CN102099076A

CN102099076A - A blocking device

Info

Publication number: CN102099076A
Application number: CN200980128157XA
Authority: CN
Inventors: J·M·B·弗雷泽里克森; K·贝克尔; K·马蒂松汉森; L·O·谢尔泰格
Original assignee: Coloplast AS
Current assignee: Coloplast AS
Priority date: 2008-07-18
Filing date: 2009-07-15
Publication date: 2011-06-15
Also published as: CA2728006A1; AU2009270601A1; JP2011528244A; WO2010006619A1; US20110120892A1; EP2303383A1

Abstract

An assembly (100) for wetting a medical device (101) is provided. The assembly (100) comprises a compartment (120) for the fluid medium and a package (110) for a medical device (101). The fluid medium in the compartment (120) may be used for wetting a hydrophilic coating disposed at an 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. Prior to use, when the assembly (100) is in a storage-position, a gap between the outlet (140) and inlet (130) may be present. The outlet (140) and inlet (130) may both be closed by a barrier film (160) preventing contamination of the outlet (140) and inlet (130) prior to use. When the assembly (100) is to be used, the barrier film (160) is removed thereby opening the outlet (140) and inlet (130). The removal of the barrier film (160) may be connected to the opening of the package (110) such that the package (110) is opened as the barrier film (160) is removed. A blocking device (170) for closing the gap between the outlet (140) and inlet (130) at least in the use-position is provided.

Description

Blocking device

Technical field

The present invention relates to be enclosed in from the outlet of separate space and lead to connection between the import of package, this package is connected with the assembly that is used for the moistening medical treatment device.Separate space is equipped with fluid media (medium), and package is equipped with medical treatment device.The invention provides a kind of blocking device, be used to be enclosed in the connection between the export and import.

Background technology

The conduit that catheter is widely used in intermittently inserts, and particularly carries out surgical treatment process that conduit intermittently inserts relevant and be correlated with the spinal cord injury (wherein, the user can not control bladder) with medical personnel.In order to reduce the danger of urethral wall damaged, catheter is coated with coating usually, and this coating makes that the lip-deep frictional resistance of catheter is extremely low.This coating activates by apply fluid media (medium) (for example tap water or disinfectant) to coating usually-in the fabrication stage or before using.When before coating is being used, activating, fluid media (medium) can be provided in the isolating separate space of medical treatment device in, thereby form the assembly that comprises the package that is used for medical treatment device and be used for the separate space of fluid media (medium).Such assembly is for example shown in the WO2006/092150, and it provides a kind of and has been used for by fluid media (medium) being released into the assembly of preparing medical treatment device on the device, particularly catheter.At this device of package intermediate package, this package is equipped with the fluid media (medium) that is limited in the separate space.DE10334372 provides a kind of urinary catheter systems that is used to urinate, and it comprises: be used to insert the intravital pipe of human body or animal, this pipe has coating, and this coating can activate by liquid; The separate space that is used for receiving fluids, the liquid of this separate space comprises the disinfectant that is dissolved in the liquid.

Some users of catheter are subjected to urinary tract infection (UTI) usually.Be subjected to for 30% every year surpassing 3 UTI, be subjected to surpassing 6 UTI 10% every year.

For the danger that reduces to infect, can be sterilized to medical treatment device and fluid media (medium).For fluid media (medium), particularly all the more so when fluid media (medium) is packaged in the assembly with medical treatment device in advance.Preferably can carry out disinfection to medical treatment device and fluid media (medium) respectively, then, after disinfecting, make sealed package spare that medical treatment device is housed and the sealing separate space that fluid media (medium) is housed be attached to each other.Can be chosen in also that fluid medium and medical treatment device carry out disinfection in the assembling processing procedure.In order to keep the disinfectant content, the import of package and the outlet of separate space can all be covered by protective lining or barrier film before using.Such barrier film can be removed by spurring it, thereby reduces the danger of unexpected activation component.When cover outlet and import have only barrier film the time, in case remove barrier film, the fluid media (medium) that is included in the separate space just may overflow separate space.For such assembly, when removing barrier film, need be enclosed in the gap between separate space and the package at least.

Summary of the invention

The present invention relates to provide a kind of gap locking device (blocking device), be used for when the lid of cover outlet and import no longer exists, being enclosed at least the bottom part in the gap between separate space and the package.This gap can be sealed always, and perhaps blocking device can provide sealing when outlet is opened.This will prevent overflowing of (or minimizing) fluid media (medium) at assembly when storage location becomes the use location.Barrier film can provide by different way according to the blocking device that uses.

The present invention also provides a kind of method of moistening medical treatment device.

In first aspect, the present invention relates to a kind of assembly that is used for the moistening medical treatment device, this assembly comprises separate space that is used for fluid media (medium) and the package that is used to hold medical treatment device, wherein:

Package and separate space are the discrete components that links together;

At storage location, cover by barrier film from the outlet of separate space and the import of leading to package, in the use location, barrier film is removed from export and import, thereby allows that fluid is communicated with between export and import;

Assembly comprises blocking device, is used for being enclosed in the use location at least the gap between the export and import.

When separate space and package as discrete component but be attached at a time-out, beneficial effect is that separate space can be made a position, package can be made in the another location.Package and separate space can also be sterilized respectively.

Assembly can be only at a part of moistening medical treatment device of device, and therefore, the top section of device keeps not moistening and not smooth, and can be used to keep this device.

Making two parts keep separating can also have such advantage, in storage process, keeps the leakage of separate space can not interfere with medical treatment device from liquid.And the pollutant on the separate space outside can not enter in the package.

