EP1814617A1

EP1814617A1 - Device, in particular, a medical device, for administering an active substance, in particular in the form of a plastic dual-chambered syringe

Info

Publication number: EP1814617A1
Application number: EP05813961A
Authority: EP
Inventors: Arthur Fabian
Original assignee: Cilag AG
Current assignee: Cilag AG
Priority date: 2004-11-24
Filing date: 2005-11-24
Publication date: 2007-08-08
Also published as: WO2006056452A1; DE102004056617A1

Abstract

The invention relates to a device, in particular, in the form of a dual-chambered syringe, for administering a liquid active substance. Said device comprises a cylinder-shaped cavity provided with a first end comprising an outlet and a second end which is opposite thereto. One first and one second piston stopper are arranged in a displaceable manner along the longitudinal axis of the cavity inside the cavity. A first chamber extending between the first end and the first piston stopper and a second chamber extending between the first piston stopper and the second piston stopper are formed prior to the adminstration of the active substance within the cavity by means, respectively, of the first piston stopper and the second piston stopper. The cavity is provided with said type of inner diameter projection such that the cavity in the region of the first chamber has a first inner diameter which is smaller than the inner diameter of the second chamber.

Description

Arthur Fabian

Winkelriedstrasse 42

CH-8203 Sheepflies

Device for, in particular medical, administration of an active substance, in particular in the form of a double-chamber syringe made of plastic

description

The invention relates to a device for, in particular medical, administration of a liquid active substance, such as a medicament, comprising at least one essentially cylindrical hollow body with a first end comprising at least one outlet opening for the liquid active substance and having a first end opposite second. End, wherein within the hollow body at least one of the first end facing and at least along a longitudinal axis of the hollow body movable first piston plug and at least one second end facing and at least along the longitudinal axis of the hollow body movable second plunger stopper at least temporarily can be arranged, wherein at least prior to administration of the Drug within the hollow body by means of Ers¬ th piston stopper at least one plug between the first end and the first Kolben¬ extending first chamber and by means of the second piston plug at least one extending between the first piston plug and the second piston plug second chamber is formed, in particular Form of a dual-chamber syringe according to patent claims 1 to 9.

Medicaments which are lyophilised or freeze-dried are currently mainly filled in pharmaceutical vials and subsequently freeze-dried in these containers: In clean rooms or insulators, the sterilized vials are filled. Thereafter, a special stopper is placed on the vial (the stopper in the so-called setting position does not close the vial yet). Then the vial is placed in the setting position in the lyophilization chamber with the stopper. After completion of the freeze-drying process or the lyophilization, the vial is closed at a pressure level well below the atmospheric pressure, for example 500 mbar (absolute).

The freeze-dried medicament must first be dissolved by a solvent (diluent) before administration. For this purpose, the solvent is usually injected into the pharmaceutical material with the freeze-dried product. Furthermore, the solution is drawn from the pharmaceutical vial into an injection syringe (transferred) and then administered in this via an injection cannula to the patient.

Furthermore, generic devices are known from the prior art. Thus, EP 0 440 846 A1, filed on February 7, 1990 and published on August 14, 1991, describes a dual-chamber syringe. The syringe chambers separated from one another by a piston stopper are connected to one another by a by-pass in the case of a certain positioning of the piston stopper. The by-pass is formed by an axially extending cross-sectional widening. The by-pass forms a bump on the cylinder outer and inner wall in the tangential and axial directions.

The company Vetter from Ravensburg (Germany) offers, under the name Vetter Lyo-Ject®, a glass syringe barrel corresponding to this description of EP 0 440 846 A1.

Furthermore, EP 0 599 649 A1 describes another generic device in the form of a dual-chamber syringe. The syringe chambers are separated from each other by a piston stopper as described in EP 0 440 846 A1. With proper positioning, the two chambers are also connected by a by-pass. The by-pass is achieved by a partial enlargement of the inside diameter in the axial direction. forms. Since the by-pass is realized by a partial reduction of the cylinder wall thickness, the cylinder outer wall in the tangential and axial direction is flat.

A disadvantage of this genus in modern devices, however, is that the manufacturing process for the syringe barrel due to the formation of undercuts at least on an inner side of the syringe barrel in the axial direction complicated and thus expensive.

The object of the present invention is therefore to further develop the generic devices such that the disadvantages of the prior art are overcome, in particular a device is provided which has the functionality of a dual-chamber syringe, but at the same time can be produced in a simplified manufacturing process. In one embodiment, in particular a cost-effective in production double-chamber syringe barrels made of plastic, for the administration of drugs that are preserved by freeze-drying over a longer period of time to be provided.

This object is achieved in that in the device of Hohlkör¬ by at least one such inner diameter taper, that the hollow body in the region of the first chamber has a substantially first inner diameter and in the region of the second chamber has a substantially second inner diameter, wherein the first Inner diameter is less than the second inner diameter.

In this case, provision may in particular be made for the hollow body to comprise at least a first and at least a second element, wherein in particular the first and the second element are substantially tubular, and the second element can be arranged at least in the region of the first chamber within the first element is, wherein preferably the inner diameter of the second element substantially corresponds to the first inner diameter ent. It is preferred that the device is characterized by at least one at least one surface of the hollow body, in particular at least partially in the region of the first chamber and / or the inner diameter taper, formed depression, such as in the form of a groove, wherein by means of the recess, preferably after a movement of the first piston stopper into the region of the inner diameter taper and / or a reduction in a volume of the second chamber, in particular by movement of the second piston stopper in the direction of the first piston stopper, a fluid present in the second chamber into the first one Chamber is conductive.

The invention also proposes that at least one depression is formed on an inner wall of the hollow body, in particular on a surface of the second element of the hollow body facing away from an inner wall of the first element of the hollow body.

In the two aforementioned alternatives it is preferred that at least one depression is formed on one, preferably substantially smooth, inner wall of the first element of the hollow body facing surface of the second element of the hollow body, in particular the second element of the hollow body comprises at least one flow channel with the recess and at least one opening in the inner wall of the first Elemen¬ tes of the hollow body facing away from the surface of the second element is operatively connected.

It is also proposed with the invention that the depth of the recess is less than or equal to half the difference of the first and second inner diameter.

A device according to the invention preferably comprises at least two, preferably a plurality, in particular three, four, five or six, of depressions and / or Durchfluß¬ channels.

