WO1998056438A1 - Recipient prerempli - Google Patents

Recipient prerempli Download PDF

Info

Publication number
WO1998056438A1
WO1998056438A1 PCT/AU1998/000407 AU9800407W WO9856438A1 WO 1998056438 A1 WO1998056438 A1 WO 1998056438A1 AU 9800407 W AU9800407 W AU 9800407W WO 9856438 A1 WO9856438 A1 WO 9856438A1
Authority
WO
WIPO (PCT)
Prior art keywords
container
barrel
sealing means
needle
cartridge
Prior art date
Application number
PCT/AU1998/000407
Other languages
English (en)
Inventor
Frank Alexander Popovsky
Original Assignee
Astra Pharmaceuticals Pty. Ltd.
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Astra Pharmaceuticals Pty. Ltd. filed Critical Astra Pharmaceuticals Pty. Ltd.
Priority to AU76307/98A priority Critical patent/AU7630798A/en
Publication of WO1998056438A1 publication Critical patent/WO1998056438A1/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

Definitions

  • This invention relates to prefilled containers, cartridges and syringes and in particular to closure systems suitable for use with such products.
  • the injectable liquid can be packaged and sealed aseptically. This removes the risks of contamination inherent in drawing a liquid pharmaceutical from a container holding a larger quantity of the liquid required, immediately prior to use.
  • prefilled cartridges and syringes can be accurately filled and marked. This reduces the risk of incorrect dosing and spares the user from meticulous measuring and transfer immediately prior to use. This is crucial if the injectable liquid is to be drawn into the container syringe or cartridge from a larger container.
  • Xylocaine TM lignocaine hydrochloride
  • dental practitioners generally use a cartridge which has been aseptically filled and sealed.
  • the prefilled cartridge is inserted into a cartridge holder which has a plunger rod at one end which can be engaged with a stopper located in the open end of the prefilled cartridge, and a needle fitting at the other end suited to receive a double sided needle, (i.e. a hypodermic needle which is fixed to a support with a first end of the needle extending away from the support in a first direction and a second end of the needle extending away from the support in the opposite direction).
  • a double sided needle i.e. a hypodermic needle which is fixed to a support with a first end of the needle extending away from the support in a first direction and a second end of the needle extending away from the support in the opposite direction.
  • the prefilled cartridge includes a penetrable membrane at one end. When the cartridge is inserted into the cartridge holder this end of the cartridge is positioned adjacent to the needle fitting.
  • a double sided needle is usually attached to the needle fitting of the holder before the cartridge is inserted.
  • the forward facing needle of the double sided needle is hollow and intended for use as a hypodermic.
  • the rearward facing needle (also hollow) is constructed to puncture the penetrable membrane which seals the end of the before it is inserted into the cartridge holder.
  • prefilled cartridges suitable for use in cartridge holders such as those used by dental practitioners
  • the present invention is by no means limited to this application. It is also ideally suited for use in prefilled syringes and in other similar applications.
  • the present invention is hereafter described primarily by reference to a prefilled cartridge.
  • the Prior Art Prefilled cartridges have conventionally been made from glass. These products include an elongate barrel sealed at one end by a stopper which is moveable within the barrel and sealed at the other end by a membrane (usually a rubber layer) held in position by an aluminium cap crimped about the end of the barrel.
  • the aluminium cap generally includes a central aperture exposing a portion of the membrane for puncture by a needle.
  • the exposed portion is penetrable by the rearward facing needle of a double sided needle and permits ready access to the contents of the cartridge.
  • This product has some major shortcomings - being made of glass there is the risk of breakage; it involves a number of components and it depends on a crimping force to ensure proper sealing.
  • a container suitable for holding an injectable liquid said container including a cylindrical barrel, a first sealing means positioned within the said barrel and which can be moved therein and a second sealing means positioned within the said barrel; wherein an injectable liquid is housed within the said barrel between the said first sealing means and the second sealing means.
  • the first sealing means is a stopper.
  • the stopper may be made from any suitable material. Most preferably, it is made from a silicone rubber and includes a recess into which the end of a plunger rod may be received. It can be moved in the cylindrical barrel - preferably being moveable by a plunger rod or the like once the second sealing means has been punctured.
