WO2022058221A1

WO2022058221A1 - Injection device for administering a liquid product

Info

Publication number: WO2022058221A1
Application number: PCT/EP2021/074747
Authority: WO
Inventors: Reto Michel; Adrian STAMM
Original assignee: Ypsomed Ag
Priority date: 2020-09-16
Filing date: 2021-09-09
Publication date: 2022-03-24
Also published as: CN116075330A; EP4213917A1; CH717876A2

Abstract

The invention relates to an injection device for administering a liquid product, said device comprising a retaining element (9) for attaching a cartridge (10) on or in the cartridge holder (8), wherein the retaining element (9) is designed such that the retaining element (9) exerts a frictional force acting in the axial direction on the housing (6) in order to attach the cartridge (10) on or in the cartridge holder (8) and such that the frictional force acting in the axial direction acts counter to a force acting in the distal direction.

Description

Injection device for administering a fluid product

The present invention relates to an injection device for administering a fluid product, in particular a medicament such as teriparatide for osteoporosis therapy.

The term "medicament" as used herein includes any flowable medicinal formulation suitable for controlled administration through a means such as a cannula or hypodermic needle, for example comprising a liquid, solution, gel, or fine suspension containing one or more medicinally active ingredients contains. Medicament may be a single active ingredient composition or a premixed or co-formulated multiple active ingredient composition from a single container. Drug includes drugs such as peptides (e.g. insulins, insulin-containing drugs, GLP-1-containing and derived or analogous preparations), proteins and hormones, biologically derived or active substances, substances based on hormones or genes, nutritional formulations, enzymes and other substances both in solid (suspended) or liquid form but also polysaccharides, vaccines, DNA or RNA or oligonucleotides, antibodies or parts of antibodies as well as suitable basic, auxiliary and carrier materials.

An injection device with a carpule holder for receiving a carpule is known from WO2016/134491 A1, with an elastically designed retaining element being provided for fastening the carpule on or in the carpule holder.

It is an object of the present invention to provide an alternative injection device for administering a fluid product, wherein a carpule can be attached to or in the carpule holder, in particular can be held without play, in order to contribute to the dosing accuracy of the injection device.

Furthermore, it is an object of the present invention to provide a method for mounting a carpoule on or in a carpoule holder, with the carpoule being held in particular on or in the carpoule holder without play.

These objects are solved by the subject matter of the independent claims. Advantageous embodiments result from the dependent claims.

In the following, distal means a direction towards the end of the injection device on the injection needle side and proximal towards the end on the drive and/or metering device side and/or the housing side. The invention relates to an injection device for administering a fluid product. Furthermore, the injection device comprises a carpule holder for receiving a carpule and for attachment to or in a housing of the injection device. Furthermore, the injection device comprises an elastically designed retaining element for fastening the carpule on or in the carpule holder, with the retaining element being positioned on or in the housing in the proximal direction and supported on or in the carpule in the distal direction, in particular via a corresponding force- and / or positive connection is positioned and supported and is designed such that the holding element exerts a force acting in the distal direction on the carpule. The holding element is also designed such that the holding element exerts a frictional force acting in the axial direction on the housing of the injection device for fastening the carpule on or in the carpule holder and that the frictional force acting in the axial direction counteracts the force acting in the distal direction.

The holding element has a holding and/or fixing and/or positioning function. The holding element has a spring force. The holding element can be used to hold and/or fix and/or position a component of the injection device on or in another component by the holding element holding one of the components in a specific position relative to the other in a compressed state. The holding element can thus hold a component of the injection device in a defined position in the injection device. The defined position is determined by the local arrangement of the component to be held relative to another component of the injection device. The components of the injection device can be a carpule in a carpule holder. The carpule can preferably be held without play by means of the holding element on or in the carpule holder, in that the carpule is held in axial stop contact in the carpule holder on the distal side and with the aid of the holding element on the proximal side. The spring force of the holding element is a force acting in the distal direction, which acts on the carpule in order to hold the carpule on or in the carpule holder, preferably without play. In this way, manufacturing and assembly tolerances can be compensated. In addition, the spring force of the holding element prevents the carpule from being able to shift relative to the housing or the carpule holder when the injection needle is placed on it.

The frictional force acting in the axial direction can preferably at least partially, preferably completely, compensate the force acting in the distal direction. The frictional force acting in the axial direction counteracts the force acting in the distal direction. The frictional force acting in the axial direction can preferably act against the force acting in the distal direction in such a way that the resulting force is approximately zero.

It can thus be achieved that no permanent spring force of the holding element acts on the carpule. This prevents the spring force from the holding element from acting on the injection device via another component and thus prevents undesired forces on the component of the injection device exercises Thus, for example, a relaxation of a snap connection in the injection device, for example a snap connection between the housing and the carpule holder of the injection device, can be minimized. Furthermore, it is advantageous that when the carpoule is axially displaced relative to the carpoule holder in the proximal direction, both the force of the holding element acting in the distal direction and the frictional force of the holding element acting in the axial direction must be overcome. The dosing accuracy of the injection device can thus be improved.

