EP1814617A1 - Dispositif servant a administrer une substance, notamment dans le domaine medical, et se presentant en particulier sous la forme d'une seringue en plastique a deux chambres - Google Patents

Dispositif servant a administrer une substance, notamment dans le domaine medical, et se presentant en particulier sous la forme d'une seringue en plastique a deux chambres

Info

Publication number
EP1814617A1
EP1814617A1 EP05813961A EP05813961A EP1814617A1 EP 1814617 A1 EP1814617 A1 EP 1814617A1 EP 05813961 A EP05813961 A EP 05813961A EP 05813961 A EP05813961 A EP 05813961A EP 1814617 A1 EP1814617 A1 EP 1814617A1
Authority
EP
European Patent Office
Prior art keywords
hollow body
chamber
piston
dual
chamber syringe
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.)
Withdrawn
Application number
EP05813961A
Other languages
German (de)
English (en)
Inventor
Arthur Fabian
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.)
Cilag AG
Original Assignee
Cilag AG
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 Cilag AG filed Critical Cilag AG
Publication of EP1814617A1 publication Critical patent/EP1814617A1/fr
Withdrawn legal-status Critical Current

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
    • A61M5/28—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
    • 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
    • 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
    • A61M2005/3132—Syringe barrels having flow passages for injection agents at the distal end of the barrel to bypass a sealing stopper after its displacement to this end due to internal pressure increase
    • 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
    • A61M5/32—Needles; Details of needles pertaining to their connection with syringe or hub; Accessories for bringing the needle into, or holding the needle on, the body; Devices for protection of needles
    • A61M5/3202—Devices for protection of the needle before use, e.g. caps

