CN102065944A - A package for a urinary catheter - Google Patents

A package for a urinary catheter Download PDF

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Publication number
CN102065944A
CN102065944A CN2009801217893A CN200980121789A CN102065944A CN 102065944 A CN102065944 A CN 102065944A CN 2009801217893 A CN2009801217893 A CN 2009801217893A CN 200980121789 A CN200980121789 A CN 200980121789A CN 102065944 A CN102065944 A CN 102065944A
Authority
CN
China
Prior art keywords
catheter
package
protection sleeve
sleeve
length
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Pending
Application number
CN2009801217893A
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Chinese (zh)
Inventor
K·马蒂松汉森
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Coloplast AS
Original Assignee
Coloplast AS
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Coloplast AS filed Critical Coloplast AS
Publication of CN102065944A publication Critical patent/CN102065944A/en
Pending legal-status Critical Current

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Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00Catheters; Hollow probes
    • A61M25/002Packages specially adapted therefor ; catheter kit packages
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00Catheters; Hollow probes
    • A61M25/01Introducing, guiding, advancing, emplacing or holding catheters
    • A61M25/0105Steering means as part of the catheter or advancing means; Markers for positioning
    • A61M25/0111Aseptic insertion devices

Abstract

A package including an intermittent urinary catheter and a protective sleeve is provided. The protective sleeve is adapted to cover the surface of the catheter prior to use, thereby preventing contamination of the surface. The protective sleeve is compressed in a storage-position, and in a use-position it is extended to cover most of the insertable length of the catheter. In the compressed state, the urinary catheter may be wetted if the catheter is provided with a hydrophilic coating. The protective sleeve may be made of flexible material, which may be folded or pre-folded into a concertina-like configuration. A package which includes an intermittent urinary catheter with a protective sleeve is provided. An assembly, which includes a package with an intermittent urinary catheter, and a compartment containing a fluid medium, is provided. Finally, a method for wetting an intermittent urinary catheter including a protective sleeve is provided.