Before using, need to remove barrier film and will help to prevent unexpected activation component, because the user need apply pulling force to barrier film, so that opening is to fluid media (medium) and package.

Fluid media (medium) can be water or saline solution, for example 0.9% normal saline.In one embodiment, fluid media (medium) can comprise antibacterial, for example hydrogen peroxide.Use hydrogen peroxide to provide bactericidal effect to medical treatment device, this helps to protect from infection.

Assembly comprises package and separate space, and they are two discrete parts, but is attached at together.Before using, fluid media (medium) is stored in the separate space.Package comprises import, and separate space comprises the outlet that is used for fluid media (medium).Export and import can be used for moving to the position that export and import is in contact with one another from the position that they are not in contact with one another.In primary importance, assembly is in storage location, and at second link position, assembly is in the use location.

In whole application, the top of assembly or upside are meant the end that comprises the capsule bag.

Package can be by the paper tinsel manufacturing, and this paper tinsel can weld along sidepiece.For this reason, suitable material is for example aluminum, polyethylene terephthalate (PETP), low density polyethylene (LDPE) (LDPE), high density polyethylene (HDPE) (HDPE), polypropylene (PP), polrvinyl chloride (PVC), polyamide (PA), amorphous polyester (PET) and surface treatment paper.At the top, package can partly be covered by tensile barrier film on the top.Like this, package is opened when removing barrier film, thereby can be directly near the medical treatment device that is stored in the package.

Separate space also can be made by the paper tinsel element.Such element can for example aluminum, PETP, LDPE, HDPE, PP, PVC, PA, PET and surface treatment paper be made by material.Such package and separate space be packing and storage easily, because they only occupy the same big space with the requirement of fluidic amount or medical treatment device.Separate space can weld along sidepiece, and like this, it will have the trend of compressing fully when fluid media (medium) leaves separate space.When separate space was folding along a side, separate space will be when fluid media (medium) leaves leaves very little volume in inside, thereby leaves small volume of fluid in separate space.

In certain embodiments, at storage location, export and import is covered by barrier film.In most of embodiment, barrier film will be made of one section or two sections films, and the end of membrane component will be used for cover outlet and import, and relative end will be used to spur barrier film.These parts of the barrier film of cover outlet and import are defined as the cover part of barrier film.The part of the film that the user spurs when removing barrier film is defined as pull portion structure.The cover part of barrier film can be united with a pull portion structure.The multistage film that constitutes barrier film can be from upwards applying a shade below export and import between separate space and package.Film can also apply downwards from being higher than export and import a little, so that cover outlet and import are folding then, so that extend upward between separate space and package.Burst can be lower than export and import just, and perhaps it can be lower than the flange that is attached on separate space and the package and is lower than export and import.

In other embodiments, barrier film extends between export and import, so it self constitutes the cover part of cover outlet and import.Barrier film can also comprise covering only cover part from the outlet of separate space, this means that an end of single hop film is used for cover outlet, and the other end is as pull portion structure.

In certain embodiments, the cover part of barrier film can loosely be attached on the export and import.The lax attached meaning is can relatively easily peel off attached.But, attached can not be too lax so that the cover part when not being subjected to pulling force and influencing, just fall.Usually, lax attached can the realization (for example more weak welding, like this, material can strip off) by peeling off welding.Such welding can be undertaken by be coated with one deck coating on material before welding, thereby prevents that two layers of material from fusing mutually.Attachedly also can realize by in paper tinsel, providing than weak part, tear line for example, or more weak bonding, for example pass through pressure adhesive.

In other or related embodiment, each pull portion structure of film can permanently be attached to each other.Equally, become the additional cover part of release liner form permanently to be attached on the barrier film.The permanently attached meaning is attached as suitable welding or strengthening adhering to, and like this, two parts can not be separated from each other at an easy rate.

Barrier film can be made by polyethylene (PE), and can be thick for about 40 μ m.In order to make barrier film remove easily, it is along folding transverse to the direction of pulling direction.Therefore, the direction of pulling force be along with adhere to the vertical direction in plane.

In one embodiment, being loaded on medical treatment device in the package lies at least partially in the surface and is provided with hydrophilic coating.Medical treatment device can be according to the purposes of medical treatment device and is being applied on the whole outer surface or on the part at outer surface.The medical treatment device of possess hydrophilic property coating should be encapsulated in the material of steam impermeable after coating as quickly as possible, because coating will expand when being subjected to steam and influencing.

Medical treatment device can be a catheter, and this catheter can be provided with hydrophilic coating.Catheter is known in this field.The example of catheter provides the catheter into the pipe of being made by polyurethane (PU) or PVC, and this catheter at one end provides adapter.In the opposite end (tip), catheter provides one or more eyelets, is used for making that urine enters in the pipe.For male's catheter, can insert length is 250-300mm, for female catheter, can insert length between 60-130mm.Can insert the length that length equals tubular element and remove the 3-5cm of close adapter.This part of catheter is uncoated, because catheter applies by immersion.The uncoated part of catheter also makes adapter to weld or to be glued on the catheter.When inserting catheter in the urethra, preferably catheter can be held and handle, and it hold a little not smooth.Assembly makes that catheter can moistening below adapter (moistening can be inserted length), and like this, adapter can be used to hold catheter.

When assembly is in storage location, from the outlet of separate space with lead to can be gapped between the import of package.At this storage location, export and import covers by barrier film (by two cover parts or the film by extending between them).Assembly comprises blocking device, and this blocking device is used for being enclosed in the part of bottom at least in the gap between the export and import when removing barrier film.By removing barrier film, export and import fluid mutually is communicated with, and like this, can flow through import and enters in the package from the fluid media (medium) of separate space.When fluid media (medium) flows between export and import, the sealing of the base section in gap will prevent overflowing of (most of at least) fluid media (medium).Blocking device can cover the part of bottom at least in the gap between the export and import.Blocking device is this bottom part of coverage gap always, and perhaps blocking device only can be used in the use location the just bottom part of coverage gap.

