EP0591156B1 - Unit dose container - Google Patents

Unit dose container Download PDF

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Publication number
EP0591156B1
EP0591156B1 EP91900129A EP91900129A EP0591156B1 EP 0591156 B1 EP0591156 B1 EP 0591156B1 EP 91900129 A EP91900129 A EP 91900129A EP 91900129 A EP91900129 A EP 91900129A EP 0591156 B1 EP0591156 B1 EP 0591156B1
Authority
EP
European Patent Office
Prior art keywords
container
syringe
engagement portion
fitting
screw thread
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
EP91900129A
Other languages
German (de)
English (en)
French (fr)
Other versions
EP0591156A4 (en
EP0591156A1 (en
Inventor
Michael Browning Kimber
Anders Tore Kers
Borje Jonsson
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.)
AstraZeneca AB
Original Assignee
Astra AB
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 Astra AB filed Critical Astra AB
Publication of EP0591156A4 publication Critical patent/EP0591156A4/en
Publication of EP0591156A1 publication Critical patent/EP0591156A1/en
Application granted granted Critical
Publication of EP0591156B1 publication Critical patent/EP0591156B1/en
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
    • 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
    • B65D1/00—Containers having bodies formed in one piece, e.g. by casting metallic material, by moulding plastics, by blowing vitreous material, by throwing ceramic material, by moulding pulped fibrous material, by deep-drawing operations performed on sheet material
    • B65D1/02—Bottles or similar containers with necks or like restricted apertures, designed for pouring contents
    • B65D1/0223—Bottles or similar containers with necks or like restricted apertures, designed for pouring contents characterised by shape
    • B65D1/023—Neck construction
    • B65D1/0238—Integral frangible closures
    • 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
    • B65D1/00—Containers having bodies formed in one piece, e.g. by casting metallic material, by moulding plastics, by blowing vitreous material, by throwing ceramic material, by moulding pulped fibrous material, by deep-drawing operations performed on sheet material
    • B65D1/09—Ampoules
    • B65D1/095—Ampoules made of flexible material
    • 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
    • A61J1/2048—Connecting means
    • A61J1/2055—Connecting means having gripping 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
    • A61J1/20—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

