WO2010081489A1

WO2010081489A1 - Apparatus for administering an injectable product

Info

Publication number: WO2010081489A1
Application number: PCT/EP2009/000215
Authority: WO
Inventors: Ulrich Moser; Jürg HIRSCHEL; Markus Tschirren; Stefan Burren
Original assignee: Tecpharma Licensing Ag
Priority date: 2009-01-15
Filing date: 2009-01-15
Publication date: 2010-07-22

Abstract

The invention relates to an apparatus for administering an injectable product, comprising a housing (5) and a drive unit (10) that can be inserted separately, characterized in that the drive unit (10) that can be inserted separately comprises a charged energy accumulator (4).

Description

Device for administering an injectable product

The present invention relates to a device for administering an injectable product preferably from an ampule, such as a two-chamber ampule, which can be advantageously blended just prior to administration.

The administering or injecting device (pen) makes it possible to dose a substance to be administered and to be injected, for example in the form of a single dose, a subsequent distribution being possible and the injection device preferably being blocked after the distribution has taken place in order to prevent further distribution. In this case, the dosage can be made variable, that is, the discharge volume is adjustable, wherein a limited selection can be specified for adjusting the Ausschüttvolumens, for example in the form of four selectable different doses or quantities. Preferably, the distribution after adjustment or dosage and optional priming is done automatically, for example by pressing a trigger button, wherein after the actuation of the trigger button set with a dosing or dosing dose, for example, by means of a preloaded spring automatically distributed, so for example from in the Injection device located ampoule is automatically displaced, so that this set dose can be injected or administered by means of a patch on the injection device injection needle. A dose not administered from the injection device or from the ampoule remains in the injection device or ampoule and can preferably no longer be dispensed, since the injection device is blocked after the distribution has taken place. For example, the Do- be blocked sierelement and / or the release button can be secured against further actuation.

According to a first aspect, the invention relates to a drive unit and in particular a charged or tensioned energy storage having drive unit, which can be separated from an injection device, for example outside the housing of the injection device, assembled, wherein the contained in the drive unit Energy storage, for example in the form of a spring, such as a compression spring, tension spring or coil spring, can be loaded or stretched before or during assembly of the drive unit. The drive unit with the energy store which is charged or tensioned during assembly of the drive unit can subsequently be used as a functional unit or component in the injection device, that is, for example, in a housing of the injection device. This allows the energy storage, so for example a compression spring, simple and controlled and accessible from the outside, for example, mounted on a piston rod and by an attachable to the piston rod element, such as a can be placed on the piston rod and connectable to the piston rod or latched flange, be tense and secured. Thus, a so-called "blind mounting" of the spring inside the housing is prevented.

The energy store may be a per se known spring element, for example in the form of a metal or plastic spring. Likewise, the energy storage as pressure accumulator with, for example, a compressed or compressible gas or other functional mechanism consist, which can be charged or stretched and can cause a mechanical movement, for example, a piston rod during unloading or relaxing.

Preferably, the drive unit with the already tensioned or yet to exciting spring a metering element, such as a metering unit or a metering sleeve having. In this case, the dose to be dispensed can be determined by a movement, that is, for example, a rotation of the dosing unit preferably about a longitudinal axis of the injection device. Likewise, it is possible that the metering element in the axial direction of the Injektionsvorrich tion is movable, that is, for example, pulled out of the injection device or pushed in or out or is screwed into it.

The drive unit with the loadable or tensionable energy store can have a piston rod or threaded rod on which the energy store can act. For example, a compression spring can be placed on a piston rod or threaded rod. Likewise, a coil spring can be coupled to a threaded rod in order, for example, to convert the energy stored in the spiral spring into a rotational movement of the threaded rod after release. In this case, the drive unit preferably has two functional components or elements between which the energy store can be inserted, tensioned or acting. For example, the energy storage can be supported on one side against a piston rod or threaded rod and, for example, come directly into contact with this or be indirectly coupled with this and supported on the opposite side against another support element. The further supporting element may be, for example, a triggering mechanism or release button, a holding sleeve or a metering element.

Advantageously, the elements or components between which the energy storage is arranged or on which the energy storage acts, so coupled that the energy stored in the energy storage energy can not be released immediately, but only after pressing an energy release button or trigger mechanism, such as a release button, is released directly or indirectly, so that the energy released, for example, in a feed movement of a piston or threaded rod relative to the Inj tion device or a housing thereof can be implemented.

According to a further aspect, the invention relates to an injection device with a separately usable drive unit as described above with charged energy storage and an ampoule holder, which can be screwed or inserted into the device or a housing thereof, for example, be in the ampoule holder be - mix and / or prime a suitable ampoule, for example a two-chamber ampoule. According to a further aspect, the invention relates to a method for assembling an injection device, wherein a for the injection, so for example for the automatic feed of the piston or threaded rod, required energy storage in a drive unit ge before the onset of the drive unit in the Injektionsvoπchtung ge loading or prestressing and wherein the drive unit is inserted into the injection device or a housing thereof only after the charging or pretensioning of the energy store.