Barrier film can stick on the flange that is arranged in outlet and/or import department.When not having flange, barrier film can directly stick on separate space and the package.In such embodiments, flange can be arranged in the inside and the close exit of separate space, thereby provides stability in this zone.In these embodiments, blocking device can constitute by welding below export and import or adhere between separate space and package.In other embodiments, the barrier film that provides specially can be provided blocking device, and like this, barrier film (comprising adhering to/be welded on package and the separate space) constitutes blocking device.

In one embodiment, blocking device comprises inlet flange and outlet flange.Inlet flange is positioned at the import department of leading to package, and the outlet flange is positioned at the exit from separate space.

Inlet flange and outlet flange can comprise top part and bottom part, and perhaps it can comprise the annular lip of determining top part and bottom part.Preferably can so that flange respectively around import and outlet, because this can provide additional strength in this zone.Whether this may stick on separate space and the package relevant respectively with barrier film in import with above the outlet.But, reduce cost and can cause such embodiment, this embodiment only provides flange in the position of needs, and it is lower than import and outlet.Also can select, flange can be set to below import and outlet and above the two-piece type flange, thereby provide intensity to separate space and package.

The advantageous material that is used for flange is polyolefin, particularly PP, PE and the material material of acrylonitrile-butadiene-styrene (ABS) (ABS), Merlon (PC), silicone and styrene-based for example normally.

One in inlet flange or the outlet flange can be at bottom part place than thicker at top part place.Thicker this flange that means is vertical with opposing flanges and bigger size arranged in the plane of this opposing flanges.This is corresponding to flow direction.When flange was thicker below import or export, the bottom part of flange can contact with the bottom part of opposing flanges on whole surface when the bottom part is removed at barrier film.Contact on whole surface can realize, even because when the bottom part contacts, be useful on the space of barrier film between the part of the top of export and import flange on whole surface.

About these embodiment, barrier film can be attached on the assembly with foregoing different modes.When barrier film stretches, just seal this underclearance in case provide thicker flange will guarantee to remove the underclearance of barrier film between the bottom part of each flange below between each flange.Just, before barrier film is removed from outlet, two bottom parts of each flange will be in contact with one another on whole surface.This means that when underclearance sealed, the fluid media (medium) in separate space was merely able to leave by outlet.

Flange can be flange only about half of at the thickness at place, bottom at the thickness at top place.In order to optimize the probability of bottom to the crack complete closed, the thickness difference of flange should equal the required thickness of barrier film at least.How this thickness depend on attached barrier film, and for example for some embodiment, it may equal two folded parts of film, and in other embodiments, it may equal two parts film, that be in contact with one another.Barrier film can be thick for about 40 μ m, and two sections barrier films (not folded shrilly) of each autofolding 180 degree need the distance of about 1mm conveniently to remove.

The more thickness portion of flange can be included in towards the bond layer of opposing flanges one side.

Inlet flange can be different thickness with the outlet flange.Another embodiment relates to the blocking device that comprises flexible member, and at storage location, this flexible member keeps compression by barrier film, and in the use location, discharges this flexible member, so that be enclosed in the bottom part in the gap between the export and import.This embodiment mainly is very favourable when barrier film extended downwards between the part of the bottom in gap before extending upward between separate space and the package.When barrier film when the bottom part in gap is removed, flexible member will discharge, and will contact with opposing flanges.Therefore, the bottom part in gap will be before barrier film be removed from outlet complete closed.

Flexible member can be foam element (for example honeycomb PU or silicone) or rubber washer.Requirement is that material should have low compression deformation or pressure stable skew.And, when device uses, should avoid fluid media (medium) to drip from device.Basically, material can absorb the small volume of fluid medium, as long as it does not drip.

Flexible member can be contained between the outlet flange and inlet flange that is kept together by buckle element.Each flange can also keep together by welding or by being slidingly connected.The connection of these types provides the mode that makes things convenient for that is used for build-up member, like this, when assembly is in storage location, the flexible member compression, and in storage process, keep compression.

Flexible member can be provided in just below outlet or import.In another embodiment, flexible member is a ring-type element.For example, shape can be circular, avette, oval, block avette or square.When flexible member is ring-type element, when barrier film is removed fully with the whole periphery of closed-loop around export and import.This means assembly to be reversed and can not overflow.

Flexible member can be arranged in the inlet flange place; But, it can also be arranged in outlet flange place.The advantageous effects that flexible member is arranged in the inlet flange place is that before fluid media (medium) leaves separate space, flexible member will be enclosed in the gap between the export and import.Therefore, flexible member will be not easy to absorb a large amount of fluid media (medium)s.

In one embodiment, blocking device comprises outlet flange and inlet flange.A flange in outlet flange and the inlet flange is included at least one projection at part place, bottom, so that cooperate with the flexible member that inserts between the flange.This flexible member can be a foam element.

Projection will be exerted pressure on flexible member, thereby push it to opposing flanges.Because barrier film is arranged between flexible member and the opposing flanges (flange that does not have projection), so barrier film is limited in this position, up to apply pulling force on film.To help to make the gap between the export and import to keep sealing at the pressure on the flexible member.Therefore, this embodiment provides a kind of almost completely liquid seal and can prevent the scheme that fluid media (medium) overflows.

Projection can constitute ring-type element.When flange is an annular, and projection is when being set to ring-type element, with the complete closure that provides around export and import.This makes assembly to be reversed and fluid media (medium) can not overflow.

