WO2006045132A2 - Verfahren und vorrichtungen zum lyophilisieren, rekonstituieren und verabreichen eines rekonstituierten wirkstoffes - Google Patents
Verfahren und vorrichtungen zum lyophilisieren, rekonstituieren und verabreichen eines rekonstituierten wirkstoffes Download PDFInfo
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- WO2006045132A2 WO2006045132A2 PCT/AT2005/000423 AT2005000423W WO2006045132A2 WO 2006045132 A2 WO2006045132 A2 WO 2006045132A2 AT 2005000423 W AT2005000423 W AT 2005000423W WO 2006045132 A2 WO2006045132 A2 WO 2006045132A2
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- Prior art keywords
- chamber
- carpule
- housing
- piston
- housing end
- Prior art date
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- 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
- 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
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
- A61M5/178—Syringes
- A61M5/24—Ampoule syringes, i.e. syringes with needle for use in combination with replaceable ampoules or carpules, e.g. automatic
- A61M5/2448—Ampoule syringes, i.e. syringes with needle for use in combination with replaceable ampoules or carpules, e.g. automatic comprising means for injection of two or more media, e.g. by mixing
- A61M2005/2451—Ampoule syringes, i.e. syringes with needle for use in combination with replaceable ampoules or carpules, e.g. automatic comprising means for injection of two or more media, e.g. by mixing preventing delivery before mixing is completed, e.g. by locking mechanisms
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- 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
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- 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
- A61M2005/3106—Plugs 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
- A61M2005/3117—Means preventing contamination of the medicament compartment of a syringe
- A61M2005/3121—Means preventing contamination of the medicament compartment of a syringe via the proximal end of a syringe, i.e. syringe end opposite to needle cannula mounting end
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
- A61M5/178—Syringes
- A61M5/31—Details
- A61M2005/3123—Details having air entrapping or venting means, e.g. purging channels in pistons
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- 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
- A61M2005/3142—Modular constructions, e.g. supplied in separate pieces to be assembled by end-user
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- 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
- A61M5/31596—Pistons; Piston-rods; Guiding, blocking or restricting the movement of the rod or piston; Appliances on the rod for facilitating dosing ; Dosing mechanisms comprising means for injection of two or more media, e.g. by mixing
- A61M2005/31598—Pistons; Piston-rods; Guiding, blocking or restricting the movement of the rod or piston; Appliances on the rod for facilitating dosing ; Dosing mechanisms comprising means for injection of two or more media, e.g. by mixing having multiple telescopically sliding coaxial pistons encompassing volumes for components to be mixed
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
- A61M5/178—Syringes
- A61M5/24—Ampoule syringes, i.e. syringes with needle for use in combination with replaceable ampoules or carpules, e.g. automatic
- A61M5/2448—Ampoule syringes, i.e. syringes with needle for use in combination with replaceable ampoules or carpules, e.g. automatic comprising means for injection of two or more media, e.g. by mixing
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
- A61M5/178—Syringes
- A61M5/28—Syringe ampoules or carpules, i.e. ampoules or carpules provided with a needle
- A61M5/285—Syringe ampoules or carpules, i.e. ampoules or carpules provided with a needle with sealing means to be broken or opened
- A61M5/286—Syringe ampoules or carpules, i.e. ampoules or carpules provided with a needle with sealing means to be broken or opened upon internal pressure increase, e.g. pierced or burst
-
- 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
- A61M5/50—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 having means for preventing re-use, or for indicating if defective, used, tampered with or unsterile
- A61M5/5013—Means for blocking the piston or the fluid passageway to prevent illegal refilling of a syringe
- A61M5/502—Means for blocking the piston or the fluid passageway to prevent illegal refilling of a syringe for blocking the piston
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- 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
- A61M5/50—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 having means for preventing re-use, or for indicating if defective, used, tampered with or unsterile
- A61M5/5086—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 having means for preventing re-use, or for indicating if defective, used, tampered with or unsterile for indicating if defective, used, tampered with or unsterile
Definitions
- the invention relates to a process for the lyophilization, reconstitution and administration of active ingredients and an applicator part or an applicator equipped with such an applicator part for a reconstituted active substance.
- a further connection of the piston into the cylindrical interior of the applicator can be used to produce a line connection to an outlet which can be connected to an injection needle, so that the reconstituted active substance can be administered immediately after reconstitution.
- a disadvantage of this applicator is that elastically deformable containers are required and some needle inserts are required.
- This receiving chamber is tightly closed at its discharge-side, front housing end with a detachable closure with a Luer-lock connection and at its end facing away from the front housing with a piston in conjunction with an adapter used in this.
- the adapter is made in two parts and consists of two integrated otherwise guided, tubular parts, wherein the outer part is slidably mounted on the inner wall of the receiving chamber, wherein the inner rohrformige part is screwed via a thread in the outer tubular part and closes a füreriesöffiiung in the piston into which the lyophilized active substance accommodating receiving chamber ,
- the inner part can be unscrewed and instead of a filled with a solvent injection device are screwed.
- the mixing process between lyophilized material and solvent should also be optimized independently.
- the object of the present invention is solved by the features in the independent claims 1, 29, 34, 38, 40, 44, 46 and 47.
- the device can be stored in different preparation stages each sealed for use and still form individual parts of an overall system, which fen with a few Handgrif ⁇ to an injection device or to a dispenser for administering the reconstituted Active ingredient can be assembled. If the device in each case has the lyophilised active substance stored in the first chamber, the number of devices to be held in stock can be reduced overall if the remaining device parts are also assembled and packaged in a sterilized state. Thus, only the device parts need to be stored with the active ingredient with different active ingredients and it can be kept a smaller number of actuator with Kar ⁇ pule, as they can be coupled with the same device parts that have different lent agents, immediately.
- the carpule with the liquid for reconstituting the lyophilized active substance is already contained in the sterilized and sealed device with the lyophilized active substance.
