EP0344476B1 - Ampoule - Google Patents

Ampoule Download PDF

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Publication number
EP0344476B1
EP0344476B1 EP89107869A EP89107869A EP0344476B1 EP 0344476 B1 EP0344476 B1 EP 0344476B1 EP 89107869 A EP89107869 A EP 89107869A EP 89107869 A EP89107869 A EP 89107869A EP 0344476 B1 EP0344476 B1 EP 0344476B1
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EP
European Patent Office
Prior art keywords
ampoule
neck
container
application device
ampoule neck
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
EP89107869A
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German (de)
French (fr)
Other versions
EP0344476A2 (en
EP0344476A3 (en
Inventor
Werner Deussen
Heino Deussen
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.)
DEUSSEN KUNSTSTOFFTECHNIK INHABER HEINO DEUSSEN
Original Assignee
Deussen Kunststofftechnik Inhaber Heino Deussen
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Publication of EP0344476A2 publication Critical patent/EP0344476A2/en
Publication of EP0344476A3 publication Critical patent/EP0344476A3/en
Application granted granted Critical
Publication of EP0344476B1 publication Critical patent/EP0344476B1/en
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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
    • A61J1/05Containers specially adapted for medical or pharmaceutical purposes for collecting, storing or administering blood, plasma or medical fluids ; Infusion or perfusion containers
    • A61J1/06Ampoules or carpules
    • A61J1/067Flexible ampoules, the contents of which are expelled by squeezing
    • 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
    • A61J1/1468Containers characterised by specific material properties
    • 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
    • A61J1/20Arrangements for transferring or mixing fluids, e.g. from vial to syringe
    • A61J1/2003Accessories used in combination with means for transfer or mixing of fluids, e.g. for activating fluid flow, separating fluids, filtering fluid or venting
    • A61J1/2068Venting means
    • A61J1/2075Venting means for external venting
    • 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
    • A61J1/20Arrangements for transferring or mixing fluids, e.g. from vial to syringe
    • A61J1/2096Combination of a vial and a syringe for transferring or mixing their contents
    • 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
    • A61J2205/00General identification or selection means
    • YGENERAL 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
    • Y10TECHNICAL SUBJECTS COVERED BY FORMER USPC
    • Y10STECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10S215/00Bottles and jars
    • Y10S215/902Vent

