JP2011528244A - Blocking device - Google Patents

Abstract

  An assembly (100) for wetting the medical device (101) is provided. The assembly (100) comprises a fluid medium compartment (120) and a medical device (101) package (110). The fluid medium in the compartment (120) can be used to wet a hydrophilic coating disposed on the outer surface of the medical device (101). The compartment (120) comprises an outlet (140) and the package (110) comprises an inlet (130) for the fluid medium. Before use, there is a gap between the outlet (140) and the inlet (130) when the assembly (100) is in the storage position. Both the outlet (140) and the inlet (130) are closed before use by the barrier film (160), and the barrier film (160) prevents contamination of the outlet (140) and inlet (130). When the assembly (100) is to be used, the barrier film (160) is removed, thereby opening the outlet (140) and the inlet (130). Removal of the barrier film (160) can be associated with unpacking the package (110) so that the package (110) is unpacked when the barrier film (160) is removed. A blocking device (170) is provided for closing the gap between the outlet (140) and the inlet (130), at least in the use position.

Description

  The present application relates to closing a joint between an outlet from a compartment and an inlet to a package in connection with an assembly for wetting a medical device. The compartment contains a fluid medium and the package contains a medical device. The present invention provides a blocking device used to close the joint between the outlet and the inlet.

  Urinary catheters are widely used in intermittent catheterization, particularly in intermittent catheterization related to procedures where caregivers perform intermittent catheterization, and in intermittent catheterization related to spinal cord injury where the user loses bladder control . In order to reduce the risk of damage to the urethral wall, the catheter is typically coated with a coating that imparts very low friction to the surface of the catheter. Typically, the coating is activated at the manufacturing stage or by applying a fluid medium (eg, tap water or sterilized water) to the coating prior to use. If the coating is activated prior to use, the fluid medium may be provided in a separate compartment from the medical device, thereby forming an assembly comprising the medical device package and the fluid medium compartment. Such an assembly is shown, for example, in WO 2006/092150, which prepares a medical device, in particular a urinary catheter, by releasing a fluid medium onto the medical device. An assembly is provided. The medical device is packaged in a package that contains a fluid medium confined within the compartment. German Patent No. 10334372 provides a catheter system for urination, which is a tube for insertion into the human or animal body, provided with a coating that can be activated by a liquid. A tube and a compartment for containing a liquid, wherein the compartment liquid comprises a disinfectant dissolved in the liquid.

  Some catheter users frequently experience urinary tract infection (UTI). 30% experience more urinary tract infections 3 times a year and 10% experience more urinary tract infections 6 times a year.

  In order to reduce the risk of infection, not only medical devices but also fluid media are sterilized. For fluid media, this is particularly done when the fluid media is prepackaged with the medical device in the assembly. It is beneficial to be able to sterilize the medical device and the fluid medium separately and then connect the closed package containing the medical device and the closed compartment containing the fluid medium to each other after the sterilization process. Alternatively, the fluid medium and medical device may be sterilized during the assembly operation. In order to keep the contents sterile, both the inlet to the package and the outlet from the compartment are covered with a protective liner or barrier film before use. Such a barrier film can be removed by pulling it, thereby reducing the risk of unintentional activation of the assembly. If the barrier film only covers the outlet and the inlet, immediately after the barrier film is removed, the fluid medium contained in the compartment can overflow the compartment. For such an assembly, the gap between the compartment and the package needs to be at least closed when the barrier film is removed.

  The present invention relates to the provision of a gap closing device (blocking device) for closing at least the lower part of the gap between the compartment and the package when there is no longer a cover covering the outlet and the inlet. The gap may always be closed, or the blocking device may close the gap when the outlet is open. This will prevent (or minimize) spillage of the fluid medium when the assembly is to be transferred from the storage position to the use position. The barrier film is provided in various ways according to the blocking device to be used.

  The present invention also provides a method of wetting a medical device.

  In a first aspect, the present invention is an assembly for wetting a medical device comprising a compartment for a fluid medium and a package for containing the medical device, wherein the package and the compartment are connected to each other In the storage position, the outlet from the compartment and the inlet to the package are covered with a barrier film, and in the use position, the barrier film is removed from the outlet and the inlet, so that the gap between the outlet and the inlet is The present invention relates to an assembly that allows fluid communication and that the assembly comprises a blocking device for closing the gap between the outlet and the inlet at least in the use position.

  Having separate compartments and packages that are connected to each other has the effect of producing the compartments in one place and the packages in another place. The package and compartment can also be sterilized separately.

  The assembly allows the medical device to be wetted with only a portion of the medical device. Thereby, the upper end portion of the instrument remains wet and is not slippery so that it can be used to hold the instrument.

  It is also advantageous to keep the two parts separate because leakage from the compartment holding the liquid will not affect the medical device being stored. Furthermore, contamination outside the compartment will not enter the package.

  The need to remove the barrier film prior to use prevents the unintentional activation of the assembly as the user will need to apply a tensile force to the barrier film to release the fluid medium into the package. Will help.

  The fluid medium is water or saline, for example 0.9% saline. In one embodiment, the fluid medium comprises an antimicrobial agent such as hydrogen peroxide. The use of hydrogen peroxide provides an antibacterial effect on medical devices, which helps prevent infections.

  The assembly comprises a package and a compartment, the package and compartment being two separate parts but connected to each other. Prior to use, the fluid medium is stored in the compartment. The package has an inlet and the compartment has an outlet for the fluid medium. The outlet and inlet may be suitable for being moved from a position where the outlet and inlet are not in 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 the storage position, and in the second coupling position, the assembly is in the use position.

