the compartment may also be made as a foil element.
• Such an element may be made of materials like aluminium, PETP, LDPE, HDPE, PP, PVC, PA, PET and surface treated paper.
• the compartment may be welded along the sides such that it will have a tendency to completely collapse as the fluid medium exits the compartment. If the compartment were folded along one side, then the compartment would be left with a slight volume inside at the same time as the fluid medium exits, thereby leaving a small amount of fluid inside the compartment.
• the outlet and the inlet are covered by a barrier film in a storage- position.
• the barrier film will in most embodiments be constituted of one or two lengths of film, where ends of the film elements will be used to cover the outlet and inlet, and the opposite ends will be used for pulling at the barrier film.
• These parts of the barrier film that cover the outlet and inlet are defined as the covering parts of the barrier film.
• the part(s) of the film that the user pulls when removing the barrier film is defined as the pulling part(s).
• the covering parts of the barrier film may be united into one pulling part.
• the lengths of film that constitute the barrier film may be applied from slightly below the outlet and inlet and upwards between the compartment and package.
• the film may also be applied from slightly above the outlet and inlet, downwards to cover the outlet and inlet, and then folded to extend upwards between the compartment and package.
• the fold may be just below the outlet and inlet or it may be below flanges attached to the compartment and package below the outlet and inlet.
• the barrier film extends between the outlet and inlet and hence in itself constitutes a covering part that covers both the outlet and the inlet.
• the barrier film may also comprise only one covering part that covers the outlet from the compartment, meaning that one end of a single length of film is used to cover the outlet, and the other end is used as a pulling part.
• covering parts of the barrier film may be loosely attached to the outlet and inlet.
• loose attachment is meant an attachment, which may be peeled off with relative ease. However, the attachment should not be so loose that the covering parts fall off without influence from a pulling force.
• the loose attachment may be achieved by a peel welding (for example a weak welding such that the materials may be peeled apart).
• Such a welding may be made by providing a layer of coating at the material prior to welding, thereby preventing the two layers of material from melting into each other.
• the attachment may also be achieved by a weakness provided in the foil, for example a tear-line or a weak adherence, for example by a pressure-sensitive adhesive.
• the pulling parts of the film may be permanently attached to each other.
• an additional covering part in form of a release liner may be permanently attached to the barrier film.
• permanent attachment is meant an attachment like a proper welding or strongly adherence such that the two parts cannot be readily detached from each other.
• the barrier film may be made of PolyEthylene (PE) and may be approximately 40 ⁇ m thick. To the barrier film easy to remove, it is folded in a direction transverse to the pulling direction. Thereby the pulling forces are directed in a direction perpendicular to the adherence plane.
• PE PolyEthylene
• the medical device contained in the package is at least partly provided with a hydrophilic coating at the surface.
• the medical device may be coated on the entire outer surface or on a part of the outer surface depending on the use of the medical device.
• a medical device with a hydrophilic coating should be enclosed in vapour- impermeable material as soon as possible after coating, as the coating will swell when influenced by vapour.
• the medical device may be a urinary catheter, which may be provided with a hydrophilic coating.
• Urinary catheters are well known in the art.
• An example of a urinary catheter is a catheter provided as a tube made of Polyurethane (PU) or PVC, and which is provided with a connector in one end. In the opposite end (the tip end), the catheter is provided with one or more eyelets for letting urine enter into the tube.
• the insertable length is between 250-300 mm and for a female catheter the insertable length is between 60-130 mm.
• the insertable length corresponds to the length of the tubular element except for the 3-5 cm that are closest to the connector. This part of the catheter is uncoated because the catheter is coated by dipping.
• the uncoated part of the catheter also enables welding or gluing of the connector to the catheter. While inserting the catheter into the urethra, it is an advantage if the catheter can be held and steered without it being slippery at the point of holding. Assemblies allow the catheter to be wetted below the connector (the insertable length only) such that the connector may be used for holding the catheter.