It is preferred that at least two recesses and / or at least two flow channels have two different geometries, in particular different cross sections, such as different end cross sections, different widths, different depths and / or different courses, in particular along the longitudinal direction of the hollow body. sen, in particular for swirling of the means of the wells and / or Durchflußka¬ channels from the second into the first chamber led fluid in the first chamber.

It is also proposed with the invention that at least one recess is not completely coverable or closable by the first piston plug, in particular the extent of at least one recess along the longitudinal axis of the hollow body is greater than the Erstre¬ ckimg of the first piston plug along the longitudinal axis of the hollow body.

It is further preferred that, by means of the first and second piston plugs, in particular after the fluid has been passed from the second chamber into the first chamber, a Verbin¬ tion of the first chamber with a portion of the hollow body between the second Kolben¬ plug and the second end , in particular a connection via at least one distribution and / or at least one passage opening, can be closed, preferably the extent of the at least one recess or depressions along the longitudinal axis of the hollow body is less than or equal to the sum of the extent of the first piston stopper and the Extension of the second piston plug along the longitudinal axis of the hollow body is.

In a particularly advantageous embodiment it is provided that the first and / or the second piston stopper comprises pharmaceutical rubber, preferably comprising butyl rubber, and / or at least one surface of the first piston stopper and / or of the second piston stopper, preferably at least one with at least one surface of the Hollow body, ins¬ particular at least one surface of the first and / or second element, at least temporarily in contact surface and / or at least one surface of Hohlkör¬ pers, in particular at least one surface of the first and / or the second element, preferably one with at least Having the first and / or the second piston plug at least temporarily in contact surface, a coating, preferably comprising ethylene-tetrafluoroethylene (ETFE) and / or polytetrafluoroethylene (PTFE).

Furthermore, a device may be characterized by at least one active substance discharge device operatively connected to the hollow body, such as a cannula and / or an infusion tube, wherein the active substance discharge device preferably comprises at least a connecting device arranged in the region of the outlet opening can be connected to the hollow body, in particular comprising at least one plug connection, at least one screw connection, at least one latching connection and / or at least one Einsteckver¬ binding, such as a Luer cone adapter, a Luer lock adapter and or a Bördel¬ edge or crimp neck edge, and / or the Wirkstoffabfuhreinrichtung by means of at least one adhesive, at least one welded joint, at least one thermoplastic compound is connected to the hollow body.

Furthermore, it is preferred that the connecting device is connected by means of at least one first closure device, such as a tip-cap, a crimp neck closure or crimp closure and / or a stopper, and / or the drug delivery device by means of at least one second closure device, such as a Needle shield and / or rigid needle shield, preferably sterile sealing, closable.

It is further proposed with the invention that the first and / or the second closure device comprise or comprise at least one metal, such as aluminum, plastic and / or pharmaceutical rubber, preferably comprising butyl rubber.

In an advantageous embodiment of the device according to the invention, the device has at least one feed opening arranged at the second end of the hollow body for introducing at least one actuating device, wherein in particular the actuating device is preferably detachable, as by means of a clip, plug and / or Screw connection with the second piston plug is connectable, in particular the second piston plug comprises at least one internal thread, and / or the actuating device is designed in the form of at least one piston rod.

In this case, a device is characterized by at least one, in particular in the region of the second end of the hollow body, preferably releasably, can be arranged, abutment device, in particular in the form of at least one finger rest and / or at least one handle plate. The invention also proposes that at least one first, preferably solid, in particular pulverulent and / or freeze-dried, component of the active substance and in the second chamber at least one second, essentially liquid, component of the active ingredient, in particular in the form of a solvent, can be introduced.

It is particularly preferred that the hollow body, in particular the first element and / or the second element, the connecting device, the first closure device and / or the second closure device at least partially comprises at least one thermoplastic material, in particular polycarbonate (PC), cycloolefin copolymer (COC) , Cycloolefin polymer (COP), polypropylene (PP), polystyrene (PS), polyethylene (PE) and / or polyamide (PA).

Finally, it is proposed with the invention that the hollow body can be produced by injection molding.

The invention also proposes a double-chambered syringe in cylindrical form for administering medicaments in liquid form by means of a plunger stopper system.

Additionally or alternatively, it is proposed a double-chamber syringe with a Finger¬ pad at one end of the cylinder and a Luer cone or Luer Lock adapter or with a glued-cannula on the other.

Furthermore claimed is a double-chamber syringe which has an inner diameter taper approximately in the center of the cylinder, wherein in the area of the diameter taper there are a certain number of grooves in the cylinder inner wall and the height of the grooves is at most half of that Inner diameter difference corresponds.

With the invention it is also proposed a double-chamber syringe in which the two chambers are formed by a piston stopper to be placed. In the four aforementioned alternatives of a dual-chamber syringe can be provided that the dual-chamber syringe is closed on the adapter or needle side with a tip cap made of pharmaceutical rubber.

It is preferred that the dual-chamber syringe on the adapter or needle side with a tip cap made of plastic, if necessary, to unscrew, closed.

Alternatively it can be provided that the double-chamber syringe on the adapter or Na¬ delseite is closed with a Needle Shield or Rigid Needle Shield.

It is also preferred that the dual-chamber syringe is a syringe manufactured by injection molding.

Finally, with the invention for a dual-chamber syringe according to the invention vor¬ beaten that the syringe barrel consists of a thermoplastic material, in particular polycarbonate (PC), Cyloolefmes copolymer (COC), cycloolefin polymer (COP), polypropylene (PP) , Polystyrene (PS), polyethylene (PE) or polyamide (PA).

Furthermore, it is proposed for the inventive device that the device is designed as a double-chamber syringe according to the invention, wherein preferably the hollow body of the syringe barrel, which corresponds to a cylinder end of the first end of the hollow body and / or the other cylinder end of the second end of the hollow body.

Alternatively, it is proposed that the device be ausgebil¬ det in the form of a cylindrical ampoule, wherein preferably at the first end of the hollow body, in particular in the region of the outflow, a crimp neck edge or flanged edge is formed and / or at the zwei¬ th end of the hollow body , preferably releasably, a finger rest and / or handle plate a- northbar is.

The invention is therefore based on the surprising finding that the known devices according to the invention, in particular double-chamber syringes, continue to develop in this way. It can be disgusted that a device, in particular a double-chamber syringe, is provided which does not contain a hollow body or syringe barrel in comparison to the double-chamber syringe barrel made of plastic, in particular in the initially cited prior art in the form of EP 0 599 649 A1 Having a so-called Hin¬ terschnitt in the cylinder area, in particular in an axial direction, ie along a longitudinal axis of the syringe barrel or hollow body. This results in the following advantages:

- Shorter cycle times in the production, in particular in an injection molding, and thereby lower production costs

o Temperature control channels can be arranged more optimally, since no core pullers are necessary for demolding undercuts in the injection molding tool.

