WO2000023133A2

WO2000023133A2 - Method for reconstituting an injection fluid, and injection apparatus for implementing said method

Info

Publication number: WO2000023133A2
Application number: PCT/EP1999/007587
Authority: WO
Inventors: Jochen Gabriel; Ulf Polzin
Original assignee: Medico Development Investment Company
Priority date: 1998-10-21
Filing date: 1999-10-09
Publication date: 2000-04-27
Also published as: JP2002527210A; CA2356614A1; EP1123124A2; DE29818721U1; WO2000023133A3; DE19948988A1

Abstract

The invention relates to an injection apparatus comprising a housing (42) designed for receiving a container (50) containing a liquid. An axially sliding member (92) which is received in the housing (42) is used to act upon said container (50). An actuating member (174) is used to influence the position of the axially sliding member (92) relative to itself. An element (144) is placed in the housing (42) in such a way that it can slide axially but is substantially rotatively-blocked relatively to the housing (42). The actuating member (174) can take at least two different positions relatively to said element (144). In a first position (Fig. 12), it can rotate relatively to said element (144) and in a second position (Fig. 13), it is rotatively blocked relatively to said element (144). The invention also relates to a method for reconstituting an injection fluid and a method for performing an injection.

Description

Method for reconstituting an injection liquid, and injection device for performing such a method

The invention relates to a method for reconstituting an injection liquid, and an injection device for performing such a method. From DE 3 638 984 C2 one knows an injection device with a housing and a threaded rod, which is provided with an external thread, is used to squeeze liquid out of a liquid container, and which is arranged in the housing in an axially displaceable but non-rotatable manner. The threaded rod is used to first insert an injection needle during the injection process and then to inject liquid through this needle.

It is an object of the invention to provide a new method for reconstituting an injection liquid and an injection device for carrying out such a method.

According to the invention this object is achieved by an injection device according to claim 1. This gives the possibility of rotating the actuator in the first position relative to the axially displaceable part, and thereby influencing the axially displaceable part in a certain way, and one can after completion of this process, bring the actuator into the second position, in which this rotation is blocked and the actuator is forced to follow the movements of the axially displaceable element, the actuator in the second position being particularly preferably locked with the axially displaceable element becomes. This enables two different operating modes of such an injection device, e.g. the first operating mode can be reserved for the medical specialist (doctor, nurse), and only the second operating mode is released for the patient, and the patient e.g. cannot return to the first operating mode from the second operating mode. This is an important safety feature in order to avoid incorrect operation of such an injection device by the patient.

Another solution to the problem is provided by an injection device according to claim 7. Such an injection device has the advantage that a movement of the threaded rod in the proximal direction and in the distal direction is made possible by a relative rotary movement between the external thread of the threaded rod and the internal thread of the actuator, such as that for example is necessary for the reconstitution of an injection liquid, while an axial displacement of the actuator relative to the threaded rod allows the teeth of the internal thread (the actuator) to slide along the teeth of the external thread and thus enables simple and easy-to-understand handling by the patient during the injection.

A method according to the invention for the reconstitution of an injection liquid is the subject of claim 38 and a method according to the invention for carrying out an injection is the subject of claim 41. In the method according to claim 38, switching to single injection results in a sensible and easily understandable process which avoids operating errors. The method of claim 41 has the advantage that The needle can be inserted by means of a "mechanical drive" and that the pressure increase in the cartridge required for the "hydraulic drive" does not have to be effected until the needle has already been inserted, so that no or only a slight loss of fluid can occur due to the pressure increase .

Further details and advantageous developments result from the exemplary embodiments described below and shown in the drawing, which are in no way to be understood as a restriction of the invention, and from the remaining claims. It shows:

1 is an external view of an injection device according to the invention in the state as it leaves the factory, ie before the reconstitution of the lyophilisate,

2 shows an external view of the injection device in the state after the preparation of the device for injections, that is to say after the reconstitution of the lyophilisate, and after setting an injection dose of approximately 20 units,

3 shows a longitudinal section through the injection device of FIG. 1,

4 shows a longitudinal section analogous to FIG. 3, but perpendicular to the plane of FIG. 3,

5 shows a longitudinal section through a threaded rod as used in the injection device, seen in the direction of the arrows V-V of FIG. 7,

6 is a plan view of the threaded rod of FIG. 5, seen in the direction of arrow VI of FIG. 7,

7 is a plan view of the upper end of the threaded rod according to FIGS. 5 and 6,

8 shows a detail VIII of FIG. 5,

9 shows a detail IX of FIG. 5,

10 is a spatial representation of a trigger member used in the injection device according to FIGS. 1 to 10 with locking member,

11 is a spatial representation of an actuator used in the injection device,

12 shows an enlarged detail from FIG. 4,

13 shows a representation analogous to FIG. 12, but in the position of the parts after completion of a reconstitution,