Definitions

  • the invention relates to an ampoule for receiving a dose of a liquid agent to be taken into an application device, preferably an injection syringe, on the ampoule vessel of which an ampoule neck with a predetermined breaking point and handle for opening the, for example, conical head of the application device is provided.
  • an application device preferably an injection syringe
  • Ampoules of this type have so far mostly been made of glass, the ampoule neck being melted at its free end to seal it tightly after the ampoule has been filled; to open such an ampoule, the user has to break off the wall of the ampoule neck at a suitable point, be it after scoring by means of an ampoule saw or be it that a corresponding predetermined breaking point is already provided on the ampoule neck.
  • a suitable point be it after scoring by means of an ampoule saw or be it that a corresponding predetermined breaking point is already provided on the ampoule neck.
  • the neck of the ampoule is broken off, a small amount of the finest glass fragments is generated, which can at least partially get into the contents of the ampoule. Otherwise, the attachment point for the head of the application device formed by breaking off the ampoule neck does not offer a firm hold of the application device on the ampoule vessel.
  • Ampoules are described in the older, but not prepublished, European patent applications EP-A-0 326 391 and EP-A-0 327 397, in which the ampoule body is made of flexible plastic and the ampoule neck is funnel-shaped around the head of an application device, for example to be able to use the intake cone of an injection syringe.
  • the seat of the application device head on the ampoule neck is considerably safer, but possibilities must be created for air to be taken in during the aspiration of ampoule contents.
  • these air inlets are formed by channels which extend as lateral depressions along the outlet in the ampoule neck.
  • the object of the invention is to substantially improve ampoules which are used to hold liquid agents to be taken up in application devices, for example injection syringes, in such a way that the transfer of the ampoule content into the application device, for example the drawing up of the ampoule content onto an injection syringe, is considerably easier and safer , in particular with regard to avoiding the transfer of swirled air with ampoule contents into the application device.
  • the ampoule neck is designed as an elastically stretchable insertion and holding ring for securely attaching the application device head, and a ventilation device leading into the interior of the ampoule is provided separately next to the ampoule neck.
  • Attaching the ventilation device separately, ie separately from the outlet opening, is of particular importance for the functionality of the ampoule when the contents of the ampoule are drawn onto an application device, in particular an injection syringe.
  • the spatial separation of the ventilation device and the outlet opening prevents air from being swirled into the container contents before the application device is admitted.
  • the air entering the ampoule is kept away from the liquid flow directed towards the interior of the application device.
  • the ampoule with its ampoule neck can be plugged into the respective application device securely and for the takeover of ampoule content sufficiently firmly.
  • the user no longer has to hold the ampoule while the ampoule content is being transferred to the application device, but rather can safely insert the application device into the open ampoule neck and hold the application device, for example an injection syringe, with one hand and with the other hand to pull up the ampoule content actuate.
  • the user can focus his attention to the fact that no swirled air is taken over into the application device.
  • the separate ventilation opening to be provided next to the ampoule neck can be formed by a thinned, penetrable wall point of the ampoule shoulder.
  • the ventilation opening of the ampoule is formed on a ventilation tube which extends parallel to the ampoule neck.
  • This ventilation tube offers a particularly high degree of safety in separating the air inlet from the outlet for the ampoule contents.
  • a further improvement for the separation of the air inlet from the flow of ampoule contents flowing to the application device can be achieved if the ventilation tube is extended towards the ampoule neck after the ampoule interior.
  • the ampoule neck carries at its free end a closure piece which is integrally connected to the mouth area of the ampoule neck via an annular predetermined breaking point is.
  • a common closure piece for the mouth of the ampoule neck and the separate ventilation device can be provided.
  • the ampoule neck can be designed with a rounded curvature at its mouth edge to form a funnel-shaped insertion for the head of the application device.
  • the ampoule container together with the ampoule neck and the ventilation device, is formed in one piece from thermoplastic, preferably polypropylene, and is sealed at its end opposite the ampoule neck after filling.
  • thermoplastic preferably polypropylene
  • the ampoule container can be particularly advantageously thicker on its part adjacent to the ampoule neck than on its part opposite the ampoule neck. As a result, the ampoule on its part adjacent to the ampoule neck is designed to be significantly less flexible than on the part opposite the ampoule neck.
  • the ampoule vessel can preferably be designed with a cylindrical outer shape and, after the open end opposite the ampoule neck, with a slightly conically widening inner shape and correspondingly with a wall thickness that decreases continuously from the ampoule neck to the open end.
  • the cylindrical outer shape of the wall of the ampoule container offers the advantage that any further processing, in particular printing and feeding within the filling and welding machine is considerably facilitated, on the other hand the cylindrical outer shape offers the advantage that the inevitable expansion of shape at the welding point during welding is noticeably less than that of ampoules, in which the conical shape of the ampoule container is assumed.
  • ampoules according to the invention with a cylindrical outer shape of the ampoule container by injection molding is made possible by the inner shape of the ampoule, which is flared from the ampoule neck to the open end.
  • this inner shape considerably simplifies the demolding of the ampoule according to the invention during production by injection molding, and on the other hand it achieves a desired wall configuration of the ampoule vessel with less flexibility in the part adjacent to the ampoule neck and greater flexibility in the part away from the ampoule neck.
  • the transition from the ampoule container to the ampoule neck can also be designed as an ampoule shoulder, in which blind embossments are attached, for example for information about the volume and content of the respective ampoule.
  • This blind embossing on the ampoule shoulder inevitably falls in the user's field of vision when touching the ampoule to open it and when attaching the ampoule to an application device, so that additional security can be given to ensure that an ampoule before opening and before applying the application device to the correct content and correct amount is checked.
  • the empty ampoule can also be kept as a control piece. All other information such as batch number, date of manufacture, expiry date can be embossed on the day the ampoules are filled as blind embossing into the resulting weld seam by the press jaws of the sealing machine.
  • the ampoule 10 is made in one piece from thermoplastic, namely polypropylene by injection molding. It has an ampoule container 11 which merges into an ampoule neck 13 via an ampoule shoulder 12. A closure piece 14 is formed on the free end of the ampoule neck 13 and can be removed by twisting it off while simultaneously breaking off and tearing it off. At the end remote from the ampoule neck 13, the peripheral wall of the ampoule container 11 is compressed flat after filling and welded tightly at a closure seam 15.
  • the ampoule neck 13 is elastically stretchable due to the production of the entire ampoule 10 from polypropylene and as an insertion and retaining ring for the head of one Application device, for example the receiving cone 17, an injection syringe 16, wherein this conical head or receiving cone 17 is used to attach the actual applicator, for example a conventional injection needle.
  • the ampoule neck 13 is elastically expanded from the free end when the conical head of an application device, for example the receiving cone 17 of an injection syringe 16, is inserted, so that the ampoule neck 13 with its inner surface is firmly attached to the outer surface of the conical head or the Recording cone 17 sets.
  • the application device for example the injection syringe 16 and the attached ampoule 10, then form a firmly held unit, in which the opening of the ampoule contents onto the application device is made considerably easier.
  • the ventilation device is formed by a separate, but integrally molded, ventilation tube 41 on the ampoule neck 13 '.
  • a common closure piece 14' is formed so that when the closure piece 14 'is broken, the container neck 13' and the ventilation tube 41 are opened at the same time.
  • the ventilation tube 41 extends parallel to the ampoule neck 13 'and opens a distance 42 deeper in the interior of the ampoule than the ampoule neck 13, so that the partition wall 43 formed between the ampoule neck 13 and the ventilation tube 41 is still at the mouth of the ampoule neck 13 extends into the interior of the ampoule. In this way, the direct passage of air from the ventilation tube 41 into the ampoule neck 13 'and from there into the application device is prevented when the contents of the ampoule are drawn up.
  • the parallel ventilation tube 41 'formed on the ampoule neck 13' can also extend over a larger distance 42 'beyond the ampoule neck 13' into the interior of the ampoule.
  • the ventilation tube 41 is preferably formed with a substantially smaller clear cross section than the ampoule neck 13 '.
  • the passage of the ampoule neck 13 ' may have approximately twice the diameter 44 as the corresponding diameter 45 of the ventilation tube 41.
  • the closure piece 14 has a disk-shaped part 18 and an actuating part 19.
  • the disc-shaped part 18 of the closure piece 14 is arranged in the interior of the mouth edge region 20 of the container neck 13 and is connected in one piece to the mouth edge region 20 of the ampoule neck 13 via an annular predetermined breaking point 21 surrounding the periphery of the disc-shaped part 18.
  • the container neck 13 is sealed at its free end by the disk-shaped part 18 of the closure piece 14 and the predetermined breaking point 21.
  • the predetermined breaking point 21 is destroyed by unscrewing, breaking off and tearing off the closure piece 13. After removal of the closure piece 14, the mouth of the ampoule neck 13 is exposed.
  • the head of an application device for example the receiving cone 17 of an injection syringe, 16 can now be inserted into the open end of the ampoule neck 13.
  • the mouth edge region 20 of the ampoule neck can be essentially funnel-shaped towards the inside.
  • the different embodiments shown in the drawing show variations in the design of this funnel-shaped introduction.
  • the actual mouth edge 25 is provided with a curvature whose radius of curvature increases from the outside inwards, so that there is an intensely curved funnel inlet.
  • the predetermined breaking point 21 is recessed in the mouth edge area 20 of the ampoule neck 13, so that the head of the application device or the receiving cone 17 of an injection syringe 16 is already inserted into the actual mouth rim 25 of the ampoule neck 13 before it has the remnants of the predetermined breaking point 21 reached.
  • the actuating part 19 of the closure piece 14 can be approximately plate-shaped or tab-shaped in order to ensure secure gripping for twisting, breaking off and tearing off the closure piece 14.
  • axially extending grip ribs 31 can be formed on the actuating part 19.
  • the ampoule container 11 is initially open at its end opposite the ampoule neck 13 in order to fill it from this end.
  • the peripheral wall of the ampoule container 11 has a greater thickness in the vicinity of the ampoule neck 13 and the ampoule shoulder 12 than at its open end.
  • the peripheral wall of the ampoule housing 11 can consistently be slightly conical after the open End-widening shape and a portion 32 of greater thickness 33 adjacent to the ampoule shoulder 12, for example of approximately 0.5 mm.
  • a portion 34 of the peripheral wall having a thickness 35 of about 0.35 mm is formed in the vicinity of the open end.
  • the peripheral wall of the ampoule container 11 is cylindrical on its outside and has a decreasing wall thickness from the ampoule shoulder 12 to the open end, specifically a thickness 36 adjacent to the ampoule shoulder 12, for example 0.55 mm and a thickness 37 of examples 0.35 mm at the open end.
  • a thickness 36 adjacent to the ampoule shoulder 12 for example 0.55 mm
  • a thickness 37 of examples 0.35 mm at the open end As a result, the interior formed in the ampoule container 11 before the closure tapers conically from the open end to the ampoule shoulder 12.
  • an easily penetrable thinned point could be formed at a distance from the ampoule neck 13. This could be, for example, at a point indicated by the arrow 46 in FIGS. 1 and 2. It could also be molded into the ampoule shoulder 12 at point 46, a ventilation tube completely separate from the ampoule neck 13 and carry a breakable closure piece separate from the ampoule neck 13.
  • blind embossments 40 are provided on the ampoule shoulder, which provide information about the content and volume of the ampoule 10. These blind embossments 40 cannot be overlooked when opening the ampoule 10 and when inserting the receiving cone 17. They are also indelible and therefore suitable for the emptied ampoule 10, possibly as evidence for administered medicine and the like. repeal.

