WO1992001485A1 - Seringue a deux compartiments - Google Patents

Seringue a deux compartiments Download PDF

Info

Publication number
WO1992001485A1
WO1992001485A1 PCT/DK1991/000177 DK9100177W WO9201485A1 WO 1992001485 A1 WO1992001485 A1 WO 1992001485A1 DK 9100177 W DK9100177 W DK 9100177W WO 9201485 A1 WO9201485 A1 WO 9201485A1
Authority
WO
WIPO (PCT)
Prior art keywords
distal
barrel
proximal
piston
compartment
Prior art date
Application number
PCT/DK1991/000177
Other languages
English (en)
Inventor
Ib Hansen
Original Assignee
Novo Nordisk A/S
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 Novo Nordisk A/S filed Critical Novo Nordisk A/S
Publication of WO1992001485A1 publication Critical patent/WO1992001485A1/fr

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES 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
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A61M5/24—Ampoule syringes, i.e. syringes with needle for use in combination with replaceable ampoules or carpules, e.g. automatic
    • A61M5/2448—Ampoule syringes, i.e. syringes with needle for use in combination with replaceable ampoules or carpules, e.g. automatic comprising means for injection of two or more media, e.g. by mixing
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES 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
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A61M5/28—Syringe ampoules or carpules, i.e. ampoules or carpules provided with a needle
    • A61M5/284—Syringe ampoules or carpules, i.e. ampoules or carpules provided with a needle comprising means for injection of two or more media, e.g. by mixing
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES 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
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A61M5/31—Details
    • A61M5/3129—Syringe barrels
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES 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
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A61M5/31—Details
    • A61M2005/3123—Details having air entrapping or venting means, e.g. purging channels in pistons