- the outer and inner regions of the carpule as well as the chamber for the active ingredient are sterilized continuously by the closure-side piston, which has the liquid for reconstituting the active substance, and can also be, for example, a piston rod or an additional component when assembled with the drive units Piston rod housing or a Autoinjectorica the sterility are not destroyed.
- An embodiment according to claim 7 is advantageous in that, as a result, the entire path taken by the active substance in the interior of the device, as well as the path of the solvent or the liquid for dissolving the active substance, are sterile and, as a result, the connection between the drug Lyophilisate-containing chamber and the solvent ent ⁇ holding carpule must be opened only when putting into use and a primary leakage of closures is therefore avoided as possible.
- a further embodiment according to claim 8 has proven to be advantageous in that it is made with a single connection cannula, the connection between the chamber containing the lyophilisate and the carpule containing the solvent, in ⁇ this connecting cannula the piston occluding the chamber and Dichtschei ⁇ pierced, which closes the carpule.
- a cannula accommodated in the piston can be provided, whereby a component carrying the cannula is saved.
- the cannula end directed against the carpule is advantageously covered with a cap made of a rubber-elastic material, so that the sterility in the interior of the chambers is ensured even in this embodiment.
- the first chamber can be formed by a glass cylinder, which in turn is accommodated in the housing.
- the active substance can be lyophilized in this glass cylinder beforehand.
- the embodiment according to claim 13 offers advantages in the assembly of the device.
- claims 14 and 15 facilitate sterile occlusion and prevent inadvertent opening of the lyophilisate-containing chamber.
- Claims 16 and 17 relate to embodiments which are advantageous in lyophilizing the active substance in the first chamber.
- Embodiments of claims 18 and 19 are also advantageous because it is immediately possible to detect when the device has been manipulated, which could compromise their sterility.
- the embodiment according to claim 20, which relates to a two-part housing, offers considerable advantages in the manufacture and assembly of the device. If, according to claim 21, the two housing parts are connected to one another by a thread, they can be particularly easy to assemble. Also, this threaded connection is advantageously provided according to claim 22 with a tamper-evident, so that it can be determined whether the Ver ⁇ binding was separated.
- claims 23 and 24 facilitate lyophilization of the drug in the first chamber while maintaining sterility.
- the embodiment described in claim 25 allows the sterile storage of the device without actuating means.
- the actuating means advantageously serves a coupling part according to claim 26.
- the object of the invention can also be solved independently of the embodiment of the device by the method according to claim 29.
- the process chosen does not only simplify the lyophilization of the active ingredient, but also achieves a continuous process for the production of the lyophilized active ingredient and its sterile packaging for economical further use and simple operation for dispensing the lyophilized, reconstituted active ingredient.
- excellent quality of the lyophilized active ingredient and its sufficient storage time can be achieved while at the same time ensuring sterility until reconstitution of the active ingredient.
- An advantage of this solution lies in the manifold possibilities for the individual method steps, which open up a multiplicity of device-technical possibilities and above all enable a cost-effective modular system.
- Claims 30 to 33 relate to advantageous embodiments of this method.
- the preferred embodiment according to claim 35 allows a stepwise actuation of the device and the embodiment according to claim 36 shows a possible Ausgestal ⁇ tion of the locking means.
- the object of the invention is achieved independently by a device according to claim 38 An ⁇ .
- This solution ensures a certain sequence of the steps taking place in the liner of the device during its actuation.
- the defined in claim 39 embodiment of this device shows a particularly simple way to realize the restraint device.
- the object of the invention is achieved independently by a device according to claim 40 An ⁇ .
- This solution ensures a certain sequence of the steps taking place in the interior of the device during its actuation.
- the object of the invention is also achieved independently by a device according to claim 44 An ⁇ .
- the Ausbowungsart according to claim 45 brings a further improvement in the control of the feed rate with it.
- the object of the invention is achieved independently by a device according to the claim 46 An ⁇ .
- the feature combination of this claim defines, in a surprising and very advantageous manner, a device in which the re-synthesis of the active substance takes place automatically.
- the object of the invention is achieved independently by a device according to claim 47 An ⁇ .
- the restraint device increases the safety of the sequence of operations occurring during actuation of the device.
- the types of execution according to claims 48 and 49 show advantageous and safely functioning variants of the restraint device.
- FIG. 1 shows a longitudinal section through a first embodiment of the device.
- Fig. 2 is a longitudinal section through a second embodiment of the device
- Fig. 3 is a longitudinal section through a third embodiment of the device
- FIGS. 4a to 4f show the functional sequence during use of the device according to FIG. 2;
- FIGS. 5a to 5f show the functional sequence during use of the device according to FIG. 3;
- Fig. 6 is a longitudinal section through an embodiment of the injection unit
- FIG. 7 shows a longitudinal section through a further embodiment of the device
- FIG. 1 shows a first embodiment of a device according to the invention.
- a first chamber 1 containing a lyophilisate 26 is arranged in a housing 3 close to its front, discharge-side housing end 6.
- the first chamber 1 is formed in a glass cylinder 23, which in turn is housed in the be ⁇ stationary housing 3.
- the lyophilizate 26 was formed in the first chamber 1, as will be described later.
- the glass cylinder 23 containing the lyophilizate 26 has at its end located near the discharge-side, front housing end 6 a narrowed orifice 24 onto which an adapter 25 made of plastic is placed.
- the adapter 25 made of plastic can be formed on the glass cylinder 23 or glued or be attached to the glass cylinder 23 with a snap device.
- the downstream end side of the glass cylinder projecting cylindrical projection which is occupied by the mouth 24 this extension between the end face of the glass cylinder 23 and the discharge end thereof has a circumferential groove 50.
- the adapter 25 further has a luer-lock attachment in its end region facing away from the glass cylinder 23.