The holding element is a separate component of the injection device. The holding element has a holding and/or fixing and/or positioning function. The holding element can preferably be made of plastic. The plastic includes a biodegradable and/or a non-biodegradable plastic. The holding element is designed to be elastic. Alternatively, the holding element can have one component or a plurality of components which are designed to be elastic. The holding element can be ring-shaped or sleeve-shaped. The holding element can be provided inside the housing of the injection device. The holding element can be used or inserted into the housing as a separate component.

The holding element can comprise a spring element or be designed as a spring element, with the spring element exerting the force acting in the distal direction.

The spring element can be ring-shaped or sleeve-shaped. Furthermore, the spring element can preferably be of cylindrical design.

A first and a second spring seat can be provided on the spring element. The spring element can comprise a plurality of brackets and a plurality of connecting webs, it being possible for the first spring seat to be connected to the second spring seat via the plurality of brackets and via the plurality of connecting webs. The brackets and preferably the connecting webs are elastically deformable in the axial direction. Alternatively, the connecting webs can be designed to be axially stiff. The brackets extend in the circumferential direction, being curved towards the distal or towards the proximal. The first spring seat may be connected to a first bracket via a first connecting web, wherein the first bracket may be connected to a second bracket via a second connecting web and the second bracket may be connected to the second spring seat via a second connecting web. The first and second brackets can form elastic bending arms. The first and the second bracket thus protrude in the axial direction from the first and the second spring seat via the connecting webs.

Alternatively, a different number of brackets, connecting webs and spring seats can also be provided on the spring element. Alternatively, the spring element can in particular have no bracket and no connecting web. The spring element can be sleeve-shaped and have a first and a second spring seat. The sleeve-shaped spring element is elastic.

Furthermore, the spring element can also have a different design, provided that the spring element can be loaded in compression along the axial axis.

The holding element can comprise a clamping element or be designed as a clamping element, with the clamping element exerting the frictional force acting in the axial direction. The clamping element can be elastic.

The holding element is preferably designed in such a way that the holding element exerts the force acting in the distal direction on the carpule for holding the carpule on or in the carpule holder without play. The spring element of the holding element or the holding element designed as a spring element is particularly preferably designed such that the spring element or the holding element designed as a spring element exerts the force acting in the distal direction on the carpule for holding the carpule on or in the carpule holder without play.

Furthermore, the holding element is preferably designed in such a way that the holding element exerts the frictional force acting in the axial direction on the housing to form a non-positive connection between the holding element and the housing. The clamping element of the holding element or the holding element designed as a clamping element is particularly preferably designed in such a way that the clamping element or the holding element designed as a clamping element exerts the frictional force acting in the axial direction on the housing to form a non-positive connection between the holding element and the housing.

The carpoule holder can include a carpoule holder housing, in particular a cylindrical carpoule holder housing. The carpoule holder, in particular the carpoule holder housing, is designed in such a way that it can accommodate a carpoule. A needle connecting element can be provided at the distal end of the carpoule holder, which is provided for the detachable attachment of an injection needle. The carpoule holder can be attached to or in the housing by means of a form fit and/or a friction fit.

The proximal end of the carpoule holder can be designed in such a way that the carpoule holder can be fastened to or in the housing of the injection device via a form fit and/or a friction fit. Particularly preferably, a snap connection can be provided between the carpoule holder and the housing. Alternatively, the connection can be in the form of an adhesive connection or a welded connection be. The connection between the carpoule holder and the housing can be an axially fixed connection, in particular an axially fixed and non-rotatable connection between the carpoule holder and the housing. Alternatively, the connection between the carpoule holder and the housing can be detachable.

The carpoule holder is particularly preferably at least partially accommodated by the housing. Thus, the holding element accommodated or positioned in the housing can exert the force acting in the distal direction on the carpule during or after the insertion of the carpule holder accommodated with the carpule, in particular by impact contact between a proximal end of the carpule, in particular a proximal carpule edge and the holding element. in particular to hold the carpule on or in the carpule holder without play. The holding element is supported in the distal direction on the carpule, in particular on the proximal end of the carpule, particularly preferably on the proximal carpule edge. Particularly preferably, the holding element can comprise a support element, with the support element of the holding element being supported on the proximal end of the carpule, in particular on a proximal carpule edge. Furthermore, the holding element can preferably comprise a proximal positioning element in order to position the holding element in the proximal direction on or in the housing. The spring element of the holding element can be pretensioned, unloaded or precompressed for positioning in the housing. The support element and/or the proximal positioning element and/or the distal positioning element described below can be elastic.