Advantageously, a spring, in particular a compression spring, is placed or pushed onto a piston rod or threaded rod connected to a support element of the drive unit and tensioned onto the piston or threaded rod by subsequent sliding of an element, such as a flange, so that the Piston or threaded rod is disposed within the tensioned spring. The patch element for tensioning and holding the energy storage device can advantageously be connected or latched to the piston rod or threaded rod after the spring has been tensioned.

***

In another aspect, the invention relates to a retention mechanism, and more particularly to a releasable retention mechanism for holding a piston rod or threaded rod in an injection device. The holding mechanism has at least one holding element for holding the piston or threaded rod, in particular against the force of a charged energy store or a tensioned spring. The retaining element is coupled to the piston or threaded rod and preferably formed integrally therewith or attached thereto. For example, the piston or threaded rod together with the at least one holding element and optionally together with at least one releasable blocking element for releasable locking of the holding element made of the same material are integrally formed. The blocking element is advantageously coupled to the piston rod or threaded rod and, for example, detachably connected on one side to the piston or threaded rod or a holding element and pivotable at another point, for example by means of a deformable portion or joint on the piston or threaded rod or attached to the retaining element. The blocking element may, for example, be a pivot rod attached to the piston rod or threaded rod on one side and pivoted or folded in such a way that the holding element or elements can not be moved or compressed, for example, in one starting position of the articulated rod or locking element and after one Pivoting or folding the locking element moves and can be moved or bent for example in the direction of a central axis or longitudinal axis of the piston rod or threaded rod. The at least one holding element is advantageously arranged on an elastic or spring arm of the piston rod, preferably in the distal region of the piston rod lying opposite the flange, for example.

The blocking element or the articulated rod may have a deflection limitation, for example in the form of a nose, which is designed such that the blocking element is pivoted or pivoted, for example, only so far after pivoting and releasing the at least one retaining element that the at least one blocking element only defines one Release movement can perform. For example, the radially inwardly directed release movement of the blocking element can be limited to a predetermined maximum distance, so that the at least one blocking element can not be deflected further than by the articulated rod or the blocking element in the deflected position.

In another aspect, the invention relates to an injection device having a releasable retention mechanism as described above. Advantageously, the holding mechanism or the at least one holding element preferably hold the piston rod in a metering element or in the housing of the injection device against axial displacement so that, for example, a piston rod is held against the force of a spring constantly pressing on the piston rod. If the blocking element is moved, for example, by a release button, wherein, for example, the locking element hinged to the piston rod is deflected, the at least one retaining element can be released in order to permit axial movement of the piston rod.

*** According to a further aspect, the invention relates to an injection device with a dosing element for adjusting a dose to be dispensed from the injection device and with an ampoule holder which is inserted into the injection device or a housing thereof together with an ampoule, preferably a two-chamber ampoule, arranged therein. can be inserted or screwed. The dosing can be locked with respect to a dosing, so for example a rotary motion and / or axial movement, for example, by a blocking element or Schnapparm, for example, on a dosing, a dosing, the housing or another element is arranged, which by a vial holder or an ampoule, which is screwed into the injection device, can be solved to release the dosing. For example, the blocking element can be displaced in the axial and / or radial direction, for example, inwardly or outwardly relative to the injection device by an end face or other element of the ampoule holder to bring the locking element or the Schnapparm in a release position, so that a setting or Rotary movement of the metering element is no longer blocked by the blocking element. Advantageously, the injection device is dimensioned or the blocking element or the Schnapparm arranged at such a location that the release of the metering element takes place only when a introduced into the injection device or screwed two-chamber ampoule is completely blended and / or primed, so that an adjustment movement can be made only after mixing the two-chamber ampoule and / or priming the ampoule.

Preferably, the blocking element and / or the element releasing the blocking element, for example an ampoule holder or an ampoule, has an inclined contact surface with respect to an axial direction of the injection device, so that an axial relative movement between the blocking element and the element releasing the blocking element is provided Contact with a radial movement of the locking element in the injection device leads, wherein the radial movement brings the locking element out of engagement with the adjusting element and thus releases it. Likewise, the locking element can be moved in the axial direction during insertion of the ampoule to release the adjustment.

According to a further aspect, the invention relates to a method for preparing an injection device for an injection, wherein a dosing element before introduction an ampoule or two-chamber ampoule is locked in the injection device and only during or after the introduction of the ampoule, preferably after mixing the two-chamber ampoule and / or after priming the ampoule, dissolved or released, so that a Dose setting can be made.