• the assembly When the assembly is in the storage-position there may be a gap between the outlet from the compartment and the inlet to the package.
• the outlet and inlet are covered by a barrier film, either by two covering parts or by the film extending between them.
• the assembly comprises a blocking device, which is adapted to close at least the lower part of this gap between the outlet and inlet when a barrier film is removed. By removing the barrier film, the outlet and the inlet may be brought into fluid communication with each other, such that the fluid medium from the compartment is allowed to flow through the inlet and into the package.
• the closing of the lower part of the gap should prevent spillage of (at least most of) the fluid medium as it flows between the outlet and the inlet.
• the blocking device may cover at least a lower part of a gap between the outlet and the inlet. The blocking device may cover this lower part of the gap at all times, or the blocking device may be adapted to cover this lower part of the gap only in the use- position.
• the barrier film may be adhered to flanges provided at the outlet and/or the inlet. If no flanges are present, the barrier film may be adhered directly to the compartment and the package. In such embodiments, a flange may be provided on the inside of the compartment near the outlet, thereby providing stability in this area.
• the blocking device may, in these embodiments, be constituted by a weld or adherence between the compartment and the package below the outlet and inlet. In other embodiments, the blocking device may comprise a special provision of the barrier film, such that the barrier film, including the adherence/welding to the package and compartment, constitutes the blocking device.
• the blocking device comprises an inlet flange and an outlet flange.
• the inlet flange is positioned at the inlet to the package and the outlet flange is positioned at the outlet from the compartment.
• the inlet flange and outlet flange may comprise an upper part and a lower part, or it may comprise an annular flange defining an upper part and a lower part. It may be an advantage to have the flange surrounding the inlet and outlet respectively, because this may provide for additional strength in this area. This may be of relevance if the barrier film is adhered to the compartment and package above the inlet and outlet respectively. However, minimizing the cost may lead to an embodiment which provides the flanges only where they are needed, that is below the inlet and outlet. Alternatively, the flanges may be provided as two-part flanges below and above the inlet and outlet, thereby providing strength to the compartment and package.
• Useful materials for the flanges are polyolefins in general, particularly PP, PE and materials such as Acrylonitrile-Butadiene-Styrene (ABS), Poly-Carbonate (PC), silicone and styrene-based materials.
• ABS Acrylonitrile-Butadiene-Styrene
• PC Poly-Carbonate
• silicone silicone and styrene-based materials.
• One of the inlet flanges or outlet flanges may be thicker at the lower part than at the upper part.
• thicker is meant that the flange has a larger dimension in a plane perpendicular to and towards the opposite flange. This corresponds to the fluid direction.
• the barrier film may be attached to the assembly in different ways as described earlier. If the barrier film stretches between the flanges, the provision of a thicker flange below will ensure that the lower gap is closed as soon as the barrier film is removed from the lower gap between the lower parts of the flanges. That is, the two lower parts of the flanges will be in contact with each other over the entire surface prior to removing the barrier film from the outlet. This means that fluid medium in the compartment will only be able to exit through the outlet upon closing of the lower gap.
• the thickness of the flange at the top may be approximately half the thickness of the flange at the lower part. To optimize the possibility of a complete closure of the lower gap, the difference in thickness of the flanges should at least correspond to the thickness that is required by the barrier film. This thickness depends on how the barrier film is attached, for example for some embodiments it may be equal to two folded parts of film, and in other embodiments it may be equal to two parts of film in contact with each other.
• the barrier film may be approximately 40 ⁇ m thick. Two lengths of barrier film each folded 180 degrees without being sharply folded require approximately 1 mm distance to be easily removed.
• the thicker part of the flange may comprise an adhesive layer at the side facing the opposite flange.
• Both the inlet flange and the outlet flange can be of different thicknesses.
• Another embodiment relates to the blocking device comprising a resilient element, which in the storage-position is kept compressed by the barrier film and in the use-position is released to close the lower part of a gap between the outlet and the inlet.
