EP3203972A1 - Système et procédé pour la préparation d'une injection - Google Patents

Système et procédé pour la préparation d'une injection

Info

Publication number
EP3203972A1
EP3203972A1 EP15774926.8A EP15774926A EP3203972A1 EP 3203972 A1 EP3203972 A1 EP 3203972A1 EP 15774926 A EP15774926 A EP 15774926A EP 3203972 A1 EP3203972 A1 EP 3203972A1
Authority
EP
European Patent Office
Prior art keywords
container
substance
containers
injection
volume
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Withdrawn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
EP15774926.8A
Other languages
German (de)
English (en)
Inventor
Tilman Roedle
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.)
Vetter Pharma Fertigung GmbH and Co KG
Original Assignee
Vetter Pharma Fertigung GmbH and Co KG
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 Vetter Pharma Fertigung GmbH and Co KG filed Critical Vetter Pharma Fertigung GmbH and Co KG
Publication of EP3203972A1 publication Critical patent/EP3203972A1/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Withdrawn legal-status Critical Current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
    • A61M3/00—Medical syringes, e.g. enemata; Irrigators
    • A61M3/005—Medical syringes, e.g. enemata; Irrigators 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
    • A61J1/05—Containers specially adapted for medical or pharmaceutical purposes for collecting, storing or administering blood, plasma or medical fluids ; Infusion or perfusion containers
    • A61J1/06—Ampoules or carpules
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/05—Containers specially adapted for medical or pharmaceutical purposes for collecting, storing or administering blood, plasma or medical fluids ; Infusion or perfusion containers
    • A61J1/06—Ampoules or carpules
    • A61J1/067—Flexible ampoules, the contents of which are expelled by squeezing
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/05—Containers specially adapted for medical or pharmaceutical purposes for collecting, storing or administering blood, plasma or medical fluids ; Infusion or perfusion containers
    • A61J1/10—Bag-type containers
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/14—Details; Accessories therefor
    • 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
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/14—Details; Accessories therefor
    • A61J1/20—Arrangements for transferring or mixing fluids, e.g. from vial to syringe
    • A61J1/2003—Accessories used in combination with means for transfer or mixing of fluids, e.g. for activating fluid flow, separating fluids, filtering fluid or venting
    • A61J1/2048—Connecting means
    • 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
    • A61J1/2093—Containers having several compartments for products to be mixed
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B65—CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
    • B65D—CONTAINERS FOR STORAGE OR TRANSPORT OF ARTICLES OR MATERIALS, e.g. BAGS, BARRELS, BOTTLES, BOXES, CANS, CARTONS, CRATES, DRUMS, JARS, TANKS, HOPPERS, FORWARDING CONTAINERS; ACCESSORIES, CLOSURES, OR FITTINGS THEREFOR; PACKAGING ELEMENTS; PACKAGES
    • B65D35/00—Pliable tubular containers adapted to be permanently or temporarily deformed to expel contents, e.g. collapsible tubes for toothpaste or other plastic or semi-liquid material; Holders therefor
    • B65D35/02—Body construction
    • B65D35/04—Body construction made in one piece
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B65—CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
    • B65D—CONTAINERS FOR STORAGE OR TRANSPORT OF ARTICLES OR MATERIALS, e.g. BAGS, BARRELS, BOTTLES, BOXES, CANS, CARTONS, CRATES, DRUMS, JARS, TANKS, HOPPERS, FORWARDING CONTAINERS; ACCESSORIES, CLOSURES, OR FITTINGS THEREFOR; PACKAGING ELEMENTS; PACKAGES
    • B65D35/00—Pliable tubular containers adapted to be permanently or temporarily deformed to expel contents, e.g. collapsible tubes for toothpaste or other plastic or semi-liquid material; Holders therefor
    • B65D35/44—Closures
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/14—Details; Accessories therefor
    • A61J1/20—Arrangements for transferring or mixing fluids, e.g. from vial to syringe
    • A61J1/2003—Accessories used in combination with means for transfer or mixing of fluids, e.g. for activating fluid flow, separating fluids, filtering fluid or venting
    • A61J1/2006—Piercing means
    • A61J1/201—Piercing means having one piercing end
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/14—Details; Accessories therefor
    • A61J1/20—Arrangements for transferring or mixing fluids, e.g. from vial to syringe
    • A61J1/2003—Accessories used in combination with means for transfer or mixing of fluids, e.g. for activating fluid flow, separating fluids, filtering fluid or venting
    • A61J1/2048—Connecting means
    • A61J1/2058—Connecting means having multiple connecting ports
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/14—Details; Accessories therefor
    • A61J1/20—Arrangements for transferring or mixing fluids, e.g. from vial to syringe
    • A61J1/2096—Combination of a vial and a syringe for transferring or mixing 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
    • A61M2207/00—Methods of manufacture, assembly or production