  Throughout this application, when referring to the top or top of the assembly, the reference is directed to the end containing the pouch.

  The package may be manufactured from foil that is welded along its sides. For this purpose, aluminum, polyethylene terephthalate (PETP), low density polyethylene (LDPE), high density polyethylene (HDPE), polypropylene (PP), polyvinyl chloride (PVC), polyamide (PA), amorphous polyester ( Materials such as PET) and surface-treated paper are suitable. The package can be closed at the top of the package with a portion of the barrier film extending over the top of the package. In this way, the package is unpacked at the same time as the barrier film is removed, thereby allowing immediate access to medical devices stored in the package.

  Compartments can also be manufactured as film elements. Such elements can be made from materials such as aluminum, PETP, LDPE, HDPE, PP, PVC, PA, PET, and surface treated paper. Such packages and compartments will only occupy the amount of fluid or space equivalent to that required by the medical device and will be easy to pack and store. The compartment can be welded along its side so that when the fluid medium exits the compartment, it has a tendency to collapse completely. If the compartment is folded along one side, then the compartment will leave a small volume inside as soon as the fluid medium escapes, thereby leaving a small amount of fluid in the compartment. Let's go.

  In some embodiments, in the storage position, the outlet and inlet are covered by a barrier film. In most embodiments, the barrier film consists of one or two lengths of film, where the end of the film element is used to cover the outlet and inlet, and the opposite end is Will be used to pull the barrier film. These portions of the barrier film that cover the outlet and the inlet are defined as the coating portions of the barrier film. The portion of the film that the user pulls when removing the barrier film is defined as the tensile portion. Multiple coated portions of the barrier film can be integrated into one tensile portion. The length portion of the film constituting the barrier film can be applied upward between the compartment and the package from slightly below the outlet and inlet. The film may also be applied from slightly above and below the outlet and inlet to cover the outlet and inlet and then folded to extend upward between the compartment and the package. The folding may be done directly below the outlet and inlet, or below the flange connected to the compartment and package below the outlet and inlet.

  In other embodiments, the barrier film extends between the outlet and the inlet, and therefore the barrier film itself constitutes a covering portion that covers both the outlet and the inlet. The barrier film may also have only one covering part that covers the outlet from the compartment, which is used to cover the outlet at one end of a single length of the film. And the other end is used as a tensile part.

  In some embodiments, the coated portion of the barrier film can be loosely connected to the outlet and inlet. A loose connection means a connection that can be peeled off relatively easily. However, the connection should not be so loose that the covering part will peel off without the influence of tensile forces. Typically, a loose connection can be achieved by peel welding (eg, weak welding such that multiple materials can be peeled apart). Such welding can be done by providing a coating layer on the material prior to welding, thereby preventing the two layers of material from dissolving within each other. The connection may also be realized by a weak part provided in the foil, for example a tear line, or a weak adhesion, for example by an adhesive.

  In other or related embodiments, multiple tensile portions of the film can be permanently connected to each other. Similarly, an additional covering portion in the form of a release liner can be permanently connected to the barrier film. Permanent connection means a connection such as proper welding or strong adhesion, where the two parts cannot be easily separated from each other.

  The barrier film can be made from polyethylene (PE) and is approximately 40 μm thick. In order to easily remove the barrier film, the barrier film is folded transversely to the tensile direction. Thereby, the tensile force is directed in a direction perpendicular to the bonding plane.

  In one embodiment, a hydrophilic coating is provided at least partially on the surface of the medical device contained within the package. The medical device may be coated on the entire outer surface or a portion of the outer surface depending on the use of the medical device. A medical device with a hydrophilic coating should be encased in a material that is water vapor impermeable as soon as possible after coating, as the coating will expand when affected by water vapor.

  The medical device may be a urinary catheter and a hydrophilic coating may be provided on the urinary catheter. Urinary catheters are known in the art. An example of a urinary catheter is a catheter provided as a tube made of polyurethane (PU) or PVC, with a connector at one end. One or more small holes for allowing urine to enter the tube are provided at the opposite end (tip) of the catheter. The insertable length of the male catheter is between 250 and 300 mm, and the insertable length of the female catheter is between 60 and 130 mm. The insertable length corresponds to the length of the tubular element except 3-5 cm closest to the connector. The 3-5 cm section closest to the connector is uncoated because the catheter is coated by dipping. The uncoated portion of the catheter also allows the connector to be welded or bonded to the catheter. During insertion of the catheter into the urethra, it is advantageous for the catheter to be held and manipulated in a holding position without slipping. The assembly wets the catheter below the connector (only the insertable length) so that the connector can be used to hold the catheter.

  When the assembly is in the storage position, there is a gap between the outlet from the compartment and the inlet to the package. In this storage position, the outlet and the inlet are covered by a barrier film, i.e. either the two covering parts or a film extending between the outlet and the inlet. The assembly comprises a blocking device, which is suitable for closing at least the lower part of this gap between the outlet and the inlet when the barrier film is removed. Removing the barrier film can provide fluid communication with each other at the outlet and inlet so that fluid medium from the compartment can flow into the package through the inlet. Closing the lower part of the gap should prevent (at least most) fluid medium from spilling when the fluid medium flows between the outlet and the inlet. The blocking device can cover at least the lower part of the gap between the outlet and the inlet. The blocking device may always cover this lower part of the gap, or the blocking device may be suitable to cover this lower part of the gap only in the use position.

