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WO2009144553A1 - Fiole destinée à contenir des fluides injectables, en particulier des produits médicaux, pharmaceutiques, cosmétiques ou similaires - Google Patents

Fiole destinée à contenir des fluides injectables, en particulier des produits médicaux, pharmaceutiques, cosmétiques ou similaires Download PDF

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Publication number
WO2009144553A1
WO2009144553A1 PCT/IB2009/005634 IB2009005634W WO2009144553A1 WO 2009144553 A1 WO2009144553 A1 WO 2009144553A1 IB 2009005634 W IB2009005634 W IB 2009005634W WO 2009144553 A1 WO2009144553 A1 WO 2009144553A1
Authority
WO
WIPO (PCT)
Prior art keywords
bottle according
cover
cap
bottle
plug
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.)
Ceased
Application number
PCT/IB2009/005634
Other languages
English (en)
Inventor
Antonio Fontana
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.)
Lameplast SRL
Original Assignee
Lameplast SRL
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 Lameplast SRL filed Critical Lameplast SRL
Priority to ES09754181T priority Critical patent/ES2391068T3/es
Priority to EP20090754181 priority patent/EP2303716B1/fr
Publication of WO2009144553A1 publication Critical patent/WO2009144553A1/fr
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

Links

Classifications

    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B65—CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
    • B65D—CONTAINERS 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
    • B65D51/00—Closures not otherwise provided for
    • B65D51/002—Closures to be pierced by an extracting-device for the contents and fixed on the container by separate retaining means
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS 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
    • A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/14—Details; Accessories therefor
    • A61J1/18—Arrangements for indicating condition of container contents, e.g. sterile condition
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B65—CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
    • B65D—CONTAINERS 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
    • B65D51/00—Closures not otherwise provided for
    • B65D51/18—Arrangements of closures with protective outer cap-like covers or of two or more co-operating closures
    • B65D51/20—Caps, lids, or covers co-operating with an inner closure arranged to be opened by piercing, cutting, or tearing
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS 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
    • A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/14—Details; Accessories therefor
    • A61J1/1468—Containers characterised by specific material properties
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B65—CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
    • B65D—CONTAINERS 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
    • B65D2251/00—Details relating to container closures
    • B65D2251/0003—Two or more closures
    • B65D2251/0006—Upper closure
    • B65D2251/0025—Upper closure of the 47-type
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B65—CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
    • B65D—CONTAINERS 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
    • B65D2251/00—Details relating to container closures
    • B65D2251/0003—Two or more closures
    • B65D2251/0068—Lower closure
    • B65D2251/009—Lower closure of the 51-type