Definitions

  • This invention relates to a thermoplastic container suitable for use in holding and transferring injectable solutions to a syringe.
  • Screw thread engagement fittings of interest in the context of the present invention are female fittings having an internal thread such as in the case of the luer lock fitting and all references to screw thread engagement fittings on syringes hereafter are references to female fittings.
  • a screw thread engagement fitting is the fitting of preference where the circumstances of use indicate that there is some prospect of the needle becoming disengaged with the syringe body (e.g. epidural injections). This invention is particularly concerned with containers suitable for transferring injectable solutions to syringes having a screw thread engagement fitting.
  • thermoplastic unit dose container which comprises the features of the preamble of claim 1.
  • the container thereby comprises a body portion, a neck portion, an outlet opening provided at the end of the neck portion and sealed by a non resealable cap, the neck portion is in the shape of an outwardly widening truncated cone having an engagement portion being provided at the edge of said outwardly truncated cone, said engagement portion being adapted to engage with the end of a syringe, thus enabling sealing connection of the container to the said syringe, so that liquid within the container may be directly transferred from the container to the syringe.
  • the engagement portion of the container described in this document is not constructed to be deformable and is not formed as a thread engagement portion intended to be inserted in a thread engagement fitting of a syringe and will therefore not provide an air tight sealing between the container and the syringe.
  • the position and construction of the yokes prevents the insertion of the neck portion into the thread engagement fitting of a syringe.
  • the cross section of the container is circular the walls of the body must be made thick in order to give the container the required stability when the cap is to be removed. This will make the withdrawal of the contents of the container into the syringe difficult.
  • the present invention provides a container suitable for use with a syringe having a screw thread engagement fitting to facilitate more secure, easier and more convenient transfer of an injection solution to a syringe which has a screw thread engagement fitting than has hitherto been possible.
  • a liquid containing thermoplastic unit dose container which comprises a body portion, a neck portion, an outlet opening provided at the end of the neck portion and sealed by a non resealable cap, the neck portion being in the shape of an outwardly widening truncated cone having an engagement portion being provided at the edge of said outwardly truncated cone, said engagement portion being adapted to engage with the end of a syringe, thus enabling sealing connection of the container to the said syringe, so that liquid within the container may be directly transferred from the container to the syringe.
  • Said engagement portion is formed as a thread engagement portion being adapted to be inserted in an inwardly facing screw thread channel at the end of a syringe whereby said portion is slightly deformed thereby providing a sealing connection between the thread engagement portion of the container and the peripheral wall of the syringe.
  • the top of said body portion has a hexagonal cross section.
  • the hexagonal form of the body of the container makes it easier to connect the container to the syringe as it strengthens the container in such a way that it can stand radial and axial strains better.
  • Two yokes are preferably provided on either side of the ampoule substantially 180° to each other in order to further strengthen the body of the container. The yokes also reduce the risk of the container being punctured during production.
  • the container of the present invention is intended to be used with syringes having screw thread engagement fittings such as the "Luer Lock” fitting.
  • the luer lock fitting comprises a central male cone, an outer peripheral wall and a bottom wall. The outside wall of the cone, the bottom wall and the inside of the peripheral wall together define an annular chamber. On the inside of the peripheral wall there is provided a screw thread.
  • the thread engagement portion provided on the container preferably comprises a shoulder shaped to fit within the inwardly facing screw thread channel at the end of a Luer Lock syringe and said thread engagement portion is preferably formed such that it is adapted to be screw threadingly engaged within the Luer Lock fitting of a syringe.
  • outlet opening of the container is formed to be adapted to a cone provided within the screw thread channel of the Luer Lock syringe to which the container is to be connected to.
  • the non resealable cap is attached to the outlet opening along a weakened section of the container so that it can be readily detached by a rocking or twisting action.
  • the walls of the body of the container is made flexible in order to collapse when the contents is drawn into the syringe.
  • the container of the invention is of a thermoplastic material, it is capable of slight deformation and the diameter of the neck portion in at least one position is most preferably slightly smaller than the outside diameter of the syringe so to sealingly abut against the cone at that point or points.
  • sealing engagement is facilitated in this manner, it is not necessary that the engagement portion of the container neck also provide a seal with the fitting although this is desirable. It is however very important that sealing engagement occur either between the engagement portion of the neck and the peripheral wall of the fitting or alternatively between a portion of the inside of the container neck and the central male cone. If there is no sealing connection, it is possible for the intrusion of unsterile air into the container and this may lead to contamination of the container contents of the syringe.
  • Sealing between the container and the syringe fitting is also enhanced if the engagement portion of the neck is slightly greater in cross sectional diameter than the internal diameter of the annular channel.
  • the non resealable container cap is removed by a rocking or twisting action and separates from the container along the weakened portion adjacent the outlet opening.
  • the container is held in an upright position and the syringe into which it is intended to transfer the solution is placed so that the screw thread engagement fitting aligns with the outlet opening.
  • the plunger in the syringe should be fully inserted.
  • the container is then sealingly engaged with the syringe fitting by rotating the syringe and container with respect to each other until the container has completely engaged with the screw thread on the syringe.
  • the contents of the container may be conveniently withdrawn into the syringe by the rearward action of the plunger in the syringe body and if necessary, assistance in this fluid transfer may be given by partial deformation of the outside walls of the container.
  • FIG 1 there is shown a container 1 of thermoplastic material which can be readily deformed. Suitable materials for the manufacture of such containers are well known in the art but include polyethylene and polypropylene.
  • the container 1 comprises a body portion 2 and a neck portion 3. At the end of the neck portion, there is provided a non resealable cap 4 connected to the end of neck 3 along weakened line 5.
  • Neck portion 3 is in the form of an outwardly widening truncated cone and this feature is easier to identify in figure 2.
  • figure 3 there is shown that the top of the body is formed hexagonally and the body is strengthened by one yoke on each side.
  • the non resealable cap 4 may be removed from neck portion 3 by a rocking or twisting action and separates from the neck portion 3 along weakened line 5. After removal of the non resealable cap, there is revealed an outlet opening 7 at the end of neck portion 3 through which, liquid contained in container 1 may pass.
  • Neck portion 3 comprises a thread engagement portion being the shoulder 8 located about the peripheral edge of outlet 7.
  • the neck portion also comprises a non engagement portion 9 of reduced cross sectional diameter.
  • Figures 4 and 5 show the connection of such a container to a syringe so to facilitate transfer of the liquid contained in the container to the syringe.
  • These figures illustrate a syringe having a luer lock needle fitting 10.
  • This fitting has a central male cone 11, an outer peripheral wall 12 and a bottom wall 13. These walls form the boundary of an annular channel 14.
  • a screw thread 15 is provided on the inside wall of peripheral wall 12.
  • the central luer cone 11 is provided with a transfer channel 16 which is open at its outer most end 17.
  • the engagement portion has a less sharply defined edge.
  • This shoulder is adapted to engage with the screw thread fitting of the syringe but may require continued application of force during connection with the screw thread to ensure engagement.
  • the neck is strengthened by yokes 6 and the top of the package is hexagonally formed.
  • the container 1 is adapted to engage with the luer lock fitting 10 as follows. After the non resealable cap 4 is removed from container 1, it is held in an upright position and the syringe fitting 10 is located adjacent to the outlet opening 7 of container 1 whereby central luer cone 11 is inserted into the outlet opening 7. By relative rotation of the container with respect to the syringe fitting, thread engagement shoulder 8 on neck 3 is caused to engage with thread 15. To assist in initial engagement, the syringe fitting may be pushed slightly down into the outlet opening 7. Once the thread "takes", shoulder 8 fits behind the thread 15 and abuts against the underside 17 of the thread and the inside of peripheral wall 12. The non engagement portion 9 of neck 3 is of narrower cross section so that it does not interfere with the thread 15 but can move freely into channel 14 whilst the container is screwed onto the syringe fitting.
  • neck 3 at point 19 is slightly smaller than the outside cross sectional diamter of cone 11. As can be seen in figure 5, this ensures sealing engagement between the components at the area generally designated by the numeral 20.
  • the extent of the sealing at 20 improves as the container is screwed onto the luer lock fitting as in a standard luer cone, the side wall of the cone is slightly inclined with the base of the cone being of slightly increased diameter than the top of the cone.
  • FIG 5 there is also shown in hatch lines the position of the container once fully screwed onto the needle fitting. In this position, the top of the outlet opening 7 abuts against the base 13 of the needle fitting to further ensure sealing engagement of the container onto the needle fitting.
  • the container side walls are flexible enough so that the container can partially collapse in the drawing out of the injection solution. Transfer of the solution can be assisted by squeezing the outside walls 21 of the container.
  • the container of the present invention can be filled with a solution of any drug which is suitable for injection but is particularly advantageous for use with aqueous solutions of autoclavable local anaesthetics such as lidocaine, prilocaine, mepivocaine, bupivocaine, etidocaine or other drugs which are used under conditions where the demands for easy handling and sterility are especially high.
  • autoclavable local anaesthetics such as lidocaine, prilocaine, mepivocaine, bupivocaine, etidocaine or other drugs which are used under conditions where the demands for easy handling and sterility are especially high.