- a Luer-Lock approach which can be provided with ent speaking locking means for setting and holding the closure 9 and a, to be connected to the adapter 25 injection needle.
- the contamination-free application of the injection solution i. of the reconstituted active substance or of the lyophilizate 26 a significant advantage of the device according to the invention of the method according to the invention.
- This contamination freedom must be ensured over the entire period of application of the device.
- the seal on the discharge-side Geotrou ⁇ seende 6 by means of the latchable and, if necessary, releasable cap 27 with the integrated sealing element 10 made of rubber rubber, which closes the opening of the gas cylinder 23 bacteria-tight.
- the adapter 25 has a luer-lock closure with adaptation, since unintentional release of the closure 9 is thereby avoided even when handling the device for its final use.
- a closure 9 which consists of a cap 27 made of plastic and a sealing element 10 held in this.
- the latter consists of pharmaceutical rubber and protrudes into the mouth 24 to close this tight.
- the closure cap 27 is provided with a locking projection 46 which prevents unintentional removal of the closure 9.
- the glass cylinder 23 has bypasses 45 running in the axial direction, which facilitate the gas exchange during lyophilization. serve as will be explained below.
- a cylinder plug 11 which also has been ordered from pharmaceutical rubber and has such axia ⁇ le extent, or can take in different positions, so that it either extends beyond the length of the bypasses 45 or moved into position can, in which the cylinder plug 11, the glass cylinder 23 tightly seals.
- a second chamber 2 On the rear side of the cylinder stopper 11 facing away from the first chamber 1, a second chamber 2 begins, in which a carpule 12 consisting of glass or plastic is accommodated, which contains a solvent.
- the carpule 12 is closed at its discharge-side end by means of a cartridge rubber cartridge disc 37 which is held by a crimp cap 38 on the carpule 12.
- the discharge side facing away from the end of the carpule 12 is a Karpulenstopfen 31, which closes the solvent-containing interior of the carpule tight.
- a gas passage extending in the longitudinal direction of the housing 3 is provided.
- This gas passage can consist of clearance between the outer diameter of the carpule and the inner diameter of the housing, or fine longitudinal ribs or longitudinal grooves or elevations distributed over the surface or a corresponding roughness can be provided inside the housing or on the outside of the carpule ,
- the gas passage serves for further sterilization of the device with ethylene oxide, which is described in more detail below.
- At least one carpule support 39 is arranged on the inner wall of the housing 3, on which the carpule 12 is supported with its cartridge shoulder 36.
- a plurality of carpule supports 39 are arranged distributed on the circumference of the housing 3, which can be formed, for example, by softening and slight depression of the housing wall or with a separate component which can be inserted in the housing part.
- a transfer set 16 is arranged, which has the task, in use of the device, to direct the solvent contained in the cartridge 12 into the first chamber 1 for reconstitution of the lyophilisate.
- the transfer set 16 contains a continuous, held in a cannula guide 17 Connecting cannula 18.
- the connecting cannula 18 is open in this embodiment and therefore also continuous for gas, so that both sides of the transfer set 16 can be sterilized with ethylene oxide.
- the transfer set 16 is held in its axial position in the housing 3 by integrally formed on its circumference spring latching tabs 47 which engage in an arranged in the rear housing part 5 annular groove 48.
- the housing 3 of the device can expediently consist of a front, discharge-side housing part 4 and a rear housing part 5, which are screwed to each other at a kaus ⁇ 8 releasably.
- the connection point 8 may be covered with a label 35.
- This label 35 can be used for tamper evidence but also to ensure and maintain the sterility of the entire interior of Vor ⁇ direction, because the destruction or breakage of the label 35 indicates that the housing part 4 and 5 were separated from each other and thus the originality and thus If appropriate, the sterility is no longer given.
- the rear housing part 5 is provided with a support surface arranged perpendicular to the longitudinal axis (flange 56 in FIG. 7) for placing and sealing on a sealing foil.
- a connecting device in particular a snap device, is arranged, with which the piston rod 29 or a first of several detents 40 for coupling and fixing the piston rod 29, the rear housing part 5 can be used.
- This connecting device which may be formed by a jumping to the longitudinal axis 4, circumferential point, can be engaged behind by radially to the longitudinal axis elastically adjustable snap arms and allows a support of the piston rod 29 between the cartridge plug 31 and the inwardly projecting point of the connecting device is positioned and positioned can exert a feed motion on the cartridge plug 31.
- the carpule 12 can act with a partially over the surface of the outside of the carpule 12 Press fit be connected to the rear housing part 5, or there are corresponding over the inner surface of the rear housing part 5 forward protruding projections formed holding elements for the carpule.
- the retention force of the press fit or restraint devices is less than a support of the cartridge sealing disc 37 with the crimp cap 38, since the advancement of the carpule 12 for engagement in a transfer seat 16 using the medium in the carpule 11, due to the incompressibility of the liquid via the cartridge plug 31 of the carpule 12 takes place. That is to say the anchoring of the cartridge sealing disc 37 must be so strong that the force required to overcome the interference fit or the retraction results in a necessary thrust force exerted on the carpule in the region of the carpule sealing disc 37, the piston rod 29 and the cartridge plug 31. before the carpule sealing washer 37 is pierced by the connecting cannula 18 of the transfer set 16.
- the piston rod 29 is equipped with a plurality of detents 40, whose function will be explained in more detail below.
- a flange-like finger rest 32 is formed at the rear end of the housing 7.
- the piston rod is received axially displaceably in a brake cylinder shoulder 41 formed in the rear housing part 5.
- a piston rod housing 30 completely covering the piston rod 29 is connected to a connecting flange 33 with the rear housing part 5, for example by a weld 42, which can be made by ultrasound or gluing or Anformung and only so strongly dimensioned that they quasi a breaking point and thus forms an additional quality criterion that makes it possible to remove the piston rod housing 30 from the housing 3.