Flange can comprise a plurality of projectioies, particularly below export and import.Two or more projectioies have improved and have prevented that fluid from passing through the reliability that the contact portion between flange is leaked.

Barrier film can an extend past upper lobes.At this moment, it can provide the cover part that loosely is attached at the exit.In another embodiment, barrier film extend past export and import, and surpass lower lobes.The meaning that surpasses is to be lower than lower lobes.In first kind of situation, the bottom part in the gap between export and import is sealed always.In second kind of situation, at first provide little gap by barrier film.This gap will be sealed when barrier film is removed.

Another embodiment relates to a kind of blocking device, and this blocking device comprises exit portion and inlet part, this exit portion and inlet part be attached to each other for make they by prestress to be enclosed in the gap between them.Cheap and the manufacturing easily of this embodiment of blocking device is installed because each parts is molded then.And this embodiment includes only fewer parts, and this makes it simple and convenient.

A kind of mode that the blocking device of prestress is provided is the marginal portion permanently is attached to each other and forms the gap between exit portion and inlet part by two opposite side places in exit portion and inlet part, and this gap is stayed open by the barrier film that extends by the gap.The meaning of marginal portion is the outermost 3-10mm of exit portion and inlet part.Permanent attached will be by two edge be partly welded, glued joint or clip together and carry out.The export and import part can have arbitrary shape, for example circle or tetragon.Two opposite sides are corresponding to specific extension, make two parts and be not easy to separate, and these two parts push toward each other.When the gap was stayed open by barrier film, this gap was sealed when removing barrier film automatically.

Exit portion and inlet part can comprise separately by ridge around the hole, wherein, the ridge in the import department office is assemblied in the keel of exit portion.In other words, the outward flange of the ridge of inlet part is spaced apart with first distance.This first distance is equal to or less than the second distance between the inward flange of the ridge of exit portion.At storage location, will be resisted against two ridges on the part at the barrier film that extends between two parts.When removing barrier film, the prestress of two parts pushes two parts toward each other.Then, the ridge of import will enter in the space that the ridge by the exit provides.Two relative ridges will only need to overlap a little, for use in the sealing in gap, and prevent that fluid media (medium) from too much overflowing.

The export and import part should be made by the material with the strong trend of seeking its initiating structure.This is the material that has the perfect elasticity feature and have low viscoelasticity characteristic.Such material will make this easier gap that is enclosed between them of two parts.The examples of materials that satisfies these requirements is polyether-ether-ketone (PEEK).

Blocking device can also comprise: the end of barrier film, this end permanently are attached on separate space and the package below export and import respectively; And at least one pull portion structure of extending downwards, wherein, the cover part of barrier film is the part of the barrier film between pull portion structure and permanent attached end.This provides the very simple mode of blocking device, because it only needs the mode of a special attached barrier film.Blocking device just can work then.

In related embodiment, blocking device can also comprise exit portion and the inlet part that is arranged at least below the export and import, and wherein, the end of barrier film permanently is attached on this exit portion and the inlet part respectively.As previously mentioned, these flanges (or part) are used for strengthening the intensity around the zone of export and import, particularly in the zone of attached barrier film permanently.Exit portion and inlet part can also comprise the hole of aliging with export and import respectively separately, and like this, exit portion and inlet part are arranged around export and import.Have, this has improved the intensity in the zone that is subjected to maximum stress again.

Blocking device can also be included in the delay release liner in exit.When the bottom in gap part was opened in storage location, what postpone that release liner can deferred exit opened, thereby guarantees gap complete closed before outlet is opened.Postponing release liner can be by making with the barrier film identical materials.It can loosely be attached in the outlet, and permanently is attached on the barrier film.Like this, postponing release liner can remove from outlet at an easy rate, and will remove with barrier film.Postponing release liner can comprise one or more folding.Barrier film pull portion structure at outlet side can comprise the extension, and this pull portion structure sticks on the pull portion structure of barrier film at inlet side on the extension then.This be a kind of import open and export open between the method for delay is provided.

The invention still further relates to open package when removing barrier film.The meaning simultaneously is to open and remove in a motion to finish.It must not carry out in lucky identical moment, but is carrying out in relatively short time bar, and like this, the user will think that it is a step.The user's of this assembly manual dexterity can be lower.Therefore, it advantage is to reduce the user needed the step of carrying out before using number.Package can comprise the opening paper tinsel that covers the package opening, and this opening paper tinsel can be adapted to be with barrier film to be removed.The opening paper tinsel can comprise the pull portion structure and the cover part that is used to cover opening that is used in the pulling of paper tinsel place.The cover part of opening paper tinsel can be gluedd joint or strippingly is welded on the package, and like this, it is the complete closed package before using.But, it can be removed by peel off it in the time will using package.In one embodiment, the pull portion structure of opening paper tinsel can be attached on the barrier film, for example by welding or splicing.In other embodiments, the pull portion structure of opening paper tinsel can be arranged to around the spool element, and the spool element can be connected with barrier film.The spool element can become the form of rigid plastic material bar, and its welds or is glued on the barrier film.The spool element can also be the form of the whole paper tinsel element of the part that constitutes barrier film.Last embodiment can extend and makes by the hole of passing barrier film being provided and making the opening paper tinsel pass the hole.When the pull portion structure of opening paper tinsel was attached on the assembly, the barrier film that extends below opening paper tinsel part will be with the spool that acts on the opening paper tinsel.Assembly can be included in the draw ring of top and bottom, and like this, assembly can be hung by hook.Then, the user can be so that finger passes bottom part ring (for example being arranged in the place, bottom of separate space) and pulling downwards.The lower user of the motility of hands can find that easier feasible finger passes the hole so that apply pulling force, rather than catches the paper tinsel element.