• This embodiment is mainly an advantage if the barrier film is extended downwards between the lower part of the gap prior to extending upwards between the compartment and package. As the barrier film is removed from the lower part of the gap, the resilient element will be released and will come into contact with the opposite flange. Thus the lower part of the gap will be completely closed prior to removing the barrier film from the outlet.
• the resilient element may be a foam element (for example cellular PU or silicone) or a rubber gasket.
• the requirement is that the material should have a low compression set or a stable compression force deflection. Furthermore, when the device is in use, dripping of fluid medium from the device should be avoided. Basically, the material may absorb small amounts of the fluid medium as long as it does not drip.
• the resilient element may be contained between an outlet flange and an inlet flange held together by a snap element.
• the flanges may also be held together by welding or by a slid-connection. These types of connections provide a convenient way to assemble the parts such that the resilient element is compressed and kept compressed during the storage, when the assembly is in a storage-position.
• the resilient element may be provided just below the outlet or inlet.
• the resilient element is an annular element.
• the shapes can be circular, oval, ellipsoid, cut-off oval or square. If the resilient element is an annular element, then the entire periphery surrounding the outlet and inlet would be closed when the barrier film is completely removed. This means that the assembly may be inverted without spillage.
• the resilient element may be placed at the inlet flange; however, it may also be placed at the outlet flange. Placing the resilient element at the inlet flange has the beneficiary effect that the resilient element will close the gap between the outlet and inlet prior to fluid medium exiting the compartment. Thereby the resilient element will be less prone to take up large amounts of fluid medium.
• the blocking device comprises an outlet flange and an inlet flange.
• One of the flanges comprises at least one protrusion at the lower part to cooperate with a resilient element interposed between the flanges.
• the resilient element may be a foam element.
• the protrusion(s) will exert a pressure on the resilient element thereby urging this towards the opposite flange. Because the barrier film is disposed between the resilient element and the opposite flange (the one without protrusion), then the barrier film is withheld in this position until a pulling force is exerted upon the film. The pressure on the resilient element will assist in keeping the gap between the outlet and the inlet closed. This embodiment will therefore provide for a solution which is almost completely liquid-tight, and which will be able to prevent spillage of the fluid medium.
• the protrusion(s) may be constituted as ring element(s). If the flanges are annular and the protrusions are provided as ring elements, then a complete enclosure surrounding the outlet and inlet is provided. This will allow for inversion of the assembly without spillage of the fluid medium.
• the flanges may comprise more than one protrusion, particularly below the outlet and inlet. Two or more protrusions enhance the security against leakage of liquid through the contact between the flanges.
• the barrier film may extend only past the upper protrusions. Then it may be provided with a covering part that is loosely attached at the outlet. In another embodiment, the barrier film extends past the outlet and inlet and beyond the lower protrusions. By beyond is meant below. In the first situation, the lower part of the gap between the outlet and inlet is closed at all times. In the second situation, there will initially be a small gap provided by the barrier film. This gap will close at the same time as the barrier film is removed.
• Another embodiment relates to the blocking device that comprises an outlet part and an inlet part that are attached to each other such that they are pre-stressed to close a gap between them. This embodiment of the blocking device is cheap and easy to produce as the parts are moulded and then attached. Furthermore, this embodiment comprises only a few parts, which makes it simple and easy.
• a way of providing the pre-stressed blocking device is by permanently attaching rim parts at two opposite sides of the outlet part and the inlet part to each other and forming a gap between the outlet part and the inlet part, the gap of which is held open by the barrier film that extends through the gap.
• rim parts is meant the outermost 3-10 mm of the outlet and inlet parts.
• the permanent attachment is done by welding, gluing or clamping the two rim parts together.
• the outlet and inlet part may have any shape, for example a circular or quadrangular. Two opposite sides correspond to a certain extension such that the two parts do not separate easily and such that the two parts are urged towards each other.