Description

Die Erfindung betrifft eine Ampulle zur Aufnahme einer in ein Applikationsgerät, vorzugsweise eine Injektionsspritze, zu übernehmenden Dosis eines flüssigen Mittels, an deren Ampullengefäß ein zum Einführen des beispielsweise konischen Kopfes des Applikationsgerätes geeigneter Ampullenhals mit Sollbruchstelle und Handhabe zum Öffnen vorgesehen ist.The invention relates to an ampoule for receiving a dose of a liquid agent to be taken into an application device, preferably an injection syringe, on the ampoule vessel of which an ampoule neck with a predetermined breaking point and handle for opening the, for example, conical head of the application device is provided.

Ampullen dieser Art sind bisher meist aus Glas hergestellt, wobei der Ampullenhals nach dem Füllen der Ampulle an seinem freien Ende zum dichten Verschließen zugeschmolzen ist, zum Öffnen einer solchen Ampulle hat der Benutzer die Wand des Ampullenhalses an geeigneter Stelle abzubrechen, sei es nach vorherigem Anritzen mittels einer Ampullensäge oder sei es, daß eine entsprechende Sollbruchstelle bereits am Ampullenhals vorgesehen ist. In jedem Fall wird aber mit dem Abbrechen des Ampullenhalses eine kleine Menge feinster Glassplitterchen erzeugt, die zumindest zum Teil in den Ampulleninhalt gelangen können. Im übrigen bietet die durch Abbrechen des Ampullenhalses gebildete Ansatzstelle für den Kopf des Applikationsgerätes keinen festen Halt des Applikationsgerätes am Ampullengefäß. Das Übernehmen von Ampulleninhalt in das Applikationsgerät, also das Aufziehen des Inhaltes auf eine Injektionsspritze, erfordert deshalb besondere Geschicklichkeit des Benutzers und kann vielfach nur mittels der vorher aufgesetzten Injektionsnadel bzw. einer Kanüle erfolgen. Letzteres ist besonders zeitaufwendig und kann die Sterilität der Injektionsnadel beeinträchtigen. Der Benutzer muß in jedem Fall beim Übernehmen von Ampulleninhalt in das Applikationsgerät beide Hände benutzen.Ampoules of this type have so far mostly been made of glass, the ampoule neck being melted at its free end to seal it tightly after the ampoule has been filled; to open such an ampoule, the user has to break off the wall of the ampoule neck at a suitable point, be it after scoring by means of an ampoule saw or be it that a corresponding predetermined breaking point is already provided on the ampoule neck. In any case, when the neck of the ampoule is broken off, a small amount of the finest glass fragments is generated, which can at least partially get into the contents of the ampoule. Otherwise, the attachment point for the head of the application device formed by breaking off the ampoule neck does not offer a firm hold of the application device on the ampoule vessel. The transfer of ampoule contents into the application device, that is to say the drawing up of the contents onto an injection syringe, therefore requires special Skill of the user and can often only be done using the previously attached injection needle or a cannula. The latter is particularly time-consuming and can impair the sterility of the injection needle. In any case, the user must use both hands when transferring ampoule contents into the application device.

In den prioritätsälteren, aber nicht vorveröffentlichten europäischen Patentanmeldungen EP-A-0 326 391 und EP-A-0 327 397 sind Ampullen beschrieben, bei denen der Ampullenkörper aus nachgiebigem Kunststoff besteht und der Ampullenhals trichterförmig ausgebildet ist, um den Kopf eines Applikationsgerätes, beispielsweise den Aufnahmekonus einer Injektionsspritze einsetzen zu können. Hierdurch wird zwar der Sitz des Applikationsgeräte-Kopfes am Ampullenhals wesentlich sicherer, jedoch müssen Möglichkeiten zum Einlassen von Luft während des Absaugens von Ampulleninhalt geschaffen werden. Diese Lufteinlässe sind nach den prioritätsälteren Vorschlägen durch Kanäle gebildet, die sich als seitliche Vertiefungen entlang des Auslasses im Ampullenhals erstrecken. Solche Lufteinlaßkanäle bedingen aber den Mangel, daß beim Aufziehen von flüssigem Ampulleninhalt einströmende Luft vor der Ansaugöffnung des Applikationsgerätes aufgewirbelt und zusammen mit dem flüssigen Ampulleninhalt in das Applikationsgerät gezogen wird. Diese aufgewirbelte Luft verhindert nicht allein das vollständige Füllen des Applikationsgerätes sondern bildet auch in dem in das Applikationsgerät aufgezogenen Ampulleninhalt feine Bläschen, die sich nur langsam im Zylinder des Applikationsgerätes wieder aus der Flüssigkeit aussondern oder gar erhebliche Gefahren bei der Applikation einer Injektion hervorrufen können.Ampoules are described in the older, but not prepublished, European patent applications EP-A-0 326 391 and EP-A-0 327 397, in which the ampoule body is made of flexible plastic and the ampoule neck is funnel-shaped around the head of an application device, for example to be able to use the intake cone of an injection syringe. As a result, the seat of the application device head on the ampoule neck is considerably safer, but possibilities must be created for air to be taken in during the aspiration of ampoule contents. According to the proposals with the higher priority, these air inlets are formed by channels which extend as lateral depressions along the outlet in the ampoule neck. However, such air inlet ducts cause the defect that air flowing in when liquid ampoule contents are drawn up is swirled up in front of the suction opening of the application device and is drawn into the application device together with the liquid ampoule content. This swirled air not only prevents the application device from being completely filled, but also forms fine bubbles in the ampoule contents drawn into the application device, which bubbles slowly separate out of the liquid in the cylinder of the application device or can even cause considerable dangers when an injection is applied.

Aufgabe der Erfindung ist es, Ampullen, die zur Aufnahme von in Applikationsgeräte, beispielsweise Injektionsspritzen zu übernehmenden flüssigen Mitteln dienen, dahingehend wesentlich zu verbessern, daß die Übernahme des Ampulleninhaltes in das Applikationsgerät, beispielsweise das Aufziehen des Ampulleninhaltes auf eine Injektionsspritze wesentlich erleichtert und sicherer wird, insbesondere hinsichtlich der Vermeidung von Übernahme von aufgewirbelter Luft mit Ampulleninhalt in das Applikationsgerät.The object of the invention is to substantially improve ampoules which are used to hold liquid agents to be taken up in application devices, for example injection syringes, in such a way that the transfer of the ampoule content into the application device, for example the drawing up of the ampoule content onto an injection syringe, is considerably easier and safer , in particular with regard to avoiding the transfer of swirled air with ampoule contents into the application device.