Definitions

  • the invention relates to a system for preparing an injection according to the preamble of claim 1, moreover a combination of a syringe or carpule with a tube according to claim 12 and a method for preparing an injection according to the preamble of claim 13.
  • first container which is designed as a cylindrical body with a first cavity and, for example, represents a syringe or carpule.
  • a powdery substance in particular a lyophilisate is present, which is a medicinal substance.
  • This is used to inject a patient. For this it is necessary to dissolve the powdery substance.
  • the generated solution can then be administered to a patient.
  • the second container is made of glass or a solid clear plastic material.
  • He is, as usually the first container, not completely filled and contains a volume of air. This makes it possible to transfer the solvent, also referred to as diluent, from the cavity of one container into the cavity of the other container in order to dissolve the powdery substance. It has been shown that when the powdery substance is difficult to dissolve, the solution process is time consuming. It can also happen that the powdery substance does not dissolve completely, which can lead to problems in the application or injection.
  • Such systems are also known, which have a first and a second container, but, in contrast to the above, both containers have a liquid. To prepare for an injection, these two fluids must be mixed together. It is essential that the mixing of these liquids is complete, so that the constituents of both liquids are virtually homogeneously distributed before the mixture is applied. For some medicinal fluids, it has been found that their complete and homogeneous mixing is difficult to achieve. This is the case in particular with vaczines and vitamin preparations, for example. The object of the invention is therefore to provide a system which avoids this disadvantage
  • a system for preparing an injection which has the features of claim 1. It comprises a first container enclosing a first cavity, which has a rigid outer wall and two ends, wherein on one side of the first cavity a movable plug is provided, which closes off this seal and is displaceable within the container.
  • the system has a second container enclosing a second cavity.
  • the system is characterized by a coupling device which has a first first coupling element provided on the first container and a second coupling element provided on the second container, and in that the two containers can be connected to one another by means of the coupling elements such that their cavities in fluid communication with each other.
  • the system is further characterized in that the second container comprises a variable volume.
  • the system proposed here is characterized in that the second container has an at least partially elastic wall, so that it comprises a variable volume.
  • the system is set up so that the second container is expanded by introducing a gas and / or liquid volume, so that the wall addressed here is stretched elastically at least in some areas. Due to the inherent elasticity of the wall, the interior of the second container is under an internal pressure in such a way that a substance provided here can be discharged under pressure and thereby reaches the first container.
  • the liquid substance present in the second container is transferred to the first container. It can flow completely into the first container, because the elastic outer wall of the second container is einwölbbar, so that the volume of the enclosed space in the second container can be reduced. If, therefore, the volume in the second container increases during the introduction of a liquid by widening of the partially elastic outer wall, this can, as stated, also become smaller. This results in a much better mixing of the two substances, as is the case with conventional systems. As a result, thorough mixing of the second substance expelled in the second container and from there with the first substance in the first container takes place.
  • the second container is designed as a tube
  • tube an element is addressed, which has a hollow, in particular tubular Grundkör- per, which is closed at one end.
  • the main body can be welded shut, be it by heat, frictional heat or by means of ultrasonic welding. Other materials and sealing methods can easily be used here.
  • the opposite other end of the base body is formed as a preferably integral lid thereof and has a closable opening, which is preferably surrounded by a preferably cylindrical approach.
  • the lid is somewhat more stable than the side walls of the main body.
  • the cylindrical projection can preferably be provided with an external thread on which a screw cap with an internal thread is applied. Also conceivable are plug or squeeze closures. It is crucial that the production of tubes with today's known methods is simple and extremely cost-effective to implement, even if the outer wall of the tube is at least partially elastic and preferably realized opaque or transparent.