14 is a sectional view taken along the line XIV-XIV of FIG. 13, 15 is a sectional view taken along the line XV-XV of FIG. 13,

16 shows a longitudinal section through a preferred connecting part according to the invention,

17 shows a section through the connecting part of FIG. 16, with which a container with a lyophilized drug is connected,

18 is an illustration showing how reconstitution begins;

19 is a diagram showing the processes in the reconstitution,

20 is an enlarged view of detail XX of FIG. 19,

21 is an enlarged view of detail XXI of FIG. 19,

22 is a diagram showing the sucking back of the reconstituted liquid into the injection device,

23 is an enlarged view of detail XXIII of FIG. 22,

24 is an illustration for explaining the dose setting after completion of the reconstitution,

25 is an illustration for explaining the first section of the tensioning process in which the injection needle is displaced by the insertion path into the interior of the housing,

26 is an enlarged view of detail XXVI of FIG. 25,

27 is an illustration for explaining the second section of a tensioning process, in which the injection needle remains in the position according to FIG. 25 and the actuating button is shifted further in the distal direction in accordance with the set dose,

28 is an enlarged view of detail XXVIII of FIG. 27 with a signal button to indicate that a reconstitution has taken place,

29 shows a representation analogous to FIG. 27, but in a plane perpendicular to FIG. 27,

30 is an enlarged view of the detail XXX of FIG. 29,

31 is an illustration of the injection process (after its completion),

32 is an enlarged view of the central parts of the injection device in the tensioned state before an injection, 33 shows a representation analogous to FIG. 32 in the initial phase of an injection,

34 shows a representation analogous to FIG. 33, the injection needle being fully inserted,

35 shows a representation analogous to FIGS. 32 to 34 after the completion of an injection,

FIG. 36 is an illustration showing how the device is prepared for injections after reconstitution, in a longitudinal section analogous to FIG. 3, and

37 shows an illustration in the same position as in FIG. 36, but in a sectional plane offset by 90 ° to this.

1 shows an injection device 40 in the state in which it leaves the manufacturer's factory. It looks something like an oversized fountain pen and has an elongated, tubular housing 42. At the top there is an actuation button 44, and at the bottom, where a cover cap 46 is shown, a needle is attached before use, cf. Fig. 24.

As is common in medicine, the terms distal and proximal are used as follows: Proximal: The side facing the patient, that is to say the side with the needle (in FIG. 1 below). Distal: The side facing away from the patient, that is to say the side with the

Actuation button 44.

In the proximal part of the housing 42 there is a window 48 through which the patient can see how much liquid 49 remains in a cartridge 50 there (FIG. 3).

On the central part of the housing 42, a metering wheel 52 is rotatably but axially immovable. It has an internal thread 54 (FIG. 3) which engages in an external thread (steep thread) 56 (FIG. 2) of a dose setting part 58 which is guided axially displaceably but non-rotatably in longitudinal grooves 59, 59 'of the housing 42, cf. Fig. 20. If the dosing wheel 52 is rotated, the dose setting part 58 is correspondingly axially displaced, as a comparison of Figs. 1 and 2 shows, i.e. FIG. 1 shows the dose setting "0", recognizable by the "0" shown at 60, and FIG. 2 shows the dose setting "20". So you can adjust the injection dose by turning the dosing wheel 52, and if this is not changed, this set dose is injected with each injection. This is known as a "steady dose injector". If desired, the dosage can be changed before each injection.

A resilient clip 62, which serves to trigger an injection, is arranged on the dose setting part 58. At its free end it has a projection 64 which projects towards the device 40 and which lies opposite a latching opening 66 of the dose setting part 58. As a comparison of FIGS. 1 and 2 shows, this opening 66 is displaced in the distal direction when the dose is increased. FIG. 1 shows a rotating arrow 68 at the distal end, that is to say at the top, to indicate that in the state according to FIG. 1 the actuating button 44 can be turned in both directions. Alternatively, the button 44 can also be moved in the direction of an arrow 70 in the distal direction.

2, that is to say in the “prepared” state of the injection device 40 after the reconstitution of the lyophilisate, there is no possibility of turning the knob 44, and this can only be moved axially (FIG. 2: arrow 70).

3 is a longitudinal section through the injection device 40 of FIG. 1, and FIG. 4 is an analogous longitudinal section, but in a plane perpendicular to FIG. 3.

In the proximal part of the housing 42 there is a transparent cartridge holder 74, which is composed of a proximal part 76 and a distal part 78 and holds the cartridge 50 in its interior. The parts 76, 78 are connected to one another by a micro-catch 77, which is shown on an enlarged scale in FIG. 30. It allows a simple and highly precise adjustment of the length of the cartridge holder 74 to adapt to the cartridge 50 and its filling quantity.

The part 78 has a radial projection 80 which is guided in a longitudinal groove 82 of the housing 42 and can be displaced there between two stops 84, 86. As a result, the cartridge holder 74 cannot be rotated relative to the housing 42 and can only be axially displaced to a limited extent. 21 shows the projection 80 on an enlarged scale.