Preferably, a triggering element of the injection device for triggering an injection and preferably an autoinjection is blocked before setting a dose with the dosing element and is released only after the setting of a dose. For example, the metering can be sleeve-shaped and rotatable, wherein one or more recesses are provided in the circumferential direction, for example in the form of axially extending grooves into which a web or arm of the release button can be inserted if, for example, made by rotating the metering a dosage has been. Before rotating the metering element, for example, the web or arm of the release button is attached to an end face of the metering element and thus can not be released before setting a dose.

***

According to a further aspect, the invention relates to an injection device for delivering an adjustable dose with a dose setting element having a plurality of limiting elements, for example in the form of a depression or an opening, for determining a dose and with a dispensing element having a holding element which cooperates with, or can snap into, or snap into, for example, at least one restrictor to advantageously confine or lock a dispensed dose. Advantageously, upon snapping or snapping, a sound and / or tactile mechanical impulse is generated to provide a user with an audible or visual stimulus to give haptic feedback regarding the injection being made.

Preferably, the limiting element is sleeve-shaped or has a sleeve-shaped section, which in the circumferential direction and in the axial direction in each case staggered boundary elements or depressions or openings, so that, depending on the rotational position of the preferably axially displaceable mounted Begren- tion element is located in the axial displacement direction of one or the holding element of the Ausschüttelements located depression or opening in one of the fixed dose determined by the rotation of each associated different axial position. In this case, the retaining element of the dispensing element is preferably mounted torsion-proof in the injection device and preferably can not rotate with the limiting element when setting a dose.

Advantageously, the delimiting elements or depressions of the dose setting element lie on a helical line and advantageously on the inner or outer circumferential surface of a sleeve-shaped dose setting element, so that the delimiting elements are arranged, for example, in a staircase shape.

The holding element of the Ausschüttelements, so for example a piston rod or threaded rod, is advantageously an elastic or resilient snap or locking element, such as a radially outwardly or inwardly biased Schnapparm.

The invention will be described below with reference to Ausiuhrungsbeispielen. Show it:

FIG. 1 shows a cross-sectional view of an injection device according to a first embodiment;

FIG. 2 is an individual part overview of the injection device shown in FIG. 1;

Figures 3A and 3B show the injection device shown in Figure 1 in the delivery state in two mutually orthogonal sectional views.

Figure 3C is a detail view of Dosierknopfsperrung;

FIG. 3D shows a detailed view of the release button lock;

FIG. 4A shows the injection device shown in FIG. 3A in the mixed state; Figure 4B is a cross-sectional view of the injection device shown in Figure 4 A;

FIG. 5 shows the injection device shown in FIG. 4 after stirring by priming;

Figure 5A is a detail view of the unlocked Dosierknopfs;

Figure 6A is a cross-sectional view of the injection device to illustrate the limitation of dose setting;

Figure 6B is a cross-sectional view of the release button released by the dosing button;

FIG. 7 shows the injection device in the triggered state;

FIG. 8 shows the injection device after dispensing the set dose;

Figure 8A is a perspective view of the Dosierknopfes;

Figure 9 is a cross-sectional view of a second embodiment of an injection device;

FIG. 10A shows an individual part overview of a drive unit of the injection device shown in FIG. 9;

Figure 1OB the partially assembled drive unit shown in Figure 1 OA;

Figure IOC the fully assembled drive unit;

FIG. 11 shows the functional components of the injection device shown in FIG. 9; FIG. 12 shows the injection device in the delivery state;

Figure 12A is a perspective detail view of the blocking of the Dosierknopfs;

Figure 12B is a detail cross-sectional view of the lock of the release button;

FIG. 13A, the injection device in the mixed state;

Figure 13B is a cross-sectional view of the injection device of Figure 13A;

FIG. 14 shows the injection device after priming has been carried out;

FIG. 14A shows a perspective detailed view of the release of the metering mechanism;

FIG. 14B shows a cross-sectional view of the injection device according to FIG. 14;

Figure 15 shows the injection device after unlocking and release;

Figure 15A is a detail view of a recess of the metering element for inserting a web for releasing the release button;

Figure 15B is a cross-sectional view of the injection device of Figure 15;

Figure 16 shows the injection device after dumping;

FIG. 16A shows a detailed view of the tilting element for limiting the radial deflection of the locking element; and

FIG. 16B is a perspective view of the dose limiting apertures of FIG

Dosing. 1 shows a first embodiment of an injection device with a housing 5, which in the distal (shown in Figure 1 left front) region has an internal thread 5 a, in which an ampoule holder 1 with external thread Ia and a two-chamber ampoule 2 present therein screwed can be. At the proximal end of the injection device (shown on the right in FIG. 1), a trigger button 8 protrudes in the axial direction, which is blocked by the dose selection ring or dosing button 7 before mixing and before dose selection. The dosing button 7 is locked before the complete mixing of the two-chamber ampoule 2, as will be described below. An already stretched injection spring 4 is supported proximally against a holding sleeve 6 and distally against a piston rod 3. In the housing 5, a radially inwardly projecting web or bottom 5b is provided, which is omitted in the described second embodiment for simpler manufacture of the housing 5 without forced removal.