The housing of the injection device can include a drive and/or a dosing device for administering a fluid product, in particular a medicament, which is accommodated in the carpule. For this purpose, the drive and/or the dosing device can move a stopper accommodated in the carpule in the distal direction in order to pour out the fluid product, in particular the medicament.

The drive and/or dosing device can be designed in such a way that a fixed dose of the fluid product or a dose of the fluid product to be set can be set and dispensed.

Furthermore, the invention relates to a method for mounting a carpoule on or in a carpoule holder.

In one step, a housing of an injection device is provided. The housing can include a drive and/or dosing device as described above for administering a fluid product, in particular a medicament, which is accommodated in a carpule.

Furthermore, an elastically designed holding element, as described above, is inserted in the proximal direction in the housing of the injection device for fastening the carpule to or in a carpule holder used or inserted. The cartridge holder is used to hold the cartridge. The holding element is inserted or inserted into the housing of the injection device, in particular until the holding element is positioned in the proximal and distal direction on or in the housing, in particular is positioned on or in the housing via a non-positive and/or positive connection. The holding element is preferably positioned on or in the housing in the distal direction and in the proximal direction, in particular positioned on or in the housing via a non-positive and/or positive connection. The connection can be designed as a friction connection and/or a stop connection. For this purpose, the holding element can have a distal and a proximal positioning element. The distal and the proximal positioning element can preferably be connected, in particular detachably connected, to the housing via a friction connection and/or a stop connection. The distal and/or the proximal positioning element can preferably be provided on a jacket inner surface or on a jacket outer surface of the holding element. Alternatively, the distal and/or the proximal positioning element can be provided at the distal and/or the proximal end of the holding element. The housing can have corresponding counter-positioning elements. The housing can particularly preferably have a stop surface or a friction surface for positioning the holding element. A stop surface of the housing can particularly preferably interact with the distal positioning element of the holding element and a stop surface and/or a friction surface of the housing can interact with the proximal positioning element in order to position the holding element on or in the housing and hold it captively. The housing used with the holding element can, for example, be transportable as an assembly unit. The assembly unit can be installed at a different location, for example at an assembly location with the carpoule holder that has received the carpoule.

In a further step, the carpule holder with the carpule is inserted or inserted in the proximal direction into the housing of the injection device until the carpule holder is fixed relative to the housing via a form fit and/or a friction fit on the housing, with a proximal end of the Carpule, in particular a proximal carpule edge, comes into abutting contact with the holding element and the holding element exerts a force acting in the distal direction on the carpule. For this purpose, the holding element can have a supporting element. The holding element is supported in the distal direction on or in the carpule, in particular via the supporting element. The support element is designed in such a way that the proximal end of the carpule, in particular the proximal carpule edge, can come into abutting contact with the support element in order to pretension the holding element in particular in the axial direction. The support element of the holding element is preferably arranged on an inner surface of the holding element. When inserting the carpoule holder, the non-positive and/or positive connection between the distal positioning element of the holding element and the housing is preferably released. Furthermore, the holding element, in particular the clamping element of the holding element, exerts a frictional force acting in the axial direction on the housing Attachment of the carpule on or in the Karpu lenhalter, wherein the frictional force acting in the axial direction acts against the force acting in the distal direction. Furthermore, the holding element is positioned on or in the housing in the proximal direction, in particular via the proximal positioning element on or in the housing, and is supported in the distal direction on the proximal end of the carpule, in particular on the proximal carpule edge.

Particularly preferably, the retaining element can be inserted or inserted into the housing in the proximal direction by means of a tool, in particular by means of a press die, with the tool, in particular the press die, moving the retaining element provided in the housing axially in the proximal direction until the retaining element is pushed in the proximal and in distal direction, in particular is positioned on or in the housing via a non-positive and/or positive connection. For this purpose, the tool, in particular the press ram and/or the holding element, can preferably comprise a driver element and/or a counter driver element. Alternatively or additionally, the support element of the holding element can form the counter-entrainment element of the holding element. The non-positive and/or positive connection between the holding element and the housing is preferably detachable. The holding element is preferably positioned in the distal direction and in the proximal direction on or in the housing. The holding element can enter into a non-positive and/or positive connection with the housing in the distal direction and in the proximal direction. The connection can particularly preferably be designed as a friction connection and/or a stop connection. The holding element is particularly preferably positioned on or in the housing in the proximal direction via a friction connection and in the distal direction via a stop connection and/or a friction connection.

After inserting or inserting the holding element into the housing, the holding element is held axially fixed relative to the housing by a friction fit and/or a positive fit in the distal and/or proximal direction.

Particularly preferably, the frictional force acting in the axial direction at least partially, preferably completely, compensates for the force acting in the distal direction. The frictional force acting in the axial direction can preferably act against the force acting in the distal direction in such a way that the resulting force is approximately zero. The frictional force acting in the axial direction is particularly preferably greater than the force acting in the distal direction.

