DE11175010T1 - Dampfhydration eines hydrophilen Katheters in einer Verpackung - Google Patents

Dampfhydration eines hydrophilen Katheters in einer Verpackung Download PDF

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Publication number
DE11175010T1
DE11175010T1 DE11175010.5T DE11175010T DE11175010T1 DE 11175010 T1 DE11175010 T1 DE 11175010T1 DE 11175010 T DE11175010 T DE 11175010T DE 11175010 T1 DE11175010 T1 DE 11175010T1
Authority
DE
Germany
Prior art keywords
sealed cavity
catheter assembly
hydrophilic
catheter
fluid
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
DE11175010.5T
Other languages
English (en)
Inventor
Michael Murray
Thomas H. Gilman
Sean Sweeney
Martin Creaven
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.)
Hollister Inc
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=DE11175010(T1) "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 DE11175010T1 publication Critical patent/DE11175010T1/de
Pending legal-status Critical Current

Links

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

Abstract

Verwendungsbereite hydrophile Katheteranordnung (10, 110, 310, 410, 510, 610, 710, 810) mit: einer gasundurchlässigen Verpackung (12, 312, 412, 512, 812), die einen abgedichteten Hohlraum aufweist, einem hydrophil beschichteten Katheter (10, 110, 310, 410, 510, 610, 710, 810), der ein Rohr (14, 114, 314, 414, 514, 614, 714, 814) und eine hydrophile Oberflächenbeschichtung aufweist, die zumindest an einem Teil desselben angehaftet ist; einer Menge von Flüssigkeit, die innerhalb des abgedichteten Hohlraums angeordnet ist; gekennzeichnet durch eine flexible, faltbare Hülse (20, 120, 320, 720), die das Rohr umgibt, um das Greifen des Rohres oder Schafts durch die Hülse (20, 120, 320, 720) zu ermöglichen.

Claims (13)