- a label 34 which protects the connecting flange 33 and the finger rest 32 serves as a guarantee seal, the breakage of which indicates that the piston rod housing 30 has been removed from the housing 3.
- the end face at its rear end, the piston rod housing 30 has an opening 13 which is closed by a resting on a support grid 28 membrane 14.
- the mem brane 14 is such that it is permeable to gas, but not to bacteria. So-called medical grade paper meets this requirement.
- the membrane 14 serves to prevent unintentional puncture of Teretpapiers during sterilization or during subsequent transport until use.
- This membrane 14 can be integrally formed in the piston rod housing 30 or mitge be injected and it is also possible to press in the support grid, glued, ein ⁇ snap or otherwise secure or to replace by a flow of a fabric, knitted fabric or a sons ⁇ term membrane or a filter.
- the front housing part 4, the glass cylinder 23, the glass cylinder 23 behind tightly ver ⁇ closing cylinder stopper 11 and the glass cylinder 23 front sealingly closing adapter 25 with the attached to this closure 9 form a unit that produced in a closed process and as such sold and / or the further processing can be supplied.
- the manufacture and assembly of this unit take place in corresponding clean rooms in order to ensure as particle-free production as possible even before sterilization.
- the pharmaceutical rubber parts consist of a suitable for lyophilization ge rubber formulation.
- the pre-assembly of this unit is carried out in such a way that first the closure 9 is assembled by the sealing element 10 is installed with a mounting device in the cap 27. Then, the shutter 9 is connected to the adapter 25, e.g. connected by means of Luer-lock system, wherein the closure cap 27 engages with the locking projection 46 in the adapter 25, so that a secure, but again releasable, safeguard against unintentional Lö ⁇ sen of the two parts is given from each other.
- Vorbe ⁇ preparation cylinder plugs 11 which have already been washed by default, siliconized and sterilized delivered, introduced into receiving magazines a bottling plant and deposited for further processing.
- the cylinder plugs 11 can also be washed, siliconized, sterilized and dried in a standard filling plant.
- glass cylinder 23 are introduced into the bottling plant, washed, siliconized and sterilized in a hot air tunnel.
- the adapter 25 by means of a snap connection at the undercut of the glass cylinder neck 23 indissoluble.
- the mouth 24 of the glass cylinder 23 is sealed bacteria-tight with the sealing element 10 of the closure 9.
- the dispensing side sterile closed glass cylinder 23 are placed in recordings standing in the bottling plant and the drug solution can now be dosed into the open glass cylinder 23.
- the lyophilization process is initiated at this moment, the venting or the gas exchange taking place via the still open cross-sections of the glass cylinder 23.
- the cylinder plugs 11 are automatically pushed into the glass cylinders 23, sealing them tightly. In this embodiment, it is possible to dispense with the bypasses 45 in the glass cylinder.
- the prepared, sterile cylinder plugs 11 are supplied and inserted into the glass cylinders 23 in a precisely positioned position, only to the extent that the bypasses 45 of the glass cylinder 23 remain open, so that a gas exchange during the following Lyophilization via the open transverse steps of the bypasses 45 can take place.
- the lyophilization process can be initiated, wherein the venting or the gas exchange via the open cross sections of the bypasses 45 takes place.
- the cylinder plugs 11 are automatically pushed to the end position in the glass cylinders 23, whereby the bypasses 45 are sealed.
- Glass cylinder 23 and have in the region of its circumference axially extending ventilation passages. At least in the area of these vent passages, the cylinder plug 11 has a larger diameter beyond it, so that when the latter is inserted more deeply into the chamber, the vent passages are tightly closed by the stronger compression.
- the cross-section of these vent passages is dimensioned so that it is closed by the elastic deformation of the cylinder plug 11 when it is completely accommodated in the glass cylinder 23.
- the glass cylinders 23 are first closed tightly at their mouth facing away from the mouth 24 with the cylinder plug 11 and then placed in receptacles with upwardly directed mouth 24 standing in the filling system. Thereafter, the drug solution is filled through the mouth 24 into the glass cylinder 23 metered. In the subsequent lyophilization, the gas exchange takes place through the open mouth 24 of the glass cylinder 23. After completion of the lyophilization, the glass cylinders 23 are closed with the pre-assembled closures 9 on the discharge side. In this case, the adapter 25 by means of a snap connection at the undercut of the glass cylinder neck 23 indissoluble. As a result, the mouth 24 of the glass cylinder 23 is closed bacteria-tight with the sealing element 10 of the closure 9.
- the assembly steps of the device described below can be performed temporally and locally independently of the previously described assembly steps.
- the finished, on both sides bacteria-tight sealed glass cylinder 23 with the lyophilized active ingredient is introduced by means of a mounting device in the front housing part 4.
- a secure coupling and optionally a torsion protection between the housing part 4 and the adapter 25 and the glass cylinder 23 is achieved, so that the closure 9 can be removed from the device without causing a relative movement or, if appropriate, a rotation between the glass cylinder 23 can come relative to the adapter 25 and the housing part 4.
- injection unit is thus completed for further assembly.
- the assembly steps of the device described below can in turn be performed temporally and locally independently of the previously described assembly steps.
- Another unit of the device is formed as follows. In the at its rear end e.g. through the inner circumferential collar narrowed rear housing part 5, the carpule 12 with the solvent (water for inji ⁇ edible preparations) and finally the transfer set 16 is introduced from the joint 8 forth ago.
- the piston rod 29 is first inserted through the constriction until it engages with its snap connection, then the piston rod housing 30 with the integrally formed connecting flange 33 is placed on the finger rest 32 of the housing part 5. In addition, the connection is still secured with a 4-point weld. Subsequently, the flange Fingerauflagen für is completely labeled to provide the originality can.
- This unit referred to as the activator unit, can now be connected to the injection unit described above by screwing the rear housing part 5 onto the front housing part 4 and subsequently also labeling the connection point 8 in order to be able to provide proof of quality at this point as well.