• the outlet part and the inlet part may each comprise a hole surrounded by ridges, where the ridges at the inlet part fit within the ridges at the outlet part.
• the outer edges of the ridges of the inlet part are spaced a first distance apart. This first distance is equal to or less than a second distance between the inner edges of the ridges of the outlet part.
• the barrier film that extends between the two parts will rest against the ridges at both parts in the storage-position. While removing the barrier film, the pre-stressing of the parts will urge the parts towards each other.
• the ridges of the inlet will then enter into the space provided by the ridges at the outlet. Two opposite ridges will only need to have a slight overlap to provide for a closure of the gap and prevent excessive spilling of the fluid medium.
• the outlet and inlet part should be made of a material that has a high tendency to seek its original configuration. That is a material with ideal-elastic properties and with low visco- elastic properties. Such material will make it easier for the parts to close the gap between them.
• a material that fulfils these requirements is Polyetheretherketone (PEEK).
• the blocking device may also comprise ends of the barrier film that are permanently attached to the compartment and the package below the outlet and inlet respectively, at least one downwardly extending pulling part, and where covering parts of the barrier film are parts of the barrier film between the pulling part and the permanently attached ends.
• the blocking device may further comprise an outlet part and an inlet part disposed at least below the outlet and inlet, and where the ends of the barrier film are permanently attached to the outlet part and the inlet part respectively.
• these flanges provide for enhanced strength in the areas surrounding the outlet and inlet, and in particular in the areas where the barrier film is to be permanently attached.
• the outlet part and the inlet part may also each comprise a hole aligned with the outlet and inlet respectively, such that the outlet part and the inlet part are disposed surrounding the outlet and inlet. Again, this provides for enhanced strength in the areas most subjected to stress.
• the blocking device may further comprise a delaying release liner at the outlet. If the lower part of the gap is open in a storage-position, then the delaying release liner may delay the opening of the outlet, thereby ensuring that the gap closes completely prior to opening of the outlet.
• the delaying release liner may be made of the same material as the barrier film. It may be loosely attached to the outlet and permanently attached to the barrier film. That way, the delaying release liner will be easy to remove from the outlet and will be removed together with the barrier film.
• the delaying release liner may comprise one or more folds.
• the pulling part of the barrier film at the outlet side may comprise an extension, and this pulling part is then adhered to the pulling part of the barrier film at the inlet side above the extension. This is a way of providing a delay between the opening of the inlet and the opening of the outlet.
• the invention also relates to opening of the package simultaneously with removing the barrier film.
• simultaneously is meant that the opening and the removing is done in one movement. It does not have to occur at the exact same moment but within a relatively short period of time, such that a user would perceive it as one step. Users of these types of assemblies may have a low dexterity in their hands. Therefore it is an advantage to minimise the number of steps that the user needs to take prior to use.
• the package may comprise an opening foil that covers the package opening, and this opening foil may be adapted for removal with the barrier film.
• the opening foil may comprise a pulling part for pulling at the foil and a covering part for covering the opening.
• the covering part of the opening foil may be glued or peel-welded to the package, such that it closes the package completely prior to use.
• the pulling part of the opening foil may be attached to the barrier film, for example by welding or gluing.
• the pulling part of the opening foil may be disposed around a reel element, and the reel element may be connected to the barrier film.
• the reel element may be in the form of a rod of a rigid plastic material that is welded or glued to the barrier film.
• the reel element may also be in the form of an integral foil element constituting part of the barrier film. The last embodiment may be made by providing a hole through the barrier film and extending the opening foil through the hole.
• the assembly may comprise pulling rings at the top and bottom, such that the assembly may be hanged from a hook. Then a user may put a finger through the bottom ring (for example placed at the bottom of the compartment) and pull downwards. A user with low dexterity in their hands may find it easier to put a finger through a hole to exert a pulling force, rather than gripping a foil element.
