DK1606196T4 - Damphydrering i en hydrofil kateteremballage - Google Patents

Damphydrering i en hydrofil kateteremballage Download PDF

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Publication number
DK1606196T4
DK1606196T4 DK04780281.4T DK04780281T DK1606196T4 DK 1606196 T4 DK1606196 T4 DK 1606196T4 DK 04780281 T DK04780281 T DK 04780281T DK 1606196 T4 DK1606196 T4 DK 1606196T4
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DK
Denmark
Prior art keywords
catheter
liquid
vapor
catheter assembly
package
Prior art date
Application number
DK04780281.4T
Other languages
English (en)
Other versions
DK1606196T3 (da
Inventor
Michael Murray
Thomas Gilman
Sean Sweeney
Martin Creaven
Original Assignee
Hollister Inc
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
Family has litigation
First worldwide family litigation filed litigation Critical https://patents.darts-ip.com/?family=34135250&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=DK1606196(T4) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by Hollister Inc filed Critical Hollister Inc
Publication of DK1606196T3 publication Critical patent/DK1606196T3/da
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Publication of DK1606196T4 publication Critical patent/DK1606196T4/da

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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
    • A61M25/0009Making of catheters or other medical or surgical tubes
    • 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
    • A61M25/0017Catheters; Hollow probes specially adapted for long-term hygiene care, e.g. urethral or indwelling catheters to prevent infections
    • 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
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B65CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
    • B65BMACHINES, APPARATUS OR DEVICES FOR, OR METHODS OF, PACKAGING ARTICLES OR MATERIALS; UNPACKING
    • B65B5/00Packaging individual articles in containers or receptacles, e.g. bags, sacks, boxes, cartons, cans, jars
    • B65B5/04Packaging single articles
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B65CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
    • B65BMACHINES, APPARATUS OR DEVICES FOR, OR METHODS OF, PACKAGING ARTICLES OR MATERIALS; UNPACKING
    • B65B55/00Preserving, protecting or purifying packages or package contents in association with packaging
    • B65B55/22Immersing contents in protective liquids
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B65CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
    • B65BMACHINES, APPARATUS OR DEVICES FOR, OR METHODS OF, PACKAGING ARTICLES OR MATERIALS; UNPACKING
    • B65B7/00Closing containers or receptacles after filling
    • B65B7/02Closing containers or receptacles deformed by, or taking-up shape, of, contents, e.g. bags, sacks
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B65CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
    • B65DCONTAINERS FOR STORAGE OR TRANSPORT OF ARTICLES OR MATERIALS, e.g. BAGS, BARRELS, BOTTLES, BOXES, CANS, CARTONS, CRATES, DRUMS, JARS, TANKS, HOPPERS, FORWARDING CONTAINERS; ACCESSORIES, CLOSURES, OR FITTINGS THEREFOR; PACKAGING ELEMENTS; PACKAGES
    • B65D81/00Containers, packaging elements, or packages, for contents presenting particular transport or storage problems, or adapted to be used for non-packaging purposes after removal of contents
    • B65D81/18Containers, packaging elements, or packages, for contents presenting particular transport or storage problems, or adapted to be used for non-packaging purposes after removal of contents providing specific environment for contents, e.g. temperature above or below ambient
    • B65D81/22Containers, packaging elements, or packages, for contents presenting particular transport or storage problems, or adapted to be used for non-packaging purposes after removal of contents providing specific environment for contents, e.g. temperature above or below ambient in moist conditions or immersed in liquids
    • 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
    • A61M25/0043Catheters; Hollow probes characterised by structural features
    • A61M25/0045Catheters; Hollow probes characterised by structural features multi-layered, e.g. coated
    • A61M2025/0046Coatings for improving slidability
    • 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
    • A61M25/06Body-piercing guide needles or the like
    • A61M25/0662Guide tubes
    • A61M2025/0681Systems with catheter and outer tubing, e.g. sheath, sleeve or guide tube
    • 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
    • A61M25/0067Catheters; Hollow probes characterised by the distal end, e.g. tips
    • A61M25/0068Static characteristics of the catheter tip, e.g. shape, atraumatic tip, curved tip or tip structure
    • A61M25/007Side holes, e.g. their profiles or arrangements; Provisions to keep side holes unblocked

Claims (21)