Since no core pull movements are necessary, time-consuming additional movements for removing the plastic molded part from the cavity are eliminated.

- Low investment costs for machine and tool technology due to the molding design:

o Due to the lack of undercuts, special technologies in the injection mold do not have to be used to produce the hollow body or the double-chamber syringe barrel. It can be used on marieübliche systems for the production of plastic disposable syringes (be¬ limited: tempering, Anspritztechnologie, Entformungstechnologie, Weite¬ Res). o The simpler tool technology also has an effect on the machine technology: Injection molding machine or removal robot, equipped with less additional equipment, can be used.

- molding quality

o Optimally arranged tempering channels in the injection molding tool lead to a more optimal temperature distribution in the molded part during the repressurization and residual cooling time. This leads i.d.R. also to a higher quality plastic molding.

Furthermore, the device according to the invention, in particular the double-chamber syringe according to the invention, or the hollow body, in particular the double-chamber syringe cylinder, at the same time has the advantage over the filling in pharmaceutical vials that it or it is suitable for administering freeze-dried medicaments without costly preparation (mixture of freeze-dried preparation and Lösungs¬ medium and subcutaneous, intramuscular or intravenous administration by simply pushing the plunger stopper with a stop) is or are. In particular, the active ingredient is freeze-dried or lyophilized directly in the application container (i.e., syringe barrel or hollow body, in particular in the first chamber). The other or second chamber of the device, in particular the syringe contains the solvent, which is mixed with the active ingredient only during use, without transfer to another container.

Particularly in the case of the at least partial production of the device, in particular the double-chamber syringe made of plastic, the device, in particular the double-chamber syringe, has the advantage over the present invention of double-chamber syringes of glass according to EP 0 440 846 A1 that it is less expensive because hollow body, in particular syringe barrel or hollow body made of plastic with the comparatively kosten¬ cheap manufacturing process of injection molding (manufacturing process of molded plastic parts) can be produced. Furthermore, the device according to the invention or the erfmdungs- suitable double-chamber syringe suitable for existing automation concepts for Befül¬ development of commercially available disposable syringes, since the hollow body or cylinder outer surface rota¬ is rotationally symmetrical (no unevenness in the axial or tangential direction).

The invention thus provides a device with a hollow body, in particular a double-chamber syringe cylinder, with a taper of the inner diameter in the direction of a syringe barrel end, onto which a cannula is plugged or screwed on, be¬ provided. In the region of the taper, the hollow body of the device, in particular the dual-chamber syringe cylinder, in one preferred embodiment has one or more grooves which are arranged in the axial direction and can run parallel to one another. The height of a groove preferably corresponds to a maximum of half the inner diameter reduction. This dimensioning of the grooves ensures that it is possible to dispense with undercuts in the axial direction of the hollow body, in particular the syringe barrel.

Further features and advantages of the invention will become apparent from the following descrip tion, in which preferred embodiments of the invention by way of example to a schematic drawings are explained in detail. It shows or show:

Figure Ia is a cross-sectional view of a hollow body of a first embodiment of a device according to the invention in the form of a double-chamber injection-molded plastic cylinder;

Figure Ib is a cross-sectional view A-A of Figure Ia;

Figure 2 is a cross-sectional view of a first piston plug (without internal thread);

Figure 3 is a ^{"cross-sectional} view of a second piston stopper (internally threaded);

Figure 4 is a cross-sectional view of a first closure device in the form of a

Cap made of pharmaceutical rubber, more precisely in the form of a tip cap made of pharmaceutical rubber;

FIG. 5 shows a cross-sectional view of a filled device in the form of a double-chamber syringe; Figures 6a to 6f sequences of operation of the device according to the invention in the form of a dual-chamber syringe;

FIG. 7a shows a cross-sectional view of a hollow body of a second embodiment of a device according to the invention in the form of a cylindrical ampoule;

Figure 7b is a cross-sectional view B-B of Figure 7a;

8a shows a cross-sectional view of a third embodiment of a device according to the invention in the form of a cylindrical ampoule;

Figure 8b is a cross-sectional view C-C of Figure 8a; and

FIG. 8c shows a cross-sectional view D-D of FIG. 8a.

In the following, a first embodiment of the device according to the invention in the form of a dual-chamber syringe 33 will first be explained with reference to the figures Ia to 6f.

In the embodiment of the invention described below with reference to FIGS. 1 a to 6 f, the system is composed of the following components:

• One-piece double-chamber syringe cylinder 1 made of plastic (Figures Ia, Ib).

The double-chamber syringe barrel 1 can be designed with a Luer Lock or Luer cone adapter 3 or with a cannula attached to it. The syringe cylinder 1 has approximately in the cylinder center an inner diameter taper. In the area of the diameter taper there are a certain number of grooves 5 in the cylinder inner wall. The height or depth of the grooves 5 corresponds to at most half of the inner diameter difference. The grooves 5 are shown in section A-A of Figure Ia.

Piston plugs made of pharmaceutical rubber without internal thread (FIG. 2)

The piston plug is shorter in the axial direction than the grooves running in the syringe barrel. If necessary, the piston stopper is also coated.

Piston plugs made of pharmaceutical rubber with internal thread (FIG. 3) If necessary, the piston stopper is also coated.

Cap made of pharmaceutical rubber or plastic (FIG. 4)

Piston rod 7 (commercially available, FIG. 5)

• compilation (filled double chamber syringe); (FIG. 5) with syringe cylinder 1, piston rod 7, piston plug with internal thread 9, piston plug without internal thread 11, tip cap 13, diluent 15 and freeze-dried medicament 17.

There now follows a more detailed description of these components of the embodiment of the device according to the invention with reference to the individual figures.