• Another aspect relates to a method of wetting a medical device stored in an assembly comprising a compartment for the fluid medium, - a package for the medical device including an inlet to the package, a barrier film that comprises pulling part(s) and covering part(s) that cover an outlet from the compartment, where the assembly further comprises a blocking device,
• the method comprises pulling at the pulling part(s) of the barrier film thereby removing the covering part(s) from the outlet and inlet and allowing the fluid medium stored in the compartment to exit the compartment,
• the blocking device is adapted to close the gap between the compartment and the package such that the fluid medium will enter through the inlet into the package.
• the barrier film is disposed at the outlet and inlet prior to use, thereby preventing contamination of the outlet and inlet.
• This barrier film has to be removed prior to use.
• the advantage is that the film barrier can be removed at the same time as the fluid medium enters into the package.
• the package is opened at the same time as the barrier film is removed. This makes the assembly even easier to use, because a user only needs to perform one movement, and then the medical device that is stored in the assembly is ready to use.
• the assembly has a ring element at the top and the bottom of the compartment. When in use, the assembly is hanged onto a hook by the top ring element, a user puts a finger through the lower ring element, and then pulls downwards to open the package and remove the barrier film.
• Figure 1 illustrates a sectional view of an assembly which includes a package with a medical device (a catheter) and a compartment.
• a medical device a catheter
• Figure 2 illustrates an embodiment of the blocking device, where a flange is thicker at the bottom of the connection between the package and the compartment.
• Figure 3 illustrates an embodiment of the blocking device, where the device comprises a resilient element captured within a flange.
• Figure 4 illustrates an embodiment of the blocking device, where the device comprises protruding elements.
• Figure 5 illustrates an embodiment of the blocking device very similar the one in figure 4, the only difference being that in this embodiment the barrier film is loosely attached to the outlet prior to use.
• Figure 6 illustrates an embodiment of the blocking device comprising pre-stressed elements.
• Figure 7 illustrates an embodiment comprising a downwards extending barrier film
• FIGS 8 to 11 illustrate different ways of opening the package.
• Figure 1 illustrates an assembly 100 for wetting a medical device 101 including a package 110 and a compartment 120.
• the package may be made of two foil elements 111 and 112 that are welded together along their sides (not shown).
• the figure shows only the part where the package 110 encloses the medical device 101. This would normally not be the case because the package should prevent contamination of the medical device and then naturally enclose the entire medical device.
• the foil elements are closed at the bottom, below the medical device and at the top, above the medical device.
• the compartment comprises two foil elements 121 and 122 closed at their sides, for example by welding (not shown), and at the bottom 123 and top 124.
• the package also comprises an inlet opening 130 for entering a fluid medium into the package, and the compartment comprises an outlet 140 for letting out the fluid medium 150 that is contained in the compartment.
• the inlet 130 and the outlet 140 Prior to use, the inlet 130 and the outlet 140 are covered by a barrier film 160, such that contamination of the fluid medium 150 and medical device 101 is minimised.
• the outlet 140 from the compartment must be brought into contact with the inlet 130 to the package and the barrier film 160 must be removed.
• the barrier film is removed from the outlet 140, the fluid medium will be able to exit the compartment.
• the embodiments relate to different blocking devices 170 and enable the contact between the outlet and the inlet to be established prior to removing the barrier film from the outlet.
• the assembly 100 further comprises a foil 180, which, upon removal, would open the package, such that the medical device 101 may be removed.
• the foil is attached to the barrier film 160, such that the two parts are removed simultaneously.
• Figures 2a to 2e illustrate an embodiment of the blocking device, where the blocking device 270 comprises two flanges, an outlet flange 271 at the outlet 240 and an inlet flange 272 at the inlet 230.
• the inlet flange 272 is thicker at the lower part 273 than at the upper part 274.
• the package is schematically illustrated at 210 and the compartment at 220.
• the barrier film 260 comprises two covering parts, an outlet covering part 261 and an inlet covering part 262.
• the barrier film further comprises two pulling parts 263 and 264, which may be attached together to constitute a single pulling part.