1, 3 and 4, the liquid 49 in the cartridge 50 is only a solvent. An active ingredient must be added to this solvent, which is usually present as a lyophilized product in a container, cf. the container 224 in FIG. 18 with the lyophilisate 226. How this happens is described in detail below. This is called the reconstitution of the liquid 49, or put another way: its conversion into a drug. For this purpose, the injection device must be "prepared" accordingly before it can be used by the patient. The reason for the separate storage of solvent and active ingredient is that the reconstituted liquid has a limited shelf life, usually only two to three weeks. The reconstitution is usually carried out by specialist staff (nurse, doctor), but can also be carried out by a trained patient.

The cartridge 50 has, in the usual way, a rubber membrane 88 at its proximal end, which can be pierced by a needle, cf. Fig. 25. At its distal end it has a rubber washer 90 to which the proximal end of a threaded rod 92 is fastened, which is shown enlarged in FIGS. 5 to 9 and which - because of its double function - can also be referred to as a toothed rack. For this purpose, the proximal end of the threaded rod 92 is buttoned into a complementary recess 96 of the rubber piston 90 with a mushroom-like projection 94, cf. 5 and 6. This can be done with the help of micro-detent 77. FIG. 7 shows a plan view of the distal end 98 of the threaded rod 92. This has an essentially circular cross section, with two opposite longitudinal grooves 100, 102 for axial longitudinal guidance. These are guided in radially inwardly projecting projections 104 (FIGS. 3 and 15) of the distal part 78 of the cartridge holder 74, which itself is secured against rotation by its radial projection 80, so that the piston rod 92 does not rotate relative to the housing 42 - but is only axially displaceable.

As shown in FIG. 6, the teeth 104 of the threaded rod 92 are designed as external threads, but have the sawtooth shape which is characteristic of a toothed rack, cf. Fig. 8, i.e. the proximal part 106 of a tooth 104 has a flat pitch, while the distal part 108 has a large pitch.

A proximal part 110 (FIG. 6) of the rack 92 is solid, and a distal part 112 has a cylindrical recess 114 on the inside, which, however, does not extend radially to the longitudinal grooves 100, 102. A pin 116 (FIGS. 5, 8, 9) is guided axially displaceably in the recess 114. This has at its proximal end two resilient parts 118 which project radially outwards through two diametrically opposite openings 120, 121 of the grooves 100, 102, cf. Fig. 9, from which the shape of the projections 118 and the position of the openings 120, 121 is clear. These lie at the proximal end 122 of the recess 114.

The distal end of the pin 116 has a recess 124 (FIG. 8) in which a green signal body 126 is releasably locked with a resilient pin 128. There are also lateral barbs 130 at the distal end of the pin 116, which snap into corresponding recesses in the recess 114 and releasably hold the pin 116 in the position according to FIG. 8 after assembly. Furthermore, at the distal end 98 of the threaded rod 92 there is a radially extending recess 132 which cuts the longitudinal grooves 100, 102, cf. Fig. 7, and into which the barbs 130 engage during reconstitution, cf. 22 and 23 below.

4 and 12 clearly show, at the distal end of the part 78 there are two resilient parts 136, 137, which are provided on their side facing the rack 92 with locking teeth 138 and 139 for engagement in the teeth 104 of the rack 92.

1, as shown in FIGS. 4 and 12, the locking teeth 138, 139 are not in engagement with the teeth 104, so that the rack 92 can be axially displaced by the parts 136, 137 without hindrance. The resilient parts 136, 137 can, however, be moved radially inward for engagement with the rack 92 by a corresponding cam control. Corresponding cams 140, 142 (FIG. 4) are located on the inside of the housing 42. An element 144 which is axially displaceable in the housing 42 and is depicted in three dimensions in FIG. 10 has a frustoconical section 146 at its proximal end, which also acts as a cam and, after completing an injection, compresses the resilient parts 136, 137 and engages the rack 92, cf. 31 and 35, also after completion of the reconstitution, cf. Fig. 13.

The element 144, which is axially displaceable in the housing 42, has two on its outer side 148 Longitudinal grooves 150, 151, which are axially guided in corresponding projections 152, 153 of the housing 42. Furthermore, it has a resilient latching hook 156 with a radially outwardly projecting projection 158, which can engage in the recess 66 (FIG. 1) of the dose setting part 58, as shown, for example, in FIG. 36. In injection mode, i.e. after reconstitution, it serves as a tension and release link.

During the reconstitution, which will be described below, the element 144 axially displaceable in the housing 42 is held in the position according to FIGS. 3 and 4.

In its proximal area, the element 144 is pierced by two diametrically opposed longitudinal grooves 162, 164, which are guided in the longitudinal direction according to FIG. 4 on the cams 140 and 142 fixed to the housing and during injection with their distal ends 162 ', 164' against them Cams come into contact, cf. Fig. 35.

