EP2662065B1 - Dispositif d'essai en aveugle - Google Patents

Dispositif d'essai en aveugle Download PDF

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Publication number
EP2662065B1
EP2662065B1 EP13164845.3A EP13164845A EP2662065B1 EP 2662065 B1 EP2662065 B1 EP 2662065B1 EP 13164845 A EP13164845 A EP 13164845A EP 2662065 B1 EP2662065 B1 EP 2662065B1
Authority
EP
European Patent Office
Prior art keywords
container
blinding
lid
closure
opening
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.)
Active
Application number
EP13164845.3A
Other languages
German (de)
English (en)
Other versions
EP2662065A1 (fr
Inventor
Guido Hunkeler
Jörg Spettl
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.)
Fisher Clinical Services GmbH
Original Assignee
Fisher Clinical Services GmbH
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 Fisher Clinical Services GmbH filed Critical Fisher Clinical Services GmbH
Publication of EP2662065A1 publication Critical patent/EP2662065A1/fr
Application granted granted Critical
Publication of EP2662065B1 publication Critical patent/EP2662065B1/fr
Active legal-status Critical Current
Anticipated expiration legal-status Critical

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Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61JCONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J1/00Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/14Details; Accessories therefor
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61JCONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J1/00Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/14Details; Accessories therefor
    • A61J1/1412Containers with closing means, e.g. caps
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61JCONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J1/00Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/14Details; Accessories therefor
    • A61J1/16Holders for containers
    • 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
    • B65D51/00Closures not otherwise provided for
    • B65D51/18Arrangements of closures with protective outer cap-like covers or of two or more co-operating closures
    • 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
    • B65D77/00Packages formed by enclosing articles or materials in preformed containers, e.g. boxes, cartons, sacks or bags
    • B65D77/04Articles or materials enclosed in two or more containers disposed one within another
    • B65D77/048Articles or materials enclosed in two or more containers disposed one within another the inner and outer containers being rigid and the outer container being of curved cross-section, e.g. cylindrical
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61JCONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J1/00Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/14Details; Accessories therefor
    • A61J1/1406Septums, pierceable membranes
    • 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
    • B65D2251/00Details relating to container closures
    • B65D2251/0003Two or more closures
    • B65D2251/0006Upper closure
    • B65D2251/0015Upper closure of the 41-type
    • 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
    • B65D2251/00Details relating to container closures
    • B65D2251/0003Two or more closures
    • B65D2251/0068Lower closure
    • B65D2251/0078Lower closure of the 41-type

Definitions

  • the invention relates to a device for blinding containers for clinical trials.
  • container or small container vials are used, in which usually preparations, i. usually liquid drugs, are provided for clinical trials.
  • a shell for a product is for example from the US 2007/0163914 known.
  • the blinding sheath described herein is a rigid, hard shell shell, in contrast to known easily deformable sheaths.
  • the blinding sheath 1 for a container 2 consists of a middle part 3, a bottom 4 inserted at the lower end of the middle part and a lid 5 arranged on the upper side of the middle part 5.
  • the central part 3 has a cylindrical lower portion with a diameter which is larger than the diameter of the container.
  • the middle part is tapered to a smaller diameter.
  • the upper area is offset laterally with respect to the axis of the lower area with its axis. in such a way that the transition between the lower and the upper region of the central part is strong on one side, left in the figures, and only slightly inclined in relation to each other. In between, there is a uniform course of the slope.
  • a circumferential groove 6 On the outside of the upper portion of the central part of a circumferential groove 6 is formed, which is provided on the side of the steeply inclined transition and opposite each with a downward branch. The function of this groove and its branches will be described below together with the function of the lid 5.
  • the container is arranged eccentrically on the side of the steeply inclined transition of the middle part.
  • a support in the manner of a false bottom 7 with an opening 8 and a circumferential, downwardly directed skirt 9, which is on the side of the steeply inclined transition into the wall of the upper area passes.
  • Through the opening extends the neck of the container with its tapered area being held by the lower edge of the skirt.
  • the underside of the container is fixed in this position by the bottom 4, which for this purpose on the one hand has an upward thickening 10, through which the container is pressed up against the lower edge of the skirt, and on the other hand with an upstanding Edge 11 is provided for lateral fixation of the container.
  • the bottom is pressed after the introduction of the container in the lower opening of the middle part.
  • Containers whose diameter over their entire axial length is not or only slightly larger than that of the closure capsule can not be fixed in this way in the shell.
  • suitable webs can be arranged in the interior of the casing and / or the casing can consist, for example, of two half-shells separated in the longitudinal direction.
  • the cover 5 consists of a top cover 12 corresponding to the upper opening of the middle part and a skirt 13 which extends downwards and embraces the upper edge of the middle part. Near the lower edge of the skirt two inwardly directed cams 14 are arranged, arranged opposite one another. which engage in the groove 6 described above. By this engagement, the lid is connected to the middle part. As the cams engage the downward branches, the lid can be moved axially with respect to the central portion. In its upper position, the lid can be rotated relative to the central part by the cams are guided in the circumferential groove.
  • a plurality of gripping elements 15 are mounted in the form of hooks which engage under the cap of the container.
  • a removal point in the present case provided with a tubular downwardly extending extension 17 through opening 16, for a removal needle for removal of a Amount of preparation from the container.
  • the through-opening can be closed by an elastic plug or the like, which is pierced with the needle for removal.
  • FIG. 1 The arrangement shown represents the situation of the blinded container for storage, transportation, etc., ie for the provision for the purpose of a clinical study.
  • the cams of the lid are located at the lower ends of the branches of the circumferential groove.
  • the lid, as in Fig. 2 shown as far as raised until the cams 14 to the height of the revolving Pass groove.
  • the cap With the lifting of the lid, the cap is lifted off the container by the gripping elements.
  • the next step is to remove the lid with the capsule removed from the container, as in Fig.