Description

The package that is used for catheter
Technical field
The application relates to provides a kind of and interrupted catheterization pipe to unite the protection sleeve of use.Catheter with protection sleeve wraps in the package before use.Protection sleeve is used for covering just the surface of catheter before using.Therefore, this surface can be not contaminated.
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 has extremely low friction on the surface of catheter.In the fabrication stage or before using, this coating activates by apply fluid media (medium) (for example tap water or disinfectant) to coating usually.
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, catheter and fluid media (medium) can be sterilized.And it is uncontaminated that the surface of catheter preferably can keep before using.
Can use protection sleeve, this protection sleeve is covering surfaces before inserting.Such protection sleeve makes the user to keep catheter and can not slide owing to coating, and can not pollute disinfecting surface.The example of such insert represents that in WO07/050685 this WO07/050685 relates to a kind of interrupted catheterization pipe of pre-moistening, and it comprises collapsible container and the wetting fluid that is furnished with conduit.Conduit has to be arranged superincumbent lubriciously, and like this, coating is producing hydration when wetting fluid in the container contact, thereby is provided for the sliding surface of conduit, and this helps in the conduit introducing user body.
Summary of the invention
The present invention relates to a kind of package that comprises the interrupted catheterization pipe.Protection sleeve is installed on the interrupted catheterization pipe at far-end.Protection sleeve is used for covering the surface of catheter before using, like this, the user can utilize it to keep catheter.Thereby prevent contaminated surface.Protection sleeve has two positions: compression position, and this compression position allows the moistening catheter; And extended position, this extended position covers the surface of catheter.Catheter is stored in the package, and the near-end of protection sleeve is installed on the package by more weak attachment.Therefore, during the moistening catheter, the user catches the adapter at the catheter of far-end, and it is pulled out package before the user is using just.Because the proximal attachment of protection sleeve is on package, so protection sleeve will be drawn out to extended position on catheter, and at this extended position, its covers the surface of catheter.
The invention still further relates to a kind of assembly, this assembly comprises package, and this package has the interrupted catheterization pipe and is used for the separate space of fluid media (medium), the invention still further relates to a kind of method of moistening interrupted catheterization pipe, and this interrupted catheterization pipe comprises protection sleeve.
In first aspect, the present invention relates to a kind of package that comprises catheter, this package comprises:
Near-end and far-end;
Protection sleeve, this protection sleeve are used for being compressed into storage location when storing catheter, and extend to the use location in the time will using catheter, so that cover the most surfaces of catheter;
Wherein, the distal attachment of protection sleeve is on the far-end of catheter, and the near-end of protection sleeve is attached on the package by more weak attachment;
The attachment of protection sleeve is for like this, and when taking out catheter from package, protection sleeve will be pulled through the catheter of certain-length; stretch out up to sleeve; then, the more weak attachment between sleeve and package will disconnect, and can take out fully to comprise telescopic catheter from package.
The package that comprises interrupted catheterization pipe and protection sleeve makes it possible to moistening catheter before using.After moistening, catheter can be removed from package, and protection sleeve will pulling downwards on the whole length of catheter automatically.This is because the attachment between catheter and protection sleeve.When sleeve launches fully, further spur catheter and will make the more weak attachment between sleeve and package disconnect.Then, the catheter that comprises protection sleeve can take out from package fully.
Catheter comprises near-end and far-end.Should be known in here, before the near-end of element or parts is meant just in catheter insertion urethra, the most close user's of element or parts (for example carrying out the people of emptying bladder) a side or a part.Equally, far-end is the end opposite with near-end.In other words, near-end is most advanced and sophisticated corresponding with catheter, and far-end is corresponding with connector end.
At storage location, protection sleeve compresses along its length, so that it is also lucky below adapter to store the far-end of catheter.In the use location, protection sleeve is pulling downwards on catheter, and like this, it covers most of catheter.
The interrupted catheterization pipe is known in this field.The example of catheter provides the catheter into the pipe of being made by polyurethane (PU) or polrvinyl chloride (PVC), and this catheter at one end provides adapter.In the opposite end (tip), catheter provides one or more eyelets, and this eyelet makes urine enter in the pipe.For male's catheter, can insert length is 250-300mm, for female catheter, can insert length between 60-130mm.Can insert length and remove the 3-5cm of close adapter corresponding to the length of tubular element.This part of catheter is uncoated, because catheter applies by dipping.And uncoated part makes adapter to weld or to be glued on the catheter.
Catheter can be included in its lip-deep hydrophilic coating.According to how to use catheter, can apply the part on whole surface or surface.
Protection sleeve guarantees to hold on the interrupted catheterization pipe, because the surface of device is because coating and very sliding.Do not having under the situation of protection sleeve, catheter will be difficult to reliable maintenance.
The interrupted catheterization pipe preferably provides sliding coating, and for example hydrophilic coating is subjected to stress with the inner surface of avoiding urethra.And UTI is a subject matter, and this is to make catheter keep sterilizing as far as possible very important reasons.
At storage location, catheter and sleeve stored dry-just in package, do not have substantially free fluid.Before using, the necessary moistening of catheter is so that activate the hydrophilic coating that is arranged on the catheter.Utilize fluid media (medium) to carry out moistening, this fluid media (medium) also can be stored in the package, perhaps is provided as the extra separate space of package.In the wet processes of catheter, protection sleeve is also nonwetting, because it is arranged in the compressive state near adapter.Have only coated portion catheter, below adapter to want moistening.Therefore, when catheter moistening, sleeve is still dry, and keeps easily.Therefore, the user will avoid his/her hands to be got wet by fluid media (medium).
The far-end of protection sleeve is attached at end on the adapter corresponding to protection sleeve.The near-end of protection sleeve is corresponding to the opposite end.Protection sleeve is attached on adapter or the catheter at connector end.Attached can being undertaken by welding or splicing perhaps passes through around the attached pyrocondensation paper tinsel of protection sleeve.The near-end of protection sleeve is attached at the inside of package, for example line or more weak bonding agent by more weak attachment.It can also be by protection sleeve being welded on the package and attached, makes it that more weak tear line (for example perforation) near welding is arranged then.Like this, protection sleeve will separate with package at the tear line place.
Protection sleeve can comprise Foldable material, also has, and protection sleeve is folding at storage location, in the use location, and stretching should folding.Protection sleeve can also be folded into the accordion foldable structure in advance.In material, can make in advance folding structure, and to flexibility without any specific (special) requirements.When material does not fold in advance and need fold, some flexibility of material require.
In storage location, the length of compression protection sleeve can be about 20mm.Length under compressive state should be less than the uncoated part of catheter.When protection sleeve was compressed to this length, whole length inserted can both be by the fluid media (medium) moistening.
