WO1994013345A1 - Seringue sterilisee pre-remplie et procede de fabrication - Google Patents

Seringue sterilisee pre-remplie et procede de fabrication Download PDF

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Publication number
WO1994013345A1
WO1994013345A1 PCT/US1993/011977 US9311977W WO9413345A1 WO 1994013345 A1 WO1994013345 A1 WO 1994013345A1 US 9311977 W US9311977 W US 9311977W WO 9413345 A1 WO9413345 A1 WO 9413345A1
Authority
WO
WIPO (PCT)
Prior art keywords
container
piston
prefilled
delivery apparatus
syringe
Prior art date
Application number
PCT/US1993/011977
Other languages
English (en)
Inventor
Karen Coulson
Original Assignee
Mallinckrodt Medical, Inc.
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 Mallinckrodt Medical, Inc. filed Critical Mallinckrodt Medical, Inc.
Priority to AU57454/94A priority Critical patent/AU5745494A/en
Publication of WO1994013345A1 publication Critical patent/WO1994013345A1/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
    • A61M5/31—Details
    • A61M5/315—Pistons; Piston-rods; Guiding, blocking or restricting the movement of the rod or piston; Appliances on the rod for facilitating dosing ; Dosing mechanisms
    • A61M5/31511—Piston or piston-rod constructions, e.g. connection of piston with piston-rod
    • A61M5/31513—Piston constructions to improve sealing or sliding
    • 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
    • A61M2005/3103—Leak prevention means for distal end of syringes, i.e. syringe end for mounting a needle
    • A61M2005/3104—Caps for syringes without needle
    • 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
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/02—General characteristics of the apparatus characterised by a particular materials
    • A61M2205/0222—Materials for reducing friction
    • 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
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/02—General characteristics of the apparatus characterised by a particular materials
    • A61M2205/0238—General characteristics of the apparatus characterised by a particular materials the material being a coating or protective layer
    • 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
    • A61M2207/00—Methods of manufacture, assembly or production