  The barrier film can be bonded to a flange provided at the outlet and / or inlet. In the absence of a flange, the barrier film may be bonded directly to the compartment and package. In such an embodiment, the flange can be provided inside the compartment near the outlet, thereby providing stability to this range. In these embodiments, the blocking device may be constructed by welding or bonding between the compartment and the package below the outlet and inlet. In other embodiments, the blocking device may comprise a specially prepared barrier film such that the barrier film comprising adhesion or welding to the package and compartment constitutes the blocking device.

  In one embodiment, the blocking device comprises an inlet flange and an outlet flange. The inlet flange is placed at the inlet to the package and the outlet flange is placed at the outlet from the compartment.

  The inlet flange and the outlet flange may comprise an upper portion and a lower portion, or may comprise an annular flange that defines an upper portion and a lower portion. Having a flange surrounding each of the inlet and outlet is advantageous because it can provide additional strength in this area. This is effective when the barrier film is bonded to the compartment and package above the inlet and outlet, respectively. However, cost minimization leads to embodiments where only the required flange is provided, the flange being below the inlet and outlet. Alternatively, the flange may be provided as a two-part flange below and above the inlet and outlet, thereby providing strength to the compartment and package.

  Useful materials for the flange are materials such as polyolefins in general, especially PP, PE, and materials based on acrylonitrile butadiene styrene (ABS), polycarbonate (PC), silicone, and styrene.

  One of the inlet flange or the outlet flange can be thicker in the lower part than in the upper part. Thick means that the flange is in a plane perpendicular to the opposing flange and has a larger dimension towards the opposing flange. This direction corresponds to the direction of the fluid. When the flange is thicker below the inlet or outlet, the lower portion of the flange can then contact the entire lower portion of the opposing flange immediately after the barrier film is removed from the lower portion of the flange. There is a space for the barrier film between the upper portion of the outlet flange and the upper portion of the inlet flange, even when the lower portion of the outlet flange and the lower portion of the inlet flange are in full contact. Because there will be contact over the entire surface is feasible.

  For these embodiments, the barrier film can be connected to the assembly in a variety of ways as described above. When the barrier film extends between the flanges, providing a lower thicker flange ensures that the lower gap is closed immediately after the barrier film is removed from the lower gap between the lower portions of the flange. Would be. That is, before removing the barrier film from the outlet, the two lower portions of the flange will contact each other over the entire surface. This means that with the lower gap closed, the fluid medium in the compartment will only be able to escape through the outlet.

  The thickness of the top of the flange may be about half of the thickness of the lower portion of the flange. In order to maximize the possibility of completely closing the lower gap, the difference in flange thickness should correspond at least to the thickness required by the barrier film. This thickness depends on how the barrier films are connected, for example, in some embodiments, corresponds to the two folded portions of the film, and in other embodiments, the films in contact with each other It corresponds to the two parts. The barrier film is about 40 μm thick. A distance of about 1 mm is required for the two lengths of the barrier film, each folded 180 ° without being sharply folded, to be easily removed.

  The thicker portion of the flange can be provided with an adhesive layer on the side facing the opposing flange.

  Both the inlet flange and the outlet flange can be of different thicknesses. Another embodiment relates to a blocking device comprising an elastic element, wherein the elastic element is kept compressed by the barrier film in the storage position and the lower part of the gap between the outlet and the inlet in the use position. Freed to close. This embodiment is mainly advantageous when the barrier film extends downwardly between the lower part of the gap before extending upwardly between the compartment and the package. As the barrier film is removed from the lower portion of the gap, the elastic element will be released and will contact the opposing flange. As a result, the lower portion of the gap will be completely closed before removing the barrier film from the outlet.

  The elastic element may be a foam element (eg, cellular PU or silicone) or a rubber gasket. It is a prerequisite that the material has a low compression set or a stable compression force deflection. Furthermore, dripping of the fluid medium from the device should be avoided when the device is in use. Basically, the material can absorb a small amount of fluid medium as long as the fluid medium does not drip.

  The elastic element may be housed between an outlet flange and an inlet flange that are held together by a snap element. The flanges may also be held together by welding or slid-connection. These types of couplings provide a convenient way to assemble the parts so that the elastic element is compressed when the assembly is in the storage position and remains compressed during storage.

  The elastic element can be provided directly below the outlet or inlet. In another embodiment, the elastic element is an annular element. For example, the shape of the elastic element may be circular, oval, elliptical, cut oval, or square. If the elastic element is an annular element, then all of the peripheral parts surrounding the outlet and inlet will be closed when the barrier film is completely removed. This means that the assembly can be inverted without spilling.

  The elastic element may be installed on the inlet flange or on the outlet flange. Installing the elastic element on the inlet flange has the advantageous effect that the elastic element will close the gap between the outlet and the inlet before the fluid medium exits the compartment. Thereby, the elastic element will be less prone to take up a large amount of fluid medium.

  In one embodiment, the blocking device comprises an outlet flange and an inlet flange. One of the flanges has at least one protrusion on the lower portion to cooperate with an elastic element placed between the flanges. The elastic element may be a foam element.

  The protrusion will exert pressure on the elastic element, thereby urging the elastic element towards the opposing flange. Since the barrier film is placed between the elastic element and the opposing flange (flange without protrusions), the barrier film is then restrained in this position until a tensile force is exerted on the film. The pressure on the elastic element will help keep the gap between the outlet and the inlet closed. This embodiment would therefore provide a solution that is almost completely liquid tight and could prevent the fluid medium from spilling.

  The protrusion can be configured as a ring element. If the flange is annular and the protrusion is provided as a ring element, then a complete enclosure surrounding the outlet and inlet is provided. This would allow the assembly to be inverted without spilling the fluid medium.