Definitions

  • Device for, in particular medical, administration of an active substance in particular in the form of a double-chamber syringe made of plastic
  • the invention relates to a device for, in particular medical, administration of a liquid active substance, such as a medicament, comprising at least one essentially cylindrical hollow body with a first end comprising at least one outlet opening for the liquid active substance and having a first end opposite second.
  • a liquid active substance such as a medicament
  • Medicaments which are lyophilised or freeze-dried are currently mainly filled in pharmaceutical vials and subsequently freeze-dried in these containers:
  • the sterilized vials are filled.
  • a special stopper is placed on the vial (the stopper in the so-called setting position does not close the vial yet).
  • the vial is placed in the setting position in the lyophilization chamber with the stopper.
  • the vial is closed at a pressure level well below the atmospheric pressure, for example 500 mbar (absolute).
  • the freeze-dried medicament must first be dissolved by a solvent (diluent) before administration.
  • a solvent diiluent
  • the solvent is usually injected into the pharmaceutical material with the freeze-dried product.
  • the solution is drawn from the pharmaceutical vial into an injection syringe (transferred) and then administered in this via an injection cannula to the patient.
  • EP 0 440 846 A1 filed on February 7, 1990 and published on August 14, 1991, describes a dual-chamber syringe.
  • the syringe chambers separated from one another by a piston stopper are connected to one another by a by-pass in the case of a certain positioning of the piston stopper.
  • the by-pass is formed by an axially extending cross-sectional widening.
  • the by-pass forms a bump on the cylinder outer and inner wall in the tangential and axial directions.
  • Vetter Lyo-Ject® a glass syringe barrel corresponding to this description of EP 0 440 846 A1.
  • EP 0 599 649 A1 describes another generic device in the form of a dual-chamber syringe.
  • the syringe chambers are separated from each other by a piston stopper as described in EP 0 440 846 A1.
  • the two chambers are also connected by a by-pass.
  • the by-pass is achieved by a partial enlargement of the inside diameter in the axial direction. forms. Since the by-pass is realized by a partial reduction of the cylinder wall thickness, the cylinder outer wall in the tangential and axial direction is flat.
  • the object of the present invention is therefore to further develop the generic devices such that the disadvantages of the prior art are overcome, in particular a device is provided which has the functionality of a dual-chamber syringe, but at the same time can be produced in a simplified manufacturing process.
  • This object is achieved in that in the device of Hohlkör ⁇ by at least one such inner diameter taper, that the hollow body in the region of the first chamber has a substantially first inner diameter and in the region of the second chamber has a substantially second inner diameter, wherein the first Inner diameter is less than the second inner diameter.
  • the hollow body may comprise at least a first and at least a second element, wherein in particular the first and the second element are substantially tubular, and the second element can be arranged at least in the region of the first chamber within the first element is, wherein preferably the inner diameter of the second element substantially corresponds to the first inner diameter ent.
  • the device is characterized by at least one at least one surface of the hollow body, in particular at least partially in the region of the first chamber and / or the inner diameter taper, formed depression, such as in the form of a groove, wherein by means of the recess, preferably after a movement of the first piston stopper into the region of the inner diameter taper and / or a reduction in a volume of the second chamber, in particular by movement of the second piston stopper in the direction of the first piston stopper, a fluid present in the second chamber into the first one Chamber is conductive.
  • the invention also proposes that at least one depression is formed on an inner wall of the hollow body, in particular on a surface of the second element of the hollow body facing away from an inner wall of the first element of the hollow body.
  • At least one depression is formed on one, preferably substantially smooth, inner wall of the first element of the hollow body facing surface of the second element of the hollow body, in particular the second element of the hollow body comprises at least one flow channel with the recess and at least one opening in the inner wall of the first Elemen ⁇ tes of the hollow body facing away from the surface of the second element is operatively connected.
  • the depth of the recess is less than or equal to half the difference of the first and second inner diameter.
  • a device according to the invention preferably comprises at least two, preferably a plurality, in particular three, four, five or six, of depressions and / or Naturalfluß ⁇ channels.
  • At least two recesses and / or at least two flow channels have two different geometries, in particular different cross sections, such as different end cross sections, different widths, different depths and / or different courses, in particular along the longitudinal direction of the hollow body. sen, in particular for swirling of the means of the wells and / or Monoflußka ⁇ channels from the second into the first chamber led fluid in the first chamber.
  • At least one recess is not completely coverable or closable by the first piston plug, in particular the extent of at least one recess along the longitudinal axis of the hollow body is greater than the Clearre ⁇ ckimg of the first piston plug along the longitudinal axis of the hollow body.
  • a Verbin ⁇ tion of the first chamber with a portion of the hollow body between the second Kolben ⁇ plug and the second end in particular a connection via at least one distribution and / or at least one passage opening, can be closed, preferably the extent of the at least one recess or depressions along the longitudinal axis of the hollow body is less than or equal to the sum of the extent of the first piston stopper and the Extension of the second piston plug along the longitudinal axis of the hollow body is.