The length of the protection sleeve that in the use location, stretches out in one embodiment, equal catheter the length inserted at least 3/4.In extension state, the length of protection sleeve should long enough, so that reduce the danger that any part of outer surface when contact is polluted.On the other hand, the surface portion that is covered by protection sleeve is big more, and the danger of being polluted when the surface contacts with object (for example near tank the user or towel) accident is more little.
The Breadth Maximum of protection sleeve is preferably between the diameter big 1 and 15mm than catheter.Lower limit leaves the enough spaces around the coating that swells of catheter, and like this, coating also be can't help protection sleeve and disarrayed.But, the catheter that comprises protection sleeve does not occupy too large space.Therefore, can the limiting protecting sleeve with respect to the oversized dimensions of catheter.And when protection sleeve was too big, catheter may be difficult to keep, particularly when catheter owing to providing coating and when more sliding.
Material can be a plastic foil, for example polyethylene (PE) or polypropylene (PP) or coated paper.These are not exhaustive for example.Protection sleeve just is used for covering just the surface of interrupted catheterization pipe before using.Therefore, protection sleeve does not need waterproof for a long time.Equally, opening can be left in the end of protection sleeve.Protection sleeve should be too not permeable, sees through protection sleeve because will prevent the pollutant of aqueous vapor and hands.But, do not need complete impermeable, because it only uses when catheter inserts, this is a few minutes.The material that this means a lot of types all adapts to this purpose, must be to be foldable to compressive state and can be relatively easily to extend from this compressive state because only need material.
Package can be by the paper tinsel manufacturing, and this paper tinsel can weld along sidepiece.Therefore, suitable material is for example polyethylene terephthalate (PETP), the PETP that comprises the aluminum thin layer, low density polyethylene (LDPE) (LDPE), high density polyethylene (HDPE) (HDPE), PP, polrvinyl chloride (PVC), polyamide (PA), amorphous polyester (PET) and surface treatment paper.
Catheter can be sterilized before package, and package is to sterilising packages then.Like this, catheter is sterilized when it leaves package fully, thereby reduces to produce in use the danger of infection.
One aspect of the present invention relates to a kind of assembly that is used for moistening interrupted catheterization pipe, it comprises the package that is used to hold the separate space of fluid media (medium) and is used to hold catheter, wherein, separate space and package are the individual components that links together, separate space comprises outlet, package comprises the import that is used for fluid media (medium), and package as previously mentioned.
Assembly comprises package and separate space, and they are two separate 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).Before using, at storage location, export and import is not in contact with one another.When catheter is prepared to use (assembly is in the use location), export and import is in contact with one another.In the use location, fluid media (medium) can and flow into the package from the separate space outflow, and moistening is stored in the surface of the catheter in the package.
Make separate space and package still be attached at together as individual component, such effect is that separate space can be made a position, and package can be made in the another location.Package and separate space can be sterilized respectively.
By this assembly, can a moistening interrupted catheterization pipe, with can insert the corresponding part of length.Therefore, the still dry and still less slip of the top section of device, and can be used to keep this device.
Make two isolation of components that advantage can be arranged, because keep the leakage of separate space not hinder catheter storage process from liquid.And when separate space enters the package that comprises catheter, the pollutant that may be present on the outside of separate space will enter in the package.Therefore catheter may be contaminated.
Separate space can be made by the paper tinsel element, and is similar with package.Such element can for example aluminum, PETP, LDPE, HDPE, PP, PVC, PA, PET and surface treatment paper be made by material.When package and separate space were made by the paper tinsel element, their easy package and storages were because they only occupy the same big space with the requirement of fluidic amount or catheter.In certain embodiments, separate space needs and can push, so that make fluid come out from separate space.In such embodiments, the paper tinsel element is also very favourable.
Fluid media (medium) can be water or saline solution, for example 0.9% normal saline solution.In one embodiment, fluid can comprise for example hydrogen peroxide of antibacterial.Use hydrogen peroxide that bactericidal effect is provided, this helps to prevent the infection to the interrupted catheterization pipe.
Hydrogen peroxide is known bactericidal effect.Also known easy decomposition.Hydrogen peroxide and the reaction of reproducibility transition metal ions, for example ferrum (II) and copper (I).It decomposes by the Fenton reaction, so that form the hydroxyl with high response.Except the preservation life-span of destroying hydrogen peroxide and therefore reducing the product that comprises hydrogen peroxide, because the hydroxyl that the Fenton reaction produces also may have potential damage to polymer coating.Hydrophilic coating particularly like this, by each component reaction of it and coat system.Water is polluted by transition metal ions and for example produces by water is stored in cylinder of steel or the glass.Even in pure water,, still there is the transition metal ions of trace for example by ion exchange.Therefore, the polymer coating that comprises the liquid with hydrogen peroxide can roughly be thought and is not suitable for long-time storage.
Relate to a kind of method of using aforementioned package to come moistening interrupted catheterization pipe on the other hand, this catheter comprises protection sleeve, and wherein, this method comprises:
Moistening catheter below the protection sleeve of compression;
Make protection sleeve stretch out so that cover catheter.
The catheter that such method can moistening stores under drying regime.It can also use protection sleeve, and like this, it is uncontaminated that the surface of catheter keeps.The meaning of " below the protection sleeve of compression " is up to pointed portion and the catheter length that comprises this pointed portion from protection sleeve.
Description of drawings
Fig. 1 has represented to be packaged in the interrupted catheterization pipe in the package.
Fig. 2 has represented the package when opening.
Fig. 3 has represented the package opened, is illustrated in the catheter in the package.
Fig. 4 has represented to comprise the catheter of protection sleeve.
Fig. 5 has represented to be in the protection sleeve of extension state.
The specific embodiment
Fig. 1 has represented package 1, and this package 1 comprises the interrupted catheterization pipe.Package comprises two- layered foil 2 and 3, they along sidepiece 4,5 and at the top 6 and 7 places, bottom weld together.Package 1 also comprises two tabs 8,9, is used for by making paper tinsel 2,3 peel off and open package mutually.Fig. 2 has represented opening of package 1, and the expression catheter is in its inside, and Fig. 3 has represented package, and one of them paper tinsel is removed fully.Fig. 4 has represented catheter 10, and it takes out from package fully.Catheter 10 comprises two ends, tip 11 and connector end 12, and wherein, adapter 13 is attached on the catheter 10 at connector end 12 places.Usually, adapter 13 is by on the outside that it is welded on the pipe 14 that constitutes catheter 10 and attached.Most advanced and sophisticated 11 comprise the tip 15 that is blanked-off pipe 14 forms.Tip 15 comprises eyelet 16, is used for allowing flowing out in the urine inflow pipe 14 and by adapter 13.This figure is also clear to have represented that protection sleeve 17 is in compressive state, and wherein, it is whole folds back towards adapter 13.When with can to insert the corresponding catheter of length 10 surperficial when wetted, protection sleeve 17 can move to extended position, as shown in Figure 5.In this position, the major part that protection sleeve 17 covers catheter can be inserted length.Therefore, reduced the danger on unexpected contact sterilizing surface.In the time will using catheter 10, the user is catching catheter 10 along the somewhere of the protection sleeve that stretches out, and tip is inserted in the urethra.Protection sleeve 17 can be folded back when catheter 14 advances in the urethra.