Definitions

  • the present invention relates to a two-compartment syringe comprising an elongate barrel having a tip extending from the distal end of said barrel and having a passageway therethrough, a distal piston and a proximal piston both being slidably positioned within said barrel so as to define a distal compartment for holding a first component and located between said tip and said distal piston and a proximal compartment for holding a second component in the form of a liquid and located between said distal piston and said proximal piston, a plunger rod for axially displacing the proximal piston, and at least one by-pass of an axial length which exceeds the axial length of said distal piston so as to allow the liquid to pass from the second compartment to the first compartment when the distal piston is positioned in the zone defined by said by-pass.
  • Some drugs show a rapid loss of potency when they are in a ready to use injectable composition.
  • a solution to this problem is found in using a two compartment syringe having a distal compartment containing a component which may be a solid, e.g. a lyophilized powder, and a proximal compartment containing a liquid component, in the following designated the solvent, and means for allowing the solvent to flow from the proximal compartment to the distal compartment before an injection is to be performed.
  • These means may comprise a distal piston and a proximal piston both being slidably positioned within the barrel and at least one by-pass providing liquid communication between the two compartments when the distal piston is positioned in the by-pass zone.
  • barrels for two compartment syringes are ordinarily made from glass.
  • the use of glass barrels presents several disadvantages. Thus it is difficult and laborious to provide by-passes in the wall of a glass barrel and the rate of discarding is high. Consequently production costs become relatively high. Further ⁇ more, the dimensions of glass barrels inevitably vary consider ⁇ ably, which is inconvenient and may necessitate a separate control step in the production.
  • the object of the invention is to eliminate or con ⁇ siderably reduce the above mentioned drawbacks of the prior art two compartment syringes.
  • the barrel comprises a distal and a proximal section, the distal section having a smaller inner diameter than the proximal one, and the distal section comprising the by-pass and the proximal section comprising in the ready to sell form of the syringe a separate cylindrical insert comprising the distal and proximal pistons, the interior of the insert having such a shape and dimension that the pistons are displaceable from the insert into the distal section of the barrel.
  • the invention is based on the discovery that by using a separate insert comprising the distal and proximal piston and consequently forming the proximal compartment only the insert has to be made from a material which is compatible with the solvent whereas the remaining parts of the syringe can be made from any suitable material including a plastic material which is easy to mould and/or process.
  • the inventin permits the insert to be made from e.g. glass and the barrel from a thermoplastic material.
  • a particularly preferred embodiment of the syringe of the invention comprises vents in the form of axially extending grooves provided on the inside of the proximal section of the barrel.
  • Another particularly preferred embodiment of the syringe of the invention comprises a barrel comprising a proximal part and a distal part having means for joining the two parts together to form a unit.
  • the proximal part and the insert can be removed when the solvent has been transferred from the proximal compartment to the distal compartment and the remaining components can be used in connection with a separate injection assembly, e.g. a pen-like syringe or a delivery pump.
  • the barrels used in the syringes of the invention are preferably made from a thermoplastic material which can be moulded e.g. injection moulded.
  • suitable thermo ⁇ plastic materials are polyamides, polycarbonate, polyethylene, polypropylene and polyesters.
  • the insert is preferably made from glass or another material which does not give off substances which are incom ⁇ patible with medication solvents.
  • Fig. 1 shows a longitudinal sectional view of a barrel for use in a preferred embodiment of the syringe of the invention.
  • Fig. 2 shows a cross sectional view of a syringe barrel as shown in Fig. 1 at the line A-A.
  • Fig. 3 shows a cross sectional view of a syringe barrel as shown in Fig. 1 at the line B-B.
  • Fig. 4 shows a proximal end view of a syringe barrel as shown in Fig. 1 having a flange fixed to its proximal end.
  • Fig. 5 shows a longitudinal sectional view of the barrel illustrated in Fig. 1 and a cylindrical insert partly inserted in said barrel.
  • Fig. 6 shows a longitudinal sectional view of a fully assembled syringe.
  • Fig. 7 shows a longitudinal sectional view of a barrel consisting of two parts.