  • the cylindrical projection in the region of the cover When configuring the cylindrical projection in the region of the cover with an external thread, it is very easily possible to couple the tube to the first container, for example by a threaded connection, and to realize a fluid connection between the inner chambers of the first container and the tube.
  • the external thread of the tube can also be adapted to an internal thread of a Luer connection, so that the tube can readily be used with conventional syringes or the like.
  • a preferred embodiment of the system is characterized in that the first substance is a lyophilisate and the second substance is a diluent solvent for the lyophilisate.
  • the lyophilisate and the solvent are housed in separate cavities, results in a very good shelf life of the lyophilisate.
  • Another embodiment of the system is characterized in that lyophilisate is contained in the first container and a solvent for the lyophilisate in the second container.
  • the system is set up and designed such that, for an amount of a first substance in the first container, an amount of a second substance in the second container is provided to an amount of an injection solution for injection provide. It is thus possible to match the containers with the substances to be provided for an injection, so that the system is very easy to handle.
  • the volume of the first container is matched to the quantity of the first substance and / or the volume of the second container is matched to the quantity of the second substance.
  • a number of containers are provided with different amounts of a substance.
  • These containers may be combined with other containers containing different amounts of another substance, with a first container having a first substance and a second container being fluidly contacted with a second substance to mix the two substances together.
  • Characteristic of this system is that the amount of the second substance is exactly matched to the amount of the first substance to provide an injection solution for injection.
  • liquids are provided in the two containers, wherein the amount in the first container is adapted to the amount in the second container such that exactly a certain mixing ratio of the two liquids is achieved. On the one hand, this is relevant in order to provide an injection solution of a specific concentration for an injection.
  • this aspect is relevant to the fact that, for example, two liquids are mixed together, in which the proportions must be coordinated with each other for complete mixing. It is also possible to provide a certain amount of a first substance in a first container and to combine it with different containers in order to realize an injection solution with different concentrations.
  • a first container may be a lyophilisate.
  • the second container at least as much liquid is provided as is required for dissolving or activating the lyophilisate.
  • an injection solution of a different concentration can be produced from one amount of a lyophilisate.
  • the system designed in this way is also characterized in that lyophilisates of various types, ie first substances, are provided in a number of first containers, which differ in that they require different amounts of diluents, ie solvents, for complete dissolution. It is easily possible in the system described here to combine second containers with different quantities of diluents or solvents with the first containers with different lyophilizates. In this case, a second container with a certain amount of a diluent can be made available to a first container with a first lyophilisate in order to provide an injection solution. A container with a second lyophilisate may be supplied with a different amount of solvent by combining another second container with a larger or smaller amount of solvent.
  • the system defined here can thus be adapted in a simple manner to different cases of use, be it the use of different substances for administration to one Patients or to use injection solutions with different concentrations of the ingredients.
  • a modular system of two containers is provided here so that the two containers have different substances and / or different volumes for receiving substances in order to provide a solution for injection in a simple and optimal manner.
  • a particularly preferred embodiment of the system is characterized in that the first container is a syringe or carpule and the second container is a tube.
  • This has an at least partially elastic outer wall, so that it can be expanded and contracted when mixing the two substances in the first and second cavity, so that reduces their internal volume.
  • the system defined here is characterized in that a conventional one-chamber syringe or a one-chamber cartridge with a lyophilisate can be coupled in a simple manner with the second container in order to dissolve the lyophilisate.