  • the first and / or the second piston stopper comprises pharmaceutical rubber, preferably comprising butyl rubber, and / or at least one surface of the first piston stopper and / or of the second piston stopper, preferably at least one with at least one surface of the Hollow body, ins ⁇ particular at least one surface of the first and / or second element, at least temporarily in contact surface and / or at least one surface of Hohlkör ⁇ pers, in particular at least one surface of the first and / or the second element, preferably one with at least Having the first and / or the second piston plug at least temporarily in contact surface, a coating, preferably comprising ethylene-tetrafluoroethylene (ETFE) and / or polytetrafluoroethylene (PTFE).
  • ETFE ethylene-tetrafluoroethylene
  • PTFE polytetrafluoroethylene
  • a device may be characterized by at least one active substance discharge device operatively connected to the hollow body, such as a cannula and / or an infusion tube, wherein the active substance discharge device preferably comprises at least a connecting device arranged in the region of the outlet opening can be connected to the hollow body, in particular comprising at least one plug connection, at least one screw connection, at least one latching connection and / or at least one Einsteckver ⁇ binding, such as a Luer cone adapter, a Luer lock adapter and or a Bördel ⁇ edge or crimp neck edge, and / or the Wirkstoffabbow seen by means of at least one adhesive, at least one welded joint, at least one thermoplastic compound is connected to the hollow body.
  • the active substance discharge device preferably comprises at least a connecting device arranged in the region of the outlet opening can be connected to the hollow body, in particular comprising at least one plug connection, at least one screw connection, at least one latching connection and / or at least one Einsteckver ⁇ binding, such
  • the connecting device is connected by means of at least one first closure device, such as a tip-cap, a crimp neck closure or crimp closure and / or a stopper, and / or the drug delivery device by means of at least one second closure device, such as a Needle shield and / or rigid needle shield, preferably sterile sealing, closable.
  • first closure device such as a tip-cap, a crimp neck closure or crimp closure and / or a stopper
  • second closure device such as a Needle shield and / or rigid needle shield, preferably sterile sealing, closable.
  • first and / or the second closure device comprise or comprise at least one metal, such as aluminum, plastic and / or pharmaceutical rubber, preferably comprising butyl rubber.
  • the device has at least one feed opening arranged at the second end of the hollow body for introducing at least one actuating device, wherein in particular the actuating device is preferably detachable, as by means of a clip, plug and / or Screw connection with the second piston plug is connectable, in particular the second piston plug comprises at least one internal thread, and / or the actuating device is designed in the form of at least one piston rod.
  • a device is characterized by at least one, in particular in the region of the second end of the hollow body, preferably releasably, can be arranged, abutment device, in particular in the form of at least one finger rest and / or at least one handle plate.
  • the invention also proposes that at least one first, preferably solid, in particular pulverulent and / or freeze-dried, component of the active substance and in the second chamber at least one second, essentially liquid, component of the active ingredient, in particular in the form of a solvent, can be introduced.
  • the hollow body in particular the first element and / or the second element, the connecting device, the first closure device and / or the second closure device at least partially comprises at least one thermoplastic material, in particular polycarbonate (PC), cycloolefin copolymer (COC) , Cycloolefin polymer (COP), polypropylene (PP), polystyrene (PS), polyethylene (PE) and / or polyamide (PA).
  • PC polycarbonate
  • COC cycloolefin copolymer
  • COP Cycloolefin polymer
  • PP polypropylene
  • PS polystyrene
  • PE polyethylene
  • PA polyamide
  • the hollow body can be produced by injection molding.
  • the invention also proposes a double-chambered syringe in cylindrical form for administering medicaments in liquid form by means of a plunger stopper system.
  • a double-chamber syringe with a Finger ⁇ pad at one end of the cylinder and a Luer cone or Luer Lock adapter or with a glued-cannula on the other.
  • a double-chamber syringe which has an inner diameter taper approximately in the center of the cylinder, wherein in the area of the diameter taper there are a certain number of grooves in the cylinder inner wall and the height of the grooves is at most half of that Inner diameter difference corresponds.
  • a double-chamber syringe in which the two chambers are formed by a piston stopper to be placed.
  • the dual-chamber syringe is closed on the adapter or needle side with a tip cap made of pharmaceutical rubber.
  • the dual-chamber syringe on the adapter or needle side with a tip cap made of plastic, if necessary, to unscrew, closed.
  • the double-chamber syringe on the adapter or Na ⁇ delseite is closed with a Needle Shield or Rigid Needle Shield.
  • the dual-chamber syringe is a syringe manufactured by injection molding.
  • the syringe barrel consists of a thermoplastic material, in particular polycarbonate (PC), Cyloolefmes copolymer (COC), cycloolefin polymer (COP), polypropylene (PP) , Polystyrene (PS), polyethylene (PE) or polyamide (PA).
  • PC polycarbonate
  • COC Cyloolefmes copolymer
  • COP cycloolefin polymer
  • PP polypropylene
  • PS Polystyrene
  • PE polyethylene
  • PA polyamide
  • the device is designed as a double-chamber syringe according to the invention, wherein preferably the hollow body of the syringe barrel, which corresponds to a cylinder end of the first end of the hollow body and / or the other cylinder end of the second end of the hollow body.
  • the device be madebil ⁇ det in the form of a cylindrical ampoule, wherein preferably at the first end of the hollow body, in particular in the region of the outflow, a crimp neck edge or flanged edge is formed and / or at the sau ⁇ th end of the hollow body , preferably releasably, a finger rest and / or handle plate a- northbar is.
  • the invention is therefore based on the surprising finding that the known devices according to the invention, in particular double-chamber syringes, continue to develop in this way. It can be disgusted that a device, in particular a double-chamber syringe, is provided which does not contain a hollow body or syringe barrel in comparison to the double-chamber syringe barrel made of plastic, in particular in the initially cited prior art in the form of EP 0 599 649 A1 Having a so-called Hin ⁇ terites in the cylinder area, in particular in an axial direction, ie along a longitudinal axis of the syringe barrel or hollow body. This results in the following advantages:
  • Temperature control channels can be arranged more optimally, since no core pullers are necessary for demolding undercuts in the injection molding tool.
  • Optimally arranged tempering channels in the injection molding tool lead to a more optimal temperature distribution in the molded part during the repressurization and residual cooling time. This leads i.d.R. also to a higher quality plastic molding.
  • the device according to the invention in particular the double-chamber syringe according to the invention, or the hollow body, in particular the double-chamber syringe cylinder, at the same time has the advantage over the filling in pharmaceutical vials that it or it is suitable for administering freeze-dried medicaments without costly preparation (mixture of freeze-dried preparation and Wegs ⁇ medium and subcutaneous, intramuscular or intravenous administration by simply pushing the plunger stopper with a stop) is or are.
  • the active ingredient is freeze-dried or lyophilized directly in the application container (i.e., syringe barrel or hollow body, in particular in the first chamber).
  • the other or second chamber of the device, in particular the syringe contains the solvent, which is mixed with the active ingredient only during use, without transfer to another container.
  • the device in particular the double-chamber syringe made of plastic
  • the device has the advantage over the present invention of double-chamber syringes of glass according to EP 0 440 846 A1 that it is less expensive because hollow body, in particular syringe barrel or hollow body made of plastic with the comparatively ITA ⁇ cheap manufacturing process of injection molding (manufacturing process of molded plastic parts) can be produced.
  • the device according to the invention or the erfmdungs- suitable double-chamber syringe suitable for existing automation concepts for Beglal ⁇ development of commercially available disposable syringes since the hollow body or cylinder outer surface rota ⁇ is rotationally symmetrical (no unevenness in the axial or tangential direction).
  • the invention thus provides a device with a hollow body, in particular a double-chamber syringe cylinder, with a taper of the inner diameter in the direction of a syringe barrel end, onto which a cannula is plugged or screwed on, be ⁇ provided.
  • the hollow body of the device in particular the dual-chamber syringe cylinder, in one preferred embodiment has one or more grooves which are arranged in the axial direction and can run parallel to one another.
  • the height of a groove preferably corresponds to a maximum of half the inner diameter reduction. This dimensioning of the grooves ensures that it is possible to dispense with undercuts in the axial direction of the hollow body, in particular the syringe barrel.
  • Figure Ia is a cross-sectional view of a hollow body of a first embodiment of a device according to the invention in the form of a double-chamber injection-molded plastic cylinder;
  • Figure Ib is a cross-sectional view A-A of Figure Ia;
  • Figure 2 is a cross-sectional view of a first piston plug (without internal thread);
  • Figure 3 is a "cross-sectional view of a second piston stopper (internally threaded);
  • Figure 4 is a cross-sectional view of a first closure device in the form of a
  • Cap made of pharmaceutical rubber, more precisely in the form of a tip cap made of pharmaceutical rubber
  • FIG. 5 shows a cross-sectional view of a filled device in the form of a double-chamber syringe;
  • FIG. 7a shows a cross-sectional view of a hollow body of a second embodiment of a device according to the invention in the form of a cylindrical ampoule
  • Figure 7b is a cross-sectional view B-B of Figure 7a;
  • FIG. 8a shows a cross-sectional view of a third embodiment of a device according to the invention in the form of a cylindrical ampoule
  • Figure 8b is a cross-sectional view C-C of Figure 8a.
  • FIG. 8c shows a cross-sectional view D-D of FIG. 8a.
  • the system is composed of the following components:
  • the double-chamber syringe barrel 1 can be designed with a Luer Lock or Luer cone adapter 3 or with a cannula attached to it.
  • the syringe cylinder 1 has approximately in the cylinder center an inner diameter taper. In the area of the diameter taper there are a certain number of grooves 5 in the cylinder inner wall. The height or depth of the grooves 5 corresponds to at most half of the inner diameter difference.
  • the grooves 5 are shown in section A-A of Figure Ia.
  • the piston plug is shorter in the axial direction than the grooves running in the syringe barrel. If necessary, the piston stopper is also coated.
  • Piston plugs made of pharmaceutical rubber with internal thread (FIG. 3) If necessary, the piston stopper is also coated.
  • Cap made of pharmaceutical rubber or plastic (FIG. 4)
  • Piston rod 7 (commercially available, FIG. 5)
  • FIG. 1a shows a cross-sectional view of a hollow body of a first embodiment of a device according to the invention.
  • This device is a double-chamber syringe 33 and the hollow body is in the form of a double-chamber syringe cylinder 1.
  • the dual-chamber syringe cylinder 1 has a first end 21. At the first end 21, an outlet opening 23 is formed within the dual-chamber syringe barrel 1.
  • a first connection device in the form of a Luer cone adapter 3 is formed in the region of the outlet opening 23.
  • the Luer cone adapter 3 allows a cannula to be plugged on to seal the outlet opening 23 of the dual-chamber syringe cylinder 1 with the cannula.
  • the first end 21 of the double-chamber syringe cylinder 1 is opposite to a second end 25 of the double-chamber syringe cylinder 1.
  • the double-chamber syringe cylinder 1 is preferably formed in one piece.
  • the double-chamber syringe cylinder 1 has regions with different inner diameters. If one goes along the longitudinal axis L of the double-chamber syringe cylinder 1 from the second end 25 in the direction of the first end 21, then the dual-chamber syringe cylinder 1 initially has a second inner diameter d 2 . Approximately in the middle of the double-chamber syringe barrel 1, there is an inner diameter taper 29. In this region of the double-chamber syringe barrel 1, the inner diameter decreases to a first inner diameter d. In particular, the inner surface of the double-chamber syringe barrel 1 is inclined in the shape of a cone in the region of the inner diameter taper 29. In FIGS. 1 a and 1 b, it should be noted that the double-chamber syringe cylinder 1 is formed in one piece, and additional lines have been drawn only for clarification purposes.