  • Figs. 8-9 show other preferred embodiments of the distal end of syringes of the invention.
  • Fig. 1 shows a barrel 10 comprising a tip 11 having a central passage 12, a distal section 13 and a proximal section
  • the internal diameter of the distal section 13 is smaller than the internal diameter of the proximal section 14, and a by-pass 15 in the form of grooves are provided on the inside of the distal section 13 of the barrel.
  • the proximal section 14 of the barrel comprises a number of vents 16 in the form of grooves provided on the inside of the proximal section 14 of the barrel 10 and extending axially from the proximal end of the barrel 10.
  • the tip 11 of the barrel 10 is sealed by a piercable membrane 17 secured by a metal cap 18.
  • 20 is the wall of the distal section 13 of the barrel 10 having a by-pass 15 in the form of a groove formed therein.
  • FIG. 3 is the wall of the proximal section 14 of the barrel 10 having a number of vents 16 in the form of grooves formed therein.
  • Fig. 4 40 is a flange fixed to the proximal end of the barrel 10.
  • Fig. 5 shows an insert 50 in the form of a tube partly inserted in a barrel as shown in Fig. 1.
  • the insert 50 has a sealing ring 51 provided on the outside of its distal end and serving to establish a liquid-tight contact between the insert 50 and the inside of the barrel 10.
  • the sealing ring 51 may be ac ⁇ omodated in a circumferential groove.
  • the insert 50 further comprises a distal piston 52 and a proximal piston 60 which together delimit a compartment 61 serving to hold a liquid component.
  • the proximal piston 60 can be displaced by means of a plunger rod 62 having a pressure head 63.
  • the insert 50 is aligned with the bore of the distal section 13 of the barrel 10 and since it has the same internal diameter as said bore the pistons 52, 60 can be displaced into the distal section 13 of the barrel 10.
  • the plunger rod 62 can be depressed. Before the depression of the plunger rod 62 is initiated an open outlet through the tip 11 is established e.g. by mounting a hypodermic needle thereon.
  • the depression causes the two pistons 52, 60 to move towards the distal section 13 of the barrel 10 and when the piston 52 has moved into the zone defined by the by-pass 15, liquid can flow from the insert 50 via the by-pass 15 into the interior of the distal section 13 of the barrel. This flow will continue until the piston 60 contacts the piston 52.
  • the solvent may be desirable to shake the syringe to make sure that the substance contained in the distal section is fully dissolved in the solvent.
  • the syringe is preferably held with its distal end pointing upwards in order to allow the air contained in the distal compartment to escape through the tip.
  • a further depression of the plunger rod 62 will cause the pistons 52, 60 to move into the distal section 13 of the barrel 10 and to press liquid out through the passage 12 of the tip 11 of the barrel 10.
  • a solution of a substance may be lyophilized in situ i.e. after it has been introduced into the interior of the distal section 13 of the barrel 10.
  • the insert 50 is pressed fully home in the barrel 10 as shown in Fig. 6 and thus the communication between the distal compartment and the surrounding atmosphere is inter ⁇ rupted.
  • the solvent and the proximal piston 60 of the insert 50 can only be added after the lyphilization is completed.
  • the insert 50 can be secured in its final position e.g. by means of the flange 40 of Fig. 4 which can be snapped on or otherwise fixed on the proximal end of the barrel 10 after the insert 50 has been pressed fully home.
  • the central hole in the flange 40 has a smaller diameter than the outside diameter of the insert 50.
  • the insert 50 can be retained by inwardly protruding projections at the distal end of the proximal section 14 of the barrel 10 or by means of an adhesive.
  • Fig. 7 shows a barrel comprising two parts viz. a distal part 70 which is similar to the distal section 13 of the barrel shown in Fig. 1 and a proximal upper part 71 corresponding to the proximal section 14 of the barrel shown in Fig. 1.
  • the proximal end of the distal part 70 and the distal end of the proximal part 71 comprise threads 72 and 73 which allow the two parts to be screwed together to form a unit and which allows the unit to be separated into two parts.
  • a barrel as shown in Fig. 7 it is possible to remove the proximal part 71 together with the emptied insert when the solvent has been transferred to the interior of the distal part 70 of the barrel simply by unscrewing the proximal part 71 from the distal part 70.
  • the remaining components may be used in a separate injection assembly, e.g. a pen-like syringe or a delivery pump.
  • Fig. 8 and Fig. 9 show alternative embodiments of the tip 11 of the barrel 10.
  • the tip is fitted with a fixed needle 80
  • the tip assumes the form of an elongate standard tapered cone 90 which can be covered with a protection cap (not shown) .