Relate to the method that a kind of moistening is stored in the medical treatment device in the assembly on the other hand, this assembly comprises:

The separate space that is used for fluid media (medium);

The package that is used for medical treatment device, this package comprises the import of leading to package;

Barrier film, this barrier film comprises pull portion structure and cover part, this cover part covers the outlet of separate space;

Wherein, assembly also comprises blocking device;

This method comprises: the pulling department office at barrier film spurs, thereby removes the cover part from export and import, and makes the fluid media (medium) that is stored in the separate space leave separate space;

Wherein, blocking device is used to be enclosed in the gap between separate space and the package, and like this, fluid media (medium) will enter in the package by import.

Barrier film was arranged in the export and import place before using, thereby prevented that export and import from being polluted.This barrier film must be removed before using.Preferably barrier film can be removed, and fluid media (medium) enters in the package simultaneously.In one embodiment, package is opened when barrier film is removed.This makes the easier use of assembly, because the user only need carry out a motion, then, the medical treatment device that is stored in the assembly is in serviceable condition.In related embodiment, assembly has the ring-type element at the top of separate space and place, bottom.When using, assembly is suspended on the hook by the top annular element, and the user makes finger by the lower annular element, and pulling downwards then is so that open package and remove barrier film.

Description of drawings

Fig. 1 has represented the cutaway view of assembly, and this assembly comprises the have medical treatment device package and the separate space of (catheter).

Fig. 2 has represented an embodiment of blocking device, and wherein, the bottom of the junction of flange between package and separate space is thicker.

Fig. 3 has represented an embodiment of blocking device, and wherein, device comprises the flexible member that is stuck in the flange.

Fig. 4 has represented an embodiment of blocking device, and wherein, device comprises the protrusion element.

Fig. 5 has represented an embodiment of blocking device, and the embodiment among it and Fig. 4 is very similar, and only difference is in this embodiment, and before using, barrier film loosely is attached in the outlet.

Fig. 6 has represented an embodiment of blocking device, and this blocking device comprises prestressed element.

Fig. 7 has represented to comprise an embodiment of the barrier film of downward extension.

Fig. 8 to 11 has represented the different modes of open package.

The specific embodiment

Fig. 1 has represented to be used for the assembly 100 of moistening medical treatment device 101, and this assembly 100 comprises package 110 and separate space 120.Two paper tinsel elements 111 and 112 that package can be welded together by the sidepiece (not shown) along them are made.This accompanying drawing has only been represented the part of package 110 encapsulation medical treatment devices 101.Usually be not such situation,, therefore encapsulate whole medical treatment device naturally because package should prevent that medical treatment device from being polluted.Under most of situation (if not the whole circumstances), the paper tinsel element is in the following face closure of medical treatment device in the bottom, at the top on medical treatment device face closure.Similarly, separate space comprises two paper tinsel elements 121 and 122, these two paper tinsel elements 121 and 122 for example by the welding (not shown) their sidepiece, in the bottom 123 and at the top 124 the sealing.Package also comprises inlet openings 130, is used for allowing fluid media (medium) enter this package, and separate space comprises outlet 140, is used for making that the fluid media (medium) that is contained in separate space comes out.Before using, import 130 and outlet 140 are covered by barrier film 160, like this, will make the pollution of fluid media (medium) 150 and medical treatment device 101 be minimized.When assembly will use, must contact with the import 130 of leading to package from the outlet 140 of separate space, and must remove barrier film 160.When barrier film from exporting 140 when removing, fluid media (medium) can leave separate space.Each embodiment relates to different blocking device 170, and can set up contact before removing barrier film from outlet between export and import.In the embodiment shown in fig. 1, assembly 100 also comprises paper tinsel 180, this paper tinsel 180 when removing with open package, thereby take out medical treatment device 101.In the embodiment shown, paper tinsel is attached on the barrier film 160, and like this, two parts are removed simultaneously.

Fig. 2 a to 2e has represented an embodiment of blocking device, and wherein, blocking device 270 comprises two flanges: at the outlet flange 271 at outlet 240 places with in the inlet flange 272 at import 230 places.Inlet flange 272 is thicker at top part 274 places at bottom part 273 places ratio.Package schematically illustrates at 210 places, and separate space schematically illustrates at 220 places.Barrier film 260 comprises two cover parts: outlet cover part 261 and import cover part 262.Barrier film also comprises two

pull portion structure

263 and 264, and they can be attached at together, so that constitute single pull portion structure.Blocking device also comprises delay release liner 275, and this delay release liner 275 loosely is attached in the outlet 240, and adheres to or be welded on the outlet cover part 261 of barrier film.The effect that the delay release liner has is a cover outlet 240, contacts with the outlet flange up to the bottom of inlet flange part 273.Fig. 2 c to 2e has represented to postpone progressively removing of release liner 275, has also represented release liner 275 cover outlet 240, closely contacts with outlet flange 271 up to the bottom of inlet flange part 273.