Furthermore, the element 144 axially displaceable in the housing 42 has an inwardly projecting annular shoulder 166 in the central region of its inside, cf. 12 and 13. In addition, in the distal end region of its inside 168 it has radially inwardly projecting projections 170, one of which is shown in FIG. 10.

An adjusting member 174 is arranged in the inner side 168 of the element 144 and is shown in spatial form in FIG. 11. Its distal section 176 has the shape of a cylindrical tube, which is locked via radial recesses 178 at its distal end with radial projections 180 of the actuating button 44 and therefore forms a unit with the latter in the assembled state. The threaded rod 92 is axially guided in this tube 176.

In the proximal direction, the tube 176 merges into a part 182 with two resilient latching hooks 184, 186, which are each provided on their inside with latching teeth 184 ', 186' in the form of threaded sections of an internal thread, which are connected to the external thread in the form of the teeth 104 in the Rack 92 are approximately complementary, as shown in FIG. 11.

As can be seen from FIG. 11, the threaded rod 92 can be axially displaced by rotating the actuator 174 (using the rotary knob 44). But you can also move the actuator 174 in the direction of arrow 70 relative to the threaded rod 92, the locking teeth 184 ', 186' resiliently slide over the teeth 104 of the threaded rod 92. Because of the shape of the teeth 104, this is only possible in the distal direction (arrow 70).

For guidance in the inside 168 of the element 144, the part 182 of the actuator 174 has two guide parts 188, 190 with an essentially circular-cylindrical outline shape. There are stop parts 188 'and 190' on them, which serve to stop against the annular shoulder 166, cf. Fig. 3. Stop parts 192, 194 with a detent recess 192 'and 194' are offset by 90 ° to the stop parts 188 ', 190'. The stop parts 188 ', 190', 192, 194 also serve as abutments for the proximal end of an injection spring 200, the distal end of which rests against an end cap 202, which in the manner shown is snapped into the distal end of the housing 42 and a guide for the distal end of the tube 176 forms.

As long as the stop parts 188 ', 190', 192, 194 bear against the annular shoulder 166, as shown in FIGS. 3 and 4, the actuator 174 can be freely rotated relative to the housing 42, as is necessary for the reconstitution. 12 shows this state again on a greatly enlarged scale. It can also be seen that the resilient parts 136, 137 are sprung radially outward, because they do not bear against the cams 140, 142 of the housing 42, nor against the truncated cone 146 of the element 144 axially displaceable in the housing 42.

After reconstitution, which is described below, the inner parts of the injection device 40 are brought into a position which is shown in FIG. 13. The comparison with FIG. 12 immediately shows the differences: the actuator 174 is in the same position as in FIG. 12, but the element 144 which is axially displaceable in the housing 42 is in the proximal direction up to its stop on the cam 140, 142 moved so that its hollow truncated cone 146 now abuts the inclined surfaces 136 "and 137" of the parts 136, 137 and presses the latter against the rack 92, whereby a positive connection between the rack 92 and the part 78 of the cartridge holder 74 is produced.

The inner projections 170 of the element 144 axially displaceable in the housing 42 are now firmly engaged in the recesses 192 ', 194' of the stop parts 192, 194, so that the actuator 174 is permanently locked in place with the element 144 axially displaceable in the housing 42 and only can still move along with this. Since the element 144 is prevented from rotating by the cams 140, 142, which protrude into the grooves 162, 164, the actuator 174 can no longer be rotated in this position.

The position of the parts according to FIG. 13 is achieved in that after reconstitution in the device according to FIGS. 1, 3 and 4, the actuating button 44 is pulled up in the direction of arrow 70 until the projections 170 into the latching recesses 192 ', 194 'click into place. The device is then triggered for the first time by pressing clip 62. This is described in more detail below with reference to FIGS. 36 and 37.

An adapter 210, which is shown in FIG. 16, is used for the reconstitution. It has an approximately cylindrical housing 212 in which a cannula container 214 is fastened, e.g. by pressing, gluing, or welding. This has an upper flange 215 which projects radially beyond the upper edge of the housing 212. A standard cannula holder 216 is attached in a suitable manner with its cannula 218 in the cannula container 214. The cannula container 214 is sterile closed at the top with a peel film 220, which is releasably attached to the flange 215. As usual, an internal thread 217 is provided in the cannula carrier 216 for attachment to the injection device 40.

The cannula holder 216 and the cannula 218 can therefore be a standard component here, as is used in large quantities for injections, which makes the manufacture of the adapter 210 less expensive. - The widened flange 215 ensures a secure connection with the peel film 220. In the lower part of the housing 212 there is a displaceable rubber piston 222 which, when not in use, covers the lower end of the cannula 218, while the upper end is covered by the peel film 220. This enables the cannula 218 to be stored sterile.