Figure 2 shows an itemized overview of the six plastic parts 1, 3 and 5 to 8 and a compression spring 4 composable pens, in which the two-chamber ampule 2 can be used. In the delivery state shown in FIGS. 3A and 3B in two orthogonal successive longitudinal sectional views of the injection device, the injection spring 4 is tensioned and stores the energy for a complete discharge of the substance still to be mixed in the ampoule 2. The ampoule 2 is inserted into the ampoule holder 1, which carries an external thread Ia, which can be screwed into the internal thread 5a of the housing 5 for mixing the substance contained in the two-chamber ampoule 2. The tensioned already before insertion into the injection device spring 4 is supported in the proximal region against the retaining sleeve 6, which is secured against rotation, for example, by grooves engaging in the housing 5 and by, for example, radially outwardly biased snap arms 6b to radially inwardly projecting projections 5 b of the housing 5 is held. Along the longitudinal axis of the holding sleeve 6 extends centrally a mandrel 6c, on which the spring 4 can be placed. In the proximal region of the holding sleeve 6 radially outwardly projecting locking elements or hooks 6a and radially inwardly projecting locking elements 6d are provided. The outwardly projecting hooks 6a abut on the inside of the release button 8 and thus prevent a radially outwardly directed movement of the radially inwardly pointing locking element ment or hook 6d. The radially inwardly directed locking elements 6 d engage in recesses or, for example, a partially or completely circumferential groove 3 c of the piston rod 3 and thus hold the piston rod 3 against the force of the tensioned spring 4 in the fixed position shown on the retaining sleeve. 6

The set on the holding sleeve 6 and preferably as shown in Figure 3 A recognizable latched with the retaining sleeve 6 and with respect to the retaining sleeve 6 secured release button 8 has recesses or openings 8a, which in the delivery state shown in Figure 3 B in the axial proximal direction relative to the outwardly facing locking elements 6a of the holding sleeve 6 are offset. If the trigger button 8 is pressed in a later step in the distal direction in the Iηjektionsvorrichtung, so provided on elastic or spring arms radially outwardly projecting elements 6a of the holding sleeve 6 in the openings 8a of the release button 8 dodge and are displaced into this, since by the in the axial distal direction acting on the piston rod 3 spring force and due to the bevel of the recess or opening 3c of the piston rod 3, in which the radially inwardly projecting locking elements 6d of the holding sleeve 6, a radially outwardly acting on the locking elements 6d force is generated ,

The holding sleeve 6 inserted therein and tensioned by the piston rod 3 also used spring 4 can be assembled together with the attached release button 8 as a functional unit separately and then used in the housing 5 of the Inj ektions device, so that no "blind assembly" of the spring 4th in the housing 5 is required.

The actuation and thus an axial insertion of the trigger button 8 in the Inj ektions device in the delivery state is prevented by a nose or a web 8b of the release button 8, as shown in Figure 3D, which abuts a rib 7a of the dose selector 7.

The rotation of the dose selector ring 7 in the delivery state is prevented by a radially outwardly biased latching or spring arm 3 a of the piston rod 3, which, as shown in Figure 3 C, engages in a recess or recess 7 b of the dose selector ring 7. As can be seen from FIG. 3A, protrusions or webs 6e projecting radially outwards are provided in the rear proximal region of the retaining sleeve 6, which engage in axially extending grooves 8d of the release button and thus couple the retaining sleeve 6 in a rotationally secure manner to the release button 8.

Figure 4 shows the injection device in the mixed state, the ampoule holder 1 was screwed by means of the threaded coupling Ia, 5 a in the axial direction in the housing 5. The arranged in the ampoule holder 1 ampoule 2 is inserted into the injection device and in particular the rear or proximal plug 2a of the two-chamber ampoule 2, which rests against the front of the piston rod 3, inserted relative to the ampoule 2 in this and thus the two Chamber ampoule 2 blended, wherein the rear plug 2a and front plug 2b abut each other.

The ampoule sleeve 1 has a radially outwardly biased snap element Ib which can snap into a longitudinal groove 5d extending radially on the inside of the housing 5 upon reaching the mixing position, ie the complete mixing of the two-chamber ampoule 2. By snapping a tactile and acoustic feedback can be issued to the user of the injection device, which thus receives the confirmation that the two-chamber ampule 2 has been completely mixed. A backward or unscrewing of the ampoule holder 1 can be prevented by the snap connection Ib, 5d.