  • the double-chamber syringe cylinder 1 has no undercuts in the axial direction or in the direction of the longitudinal axis L. This results in the advantages described above in the production of the double-chamber syringe barrel 1, so that the double-chamber syringe barrel 1 can be produced inexpensively.
  • FIG. 1 b shows a cross-sectional view of the double-chamber syringe cylinder 1 of FIG. 1 a along the section A-A.
  • indentations in the form of grooves 5 in the region of the double-chamber syringe barrel 1, which has the first inner diameter di are formed on an inner wall 31 of the double-chamber syringe barrel 1.
  • the grooves 5 serve to guide a fluid, such as in the form of the solvent or diluent 15, past a first piston plug 11.
  • FIG. 2 initially shows a cross-sectional view of a first piston stopper 11.
  • the piston plug 11 is preferably made of pharmaceutical rubber, in particular um ⁇ comprehensive butyl rubber.
  • the first piston plug 11 is substantially plate-shaped and has an extension along the longitudinal axis L of the double-chamber syringe cylinder 1 or thickness d 5 and an outer diameter d 3 .
  • the outer diameter d 3 is slightly larger than the second inner diameter d 2 in order to achieve that the piston stopper 11 can be sealingly introduced into the dual-chamber syringe barrel 1, as will be explained later.
  • the surface 35 is coated, preferably with ethylene tetrafluoroethylene (ETFE) and / or polytetrafluoroethylene (PTFE).
  • ETFE ethylene tetrafluoroethylene
  • PTFE polytetrafluoroethylene
  • a second piston plug 9 is darg Robinson in cross section. Similar to the Kolben ⁇ plug 11, the second piston plug 9 is formed substantially plate-shaped and has an outer diameter d 4 .
  • the outer diameter d 4 is also slightly larger than the inner diameter di of the double-chamber syringe barrel 1 in order to achieve a seal by means of the piston stopper 9 when it is introduced into the dual-chamber syringe barrel 1.
  • the second piston plug 9 has an extension along the longitudinal axis L of the double-chamber syringe cylinder 1 or thickness d 6 .
  • an outer peripheral surface 37 of the second piston plug 9 is also coated.
  • terials In addition to ethylene tetrafluoroethylene (ETFE), terials also include polytetrafluoroethylene (PTFE), which is also referred to as Teflon.
  • PTFE polytetrafluoroethylene
  • the second piston plug 9 has an internal thread 39. As will be explained later, the female thread 39 serves for releasably securing the piston rod 7 to the second piston plug 9.
  • the tip cap 13 preferably consists of pharmaceutical rubber and has a cone 41 and a peripheral edge 43.
  • the shape of the tip cap 13 er ⁇ aims at a plugging of the tip cap 13 on the luer cone adapter 3, in particular sterile, ab ⁇ sealing closure of the outlet opening 23 of the double-chamber syringe barrel 1 er ⁇ .
  • a solution of the active ingredient is introduced into the double-chamber syringe barrel 1, which is then subsequently freeze-dried in the double-chamber syringe barrel 1.
  • the first piston stopper 11 is introduced through the passage opening 45 into the dual-chamber syringe cylinder 1.
  • the first piston plug 11 is initially pushed forward as far along the longitudinal axis L of the double-chamber syringe cylinder 1 until it is arranged above the inner diameter taper 29.
  • a first chamber 47 is formed within the dual-chamber syringe cylinder 1.
  • the first chamber 47 is on the one hand tightly closed by the tip cap 13 and on the other hand by the first Kolbenstop ⁇ fen 11, which covers in particular the grooves 5 in this position.
  • a second liquid component of the active substance which is to be administered via the dual-chamber syringe 33, is introduced via the passage opening 45.
  • it is a solvent or diluent 15.
  • the second piston stopper 9 is introduced into the dual-chamber syringe cylinder 1 via the passage opening 45.
  • the dual-chamber syringe 33 is then in its position delivery.
  • an actuating device in the form of a piston rod 7 is already in front of a release rod.
  • the double-chamber syringe 33 is connected to the second piston plug 9 via the internal thread 39 or such a connection is only made by a user of the double-chamber syringe 33 before the latter is used.
  • the state of the double-chamber syringe 33 shown in FIG. 6a essentially corresponds to the state shown in FIG.
  • a user proceeds as follows:
  • a user first removes the first closure device in the form of the tip cap 13 from the connection device in the form of the Luer cone adapter 3, so that the dual-chamber syringe 33 is in the state shown in FIG. 6b.
  • the double-chamber syringe 33 for the administration of the medical active substance is prepared by mixing the first component of the active ingredient to be administered in the form of the freeze-dried drug 17 with the second component of the active ingredient to be administered in the form of the diluent 15 is reached.
  • a user exerts a force F on the piston rod 7.
  • a user places in particular a thumb on an end surface 51 of the piston rod 7, while he the double-chamber syringe cylinder 1 with the index finger and the middle finger engages by means of the finger rest 27.
  • the force F is transmitted via the piston rod 7 to the second piston stopper 9.
  • the comparatively poor compability of the diluent 15 causes the force F to be transferred to the first piston plug 11 via the diluent 15.
  • the force F By the force F, first the first piston plug 11 is moved together with the diluent 15 and the second piston plug 9 in the direction of the first end 21 of the outlet opening 23 of the double-chamber syringe cylinder 1. Due to the inner diameter taper 29, the outer diameter d 3 of the first piston plug 11 is reduced to the first inner diameter ⁇ ⁇ . This causes the first piston plug 11 no longer the grooves 5, which are formed on the inner wall 31 of the double-chamber syringe barrel 1, ver ⁇ closes.
  • the length 1 of the grooves 5 is dimensioned such that the length 1 is greater than the Di ⁇ dke d 5 of the first piston stopper 11, in particular even if the outer diameter d 3 is reduced to the first inner diameter di.
  • the valve 15, as shown in FIG. 6 a is pressed out of the second chamber 49 through the grooves 5 into the first chamber 47.
  • the grooves 5 are only partially covered by these dimensions of the grooves 5 and the first piston plug 11.
  • the second piston stopper 9 is then moved further in the direction of the first end 21 of the double-chamber syringe cylinder 1 or in the direction of the first piston stopper 11, until it finally reaches the position shown in FIG. 6d , As a result of this movement of the second piston plug 9 relative to the first piston plug 11, the volume of the second chamber 49 is continuously reduced, as a result of which the diluent 15 is transferred into the first chamber 49.