  • the object of the invention is also to provide a combination of a syringe or cartridge and a tube, which avoids this disadvantage.
  • a combination of a syringe or carpule and at least one regionally elastic Created wall containing tube is characterized by the fact that given in the syringe or carpule volume and the volume given in the tube are coordinated so that the syringe can take a defined amount of a first substance and the tube a defined amount of a second substance. Due to the at least partially elastic wall, it is possible to press from the syringe or carpule at least a partial volume in the tube, and thus widen the wall against their given by the elasticity restoring forces. This results in the at least partially elastic wall contracting again after the introduction of a partial volume from the first container and introducing the second substance in the tube under pressure into the first container.
  • a liquid encounters a powder or a liquid in the first container at high speed and with energy, so that the mixing of the substances to produce a solution for injection takes place optimally.
  • optimal is meant here a state in which a lyophilisate is dissolved completely and without residue by a solvent or that two liquids are mixed together so that the concentration of the two liquids in the entire volume of the resulting injection solution is the same.
  • a powder can be sprayed into a liquid that is in the syringe or carpule.
  • the object of the invention is also to provide a method which avoids this disadvantage.
  • the first step involves first connecting the two containers via the coupling device in such a way that a fluid connection is realized. Then, the liquid substance is transferred to the solid, preferably powdery substance. This transfer process is very effective because it contains the liquid substance in the container, which has an at least partially elastic outer wall. For transferring the liquid substance into the cavity with the solid substance, the elastic outer wall area can be widened or drawn in, so that as much as possible of the liquid substance reaches the solid.
  • the substances in the containers are mixed by shaking and / or moving a plug provided in the one container.
  • the second container comprises an outer wall that is at least partially elastic.
  • a Luer connector is used as a first coupling element which receives an external thread of a second coupling element.
  • Figure 1 shows a system for preparing an injection with a first and second container
  • Figure 2 shows the system of claim 1 with coupled
  • Containers in a first functional position Figures 3 to 5, the system in further functional positions.
  • FIG. 1 shows a system 1 for preparing an injection with a first container 3, which encloses a first cavity 5 and comprises a rigid outer wall 7.
  • the first container 3 has two ends, wherein at a first end an opening 9 is provided, via which a movable in the first cavity 5 plug 1 1 is inserted.
  • a piston rod 13 which is coupled to the plug 1 1, the plug 1 1 can be displaced in the interior of the first container along its longitudinal axis perpendicular thereto.
  • the plug 1 1 is formed so that it bears sealingly against the inner surface of the outer wall 7, so that the cavity 5 is sealed off relative to the opening 9.
  • a first coupling element 15 is attached at the opposite end of the opening 9 of the first container 3.
  • the first container 3 has a projection 16 on which the coupling element 15 is placed.
  • the first container 3 is a syringe.
  • a projection may be formed at the end present here with a cap which seals the cavity 5 of the container.
  • the container can thus also be designed as a carpule, whereby a puncturable plug can be present at the end addressed here, but in particular it is also possible to connect a further container via a coupling element in order to obtain a fluid. idISS establish between this and the cavity 5 in the container. This will be discussed in more detail below.
  • the first container 3 contains a first substance, which is accommodated in the cavity 5.
  • the first substance is a powder, in particular a lyophilisate 17, ie a freeze-dried substance which is in powder form.
  • Above the lyophilisate 17 is an air volume 19.
  • the first substance may also be a liquid.
  • the system 1 shown here comprises a second container 21, which encloses a cavity 23.
  • a second substance for example a powder
  • the first substance is a liquid
  • the first substance is a powder
  • a solvent 25 if the first substance is a lyophil - lisat is.
  • different substances are present, preferably on the one hand a lyophilisate and on the other hand a solvent called diluent.
  • the lyophilisate 17 is in the first container 3 and the solvent 25 is in the second container 21. But it is also possible to accommodate the lyophilisate 17 in the second container 21 and the solvent in the first container 3.
  • the second container 21 has at one, in this case the upper end, a closure 27 which seals the cavity 23 of the second container 21.