The ampoule holder 1 can, however, be further screwed or screwed into the housing 5 of the injection device, so that the front plug 2b now abutting the rear plug 2a is pushed further into the ampoule 2 through this and together with it, thus priming the injection device can be.

The termination of the priming can be signaled by a further engagement of the latch Ib in the longitudinal groove 5d or another suitably arranged groove on the inside of the housing 5, to give the user a second tactile or acoustic feedback. Turning back the ampoule holder 1 is again prevented by the snap element Ib. The ampoule sleeve 1 and the latching arm 3a of the piston rod 3 have such a length that after the completed priming shown in Figure 5, the proximal end of the ampoule holder 1 or optionally also another element of the ampoule holder 1, the locking arm 3a by abutment on a slope of Rastarms 3 a radially inwardly suppressed, whereby the rotation-proof coupling between the piston rod 3 and dose selector sleeve 7 shown in Figure 3 C is released by releasing the engagement of the latching arm 3a in the recess 7b, so that the dose selection sleeve 7 is no longer pressed by the radially inward Locking arm 3 a is held, as shown in Figure 5A. Thus, a dose can be adjusted by turning the dose selection sleeve 7. The release of the dose selector sleeve 7 thus takes place in that the rotationally fixed or housing-fixed Schnapparm 3 a of the piston rod 3 is deflected in the radial direction by a slope or contact with the ampoule holder 1 and so out of engagement with the Dosierknopf or dose selector 7 is brought.

Such a locking and unlocking mechanism of a dose setting element can generally be used in a manually or automatically, for example by spring force distributing pen.

After the dosing dialing sleeve or dosing button 7 has been unlocked, the dose selection can be carried out by turning the dosing button 7. For example, a dose may be adjustable in four steps, that is, for example, four different amounts or doses of the substance to be delivered may be selected. For example, releasable latching can be provided in four rotational positions of the dosing. The dosing button 7 has radial snapper 7i, which can engage in grooves distributed radially in the housing 5 on the circumference. Therefore, the releasable latches are present in the four rotational positions of the Dosierknopfes 7; see Figures 6A and 6B.

As can be seen from FIG. 6A, for example, the dose selection knob 7 can have a radially inwardly projecting stop rib 7g, which can come into contact with two radially outward counterblows 6f of the holding sleeve 6 rotatably mounted in the housing 5, in order to be able to rotate the dose selection knob 7 to an angle smaller than 360 °. If the dose selection knob 7 is rotated, the rib 7a of the dose selection knob 7 is rotated away from the protruding nose 8b of the release button 8 from the blocking position shown in FIG. 3D, and thus the trigger button 8 for movement in the axial direction, that is to say pushing the release button 8 into the injection device, as shown in Fig. 6B.

FIG. 7 shows the injection device in the triggered state. By a pressure on the release button 8, the recess 8a of the release button 8 are moved from the blocking position shown in Figures 3B and 4 into a release position, so that they are located in the region of the radially after expressing hook or locking elements 6a and preferably opposite them, so the hooks 6a are exposed radially outwards and can engage in the recesses 8a. As a result, the inwardly pointing hooks or retaining elements 6d of the holding sleeve 6 are brought out of engagement with the piston rod 3, whereby the piston rod 3 is released. The piston rod 3 can now move in the distal direction by the pressure of the spring 4, which is supported on the holding sleeve 6 and press on the plugs 2a, 2b, whereby the blended substance located in the ampoule 2 before the distal plug 2b is distributed ,

The dispensing movement of the piston rod 3 in the distal direction can be continued until the discharge is limited by a radially outwardly biased hook or a locking element 3b of the piston rod 3, which upon reaching the dose set by rotation of the dosing 7 dose in one of the dosing 7 snaps in uni-direction and axially offset recesses or windows 7c to 7f and thus locked. In this case, a noise can be generated, for example in the form of a "click", which signals a user the end of the injection of the set dose.

FIG. 8A shows the depressions or openings 7c to 7f of the dosing sleeve 7 that are offset relative to one another in the circumferential direction and in the axial direction, which allow a different axial movement of the piston rod 3 depending on the rotational position of the dosing sleeve 7 for setting a dose until the locking element 3b of FIG Piston rod 3 in the window 7c to 7f located by the dose selection in the direction of movement of the locking element 3b a snaps and thus limits the advancing movement of the piston rod 3 and thus the distribution of the dose.

FIG. 9 shows in cross-section a second embodiment of an injection device which can be assembled from seven plastic parts 1, 3, 5, 7 to 9 and 11 and a compression spring 4.