  • the grooves 5 have different geometries, in order to achieve that the diluent 15 is fluidized during the transfer into the first chamber 49 in order to mix the diluent 15 with the freeze-dried medicament 17 to support.
  • the syringe cylinder 1 is formed by the user with a drug delivery device, which in the illustrated embodiment is designed as a cannula 53 via the connection device in the form of the luer cone adapter 3 connected. It can be provided in particular that the cannula 3 is first closed by a second closure device, such as in the form of a needle shield, which causes a sterile seal of the cannula 53.
  • Double-chamber syringe 33 After the connection of the double-chamber syringe cylinder 1 with the cannula 53 and, if appropriate, a removal of the second closure device from the cannula 53 is the Double-chamber syringe 33 in the position shown in Figure 6e. Subsequently, a force F is again exerted on the piston rod 7 by the user. This has the effect that the outer diameter d 4 of the second piston plug 9 is reduced from the second inner diameter d 2 to the first inner diameter d 1 by means of the inner diameter taper 29.
  • the grooves 5 Due to the dimension of the grooves 5 such that the length 1 of the grooves 5 is less than the sum of the thickness d 5 of the first piston plug 11 and the thickness d 6 of the second Kolbenstop ⁇ fens 9, the grooves 5 in a further movement of the first Piston stopper 11 and the second piston plug 9 in the direction of the outlet opening 23 is closed in such a way that the existing in the first chamber 47 drug can not flow through the grooves 5 on the first and second piston plugs 11, 9 past.
  • FIG. 7 a shows a cross-sectional view of a further second embodiment of a device according to the invention in the form of a cylindrical ampoule 101.
  • the cylinder cartridge 101 comprises a substantially cylindrical hollow body 103.
  • the hollow body 103 has a first end 105 and a second end 107. In the region of the first end 105 there is an outlet opening 109. In the area of the outlet opening 109, a connecting device in the form of a crimping edge or crimp-neck edge 111 is formed.
  • the hollow body 103 is made of a thermoplastic material and is integrally removablebil ⁇ det. Similar to the dual-chamber syringe cylinder 1, the hollow body 103 has an inner diameter taper 113.
  • the hollow body 103 has a first inner diameter di> on the side facing the first end 105.
  • the hollow body 103 has grooves 115 in the region of the inner diameter taper 111. These grooves 115 have a depth t 'and a length 1' in the direction of the longitudinal axis L 'of the hollow body 103.
  • the operation of the cylinder ampoule 101 substantially corresponds to that of the double-chamber syringe barrel 1.
  • a first and second chamber which are initially sealed by the first and second piston plug, formed.
  • the two components of the active substance to be administered can be obtained stored separately in the Zy ⁇ linder ampule 101.
  • the outlet opening 109 may be provided in particular that an opening 117 in the region of the crimp neck edge 111 is closed by means of a plug, not shown, made of pharmaceutical rubber, wherein the plug is secured by means of a crimp around the crimp neck edge 111.
  • the hollow body 103 is initially closed at the second end 107 by a closure cap (not shown).
  • the closure cap is then removed from the second end 107 of the cylinder ampoule 101 in order to supply an actuating device into the hollow body 103 to exert a force on a second piston stopper, not shown.
  • the plug provided at the opening 117 is pierced, for example by means of a tip, in order to connect a drug delivery device to the outlet port 109.
  • a Wiederstromreinrich- tion for example in the form of a handle plate, releasably attached to the cylinder ampoule 101 is attached.
  • FIG. 7b shows in a cross-sectional view the formation of the grooves 115 in the region of the inner diameter taper 113.
  • FIGS. 8a to 8c a third embodiment of a device according to the invention in the form of a cylindrical ampoule 101 'is shown in FIGS. 8a to 8c.
  • Identical elements of the cylinder cartridge 101 'compared to the cylinder cartridge 101 bear the same reference numerals, but simply deleted.
  • the cylinder ampoule IUI ' has a hollow body 103', which is designed in two parts.
  • the hollow body 103 ' comprises a substantially tubular first element 119' and a second, substantially tubular element 121 '. Integrally formed on the first element 119 'is again a crimp neck edge 111'.
  • Both the first element 119 'and the second element 121' of the hollow body 103 ' are preferably produced by injection molding.
  • the second member 121' is inserted into the first member 119 '.
  • the cylinder ampoule 101 ' is shown in the delivery state.
  • the second end 107 'of the cylinder ampoule 101' is closed by means of a cap 122 '.
  • the opening 117 ' is closed by means of a crimp-neck closure 112'.
  • the crimp neck closure 112 ' includes a plug 112a' secured to the crimp neck edge 111 'by an aluminum crimp 112b'.
  • FIGS. 8b and 8c respectively show a cross-sectional view of the cylinder ampule 101 'along the line CC (FIG. 8b) and DD (FIG. 8c).
  • the first element 119 ' has an inner wall 123'.
  • the second element 121' has depressions 125 '.
  • the second element 121 ' as can be seen in particular Figure 8c, flow channels 127' on.
  • a drug delivery device is first connected to the cylindrical ampoule 101' by piercing the plug 112a '. Subsequently, the cap 122 'is removed to introduce an actuating device for the second piston stopper 133'. This may in particular be a finger, such as a thumb, of a user.
  • the second piston plug 133 rests on the first piston plug 131' If the two piston plugs 131 'and 133' are displaced further, the first piston plug 131 'initially closes the flow channels 137', while the second piston plug 133 'closes the recess 125', thereby ensuring that the one present in the first chamber 135 ' Active substance via the outlet opening 109 'from the cylinder ampoule 101' is pushed out.
  • the naturalflußkanä ⁇ le 127 ' have different geometries, so that there is a turbulent flow of the out of the second chamber 137' in the first chamber 135 'flowing fluid 129', in particular for improved mixing the liquid second component 129 'of the active ingredient comes with the first component 139' of the active substance present in the first chamber.
  • Luer cone adapter ' grooves in the area of the inner diameter taper