1. Brugsklar hydrofil katetersamling (10,110, 310, 410, 510, 610, 710, 810), som omfatter: en gasimpermeabel emballage (12, 312, 412, 512, 812), som har et forseglet hulrum, et hydrofilt coatet kateter (10, 110, 310, 410, 510, 610, 710, 810), som er anbragt inde i det forseglede hulrum, idet det hydrofile coatede kateter (10, 110, 310, 410, 510, 610, 710, 810) omfatter et rør (14, 114, 314, 414, 514, 614, 714, 814), som haren ydre overflade med en hydrofil coating på i det mindste en del deraf, som skal indsættes i urinrøret; en mængde væske anbragt inde i det forseglede hulrum; kendetegnet ved, at katetersamlingen desuden omfatter en indføringsspids (16, 316, 616, 716) ved en proksimal indsættelsesende af røret (14, 114, 314, 414, 514, 614, 714, 814), og et fleksibelt hylster (20,120, 320, 720), som er udformet af et damppermeabelt materiale, der er fastgjort til indføringsspidsen (16, 316, 616, 716) og strækker sig derfra til en distal ende af røret (14, 114, 314, 414, 514, 614, 714, 814); og hvor den brugsklare tilstand af kateret skyldes den dampgivende væske, som frembringer en dampatmosfære inde i den gasimpermeable emballage (12), som aktiverer det hydrofile coatede kateter.
2. Katetersamling ifølge krav 1, hvor den gasimpermeable emballage (12, 312, 412, 512,812) er udformet af et materiale, som har en impermeabilitet, der er tilstrækkelig til en lagerholdbarhed for produktet på mellem seks måneder og fem år.
3. Katetersamling ifølge krav 1, hvor den gasimpermeable emballage (12, 312, 412, 512, 812) er udformet af aluminiumfolie.
4. Katetersamling ifølge krav 1, hvor det hydrofile coatede kateter (10, 110, 310, 410, 510, 610, 710, 810) desuden omfatter drænhuller (18, 118, 318, 718), som er udformet i røret (14, 114, 314, 414, 514, 614, 714, 814) nærved en proksimal indsættelsesende deraf, og et forbindelsesstykke (22, 122, 522, 622, 722) ved en distal ende deraf.
5. Katetersamling ifølge krav 4, hvor forbindelsesstykket (22, 122, 522, 622, 722) omfatter en tilspidset tragt, som er integreret forbundet med den distale ende af røret (14, 114, 314, 414, 514, 614, 714, 814) til forbindelse med en indretning til opsamling af urin, der passerer gennem røret (14, 114, 314, 414, 514, 614, 714, 814).
6. Katetersamling ifølge krav 1, som omfatter indføringsspidsen (16, 316, 616, 716) ved en proksimal indsættelsesende af røret (14, 114, 314, 414, 514, 614, 714, 814), som har slidser til at definere flige, der bøjer udad for at danne en åbning til indføring af røret (14, 114, 314, 414, 514, 614, 714, 814) derigennem.
7. Katetersamling ifølge krav 5, som omfatter det fleksible hylster (20, 120, 320, 720), der er udformet af et damppermeabelt materiale, som er fastgjort til den tilspidsede tragt (22, 122, 522, 622, 722) og strækker sig, således at det dækker den proksimale indsættelsesende af røret (14, 114, 314, 414, 514, 614, 714, 814).
8. Katetersamling ifølge krav 1, hvor hylsteret (20, 120, 320, 720) er udformet af et damppermeabelt, væskeimpermeabelt sammenklappeligt polymert filmmateriale, som tætsiddende omgiver røret eller skaftet.
9. Katetersamling ifølge krav 1, hvor hylsteret (20, 120, 320, 720) er udformet af et materiale, som er valgt blandt polyethylen, blødgjort PVC, polypropylen, polyurethan og polyethylenoxid-blokcopolymer.
10. Katetersamling ifølge krav 9, hvor det polymere filmmateriale er Medifilm 435-poly-ethylenoxid-blokcopolymer med en tykkelse inden for området mellem 10 og 150 mikron.
11. Katetersamling ifølge krav 1, hvor den dampgivende væske er vand, som ikke omfatter mere end 20% af volumenet af det forseglede hulrum af emballagen (12, 312, 412, 512, 812).
12. Katetersamling ifølge krav 11, hvor vandet er mellem 2 og 5 ml, som ikke omfatter mere end 5% af volumenet af det forseglede hulrum af emballagen (12, 312, 412, 512, 812).
13. Katetersamling ifølge krav 1, hvor væsken holdes tilbage af et væskesekvestre-ringselement (330, 530, 630, 830) for at minimere risikoen for udslip, mens der frigives en damp til at frembringe dampatmosfæren inde i den gasimpermeable emballage (12, 312, 412, 512, 812), således at kateterets brugsklare tilstand skyldes den damp, der aktiverer i det mindste en del af det hydrofile coatede kateter for at sikre afgivelse af det hydrofile coatede kateter til brugeren i en fuldstændigt brugsklar tilstand.
14. Katetersamling ifølge krav 13, hvor det hydrofile coatede kateter, væsken og væ-skesekvestreringselementet (330, 530, 630, 830) er indeholdt inde i det forseglede hulrum af den gasimpermeable emballage (12, 312, 412, 512, 812), og væskesekvestre-ringselementetet (330, 530, 630, 830) omfatter et materiale til at absorbere den dampgivende væske.
15. Katetersamling ifølge krav 14, hvor materialet til at absorbere den dampgivende væske er et stof eller skum, som er i stand til at absorbere i det væsentlige al tilgængelig dampgivende væske og derefter frigive en damp fra den dampgivende væske for at frembringe og opretholde en fuldt mættet dampatmosfære i en ligevægtstilstand inde i det forseglede hulrum.
16. Katetersamling ifølge krav 15, hvor det hydrofile coatede kateter omfatter et rør (14, 114, 314, 414, 514, 614, 714, 814), som har en ydre overflade med den hydrofile coating på i det mindste en del deraf, og stoffet eller skummet i det væsentlige udstrækker sig sammen med og langs med røret (14, 114, 314, 414, 514, 614, 714, 814) inde i det forseglede hulrum for at frigive dampen tæt ved røret til optagelse af den hydrofile coating.
17. Katetersamling ifølge krav 16, hvor stoffet eller skummet er løst anbragt inde i det forseglede hulrum og er dimensioneret til at indeholde en tilstrækkelig mængde af den dampgivende væske til at opretholde en fuldt mættet dampatmosfære inde i det forseglede hulrum for at sikre kontinuerlig hydrering af det hydrofile coatede kateter i en acceptabel lagerholdbarhedstid for produktet.
18. Katetersamling ifølge krav 16, hvor stoffet eller skummet er fast anbragt inde i det forseglede hulrum og er dimensioneret til at indeholde en tilstrækkelig mængde af den dampgivende væske til at opretholde en fuldt mættet dampatmosfære inde i det forseg lede hulrum for at sikre kontinuerlig hydrering af det hydrofile coatede kateter i en acceptabel lagerholdbarhedstid for produktet.
19. Katetersamling ifølge krav 16, hvor materialet til at absorbere den dampgivende væske har mellemrum til at holde den dampgivende væske og frigive en damp derfra og har en overflade, som vender indad i det forseglede hulrum, og som tillader afgivelse af dampen, mens den samtidigt forhindrer materialet i at klæbe til det hydrofile kateter.
20. Katetersamling ifølge krav 19, hvor materialet omfatter et smelteblæst mikrofiber-stof, som har et højt kapillært træk af den dampgivende væske, og overfladen er dækket med et materiale, som er valgt blandt en tynd elastomer hydrogelfilm, et polymert netmateriale og en perforeret plastfilm.
21. Katetersamling ifølge krav 20, hvor materialet omfatter et smelteblæst mikrofiber-stof, som har et højt kapillært træk af den dampgivende væske, og overfladen er behandlet med henblik på at få det smelteblæste mikrofiberstof til at kunne fugtes med den dampgivende væske.
DK04780281.4T 2003-08-08 2004-08-06 Damphydrering i en hydrofil kateteremballage DK1606196T4 (da)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US49349303P 2003-08-08 2003-08-08
PCT/US2004/025417 WO2005014055A2 (en) 2003-08-08 2004-08-06 Vapor hydration in a hydrophilic catheter package

