EP1744717A1 - Spritze für medizinische eingriffe und diese enthaltender kit zur rekonstitution unvorbereiteter substanzen - Google Patents

Spritze für medizinische eingriffe und diese enthaltender kit zur rekonstitution unvorbereiteter substanzen

Info

Publication number
EP1744717A1
EP1744717A1 EP05763666A EP05763666A EP1744717A1 EP 1744717 A1 EP1744717 A1 EP 1744717A1 EP 05763666 A EP05763666 A EP 05763666A EP 05763666 A EP05763666 A EP 05763666A EP 1744717 A1 EP1744717 A1 EP 1744717A1
Authority
EP
European Patent Office
Prior art keywords
syringe
syringe body
chamber
auxiliary
passage
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.)
Granted
Application number
EP05763666A
Other languages
English (en)
French (fr)
Other versions
EP1744717B1 (de
Inventor
Jean-Pascal Delay
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.)
Sedat SAS
Original Assignee
Sedat SAS
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 Sedat SAS filed Critical Sedat SAS
Publication of EP1744717A1 publication Critical patent/EP1744717A1/de
Application granted granted Critical
Publication of EP1744717B1 publication Critical patent/EP1744717B1/de
Ceased legal-status Critical Current
Anticipated expiration legal-status Critical

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS 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
    • A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/14—Details; Accessories therefor
    • A61J1/20—Arrangements for transferring or mixing fluids, e.g. from vial to syringe
    • A61J1/2096—Combination of a vial and a syringe for transferring or mixing their contents
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS 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
    • A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/14—Details; Accessories therefor
    • A61J1/20—Arrangements for transferring or mixing fluids, e.g. from vial to syringe
    • A61J1/2089—Containers or vials which are to be joined to each other in order to mix their contents
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS 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
    • A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/05—Containers specially adapted for medical or pharmaceutical purposes for collecting, storing or administering blood, plasma or medical fluids ; Infusion or perfusion containers
    • A61J1/10—Bag-type containers
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS 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
    • A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/14—Details; Accessories therefor
    • A61J1/1475—Inlet or outlet ports
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS 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
    • A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/14—Details; Accessories therefor
    • A61J1/20—Arrangements for transferring or mixing fluids, e.g. from vial to syringe
    • A61J1/2003—Accessories used in combination with means for transfer or mixing of fluids, e.g. for activating fluid flow, separating fluids, filtering fluid or venting
    • A61J1/2006—Piercing means
    • A61J1/201—Piercing means having one piercing end
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS 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
    • A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/14—Details; Accessories therefor
    • A61J1/20—Arrangements for transferring or mixing fluids, e.g. from vial to syringe
    • A61J1/2003—Accessories used in combination with means for transfer or mixing of fluids, e.g. for activating fluid flow, separating fluids, filtering fluid or venting
    • A61J1/2006—Piercing means
    • A61J1/2013—Piercing means having two piercing ends
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS 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
    • A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/14—Details; Accessories therefor
    • A61J1/20—Arrangements for transferring or mixing fluids, e.g. from vial to syringe
    • A61J1/2003—Accessories used in combination with means for transfer or mixing of fluids, e.g. for activating fluid flow, separating fluids, filtering fluid or venting
    • A61J1/2006—Piercing means
    • A61J1/2017—Piercing means having three or more piercing ends
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS 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
    • A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/14—Details; Accessories therefor
    • A61J1/20—Arrangements for transferring or mixing fluids, e.g. from vial to syringe
    • A61J1/2003—Accessories used in combination with means for transfer or mixing of fluids, e.g. for activating fluid flow, separating fluids, filtering fluid or venting
    • A61J1/202—Separating means
    • A61J1/2037—Separating means having valve means
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS 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
    • A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/14—Details; Accessories therefor
    • A61J1/20—Arrangements for transferring or mixing fluids, e.g. from vial to syringe
    • A61J1/2003—Accessories used in combination with means for transfer or mixing of fluids, e.g. for activating fluid flow, separating fluids, filtering fluid or venting
    • A61J1/2048—Connecting means
    • A61J1/2058—Connecting means having multiple connecting ports
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS 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
    • A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/14—Details; Accessories therefor
    • A61J1/20—Arrangements for transferring or mixing fluids, e.g. from vial to syringe
    • A61J1/2003—Accessories used in combination with means for transfer or mixing of fluids, e.g. for activating fluid flow, separating fluids, filtering fluid or venting
    • A61J1/2048—Connecting means
    • A61J1/2058—Connecting means having multiple connecting ports
    • A61J1/2062—Connecting means having multiple connecting ports with directional valves
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS 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
    • A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/14—Details; Accessories therefor
    • A61J1/20—Arrangements for transferring or mixing fluids, e.g. from vial to syringe
    • A61J1/2003—Accessories used in combination with means for transfer or mixing of fluids, e.g. for activating fluid flow, separating fluids, filtering fluid or venting
    • A61J1/2068—Venting means
    • A61J1/2072—Venting means for internal venting
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS 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
    • A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/14—Details; Accessories therefor
    • A61J1/20—Arrangements for transferring or mixing fluids, e.g. from vial to syringe
    • A61J1/2003—Accessories used in combination with means for transfer or mixing of fluids, e.g. for activating fluid flow, separating fluids, filtering fluid or venting
    • A61J1/2068—Venting means
    • A61J1/2075—Venting means for external venting