  • a cap K is provided, which is held by the coupling element 15 and serves to seal the cavity 5 of the first container 3 tightly. In this way it is ensured that the substance accommodated in the hollow space 5, in this case the lyophilisate 17, is safely enclosed and a high storage life without contamination is ensured.
  • the cap K is, as is known, preferably designed as a tamper-evident closure, so that manipulation of the cap for a user of the first container 3 is readily apparent.
  • the two containers 3 and 21 of the system 1 are separated from one another and sealed in each case, so that the substances introduced into the associated cavities 5 and 23 of the containers 3 and 21 are securely enclosed.
  • a substance enclosed in the containers 3 and 21, in this case the lyophilisate 17 in the first container 3 is to be administered to a patient, the lyophilisate 17 must be dissolved in preparation for an injection. This is done by the solvent 25 accommodated in the second container 21.
  • the two containers s and 21 In order to be able to dissolve the lyophilizate 17, the two containers s and 21 must be brought into fluid communication with one another. To make this possible, on the one hand the cap K must be removed from the first container 3 and the closure 27 from the second container 21.
  • the first coupling element 15 on the first container 3 is accessible.
  • This is preferably a Luer connection, which is placed on the projection 16 or molded onto the container 3 and has an internal thread.
  • a second coupling element which can interact with the first coupling element 15 on the first container 3, is accessible at the end of the second container 21 associated with the closure 27.
  • the first coupling element 15 is designed as a Luer connection
  • the second coupling element 29 is formed on the second container 21 as a cylindrical projection with an external thread, which cooperates with the internal thread in the Luer approach. This makes it possible to screw the second container 21 onto the first container 3, the first coupling element 15 receiving the second coupling element in a sealing manner.
  • the two coupling elements thus form a coupling device 31, which ensures a tight fluid connection between the cavity 5 in the first container 3 and the cavity 23 of the second container 21.
  • the end of the second container 21 may also be closed by means of a membrane, which is covered by the closure 27.
  • This has the advantage that the contents of the second container immediately after removal of the closure 27, which may be formed, for example, as a screw, not yet freely accessible. Through the membrane protection against contamination of the contents or even against an unwanted escape of the same is guaranteed. After removing the closure 27, the membrane can be pierced and torn open, for example by the projection 16 at the end of the first container 3. In this way, a fluid connection between the two containers 3 and 21 is then realized.
  • FIG. 2 shows the system 1 with the two coupling devices 31 comprising the two coupling elements 15 and 29 with containers 3 and 21 coupled to one another in a first functional position.
  • the first functional position of the system 1 reproduced in FIG. 2 is characterized in that a fluid connection is established via the coupling device 31 between the cavity 5 in the first container 3 and the cavity 23 in the second container 21 shown here in longitudinal section, wherein the stopper 1 1 is in its initial position shown in Figure 1 in the first container 3. The plug 1 1 inside the first container is still in its initial position.
  • FIG. 3 shows the system 1 with the two containers 3 and 21 in a second functional position.
  • the same parts are provided with the same reference numbers, so that reference is made to the preceding description.
  • the plug 1 1 has been displaced upward from the position shown in FIGS. 1 and 2 according to the arrow 33 in the direction of the coupling device 31. Since the two containers 3 and 21 are in fluid communication, in an upward movement of the plug 1 1 apparent in Figures 1 and 2 air volume 19 is displaced in the first cavity 5 and enters the second cavity 23 of the second container 21st It is possible that air is in the second cavity 23 before use of the second container 21, as shown in Figure 2, but this is not absolutely necessary.
  • the second container 21 has a variable volume: It can be seen that the wall 35 of the second container 21 at least can expand in regions as soon as an overpressure in the second cavity 23 is established by the introduced air volume 19.
  • FIG. 3 shows the second container 21 in the expanded state.
  • the second container 21 is preferably designed as a tube which consists of an elastic, in particular opaque or transparent material, so that the substance present in the cavity 23, here the solvent 25, is visible.