Definitions

  • the present invention relates to a bottle for containing injectable fluids, particularly medical, pharmaceutical, cosmetic products or the like.
  • sterile fluids are normally supplied in bottles made of glass or plastic, which are chemically inert materials and suitable for safeguarding the sterility of the fluids which they contain.
  • the bottles are usually closed by means of a closing element called “stopper”, which is fitted in the access mouth of the bottle.
  • the closing element is made of rubber to allow its penetration by a pointed extraction element, such as e.g. the needles of hypodermic syringes and infusion line spikes, and thus allow the extraction and exit of the sterile fluid.
  • a pointed extraction element such as e.g. the needles of hypodermic syringes and infusion line spikes
  • this is generally covered with a protection cap that can be screwed around the bottle neck.
  • the cap comprises a tear-off removable portion, that can be removed to gain access to the stopper from the outside.
  • the removable portion has a grip eyelet, a tab or other similar systems that permit gripping the removable portion and tearing it fully away from the rest of the protection cap, which remains stably fastened to the bottle neck.
  • Bottles of this type are described in EP 0 819 617 and EP 1 044 135. These bottles, nevertheless, have a number of drawbacks among which must be mentioned the fact that to remove the removable portion it is absolutely necessary to use both hands, one to hold the bottle firm and the other to tightly grip and tear away the grip eyelet/tab.
  • the tear-away removal of the removable portion of the cap means splitting the cap into two distinct pieces, which therefore need to be disposed of at different times and in different ways.
  • the removable portion in fact must be thrown away once removed, i.e., when the bottle is opened and at the start of its use; the rest of the bottle, on the other hand, becomes a waste to be thrown away only once it has been emptied of its contents, i.e., after it has been used. This means a further loss of time and practical use for the user who, in fact, once the bottle has been opened, is forced to find a litter bin to dispose of the removable portion after this has been removed from the cap.
  • the main aim of the present invention is to provide a bottle for containing injectable fluids, particularly medical, pharmaceutical, cosmetic products or the like, that is practical, easy and functional to use, can be opened quickly using just one hand, freeing the user from the need of having to use both hands, and at the same time permits considerably reducing waste materials, facilitating waste disposal operations.
  • Another object of the present invention is to provide a bottle for containing injectable fluids, particularly medical, pharmaceutical, cosmetic products or the like, that allows overcoming the mentioned drawbacks of the background art in the ambit of a simple, rational, easy, effective to use and low cost solution.
  • the present bottle for containing injectable fluids comprising at least a container for containing an injectable fluid having at least an access mouth, at least a closing element that is at least partially inserted in said access mouth and which has at least an area in penetrable material suitable for being crossed by an extracting element for extracting said injectable fluid, and at least a protection plug for protecting said closing element, characterized in that said plug comprises at least a cap that can be placed to at least partially cover said closing element and which has at least an opening for accessing said area, and at least a cover that is associated with said cap by interposition of rotation means around a swinging axis and which supports at least a shutter element that can be fitted sealed in said opening.
  • figure 1 is an axonometric view of a preferred form of embodiment of the bottle according to the invention in a closing configuration
  • figure 2 is a longitudinal section view of the bottle of figure 1
  • figure 3 is an axonometric view of the plug fitted on the bottle of figure 1, arranged in the initial opening configuration
  • figure 4 is an axonometric view of the plug of figure 3, arranged in the final opening configuration
  • figure 5 is an axonometric view of the plug of an alternative form of embodiment according to the invention, arranged in the initial opening configuration
  • figure 6 is an axonometric view of the plug of figure 5, arranged in the final B2009/005634
  • the bottle 1 comprises a container 2 for containing an injectable fluid 3 to be administered to a patient by means of a syringe, an infusion line or the like.
  • the container 2 has a bottom 4, at which is associable a hanger 5, and a threaded neck 6, which is arranged in the opposite direction to the bottom 4 and which terminates with an access mouth 7.
  • a closing element 8 of the type of a rubber stopper is at least in part insertable by interlock.
  • the closing element 8 has a thinned area 9, in penetrable material, which is suitable for being crossed by an extraction element for the extraction and the exit of the inj ectable fluid 3.
  • the extraction element is not shown in detail in the illustrations and, e.g., consists of a syringe needle, an infusion line spike or similar devices.
  • a plug 10 for the protection of the closing element 8.
  • Both the container 2 and the plug 10 are advantageously made of plastic, e.g., in polypropylene.
  • the plug 10 in particular, comprises a cap 11 that is placeable to cover the closing element 8 and which has an opening 12 for accessing the area 9.
  • the cap 11 has a substantially round section cylindrical shape and is composed, e.g., of a cylindrical side body 13, inside which is obtained an inner thread 14 engageable by screwing on the neck 6 of the container 2, and of an annular wall
  • the opening 12 is obtained on the annular wall 15 in such a position that, when the cap 11 is fitted on the neck 6, the opening 12 is arranged at the area 9. Furthermore, the plug 10 comprises a cover 16 that is associated with the cap 11 by interposition of the rotation means 17 around a swinging axis.