  The flange may comprise more than one protrusion, particularly below the outlet and inlet. Two or more protrusions increase the safety against liquid leakage through the contact between the flanges.

  The barrier film may extend past only the upper protrusion. Thereafter, a covering portion may be provided that is loosely connected to the outlet. In another embodiment, the barrier film extends past the outlet and inlet and beyond the lower protrusion. Beyond means below. In the former case, the lower part of the gap between the outlet and the inlet is always closed. In the latter case, there will initially be a small gap provided by the barrier film. This gap will be closed at the same time as the barrier film is removed.

  Another embodiment relates to a blocking device comprising an outlet portion and an inlet portion, wherein the outlet portion and the inlet portion are connected to each other such that the outlet portion and the inlet portion are prestressed and their The gap between them is closed. The blocking device of this embodiment is inexpensive and easy to produce because the parts are molded and then connected. Furthermore, this embodiment comprises only a small number of parts, which makes this embodiment simple and easy.

  The prestressed mode of the blocking device is to permanently connect the rim portion of the two opposite sides of the outlet portion and the inlet portion to each other and provide a gap between the outlet portion and the inlet portion. This gap is provided by forming and is held open by a barrier film extending through the gap. The rim portion means the outermost 3 to 10 mm of the discharge port portion and the injection port portion. Permanent connections are made by welding, bonding or clamping the two rim parts together. The outlet portion and the inlet portion may have any shape, for example, circular or square. The two opposite sides correspond to a predetermined extension so that the two parts are not easily separated and are urged towards each other. When the gap is held open by the barrier film, the gap is automatically closed at the same time as the barrier film is removed.

  The outlet portion and the inlet portion can each include a hole surrounded by a ridge, where the ridge of the inlet portion fits within the ridge of the outlet portion. That is, the outer edge of the raised portion of the inlet portion is separated by the first distance. This first distance is less than or equal to the second distance between the inner edges of the raised portions of the discharge port portion. A barrier film extending between the two parts will strike the ridges of both parts in the storage position. Pre-stressing both parts while removing the barrier film will encourage both parts towards each other. The inlet ridge will then enter the space provided by the outlet ridge. Two opposing ridges need only have a slight overlap to close the gap and will prevent excessive spillage of the fluid medium.

  The outlet and inlet portions should be manufactured from materials that tend to return to their original shape. This is a material with ideal elastic properties and low viscoelastic properties. Such material will make it easier for the outlet and inlet portions to close the gap between them. An example of a material that meets these requirements is polyetheretherketone (PEEK).

  The blocking device can also include an end of the barrier film, the end of the barrier film being permanently connected to the compartment and package below the outlet and inlet, respectively, and extending at least one downward. Connected to the existing tensile part, where the covering part of the barrier film is the part of the barrier film between the tensile part and the permanently connected end. This is a very simple way of providing a blocking device, as it only requires a special way of connecting the barrier films. Thereafter, the blocking device functions.

  In related embodiments, the blocking device may further comprise an outlet portion and an inlet portion disposed at least below the outlet port and the inlet port, wherein the end of the barrier film is the outlet portion and Each is permanently connected to the inlet part. As described above, these flanges (or portions) provide increased strength to the area surrounding the outlet and inlet, particularly to the area where the barrier film is to be permanently connected. Further, each of the discharge port portion and the injection port portion may include holes aligned with the discharge port and the injection port so as to surround the discharge port and the injection port. Similarly, this provides increased strength to the extent that is most subject to pressure.

  The blocking device may further comprise a delaying release liner at the outlet. If the lower part of the gap is open in the storage position, then the release delay liner can delay the opening of the outlet, thereby ensuring that the gap is completely closed before the outlet opens. Shall. The release delay liner can be made from the same material as the barrier film. The release delay liner is loosely connected to the outlet and permanently connected to the barrier film. In this way, the release delay liner is easy to remove from the outlet and will be removed along with the barrier film. The release delay liner may comprise one or more folds. The tensile portion of the barrier film on the outlet side can comprise an extension, which is adhered to the tensile portion of the barrier film on the inlet side above the extension. This is an aspect that provides a time difference between opening the inlet and opening the outlet.

  The present invention also relates to unpacking the package simultaneously with the removal of the barrier film. Simultaneously means that unpacking and removal are performed in one operation. In order for the user to recognize the operation as one step, it does not have to occur in exactly the same operation, but it must occur in a relatively short time. Users of these types of assemblies may not be hand dexterous. Therefore, it is advantageous to minimize the number of steps that a user must take before use. The package can comprise an unpacking foil that covers the opening of the package, and the unpacking foil can be suitable for removal using a barrier film. The unpacking foil may include a tension portion for pulling the foil and a covering portion for covering the opening. The covering portion of the unpacking foil can be glued or peeled to the package so that the package is completely closed before use. However, the covered portion of the unpacking foil can be removed by peeling the adhesive or peel weld when the package is to be used. In one embodiment, the tensile portion of the unpacking foil can be connected to the barrier film, for example, by welding or gluing. In other embodiments, the pull portion of the unpacking foil can be disposed around the reel element and the reel element can be bonded to the barrier film. The reel element can be in the form of a rod of hard 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 that forms part of the barrier film. The last embodiment is made by providing a hole through the barrier film and extending the unpacking foil through the hole. If the pulling portion of the unpacking foil is connected to the assembly, the portion of the barrier film that extends below the unpacking foil will function as a reel for the unpacking foil. The assembly can include tension rings at the top and bottom so that it can hang from the hook. The user can then pull down through the finger on the bottom ring (eg, installed at the bottom of the compartment). Users who are not dexterous may find it easier to pass a finger through the hole rather than gripping the foil element to exert a tensile force.