The holding element can comprise a spring element or be designed as a spring element, with the spring element exerting the force acting in the distal direction. The holding element can be designed as a clamping element or as a clamping element, with the clamping element exerting the frictional force acting in the axial direction.

The invention is described below using several figures. Show it:

Figure 1: an exploded view of an inventive embodiment of a

Injection device for administering a fluid product.

Figure 2a: a longitudinal sectional view of part of the injection device according to Figure 1, wherein a

Holding element (9) is inserted in the proximal direction into a housing (6) of the injection device by means of a tool (13).

Figure 2b: a longitudinal sectional view of part of the injection device according to Figure 1, wherein the

The holding element (9) is inserted into the housing (6) of the injection device by means of the tool (13) and is positioned on or in the housing (6) at least in the proximal direction by a friction fit and/or a form fit.

Figure 3: A longitudinal sectional view of part of the injection device according to Figure 1, wherein the

The holding element (9) was inserted into the housing (6) of the injection device by means of a tool (13) and is positioned on or in the housing (6) by a friction fit and/or a form fit in the distal and proximal direction.

Figure 4a: A longitudinal sectional view of part of the injection device according to Figure 1, with a carpoule holder (8) received with a carpoule (10) being used or inserted in the proximal direction in the housing (6) of the injection device, with the holding element (9) in the distal and is positioned in the proximal direction on or in the housing (6).

FIG. 4b: a longitudinal sectional view of a part of the injection device according to FIG.

Figure 4c: a longitudinal sectional view of a part of the injection device according to Figure 1, wherein the