FIG. 10A shows an item overview of a drive unit for an injection device according to the second embodiment. In this case, a dosing sleeve 9, a dose selector ring or dosing button 7, a guided in the Dosierknopf 7 piston rod 3 and a release button 8 are assembled, as shown in Figure 1OB. An injection spring 4 can be pushed onto the piston rod 3 and locked on it. Subsequently, a flange can be pushed with a sleeve element 3d on the piston rod 3 and locked it, so that the injection spring 4 pressed together by the deferred sleeve member and thus stretched. The unit so assembled is shown in Figure 1C and may be referred to as a power supply unit 10 providing the injection, or as a "power pack." Such a power pack 10 includes the compression spring 4 im needed to provide the discharge energy Furthermore, the power pack 10 may also contain other functions, such as functions for a metering setting or metering limitation, as well as the trigger mechanism Such a compression spring 4 to be mounted separately from the housing 5 of the injection device can be controlled easily and externally can be mounted on the piston rod 3 and clamped and secured by the flange 3. Such a functional unit or power pack 10 with the prestressed pressure spring 4 can then be easily mounted with the remainder of the injection device, the individual functional components in FIG are shown.

The injection device can be easily assembled using this functional unit or the power pack 10, wherein the power pack or the functional unit 10 is inserted into the housing 5 of the injection device and locked for example with this and / or secured against rotation. A two-chamber ampoule 2 is placed in an ampoule Pullenhalter 1 used, which guided by a threaded engagement Ia, 5 a can be screwed into the housing 5 of the injection device.

FIG. 12 shows the injection device in the delivery state with inserted and tensioned injection spring 4, which stores energy for a complete discharge of the ampoule 2. The spring 4 is supported on a distal side in a sleeve-shaped region of the dose selector sleeve or the Dosierknopfs 7 and presses on the latched to the piston rod 3 flange 3d, the front or distal region in the delivery state a small distance from the proximal plug 2a of the not yet screwed in the ampoule holder 1 inserted ampoule 2 has. The spring 4 presses on the connected to the piston rod 3 cartridge spring 11 and / or the flange 3d on the piston rod. 3

The cartridge spring 11 is snapped onto the piston rod 3. The spring 4 presses on the cartridge spring 11 and the force is transmitted via the Schnschnappung (snap arms 11 a) on the piston rod 3; see FIG. 12.

The piston rod 3 has in the proximal region two radially outwardly projecting projections or hooks 3e, which in each case engage behind projections of the dosing knob 7. Between the mutually opposing projections 3e of the piston rod 3 there is provided a hinge element 3f, which is articulated on one side, such as on the upper hook element 3e shown in FIG. 12, and has an articulated connection, whereas the articulation element 3f on the opposite side in the region of the opposite projection 3e by means of a bulge or depression in the region of an inwardly projecting projection of the threaded rod 3 is supported. Thus, by the hinge element 3f, the deflection and disengagement of the hook elements 3e which hold the piston rod 3 in a proximal position against the force of the spring 4 can be prevented.

The trigger button 8 has a web or arm 8c, which has at its end a snap element or a hook, so that it can be snapped into the Dosierknopf 7 or locked behind a stop to prevent falling out of the release button 8, as shown in FIG 12B. The actuation or pressing of the release button 8 in the axial direction is prevented by the web 8c, which is present at the end of the dosing sleeve 9.

The metering sleeve 9 has on its inner side over a portion circumferentially a groove 9a, in which the web 8c of the Dosierknopfs 8 engages and thus defines a range of rotation or adjustment.

As shown in FIG. 12A, the dosing button 7 has, for example, two webs or cams 7h, which block a movement of the dosing button 7 in the setting or dosing direction by holding or snap elements 9b on the dosing sleeve 9.

The dose button 7 has cams 7h which block a movement of the dosing button 7 in the setting or dosing direction by ribs on the holding or snap elements 9b of the dosing sleeve 9; see Figure 12 A.

Figure 13 shows the injection device in the mixed state after screwing the ampoule holder 1 in the housing 5, whereby the proximal plug 2a of the two-chamber ampoule 2 toward the distal plug 2b by the axially displaceably mounted in the axial direction flange 3d on the piston rod 3 was shifted, so that the substance contained in the two-chamber ampoule 2 is mixed. Achieving the blending position can be signaled by snapping a radial catch Ib of the ampoule holder 1 into place in a groove 5d of the housing 5 to produce a tactile and audible feedback to a user. The turning back of the ampoule holder 1 is prevented by the snapped radial snap Ib.

Figure 14 shows the injection device during priming. By further screwing the ampoule holder 1 in the housing 5, the plug 2a is further inserted into the ampoule 1 together with the second plug 2b, whereby the injection device is primed. The completion of priming may be signaled by snapping the radial latch Ib in place in the housing 5 to produce a tactile and audible feedback to a user indicating that the priming operation has been completed and completed. The reverse rotation of the ampoule holder 1 is prevented by the radial snap Ib. FIG. 14A shows that when the ampoule holder 1 is screwed in, the catch 9b of the metering sleeve 9 is deflected axially out of the blocking position shown in FIG. 12A so that the cams 7h of the metering button 7 are free and the metering button 7 is thus released for setting the dose. so it can be turned.