• the blocking device further includes a delaying release liner 275 that is loosely attached to the outlet 240 and adhered or welded to the outlet covering part 261 of the barrier film.
• the delaying release liner has the effect of covering the outlet 240 until the lower part 273 of the inlet flange is in contact with the outlet flange.
• Figures 2c to 2e illustrate the stepwise removal of the delaying release liner 275 and further illustrate that the release liner 275 covers the outlet 240 until the lower part 273 of the inlet flange is in intimate contact with the outlet flange 271.
• FIGS 3a to 3e illustrate an embodiment of the blocking device 370 comprising an entrapped resilient element, which, - in this embodiment, is a foam element 371.
• the foam element 371 is contained within the boundaries of an inlet flange 372.
• the blocking device further comprises an outlet flange 373 at the compartment side.
• This outlet flange has a bottom part 374 with an upstanding rib 375 enabling the bottom part to catch the bottom of the inlet flange 372 in a snap fitting relationship.
• the snap fitting of the two flanges will provide the necessary squeezing of the foam element.
• the barrier film 360 has two covering parts, an outlet covering part 361 and an inlet covering part 362.
• the barrier film further includes two pulling parts, an extension 363 of the outlet covering part and an extension 364 of the inlet covering part. At some point 365 above the flanges, the outlet pulling part 363 is adhered to the inlet pulling part 364.
• the outlet pulling part 363 is provided with a small loop 366 which delays the removal of the outlet covering part 361. This means that the outlet covering part is removed after the inlet covering part 362 has been removed.
• the delaying of the outlet covering part 361 is further illustrated in figures 3c to 3e, particularly in figure 3d that illustrates the inlet covering part 362 being completely removed and the outlet covering part 361 still covering approximately ⁇ A of the outlet 340. Concurrently with removing the covering parts 361 and 362, the resilient element 371 will expand towards the outlet flange 373.
• the gap 376 will be completely closed by the foam element 371 , and the fluid medium 350 will only be able to enter through the inlet 330 and into the package 320.
• Figures 4a to 4d illustrate an embodiment of a blocking device according to the invention, where the blocking device 470 has an outlet part 471 and an inlet part 472 comprising protrusions 474 to 477 that are adapted to cooperate with a foam flange 473, such that the foam flange 473 is urged into close contact with the outlet part 471.
• the inlet part 472 may be made as an annular shaped flange.
• the protrusions may be made as ring-shaped elements, such that the lower protrusion 474 is the same element as the upper protrusion 477, and the protrusions near the outlet 475 and 476 are the same ring- shaped element.
• a barrier film 460 extends between the foam flange 473 and the outlet part 471 , such that the film initially extends beyond the lower protrusion 474, see figures 4a and 4b.
• the protrusions will cause the foam flange 473 to curve slightly towards the outlet part 471.
• the barrier film 460 will be secured between the outlet part 471 and the foam flange 473.
• the outlet part 471 and the foam flange 473 enter into close contact with each other. Thereby the gap between the inlet and the outlet will remain closed at all times, see figures 4c and 4d.
• the fluid medium 450 will only be able to flow through the inlet 430 and into the package 410.
• Figure 5 illustrates an embodiment similar to the one in figures 4a to 4d.
• the only difference is the constitution of the barrier film 560, which, in this embodiment, is folded to have a covering part 561 that is loosely attached to cover the outlet 540.
• the barrier film 560 does not extend beyond the lowest protrusion 574 but only beyond the protrusion 575 closest to the inlet 530 and outlet 540.
• Figures 6a to 6e illustrate another embodiment of the blocking device, where the blocking device 670 comprises two parts, an outlet part 671 and an inlet part. 672 These two parts are assembled so that the central parts 673, 674 of the outlet part 671 and the inlet part 672 will seek to engage each other but initially will be prevented from doing so because the barrier film 660 is placed between the two central parts 673, 674.
• Figure 6a illustrates the blocking device 670 prior to use and seen from the side.