Definitions

  • the present invention relates to a syringe and a kit for reconstituting extemporaneous substances comprising such a syringe.
  • the invention relates to a syringe, of the type comprising: - a syringe body in which a passage for circulating a fluid is delimited, this circulation passage being extended by a main fluid connection member to an additional volume , and - a piston movable in the syringe body delimiting, with the syringe body, a fluid confinement chamber, which confinement chamber opens through said circulation passage.
  • a syringe In the medical field, it is known to use a syringe to ensure the reconstitution of an extemporaneous mixture consisting of a solvent and a cytotoxic active principle.
  • the active principle is for example used for the treatment by chemotherapy of patients suffering from cancer.
  • the solvent is commonly initially contained in an infusion bag, while the cytotoxic active ingredient, generally in powder form, is initially contained in a vial.
  • the practitioner takes solvent from the bag to introduce it into the body of a syringe.
  • the solvent thus withdrawn is introduced into the bottle where it mixes with the powder constituting the active principle.
  • the mixture thus reconstituted is re-aspirated into the syringe, before being transferred back to the infusion bag.
  • the latter is then placed on an infusion line to gradually administer its contents to the patient.
  • the excess air contained in the flask during the introduction of the solvent, is discharged into the atmosphere by a vent provided for this purpose.
  • the real effectiveness of such a filter is discussed and the implementation of this filter is delicate and costly.
  • the object of the invention is therefore to propose a syringe avoiding such gaseous releases which may be harmful to medical personnel.
  • the subject of the invention is a syringe of the aforementioned type, characterized in that the syringe body delimits an enclosed space in which the piston is movably mounted, which piston delimits in this enclosed space, in addition to the fluid confinement chamber, an auxiliary return chamber, the syringe body delimiting a return passage opening in said auxiliary return chamber, and that said return passage is extended by an auxiliary member for connection to said complementary volume.
  • the syringe comprises one or more of the following characteristics: - said auxiliary connection member comprises a hollow needle; - It comprises a piston actuating rod linked to the piston and projecting from the syringe body from a rear end, said circulation passage being formed at the front end of the syringe body, and said return passage is formed at near the rear end of the syringe body and the auxiliary connection member extends along the length of the syringe body of the return passage in the vicinity of the front end; -
  • the main fluid connection member comprises a distributor comprising a base delimiting at least three circulation paths and a shutter movable relative to the base, a first path being connected to said circulation passage, a second path comprising a connecting conduit said additional volume and a third channel comprising a transfer duct, said shutter being movable between a transfer position in which the first and third channels are connected and a preparation position in which the first and second channels are connected.
  • - the syringe body and the dispenser are inseparable; - the transfer duct comprises a hollow needle; and - said hollow needle of the transfer duct comprises a perforable and elastically deformable cap covering the hollow needle; -
  • the connecting conduit comprises a hollow needle; - the free end sections of the hollow needles of the auxiliary connection member and of the connecting duct are spaced less than 1 cm apart.
  • the subject of the invention is also a reconstitution kit comprising a syringe as defined above and an additional volume suitable for simultaneous connection to the confinement chamber and to the auxiliary booster chamber respectively through the main organ of fluid connection and the auxiliary connection member.
  • FIG. 1 is an exploded perspective view of a reconstruction kit comprising a syringe according to the invention
  • - Figures 2 to 6 are views in longitudinal section of the kit at successive stages of use.
  • the reconstruction kit 10 illustrated in FIG. 1 is intended in particular for the extemporaneous preparation of a cytotoxic or other drug for the treatment by cancer chemotherapy or the like.
  • This kit essentially comprises a syringe 12 and a vial 13 initially comprising an active principle in the form of powder.
  • This bottle 13 is formed, for example and as illustrated in FIG.