  • the second sealing means is preferably puncturable by a needle.
  • the second sealing means is made from a natural or synthetic rubber such as silicone rubber and includes a central membrane portion.
  • the membrane portion of the second sealing means is preferably exposed (ie not covered by any closure or otherwise encased within the barrel) so that the rearward needle of a double sided needle can be directly applied to the membrane for puncture and access to the injectable liquid.
  • the second sealing means is preferably in the form of a moveable stopper.
  • the central portion of the second sealing means is thinner than the edge portions thereof.
  • the circumferential outer portion of the stopper is preferably thicker than the central portion thereof.
  • the outer portion of the circumferential stopper should be thick enough to ensure a good seal with the internal wall of the cylindrical barrel.
  • the central portion is preferably of reduced thickness so that it may readily be punctured by a needle.
  • the circumferential outer face of the second sealing means is preferably concave in shape.
  • the circumferential outer face of the second sealing means does not contact the internal surface of the cylindrical barrel across its entire width but rather contact is made at the high points of the circumferential outer face.
  • This profile enables the smoother introduction and movement of the second sealing means in the barrel when the container is being assembled.
  • the first sealing means is positioned at or near one end
  • the second sealing means is positioned at or near the other end (hereinafter called the "top end") of the said barrel.
  • the second sealing means is positioned immediately adjacent to the top end of the barrel.
  • An internal shoulder or rib may be provided on the internal wall of the cylindrical barrel on the inward side of the second sealing means to provide resistance against movement of the second sealing means towards the first sealing means when pressure is applied to puncture the second sealing means.
  • an internal circumferential rib is provided for this purpose.
  • a critical aspect of the present invention is that the second sealing means is positioned within the barrel of the container.
  • the second sealing means can be restrained from movement towards the first sealing means by the injectable liquid - the liquid being essentially incompressible.
  • the cylindrical barrel of the container can be made of any suitable material.
  • it can be made from glass such as in conventional products although it is desirable in most instances for the barrel to be made from a plastics material such as polypropylene or high density polyethylene.
  • plastics materials include PET, polyamides or TPX.
  • the cylindrical barrel be made from a material which is transparent so that the contents are visible to the user.
  • the container is in the form of a cartridge.
  • the cartridge is of substantially the same dimensions as cartridges used in existing dental cartridge holders so that the product of the present invention may be used in place of existing products without practitioners requiring a new cartridge holder.
  • the cylindrical barrel include an abutment surface at or near the top end of the barrel which is adapted to prevent movement of the second sealing means out of the barrel.
  • the abutment surface is integral with the cylindrical barrel.
  • the abutment surface can be constituted by a shoulder or ring located on the internal wall of the cylindrical barrel.
  • the abutment surface is constituted by an end face to the cylindrical barrel.
  • the end face includes a central aperture which is of smaller diameter than the internal diameter of the cylindrical barrel.
  • the container is in the form of a syringe having a fitting at one end adapted to receive a double sided needle.
  • the second sealing means is positioned within the said barrel at the needle fitting end.
  • the second sealing means is positioned such that when a double sided needle is attached to the needle fitting it will puncture the second sealing means and thus provide access to the injectable liquid.
  • the prefilled syringe includes a plunger rod attached to the first sealing means. In this way, the user can securely support the first sealing means when attaching the double sided needle onto the needle fitting.
  • the first sealing means is preferably in the form of a stopper moveable within the barrel of the syringe to enable expression of the injectable liquid.
  • the second sealing means is preferably restrained against movement towards the first sealing means by the injectable liquid although an internal rib or shoulder may be provided on the internal surface of the cylindrical barrel to further restrict such movement.