Diese Aufgabe wird erfindungsgemäß dadurch gelöst, daß bei einer eingangs angeführten Ampulle der Ampullenhals als elastisch dehnbarer Einsteck- und Haltering zum sicheren Anbringen des Applikationsgeräte-Kopfes ausgebildet und eine in das Innere der Ampulle führende Belüftungseinrichtung separat neben dem Ampullenhals vorgesehen ist.This object is achieved in that, in the case of an ampoule mentioned at the beginning, the ampoule neck is designed as an elastically stretchable insertion and holding ring for securely attaching the application device head, and a ventilation device leading into the interior of the ampoule is provided separately next to the ampoule neck.

Das Anbringen der Belüftungseinrichtung separat, d.h. getrennt von der Auslaßöffnung, hat besondere Bedeutung für die Funktionsfähigkeit der Ampulle beim Aufziehen von Ampulleninhalt auf ein Applikationsgerät, insbesondere einer Injektionsspritze. Durch die räumliche Trennung von Belüftungseinrichtung und Auslaßöffnung läßt sich das Einwirbeln von Luft in den Behälterinhalt vor dem Einlaß des Applikationsgerätes vermeiden. Die in die Ampulle eintretende Luft wird von der nach dem Inneren des Applikationsgerätes gerichteten Flüssigkeitsstroms ferngehalten. Außerdem wird erreicht, daß die Ampulle mit ihrem Ampullenhals sicher und für die Übernahme von Ampulleninhalt ausreichend fest mit dem jeweiligen Applikationsgerät zusammengesteckt werden kann. Der Benutzer muß jetzt nicht mehr die Ampulle während der Übernahme von Ampulleninhalt in das Applikationsgerät festhalten, sondern kann vielmehr das Applikationsgerät sicher in den geöffneten Ampullenhals stecken und das Applikationsgerät, beispielsweise eine Injektionsspritze, mit der einen Hand festhalten und mit der anderen Hand zum Aufziehen des Ampulleninhaltes betätigen. Dabei kann der Benutzer im erhöhten Maße seine Aufmerksamkeit darauf richten, daß keine aufgewirbelte Luft in das Applikationsgerät übernommen wird. Die neben dem Ampullenhals vorzusehende separate Belüftungsöffnung kann durch eine verdünnte, durchstoßbare Wandstelle der Ampullenschulter gebildet sein kann.Attaching the ventilation device separately, ie separately from the outlet opening, is of particular importance for the functionality of the ampoule when the contents of the ampoule are drawn onto an application device, in particular an injection syringe. The spatial separation of the ventilation device and the outlet opening prevents air from being swirled into the container contents before the application device is admitted. The air entering the ampoule is kept away from the liquid flow directed towards the interior of the application device. In addition, it is achieved that the ampoule with its ampoule neck can be plugged into the respective application device securely and for the takeover of ampoule content sufficiently firmly. The The user no longer has to hold the ampoule while the ampoule content is being transferred to the application device, but rather can safely insert the application device into the open ampoule neck and hold the application device, for example an injection syringe, with one hand and with the other hand to pull up the ampoule content actuate. The user can focus his attention to the fact that no swirled air is taken over into the application device. The separate ventilation opening to be provided next to the ampoule neck can be formed by a thinned, penetrable wall point of the ampoule shoulder.

In bevorzugter Ausführungsform der Erfindung ist jedoch die Belüftungsöffnung der Ampulle an einem sich parallel zum Ampullenhals erstreckenden Belüftungsröhrchen gebildet. Dieses Belüftungsröhrchen bietet besonders hohe Sicherheit der Trennung des Lufteinlasses von dem Auslaß für den Ampulleninhalt. Eine weitere Verbesserung für die Trennung des Lufteinlasses von dem zum Applikationsgerät fließendem Strom von Ampulleninhalt läßt sich erreichen, wenn das Belüftungsröhrchen gegenüber dem Ampullenhals nach dem Ampulleninneren verlängert ausgebildet ist.In a preferred embodiment of the invention, however, the ventilation opening of the ampoule is formed on a ventilation tube which extends parallel to the ampoule neck. This ventilation tube offers a particularly high degree of safety in separating the air inlet from the outlet for the ampoule contents. A further improvement for the separation of the air inlet from the flow of ampoule contents flowing to the application device can be achieved if the ventilation tube is extended towards the ampoule neck after the ampoule interior.

Um einen sicheren Verschluß der Ampulle sowohl am Ampullenauslaß als auch am Lufteinlaß zu gewährleisten, bietet sich im Rahmen der Erfindung die bevorzugte Möglichkeit, daß der Ampullenhals an seinem freien Ende ein Verschlußstück trägt, das über eine ringförmige Sollbruchstelle einstückig mit dem Mündungsbereich des Ampullenhalses verbunden ist. Dabei kann ein gemeinsames Verschlußstück für die Mündung des Ampullenhalses und die separate Belüftungseinrichtung vorgesehen sein.In order to ensure a secure closure of the ampoule both at the ampoule outlet and at the air inlet, the preferred possibility within the scope of the invention is that the ampoule neck carries at its free end a closure piece which is integrally connected to the mouth area of the ampoule neck via an annular predetermined breaking point is. A common closure piece for the mouth of the ampoule neck and the separate ventilation device can be provided.

Um das Einführen des Applikationsgeräte-Kopfes in den Ampullenhals zu erleichtern, ohne die Wirksamkeit der Belüftungseinrichtung zu beeinträchtigen, kann der Ampullenhals an seinem Mündungsrand zur Bildung einer trichterförmigen Einführung für den Kopf des Applikationsgerätes mit einer abgerundeten Wölbung ausgebildet sein.In order to facilitate the insertion of the application device head into the ampoule neck without impairing the effectiveness of the ventilation device, the ampoule neck can be designed with a rounded curvature at its mouth edge to form a funnel-shaped insertion for the head of the application device.

In einer bevorzugten Ausführungsform der erfindungsgemäßen Ampulle ist das Ampullengefäß zusammen mit dem Ampullenhals und der Belüftungseinrichtung einstückig aus thermoplatischem Kunststoff, vorzugsweise Polypropylen gebildet und an seinem dem Ampullenhals entgegengesetztem Ende nach dem Füllen dicht verschlossen. Diese einstückige Ausbildung der Ampulle mit allen ihren Teilen einschließlich ihres Verschlusses, bietet den Vorteil der völlig sicheren Abdichtung der Ampulle nach dem Füllen bis zum Öffnen des Ampullenverschlusses. Besonders vorteilhaft kann in dieser Ausführungsform das Ampullengefäß an seinem dem Ampullenhals benachbarten Teil dickere Wandstärke als an seinem dem Ampullenhals entgegengesetztem Teil aufweisen. Dadurch ist die Ampulle an ihrem dem Ampullenhals benachbarten Teil deutlich weniger flexibel gestaltet als an dem dem Ampullenhals entgegengesetztem Teil. Dies bietet den Vorteil, daß beim Anfassen der Ampulle an dem dem Ampullenhals benachbartem Teil ein unerwünschtes zusammendrücken und damit versehentliches Auspressen von Ampulleninhalt vermieden und trotzdem die Ampulle fest gegriffen werden kann. Andererseits ist an dem dem Ampullenhals entferntem Ende die Ampullenwand ausreichend dünn und flexibel, so daß sie nach dem Füllen der Ampulle zusammengepreßt und verschweißt werden kann.In a preferred embodiment of the ampoule according to the invention, the ampoule container, together with the ampoule neck and the ventilation device, is formed in one piece from thermoplastic, preferably polypropylene, and is sealed at its end opposite the ampoule neck after filling. This one-piece design of the ampoule with all of its parts, including its closure, offers the advantage of completely secure sealing of the ampoule after filling until the ampoule closure opens. In this embodiment, the ampoule container can be particularly advantageously thicker on its part adjacent to the ampoule neck than on its part opposite the ampoule neck. As a result, the ampoule on its part adjacent to the ampoule neck is designed to be significantly less flexible than on the part opposite the ampoule neck. This offers the advantage that when the ampoule is gripped on the part adjacent to the ampoule neck, an undesired compression and thus inadvertent squeezing out of the ampoule contents is avoided, and the ampoule can nevertheless be firmly gripped. On the other hand, there is end of the ampoule neck, the ampoule wall is sufficiently thin and flexible that it can be compressed and welded after the ampoule has been filled.