- the thus completely assembled device can now be supplied to a final sterilization process, in which a gas, preferably ethylene oxide, is supplied to the interior of the device without thereby entering the first chamber 1.
- a gas preferably ethylene oxide
- the gas penetrates through the membrane 14, with which the present in the rear end of the piston rod housing 30 opening 13 is bacteria-tight, first enters the interior of Kol ⁇ benstangengephinuses, where it sterilizes this interior together with the piston rod 29 contained therein.
- the gas continues to flow to the delivery-side end of the carpule 12 and further through the transfer cannula 18 to the rear end of the cylinder plug 11, sterilizing all surfaces with which it is in Contact is coming.
- FIG. 2 shows a further embodiment of the device.
- the first chamber is not formed in a glass cylinder, but rather directly in the plastic housing of the front housing part 4.
- a coupling attachment 51 preferably as Luer-lock approach is formed directly on the front housing part 4 formed.
- the first chamber 1 as in the embodiment of Fi ⁇ gur 1, bacteria-tightly closed with a cylinder plug 11 made of pharmaceutical rubber, which also two different embodiments of the cylinder plug 11 can be used, namely with or without vent passages.
- bypasses 45 are present in the front housing part 4, and the cylinder plug 11 accordingly has no ventilation passages.
- the embodiment of the device according to FIG. 3 has a similar construction to the embodiment of FIG. 2 described above.
- the first chamber 1 is formed in the front housing part 4 made of plastic.
- another embodiment of the transfer set 16 is incorporated, which is constructed so that the transfer set 16 the rear boundary and seal the first chamber 1, as well as the function of a piston for ejecting the reconstituted drug from the first chamber. 1 takes over.
- the cylinder plug 11 described in connection with the embodiments according to FIGS. 1 and 2 is superfluous.
- Variants of filling and lyophilization are also applicable to the embodiments according to Figures 2 and 3. The only difference is that in place of the glass cylinder 23 in these embodiments of the device, the front housing part 4 with the Active ingredient infests and the active ingredient is lyophilized therein.
- the front housing part 4 is preferably made of cyclolefin copolymer, called in the following COC.
- the front housing part 4 assumes the function of a primary packaging which contains the lyophilisate.
- the choice of said material for the execution of this Ge housing part therefore took place in view of the high demands on the precise Formge ⁇ tion, chemical resistance, glassy transparency, high heat resistance and breaking strength, autoclaving at 121 ° C and sterilizability by Gammabestrah- hung and ethylene oxide.
- COC fulfills all requirements which are placed on pharmaceutical containers for the storage of parenteral substances according to EP / JP and USP incl. USP Class VL.
- the containers made of COC are, due to the material properties mentioned above, particularly for the packaging of biotechnical products, toxi ⁇ 's products, solvents, lyophilisates and other pharmaceutical preparations, so that pharmaceutical containers made of plastic have become a real alternative to pharmaceutical containers made of glass.
- the shape of the front housing part 4 can be optimally designed and manufactured in accordance with the requirements for size, ventilation channels (bypasses), syringe head and neck, etc., due to the shape-technical design possibilities which are possible through the use of thermoplastics.
- the carpule 12 and the first chamber 1 according to the embodiment of Figure 1, so the glass cylinder 23 are preferably made of borosilicate glass, which is known for example under the trade name Fiolax.
- This type of glass meets the requirements of the pharmacopoeia USP, European Pharmacopoeia, Japanese Pharmacopoeia and the German Pharmacopoeia (DAB) with regard to chemical resistance and light protection. Compliance with the heavy metal limit values (lead, cadmium, mercury, chromium VI) in accordance with the European Directive 94/62 / CE is guaranteed. Glass is completely inert and dense to ethylene oxide.
- a polyacetate (POM) is used for cannula rest 17.
- POM polyacetate
- POM is also designed by the manufacturer to produce parts for food contact use and complies with FDA and European Union regulations.
- the cannula guide that it does not have direct contact with the drug and the human body when the device is used as intended.
- the cannula guide receives the connecting cannula 18, it was important to use a material which is specified by the manufacturer for use in the field of medical devices.
- connection cannula 18 stainless steel (NIRO 1.403, AISI 304) was chosen.
- the inserted stainless steel is suitable and specified for the production of medical cannulas and also suitable for sterilization with ethylene oxide.
- the fixing of the connecting cannula 18 in the cannula guide 17 takes place with the aid of a UV-curing cyano-acrylate adhesive, for example an adhesive known under the trade name Loctite 4304.
- Theendede ⁇ rüfung the adhesive suitability to ensure the cannula fixation after Steri ⁇ lisation took place in the form of Kanülenfestbest phenomenon (strength between cannula guide 17 and connecting cannula 18) according to EN ISO 7864 on the injection units.
- the comparison of the test results for the needle extraction force of unsterilized and sterilized samples shows no adverse change due to the sterilization.
- the values for the pull-out force determined on the sterilized samples not only meet the standard requirements according to EN ISO 7864, but are even significantly higher than the values of the unsterilized samples.
- the selected sterilization process with ethylene oxide serves to ensure the sterility of the entire device, excluding the drug contained therein (lyophilisate) gas-tight in the first chamber 1 and the gas-tight packed solvent (WFI).
- the membranes 14 and 15, which act as bacteria-tight barriers, are made of medical paper with a basis weight of 60 g / m 2 .
- the paper is coated with the piston rod housing 30 with polyethylene for sealability.
- the material used is designed for use in the medical / pharmaceutical sector, especially for the supply of sterile goods and meets the requirements of EN 868 parts 1 and 7. It is well-permeable to ethylene oxide and specified as bacteria-proof.
