EP0399234B1 - Ampulle - Google Patents

Ampulle Download PDF

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Publication number
EP0399234B1
EP0399234B1 EP90107913A EP90107913A EP0399234B1 EP 0399234 B1 EP0399234 B1 EP 0399234B1 EP 90107913 A EP90107913 A EP 90107913A EP 90107913 A EP90107913 A EP 90107913A EP 0399234 B1 EP0399234 B1 EP 0399234B1
Authority
EP
European Patent Office
Prior art keywords
ampoule
neck
cone
section
contact
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.)
Expired - Lifetime
Application number
EP90107913A
Other languages
German (de)
English (en)
French (fr)
Other versions
EP0399234A1 (de
Inventor
Bernd Dipl.-Ing. Hansen
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.)
Individual
Original Assignee
Individual
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 Individual filed Critical Individual
Publication of EP0399234A1 publication Critical patent/EP0399234A1/de
Application granted granted Critical
Publication of EP0399234B1 publication Critical patent/EP0399234B1/de
Anticipated expiration legal-status Critical
Expired - Lifetime legal-status Critical Current

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Classifications

    • 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
    • A61J1/05—Containers specially adapted for medical or pharmaceutical purposes for collecting, storing or administering blood, plasma or medical fluids ; Infusion or perfusion containers
    • A61J1/06—Ampoules or carpules
    • A61J1/067—Flexible ampoules, the contents of which are expelled by squeezing
    • 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
    • A61J1/20—Arrangements for transferring or mixing fluids, e.g. from vial to syringe
    • A61J1/2003—Accessories used in combination with means for transfer or mixing of fluids, e.g. for activating fluid flow, separating fluids, filtering fluid or venting
    • A61J1/2068—Venting means
    • A61J1/2075—Venting means for external venting
    • 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
    • A61J1/20—Arrangements for transferring or mixing fluids, e.g. from vial to syringe
    • A61J1/2096—Combination of a vial and a syringe for transferring or mixing their contents
    • Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10—TECHNICAL SUBJECTS COVERED BY FORMER USPC
    • Y10S—TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10S215/00—Bottles and jars
    • Y10S215/902—Vent