  • the material of the second container 21 is preferably designed so that its cavity 23 is protected from UV light.
  • the wall 25 consists of a material which does not change during storage of the system 1 and which in particular does not change the substance 25 present in the cavity 23 during storage.
  • the wall 35 is coated on its inner surface facing the cavity 23. It is also possible to realize the wall two- or multi-layered in order, inter alia, to reduce its permeability. Particularly preferred is an embodiment of the wall, in which the inner, the cavity 23 facing layer is resistant to the substance present in the cavity 23. The remaining material or the remaining layers of the wall 35 can / may then optionally consist of cheaper materials. Multi-layered walls can be realized by coating and also by multi-layer extrusion. In the functional position shown in FIG.
  • FIG. 4 shows a third functional position of the system 1.
  • the same parts are provided with the same reference numerals, so that reference is made to the preceding description.
  • FIG. 4 shows that the plug 1 1 has been displaced downwards from its position shown in FIG. 3 by means of the piston rod 13 in the direction of the arrow 37, so that the solvent 25 present in the cavity 23 in the second container 21 is preferred completely enters the cavity 5 of the first container 3 and can mix with the existing there lyophilisate 17.
  • a defined volume of liquid is supplied to the lyophilisate.
  • a liquid present in the first container 3 can also be supplied to a second liquid present in the second container 21.
  • the second container 21 was widened, whereby its wall 35 was stretched. There was therefore an overpressure in the second container 21. If the plug 1 1 is now pulled downward in the direction of the arrow 37, a negative pressure is created in the cavity 5 in the first container 3, which draws the solvent 25 out of the second container 21. This encounters the lyophilisate 17 at high speed, because it is additionally injected by the positive pressure in the interior of the second container 21 into the first container 3. This leads to a very good mixing of the diluent with the powdery lyophilisate 17, or the two liquids, which may be present in the containers 3 and 21.
  • the plug 1 1 is pulled from the position shown in Figure 4 preferably further down, but so that it is not pulled out of the first container 3. As a result, the substances given in the cavity 5 remain sealed, ie, safe from contamination.
  • FIG. 5 shows the first container 3 of the system 1 in a further functional position.
  • the same parts are provided with the same reference numbers, so that reference is made to the preceding description.
  • the second container 3 is a syringe which can be coupled via a coupling element 15 to an injection needle 39.
  • the first container 3 can also be formed as a carpule, which can be coupled via a coupling device with a second container 21 to dissolve a present in or in the second container of the carpule lyophilisate by means of a solvent, which is in the other container.
  • the carpule can then be used for example in an injection system called a pen or in an infusion device.
  • the second container 21 at least partially has an elastic wall. It can ultimately be arbitrarily shaped, so for example, cylindrical. It is therefore not absolutely necessary to provide a container designed as a tube here. It is also important that the coupling device 31 must be designed so that a tight fluid connection between the two cavities is created in the containers.
  • Luer connection as a first coupling element 15 and a second container with an externally threaded approach, which serves as a second coupling element 29.
  • the two containers 3 and 21 of a system 1 which contain various substances, in particular a lyophilisate and a solvent, are initially connected to one another must be that a tight fluid connection between the enclosed by the containers 3 and 21 cavities 5 and 23 is provided.
  • the coupling device 31 which has a first coupling element 15 on the first container 3 and second coupling element 29 on the second container 21.
  • a solvent 25 is introduced from the second container 21 into the cavity 5 of the first container 3, in which the lyophilisate 17 is located.
  • the transfer of the solvent 25 into the first container 3 is promoted by having second container 21 a variable volume, preferably a wall 35 which is at least partially elastic, and that the second container 21 by an air volume 19 from the first container 3 is first expanded. It has been explained in connection with FIGS. 3 and 4 that initially the stopper 1 1 within the first container 3 is moved upwards in the direction of the arrow 33 in order to generate an overpressure in the second container 21. Due to the overpressure and by the displacement of the plug 1 1 within the first container 3 in the direction of the arrow 37 (see Figure 4), the solvent 25 is transferred from the second container 21 into the cavity 5 of the first container 3.