Fig. 3 a-3e has represented to comprise the embodiment of the blocking device 370 of nipped flexible member (in this embodiment, this nipped flexible member is a foam element 371).At the periphery place, foam element 371 is contained in the border of inlet flange 372.Blocking device also is included in the outlet flange 373 of separate space side.This outlet flange has base section 374, and this base section 374 has upright rib 375, and this upright rib 375 makes base section can block the bottom of inlet flange 372 with the relation that is clasped.Being clasped of two flanges will provide foam element required extruding.Barrier film 360 has two cover parts: outlet cover part 361 and import cover part 362.Barrier film also comprises two pull portion structure: the extension 363 of outlet cover part and the extension 364 of import cover part.On flange some put 365 places, and outlet pull portion structure 363 sticks on the import pull portion structure 364.Below sticking point 365, outlet pull portion structure 363 has little ring 366, and this little ring 366 makes opening of cover part 361 of outlet be delayed.This means that exporting the cover part opens again after import cover part 362 is opened.The delay of outlet cover part 361 also represents in Fig. 3 c to 3e, and particularly in Fig. 3 d, this Fig. 3 d has represented that import cover part 362 opens fully, outlet cover part 361 still cover outlet 340 about 1/2.When opening cover part 361 and 362, flexible member 371 will be towards 373 expansions of outlet flange.In case remove from the gap 376 between foam element 371 and outlet flange 373 outlet cover part 361, gap 376 will be sealed by foam element 371 fully, and fluid media (medium) 350 can only enter in the package 320 by import 330.

Fig. 4 a to 4d has represented the embodiment of blocking device of the present invention, wherein, blocking device 470 has exit portion 471 and inlet part 472, this inlet part 472 comprises projection 474 to 477, these projectioies 474 to 477 are used for cooperating with foam flange 473, like this, foam flange 473 is urged and closely contacts with exit portion 471.Inlet part 472 can be made for annular lip.In this case, projection can be made for ring-type element, and like this, lower lobes 474 is and upper lobes 477 components identical, and the projection 475 and 476 of close outlet is identical ring-type element.Barrier film 460 extends between foam flange 473 and exit portion 471, and like this, film at first extends beyond lower lobes 474, sees Fig. 4 a and 4b.Projection will make foam flange 473 a little towards exit portion 471 bendings, and therefore, barrier film 460 will be fixed between exit portion 471 and the foam flange 473.When removing barrier film 460, exit portion 471 becomes mutually with foam flange 473 and closely contacts.Therefore, the gap between import and outlet will keep sealing always, see Fig. 4 c and 4d.When film 460 is removed fully (as shown in Fig. 4 d), fluid media (medium) 450 can only flow in the package 410 by import 430.

Fig. 5 represented with Fig. 4 a to 4d in the similar embodiment of embodiment.Difference only is the structure of barrier film 560, and in this embodiment, this barrier film 560 folds, so that loosely attached cover part 561 with cover outlet 540 is arranged.Therefore, in this embodiment, barrier film 560 does not extend beyond bottom side projection 574, but only surpasses the projection 575 of the most close import 530 and outlet 540.

Fig. 6 a to 6e has represented another embodiment of blocking device, and wherein, blocking device 670 comprises two parts: exit portion 671 and inlet part 672.These two parts are assembled together, and like this, the core 673,674 of exit portion 671 and inlet part 672 will be sought to be bonded with each other, but such being bonded at the beginning is prevented from, because barrier film 660 is arranged between two cores 673,674.The blocking device 670 that Fig. 6 a had represented before using and seen from sidepiece.Fig. 6 b has represented the blocking device 670 seen from above, and Fig. 6 c has represented the axonometric chart of exit portion 671 and inlet part 672.In other words, two cores 673,674 are bonded with each other and by prestress towards moving into.In the embodiment shown, prestress is by making that 676 three sidepieces provide ridge 675 and realize in the hole at least for the core 673 of exit portion 671, aligns with outlet 640 in this hole 676.And the core 674 of inlet part 672 is provided with ridge 677, and this ridge 677 is around the more aperture 678 in the central part office.Fig. 6 d, 6e and 6f have represented that (being in the use location corresponding to assembly) is corresponding to the view of Fig. 6 a, 6b, 6c when blocking device 670 sealings.The ridge 677 of inlet part is assemblied in the ridge 675 of exit portion, and like this, when removed the cover part 661 and 662 of barrier film, two cores 673 will closely contact mutually with 674, as shown in Fig. 6 f.In this position, will be prevented from by exporting 640 the overflowing of fluid media (medium) 650 of leaving separate space downwards, therefore will enter in the package by import 630.

Fig. 7 a to 7e has represented an embodiment of blocking device of the present invention, and wherein, blocking device 770 comprises exit portion 771 and inlet part 772, and this exit portion 771 and inlet part 772 are attached to each other at top and sidepiece.Fig. 7 a has represented that the blocking device 770 seen from the top, Fig. 7 b represented the blocking device of seeing from separate space 770, and Fig. 7 c has represented the side view of blocking device 770.Two parts comprise first hole 773,774 of aliging with outlet 740 and import 730 respectively.Two parts also comprise second hole 775,776, and this second hole 775,776 has and is used in the folding required space of barrier film.In this embodiment, barrier film 760 is as the part of blocking device.Barrier film comprises two cover parts 761,762 and the pull portion structure 763 of extending downwards.When spurring downwards at pull portion structure 763 places, cover part 761,762 from export 740 and import 730 remove.But, barrier film permanently is attached on exit portion and the inlet part 771,772 by two attachment part 764,765 respectively.This means when spurring, be merely able to remove cover part 761,762 in the pulling department office.This will make barrier film be in the position shown in Fig. 7 d and the 7e.In this position, the fluid media (medium) that is contained in the separate space can flow in the package by outlet 740 and import 730 under the situation of not overflowing.Barrier film 760 can be provided with coating on the surface 766,767 that faces with each other, this coating can not be welded.This makes this embodiment to weld in a step because two surfaces 766,767 that face with each other will can not be welded on they from one's body.Therefore, barrier film 760 can unhinderedly spur downwards.