Definitions

  • This invention relates to prefilled sterile delivery apparatus containing various media such as fluids suitable for injection in the diagnosis and/or treatment of medical conditions and the method of manufacturing the same.
  • This lubricant is used to provide the syringe barrel and piston with requisite sliding properties that allow smooth movement of the piston within the barrel with relatively little friction.
  • the presence of the silicone lubricants in locations wherein the same come into contact with the injection fluids in the syringe presents a risk that particulates of the silicone lubricant will be incorporated in the injection fluid and injected with it.
  • the present invention provides a prefilled, sterile delivery apparatus and process for making the same in which a satisfactory sliding relationship between the " piston and syringe barrel is attained without possible entraining of silicone oil in the injection fluid stored in the syringe and delivered therefrom.
  • FIG. 1 is a sectional view of a prefilled, sterile delivery apparatus embodying the present invention.
  • FIG. 2 is a sectional view of a prefilled, sterile delivery apparatus in the form of another embodiment of the present invention.
  • a prefilled, sterile delivery apparatus in the form of a syringe indicated generally at 20 includes a container or barrel 22 having a delivery end in the form of a nozzle 24 and an open end 28 away from the nozzle 24.
  • the container 22 is shown as cylindrical, it will be recognized that such shape is exemplary only and that the container 22 can be of either a cylindrical or a non-cylindrical shape, e.g. triangular or square.
  • the nozzle 24 is shown closed by a tip seal 26, but it will be recognized that any suitable means for closing the nozzle so as to seal the contents 30 within the syringe 20 is sufficient.
  • the open end 28 of the container 22 is closed and sealed by a piston 32 to form a storage volume containing the fluid contents 30.
  • the contents 30 can be any medicinal or diagnostic fluid material, including but not limited to contrast media.
  • the term fluid means a medical fluid and encompasses liquids, gases or combinations thereof, comprising or containing pharmaceutical media.
  • the piston can be operated by a handle 38 for expelling the contents 30 through the nozzle 24.
  • the syringe parts are individually manufactured and the container 22 can be of any suitable material capable of withstanding applicable sterilization techniques, e.g. autoclaving.
  • the container 22 is produced by a suitable plastic-forming process such as injection molding of a suitable polymer such as polypropylene, or a co-polymer of polypropylene and polyethylene.
  • the tip seal 26 is likewise produced by injection molding a suitable elastomeric plastic or rubber material to the desired shape.
  • the piston 32 is formed by a piston body 34 having laminated thereto an outer solid film lubricant layer 36.
  • the piston body 34 is formed of a resilient material such as rubber and the solid film lubricant layer is a tetrafluoroethylene resin.
  • the piston 32 is similar in structure to the piston arrangement utilized in the unfilled syringe assembly disclosed in U.S. Patent Nos. 5,009,646 and 4,997,423.
  • a procedure for producing the piston includes placing a film for lamination on the surface of a rubber sheet and then simultaneously subjecting the film and sheet to molding and laminating.
  • various materials from which the piston body and solid film layer can be suitably manufactured are various materials from which the piston body and solid film layer can be suitably manufactured.
  • the piston body can be made, for example, of a rubber or elastic or resilient material including isoprene, butadiene, styrene-butadiene, ethylene-propylene, isoprene-isobutylene and nitrile rubbers.
  • the solid film lubricant layer can be made, for example, of a fluoro resin film including tetrafluoroethylene or ethylene-tetrafluoroethylene, and can also be made of a polyethylene resin.
  • the prefilled, sterile syringes of the prior art which utilize a mist of silicone oil placed on the piston and barrel, are filled with fluid and then subjected to a rigorous sterilization process, e.g. an autoclaving process which typically involves placing the filled syringes in a steam/air autoclave operating at temperatures of about 125°C.
  • the prefilled, sterile syringe apparatus of the present invention can be subjected to a harsh sterilization process, e.g. autoclaving, without any mechanical degradation such as delamination of the piston body and film layer or other compromise of the sealing properties of the piston. It is thus possible in accordance with the present invention to produce a prefilled, sterile syringe 20 in which a proper sliding relationship between the piston 32 and the container 22 is provided without the use of silicone oil lubricants. Consequently, the prefilled, sterile syringe 20 of the present invention virtually eliminates the risk of injecting contaminants with the fluids ejected from the syringe.
  • a harsh sterilization process e.g. autoclaving
  • the piston 132 has a push rod 138 which is configured to engage a recess formed in the piston body. It is also within the scope of the present invention that the piston be gripped and driven by a conventional power injecting device known in the art.
  • the syringe 120 has any suitable means for attaching additional medical apparatus thereto, for example a nut 125 threaded onto nozzle 124 for engaging the conventional luer connector of a catheter (not shown).
  • the container 22, piston 32 and tip seal 26, are first subjected to appropriate steps to wash the same and to remove any debris and contaminants as disclosed in U.S. Patent Nos. 4,628,969 and 4,718,463, assigned to the same assignee as the present application, the subject matter of which patents is incorporated herein by reference.
  • the container 22 is then filled with a desired quantity of fluid material, e.g. contrast media.
  • the piston 32 is then assembled in the open end 28 of the container 22 to seal the liquid in the syringe 20.
  • the assembled syringe 20 and its contents 30 are then sterilized by an appropriate procedure such as being placed in a steam/air autoclave.
  • the steam/air mixture autoclave may selectively add compressed air during the autoclave cycle in order to maintain a pressure on the exterior of the filled syringe which is at least as great as the pressure of the syringe contents.
  • the present invention provides a prefilled, sterile delivery apparatus having all the attributes of the prior art prefilled, sterile syringes without the disadvantages that arise from the use of silicon oil lubricants.
  • the unexpected discovery that a piston laminated with a solid film lubricant could be used in a prefilled syringe and withstand the extreme conditions that are part of the sterilization process without degradation or delamination of the piston structure provides a superior prefilled, sterile syringe. It will be understood that many modifications and variations may be made to the present invention described above without departing from the spirit and scope thereof.