Claims (10)

1. package that comprises catheter, described package comprises:
Near-end and far-end;
Protection sleeve, this protection sleeve are used for being compressed into storage location when storing catheter, and extend to the use location in the time will using catheter, so that cover the most surfaces of catheter;
Wherein, the distal attachment of protection sleeve is on the far-end of catheter, and the near-end of protection sleeve is attached on the package by more weak attachment;
The attachment of protection sleeve is for like this, and when catheter takes out from package, protection sleeve will be pulled through the catheter of certain-length; stretch out up to sleeve; then, the more weak attachment between sleeve and package will disconnect, and can take out fully to comprise telescopic catheter from package.
2. package according to claim 1, wherein: catheter is included in its lip-deep hydrophilic coating.
3. according to the described package of aforementioned any one claim, wherein: protection sleeve comprises Foldable material, also has, and protection sleeve is folding at storage location, in the use location, and this folding being straightened.
4. according to the described package of aforementioned any one claim, wherein: protection sleeve is folded into the accordion foldable structure in advance.
5. according to the described package of aforementioned any one claim, wherein: in storage location, the length of compression protection sleeve is about 20mm.
6. according to the described package of aforementioned any one claim, wherein: the length of stretching out protection sleeve in the use location equal catheter the length inserted at least 3/4.
7. according to the described package of aforementioned any one claim, wherein: between the diameter big 1 and 15mm of the Breadth Maximum of protection sleeve than catheter.
8. assembly that is used for moistening interrupted catheterization pipe, comprise the package that is used to hold the separate space of fluid media (medium) and is used to hold catheter, wherein, separate space and package are the individual components that links together, separate space comprises outlet, package comprises the import that is used for fluid media (medium), and package is according to any one is described in the claim 1 to 7.
9. assembly according to claim 8, wherein: fluid media (medium) comprises hydrogen peroxide.
10. use such as the described package of claim 1 to 7 come moistening to comprise the method for the interrupted catheterization pipe of protection sleeve, and described method comprises:
A. the compression protection sleeve below the moistening catheter;
B. make protection sleeve extend so that cover catheter.
CN2009801217893A 2008-07-16 2009-07-15 A package for a urinary catheter Pending CN102065944A (en)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
DKPA200801002 2008-07-16
DKPA200801002 2008-07-16
PCT/DK2009/050179 WO2010006620A1 (en) 2008-07-16 2009-07-15 A package for a urinary catheter

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CN102065944A true CN102065944A (en) 2011-05-18

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US (1) US20110114520A1 (en)
EP (1) EP2313142A1 (en)
JP (1) JP2011527911A (en)
CN (1) CN102065944A (en)
AU (1) AU2009270602A1 (en)
CA (1) CA2723476A1 (en)
WO (1) WO2010006620A1 (en)

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US20110114520A1 (en) 2011-05-19
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CA2723476A1 (en) 2010-01-21
WO2010006620A1 (en) 2010-01-21
EP2313142A1 (en) 2011-04-27

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