CA2457186C - Prefilled syringe or carpule for medicinal purposes - Google Patents

Prefilled syringe or carpule for medicinal purposes Download PDF

Info

Publication number
CA2457186C
CA2457186C CA002457186A CA2457186A CA2457186C CA 2457186 C CA2457186 C CA 2457186C CA 002457186 A CA002457186 A CA 002457186A CA 2457186 A CA2457186 A CA 2457186A CA 2457186 C CA2457186 C CA 2457186C
Authority
CA
Canada
Prior art keywords
cannula
cap
syringe
sealing
syringe barrel
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
CA002457186A
Other languages
French (fr)
Other versions
CA2457186A1 (en
Inventor
Udo J. Vetter
Andreas Schuetz
Joachim Glocker
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.)
Apotheker Vetter and Company Arzneimittel GmbH Ravensburg
Original Assignee
Apotheker Vetter and Company Arzneimittel GmbH Ravensburg
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 Apotheker Vetter and Company Arzneimittel GmbH Ravensburg filed Critical Apotheker Vetter and Company Arzneimittel GmbH Ravensburg
Publication of CA2457186A1 publication Critical patent/CA2457186A1/en
Application granted granted Critical
Publication of CA2457186C publication Critical patent/CA2457186C/en
Anticipated expiration legal-status Critical
Expired - Lifetime legal-status Critical Current

Links

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178Syringes
    • A61M5/31Details
    • A61M5/32Needles; Details of needles pertaining to their connection with syringe or hub; Accessories for bringing the needle into, or holding the needle on, the body; Devices for protection of needles
    • A61M5/3202Devices for protection of the needle before use, e.g. caps
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/001Apparatus specially adapted for cleaning or sterilising syringes or needles
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178Syringes
    • A61M5/28Syringe ampoules or carpules, i.e. ampoules or carpules provided with a needle
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178Syringes
    • A61M5/31Details
    • A61M5/32Needles; Details of needles pertaining to their connection with syringe or hub; Accessories for bringing the needle into, or holding the needle on, the body; Devices for protection of needles
    • A61M5/34Constructions for connecting the needle, e.g. to syringe nozzle or needle hub
    • A61M5/348Constructions for connecting the needle, e.g. to syringe nozzle or needle hub snap lock, i.e. upon axial displacement of needle assembly
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178Syringes
    • A61M5/31Details
    • A61M2005/3117Means preventing contamination of the medicament compartment of a syringe
    • A61M2005/3118Means preventing contamination of the medicament compartment of a syringe via the distal end of a syringe, i.e. syringe end for mounting a needle cannula
    • A61M2005/312Means preventing contamination of the medicament compartment of a syringe via the distal end of a syringe, i.e. syringe end for mounting a needle cannula comprising sealing means, e.g. severable caps, to be removed prior to injection by, e.g. tearing or twisting
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178Syringes
    • A61M5/28Syringe ampoules or carpules, i.e. ampoules or carpules provided with a needle
    • A61M5/285Syringe ampoules or carpules, i.e. ampoules or carpules provided with a needle with sealing means to be broken or opened
    • A61M5/286Syringe ampoules or carpules, i.e. ampoules or carpules provided with a needle with sealing means to be broken or opened upon internal pressure increase, e.g. pierced or burst
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178Syringes
    • A61M5/31Details
    • A61M5/32Needles; Details of needles pertaining to their connection with syringe or hub; Accessories for bringing the needle into, or holding the needle on, the body; Devices for protection of needles
    • A61M5/3202Devices for protection of the needle before use, e.g. caps
    • A61M5/3204Needle cap remover, i.e. devices to dislodge protection cover from needle or needle hub, e.g. deshielding devices

Landscapes

  • Health & Medical Sciences (AREA)
  • Vascular Medicine (AREA)
  • Engineering & Computer Science (AREA)
  • Anesthesiology (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Hematology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Infusion, Injection, And Reservoir Apparatuses (AREA)
  • Medical Preparation Storing Or Oral Administration Devices (AREA)