  • a syringe which includes: (a) a cartridge receiving compartment; (b) a plunger rod;
  • a double sided needle having a forward facing needle shaped conduit intended for hypodermic use and a rearward facing needle shaped conduit extending into said cartridge receiving compartment, said double sided needle being attached to said needle attachment fitting;
  • a cartridge containing an injectable liquid which is located in said cartridge receiving compartment; wherein said cartridge includes a cylindrical barrel, a stopper positioned within the said barrel which is adapted to be connected to and moved by the plunger rod and sealing means positioned within the barrel towards the needle fitting end of the syringe and wherein the rearward facing needle shaped conduit extends through said sealing means such that the injectable liquid can be expressed through the double sided needle by movement of the stopper towards the sealing means.
  • the cartridge utilised preferably has those preferred features previously described with respect to the cartridge per se.
  • a method for the manufacture of a prefilled container which includes:- (a) injection moulding in an aseptic environment a container barrel having a top end and a bottom end both of which are open;
  • the second pre-sterilised stopper is first compressed and introduced into a separate pre-sterilised tube located in the aseptic environment.
  • the second pre-sterilised stopper is introduced into the tube by means of a funnel having a conical cross section.
  • the tube holding the compressed stopper is then introduced into the bottom end of the container barrel.
  • the external diameter of the tube should be less than the internal diameter of the barrel so that air can escape from within the barrel as the tube is introduced into the bottom end.
  • the stopper is held within the tube with a push-rod and the tube is removed out of the bottom end of the container barrel leaving the second pre-sterilised stopper in a less compressed configuration within the cartridge barrel.
  • the container barrel is injection moulded to have those preferred features hereinbefore discussed with respect to the container of the invention.
  • the circumferential ring preferably provided on the internal surface of the container barrel near the top end thereof and described as a preferred embodiment to assist in retaining the sealing means in position, also provides an advantage in the injection moulding process.
  • the container barrel In injection moulding the container barrel, it is generally necessary to use a mould having a cavity into which there is inserted a pin.
  • the pin is located so that the distance between the face of the mould and the face of the pin is equal to the desired wall thickness of the container barrel.
  • To mould a circumferential ring on the internal surface of the barrel it is necessary that the pin include a circumferential groove. Molten material fills the groove to form the circumferential rib. The cured resin forming the internal rib is held in position in the groove and when the external mould is removed away from the pin the moulded barrel is supported on the pin. This reduces the likelihood of the internal surface of the moulded container barrel being scratched during the process.
  • the inside pin is hardened and is chrome plated.
  • the surface is mirror finished so that withdrawal of the pin is less likely to scratch the internal surface of the barrel when the barrel is being removed from the pin.
  • the container barrel is injection moulded using a plastic resin which will shrink away from the pin on curing.
  • a polypropylene resin of this type being of medical grade, is used.
  • Figure 1 is a perspective view of a cartridge made in accordance with the invention
  • Figure 2 is a cross sectional view of the cartridge shown in Figure 1 ;
  • FIG. 3 shows further details of the top end of the cartridge barrel shown in Figures 1 and 2;
  • Figure 4 illustrates a preferred example of the sealing means intended to be positioned at the apertured end of the cartridge shown in Figure 1 ;
  • FIG. 5 illustrates an alternative stopper to that shown in Figure 4.
  • Figure 6 is a perspective view of a cartridge with a further alternative stopper at the apertured end of the barrel.
  • Cartridge 1 there is illustrated a prefilled cartridge 1 which is suitable for use in a dental cartridge holder (not shown).
  • Cartridge 1 includes a barrel 2 which is substantially cylindrical in cross section and which is open at end 3.
  • Cartridge barrel 2 is made from a plastics material, preferably polypropylene.