Landscapes

  • Health & Medical Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Engineering & Computer Science (AREA)
  • Mechanical Engineering (AREA)
  • Closures For Containers (AREA)
  • Sewing Machines And Sewing (AREA)
  • Sampling And Sample Adjustment (AREA)
  • Medical Preparation Storing Or Oral Administration Devices (AREA)

Claims (1)

  1. Dispositif pour le masquage de récipients avec un moyen de fermeture à ôter pour prélever la préparation, caractérisé par une enveloppe de masquage entourant complètement le récipient, avec un couvercle rotatif et déplaçable axialement, lequel est pourvu de moyens pour saisir le moyen de fermeture et d'un point de prélèvement pour une aiguille de prélèvement, de façon à ce que par un mouvement axial et une rotation du couvercle, le moyen de fermeture est éloigné du récipient et le point de prélèvement se trouve au-dessus du récipient ouvert.
EP13164845.3A 2012-05-08 2013-04-23 Dispositif d'essai en aveugle Active EP2662065B1 (fr)

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
CH00637/12A CH706482A1 (de) 2012-05-08 2012-05-08 Verblindungsvorrichtung.

Publications (2)

Publication Number Publication Date
EP2662065A1 EP2662065A1 (fr) 2013-11-13
EP2662065B1 true EP2662065B1 (fr) 2015-03-04

Family

ID=47115064

Family Applications (1)

Application Number Title Priority Date Filing Date
EP13164845.3A Active EP2662065B1 (fr) 2012-05-08 2013-04-23 Dispositif d'essai en aveugle

Country Status (5)

Country Link
US (1) US9192543B2 (fr)
EP (1) EP2662065B1 (fr)
CH (1) CH706482A1 (fr)
DK (1) DK2662065T3 (fr)
ES (1) ES2546561T3 (fr)

Families Citing this family (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
GB201412065D0 (en) * 2014-07-07 2014-08-20 Moore Kenneth S A A masking package
CN107822770B (zh) * 2017-11-01 2020-04-14 莱芜职业技术学院 一种医用滴眼液辅助支架
CN107804563B (zh) * 2017-11-01 2019-11-12 范小丽 一种医用滴眼液辅助包装盒
US11542083B2 (en) 2019-09-30 2023-01-03 Fisher Clinical Services, Inc. Vial blinding assemblies and methods of assembly

Family Cites Families (9)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US2438906A (en) * 1945-04-21 1948-04-06 William D Elsas Closure
US2750066A (en) * 1953-07-10 1956-06-12 Adela F Shekter Pocket flasks
AU441022B2 (en) * 1970-07-14 1973-09-28 Fmc Corporation An improved capsule for containing an article (divisional of 408,028)
US4949858A (en) * 1989-06-19 1990-08-21 Ethylene Corp. Sample bottle and cap therefor
US5143261A (en) * 1989-12-20 1992-09-01 The Procter & Gamble Company Multi-compartment container for proportional dispensing of a plurality of liquids
US5590782A (en) * 1995-04-17 1997-01-07 Habley Medical Technology Corporation Vial holder assembly
GB0029752D0 (en) * 2000-12-06 2001-01-17 Lilly Industries Ltd A protective container and a package comprising a protective container
US20070163914A1 (en) * 2005-09-22 2007-07-19 Gehring Debra G Package closure
US8875926B2 (en) * 2012-03-16 2014-11-04 Valon Grajqevci Resealable multi-compartment beverage container

Also Published As

Publication number Publication date
CH706482A1 (de) 2013-11-15
EP2662065A1 (fr) 2013-11-13
DK2662065T3 (en) 2015-06-08
US9192543B2 (en) 2015-11-24
ES2546561T3 (es) 2015-09-24
US20130299446A1 (en) 2013-11-14

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