  Another aspect is a barrier film comprising a compartment for a fluid medium, a package for a medical device including an inlet to the package, a covering portion covering a tension portion and an outlet from the compartment, and a blocking device A fluid medium stored in a compartment by wetting a tensile portion of the barrier film, thereby removing the covering portion from the outlet and inlet The blocking device is adapted to close the gap between the compartment and the package so that the fluid medium enters the package through the inlet.

  The barrier film is placed at the outlet and inlet before use, thereby preventing contamination of the outlet and inlet. This barrier film must be removed before use. Advantageously, the barrier film can be removed as soon as the fluid medium enters the package. In one embodiment, the package is unpacked at the same time that the barrier film is removed. This makes it easier to use the assembly, since the user only needs to perform one action and then the medical instrument stored in the assembly is ready for use. In a related embodiment, the assembly has ring elements at the top and bottom of the compartment. In use, the assembly is suspended from the hook by the top ring element and the user passes his finger through the lower ring element and then pulls down to unpack the package and remove the barrier film.

FIG. 1 shows a cross-sectional view of an assembly comprising a package and compartment with a medical device (catheter). FIG. 2 shows an embodiment of the blocking device, where the flange is thicker at the bottom of the joint between the package and the compartment. FIG. 3 shows an embodiment of a blocking device, wherein the blocking device comprises an elastic element captured in a flange. FIG. 4 shows an embodiment of a blocking device, wherein the blocking device comprises a protruding element. FIG. 5 shows an embodiment of a blocking device that is very similar to the embodiment of FIG. 4, with the slight difference that in this embodiment the barrier film is loosely connected to the outlet before use. FIG. 6 shows an embodiment of a blocking device comprising pre-stressed elements. FIG. 7 shows an embodiment comprising a barrier film extending downward. FIG. 8 shows one aspect of unpacking the package. FIG. 9 shows one embodiment of unpacking the package. FIG. 10 shows one aspect of unpacking the package. FIG. 11 shows one aspect of unpacking the package.

  FIG. 1 shows an assembly 100 for wetting a medical device 101 that includes a package 110 and a compartment 120. The package can be manufactured from two foil elements 111 and 112, which are welded together along their sides (not shown). FIG. 1 shows only the part where the package 110 wraps the medical device 101. Typically this would not be the case because the package should prevent contamination of the medical device and then naturally wrap the entire medical device. In most (but not all) situations, the foil element is closed at the bottom of the medical device and the top of the medical device. Similarly, the compartment comprises two foil elements 121 and 122 closed at the side of the foil element, the bottom 123 and the top 124, for example by welding (not shown). The package also includes an inlet hole 130 for placing a fluid medium in the package, and the compartment includes an outlet 140 for allowing the fluid medium 150 contained in the compartment to flow out. Prior to use, the inlet 130 and outlet 140 are covered with a barrier film 160 so that contamination of the fluid medium 150 and medical device 101 is minimized. When the assembly is to be used, the outlet 140 from the compartment must be in contact with the inlet 130 to the package and the barrier film 160 must be removed. When the barrier film is removed from the outlet 140, the fluid medium will be able to escape from the compartment. This embodiment relates to various blocking devices 170 that allow contact between the outlet and the inlet to be established before removing the barrier film from the outlet. In the embodiment shown in FIG. 1, the assembly 100 further comprises a foil 180 that will unpack the package upon removal so that the medical device 101 is removed. In the illustrated embodiment, the foil is connected to the barrier film 160 so that the two parts are removed simultaneously.

  FIGS. 2 a-2 e show an embodiment of a blocking device, where the blocking device 270 comprises two flanges, an outlet flange 271 of the outlet 240 and an inlet flange 272 of the inlet 230. The inlet flange 272 is thicker at the lower portion 273 than at the upper portion 274. The package is shown schematically at 210 and the compartment at 220. The barrier film 260 includes two covering portions, that is, an outlet covering portion 261 and an inlet covering portion 262. The barrier film further comprises two tensile portions 263 and 264, which are connected to each other to form a single tensile portion. The blocking device further includes a release delay liner 275 that is loosely connected to the outlet 240 and adhered or welded to the outlet covering portion 261 of the barrier film. The release delay liner has the effect of covering the outlet 240 until the lower portion 273 of the inlet flange contacts the outlet flange. FIGS. 2 c-2 e show the gradual removal of the release delay liner 275 and show that the release delay liner 275 covers the outlet 240 until the lower portion 273 of the inlet flange is in intimate contact with the outlet flange 271. Show further.

  FIGS. 3 a-3 e show an embodiment of a blocking device 370 comprising a confined elastic element, which in this embodiment is a foam element 371. Foam element 371 is housed within the boundary of inlet flange 372 at its periphery. The blocking device further comprises an outlet flange 373 on the compartment side. The outlet flange has a bottom portion 374 with an upstanding rib 375 that allows the bottom portion to capture the bottom of the inlet flange 372 in a snap-coupled relationship. A snap connection of the two flanges will provide the necessary squeezing of the foam element. The barrier film 360 has two covering portions, that is, an outlet covering portion 361 and an inlet covering portion 362. The barrier film further includes two tensile portions: an outlet covering portion extension 363 and an inlet covering portion extension 364. The outlet tension portion 363 is bonded to the inlet tension portion 364 at a point 365 above the flange. A small loop 366 that delays removal of the outlet covering portion 361 is provided in the outlet tension portion 363 below the adhesion point 365. This means that the outlet covering portion is removed after the inlet covering portion 362 is removed. The delay of the outlet covering portion 361 is further illustrated in FIGS. 3c-3e, particularly in FIG. 3d, where the inlet covering portion 362 is completely removed and the outlet covering portion 361 is still about 1/2 of the outlet 340. Shows covering. At the same time as the covering portions 361 and 362 are removed, the elastic element 371 will expand toward the outlet flange 373. Immediately after the outlet covering portion 361 is removed from the gap 376 between the foam element 371 and the outlet flange 373, the gap 376 is completely closed by the foam element 371, after which the fluid medium 350 is injected into the inlet 330. It would only be possible to enter the package 320 through.