• Figure 6b illustrates the blocking device 670 seen from above
• figure 6c illustrates a perspective view of the outlet part 671 and the inlet part 672.
• the two central parts 673, 674 are pre-stressed towards movement into engagement with each other.
• the pre-stressing is obtained by providing the central part 673 of the outlet part 671 with ridges 675, at least on three sides of a hole 676, the hole 676 being in alignment with the outlet 640. Furthermore, the central part 674 of the inlet part 672 is provided with ridges 677 surrounding a smaller hole 678 at the central part.
• Figures 6d, 6e and 6f illustrate views corresponding to figures 6a, 6b and 6c when the blocking device 670 is closed, corresponding to the assembly being in the use-position.
• the inlet part ridges 677 fit within the outlet part ridges 675, such that when covering parts 661 and 662 of the barrier film is removed, the two central parts 673 and 674 will be in close contact with each other as illustrated in figure 6f. In this position, fluid medium 650 exiting the compartment through the outlet 640 will be prevented from spilling downwards and hence will enter through the inlet 630 and into the package.
• Figures 7a to 7e illustrate an embodiment of a blocking device according to the invention where the blocking device 770 comprises an outlet part 771 and an inlet part 772 which are attached to each other at the top and at the sides.
• Figure 7a illustrates the blocking device 770 seen from the top
• figure 7b illustrates the blocking device 770 seen from the compartment
• figure 7c illustrates a side view of the blocking device 770.
• the two parts comprise a first hole 773, 774 in alignment with the outlet 740 and inlet 730 respectively.
• the two parts furthermore comprise a second hole 775, 776 which provides the necessary room for the folds in the barrier film.
• the barrier film 760 functions as part of the blocking device.
• the barrier film comprises two covering parts 761 , 762 and a pulling part 763 extending downwards. Upon pulling downwards at the pulling part 763, the covering parts 761 , 762 are removed from the outlet 740 and the inlet 730. However, the barrier film is permanently attached to the outlet part and inlet part 771, 772 respectively by two attachment parts 764, 765. This means that when pulling at the pulling part only removal of the covering parts 761 , 762 will be enabled. This will bring the barrier film into the position illustrated in figures 7d and 7e. In this position, fluid medium 750 contained in the compartment will be able to flow through the outlet 740 and through the inlet 730 into the package without spilling.
• the barrier film 760 may be provided with a coating on the surfaces facing each other 766, 767, the coating being unweldable. This allows for welding this embodiment in one step because the two surfaces that are facing each other 766, 767 will not be welded to themselves. Thereby, the barrier film 760 may be pulled downward unhindered.
• Figures 8 to 11 relate to different assemblies, where the barrier film 860 is removed at the same time as the package 810 is opened.
• Figures 8a and 8b illustrate the principle of a reel element 890.
• the reel element 890 comprises a rod 891 around which the opening foil 880 is disposed.
• the end of the opening foil 880 is secured at a point 883 by gluing or welding.
• the opening foil 880 is peeled off the weak attachment 884.
• the reel element allows for removal of twice the length of the opening foil 880 compared to the length of the barrier film 860.
• Figure 8c illustrates an assembly 800 comprising a package 810 which includes a medical device 801 (in this embodiment a catheter) and a compartment 820.
• the package has an inlet 830 and the compartment has an outlet 840.
• the gap between the inlet 830 and the outlet 840 is closed by a blocking device 870 which may be of any of the aforementioned types.
• One or more covering part(s) 861 of a barrier film 860 is used to cover the outlet 840 and inlet 830 prior to use.
• the barrier film 860 further comprises a first pulling part 862 extending up between the compartment 820 and the package 810.
• the first pulling part 862 is attached to a second pulling part 863 by a permanent attachment 864 (for example a welding or a gluing.).
• An opening foil 880 covers the opening into the package and is attached to the package 810 by a weak attachment 884 (for example a peel welding or gluing).