Abstract

A prefilled syringe or carpule is provided for medical purposes, having a glass syringe barrel and inside it a syringe plunger which can be displaced by means of a plunger rod. A cannula cap, in which a cannula is fixedly inserted and held axially in a detent position, is mounted on the cannula end of the syringe barrel. Further provided is a sealing disk inserted in the cannula cap and arranged coaxially to the cannula cap. One side of the disk lies flush against the end face of the syringe barrel and the other side lies flush against the internal face of the cannula cap and the disk centrally displays a recess in the form of a blind hole, whose base forms a membrane. The end of the cannula closest to the syringe barrel projects clear through the internal face of the cannula cap into the recess of the sealing disk. Finally, the syringe possesses a sealing component consisting of a sealing cap and a locking ring joined to it by means of a predetermined breaking point, which can moved from a first detent position formed for the locking ring in the external surface of the shell of the cannula cap, thus making possible the sterilization of the interior space of the sealing component, to a locking position enclosing and sterilely sealing off the cannula cap.

Description

A
' CA 02457186 2004-02-10 PREFILLED SYRINGE OR CARPULE FOR MEDICINAL PURPOSES
Field of the Invention The present invention refers to a prefilled syringe or carpule for medicinal purposes, having a glass syringe barrel and, located within it, an injection plunger that can be displaced by means of a plunger rod. The invention further relates to a procedure for packaging such a syringe.
Background of the Invention Syringes of this type are known in many embodiments, with their configurations frequently depending on the way the cleaning, filling and packaging processes are performed.
In this regard, high-temperature processes pose a special problem, and most particularly so when the ready-made syringe must come equipped with a fixedly inserted cannula.
It is therefore desirable to create a syringe of the type described above that provides flexibility in the way that these process can be performed, and at the same time can be packaged in a simple and thus cost-effective manner.
Summary of the Invention The present invention provides a prefilled syringe or carpule for medical purposes, comprising:
(a) a glass syringe barrel;
(b) a syringe plunger located in the barrel, which can be actuated by means of a plunger rod;
(c) a cannula cap axially mounted on a cannula end of the syringe barrel and held in a first detent~
(d) a cannula fixedly inserted and extending through the cannula caps (e) a sealing disk inserted in the cannula cap and located coaxially with the cannula cap, having a first face lies flush against the cannula end of the syringe barrel and having a second face that lies flush against an internal face of the cannula caps (f) a central recess shaped as a blind hole, formed in the sealing disk, wherein a base of the recess forms a membrane, wherein an end of the cannula closest to the syringe barrel projects into the recess of the sealing disk; and (g) a sealing component defining an internal space consisting of a sealing cap and a locking ring joined to the sealing cap by means of a predetermined breaking point, wherein the locking ring moves from a detent position formed in an external shell of the cannula cap, to facilitate sterilization of the internal space, to a locking position sterilely enclosing and sealing off the cannula cap.
The present invention allows that the glass syringe barrel can be subjected to high temperature processes before filling, and more particularly to heat-curing siliconization, without problems arising in the process, as is the case when cannulae are cemented into the glass body.
Moreover, the cannul.a, when in storage, is protected not only against external impacts, but also protected by the sealing disk from contact with the pharmaceutical solution.
The possibility also exists of bubble-free filling of the syringe barrel or carpule, which simplifies manipulation before use. Further still, a self-activation takes place at the time of use, since the membrane formed in the ~
' CA 02457186 2004-02-10 locking disk is penetrated by the point of the cannula facing towards it under tha pressure of the plunger rod, transmitted to it by the fluid.
To obtain an additional protection, more particularly of the cannula, a preferred feature of the invention is to provide a needle protective,cap located in the interior of the sealing component. This needle protective cap is preferably made of rubber.
It is further proposed according to the invention that the cannula cap display a cylindrical projection surrounding the cannula, and which, in the locking position of the sealing component, tightly abuts against the internal surface of the shell of the needle protective cap.
According to another aspect of the present invention, following the cleaning of the glass syringe barrel, a heat-curing siliconization is performed so that the cannula cap with the sealing disk located in it and the sealing component situated in the detent position impinges on the syringe barrel and the syringe or carpule is then sterilized, the syringe barrel is then filled and finally the sealing component is pressed down into the locking position.
In this way, the syringe barrel can be filled without bubbles, so that after the cannula cap is mounted, no air inclusions are present in the syringe barrel, owing to the sealing disk lying flush against the end face of the syringe barrel.
Brief Description of the Drawings The present invention is more fully explained with reference to the following drawings:
Fig. 1 is an exploded, cross-sectional view of the cannula cap with the sealing disk, and the sealing component;
Fig. 2 is a cross-sectional view of the present invention, before being mounted on the syringe in a pre-packaging stage;
Fig. 3 is a cross-sectional view of the present invention, mounted on the syringe;
Fig. 4 is a cross-sectional view of the present invention, as completely packaged; and Fig. 5 is a cross-sectional view of the present invention, as prepared for application.
Detailed Description The syringe or carpule, only partly shown in Figures 2 to 5, is provided for medical purposes and consists of a glass syringe barrel 1 and a syringe plunger (not shown) which can be displaced by means of a plunger rod (also not shown). This syringe is made to be sold in prefilled condition and as far as possible ready for immediate application.
As seen in Figures 2 and 3, a cannula cap 2 is axially mounted on the cannula end of the syringe barrel 1 and held there in a decent position. A cannula 3 is fixedly inserted in the cannula cap 2.