The carpule holder (8) is connected to the housing (6) via a snap connection and the holding element (9) exerts a force acting in the distal direction on the carpule (10) to hold the carpule (10) on or in the carpule holder (8) without play and the holding element (9) exerts a frictional force acting in the axial direction on the housing (6) for fastening the carpule (10) on or in the carpule holder (8). FIG. 1 shows an exploded view of an embodiment of an injection device according to the invention for administering a fluid product. The injection device comprises a carpoule holder (8) which can hold a carpoule (10), the carpoule holder (8) being able to be connected to a housing (6) in an axially fixed manner, in particular axially and radially in a fixed manner. This connection can be designed as a snap connection. For this purpose, the carpoule holder (8) can have a carpoule holder projection (8a) which can snap into a housing recess (6a) provided on the housing (6). The housing (6) can preferably have a housing guide groove (6b), which can be in engagement with a carpoule holder guide bar (8b) arranged on the carpoule holder (8) in order to move the carpoule holder (8) received with the carpoule (10) in the proximal direction in to insert the housing (6). A needle connecting element (8c) is provided at the distal end of the carpoule holder (8), which is provided for the detachable attachment of an injection needle (not visible). The injection device also includes a closure cap (12) which can be connected to the carpoule holder (8) via a detachable connection. For this purpose, the carpoule holder (8) has a carpoule holder cam (8d) which can snap into an annular groove (not shown) in the closure cap (12). The annular groove (not visible) of the closure cap (12) can preferably have a recess (not visible) so that the closure cap (12) can be arranged in a rotationally fixed manner relative to the carpoule holder (8). Furthermore, an elastically designed holding element (9) is provided. The holding element (9) is ring-shaped or sleeve-shaped. The holding element (9) comprises a spring element (9a). The holding element (9) can also be designed as a spring element (9a). Furthermore, the holding element (9) comprises a clamping element (9b). The holding element (9) can also be designed as a clamping element (9b). The holding element (9) comprises a distal (9c) and a proximal positioning element (9d). Furthermore, the holding element (9) comprises a support element (9e). The support element (9e) serves to support a carpule (10), in particular a proximal carpule edge (10a) of the carpule (10). Furthermore, the injection device comprises a guide sleeve (1). The guide sleeve (1) is non-rotatably connected to the housing (6) via a guide sleeve web (1c) provided on the guide sleeve (1) and a groove (not visible) attached to the housing (6) and via an inwardly projecting guide sleeve projection (1d) of the The guide sleeve (1) and a housing holding arm (6c; for example in FIG. 4a) attached to the housing (6) are axially firmly connected. Alternatively, the guide sleeve (1) and the housing (6) can be made in one piece. The guide sleeve (1) has an engagement element (1a) which can interact with teeth on a threaded rod (3). The injection device also comprises a rotary sleeve (2) which is connected to the guide sleeve (1) in an axially fixed and rotatable manner. For this purpose, the rotary sleeve (2) has a rotary sleeve ring web (2c), which can abut axially on the guide sleeve holding arm (1b), preferably on two guide sleeve holding arms (1b), on its proximal side, the rotary sleeve edge (2d) also making axial abutment contact with a guide sleeve end face (Not visible) of the guide sleeve (1) can form. The rotary sleeve (2) also includes an engagement element (2a) which can interact with the toothing of the threaded rod (3). The toothing of the threaded rod (3) includes a tooth (3a), preferably several teeth, particularly preferably four teeth. Furthermore, the threaded rod (3) has an external thread (3b) which forms a threaded connection with an internal thread (6i, for example in FIG. 4a) of the housing (6). Alternatively, the internal thread can be provided on the guide sleeve (1). The engagement mechanism of the engagement elements (2a, 1a) of the rotary sleeve (2) and the guide sleeve (1) in the teeth of the threaded rod (3) is designed as a ratchet mechanism. The engagement elements (2a, 1a) of the rotary sleeve (2) and the guide sleeve (1) interact with the toothing of the threaded rod (3) in such a way that a clicking noise is generated when a specified dose is added and when a specified dose is poured out. In order to prevent another dose from being set when the last dose has been dispensed, the rotary sleeve (2) has a rotary sleeve stop (not shown) which can come into abutment contact with a threaded rod stop (3c) provided on the threaded rod (3). The injection device also includes a dosing sleeve (4). The dosing sleeve (4) is mounted non-rotatably and axially movable relative to the housing (6) of the injection device via a dosing sleeve web (4a) with a housing groove (not visible). The user can move the dosing sleeve (4) axially in the proximal direction using a dosing knob (4c) arranged on the proximal end of the dosing sleeve (4) and axially in the distal direction using a dispensing knob (5) arranged on the proximal end. The dispensing button (5) is axially fixed, in particular axially fixed and non-rotatably connected to the dosing button (4c) via a dispensing button projection (5a). The dosing sleeve (4) preferably has a display (4d) to display the individual dosing movements. The display (4d) of the dosing sleeve (4) can be seen through a housing window (6d) provided on the housing (6), it being possible for the user to see the position of the injection device. The dosing sleeve (4) is connected to the rotating sleeve (2) via a threaded connection. The inside of the dosing sleeve (4) comprises a dosing sleeve thread (4b) which engages with the rotating sleeve thread (2b) on the outside of the rotating sleeve (2). The injection device also comprises a locking ring (11) which has a ratchet tooth (11a) at its distal end which is connected to the guide sleeve (1) via a locking arm (11b) of the locking ring (11). The ratchet tooth (11a) of the locking ring (11) can engage in a ratchet toothing (not visible) of the guide sleeve (1), the ratchet tooth (11a) of the locking ring (11) and the ratchet toothing (not visible) of the guide sleeve (1) being designed in this way are that the ratchet tooth (11a) can slide relative to the ratchet teeth (not visible) of the guide sleeve (1) in a first direction of rotation over the ratchet teeth (not visible) of the guide sleeve (1) and in a direction of rotation opposite to the first direction of rotation, namely in a second direction of rotation relative rotation between the locking ring (11) and the guide sleeve (1) can be prevented. The locking ring (11) cannot be displaced in the axial direction relative to the housing (6) or the guide sleeve (1). Furthermore, the locking ring (11) has a coupling toothing (11c) on its inner surface, which can engage with a counter-coupling toothing (2e) arranged on the outer surface of the engagement element (2a) of the rotary sleeve (1). At the proximal end of the locking ring (11) is arranged an abutment surface (11d) which can come into abutting contact with a distal side of the rotary sleeve ring ridge (2c).

FIG. 2a shows a longitudinal sectional view of part of the injection device according to FIG. 1, the holding element (9) being inserted or inserted in the proximal direction into the housing (6) of the injection device by means of a tool, in particular by means of a press die (13). The holding element (9) is held by the tool, in particular by the ram (13). The tool, in particular the ram (13), inserts the retaining element (9) axially into the housing (6) in the proximal direction. The tool, in particular the ram (13), has a driver element (13a) and the holding element (9) has a counter driver element (9f). The tool, in particular the ram (13), inserts the holding element (9) into the housing (6) until the holding element (9) is positioned at least in the proximal direction on or in the housing (6). The tool, in particular the press ram (13), can preferably position the holding element (9) on or in the housing (6) by striking a housing stop surface (6e) of the housing (6). Furthermore, the tool, in particular the press ram (13), inserts the holding element (9) into the housing (6) until the holding element (9) moves at least in the proximal direction on or in the housing (6) via a force- and/or or a positive connection is positioned on or in the housing (6). As shown in FIG. 2b, the proximal positioning element (9d) of the holding element (9) can form a non-positive connection with the housing cylinder (6f) of the housing (6). In this position, the holding element (9) is preferably radially and/or axially prestressed. The preferably radial prestressing of the holding element (9), in particular the distal positioning element (9c) of the holding element (9), can serve to position the holding element (9) in the distal direction on or in the housing (6). After the holding element (9) has been positioned at least in the proximal direction on or in the housing (6), the tool, in particular the pressing ram (13), can be pulled out of the holding element (9), in particular in the distal direction.