As shown in FIG. 17, a conventional container 224, which contains a lyophilisate 226, is pressed with its lid 227 into the lower recess 228 of the housing 212 and latches there on a latching projection 230. In doing so, it pushes the rubber piston 222 upwards, and this is pierced, as shown, on a thin central part 222 'from the lower end of the cannula 218, which subsequently pierces a rubber membrane 233 in the cover 227. The film 220 is then pulled off, and the arrangement according to FIG. 17, like an injection needle, can be screwed onto the injection device 40 by means of the internal thread 217, cf. 18, the upper end of the cannula 218 in FIGS. 16 and 17 penetrates the rubber membrane 88 of the cartridge 50 and forms a connection therefrom to the container 224.

19, the actuation button 44 is now turned in the direction of arrow 234, that is to say - if one looks at button 44 in the direction of arrow 236 - counterclockwise. As a result, the threaded rod 92 is displaced in the proximal direction to an end position, which is shown in FIG. 19, displaces the rubber piston 90 in the proximal direction, and presses the liquid 49 out of the cartridge 50 through the cannula 218 into the container 224, where the lyophilizate 238 is reconstituted as shown in FIG. 19.

During this displacement of the threaded rod 92, the pin 116 abuts with its projections 118 against the parts 104 of the cartridge holder 74 and is displaced in the distal direction, as also shown in FIG. 21. As a result, the upper end of the pin 116 moves in the manner shown in FIG. 20 and engages with its projections 130 in the groove 132, so that the pin 116 is locked in this position according to FIGS. 20 and 21. The signal body 126 thereby protrudes from the distal end of the threaded rod 92, cf. Fig. 20.

The injection liquid 238 is now reconstituted and can be sucked back into the cartridge 50. This is shown in FIG. 22. For this purpose, the injection device 40 is turned upside down, and the threaded rod 92 is screwed back by turning the actuating button 44. As viewed in the direction of arrow 236, the rotary knob 44 is turned clockwise.

Since the rubber piston 90 is connected to the threaded rod 92, cf. 5 and 6, it moves in the distal direction, that is to say downward in FIG. 22, and in doing so sucks the reconstituted liquid 238 out of the container 224 through the cannula 218 into the cartridge (cartridge) 50.

At the end of this process, the signal body 126 (made of elastic plastic) is pressed through an opening 242 (FIG. 3) of the actuation button 44 and snaps there with it Ring groove 246 permanently on. As a result, the user is constantly reminded that this injection device contains reconstituted injection liquid 238 which is intended for immediate consumption. 23 shows the signal body 126 on a greatly enlarged scale. The connecting member 210 and container 224 are then unscrewed.

36 and 37 are brought into their injectable state by pulling in the direction of arrow 70 on the actuation button 44, the projection 158 being latched into the recess 66 of the dose setting part 58, as shown in FIG. 36, so that element 144 is immobilized in housing 42.

Here, the actuator 174 is displaced in the distal direction relative to the - fixed - element 144, the inner projections 170 of the element 144 firmly latching into the recesses 192 ', 194' of the stop parts 192, 194, cf. Fig. 13.

36, the cartridge holder 74 is pulled along in that the piston 90, which is connected to the piston rod 92, comes to a stop against the projections 104 of the part 78 and thereby pulls the cartridge holder 74 in the distal direction. Alternatively, the projections 104 can also snap into a groove (not shown) in the piston rod 92, as long as the piston 90 is in the position shown in FIG. 36.

36 and 37, parts 136, 137 are closed by cams 140, 142, cf. 37 and connect the piston rod 92 to the cartridge holder 74.

After reaching the position according to FIGS. 36 and 37, the device 40 is released by pressing the clip 62, and the position according to FIG. 24 is then obtained in which the parts 136, 137 are kept closed by the truncated cone 146 of the element 144 .

Once this position has been reached, injections are possible, as described below. For this purpose, a cannula 250 is screwed with its cannula carrier 252 onto the thread at the proximal end of the cartridge holder 74, cf. 24, and by turning the dosing wheel 52, the desired injection dose is set, as shown in FIG. 2 by way of example. The rotation of the metering wheel 52 is symbolized in FIG. 24 by an arrow 254.

FIG. 13 shows the position of the injection device 40 according to FIG. 24 on an enlarged scale, and as described in detail there, the resilient parts 136, 137 are held in this position by the hollow cone 146 at the proximal end of the element 144 in contact with the threaded rod 92 .

After preselection of the injection dose by turning the dosing wheel 52, cf. 2, the injection device 40 is tensioned, that is to say prepared for an injection. This is done by pulling the actuation button 44 in the distal direction, as indicated in FIG. 25 by an arrow 256.