Bevorzugt kann in dieser Ausführungsform das Ampullengefäß mit zylindrischer Außenform und nach dem dem Ampullenhals entgegengesetztem, offenen Ende hin mit sich leicht konisch erweiternder Innenform und entsprechend mit vom Ampullenhals her zum offenem Ende kontinuierlich abnehmender Wandstärke ausgebildet sein. Die zylindrische äußere Formgebung der Wand des Ampullengefäßes bietet einerseits den Vorteil, daß jede Weiterverarbeitung, insbesondere Bedrucken und das zuführen innerhalb der Füll- und Verschweißmaschine wesentlich erleichtert ist, zum anderen bietet die zylindrische Außenform den Vorteil, daß die beim Verschweißen unvermeidliche Formaufweitung an der Schweißstelle merklich geringer ist als an Ampullen, bei welchen von konischer Form des Ampullengefäßes ausgegangen wird. Die Herstellung von erfindungsgemäßen Ampullen mit zylindrischer Außenform des Ampullengefäßes im Spritzgießverfahren wird durch die von dem Ampullenhals zum offenen Ende hin konisch erweiterte Innenform der Ampulle ohne weiteres ermöglicht. Durch diese Innenform wird einerseit das Entformen der erfindungsgemäßen Ampulle bei der Herstellung durch Spritzgießen erheblich erleichtert und andererseits eine erwünschte Wandausbildung des Ampullengefäßes mit geringerer Flexibilität in dem dem Ampullenhals benachbartem Teil und größerer Flexibilität in dem vom Ampullenhals entferntem Teil erreicht.In this embodiment, the ampoule vessel can preferably be designed with a cylindrical outer shape and, after the open end opposite the ampoule neck, with a slightly conically widening inner shape and correspondingly with a wall thickness that decreases continuously from the ampoule neck to the open end. The cylindrical outer shape of the wall of the ampoule container offers the advantage that any further processing, in particular printing and feeding within the filling and welding machine is considerably facilitated, on the other hand the cylindrical outer shape offers the advantage that the inevitable expansion of shape at the welding point during welding is noticeably less than that of ampoules, in which the conical shape of the ampoule container is assumed. The production of ampoules according to the invention with a cylindrical outer shape of the ampoule container by injection molding is made possible by the inner shape of the ampoule, which is flared from the ampoule neck to the open end. On the one hand, this inner shape considerably simplifies the demolding of the ampoule according to the invention during production by injection molding, and on the other hand it achieves a desired wall configuration of the ampoule vessel with less flexibility in the part adjacent to the ampoule neck and greater flexibility in the part away from the ampoule neck.

Bei einstückiger Ausbildung der erfindungsgemäßen Ampulle aus Kunststoff, kann ferner der Übergang vom Ampullengefäß zum Ampullenhals als eine Ampullenschulter ausgebildet sein, in welcher Blindprägungen angebracht sind, beispielsweise für Angaben über Volumen und Inhalt der jeweiligen Ampulle. Diese Blindprägung auf der Ampullenschulter fällt beim Anfassen der Ampulle zum Öffnen und beim Ansetzen der Ampulle an ein Applikationsgerät dem Benutzer zwangsläufig ins Blickfeld, so daß zusätzliche Sicherung dafür gegeben werden kann, daß eine Ampulle vor dem Öffnen und vor dem Ansetzen des Applikationsgerätes auf richtigen Inhalt und richtige Menge kontrolliert wird. Die entleerte Ampulle kann außerdem als Kontrollstück aufgehoben werden. Alle weiteren Angaben wie Chargennummer, Herstellungsdatum, Verfalldatum, können am Tage der Füllung der Ampullen als Blindprägung durch die Preßbacken der Verschließmaschine in die sich ergebende Schweißnaht eingeprägt werden.With one-piece design of the invention Ampoule made of plastic, the transition from the ampoule container to the ampoule neck can also be designed as an ampoule shoulder, in which blind embossments are attached, for example for information about the volume and content of the respective ampoule. This blind embossing on the ampoule shoulder inevitably falls in the user's field of vision when touching the ampoule to open it and when attaching the ampoule to an application device, so that additional security can be given to ensure that an ampoule before opening and before applying the application device to the correct content and correct amount is checked. The empty ampoule can also be kept as a control piece. All other information such as batch number, date of manufacture, expiry date can be embossed on the day the ampoules are filled as blind embossing into the resulting weld seam by the press jaws of the sealing machine.

Ausführungsformen der erfindungsgemäßen Ampulle werden im Folgenden anhand der Zeichnungen näher erläutert. Es zeigen:

  • Figur 1 eine erfindungsgemäße gefüllte, gebrauchsfertige Ampulle in perspektivischer Darstellung;
  • Figur 2 eine erfindungsgemäße Ampulle mit zum Aufziehen des Ampulleninhaltes angesetzter Injektionsspritze in perspektivischer Darstellung;
  • Figur 3 einen axialen Teilschnitt einer Ampulle in bevorzugter Ausführungsform der Erfindung, wobei der übrige Teil der Ampullenwandung weggelassen ist;
  • Figur 4 einen Schnitt nach der Linie A-A der Figur 3;
  • Figur 5 eine teilweise Seitenansicht einer Ampulle nach Figur 3 und 4 im Sinne des Pfeiles B in Figur 3;
  • Figur 6 eine Draufsicht auf eine Ampulle nach Figur 3 bis 5 im Sinne des Pfeiles C in Figur 5;
  • Figur 7 einen Teilschnitt einer abgewandelten Ausführung nach der Linie D-D in Figur 6 und
  • Figur 8 einen Teilschnitt durch eine abgewandelte Ausführung der Ampulle nach der Linie E-E in Figur 6.
Embodiments of the ampoule according to the invention are explained in more detail below with reference to the drawings. Show it:
  • Figure 1 shows a filled, ready-to-use ampoule according to the invention in a perspective view;
  • FIG. 2 shows an ampoule according to the invention with an injection syringe attached to draw up the ampoule contents in a perspective view;
  • 3 shows a partial axial section of an ampoule in a preferred embodiment of the invention, the remaining part of the ampoule wall being omitted;
  • 4 shows a section along the line AA of Figure 3;
  • FIG. 5 shows a partial side view of an ampoule according to FIGS. 3 and 4 in the direction of arrow B in FIG. 3;
  • FIG. 6 shows a plan view of an ampoule according to FIGS. 3 to 5 in the direction of arrow C in FIG. 5;
  • 7 shows a partial section of a modified embodiment along the line DD in Figure 6 and
  • 8 shows a partial section through a modified version of the ampoule along the line EE in FIG. 6.