  • the lyophilisate 17 is dissolved.
  • the dissolution of the lyophilisate 17 and also the mixing of the substances can be promoted by moving the plug 11 up and down in the interior of the first container 3 in the direction of its longitudinal axis.
  • the plug 1 1 can be moved up and down so far that the substances to be mixed flow through the coupling region between the two containers 3 and 29. Since there is usually a relatively small flow cross section, there is a particularly good mixing of the two substances.
  • a solution of a lyophilisate in a diluent is promoted in this way.
  • the volume in the second container 21 increases, so that, as Figure 3 shows, is widened.
  • the movement of the plug 1 1 is facilitated by the fact that the second container 21 has a variable volume and thus at most opposes a slight back pressure of an upward movement of the plug 1 1.
  • a liquid from the first container passes into the second container, which originally contained the serving as a solvent or diluent liquid. Since it is preferably provided here that the quantities of the substances in the two containers are exactly matched to produce an injection solution, the solution can be forced out of the first into the second container, which can be prevented by the latter at least one elastic wall area is easily possible. This is a distinguishing feature over other systems where a large amount of liquid is provided in a container, which is drawn into a different container for multiple injections. In these known systems it is important that the medium present in the container, which is sucked into different syringes or cartridges, is in no way contaminated, so that even when the container is used several times, the injection solution to be produced is not contaminated.
  • the first container 3 is preferably a one-chamber syringe containing the lyophilisate.
  • a syringe containing the lyophilisate.
  • the lyophilizate can be easily dissolved by means of a solvent by the syringe or carpule is coupled to a second container 21 via a coupling device 31, wherein a fluid connection is created.
  • the second container 21 has a variable volume, which is realized in particular by an at least partially elastic wall 35.
  • the second container 21 is formed as a tube, which can be coupled in a simple manner with the first container, so the syringe or carpule. In this case, this tube can replace conventional containers, which usually contain a solvent and are coupled to the syringe or carpule. It is thus very easily possible to exploit the advantages of the second container 21 having a variable volume in order to dissolve a lyophilizate in conventional syringes and cartridges or to mix two different liquids with one another.
  • an essential aspect of the invention is the at least one partially elastic Wall of a container, in particular a tube, is.
  • the wall is widened to provide an injection solution, so that so the at least one partially elastic wall is stretched.
  • a medium present in the second container is expelled under pressure from the container into the first container, so that this medium mixes optimally with that in the first container.
  • a liquid jet from the second vessel hits a powdery substance in the first vessel at high speed and energy, so that it optimally mixes with the liquid.
  • this phenomenon also occurs when the liquid leaving the second container at high energy and speed encounters another liquid in the first container.
  • the media present in the containers to pass through a fluid connection between the containers by displacing the stopper 11 in the first container 3 in the direction of the second container and in the opposite direction.
  • a liquid with a powder to be mixed or with a further liquid to be mixed flows back and forth through the fluid connection. Since this has a smaller cross-section than the two containers, the substances pass through the fluid connection at high speed, which causes optimum mixing of the substances, in particular a good solution of a lyophilisate by means of a solvent or diluent.
  • the at least partially elastic wall is of great advantage because it can expand and contract during a reciprocating movement of the plug and thus prevent the mixture of substances promotes. In doing so, it sets comparatively little resistance to a widening of the second container.
  • volume of the first and second container in particular a syringe or cartridge and a tube, preferably a maximum of 100 ml are selected. Volumes of from 1 ml to 50 ml, in particular from 1 ml to 10 ml or 15 ml, have proven particularly useful.
  • the last-mentioned volumes of the first container or of the syringe or carpule and of the second container or tube result in particularly compact designs for the system for preparing an injection or a combination of syringe or carpule on the one hand and tube on the other hand.
  • This embodiment is thus characterized by a particularly good handling, which is also very manageable for patients.