- the ETO sterilization of the device must not lead to any change in the lyophilisate present in the bacteria-tightly sealed first chamber 1 and the solvent present in the carpule 12. To ensure this, it must be ensured that no ethylene oxide can penetrate into the interior of the first chamber 1 and the carpule 12. Practical verification of the ethylene oxide tightness of the syringe barrel with the lyophilizate and the carpule with the solvent (WFI) was made by examining the contents of the cartridge and the contents of the first chamber 1 of sterilized devices according to the invention, in the described embodiments on ethylene oxide. Ethylene oxide could not be detected in any of the cartridges and first chambers sterilized with ethylene oxide. Thus, a change in the solvent stored therein (water for injection purposes) and the lyophilisate can be excluded by the action of ethylene oxide.
- the activator unit In the starting position shown in FIG. 4a, the activator unit is secured to the piston rod housing 30 and the connection between the activator unit and the injection unit (rear housing part 5) is provided with the label 34.
- the piston rod housing 30 is removed from the rear housing part 5 and the device can now, as described below, be activated.
- the device is activated by the piston rod movement by slight pressure on the piston rod 29. This pressure is transmitted to the cartridge plug 31. Since the carpule is sealed and filled with a liquid solvent, the cartridge plug 31 can not be pressed into the carpule 12. Consequently, the carpule 12 releases itself from the rest position against the resistance of the cartridge support 39 and moves in the direction of the transfer set 16. As a result, the spring latching tabs 47 of the transfer set 16 are released from the annular groove 48 of the housing part 5 and the transfer set 16 becomes Direction cylinder plug 11 is pressed until it rests on the cylinder plug 11.
- connecting cannula 18 pierces the cylinder plug 11 and penetrates into the interior of the first chamber 1.
- the other end of the connecting cannula 18 also pierces the carpule sealing disc 37 of the carpule 12 and the connecting cannula 18 penetrates into the interior of the carpule 12, so that now a through connection between the carpule interior (with the solvent) and the first chamber 1 (with the lyophilisate) is made.
- One of the detents 40 of the piston rod 29 now automatically engages in the rear housing part 5 and secures the transfer set 16 in conjunction with the cylinder plug 11 in this posi ⁇ tion. Retraction of the piston rod from this position is no longer possible. As a result, it is ensured that the connection between the first chamber 1 with the lyophilate and the carpule with the solvent remains upright via the connecting cannula 18.
- Another detent 40 engages in the rear housing part 5 and holds the carpule 12 in connection with the transfer set 16 against the built-up internal pressure (Luft ⁇ cushion) in the first chamber 1 in this position. This lock will cause the return of flow of solution for injection into the carpule safely prevented.
- the device is shaken gently, checking that the lyophilisate is completely dissolved. Thereafter, the closure 9 can be removed, wherein the Vorrich ⁇ device with its discharge-side end 6 is to hold upwards, so that the present in the first chamber 1 air pressure is reduced, without escaping injection solution. After placing an injection cannula 49 and venting the first chamber 1 via this, the device is now ready for injection. This position is shown in Fig. 4e.
- the injection solution is pressed out of the first chamber 1 by means of the cylinder stopper 11.
- the device After the injection has been completed, the device finally reaches the position shown in FIG. 4f.
- a further detent 40 engages in the housing part 5 and secures the piston rod 29 in its end position against pulling out. This reuse of the device is effectively prevented.
- the activator unit In the starting position shown in FIG. 5a, the activator unit is secured to the piston rod housing 30 and the connection between the activator unit and the injection unit (rear housing part 5) is provided with the tamper-evident closure (label 34).
- the cannula protective cap 21 is compressed, the sterile connecting cannula 18 pierces the carpule sealing disc 37 and penetrates into the interior of the carpule 12 (with the solvent).
- the transfer set 16 remains, secured by the molded-on brake lugs 54, stand in position.
- the catch 40 of the piston rod 29 now automatically engages in the rear housing part 5 and secures the transfer set 16, in conjunction with the connecting cannula 18 and the carpule 12, in the position according to FIG. 5c. Retraction of the Kol ⁇ rod from this position is no longer possible.
- the closure 9 is removed and the injection cannula 49 is put on (FIG. 5 e). After venting the first chamber 1 via the cannula, the injection can take place.
- the brake lugs 54 which have hitherto retained the transfer set 16 in a projection in the front housing part 4, are pushed away and the transfer set 16 begins to move towards the delivery side of the device.
- the transfer set 16 now serves as a syringe plunger and urges the solution for injection out of the first chamber 1.
- the device After the injection, the device finally reaches the position shown in Fig. 5f, in which a further detent 40 engages in the housing part 5 and the piston rod 29 secures in its final position against withdrawal. This effectively prevents reuse of the device.
- Figure 6 shows an embodiment of an injection unit which can be manufactured, stored and sold separately and later assembled with an activator part.
- the first chamber 1 containing the lyophilizate 26 is formed directly by the front housing part 4 and on the discharge side has a coupling projection 51 which has a luer lock.
- a transfer set 16th used, which differs from the transfer set shown in Figure 3, characterized in that a recess 22, in which is the Karpu structuriitige end 20 of the connecting cannula 18 is sealed bacteria-tight by a membrane 15 against the outside.
- the membrane 15 consisting of medical sterile paper is coated with polyethylene for this purpose and tightly welded to the transfer set 16.
- the transfer set 16 is sealed by an O-ring 53 in the front housing part 4 and held by brake lugs 54 in the position shown.
- the membrane 15 When assembled with an activator unit, the membrane 15 initially remains intact. Only when the device is activated, more specifically when advancing the carpule 12, as described in connection with FIGS. 5b and 5c, is the membrane 15 punctured by the carpule 12.
- the housing 3 also consists of the front housing part 4 and the rear housing part 5 containing the carpule 12, which are screwed together at the connection point 8.
- a radially inwardly projecting flange 56 is integrally formed at the rear end of the rear Ge ⁇ koruseteils 5 .
- a membrane 55 made of polyethylene-coated, sterile medical paper is tightly welded. This forms a bacteria-proof injection unit.