FIG. 3 shows a longitudinal sectional view of a part of the injection device according to FIG. or is positioned on or in the housing (6) in a form-fitting manner in the distal and in the proximal direction. The holding element (9) is positioned on or in the housing (6) by pressing the proximal positioning element (9d) on the housing cylinder (6f) of the housing (6) via a non-positive connection. Furthermore, the holding element (9) is due to the at least partial relaxation of the holding element (9), in particular the distal positioning element (9c) of the holding element (9) by abutting contact between the distal positioning element (9c) and the housing recess surface (6h) of the housing (6). positioned on or in the housing (6) via a positive connection in the distal direction. Particularly preferably, the housing recess area (6h) is a part of Form housing recess (6a). Alternatively, the holding element (9) can be positioned in the distal direction on or in the housing (6) via a non-positive connection, in particular a friction connection, between the distal positioning element (9c) and the housing (6), in particular an inner surface (6g) of the housing.

In a further step, a carpule holder (8) held by a carpule (10) is inserted or inserted in the proximal direction into the housing (6) of the injection device held by a holding element (9), as shown in FIG. 4a.

The proximal carpule edge (10a) of the carpule (10) comes into abutting contact with the support element (9e) of the holding element (9). Particularly preferably, the support element (9e) of the holding element (9) can serve as a counter-driving element (9f) of the holding element (9). When inserting the carpule holder (8) received with the carpule (10), the holding element (9), in particular the spring element (9a) of the holding element (9), is prestressed, in particular elastically prestressed. The carpoule holder (8) accommodated with the carpoule (10) is inserted or inserted into the housing (6) until the carpoule holder (8) is axially fixed to the housing (6) via a snap connection, in particular axially fixed and rotationally fixed connected to the housing (6) as shown in Figures 4b and 4c. The non-positive or positive connection between the distal positioning element (9c) of the holding element (9) and the housing (6) is released. The carpule (10) is held without play on or in the carpule holder (8) via the holding element (9), in particular via the spring element (9a) of the holding element (9) by means of the force acting in the distal direction. The holding element (9) is positioned on or in the housing (6) in the proximal direction and supported on or in the carpule in the distal direction. The holding element (9), in particular the clamping element (9b) of the holding element (9), exerts a frictional force acting in the axial direction on the housing (6) for fastening the carpule (10) on or in the carpule holder (8), the in axial direction acting frictional force of the holding element (9), in particular the clamping element (9b) of the holding element (9) acts against the distally acting force of the holding element (9), in particular the spring element (9a) of the holding element (9). The frictional force of the holding element (9), in particular the clamping element (9b) of the holding element (9), acting in the axial direction, serves to form a non-positive connection between the holding element (9) and the housing (6). The force acting in the distal direction is particularly preferably at least partially, preferably completely, compensated for by the frictional force acting in the axial direction.

In a further step, the patient can use the injection device according to the invention to administer a fluid product, with the dosing sleeve (4) being in an initial position. The dosing sleeve (4), which is axially movable and non-rotatably mounted in the housing (6), is pushed into the injection device, with the display (4d) attached to the dosing sleeve (4) being visible through the housing window (6d) and showing the user that the injection device is in the initial position. The dosing sleeve (4) is above the Metering sleeve thread (4b) in threaded engagement with the rotary sleeve thread (2b) of the rotary sleeve (2). A radially outwardly projecting projection (not visible) of the rotary sleeve (2) is in stop contact, in particular in rotational stop contact, with a first radially inwardly projecting projection (not visible) on the guide sleeve (1). A head (not visible) attached to the engagement element (2a) of the rotary sleeve (2) engages with the toothing of the threaded rod (3). To do this, the head (not visible) of the engagement element (2a) of the rotary sleeve (2) engages between two adjacent teeth (3a) in a tooth gap (not visible) on the threaded rod (3), namely between a steep flank (not visible) of a tooth ( 3a) and a flat flank (not visible) of an adjacent tooth (3a) of the threaded rod (3). Furthermore, a head (not visible) provided on the engagement element (1a) of the guide sleeve (1) is also in engagement with the toothing of the threaded rod (3). For this purpose, the head (not visible) of the engagement element (1a) of the guide sleeve (1) also engages between two adjacent teeth (3a) in a tooth gap (not visible) on the threaded rod (3). The head (not visible) of the engagement element (1a) of the guide sleeve is located between a steep flank (not visible) of a tooth (3a) and a flat flank (not visible) of an adjacent tooth (3a) of the threaded rod (3).