Definitions

  • the invention relates to an ampoule, in particular made of plastic, for a liquid which is withdrawn from the ampoule by means of a syringe body which has a standard cone at its end to be inserted into the ampoule neck, with a design of the ampoule neck for the standard cone to rest on the inner wall of the ampoule neck along a line.
  • EP-A-0 326 391, EP-A-0 327 397 and EP-A-0 344 476 which form prior art in accordance with Article 54 (3) EPC and are therefore not prepublished to design the ampoule neck so that air can enter the ampoule while the contents are being removed.
  • a section of the ampoule neck which has either a cylindrical or a conical inner surface has, to which the outer circumferential surface of the cone of a syringe can be brought into tight contact, provided with two diametrically arranged longitudinal channels which extend over the entire length of this section and are open to the interior of the ampoule neck.
  • the same effect as with these groove-like longitudinal channels is obtained with an ampoule neck, the portion of which serves to receive the cone of the syringe forms an oval channel.
  • the ampoule neck can also have, in addition to the channel which serves to receive the cone of the syringe, a channel which is completely separate therefrom for the passage of air.
  • a section with a larger diameter adjoins this section towards the free end.
  • the invention is based on the object To create an ampoule in which, while the contents are withdrawn between the standardized cone of a syringe inserted into the ampoule neck and the inner wall of the ampoule neck, no liquid can escape, but the ampoule neck does not need to be provided with longitudinal channels. This object is achieved by an ampoule with the features of claim 1.
  • An embodiment of the ampoule neck according to claim 2 is particularly advantageous, since such an ampoule neck ensures that the contact between the cone and the ampoule neck can only take place in the designated area of the ampoule neck.
  • the free end of the ampoule neck is designed as a contact surface for the end face of the syringe body that carries the cone.
  • an embodiment of the ampoule neck according to claim 2 is particularly advantageous, since such an ampoule neck ensures that the contact between the cone and the ampoule neck can only take place in the area of the ampoule neck intended for this purpose.
  • the design of the ampoule neck can be such that the inner wall of the ampoule neck has a conical or circular-cylindrical shape at least in the area intended for receiving the cone.
  • Such a section can be calibrated relatively easily during ampoule production to the desired value and with the desired tolerance.
  • first section 5 of the neck 2 the diameter of which is smaller than that of the ampoule body.
  • This section is followed by a smaller diameter cylindrical section 6, the inside diameter of which is somewhat larger than the largest diameter of a standardized cone 7 for medical devices, which is provided on one end face of a syringe body 8.
  • the end of the cylindrical section 6 facing away from the first section 5 is followed by a third section 9, which forms an annular bead projecting inward beyond the inner wall of the cylindrical section 6.
  • the inside diameter of the neck 2 at the narrowest point formed by the annular bead is somewhat smaller than the largest diameter of the cone 7.
  • the third section 9 merges into a fourth section 10, which extends outwards over the cylindrical section 6 and the third section 9 protruding bead forms and a larger inner diameter than the third section 9.
  • the fourth section 10 is connected to the head 3 via a predetermined breaking point with reduced wall thickness.
  • the head 3 can be separated from the neck 2 by rotating or tilting the toggle 4. Since the end face 10 'of the fourth section 10 which is exposed after the head 3 is separated from the neck 2 forms the contact surface for the end face of the syringe body 8 which carries the cone 7, the distance of the end face 10' measured in the longitudinal direction of the neck 2 is from the narrowest point of the neck 2 in the region of the third section 9 is selected such that the cone inserted into the neck 2 lies at a defined, relatively low pressure on the third section 9 of the neck 2 when the end face of the syringe body 8 carrying the cone 7 is on the end face 10 'is present.
  • the contact pressure between the cone 7 and the inner surface of the third section 9 is chosen such that air can enter the ampoule 1 to the extent that its content is sucked through the cone 7 by means of a piston contained in the syringe body 8, but that the liquid contained in the ampoule 1 is not along the jacket of the cone 7 or the inner lateral surface of the neck 2 can emerge, even if the ampoule 1, as usual, is upside down during the withdrawal of the liquid, that is to say its neck 2 points downward.
  • the invention relates to an ampoule, in particular made of plastic, for a liquid which is removed from the ampoule by means of a syringe body which has a standard cone at its end to be inserted into the ampoule neck.
  • the ampoule neck which is closed by means of a breakable head formed in one piece with it, forms an inner cone which is adapted to the cone of the syringe body.
  • the ampoule is therefore sealed when the cone of the syringe body is completely inserted into the ampoule neck in order to remove the contents of the ampoule. If the ampoule can collapse when its contents are removed, there is at most a slight negative pressure in the ampoule, which practically does not interfere with the removal of the liquid from the ampoule.