  • a stopper 5 is positioned wholly within the barrel. Stopper 5 is made from a silicone rubber and sealingly engages against the internal wall 6 of barrel 2. Stopper 5 is moveable within cartridge barrel 2.
  • end face 8 which is integral with barrel 2.
  • End face 8 includes a central aperture 9 which is of smaller diameter than the internal diameter of barrel 2.
  • An injectable liquid 11 is housed within barrel 2 between stoppers 5 and 10.
  • Figure 2 illustrates a cross sectional view of the cartridge shown in Figure 1 and shows how stopper 10 is positioned immediately adjacent to the inner face of end wall 8.
  • the inner face of end wall 8 provides an abutment surface which restrains stopper 2 preventing it from being pushed out of barrel 2.
  • Figure 3 illustrates a portion of the top end of cartridge 1 in detail.
  • stopper 10 is not included within this illustration.
  • end face 10 have a curved portion 12 towards the edge of aperture 9.
  • the inside surface 13 of end face 8 provides an abutment surface to ensure that stopper 10 is held within barrel 2.
  • the internal surface of barrel 2 includes a circumferential rib 14 located a short distance from the abutment surface 13.
  • stopper 10 is positioned within barrel 2 between abutment surface 13 and circumferential rib 14.
  • FIG. 4 Alternative stoppers suitable for use as stopper 10 are shown in Figures 4 and 5.
  • the stopper illustrated in Figure 4 has a thin penetrable membrane portion 15 and edge portions 16 which are thicker in transverse cross section than the central portion 15.
  • the outer face of edge portion 16 is concave having high points 17 and 18 adapted to form sealing engagement with the internal wall of barrel 2.
  • Pips 19 and 20 are provided on the external face of the stopper shown in Figure 4 and these are shaped to engage within groove 21 shown in Figure 3. This assists in the correct location of stopper 10 within barrel 2.
  • pips 19 and 20 are useful in the mechanised assembly of the cartridge.
  • an automated process would involve a number of similar stoppers being held together and individually transferred and inserted within plastic barrels.
  • FIG. 5 illustrates an alternative stopper in which the central membrane portion 22 is centrally disposed.
  • the edge portion 23 is again broader to ensure sealing engagement against the internal wall of barrel 2 and the profile of the edge portion is once again concave.
  • Pips 24, 25, 26 and 27 are utilised for the same purpose as pips 19 and 20 on the stopper shown in Figure 4.
  • the prefilled cartridge 1 shown in Figure 1 is preferably formed by injection moulding barrel 2 in an aseptic environment and by thereafter introducing a pre- sterilised stopper 2 through opening 3 and pushing the said stopper 10 along the barrel till it contacts abutment surface 13. This involves passing the stopper 10 over circumferential rib 14.
  • Cartridge 1 is then filled with the required injectable liquid. Again, this is done in an aseptic environment. Once filled, stopper 5 (again pre-sterilised) is introduced into barrel 2 to seal the end of the barrel.
  • cartridge 1 is inserted into a cartridge holder to which a double sided needle has been attached to the needle fitting.
  • cartridge 1 is inserted into the cartridge holder by introducing the front end first to ensure that aperture 9 is aligned with the rearward facing needle of the double sided needle attached to the cartridge holder.
  • This rearward facing needle is adapted to pass through aperture 9 and puncture the thin membrane of stopper 10 (this being either membrane 15 of the stopper shown in Figure 4 or membrane 22 of the stopper shown in Figure 5).
  • the cartridge 1 is then locked into position within the cartridge holder. Thereafter, movement of stopper 5 towards stopper 10 will cause the injectable liquid to pass out of the barrel through the double sided needle.
  • stopper 10 is restrained from moving towards stopper 5 by the circumferential rib 14 and also by the injectable liquid 11 itself which is substantially incompressible.
  • FIG 6 there is illustrated a cartridge similar to that shown in Figure 1 but with an alternative stopper 10a at the top end 7 of the cartridge barrel 2.
  • Stopper 10a is identical to stopper 5 and includes an opening and internal passage (suitable for receiving a plunger rod at the bottom end) on one side of the stopper and a membrane on the other side of the stopper.
  • stopper 10a should be oriented so that the membrane side of the stopper is adjacent to end face 8 and the opening and internal passage of the stopper 10a faces stopper 5.
  • the cartridge of the present invention avoids the necessity of prior arrangements of attaching a separate sealing member over the end of the cartridge.
  • the cartridge of the present invention is simple to manufacture and assemble and is applicable in a number of different applications.