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  • 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 dispositif se présentant par exemple sous la forme d'une seringue à deux chambres et servant à administrer une substance liquide. Ce dispositif comprend un corps creux cylindrique qui comporte une première extrémité pourvue d'une ouverture de sortie, et une deuxième extrémité opposée. Un premier et un deuxième obturateur à piston sont montés dans le corps creux, de manière à pouvoir se déplacer le long de l'axe longitudinal du corps creux. Avant l'administration d'une substance, une première chambre qui s'étend entre la première extrémité et le premier obturateur à piston est formée dans le corps creux au moyen du premier obturateur à piston, et une deuxième chambre qui s'étend entre le premier obturateur à piston et le deuxième obturateur à piston est formée dans le corps creux au moyen du deuxième obturateur à piston. Le diamètre interne du corps creux présente une diminution, de sorte que le corps creux présente, dans la zone de la première chambre, un premier diamètre interne qui est inférieur au diamètre interne de la deuxième chambre.
EP05813961A 2004-11-24 2005-11-24 Dispositif servant a administrer une substance, notamment dans le domaine medical, et se presentant en particulier sous la forme d'une seringue en plastique a deux chambres Withdrawn EP1814617A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
DE200410056617 DE102004056617A1 (de) 2004-11-24 2004-11-24 Medizinische Doppelkammer-Spritze aus Kunststoff
PCT/EP2005/012594 WO2006056452A1 (fr) 2004-11-24 2005-11-24 Dispositif servant a administrer une substance, notamment dans le domaine medical, et se presentant en particulier sous la forme d'une seringue en plastique a deux chambres