In den in der Zeichnung dargestellten Beispielen ist die Ampulle 10 einstückig aus thermoplastischem Kunststoff, und zwar Polypropylen durch Spritzgießen, hergestellt. Sie weist ein Ampullengefäß 11 auf, das über eine Ampullenschulter 12 in einen Ampullenhals 13 übergeht. An das freie Ende des Ampullenhalses 13 ist ein Verschlußstück 14 angeformt, das durch Abdrehen unter gleichzeitigem Abbrechen und Abreißen entfernbar ist. An dem vom Ampullenhals 13 entfernten Ende ist die Umfangswand des Ampullengefäßes 11 nach dem Füllen flach zusammengepreßt und an einer Verschlußnaht 15 dicht verschweißt.In the examples shown in the drawing, the ampoule 10 is made in one piece from thermoplastic, namely polypropylene by injection molding. It has an ampoule container 11 which merges into an ampoule neck 13 via an ampoule shoulder 12. A closure piece 14 is formed on the free end of the ampoule neck 13 and can be removed by twisting it off while simultaneously breaking off and tearing it off. At the end remote from the ampoule neck 13, the peripheral wall of the ampoule container 11 is compressed flat after filling and welded tightly at a closure seam 15.

Der Ampullenhals 13 ist aufgrund der Herstellung der gesamten Ampulle 10 aus Polypropylen elastisch dehnbar und als Einsteck- und Haltering für den Kopf eines Applikationsgerätes, beispielsweise den Aufnahmekonus 17, einer Injektionsspritze 16 ausgebildet, wobei dieser konische Kopf bzw. Aufnahmekonus 17 zum Aufstecken des eigentlichen Applikators, beispielsweise einer herkömmlichen Injektionsnadel, dient.The ampoule neck 13 is elastically stretchable due to the production of the entire ampoule 10 from polypropylene and as an insertion and retaining ring for the head of one Application device, for example the receiving cone 17, an injection syringe 16, wherein this conical head or receiving cone 17 is used to attach the actual applicator, for example a conventional injection needle.

Wie Figur 2 zeigt, wird der Ampullenhals 13 beim Einstecken des konischen Kopfes eines Applikationsgerätes, beispielsweise des Aufnahmekonus 17 einer Injektionsspritze 16 vom freien Ende her elastisch aufgeweitet, so daß sich der Ampullenhals 13 mit seiner Innenfläche fest auf die Außenfläche des konischen Kopfes bzw. des Aufnahmekonus 17 setzt. Das Applikationsgerät, beispielsweise die Injektionsspritze 16 und die aufgesetzte Ampulle 10 bilden dann eine fest zusammengehaltene Einheit, bei der das Aufziehen des Ampulleninhalts auf das Applikationsgerät wesentlich erleichtert ist.As FIG. 2 shows, the ampoule neck 13 is elastically expanded from the free end when the conical head of an application device, for example the receiving cone 17 of an injection syringe 16, is inserted, so that the ampoule neck 13 with its inner surface is firmly attached to the outer surface of the conical head or the Recording cone 17 sets. The application device, for example the injection syringe 16 and the attached ampoule 10, then form a firmly held unit, in which the opening of the ampoule contents onto the application device is made considerably easier.

Bei der in den Figuren 3 bis 6 gezeigten bevorzugten Ausführungsform der Erfindung ist die Belüftungseinrichtung durch ein an den Ampullenhals 13′ einstückig angeformtes, aber separates Belüftungsröhrchen 41 gebildet. Über den Behälterhals 13′ und das Belüftungsröhrchen 41 ist ein gemeinsames Verschlußstück 14′ geformt, so daß beim Abbrechen des Verschlußstückes 14′ gleichzeitig der Behälterhals 13′ und das Belüftungsröhrchen 41 geöffnet werden. Wie Figur 11 zeigt, erstreckt sich das Belüftungsröhrchen 41 parallel zum Ampullenhals 13′ und mündet um eine Strecke 42 tiefer im Ampulleninneren als der Ampullenhals 13, so daß die zwischen dem Ampullenhals 13 und dem Belüftungsröhrchen 41 gebildete Scheidewand 43 sich noch an der Mündung des Ampullenhalses 13 vorbei in das Ampulleninnere erstreckt. Auf diese Weise wird der direkte Übertritt von Luft aus dem Belüftungsröhrchen 41 in den Ampullenhals 13′ und von da in das Applikationsgerät beim Aufziehen des Ampulleninhalts verhindert.In the preferred embodiment of the invention shown in FIGS. 3 to 6, the ventilation device is formed by a separate, but integrally molded, ventilation tube 41 on the ampoule neck 13 '. About the container neck 13 'and the ventilation tube 41, a common closure piece 14' is formed so that when the closure piece 14 'is broken, the container neck 13' and the ventilation tube 41 are opened at the same time. As Figure 11 shows, the ventilation tube 41 extends parallel to the ampoule neck 13 'and opens a distance 42 deeper in the interior of the ampoule than the ampoule neck 13, so that the partition wall 43 formed between the ampoule neck 13 and the ventilation tube 41 is still at the mouth of the ampoule neck 13 extends into the interior of the ampoule. In this way, the direct passage of air from the ventilation tube 41 into the ampoule neck 13 'and from there into the application device is prevented when the contents of the ampoule are drawn up.

Um den Übertritt von Luft mit noch größerer Sicherheit zu verhindern, kann in einer abgewandelten Ausführung nach Figur 7 das an den Ampullenhals 13′ angeformte parallele Belüftungsröhrchen 41′ sich auch über eine größere Strecke 42′ über den Ampullenhals 13′ hinaus in das Ampulleninnere erstrecken.In order to prevent the passage of air with even greater certainty, in a modified embodiment according to FIG. 7, the parallel ventilation tube 41 'formed on the ampoule neck 13' can also extend over a larger distance 42 'beyond the ampoule neck 13' into the interior of the ampoule.