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

L'invention concerne un récipient (1) pouvant contenir un liquide injectable (11), qui comprend un corps de pompe cylindrique (2), un premier dispositif obturateur (5) positionné à l'intérieur dudit corps de pompe et pouvant être déplacé à l'intérieur de celui-ci, et un second dispositif obturateur (10) positionné à l'intérieur dudit corps. Un liquide injectable est contenu dans le corps de pompe, entre le premier et le second dispositif obturateur.
PCT/AU1998/000407 1997-06-10 1998-06-02 Recipient prerempli WO1998056438A1 (fr)

Priority Applications (1)

Application Number Priority Date Filing Date Title
AU76307/98A AU7630798A (en) 1997-06-10 1998-06-02 Prefilled container

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
AUPO7239 1997-06-10
AUPO7239A AUPO723997A0 (en) 1997-06-10 1997-06-10 Prefilled container

Publications (1)

Publication Number Publication Date
WO1998056438A1 true WO1998056438A1 (fr) 1998-12-17

Family

ID=3801530

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/AU1998/000407 WO1998056438A1 (fr) 1997-06-10 1998-06-02 Recipient prerempli

Country Status (2)

Country Link
AU (1) AUPO723997A0 (fr)
WO (1) WO1998056438A1 (fr)

Cited By (11)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
FR2805166A1 (fr) * 2000-02-22 2001-08-24 Sedat Seringue preemplie a deux pistons mobiles retenant un liquide a injecter
FR2809628A1 (fr) * 2000-06-05 2001-12-07 Sedat Seringue preemplie a deux pistons mobiles retenant un liquide a injecter
US8177767B2 (en) 2001-08-27 2012-05-15 Novo Nordisk A/S Cartridge and medical delivery system accommodating such cartridge
US8579868B2 (en) 2006-07-15 2013-11-12 Novo Nordisk A/S Medical delivery system with flexible blocking element
US8613731B2 (en) 2006-07-15 2013-12-24 Novo Nordisk A/S Medical delivery system with asymmetrical coding means
US8632506B2 (en) 2006-06-30 2014-01-21 Novo Nordisk A/S Medical delivery system comprising a coding mechanism
US8740857B2 (en) 2006-12-21 2014-06-03 Novo Nordisk A/S Syringe device
US9289558B2 (en) 2006-11-21 2016-03-22 Novo Nordisk A/S Medical delivery system comprising locking ring with L-shaped grooves
US10905786B2 (en) 2017-03-27 2021-02-02 Regeneron Pharmaceuticals, Inc. Sterilisation method
US11433186B2 (en) 2017-12-13 2022-09-06 Regeneron Pharmaceuticals, Inc. Devices and methods for precision dose delivery
US11439758B2 (en) 2019-06-05 2022-09-13 Regeneron Pharmaceuticals, Inc. Devices and methods for precision dose delivery

Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US3858580A (en) * 1969-06-04 1975-01-07 Ims Ltd Intravenous container mixing assembly
AU4162578A (en) * 1977-11-16 1979-05-24 Smith & Nephew Australia Hypodermic syringe assembly
AU7363281A (en) * 1981-08-03 1983-02-10 George Daskal Disposable vial-syringe
US4529403A (en) * 1981-08-10 1985-07-16 Duphar International Research B.V. Automatic injection syringe
GB2152818A (en) * 1985-08-12 1985-08-14 Frank Smith Fluid injector for injecting medicaments
EP0219899A1 (fr) * 1985-10-11 1987-04-29 Duphar International Research B.V Seringue automatique

Patent Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US3858580A (en) * 1969-06-04 1975-01-07 Ims Ltd Intravenous container mixing assembly
AU4162578A (en) * 1977-11-16 1979-05-24 Smith & Nephew Australia Hypodermic syringe assembly
AU7363281A (en) * 1981-08-03 1983-02-10 George Daskal Disposable vial-syringe
US4529403A (en) * 1981-08-10 1985-07-16 Duphar International Research B.V. Automatic injection syringe
GB2152818A (en) * 1985-08-12 1985-08-14 Frank Smith Fluid injector for injecting medicaments
EP0219899A1 (fr) * 1985-10-11 1987-04-29 Duphar International Research B.V Seringue automatique

Cited By (13)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
FR2805166A1 (fr) * 2000-02-22 2001-08-24 Sedat Seringue preemplie a deux pistons mobiles retenant un liquide a injecter
FR2809628A1 (fr) * 2000-06-05 2001-12-07 Sedat Seringue preemplie a deux pistons mobiles retenant un liquide a injecter
US8177767B2 (en) 2001-08-27 2012-05-15 Novo Nordisk A/S Cartridge and medical delivery system accommodating such cartridge
US8632506B2 (en) 2006-06-30 2014-01-21 Novo Nordisk A/S Medical delivery system comprising a coding mechanism
US8579868B2 (en) 2006-07-15 2013-11-12 Novo Nordisk A/S Medical delivery system with flexible blocking element
US8613731B2 (en) 2006-07-15 2013-12-24 Novo Nordisk A/S Medical delivery system with asymmetrical coding means
US9050397B2 (en) 2006-07-15 2015-06-09 Novo Nordisk A/S Medical delivery system with a rotatable coding element
US9289558B2 (en) 2006-11-21 2016-03-22 Novo Nordisk A/S Medical delivery system comprising locking ring with L-shaped grooves
US8740857B2 (en) 2006-12-21 2014-06-03 Novo Nordisk A/S Syringe device
US10905786B2 (en) 2017-03-27 2021-02-02 Regeneron Pharmaceuticals, Inc. Sterilisation method
US10918754B2 (en) 2017-03-27 2021-02-16 Regeneron Pharmaceuticals, Inc. Sterilisation method
US11433186B2 (en) 2017-12-13 2022-09-06 Regeneron Pharmaceuticals, Inc. Devices and methods for precision dose delivery
US11439758B2 (en) 2019-06-05 2022-09-13 Regeneron Pharmaceuticals, Inc. Devices and methods for precision dose delivery

Also Published As

Publication number Publication date
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