  4a to 4d show an embodiment of a blocking device according to the invention, wherein the blocking device 470 has an outlet part 471 and an inlet part 472 with protrusions 474-477, the protrusions being Suitable for cooperating with the foam flange 473, the foam flange 473 is encouraged to make intimate contact with the outlet portion 471. The inlet portion 472 can be made as an annular flange. In this case, the protrusion is made as a ring-shaped element so that the lower protrusion 474 is the same element as the upper protrusion 477 and the protrusions 475 and 476 near the outlet are the same ring-shaped element. Referring to FIGS. 4 a and 4 b, the barrier film 460 extends between the foam flange 473 and the outlet portion 471 so that it initially extends beyond the lower protrusion 474. The protrusion will cause the foam flange 473 to be slightly curved toward the outlet portion 471. Thereby, the barrier film 460 will be secured between the outlet portion 471 and the foam flange 473. At the same time that the barrier film 460 is removed, the outlet portion 471 and the foam flange 473 are in intimate contact with each other. Referring to FIGS. 4c and 4d, thereby the gap between the inlet and outlet will always remain closed. At the same time that the film 460 is completely removed (as shown in FIG. 4d), the fluid medium 450 could only flow through the inlet 430 and into the package 410.

  FIG. 5 shows an embodiment similar to the embodiment of FIGS. The slight difference is the configuration of the barrier film 560, which in this embodiment is folded to have a covering portion 561, and the covering portion 561 is loosely connected to cover the outlet 540. As a result, in this embodiment, the barrier film 560 extends only beyond the protrusion 575 closest to the inlet 530 and outlet 540 without exceeding the lowermost protrusion 574.

  FIGS. 6a-6e show another embodiment of a blocking device, wherein the blocking device 670 comprises two parts: an outlet part 671 and an inlet part 672. FIG. These two parts are assembled so that the central part 673 of the outlet part 671 and the central part 674 of the inlet part 672 engage each other, but the barrier film 660 is between the two central parts 673 and 674. Will be prevented from engaging at first. FIG. 6a shows the blocking device 670 before use, as seen from the side. FIG. 6 b shows the blocking device 670 viewed from above, and FIG. 6 c shows a perspective view of the outlet portion 671 and the inlet portion 672. In other words, the two central portions 673 and 674 are pre-stressed and the direction is the direction of movement in which the two central portions engage each other. In the illustrated embodiment, the pre-stress is obtained by providing a raised portion 675 in the central portion 673 of the outlet portion 671 on at least three sides of the hole 676, the hole 676 being an outlet. 640. Moreover, a ridge 677 is provided in the central portion 674 of the inlet portion 672 that surrounds the smaller hole 678 in the central portion. FIGS. 6d, 6e, and 6f show views corresponding to FIGS. 6a, 6b, and 6c when the blocking device 670 is closed, corresponding to the assembly in the use position. Since the inlet portion ridge 677 fits within the outlet portion ridge 675, the two central portions 673 and 674 have the barrier film covering portions 661 and 662 removed, as shown in FIG. 6f. Will be in close contact with each other. In this position, the fluid medium 650 exiting the compartment through the outlet 640 is prevented from spilling down and will therefore enter the package through the inlet 630.

  7a-7e show an embodiment of a blocking device according to the invention, wherein the blocking device 770 comprises an outlet portion 771 and an inlet portion 772 that are connected to each other at the top and sides. FIG. 7 a shows the blocking device 770 viewed from the top, FIG. 7 b shows the blocking device 770 viewed from the compartment, and FIG. 7 c shows a side view of the blocking device 770. The two parts include first holes 773 and 774 that are aligned with the outlet 740 and the inlet 730, respectively. The two parts further comprise second holes 775, 776, which provide the space necessary for folding the barrier film. In this embodiment, the barrier film 760 functions as part of the blocking device. The barrier film includes two covering portions 761 and 762 and a tensile portion 763 extending downward. When the pulling portion 763 is pulled downward, the covering portions 761 and 762 are removed from the outlet 740 and the inlet 730. However, the barrier film is permanently connected to the outlet portion 771 and the inlet portion 772 by two connecting portions 764, 765, respectively. This means that only the covering portions 761, 762 are removed when pulling the tension portion. This will move the barrier film to the position shown in FIGS. 7d and 7e. In this position, the fluid medium 750 contained in the compartment would be able to flow into the package without spilling through the outlet 740 and inlet 730. Coatings can be provided on the mutually facing surfaces 766, 767 of the barrier film 760 and the coatings are not weldable. This makes it possible to perform the welding of this embodiment in one step, since the two surfaces 766, 767 facing each other will not be welded to themselves. Thereby, the barrier film 760 is pulled downward without being obstructed.