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

On décrit un dispositif de diffusion stérile pré-rempli (20) et son procédé de fabrication. Ce dispositif prend la forme d'une seringue qui présente un compartiment (22) rempli de liquide, une buse obturée (24) à une extrémité, ainsi qu'une autre extrémité obturée par un piston (32). Ce dernier comporte une partie du corps élastique dotée sur sa face externe d'un lubrifiant à couche solide (36) destiné à faciliter le coulissement du piston au contact de la paroi interne du compartiment. L'ensemble obturé est stérilisé et donne une seringue stérile dotée d'un contenu stérile. Le lubrifiant à couche solide confère au piston la propriété de coulisser tout en évitant l'utilisation d'huiles de silicone ou autres qui peuvent contaminer le contenu liquide. Le piston subit une stérilisation quand il se trouve dans le compartiment, sans effet contraire tel qu'une délamination. Le procédé exposé consiste à remplir le compartiment de la seringue avec un fluide déterminé, un milieu de contraste par exemple, à obturer le compartiment avec le piston et à stériliser l'ensemble obturé.
PCT/US1993/011977 1992-12-14 1993-12-09 Seringue sterilisee pre-remplie et procede de fabrication WO1994013345A1 (fr)

Priority Applications (1)

Application Number Priority Date Filing Date Title
AU57454/94A AU5745494A (en) 1992-12-14 1993-12-09 Pre-filled, sterilized syringe and method of making

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US98827692A 1992-12-14 1992-12-14
US07/988,276 1992-12-14

Publications (1)

Publication Number Publication Date
WO1994013345A1 true WO1994013345A1 (fr) 1994-06-23

Family

ID=25533998

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/US1993/011977 WO1994013345A1 (fr) 1992-12-14 1993-12-09 Seringue sterilisee pre-remplie et procede de fabrication

Country Status (2)

Country Link
AU (1) AU5745494A (fr)
WO (1) WO1994013345A1 (fr)

Cited By (12)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
FR2750961A1 (fr) * 1996-07-15 1998-01-16 Aubert Guy Tete de piston aseptique et interchangeable
WO1998017339A1 (fr) * 1996-10-18 1998-04-30 Schering Aktiengesellschaft Seringue avec bouchon en polyethylene
US6189292B1 (en) 1998-03-13 2001-02-20 Becton Dickinson And Company Method and apparatus for manufacturing, filling and packaging medical devices and medical containers
WO2002014045A1 (fr) * 2000-08-15 2002-02-21 Borealis Technology Oy Procede de moulage par injection d'une seringue a partir d'une cire polyethylene renfermant du polypropylene, seringue ainsi obtenue et composition particulaire de la cire
EP1317937A1 (fr) * 2000-09-14 2003-06-11 Terumo Kabushiki Kaisha Joint et son procede de fabrication
WO2006128564A1 (fr) * 2005-05-31 2006-12-07 Baxter International Inc. Cylindre creux en polypropylene pourvu d'un piston en caoutchouc coulissant
EP1819383A1 (fr) * 2004-12-01 2007-08-22 Wlt Distributors Inc. Injecteur sans aiguille
US7587820B2 (en) 2001-12-27 2009-09-15 Terumo Kabushiki Kaisha Metal tubular body and manufacturing method thereof
US8343094B2 (en) 2008-10-22 2013-01-01 Shaw Thomas J Universal syringe with retractable needle
US20150018800A1 (en) * 2013-07-10 2015-01-15 Merit Medical Systems, Inc. Pre-loaded syringes and methods related thereto
US9295790B2 (en) 2006-05-05 2016-03-29 Retractable Technologies, Inc. Syringe with recessed nose and protective guard for use with frontal attachments
CN111579623A (zh) * 2015-03-27 2020-08-25 株式会社日立高新技术 电泳装置及电泳方法

Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4718463A (en) * 1985-12-20 1988-01-12 Mallinckrodt, Inc. Method of producing prefilled sterile plastic syringes
US4997423A (en) * 1986-10-15 1991-03-05 Daikyo Gomu Seiko Ltd. Laminated sliding stopper for a syringe

Patent Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4718463A (en) * 1985-12-20 1988-01-12 Mallinckrodt, Inc. Method of producing prefilled sterile plastic syringes
US4997423A (en) * 1986-10-15 1991-03-05 Daikyo Gomu Seiko Ltd. Laminated sliding stopper for a syringe