The blocking of the rotational movement of the Dosierknopfs 7 by the snap arms 9b can thus be released via the screwed ampoule holder 1, which can deflect the Schnübme 9b at the end of the mixing process in the axial direction, so that the snap arms 9b in the deflected state out of engagement with a housing fixed or relative to the housing 5 are torsion-resistant cam 7h.

FIG. 15 shows the injection device in the unlocked and released state. For dose setting, the dosing knob or Dosierwählring 7 is rotated in the dosing sleeve 9. The radial snapper 7i of the dosing button 7 signal by an acoustic feedback the position of the DosierwÃ¼rs or Dosierwährings 7 in the dosing 9. The dosing 9 has in the embodiment shown in four adjustable dose positions an axially extending groove or recess 9c, in which the web 8c of Release button 8 can be inserted axially. This ensures that the trigger button 8 can only be pressed in at one of four fixed preset doses and thus the injection device can be triggered.

By pressing the release button 8 in the Dosierknopf 7, the joint rod 3f of the piston rod 3 is deflected by a rib 8b of the release button 8.

Since the opposing hooks 3e of the threaded rod 3 are no longer held apart by the articulated rod 3f, they can be deflected radially inwardly due to the piston rod 3 prestressed in the distal direction by the spring 4 and thus the piston rod 3 is released , After deflection of the hooks 3e, the piston rod 3 is thus pushed forward in the axial direction by the relaxing spring 4, as a result of which the plugs 2a, 2b are inserted into the ampoule 2 and the mixed substance contained in the ampoule 2 is displaced from the ampoule 2 , whereby the distribution takes place. FIG. 16 shows the injection device in the spilled state, wherein the discharge can be limited by axial and radial displacements 9d of the dosing sleeve 9 shown in FIG. 16B, into which the radially outwardly biased hook 3e of the piston rod 3 engages, thereby providing acoustic feedback can be realized upon termination of the distribution. The nose 3f on the piston rod 3 limits the deflection of the hooks 3e. As a result, the piston rod 3 is additionally secured if the snap arms should relax with the hooks 3e. By limiting the deflection, it can be avoided that the piston rod 3 can not be displaced further than the openings provided in the dosing sleeve 9 for the dosing restriction. Thus, an overdose can be excluded.

LIST OF REFERENCE NUMBERS

1 ampoule holder

Ia external thread

Ib snap element

2 two-chamber ampoule

2a posterior (proximal) stopper

2b anterior (distal) plug

3 piston rod

3a locking arm

3b hook, locking element

3c groove

3d flange

3e hooks, protrusions

3f joint element, joint rod, nose

4 compression spring, injection spring

5 housing

5a internal thread

5b footbridge

5d longitudinal groove

6 holding sleeve

6a hook, locking element

6b snap arms

6c thorn

6d hook, locking element

6e footbridge

6f counter attacks

7 dose selector ring, dose selector sleeve, dosing button

7a rib

7b recess, recess

Ic - If windows, wells, breakthroughs

7g stop rib

7h cam

7i radial snapper

8 release button, release button

8a recess, opening

8b rib, bridge

8c bridge, arm

8d groove

9 dosing sleeve

9a groove

9b snap elements

9c recess

9d breakthroughs

10 power pack, drive unit

11 cartridge spring

Claims

claims

1. A device for administering an injectable product with a housing (5) and a separately insertable drive unit (10), characterized in that the separately usable drive unit (10) contains a charged energy store (4).

2. Apparatus according to claim 1, wherein the energy storage is a spring or a compression spring (4) or a coil spring.

3. Device according to one of the preceding claims, wherein the drive unit (10) has a metering unit (7) or dosing sleeve (9).

4. Device according to one of the preceding claims, wherein the drive unit (10) has a triggering or release mechanism (8) for releasing or discharging the energy storage device (4).

5. Device according to one of the preceding claims, wherein the drive unit (10) comprises a piston rod or threaded rod (3).

6. Device according to one of the preceding claims, wherein the energy store or the spring (4) on one side against a piston rod or threaded rod (3) or an attachment of the piston rod or threaded rod (3) and on the opposite side against a retaining sleeve ( 6) or a triggering mechanism or release button (8) is supported.

7. Metering device according to one of claims 1 to 5, wherein the energy store or the spring (4) on one side against the piston rod or threaded rod (3) or a Supports attachment of the piston rod or threaded rod (3) and supported on the other side against a metering or dose selector ring (7).