FIG. 1a shows a cross-sectional view of a hollow body of a first embodiment of a device according to the invention. This device is a double-chamber syringe 33 and the hollow body is in the form of a double-chamber syringe cylinder 1. The dual-chamber syringe cylinder 1 has a first end 21. At the first end 21, an outlet opening 23 is formed within the dual-chamber syringe barrel 1. In order to be able to connect the outlet opening 23 with a drug delivery device, for example a cannula, as will be explained later, a first connection device in the form of a Luer cone adapter 3 is formed in the region of the outlet opening 23. The Luer cone adapter 3 allows a cannula to be plugged on to seal the outlet opening 23 of the dual-chamber syringe cylinder 1 with the cannula. The first end 21 of the double-chamber syringe cylinder 1 is opposite to a second end 25 of the double-chamber syringe cylinder 1. The double-chamber syringe cylinder 1, which is preferably made of a thermoplastic plastic and is preferably manufactured by injection molding, has in the region of the second end 25 a restoring device in the form of a finger rest 27, the function of which will be explained later with reference to FIGS. 6a to 6f , on. The double-chamber syringe cylinder 1 is preferably formed in one piece. As can be seen from FIG. 1a, the double-chamber syringe cylinder 1 has regions with different inner diameters. If one goes along the longitudinal axis L of the double-chamber syringe cylinder 1 from the second end 25 in the direction of the first end 21, then the dual-chamber syringe cylinder 1 initially has a second inner diameter d ₂ . Approximately in the middle of the double-chamber syringe barrel 1, there is an inner diameter taper 29. In this region of the double-chamber syringe barrel 1, the inner diameter decreases to a first inner diameter d. In particular, the inner surface of the double-chamber syringe barrel 1 is inclined in the shape of a cone in the region of the inner diameter taper 29. In FIGS. 1 a and 1 b, it should be noted that the double-chamber syringe cylinder 1 is formed in one piece, and additional lines have been drawn only for clarification purposes.

It can be seen from FIG. 1 a that the double-chamber syringe cylinder 1 has no undercuts in the axial direction or in the direction of the longitudinal axis L. This results in the advantages described above in the production of the double-chamber syringe barrel 1, so that the double-chamber syringe barrel 1 can be produced inexpensively.

FIG. 1 b shows a cross-sectional view of the double-chamber syringe cylinder 1 of FIG. 1 a along the section A-A. As can be seen from FIG. 1b, indentations in the form of grooves 5 in the region of the double-chamber syringe barrel 1, which has the first inner diameter di, are formed on an inner wall 31 of the double-chamber syringe barrel 1. As will be explained later, the grooves 5 serve to guide a fluid, such as in the form of the solvent or diluent 15, past a first piston plug 11.

Urn to avoid that in the formation of the grooves 5, an undercut in the axial direction Rich¬ in the inner wall 31 of the double-chamber syringe barrel 1, the Grooves 5 on a depth t, which is less than or equal to half the difference of the second In¬ nendurchmessers d ₂ and the first inner diameter di.

In the following, the other components of the first embodiment of a device according to the invention will now be explained with reference to Figures 3 to 5. The combination of these components with the first embodiment of a device according to the invention in the form of a dual-chamber syringe 33 will be explained with reference to FIG.

FIG. 2 initially shows a cross-sectional view of a first piston stopper 11. The piston plug 11 is preferably made of pharmaceutical rubber, in particular um¬ comprehensive butyl rubber. The first piston plug 11 is substantially plate-shaped and has an extension along the longitudinal axis L of the double-chamber syringe cylinder 1 or thickness d ₅ and an outer diameter d ₃ . The outer diameter d ₃ is slightly larger than the second inner diameter d ₂ in order to achieve that the piston stopper 11 can be sealingly introduced into the dual-chamber syringe barrel 1, as will be explained later. In order to reduce the static friction between a surface 35 of the piston plug 11 with the inner wall 31 of the dual-chamber syringe barrel 1, the surface 35 is coated, preferably with ethylene tetrafluoroethylene (ETFE) and / or polytetrafluoroethylene (PTFE).

In Figure 3, a second piston plug 9 is dargstellt in cross section. Similar to the Kolben¬ plug 11, the second piston plug 9 is formed substantially plate-shaped and has an outer diameter d ₄ . The outer diameter d ₄ is also slightly larger than the inner diameter di of the double-chamber syringe barrel 1 in order to achieve a seal by means of the piston stopper 9 when it is introduced into the dual-chamber syringe barrel 1. The second piston plug 9 has an extension along the longitudinal axis L of the double-chamber syringe cylinder 1 or thickness d ₆ . In order to reduce stiction between the second piston plug 9 and the inner wall 31 of the double-chamber syringe barrel 1, an outer peripheral surface 37 of the second piston plug 9 is also coated. Suitable coating In addition to ethylene tetrafluoroethylene (ETFE), terials also include polytetrafluoroethylene (PTFE), which is also referred to as Teflon. In contrast to the first piston plug 11, the second piston plug 9 has an internal thread 39. As will be explained later, the female thread 39 serves for releasably securing the piston rod 7 to the second piston plug 9.

4 shows a first closure device in the form of a tip cap 13 for closing the outlet opening 23 by attachment to the Luer taper adapter 3 is shown. The tip cap 13 preferably consists of pharmaceutical rubber and has a cone 41 and a peripheral edge 43. The shape of the tip cap 13 er¬ aims at a plugging of the tip cap 13 on the luer cone adapter 3, in particular sterile, ab¬ sealing closure of the outlet opening 23 of the double-chamber syringe barrel 1 er¬.

In the following, one way in which the described double-chamber syringe can be filled is described:

1. Sterilization of the dual-chamber syringe barrel

2. Sterilization of the cap

3. Put the cap on double chamber syringe barrel

4. Filling the drug into the dual-chamber syringe

5. Freeze drying

6. Set the sterilized plunger stopper without internal thread

7. Fill the double-chamber syringe with the solvent

8. Place the sterilized piston plug with internal thread

This assembly of a device according to the invention in the form of a dual-chamber syringe or its filling will now be described in more detail with reference to FIG 5. After the preparation of the double-chamber syringe barrel 1, it is first sterilized, preferably together with the tip cap 13, the first plunger stopper 11 and the second plunger stopper 11. After the outlet opening 23 of the double-chamber syringe barrel 1 is sealed in a sterile sealing manner by means of the tip cap 13, a first component of a, in particular medicinal, active substance is first introduced into the passage opening via a passage opening arranged at the second end of the double-chamber syringe barrel 1 Double-chamber syringe cylinder 1 introduced. This can be done by already introducing a solid, in particular pulverulent, active ingredient, in particular in the form of a freeze-dried medicament 17, into the double-chamber syringe cylinder 1. Alternatively, it can also be provided that initially a solution of the active ingredient is introduced into the double-chamber syringe barrel 1, which is then subsequently freeze-dried in the double-chamber syringe barrel 1. After introduction of the freeze-dried medicament 17 into the double-chamber syringe cylinder 1, the first piston stopper 11 is introduced through the passage opening 45 into the dual-chamber syringe cylinder 1. In this case, the first piston plug 11 is initially pushed forward as far along the longitudinal axis L of the double-chamber syringe cylinder 1 until it is arranged above the inner diameter taper 29. As a result, a first chamber 47 is formed within the dual-chamber syringe cylinder 1. The first chamber 47 is on the one hand tightly closed by the tip cap 13 and on the other hand by the first Kolbenstop¬ fen 11, which covers in particular the grooves 5 in this position.