  • the syringe 12 is suitable for being connected, on the one hand, to the bottle 13 and, on the other hand, to an infusion bag 16. More specifically, the syringe 12 comprises a syringe body 18 carrying graduations 19 and a dispenser three ways 20 allowing the selective connection of a chamber of the syringe body selectively to the bottle 12 or to the infusion bag 16. As illustrated in FIGS. 2 to 6, the syringe body 18 comprises a cylindrical wall 22 of generally circular section closed at one front end by a transverse wall 24 delimited by a base 26 of the dispenser 20.
  • This wall 24 is pierced with a passage 28 for circulation of a fluid entering or leaving the syringe.
  • the passage 28 is extended by a conduit 30 forming a first channel of the dispenser 20.
  • the cylindrical wall 22 is closed by a transverse wall 31 pierced in its center with an orifice 32 for the circulation of a piston rod 34.
  • the piston rod 34 is disposed along the axis of the syringe body and has, at its end received in the syringe body, a piston 36 which can be moved axially from one end to the other of the syringe body and having a peripheral lip 38 ensuring sealing along the wall.
  • the piston rod 34 has a transverse bearing surface 38.
  • An O-ring seal 40 is disposed against the transverse wall 31 at the periphery of the piston rod 34. This seal is compressed by a support washer 42.
  • the piston 36 delimits in the syringe body, at the front, a chamber 44 for confining the fluid. This chamber is generally closed and is only open via the circulation passage 28.
  • On the other side of the piston 36 is defined an auxiliary chamber 46 for booster gas excess.
  • the chambers 44 and 46 are complementary and together form an enclosed space delimited by the syringe body 18.
  • the auxiliary return chamber 46 is closed and opens only by a passage 48 for recalling an excess of gas.
  • the auxiliary connection member 50 is formed from a metal or plastic tube of reduced section, for example 0.5 mm inside diameter. This comprises a main rectilinear section 50A and two bent end sections 50B, 50C generally extend perpendicular to the main rectilinear section 50A.
  • the straight section 50A has a length very slightly greater than the length of the syringe body 18.
  • the rear bent end 50B is engaged in the return passage 48.
  • the main straight section 50A extends along the length of the cylindrical wall 22 To maintain the tube 50, the syringe body pre- feels, on its outer surface, a channel 52 delimited by two longitudinal lips 54 visible in FIG. 1.
  • the front curved end 50C is bevelled at its end denoted 50D, so that the auxiliary connection member 50 constitutes a hollow needle .
  • the beveled end 50D is suitable for engaging through the perforable cap 15 closing the neck of the bottle 13.
  • the base 26 of the dispenser 20 is formed for example from injected plastic.
  • the wall 24 forming the end of the syringe body is bordered on the outside by a flange 60 allowing the cylindrical wall 22 to be joined. This joining is carried out inseparably, for example by gluing or ultrasonic welding, so that the dispenser cannot be dissociated from the syringe body 18.
  • the base 26 defines a cylindrical seat 62 in which a sliding plug 64 is received from the dispenser.
  • a conduit 70 for connection to the bottle 13 forms a second channel of the dispenser. It comprises a hollow needle 72 protruding from the base 26. The needle 72 extends parallel to the bent section 50C and is intended, like him, to enter the bottle 13 through the perforable cap 15.
  • the beveled ends of needles 50 and 72 are arranged in the vicinity of one another and are preferably spaced less than 1 cm and preferably 1 to 3 mm.
  • the base 26 has a collar 74 surrounding the projecting end of the needle 72.
  • This collar defines a space for receiving the neck of the bottle 13 and comprises profiles 76 of elastic engagement behind the neck to ensure a mechanical connection of the bottle and dispenser.
  • the bent section 50C extends in the space delimited by the flange 74, the section 50C and the needle 72 extending parallel to each other for a perforation of the cover 15.
  • the third way of the dispenser comprises a conduit 80 for transfer to the infusion bag 16.
  • This conduit is provided with a hollow needle 82 projecting relative to the base 26, in a generally cylindrical base 84 formed in the base and suitable for receiving a nose 86 of the infusion bag 16.
  • this nose 86 is generally cylindrical and is perforable to allow access to the bag by an access duct 88.
  • the projecting end of the needle 82 is covered on its entire length by an elastic perforable cap 90 in the form of a bellows capable of being compressed axially along the needle 82.
  • the plug 64 is mounted to rotate about its axis, the latter extending perpendicular to the plane in which s '' expand conduits 3 0, 70 and 80.
  • a peripheral groove 92 is provided on the plug 64 to allow the selective connection of the conduits. This groove extends over 180 °.
  • the plug is suitable for, in a first so-called transfer position, ensuring the connection of the conduits 30 and 80, the conduit 70 being closed and, in a second so-called preparation position, ensuring the connection of the conduits 30 and 70, the conduit 80 being closed.