25 and 26 show the first part of the tensioning process. As a comparison of Fig. 24 and 25, the cannula 250 is pulled completely into the interior of the housing 42 so that it is no longer visible to the patient. The parts 136, 137 slide with their sections 270, 272 (FIG. 33) between the cams 140, 142 on the inside of the housing 42 and are kept closed by them. At the same time, the radial projection 80 of the cartridge holder comes into abutment against the distal end 84 of the groove 82, which prevents further displacement of the cartridge holder 74 in the distal direction.

27 and 29, the actuation button 44 is pulled further in the distal direction until the element 144, which is axially displaceable in the housing 42, engages with its catch element 158 in the recess 66 of the dose setting part 58.

Since the cartridge holder 74 can no longer follow this distal movement, the resilient latching hooks 184, 186 (FIGS. 29, 30) with their latching teeth 184 ', 186' (FIG. 11) now slide linearly over the teeth 104 (FIGS. 5 and 6) the rack 92, wherein each tooth 104 means a dosing unit X, cf. Fig. 6.

In the position according to FIGS. 27 to 30, the injection device 40 is therefore cocked and the desired injection dose is set. FIG. 28 shows that the signal body 126 is pulled out of the recess 124 of the cylindrical pin 116 during this tensioning process and is held in the recess 242 of the actuating button 44. As a result, the signal body 126 remains constantly visible to the user.

According to FIG. 31, an injection is now triggered by pressing the clip 62 (arrow 260 in FIG. 31). A body part is symbolically indicated at 262, into which the cannula 250 has already been inserted and the previously set dose 238 'of the liquid 238 has been injected.

The processes during the injection are explained with reference to FIGS. 32 to 35. These relate to a) the insertion of the cannula 250, and b) the injection through the inserted cannula 250. These processes can partially overlap.

32 corresponds to the position according to FIGS. 27 to 30, i.e. the injection device 40 is cocked.

33 shows the beginning of an injection, namely the so-called puncture phase, in which the cannula 250 is inserted into the body part 262. The resilient parts 136, 137 are initially kept closed by the cams 140, 142 of the housing 42, since they have a longer section 270 or 272 which is parallel to the longitudinal axis of the device 40 and which is made up of the complementary straight section 140 'and 142 'The cam 140, 142 gradually slides out, so that the resilient parts 136, 137 are kept closed for approximately the first third of the puncture path and the force F is transmitted directly, ie mechanically, from the rack 92 to the cartridge holder 74. (According to FIG. 31, the force F of the injection spring 200 is transmitted to the rack 92 via the actuator 174.) As shown in FIG. 34, the resilient parts 136, 137 finally slide out of the cams 140, 142 and spread through their spring force, so that the force F from the rack 92 now acts directly on the rubber piston 90. This increases the pressure in the injection liquid 238, which acts like a solid body and continues to transmit the force F to the cannula 250 until the projection 80 of the cartridge holder 74 abuts its proximal stop 86, which ends the puncturing phase, ie the cannula 250 then has the position according to FIG. 31. The resilient parts 136, 137 are open in the position of FIG. 34, so that the toothed rack 92 can be displaced relative to the cartridge holder 74 independently of the latter.

35 then follows. The rack 92 displaces the piston 90 in the (now stationary) container 50 and presses the quantity of liquid 238 'set with the metering wheel 52 out of the container 50, cf. Fig. 31.

At the end of this pressing-out process, the element 144, which is axially displaceable in the housing 42, reaches its proximal end division according to FIG. 35, thereby pressing with its hollow truncated cone 146 onto the oblique portions 136 ", 137" of the resilient parts 136, 137, and thereby bringing the latter back again Engagement with the rack 92 so that a new clamping process can begin, as described in Fig. 25 ff.

During the injection process, the cannula 250 is initially pierced by a mechanical force transmission (via the parts 136, 137) and then by a hydraulic force transmission, which results in a high dosing accuracy, since none occurs during the mechanical force transmission, which leads to the puncture of the cannula 250 Liquid can leak out of it. Liquid that may emerge from the cannula 250 during the subsequent hydraulic power transmission is injected into the body.

After the completion of an injection (FIG. 31), the cannula 250 is pulled out of the body part 262 and replaced by a new cannula, which is covered in a sterile manner with a closure cap 46 (FIG. 2). This cap is only removed before the next injection.

Various modifications are possible in the present invention. For example, one of the resilient parts 136, 137 would suffice for the mechanical power transmission to the cartridge holder 74. Except for the injection spring 200 and the cartridge 50, all parts can be made of a suitable plastic, and therefore the device can be easily recycled.

Claims

Expectations

1. Injection device with a housing (42), which is designed to receive a container (50) with a liquid, with an axially displaceable part (92) arranged in the housing (42) for acting on this container (50), with an actuator (174) for influencing the position of the axially displaceable part

(92) relative to this actuator (174), furthermore with an element (144) arranged axially displaceably in the housing (42) but essentially non-rotatably relative to the housing (42), the actuator (174) relative to this element (144 ) can assume at least two different positions and in a first of these positions (Fig.