To set or draw a dose, the user pulls the dose knob (4c) proximally. The dosing sleeve (4) is pushed axially in the proximal direction. Due to the threaded engagement between the dosing sleeve (4) and the rotary sleeve (2), the rotary sleeve (2) rotates in the first direction of rotation until the projection (not visible) of the rotary sleeve (2) comes into abutting contact with a second radially inwardly projecting projection (not visible) of the guide sleeve (1) is in stop contact. The flat flank (not visible) of the head (not visible) of the engagement element (2a) of the rotary sleeve (2) slides over the flat flank (3a') of the tooth (3a) of the threaded rod (3) and reaches an adjacent tooth gap (not apparent). The steep flank (not visible) of the head (not visible) of the engagement element (1a) of the guide sleeve (1) is in abutting contact with the steep flank (not visible) of the tooth (3a) of the threaded rod (3), so that the threaded rod ( 3) is held against rotation. The indicator (4d) attached to the dosing sleeve (4) shows the user through the housing window (6d) that the injection device is in the drawn position.

When setting or when drawing a dose, the engagement element (2a) of the rotary sleeve (2) is deflected radially. The counter-coupling toothing (2e) of the rotating sleeve (2) engages with the coupling toothing (11c) of the locking ring (11). The coupling between the rotary sleeve (2) and the locking ring (11) turns the locking ring (11) and the rotary sleeve (2) in the first direction of rotation relative to the housing (6) or the guide sleeve (1). The ratchet tooth (11a) of the locking ring (11) slides over the ratchet teeth (not visible) of the guide sleeve (1). The ratchet tooth (11a) of the locking ring (11) can only slide in the first direction of rotation relative to the guide sleeve (1) via the ratchet teeth (1 g) of the guide sleeve (1), while a relative rotation in the second direction of rotation is prevented. The engagement element (2a) of the rotary sleeve (2) is deflected radially until the head (not visible) of the engagement element reaches the tooth gap (not visible) of the threaded rod (3), or until a specified dose has been fully set or wound up. It can thus be prevented that an incompletely set or drawn-up dose can be poured out.

The opening movement of the dosing sleeve (4) and the pouring movement of the threaded rod (3) are translated. The thread pitch of the threaded connection (4b, 2b) between the dosing sleeve (4) and the rotating sleeve (2) is greater than the thread pitch of the threaded connection (3b, 6i) between the threaded rod (3) and the housing (6).

In order to dispense a fixed dose, the user presses the dispensing button (5) in the distal direction, with the dosing sleeve (4) being axially displaced in the distal direction. The rotary sleeve (2) rotates in the opposite direction of rotation to the first direction of rotation, namely in the second direction of rotation, until the projection (not visible) of the rotary sleeve (2) makes abutting contact with the first radially inwardly projecting projection (not visible) on the guide sleeve (1). came into contact. The steep flank (not visible) of the head (not visible) of the engagement element (2a) of the rotary sleeve (2) is in abutting contact with the steep flank (not visible) of the tooth (3a) of the threaded rod (3) and transmits a torque to the threaded rod (3). The threaded rod (3) is thereby screwed in the distal direction due to the threaded connection between the internal thread (6i) of the housing (6) and the external thread (3b) of the threaded rod (3). The head (not visible) of the engagement element (2a) of the rotating sleeve (2) slides axially along the tooth gap (not visible) of the threaded rod (3). The coupling teeth (11c) of the locking ring (11) are disengaged from the counter-coupling teeth (2e) of the rotary sleeve (2), so that the rotary sleeve (2) can rotate in the second direction of rotation relative to the locking ring (11). The ratchet tooth (11c) of the locking ring (11) protrudes into the ratchet teeth (1g) of the guide sleeve (1). The flat flank of the head (not visible) of the guide sleeve (1) slides over the flat flank of the tooth (not visible) on the threaded rod. A stopper (10b, for example in FIG. 4a) accommodated in a carpule (10) is pushed in the distal direction via a flange (7) fixed axially to the threaded rod (3). The stopper (10b, for example in FIG. 4a) can press out the fluid product via an injection needle (not visible) attached to the carpoule holder.

After the last dose has been poured out of the injector, two rotating sleeve stops (not shown) of rotating sleeve (2) are in abutting contact with the corresponding two threaded rod stops (3c) of threaded rod (3). No further dose can thus be drawn up via the dosing sleeve (4), since rotation of the rotating sleeve (2) is blocked. References:

1 guide sleeve

1a engagement element

1b Guide sleeve support arm

1c guide sleeve bar

1d guide sleeve projection

2 rotation sleeve

2a engaging element

2b rotary sleeve thread

2c rotary sleeve ring land

2d rotary sleeve edge

2nd counter-coupling toothing

3 threaded rod

3a tooth

3b external thread

3c threaded rod stop

4 dosing sleeve

4a dosing sleeve bar

4b dosing sleeve thread

4c dose knob

4d display

5 dump button

5a dump button projection

6 housing

6a housing recess

6b housing guide groove

6c housing support arm

6d housing window

6e housing stop surface

6f housing cylinder

6g housing inner surface

6h housing recess area

7 flange

8 cartridge holders

8a Carpoule holder projection

8b cartridge holder guide

8c needle connector 8d cartridge holder cam holding element

9a spring element

9b clamping element

9c distal location element

9d proximal location element

9e support element

9f counter-entrainment element carpule

10a Proximal carpule edge

10b Plug locking ring

11a ratchet tooth

11b latch arm

11c clutch teeth

11d Stopping surface sealing cap tool, press die

13a carrier element

Claims

patent claims

1. Injection device for administering a fluid product, comprising: a carpule holder (8) for receiving a carpule (10) and for attachment to or in a housing (6) of the injection device, an elastically designed holding element (9) for attachment of the carpule (10) on or in the carpule holder (8), wherein the holding element (9) is positioned in the proximal direction on or in the housing (6) and is supported in the distal direction on or in the carpule (10), in particular via a corresponding force and /or positive connection is positioned and supported and is designed in such a way that the holding element (9) exerts a force acting in the distal direction on the carpule (10), characterized in that the holding element (9) is designed in such a way that the holding element ( 9) also exerts a frictional force acting in the axial direction on the housing (6) for fastening the carpoule (10) on or in the carpoule holder (8) and that they act in the axial direction de Frictional force acts against the force acting in the distal direction.

2. Injection device according to claim 1, characterized in that the frictional force acting in the axial direction at least partially, preferably completely, compensates for the force acting in the distal direction.

3. Injection device according to claim 1 or 2, characterized in that the holding element (9) is annular or sleeve-shaped.

4. Injection device according to one of the preceding claims, characterized in that the holding element (9) is provided inside the housing (6).

5. Injection device according to one of the preceding claims, characterized in that the holding element (9) comprises a spring element (9a) or is designed as a spring element (9a), the spring element (9a) exerting the force acting in the distal direction.

6. Injection device according to one of the preceding claims, characterized in that the holding element (9) comprises a clamping element (9b) or is designed as a clamping element (9b), the clamping element (9b) exerting the frictional force acting in the axial direction.

7. Injection device according to one of the preceding claims, characterized in that the holding element (9) is designed such that the holding element (9) the force acting in the distal direction on the carpule (10) to hold the carpule (10) without play on or in the carpoule holder (8) and/or the holding element (9) exerts the frictional force acting in the axial direction on the housing (6) to form a non-positive connection between the holding element (9) and the housing (6).

8. Injection device according to one of the preceding claims, characterized in that the carpoule holder (8) is fastened to or in the housing (6) via a form fit and/or a friction fit.

9. Injection device according to one of the preceding claims, characterized in that the carpoule holder (8) is at least partially accommodated by the housing (6).

10. Method for mounting a cartridge (10) on or in a cartridge holder (8) with the following steps:

providing a housing (6) of an injection device,

Insertion of an elastically designed retaining element (9) in the proximal direction into the housing (6) of the injection device for fastening a carpule (10) on or in a carpule holder (8), in particular up to the retaining element (9) in the proximal and distal direction on or is positioned in the housing (6), in particular is positioned on or in the housing (6) via a non-positive and/or positive connection,

Insertion of the carpoule holder (8) received with the carpoule (10) in the proximal direction into the housing (6) of the injection device until the carpoule holder (8) relative to the housing (6) via a form fit and/or a friction fit on or in the housing (6), wherein a proximal end of the carpule (10) comes into abutting contact with the holding element and the holding element exerts a force acting in the distal direction on the carpule (10), characterized in that the holding element (9) also has an in frictional force acting in the axial direction on the housing (6) for fastening the carpoule (10) on or in the carpoule holder (8), the frictional force acting in the axial direction acting against the force acting in the distal direction.

11. The method according to claim 10, characterized in that the holding element (9) is inserted in the proximal direction into the housing (6) by means of a tool, in particular by means of a press ram (13), the tool, in particular the press ram (13) the holding element (9) provided in the housing (6) is moved axially in the proximal direction until the holding element (9) enters into a non-positive and/or positive connection with the housing (6).

12. The method according to claim 10 or 11, characterized in that after the insertion of the holding element (9) into the housing (6), the holding element (9) by a friction fit and / or a positive fit in the distal and / or proximal direction is held relative to the housing (6).

13. The method as claimed in one of the preceding claims, characterized in that the frictional force acting in the axial direction at least partially, preferably completely, compensates for the force acting in the distal direction.

14. The method according to any one of the preceding claims, characterized in that the holding element (9) comprises a spring element (9a) or is designed as a spring element (9a), the spring element (9a) exerting the force acting in the distal direction.

15. The method according to any one of the preceding claims, characterized in that the holding element (9) comprises a clamping element (9b) or is designed as a clamping element (9b), the clamping element (9b) exerting the frictional force acting in the axial direction.