After introduction of the first piston stopper 11 into the dual-chamber syringe cylinder 1, a second liquid component of the active substance, which is to be administered via the dual-chamber syringe 33, is introduced via the passage opening 45. In the exemplary embodiment shown, it is a solvent or diluent 15. After the double-chamber syringe 33 has been filled with the diluent 15, the second piston stopper 9 is introduced into the dual-chamber syringe cylinder 1 via the passage opening 45. As a result, between the first piston plug 11 and the second piston plug 9, a second chamber 49, which is tightly sealed by the first piston plug 11 and the second piston plug 9, is formed. As already mentioned above, there is no connection between the first chamber 47 and the second chamber 49, in particular in the position of the first piston stopper 11 and the second piston stopper 9 shown in FIG. 5. The dual-chamber syringe 33 is then in its position delivery. Optionally, it can be provided that an actuating device in the form of a piston rod 7 is already in front of a release rod. the double-chamber syringe 33 is connected to the second piston plug 9 via the internal thread 39 or such a connection is only made by a user of the double-chamber syringe 33 before the latter is used.

The operation of the dual-chamber syringe 33 will now be explained in more detail with reference to FIGS. 6a to 6f.

The state of the double-chamber syringe 33 shown in FIG. 6a essentially corresponds to the state shown in FIG. In order to administer the active substance present in the dual-chamber syringe 33, a user proceeds as follows:

In a first step, a user first removes the first closure device in the form of the tip cap 13 from the connection device in the form of the Luer cone adapter 3, so that the dual-chamber syringe 33 is in the state shown in FIG. 6b.

In a next step, the double-chamber syringe 33 for the administration of the medical active substance is prepared by mixing the first component of the active ingredient to be administered in the form of the freeze-dried drug 17 with the second component of the active ingredient to be administered in the form of the diluent 15 is reached. For this purpose, a user exerts a force F on the piston rod 7. For this purpose, a user places in particular a thumb on an end surface 51 of the piston rod 7, while he the double-chamber syringe cylinder 1 with the index finger and the middle finger engages by means of the finger rest 27. The force F is transmitted via the piston rod 7 to the second piston stopper 9. The comparatively poor compability of the diluent 15 causes the force F to be transferred to the first piston plug 11 via the diluent 15. By the force F, first the first piston plug 11 is moved together with the diluent 15 and the second piston plug 9 in the direction of the first end 21 of the outlet opening 23 of the double-chamber syringe cylinder 1. Due to the inner diameter taper 29, the outer diameter d _{3 of} the first piston plug 11 is reduced to the first inner diameter ά _\ . This causes the first piston plug 11 no longer the grooves 5, which are formed on the inner wall 31 of the double-chamber syringe barrel 1, ver¬ closes. The length 1 of the grooves 5 is dimensioned such that the length 1 is greater than the Di¬ dke d _{5 of} the first piston stopper 11, in particular even if the outer diameter d _{3 is} reduced to the first inner diameter di. As a result of the force F, the valve 15, as shown in FIG. 6 a, is pressed out of the second chamber 49 through the grooves 5 into the first chamber 47. In particular, the grooves 5 are only partially covered by these dimensions of the grooves 5 and the first piston plug 11.

As a result of the further exertion of the force F on the piston rod 7, the second piston stopper 9 is then moved further in the direction of the first end 21 of the double-chamber syringe cylinder 1 or in the direction of the first piston stopper 11, until it finally reaches the position shown in FIG. 6d , As a result of this movement of the second piston plug 9 relative to the first piston plug 11, the volume of the second chamber 49 is continuously reduced, as a result of which the diluent 15 is transferred into the first chamber 49.

In a non-illustrated embodiment, it may be provided, in particular, that the grooves 5 have different geometries, in order to achieve that the diluent 15 is fluidized during the transfer into the first chamber 49 in order to mix the diluent 15 with the freeze-dried medicament 17 to support.

After sufficient mixing of the diluent 15 with the freeze-dried medicament 17 has been achieved, the syringe cylinder 1 is formed by the user with a drug delivery device, which in the illustrated embodiment is designed as a cannula 53 via the connection device in the form of the luer cone adapter 3 connected. It can be provided in particular that the cannula 3 is first closed by a second closure device, such as in the form of a needle shield, which causes a sterile seal of the cannula 53.

After the connection of the double-chamber syringe cylinder 1 with the cannula 53 and, if appropriate, a removal of the second closure device from the cannula 53 is the Double-chamber syringe 33 in the position shown in Figure 6e. Subsequently, a force F is again exerted on the piston rod 7 by the user. This has the effect that the outer diameter d _{4 of} the second piston plug 9 is reduced from the second inner diameter d ₂ to the first inner diameter d ₁ by means of the inner diameter taper 29. Due to the dimension of the grooves 5 such that the length 1 of the grooves 5 is less than the sum of the thickness d _{5 of} the first piston plug 11 and the thickness d _{6 of} the second Kolbenstop¬ fens 9, the grooves 5 in a further movement of the first Piston stopper 11 and the second piston plug 9 in the direction of the outlet opening 23 is closed in such a way that the existing in the first chamber 47 drug can not flow through the grooves 5 on the first and second piston plugs 11, 9 past.

As a result of the further movement of the first piston stopper 11 in the direction of the outlet opening 23, the active substance present in the first chamber 47 is pressed into the cannula 53 on the outlet opening 23 until the first piston stopper 11, as shown in FIG. 6f, at the first end 21 the double-chamber syringe cylinder 1 is applied.

In the following, further embodiments of a device according to the invention will now be explained with reference to FIGS. 7a to 8c.