- an actuating unit is shown which consists of a coupling part 58 carrying the piston rod 29. The latter has a finger rest 32 and can be connected to the rear housing part 5 by means of a bayonet coupling 59.
- the piston rod 29 is guided in a brake cylinder approach 41.
- latching means 60 are arranged, which consist of radially inwardly projecting locking lugs which protrude into existing on the piston rod 29 notches and ensure that the piston rod 29 to move a certain Kraftauf ⁇ wall is required.
- cutting means 57 Disposed on the end of the piston rod 29 are cutting means 57 which sever the membrane 55 as soon as the actuating unit is connected to the rear housing part 5 by means of the bayonet connection 59.
- FIGS. 8a to 8c show a further embodiment of the device, in which the activation takes place automatically by spring force.
- the device essentially corresponds to that according to FIG. 2, only the rear end of the piston rod housing 30 is different, as described below.
- a spring housing 63 With the open, rear end of the piston rod housing 30, a spring housing 63 is connected by means of a welded, screwed or marnapp ⁇ th connection 65. This carries in its interior a plunger 66 which is widened plate-like at its front end and carries at its rear end two Ratshaken 67.
- a locking disk 68 is als ⁇ taken, which has a through hole, in which sit the latching hooks 61 in the starting position shown in Figure 8 a.
- a spring 64 is seated on the plunger 66 and is biased between its plate-like extension and the locking disc 68.
- the spring housing 63 is closed with an end cap 69 which has a central opening 70.
- a safety cap 61 is placed in the starting position shown in FIG 8a, which has a central locking pin 62 which extends through the opening 70 of the end cap 69 through between the latching hook 67.
- the latching hooks 67 are prevented from moving against each other and to slip in the sequence through the opening in the locking disc, thus the device is secured in this position shown in Figure 8 a and can not be triggered.
- a label (not shown) may be attached, which serves as a guarantee seal. It is also possible to secure the connection points between the rear housing part 5 and the piston rod housing 30, between the piston rod housing 30 and the spring housing 63 and between the spring housing 63, the end cap 69 and the securing cap 61 with a single continuous label.
- the safety cap 61 is first pulled off, as indicated by the arrow in Figure 8a. Now the activation of the device can be triggered. This is done by pressing the end cap in the direction of the delivery end of the device. This has the consequence that the existing in the end cap 69, conically shaped opening 70 presses the latching hooks 76 against each other so that they move under the force of the prestressed spring 64 through the opening of the locking disc 68 therethrough.
- FIGS. 8a and 8b clearly shows that the end cap 69 travels an axial distance to trigger the device.
- FIG. 8b shows a position which corresponds to the position according to FIG. 4d with regard to the injection unit.
- piston rod housing 30, together with the spring housing and the components disposed therein, can be removed from the device, as illustrated in FIG. 8c and illustrated by an arrow.
- a sealed with a membrane opening may be provided in the jacket of the piston rod housing 30, in the shell of the spring housing 63 or in the fuse cap 61.
- FIGS. 9a to 9e describe the use of a further embodiment of the device according to the invention.
- the device is similar in construction to the device described above with reference to Fig. 1, the most important differences are also explained below.
- the device has a housing consisting of a front housing part 4 and a rear housing part 5, wherein in the front housing part 4 a glass cylinder 23 is awakege ⁇ introduced, which contains the lyophilisate 26.
- the glass cylinder 23 is provided with an adapter 71 which engages in the groove 50 of the glass cylinder 23.
- a closure 72 which closes the glass cylinder 23 tight.
- an O-ring 73 is arranged between the outside of the adapter 71 and the inside of the neck of the front Ge housing part 4. This construction makes it possible to insert the glass cylinder 23 containing the lyophilizate 26 and closed with the adapter 71 and the closure 72 into the front housing part 4.
- the transfer set 75 differs from the transfer set 16 according to FIG. 1 in that, in addition to the outer spring tab 76 interacting with the inner wall of the rear housing part 5, it also has inner spring latching tabs 74 cooperating with the cartridge head. In the starting position according to FIG. 9 a, the carpule 12 with the cartridge head sits on inner spring latching lugs 74 of the transfer set 75. The outer spring latching tabs 76 of the transfer set 75 are locked in this position in a first, formed for example by an annular groove 77 in the rear housing part 5 locking position.
- the outer and inner spring latching tabs are dimensioned such that the force for overcoming the braking action of the outer spring latching tabs 76 lies in a range of, for example, 1 to 1.5 Newtons and is therefore smaller than the force for overcoming the braking action of the inner spring latching tabs. which is for example about 2 Newtons.
- the piston rod housing 30 is removed, so that the piston rod is exposed and can be actuated.
- the piston rod 29 presses on the cartridge plug 31 and pushes the carpule 12 with the transfer set 75 by the path 79 to the front.
- the outer spring latching tabs 76 of the transfer set 75 inevitably come loose from the annular groove 77 and engage again in the course of the forward movement in the annular groove 78 of the rear housing part 5.
- the cylinder plug 11 is pierced with the connecting cannula 18, which covers the path 80 corresponding to the path 79, so that now the front cannula tip comes to rest within the first chamber 1 of the glass cylinder 23.
- the needle attachment part 81 of the transfer set 75 seals the conical recess 82 of the cylinder stop 11.
- the needle attachment part 81 spring elements are provided which engage in this step in the conical recess 82 of the cylinder plug 11 and so connect the transfer set 75 with the cylinder plug 11. In this case, it is prevented, in particular, that the transfer set 75 is removed from the cylinder stopper 11 again and liquid flows into the space between the rear housing part 5 and the carpule 12.
- the now reached position shown in FIG. 9b is secured by engagement of a detent 40 of the piston rod 29.
- the first chamber 1 now contains the reconstituted active substance 85 and air 86.