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)

Abstract

Seringue à deux compartiments, comprenant un cylindre (10) ayant deux parties distale et proximale, la partie distale (13) comprenant au moins une dérivation (15) et la partie proximale comprenant, dans la version prête pour la vente de la seringue, in insert cylindrique séparé (50) ayant un piston distal (52) et un piston proximal (60), l'intérieur de l'insert (50) ayant une forme et des dimensions telles que les pistons (52, 60) peuvent se déplacer depuis l'insert (50) jusque dans la partie distale (13) du cylindre (10).
PCT/DK1991/000177 1990-07-20 1991-06-28 Seringue a deux compartiments WO1992001485A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
DK1743/90 1990-07-20
DK174390A DK174390D0 (da) 1990-07-20 1990-07-20 Tokammersproejte

Publications (1)

Publication Number Publication Date
WO1992001485A1 true WO1992001485A1 (fr) 1992-02-06

Family

ID=8107707

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/DK1991/000177 WO1992001485A1 (fr) 1990-07-20 1991-06-28 Seringue a deux compartiments

Country Status (3)

Country Link
AU (1) AU8239291A (fr)
DK (1) DK174390D0 (fr)
WO (1) WO1992001485A1 (fr)

Cited By (15)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO1995017915A2 (fr) * 1993-12-30 1995-07-06 Eisai Co., Ltd. Seringue pre-remplie, outillage pour empecher l'enlevement d'un piston de la seringue, et procede de sterilisation a l'aide de l'outillage
US5522804A (en) * 1994-02-15 1996-06-04 Lynn; Lawrence A. Aspiration, mixing, and injection syringe
WO1996030066A1 (fr) * 1995-03-29 1996-10-03 Abbott Laboratories Corps de seringue pour lyophilisation, reconstitution et administration
US5637100A (en) * 1992-11-27 1997-06-10 Daikyo Seiko, Ltd. Syringe-cum-container
US5785682A (en) * 1995-03-22 1998-07-28 Abbott Laboratories Pre-filled syringe drug delivery system
US5876372A (en) * 1995-03-22 1999-03-02 Abbott Laboratories Syringe system accomodating seperate prefilled barrels for two constituents
WO2001089614A1 (fr) * 2000-05-22 2001-11-29 Pharmacia Ab Dispositif medical
EP1189659A1 (fr) * 1999-04-30 2002-03-27 Prismedical Corporation Poche amelioree d'administration de medicaments
US6740062B2 (en) 2000-05-22 2004-05-25 Pharmacia Ab Medical device
EP1911478A1 (fr) * 2006-10-09 2008-04-16 E-Z-EM, Inc. Dispositif de seringue et système injecteur incluant une sortie pour dégager le vide dans la seringue
EP1913966A1 (fr) * 2006-10-17 2008-04-23 Arte Corporation Seringue à réservoir combinée
US8613730B2 (en) 2008-11-26 2013-12-24 Acist Medical Systems, Inc. Apparatus and methods for fluid pressurizing units of injection systems
EP2167169B2 (fr) † 2007-06-14 2016-03-09 Sanofi-Aventis Deutschland GmbH Carpule à double chambre dotée d'un chapiteau
US11033678B2 (en) 2017-11-20 2021-06-15 Agist Medical Systems, Inc. Compact injector drive
US11040147B2 (en) 2017-11-21 2021-06-22 Acist Medical Systems, Inc. Injector position sensing

Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US3685514A (en) * 1969-09-23 1972-08-22 Paul E Cheney Two compartment syringe
US4254768A (en) * 1979-09-14 1981-03-10 Ty Perla J Hypodermic syringe
US4613326A (en) * 1985-07-12 1986-09-23 Becton, Dickinson And Company Two-component medication syringe assembly
EP0207544A1 (fr) * 1985-06-27 1987-01-07 Duphar International Research B.V Seringue à plusieurs compartiments
EP0302248A1 (fr) * 1987-07-21 1989-02-08 WASSERBURGER ARZNEIMITTELWERK DR. MADAUS GMBH & CO. KG Seringue à injection pour usage médical

Patent Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US3685514A (en) * 1969-09-23 1972-08-22 Paul E Cheney Two compartment syringe
US4254768A (en) * 1979-09-14 1981-03-10 Ty Perla J Hypodermic syringe
EP0207544A1 (fr) * 1985-06-27 1987-01-07 Duphar International Research B.V Seringue à plusieurs compartiments
US4613326A (en) * 1985-07-12 1986-09-23 Becton, Dickinson And Company Two-component medication syringe assembly
EP0302248A1 (fr) * 1987-07-21 1989-02-08 WASSERBURGER ARZNEIMITTELWERK DR. MADAUS GMBH & CO. KG Seringue à injection pour usage médical