  • the rotation means 17 are arranged on the periphery of the cap 11, i.e., on the edge of the annular wall 15, and tangent with this, and are composed of a first folding line with weakened section.
  • the cap 11 and the cover 16 are made in a single body by means of injection moulding and remain joined together at the first folding line 17, the weakened section of which permits turning the cap 11 and the cover 16, the one with respect to the other, between a closing configuration, in which the cover 16 is up against the annular wall 15, and an opening configuration, in which on the other hand the cover 16 is turned with respect to the annular wall 15.
  • the cap 11 and the cover 16 are made in two or more pieces which may be assembled together.
  • the cover 16 supports a shutter element 18 which in the closing configuration of the plug 10 can be fitted sealed in the opening 12.
  • the shutter element 18 is defined by a cylindrical body with shape substantially complementary to that of the opening 12. Between the cap 11 and the cover 16 are interposed first anti-tampering seal means 19, 20, 21 suitable for evidencing whether or not the plug 10 has been previously opened.
  • the first anti-tampering seal means 19, 20, 21 consist, e.g., of a protruding element 19, of the type of a tooth or the like, that is associated with the cover 16 by interposition of first tearable support means 20, and of a retention seat 21, that is obtained on the cap 11 and in which the protruding element 19 can be slotted in the closing configuration of the plug 10.
  • the tooth 19 is defined on a flap 22 that is arranged on the diametrically opposite side of the cover 16 with respect to the first folding line 17 and which is associated with the rest of the cover 16 along a second folding line 23 with weakened section, substantially parallel with the first folding line 17, that enables the flap 22 to fold with respect to the rest of the cover 16.
  • a through slot 24 on the inner edge of which are arranged the first tearable support means 20 made up, e.g., of a series of preset fracture connecting bridges suitable for breaking once the tooth 19 is fitted in the retention seat 21.
  • the retention seat 21 is obtained on the annular wall 15 of the cap 11 on the diametrically opposite side with respect to the first folding line 17 so that in closing configuration of the plug 10 the tooth 19 fits exactly in the retention seat 21.
  • the plug 10 comprises second anti-tampering seal means 25, 26 placed between the cover 16 and the shutter element 18.
  • the shutter element 18 is associated with the cover 16 by means of the second anti-tampering seal means 25, 26.
  • second anti-tampering seal means comprise second tearable support means 25, of the type of a series of preset fracture connecting bridges, and a supporting edge 26 suitable for keeping the cover 16 and the shutter element 18 joined together upon breakage of the second tearable support means 25.
  • the supporting edge 26, in detail, is obtained on the cover 16 on the part arranged at and near the first folding line 17.
  • This arrangement of the supporting edge 26, together with the particular sizing of the section of the second tearable support means 25, causes, when the cover 16 is opened starting from the closing configuration, the shutter element 18 to remain temporarily blocked inside the opening 12 so as to allow the breakage of the second tearable support means 25 while, once out of the opening 12, the shutter element 18 remains attached to the cover 16 by means of the supporting edge 26.
  • third anti- tampering seal means 27, 28, 29 placed between the cap 11 and the container 2 are third anti- tampering seal means 27, 28, 29.
  • the third anti-tampering seal means 27, 28, 29 comprise a seal ring 27 which is associated with the base of the cap 11 by interposition of third tearable support means 28 and can be coupled by slotting in with a retention edge 29 obtained on the neck 6 of the container 2.
  • the seal ring 27 is obtained in a single body with the cap 11 and the third tearable support means 28 are composed of a series of preset fracture connecting bridges.
  • the seal ring 27 and the retention edge 29 are shaped so the cap 11 can be fitted on the neck 6 without causing the breakage of the third tearable support means 28 while, on the contrary, when we try to unscrew the plug 10, the retention edge 29 opposes resistance to the moving away of the seal ring 27 determining the fracture of the third tearable support means 28.
  • the plug 10 is arranged in an initial opening configuration (figure 3) in which the first, the second and the third tearable support means 20, 25 and 28 are integral, the tooth 19 is fitted on the flap 22, the shutter element 18 is fitted on the cover 16 and the seal ring 27 is fitted on the base of the cap 11. At this point, the plug 10 is screwed onto the container 2 and the cover 16 is closed.
  • the tooth 19 slots stably into the inside of the retention seat 21 and the shutter element 18 is seal fitted and partially slotted into the opening 12, as seen in figure 2.
  • the user levers on the flap 22 and pushes the cover 16 to turn around the first folding line 17 placing the plug in the final opening configuration shown in the figure 4.
  • Such operation is particularly simple and can also be performed by the user with just one hand, enabling him/her to keep the other hand free or use it to grip the extraction element and prepare it for its subsequent fitting in the closing element 8.
  • the bottle 1 has a container 2 that is completely identical to that of the previous embodiment; consequently, in these illustrations, the container 2 has not been shown, but only the plug 10.
  • the plug 10 of this embodiment is altogether similar to that shown in the figures from 1 to 4 and comprises a cap 11 5 a cover 16, a shutter element 18, first anti- tampering seal means 19, 20, 21 and third anti-tampering seal means 27, 28, 29 identical to those previously described and which, therefore, will not be the subject of further detailed explanation, it remaining understood that for these reference is best made to the above description.