12) rotatable relative to this element (144) and in a second of these positions

(Fig. 13) relative to this element (144) is not rotatable.

2. Injection device according to claim 1, wherein the actuator (174) in the second position (Fig. 13) is locked with the axially displaceable element (144), so that it can only be moved together with this.

3. Injection device according to claim 1 or 2, in which the part arranged axially displaceably in the housing (42) is designed as a threaded rod (92) which is axially displaceable in the housing (42) but non-rotatable relative to the housing (42).

4. Injection device according to claim 3, wherein the external thread (104) of the threaded rod (92) engages with a corresponding internal thread (Fig. 11: 184 ', 186') of the actuator (174).

5. Injection device according to claim 4, in which the external thread of the threaded rod (92) is designed in the manner of a toothed rack, and the internal thread (Fig. 11: 184 ', 186') of the actuator (174) to this external thread (104) essentially is complementary.

6. Injection device according to claim 4 or 5, wherein the internal thread of the actuator (174) is designed as a partial thread (Fig. 11: 184 ', 186') on at least one resilient element (184, 186) of the actuator (174) allow movement of this resilient element (184, 186) transversely to the teeth of the threaded rod (92).

7. Injection device with a housing (42), which is designed to receive a container (50) with a liquid, in which container (50) a piston (90) is slidably arranged, with a threaded rod (92) for moving this piston ( 90), which threaded rod has an external thread (104) and in the housing

(42) is axially displaceable but non-rotatable, with an actuator (174) which is provided with an internal thread (184 ', 186') for engagement with the external thread (104) of the threaded rod (92), by a relative An axial rotation between actuator (174) and threaded rod (92)

To allow displacement of the threaded rod (92), the external thread (104) of the threaded rod (92) having the shape of a tooth

Has rack, and this essentially complementary internal thread

(184 ", 186 ') of the actuator (174) is arranged on at least one resilient element (184, 186) of the actuator (174) in order to allow the teeth of the latter to slide by axial displacement of the actuator (174) relative to the threaded rod (92) Internal thread (184 ', 186') transverse to the teeth of the

To allow external thread (104) of the threaded rod (92).

8. Injection device according to claim 7, wherein the threaded rod (92) is connected at its proximal end (96) to the piston (90) which is arranged displaceably in the container (50).

9. Injection device according to claim 7 or 8, in which the teeth (104) of the threaded rod (92) are substantially sawtooth-shaped and, viewed in cross section, each have a proximal section (106) with a small pitch and a distal section (108) with a large pitch have in order to enable an axial displacement between the threaded rod (92) and the actuator (174) only in one direction.

10. Injection device according to one or more of claims 7 to 9, in which the actuator (174) can assume at least two different positions relative to an element (144) which is arranged axially displaceably but non-rotatably in the housing (42), wherein the actuator (174) is rotatable relative to this element (144) in one of these positions (FIG. 12) and non-rotatable relative to this element (144) in another of these positions (FIG. 13).

11. Injection device according to claim 10, in which between the actuator (174) and in the housing (42) axially displaceable element (144) at least one locking element (170, 192 ', 194') is provided in order to lock between the actuator (174) and enable this element (144) in at least one of the positions mentioned.

12. Injection device according to claim 10 or 11, in which a latching member (170, 192 ', 194') is provided for latching in the position in which the actuator (174) relative to the element (144) axially displaceable in the housing (42). is not rotatable.

13. Injection device according to one or more of claims 7 to 12, in which the liquid container (50) is axially displaceable relative to the housing (42) in order to move the liquid container (50) with a puncturing movement Allow liquid container (50) connected cannula (250) into the patient's skin.

14. Injection device according to claim 13, wherein a mechanical connection (136, 137) influenced by the axial position of the liquid container (50) is provided between the displaceable liquid container (50) and the threaded rod (92).

15. Injection device according to one or more of claims 7 to 14, which has an indicator (126) which is actuated when the threaded rod (92) by rotating the actuator (174) first by a predetermined value in the proximal direction and then by one predetermined value has been shifted in the distal direction.

16. Injection device according to claim 15, in which in a recess (114) of the threaded rod (92) a displaceable member (116) is arranged, at the distal end of which the indicator (126) is releasably attached.

17. The injection device as claimed in claim 16, in which the displaceable member (116) has a stop member (118) which, when the threaded rod (92) moves proximally, abuts a stop (FIG. 21: 104) and thereby the displaceable member (116 ) from a first locking position (FIG. 5) in the distal direction into a second locking position (FIG. 23), in which the indicator (126) is activated.

18. Injection device according to one or more of the preceding claims, with a spring (20) for storing energy for an injection, which spring (200) can be tensioned in the distal direction by displacing a tension member (144), and with a latching member (156, 158) for releasably latching the tendon (144) in this displaced position.

19. Injection device according to claim 18, in which in the housing (42) cams (140, 142) are provided which, in the displaced position of the clamping member (144), a position-dependent mechanical connection (136, 137) between the threaded rod (92) and the liquid container ( 50) activate.