Wie Figur 4 zeigt, wird das Belüftungsröhrchen 41 bevorzugt mit wesentlichen kleinerem lichtem Querschnitt als der Ampullenhals 13′ ausgebildet. Beispielsweise kann der Durchlaß des Ampullenhalses 13′ etwa doppelten Durchmesser 44 wie der entsprenchende Durchmesser 45 des Belüftungsröhrchens 41 haben.As Figure 4 shows, the ventilation tube 41 is preferably formed with a substantially smaller clear cross section than the ampoule neck 13 '. For example, the passage of the ampoule neck 13 'may have approximately twice the diameter 44 as the corresponding diameter 45 of the ventilation tube 41.

Wie die Figuren 3, 7, und 8 zeigen, weist das Verschlußstück 14 einen scheibenförmigen Teil 18 und einen Betätigungsteil 19 auf. Der scheibenförmige Teil 18 des Verschlußstückes 14 ist im Inneren des Mündungsrandbereiches 20 des Behälterhalses 13 angeordnet und über eine den Umfang des scheibenförmigen Teiles 18 umgebende ringförmige Sollbruchstelle 21 mit dem Mündungsrandbereich 20 des Ampullenhalses 13 einstückig verbunden. Auf diese Weise ist der Behälterhals 13 an seinem freien Ende durch den scheibenförmigen Teil 18 des Verschlußstückes 14 und die Sollbruchstelle 21 dicht verschlossen. Durch Abdrehen, Abbrechen und Abreißen des Verschlußstückes 13 wird die Sollbruchstelle 21 zerstört. Nach Entfernen des Verschlußstückes 14 liegt die Mündung des Ampullenhalses 13 frei. Es kann jetzt der Kopf eines Applikationsgerätes, beispielsweise der Aufnahmekonus 17 einer Injektionsspritze, 16 in das offene Ende des Ampullenhalses 13 eingesteckt werden. Um das sichere zügige Einführen dieses Kopfes bzw. Aufnahmekonus 17 zu erleichtern, kann der Mündungsrandbereich 20 des Ampullenhalses nach innen hin im wesentlichen trichterförmig ausgebildet sein. Die in der Zeichnung gezeigten unterschiedlichen Ausführungsformen zeigen Variationen in der Ausbildung dieser trichterförmigen Einführung. Im Beispiel der Figur 8 ist der eigentliche Mündungsrand 25 mit einer Wölbung vorgesehen, deren Krümmungsradius von außen nach innen größer wird, so daß sich ein verstärker gewölbter Trichtereinlaß ergibt. Wie Figur 8 zeigt, liegt die Sollbruchstelle 21 vertieft in dem Mündungsrandbereich 20 des Ampullenhalses 13, so daß der Kopf des Applikationsgerätes bzw. der Aufnahmekonus 17 einer Injektionsspritze 16 bereits in den eigentlichen Mündungsrand 25 des Ampullenhalses 13 eingeführt ist, bevor er die Reste der Sollbruchstelle 21 erreicht.As FIGS. 3, 7 and 8 show, the closure piece 14 has a disk-shaped part 18 and an actuating part 19. The disc-shaped part 18 of the closure piece 14 is arranged in the interior of the mouth edge region 20 of the container neck 13 and is connected in one piece to the mouth edge region 20 of the ampoule neck 13 via an annular predetermined breaking point 21 surrounding the periphery of the disc-shaped part 18. In this way, the container neck 13 is sealed at its free end by the disk-shaped part 18 of the closure piece 14 and the predetermined breaking point 21. The predetermined breaking point 21 is destroyed by unscrewing, breaking off and tearing off the closure piece 13. After removal of the closure piece 14, the mouth of the ampoule neck 13 is exposed. The head of an application device, for example the receiving cone 17 of an injection syringe, 16 can now be inserted into the open end of the ampoule neck 13. In order to facilitate the safe, swift insertion of this head or receiving cone 17, the mouth edge region 20 of the ampoule neck can be essentially funnel-shaped towards the inside. The different embodiments shown in the drawing show variations in the design of this funnel-shaped introduction. In the example in FIG. 8, the actual mouth edge 25 is provided with a curvature whose radius of curvature increases from the outside inwards, so that there is an intensely curved funnel inlet. As FIG. 8 shows, the predetermined breaking point 21 is recessed in the mouth edge area 20 of the ampoule neck 13, so that the head of the application device or the receiving cone 17 of an injection syringe 16 is already inserted into the actual mouth rim 25 of the ampoule neck 13 before it has the remnants of the predetermined breaking point 21 reached.

Wie Figur 8 ferner zeigt, kann der Betätigungsteil 19 des Verschlußstückes 14 etwa plattenförmig oder laschenförmig ausgebildet sein, um ein sicheres Erfassen zum Abdrehen, Abbrechen und Abreißen des Verschlußstückes 14 zu gewährleisten. Zur weiteren Verbesserung können auf dem Betätigungsteil 19 sich axial erstreckende Griffrippen 31 ausgebildet sein.As FIG. 8 also shows, the actuating part 19 of the closure piece 14 can be approximately plate-shaped or tab-shaped in order to ensure secure gripping for twisting, breaking off and tearing off the closure piece 14. For further improvement, axially extending grip ribs 31 can be formed on the actuating part 19.

Das Ampullengefäß 11 ist zunächst an seinem dem Ampullenhals 13 entgegengesetzten Ende offen, um es von diesem Ende her zu füllen. Die Umfangswand des Ampullengefäßes 11 hat in Nachbarschaft des Ampullenhalses 13 und der Ampullenschulter 12 größere Dicke als an ihrem offenen Ende.The ampoule container 11 is initially open at its end opposite the ampoule neck 13 in order to fill it from this end. The peripheral wall of the ampoule container 11 has a greater thickness in the vicinity of the ampoule neck 13 and the ampoule shoulder 12 than at its open end.

Die Umfangswand des Ampullen gehäuses 11 kann durchweg leicht konische sich nach dem offenen Ende hin erweiternde Form und einen der Ampullenschulter 12 benachbarten Teil 32 größerer Dicke 33, beispielsweise von etwa 0,5 mm, haben. In Nachbarschaft des offenen Endes ist ein Teil 34 der Umfangswand mit einer Dicke 35 von etwa 0,35 mm gebildet.The peripheral wall of the ampoule housing 11 can consistently be slightly conical after the open End-widening shape and a portion 32 of greater thickness 33 adjacent to the ampoule shoulder 12, for example of approximately 0.5 mm. A portion 34 of the peripheral wall having a thickness 35 of about 0.35 mm is formed in the vicinity of the open end.

Bei einer anderen Ausführung ist die Umfangswand des Ampullengefäßes 11 an ihrer Außenseite zylindrisch ausgebildet und weist von der Ampullenschulter 12 her bis zum offenen Ende hin abnehmende Wandstärke, und zwar eine der Ampullenschulter 12 benachbarte Dicke 36, von beispielsweise 0,55 mm und eine Dicke 37 von beispiele 0,35 mm am offenen Ende. Hierdurch verjüngt sich der im Ampullengefäß 11 vor dem Verschließen gebildete Innenraum konisch vom offenen Ende zur Ampullenschulter 12 hin.In another embodiment, the peripheral wall of the ampoule container 11 is cylindrical on its outside and has a decreasing wall thickness from the ampoule shoulder 12 to the open end, specifically a thickness 36 adjacent to the ampoule shoulder 12, for example 0.55 mm and a thickness 37 of examples 0.35 mm at the open end. As a result, the interior formed in the ampoule container 11 before the closure tapers conically from the open end to the ampoule shoulder 12.