Landscapes

  • Engineering & Computer Science (AREA)
  • Health & Medical Sciences (AREA)
  • Ceramic Engineering (AREA)
  • Mechanical Engineering (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Hematology (AREA)
  • Crystals, And After-Treatments Of Crystals (AREA)
  • Control And Other Processes For Unpacking Of Materials (AREA)
  • Devices For Use In Laboratory Experiments (AREA)
  • Infusion, Injection, And Reservoir Apparatuses (AREA)
  • Closures For Containers (AREA)
  • Medical Preparation Storing Or Oral Administration Devices (AREA)
  • Packages (AREA)
  • Containers And Packaging Bodies Having A Special Means To Remove Contents (AREA)
  • Transition And Organic Metals Composition Catalysts For Addition Polymerization (AREA)
  • Steroid Compounds (AREA)
  • Seasonings (AREA)
  • Measurement Of Radiation (AREA)
  • Coupling Device And Connection With Printed Circuit (AREA)
  • External Artificial Organs (AREA)
EP91900129A 1989-12-11 1990-11-19 Unit dose container Expired - Lifetime EP0591156B1 (en)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
AU46152/89 1989-12-11
AU46152/89A AU622740B2 (en) 1989-12-11 1989-12-11 Unit dose container
PCT/AU1990/000551 WO1991008729A1 (en) 1989-12-11 1990-11-19 Unit dose container

Publications (3)

Publication Number Publication Date
EP0591156A4 EP0591156A4 (en) 1992-08-21
EP0591156A1 EP0591156A1 (en) 1994-04-13
EP0591156B1 true EP0591156B1 (en) 1997-03-05

Family

ID=3733248

Family Applications (1)

Application Number Title Priority Date Filing Date
EP91900129A Expired - Lifetime EP0591156B1 (en) 1989-12-11 1990-11-19 Unit dose container

Country Status (17)

Country Link
EP (1) EP0591156B1 (no)
JP (1) JP2919966B2 (no)
AT (1) ATE149341T1 (no)
AU (2) AU622740B2 (no)
BR (1) BR9007908A (no)
CA (1) CA2069610C (no)
DE (1) DE69030117T2 (no)
DK (1) DK0591156T3 (no)
ES (1) ES2098342T3 (no)
FI (1) FI107876B (no)
GR (1) GR3023376T3 (no)
HK (1) HK1001552A1 (no)
HU (1) HU215254B (no)
NO (1) NO301453B1 (no)
NZ (1) NZ236254A (no)
SG (1) SG45326A1 (no)
WO (1) WO1991008729A1 (no)