Cited By (32)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5637100A (en) * 1992-11-27 1997-06-10 Daikyo Seiko, Ltd. Syringe-cum-container
WO1995017915A3 (fr) * 1993-12-30 1995-09-08 Eisai Co Ltd Seringue pre-remplie, outillage pour empecher l'enlevement d'un piston de la seringue, et procede de sterilisation a l'aide de l'outillage
WO1995017915A2 (fr) * 1993-12-30 1995-07-06 Eisai Co., Ltd. Seringue pre-remplie, outillage pour empecher l'enlevement d'un piston de la seringue, et procede de sterilisation a l'aide de l'outillage
US5769825A (en) * 1994-02-15 1998-06-23 Lynn; Lawrence A. Self-contained syringe and pharmaceutical packaging system for enclosed mixing of pharmaceutical and diluent
US5522804A (en) * 1994-02-15 1996-06-04 Lynn; Lawrence A. Aspiration, mixing, and injection syringe
US5549569A (en) * 1994-02-15 1996-08-27 Lawrence A. Lynn Ex vivo blood isolation system
US5643218A (en) * 1994-02-15 1997-07-01 Lawrence A. Lynn Auto-flushing medical fluid injection system
US5697915A (en) * 1994-02-15 1997-12-16 Lynn; Lawrence A. Displacement-activated medical check valve
US5743886A (en) * 1994-02-15 1998-04-28 Lawrence A. Lynn Sequential medical fluid aspiration and injection system and method
US5876372A (en) * 1995-03-22 1999-03-02 Abbott Laboratories Syringe system accomodating seperate prefilled barrels for two constituents
US5785682A (en) * 1995-03-22 1998-07-28 Abbott Laboratories Pre-filled syringe drug delivery system
US5779668A (en) * 1995-03-29 1998-07-14 Abbott Laboratories Syringe barrel for lyophilization, reconstitution and administration
WO1996030066A1 (fr) * 1995-03-29 1996-10-03 Abbott Laboratories Corps de seringue pour lyophilisation, reconstitution et administration
AU712959B2 (en) * 1995-03-29 1999-11-18 Abbott Laboratories Syringe barrel for lyophilization, reconstitution and administration
EP1189659A4 (fr) * 1999-04-30 2008-06-25 Prismedical Corp Poche amelioree d'administration de medicaments
EP1189659A1 (fr) * 1999-04-30 2002-03-27 Prismedical Corporation Poche amelioree d'administration de medicaments
US6740062B2 (en) 2000-05-22 2004-05-25 Pharmacia Ab Medical device
US7033337B2 (en) 2000-05-22 2006-04-25 Pharmacia Ab Medical device
US7104971B2 (en) 2000-05-22 2006-09-12 Pharmacia Ab Medical device
WO2001089614A1 (fr) * 2000-05-22 2001-11-29 Pharmacia Ab Dispositif medical
WO2008045876A2 (fr) * 2006-10-09 2008-04-17 Acist Medical Systems, Inc. Dispositif de seringue et système d'injection comprenant une prise d'air destinée à réduire le vide à l'intérieur d'une seringue
WO2008045876A3 (fr) * 2006-10-09 2008-06-05 E Z Em Inc Dispositif de seringue et système d'injection comprenant une prise d'air destinée à réduire le vide à l'intérieur d'une seringue
EP1911478A1 (fr) * 2006-10-09 2008-04-16 E-Z-EM, Inc. Dispositif de seringue et système injecteur incluant une sortie pour dégager le vide dans la seringue
US8540683B2 (en) 2006-10-09 2013-09-24 Acist Medical Systems, Inc. Syringe device and injector system including a vent for relieving a vacuum within a syringe
EP1913966A1 (fr) * 2006-10-17 2008-04-23 Arte Corporation Seringue à réservoir combinée
EP2167169B2 (fr) † 2007-06-14 2016-03-09 Sanofi-Aventis Deutschland GmbH Carpule à double chambre dotée d'un chapiteau
US8613730B2 (en) 2008-11-26 2013-12-24 Acist Medical Systems, Inc. Apparatus and methods for fluid pressurizing units of injection systems
US9352105B2 (en) 2008-11-26 2016-05-31 Acist Medical Systems, Inc. Apparatus and methods for fluid pressurizing units of injection systems
US9925338B2 (en) 2008-11-26 2018-03-27 Acist Medical Systems, Inc. Apparatus and methods for fluid pressurizing units of injection systems
US11033678B2 (en) 2017-11-20 2021-06-15 Agist Medical Systems, Inc. Compact injector drive
US11730885B2 (en) 2017-11-20 2023-08-22 Acist Medical Systems, Inc. Compact injector drive
US11040147B2 (en) 2017-11-21 2021-06-22 Acist Medical Systems, Inc. Injector position sensing

Also Published As

Publication number Publication date
AU8239291A (en) 1992-02-18
DK174390D0 (da) 1990-07-20

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