  • EP-A-0 088 056 proposes either to only partially fill the ampoule or to press air into the ampoule before the contents are removed. The former is uneconomical and the latter is difficult. In addition, the injection of air is undesirable for reasons of sterility.
  • a section of the ampoule neck intended for the installation of the standard cone is provided on its inside with at least one inwardly open longitudinal groove which allows air to pass through, but not liquid to pass between the cone wall and the inner wall of the ampoule neck.
  • an embodiment of the ampoule neck according to claim 4 is particularly advantageous, since such an ampoule neck ensures that the contact between the cone and the ampoule neck can only take place in the area of the ampoule neck intended for this purpose.
  • the design of the ampoule neck can be such that the inner wall of the ampoule neck has a conical or circular-cylindrical shape at least in the area intended for receiving the cone.
  • Such a section can be calibrated relatively easily during ampoule production to the desired value and with the desired tolerance.
  • a dimensionally stable ampoule 1 made of plastic in a blowing process contains a pharmaceutical liquid to be injected by means of a syringe.
  • a neck 3 of the ampoule 1, which is designated as a whole by 2 is followed by a head 3 which is formed in one piece with it and which in turn is formed in one piece with a molded-on toggle 4.
  • the neck 2, the head 3 and the gag 4 are shaped in a known manner following the filling of the ampoule body, the ampoule 1 being closed at the same time.
  • first section 5 of the neck 2 the diameter of which is smaller than that of the ampoule body.
  • This section is followed by a smaller diameter cylindrical section 6, the inside diameter of which is somewhat larger than the largest diameter of a standardized cone 7 for medical devices, which is provided on one end face of a syringe body 8.
  • the end of the cylindrical section 6 facing away from the first section 5 is followed by a third section 9, which forms an annular bead projecting inward beyond the inner wall of the cylindrical section 6.
  • the inside diameter of the neck 2 at the narrowest point formed by the annular bead is somewhat smaller than the largest diameter of the cone 7.
  • the third section 9 merges into a fourth section 10, which extends outwards over the cylindrical section 6 and the third section 9 protruding bead forms and a larger inner diameter than the third section 9.
  • the fourth section 10 is connected to the head 3 via a predetermined breaking point with reduced wall thickness.
  • the head 3 can be separated from the neck 2 by rotating or tilting the toggle 4. Since the end face 10 'of the fourth section 10 which is exposed after the head 3 is separated from the neck 2 forms the contact surface for the end face of the syringe body 8 which carries the cone 7, the distance of the end face 10' measured in the longitudinal direction of the neck 2 is from the narrowest point of the neck 2 in the region of the third section 9 is selected such that the cone inserted into the neck 2 lies at a defined, relatively low pressure on the third section 9 of the neck 2 when the end face of the syringe body 8 carrying the cone 7 is on the end face 10 'is present.
  • the contact pressure between the cone 7 and the inner surface of the third section 9 is chosen such that air can enter the ampoule 1 to the extent that its content is sucked through the cone 7 by means of a piston contained in the syringe body 8, but that the liquid contained in the ampoule 1 is not along the jacket of the cone 7 or the inner lateral surface of the neck 2 can emerge, even if the ampoule 1, as usual, is upside down during the withdrawal of the liquid, that is to say its neck 2 points downward.
  • the second exemplary embodiment which is shown incompletely in FIG. 4, differs from the first exemplary embodiment in that the neck 102 of the ampoule 101 has only three sections because the third section forming the inwardly projecting annular bead is missing. So that a self-contained, linear contact between the cone 7 inserted into the neck 102 and the inner wall of the neck 102 is achieved, which prevents the passage of liquid but allows the passage of air, the inner diameter of the cylindrical portion 106 is somewhat smaller chosen as the largest diameter of the cone 7, but somewhat larger than its smallest diameter.
  • the axial length of the section 110 which adjoins the cylindrical section 106 and forms an outwardly projecting annular bead, is selected so that the cone 7 with the required, relatively low contact pressure, which is necessary to prevent the passage of liquid the inner wall of the cylindrical section 106 abuts when the end face of the syringe body 8 bearing the cone 7 abuts the free end face 110 'of the neck 102.
  • the neck 102 is provided at two diametrically arranged locations, each with an inwardly open longitudinal groove 111, the cross section of which is selected such that the inflowing air prevents liquid from escaping.
  • the cross section of which is selected such that the inflowing air prevents liquid from escaping.
  • only a single longitudinal groove could also be provided or the groove arrangement selected differently.
  • One or more longitudinal grooves of this type could be provided on the inside of the third section 9 of the neck 2 of the first embodiment.