Publications (2)

Publication Number Publication Date
DK1606196T3 DK1606196T3 (da) 2012-07-02
DK1606196T4 true DK1606196T4 (da) 2016-04-04

Family

ID=34135250

Family Applications (7)

Application Number Title Priority Date Filing Date
DK04780281.4T DK1606196T4 (da) 2003-08-08 2004-08-06 Damphydrering i en hydrofil kateteremballage
DK11175010.5T DK2423125T3 (da) 2003-08-08 2004-08-06 Damphydrering af et hydrofilt kateter i en emballage
DK17205430.6T DK3392167T3 (da) 2003-08-08 2004-08-06 Hydrofilt kateter i en emballage
DK17150789.0T DK3210909T3 (da) 2003-08-08 2004-08-06 Hydrofilt kateter i en pakning
DK11175016.2T DK2423126T4 (da) 2003-08-08 2004-08-06 Damphydrering af et hydrofilt kateter i en emballage
DK11175017.0T DK2423127T4 (da) 2003-08-08 2004-08-06 Damphydratisering af et hydrofilt kateter i en emballage
DKBA201300115U DK201300115U3 (da) 2003-08-08 2013-07-30 Damphydrering af et hydrofilt kateter i en emballage

Family Applications After (6)

Application Number Title Priority Date Filing Date
DK11175010.5T DK2423125T3 (da) 2003-08-08 2004-08-06 Damphydrering af et hydrofilt kateter i en emballage
DK17205430.6T DK3392167T3 (da) 2003-08-08 2004-08-06 Hydrofilt kateter i en emballage
DK17150789.0T DK3210909T3 (da) 2003-08-08 2004-08-06 Hydrofilt kateter i en pakning
DK11175016.2T DK2423126T4 (da) 2003-08-08 2004-08-06 Damphydrering af et hydrofilt kateter i en emballage
DK11175017.0T DK2423127T4 (da) 2003-08-08 2004-08-06 Damphydratisering af et hydrofilt kateter i en emballage
DKBA201300115U DK201300115U3 (da) 2003-08-08 2013-07-30 Damphydrering af et hydrofilt kateter i en emballage

Country Status (11)

Country Link
US (9) US7380658B2 (da)
EP (7) EP3210909B1 (da)
JP (2) JP4682135B2 (da)
AT (1) ATE549056T1 (da)
AU (1) AU2004263129B2 (da)
DE (3) DE11175010T1 (da)
DK (7) DK1606196T4 (da)
ES (6) ES2824624T3 (da)
HU (4) HUE028572T2 (da)
TR (1) TR201808596T4 (da)
WO (1) WO2005014055A2 (da)

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DK1606196T3 (da) 2012-07-02
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