  8-11 relate to various assemblies, where the barrier film 860 is removed at the same time that the package 810 is unpacked. 8a and 8b show the principle of the reel element 890. FIG. The reel element 890 includes a rod 891 and an unpacking foil 880 is disposed around the rod. The end of the unpacking foil 880 is secured at point 883 by adhesion or welding. For example, pulling the reel element 890 with a portion of the barrier film 860 connected to the reel element 890 causes the weak connection 884 of the unpacking foil 880 to peel off. The reel element allows removal of twice the length of the unpacking foil 880 compared to the length of the barrier film 860. FIG. 8 c shows an assembly 800 comprising a package 810 containing a medical device 801 (a catheter in this embodiment) 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 any of the types described above. One or more covering portions 861 of the barrier film 860 are used to cover the outlet 840 and the inlet 830 prior to use. The barrier film 860 further includes a first tensile portion 862 that extends upwardly between the compartment 820 and the package 810. The first tension portion 862 is connected to the second tension portion 863 by a permanent connection 864 (eg, welding or gluing). An unpacking foil 880 covers the opening of the package and is connected to the package 810 by a weak connection 884 (eg, peel welding or gluing). The unpacking foil 880 includes a covering portion 881 and a tension portion 882 where the end of the tension portion is secured to the package 810 at a connection point 883. Unpacking foil tension portion 882 is disposed about reel element 890 in conjunction with barrier film 860. The reel element is shown in more detail in FIG. In this embodiment, the reel element 890 consists of a hole 892 in the second tension portion 863 and a piece of foil that forms the rod element 891. When the second pulling portion 863 is pulled in the direction indicated by the arrow, the rod element 891 is moved upward, thereby pulling the pulling portion 882 of the unpacking foil using the rod element. At the same time, the second tension portion 863 pulls the first tension portion 862, the first tension portion 862 pulls the covering portion 861, and then the barrier film is removed from the outlet and inlet. Since the covering portion 861 has a length of about 30 to 60 mm, and the covering portion is bent, the tensile length for removing the covering portion is about 60 to 70 mm. In order to ensure complete removal of the covering portion 861, the user will pull the tension portion 60-70 mm. Without the reel element, this tensile length would not remove the covering portion 881 of the unpacking foil 880 since the length of the covering portion 881 of the unpacking foil 880 is about 120 mm. Since the reel element 890 removes the tensile length of the unpacking foil 880 to be doubled, the tensile length of 60 mm at the second tensile portion 863 is the tensile length of the tensile portion 882 of the unpacking foil 880. It corresponds to 120 mm.

  The embodiment of FIG. 1 does not include a reel element. This ensures that the fluid enters the package to wet the medical device before unpacking, thereby reducing the risk that the user will inadvertently try to use the dry medical device. .

  Figures 9a and 9b show an unpacking embodiment similar to the embodiment of Figures 8c and 8d. The slight difference is the position of the connection point 983 at the end of the unpacking foil 980. In the embodiment of FIGS. 9 a and 9 b, the connection point 983 is installed in the compartment 920 instead of the package 910. This allows a straighter arrangement of the barrier film 960 such that the first tensile portion 962 is integral with the second tensile portion 963. This embodiment functions in exactly the same way as the embodiment of FIG.

  Figures 10a and 10b show another embodiment of unpacking, which is also similar to the embodiment of Figures 8c, 9a, and 9b. In this embodiment, the first tensile portion 1062 is integral with the tensile portion 1082 of the unpacking foil 1080. Since the connection of the covering portion 1081 of the unpacking foil 1080 is weaker than the connection and locking of the covering portion 1061 of the barrier film, the pulling of the covering portion 1081 of the unpacking foil 1080 is first performed by pulling the second tensile portion 1063. Would start. Once the covering portion 1081 of the unpacking foil 1080 has been removed to a connection point 1083 that is placed directly above the opening (as shown in FIG. 10c), then pulling the second tension portion 1063 is a barrier film. Will exert a tensile force on the coated portion 1061 of the substrate. Also, the connection of the unpacking foil covering portion 1081 and the connection and locking of the barrier film covering portion 1061 may be balanced so that removal occurs approximately simultaneously.

  FIGS. 11 a and 11 b show another aspect of the arrangement of the unpacking foil 1180, where the user pulls the pulling portion 1182 of the unpacking foil 1180 directly. The tension portion 1182 is permanently connected to the tension portion 1162 (eg, in the form of a thread) of the barrier film 1160. The tension portion 1162 is connected to the covering portion 1161 of the barrier film. The covering portion 1181 of the unpacking foil 1080 is loosely connected to the package at the connection point 1083. When the user pulls on the pulling portion 1182 of the unpacking foil 1180, first the covering portion 1181 of the unpacking foil will be pulled away. Further pulling is transmitted to the barrier film tension portion 1162 and eventually the unpacking foil covering portion 1181 will separate from the connection point (see FIG. 11b). Once the unwrapped foil covering portion 1181 has been separated from the package, the user will then be able to completely remove the barrier film 1160.