Landscapes

  • Health & Medical Sciences (AREA)
  • Hematology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Medical Preparation Storing Or Oral Administration Devices (AREA)
  • Infusion, Injection, And Reservoir Apparatuses (AREA)
EP90107913A 1989-05-24 1990-04-26 Ampulle Expired - Lifetime EP0399234B1 (de)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
DE19893916840 DE3916840A1 (de) 1988-09-21 1989-05-24 Ampulle
DE3916840 1989-05-24

Publications (2)

Publication Number Publication Date
EP0399234A1 EP0399234A1 (de) 1990-11-28
EP0399234B1 true EP0399234B1 (de) 1994-06-08

Family

ID=6381265

Family Applications (1)

Application Number Title Priority Date Filing Date
EP90107913A Expired - Lifetime EP0399234B1 (de) 1989-05-24 1990-04-26 Ampulle

Country Status (9)

Country Link
US (1) US5046627A (sv)
EP (1) EP0399234B1 (sv)
JP (1) JPH037162A (sv)
CA (1) CA2016892C (sv)
DE (1) DE3916840A1 (sv)
DK (1) DK0399234T3 (sv)
ES (1) ES2054142T3 (sv)
FI (1) FI100020B (sv)
MX (1) MX171693B (sv)

Families Citing this family (33)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
AU8880991A (en) * 1990-12-04 1992-06-11 Automatic Liquid Packaging, Inc. Hermetically sealed vial
CA2086916A1 (en) * 1992-01-17 1993-07-18 John D. Culter Flexible bottle having an improved, integral closure
US5188250B1 (en) * 1992-06-05 1994-07-05 Kraft Gen Foods Inc Plastic beverage bottle with twist-off closure
US5305658A (en) * 1992-07-01 1994-04-26 Sterling Winthrop Inc. Capsule transfer device
DE4230645C2 (de) * 1992-09-12 1996-03-07 Bernd Hansen Ampulle
SK3296A3 (en) * 1993-12-28 1996-05-08 Tetsuro Higashikawa The syringe
US5758637A (en) 1995-08-31 1998-06-02 Aerogen, Inc. Liquid dispensing apparatus and methods
EP0801940A3 (de) * 1996-04-18 1998-04-08 Nizell-Produkte Ampulle und Verwendung der Ampulle
US6203870B1 (en) 1998-02-24 2001-03-20 Plastipak Packaging, Inc. Liner and preform
GB9804005D0 (en) * 1998-02-25 1998-04-22 Nycomed Imaging As Container
US6068148A (en) 1998-05-26 2000-05-30 Automatic Liquid Packaging, Inc. Hermetically sealed container including a nozzle with a sealing bead
US6235177B1 (en) 1999-09-09 2001-05-22 Aerogen, Inc. Method for the construction of an aperture plate for dispensing liquid droplets
FR2804940B1 (fr) * 2000-02-10 2002-08-30 Au Liegeur Ets J Pontneau Deni Bouchon pour bouteilles a vins effervescents et procede de fabrication d'un tel bouchon
US7971588B2 (en) 2000-05-05 2011-07-05 Novartis Ag Methods and systems for operating an aerosol generator
US7100600B2 (en) * 2001-03-20 2006-09-05 Aerogen, Inc. Fluid filled ampoules and methods for their use in aerosolizers
US8336545B2 (en) 2000-05-05 2012-12-25 Novartis Pharma Ag Methods and systems for operating an aerosol generator
EP1598059A1 (en) 2001-05-18 2005-11-23 Chiron Corporation Methods and unit dose formulations for the inhalation administration of aminoglycoside antibiotics
ES2261735T3 (es) 2001-05-18 2006-11-16 Chiron Corporation Sistema para la administracion de una formulacion de tobramicina.
MXPA04006629A (es) 2002-01-07 2004-11-10 Aerogen Inc Aparatos y metodos para nebulizar fluidos para inhalacion.
US7677467B2 (en) 2002-01-07 2010-03-16 Novartis Pharma Ag Methods and devices for aerosolizing medicament
WO2003059424A1 (en) 2002-01-15 2003-07-24 Aerogen, Inc. Methods and systems for operating an aerosol generator
WO2003097126A2 (en) 2002-05-20 2003-11-27 Aerogen, Inc. Aerosol for medical treatment and methods
DE10317665A1 (de) * 2003-04-17 2004-11-11 Bernd Hansen Ampulle
DE10330678A1 (de) * 2003-07-08 2005-01-27 Mann + Hummel Gmbh Steckverbindung
US8616195B2 (en) 2003-07-18 2013-12-31 Novartis Ag Nebuliser for the production of aerosolized medication
US7946291B2 (en) 2004-04-20 2011-05-24 Novartis Ag Ventilation systems and methods employing aerosol generators
SG163503A1 (en) 2005-05-25 2010-08-30 Aerogen Inc Vibration systems and methods
US20080000798A1 (en) * 2006-03-20 2008-01-03 Werner Gutmann Dose packaging system for load-dose titration administration of a liquid formulation
US7862841B1 (en) * 2006-07-05 2011-01-04 Michael D Boyd Multiple serving container
US20080228162A1 (en) * 2007-03-16 2008-09-18 Medlmmune Vaccines, Inc. Single-use ampoule
US20120310203A1 (en) * 2010-01-19 2012-12-06 Cambridge Enterprise Limited Apparatus and method
US20160221707A1 (en) * 2015-02-03 2016-08-04 Avail Vapor Llc Disposable refill ampule
DE102017009012A1 (de) 2017-09-26 2019-03-28 Kocher-Plastik Maschinenbau Gmbh Behälter sowie Verbindungs- und Herstellvorrichtung

Family Cites Families (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US3143251A (en) * 1961-06-09 1964-08-04 Baxter Don Inc Additive container for medicants or the like
US3356244A (en) * 1966-03-28 1967-12-05 Leco Industries Ltd Container for convenient opening
US3608550A (en) * 1969-05-07 1971-09-28 Becton Dickinson Co Transfer needle assembly
DE3382534D1 (de) * 1982-02-08 1992-04-30 Astra Laekemedel Ab Mit normaldosis gefuellter behaelter.
GB8801655D0 (en) * 1988-01-26 1988-02-24 Waverley Pharma Ltd Ampoules
GB8802349D0 (en) * 1988-02-03 1988-03-02 Waverley Pharma Ltd Ampoule with luer
DE3818682A1 (de) * 1988-06-01 1989-12-21 Deussen Stella Kg Ampulle
DE3823428A1 (de) * 1988-07-11 1990-01-18 Hansen Bernd Ampulle aus kunststoff

Also Published As

Publication number Publication date
JPH0352984B2 (sv) 1991-08-13
EP0399234A1 (de) 1990-11-28
FI100020B (sv) 1997-08-29
ES2054142T3 (es) 1994-08-01
DE3916840A1 (de) 1990-03-29
DE3916840C2 (sv) 1993-06-09
JPH037162A (ja) 1991-01-14
US5046627A (en) 1991-09-10
DK0399234T3 (da) 1994-09-19
CA2016892A1 (en) 1990-11-24
FI902502A0 (fi) 1990-05-21
CA2016892C (en) 1997-11-18
MX171693B (es) 1993-11-10

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