  • the reconstitution kit is used as follows. Initially, the bag 16 and the bottle 13 are not linked to the syringe 12, as illustrated in FIG. 2. The syringe is stored in a sterile packaging. After removal from the packaging, the syringe 12 is first connected to the pocket 16 from the needle 82. For this purpose, the nose 86 of the pocket is engaged in the base 84, so that the cap 90 is perforated by needle 82 and retracts along this needle.
  • the beveled end of the needle 82 pierces the nose of the pocket and thus comes into contact with the solvent contained in it, as illustrated in FIG. 3.
  • the valve of the distributor being in its transfer position and connecting the conduits 30 and 80, the piston 36, initially pressed against the front wall 24, is pulled back. Under the action of the displacement of the piston 36, solvent is gradually extracted from the bag and is received in the confinement chamber 44, as illustrated in FIG. 3.
  • the air contained in the auxiliary chamber 46 is gradually evacuated through the auxiliary connection member 50. The air is discharged into the atmosphere, without consequence, this air being sterile.
  • the bottle 13 is connected. For this purpose, the neck of the bottle is introduced into the space delimited by the collar 74.
  • the cover 15 is then perforated both by the needle 72 and by the needle 50.
  • the plug 64 is then turned 90 ° to be brought into its preparation position, so that the conduits 30 and 70 are connected to each other, the conduit 80 being insulated.
  • the confinement chamber 44 is connected to the bottle 13 through the needle 72, while the auxiliary return chamber 46 is also connected to the bottle 13 by the auxiliary connection member formed by the needle 50.
  • the bottle is placed with its neck facing upwards and, as illustrated in FIG. 4, the piston is then pushed forward, leading to the expulsion of the solvent towards the inside of the bottle through , successively, conduits 30 and 70. Simultaneously, the excess gas contained in the bottle 13 is drawn into the auxiliary return chamber 46 through the needle 50.
  • the excess gas contained in the bottle is transferred to the return chamber under the combined action of the overpressure emerging in the bottle 13 and under the action of the suction of the auxiliary chamber 46, due to the displacement of the piston 36.
  • All the solvent contained in the confinement chamber 44 is so transferred to the bottle.
  • the solvent then mixes with the powder constituting the active cytotoxic principle.
  • the vial 13 is then inverted, so that the free end of the needle 72 is in contact with the mixture, as illustrated in FIG. 5.
  • the piston 36 is then moved towards the rear of the syringe body by traction on the rod 34, as illustrated in FIG. 5.
  • the mixture is thus re-aspirated into the confinement chamber 44 through, successively, the conduits 70 and 30.
  • the gas previously aspirated in the auxiliary return chamber 46 is reintroduced into the bottle 13, to occupy the space left free by the mixture discharged towards the confinement chamber 44. All the mixture is thus re-aspirated into the syringe.
  • the plug 64 is then returned to its transfer position, ensuring the connection between the conduits 30 and 80.
  • the mixture contained in the confinement chamber 44 is then reintroduced towards the pocket 16 through, successively, conduits 30 and 80 under the action of the piston 36 pushed axially towards the front of the syringe body.
  • the bottle 13 remains connected and gas extracted from the bottle is drawn into the return chamber. Thus, a slight depression is created in the bottle 13.
  • the bag 16 After transfer of all the mixture contained in the confinement chamber 44 or of a volume determined using the graduations of the syringe, the bag 16 is separated from the syringe by release of the nose 86 out of the base 84. Under the action of the elasticity of the cap 90, the latter then relaxes along the needle 82 to completely cover the end of the latter. Thus, the mixture still contained in the needle is confined inside the cap 90, avoiding any transfer of mixture in liquid and gaseous form to the outside. With such a device, no gaseous release containing molecules of the active cytotoxic principle is released into the atmosphere.
  • the gassing that can take place in the bottle during the reconstitution of the extemporaneous mixture during the various phases of use of the syringe are systematically confined in the bottle and / or in the auxiliary booster chamber 46.
  • the bottle 14 and the syringe 46 remaining permanently secured, no contact between the inside of the vial and the chamber 46 with the outside takes place. It is understood that with such a device, the operator is protected against possible pollution resulting from the use of the cytotoxic active principle.