FIG. 7 a shows a cross-sectional view of a further second embodiment of a device according to the invention in the form of a cylindrical ampoule 101. The cylinder cartridge 101 comprises a substantially cylindrical hollow body 103. The hollow body 103 has a first end 105 and a second end 107. In the region of the first end 105 there is an outlet opening 109. In the area of the outlet opening 109, a connecting device in the form of a crimping edge or crimp-neck edge 111 is formed. The hollow body 103 is made of a thermoplastic material and is integrally ausgebil¬ det. Similar to the dual-chamber syringe cylinder 1, the hollow body 103 has an inner diameter taper 113. Thus, the hollow body 103 has a first inner diameter di> on the side facing the first end 105. In the area of the Irrnendurchmesserverjüngung 113, the inner diameter of the Hohlkör¬ pers 103 along the longitudinal axis L 'to the second inner diameter άr to. Similar to the double-chamber syringe cylinder 1, the hollow body 103 has grooves 115 in the region of the inner diameter taper 111. These grooves 115 have a depth t 'and a length 1' in the direction of the longitudinal axis L 'of the hollow body 103.

The operation of the cylinder ampoule 101 substantially corresponds to that of the double-chamber syringe barrel 1. By introducing a not-shown first and second piston plug, a first and second chamber, which are initially sealed by the first and second piston plug, formed. In the first chamber in the region of the hollow body 103, which has the first inner diameter dp and in a second chamber in the region of the hollow body 103, which has an inner diameter d ₂ >, initially the two components of the active substance to be administered can be obtained stored separately in the Zy¬ linder ampule 101.

For closing the outlet opening 109 may be provided in particular that an opening 117 in the region of the crimp neck edge 111 is closed by means of a plug, not shown, made of pharmaceutical rubber, wherein the plug is secured by means of a crimp around the crimp neck edge 111. Furthermore, it can be provided that the hollow body 103 is initially closed at the second end 107 by a closure cap (not shown). When using the cylinder ampoule 101, the closure cap is then removed from the second end 107 of the cylinder ampoule 101 in order to supply an actuating device into the hollow body 103 to exert a force on a second piston stopper, not shown. In order to achieve administration of the medicinal agent present in the cartridge 101, the plug provided at the opening 117 is pierced, for example by means of a tip, in order to connect a drug delivery device to the outlet port 109.

In a preferred embodiment it can be provided that at the second end 107 of the cylinder ampoule 101, after removal of the cap, a Wiederanlagereinrich- tion, for example in the form of a handle plate, releasably attached to the cylinder ampoule 101 is attached.

FIG. 7b shows in a cross-sectional view the formation of the grooves 115 in the region of the inner diameter taper 113.

Finally, a third embodiment of a device according to the invention in the form of a cylindrical ampoule 101 'is shown in FIGS. 8a to 8c. Identical elements of the cylinder cartridge 101 'compared to the cylinder cartridge 101 bear the same reference numerals, but simply deleted. In comparison to the cylindrical ampoule 101, the cylinder ampoule IUI 'has a hollow body 103', which is designed in two parts. Thus, the hollow body 103 'comprises a substantially tubular first element 119' and a second, substantially tubular element 121 '. Integrally formed on the first element 119 'is again a crimp neck edge 111'. Both the first element 119 'and the second element 121' of the hollow body 103 'are preferably produced by injection molding. Upon completion of the first member 119 ', the second member 121' is inserted into the first member 119 '. In Figure 8a, the cylinder ampoule 101 'is shown in the delivery state. In this case, the second end 107 'of the cylinder ampoule 101' is closed by means of a cap 122 '. On the other hand, the opening 117 'is closed by means of a crimp-neck closure 112'. The crimp neck closure 112 'includes a plug 112a' secured to the crimp neck edge 111 'by an aluminum crimp 112b'.

FIGS. 8b and 8c respectively show a cross-sectional view of the cylinder ampule 101 'along the line CC (FIG. 8b) and DD (FIG. 8c). As can be seen in FIG. 8b, the first element 119 'has an inner wall 123'. On the surface facing the inner wall 123 ', the second element 121' has depressions 125 '. Furthermore, the second element 121 ', as can be seen in particular Figure 8c, flow channels 127' on. Due to the interaction of the recess 125 'with the flow channels 127', when using the cylinder ampoule 101 ', a fluid 129' from a second chamber 137 ', the first between a first piston plug 131' and a second piston plug 133 ' is formed, due to a closure of the recess 125 'via the first Kolbenstop¬ fen 131' not in a first chamber 135 ', which has in the region of the hollow body 103', the ei¬ nen first inner diameter dy and in which a freeze-dried medicament ¬ tel 139 'is. For use of the cylindrical ampoule 101 ', a drug delivery device is first connected to the cylindrical ampoule 101' by piercing the plug 112a '. Subsequently, the cap 122 'is removed to introduce an actuating device for the second piston stopper 133'. This may in particular be a finger, such as a thumb, of a user.

When the first piston plug 131 'is displaced in the direction of the second element 121' along a longitudinal axis L "of the cylindrical ampule 101 ', the closure of the depressions 125' is canceled by the first plunger stop 131. As a result, the fluid 129 'can pass through the depressions 125 and the flow channels 127 'flow into the first chamber 135. If the fluid 129' present in the second chamber 137 'is transferred into the first chamber 135', the second piston plug 133 'rests on the first piston plug 131' If the two piston plugs 131 'and 133' are displaced further, the first piston plug 131 'initially closes the flow channels 137', while the second piston plug 133 'closes the recess 125', thereby ensuring that the one present in the first chamber 135 ' Active substance via the outlet opening 109 'from the cylinder ampoule 101' is pushed out.

In a further embodiment, not shown, it is provided that the Durchflußkanä¬ le 127 'have different geometries, so that there is a turbulent flow of the out of the second chamber 137' in the first chamber 135 'flowing fluid 129', in particular for improved mixing the liquid second component 129 'of the active ingredient comes with the first component 139' of the active substance present in the first chamber.

The features of the invention disclosed in the foregoing description, the drawings and the claims may be essential both individually and in any combination for the realization of the invention in its various embodiments. Bezuεszeichenliste

Dual-chamber syringe barrel

Luer cone adapter ^' grooves in the area of the inner diameter taper

piston rod

Piston plugs with internal thread

Piston plugs without internal thread

Tip cap

Diluent

Freeze dried medicine

The End

outlet

The End

finger rest

Inner diameter taper

inner wall

Dual-chamber syringe

surface

inner thread

cone

edge

Through opening

chamber

end face

Cannula 1, 101 'cylindrical ampule 3, 103' hollow body 5, 105 'end 107, 107 'end

109, 109 'outlet opening

111,111 'crimp neck edge

112 'crimp-neck closure

112a 'stopper

112b 'crimping

113, 113 'inner diameter taper

115 grooves

117, 117 'opening

119 'element

121 'element

122 'cap

123 'inner wall

125 'deepening

127 'flow channel

129 'fluid

131 'piston stopper

133 'piston stopper

135 'chamber

137 'chamber

139 'Medicines

F force

1, 1 'length

L, L ', L "longitudinal axis dι, dy, Cl _1" , d ₂ , d _2' , d ₂ »inner diameter t, f depth d ₅ , d ₆ thickness d ₃ , d ₄ outer diameter

Claims

Arthur FabianWinkelriedstraße 42CH-8203 SchaffhausenDevice for, in particular medical, administration of an active substance, in particular in the form of a double-chamber syringe made of plastic claims

A dual chamber syringe (33) in cylindrical form for administering medicaments in liquid form (15, 17) by means of a plunger stopper system.