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Hematology (AREA)
  • Engineering & Computer Science (AREA)
  • Mechanical Engineering (AREA)
  • Physics & Mathematics (AREA)
  • Fluid Mechanics (AREA)
  • Anesthesiology (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Infusion, Injection, And Reservoir Apparatuses (AREA)
  • Medical Preparation Storing Or Oral Administration Devices (AREA)

Abstract

L'invention concerne un système (1) destiné à la préparation d'une injection, comprenant un premier récipient (3), qui est réalisé avec une première cavité (5), et une paroi extérieure rigide (7) ainsi que deux extrémités, une face de la première cavité (5) abritant un bouchon (11) mobile, qui ferme celle-ci de manière étanche et peut être déplacé à l'intérieur du premier récipient (3), et comprenant un deuxième récipient (21), entourant une deuxième cavité (23), un récipient renfermant une première substance et l'autre récipient renfermant une deuxième substance. L'invention se caractérise en ce que le deuxième récipient (21) comprend une paroi au moins par endroits élastique (35) et, de ce fait, un volume variable, en ce que le deuxième récipient (21) est configuré de telle manière qu'une pression puisse se constituer à l'intérieur du deuxième récipient (21) au moyen de la paroi au moins par endroits élastique, et en ce que le deuxième récipient (21) est un tube.
EP15774926.8A 2014-10-08 2015-10-06 Système et procédé pour la préparation d'une injection Withdrawn EP3203972A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
DE102014220365.1A DE102014220365A1 (de) 2014-10-08 2014-10-08 System und Verfahren zur Vorbereitung einer Injektion
PCT/EP2015/072998 WO2016055445A1 (fr) 2014-10-08 2015-10-06 Système et procédé pour la préparation d'une injection

Publications (1)

Publication Number Publication Date
EP3203972A1 true EP3203972A1 (fr) 2017-08-16

Family

ID=54251518

Family Applications (1)

Application Number Title Priority Date Filing Date
EP15774926.8A Withdrawn EP3203972A1 (fr) 2014-10-08 2015-10-06 Système et procédé pour la préparation d'une injection

Country Status (9)

Country Link
US (1) US20170304525A1 (fr)
EP (1) EP3203972A1 (fr)
JP (1) JP2017530804A (fr)
BR (1) BR112017007299A2 (fr)
CA (1) CA2963449A1 (fr)
DE (1) DE102014220365A1 (fr)
MX (1) MX2017004511A (fr)
RU (1) RU2704016C2 (fr)
WO (1) WO2016055445A1 (fr)

Families Citing this family (2)

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Publication number Priority date Publication date Assignee Title
TWI746569B (zh) 2016-06-08 2021-11-21 瑞士商瑞健醫療股份有限公司 計量器具、注射裝置、及其應用
JP7053614B2 (ja) 2016-11-28 2022-04-12 エスエイチエル・メディカル・アーゲー 物質を投与する装置

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US2798488A (en) * 1954-09-15 1957-07-09 Merck & Co Inc Syringe unit
ES370617A1 (es) * 1968-08-28 1971-05-01 Pfizer Dispositivo de inyector de camara doble, especialmente parafines veterinarios.
GB8800448D0 (en) * 1988-01-09 1988-02-10 Smiths Industries Plc Liquid containers
FR2653661A1 (fr) * 1989-10-26 1991-05-03 Faure Jean Marie Conditionnement pour l'administration de liquides steriles, notamment liquides pharmaceutiques.
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JP4187790B2 (ja) * 1996-01-11 2008-11-26 デュオジェクト・メディカル・システムズ・インコーポレーテッド 薬剤ガラス瓶に詰められた薬剤のための配達方式
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US6308747B1 (en) * 1998-10-01 2001-10-30 Barry Farris Needleless method and apparatus for transferring liquid from a container to an injecting device without ambient air contamination
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US20060058734A1 (en) * 2004-09-15 2006-03-16 Phillips John C Self-sealing male Luer connector with molded elastomeric tip
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Also Published As

Publication number Publication date
RU2704016C2 (ru) 2019-10-23
RU2017115841A (ru) 2018-11-13
WO2016055445A1 (fr) 2016-04-14
BR112017007299A2 (pt) 2018-03-13
JP2017530804A (ja) 2017-10-19
MX2017004511A (es) 2017-08-08
DE102014220365A1 (de) 2016-04-28
CA2963449A1 (fr) 2016-04-14
RU2017115841A3 (fr) 2018-12-25
US20170304525A1 (en) 2017-10-26

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