Publications (1)

Publication Number Publication Date
EP1814617A1 true EP1814617A1 (fr) 2007-08-08

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EP05813961A Withdrawn EP1814617A1 (fr) 2004-11-24 2005-11-24 Dispositif servant a administrer une substance, notamment dans le domaine medical, et se presentant en particulier sous la forme d'une seringue en plastique a deux chambres

Country Status (3)

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EP (1) EP1814617A1 (fr)
DE (1) DE102004056617A1 (fr)
WO (1) WO2006056452A1 (fr)

Families Citing this family (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2011117877A1 (fr) * 2010-03-22 2011-09-29 Pawan Trilokchand Agrawal Seringue pré-remplie à chambre double
ES2833276T3 (es) 2011-08-31 2021-06-14 Abbvie Inc Disposión de sellado para jeringa
WO2014066731A1 (fr) 2012-10-26 2014-05-01 Massachusetts Institute Of Technology Emballages pour reconstitution rapide pour le mélange et l'administration de médicaments
EP2956191A1 (fr) * 2013-02-12 2015-12-23 AbbVie Inc. Seringue avec pression d'étanchéité à deux étages
CN108421132B (zh) * 2018-03-11 2024-04-12 杨一博 药物复原装置

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EP0071288B1 (fr) * 1981-07-29 1985-10-02 Duphar International Research B.V Seringue hypodermique
DE3736343C2 (de) * 1987-10-27 1996-07-18 Wasserburger Arzneimittelwerk Injektionsspritze
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US5817055A (en) * 1992-07-07 1998-10-06 Pharmacia & Upjohn Aktiebolag Dual-chamber injection cartridge
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DE102004056617A1 (de) 2006-06-01
WO2006056452A1 (fr) 2006-06-01

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