Also provided is a sealing disk 4 fitted coaxially in the cannula cap 2 and with one face flush against the end face of the syringe barrel l and the other flush against the internal face of the cannula cap 2. This sealing disk 4 5 has a central recess 5 in the form of a blind hole, with a base of the recess 5 forming a thin membrane.
An end of the cannula 3 closest to the syringe barrel 1 projects past the internal face of the cannula cap 2 into the recess 5 of the sealing disk 4, so that under the pressure of the syringe plunger, which is transmitted onto the membrane by the fluid, the membrane is pushed against the inner tip 6 of the cannula 3 and thus pierced or destroyed. In this way, the syringe is ready for use in a self-activating manner.
As seen in Figure 1, also provided is a sealing component 7 protecting the cannula 3, consisting of a sealing cap 8 and a locking ring 9. The Sealing cap 8 is joined to the locking ring 9 by means of a predetermined break point 10.
This predetermined breakpoint 10 simplifies detaching the sealing cap 8 before using the syringe.
A detent position 11 is provided on the external shell of the cannula cap 2 for engagement with the locking ring 9, to place the locking ring 9 in a detent position to allow communication between the internal space of the sealing component 7 and the external environment, so that the inner space can be sterilized. This detent position 11 is shown in Figures 2 and 3. When sterilization is completed, the sealing component 7 - still under sterile conditions - can be shifted to the locking position shown in Figure 4, by simply pressing on it, which thus produces a sterile seal against the cannula cap 2.
As well, a rubber needle protective cap 12 is located in the interior of the sealing cap 7.
The cannula cap 2 has a cylindrical projection 13 surrounding the cannula 3 which, in the locking position of the sealing component 7, lies flush against the internal surface of the needle protective cap 12, forming a seal.
This embodiment simplifies the preparation of a syringe for use, since for its application only the sealing cap 8 has to be detached. More particularly, the syringe is already fitted with the cannula 3 without having to accept restrictions in the flow of the process. The syringe barrel 1 can more particularly also be subjected to high-temperature processes, such as for instance heat-curing siliconization, without the seating or purchase of the cannula being affected. Further, the arrangement permits bubble-free filling of the syringe barrel 1 with a pharmaceutical substance.