2. Double-chamber syringe (33), in particular according to claim 1, with a finger rest (27) on a cylinder end (25) and a Luer cone or Luer lock adapter (3) or with a glued-in cannula (53) at the other (21).

3. A dual-chamber syringe (33), in particular according to claim 1 or 2, which has an inner diameter taper (29) approximately in the middle of the cylinder, wherein in the region of the diameter taper (29) a certain number of grooves ( 5) in the cylinder inner wall (31) and the height (t) of the grooves (5) corresponds to a maximum of half the Innen¬ diameter difference.

4. dual-chamber syringe (33), in particular according to one of the preceding claims, in which the two chambers (47, 49) are gebil¬ det by a piston stopper (11) to be placed.

5. dual-chamber syringe (33) according to claim 1, 2, 3 and / or 4, characterized in that the double-chamber syringe (33) is closed on the adapter or needle side (21) with a tip cap (13) made of pharmaceutical rubber.

6. dual-chamber syringe (33) according to claim 1, 2, 3 and / or 4, characterized in that the dual-chamber syringe (33) on the adapter or needle side (21) with a tip cap (13) made of plastic , if necessary, to unscrew, is closed.

7. dual-chamber syringe (33) according to claim 1, 2, 3 and / or 4, characterized in that the double-chamber syringe (33) on the adapter or needle side (21) with a Needle Shield or Rigid Needle Shield closed is.

8. dual-chamber syringe (33) according to claim 1, 2, 3 and / or 4, characterized in that the dual-chamber syringe (33) represents a syringe produced by injection molding dar¬.

9. dual-chamber syringe (33) according to claims 1, 2, 3 and / or 4, characterized gekenn¬ characterized in that the syringe barrel (1) consists of a thermoplastic material, in particular polycarbonate (PC), Cyloolefmes copolymer (COC ), Cycloolefin polymer (COP), polypropylene (PP), polystyrene (PS), polyethylene (PE) or polyamide (PA).

10. Device (33 ₅ 101,101 ') for, in particular medical, administration of a liquid active substance (15,17,129', 139 '), such as a drug comprising at least one substantially cylindrical hollow body (1, 103, 103') with a first End (21, 105, 105 ') comprising at least one outlet opening (23, 109, 109') for the liquid active substance and with a first end (21, 105, 105 ') opposite the second end (25, 107, 107 '), wherein within the hollow body (1, 103, 103') at least one of the first End (21, 105, 105 ') facing and at least along a longitudinal axis (L, L', L ") of the hollow body (1, 103, 103 ') movable first piston plug (11, 131') and at least one of the second end ( 25, 107, 107 ') and at least along the longitudinal axis (L, L', L ") of the hollow body (1, 103, 103 ') movable second piston plug (9, 133') are at least temporarily arranged, wherein at least one Administration of the active substance within the hollow body (1, 103, 103 ') by means of the first piston stopper (11, 131') at least one stopper between the first end (21, 105, 105 ') and the first piston stop (11, 131 ') extending first chamber (47, 135') and by means of the second Kol¬ benstopfens (9, 133 ') at least one between the first piston plug (11, 131') and the second piston plug (9, 133 ') extending second Chamber (49, 137 ') can be formed, characterized in that the hollow body (1, 103, 103') at least one such inner diameter taper (29, 113 , 113 ') that the hollow body (1, 103, 103') in the region of the first chamber (47, 135 ') substantially a first inner diameter (d _l5 d ^, you) and in the region of the second chamber (49, 137 ') essentially has a second inner diameter (d ₂ , d ₂ >, dz _" ), wherein the first inner diameter (d _ls dr, dy) is less than the second inner diameter (d ₂ , d ₂ -, d ₂ " ).

11. The device according to claim 10, characterized in that the hollow body (103 ') at least a first (119') and at least one second element (121 '), wherein in particular the first (119') and the second element (121 ') are substantially tubular in design, and the second element (121') can be arranged within the first element (119 ') at least in the region of the first chamber (135'), wherein preferably the inner diameter (di) of the second element (121 ') substantially corresponding to the first inner diameter (di »).

12. The device according to claim 10 or 11, characterized by at least one on at least one surface (31, 123 ') of the hollow body (1, 103, 103'), in particular at least partially in the region of the first chamber (47, 135 ') and / or the inner diameter taper (29, 113, 113 '), formed recess (5, 115, 125'), as in the form of a groove, wherein by means of the recess (5, 115, 125 '), preferably according to a ner movement of the first piston stopper (11, 131 ') in the region of the Innendurchmes¬ serverjüngung (29, 113, 113') into it and / or a reduction of a volume of the second chamber (49, 137 '), in particular by movement of the second piston stopper (9, 133 ') in the direction of the first piston stopper (47, 135'), in the second chamber (45, 137 ') existing fluid (15, 129') in the first chamber (47, 135 ') is conductable.

13. The device according to claim 12, characterized in that at least one recess (5, 115) on an inner wall (31) of the hollow body (1, 103) is formed, in particular on an inner wall of the first element of Hohl¬ body facing away from the surface second element of the hollow body.

14. The apparatus of claim 12 or 13, characterized in that at least one recess (125 ') on one, preferably substantially smooth, inner wall (123') of the first element (119 ') of the hollow body (103') facing Ober¬ surface of the second element (121 ') of the hollow body (103') is formed, in particular the second element (121 ') of the hollow body (103') at least one flow channel (127 ') which coincides with the recess (125') and at least an opening in which the inner wall of the first element (119 ') of the hollow body (103') facing away from the surface of the second element (121 ') is in operative connection.

15. Device according to one of claims 12 to 14, characterized in that the depth (t, t ') of the recess (5, 115) is less than or equal to half the difference of the first ((I ₁ , dy) and second inner diameter ( d ₂ , d ₂ >).