Landscapes

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

Abstract

L'invention porte sur une fiole destinée à contenir des fluides injectables, en particulier des produits médicaux, pharmaceutiques, cosmétiques ou similaires. La fiole comprend un contenant de confinement (2) d'un fluide injectable (3) comportant une embouchure d'accès (7) ; un élément de fermeture (8) au moins partiellement introduit dans l'embouchure d'accès (7) ; une zone en matériau pénétrable pouvant être traversée par un élément d'extraction de fluide injectable ; et un bouchon de protection (10) destiné à protéger l'élément de fermeture (8) et formé d’un capuchon (11) qui peut être placé de façon à recouvrir au moins partiellement l'élément de fermeture (8) et qui comporte une ouverture permettant d'accéder à la zone en matériau pénétrable ; et un couvercle (16) associé au capuchon (11) par des moyens de rotation (17) autour d'un axe de pivotement et portant un élément obturateur (18) ajustable de façon étanche dans l'ouverture.
PCT/IB2009/005634 2008-05-27 2009-05-18 Fiole destinée à contenir des fluides injectables, en particulier des produits médicaux, pharmaceutiques, cosmétiques ou similaires Ceased WO2009144553A1 (fr)

Priority Applications (2)

Application Number Priority Date Filing Date Title
ES09754181T ES2391068T3 (es) 2008-05-27 2009-05-18 Botella para contener fluidos inyectables, en particular productos médicos, farmacéuticos, cosméticos o similares
EP20090754181 EP2303716B1 (fr) 2008-05-27 2009-05-18 Fiole destinée à contenir des fluides injectables, en particulier des produits médicaux, pharmaceutiques, cosmétiques ou similaires

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
IT000160A ITMO20080160A1 (it) 2008-05-27 2008-05-27 Flacone per il contenimento di fluidi iniettabili, particolarmente prodotti medicali, farmaceutici, cosmetici o simili
ITMO2008A000160 2008-05-27

Publications (1)

Publication Number Publication Date
WO2009144553A1 true WO2009144553A1 (fr) 2009-12-03

Family

ID=40302884

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/IB2009/005634 Ceased WO2009144553A1 (fr) 2008-05-27 2009-05-18 Fiole destinée à contenir des fluides injectables, en particulier des produits médicaux, pharmaceutiques, cosmétiques ou similaires

Country Status (4)

Country Link
EP (1) EP2303716B1 (fr)
ES (1) ES2391068T3 (fr)
IT (1) ITMO20080160A1 (fr)
WO (1) WO2009144553A1 (fr)

Cited By (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2015193772A1 (fr) 2014-06-20 2015-12-23 Lameplast S.P.A. Procédé de fabrication de bandes de flacons pour des produits fluides, en particulier des produits médicaux, pharmaceutiques, cosmétiques, alimentaires ou similaires
WO2015193773A1 (fr) 2014-06-20 2015-12-23 Lameplast S.P.A. Bandes de flacons pour produits fluides, notamment des produits médicaux, pharmaceutiques, cosmétiques, alimentaires ou analogues
WO2016016764A1 (fr) 2014-07-31 2016-02-04 Lameplast S.P.A. Bandelettes de flacons pour produits fluides, en particulier pour produits médicaux, pharmaceutiques, cosmétiques, alimentaires et analogues
WO2025166846A1 (fr) * 2024-02-07 2025-08-14 湖南千山制药机械股份有限公司 Flacon vétérinaire intégré hautement isolant doté d'un canal d'écoulement interne

Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO1990000143A1 (fr) * 1988-06-28 1990-01-11 Microplast B.V. Ensemble de couvercle d'obturation et son procede de fabrication
GB2252099A (en) * 1991-01-21 1992-07-29 Martyn Neil Jones Safety valved cover for mouth of a vessel
EP0614820A1 (fr) * 1993-03-12 1994-09-14 Hoechst Aktiengesellschaft Fermeture avec capuchon à arracher de flacons pour injection ou perfusion
EP1870347A2 (fr) * 2006-06-19 2007-12-26 Grifols, S.A. Butoir pour flacons de produits stériles et utilisation de ce butoir pour un remplissage mesuré stérile

Patent Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO1990000143A1 (fr) * 1988-06-28 1990-01-11 Microplast B.V. Ensemble de couvercle d'obturation et son procede de fabrication
GB2252099A (en) * 1991-01-21 1992-07-29 Martyn Neil Jones Safety valved cover for mouth of a vessel
EP0614820A1 (fr) * 1993-03-12 1994-09-14 Hoechst Aktiengesellschaft Fermeture avec capuchon à arracher de flacons pour injection ou perfusion
EP1870347A2 (fr) * 2006-06-19 2007-12-26 Grifols, S.A. Butoir pour flacons de produits stériles et utilisation de ce butoir pour un remplissage mesuré stérile

Cited By (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2015193772A1 (fr) 2014-06-20 2015-12-23 Lameplast S.P.A. Procédé de fabrication de bandes de flacons pour des produits fluides, en particulier des produits médicaux, pharmaceutiques, cosmétiques, alimentaires ou similaires
WO2015193773A1 (fr) 2014-06-20 2015-12-23 Lameplast S.P.A. Bandes de flacons pour produits fluides, notamment des produits médicaux, pharmaceutiques, cosmétiques, alimentaires ou analogues
WO2016016764A1 (fr) 2014-07-31 2016-02-04 Lameplast S.P.A. Bandelettes de flacons pour produits fluides, en particulier pour produits médicaux, pharmaceutiques, cosmétiques, alimentaires et analogues
WO2025166846A1 (fr) * 2024-02-07 2025-08-14 湖南千山制药机械股份有限公司 Flacon vétérinaire intégré hautement isolant doté d'un canal d'écoulement interne

Also Published As

Publication number Publication date
ITMO20080160A1 (it) 2009-11-28
EP2303716A1 (fr) 2011-04-06
EP2303716B1 (fr) 2012-07-11
ES2391068T3 (es) 2012-11-21

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