Cited By (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US6068148A (en) * 1998-05-26 2000-05-30 Automatic Liquid Packaging, Inc. Hermetically sealed container including a nozzle with a sealing bead
EP2803348A1 (de) 2013-05-15 2014-11-19 hameln rds gmbh Verfahren zur Befüllung von Spritzen für Dosierpumpen
CN105377214A (zh) * 2013-07-16 2016-03-02 费森尤斯卡比德国有限公司 用于医用液体的安瓿和制造安瓿的方法
FR3132826A1 (fr) * 2022-02-24 2023-08-25 L'oreal Contenant de produit cosmétique fluide formant recharge pour un flacon principal

Families Citing this family (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
DE29602173U1 (de) * 1996-02-08 1997-06-26 Braun Melsungen Ag Applikationsvorrichtung für medizinische Flüssigkeiten
EP0801940A3 (de) * 1996-04-18 1998-04-08 Nizell-Produkte Ampulle und Verwendung der Ampulle
GB9700177D0 (en) 1997-01-07 1997-02-26 Nycomed Imaging As Container
GB9804005D0 (en) 1998-02-25 1998-04-22 Nycomed Imaging As Container
WO2007068032A1 (en) * 2005-12-12 2007-06-21 Nature Vet Pty Ltd An apparatus for holding and dispensing flowable preparations
DE102014208845A1 (de) 2014-05-12 2015-11-12 Hameln Pharma Plus Gmbh Auswahl von Sterilisationsverfahren für Tuben
DE102017009012A1 (de) * 2017-09-26 2019-03-28 Kocher-Plastik Maschinenbau Gmbh Behälter sowie Verbindungs- und Herstellvorrichtung
JP2021020739A (ja) * 2019-07-29 2021-02-18 ウェイラー エンジニアリング インコーポレイテッド 熱可塑性材料の気密封止容器

Family Cites Families (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
ATE73989T1 (de) * 1982-02-08 1992-04-15 Astra Laekemedel Ab Mit normaldosis gefuellter behaelter.
SE442264B (sv) * 1983-12-23 1985-12-16 Bengt Gustavsson Ampull
GB8801655D0 (en) * 1988-01-26 1988-02-24 Waverley Pharma Ltd Ampoules
DE3818682A1 (de) * 1988-06-01 1989-12-21 Deussen Stella Kg Ampulle
DE3833036C2 (de) * 1988-09-29 1998-03-19 Bernd Hansen Doppelkammerbehälter
US5035689A (en) * 1989-03-13 1991-07-30 Schroeder Thomas J Luer-loc-tipped vial--syringe combination

Cited By (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US6068148A (en) * 1998-05-26 2000-05-30 Automatic Liquid Packaging, Inc. Hermetically sealed container including a nozzle with a sealing bead
EP2803348A1 (de) 2013-05-15 2014-11-19 hameln rds gmbh Verfahren zur Befüllung von Spritzen für Dosierpumpen
CN105377214A (zh) * 2013-07-16 2016-03-02 费森尤斯卡比德国有限公司 用于医用液体的安瓿和制造安瓿的方法
CN105377214B (zh) * 2013-07-16 2019-09-06 费森尤斯卡比德国有限公司 用于医用液体的安瓿和制造安瓿的方法
FR3132826A1 (fr) * 2022-02-24 2023-08-25 L'oreal Contenant de produit cosmétique fluide formant recharge pour un flacon principal

Also Published As

Publication number Publication date
AU4615289A (en) 1991-06-13
NZ236254A (en) 1993-12-23
EP0591156A4 (en) 1992-08-21
DK0591156T3 (da) 1997-07-21
DE69030117T2 (de) 1997-06-12
FI107876B (fi) 2001-10-31
NO922259D0 (no) 1992-06-09
WO1991008729A1 (en) 1991-06-27
CA2069610C (en) 1999-05-11
BR9007908A (pt) 1992-09-29
GR3023376T3 (en) 1997-08-29
HU215254B (hu) 1998-11-30
NO922259L (no) 1992-06-09
AU6895391A (en) 1991-07-18
FI922686A0 (fi) 1992-06-10
EP0591156A1 (en) 1994-04-13
CA2069610A1 (en) 1991-06-12
AU622740B2 (en) 1992-04-16
NO301453B1 (no) 1997-11-03
HUT64462A (en) 1994-01-28
SG45326A1 (en) 1998-01-16
ATE149341T1 (de) 1997-03-15
ES2098342T3 (es) 1997-05-01
JP2919966B2 (ja) 1999-07-19
JPH05500020A (ja) 1993-01-14
HK1001552A1 (en) 1998-06-26
DE69030117D1 (de) 1997-04-10

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