Cited By (25)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
FR2750961A1 (fr) * 1996-07-15 1998-01-16 Aubert Guy Tete de piston aseptique et interchangeable
WO1998017339A1 (fr) * 1996-10-18 1998-04-30 Schering Aktiengesellschaft Seringue avec bouchon en polyethylene
WO1998017338A1 (fr) * 1996-10-18 1998-04-30 Schering Aktiengesellschaft Seringues steriles pre-remplies, a bouchon en polyethylene
US6792743B2 (en) 1998-03-13 2004-09-21 Becton, Dickinson And Company Method and apparatus for manufacturing, filling and packaging medical devices and medical containers
US6189292B1 (en) 1998-03-13 2001-02-20 Becton Dickinson And Company Method and apparatus for manufacturing, filling and packaging medical devices and medical containers
US6250052B1 (en) 1998-03-13 2001-06-26 Becton, Dickinson And Company Method and apparatus for assembling and packaging medical devices
US6263641B1 (en) 1998-03-13 2001-07-24 Becton, Dickinson And Company Method and apparatus for manufacturing, filling and packaging medical devices and medical containers
USRE46510E1 (en) 1998-03-13 2017-08-15 Becton, Dickinson And Company Method and apparatus for manufacturing, filling and packaging medical devices and medical containers
WO2002014045A1 (fr) * 2000-08-15 2002-02-21 Borealis Technology Oy Procede de moulage par injection d'une seringue a partir d'une cire polyethylene renfermant du polypropylene, seringue ainsi obtenue et composition particulaire de la cire
US7182987B2 (en) 2000-08-15 2007-02-27 Borealis Technology Oy Process of injection moulding a syringe from polyethylene wax containing polypropylenne, syringe obtained thereby and particulate composition therefor
CZ300021B6 (cs) * 2000-08-15 2009-01-14 Borealis Technology Oy Cásticová polypropylenová smes pro injekcní vstrikování, telo injekcní stríkacky vytvorené z této smesi a injekcní stríkacka mající takové telo
EP1317937A4 (fr) * 2000-09-14 2006-02-08 Terumo Corp Joint et son procede de fabrication
EP1317937A1 (fr) * 2000-09-14 2003-06-11 Terumo Kabushiki Kaisha Joint et son procede de fabrication
US7587820B2 (en) 2001-12-27 2009-09-15 Terumo Kabushiki Kaisha Metal tubular body and manufacturing method thereof
EP1819383A1 (fr) * 2004-12-01 2007-08-22 Wlt Distributors Inc. Injecteur sans aiguille
JP2008521522A (ja) * 2004-12-01 2008-06-26 ダブリューエルティ ディストリビューターズ インク 無針注射器
EP1819383A4 (fr) * 2004-12-01 2010-08-18 Acushot Inc Injecteur sans aiguille
EP2532378A3 (fr) * 2004-12-01 2013-03-06 AcuShot, Inc. Injecteur sans aiguille
WO2006128564A1 (fr) * 2005-05-31 2006-12-07 Baxter International Inc. Cylindre creux en polypropylene pourvu d'un piston en caoutchouc coulissant
US8636688B2 (en) 2006-05-05 2014-01-28 Retractable Technologies, Inc. Universal syringe with retractable needle
US9295790B2 (en) 2006-05-05 2016-03-29 Retractable Technologies, Inc. Syringe with recessed nose and protective guard for use with frontal attachments
US8343094B2 (en) 2008-10-22 2013-01-01 Shaw Thomas J Universal syringe with retractable needle
US20150018800A1 (en) * 2013-07-10 2015-01-15 Merit Medical Systems, Inc. Pre-loaded syringes and methods related thereto
US9744303B2 (en) * 2013-07-10 2017-08-29 Merit Medical Systems, Inc. Pre-loaded syringes and methods related thereto
CN111579623A (zh) * 2015-03-27 2020-08-25 株式会社日立高新技术 电泳装置及电泳方法

Also Published As

Publication number Publication date
AU5745494A (en) 1994-07-04

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