Landscapes

  • Health & Medical Sciences (AREA)
  • Pharmacology & Pharmacy (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)
  • Error Detection And Correction (AREA)
EP20050763666 2004-05-03 2005-04-27 Spritze für medizinische eingriffe und diese enthaltender kit zur rekonstitution unvorbereiteter substanzen Ceased EP1744717B1 (de)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
FR0404717A FR2869533B1 (fr) 2004-05-03 2004-05-03 Seringue pour interventions medicales et necessaire de reconstitution de substances extemporanees comportant une telle seringue
PCT/FR2005/001046 WO2005120431A1 (fr) 2004-05-03 2005-04-27 Seringue pour interventions medicales et necessaire de reconstitution de substances extemporanees comportant une telle seringue

Publications (2)

Publication Number Publication Date
EP1744717A1 true EP1744717A1 (de) 2007-01-24
EP1744717B1 EP1744717B1 (de) 2008-09-03

Family

ID=34946128

Family Applications (1)

Application Number Title Priority Date Filing Date
EP20050763666 Ceased EP1744717B1 (de) 2004-05-03 2005-04-27 Spritze für medizinische eingriffe und diese enthaltender kit zur rekonstitution unvorbereiteter substanzen

Country Status (5)

Country Link
US (1) US7896849B2 (de)
EP (1) EP1744717B1 (de)
DE (1) DE602005009521D1 (de)
FR (1) FR2869533B1 (de)
WO (1) WO2005120431A1 (de)

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EP2271387A1 (de) * 2008-04-01 2011-01-12 Yukon Medical, LLC Flüssigkeitsübertragungsvorrichtung mit doppelcontainer

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US20090035346A1 (en) 2005-06-21 2009-02-05 Pervasis Therpeutics, Inc. Methods and Compositions for Enhancing Vascular Access
US8529502B2 (en) 2006-04-24 2013-09-10 Novo Nordisk Healthcare Ag Transfer system for forming a drug solution from a lyophilized drug
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US8398583B2 (en) * 2008-07-09 2013-03-19 Massachusetts Institute Of Technology Method and apparatus for extraction of a sample from a sample source
CN102186447B (zh) 2008-10-15 2013-06-19 诺沃—诺迪斯克保健股份有限公司 用于粉末药物重构的系统
CN104287966B (zh) * 2009-05-04 2017-03-15 瓦莱里塔斯公司 流体传输装置
IL200547A (en) * 2009-08-23 2014-06-30 Eli Shemesh A system for mixing drugs in many containers
GB201001447D0 (en) * 2010-01-29 2010-03-17 Seldoren Ltd An assembly for delivering a fluid drug and method
CA2790050C (en) * 2010-03-23 2021-04-20 Hyperbranch Medical Technology, Inc. Disposable syringe applicators for multi-component formulations, and methods of use thereof
AU2011323060A1 (en) * 2011-11-04 2013-05-23 Spectrum Pharmaceuticals, Inc Safely preparing and administering drug substances
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DE602005009521D1 (de) 2008-10-16
EP1744717B1 (de) 2008-09-03
US20080009790A1 (en) 2008-01-10
WO2005120431A1 (fr) 2005-12-22
FR2869533A1 (fr) 2005-11-04
US7896849B2 (en) 2011-03-01
FR2869533B1 (fr) 2006-07-28

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