8. Injection device with a device according to one of the preceding claims and an ampoule holder (1) which can be screwed into the device or a housing (5) in order to mix an ampoule (2) located in the ampoule holder (1) and / / or to prime.

9. A method for assembling an injection device, wherein an energy store (4) required for the injection is charged or prestressed in a drive unit (10) and subsequently the drive unit (10) with the charged or prestressed energy store (4) in a housing (5) the injection device is used.

10. The method according to claim 9, wherein a spring (4) on a with a support element (7, 8, 9) connected to the piston rod (3) and tensioned by placing a flange (3d) on the piston rod (3).

11. The method according to claim 10, wherein the flange (3d) with the piston rod (3) after the tensioning of the spring (4) is connected or latched.

12. A releasable holding mechanism for holding a piston rod (3) or threaded rod in an injection device with at least one holding element (3e) for holding the piston rod (3) or threaded rod against the force of an energy store or a spring (4), wherein the holding element (3e) coupled to the piston rod (3) or threaded rod or integrally formed therewith and having a releasable locking element (3f) for locking the retaining element (3e), wherein the locking element (3f) is coupled to the piston rod (3) or threaded rod or integrally therewith is trained.

13. The holding mechanism of claim 12, wherein the at least one retaining element is a radially inwardly or outwardly biased hook or snap hook (3e).

14. releasable holding mechanism according to one of the preceding claims with at least two preferably with respect to a central axis of the piston rod (3) or threaded rod opposite holding elements (3e).

15. A releasable retaining mechanism according to any one of the preceding claims, wherein the releasable blocking element (3f) and / or the at least one retaining element (3e) are part of a piston rod (3) or threaded rod.

A releasable retaining mechanism according to any one of the preceding claims, wherein the locking element (3f) has a hinge and is pivotable or hinged relative to the retaining mechanism or at least one retaining element (3e).

17. releasable holding mechanism according to one of the preceding claims, wherein the at least one holding element (3e) has an inclined support.

18. releasable holding mechanism according to one of the preceding claims with a Auslenkbegrenzung or nose of the locking element (3f), which can limit a release movement or a deflection of the at least one holding element (3e).

19. Injection device with a releasable holding mechanism (3e, 3f) according to any one of the preceding claims.

20. Injection device according to the preceding claim, wherein the at least one holding element (3e) holds the holding mechanism in a metering element (7, 9) and / or in the housing (5) of the injection device.

21. Inj ektions device according to one of the two preceding claims with a release button (8), which can release the blocking element (3 f) for releasing the retaining element (3 e).

22. Injection device with a dosing element (7) for setting a dose to be dispensed and an ampoule holder (1) which can be introduced into the injection device or a housing (5) together with an ampoule or two-chamber ampoule (2) arranged therein, characterized in that the metering element (7) can be locked with respect to a metering movement until the ampoule holder (1) is inserted so far into the injection device that a substance contained in the ampoule (2) is blended and / or primed.

23. Injection device according to the preceding claim, wherein the metering element (7) is rotatable.

24. Injection device according to one of the two preceding claims, wherein the metering element (7) by a releasable locking element (9b) is held.

25. Injection device according to the preceding claim, wherein the releasable locking element (9b) is a snap arm or a movable element in the radial direction.

26. Inj ektions device according to one of the two preceding claims, wherein the releasable locking element (9 b) in the axial direction has an inclined surface with which a

Ampoule holder (1) can come into contact.

27. Injection device according to one of the preceding claims, wherein the locking element (9b) released by the injection device introduced into the injection device or screwed in vial holder (1) and / or moved in the axial direction and the dosing (7) can be released.

28. A method for preparing an injection device for an injection, wherein a metering element (7) prior to introduction of an ampoule or two-chamber ampoule (2) in. the injection device is locked and only during or after the introduction of the

Ampoule (2) is released or released to make a dose adjustment.

29. The method according to the preceding claim, wherein a trigger element (8) of the injection device for triggering an injection before setting a dose with the metering element (7) is locked and is released only after setting a dose.

30. Injection device for delivering an adjustable dose with a dose setting element (7, 9) with a plurality of limiting elements (7c to 7g, 9d) for determining a dose and with a dispensing element (3) with a holding element (3b, 3e), which with at least one limiting element for limiting or determining the delivered dose can cooperate.

31. Inj ektions device according to the preceding claim, wherein the limiting element (7, 9) is a sleeve which in the circumferential direction and in the axial direction in each case offset from one another depressions or openings (7c to 7g, 9d).

32. Injection device according to the preceding claim, wherein the boundary elements, depressions or openings (7c to 7g, 9d) of the dose setting element (7, 9) lie on a helical line.

33. Injection device according to one of the preceding claims, wherein the dose-setting element (7, 9) is rotatable.

34. Injection device according to one of the preceding claims, wherein the holding element (3b, 3e) is an elastic or resilient snap element.