- the injector is to be held at this moment so that the closure 72 is at the top. Only now is the closure 72 removed from the injector and the injection cannula 49 put on. The sterility of the injector or the injection solution is ensured until the insertion of the injection cannula 49.
- the air is displaced and injected the required amount of solution, the path 87 is covered. So that only a subset of the active substance 85 can be injected as required, a scale 88 is arranged on the glass cylinder 23 or on the front housing part 4. After spraying out the solution, the corresponding locking catch engages 40 of the piston rod 29 automatically in the cartridge housing 3 and secures the piston rod 29 in the final position. Thus, a manipulation (pulling out the piston rod) with the injector is no longer possible.
- the piston rod housing 30 is simply placed on the front housing part 4 via the cannula 49 after er ⁇ following injection, as shown in Fig. 9e, and locked inextricably.
- the now closed on both sides injector, which is no longer manipulatable, can now be problem-free disposal and without risk of injury.
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Abstract
Description
Claims
Priority Applications (9)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
DK05799629.0T DK1804862T3 (da) | 2004-10-25 | 2005-10-25 | Fremgangsmåde og indretninger til frysetørring, rekonstituering og indgivelse af et rekonstitueret middel |
US11/666,263 US8814823B2 (en) | 2004-10-25 | 2005-10-25 | Method and devices for lyophilizing, reconstituting, and administering a reconstituted agent |
CA2585139A CA2585139C (en) | 2004-10-25 | 2005-10-25 | Method and devices for lyophilizing, reconstituting, and administering a reconstituted agent |
PL05799629T PL1804862T3 (pl) | 2004-10-25 | 2005-10-25 | Sposób i urządzenie do liofilizacji, odtwarzania i podawania odtworzonej substancji czynnej |
AT05799629T ATE541601T1 (de) | 2004-10-25 | 2005-10-25 | Verfahren und vorrichtungen zum lyophilisieren, rekonstituieren und verabreichen eines rekonstituierten wirkstoffes |
ES05799629T ES2382294T3 (es) | 2004-10-25 | 2005-10-25 | Procedimiento y dispositivos para la liofilización, la reconstitución y la administración de un principio activo reconstituido |
JP2007538213A JP4829243B2 (ja) | 2004-10-25 | 2005-10-25 | 薬剤を凍結乾燥し、元に戻し、かつ元に戻した薬剤を投与する方法および装置 |
EP05799629A EP1804862B1 (de) | 2004-10-25 | 2005-10-25 | Verfahren und vorrichtungen zum lyophilisieren, rekonstituieren und verabreichen eines rekonstituierten wirkstoffes |
CN2005800420308A CN101090745B (zh) | 2004-10-25 | 2005-10-25 | 用于冻干、复原和供给高效物质的方法和装置 |
Applications Claiming Priority (2)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
AT0180404A AT500930B1 (de) | 2004-10-25 | 2004-10-25 | Verfahren und vorrichtung zum lyophilisieren, rekonstituieren und verabreichen eines rekonstituierten wirkstoffes |
ATA1804/2004 | 2004-10-25 |
Publications (2)
Publication Number | Publication Date |
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WO2006045132A2 true WO2006045132A2 (de) | 2006-05-04 |
WO2006045132A3 WO2006045132A3 (de) | 2006-07-13 |
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Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
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PCT/AT2005/000423 WO2006045132A2 (de) | 2004-10-25 | 2005-10-25 | Verfahren und vorrichtungen zum lyophilisieren, rekonstituieren und verabreichen eines rekonstituierten wirkstoffes |
Country Status (11)
Country | Link |
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US (1) | US8814823B2 (de) |
EP (1) | EP1804862B1 (de) |
JP (1) | JP4829243B2 (de) |
CN (1) | CN101090745B (de) |
AT (2) | AT500930B1 (de) |
CA (1) | CA2585139C (de) |
DK (1) | DK1804862T3 (de) |
ES (1) | ES2382294T3 (de) |
PL (1) | PL1804862T3 (de) |
RU (1) | RU2384349C2 (de) |
WO (1) | WO2006045132A2 (de) |
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JP2010517727A (ja) * | 2007-02-14 | 2010-05-27 | 丁 玉英 | 注射用パウダーを自動的に混合する機械 |
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WO2015074641A1 (de) * | 2013-11-21 | 2015-05-28 | fzmb GmbH, Forschungszentrum für Medizintechnik und Biotechnologie | Verfahren zum lagern und rekonstituieren eines getrockneten wirkstoffs sowie spritze dazu |
US11185629B2 (en) | 2016-06-08 | 2021-11-30 | Shl Medical Ag | Dosing apparatus and injection device |
US11253652B2 (en) | 2016-11-28 | 2022-02-22 | Shl Medical Ag | Device for dispensing a substance |
US11014529B2 (en) | 2019-04-30 | 2021-05-25 | Joyson Safety Systems Acquisition Llc | Seat belt retractor |
Also Published As
Publication number | Publication date |
---|---|
JP2008517678A (ja) | 2008-05-29 |
RU2384349C2 (ru) | 2010-03-20 |
US20090131864A1 (en) | 2009-05-21 |
CA2585139C (en) | 2014-07-29 |
CN101090745A (zh) | 2007-12-19 |
CA2585139A1 (en) | 2006-05-04 |
JP4829243B2 (ja) | 2011-12-07 |
ATE541601T1 (de) | 2012-02-15 |
ES2382294T3 (es) | 2012-06-07 |
RU2007119397A (ru) | 2008-11-27 |
PL1804862T3 (pl) | 2012-06-29 |
DK1804862T3 (da) | 2012-05-14 |
EP1804862A2 (de) | 2007-07-11 |
AT500930B1 (de) | 2007-03-15 |
AT500930A1 (de) | 2006-05-15 |
US8814823B2 (en) | 2014-08-26 |
CN101090745B (zh) | 2010-09-01 |
WO2006045132A3 (de) | 2006-07-13 |
EP1804862B1 (de) | 2012-01-18 |
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