Fig. 8 to 11 relates to different assemblies, and wherein, barrier film 860 is removed when package 810 is opened.Fig. 8 a and 8b have represented the principle of spool element 890.Spool element 890 comprises bar 891, and opening paper tinsel 880 is arranged to around this bar 891.The end of opening paper tinsel 880 is by glueing joint or welding and fixing at point 883 places.By spur (for example by being attached at the part of the barrier film 860 on the spool element 890) at spool element 890 places, opening paper tinsel 880 will be peeled off at more weak attachment 884 places.Compare with the length of barrier film 860, the spool element can be removed the opening paper tinsel 880 of double length.Fig. 8 c has represented to comprise the assembly 800 of package 810 and separate space 820, and this package 810 comprises medical treatment device 801 (being catheter in this embodiment).Package has import 830, and separate space has outlet 840.In import 830 with export gap between 840 by blocking device 870 sealing, this blocking device 870 can be any aforementioned type.One or more cover parts 861 of barrier film 860 are used for cover outlet 840 and import 830 before using.Barrier film 860 also comprises first pull portion structure 862, and this first pull portion structure 862 extends upward between separate space 820 and package 810.First pull portion structure 862 is attached on second pull portion structure 863 by permanent attachment 864 (for example welding or splicing).Opening paper tinsel 880 covers the opening that enters in the package, and is attached on the package 810 by more weak attachment 884 (for example peelable welding or splicing).Opening paper tinsel 880 comprises cover part 881 and pull portion structure 882, and wherein, the end of pull portion structure is fixed on the package 810 at attachment point 883 places.The pull portion structure 882 of opening paper tinsel is walked around spool element 890 and is arranged to be connected with barrier film 860.More detailed expression spool element in Fig. 8 d.In this embodiment, spool element 890 is included in the hole 892 and a paper tinsel that constitutes rod element 891 in second pull portion structure 863.When direction shown in the arrow spurs second pull portion structure 863, rod element 891 moves upward, thereby the pull portion structure 882 of opening paper tinsel is spurred with it.Simultaneously, second pull portion structure 863 is in the pulling of first pull portion structure, 862 places, and this first pull portion structure 862 is the pulling of 861 places in the cover part, thereby opens barrier film from export and import.Can there be the length of about 30-60mm cover part 861, and because they are folding, and the pulling length that therefore is used to open the cover part is about 60-70mm.In order to guarantee to open cover part 861 fully, the user will spur this pull portion structure 60-70mm.When not having the spool element, this length can not be opened the cover part 881 of opening paper tinsel 880, because the length of cover part 881 is about 120mm.Spool element 890 can be removed the opening paper tinsel 880 of Double Length, and like this, 60mm spurs 120mm corresponding to pull portion structure 882 places at opening paper tinsel 880 in the pulling of second pull portion structure, 863 places.

The embodiment of Fig. 1 does not comprise the spool element.This can guarantee that fluid entered before package is opened in the package so that the moistening medical treatment device, thereby has reduced the danger that the user by mistake uses dried medical treatment device.

Fig. 9 a and 9b have represented to be similar to the embodiment of the opening of Fig. 8 c and 8d.Only difference is the end that attachment point 983 is arranged in opening paper tinsel 980.In the embodiment of Fig. 9 a and 9b, attachment point 983 is arranged in separate space 920 places, rather than at package 910 places.This can more directly arrange barrier film 960, thereby first pull portion structure 962 and second pull portion structure 963 are integral.This embodiment is to work with the identical mode of the embodiment of Fig. 8 c.

Figure 10 a and 10b have represented another embodiment of opening, and it is still similar with the embodiment of Fig. 8 c, 9a and 9b.In this embodiment, first pull portion structure 1062 is integral with the pull portion structure 1082 of opening paper tinsel 1080.To at first start drag in second pull portion structure, 1063 places pullings, because the attached cover part 1061 than barrier film of cover part 1081 is attached and fixing more weak at 1081 places, cover part of opening paper tinsel 1080.When the cover part 1081 of removing opening paper tinsel 1080 during up to the attachment point 1083 that is arranged in just above the opening (as shown in Figure 10 c), the pulling at second pull portion structure, 1063 places will apply pulling force at 1061 places, cover part of barrier film.Also can be to the attached and fixing balance in addition of the cover part 1061 of the attached and barrier film of the cover part 1081 of opening paper tinsel, thus will side by side remove basically.

Figure 11 a and 11b have represented the another way of arrange openings paper tinsel 1180, and wherein, the user is directly in the pulling of pull portion structure 1182 places of opening paper tinsel 1180.Pull portion structure 1182 permanently is attached on the pull portion structure 1162 (for example becoming the form of rope) of barrier film 1160.Pull portion structure 1162 is connected with the cover part 1161 of barrier film.The cover part 1181 of opening paper tinsel 1080 loosely is attached on the package at attachment point 1083 places.When the user spurs the pull portion structure 1182 of opening paper tinsel 1180, the cover part 1181 of opening paper tinsel will at first be drawn back.Further pulling will pass to the pull portion structure 1162 of barrier film, and final, the cover part 1181 of opening paper tinsel will separate (seeing Figure 11 b) with attachment point.When the cover part 1181 of opening paper tinsel separated with package, the user can remove barrier film 1160 fully.

Claims

1. assembly that is used for the moistening medical treatment device, this assembly comprise the separate space that is used for fluid media (medium) and be used to hold the package of medical treatment device, wherein:

Package and separate space are the discrete components that links together;

At storage location, be blocked film from the outlet of separate space and the import of leading to package and cover, in the use location, barrier film is removed from export and import, thereby allows that fluid is communicated with between export and import;

2. assembly according to claim 1, wherein: the medical treatment device that is contained in the package is provided with hydrophilic coating in the part at least.