  1. Verwendungsbereite hydrophile Katheteranordnung (10, 110, 310, 410, 510, 610, 710, 810) mit: einer gasundurchlässigen Verpackung (12, 312, 412, 512, 812), die einen abgedichteten Hohlraum aufweist, einem hydrophil beschichteten Katheter (10, 110, 310, 410, 510, 610, 710, 810), der ein Rohr (14, 114, 314, 414, 514, 614, 714, 814) und eine hydrophile Oberflächenbeschichtung aufweist, die zumindest an einem Teil desselben angehaftet ist; einer Menge von Flüssigkeit, die innerhalb des abgedichteten Hohlraums angeordnet ist; gekennzeichnet durch eine flexible, faltbare Hülse (20, 120, 320, 720), die das Rohr umgibt, um das Greifen des Rohres oder Schafts durch die Hülse (20, 120, 320, 720) zu ermöglichen.
  2. Verwendungsbereite hydrophile Katheteranordnung (10, 110, 310, 410, 510, 610, 710, 810) nach Anspruch 1, wobei die flexible Hülse (20, 120, 320, 720) aus einem dampfdurchlässigen Material gebildet ist und innerhalb des abgedichteten Hohlraums derart angeordnet ist, dass direkter Flüssigkeitskontakt mit der hydrophilen Oberflächenbeschichtung vermieden wird, der den hydrophil beschichteten Katheter in den aktiven Zustand versetzt, und wobei die flexible Hülse (20, 120, 320, 720) ausreichend direkten Dampfkontakt mit der hydrophilen Oberflächenbeschichtung erlaubt, um den hydrophil beschichteten Katheter (10, 110, 310, 410, 510, 610, 710, 810) in den aktivierten Zustand zu versetzen, wodurch der hydrophil beschichtete Katheter (10, 110, 310, 410, 510, 610, 710, 810) verwendungsbereit ist.
  3. Katheteranordnung nach Anspruch 1 oder 2, wobei die gasundurchlässige Verpackung einen abgedichteten Hohlraum aufweist, wobei die Verpackung aus einem Material gebildet ist, das eine Gasundurchlässigkeit aufweist, die ausreichend für eine Produktlagerbeständigkeit im Bereich zwischen 6 Monaten und 5 Jahren ist, und wobei der hydrophil beschichtete Katheter und die dampfspendende Flüssigkeit innerhalb des abgedichteten Hohlraums enthalten sind.
  4. Katheteranordnung nach einem der vorangehenden Ansprüche, wobei die Hülse aus einem Material gebildet ist, das aus Polyethylen, Weich-PVC, Polypropylen, Polyurethan und Polyethylenoxid-Block-Copolymer gewählt ist.
  5. Katheteranordnung nach einem der vorangehenden Ansprüche, wobei die Hülse aus Medifilm 435 Polyethylenoxid-Block-Copolymer mit einer Dicke innerhalb eines Bereichs zwischen 10 und 150 Mikrometern gebildet ist.
  6. Katheteranordnung nach einem der vorangehenden Ansprüche mit einem Flüssigkeit-Sequestierelement, das innerhalb des abgedichteten Hohlraums der gasundurchlässigen Verpackung zum Reduzieren des Auslaufrisikos angeordnet ist.
  7. Katheteranordnung nach Anspruch 6, wobei das Flüssigkeit-Sequestierelement ein Gewebe oder Schaumstoff ist und dazu imstande ist, im Wesentlichen die gesamte Flüssigkeit aufzunehmen und einen Dampf freizusetzen, um eine voll gesättigte Dampfatmosphäre in einem Gleichgewichtszustand innerhalb des abgedichteten Hohlraums herzustellen und aufrechtzuerhalten.
  8. Katheteranordnung nach einem der vorangehenden Ansprüche, wobei die gasundurchlässige Verpackung eine periphere Dichtung komplett um sie herum aufweist und einen Urinsammelbeutel mit einer Einführspitze an einem Ende desselben enthält.
  9. Katheteranordnung nach Anspruch 8, wobei der hydrophil beschichtete Katheter innerhalb des Urinsammelbeutels mit einem proximalen Einführende desselben an die Einführspitze angrenzend angeordnet ist.
  10. Katheteranordnung nach Anspruch 9, wobei die Hülse sich von dem proximalen Einführende des Rohrs zu dem verjüngten Trichter erstreckt und ausreichend groß ist, um den verjüngten Trichter aufzunehmen, wenn das Rohr durch den Port vorwärts bewegt wird.
  11. Katheteranordnung nach Anspruch 6, wobei das Material zum Aufnehmen der Flüssigkeit ein Gewebe oder Schaumstoff ist und imstande ist, im Wesentlichen die gesamte verfügbare Flüssigkeit aufzunehmen und dann einen Dampf freizusetzen, um eine voll gesättigte Dampfatmosphäre in einem Gleichgewichtszustand innerhalb des abgedichteten Hohlraums zu erzeugen und aufrechtzuerhalten.
  12. Katheteranordnung nach Anspruch 11, wobei das Gewebe oder der Schaumstoff lose innerhalb des abgedichteten Hohlraums angeordnet ist und ausreichend groß ist, um eine ausreichende Menge der Flüssigkeit zu enthalten, um eine voll gesättigte Dampfatmosphäre innerhalb des abgedichteten Hohlraums aufrechtzuerhalten, um eine kontinuierliche Hydration des hydrophil beschichteten Katheters während einer gesamten annehmbaren Produktlagerbeständigkeit sicherzustellen.
  13. Katheteranordnung nach Anspruch 6, wobei das Gewebe oder der Schaumstoff unbeweglich innerhalb des abgedichteten Hohlraums angeordnet ist und ausreichend groß ist, um eine ausreichende Menge der Dampf spendenden Flüssigkeit zu enthalten, um eine voll gesättigte Dampfatmosphäre innerhalb des abgedichteten Hohlraums aufrechtzuerhalten, um eine kontinuierliche Hydration des hydrophil beschichteten Katheters während einer gesamten annehmbaren Produktlagerbeständigkeit sicherzustellen.
DE11175010.5T 2003-08-08 2004-08-06 Dampfhydration eines hydrophilen Katheters in einer Verpackung Pending DE11175010T1 (de)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US49349303P 2003-08-08 2003-08-08
US493493P 2003-08-08
EP11175010.5A EP2423125B1 (de) 2003-08-08 2004-08-06 Dampfhydration eines hydrophilen Katheters in einer Verpackung

Publications (1)

Publication Number Publication Date
DE11175010T1 true DE11175010T1 (de) 2016-06-02

Family

ID=34135250

Family Applications (3)

Application Number Title Priority Date Filing Date
DE202004021966U Expired - Lifetime DE202004021966U1 (de) 2003-08-08 2004-08-06 Gebrauchsfertige dampfhydrierte hydrophile Katheteranordnung
DE11175017.0T Pending DE11175017T1 (de) 2003-08-08 2004-08-06 Dampfhydration eines hydrophilen Katheters in einer Verpackung
DE11175010.5T Pending DE11175010T1 (de) 2003-08-08 2004-08-06 Dampfhydration eines hydrophilen Katheters in einer Verpackung

Family Applications Before (2)

Application Number Title Priority Date Filing Date
DE202004021966U Expired - Lifetime DE202004021966U1 (de) 2003-08-08 2004-08-06 Gebrauchsfertige dampfhydrierte hydrophile Katheteranordnung
DE11175017.0T Pending DE11175017T1 (de) 2003-08-08 2004-08-06 Dampfhydration eines hydrophilen Katheters in einer Verpackung

Country Status (11)

Country Link
US (9) US7380658B2 (de)
EP (7) EP2423126B2 (de)
JP (2) JP4682135B2 (de)
AT (1) ATE549056T1 (de)
AU (1) AU2004263129B2 (de)
DE (3) DE202004021966U1 (de)
DK (7) DK3210909T3 (de)
ES (6) ES2824624T3 (de)
HU (4) HUE053032T2 (de)
TR (1) TR201808596T4 (de)
WO (1) WO2005014055A2 (de)

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