• the opening foil 880 comprises a covering part 881 and a pulling part 882 where the end of the pulling part is secured to the package 810 at an attachment point 883.
• the pulling part 882 of the opening foil is disposed around a reel element 890 in connection with the barrier film 860.
• the reel element is shown in more detail in figure 8d.
• the reel element 890 consists of a hole 892 in the second pulling part 863 and a piece of foil constituting a rod element 891.
• the second pulling part 863 When the second pulling part 863 is pulled in the direction indicated by the arrow, the rod element 891 is moved upwards thereby pulling the pulling part 882 of the opening foil with it. At the same time, the second pulling part 863 pulls at the first pulling part 862 which pulls at the covering part(s) 861 and then removing the barrier film from the outlet and the inlet.
• the covering part(s) 861 may have a length of approximately 30-60 mm and because they are folded, the pulling length for removing the covering part(s) is approximately 60-70 mm. To ensure complete removal of the covering part(s) 861 , a user would pull the pulling part 60-70 mm.
• the reel element 890 allows for the length of opening foil 880 to be removed, to be doubled so that pulling 60 mm at the second pulling part 863 corresponds to pulling 120 mm at the pulling part 882 of the opening foil 880.
• the embodiment of figure 1 does not include a reel element. This may ensure that the fluid has entered into the package to wet the medical device prior to opening of the package, thereby reducing the risk of the user inadvertently trying to use a dry medical device.
• Figures 9a and 9b illustrate an embodiment of the opening similar to the one in figures 8c and 8d. The only difference is the placing of the attachment point 983 at the end of the opening foil 980. In the embodiment in figures 9a and 9b, the attachment point 983 is placed at the compartment 920 instead of at the package 910. This allows for a more direct disposition of the barrier film 960 so that the first pulling part 962 is integral with the second pulling part 963. This embodiment functions in exactly the same way as the embodiment of figure 8c.
• Figures 10a and 10b illustrate another embodiment of the opening, which again is similar to the ones of figures 8c, 9a and 9b.
• the first pulling part 1062 is integral with the pulling part 1082 of the opening foil 1080. Pulling at the second pulling part 1063 would first initiate pulling at the covering part 1081 of the opening foil 1080 as the attachment of the covering part 1081 is weaker than the attachment and securing of the covering part(s) 1061 of the barrier film.
• the covering part 1081 of the opening foil 1080 is removed until the attachment point 1083 that is placed just above the opening
• the pull at the second pulling part 1063 will exert a pulling force at the covering part(s) 1061 of the barrier film.
• the attachment of the covering part 1081 of the opening foil, and the attachment and securing of the covering part(s) 1061 of the barrier film may also be balanced such that the removal more or less occurs at the same time.
• Figures 11 a and 11 b illustrate another way of disposing the opening foil 1180, where the user pulls directly at the pulling part 1182 of the opening foil 1180.
• the pulling part 1182 is permanently attached to a pulling part 1162 (for example in the form of a string) of the barrier film 1160.
• the pulling part 1162 is connected to a covering part 1161 of the barrier film.
• the covering part 1181 of the opening foil 1080 is loosely attached to the package at an attachment point 1083.

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• Health & Medical Sciences (AREA)
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• Engineering & Computer Science (AREA)
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• 2009
  • 2009-07-15 AU AU2009270601A patent/AU2009270601A1/en not_active Abandoned
  • 2009-07-15 CN CN200980128157XA patent/CN102099076A/zh active Pending
  • 2009-07-15 US US13/054,569 patent/US20110120892A1/en not_active Abandoned
  • 2009-07-15 JP JP2011517753A patent/JP2011528244A/ja active Pending
  • 2009-07-15 WO PCT/DK2009/050178 patent/WO2010006619A1/en active Application Filing
  • 2009-07-15 EP EP09776244A patent/EP2303383A1/de not_active Withdrawn
  • 2009-07-15 CA CA2728006A patent/CA2728006A1/en not_active Abandoned

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