20. Injection device according to one or more of the preceding claims, in which the liquid container (50) is assigned a holder (74) which is axially displaceable in the housing (42) between a proximal and a distal end position and for receiving the liquid container (50) is trained.

21. Injection device according to claim 20, wherein the length of the holder (74) is variable.

22. The injection device according to claim 21, wherein the holder (74) has a proximal section (76) and a distal section (78), which by a adjustable connection (77) are connected to each other, which allows a change in the total length of the holder (74).

23. The injection device according to claim 22, wherein the adjustable connection has a micro-catch (77) which connects a proximal section (76) and a distal section (78) of the holder (74) to one another in an adjustable manner.

24. Injection device according to one or more of claims 20 to 23, in which the holder (74) is provided in its distal region with stop means (80) which fix its proximal and / or its distal end position relative to the housing (42), and in which the length of the holder (74) is adjusted relative to these stop means, so that when the holder (74) changes in length, the position of the liquid container (50) relative to the threaded rod (92) is changed.

25. Injection device according to one or more of the preceding claims, in which a dose setting part (58) which is displaceable in the longitudinal direction relative to the housing (42) has latching means (66) for latching a latching member (158).

26. Injection device according to claim 25, in which a link (62) for releasing the latching between the latching means (66) and the latching member (158) is provided on the displaceable dose setting part (58).

27. Injection device according to claim 25 or 26, in which on the housing (42) is rotatable relative to this but not axially displaceable relative to it threaded sleeve (52) is provided, which with a thread (56) on the displaceable dose setting part (58) in engagement stands.

28. Injection device according to one or more of claims 25 to 27, in which the displaceable dose setting part (58) cannot be rotated relative to the housing (42).

29. Adapter for fastening a container (224) provided with a rubber membrane (233) to an injection device, with a housing (212), with a cannula (218) arranged in this housing (212), which can be found both in

Direction to the injection device (40) as in the direction of the container (224) and attached to a cannula holder (216), with one provided at one end region of the cannula holder (216)

Internal thread (217) for attachment to an external thread of the injection device

(40), and with one provided at the opposite end region of the housing (212)

Receptacle (228) for the part (227) of the container which is provided with the rubber membrane (233) (Fig. 16, 17).

30. The adapter of claim 29, wherein the at the opposite end of the Housing (212) provided receptacle (228) is provided with a radially inwardly projecting locking projection (230) in order to be able to lock the container (224) in the housing (212) of the adapter.

31. An adapter according to claim 29 or 30, in which a part (222) which can be perforated by the cannula (218) is slidably arranged in the opposite end region.

32. Adapter according to claim 31, in which the part (222) perforable by the cannula (218) in the state before the perforation (FIG. 16) covers the associated end of the cannula (218) in a sterile manner.

33. Adapter according to one or more of the preceding claims, wherein the one end region (217) of the housing (212) is covered under sterile conditions.

34. An adapter according to claim 33, wherein a holder (214) for the cannula holder (216) is provided between the cannula holder (216) and the tubular housing (212), and the sterile cover (220) at one end of this holder (214 ) is provided.

35. Adapter according to claim 33 or 34, in which a peel film (220) or the like is provided for sterile covering.

36. Adapter according to one or more of claims 29 to 35, in which the housing (212) is subdivided by the cannula carrier (216) into partial areas which are in fluid communication with one another via the cannula (218).

37. Adapter according to one or more of claims 29 to 36, in which the cannula carrier (216) and the cannula (218) are designed essentially as a standard component, as is used for injections with conventional injection devices.

38. A method for reconstituting an injection liquid, comprising the following steps: a) by actuating this injection device, solvent is transferred from an injection device into a container with a lyophilisate to be reconstituted; b) the reconstituted lyophilisate is sucked back out of the container into the injection device by actuating the injection device; c) the injection device is switched over to operation with single injections in order to be able to inject the aspirated reconstituted lyophilisate.

39. The method according to claim 38, wherein the injection device has a threaded rod which is provided with an external thread and is guided axially displaceably but non-rotatably in the injection device, and which is assigned an actuator, the internal thread of which engages with the external thread of the threaded rod , wherein in step a) the transfer of the solvent and in step b) the suction of the reconstituted lyophilisate by rotating the actuator relative to Threaded rod is done.

40. The method of claim 39, wherein the threaded rod has an external thread with a sawtooth-shaped cross-section, and the actuator is designed to be radially resilient in order to be able to slide across the external thread, and in step c) the actuator is immobilized against rotation.

41.Method for performing an injection, in which an injection cannula is first inserted through the action of energy stored in a spring and injection fluid is injected after the injection, the injection needle injection using the stored energy first by direct mechanical drive of the injection cannula and then by hydraulic Power is transmitted by increasing the pressure in a displaceable liquid container that stores the injection liquid.