Claims (42)

An assembly for wetting a medical device comprising a compartment for a fluid medium and a package for containing the medical device,
The package and the compartment are separate elements connected to each other;
In the storage position, the outlet from the compartment and the inlet to the package are covered with a barrier film, and in the use position, the barrier film is removed from the outlet and the inlet, whereby the outlet and the inlet. Fluid communication between
The assembly comprises a blocking device for closing a gap between the outlet and the inlet at least in a use position.   The assembly of claim 1, wherein a hydrophilic coating is provided at least in part on the medical device contained within the package.   The assembly according to claim 1 or 2, wherein the medical device is a urinary catheter.   The assembly according to claim 1, wherein the blocking device comprises an inlet flange and an outlet flange.   The assembly of claim 4, wherein the inlet flange and outlet flange comprise an upper portion and a lower portion.   The assembly of claim 4, wherein the inlet flange and outlet flange comprise annular flanges defining an upper portion and a lower portion.   The assembly according to any one of claims 4 to 6, wherein the inlet flange or the outlet flange is thicker at a lower part thereof than at an upper part thereof.   The assembly of claim 7, wherein the barrier film comprises two length portions of the film.   The assembly of claim 7, wherein the thickness of the top of the flange is about half of the thickness of the lower portion of the flange.   The assembly according to any one of claims 4 to 9, wherein the thick part of the flange comprises an adhesive layer on the side facing the opposing flange.   11. An assembly according to any one of claims 4 to 10, wherein the flanges having different thicknesses are the inlet flanges.   The blocking device comprises an elastic element, the elastic element being kept compressed by the barrier film in the storage position, and a lower part of the gap between the discharge port and the injection port in the use position 4. The assembly according to any one of claims 1 to 3, wherein the assembly is released to close.   13. An assembly according to claim 12, wherein the elastic element is a foam element.   13. An assembly according to claim 12, wherein the elastic element is a rubber gasket.   15. An assembly according to any one of claims 12 to 14, wherein the elastic element is housed between an outlet flange and an inlet flange held together by a snap element.   16. An assembly according to any one of claims 12 to 15, wherein the elastic element is an annular element.   17. An assembly according to any one of claims 12 to 16, wherein the elastic element is installed on the inlet flange.   The blocking device comprises an outlet flange and an inlet flange, one of the flanges comprising at least one protrusion on a lower portion of the flange to cooperate with an elastic element placed between the flanges. Item 4. The assembly according to any one of Items 1 to 3.   The assembly of claim 18, wherein the outlet flange and inlet flange are annular elements surrounding the outlet and inlet, respectively.   20. An assembly according to claim 18 or 19, wherein the protrusion is configured as a ring element.   21. An assembly according to any one of claims 18 to 20, wherein the flange comprises more than one protrusion at least below the outlet and inlet.   The assembly according to any one of claims 18 to 21, wherein the barrier film extends beyond the lower protrusion.   The assembly according to any one of claims 18 to 21, wherein a covering portion of the barrier film is loosely connected to the outlet.   24. An assembly according to any one of claims 18 to 23, wherein the flange comprising the protrusion is installed at the inlet.   The blocking device includes a discharge port portion and an injection port portion, and the discharge port portion and the injection port portion are connected to each other so that stress is preliminarily applied to the discharge port portion and the injection port portion; The assembly according to any one of claims 1 to 3, wherein a gap between the inlet portion and the inlet portion is closed.   Two opposite rim portions of the discharge port portion and the injection port portion are permanently connected to each other, and a gap is formed between the discharge port portion and the injection port portion, and the gap defines the gap. 26. The assembly of claim 25, held open by the barrier film extending therethrough.   27. A set according to claim 25 or claim 26, wherein each of the outlet portion and the inlet portion comprises a hole surrounded by a raised portion, and the raised portion of the inlet portion fits into the raised portion of the outlet portion. Solid.   28. An assembly according to any one of claims 25 to 27, wherein the outlet portion and the inlet portion are made from a material having low viscoelastic properties.   30. The assembly of claim 28, wherein the material is PEEK.   The blocking device comprises an end of the barrier film permanently connected to the compartment and package, respectively, below the outlet and inlet, and at least one downwardly extending tensile portion; The assembly according to any one of claims 1 to 3, wherein the covering portion of the barrier film is a portion of the barrier film between the tensile portion and the end portion to be permanently connected.   The blocking device further includes a discharge port portion and an injection port portion disposed at least below the discharge port and the injection port, and the end portions of the barrier film are permanently attached to the discharge port portion and the injection port portion, respectively. 32. The assembly of claim 30, wherein the assemblies are connected.   32. The assembly of claim 31, wherein the outlet portion and the inlet portion each comprise a hole that is aligned with the outlet and the inlet, respectively, so as to be disposed surrounding the outlet and the inlet. .   35. The assembly of any one of claims 1-32, wherein the blocking device further comprises a release delay liner at the outlet.   34. The assembly of claim 33, wherein the release delay liner is loosely connected to the outlet and permanently connected to the barrier film.   35. An assembly according to claim 33 or 34, wherein the release delay liner comprises three portions folded together.   36. The outlet portion of the barrier film tension portion comprises an extension portion, the tension portion being bonded to the inlet portion barrier film tension portion above the extension portion. The assembly according to any one of the above.   37. An assembly according to any one of the preceding claims, wherein the package comprises an unpacking foil covering the opening of the package, the unpacking foil being adapted to be removed using the barrier film. .   38. The assembly of claim 37, wherein the unpacking foil comprises a tension portion for pulling the foil and a covering portion for covering the opening.   40. The assembly of claim 38, wherein a tensile portion of the unpacking foil is connected to the barrier film.   39. The assembly of claim 38, wherein a pull portion of the unpacking foil is disposed about a reel element, and the reel element is coupled to the barrier film. A fluid medium compartment; a package for a medical device that includes an inlet to the package; a barrier film that includes a tension portion and a covering portion that covers an outlet from the compartment; and a blocking device. A method of wetting a medical device stored in an assembly
Pulling the tensile portion of the barrier film, thereby removing the covering portion from the outlet and inlet, allowing the fluid medium stored in the compartment to escape from the compartment;
The method wherein the blocking device is adapted to close a gap between the compartment and the package such that the fluid medium enters the package through the inlet.   42. The method of claim 41, wherein the package is unpacked when the barrier film is removed.

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