Anstelle der dargestellten Beispiele kann auch vorgesehen sein, die Belüftungseinrichtung völlig getrennt vom Behälterhals 13 an der Ampullenwand, vorzugsweise an der Ampullenschulter 12, vorzusehen. Beispielsweise könnte in Abstand vom Ampullenhals 13 eine leicht durchstoßbare verdünnte Stelle ausgebildet sein. Dies könnte beispielsweise an einer in den Figuren 1 und 2 durch den Pfeil 46 angedeuteten Stelle sein. Es könnte auch an der Stelle 46 ein vom Ampullenhals 13 völlig getrenntes Belüftungsröhrchen in die Ampullenschulter 12 eingeformt sein und ein von dem Ampullenhals 13 getrenntes abbrechbares Verschlußstück tragen.Instead of the examples shown, provision can also be made to provide the ventilation device completely separate from the container neck 13 on the ampoule wall, preferably on the ampoule shoulder 12. For example, an easily penetrable thinned point could be formed at a distance from the ampoule neck 13. This could be, for example, at a point indicated by the arrow 46 in FIGS. 1 and 2. It could also be molded into the ampoule shoulder 12 at point 46, a ventilation tube completely separate from the ampoule neck 13 and carry a breakable closure piece separate from the ampoule neck 13.

Wie die Figuren 1 und 2 zeigen, sind im dargestellten Beispiel auf der Ampullenschulter 12 Blindprägungen 40 angebracht, die Aufschluß über Inhalt und Volumen der Ampulle 10 geben. Diese Blindprägungen 40 sind beim Öffnen der Ampulle 10 und beim Einführen des Aufnahmekonus 17 unübersehbar. Sie sind auch unverwischbar und dadurch geeignet, auch die entleerte Ampulle 10 evtl. noch als Beweisstück für verabreichte Medizin u.dgl. aufzuheben.As FIGS. 1 and 2 show, in the example shown 12 blind embossments 40 are provided on the ampoule shoulder, which provide information about the content and volume of the ampoule 10. These blind embossments 40 cannot be overlooked when opening the ampoule 10 and when inserting the receiving cone 17. They are also indelible and therefore suitable for the emptied ampoule 10, possibly as evidence for administered medicine and the like. repeal.

Claims (12)

  1. An ampoule for receiving a dose of a fluid medium which is to be transferred to an application device, preferably a syringe (16), a suitable ampoule neck (13) with an intended breackage point and grip for opening being provided on the ampoule container (11) for introducing the, for example, conical head (17) of the application device, the ampoule neck (13) being designed as an elastically flexible insertion and retaining ring for the secure introduction of the application device head (17) and a ventilating device (41, 41′) leading inside the ampoule (10) being provided separately adjacent the ampoule neck (13).
  2. An ampoule according to claim 1, characterised in that the ventilation opening is formed on a ventilating tube (41, 41′) extending parallel to the ampoule neck (13).
  3. An ampoule according to claim 2, characterised in that the ventilating tube (41′) is extended into the ampoule interior relative to the ampoule neck (13).
  4. An ampoule according to one of claims 1 to 3, characterised in that, at its free end, the ampoule neck (13) supports a sealing element (14), which is integrally connected via an annular intended breakage point (21) with the opening edge region (20) of the ampoule neck (13).
  5. An ampoule according to one of claims 1 to 4, characterised in that a common sealing element (14, 14′) is provided for the opening of the ampoule neck (13) and the separate ventilating device (ventilating tube 41, 41′).
  6. An ampoule according to one of claims 1 to 5, characterised in that the ampoule neck (13) is designed at its opening edge to form a funnel-shaped inlet for the head of the application device (syringe 16) with a rounded edge (25).
  7. An ampoule according to one of claims 1 to 6, characterised in that the ampoule container (11) is integrally formed together with the ampoule neck (13) and the ventilating device (ventilating tube 41, 41′) from a thermoplastic plastics material, preferably polypropylene, and at its end opposite the ampoule neck (13) is hermetically sealing after filling.
  8. An ampoule according to claim 7, characterised in that, in its section (32) adjacent the ampoule neck, the ampoule container (11) has a greater wall thickness than in its section (34) opposite the ampoule neck.
  9. An ampoule according to claims 7 to 8, characterised in that, at its end opposite the ampoule neck, the ampoule container (11) is compressed flat in the manner of a tube after filling and sealed by welding along a transversely extending seam (15).
  10. An ampoule according to one of claims 7 to 9, characterised in that the ampoule container (11) is designed with a cylindrical outer form and with an inner form slightly conically widening towards the open end opposite the ampoule neck (13) and with a wall thickness correspondingly continuously decreasing from the ampoule neck to the open end.
  11. An ampoule according to one of claims 1 to 10, characterised in that the ampoule container (11) is integrally formed together with the ampoule neck (13) and the ventilating device (ventilating tube 41, 41′) by injection moulding.
  12. An ampoule according to one of claims 1 to 11, characterised in that an ampoule shoulder (12) is formed at the transition from the ampoule container (11) to the ampoule neck (13), in which shoulder blind embossing (40) is disposed, for example for indicating the volume and content of the respective ampoule (10).
EP89107869A 1988-06-01 1989-04-29 Ampoule Expired - Lifetime EP0344476B1 (en)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
DE19883818682 DE3818682A1 (en) 1988-06-01 1988-06-01 AMPOULE
DE3818682 1988-06-01

Publications (3)

Publication Number Publication Date
EP0344476A2 EP0344476A2 (en) 1989-12-06
EP0344476A3 EP0344476A3 (en) 1990-03-28
EP0344476B1 true EP0344476B1 (en) 1992-09-02

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EP89107869A Expired - Lifetime EP0344476B1 (en) 1988-06-01 1989-04-29 Ampoule

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US (1) US4926915A (en)
EP (1) EP0344476B1 (en)
JP (1) JPH0245056A (en)
AU (1) AU3597689A (en)
BR (1) BR8902517A (en)
DE (2) DE3818682A1 (en)
ES (1) ES2034471T3 (en)
SU (1) SU1727518A3 (en)

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Also Published As

Publication number Publication date
SU1727518A3 (en) 1992-04-15
ES2034471T3 (en) 1993-04-01
AU3597689A (en) 1989-12-07
DE3818682A1 (en) 1989-12-21
BR8902517A (en) 1990-01-23
EP0344476A2 (en) 1989-12-06
DE58902185D1 (en) 1992-10-08
EP0344476A3 (en) 1990-03-28
JPH0245056A (en) 1990-02-15
US4926915A (en) 1990-05-22
JPH0588619B2 (en) 1993-12-22

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