16. Device according to one of claims 12 to 15, characterized by at least two, preferably a plurality, in particular three, four, five or six, of recesses (5, 115, 125 ') and / or Durchfämmkanälen (127').

17. The apparatus according to claim 16, characterized in that at least two recesses and / or at least two flow channels two unter¬ different geometries, in particular different cross sections, such as different Endquerschnitte, different widths, different depths and / or unterschied¬ Liche courses in particular along the longitudinal direction of the hollow body have, in particular for turbulence of the means of the wells and / or the flow channels from the second into the first chamber led fluid in the first chamber.

18. Device according to one of claims 12 to 17, characterized in that at least one recess (5, 115) is not completely coverable by the first Kolbstopfen (11) or closable, in particular the extension (1, 1 ') at least one recess (5, 115) along the longitudinal axis (L, L ') of the hollow body is greater than the Erstre¬ cover (d ₅ ) of the first piston plug along the longitudinal axis (L, L') of the hollow body (1, 103 ').

19. Device according to one of claims 10 to 18, characterized in that by means of the first (11, 131 ') and the second piston plug (9, 133'), in particular after the fluid (15, 129 ') from the second chamber ( 49, 137 ') was conducted into the first chamber (47, 135'), a connection of the first chamber (47, 135 ') with a region of the hollow body (1, 103') between the second piston plug (9, 133 ') and the second end (25, 107, 107'), in particular a connection via at least one Vertie¬ tion (5, 115) and / or at least one Durchlaßöfmung (127 '), can be closed, vor¬ preferably the extension (1 , 1 ') of the at least one depression (5, 115) or the recesses along the longitudinal axis (L, L') of the hollow body is less than or equal to the sum of the extent (d ₅ ) of the first piston stopper (131 ') and the Extension (d ₆ ) of the second piston stopper (9, 133 ') along the longitudinal axis (L, L') of the hollow body (1, 103 ').

20. Device according to one of claims 10 to 19, characterized in that the first (11, 131 ') and / or the second piston plug (9, 133') pharmaceutical rubber, preferably wise Butylkautscb.uk, comprises and / or at least a surface (35, 37) of the first piston stopper (11, 131 ') and / or the second piston stopper (9, 133'), preferably at least one with at least one surface (31) of the hollow body (1), in particular at least one surface of the first and / or second element, at least temporarily in contact surface (35, 37) and / or at least one surface the hollow body, in particular at least one surface of the first and / or the second element, preferably a surface at least temporarily in contact with at least the first and / or the second piston plug, a coating, preferably comprising ethylene-tetrafluoroethylene (ETFE) and / or polytetrafluoroethylene (PTFE).

21. Device according to one of claims 10 to 20, characterized by at least one with the hollow body (1, 103, 103 ') in operative connection Wirk¬ stoffabfuhreinrichtung (53), such as a cannula and / or an infusion tube, vor¬ preferably the Active ingredient discharge means (53) by means of at least one in the outlet opening (23, 109, 109 ') arranged connecting means (3, 111, 111') with the hollow body (1, 103, 103 ') is connectable, in particular comprising at least one connector, at least a screw connection, at least one snap-in connection and / or at least one plug-in connection, such as a Luer cone adapter (3), a Luer lock adapter and / or a crimping edge or crimp neck edge (111, 111 '), and / or the drug delivery device is connected by at least one adhesive, at least one welded joint, at least one thermoplastic compound with the hollow body.

22. Device according to one of claims 10 to 21, characterized in that the connecting means (3, 111, 111 ') by means of at least a first Verschlußein¬ direction, such as a tip cap (13), a crimp neck closure (112') or Bördel¬ closure and / or a stopper (112a '), and / or the Wirkstoffabführeinrichtung by means of at least one second closure device, such as a Needle Shield and / or Ri¬ gid Needle Shield, preferably sterile sealing, can be closed.

23. Device according to one of claims 10 to 22, characterized in that the first and / or the second closure device comprises at least one metal, such as aluminum, plastic and / or pharmaceutical rubber, preferably comprising butyl rubber, or comprise.

24. Device according to one of claims 10 to 23, characterized by at least one at the second end (25, 107, 107 ') of the hollow body (1, 103, 103') an¬ arranged through-opening (45) for introducing at least one actuating device, wherein in particular the actuating device is preferably releasably connectable to the second piston plug (9) by means of a clip, plug and / or screw connection, in particular the second piston plug (9) comprises at least one internal thread (39), and / or the actuating device is formed in the form of at least one piston rod (7) aus¬.

25. Device according to one of claims 10 to 24, characterized by at least one, in particular in the region of the second end (25) of the hollow body, vor¬ preferably detachable, can be arranged, abutment device, in particular in the form of at least ei¬ ner finger rest (27) and / or at least a handle plate.

26. Device according to one of claims 10 to 25, characterized in that in the first chamber (47, 135 ') at least a first, preferably solid, in particular powdered and / or freeze-dried, component (17, 139') of the active ingredient and in the second chamber (49, 137) at least a second, substantially liquid, component of the active ingredient, in particular in the form of a solvent (15, 129 '), can be introduced.

27. Device according to one of claims 10 to 26, characterized in that the hollow body (1, 103, 103 '), in particular the first element (119') and / or the second element (121 '), the connecting means (3, 111, 111 '), the first closure device (13, 112') and / or the second closure device at least partially comprises at least one thermoplastic material, in particular polycarbonate (PC), cycloolefin copolymer (COC), cycloolefin polymer (COP), polypropylene (PP ), Polystyrene (PS), polyethylene (PE) and / or polyamide (PA).

28. Device according to one of claims 10 to 27, characterized in that the hollow body (1, 103, 103 ') can be produced by injection molding.

29. Device according to one of claims 10 to 28, characterized in that the device is designed as a dual-chamber syringe (33) according to one of claims 1 to 9, wherein preferably the hollow body of the syringe barrel (1), the one cylinder end of the first End (21) of the hollow body and / or the other cylinder end of the second end (25) of the hollow body corresponds.

30. Device according to one of claims 10 to 28, characterized in that the device in the form of a cylindrical ampoule (101, 101 ') is formed, vor¬ preferably at the first end of the hollow body (103, 103') in particular in the region of Outlet opening (109, 109 '), a crimp neck edge or flanged edge (111, 111') is ausgebil¬ det and / or at the second end of the hollow body, preferably releasably, a Finger¬ pad and / or handle plate can be arranged.