3. according to the described assembly of aforementioned any one claim, wherein: medical treatment device is a catheter.

4. according to the described assembly of aforementioned any one claim, wherein: blocking device comprises inlet flange and outlet flange.

5. assembly according to claim 4, wherein: inlet flange and outlet flange comprise top part and bottom part.

6. assembly according to claim 4, wherein: inlet flange and outlet flange comprise the annular lip of determining top part and bottom part.

7. according to any one described assembly among the claim 4-6, wherein: inlet flange or outlet flange are thicker at top part place at bottom part place ratio.

8. assembly according to claim 7, wherein: barrier film comprises two sections films.

9. assembly according to claim 7, wherein: the thickness of flange at top place is approximately flange in half of the thickness at bottom part place.

10. according to any one described assembly among the claim 4-9, wherein: the more thickness portion of flange comprises bond layer in the side towards opposing flanges.

11. according to any one described assembly among the claim 4-10, wherein: the flange that comprises different-thickness is an inlet flange.

12. according to any one described assembly among the claim 1-3, wherein: blocking device comprises flexible member, this flexible member keeps compression by barrier film in storage location, and discharges to be enclosed in the bottom part in the gap between the export and import in the use location.

13. assembly according to claim 12, wherein: flexible member is a foam element.

14. assembly according to claim 12, wherein: flexible member is a rubber washer.

15. according to any one described assembly among the claim 12-14, wherein: flexible member is included between the outlet flange and inlet flange that is kept together by buckle element.

16. according to any one described assembly among the claim 12-15, wherein: flexible member is a ring-type element.

17. according to any one described assembly among the claim 12-16, wherein: flexible member is arranged in the inlet flange place.

18. according to any one described assembly among the claim 1-3, wherein: blocking device comprises outlet flange and inlet flange, and a flange in outlet flange and the inlet flange is included at least one projection at part place, bottom, so that cooperate with the flexible member that inserts between outlet flange and the inlet flange.

19. assembly according to claim 18, wherein: outlet flange and inlet flange are respectively around the ring-type element of export and import.

20. according to any one described assembly among the claim 18-19, wherein: projection constitutes loop member.

21. according to any one described assembly among the claim 18-20, wherein: flange comprise be lower than at least export and import more than a projection.

22. according to any one described assembly among the claim 18-21, wherein: barrier film extends beyond lower lobes.

23. according to any one described assembly among the claim 18-21, wherein: the cover part of barrier film loosely is attached in the outlet.

24. according to any one described assembly among the claim 18-23, wherein: the flange arrangement that comprises projection is in import department.

25. according to any one described assembly among the claim 1-3, wherein: blocking device comprises exit portion and the inlet part that is attached to each other, they by prestress so that be enclosed in gap between them.

26. assembly according to claim 25, wherein: the marginal portion at two opposite side places of exit portion and inlet part permanently is attached to each other, and form the gap between exit portion and inlet part, this gap stays open by the barrier film that passes the gap extension.

27. according to any one described assembly among the claim 25-26, wherein: exit portion and inlet part comprise separately by ridge around the hole, and the ridge in the import department office is assemblied in the keel of export department office.

28. according to any one described assembly among the claim 25-27, wherein: exit portion and inlet part are by the material manufacture with low viscoelasticity characteristic.

29. assembly according to claim 28, wherein: this material is PEEK.

30. according to any one described assembly among the claim 1-3, wherein: blocking device comprises: the end of barrier film, this end permanently are attached on separate space and the package below export and import respectively; Pull portion structure that at least one extends downwards, wherein, the cover part of barrier film is the part of the barrier film between pull portion structure and permanent attached end.

31. assembly according to claim 30, wherein: blocking device also comprises exit portion and the inlet part that is arranged at least below the export and import, and wherein, each end of barrier film permanently is attached on this exit portion and the inlet part respectively.

32. assembly according to claim 31, wherein: exit portion and inlet part comprise the hole of aliging with export and import respectively separately, and exit portion and inlet part are arranged around export and import.

33. according to the described assembly of aforementioned any one claim, wherein: blocking device also is included in the delay release liner in exit.

34. assembly according to claim 33, wherein: postpone release liner and loosely be attached in the outlet, and permanently be attached on the barrier film.

35. according to any one described assembly among the claim 33-34, wherein: postpone release liner and comprise three parts that fold.

36. according to the described assembly of aforementioned any one claim, wherein: the barrier film pull portion structure at outlet side comprises the extension, and this pull portion structure sticks on the pull portion structure of barrier film at inlet side on the extension.

37. according to the described assembly of aforementioned any one claim, wherein: package comprises the opening paper tinsel that covers the opening that enters package, and this opening paper tinsel is used for removing with barrier film.

38. according to the described assembly of claim 37, wherein: the opening paper tinsel comprises the cover part that is used to spur the pull portion structure of this opening paper tinsel and is used to cover opening.

39. according to the described assembly of claim 38, wherein: the pull portion structure of opening paper tinsel is attached on the barrier film.

40. according to the described assembly of claim 38, wherein: the pull portion structure of opening paper tinsel is arranged to around the spool element, and the spool element is connected with barrier film.

41. a moistening is stored in the method for the medical treatment device in the assembly, this assembly comprises:

The separate space that is used for fluid media (medium);

Wherein, this assembly also comprises blocking device;

This method comprises: the pulling department office at barrier film spurs, thereby removes the cover part from export and import, and makes the fluid media (medium) that is stored in the separate space can leave separate space;

Wherein, blocking device is used to be enclosed in the gap between separate space and the package, makes fluid media (medium) to enter in the package by import.

42. according to the described method of claim 41, wherein: package is opened when barrier film is removed.