Claims (6)

1. A prefilled syringe or carpule for medical purposes, comprising:
(a) a glass syringe barrel;
(b) a syringe plunger located in the barrel, which can be actuated by means of a plunger rod;
(c) a cannula cap axially mounted on a cannula end of the syringe barrel and held in a detent;
(d) a cannula fixedly inserted in and extending through the cannula cap;
(e) a sealing disk inserted in the cannula cap and located coaxially with the cannula cap, having a first face lies flush against the cannula end of the syringe barrel and having a second face that lies flush against an internal face of the cannula cap;
(f) a central recess, shaped as a blind hole, formed in the sealing disk, wherein a base of the recess forms a membrane; wherein an end of the cannula closest to the syringe barrel projects into the recess of the sealing disk; and (g) a sealing component defining an internal space and consisting of a sealing cap and a locking ring joined to the sealing cap by means of a predetermined breaking point, wherein the locking ring moves from a detent position formed in an external shell of the cannula cap to facilitate sterilization of the internal space, to a locking position sterilely enclosing and sealing off the cannula cap.
2. A syringe or carpule according to claim 1, further comprising a needle protective cap located in the interior space of the sealing component.
3. A syringe or carpule according to claim 2, characterized in that the needle protective cap is made of rubber.
4. A syringe or carpule according to claim 2 or 3, characterized in that the cannula cap displays a cylindrical projection enclosing the cannula, which, in the locking position of the sealing component, abuts and seals off the internal surface of the shell of the needle protective cap.
5. Procedure for packaging a syringe or carpule as defined by any one of claims 1 to 4, comprising:
(a) cleaning of the glass syringe barrel;
(b) performing a heat-curing siliconization so that the cannula cap with the sealing disk located inside it and the sealing part mounted in the detent position presses against the syringe barrel;
(c) sterilizing the syringe or carpule; and (d) filling the syringe barrel; and pushing down the sealing component into the locking position.
6. Procedure according to claim 5, wherein the syringe barrel is bubble-free when it is filled.
CA002457186A 2003-04-09 2004-02-10 Prefilled syringe or carpule for medicinal purposes Expired - Lifetime CA2457186C (en)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
DE10316127.9-44 2003-04-09
DE10316127A DE10316127A1 (en) 2003-04-09 2003-04-09 Pre-filled syringe or cartridge for medical purposes

Publications (2)

Publication Number Publication Date
CA2457186A1 CA2457186A1 (en) 2004-10-09
CA2457186C true CA2457186C (en) 2007-03-13

Family

ID=32864392

Family Applications (1)

Application Number Title Priority Date Filing Date
CA002457186A Expired - Lifetime CA2457186C (en) 2003-04-09 2004-02-10 Prefilled syringe or carpule for medicinal purposes

Country Status (11)

Country Link
US (1) US7331941B2 (en)
EP (1) EP1466638B1 (en)
JP (1) JP4347718B2 (en)
AT (1) ATE366596T1 (en)
CA (1) CA2457186C (en)
CY (1) CY1106869T1 (en)
DE (2) DE10316127A1 (en)
DK (1) DK1466638T3 (en)
ES (1) ES2289232T3 (en)
PT (1) PT1466638E (en)
SI (1) SI1466638T1 (en)

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FR3041334B1 (en) * 2015-09-21 2020-02-14 Disposable-Lab PROCESS FOR SEALING A CONTAINER COMPRISING AT LEAST ONE PLUG, IN PARTICULAR A CARPULE, MEANS OF INSERTION AND ASSOCIATED SEALING LINE
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Also Published As

Publication number Publication date
EP1466638A2 (en) 2004-10-13
SI1466638T1 (en) 2007-10-31
CY1106869T1 (en) 2012-09-26
PT1466638E (en) 2007-09-05
EP1466638B1 (en) 2007-07-11
US7331941B2 (en) 2008-02-19
DE10316127A1 (en) 2004-11-04
CA2457186A1 (en) 2004-10-09
US20050027259A1 (en) 2005-02-03
ATE366596T1 (en) 2007-08-15
JP4347718B2 (en) 2009-10-21
DK1466638T3 (en) 2007-10-22
ES2289232T3 (en) 2008-02-01
JP2004305720A (en) 2004-11-04
EP1466638A3 (en) 2006-05-24
DE50307650D1 (en) 2007-08-23

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